data
stringlengths 358
80.8k
|
|---|
protocolSection identificationModule nctId: NCT06364059, orgStudyIdInfo id: aSDH-TT, briefTitle: A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Charles University, Czech Republic, class: OTHER, collaborators name: Military University Hospital, Prague, descriptionModule briefSummary: Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes., conditionsModule conditions: Acute Subdural Hematoma, conditions: Acquired Brain Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Decompressive craniectomy with evacuation of subdural hematoma, outcomesModule primaryOutcomes measure: Level of consciousness at time of injury, primaryOutcomes measure: Initial size of subdural hematoma, primaryOutcomes measure: Initial midline shift, primaryOutcomes measure: Chronic use of anti-clotting medication, primaryOutcomes measure: Trauma severity analyzed using Injury Severity Score (ISS)., primaryOutcomes measure: Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II), primaryOutcomes measure: The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC)., primaryOutcomes measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months., primaryOutcomes measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months., secondaryOutcomes measure: Number of revisions., secondaryOutcomes measure: Time from injury to surgery., secondaryOutcomes measure: Time of operation., secondaryOutcomes measure: The need for reversal of the effects of anticoagulants., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Military University Hospital Prague, city: Praha, zip: 16209, country: Czechia, contacts name: Michal Soták, M.D., Ph.D., role: CONTACT, phone: +420973202999, email: michal.sotak@uvn.cz, contacts name: Tomáš Tyll, M.D., Ph.D., role: CONTACT, phone: +420973202999, email: tomas.tyll@uvn.cz, contacts name: Tomáš Tyll, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False |
protocolSection identificationModule nctId: NCT06364046, orgStudyIdInfo id: ZJLS-KLDMIR-22006, briefTitle: Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The Central Hospital of Lishui City, class: OTHER, descriptionModule briefSummary: This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice., conditionsModule conditions: Carcinoma, conditions: Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Drug-eluting beads bronchial arterial chemoembolization, interventions name: Serplulimab, interventions name: Intravenous chemotherapy, outcomesModule primaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Time to tumor untreatable progression, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Overall Response, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Eastern Cooperative Oncology Group Score, secondaryOutcomes measure: Recurrence rate of hemoptysis, secondaryOutcomes measure: Quality of life Questionare-Core score, secondaryOutcomes measure: The incidence of adverse events and serious adverse events, secondaryOutcomes measure: Pain assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lishui central hospital, city: Lishui, state: Zhejiang, zip: 323000, country: China, geoPoint lat: 28.46042, lon: 119.91029, hasResults: False |
protocolSection identificationModule nctId: NCT06364033, orgStudyIdInfo id: CLL2624, briefTitle: Biological and Clinical Efficacy of Shingrix in Patients With CLL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2028-10, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Gruppo Italiano Malattie EMatologiche dell'Adulto, class: OTHER, descriptionModule briefSummary: This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix., conditionsModule conditions: Chronic Lymphocytic Leukemia, conditions: Small Lymphocytic Lymphoma, conditions: CLL-like MBL, conditions: Varicella-zoster Virus Reactivation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: serologic response evaluation, outcomesModule primaryOutcomes measure: Serologic response evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UOC Ematologia ASST dei Sette Laghi, city: Varese, country: Italy, contacts name: Marta Coscia, role: CONTACT, geoPoint lat: 45.82058, lon: 8.82511, hasResults: False |
protocolSection identificationModule nctId: NCT06364020, orgStudyIdInfo id: APHP230067, briefTitle: Assessment of Risk Factors in Patients With Non-carious Cervical Lesions, acronym: LACIS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: In the management of patients with noncarious cervical lesions (NCCL), we observe that they frequently present signs of anxiety, traumatic brushing, bruxism or eating disorders. These multifactorial and interrelated etiologies make diagnosis and management difficult. Furthermore, in the literature, there is a lack of studies that evaluate the relationship between these risk factors and NCCL. A better understanding of the etiology and risk factors would help to optimize patient management and direct patients to the most appropriate therapies., conditionsModule conditions: Anxiety, conditions: Stress, conditions: Non-carious Cervical Lesions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To investigate the association between anxiety/stress and the presence of