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protocolSection identificationModule nctId: NCT06369259, orgStudyIdInfo id: 2023-0997, secondaryIdInfos id: NCI-2024-03302, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer., conditionsModule conditions: Advanced Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Defactinib, interventions name: Cetuximab, interventions name: Avutometinib, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77807, country: United States, contacts name: Christine Parseghian, MD, role: CONTACT, contacts name: Christine Parseghian, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06369246, orgStudyIdInfo id: 2023-0893, secondaryIdInfos id: NCI-2024-03308, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer., conditionsModule conditions: Advanced Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic Body Radiation Therapy, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Comron Hassanzadeh, MD, role: CONTACT, phone: 713-657-9802, email: [email protected], contacts name: Comron Hassanzadeh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06369233, orgStudyIdInfo id: LNC-MS-002, briefTitle: Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: L&C Bio, class: INDUSTRY, collaborators name: PROMeDis, descriptionModule briefSummary: This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied., conditionsModule conditions: Herniation, Disc, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: MegaShield®-SP, interventions name: Guardix-SP Plus, outcomesModule primaryOutcomes measure: MRI scar score, secondaryOutcomes measure: Oswestry Disability Index(ODI) score, secondaryOutcomes measure: Visual Analog Scale(VAS) Back & Leg Pain Score, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eunpyeong ST. Mary's Hospital, status: RECRUITING, city: Seoul, zip: 03312, country: Korea, Republic of, contacts name: HyungYul Park, role: CONTACT, phone: 02-2030-4536, email: [email protected], contacts name: HyungYul Kim, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: Severance Hospital, status: RECRUITING, city: Seoul, zip: 03722, country: Korea, Republic of, contacts name: Siyoung Park, role: CONTACT, phone: 2228-2194, email: [email protected], contacts name: Siyoung Park, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: Gangnam Severance Hospital, status: RECRUITING, city: Seoul, zip: 06273, country: Korea, Republic of, contacts name: Jiwon Kwon, role: CONTACT, phone: 2019-3411, email: [email protected], contacts name: Jiwon Kwon, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: Bundang Seoul National University Hospital, status: RECRUITING, city: Seoul, zip: 13620, country: Korea, Republic of, contacts name: Hojung Kim, role: CONTACT, phone: 031-787-7202, email: [email protected], contacts name: Hojung Kim, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06369220, orgStudyIdInfo id: LIA-STI-542, briefTitle: A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Hoffmann-La Roche, class: INDUSTRY, collaborators name: Roche Molecular Systems, Inc, descriptionModule briefSummary: This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG)., conditionsModule conditions: Chlamydia Trachomatis Infection, conditions: Neisseria Gonorrhoeae Infection, conditions: Mycoplasma Genitalium Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 348, type: ESTIMATED, armsInterventionsModule interventions name: cobas® liat CT/NG/MG nucleic acid test, interventions name: Standard of Care (SOC): Clinician's Standard Practice, outcomesModule primaryOutcomes measure: Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG), secondaryOutcomes measure: Percentage of Participants Given Inappropriate Treatment for CT Infection, secondaryOutcomes measure: Percentage of Participants Given Inappropriate Treatment for NG Infection, secondaryOutcomes measure: Percentage of Participants Given Inappropriate Treatment for MG Infection, secondaryOutcomes measure: Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire, secondaryOutcomes measure: Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369207, orgStudyIdInfo id: 113454, briefTitle: Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Evaluation of Reflux Transmission Pathways in Chronic Venous Insufficiency Patients Secondary to Saphenofemoral Reflux, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-12, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Golestan University of Medical sciences, class: OTHER, descriptionModule briefSummary: Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Although the pathway of reflux transmission is not the same in all patients, the removal or ablation of the greater saphenous vein (GSV) is considered a standard treatment in these patients. However, in patients whose reflux is transmitted to branches other than GSV, this treatment leads to the unnecessary destruction of a competent segment of GSV in addition to remaining at least some segments of incompetent veins. So, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency. This cross-sectional study will be conducted with a descriptive-analytical approach. ., conditionsModule conditions: Venous Insufficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ACTUAL, outcomesModule primaryOutcomes measure: Determination of reflux transmission pathways in CVI patients with SFJ incompetency, secondaryOutcomes measure: Anatomic variations of GSV in CVI patients with SFJ incompetency, secondaryOutcomes measure: Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency, secondaryOutcomes measure: Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pezhman Kharazm, MD, city: Gorgan, state: Golestan, zip: 4917956808, country: Iran, Islamic Republic of, geoPoint lat: 36.8427, lon: 54.44391, hasResults: False |
protocolSection identificationModule nctId: NCT06369194, orgStudyIdInfo id: POWER5, briefTitle: POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-14, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Grupo Español de Rehabilitación Multimodal, class: OTHER, descriptionModule briefSummary: The main objective of this study is to analyze the impact on five years survival of an enhanced recovery program (PRI) after radical surgery for colorectal cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT).It is proposed to review the medical records of oncology patients included in POWER 1 (as already foreseen in that study), with the aim of performing a 5-year follow-up.To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p \<0.05 (two tails)., conditionsModule conditions: Colorectal Surgery, conditions: Critical Pathways, conditions: Enhanced Recovery After Surgery, conditions: Retrospective Studies, conditions: Chemotherapy, Adjuvant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 847, type: ACTUAL, armsInterventionsModule interventions name: Colorectal Surgery, outcomesModule primaryOutcomes measure: Overall Survival, primaryOutcomes measure: Disease-free survival, primaryOutcomes measure: Time to disease recurrence, primaryOutcomes measure: Time to return to intended oncologic treatment (RIOT), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Virgen de los Lirios de Alcoy, city: Alcoy, state: Alicante, country: Spain, geoPoint lat: 38.70545, lon: -0.47432, locations facility: Hospital General Universitario de Elche, city: Elche, state: Alicante, country: Spain, geoPoint lat: 38.26218, lon: -0.70107, locations facility: Hospital Universitario Central de Asturias, city: Oviedo, state: Asturias, country: Spain, geoPoint lat: 43.36029, lon: -5.84476, locations facility: Hospital de Igualada, city: Igualada, state: Barcelona, country: Spain, geoPoint lat: 41.58098, lon: 1.6172, locations facility: Hospital de Sant Joan Despí Moisès Broggi, city: Sant Joan d'Espi, state: Barcelona, country: Spain, geoPoint lat: 41.36718, lon: 2.0574, locations facility: Fundación Hospital del Espíritu Santo, city: Santa Coloma De Gramenet, state: Barcelona, country: Spain, geoPoint lat: 41.45152, lon: 2.2081, locations facility: Hospital Universitari Mútua Terrassa, city: Terrassa, state: Barcelona, country: Spain, geoPoint lat: 41.56667, lon: 2.01667, locations facility: Hospital Universitario de Vic, city: Vic, state: Barcelona, country: Spain, geoPoint lat: 41.93012, lon: 2.25486, locations facility: Hospital General Universitario de Castellón, city: Castellon de la Plana, state: Castellón, country: Spain, geoPoint lat: 39.98567, lon: -0.04935, locations facility: Hospital Universitario Puerta de Hierro, city: Majadahonda, state: Madrid, country: Spain, geoPoint lat: 40.47353, lon: -3.87182, locations facility: Hospital Universitario de Móstoles, city: Mostoles, state: Madrid, country: Spain, geoPoint lat: 40.32234, lon: -3.86496, locations facility: Hospital Universitario Rafael Méndez, city: Lorca, state: Murcia, country: Spain, geoPoint lat: 37.67119, lon: -1.7017, locations facility: Hospital Costa del Sol, city: Marbella, state: Málaga, country: Spain, geoPoint lat: 36.51543, lon: -4.88583, locations facility: Hospital Nuestra Señora del Prado, city: Talavera de la Reina, state: Toledo, country: Spain, geoPoint lat: 39.96348, lon: -4.83076, locations facility: Hospital Universitario Araba, city: Alava, country: Spain, geoPoint lat: 43.36057, lon: -6.19946, locations facility: Hospital General Universitario de Alicante, city: Alicante, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, locations facility: Hospital Clínic Universitat de Barcelona, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital del Mar, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario Santa Creu i Sant Pau, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario Vall d´Hebrón, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital General Universitario de Ciudad Real, city: Ciudad Real, country: Spain, geoPoint lat: 38.98626, lon: -3.92907, locations facility: Hospital de Galdakao-Usansolo, city: Galdakao, country: Spain, geoPoint lat: 43.23333, lon: -2.83333, locations facility: Hospital Universitario Insular de Gran Canaria, city: Las Palmas de Gran Canaria, country: Spain, geoPoint lat: 28.09973, lon: -15.41343, locations facility: Hospital Universitario de Gran Canaria Doctor Negrín, city: Las Palmas, country: Spain, geoPoint lat: 28.58232, lon: -16.16555, locations facility: Hospital de La Princesa, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario 12 de Octubre, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Infanta Leonor, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Ramón y Cajal, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario San Carlos, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Complejo Hospitalario de Salamanca, city: Salamanca, country: Spain, geoPoint lat: 40.96882, lon: -5.66388, locations facility: Hospital Universitario Donostia, city: San Sebastián, country: Spain, geoPoint lat: 43.31283, lon: -1.97499, locations facility: Hospital Universitario Virgen Macarena, city: Sevilla, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Consorcio Hospital General Unidersitario de Valencia, city: Valencia, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Hospital Clínico Universitario de Valencia, city: Valencia, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Hospital Clínico de Valladolid, city: Valladolid, country: Spain, geoPoint lat: 41.65518, lon: -4.72372, locations facility: Hospital Universitario Miguel Server, city: Zaragoza, country: Spain, geoPoint lat: 41.65606, lon: -0.87734, hasResults: False |
protocolSection identificationModule nctId: NCT06369181, orgStudyIdInfo id: NET 2020, briefTitle: Neuroendocrine Transformation in RB1/TP53 Inactivated NSCLC, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: Histology transformation from non-small cell lung cancer (NSCLC) to neuroendocrine carcinomas (NEC), especially from epidermal growth factor receptor (EGFR) mutant lung adenocarcinoma (LADC) to small cell lung cancer (SCLC), is widely recognized as a rare mechanism for NSCLC to confer tyrosine kinase inhibitors (TKIs) resistance. The probability of its occurrence is about 3-14% in NSCLC patients who are resistant to TKI treatment. In addition to EGFR mutations, NSCLC patients carrying ALK/ROS1 mutations and receiving corresponding TKI treatment may also experience NEC transformation(NET).In a previous study \[Pubmed ID: 35609408\], the investigators demonstrated that NET also develops in NSCLCs without TKI targets or treatments. This phenomenon could be under-recognized, because re-biopsy was less frequently performed in these patients. The investigators had also shown that p53/Rb inactivation might correlated with NET and should be considered for NET risk prediction. In another retrospective studies, it was found that NSCLC patients with RB1/TP53 dual inactivation mutations had a significantly higher probability of NEC pathological transformation than those without RB1/TP53 inactivation mutations (43 times higher than those without mutations). Therefore, the subgroup of NSCLC patients with tumor suppressor gene RB1/TP53 dual inactivation might have elevated risk for NET.In this study, the investigators proposed to prospectively follow up NSCLC patients with dual RB1/TP53 inactivation (approximately 5% of the total NSCLC). Through prospective and systematic collection of baseline pathological information, clinical treatment process, and imaging data, and as much as possible, repeat pathological biopsies will be performed during disease progression., conditionsModule conditions: Neuroendocrine Carcinoma, conditions: Non-small Cell Lung Cancer, conditions: Histology Transformation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: neuroendocrine transformation rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Zhengfei Zhu, MD, role: CONTACT, phone: +86 18017312901, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06369168, orgStudyIdInfo id: Kliniken Essen-Mitte, briefTitle: Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy, acronym: OhrHit, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2024-11-20, completionDateStruct date: 2025-11-20, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Kliniken Essen-Mitte, class: OTHER, collaborators name: Karl and Veronica Carstens Foundation, descriptionModule briefSummary: With this clinical trial we investigate whether auricular acupuncture during adjuvant endocrine therapy has an improving effect on hot flashes, which are often perceived as psychologically and physically stressful in self-assessment of women with breast cancer.Empirical studies indicate that body acupuncture has positive effects on hot flashes. As auricular acupuncture offers a number of advantages over body acupuncture, a three-armed randomised controlled research design is being used to investigate whether hot flashes caused by endocrine therapy are also reduced by ear acupuncture. Balanced ear acupuncture will be compared with NADA ear acupuncture in terms of efficacy and effectiveness. In addition, the effects of the two forms of therapy on the patients' individual quality of life, fatigue, stress perception and sleep quality will be analysed., conditionsModule conditions: Hot Flashes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 99, type: ESTIMATED, armsInterventionsModule interventions name: auricular acupuncture, outcomesModule primaryOutcomes measure: subscale somato-vegetative symptoms of the Menopause Rating Scale (MRS), secondaryOutcomes measure: Menopause Rating Scale (MRS) total score, secondaryOutcomes measure: Psychological symptoms and urogenital symptoms subscales of the MRS, secondaryOutcomes measure: functional assessment of cancer therapy - breast (FACT-B), secondaryOutcomes measure: perceived stress questionnaire (PSQ), secondaryOutcomes measure: insomnia severity index (ISI), secondaryOutcomes measure: big five inventory (BFI), secondaryOutcomes measure: Expected effect of the respective intervention on a 100mm visual analogue scale, secondaryOutcomes measure: intensity and degree of impairment due to hot flashes on a 100mm visual analogue scale, secondaryOutcomes measure: adverse events (AEs), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06369155, orgStudyIdInfo id: 24-061, briefTitle: Azenosertib in Uterine Serous Carcinoma: Biomarker Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Joyce Liu, MD, class: OTHER, collaborators name: National Cancer Institute (NCI), collaborators name: Zentalis, descriptionModule briefSummary: This research study is being done to investigate how Azenosertib affects tumor cells of persistent or recurrent uterine serous carcinoma.The name of the study drug involved in this study is:-Azenosertib (a type of Wee1 inhibitor), conditionsModule conditions: Uterine Serous Carcinoma, conditions: Uterine Carcinoma, conditions: Uterine Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Azenosertib, outcomesModule primaryOutcomes measure: Percentage Change in Replication Fork Speed in Overall Response, primaryOutcomes measure: Percentage Change in Replication Fork Speed in 6 Month Progression Free Survival (PFS6), secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: 6-month Progression-Free Survival (PFS6), secondaryOutcomes measure: Clinical Benefit Rate (CBR), secondaryOutcomes measure: Median Duration of Overall Response (DOR), secondaryOutcomes measure: Median Progression-Free Survival (PFS), secondaryOutcomes measure: Grade 3-5 Treatment-related Toxicity Rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Joyce Liu, MD, MPH, role: CONTACT, phone: 617-632-5269, email: [email protected], contacts name: Joyce Liu, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Joyce Liu, MD, MPH, role: CONTACT, phone: 617-632-5269, email: [email protected], contacts name: Joyce Liu, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06369142, orgStudyIdInfo id: GE IDE No. L00123, briefTitle: Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy, acronym: ISAR-WAVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Deutsches Herzzentrum Muenchen, class: OTHER, collaborators name: Gemeinsamer Bundesaussschuss, collaborators name: EvidentIQ Germany GmbH, collaborators name: Monitoring Services GmbH, collaborators name: Institute of AI and Informatics in Medicine Technical University of Munich, descriptionModule briefSummary: The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The study participant as well as the follow-up physicians and site personal are blinded., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 666, type: ESTIMATED, armsInterventionsModule interventions name: Intravascular lithotripsy (IVL), interventions name: Standard non-IVL methods, outcomesModule primaryOutcomes measure: Combined endpoint of major cardiac and cerebrovascular events, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Cardiac mortality, secondaryOutcomes measure: Non-fatal myocardial infarction, secondaryOutcomes measure: Non-fatal stroke, secondaryOutcomes measure: Clinically indicated target vessel revascularization, secondaryOutcomes measure: Definite stent thrombosis, secondaryOutcomes measure: Clinically indicated non-target vessel revascularization, secondaryOutcomes measure: Hospitalization due to acute coronary syndrome, secondaryOutcomes measure: Symptoms of coronary heart disease (CHD): physical health status, secondaryOutcomes measure: Symptoms of CHD: mental health status, secondaryOutcomes measure: Bleeding during index hospitalization or ≤30 days (BARC 3-5), secondaryOutcomes measure: Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure), secondaryOutcomes measure: Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Deutsches Herzzentrum München, city: Munich, state: Bavaria, zip: 80636, country: Germany, contacts name: Salvatore Cassese, MD, PHD, role: CONTACT, phone: 0049891218, phoneExt: 2764, email: [email protected], contacts name: Salvatore Cassese, MD, PDH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False |
protocolSection identificationModule nctId: NCT06369129, orgStudyIdInfo id: CEBD-CU-2024-06-16, briefTitle: Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures ., conditionsModule conditions: Blow-Out Fractures, conditions: Orbital Fractures, conditions: Orbital Floor Fracture, conditions: Orbital Trauma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized clinical trial.* Parallel group study.* A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University .* Equal randomization : participants with equal probabilities for intervention.* Positive controlled : Both groups receiving treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Orbital floor reconstruction with Patient Specific Zirconia Implant, interventions name: Orbital floor reconstruction with Patient Specific Titanium Implant, outcomesModule primaryOutcomes measure: Orbital Volume, secondaryOutcomes measure: Accuracy of the patient specific implant in the orbital floor reconstruction, secondaryOutcomes measure: Cost effectiveness, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University, status: RECRUITING, city: Cairo, zip: 11511, country: Egypt, contacts name: OLA A. ELMORSY, PHD, role: CONTACT, phone: 00201141234877, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06369116, orgStudyIdInfo id: CLS-017B, secondaryIdInfos id: HSTAR012, type: OTHER, domain: HSTAR Programme, secondaryIdInfos id: WRHI071, type: OTHER, domain: Ezintsha, briefTitle: Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-12, primaryCompletionDateStruct date: 2023-11-17, completionDateStruct date: 2024-04-22, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: bioLytical Laboratories, class: INDUSTRY, descriptionModule briefSummary: This is a controlled study intended to evaluate the usability, label comprehension and performance of the INSTI® HCV Self Test in the hands of untrained lay users using fingerstick blood, with instructions for use specifically designed for a lay person who has not used any hepatitis C rapid self test prior to the study and to assess "lay" users ability to comprehend key concepts and information provided on the outside of the pouch and in the accompanying Instructions for Use. Comprehension will be assessed without product familiarization (demonstration/training) by a healthcare professional., conditionsModule conditions: Hepatitis C, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants are recruited and enrolled to conduct INSTI HCV Self Test and then participate in the usability portion of the study., primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 1400, type: ESTIMATED, armsInterventionsModule interventions name: INSTI HCV Self Test, outcomesModule primaryOutcomes measure: Clinical sensitivity and specificity of INSTI HCV Self Test, secondaryOutcomes measure: To assess the usability and label comprehension of the INSTI HCV Self Test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ezintsha, a division of Wits Health Consortium (Pty) Ltd, status: RECRUITING, city: Parktown, zip: 2193, country: South Africa, contacts name: Vanessa Tiyamike Msolomba, role: CONTACT, phone: +27 74 830 9063, email: [email protected], geoPoint lat: -26.18205, lon: 28.02671, hasResults: False |
