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protocolSection identificationModule nctId: NCT06295146, orgStudyIdInfo id: STUDY23050075, briefTitle: Virtual Peer Coaching in Manual Wheelchair Skills, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, descriptionModule briefSummary: The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program. First, peer coaches will be enrolled and trained. Then, trainees will be enrolled into one of three interventions: intervention with remote feedback (Group 1), wait list control group (Group 2), and structured self-study (Group 3)., conditionsModule conditions: Wheelchair, conditions: Paraplegia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: For trainees, we will use a randomized, single-blinded, two-period cross-over study design for Groups 1 and 2. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After we have completed enrollment for Groups 1 and 2 (N=40 per group) we will enroll participants into Group 3 ( N=40 per group)., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Intervention A: 1-on-1 wheelchair skills training by a peer coach, interventions name: Intervention B: Training via educational videos, outcomesModule primaryOutcomes measure: Capacity, confidence, and performance of wheelchair skills will improve following training, secondaryOutcomes measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline following training, secondaryOutcomes measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (6 months), secondaryOutcomes measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (12 months), secondaryOutcomes measure: Goal Attainment Scale (GAS) improvement from baseline (post training), secondaryOutcomes measure: Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (6 months), secondaryOutcomes measure: Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (1 year), secondaryOutcomes measure: Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (6 months), secondaryOutcomes measure: Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (1 year), secondaryOutcomes measure: Life Space Assessment (LSA) improvement from baseline (6 months), secondaryOutcomes measure: Life Space Assessment (LSA) improvement from baseline (1 year), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295133, orgStudyIdInfo id: PROMESS - STRESS, briefTitle: Preventive Remediation of Stress for Optimal MEdical StudentS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-11, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Research on Healthcare Performance Lab U1290, class: OTHER, descriptionModule briefSummary: Medical students are subjected to a high competitive pressure throughout their curriculum. High levels of stress are associated with a deterioration in quality of life and learning abilities.Our field surveys conducted in 2022 and 2023 at the Lyon Est Medical School revealed that second-cycle students presented a high level of stress. It is expected that these feelings significantly degrade their quality of life as well as their health. Furthermore, a local survey reported that one in two medical students had experienced at least one depressive episode, and one in three had already had suicidal thoughts during their curriculum.Thus, it would become crucial for medical students to manage stressful situations and reduce stress levels during their studies.The PROMESS - STRESS project aims to offer solutions to students to reduce their stress levels during their medical studies. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested" and/or "interested" in following a intervention aimed at stress reduction. An early knowledge of stress remediation tools would allow students to quickly acquire the necessary tools to cope with stressful situations they will encounter during their training and their life as future physicians. The objective of this study is to determine the influence of a stress management intervention on medical students levels of psychophysiological stress and satisfaction., conditionsModule conditions: Health Behavior, conditions: Health-Related Behavior, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All volunteers will receive a stress management intervention., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Stress, outcomesModule primaryOutcomes measure: Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS)., secondaryOutcomes measure: Scale of Holmes and Rahe : score obtained at the Holmes and Rahe Questionnaire Inventory., secondaryOutcomes measure: Big-5 : scores obtained at the Big-5 questionnaire., secondaryOutcomes measure: Coping strategies : scores obtained at the Brief Cope Inventory (BCI)., secondaryOutcomes measure: Perceived level of stress : score obtained at the Perceived Stress Scale, secondaryOutcomes measure: Heart rate variability (HRV) marker: cardiac coherence score during the pre-intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: SDNN during the pre-intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: RMSSD during the pre-intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: Low frequency / High frequency ratio (LF/HF) during the pre-intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: pnn50% during the pre-intervention., secondaryOutcomes measure: Coping strategies : Evolution in scores obtained at the Brief Cope Inventory (BCI)., secondaryOutcomes measure: Heart rate variability (HRV) marker: Evolution in cardiac coherence score during the intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: Evolution in SDNN score during the intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: Evolution in RMSSD score during the intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: Evolution in LF/HF ratio during the intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: Evolution in pnn50% score during the intervention., secondaryOutcomes measure: VAS - stressors quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors, secondaryOutcomes measure: VAS - stress quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress., secondaryOutcomes measure: VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level., secondaryOutcomes measure: VAS - stress coping: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations., secondaryOutcomes measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert., secondaryOutcomes measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set., secondaryOutcomes measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention., secondaryOutcomes measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5., secondaryOutcomes measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress., secondaryOutcomes measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RESHAPE, status: RECRUITING, city: Lyon, zip: 69008, country: France, contacts name: Sophie Schlatter, Dr., role: CONTACT, phone: 07 68 21 05 51, phoneExt: 33, email: [email protected], contacts name: Angèle Métais, Dr., role: CONTACT, phone: 06 77 39 89 66, phoneExt: 33, email: [email protected], geoPoint lat: 45.74848, lon: 4.84669, hasResults: False |
protocolSection identificationModule nctId: NCT06295120, orgStudyIdInfo id: 362-1, briefTitle: The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D), acronym: CAP-D, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Research Unit for General Practice in Aalborg, class: OTHER, descriptionModule briefSummary: The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice.Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily., conditionsModule conditions: Community-acquired Pneumonia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Phenoxymethylpenicillin 1.2 MIE 4 times daily, outcomesModule primaryOutcomes measure: Treatment failure at day 30, secondaryOutcomes measure: Clinical recovery at day 8, secondaryOutcomes measure: The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score, secondaryOutcomes measure: Prolonged antibiotic treatment, secondaryOutcomes measure: Change in type of antibiotic, secondaryOutcomes measure: Relapse of acute Lower Respiratory Tract Infection (LRTI), secondaryOutcomes measure: Reconsultation, secondaryOutcomes measure: New prescriptions within 30 days, secondaryOutcomes measure: Hospitalisation, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Treatment adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Research Unit for General Practice Aalborg, status: RECRUITING, city: Gistrup, zip: 9260, country: Denmark, contacts name: Line Maj Jensen, role: CONTACT, phone: +45 25 69 99 33, email: [email protected], geoPoint lat: 56.9943, lon: 9.99085, hasResults: False |