NCCL., secondaryOutcomes measure: To investigate the association between bruxism and the presence of NCCL., secondaryOutcomes measure: To investigate the association between eating disorders and the presence of NCCL., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Rothschild - Service Odontologie, city: Paris, zip: 75012, country: France, contacts name: Caroline Mocquot, MCU-PH, role: CONTACT, phone: +33622971627, email: caroline.mocquot@aphp.fr, contacts name: Maria Clotilde Carra, Professor, role: CONTACT, phone: +33630746555, email: mariaclotilde.carra@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06364007, orgStudyIdInfo id: SLiu0401, briefTitle: HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sulai Liu, class: OTHER, descriptionModule briefSummary: The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: HAIC+STRIDE+Len, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: DCR, secondaryOutcomes measure: AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University), status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Chuang Peng, PhD, role: CONTACT, phone: 15200850489, email: pengchuangcn@163.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False |
protocolSection identificationModule nctId: NCT06363994, orgStudyIdInfo id: ICP-CL-00128, briefTitle: A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-25, primaryCompletionDateStruct date: 2034-12-25, completionDateStruct date: 2035-12-25, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: InnoCare Pharma Inc., class: INDUSTRY, descriptionModule briefSummary: Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL), conditionsModule conditions: Mantle Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 490, type: ESTIMATED, armsInterventionsModule interventions name: Orelabrutinib, interventions name: Bendamustine Injection, interventions name: Rituximab, interventions name: Orelabrutinib Placebo, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Progression-free Survival (PFS) for Arm A vs. Arm C, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06363981, orgStudyIdInfo id: JagiellonianU72, briefTitle: Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Jakub Antczak, class: OTHER, collaborators name: Andrzej Frycz Modrzewski Krakow University, descriptionModule briefSummary: Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression., conditionsModule conditions: Unipolar Depression, conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Placebo intervention will be delivered with a programmable coil for magnetic stimulation, which can be switched by a third person between modes of active (therapeutic) and sham stimulation. In the sham-mode coil elicits similar sounds as in the active stimulation, but induces only negligible magnetic field., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Active rTMS over the left DLPFC and over the left DMPFC, interventions name: Active rTMS over the left DLPFC, interventions name: Sham rTMS, outcomesModule primaryOutcomes measure: Beck Depression Inventory 2, primaryOutcomes measure: Froward digit span, primaryOutcomes measure: Language part of Addenbrooke's Cognitive Examination, secondaryOutcomes measure: Dimensional Anhedonia Rating Scale, secondaryOutcomes measure: Athens Insomnia Scale, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Epworth Sleepiness Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Education of Research and Development Center, Babinski Clinical Hospital, city: Cracovia, zip: 30393, country: Poland, contacts name: Wojciech Korzeniowski, MD, role: CONTACT, phone: +48 12 652 42 00, email: wojciech.korzen@gmail.com, contacts name: Jakub Antczak, MD, role: CONTACT, phone: +48 12 25 50, email: jakub.antczak@uj.edu.pl, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False |
protocolSection identificationModule nctId: NCT06363968, orgStudyIdInfo id: 1743326, briefTitle: Biomarkers in the Retina for Prognosticating Mental Health Treatments, acronym: BRIGHT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2030-09-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: VA Puget Sound Health Care System, class: FED, descriptionModule briefSummary: Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot studyPosttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are:1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD?2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment?Participants will be asked to:* Undergo ERG recordings before and after a single dose of sertraline.* Provide relevant clinical information related to PTSD symptoms and treatment history.Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording., conditionsModule conditions: PTSD, conditions: Posttraumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: RETeval, outcomesModule primaryOutcomes measure: ERG b-wave amplitude response to SSRI, secondaryOutcomes measure: Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score, secondaryOutcomes measure: Total PTSD Checklist for DSM-5 (PCL-5), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA Puget Sound Health Care System, status: RECRUITING, city: Seattle, state: Washington, zip: 98108, country: United States, contacts name: Rebecca C Hendrickson, MD, PhD, role: CONTACT, phone: 206-277-5054, email: rebecca.hendrickson@va.gov, contacts name: Katharine J Liang, MD, PHD, role: SUB_INVESTIGATOR, contacts name: Rebecca C Hendrickson, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False |