protocolSection identificationModule nctId: NCT06369103, orgStudyIdInfo id: FMBSUREC/03032024/Fakhry, briefTitle: The Sedative Effects of Dexmedetomidine VS Propofol During Peribulbar Anesthesia in Patients Undergoing Vitrectomy Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Beni-Suef University, class: OTHER, descriptionModule briefSummary: The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic, respiratory parameters, recovery profile, analgesic effects, post-operative cognitive function, patients satisfaction and adverse events., conditionsModule conditions: Patient, conditions: Satisfaction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine, interventions name: Propofol, outcomesModule primaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Visual analogue scale, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beni Suef University Hospital, status: RECRUITING, city: Banī Suwayf, state: Beni Suef, zip: 62814, country: Egypt, contacts name: Dina M Fakhry, MD, role: CONTACT, phone: 0201289998680, email: [email protected], contacts name: Dina M Fakhry, MD, role: CONTACT, phone: +201289998680, email: [email protected], geoPoint lat: 29.07441, lon: 31.09785, hasResults: False |
protocolSection identificationModule nctId: NCT06369090, orgStudyIdInfo id: JP/1/2013, briefTitle: Effect of Breast Size on the Electrical Impedance Tomography Measurement, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-11-01, primaryCompletionDateStruct date: 2014-05-31, completionDateStruct date: 2014-05-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Czech Technical University in Prague, class: OTHER, descriptionModule briefSummary: Twenty-two healthy female volunteers were monitored using electrical impedance tomogprahy (EIT) in two different situations. First, with electrode belt placed over the breast tissue and second, with the electrode belt under the breast tissue. The EIT measurement was performed with adjunct spirometric measurement. The changes of regional ventilation related to the breast tissue and the size of breast tissue were evaluated., conditionsModule conditions: Effect of Breast Tissue on EIT Lung Monitoring, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Monitoring of 22 subjects, each subject was measured twice with electrode belt in two different positions., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Electrical impedance tomography (EIT), outcomesModule primaryOutcomes measure: Regional ventilation changes possibly caused by the breast tissue, secondaryOutcomes measure: Female subjects enrollment in EIT studies and clinical applications, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Biomedical Engineering, Czech Technical University in Prague, city: Kladno, zip: 27201, country: Czechia, geoPoint lat: 50.14734, lon: 14.10285, hasResults: False |
protocolSection identificationModule nctId: NCT06369077, orgStudyIdInfo id: CTGlaucoma1, briefTitle: How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure?, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: CT Glaucoma Associates, class: OTHER, descriptionModule briefSummary: IOP effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose. Further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost. Dry eye effects of the different treatments will be assessed., conditionsModule conditions: Glaucoma, Open-Angle, conditions: Glaucoma; Drugs, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Subjects will have baseline IOP measurements (7-9 am and 3-5 pm) after using using latanoprost every other day and dorzolamide-timolol every morning. They will then randomly be assigned in phase 2 to either: double the frequency to latanoprost daily and dorzolamide-timolol twice daily; or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost. IOP measurements will be repeated 3 weeks after using the phase 2 medications. For phase 3, subjects will use the treatment to which they were not assigned in phase 2, and IOP measurements will again be repeated 3 weeks later.At each study visit, dry eye signs will be assessed and brief dry eye survey will be administered., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Technician measuring IOP and assessing dry eye is masked regarding phase 2 and phase 3 crossover assignment order., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: dorzolamide/timolol, outcomesModule primaryOutcomes measure: intraocular pressure, secondaryOutcomes measure: dry eye, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CT Glaucoma Associates, status: RECRUITING, city: Norwalk, state: Connecticut, zip: 06851, country: United States, contacts name: Peter E Libre, MD, role: CONTACT, phone: 203-853-2020, email: [email protected], contacts name: Faria Mahjabin, BA, role: CONTACT, email: [email protected], geoPoint lat: 41.1176, lon: -73.4079, hasResults: False |
protocolSection identificationModule nctId: NCT06369064, orgStudyIdInfo id: 2023A02707-38, briefTitle: Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient, acronym: CompEER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2026-08-15, completionDateStruct date: 2026-08-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD).To our knowledge, there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis (and the same filter).In the CompEER study, we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury.The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance, facilitating antibiotic management during RRT., conditionsModule conditions: Acute Kidney Injury, conditions: Continuous Renal Replacement Therapy, conditions: Intensive Care Unit, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: CVVHD Dialysis parameters, interventions name: CVVHDF Dialysis parameters, outcomesModule primaryOutcomes measure: urea reduction rate (URR), secondaryOutcomes measure: Creatinine clearance at H24, secondaryOutcomes measure: Urea clearance at H24, secondaryOutcomes measure: Urea clearance at H48, secondaryOutcomes measure: ICU Mortality, secondaryOutcomes measure: Mortality at Day 28, secondaryOutcomes measure: Organ failure-free days at Day 28, secondaryOutcomes measure: Hypokalemia at Day 28, secondaryOutcomes measure: Hypophosphatemia at Day 28, secondaryOutcomes measure: Hypomagnesemia at Day 28, secondaryOutcomes measure: Hyperkalemia at Day 28, secondaryOutcomes measure: Medical Cost, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Nimes, city: Nîmes, zip: 30029, country: France, contacts name: Claire Roger, MD, PhD, role: CONTACT, email: [email protected], contacts name: Claire Roger, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Aurèle Buzancais, MD, role: SUB_INVESTIGATOR, contacts name: Sylvain Garnier, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.83333, lon: 4.35, hasResults: False |
protocolSection identificationModule nctId: NCT06369051, orgStudyIdInfo id: YSEmploy, briefTitle: Supporting Self-employment in Young Adults With Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: This project will investigate the effects of an 8-week theory-driven online/hybrid Self-employment Skill Building Intervention on the rate of self-employment, self-efficacy, life satisfaction, and psychosocial outcomes among working-age stroke survivors., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Self-employment support intervention, outcomesModule primaryOutcomes measure: Self-employment rate, secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Life satisfaction, secondaryOutcomes measure: Emotional well-being, secondaryOutcomes measure: Community reintegration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Non-government organisations, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Suzanne Lo, role: CONTACT, phone: 85239434485, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06369038, orgStudyIdInfo id: CUP3222024, briefTitle: Children's Drawing as a Projective Tool to Assess Dental Anxiety, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim in this study is to compare the results of anxiety measurement of the child using the CD:H scale with the long-used Face,Legs,Activity,Cry and Consolability scale (FLACC scale) and pulse oximeter reading, to see if the drawing alone can be a reliable tool to predict the child's behaviour before the dental procedure., conditionsModule conditions: Dental Anxiety, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: observation of level of dental anxiety in children, outcomesModule primaryOutcomes measure: FLAAC behavioral scale, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06369025, orgStudyIdInfo id: PreVio, briefTitle: Preventing Physical and Emotional Violence by Parents and Teachers in Public Schools in Tanzania (ICC-T/ICC-P_Tanz), acronym: PreVio, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Bielefeld University, class: OTHER, collaborators name: Technical University of Munich, collaborators name: Dar es Salaam University College of Edcuation, collaborators name: Muhimbili University of Health and Allied Sciences, descriptionModule briefSummary: More than 1.7 billion children worldwide experience violence in their upbringing. Prevalence rates are particularly high in Africa. Toxic stress associated with violence impacts the developing brain. This affects behavioral, social, and emotional functioning of children. The present project will test an intervention that simultaneously aims at reducing violence against children at home and at school. Within the project, (1) the feasibility, acceptability, and cost-effectiveness of the Intervention and (2) the initial effectiveness of reducing parental and teacher violence will be tested. To this end, a mixed-methods two-arm school-based pilot cluster-randomized controlled trial (CRCT) in Tanzania will be conducted.One unique and novel aspect of this project is to test a school-based intervention approach that targets both teachers and parents. A school-based approach including both teachers and parents has the following key advantages: (1) parents of different social, economic, and educational backgrounds can be motivated to participate and (2) using the existing infrastructure of schools reduces costs and will later improve the scalability of the program. The project is bringing together the global health, development economy, and psychological perspectives to promote our collaboration within the German global health community and with research and policy partners in Tanzania., conditionsModule conditions: Violence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1840, type: ESTIMATED, armsInterventionsModule interventions name: Interaction Competencies with Children, outcomesModule primaryOutcomes measure: Reduction of children's exposure to emotional and physical violence by parents and teachers, primaryOutcomes measure: Reduction of parents' or teachers' use of emotional and physical violence, secondaryOutcomes measure: Change of parents' and teachers' attitudes towards emotional and physical violence, secondaryOutcomes measure: Improvement of children's mental health, secondaryOutcomes measure: Increase of children's quality of life, secondaryOutcomes measure: Improvement of school climate, otherOutcomes measure: Reduction of children's perceived stress, otherOutcomes measure: Reduction of parents' and teachers' perceived stress, otherOutcomes measure: Improvement of teachers' decision making, otherOutcomes measure: Improvement of teachers' self-efficacy, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Daressalaam University College of Education, status: RECRUITING, city: Daressalam, country: Tanzania, contacts name: Mabula Nkuba, Dr., role: CONTACT, contacts name: Eliud Kabelege, role: CONTACT, geoPoint lat: -6.82349, lon: 39.26951, hasResults: False |
protocolSection identificationModule nctId: NCT06369012, orgStudyIdInfo id: Rania Gamal, briefTitle: Management of Abnormal Uterine Bleeding, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Egymedicalpedia, class: INDUSTRY, descriptionModule briefSummary: Abnormal uterine bleeding "AUB" describes all abnormal forms of menstrual bleeding which may result from several causes including anovulation, problems related to pregnancy, infections, vaginal and cervical abnormalities, uterine pathologies including benign and malignant tumors, coagulopathies, endocrine disorders, trauma, foreign bodies, systemic diseases and iatrogenic causes. AUB may be clinically presented by menorrhagia, metrorrhagia or menometrorrhagia. It's the most common complaint for the reproductive age females and accounts for 33% of female patients referred to gynecologists, conditionsModule conditions: Abnormal Uterine Bleeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Mefenamic acid 500 mg, outcomesModule primaryOutcomes measure: Bleeding Control, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ain Shams University Hospitals, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Rania Gamal Anwar, M.D, role: CONTACT, phone: +201283262383, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06368999, orgStudyIdInfo id: EEGCOV, briefTitle: Neurophysiological and Neuropsychological Evalution in Healthcare Workers, acronym: EEGCOV, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-05-27, primaryCompletionDateStruct date: 2020-12-21, completionDateStruct date: 2021-01-09, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to compare in participant population the effect of stress condition on cerebral EEG activity Participants will do an 8 minutes EEG registration. Researchers will compare EEG activity of heathcare workers., conditionsModule conditions: Stress Disorders, Post-Traumatic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: study of brain EEG activity, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: EEG, outcomesModule primaryOutcomes measure: EEG activity, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, city: Milan, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06368986, orgStudyIdInfo id: 222420, briefTitle: A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-06-12, completionDateStruct date: 2024-06-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: ViiV Healthcare, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: VH4011499, outcomesModule primaryOutcomes measure: Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499, primaryOutcomes measure: Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4011499, primaryOutcomes measure: Maximum observed plasma drug concentration (Cmax) of VH4011499, primaryOutcomes measure: Time to maximum observed plasma concentration (Tmax) of VH4011499, secondaryOutcomes measure: Number of participants with AEs (Adverse Events), by severity, secondaryOutcomes measure: Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters, secondaryOutcomes measure: Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter), secondaryOutcomes measure: Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368973, orgStudyIdInfo id: RC16-4-2023, briefTitle: Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Benha University, class: OTHER, descriptionModule briefSummary: The goal of this study was to identify the prevalence of mechanical ventilation-associated complications and co-morbidities in pediatric patients admitted to the PICU of Benha University Hospital, uncover how often these problems occur, their types, factors linked to them and to compare the epidemiology of MV-associated complications., conditionsModule conditions: Mechanical Ventilation Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 315, type: ACTUAL, outcomesModule primaryOutcomes measure: Adverse events associated with mechanical ventilation, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Benha University Hospital, city: Cairo, zip: 13511, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06368960, orgStudyIdInfo id: BM201-1001, secondaryIdInfos id: CTR20223162, type: REGISTRY, domain: National Medical Products Administration, briefTitle: BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors, acronym: BM201-1001, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-07, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: InnoBM Pharmaceuticals Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, interventions name: BM201 injection, outcomesModule primaryOutcomes measure: DLT and MTD, primaryOutcomes measure: Pharmacokinetic (PK) parameters, primaryOutcomes measure: Number of patients with adverse events (AEs), secondaryOutcomes measure: ORR, secondaryOutcomes measure: Peripheral blood cytokine profiling in study participants., secondaryOutcomes measure: The variation in peripheral blood tumor biomarker concentrations., secondaryOutcomes measure: Other exploring outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Juan L GCP Director, role: CONTACT, phone: 800-555-5555, email: [email protected], contacts name: Baorui L Chief Physician, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06368947, orgStudyIdInfo id: B.30.2.ATA.0.01.00/172, briefTitle: Therapeutic Play on Pain Tolerance and Emotion Regulation in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-12-29, completionDateStruct date: 2026-12-29, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: The research is a randomized controlled experimental study. The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic Play, outcomesModule primaryOutcomes measure: Pain Tolerance Scale for Children with Cancer, primaryOutcomes measure: Emotion Regulation Scale for Children and Adolescents, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ataturk University Nursing of Faculty, status: RECRUITING, city: Erzurum, zip: 25240, country: Turkey, contacts name: ARZU SARIALİOĞLU, PHD, role: CONTACT, phone: 04422315795, email: [email protected], geoPoint lat: 39.90861, lon: 41.27694, hasResults: False |
protocolSection identificationModule nctId: NCT06368934, orgStudyIdInfo id: KY2024-011, briefTitle: Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Huashan Hospital, class: OTHER, descriptionModule briefSummary: Glioblastoma is recognized as the most common and aggressive form of primary malignant brain tumor, with treatment options that are limited and prognosis that is extremely poor, showing median progression-free survival of 12 months and median overall survival of less than 18 months. Surgical resection plays a critical role in the treatment, with the extent of resection significantly impacting patient outcomes. Historical approaches to surgical resection have evolved, moving from radical strategies to more conservative ones that aim to preserve normal brain function while removing the tumor as completely as possible. Recent studies have suggested that increasing the extent of surgical resection, particularly along the T2 FLAIR border rather than the traditional T1-enhanced border, can significantly improve patient prognosis. There is, however, a lack of consensus on the optimal surgical approach, and the heterogeneity of tumors presents challenges in standardizing surgical strategies. Extended resection has been shown to prolong survival, and novel intraoperative molecular diagnostics have emerged to improve accuracy in tumor classification and prognosis. Building on these advancements, a multicenter, prospective, randomized controlled trial is proposed to evaluate the efficacy of sub-lobectomy in treating IDH wild-type/TERTp-mutant glioblastoma, aiming to improve evidence levels and establish standardized surgical practices for this devastating disease., conditionsModule conditions: Glioma, conditions: Glioblastoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Type of study: randomized parallel controlled, open-label, multicenter clinical trial.Interventions: the intervention group was to receive frontal, temporal, parietal, and occipital sub-lobotomies that met anatomical criteria, and the control group was to receive imaging total resection (T1-enhanced borders) that met the Response Assessment in Neuro-Oncology (RANO) criteria.Randomization The control group and intervention group were equal in size. Following intraoperative pathological diagnosis, participants were randomly assigned using a centralized randomization system known as the Interactive Web Response System (IWRS). Stratification factors included preoperative age brackets of \[18-65\] and (65-80), gender (male or female), and tumor site in the frontal, temporal, parietal, and occipital lobes., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This study employed a single-blind approach whereby the participants were unaware of the kind of surgical resection they were receiving., whoMasked: PARTICIPANT, enrollmentInfo count: 326, type: ESTIMATED, armsInterventionsModule interventions name: sub-lobectomy, interventions name: imaging total resection, outcomesModule primaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Overall Survival, otherOutcomes measure: Postoperative quality of life, otherOutcomes measure: Adverse effects, otherOutcomes measure: Cognitive function, otherOutcomes measure: Language function, otherOutcomes measure: Limb muscle strength, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hushan Hospital, Fudan University, city: Shanghai, state: Shanghai, zip: 200040, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06368921, orgStudyIdInfo id: VRT106-C01, briefTitle: A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Guangzhou Virotech Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors., conditionsModule conditions: 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: VRT106, outcomesModule