protocolSection identificationModule nctId: NCT06295107, orgStudyIdInfo id: 2023-00195-01, briefTitle: Reliability of Range of Movement Measurements in Cerebral Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Region Skane, class: OTHER, descriptionModule briefSummary: The aim is to investigate the inter-rater reliability of passive range of motion (pROM) measurement with goniometer of knee extension and ankle dorsiflexion for children with unilateral spastic cerebral palsy (USCP) and secondary to explore to what extent spasticity influences the reliability., conditionsModule conditions: Cerebral Palsy, conditions: Movement Disorders in Children, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Ankle Passive Range of Movement (pROM), interventions name: Knee Passive Range of Movement (pROM), outcomesModule primaryOutcomes measure: Ankle range of motion, primaryOutcomes measure: Knee range of motion, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children Habilitation Unit, status: RECRUITING, city: Lund, state: Skane, zip: 22241, country: Sweden, contacts name: Olof Linden, MD, role: CONTACT, phone: 0046708475690, email: [email protected], geoPoint lat: 55.70584, lon: 13.19321, hasResults: False |
protocolSection identificationModule nctId: NCT06295094, orgStudyIdInfo id: PIPAC-OPC6, briefTitle: The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients., acronym: EPICURE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Karolinska University Hospital, descriptionModule briefSummary: The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment., conditionsModule conditions: Gastric Cancer, conditions: Chemotherapy, Adjuvant, conditions: Peritoneal Metastases, conditions: Minimally Invasive Surgical Procedures, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Cisplatin, interventions name: Doxorubicin, outcomesModule primaryOutcomes measure: Peritoneal disease-free survival, secondaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Postoperative toxicity, secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Postoperative mortality, secondaryOutcomes measure: Rate of positive peritoneal lavage, secondaryOutcomes measure: Patient-reported Quality of life, secondaryOutcomes measure: Patient-reported Quality of life, secondaryOutcomes measure: Number of patients not receiving adjuvant chemotherapy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Yanghee Woo, PhD, role: CONTACT, email: [email protected], geoPoint lat: 34.13945, lon: -117.97729, locations facility: Odense University Hospital, city: Odense C, zip: 5000, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, locations facility: University Hospital Lille, city: Lille, country: France, contacts name: Clarisse Eveno, PhD, role: CONTACT, email: [email protected], geoPoint lat: 50.63297, lon: 3.05858, locations facility: Charité, University of Berlin, city: Berlin, country: Germany, contacts name: Beate Rau, PhD, role: CONTACT, email: [email protected], geoPoint lat: 52.52437, lon: 13.41053, locations facility: Karolinska University Hospital, city: Stockholm, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False |
protocolSection identificationModule nctId: NCT06295081, orgStudyIdInfo id: NL79864.091.22, secondaryIdInfos id: 112927, type: OTHER, domain: RadboudUMC, briefTitle: TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance, acronym: TREAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-15, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2044-07-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, collaborators name: Maastricht University Medical Center, descriptionModule briefSummary: The goal of this observational study is to learn about cardiac biomarker release following exercise in amateur athletes.The main questions it aims to answer are:Question 1: What are the reference values for exercise-induced cardiac troponin elevations following walking, cycling and running exercise? Hypothesis 1: We hypothesize that the exercise-induced cTn release is different following walking, cycling and running exercise. Therefore, we will establish reference values for post-exercise cTn concentrations across each of these sport types.Question 2: Is the prevalence of (subclinical) coronary artery disease higher in individuals with high post-exercise cardiac troponin concentrations in comparison to individuals with low post-exercise cardiac troponin concentrations? Hypothesis 2: We hypothesize that athletes with the highest post-exercise cTn concentrations have a higher prevalence of coronary atherosclerosis compared to athletes matched for sex and age with the lowest post-exercise cTn concentrations.Question 3: What is the association between post-exercise cardiac troponin concentrations and major adverse cardiovascular events (MACE) and mortality during long-term follow-up? Hypothesis 3: We hypothesize that post-exercise cTn concentrations beyond the 99th percentile are associated with an increased risk for MACE and mortality during follow-up.This study consists of three phases:Phase 1: two or three visits to the study location for (amongst other measurements) blood draws to assess cardiac troponin concentrationsPhase 2: CT scan of the heart in 10% of participants to assess the prevalence of (subclinicial) coronary artery disease.Phase 3: longitudinal follow-up to assess the incidence of major adverse cardiovascular events and mortality during 20-year follow-up.Participants will visit our study centre two, three or four times:Visit 1: baseline measurements including height, weight, body composition and blood pressure will be obtained and a blood sample will be drawn.Visit 2: a blood sample will be drawn and activity data will be obtained from participants' own sports watch or bike computer.Optional visit 3: a blood sample will be drawn. Visit 4: 10% of participants will undergo a cardiac CT scan to assess the prevalence of (subclinical) coronary artery disease., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Exercise exposure, outcomesModule primaryOutcomes measure: High-sensitivity cardiac troponin I (hs-cTnI), primaryOutcomes measure: High-sensitivity cardiac troponin T (hs-cTnT), secondaryOutcomes measure: General CT scan data, secondaryOutcomes measure: Coronary artery calcification score, secondaryOutcomes measure: Coronary stenosis and plaque characteristics, secondaryOutcomes measure: Computed tomography derived Fractional Flow Reserve, secondaryOutcomes measure: Incidence of mortality, secondaryOutcomes measure: Incidence of major adverse cardiovascular events, otherOutcomes measure: Participant characteristics (personal info), otherOutcomes measure: Participant characteristics (baseline measurements), otherOutcomes measure: Participant characteristics (Exercise characteristics):, otherOutcomes measure: Medical History questionnaire, part 1 (general info and cardiovascular complaints), otherOutcomes measure: Medical History questionnaire, part 2 (diseases and/or conditions), otherOutcomes measure: Medical History questionnaire, part 3 (family history, COVID-19 info and medication use), otherOutcomes measure: Exercise History questionnaire, part 1 (exercise history, participation in endurance races and current training status), otherOutcomes measure: Exercise History questionnaire, part 2 (strength exercise), otherOutcomes measure: Other biomarker concentrations in blood, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RadboudUMC, status: RECRUITING, city: Nijmegen, state: Gelderland, zip: 6525 GC, country: Netherlands, contacts name: Sylvan Janssen, MSc, role: CONTACT, phone: +31243613416, email: [email protected], contacts name: IKS Integraal kwaliteitssysteem, role: CONTACT, phone: +31243614894, email: integraalkwaliteitssysteemwetenschappelijkonderzoek@radboudumc.nl, geoPoint lat: 51.8425, lon: 5.85278, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2023-01-16, uploadDate: 2023-04-13T09:57, filename: Prot_SAP_ICF_000.pdf, size: 852144, hasResults: False |
protocolSection identificationModule nctId: NCT06295068, orgStudyIdInfo id: PRT-1400-11, briefTitle: Evaluation of ARi With OpSens SavvyWire, acronym: ARi, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-30, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Opsens, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography., conditionsModule conditions: Aortic Valve Insufficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Transcatheter Aortic Valve Replacement (TAVR), interventions name: Balloon Aortic Valvuloplasty (BAV), outcomesModule primaryOutcomes measure: Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography, secondaryOutcomes measure: Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography, secondaryOutcomes measure: Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AHS Morristown Medical Center, status: RECRUITING, city: Morristown, state: New Jersey, zip: 07960, country: United States, contacts name: Christine Ciprich, role: CONTACT, phone: 973-971-7541, email: [email protected], contacts name: Philippe Généreux, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.79677, lon: -74.48154, hasResults: False |