protocolSection identificationModule nctId: NCT06363955, orgStudyIdInfo id: INTM-PMCF-UNIMOUTH, secondaryIdInfos id: 750/13.02.2023, type: OTHER, domain: National and Kapodistrian University of Athens, briefTitle: Assessing the Efficacy of a Hydrogen Peroxide Mouthwash for Oral Wound Healing, Oral Hygiene and Xerostomia Relief, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-25, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National and Kapodistrian University of Athens, class: OTHER, collaborators name: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A., descriptionModule briefSummary: The aim of this study is to evaluate the efficacy and safety of a hydrogen carbamide/peroxide mouthwash, named UNISEPT® MOUTHWASH, regarding oral wound healing, postoperative symptoms, xerostomia (dry mouth) and oral hygiene improvement. Study participants have reported dry mouth and are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögren's Syndrome, following consultation with their rheumatologist. This is a standardized diagnostic procedure that leads to healing by primary intention (i.e. wound edges are closely re-approximated with sutures).Researchers are comparing this mouthwash with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving dry mouth and/or oral hygiene. Participants randomly get the hydrogen carbamide/peroxide mouthwash or the placebo one to use for 14 days after the biopsy. The investigators will not know which one they are providing as the bottles will be identical.Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation), improvement of dry mouth and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial consultation and the biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (such as measuring saliva) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed., conditionsModule conditions: Wound Heal, conditions: Oral Dryness, conditions: Postoperative Pain, conditions: Sjogren's Syndrome, conditions: Biopsy Wound, conditions: Mouth; Wound, conditions: Mouth Dryness, conditions: Dental Plaque, conditions: Gingival Inflammation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This trial is designed as a prospective, randomized, placebo-controlled, triple blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of a hydrogen carbamide/peroxide mouthwash or placebo mouthwash, made by the same manufacturer., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Hydrogen Carbamide/Peroxide Mouthwash, interventions name: Placebo mouthwash, outcomesModule primaryOutcomes measure: Assessment of wound healing based on the modified Landry Healing Index on day 14, primaryOutcomes measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 14, primaryOutcomes measure: Assessment of wound healing based on the modified Landry Healing Index on day 7, primaryOutcomes measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 7, secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home), secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) on day 7, secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) on day 14, secondaryOutcomes measure: Wound healing based on the incision/wound length, secondaryOutcomes measure: Subjective oral dryness symptoms (8-item VAS questionnaire), secondaryOutcomes measure: Observed (objective) signs of oral dryness, secondaryOutcomes measure: Change in Unstimulated Saliva Flow Rate, secondaryOutcomes measure: Oral Hygiene - Dental Plaque: Full-Mouth Plaque Index, secondaryOutcomes measure: Oral Hygiene - Gingival Inflammation: Full Mouth Gingival Index, secondaryOutcomes measure: Oral Health Related Quality of Life, secondaryOutcomes measure: Assessment of swelling in the biopsy area, otherOutcomes measure: Adverse Events, otherOutcomes measure: Participant's comments and satisfaction regarding the provided treatment/use of the products, otherOutcomes measure: Compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens, city: Athens, state: Attiki, zip: 11527, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, hasResults: False |
protocolSection identificationModule nctId: NCT06363942, orgStudyIdInfo id: 2024-5973, briefTitle: A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-04-15, completionDateStruct date: 2026-04-15, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not., conditionsModule conditions: Fall Injury, conditions: Frailty, conditions: Old Age; Atrophy, conditions: Age-Related Atrophy, conditions: Age-Related Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: SAFE program (exercise intervention), outcomesModule primaryOutcomes measure: Objective 1, primaryOutcomes measure: Objective 2, secondaryOutcomes measure: Objective 4, eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Victoria Hospital - Glen site, city: Montréal, state: Quebec, zip: H4A 3J1, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06363929, orgStudyIdInfo