primaryOutcomes measure: Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106., primaryOutcomes measure: Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels., secondaryOutcomes measure: Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106., secondaryOutcomes measure: Assess the immunogenicity of intratumoral injection of VRT106., secondaryOutcomes measure: Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators., secondaryOutcomes measure: Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Hongyun Zhao, role: CONTACT, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06368908, orgStudyIdInfo id: 6I/2023/3, briefTitle: Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill, acronym: FMS_ICU, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-08, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: General and Teaching Hospital Celje, class: OTHER, descriptionModule briefSummary: ICU-Acquired weakness (ICU-AW) is a significant complication of critical illness. ICU-AW is common in patients with sepsis, systemic inflammatory response, and mechanically ventilated. It is estimated that around 50% of patients recovering from the primary illness remain in intensive care with characteristic muscle weakness. This leads to dependence on mechanical ventilation, prolonging costly intensive care hospitalization. The myopathy causes persistent functional impairment, endangering patients long after hospital discharge.Magnetic stimulation prevents inactivation atrophy of skeletal muscles, as demonstrated in the mobilized limb of rats. Transcutaneous magnetic stimulation of the quadriceps via the femoral nerve is a safe and painless method even when applied to humans.In patients with chronic obstructive pulmonary disease (COPD), quadriceps magnetic stimulation increased spontaneous contraction force compared to the control group and improved quality of life. Patients with COPD tolerate quadriceps magnetic stimulation well, as it does not affect oxidative stress in muscles but does increase the size of slow-twitch muscle fibers.In intensive care medicine, magnetic stimulation has been primarily used for diagnostic purposes in assessing diaphragm function, peripheral muscle strength assessment, and transcranial electrical stimulation as a diagnostic tool and therapeutic stimulation of brain cells. With the development of modern transcutaneous magnetic stimulators, the possibility arises for their use in intensive care medicine for therapeutic purposes such as preventing critical illness myopathy.To date, no research has been conducted on the use and effectiveness of magnetic stimulation of peripheral muscles in critically ill individuals.The aim of the study is to investigate the effect of Functional Muscle Magnetic Stimulation (FMS) on the development of ICU-AW., conditionsModule conditions: Critical Illness Myopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One of legs is randomised to be stimulated by trans-cutaneous functional magnetic stimulation (Arm 1), the other leg is control (Arm 2), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous Functional Magnetic Muscle Stimulation, outcomesModule primaryOutcomes measure: Measurement of Thickness of Thigh Muscles, secondaryOutcomes measure: Measurement of Thigh Circumference, secondaryOutcomes measure: Assessment of Muscle Strength and Communication Ability, secondaryOutcomes measure: Body composition measurement by bioimpedance- Extracellular water, secondaryOutcomes measure: Body composition measurement by bioimpedance- Intracellular water, secondaryOutcomes measure: Body composition measurement by bioimpedance- skeletal muscle mass, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General Hospital Celje, status: RECRUITING, city: Celje, zip: 300, country: Slovenia, geoPoint lat: 46.23092, lon: 15.26044, hasResults: False |
protocolSection identificationModule nctId: NCT06368895, orgStudyIdInfo id: 2188, briefTitle: Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-07, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy.The aims of the study are:To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy.To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement.To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement., conditionsModule conditions: Hepatic Encephalopathy, conditions: Dysbiosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Fecal microbiota transplantation delivery through colonoscopy, interventions name: Fecal microbiota transplantation delivery through oral capsules, outcomesModule primaryOutcomes measure: Evaluation of safety of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy, primaryOutcomes measure: Evaluation of efficacy of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy, secondaryOutcomes measure: Evaluation of changes in the gut microbiota composition following the fecal microbiota transplantation, secondaryOutcomes measure: Evaluation of changes in the systemic inflammatory following the fecal microbiota transplantation, secondaryOutcomes measure: Evaluation of changes in the intestinal inflammatory following the fecal microbiota transplantation, secondaryOutcomes measure: Comparison between protein metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation, secondaryOutcomes measure: Comparison between lipid metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation, secondaryOutcomes measure: Comparison between carbohydrates metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Agostino Gemelli IRCCS, status: RECRUITING, city: Rome, zip: 00168, country: Italy, contacts name: Francesca Ponziani, MD, role: CONTACT, phone: +390630156018, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06368882, orgStudyIdInfo id: Yongping _Chen, briefTitle: Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Wenzhou Medical University, class: OTHER, descriptionModule briefSummary: This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease.A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly.The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index, liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up.The security assessment includes adverse events, vital signs, and imaging., conditionsModule conditions: Nonalcoholic Fatty Liver Disease, conditions: Chronic Hepatitis b, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Peg-Interferon α, outcomesModule primaryOutcomes measure: HBsAg clearance, secondaryOutcomes measure: HBsAg clearance at 96 weeks, secondaryOutcomes measure: Cumulative HBsAg clearance rate, secondaryOutcomes measure: Liver Function Tests, secondaryOutcomes measure: The incidence of liver cirrhosis and liver cancer, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ningbo No.2 Hospital, status: RECRUITING, city: Ningbo, country: China, contacts name: Hongshan Li, role: CONTACT, phone: 13738865021, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Ruian People's Hospital, status: RECRUITING, city: Rui'an, country: China, contacts name: Liang Hong, role: CONTACT, phone: 13958805550, locations facility: The Second Affiliated Hospital of Wenzhou Medical University, status: RECRUITING, city: Wenzhou, country: China, contacts name: Chenwei Pan, role: CONTACT, phone: 13587655994, geoPoint lat: 27.99942, lon: 120.66682, locations facility: Wenzhou People's Hospital, status: RECRUITING, city: Wenzhou, country: China, contacts name: Ran Ding, role: CONTACT, phone: 18057788513, geoPoint lat: 27.99942, lon: 120.66682, locations facility: Yueqing People's Hospital, status: RECRUITING, city: Yueqing, country: China, contacts name: Hui Zhao, role: CONTACT, phone: 13968713322, hasResults: False |
protocolSection identificationModule nctId: NCT06368869, orgStudyIdInfo id: #1/2022, briefTitle: The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-10, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2024-01-20, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: amr elshimy, class: OTHER, descriptionModule briefSummary: Aim of the study was to evaluate the color stability of lithium disilicate ceramic veneers and zirconia reinforced lithium silicate ceramic veneers by using two different types of resin cements including light cured and dual cured cements., conditionsModule conditions: Color; Change Teeth, Posteruptive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ACTUAL, armsInterventionsModule interventions name: Livento press veneers luted with dual cured resin cement, interventions name: Livento press veneers luted with light cured resin cement, interventions name: Celtra duo veneers luted with dual cured resin cement, interventions name: Celtra duo veneers luted with light cured resin cement, outcomesModule primaryOutcomes measure: Color stability assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Alexandria University, city: Alexandria, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False |
protocolSection identificationModule nctId: NCT06368856, orgStudyIdInfo id: 20CH024, secondaryIdInfos id: 2020-006105-30, type: EUDRACT_NUMBER, briefTitle: Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study, acronym: MUPIPHARM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: Mupirocin is an old antibiotic used topically since the 1970s. Initially used in the treatment of skin infections for its antistaphylococcal action, it is now part of the decolonization strategy for Staphylococcus aureus (SA) carriage, in association with chlorhexidine. This decolonization strategy has been recommended in France for preoperative cardiac surgery in nasal SA carriers since 2013 by the French Hospital Hygiene Society, and recommended for cardiac and orthopedic surgery in SA carriers by the World Health Organization (WHO) since 2016. This strategy includes nasal decolonization using mupirocin ointment nasally (2 to 3 applications/day), a daily shower with chlorhexidine soap and + /- mouthwashes all over 5 days, often pre-operatively.As a result, mupirocin is now widely used throughout the world, all the more so as, for reasons of ease of organization, many centers use this decolonization procedure universally (i.e. without prior screening for Staphylococcus aureus carriage), thus further increasing the use of this molecule.Mupirocin administration methods are very vague, ranging from 2 to 3 applications per day and the application of "a match head", i.e. 50 mg, to 500 mg per nostril.Mupirocin is bacteriostatic at low doses, becoming bactericidal at higher concentrations; low concentrations could favor the selection of resistance, so using the most effective dosage seems essential. This lack of precision in administration is linked to an almost complete ignorance of the pharmacokinetics of mupirocin and its metabolite (monic acid) after nasal application.It therefore seems essential to conduct a pharmacokinetic study of this molecule, in order to eventually offer patients the regimen with the administration methods offering the best characteristics in terms of dosage and efficacy., conditionsModule conditions: Healthy, conditions: Staphylococcus Aureus Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Single-center, randomized, open-label pharmacokinetic study of mupirocin in 40 healthy subjects with 2 randomization :* first randomization - single dose part : 50mg or 500mg of mupirocin* wash-out: one month* second randomization - repeated doses part: 50mg mupirocin twice a day or 50 mg 3 times a day 500mg mupirocin twice a day or 500mg mupirocin 3 times a day, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Mupirocin (50 mg), interventions name: Mupirocin (500 mg), interventions name: blood samples after Single dose part, interventions name: nasal swab after Single dose part, interventions name: Collection of urine after Single dose part, interventions name: nasal swab during Repeated dose part, interventions name: Collection of urine during Repeated dose part, interventions name: nasal swab after Repeated dose part, outcomesModule primaryOutcomes measure: plasma concentrations of mupirocin, primaryOutcomes measure: plasma concentrations of mupirocin, primaryOutcomes measure: plasma concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, secondaryOutcomes measure: presence of Staphylococcus aureus, secondaryOutcomes measure: presence of Staphylococcus aureus, secondaryOutcomes measure: presence of Staphylococcus aureus, secondaryOutcomes measure: presence of Staphylococcus aureus, secondaryOutcomes measure: urinary concentrations of monic acid, secondaryOutcomes measure: urinary concentrations of monic acid, secondaryOutcomes measure: urinary concentrations of monic acid, secondaryOutcomes measure: urinary concentrations of monic acid, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de SAINT-ETIENNE, status: RECRUITING, city: Saint-Étienne, country: France, contacts name: Kasra AZARNOUSH, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Elisabeth BOTELHO-NEVERS, MD PhD, role: SUB_INVESTIGATOR, contacts name: Anne CARRICAJO, MD, role: SUB_INVESTIGATOR, contacts name: Philippe BERTHELOT, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False |
protocolSection identificationModule nctId: NCT06368843, orgStudyIdInfo id: Ketamine for POST, briefTitle: the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-09-20, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction., conditionsModule conditions: Postoperative Sore Throat, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Gargle with ketamine, outcomesModule primaryOutcomes measure: Sore throat, secondaryOutcomes measure: Cough, secondaryOutcomes measure: Hoarseness of voice, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ministry of Health, city: Baghdad, state: Thi-Qar, zip: 00964, country: Iraq, geoPoint lat: 33.34058, lon: 44.40088, hasResults: False |
protocolSection identificationModule nctId: NCT06368830, orgStudyIdInfo id: 2024-0337, secondaryIdInfos id: A534100, type: OTHER, domain: UW Madison, secondaryIdInfos id: Protocol Version 3/4/24, type: OTHER, domain: UW Madison, briefTitle: Oral and Swallowing Function in Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: The purpose of this study is to learn about oral and swallowing function in older adults presenting to the emergency department. The hypothesis is that older adults often have problems with oral and swallowing function and these problems relate to other conditions. Study activities are done during the emergency department visit and include providing saliva samples, completing a bedside water swallow test, completing oral function assessments, completing respiratory function tests, and answering survey questions., conditionsModule conditions: Oropharyngeal Dysphagia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: 3-ounce water swallow test, interventions name: Kayser-Jones Brief Oral Health Status Examination (BOHSE), interventions name: Tongue pressure, interventions name: Test of Masticating and Swallowing Solids (TOMASS), interventions name: Respiratory function tests, outcomesModule primaryOutcomes measure: Positive oropharyngeal dysphagia screen prevalence, secondaryOutcomes measure: Mean brief oral health status examination (BOHSE) score, secondaryOutcomes measure: Oral dryness prevalence, secondaryOutcomes measure: Decreased tongue pressure prevalence, secondaryOutcomes measure: Decreased masticatory function prevalence, secondaryOutcomes measure: pH of saliva sample, secondaryOutcomes measure: Extensional viscosity of saliva sample, secondaryOutcomes measure: Salivary Substance P Concentration, secondaryOutcomes measure: Oral microbiome, secondaryOutcomes measure: Cell barrier function, secondaryOutcomes measure: Protein composition, secondaryOutcomes measure: Gene expression, secondaryOutcomes measure: Immunofluorescent staining, secondaryOutcomes measure: Immune cell trafficking, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368817, orgStudyIdInfo id: ACNS2321, briefTitle: Chemotherapy Followed by Response-Based Reduced Radiation Therapy for Patients With Central Nervous System Germinomas, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-04, primaryCompletionDateStruct date: 2033-11-04, completionDateStruct date: 2033-11-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Children's Oncology Group, class: NETWORK, descriptionModule briefSummary: A phase II trial that is attempting to build upon the excellent results of ACNS1123 stratum 2 by reducing the Radiotherapy (RT) dose for patients in a Complete Response (CR) after chemotherapy. The trial will be testing a further reduction in the whole ventricular irradiation (WVI) dose. Additionally, patients with metastatic disease and basal ganglia and thalamic germinoma will be included, and they will be treated with craniospinal irradiation (CSI) or whole brain irradiation (WBI) respectively., conditionsModule conditions: Intracranial Germ Cell Tumor, conditions: Childhood Central Nervous System Germinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: 3-Dimensional Conformal Radiation Therapy, interventions name: Carboplatin, interventions name: Etoposide, interventions name: Intensity-Modulated Radiation Therapy, outcomesModule primaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Estimate the EFS distribution for eligible and evaluable patients in Stratum 2, secondaryOutcomes measure: To estimate the EFS distribution for eligible and evaluable patients in Stratum 3, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Determine the impact of tumor location, treatment regimen and treatment modalities on the long-term neuroendocrine function for patients with CNS germinomas., secondaryOutcomes measure: Prospectively evaluate processing speed of children and young adults with CNS germinoma through the Children's Oncology Group (COG) Standardized assessment battery., otherOutcomes measure: EFS distribution for eligible and evaluable patients in Stratum 4 and Stratum 5., otherOutcomes measure: EFS distribution for eligible and evaluable patients in Stratum 6 and Stratum 7., otherOutcomes measure: prospectively collect blood, cerebrospinal fluid, and tumor tissue at diagnosis and second-look surgery (if feasible) for future biology studies., otherOutcomes measure: Incidence of cerebral vascular events (stroke or transient ischemic attacks) of children and young adults with CNS germinoma through the COG Standardized assessment battery: Patient-reported outcome measures, otherOutcomes measure: Incidence of cerebral vascular events (stroke or transient ischemic attacks) of children and young adults with CNS germinoma through the COG Standardized assessment battery: Health-reported quality of life, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368804, orgStudyIdInfo id: ANTEIPA, secondaryIdInfos id: 2022-A01575-38, type: OTHER, domain: ID-RCB, briefTitle: Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis, acronym: ANTEIPA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2028-06-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Intercommunal Creteil, class: OTHER, collaborators name: Assistance Publique - Hôpitaux de Paris, descriptionModule briefSummary: Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection (early PA infection). Several antibiotic regimens may be proposed, ranging from a monotherapy with oral fluoroquinolone (FQ) to an intravenous cotherapy with the addition of inhaled antibiotics that seems to improve the rate of PA eradication. As no study strictly favoured one regimen, current practices are heterogeneous and could certainly benefit from stronger evidence, with both medical and economic impact., conditionsModule conditions: Bronchiectasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 196, type: ESTIMATED, armsInterventionsModule interventions name: Antibiotic monotherapy treatment and follow-up, interventions name: Antibiotic bitherapy treatment and follow-up, outcomesModule primaryOutcomes measure: PA-eradication rate, secondaryOutcomes measure: Time to first exacerbation, secondaryOutcomes measure: 1 year-exacerbation rate, secondaryOutcomes measure: Quality-of-life using questionnaires, secondaryOutcomes measure: Quality-of-life using questionnaires, secondaryOutcomes measure: Treatment burden assessment using questionnaires, secondaryOutcomes measure: Quality-of-life using questionnaires, secondaryOutcomes measure: Detection of PA at 3-month and 1 year, secondaryOutcomes measure: Time to first PA-recurrence, secondaryOutcomes measure: Emergence of FQ-resistant strains of (PA or other bacteria), secondaryOutcomes measure: Adverse event (AE) and serious AE at 12 months follow-up, secondaryOutcomes measure: Number of premature ending of one of the treatment in study due to any AE, secondaryOutcomes measure: Number of premature ending of one of the treatment in study, secondaryOutcomes measure: Proportion of non-administered doses of nebulized colistin, secondaryOutcomes measure: Cost and incremental cost effectiveness ratio at 1 year, secondaryOutcomes measure: Cost and incremental cost effectiveness ratio at 1 year, secondaryOutcomes measure: Cost and incremental cost effectiveness ratio at 1 year, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens-Picardie, city: Amiens, country: France, contacts name: Damien BASILLE, role: CONTACT, geoPoint lat: 49.9, lon: 2.3, locations facility: CHU Haut Leveque, Bordeaux, city: Bordeaux, country: France, contacts name: Julie MACEY, role: CONTACT, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHRU Brest, city: Brest, country: France, contacts name: Francis COUTURAUD, role: CONTACT, geoPoint lat: 48.3903, lon: -4.48628, locations facility: CH Pontoise, city: Cergy-Pontoise, country: France, contacts name: Bruno PHILIPPE, role: CONTACT, geoPoint lat: 49.03894, lon: 2.07805, locations facility: Centre hospitalier intercommunal de Créteil, city: Créteil, zip: 94010, country: France, contacts name: Bernard MAITRE, role: CONTACT, geoPoint lat: 48.78333, lon: 2.46667, locations facility: APHP, Henri Mondor, city: Créteil, country: France, contacts name: Fréderic SCHLEMMER, role: CONTACT, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Hôpital de la Croix Rousse, HCL, Lyon, city: Lyon, country: France, contacts name: Gilles DEVOUASSOUX, role: CONTACT, geoPoint lat: 45.74848, lon: 4.84669, locations facility: CHU Nantes, city: Nantes, country: France, contacts name: François-Xavier BLANC, role: CONTACT, geoPoint lat: 47.21725, lon: -1.55336, locations facility: CHU H. Pasteur, Nice, city: Nice, country: France, contacts name: Sylvie LEROY, role: CONTACT, geoPoint lat: 43.70313, lon: 7.26608, locations facility: APHP, Cochin, city: Paris, country: France, contacts name: Clémence MARTIN, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: APHP, Saint Louis, city: Paris, country: France, contacts name: Abdellatif TAZI, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: APHP, Tenon, city: Paris, country: France, contacts name: Nathalie ROZENSTAJ, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Foch, Suresnes, city: Suresnes, country: France, contacts name: Emilie CATHERINOT, role: CONTACT, geoPoint lat: 48.87143, lon: 2.22929, locations facility: CHU H. Larrey, Toulouse, city: Toulouse, country: France, contacts name: Marlene MURIS-ESPIN, role: CONTACT, geoPoint lat: 43.60426, lon: 1.44367, locations facility: CH Versailles, city: Versailles, country: France, contacts name: Charlotte COLIN, role: CONTACT, geoPoint lat: 48.8, lon: 2.13333, locations facility: CH Villefranche s/Saône, city: Villefranche-sur-Saône, country: France, contacts name: Sonia BLANDIN, role: CONTACT, geoPoint lat: 45.98333, lon: 4.71667, hasResults: False |