protocolSection identificationModule nctId: NCT06295055, orgStudyIdInfo id: Dentistry Prince of Songkla, briefTitle: Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA), acronym: SSBS for ABA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-04, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement., conditionsModule conditions: Guided Bone Regeneration, conditions: Bone Formation, conditions: Bone Volume, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Before- after augmentation in patients with alveolar bone defects, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Ridge augmentation with semi-rigid shell barrier system, outcomesModule primaryOutcomes measure: Bone gain evaluation, primaryOutcomes measure: Biocompatibility evaluation, secondaryOutcomes measure: Ridge volume change of alveolar ridge evaluation, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Songkla, status: RECRUITING, city: Songkhla, state: Hatyai, zip: 90110, country: Thailand, contacts name: panisa tantiwongs, role: CONTACT, phone: 0824864497, email: [email protected], geoPoint lat: 7.19882, lon: 100.5951, hasResults: False |
protocolSection identificationModule nctId: NCT06295042, orgStudyIdInfo id: 32-235 ex 19/20, briefTitle: Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-10, primaryCompletionDateStruct date: 2023-11-28, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, descriptionModule briefSummary: Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive. Despite the great demand for more in-depth, long-term studies of both techniques, current evidence is low or moderate and there are only few studies focusing on both health-related quality of life and complication rates in the same patient collective.This study aims at investigating the complex relationship between the occurrence of complications and patient-reported long-time satisfaction in autologous and alloplastic breast reconstruction., conditionsModule conditions: Complications, Postoperative/Perioperative, conditions: Quality of Life, conditions: Satisfaction, Patient, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 162, type: ACTUAL, armsInterventionsModule interventions name: BREAST-Q Questionnaire, outcomesModule primaryOutcomes measure: Complications, secondaryOutcomes measure: Health-related quality of life and satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Graz, city: Graz, zip: 8036, country: Austria, geoPoint lat: 47.06667, lon: 15.45, hasResults: False |
protocolSection identificationModule nctId: NCT06295029, orgStudyIdInfo id: CPA-Z05-ZC-2023-002, briefTitle: Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, descriptionModule briefSummary: Severe neutropenia caused by venetoclax,a B-cell lymphoma-2(BCL-2) inhibitor, is the main cause of venetoclax tapering, drug discontinuation, and treatment delay. This study combines machine learning and genomics, hoping to develop models to predict venetoclax dose in Acute myeloid leukemia(AML) patients and compare the efficacy and safety differences of model-guided individualized medication regimen with current conventional regimen. According to the demographic information, the drug information, the drug concentration of the target patients, the laboratory examination, the single nucleotide polymorphism(SNP) information and the adverse reactions of the AML patients, and the model was constructed through machine learning., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Overall survival (OS), primaryOutcomes measure: Progression-free survival (PFS), primaryOutcomes measure: Overall adverse event rate, primaryOutcomes measure: Incidence of grade III and above adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06295016, orgStudyIdInfo id: NYCU112130AE, briefTitle: Stressors and Recovery Regulation on the Super-compensation Effect, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: National Yang Ming University, class: OTHER, descriptionModule briefSummary: Purpose: Investigating the effects of stressors and recovery regulation on the super-compensation effect of high-intensity intensive training (IT) in endurance athletes. Methods: This study will recruit 176 competitively trained endurance adult athletes. Participants will conduct a 7-week 3-stage experiment, including 3 weeks of regular training, 3 weeks of 130% progressive IT, and 1 week of 55% taper. Measurement will include training responses (performance and fatigue symptoms), stressors, recovery regulation, and mood state at baseline, during and after regular training, IT, and taper separately. According to the performance after taper, all participants will category into either the responder or non-responder of well-response to supercompensation effect. Statistic analysis: Independent t-test, Chi-squared test, and binary logistic regression will be used to compare the difference in training responses, stressors, recovery regulation, and mood state characteristics between responder and non-responder groups. P value sets at 0.15 for identifying the potential predictors. Logistic stepwise multiple regression will be used further to determine the significant predictors for the responders of well-response to the super-compensation among endurance athletes. P value sets at 0.05., conditionsModule conditions: Exercise Overtraining, conditions: Stressor, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The present study is designed as a prospective intervention and prognostic prediction study, employing a single-subject design with a reversal (ABA) design. This design involves a self-controlled intervention experiment with three phases: baseline training period (A), high-intensity, high-volume training period (B), and reduced training period (A). Subsequently, the study aims to explore predictive factors influencing the presence or absence of favorable compensatory training effects following the intervention., primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, maskingDescription: Prior to the commencement of the experiment and during the experimental period, both the participants and the investigator will be unaware of whether the participants exhibit a good response to compensatory training effects. After the participants complete the entire experimental procedure, they will be grouped post hoc based on their outcomes following the intervention, according to predetermined criteria.The criteria for determining whether there is a good response to compensatory training effects:1. Non-response group: Exercise performance during the tapering period (week 7) shows a significant increase compared to post-intervention (week 6) and is higher than pre-intervention (week 3) exercise performance.2. Response group: Exercise performance during the tapering period (week 7) shows a significant increase compared to post-intervention (week 6) and is higher than the change in exercise performance during normal training (= week 3 - week 1)., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule interventions name: High-intensity intensive training, interventions name: Taper, outcomesModule primaryOutcomes measure: Stressor, primaryOutcomes measure: Recovery regulation, primaryOutcomes measure: Mood state, primaryOutcomes measure: Peak power output, secondaryOutcomes measure: Maximal heart rate, secondaryOutcomes measure: Fatigue state, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University, status: RECRUITING, city: Taipei, zip: 112304, country: Taiwan, contacts name: Wei-Wun Tsai, role: CONTACT, phone: +886-02-2826-7939, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06295003, orgStudyIdInfo id: CEFA-COVID, briefTitle: Impact of COVID-19 Pandemic on Headache Evaluations in the Pediatric Emergency Department, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-30, primaryCompletionDateStruct date: 2022-05-30, completionDateStruct date: 2022-05-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Background: To evaluate the impact of COVID-19 on evaluations in the pediatric emergency department (ED) because of headache as main symptom.Methods: Number and clinical features of patients evaluated in the pediatric ED of a single site in Milan,Italy, were collected between January 2017 and January 2022. The impact of COVID-19 on evaluation rates was quantified by using the incidence rate ratio (IRR) and 95% confidence intervals (CI) between the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020)., conditionsModule