id: 341-23, briefTitle: Continuous Glucose Monitoring in Neonatal Hyperinsulinism, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: MemorialCare Health System, class: OTHER, collaborators name: DexCom, Inc., descriptionModule briefSummary: The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly., conditionsModule conditions: Hyperinsulinism, conditions: Hypoglycemia Neonatal, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Dexcom G6 continuous glucose monitor, outcomesModule primaryOutcomes measure: Mean absolute relative difference (MARD), secondaryOutcomes measure: Mean absolute difference (MAD), eligibilityModule sex: ALL, minimumAge: 24 Hours, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule locations facility: Miller Children's Hospital, status: RECRUITING, city: Long Beach, state: California, zip: 90806, country: United States, contacts name: Erin Okawa, role: CONTACT, phone: 310-825-6244, email: eokawa@memorialcare.org, geoPoint lat: 33.76696, lon: -118.18923, hasResults: False |
protocolSection identificationModule nctId: NCT06363916, orgStudyIdInfo id: 2023-A00335-40, briefTitle: Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System, acronym: SEECLOOP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Medtrum France, class: INDUSTRY, collaborators name: Axonal-Biostatem, descriptionModule briefSummary: The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study.The main question it aims to answer is :• Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ?Participants will be :* Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system* Randomized to the Open Loop or Closed Loop group* Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire statusResearchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group., conditionsModule conditions: Type 1 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Insulin Management System in Manual mode of operation, interventions name: Insulin Management System in Automatic mode of operation, outcomesModule primaryOutcomes measure: Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups, secondaryOutcomes measure: Evolution of TIR, secondaryOutcomes measure: Evolution of coefficient of glycemic variation, secondaryOutcomes measure: Superiority in Glycated Haemoglobin (HbA1c) improvement, secondaryOutcomes measure: Evolution of Time spent Above Range (TAR), secondaryOutcomes measure: Evolution of Time spent Below Range (TBR), secondaryOutcomes measure: Body Mass Index change, secondaryOutcomes measure: Glucose sensor measurement change, secondaryOutcomes measure: Percentage of patients with TIR > 70%, secondaryOutcomes measure: Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1%, secondaryOutcomes measure: Evolution of glucose management indicator (GMI), secondaryOutcomes measure: Evolution of dosage of insulin, secondaryOutcomes measure: Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop), secondaryOutcomes measure: Evolution of Self-administered Questionnaires scores, secondaryOutcomes measure: Evolution of Diabetes Treatment Satisfaction score, secondaryOutcomes measure: Safety Events, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TIR, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on glucose sensor measurements, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TAR, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TBR, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on GMI, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on dosage of insulin, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on Self-administered Questionnaires scores, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Angers, city: Angers, country: France, contacts name: Regis COUTANT, role: CONTACT, contacts name: Regis COUTANT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.46667, lon: -0.55, locations facility: CHU Besançon, city: Besançon, country: France, contacts name: Sophie BOROT, role: CONTACT, contacts name: Sophie BOROT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.24878, lon: 6.01815, locations facility: CHU Bordeaux, city: Bordeaux, country: France, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Caen, city: Caen, country: France, contacts name: Michael JOUBERT, role: CONTACT, contacts name: Michael JOUBERT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Centre Hospitalier Sud-Francilien, city: Corbeil-Essonnes, country: France, contacts name: Freddy PENFORNIS, role: CONTACT, contacts name: Freddy PENFORNIS, role: PRINCIPAL_INVESTIGATOR, contacts name: Thanh-Lan DANG DUY, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.60603, lon: 2.48757, locations facility: Centre Hospitalier de Gonesse, city: Gonesse, country: France, contacts name: Jennifer ALLAIN, role: CONTACT, contacts name: Jennifer ALLAIN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.98693, lon: 2.44892, locations facility: Centre Hospitalier Saint-Louis, city: La Rochelle, country: France, contacts name: Didier GOUET, role: CONTACT, contacts name: Didier GOUET, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.16667, lon: -1.15, locations facility: Hôpital Hôtel-Dieu, city: Le Creusot, country: France, contacts name: Sylvaine CLAVEL, role: CONTACT, contacts name: Sylvaine CLAVEL, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.80714, lon: 4.41632, locations facility: Hospices Civils de Lyon, city: Lyon, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Hôpital Européen, city: Marseille, country: France, contacts name: Denis RACCAH, role: CONTACT, contacts name: Denis RACCAH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Hôpital La Timone, city: Marseille, country: France, contacts name: Rachel REYNAUD, role: CONTACT, contacts name: Rachel REYNAUD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: CHU Montpellier, city: Montpellier, country: France, contacts name: Fabienne DALLA VALE, role: CONTACT, contacts name: Fabienne DALLA VALE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: CHU Nantes, city: Nantes, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Hôpital Lariboisière, city: Paris, country: France, contacts name: Jean-Pierre RIVELINE, role: CONTACT, contacts name: Jean-Pierre RIVELINE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Necker, city: Paris, country: France, contacts name: Jacques BELTRAND, role: CONTACT, contacts name: Jacques BELTRAND, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Robert Debré, city: Paris, country: France, contacts name: Elise BISMUTH, role: CONTACT, contacts name: Elise BISMUTH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Rangueil, city: Toulouse, country: France, contacts name: Vincent MELKI, role: CONTACT, contacts name: Vincent MELKI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False |
protocolSection identificationModule nctId: NCT06363903, orgStudyIdInfo id: 2022-MMC-051, briefTitle: ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-09, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Maxima Medical Center, class: OTHER, collaborators name: Amsterdam UMC, collaborators name: Maastricht University Medical Center, descriptionModule briefSummary: In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics., conditionsModule conditions: Autoimmunity, conditions: Inguinal Hernia, conditions: Stress Urinary Incontinence, conditions: Pelvic Organ Prolapse, conditions: Implant Complication, conditions: Systemic Autoimmune Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: mesh allergy test, interventions name: blood tests, interventions name: Mesh removal, outcomesModule primaryOutcomes measure: Positive diagnostic tests, secondaryOutcomes measure: Autoimmune complaints and objective findings in immunologic blood test, secondaryOutcomes measure: Autoimmune complaints and objective findings in mesh allergy test (MAT), secondaryOutcomes measure: Mesh removal and subjective complaints, secondaryOutcomes measure: Mesh histopathology, secondaryOutcomes measure: Patient demographics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Centre, status: ACTIVE_NOT_RECRUITING, city: Maastricht, state: Limburg, zip: 6229HX, country: Netherlands, geoPoint lat: 50.84833, lon: 5.68889, locations facility: Maxima Medical Centre, status: RECRUITING, city: Veldhoven, state: Noord-Brabant, zip: 5504DB, country: Netherlands, contacts name: Willem AR Zwaans, MD PhD, role: CONTACT, phone: +31408888550, email: willem.zwaans@mmc.nl, contacts name: Maurits JC Gielen, MD, role: SUB_INVESTIGATOR, geoPoint lat: 51.41833, lon: 5.40278, locations facility: Amsterdam UMC, status: NOT_YET_RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1105AZ, country: Netherlands, contacts name: Prof. Dr. J.P. Roovers, role: CONTACT, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06363890, orgStudyIdInfo id: TD02, briefTitle: Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia, acronym: AusTD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Lumen Bioscience, Inc., class: INDUSTRY, descriptionModule briefSummary: The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population., conditionsModule conditions: Travelers Diarrhea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: TAQMan Array Card, outcomesModule primaryOutcomes measure: Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06363877, orgStudyIdInfo id: 5220078, briefTitle: Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Loma Linda University, class: OTHER, descriptionModule briefSummary: This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds., conditionsModule conditions: Surgical Site Infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1100, type: ESTIMATED, armsInterventionsModule interventions name: Povidone-Iodine, interventions name: Normal Saline, outcomesModule primaryOutcomes measure: Surgical Site Infection, secondaryOutcomes measure: Readmission, secondaryOutcomes measure: Return to the Operating Room, secondaryOutcomes measure: Ileus, secondaryOutcomes measure: Small Bowel Obstruction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Loma Linda University Health, city: Loma Linda, state: California, zip: 92354, country: United States, contacts name: Martin G Rosenthal, MD, role: CONTACT, email: mrosenthal@llu.edu, contacts name: Martin Rosenthal, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mohamed H El-Farra, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.04835, lon: -117.26115, hasResults: False |