protocolSection identificationModule nctId: NCT06368791, orgStudyIdInfo id: 30001479, briefTitle: Anti-Stress Intervention Among Physicians Study, acronym: ASIP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Charite University, Berlin, Germany, class: OTHER, descriptionModule briefSummary: Medical practice often comes with high stress. Stress negatively affects our health and well-being and is linked to doctors making mistakes, some of which can be deadly.In this study, the effect of two quick stress-relief methods on daily stress levels is estimated. The two anti-stress exercises are designed to easily fit into daily routines:1. Box breathing (6 minutes) is known to reduce stress and lower the heart rate. It is used by the military and law enforcement, among others, to manage stress.2. Breathing and mindfulness exercise (10 minutes): This guided breathing and mindfulness intervention combines mindful breathing with simple body movements, developed to reduce the perceived level of stress.The effectiveness of these interventions is being examined in a series of N-of-1 trials. Each participant can choose between the interventions. After being randomly allocated to an individual sequence of one-week intervention and control phases, the study begins. Participants record their stress levels daily over the four-week study period. The intervention is only performed in the intervention phases. Upon completing the study, the stress levels during the intervention phases are compared to those in the control phases. Each participant will receive an individual analysis based on the collected data. In addition, the investigators will estimate the effects at the population level.Three months after the study, a survey will be sent to the participants to check if the benefits have persisted., conditionsModule conditions: Stress, Psychological, conditions: Burnout, Psychological, conditions: Subjective Stress, conditions: Occupational Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Box Breathing, interventions name: Breathing and Mindfulness Exercise, interventions name: Everyday life control, outcomesModule primaryOutcomes measure: Daily perceived stress, primaryOutcomes measure: Daily expectation of perceived stress level on the following day, secondaryOutcomes measure: Level of agreement between expected and actually perceived level of stress, secondaryOutcomes measure: Compliance with the study protocol: number of participant reported outcomes, secondaryOutcomes measure: Compliance with the study protocol: number of performed anti-stress interventions, secondaryOutcomes measure: Successful study completion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité - Universitätsmedizin Berlin, status: RECRUITING, city: Berlin, zip: 10117, country: Germany, contacts name: Valentin M Vetter, MD, role: CONTACT, phone: 0049 30 450 566 298, email: [email protected], geoPoint lat: 52.52437, lon: 13.41053, hasResults: False |
protocolSection identificationModule nctId: NCT06368778, orgStudyIdInfo id: 166591, briefTitle: Real-Time Biofeedback on Partial Weightbearing Training, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-13, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the effectiveness of a biofeedback device (Loadsol) in training healthy subjects to comply with partial weightbearing, and to compare its outcomes with the standard of care training. Partial weightbearing is an essential component of rehabilitation and recovery for many orthopedic patients, yet it remains challenging for individuals to accurately gauge their weightbearing restrictions without proper guidance and feedback.The primary objective of the study is to determine whether the use of the biofeedback device (Loadsol) can reduce the time it takes for healthy subjects to learn and comply with partial weightbearing, compared to traditional training methods. The Loadsol device provides real-time auditory feedback on the individual's weightbearing status, potentially enhancing the learning process and adherence to weightbearing restrictions.Secondary objectives of the study include:Assessing the compliance of subjects with weightbearing restrictions in both the biofeedback and standard of care training groups, and comparing the results to identify any significant differences in adherence to the prescribed weightbearing limitations.Evaluating subject satisfaction with the training methods, as measured through questionnaires and the use of Patient-Reported Outcomes Measurement Information System (PROMIS) tools. This evaluation will help determine if the biofeedback device (Loadsol) leads to higher levels of satisfaction among subjects compared to the standard of care training.By examining these objectives, this study aims to provide valuable insights into the potential benefits of using a biofeedback device in partial weightbearing training, and to establish whether its implementation can lead to improved outcomes in learning, compliance, and overall patient satisfaction., conditionsModule conditions: Physical Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Verbal Advice, interventions name: Bathroom Scale, interventions name: Loadsol Biofeedback, outcomesModule primaryOutcomes measure: Average peak force (Newtons, (N)), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Utah Orthopaedic Center, city: Salt Lake City, state: Utah, zip: 84108, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False |
protocolSection identificationModule nctId: NCT06368765, orgStudyIdInfo id: BL72, briefTitle: Oral Rehydration Solution and Dehydration Recovery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Abbott Nutrition, class: INDUSTRY, descriptionModule briefSummary: This is a prospective, randomized, controlled, blinded, crossover, study to evaluate the effects of an oral hydration solution., conditionsModule conditions: Dehydration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Oral Rehydration Solution (ORS), interventions name: Water, outcomesModule primaryOutcomes measure: Plasma Volume, secondaryOutcomes measure: Body Mass, secondaryOutcomes measure: Hydration Status Urine, secondaryOutcomes measure: Blood Biomarker - Plasma Osmolality, secondaryOutcomes measure: Blood Biomarker - Plasma Electrolyte Concentration, secondaryOutcomes measure: Blood Biomarker - Plasma Glucose Concentration, secondaryOutcomes measure: Body Temperature, otherOutcomes measure: Body Composition, otherOutcomes measure: Reaction Time, otherOutcomes measure: Handgrip Strength, otherOutcomes measure: Urine Volume, otherOutcomes measure: Hydration Status Saliva, otherOutcomes measure: Heart Rate, otherOutcomes measure: Blood Pressure, otherOutcomes measure: Thirst Sensation Scale, otherOutcomes measure: Gagge Thermal Scale, otherOutcomes measure: Urine Color, otherOutcomes measure: Palatability, otherOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368752, orgStudyIdInfo id: H-22063621, briefTitle: The Role of Endogenous GIP in Glycosis Metabolism During Fasting, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-05-04, primaryCompletionDateStruct date: 2023-12-12, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Frederikke Koefoed-Hansen, class: OTHER, descriptionModule briefSummary: This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP\[3-30\]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The trial is a randomized, double-blind, crossover study. We give intravenous infusion of GIP\[3-30\]NH2, and thus describe the effects of GIP by comparing with what happens during a saline infusion (placebo)., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: The infusion is mixed by an external coordinator. Neither the investigator or the participants knows whether is the GIP\[3-30\]NH2 infusion or saline infusion that is being given. Which infusion that is given on each trial day is randomized for each participant., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: GIP[3-30]NH2, interventions name: Saline, outcomesModule primaryOutcomes measure: Plasma glucagon concentrations, secondaryOutcomes measure: Plasma levels of C-peptide, secondaryOutcomes measure: Plasma levels of insulin, secondaryOutcomes measure: Resting metabolic rate, secondaryOutcomes measure: Activity in brown adipose tissue, secondaryOutcomes measure: Appetite, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Puls, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gentofte Hospital, city: Hellerup, zip: 2900, country: Denmark, geoPoint lat: 55.73204, lon: 12.57093, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-04-10, uploadDate: 2024-04-11T04:12, filename: Prot_SAP_000.pdf, size: 120286, hasResults: False |
protocolSection identificationModule nctId: NCT06368739, orgStudyIdInfo id: STUDY00005622, briefTitle: Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-10-17, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Texas at Austin, class: OTHER, collaborators name: Driscoll Health Plan, descriptionModule briefSummary: With funding from the Episcopal Health Foundation, the researchers will conduct a secondary data analysis to evaluate the impact of Driscoll Health Plan's Nurture program for pregnant members using claims data., conditionsModule conditions: Pregnancy Related, conditions: Financial Gift, conditions: Nutrition, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: From the eligible population, DHP randomly selected a subset of approximately 500 women during the pilot period, from which approximately 200 were in the program, the "exposed group." The women who were covered during the same period but were not selected were not exposed to the program and will compose the "comparison group.", primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 224, type: ACTUAL, armsInterventionsModule interventions name: Nurture program, interventions name: Regular benefits, outcomesModule primaryOutcomes measure: Composite outcome 1: Adverse health events during pregnancy, primaryOutcomes measure: Composite outcome 2: Adverse health events at birth and newborn-related, otherOutcomes measure: Emergency Department visits, otherOutcomes measure: Cost (outpatient), otherOutcomes measure: Cost (inpatient), otherOutcomes measure: Cost (pharmacy/medication), otherOutcomes measure: Cost (total), otherOutcomes measure: Delivery mode (vaginal, C-section), otherOutcomes measure: Birthweight, eligibilityModule sex: FEMALE, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Driscoll Health Plan, city: Corpus Christi, state: Texas, zip: 78415, country: United States, geoPoint lat: 27.80058, lon: -97.39638, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-24, uploadDate: 2024-02-12T16:26, filename: Prot_SAP_000.pdf, size: 630078, hasResults: False |
protocolSection identificationModule nctId: NCT06368726, orgStudyIdInfo id: SFND04042024, briefTitle: Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders, acronym: tDCS&ASD, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Spanish Foundation for Neurometrics Development, class: OTHER, collaborators name: Fundacion para la Salud Materno Infantil, descriptionModule briefSummary: Results of the application of 100 sessions of tDCS for 12 months in children between 6 and 11 years old with autism spectrum disorder with rare diseases, genetic problems or PANDAS, conditionsModule conditions: Attention, conditions: Visual Perceptual Weakness, conditions: Social Behavior, conditions: Fluency Disorder, conditions: EEG With Periodic Abnormalities, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups of childs: 90 childs receive tDCS treatment and 90 traditional treatments with Risperidone educational training, speech therapy and visual training., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Assessments regarding clinical recovery will be conducted by an assessor blind to treatment allocation., whoMasked: INVESTIGATOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: tDCS or Transcranial Direct Current Stimulation, interventions name: Risperidone, outcomesModule primaryOutcomes measure: FFT, primaryOutcomes measure: Power Density Spectrum Changes or PSD, primaryOutcomes measure: ERP MMN changes, primaryOutcomes measure: ERP MMN Changes, secondaryOutcomes measure: Attention, secondaryOutcomes measure: Social Skills, secondaryOutcomes measure: Language, secondaryOutcomes measure: Visual Contact, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: New Remedies Ltd, city: Liverpool, state: Merseyside, zip: L1 0AH, country: United Kingdom, geoPoint lat: 53.41058, lon: -2.97794, hasResults: False |
protocolSection identificationModule nctId: NCT06368713, orgStudyIdInfo id: PD-GIEX, briefTitle: Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Sichuan Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients., conditionsModule conditions: Peritoneal Dialysis, conditions: Exercise, conditions: Gastrointestinal Function, conditions: Quality of Life, conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Change in GIQLI, secondaryOutcomes measure: Change in GSRS, secondaryOutcomes measure: Change in PAC-SYM, secondaryOutcomes measure: Change in 6-MWT, secondaryOutcomes measure: Change in SGA, secondaryOutcomes measure: Change in measured Gastrointestinal Hormones, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Jin Chen, Doctor, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06368700, orgStudyIdInfo id: CL-00001, briefTitle: The Hyalex Early Feasibility Study (EFS), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Hyalex Orthopaedics, Inc., class: INDUSTRY, descriptionModule briefSummary: The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant., conditionsModule conditions: Cartilage Injury, conditions: Cartilage Damage, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Hyalex Knee Cartilage System, outcomesModule primaryOutcomes measure: Freedom from implant rejection and infection., primaryOutcomes measure: Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months., eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital for Special Surgery, status: RECRUITING, city: New York, state: New York, zip: 10021, country: United States, contacts name: Ava Neijna, role: CONTACT, phone: 917-260-3677, email: [email protected], contacts name: Morgan Rizy, role: CONTACT, contacts name: Sabrina Strickland, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Andreas Gomoll, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Oregon Health & Science University, status: RECRUITING, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Jessica Ballin, role: CONTACT, phone: 503-418-9580, email: [email protected], contacts name: Dennis Crawford, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False |
protocolSection identificationModule nctId: NCT06368687, orgStudyIdInfo id: 2023-06112-01, briefTitle: TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum, acronym: TRANPAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Göteborg University, class: OTHER, descriptionModule briefSummary: In a pilot study, we will validate a so-called autism care location in an inpatient ward. The care location will be adapted for patients with anorexia nervosa (AN) and concurrent autism (AN+autism). In order to investigate the effect of a tailored care location for patients with AN + autism, the evaluation will include weight development and changes in nutritional intake, eating disorder and anxiety symptoms. The overall aim is to improve treatment for this specific AN subgroup, that otherwise has a worse prognosis regarding AN recovery., conditionsModule conditions: Anorexia Nervosa, conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pilot study. Ten consecutive patients with anorexia nervosa (AN) plus autism will be admitted to the autism care location at an inpatient ward for eating disorders. The planned period of care for each patient is 12 weeks. The patient will be assessed (including weight, height, self-report questionnaires and interviews) before admission, at discharge and 6 months later., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Anorexia nervosa plus autism, outcomesModule primaryOutcomes measure: BMI change between baseline and discharge 12 weeks later, secondaryOutcomes measure: Change of level of anxiety between baseline and discharge 12 weeks later, secondaryOutcomes measure: Change of Quality of life between baseline and discharge 12 weeks later, eligibilityModule sex: ALL, minimumAge: 25 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368674, orgStudyIdInfo id: 2023-00363, briefTitle: Bridging the Gap: Creating a Continuum of Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Göteborg University, class: OTHER, collaborators name: Vastra Gotaland Region, collaborators name: Narhalsan Reasearch and Development primary care Region Vastra Gotaland, collaborators name: Sahlgrenska University Hospital, Sweden, collaborators name: Forte, descriptionModule briefSummary: Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. This study evaluates the effects of an active follow-up by a CM in primary care after discharge from a geriatric ward, with the following research questions: Can an active follow-up by CM for frail older people discharged from an acute geriatric ward, compared to those not receiving active follow up, Maintain/increase independence in activities of daily living, self-rated health and life satisfaction? Increase satisfaction with health care? Reduce health care consumption/be cost-effective? How feasible is the intervention and the study design from the perspective of the caregivers and the older person? This is a clinical controlled study with a process evaluation. Inclusion criteria are 75 years or older, frail and admitted to a geriatric ward.This study is relevant since today's highly specialized acute care is poorly adapted to the comprehensive needs of frail older people, and exposes them to avoidable risks such as loss of functional capacities causing unnecessary care needs and decreased wellbeing. Active follow-up by a CM after discharge may be an important way to integrate the care for frail older people, after receiving in-hospital geriatric care. This can improve the quality of care for this vulnerable group, and direct the right health care actions towards those in most need.The intervention is a active follow-up after discharge by a CM (nurse) in primary care. CM will secure that discharge and care plans are executed and to address new needs. If there are unmet needs, the CM will ensure that adequate actions are performed to meet the needs. The intervention group consists of participants discharged to a primary health care centre with a CM, who actively follows-up after discharge. The control group consists of participants discharged to a primary health care centre without CM, and thereby no active follow-up after discharge. All participants will be followed-up by the research team during one year, concerning dependence in activities of daily living, self-rated health, health care consumption and satisfaction with care., conditionsModule conditions: Frailty, conditions: Dependence, conditions: Integrated Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Clinical control study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Intervention group Case Manager (CM), interventions name: Control Group, outcomesModule primaryOutcomes measure: Dependency in Activities of Daily Living (ADL), secondaryOutcomes measure: Self-rated health, secondaryOutcomes measure: Life satisfaction, secondaryOutcomes measure: Satisfaction with quality of care, secondaryOutcomes measure: Health economics, eligibilityModule sex: ALL, minimumAge: 75 Years, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06368661, orgStudyIdInfo id: 23.79 Colo-MAR 1, briefTitle: Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Fundación Vithas, class: OTHER, collaborators name: CEU San Pablo University, descriptionModule briefSummary: This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention., conditionsModule conditions: Nutrition Related Neoplasm/Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Dietary habits registry from participants: the dietary intake, primaryOutcomes measure: Biomarkers in colon mucosa, precancerous lesions and colorectal cancer, primaryOutcomes measure: Gut microbiota profile, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ciro Cabezas Checchi, status: RECRUITING, city: Vigo, state: Pontevedra, zip: 36206, country: Spain, contacts name: Ciro Cabezas Checchi, MD, role: CONTACT, phone: +34 986 82 11 00, email: [email protected], geoPoint lat: 42.23282, lon: -8.72264, hasResults: False |