conditions: COVID-19, conditions: Headache Disorders, conditions: Emergency Service, Hospital, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 700, type: ACTUAL, outcomesModule primaryOutcomes measure: During the study period, 890 evaluations were registered: the number of partecipants was 689 over the prepandemic period and 201 over the pandemic period. Mean age at evaluation was 10 years (range: 1 to 17 years)., secondaryOutcomes measure: Evaluation rates per month were 18.1 during the prepandemic period and 8.7 during COVID-19 pandemic, with peaks in autumn and winter and drops in summer. The reduction in evaluation rate was higher for secondary headache when compared with primary one, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06294990, orgStudyIdInfo id: 2023-505854-16-00, briefTitle: Klinefelter Syndrome and Testosterone Treatment in Puberty, acronym: TiPY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Lise Aksglæde, class: OTHER, descriptionModule briefSummary: The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY).The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.Participants will be randomized to two years treatment with testosterone or placebo., conditionsModule conditions: Klinefelter Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-center, national, randomized, double-blind, placebo-controlled intervention study, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Testosterone gel, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in body fat mass, secondaryOutcomes measure: Pubertal development and virilization, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Bone mineralization, secondaryOutcomes measure: Neuropsychological evaluation, secondaryOutcomes measure: Neuropsychological evaluation,, eligibilityModule sex: MALE, minimumAge: 10 Years, maximumAge: 14 Years, stdAges: CHILD, hasResults: False |
protocolSection identificationModule nctId: NCT06294977, orgStudyIdInfo id: CRISI-COVID, briefTitle: Impact of COVID-19 Pandemic on Epilepsy Evaluations in the Pediatric Emergency Department, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-30, primaryCompletionDateStruct date: 2022-12-30, completionDateStruct date: 2022-12-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Background. Seizures are a common cause of evaluation in the pediatric emergency department (ED). Several studies about the impact of COVID-19 pandemic on ED attendances report a considerable reduction in general pediatric care. The aim of our study was to evaluate the impact of COVID-19 on the admission to the pediatric ED for seizures.Materials and methods. We performed a retrospective study to assess the rate of ED admission for seizures at the pediatric ED of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan between January 2017 and December 2021, comparing the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021)., conditionsModule conditions: Epilepsy, conditions: Emergency Services, Hospital, conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ACTUAL, outcomesModule primaryOutcomes measure: During the study period, 1,091 patients with seizures were admitted to pediatric ED, 776 before the pandemic and 315 during the pandemic. In particular, the evaluation rates per month were 20.4 before the pandemic and 14.3 afterward, secondaryOutcomes measure: Patients with a history of previous seizures showed a greater decrease in the monthly number of ED visits compared to those with a first seizure. An increased rate of unprovoked seizures and a decreased rate of provoked ones were observed in the pandemic, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06294964, orgStudyIdInfo id: Sleep Education, briefTitle: Intervention and Effect of Sleep Pattern on Cardio-cerebrovascular Disease, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: Because of the growing population of older people, cardio-cerebrovascular diseases has been the most important aging-related chronic disease, studying the pathogenesis and early warning mechanisms of cardio-cerebrovascular diseases in depth, exploring optimal strategies for early diagnosis and treatments of cardio-cerebrovascular diseases has becoming the urgent public health problem in China. Aging causes cellular changes that change the sleep status in older adults, leading to an increased risk of disease and death. Meanwhile, the rising prevalence of chronic diseases among older adults also increases the impact of sleep deprivation. Insufficient sleep has being a serious challenge to the health status of the elderly. However, there is no clinically significant treatment for sleep disorders caused by chronic diseases. Medication helps to sleep but will also lead to drug dependence and increasing the risk of recurrent sleep disorders, which is unfavorable for disease control.Studies have shown that older adults who sleep 7-8 hours at night have better physical and mental health, cognition and quality of life. Shorter sleep durations (6 hours or less) and longer sleep durations (greater than 9 hours) had strong associations with adverse health outcomes such as cardiovascular, metabolic, immune, cognitive diseases, other psychiatric disorders, and mortality.Therefore, on the basis of the established Pudong community cohort, the project applicant led the team to adopt an open-label, blind endpoint, and cluster-randomized two-phase trial method to randomly assign cohort members into intervention group and control group. According to the sleep health intervention plan formulated by the clinical team, family doctor provides health education materials according to the actual situation of the intervention group regularly. Family doctors in the control group used conventional management methods. The final assessment was that compared to control group, whether the intervention group improved members' sleep quality, reduced members' cardiovascular disease events, and individual cardiovascular disease morbidity and all-cause mortality during the study period., conditionsModule conditions: Cardiovascular Diseases, conditions: Non-Communicable Chronic Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 12800, type: ESTIMATED, armsInterventionsModule interventions name: sleep education, behavioral education, outcomesModule primaryOutcomes measure: the incidence and/or prevalence of cardiovascular diseases such as myocardial infarction, stroke, heart failure, and cardiovascular death, secondaryOutcomes measure: all cause death, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cardiology, Ren Ji Hospital, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06294951, orgStudyIdInfo id: IIT-2023-0225, briefTitle: fMRI for BPS: A Descriptive Study of Findings and Symptoms, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to investigate the relationship between functional magnetic resonance imaging (fMRI) findings of the brain and symptom presentation in patients with bladder pain syndrome (BPS). The main questions it aims to answer are:1. To explore the distribution characteristics of fMRI imaging and possible target lesions in the patient population.2. To provide appropriate clues and evidence for etiological exploration and therapeutic targeting of BPS.Participants will undergo fMRI as well as other routine laboratory tests and queries., conditionsModule conditions: Bladder Pain Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: fMRI, outcomesModule primaryOutcomes measure: fMRI findings, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200127, country: China, contacts name: Zhebin Du, Dr., role: CONTACT, phone: +86-13512179027, email: [email protected], contacts name: Zhebin Du, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Yinghui Fan, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Yingfu Jiao, Dr., role: SUB_INVESTIGATOR, contacts name: Liang Dong, Dr., role: SUB_INVESTIGATOR, contacts name: Qixiang Song, Dr., role: SUB_INVESTIGATOR, contacts name: Xinxing Du, Dr., role: SUB_INVESTIGATOR, contacts name: Yanhao Dong, Dr., role: SUB_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06294938, orgStudyIdInfo id: M.WRI-2023-INQ-2224, briefTitle: Glycemic Index of Cacao Fruit Pulp in Healthy, Human Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-30, primaryCompletionDateStruct date: 2023-01-24, completionDateStruct date: 2023-05-23, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Mars Wrigley, class: INDUSTRY, collaborators name: INQUIS Clinical Research, descriptionModule briefSummary: Cacao fruit pulp is a sweet and fruity carbohydrate-rich edible mucilage that is often discarded. The objective of this study is to assess the glycemic response and determine the glycemic index of cacao fruit pulp., conditionsModule