protocolSection identificationModule nctId: NCT06363864, orgStudyIdInfo id: LL-IRB-2401, briefTitle: Investigation of Metabolomics Differences Between Metabolic Syndrome and Healthy Individuals in Taiwan, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2029-10-31, completionDateStruct date: 2029-10-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Leeuwenhoek Laboratories Co. Ltd., class: INDUSTRY, descriptionModule briefSummary: The prevalence of metabolic syndrome in Taiwan has been increasing yearly. In this project, the database of blood test results from healthy and metabolic syndromes individuals will be analyzed to identify the small molecules related to the severity of metabolic syndrome. These identified small molecules could be used as biomarkers to predict the development of metabolic syndromes in the future., conditionsModule conditions: Metabolic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Concentration changes of small molecules in blood., eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06363851, orgStudyIdInfo id: Kylo-11-I-C01, briefTitle: Single-ascending Dose Study of Kylo-11 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Kylonova (Xiamen) Biopharma co., LTD., class: INDUSTRY, descriptionModule briefSummary: This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects., conditionsModule conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Kylo-11, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax), secondaryOutcomes measure: PK parameter of time of maximum observed concentration (Tmax), secondaryOutcomes measure: PK parameter of area under the concentration time curve (AUC), secondaryOutcomes measure: Change in serum Lp(a) over time, secondaryOutcomes measure: Percent change in serum Lp(a) over time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chengdu Xinhua Hospital, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Xiaolan Yong, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06363838, orgStudyIdInfo id: ordu eah, briefTitle: Evaluation of Neuromuscular Morphometry of the Vaginal Wall, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-12-01, primaryCompletionDateStruct date: 2020-06-25, completionDateStruct date: 2020-06-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Gaziosmanpasa Research and Education Hospital, class: OTHER_GOV, collaborators name: T.C. ORDU ÜNİVERSİTESİ, descriptionModule briefSummary: In this prospective study, women aged between 40 and 75 years who had not undergone any vaginal surgery and had not undergone any abdominal prolapse surgery were included. Thirty-one women diagnosed with rectocele on examination were included in the study group. Thirty-one patients who underwent vaginal intervention and hysterectomy for reasons other than rectocele (colposcopy, conization, etc.) without anterior or posterior wall prolapse were included in the control group., conditionsModule conditions: Pelvic Organ Prolapse, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 62, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: epithelial thickness, primaryOutcomes measure: smooth muscle density, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hakan Timur, city: Ordu, country: Turkey, geoPoint lat: 40.97782, lon: 37.89047, hasResults: False |
protocolSection identificationModule nctId: NCT06363825, orgStudyIdInfo id: MRCTA,ECFAH Of FMU[2024]373, briefTitle: A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2026-04-11, completionDateStruct date: 2027-05-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load, conditionsModule conditions: Advanced Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 57, type: ESTIMATED, armsInterventionsModule interventions name: camrelizumab, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Tumor progression time (TTP), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinhua Chen, status: RECRUITING, city: Fuzhou, country: China, contacts name: Yiping Chen, role: CONTACT, phone: 13805066904, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False |
protocolSection identificationModule nctId: NCT06363812, orgStudyIdInfo id: The POST, briefTitle: Probability of OncotypeDx to Reallocate as Low or High Risk of Recurrence Breast Cancer Patients With Uncertain Biology, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-03-08, primaryCompletionDateStruct date: 2021-05-15, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Fondazione Sandro Pitigliani, class: OTHER, collaborators name: Genomic Health®, Inc., collaborators name: Istituto Toscano Tumori, descriptionModule briefSummary: In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 258, type: ACTUAL, outcomesModule primaryOutcomes measure: the proportion of tumor samples with a useful OncotypeDx, secondaryOutcomes measure: the proportion of patients in which the result of the test has induced a modification in the initial treatment plan, secondaryOutcomes measure: the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital of Prato, city: Prato, zip: 59100, country: Italy, geoPoint lat: 43.8805, lon: 11.09699, hasResults: False |