protocolSection identificationModule nctId: NCT06368648, orgStudyIdInfo id: CP-1, briefTitle: CoMind Early Feasibility Study, acronym: CoMind EFS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: CoMind Technologies Limited, class: INDUSTRY, collaborators name: Lindus Health, descriptionModule briefSummary: The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP., conditionsModule conditions: Intracranial Pressure, conditions: Intracranial Pressure Changes, conditions: Traumatic Brain Injury, conditions: Intracerebral Hemorrhage, conditions: Encephalitis, conditions: Encephalopathy, conditions: Hydrocephalus, conditions: Stroke, conditions: Autoregulation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 581, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: A test of the difference in estimation errors between two non-invasive ICP estimation models: one trained with ABP and CoMind One EFS CBFi, and one trained only using ABP, primaryOutcomes measure: Models trained using CoMind CBFi and ABP will be evaluated based on their limits of agreement (LOA) with invasive ICP., secondaryOutcomes measure: Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population., secondaryOutcomes measure: Demonstration of a non-invasive ICP model that can classify the transition between ICP 'states', i.e. transitions between low ICP (less than 20 mmHg), and high ICP (greater than 20 mmHg)., secondaryOutcomes measure: Demonstration of a non-invasive ICP waveform prediction model and assessment of its accuracy against the invasively-measured ICP waveform., secondaryOutcomes measure: Demonstration of an non-invasive ICP model that can predict trends in ICP, otherOutcomes measure: A comparison of metrics of CAR derived from CoMind One EFS CBFi, CoMind One EFS device estimates of ICP, and ABP., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368635, orgStudyIdInfo id: 2022-GSP-QN-8, briefTitle: The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study, acronym: CCMD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Weijing Wang, class: OTHER_GOV, collaborators name: Chinese Academy of Medical Sciences, Fuwai Hospital, descriptionModule briefSummary: Ischaemic heart disease (IHD) and degenerative brain disease are two major sources of death and disability affecting all countries. While the consequences of obstructive disease in major vessels supplying blood to both organs have been widely documented, less attention has been paid to disease processes affecting the microcirculation that may affect cardiac and cerebral function. Yet, over the last decade significant progress has been made in understanding the substrate of microvascular disease in both organs. In the heart, arteriolar thickening and capillary rarefaction that reduce the conductance of the microvasculature and its ability to vasodilate in response to increased myocardial oxygen demands constitute the leading cause of coronary microvascular dysfunction (CMD). In the brain, concentric hyaline thickening of deep penetrating small arteries (arteriolosclerosis) with associated fibrosis of the vessel wall constitutes the most frequent substrate for cerebral small vessel disease (CSVD). Of note, both CMD and CSVD share common risk factors, such as age, hypertension, and diabetes.3 These factors might have a common effect on the microvascular domain of cardiac and cerebral vascular beds.Although a potential link between both conditions has been hypothesized based on the similarities between pathological changes and risk factors, advance in knowledge exploring this has been hampered by lacking objective evidence of CMD and pathological brain changes indicative of CSVD in prior research studies. Thus, the relationship between CMD and CSVD is unknown.The main objective of this study was to analyse the relationship between cerebrovascular disease and CMD in patients with atherosclerotic coronary artery disease (CAD)., conditionsModule conditions: Microcirculation, conditions: Coronary Artery Disease, conditions: Cerebrovascular Circulation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Coronary angiography, outcomesModule primaryOutcomes measure: MACE, primaryOutcomes measure: MACE, secondaryOutcomes measure: Cerebral microcirculation, secondaryOutcomes measure: Cerebral microcirculation, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Weijing Wang, PhD, role: CONTACT, phone: +8601088326200, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06368622, orgStudyIdInfo id: CDM10001814, briefTitle: Evolve China PMCF Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-11, completionDateStruct date: 2031-08, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Stryker Neurovascular, class: INDUSTRY, collaborators name: Stryker (Beijing) Healthcare Products Co., Ltd, descriptionModule briefSummary: A prospective, multi-center, single-arm, open-label, observational post-market real-world registry. The expected duration of the study is 8 years (including up to 5-years' follow-up).Each subject will be followed in accordance with the standard of care (SOC) at each participating hospital., conditionsModule conditions: Intracranial Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Surpass Evolve Flow Diverter System, outcomesModule primaryOutcomes measure: Neurological death or disabling stroke, primaryOutcomes measure: 100% occlusion without significant parent artery stenosis, secondaryOutcomes measure: Procedure- and device-related serious adverse events, secondaryOutcomes measure: Key neurological events, secondaryOutcomes measure: Procedural success, secondaryOutcomes measure: Device success, secondaryOutcomes measure: Re-sheathing success, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital Capital Medical University, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06368609, orgStudyIdInfo id: 2024-09, briefTitle: Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection, acronym: PROTOSS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: Single center, no profit experimental study on sera available in the Tropica Biobank., conditionsModule conditions: Strongyloides Stercoralis Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: IgG RDT, interventions name: IgG4 RDT, outcomesModule primaryOutcomes measure: RDTs IgG results: positive or negative, primaryOutcomes measure: RDTs IgG4 results: positive or negative, secondaryOutcomes measure: Agreement between readers, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Dora Buonfrate, role: CONTACT, email: [email protected], contacts name: Dora Buonfrate, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False |
protocolSection identificationModule nctId: NCT06368596, orgStudyIdInfo id: 2024-04, briefTitle: ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis, acronym: ENDS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation.A control group would however be recruited for secondary objective 1 and 2.The study is classified as interventional, as Fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice., conditionsModule conditions: Endometriosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 845, type: ESTIMATED, armsInterventionsModule interventions name: Fusobacterium detection, outcomesModule primaryOutcomes measure: Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis, secondaryOutcomes measure: Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis, secondaryOutcomes measure: Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled, secondaryOutcomes measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis ., secondaryOutcomes measure: Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present, secondaryOutcomes measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis, secondaryOutcomes measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria di Negrar, city: Negrar, state: Verona, country: Italy, contacts name: Marcello Ceccaroni, Doctor, role: CONTACT, email: [email protected], contacts role: CONTACT, phone: 0456013111, contacts name: Marcello Ceccaroni, role: PRINCIPAL_INVESTIGATOR, contacts name: Dora Buonfrate, role: SUB_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False |
protocolSection identificationModule nctId: NCT06368583, orgStudyIdInfo id: 24-05, briefTitle: The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia, acronym: PAS-EDU-NLA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital, class: OTHER, descriptionModule briefSummary: During the process of labour and delivery, patients may experience a wide range of events in a short time frame. This study focuses on exploring these experiences and aims to incorporate the improvements from these experiences so that in future, the expectations of patients delivering can be met as much as possible. Since every patient and encounter is unique, they might have a variety of experiences, be it during the labour epidural placement or during the delivery of the baby. Our study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience and to then use this information to enhance the quality of future anesthesia care during labour and delivery.Patients who underwent labour and delivery and received labour epidural for pain management will be approached the day following the delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of the obstetricians, anesthesiologists, and nurses with the goals of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice, a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during labour and delivery., conditionsModule conditions: Well-Being, Psychological, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Interview, outcomesModule primaryOutcomes measure: Patient questionnaire, primaryOutcomes measure: Patient interview, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, city: Toronto, state: Ontario, zip: M5G1X5, country: Canada, contacts name: Sabine Nabecker, MD, role: CONTACT, phone: 416-586-4800, phoneExt: 5270, email: [email protected], contacts name: Ron George, MD, role: SUB_INVESTIGATOR, contacts name: Kristi Downey, MSc, role: SUB_INVESTIGATOR, contacts name: Sunti Barahi, MD, role: SUB_INVESTIGATOR, contacts name: Ratesh Bassi, MD, role: SUB_INVESTIGATOR, contacts name: Afsheen Nasir, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06368570, orgStudyIdInfo id: 24-04, briefTitle: The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery, acronym: PAS-EDU-RCD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital, class: OTHER, descriptionModule briefSummary: This study aims to explore the experience that the patient has as they undergo a routine Cesarean Delivery (CD). The indication for undergoing a routine CD varies amongst patients, but usually there is either an obstetric or medical reason for requiring a planned delivery of an infant via CD. Similarly, the experience of the CD varies significantly between patients as there are many patient, surgical and anesthetic factors that interact to create the unique experience each patient has. This study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience of CD and to then use this information to enhance the quality of future anesthesia care for elective CD.Patients who have undergone a routine CD will be approached the day following their delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study, which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of obstetricians, anesthesiologists and nurses with the goal of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during elective CD., conditionsModule conditions: Well-Being, Psychological, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Interview, outcomesModule primaryOutcomes measure: Patient questionnaire, primaryOutcomes measure: Patient interview, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G1X5, country: Canada, contacts name: Sabine Nabecker, MD, role: CONTACT, phone: 416-586-4800, phoneExt: 5270, email: [email protected], contacts name: Ron George, MD, role: SUB_INVESTIGATOR, contacts name: Kristi Downey, MSc, role: SUB_INVESTIGATOR, contacts name: Fernanda Septimio Lanza Oliveira, MD, role: SUB_INVESTIGATOR, contacts name: Lada Kordich, MD, role: SUB_INVESTIGATOR, contacts name: Afsheen Nasir, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06368557, orgStudyIdInfo id: 22/59602, briefTitle: Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Region of Southern Denmark, class: OTHER, collaborators name: University of Aarhus, descriptionModule briefSummary: The goal of the randomized controlled trial is to find out if the internet-based therapy (iCBT) intervention CoolMinds, is effective in helping adolescents with anxiety. The adolescents in the study are aged between 12 and 17 years of age, who live in the region of Southern Denmark. They must have an anxiety diagnosis according to theDiagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are:1. If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.2. What effect different degrees of therapist support have on the treatment.Participants will be getting 14 weeks of the iCBT intervention CoolMinds, and they will be asked to answer questionnaires about their mental health before and after the treatment.Researchers will compare three different groups, with 56 adolescents in each group. The first group will receive iCBT with weekly scheduled feedback. The second group will get iCBT with feedback whenever the adolescents ask for it. The last group will be on a waiting list for 14 weeks, before receiving treatment., conditionsModule conditions: Anxiety Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: The RCT is designed as a superiority RCT with the three conditions 1) iCBT with planned feedback 2) iCBT with on-demand feedback and 3) waitlist control. The allocation ratio is 1:1:1 for each condition. The participants will be stratified by aged into the age groups 12-14 years and 15-17 years respectively to secure an even age distribution across conditions. Additionally upon completing session 8 in the program, participants will be randomized to receive or not receive a booster session 12 weeks after finishing the intervention with an allocation ratio of 1:1. The design of the randomized trial is thus factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). Data will be collected with parent and adolescent questionnaires at five time points: pre-treatment, post-treatment and at follow-ups after 3, 6 and 12 months., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: As the study concerns itself with psychotherapy and examines the difference in therapist support, it is practically impossible to blind participants and clinicians, and thus they are not blinded. The research team is involved in the day-to-day operation of the project, including the screening for suicidality, why blinding of the research team is also practically impossible with the current setup. However the analyzes of the trial results will be pseudo-anonymized, so that only the ID number appears on the data sheet in order to get as close to blinding as possible in relation to the research design., enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: CoolMinds: Internet-based cognitive behavioral therapy (iCBT), outcomesModule primaryOutcomes measure: The Youth Online Diagnostic Assessment - Child and Parent Versions, primaryOutcomes measure: Spence Children's Anxiety Scale- Child and Parent Versions, secondaryOutcomes measure: Child Anxiety Life Interference Scale- Child and Parent Version, secondaryOutcomes measure: The Mood and Feelings Questionnaire- Child and Parent Version, secondaryOutcomes measure: Working Alliance Inventory - Short Form, secondaryOutcomes measure: Working Alliance Inventory for Online Interventions, otherOutcomes measure: Children´s Anxiety Scale, otherOutcomes measure: The Short Mood and Feelings questionnaire, otherOutcomes measure: EuroQol-5 Dimension Youth, otherOutcomes measure: Client Satisfaction Questionnaire-8, otherOutcomes measure: Systems Usability Scale, otherOutcomes measure: Negative Effects Questionnaire, otherOutcomes measure: Sociodemographic measures, otherOutcomes measure: Engagement, otherOutcomes measure: Cost-effectiveness, otherOutcomes measure: Cost-effectiveness, otherOutcomes measure: The Anxiety Disorders Interview Schedule for Children, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Centre for Digital Psychiatry, status: RECRUITING, city: Odense, state: Region Of Southern Denmark, zip: 5000, country: Denmark, contacts name: Helene Skaarnes, MSc (psych)), role: CONTACT, phone: +4529649702, email: [email protected], contacts name: Kim Mathiasen, Ph.d., role: CONTACT, phone: +4561677747, email: [email protected], geoPoint lat: 55.39594, lon: 10.38831, hasResults: False |
protocolSection identificationModule nctId: NCT06368544, orgStudyIdInfo id: M2023816, briefTitle: Effect of Early Gait Training on Knee Cartilage Degeneration After Anterior Cruciate Ligament Reconstruction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-07, primaryCompletionDateStruct date: 2030-02-07, completionDateStruct date: 2030-02-07, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for middle-aged people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation., conditionsModule conditions: Anterior Cruciate Ligament Injuries, conditions: Cartilage Degeneration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: lower-body positive-pressure, outcomesModule primaryOutcomes measure: Gait biomechanical data, primaryOutcomes measure: Gait biomechanical data, primaryOutcomes measure: Gait biomechanical data, primaryOutcomes measure: Gait biomechanical data, primaryOutcomes measure: Gait biomechanical data, primaryOutcomes measure: Biochemical characteristics of knee cartilage, primaryOutcomes measure: Biochemical characteristics of knee cartilage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: ren shuang, role: CONTACT, phone: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06368531, orgStudyIdInfo id: 2314270, briefTitle: Long-term Monitoring of Sleep With Ear-EEG in Patients With Chronic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-08-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: University of Aarhus, collaborators name: T&W Engineering A/S, descriptionModule briefSummary: Insomnia is reported by more than 50% of patients with chronic pain. In this study, the investigators aim to advance the understanding of physiological sleep in individuals with chronic pain. To do this the investigators will monitor at-home sleep with an ear-EEG over 20 nights in patients with chronic pain and collect self-reported measures of sleep and pain. The collected data will be used to explore and characterize intra-individual variations in sleep metrics (e.g. total sleep time, time in each sleep stage (N1, N2, N3, REM), sleep latency, REM stage latency, wake after sleep onset, sleep efficiency, number of arousals and arousal index) over 20 nights., conditionsModule conditions: Chronic Pain, conditions: Insomnia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, outcomesModule primaryOutcomes measure: sleep period time (SPT) from Ear EEG, primaryOutcomes measure: Qualitative sleep parameters obtained from sleep diary., primaryOutcomes measure: Pain intensity rating, primaryOutcomes measure: Time from sleep onset until final awakening (TST) from Ear EEG, primaryOutcomes measure: Sleep efficiency (SE) from Ear EEG, primaryOutcomes measure: Sleep onset latency (SOL) from Ear EEG, primaryOutcomes measure: Wake after sleep onset (WASO) from Ear EEG, primaryOutcomes measure: REM sleep latency from Ear EEG, primaryOutcomes measure: Time from sleep onset until first epoch of REM stage sleep from Ear EEG, primaryOutcomes measure: Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG, primaryOutcomes measure: Number of awakenings within TST from Ear EEG, primaryOutcomes measure: Arousal index which is number of arousals per hour from Ear EEG, secondaryOutcomes measure: Ease-of-use and Comfort with ear EEG, secondaryOutcomes measure: Adverse device effects, secondaryOutcomes measure: Polysomnography, otherOutcomes measure: Sleep quality, otherOutcomes measure: Insomnia, otherOutcomes measure: The Graded Chronic Pain Scale Revised, otherOutcomes measure: Age, otherOutcomes measure: Sex, otherOutcomes measure: Ethnicity, otherOutcomes measure: Height, otherOutcomes measure: Weight, otherOutcomes measure: Level of education, otherOutcomes measure: Obstructive sleep apnea, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense, status: RECRUITING, city: Odense, zip: 5000, country: Denmark, contacts name: Henrik B Vaegter, PhD, role: CONTACT, phone: 004565413869, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False |
protocolSection identificationModule nctId: NCT06368518, orgStudyIdInfo id: ID01/2024/MZHCM-Reg/NV, briefTitle: Austrian HCM Registry, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2034-03, completionDateStruct date: 2034-03, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, descriptionModule briefSummary: The Austrian Hypertrophic Cardiomyopathy (HCM) Registry is a prospective, multicenter registry enrolling patients at multiple outpatient clinics across Austria including academic and non-academic centers. Patients will undergo a structured examination process including assessment for symptoms of HCM, past medical history, concomitant medication, family history and the presence of HCM-specific red flags. Furthermore, clinical data derived from electrocardiogram, echocardiography, laboratory analysis, and genetic testing will be collected focusing on a lean variable dictionary and, in addition, specific hypothesis-driven research parameters. All data are entered into an electronic case report form (eCRF) (Phoenix Clinical Trial Management System). In order to perform multicenter analyses, data can be extracted from the eCRF after approval by the steering committee., conditionsModule conditions: Hypertrophic Cardiomyopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: All cause mortality, primaryOutcomes measure: Cardiovascular events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Graz, status: RECRUITING, city: Graz, state: Styria, zip: 8036, country: Austria, contacts name: Nicolas Verheyen, MD, PHD, role: CONTACT, phone: 004331638530173, email: [email protected], contacts name: Viktoria Santner, MD, role: CONTACT, email: [email protected], contacts name: Nicolas Verheyen, MD, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.06667, lon: 15.45, hasResults: False |