conditions: Blood Sugar; High, conditions: Blood Sugar; Low, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: acute, open-labeled, randomized design, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Cacao fruit pulp, interventions name: Dextrose, outcomesModule primaryOutcomes measure: Plasma Glucose, primaryOutcomes measure: Incremental area under the curve, primaryOutcomes measure: Peak plasma glucose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: INQUIS Clinical Research, city: Toronto, state: Onterio, zip: M5C 2N8, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06294925, orgStudyIdInfo id: C5041041, secondaryIdInfos id: EFFECT-UC, type: OTHER, domain: Alias Study Number, briefTitle: A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis, acronym: EFFECT-UC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-20, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod., conditionsModule conditions: Colitis, Ulcerative, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Etrasimod, outcomesModule primaryOutcomes measure: Proportion of patients with symptomatic remission, primaryOutcomes measure: Proportion of patients with symptomatic remission, secondaryOutcomes measure: Proportion of patients with clinical response, secondaryOutcomes measure: Proportion of patients with clinical response., secondaryOutcomes measure: Proportion of corticosteroid-free patients with symptomatic remission, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294912, orgStudyIdInfo id: 7602-003, secondaryIdInfos id: MK-7602-003, type: OTHER, domain: Merck, briefTitle: A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2025-03-10, completionDateStruct date: 2025-03-10, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection., conditionsModule conditions: Malaria, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Plasmodium falciparum, interventions name: MK-7602, interventions name: Artemether/lumefantrine, interventions name: Primaquine, interventions name: Artesunate, interventions name: Atovaquone/proguanil, outcomesModule primaryOutcomes measure: Parasite reduction ratio (PRR48) (Parts 1 and 2), primaryOutcomes measure: Parasite Clearance Half-life (PCt1/2) (Parts 1 and 2), primaryOutcomes measure: Parasite Regrowth (Parts 1 and 2), primaryOutcomes measure: Part 1 Single dose: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of MK-7602, primaryOutcomes measure: Part 1 Single dose: Maximum Plasma Concentration (Cmax) of MK-7602, primaryOutcomes measure: Part 1 Single dose: Concentration at 24 Hours (C24) of MK-7602, primaryOutcomes measure: Part 1 Single dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602, primaryOutcomes measure: Part 1 Single dose: Elimination Half-life (t1/2) of MK-7602, primaryOutcomes measure: Part 2 Multiple dose: Area Under the Curve Time 0 to End of the Dosing Interval (AUC0-tau) of MK-7602, primaryOutcomes measure: Part 2 Multiple dose: Maximum Plasma Concentration (Cmax) of MK-7602, primaryOutcomes measure: Part 2 Multiple dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602, primaryOutcomes measure: Part 2 Multiple dose: Elimination Half-life (t1/2) of MK-7602, secondaryOutcomes measure: Number of Participants Who Experience an Adverse Event (AE), secondaryOutcomes measure: Number of Participants Who Discontinue Study Intervention Due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294899, orgStudyIdInfo id: 23/222-P, briefTitle: CRP and Lung Ultrasound in Respiratory Evaluation, acronym: PLURE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, class: OTHER, descriptionModule briefSummary: Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists.This study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections., conditionsModule conditions: C-Reactive Protein, conditions: Ultrasonography, conditions: Primary Health Care, conditions: Lower Respiratory Tract Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 202, type: ESTIMATED, armsInterventionsModule interventions name: Lung ultrasound, outcomesModule primaryOutcomes measure: Ultrasound patterns, primaryOutcomes measure: C-Reactive Protein, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294886, orgStudyIdInfo id: Innovis RD-2401, briefTitle: Vaginal Fluid Collection for Detection of Endometrial Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Innovis LLC, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN., conditionsModule conditions: Endometrial Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Screening test to detect endometrial cancer and precancer, outcomesModule primaryOutcomes measure: Detection of endometrial cancer and precancer, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Trials365, status: RECRUITING, city: Shreveport, state: Louisiana, zip: 71118, country: United States, contacts name: Jen Cory, role: CONTACT, phone: 318-408-1198, email: [email protected], contacts name: Destin Black, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.52515, lon: -93.75018, hasResults: False |
protocolSection identificationModule nctId: NCT06294873, orgStudyIdInfo id: Innovis RD-2301, briefTitle: Stool Sample Collection Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-20, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Innovis LLC, class: INDUSTRY, collaborators name: Exact Sciences Corporation, descriptionModule briefSummary: The primary objective of this study is to obtain de-identified stool specimens from participants with colonoscopic biopsy-based histopathologic diagnosis of colorectal cancer (CRC) and/or a ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of neoplasms of the aerodigestive tract., conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: A screening device for the detection of colorectal and other aerodigestive tract cancers, outcomesModule primaryOutcomes measure: Detection of colon cancer or precancer, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Associated Gastroenterology Medical Group, status: RECRUITING, city: Anaheim, state: California, zip: 92810, country: United States, contacts name: Brian Riff, MD, role: CONTACT, phone: 714-778-1300, phoneExt: 227, email: [email protected], contacts name: Brian Riff, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.83529, lon: -117.9145, locations facility: Sarkis Clinical Trials, status: RECRUITING, city: Ocala, state: Florida, zip: 34474, country: United States, contacts name: Jen Corcoran, role: CONTACT, phone: 352-363-5395, phoneExt: 272, email: [email protected], contacts name: Vishnu Reddy, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.1872, lon: -82.14009, locations facility: Gastro One, status: RECRUITING, city: Cordova, state: Tennessee, zip: 38018, country: United States, contacts name: Brian Dragutsky, role: CONTACT, phone: 901-606-8924, email: [email protected], contacts name: Ziad Younes, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.15565, lon: -89.7762, hasResults: False |
protocolSection identificationModule nctId: NCT06294860, orgStudyIdInfo id: 01C317, briefTitle: Biological Age in Children With GH Deficiency Undergoing Hormone Replacement Therapy, acronym: ETABIOGHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The primary objective of the study is to evaluate the epigenetic age in children with GH deficiency, before and after 6 months of treatment with growth hormone replacement therapy. The secondary objective is to correlate the epigenetic age with the auxometric and biochemical parameters used in the clinical-endocrinological practice. The results of the study will be useful to set up the clinical and biochemical follow-up of the hormone replacement therapy with rhGH and to understand the biomolecular mechanisms at the base of the debated "anti" or "pro" aging action of GH, the most important anabolic hormone of the human organism., conditionsModule conditions: Growth Hormone Deficiency, conditions: Short Stature, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Measurement of biological (epigenetic) age, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milano, zip: 20145, country: Italy, contacts name: Alessandro Sartorio, role: CONTACT, phone: +390261911, phoneExt: 2426, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06294847, orgStudyIdInfo id: 2021_0025, briefTitle: Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery, acronym: UDCA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Hopital Foch, class: OTHER, descriptionModule briefSummary: This study is indicated for patients with extended rhegmatogenous retinal detachment (RRD) (≥ 2 quadrants) with macula OFF lasting 7 days or less, pseudophakic or aphakic, and scheduled to undergo surgical intervention with vitrectomy and gas tamponade in one of the