protocolSection identificationModule nctId: NCT06368505, orgStudyIdInfo id: R.24.02.2506.R1, briefTitle: Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2024-06-16, completionDateStruct date: 2024-07-16, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Osama Ahmed Elshafei, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. The main questions it aims to answer are:* Which modality is more effective in reducing symptoms and improving function in patients with Carpal tunnel syndrome* Asses safety profile of both methodsParticipants will:* Randomized to one of the two arms* Visit the clinic 1 and 3 months after intervention* Assessed for efficacy and safety of the intervention, conditionsModule conditions: Carpal Tunnel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: ultrasound guided PRP injection, interventions name: ultrasound guided hydrodissection, outcomesModule primaryOutcomes measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), primaryOutcomes measure: The visual analog scale (VAS), secondaryOutcomes measure: The cross-sectional area (CSA) of the Median nerve, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mansoura University, status: RECRUITING, city: Mansoura, zip: 35511, country: Egypt, contacts name: osama elshafei, MD PHD, role: CONTACT, email: [email protected], contacts name: Dena El-Ghzzawy, role: CONTACT, email: [email protected], contacts name: Dena El-Ghzzawy, MD, role: SUB_INVESTIGATOR, contacts name: OSAMA ELSHAFEI, MD PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False |
protocolSection identificationModule nctId: NCT06368492, orgStudyIdInfo id: P137, secondaryIdInfos id: 2021-002909-10, type: EUDRACT_NUMBER, secondaryIdInfos id: NL78008.068.21, type: OTHER, domain: METC azM/Maastricht University, briefTitle: The Impact of Psilocybin on Pain in Fibromyalgia Patients, acronym: PsiloFM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Maastricht University, class: OTHER, collaborators name: Leiden University Medical Center, descriptionModule briefSummary: Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions.Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients.Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients.Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: double-blind, randomized, within-subjects, placebo-controlled design., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Blinding will be handled by one of the study pharmacies and order and allocation of the treatment to each participant will be completely randomized. This setup ensures that neither the participant nor the experimenter running the test day will be aware of the contents of the capsule., enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, interventions name: Hypnosis script, outcomesModule primaryOutcomes measure: Ischemic Pain perception, primaryOutcomes measure: Pressure-evoked Pain perception, primaryOutcomes measure: Self-reported pain, secondaryOutcomes measure: Subjective effects: psychedelic phenomenology, secondaryOutcomes measure: Subjective effects: mood, secondaryOutcomes measure: Subjective effects: intensity of effects, secondaryOutcomes measure: Subjective effects: Ego dissolution, secondaryOutcomes measure: Subjective effects: Dissociation, secondaryOutcomes measure: Psychiatric symptoms, secondaryOutcomes measure: Cognitive performance, secondaryOutcomes measure: Vigilance, secondaryOutcomes measure: Empathy, secondaryOutcomes measure: Creativity, secondaryOutcomes measure: Creativity, secondaryOutcomes measure: Autobiographical memory, secondaryOutcomes measure: Autobiographical memory, secondaryOutcomes measure: Treatment expectancy, secondaryOutcomes measure: Treatment expectancy, secondaryOutcomes measure: Fibromyalgia-related pain, secondaryOutcomes measure: Personality, secondaryOutcomes measure: Absorption, secondaryOutcomes measure: Interpersonal Reactivity, secondaryOutcomes measure: Depression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University, city: Maastricht, state: Limburg, zip: 6226AK, country: Netherlands, contacts name: Mauro Cavarra, MSc, role: CONTACT, phone: +313494438261, email: [email protected], geoPoint lat: 50.84833, lon: 5.68889, locations facility: Leiden University Medical Center, city: Leiden, state: South Holland, zip: 2333, country: Netherlands, contacts name: Monique van Velzen, PhD, role: CONTACT, email: [email protected], geoPoint lat: 52.15833, lon: 4.49306, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-09-08, uploadDate: 2023-10-30T07:36, filename: Prot_SAP_000.pdf, size: 673739, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-10-10, uploadDate: 2023-10-30T07:38, filename: ICF_001.pdf, size: 451492, hasResults: False |
protocolSection identificationModule nctId: NCT06368479, orgStudyIdInfo id: CLS-016B, briefTitle: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: bioLytical Laboratories, class: INDUSTRY, descriptionModule briefSummary: A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care., conditionsModule conditions: Hepatitis B, conditions: Hepatitis B Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 4400, type: ESTIMATED, armsInterventionsModule interventions name: iStatis HBsAg Test, outcomesModule primaryOutcomes measure: iStatis Performance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Epicentre Health Research, status: RECRUITING, city: Hillcrest, state: Kwazulu Natal, zip: 3650, country: South Africa, contacts name: Cherie Cawood, role: CONTACT, phone: +27828202955, email: [email protected], hasResults: False |
protocolSection identificationModule nctId: NCT06368466, orgStudyIdInfo id: CLS-016A, briefTitle: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: bioLytical Laboratories, class: INDUSTRY, collaborators name: St Vincent's Hospital Melbourne, descriptionModule briefSummary: A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare professional. The collected samples of capillary and EDTA whole blood are tested on iStatis and EDTA whole blood sample will be processed to obtain serum and plasma samples to be tested on the iStatis. An aliquot of the collected serum sample will be shipped to the central laboratory for confirmatory testing. The results from iStatis HBsAg Test results will not be used for patient management decisions., conditionsModule conditions: Hepatitis B, conditions: Hepatitis B Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: iStatis HBsAg Test, outcomesModule primaryOutcomes measure: Performance, primaryOutcomes measure: Sensitivity and Specificity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Vincent's Hospital, Melbourne, city: Melbourne, state: Fitzroy Victoria, zip: 3065, country: Australia, contacts name: Alex Thompson, role: CONTACT, geoPoint lat: -37.814, lon: 144.96332, hasResults: False |
protocolSection identificationModule nctId: NCT06368453, orgStudyIdInfo id: CLS-003, briefTitle: A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: bioLytical Laboratories, class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing.The study aims to:To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test., conditionsModule conditions: Human Immunodeficiency Virus I Infection, conditions: Human Immunodeficiency Virus II Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 1700, type: ESTIMATED, armsInterventionsModule interventions name: INSTI® HIV Self-Test, outcomesModule primaryOutcomes measure: Clinical sensitivity and specificity of the INSTI® HIV Self-Test, secondaryOutcomes measure: The INSTI® HIV Self-Test usability and result interpretation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368440, orgStudyIdInfo id: D7860C00003, briefTitle: A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-10-04, completionDateStruct date: 2024-10-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: AZD6793, interventions name: AZD6793, interventions name: Placebo, outcomesModule primaryOutcomes measure: Part 1 (SAD): Number of Participants with Adverse Events, primaryOutcomes measure: Part 2 (MAD): Number of Participants with Adverse Events, secondaryOutcomes measure: Part 1 (SAD) : Maximum Observed Plasma Drug Concentration, secondaryOutcomes measure: Part 1 (SAD): Time to Reach Peak Concentration (tmax), secondaryOutcomes measure: Part 1 (SAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz), secondaryOutcomes measure: Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz), secondaryOutcomes measure: Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 12 (AUC[0-12]), secondaryOutcomes measure: Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]), secondaryOutcomes measure: Part 1 (SAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast), secondaryOutcomes measure: Part 1 (SAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf), secondaryOutcomes measure: Part 1 (SAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F), secondaryOutcomes measure: Part 1 (SAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F), secondaryOutcomes measure: Part 1 (SAD): Dose Normalized AUClast, secondaryOutcomes measure: Part 1 (SAD): Dose Normalized AUCinf, secondaryOutcomes measure: Part 1 (SAD): Dose Normalized Cmax, secondaryOutcomes measure: Part 2 (MAD): Maximum Observed Plasma Drug Concentration (Cmax), secondaryOutcomes measure: Part 2 (MAD) : Concentration at the End of The Dosing Interval (Ctrough), secondaryOutcomes measure: Part 2 (MAD): Temporal Change Parameter (TCP), secondaryOutcomes measure: Part 2 (MAD): Time to Reach Peak Concentration (tmax), secondaryOutcomes measure: Part 2 (MAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz), secondaryOutcomes measure: Part 2 (MAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz), secondaryOutcomes measure: Part 2 (MAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]), secondaryOutcomes measure: Part 2 (MAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast), secondaryOutcomes measure: Part 2 (MAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf), secondaryOutcomes measure: Part 2 (MAD): Area Under Plasma Concentration-Time Curve in The Dosing Interval Tau (AUCtau), secondaryOutcomes measure: Part 2 (MAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F), secondaryOutcomes measure: Part 2 (MAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F), secondaryOutcomes measure: Part 2 (MAD): Dose Normalized AUClast, secondaryOutcomes measure: Part 2 (MAD): Dose Normalized AUCtau, secondaryOutcomes measure: Part 2 (MAD): Dose Normalized Cmax, secondaryOutcomes measure: Part 2 (MAD): Ratio of the Area Under the Curve (Rac AUC), secondaryOutcomes measure: Part 2 (MAD): Accumulation Ratio Based on Cmax (Rac Cmax), secondaryOutcomes measure: Part 2 (MAD): Amount of Unchanged Drug Excreted into Urine from Time t1 to Time t2 (Ae[t1-t2]), secondaryOutcomes measure: Part 2 (MAD): Cumulative Amount of Unchanged Drug Excreted into Urine (Aeinf), secondaryOutcomes measure: Part 2 (MAD): Renal Clearance (CLR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Research Site, city: Glendale, state: California, zip: 91206, country: United States, geoPoint lat: 34.14251, lon: -118.25508, hasResults: False |
protocolSection identificationModule nctId: NCT06368427, orgStudyIdInfo id: D5980R00100, briefTitle: Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD, acronym: COnCORD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to describe patients' clinical and self-reported outcomes of treatment with budesonide / glycopyrronium / formoterol Metered dose inhaler (BGF MDI) in Romania in real-life setting, up to 6 month of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks (3 months) of treatment with no pre-defined hypothesis., conditionsModule conditions: Chronic Obstructive Pulmonary Disease (COPD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: budesonide / glycopyrronium / formoterol, outcomesModule primaryOutcomes measure: Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score, secondaryOutcomes measure: Change from baseline to 6 months in the CAT score, secondaryOutcomes measure: Treatment Satisfaction Questionnaire for Medication (TSQM) scores after 12 weeks and 6 months of treatment, secondaryOutcomes measure: Percent responders of the CAT [MID=2] after 12 weeks of treatment, secondaryOutcomes measure: Proportion of days covered (PDC) Time to discontinuation Reasons for treatment discontinuation, secondaryOutcomes measure: Drivers for initiation or switch to BGF MDI via physician questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368414, orgStudyIdInfo id: KCMLWP-2021-04, briefTitle: A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia, acronym: AsterA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2028-08-31, completionDateStruct date: 2028-08-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Korean Society of Hematology, class: NETWORK, descriptionModule briefSummary: To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI, conditionsModule conditions: Chronic Myeloid Leukemia, Chronic Phase, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: Asciminib, outcomesModule primaryOutcomes measure: MR3.0 or less by 1 year, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-21, uploadDate: 2024-04-11T22:40, filename: Prot_000.pdf, size: 903002, largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-21, uploadDate: 2024-04-11T22:40, filename: Prot_001.pdf, size: 903226, hasResults: False |
protocolSection identificationModule nctId: NCT06368401, orgStudyIdInfo id: TP_01428, briefTitle: A First in Human Study for the Versa Device for Tricuspid Regurgitation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Versa Vascular, Inc, class: INDUSTRY, descriptionModule briefSummary: This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates., conditionsModule conditions: Tricuspid Regurgitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Versa Implant, outcomesModule primaryOutcomes measure: Acute Procedural Success, primaryOutcomes measure: Incidence of major adverse events (MAE), secondaryOutcomes measure: Tricuspid Regurgitation Severity Change, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Auckland City Hospital, city: Auckland, country: New Zealand, contacts name: Mark Webster, MD, role: CONTACT, geoPoint lat: -36.84853, lon: 174.76349, hasResults: False |
protocolSection identificationModule nctId: NCT06368388, orgStudyIdInfo id: S64854, briefTitle: Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force, acronym: PHAGEFORCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: KU Leuven, descriptionModule briefSummary: PHAGEFORCE is a prospective, observational registry study. The University Hospitals Leuven has approved the application of phage therapy as standard-of-care only in patients for whom no curative treatment alternatives (antibiotic and/or surgical) are available ('last-resort cases'). A multidisciplinary phage task force, referred to as the Coordination group for Bacteriophage therapy Leuven (CBL) was set up. The CBL screens patients with difficult-to-treat infections, evaluates who could benefit from phage therapy and sets up the treatment protocol. With this study, the CBL aims to gain insight in the safety and efficacy of phage therapy by integrating and optimizing phage therapy in five distinct medical disciplines (with distinct routes of administration), facilitating long-term follow-up of patients. Furthermore, this study will gain insight in the biodistribution and exact mechanisms of action of phage therapy and thus be able to provide standardized guidelines for each patient population and route of administration., conditionsModule conditions: Musculoskeletal Infection, conditions: Chronic Rhinosinusitis (Diagnosis), conditions: Sepsis, conditions: Pulmonary Infection, conditions: Hidradenitis Suppurativa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Prospective data collection, interventions name: Prospective data collection, outcomesModule primaryOutcomes measure: Disease free period, primaryOutcomes measure: Bacterial eradication, secondaryOutcomes measure: PROMIS global health (patient-reported outcome measurement information system), secondaryOutcomes measure: PROMIS (patient-reported outcome measurement information system) physical function, secondaryOutcomes measure: PROMIS (patient-reported outcome measurement information system) pain interference, secondaryOutcomes measure: Sino-nasal outcome test (SNOT)-22, secondaryOutcomes measure: Visual Analogue Scale (VAS) score, secondaryOutcomes measure: Cystic fibrosis questionnaire (CF-Q-R), secondaryOutcomes measure: Dermatology Life Quality Index (DLQI), secondaryOutcomes measure: Hidradenitis Suppurativa Quality of Life (HiSQoL), otherOutcomes measure: Rate of exacerbations, otherOutcomes measure: Abscess and inflammatory nodule (AN) count with Hidradenitis suppurativa Clinical Response (HiSCR), otherOutcomes measure: Lund-Mackay CT score, otherOutcomes measure: Lund Kennedy endoscopy score, otherOutcomes measure: Modified Davos score, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Leuven, status: RECRUITING, city: Leuven, zip: 3000, country: Belgium, contacts name: Jolien Onsea, PhD, role: CONTACT, phone: 003216342041, email: [email protected], contacts name: Willem-Jan Metsemakers, MD, PhD, role: CONTACT, phone: 003216344277, email: [email protected], contacts name: Willem-Jan Metsemakers, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False |
protocolSection identificationModule nctId: NCT06368375, orgStudyIdInfo id: PRPF31-3102022BO2, briefTitle: Clinical and Genetic Findings in Patients With PRPF31-associated Retinitis Pigmentosa, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: Retrospective chart review study to elucidate the genotype and phenotype of patients with PRPF31-associated retinitis pigmentosa and asymptomatic carriers of the respective variant(s), conditionsModule conditions: Retinitis Pigmentosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 87, type: ACTUAL, outcomesModule primaryOutcomes measure: Best Corrected Visual Acuity (BCVA), primaryOutcomes measure: Visual Field (VF), primaryOutcomes measure: Fundus Photography (FP), primaryOutcomes measure: Optos, primaryOutcomes measure: Autofluorescence (AF), primaryOutcomes measure: Optical Coherence Tomography (OCT), primaryOutcomes measure: Full-Field Electroretinogram (ff-ERG), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Tuebingen, city: Tuebingen, state: Baden-Wuerttemberg, zip: 72076, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False |
protocolSection identificationModule nctId: NCT06368362, orgStudyIdInfo id: CBM-I001, briefTitle: Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-17, primaryCompletionDateStruct date: 2021-05-01, completionDateStruct date: 2021-05-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Southampton, class: OTHER, collaborators name: Economic and Social Research Council, United Kingdom, descriptionModule briefSummary: Cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign, rather than interpret it as being related to pain. The goal of this randomised controlled trial was to explore the feasibility and potential clinical benefits of CBM-I in people with chronic pain and also healthy, pain-free individuals., conditionsModule conditions: Chronic Pain, conditions: Musculoskeletal Pain Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups of participants (chronic musculoskeletal pain, healthy) were recruited, and within each group participants were randomised to one of two experimental conditions with a 1:1 allocation ratio with a parallel design. Participants with chronic musculoskeletal pain were randomised to benign CBM-I or no CBM-I, and healthy participants were randomised to benign CBM-I or pain-related CBM-I., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants are not informed of the conditioned they are randomised to in this psychological intervention., whoMasked: PARTICIPANT, enrollmentInfo count: 84, type: ACTUAL, armsInterventionsModule interventions name: Benign cognitive bias modification for interpretation, interventions name: Pain-related cognitive bias modification for interpretation, outcomesModule primaryOutcomes measure: Emotional response to exercise induced pain, primaryOutcomes measure: Emotional response to pain-related images, secondaryOutcomes measure: Fear of Pain, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Emotional response to average clinical pain, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Pain interference, secondaryOutcomes measure: Pain-related interpretation bias index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Southampton, city: Southampton, state: Hampshire, zip: SO17 1BJ, country: United Kingdom, geoPoint lat: 50.90395, lon: -1.40428, hasResults: False |
protocolSection identificationModule nctId: NCT06368349, orgStudyIdInfo id: 202101771B0, briefTitle: Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-06-21, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed. In a prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry., conditionsModule conditions: Lymphopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 190, type: ACTUAL, outcomesModule primaryOutcomes measure: Persistent lymphopenia predict poor overall survival, primaryOutcomes measure: T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient, primaryOutcomes measure: Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Surgery, city: Kaohsiung, zip: 833, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-10-20, uploadDate: 2024-04-11T03:02, filename: Prot_SAP_000.pdf, size: 422513, hasResults: False |
protocolSection identificationModule nctId: NCT06368336, orgStudyIdInfo id: 994894, briefTitle: Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study., statusModule overallStatus: COMPLETED, startDateStruct date: 2008-01-01, primaryCompletionDateStruct date: 2022-04-01, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Uppsala University Hospital, class: OTHER, collaborators name: Sepsisfonden, descriptionModule briefSummary: The study aims to map the health-related quality of life (HRQoL) after intensive care for Sepsis with the hypothesis that it will be lower than that in the general population. The investigators also want to identify factors that are associated with low HRQoL, to see if those are available for interventions from the health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (ICU)., conditionsModule conditions: Sepsis, conditions: Septic Shock, conditions: Sepsis, Severe, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 210484, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis, secondaryOutcomes measure: Ability to work before and after ICU (intensive care unit) treatment for Sepsis, secondaryOutcomes measure: The burden of disease at ICU (intensive care unit) admittance and after ICU treatment for Sepsis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368323, orgStudyIdInfo id: H-01-24-9931, briefTitle: Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Ottawa, class: OTHER, collaborators name: Toronto Metropolitan University, collaborators name: Université de Montréal, collaborators name: Université du Québec à Trois-Rivières, collaborators name: University of South Florida, descriptionModule briefSummary: The goal of this randomized controled trial is to test the effects of assigning people with chronic post-stroke aphasia to 12 weekly choir sessions, compared to usual care.The main question it aims to answer is:Does the assignment to a choir singing program causes a beneficial effect on functional communication and language recovery as well as psychosocial outcomes compared to usual care in the rehabilitation of people with chronic post-stroke aphasia?Participants will have:12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master, and home singing training (3 x 30-minutes-sessions/week, total 18h), conditionsModule conditions: Aphasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A parallel group randomized trial design with a secondary crossover extension, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcomes will be measured by blinded assessors where possible, using blinded video or audio recordings., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Choir singing, interventions name: Usual care, outcomesModule primaryOutcomes measure: Communication Index, secondaryOutcomes measure: Level of confidence in communication, secondaryOutcomes measure: Aphasia severity index, secondaryOutcomes measure: Speech and language in functional communication, secondaryOutcomes measure: Apraxia of speech severity, secondaryOutcomes measure: Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39), secondaryOutcomes measure: Emotional wellbeing, secondaryOutcomes measure: Social participation, secondaryOutcomes measure: Generic measure of health, secondaryOutcomes measure: Appetence to music, secondaryOutcomes measure: Singing voice abilities, otherOutcomes measure: Voice - Pitch, otherOutcomes measure: Voice - Maximum Phonation Time, otherOutcomes measure: Voice - Dynamic range, otherOutcomes measure: Mood, otherOutcomes measure: Biosocial indexes, otherOutcomes measure: Expectations on a 100-scale, otherOutcomes measure: Satisfaction on a 100-scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of South Florida, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33620, country: United States, contacts name: Jennifer Bugos, Ph.D., role: CONTACT, email: [email protected], geoPoint lat: 27.94752, lon: -82.45843, locations facility: University of Ottawa, status: RECRUITING, city: Ottawa, state: Ontario, zip: K1N 6N5, country: Canada, contacts name: Anna Zumbansen, PhD, role: CONTACT, phone: 613-562-5800, phoneExt: 8393, email: [email protected], contacts name: Narges Bayat, Master, role: CONTACT, phone: 613-562-5800, phoneExt: 8393, email: [email protected], geoPoint lat: 45.41117, lon: -75.69812, locations facility: Toronto Metropolitan University, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M5B 0C3, country: Canada, contacts name: Arla Good, Ph.D., role: CONTACT, email: [email protected], geoPoint lat: 43.70011, lon: -79.4163, locations facility: Université de Montréal, status: NOT_YET_RECRUITING, city: Montréal, state: Quebec, zip: H3C 3J7, country: Canada, contacts name: Carole Anglade, Ph.D., role: CONTACT, email: [email protected], geoPoint lat: 45.50884, lon: -73.58781, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-16, uploadDate: 2024-04-10T11:45, filename: ICF_000.pdf, size: 129388, hasResults: False |
protocolSection identificationModule nctId: NCT06368310, orgStudyIdInfo id: R124807, secondaryIdInfos id: 23/WM/0166, type: OTHER, domain: NHS Research Ethics Committee Reference, briefTitle: FIH Clinical Investigation of Graphene Electrodes for Brain Mapping, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-28, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Manchester, class: OTHER, collaborators name: Northern Care Alliance NHS Foundation Trust, collaborators name: European Commission, collaborators name: Inbrain Neuroelectronics, descriptionModule briefSummary: The goal of this clinical investigation of a medical device is to test the safety of graphene based electrodes when used during surgery for resection of brain tumors. The main questions that it aims to answer are:* To understand the safety of these new electrodes when used during brain tumor surgery (primary objective);* To assess the quality of the brain signals recorded with the new electrodes, their ability to stimulate the brain, how stable their function is over the duration of an operation, and their suitability for use in the operating theatre (secondary objectives).Participants will undergo tumor surgery as usual with the study electrodes being tested alongside a standard monitoring system. If they are awake for part of their surgery they may be asked to complete specific tasks such as naming objects from a list modified for the study. They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery., conditionsModule conditions: Brain Tumor, conditions: Glioma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: INBRAIN Graphene Cortical Interface, outcomesModule primaryOutcomes measure: To evaluate the preliminary safety of the investigational device for its intended use, secondaryOutcomes measure: Assess the ability of the device to record signals from the brain, secondaryOutcomes measure: Evaluate the ability of the device to provide functional stimulation of the brain, secondaryOutcomes measure: Assess stability of sensing and stimulating electrodes, secondaryOutcomes measure: Evaluate device usability - an assessment by questionnaire of the operating surgeon's impression of the suitability of the device for sensing and stimulation during brain tumor surgery, otherOutcomes measure: Assess the quality of the recorded somatosensory evoked potentials (SEPs) - sensing part A (exploratory), otherOutcomes measure: Assess the quality of the recorded baseline brain activity - sensing part B (exploratory), otherOutcomes measure: Assess the ability of detecting brain evoked responses during stimulation of the brain (exploratory), otherOutcomes measure: Evaluate decoding capability from data recorded during language task (exploratory), otherOutcomes measure: Evaluate signal characteristics of tumour infiltrated brain regions (exploratory), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, city: Salford, state: Greater Manchester, zip: M6 8HD, country: United Kingdom, contacts name: Hannah Howlett, role: CONTACT, email: [email protected], contacts name: David J Coope, PhD FRCS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.48771, lon: -2.29042, hasResults: False |
protocolSection identificationModule nctId: NCT06368297, orgStudyIdInfo id: BSERE22-APP007-FED, briefTitle: The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Macau, class: OTHER, descriptionModule briefSummary: This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses., conditionsModule conditions: Overweight and Obesity, conditions: Cognitive Change, conditions: Psychophysiologic Reaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Ketone Monoester Supplementation, interventions name: Ketogenic diet, outcomesModule primaryOutcomes measure: Brain Plasticity, primaryOutcomes measure: Grey Matter Volume, primaryOutcomes measure: Cortical Thickness, primaryOutcomes measure: Blood-Oxygen-Level-Dependent (BOLD) Signal Changes, secondaryOutcomes measure: Blood Glucose, secondaryOutcomes measure: Blood Beta-Hydroxybutyrate, secondaryOutcomes measure: Blood Insulin, secondaryOutcomes measure: Leptin, secondaryOutcomes measure: Ghrelin, secondaryOutcomes measure: Brain-Derived Neurotrophic Factor, secondaryOutcomes measure: Reaction Time of Attention Network Test, secondaryOutcomes measure: Accuracy of Attention Network Test, secondaryOutcomes measure: Reaction Time of Stroop Task, secondaryOutcomes measure: Accuracy of Stroop Task, secondaryOutcomes measure: Reaction Time of N-back Task, secondaryOutcomes measure: Accuracy of N-back Task, secondaryOutcomes measure: Cerebral Hemoglobin Concentration, secondaryOutcomes measure: Height in Kilograms, secondaryOutcomes measure: Weight in Meters, secondaryOutcomes measure: Body Fat Percentage, secondaryOutcomes measure: Fat Mass, secondaryOutcomes measure: Muscle Mass, secondaryOutcomes measure: Body Water, secondaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Skinfold Thickness, secondaryOutcomes measure: Maximal Oxygen Uptake, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368284, orgStudyIdInfo id: IRB-MTP_2022_09_202201170, briefTitle: Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results, acronym: TP-JET, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023.Aims of the study were to describe the initial management of the patients and to evaluate the digestive, urological and sexual functional outcomes as well as the quality of life, using validated questionnaires commonly employed in clinical practice., conditionsModule conditions: Perineum; Tear, Traumatic, conditions: Anal Tear, conditions: Anal Incontinence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident, outcomesModule primaryOutcomes measure: Rate of fecal incontinence, secondaryOutcomes measure: Rate of permanent stoma, secondaryOutcomes measure: Rate of acontractile bladder, secondaryOutcomes measure: Rate of sexual dysfunction, secondaryOutcomes measure: Rate of impact on quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Montpellier, status: RECRUITING, city: Montpellier, zip: 34295, country: France, contacts name: Thomas BARDOL, MD, role: CONTACT, phone: 04 67 33 90 69, email: [email protected], geoPoint lat: 43.61092, lon: 3.87723, hasResults: False |
protocolSection identificationModule nctId: NCT06368271, orgStudyIdInfo id: Lipidomix, briefTitle: Acute Effects of Dietary Medium-chain Fatty Acids on Lipid Profile, acronym: Lipidomix, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, descriptionModule briefSummary: In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover., conditionsModule conditions: Healthy Nutrition, conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study is a randomized, double-blinded crossover design. Participants ingest Medium-chain-fatty acids (MCT) or Long-chain fatty acids (LCT) oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consume a eucaloric control diet, and abstain from alcohol and vigorous physical activity to ensure similar conditions on experimental days., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ACTUAL, armsInterventionsModule interventions name: Lipidomics, outcomesModule primaryOutcomes measure: Meal test including medium-chain fatty acids, secondaryOutcomes measure: Resting metabolic rate, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Copenhagen, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Department of Nutrition, Exercise and Sports, city: Copenhagen, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False |
protocolSection identificationModule nctId: NCT06368258, orgStudyIdInfo id: Curr-RYR2023, briefTitle: Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-05-02, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Bologna, class: OTHER, descriptionModule briefSummary: The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk\>1% but \< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \>115 mg/dL, \< 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated., conditionsModule conditions: Hypercholesterolemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Red yeast rice, interventions name: Placebo, outcomesModule primaryOutcomes measure: Treatment-dependent change in LDL-C, secondaryOutcomes measure: Treatment-dependent change in Total Cholesterol, secondaryOutcomes measure: Treatment-dependent change in Non-HDL-C, secondaryOutcomes measure: Treatment-dependent change in liver parameters, secondaryOutcomes measure: Treatment-dependent change in CPK plasma levels, secondaryOutcomes measure: Treatment-dependent change in plasma proteomic pattern, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AOU Policlinico S.Orsola-Malpighi, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False |
protocolSection identificationModule nctId: NCT06368245, orgStudyIdInfo id: SMART, briefTitle: Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-15, primaryCompletionDateStruct date: 2027-12-15, completionDateStruct date: 2029-07-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: AO Foundation, AO Spine, class: OTHER, descriptionModule briefSummary: This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites., conditionsModule conditions: Spinal Fusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1244, type: ESTIMATED, armsInterventionsModule interventions name: long-segment posterior TL instrumented fusion, outcomesModule primaryOutcomes measure: Rod fracture (RF), secondaryOutcomes measure: Time to rod fracture, secondaryOutcomes measure: Time to rod fracture, secondaryOutcomes measure: Configurations of supplementary rod constructs, secondaryOutcomes measure: Treatment for rod fracture, secondaryOutcomes measure: Recurrent RFs, secondaryOutcomes measure: Other mechanical failures, secondaryOutcomes measure: Surgical complications, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Minnesota Medical Center, city: Minneapolis, state: Minnesota, zip: 55454, country: United States, contacts name: David Polly, MD, role: CONTACT, email: [email protected], geoPoint lat: 44.97997, lon: -93.26384, locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22908, country: United States, contacts name: Justin S Smith, MD, PhD, role: CONTACT, phone: 434-243-6339, email: [email protected], contacts name: Judith G Beenhakker, role: CONTACT, email: [email protected], geoPoint lat: 38.02931, lon: -78.47668, hasResults: False |
protocolSection identificationModule nctId: NCT06368232, orgStudyIdInfo id: 19.036.123.125, briefTitle: Nutritional Status After Sleeve Gastrectomy in Morbid Obesity: 6-Month Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-15, primaryCompletionDateStruct date: 2023-04-15, completionDateStruct date: 2023-04-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the nutritional status of morbidly obese patients following gastric bypass surgery. Data from 76 patients aged 19-64, who will be monitored by a dietitian for at least six months, will be analyzed. Preoperative and postoperative biochemical parameters along with anthropometric measurements will assess., conditionsModule conditions: Bariatric Surgery Candidate, conditions: Gastrostomy, conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 76, type: ACTUAL, armsInterventionsModule interventions name: püPatients undergoing bariatric surgery, outcomesModule primaryOutcomes measure: Body Weight, primaryOutcomes measure: BMI (Body Mass Index), primaryOutcomes measure: Lean Mass, primaryOutcomes measure: Fat Mass, primaryOutcomes measure: Fasting Blood Glucose, primaryOutcomes measure: HbA1c, primaryOutcomes measure: Iron levels, primaryOutcomes measure: Vitamin D level, primaryOutcomes measure: Lipid Profile (Triglycerides, LDL, HDL), eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ankara Yıldırım Beyazıt University, city: Ankara, zip: 06760, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06368219, orgStudyIdInfo id: 0108161, briefTitle: Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:* Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)* Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups.the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events, conditionsModule conditions: Procedural Sedation, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ketamine- midazolam versus ketamine- propofol, outcomesModule primaryOutcomes measure: Induction and recovery time for both combinations, secondaryOutcomes measure: incidence and severity of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368206, orgStudyIdInfo id: OBPM_Calfree2024, briefTitle: Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device at Fingertip (Aktiia G2C) Against Double Auscultation, and Comparison With Oscillometry and Aktiia Bracelet G2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Aktiia SA, class: INDUSTRY, descriptionModule briefSummary: The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to evaluate the performances and safety of the Aktiia.product-G2C that doesn't require any calibrations, as compared against double auscultation for BP reference measurements, and finger pulse oximeter for pulse rate reference measurements, for a cohort of subjects characterized by a wide variety of phenotypes., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Investigational device Aktiia G2C, interventions name: Marketed device used as reference for blood pressure monitoring: double auscultation cuff, interventions name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2, interventions name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff, interventions name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff, interventions name: Marketed device used as reference for pulse rate monitoring: pulse finger oximeter, outcomesModule primaryOutcomes measure: Blood pressure mean value of differences, primaryOutcomes measure: Blood pressure standard deviation of differences, secondaryOutcomes measure: Pulse rate root-mean-square error, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHUV, city: Lausanne, zip: 1011, country: Switzerland, geoPoint lat: 46.516, lon: 6.63282, hasResults: False |
protocolSection identificationModule nctId: NCT06368193, orgStudyIdInfo id: Neuralert 001, briefTitle: The Neuralert Stroke Monitor Pilot Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Neuralert Technologies LLC, class: INDUSTRY, descriptionModule briefSummary: This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration. Each monitoring session will consist of wearing a Neuralert device on each arm. For this pilot trial, we are interested in learning about Wi-Fi connectivity, successful data transmission, clinical usability, and tolerability., conditionsModule conditions: Stroke, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Neuralert Monitor, outcomesModule primaryOutcomes measure: Data Aggregation, secondaryOutcomes measure: Time to alarm reception, secondaryOutcomes measure: Time to alarm reponse, secondaryOutcomes measure: Stroke detection, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital of the University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Stephanie Cummings, role: CONTACT, phone: 215-662-3363, email: [email protected], contacts name: Scott Kasner, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06368180, orgStudyIdInfo id: 439106274, briefTitle: The Efficacy of a RAGT & BWSTT on Children With CP, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-30, primaryCompletionDateStruct date: 2021-02-21, completionDateStruct date: 2021-03-08, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: King Saud University, class: OTHER, descriptionModule briefSummary: This study compared the effects of RAGT and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral CP, conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Robotic-assisted gait training Body weight-supported treadmill training, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Robotic assisted gait training, outcomesModule primaryOutcomes measure: Gait spatio-temporal parameters, secondaryOutcomes measure: Six-minute walk test (6MWT), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: King Abdu Aziz Medical City, city: Riyadh, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, hasResults: False |
protocolSection identificationModule nctId: NCT06368167, orgStudyIdInfo id: SHR2554-202, briefTitle: A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Jiangsu HengRui Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma, conditionsModule conditions: Follicular Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: SHR2554, outcomesModule primaryOutcomes measure: Objective response rate (ORR) assessed by independent review committee (IRC), secondaryOutcomes measure: ORR assessed by investigator, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Time to Response, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Cancer Hospital, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Yuqin Song, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06368154, orgStudyIdInfo id: HCHLL-2019-08, briefTitle: Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Hunan Children's Hospital, class: OTHER_GOV, descriptionModule briefSummary: Metabolic bone disease of prematurity (MBDP) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. The early symptoms of MBDP are insidious, and there is no unified and clear diagnostic method. The diagnosis is mostly based on typical clinical manifestations and X-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. Studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. Several studies have reported the use of plasma or serum microRNAs as molecular markers for early prediction of bone diseases. In our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of microRNAs, and identified differentially expressed micrornas related to bone metabolism. In this study, exosomes were used as carriers, and digital PCR was used to verify the specificity and sensitivity of plasma exosomal microRNA as biomarkers of MBDP in a large sample size. The above biomarkers were compared and verified before and after treatment in children with MBDP. Further revealing plasma exosomal microRNA as a biological indicator for evaluating the efficacy of MBDP may improve the diagnostic level of MBDP, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs., conditionsModule conditions: Exosomes, conditions: Newborn, conditions: Bone Diseases, Metabolic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: exosomes, eligibilityModule sex: ALL, minimumAge: 0 Hours, maximumAge: 72 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Hunan Children's Hospital, status: RECRUITING, city: Changsha, state: Hunan, zip: 410007, country: China, contacts name: yinzhi y liu, master, role: CONTACT, phone: 13467532228, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, hasResults: False |