ophthalmology departments participating in the study.The main objective is to assess the effectiveness of UDCA in visual acuity recovery at 3 months (i.e., the difference between preoperative visual acuity and visual acuity 3 months after surgery) in pseudophakic or aphakic patients who have undergone successful surgical intervention (reattachment of the retina) through vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD).120 patients will be enrolled and randomized in two groups:* the experimental arm "UDCA Group," with oral administration of ursodeoxycholic acid (Ursolvan®)* the control group "Placebo Group," with oral administration of the placebo., conditionsModule conditions: Retinal Detachment, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Ursolvan, interventions name: Placebo, outcomesModule primaryOutcomes measure: Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (ETDRS scale) between the two groups (treatment and placebo), secondaryOutcomes measure: Central Nervous Epithelium (CNE) thickness, secondaryOutcomes measure: Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups., secondaryOutcomes measure: Contrast sensitivity measurement using the Clinic CSF2.0 application., secondaryOutcomes measure: Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane)., secondaryOutcomes measure: Retinal thickness measured by OCT (retinal layers and presence of cysts, layer segmentation and measurement in the central 1 and 3 mm in ETDRS quadrants)., secondaryOutcomes measure: Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE., secondaryOutcomes measure: Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT., secondaryOutcomes measure: Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity., secondaryOutcomes measure: Presence of metamorphopsia., secondaryOutcomes measure: Tolerance and occurrence of adverse events., secondaryOutcomes measure: National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative., secondaryOutcomes measure: Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times., secondaryOutcomes measure: Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Cochin, city: Paris, zip: 75014, country: France, contacts name: EYMARD Pauline, Dr, role: CONTACT, email: [email protected], contacts name: EYMARD Pauline, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Foch, city: Suresnes, zip: 92150, country: France, contacts name: Behar Cohen Francine, Pr, role: CONTACT, phone: 01 46 25 22 75, email: [email protected], contacts name: Behar Cohen Francine, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.87143, lon: 2.22929, hasResults: False |
protocolSection identificationModule nctId: NCT06294834, orgStudyIdInfo id: STUDY22010071, secondaryIdInfos id: 90SIMS0010, type: OTHER_GRANT, domain: NIDILRR, briefTitle: Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users, acronym: SKILL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-22, primaryCompletionDateStruct date: 2026-08-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, collaborators name: Dalhousie University, collaborators name: National Institute on Disability, Independent Living, and Rehabilitation Research, descriptionModule briefSummary: The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program for clinicians. The study will use three-group approach: intervention with remote feedback (Group 1), control group (Group 2), and structured self-study (Group 3). This demonstrates how the intervention compares not only to a control, but also to the next "best alternative" - therapists sourcing web-based training materials and learning independently., conditionsModule conditions: Wheelchair Skills, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized, single-blinded, two-period cross-over study design for Groups 1 and 2. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After enrollment for Groups 1 and 2 is complete, participants will be enrolled into Group 3., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: For therapists, we will use a randomized, single-blinded, two-period cross-over study design for Groups 1 and 2. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After we have completed enrollment for Groups 1 and 2 we will enroll participants into Group 3.Rehabilitation professionals who are not therapists will be enrolled in Group 4., whoMasked: PARTICIPANT, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Part 1 of intervention A - Wheelchair skills training modules, interventions name: Part 2 of intervention A - Asynchronous feedback from a remote trainer, interventions name: Intervention B: Education on wheelchair provision, outcomesModule primaryOutcomes measure: Change in Wheelchair Skills Test Questionnaire (WST-Q) score, primaryOutcomes measure: Change in Self-Efficacy on Assessing, Training, and Spotting (SEATS) score, primaryOutcomes measure: Change in number of wheelchair users trained, primaryOutcomes measure: Change in quality of wheelchair skills trained, secondaryOutcomes measure: Change in rehab professional Wheelchair Skills Test Questionnaire (WST-Q) score, secondaryOutcomes measure: Change in rehab professional Self-Efficacy on Assessing, Training, and Spotting (SEATS) score, secondaryOutcomes measure: Change in rehab professional quantity of wheelchair users trained, secondaryOutcomes measure: Change in rehab professional quality of wheelchair training, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pittsburgh / Rehab Neural Engineering Labs, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15219, country: United States, contacts name: Lee Tempest, BS, role: CONTACT, phone: 412-232-9326, email: [email protected], contacts name: Debbie Harrington, BS, role: CONTACT, phone: 412-383-1355, email: [email protected], geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06294821, orgStudyIdInfo id: 00003845, briefTitle: 4AP to Delay Carpal Tunnel Release (CTR), acronym: CTR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: John Elfar, class: OTHER, descriptionModule briefSummary: The investigators have found recent promising data supporting the use of a currently FDA approved drug, 4-aminopyridine, in the treatment of nerve injury including compression neuropathy. The purpose of this research is determine whether 4-aminopyridine can delay the need for formal surgical release in patients with known carpal tunnel syndrome who would otherwise undergo surgery., conditionsModule conditions: Compression Neuropathy, conditions: Carpal Tunnel Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: 4-Aminopyridine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Results of symptomatic improvement in the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), primaryOutcomes measure: Results of symptomatic improvement in the Michigan Hand Outcomes Questionnaire (MHQ), secondaryOutcomes measure: Electrodiagnostic improvement following treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294808, orgStudyIdInfo id: 2017-2601, briefTitle: Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-07-17, primaryCompletionDateStruct date: 2020-06-30, completionDateStruct date: 2020-06-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: National Cancer Centre, Singapore, class: OTHER, collaborators name: Singapore General Hospital, descriptionModule briefSummary: Clinical outcomes after surgical resection in HCC is a continuum and is clearly related to tumor burden but needs better definition. The researchers describe the use of the "metro ticket" approach to analyze surgical outcomes over the whole spectrum of anatomically resectable HCC to define overall survival including intermediate stage tumors (BCLC B). The analysis the researchers provide in this study enables the clinician to select the optimal surgical resection candidate based on robust long term survival data.In addition, study compares outcome for open surgery vs laparoscopic surgery, survival outcome for viral and non-viral HCC using Albumin-Bilirubin (ALBI) for more comprehensive study result., conditionsModule conditions: Hepatocellular Carcinoma Resectable, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1043, type: ACTUAL, outcomesModule primaryOutcomes measure: 5-year mortality., primaryOutcomes measure: Concordance of pre-operative radiological and post operative surgical specimen., primaryOutcomes measure: Agreement between TBI calculated from pre-operative imaging versus those obtained from post-surgical pathological assessment., eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Centre, Singapore, city: Singapore, zip: 168583, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, locations facility: Singapore General Hospital, city: Singapore, zip: 169608, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False |