protocolSection identificationModule nctId: NCT06368141, orgStudyIdInfo id: 2023294, briefTitle: Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer, acronym: NeoCHIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor (ICI) therapy in locally advanced colon cancer. The main questions it aims to answer are:* Does this neoadjuvant chemotherapy increase the pathologic complete response (pCR) of locally advanced colon cancer?* Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer?Participants will receive:* a pre-operative CAPEOX (capecitabine oral + oxaliplatin i.v.)regimen.* a sequential CAPEOX plus Serplulimab regimen.* a standard complete mesocolic excision (CME) operation., conditionsModule conditions: Colon Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Serplulimab, interventions name: Capecitabine, interventions name: Oxaliplatin, outcomesModule primaryOutcomes measure: pathologic complete response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ruijin Hospital, city: Shanghai, state: Shanghai, zip: 200025, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06368128, orgStudyIdInfo id: HS-24_51, briefTitle: Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study, acronym: CLIMB, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Northern Michigan University, class: OTHER, descriptionModule briefSummary: The aim of this pilot study is to determine the effects of a 12-week indoor rock climbing training program on heart health, mental health, and behavioral health in generally healthy adults aged 18-35 years old who do not exercise. Participants will learn to rock climb using ropes on an indoor rock climbing wall and participate in the training program 2-3 days per week for 60 minutes each session over 12 weeks. Health outcomes will be measured at 4 time points over the course of the study (pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, and 24-weeks post-intervention)., conditionsModule conditions: Lifestyle Factors, conditions: Physical Inactivity, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial with participants allocated to either a control or intervention group; comparison between groups and within groups, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Indoor Rock Climbing Exercise Training Program, outcomesModule primaryOutcomes measure: Fasting lipids, primaryOutcomes measure: Fasting glucose, primaryOutcomes measure: Hemoglobin a1c, secondaryOutcomes measure: Physical activity and sedentary behavior, secondaryOutcomes measure: Sedentary behavior bouts (30 min, 60 min, >60 min), secondaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Muscular fitness, secondaryOutcomes measure: Handgrip strength asymmetry, secondaryOutcomes measure: Lower-body dynamic balance, secondaryOutcomes measure: Health-related quality of life using CDC Health-Related Quality of Life Scale, secondaryOutcomes measure: Exercise self-efficacy measured via Self-efficacy for exercise scale, secondaryOutcomes measure: Perceptions of exercise measured via Views and Attitudes Toward Exercise Scale, secondaryOutcomes measure: Perceived stress, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Bone density, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Northern Michigan University, status: RECRUITING, city: Marquette, state: Michigan, zip: 49855, country: United States, contacts name: Lisa Eckert, PhD, role: CONTACT, phone: 906-227-1291, email: [email protected], contacts name: Megan C Nelson, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.54354, lon: -87.39542, hasResults: False |
protocolSection identificationModule nctId: NCT06368115, orgStudyIdInfo id: 00023453, secondaryIdInfos id: 4R33AG069794, type: NIH, link: https://reporter.nih.gov/quickSearch/4R33AG069794, briefTitle: A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2, acronym: DPRESCRIBE-AD2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: National Institute on Aging (NIA), collaborators name: Harvard Pilgrim Health Care, collaborators name: Humana Healthcare Research, Inc., collaborators name: Carelon Research, descriptionModule briefSummary: Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study design will be a prospective, randomized, "open-label" educational intervention trial with three arms: (1) a combined patient/caregiver and provider educational intervention mailed one time; (2) a combined patient/caregiver and provider educational intervention mailed two times; and (3) usual care., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Educational Materials, outcomesModule primaryOutcomes measure: Absence of Inappropriate Medication Prescription Dispensing, secondaryOutcomes measure: Dose Change, secondaryOutcomes measure: Polypharmacy, secondaryOutcomes measure: Rates of Health Care and Emergency Care Utilization, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Switching within Classes, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UMass Chan Medical School, city: Worcester, state: Massachusetts, zip: 01605, country: United States, contacts name: Cassie L Saphirak, role: CONTACT, phone: 508-856-3493, email: [email protected], geoPoint lat: 42.26259, lon: -71.80229, hasResults: False |
protocolSection identificationModule nctId: NCT06368102, orgStudyIdInfo id: R6-03, briefTitle: Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Uji Takeda Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration., conditionsModule conditions: Surgical Site Infection, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Ampicillin, outcomesModule primaryOutcomes measure: Occurrence of surgical site infection, secondaryOutcomes measure: Occurrence of alveolar osteitis, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368089, orgStudyIdInfo id: REC.66-474-30-2, secondaryIdInfos id: MR-PSU:66-30-21-406, type: OTHER_GRANT, domain: Faculty of Medicine, Prince of Songkla University, briefTitle: Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to:1. Compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period.2. Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program., conditionsModule conditions: Ventilator Dependent, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomization, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Inspiratory muscle training (IMT) group, interventions name: Early mobilization (EM) group, outcomesModule primaryOutcomes measure: Maximum inspiratory pressure (MIP), primaryOutcomes measure: Dynamic lung compliance (Cdyn), secondaryOutcomes measure: Weaning time, secondaryOutcomes measure: Weaning outcome, secondaryOutcomes measure: Grip strength, secondaryOutcomes measure: chest wall expansion, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital, city: Songkhla, zip: 90110, country: Thailand, geoPoint lat: 7.19882, lon: 100.5951, hasResults: False |
protocolSection identificationModule nctId: NCT06368076, orgStudyIdInfo id: H-23065096, briefTitle: High-intensity Interval Training in Patients With Spinal Muscular Atrophy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-09, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: Patients with spinal muscular atrophy who are wheelchair users often experience lower back - and gluteal pain, reduced sleep quality, constipation and reduced quality of life - symptoms that regular exercise could potentially alleviate. However, only very little research has been done on exercise for patients who are wheelchair users. The aim of this study is to explore the impact of cycle exercise on patients with spinal muscular atrophy., conditionsModule conditions: Spinal Muscular Atrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Questionnaire on fatigue, primaryOutcomes measure: Questionnaire on pain., primaryOutcomes measure: Questionnaire on constipation, primaryOutcomes measure: Questionnaire on quality of life, primaryOutcomes measure: Questionnaire on sleep quality, secondaryOutcomes measure: Blood sample, secondaryOutcomes measure: Blood sample, secondaryOutcomes measure: Blood sample, secondaryOutcomes measure: Blood sample, secondaryOutcomes measure: Blood sample, secondaryOutcomes measure: Blood sample, secondaryOutcomes measure: Blood sample, secondaryOutcomes measure: Blood sample, secondaryOutcomes measure: Blood sample, secondaryOutcomes measure: Blood sample, secondaryOutcomes measure: MRI scan liver size, secondaryOutcomes measure: MR-elastography, secondaryOutcomes measure: MRI scan liver steatosis, secondaryOutcomes measure: Ultrasound scan, secondaryOutcomes measure: MRI scan, secondaryOutcomes measure: MRI scan, secondaryOutcomes measure: Exercise test, secondaryOutcomes measure: Motorscore, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Sophia Frølich, stud.med, role: CONTACT, phone: + 45 3545 3561, email: [email protected], contacts name: Noémie Receveur, stud.med, role: CONTACT, phone: +4535453561, email: [email protected], geoPoint lat: 55.67594, lon: 12.56553, hasResults: False |
protocolSection identificationModule nctId: NCT06368063, orgStudyIdInfo id: HE-202301, briefTitle: The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Health Science Center of Xi'an Jiaotong University, class: OTHER, collaborators name: LinkDoc Technology (Beijing) Co. Ltd., collaborators name: Huazhong University of Science and Technology, descriptionModule briefSummary: The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer, conditionsModule conditions: Pancreatic Cancer Resectable, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 642, type: ESTIMATED, armsInterventionsModule interventions name: Huaier granule, interventions name: chemotherapy drugs, outcomesModule primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE), secondaryOutcomes measure: The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06368050, orgStudyIdInfo id: IRB00067187.2, briefTitle: Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: Childress Institute, descriptionModule briefSummary: The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein., conditionsModule conditions: Head Injury, conditions: Sport Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: practice structure intervention, outcomesModule primaryOutcomes measure: Number of practice head impacts, primaryOutcomes measure: Number of practice head acceleration events, primaryOutcomes measure: Practice head impact rate, primaryOutcomes measure: Practice head acceleration even rate, primaryOutcomes measure: Median linear acceleration, primaryOutcomes measure: Median rotational acceleration, primaryOutcomes measure: Median rotational velocity, primaryOutcomes measure: 95th percentile linear acceleration, primaryOutcomes measure: 95th percentile rotational acceleration, primaryOutcomes measure: 95th percentile rotational velocity, secondaryOutcomes measure: Feasibility of Intervention Measure (FIM) Values, secondaryOutcomes measure: Acceptability of Intervention Measure (AIM) Values, secondaryOutcomes measure: Number of practices the intervention was implemented as prescribed, secondaryOutcomes measure: Average minutes per practice of live time, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Wake Forest University Health Sciences, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Jill Urban, PhD, MPH, role: CONTACT, phone: 336-716-0947, email: [email protected], contacts name: Konstantia Strates, role: CONTACT, phone: 336-713-1263, email: [email protected], contacts name: Jill Urban, PhD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False |
protocolSection identificationModule nctId: NCT06368037, orgStudyIdInfo id: DragonFire-02, briefTitle: Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Hangzhou Valgen Medtech Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively., conditionsModule conditions: Obstructive Hypertrophic Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: DragonFire Transcatheter Myocardial Radiofrequency Ablation System, outcomesModule primaryOutcomes measure: The rate of freedom from major adverse events at 30 days postoperatively, primaryOutcomes measure: The success rate of treatment at 6 months postoperatively, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Theater Command General Hospital of the Chinese People's Liberation Army, city: Shenyang, country: China, geoPoint lat: 41.79222, lon: 123.43278, hasResults: False |
protocolSection identificationModule nctId: NCT06368024, orgStudyIdInfo id: CL-12-600, briefTitle: Establishment of Delphi-MD Safety Performance and Reliability, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2023-11-28, completionDateStruct date: 2023-11-28, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: QuantalX Neuroscience, class: INDUSTRY, descriptionModule briefSummary: A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as neurophysiological measurements., conditionsModule conditions: Neurologic Disorder, conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 263, type: ACTUAL, armsInterventionsModule interventions name: This is a retrospective analysis study of data collected with a diagnostic medical device, outcomesModule primaryOutcomes measure: Cortical Excitability, primaryOutcomes measure: Specific Peak Amplitudes, primaryOutcomes measure: GMFP, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: QuantalX Neuroscience Ltd., city: Kfar Saba, state: Center, zip: 4453001, country: Israel, geoPoint lat: 32.175, lon: 34.90694, hasResults: False |
protocolSection identificationModule nctId: NCT06368011, orgStudyIdInfo id: MustafaKU-CINCINOGLU-001, briefTitle: The Impact of Acceptance and Commitment Therapy on Stigmatization, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-04-15, primaryCompletionDateStruct date: 2023-07-31, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Mustafa Kemal University, class: OTHER, descriptionModule briefSummary: The goal of study is to determine the effect of acceptance and commitment therapy-based psychoeducation on the level of stigmatization applied to relatives of schizophrenia patients.Type of study: This study was planned as a pretest-posttest quasi-experimental design with an observation and control group.Participants: The population of the study consisted of the relatives of schizophrenia patients who were registered and actively attending the Community Mental Health Center in a state hospital in Ankara.Intervention: Before the psychoeducation process started, personal information form and scales were applied to the relatives of the patients in the experimental and control groups. An ACT-based psychoeducation program consisting of 8 sessions was applied to the experimental group. each session lasted approximately 90 minutes. The control group did not receive any intervention. After the psychoeducation, the scales were reapplied to the experimental and control groups. In addition, the experimental group was asked to fill out the psychoeducation evaluation form. The scales were reapplied to the experimental group after the 1-month follow-up study and evaluated., conditionsModule conditions: Stigmatization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: acceptance and commitment therapy, outcomesModule primaryOutcomes measure: Stigma Scale for Relatives of Patients with Schizophrenia, primaryOutcomes measure: Stigma Scale for Relatives of Patients with Schizophrenia, primaryOutcomes measure: Stigma Scale for Relatives of Patients with Schizophrenia, secondaryOutcomes measure: Stigmatization Scale, secondaryOutcomes measure: Stigmatization Scale, secondaryOutcomes measure: Stigmatization Scale, eligibilityModule sex: ALL, minimumAge: 18 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hatay Mustafa Kemal Üniversitesi, city: Hatay, country: Turkey, geoPoint lat: 38.40227, lon: 27.10486, hasResults: False |
protocolSection identificationModule nctId: NCT06367998, orgStudyIdInfo id: PC24MISV0017, briefTitle: The Effect of Pregabalin on Shoulder Pain of Patients With Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The Catholic University of Korea, class: OTHER, collaborators name: Viatris Korea, descriptionModule briefSummary: This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair.The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin., conditionsModule conditions: Rotator Cuff Tears, conditions: Central Sensitisation, conditions: Neuropathic Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Pregabalin, outcomesModule primaryOutcomes measure: VAS pain score, secondaryOutcomes measure: Constant shoulder score, secondaryOutcomes measure: American shouler and elbow surgeons (ASES) score, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06367985, orgStudyIdInfo id: 03/24/DD-BVMD, briefTitle: CAPA-IVM Culture With Low Oxygen Tension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mỹ Đức Hospital, class: OTHER, collaborators name: Vrije Universiteit Brussel, descriptionModule briefSummary: Capacitation in-vitro maturation (CAPA-IVM) has recently been advanced in culturing oocytes from the germinal vesicle (GV) stage following mild or no controlled ovarian stimulation. Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor (HIF). Nonetheless, it has been challenging to create the environmental culture conditions for addressing the optimal number of oocytes and the highest possibility of embryo development since consensus on the oxygen (O2) concentration index in the IVM culture environment has not been reached. Based on the outcomes of atmospheric O2 concentration (20%) and low O2 concentration (5%) during CAPA-IVM culture in mice, it has been hypothesized that a 5% O2 was the optimal culture condition for the pre-IVM step. A 20% O2 was more suitable for the IVM culture step. Therefore, this study is designed to enhance the CAPA-IVM culture system, improving treatment efficiency and providing various benefits for patients undergoing assisted reproductive technology., conditionsModule conditions: In Vitro Fertilization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Sibling oocytes, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Air Oxygen Concentration CAPA-IVM culture, interventions name: Low Oxygen Concentration CAPA-IVM culture, outcomesModule primaryOutcomes measure: Maturation rate, secondaryOutcomes measure: Total number of oocytes retrieval, secondaryOutcomes measure: Number of patients with no oocyte retrieved, secondaryOutcomes measure: Number of MII oocytes, secondaryOutcomes measure: Number of GV oocytes, secondaryOutcomes measure: Number of patients with no matured oocyte, secondaryOutcomes measure: Number of 2PN oocytes, secondaryOutcomes measure: Fertilization rate, secondaryOutcomes measure: Abnormal fertilization rate, secondaryOutcomes measure: Number of patients with no day-3 embryo, secondaryOutcomes measure: Number of day-3 embryos, secondaryOutcomes measure: Number of good quality Day-3 embryos, secondaryOutcomes measure: Number of frozen day-3 embryos, secondaryOutcomes measure: Number of blastocyst (day 5 or day 6 embryo), secondaryOutcomes measure: Number of patients with no blastocyst, secondaryOutcomes measure: Number of good quality blastocysts, secondaryOutcomes measure: Number of frozen blastocysts, secondaryOutcomes measure: Number of embryos transferred, secondaryOutcomes measure: Quality of embryos transferred (Grade 1, Grade 2, Grade 3), secondaryOutcomes measure: Positive pregnancy test rate, secondaryOutcomes measure: Implantation rate, secondaryOutcomes measure: Clinical pregnancy rate, secondaryOutcomes measure: Ectopic pregnancy rate, secondaryOutcomes measure: Ongoing pregnancy rate, secondaryOutcomes measure: Miscarriage <12 weeks rate (Early miscarriage), secondaryOutcomes measure: Miscarriage <22 weeks rate (late miscarriage), secondaryOutcomes measure: Live birth rate, secondaryOutcomes measure: Multiple pregnancy rate, secondaryOutcomes measure: Multiple delivery rate, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Gestational age at birth, secondaryOutcomes measure: Birth weight, secondaryOutcomes measure: Very low birth weight rate, secondaryOutcomes measure: Low birth weight rate, secondaryOutcomes measure: High birth weight rate, secondaryOutcomes measure: Very high birth weight rate, secondaryOutcomes measure: Small for gestational age rate, secondaryOutcomes measure: Large for gestational age rate, secondaryOutcomes measure: Hypertension in pregnancy rate, secondaryOutcomes measure: Gestational diabetes mellitus rate, secondaryOutcomes measure: Still birth rate, secondaryOutcomes measure: Premature birth rate, secondaryOutcomes measure: Antepartum haemorrhage rate, secondaryOutcomes measure: Major congenital abnormalities rate, secondaryOutcomes measure: Neonatal mortality rate, secondaryOutcomes measure: NICU admission rate, secondaryOutcomes measure: Reason for NICU admission, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 42 Years, stdAges: ADULT, contactsLocationsModule locations facility: My Duc Hospital, city: Ho Chi Minh City, country: Vietnam, contacts name: Tuong M Ho, MSc, MD, role: CONTACT, phone: +84 90 3633377, email: [email protected], geoPoint lat: 10.82302, lon: 106.62965, hasResults: False |
protocolSection identificationModule nctId: NCT06367972, orgStudyIdInfo id: 2024-0070, secondaryIdInfos id: NCI-2024-03278, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2028-10-10, completionDateStruct date: 2030-10-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation \[the removal or destruction of a body part or tissue or its function\], or embolization \[a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel\]) to all progressive sites of disease can help to control the disease compared with next-line systemic therapy., conditionsModule conditions: OligoProgressive Metastatic Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Local Consolidation Therapy, interventions name: Next-line Systemic Therapy, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Ethan Ludmir, MD, role: CONTACT, phone: 832-729-0998, email: [email protected], contacts name: Ethan Ludmir, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
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