protocolSection identificationModule nctId: NCT06294795, orgStudyIdInfo id: 2-2024, briefTitle: Toric Intraocular Lens Implantation in Pediatric Cataract, acronym: TILIPC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Kazakh Eye Research Institute, class: NETWORK, descriptionModule briefSummary: To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism, conditionsModule conditions: Cataract Congenital, conditions: Astigmatism, conditions: IOL, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: congenital/pediatric cataract surgery, interventions name: Non-Toric IOLs, interventions name: Toric IOLs, outcomesModule primaryOutcomes measure: Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity, primaryOutcomes measure: Uncorrected (UCNVA) and corrected (CNVA) near visual acuity, primaryOutcomes measure: Refraction measurements, secondaryOutcomes measure: Keratometry measurements, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Kazakh Eye Research Institute, status: RECRUITING, city: Almaty, zip: 050012, country: Kazakhstan, contacts name: Kairat Ruslanuly, MD, role: CONTACT, phone: +77019008387, email: [email protected], contacts name: Zhansaya Sultanbayeva, MD, role: CONTACT, phone: +77023777735, email: [email protected], contacts name: Lukpan Orazbekov, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kairat Ruslanuly, MD, role: SUB_INVESTIGATOR, contacts name: Zhansaya Sultanbayeva, MD, role: SUB_INVESTIGATOR, contacts name: Meruert Ashimova, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.25667, lon: 76.92861, locations facility: Kazakh Eye Research Institute, status: RECRUITING, city: Astana, zip: 010000, country: Kazakhstan, contacts name: Gulnaz Kassymbekova, MD, role: CONTACT, phone: +77478538289, email: [email protected], contacts name: Asiya Beisebayeva, MD, role: CONTACT, phone: +77018333953, contacts name: Aigerim Tuletova, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Asiya Beisebayeva, MD, role: SUB_INVESTIGATOR, contacts name: Gulnaz Kassymbekova, MD, role: SUB_INVESTIGATOR, geoPoint lat: 51.1801, lon: 71.44598, hasResults: False |
protocolSection identificationModule nctId: NCT06294782, orgStudyIdInfo id: 36/2022, briefTitle: PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia, acronym: POPSTAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-15, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Turin, Italy, class: OTHER, collaborators name: Azienda Unità Sanitaria Locale Reggio Emilia, collaborators name: IRCCS Sacro Cuore Don Calabria di Negrar, collaborators name: Fondazione IRCCS Policlinico San Matteo di Pavia, descriptionModule briefSummary: This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized., conditionsModule conditions: Refractory Ventricular Tachycardia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: STereotactic Arhythmia Radioablation (STAR), outcomesModule primaryOutcomes measure: VT storm and incessant VT, primaryOutcomes measure: adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Turin, status: RECRUITING, city: Turin, country: Italy, contacts name: Gaetano Maria De Ferrari, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False |
protocolSection identificationModule nctId: NCT06294769, orgStudyIdInfo id: 022024 Maria Fernanda, briefTitle: Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-06-19, completionDateStruct date: 2024-07-19, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo, class: OTHER, descriptionModule briefSummary: Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%., conditionsModule conditions: Acute Pain, conditions: Perioperative/Postoperative Complications, conditions: CAM, conditions: Nurse's Role, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: essencial oil of lavandula angustifolia, interventions name: grape seed vegetable oil, outcomesModule primaryOutcomes measure: Acute pain, secondaryOutcomes measure: Blood pressure (both systolic and diastolic), secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Respiratory frequency, secondaryOutcomes measure: Oxygen saturation, secondaryOutcomes measure: Temperature, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06294756, orgStudyIdInfo id: acquealbuleroma1, secondaryIdInfos id: AR1221816703484E, type: OTHER_GRANT, domain: La Sapienza University, Rome, Italy, briefTitle: Sulfureous Water Therapy in Viral Respiratory Diseases, acronym: STWandRVD, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-30, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2023-09-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Roma La Sapienza, class: OTHER, collaborators name: Università degli studi di Roma Foro Italico, collaborators name: Queen Mary University of London, collaborators name: Bios Prevention Srl, descriptionModule briefSummary: The goal of this double-blind, interventional, randomized case-control, pilot trial is to evaluate the effects of active sulfurous (STW) versus placebo (SDW) inhalations on blood test parameters, serum inflammatory cytokines, spirometry data, as well as qualitative and quantitative changes in the nasal microbiome of subjects affected by long Covid.The main questions it aims to answer are:* if STW inhalations are effective on respiratory issues due to long covid compared to the placebo inhalation (SDW)* if STW inhalations are effective on long covid related fatigue issues compared to the placebo inhalation (SDW)* if H2S inhaled with STW is effective in modulating (decreasing) cytokines which are related to long covid cytokine storm compared to placebo inhalation with no H2S (SDW)* if STW inhalation modify nasal microbiome both from a qualitative and quantitative point of view respect to placebo inhalation (SDW) Participants will be randomly assigned to active inhalations (STW) or placebo inhalations (SDW) arm and subjected to 12 consecutive sessions of 20 minutes.Both arms will be tested for:* cytokines and inflammatory markers concentration (IL1b, IL6, ACE, GSS, S100B, Hs-CRP)* spirometry (resting, forced, DLCO)* exertion response (6 minutes walking test)* nasal microbiome sampling at visit 1 (enrolment), at visit 2(right after the inhalation treatment) and at visit 3 (3 months after treatment).Researchers will compare results reported by STW to those of SDW group to see if significative differences are detectable., conditionsModule conditions: Long-COVID, conditions: Post COVID-19 Condition, conditions: Chronic COVID-19 Syndrome, conditions: Post Acute Sequelae of COVID-19, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a double-blind, interventional, randomized case-control, pilot trial assessing the efficacy of sulfureous thermal water (STW) inhalations in patients diagnosed with long-COVID. The eligible subjects were randomized in a 1:1 ratio to either: active (STW) or placebo (SDW) group for the inhalation therapy and tested at 3 timepoints: Visit 1 (prior treatment), Visit 2 (just after treatment), Visit 3 (3 months after treatment)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Neither the participants nor any of the medical researchers or laboratory staff involved in the screening, enrolment, clinical evaluation, monitoring, and laboratory as well as statistics of the participant's analyses were aware of the study intervention received (STW vs SDW). A randomization list (1:1 active vs placebo) was created prior to recruiting. The inhalation assistant randomized the participant according to the list and administered the intervention. Therefore, the inhalation assistant was unblinded to the treatment assigned but blinded to the medical condition of the participants., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Inhalation of Sulfurous Thermal Water, interventions name: Inhalation of Sterile Distilled non-pyrogenic Water, outcomesModule primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters., primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters., primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters, primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID, primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID, primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID, secondaryOutcomes measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients., secondaryOutcomes measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients., secondaryOutcomes measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients., secondaryOutcomes measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection, secondaryOutcomes measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection, secondaryOutcomes measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection, otherOutcomes measure: to assess whether thermal water inhalation determine changes in the perceived impact of respiratory related impairment on the quality of life (Qol) through a validate Saint George respiratory questionnaire, otherOutcomes measure: to assess whether thermal water inhalation determine changes in the perceived impact of respiratory related impairment on the quality of life (Qol) through a validate Saint George respiratory questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Acque Albule, Terme di Roma, city: Tivoli, state: Rome, zip: 00019, country: Italy, geoPoint lat: 41.95952, lon: 12.8016, hasResults: False |
protocolSection identificationModule nctId: NCT06294743, orgStudyIdInfo id: C202304001, briefTitle: Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-23, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Taichung Armed Forces General Hospital, class: OTHER_GOV, descriptionModule briefSummary: The goal of this crossover study is to assessed the treatment efficacy of posterior tibia nerve neuroprolotherapy on dysmenorrhea. The primary outcome is the improvement of Visual Analogue Scale. The main question it aims to answer is:•Could the posterior tibial nerve neuroprolotherapy alleviate the pain of dysmenorrhea.Participants will be randomly allocated into two groups, Group-1 will receive neuroprolotherapy in the first 2 menstrual cycles followed by oral acetaminophen(500mg) for the subsequent 2 menstrual cycles. Group02 will received oral acetaminophen(500mg) in initial 2 menstrual cycles, followed by receiving neuroprolotherapy for the subsequent 2 menstrual cycles., conditionsModule conditions: Dysmenorrhea, conditions: Prolotherapy, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Group-1, posterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles, followed by oral acetaminophen (500mg) for the subsequent two menstrual cycles. Conversely.Group-2, oral acetaminophen (500mg) will be given during the initial two menstrual cycles, followed by a transition to posterior tibial nerve neuroprolotherapy for the last two menstrual cycles., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Posterior tibial nerve neuroprolotherapy, interventions name: Acetaminophen 500Mg Tab, outcomesModule primaryOutcomes measure: Visual Analogue Scale, secondaryOutcomes measure: The SF-36v2® Health Survey, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Taichung Armed Forces General Hospital, status: RECRUITING, city: Taichung, state: Other (Non US), zip: 41168, country: Taiwan, contacts name: Jing-dung Shen, MD, role: CONTACT, phone: +886958878129, email: [email protected], contacts name: Jing-dung Shen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False |
protocolSection identificationModule nctId: NCT06294730, orgStudyIdInfo id: 2018/1891-31, briefTitle: COronary Microcirculation and Troponin Elevation in Septic Shock, acronym: COMTESS, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-06-13, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: Plasma cardiac troponin (cTn) elevation is an indicator of increased mortality in patients with sepsis yet the underlying cause of troponin elevation in sepsis is not known. The COMTESS study investigates whether elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in hemodynamically unstable patients with sepsis can be explained by an underlying coronary artery disease or a process within the coronary microcirculation. Fifty patients with sepsis and with hs-cTnT elevation (\>15 ng/L) will undergo coronary angiography, including an assessment of coronary flow using a method called thermo-dilution to record the index of microcirculatory resistance (IMR) in the left anterior descending artery (LAD). The relationship between IMR and hs-cTnT will subsequently be analysed. It is important to identify the underlying causes of elevated cTn during sepsis to target further research with an aim to improve the survival in patients suffering from this condition., conditionsModule conditions: Sepsis, conditions: Myocardial Injury, conditions: Coronary Microvascular Dysfunction, conditions: Endothelial Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Relationship between hs-cTnT and IMR, secondaryOutcomes measure: Relationship between hs-cTnT and CFR, secondaryOutcomes measure: Relationship between hs-cTnT and BRI, secondaryOutcomes measure: Relationship between hs-cTnT and number of diseased epicardial coronary vessels, secondaryOutcomes measure: Relationship between hs-cTnT and Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX)-score, secondaryOutcomes measure: Relationship between hs-cTnT and left ventricular end diastolic pressure (LVEDP), secondaryOutcomes measure: Relationship between hs-cTnT and Tricuspid annular plane systolic excursion (TAPSE), secondaryOutcomes measure: Relationship between hs-cTnT and echocardiographic measurements of left ventricular global strain, secondaryOutcomes measure: Relationship between hs-cTnT and echocardiographic measurements of left diastolic dysfunction, secondaryOutcomes measure: Relationship between measures of endothelial dysfunction and IMR, secondaryOutcomes measure: Relationship between measures NETs and IMR, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, Danderyd University Hospital, status: RECRUITING, city: Stockholm, zip: 182 88, country: Sweden, contacts name: Jonas Persson, MD, PhD, role: CONTACT, phone: +46 70-089 1412, email: [email protected], contacts name: Samantha Lörstad, MD, role: CONTACT, phone: +46708693973, email: [email protected], contacts name: Jonas Persson, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Samantha Lörstad, MD, role: SUB_INVESTIGATOR, contacts name: Tomas Jernberg, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Sara Tehrani, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Per Åstrand, MD, role: SUB_INVESTIGATOR, contacts name: Christina Ekenbäck, MD, role: SUB_INVESTIGATOR, contacts name: Fadi Jokhaji, MD, role: SUB_INVESTIGATOR, contacts name: Kambiz Shahgaldi, PhD, role: SUB_INVESTIGATOR, contacts name: Charlotte Thålin, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Patrik Gille-Johnson, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False |
protocolSection identificationModule nctId: NCT06294717, orgStudyIdInfo id: AtaturkUPhStudentNeslihanATLI, briefTitle: The Effect of Progressive Relaxation Exercises on Physiological Parameters, Pain and Anxiety After Cesarean Section, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: Caesarean section is a surgical procedure that can be performed before or during birth in cases where the life of the mother and fetus is threatened or upon the request of the mother and father. One of the most common problems after cesarean section is abdominal pain. Progressive relaxation exercises are a method that allows certain muscle groups in the body to first contract and then relax. Progressive relaxation exercises have been proven to have positive effects on anxiety. By applying progressive relaxation exercises, the parasympathetic nervous system is activated; Thus, heart and respiratory rate and blood pressure can be kept within normal limits. This study will be conducted to determine the physiological parameters, pain and anxiety levels of progressive relaxation exercises, one of the non-pharmacological methods, on women giving birth by cesarean section., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 2, type: ESTIMATED, armsInterventionsModule interventions name: Progressive relaxation exercises will be applied., outcomesModule primaryOutcomes measure: Beck Anxiety Scale, secondaryOutcomes measure: Visual Analog Scale (VAS), eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294704, orgStudyIdInfo id: 2024/0004, briefTitle: Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes, acronym: PompBariatDT1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Sud Francilien, class: OTHER, descriptionModule briefSummary: Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published., conditionsModule conditions: Bariatric Surgery, conditions: Type 1 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: bariatric surgery, outcomesModule primaryOutcomes measure: time spent within glycemic target 70-180 mg/dL, secondaryOutcomes measure: Time spent in level 1 hyperglycemia (181-250 mg/dL), secondaryOutcomes measure: Time spent in level 2 hyperglycemia (>250 mg/dL), secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Coefficient of variation, secondaryOutcomes measure: Time spent in level 1 hypoglycemia (51-70 mg/dl), secondaryOutcomes measure: Time spent in level 2 hypoglycemia (< 50 mg/gdl), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Sud Francilien, city: Corbeil-Essonnes, zip: 91106, country: France, contacts name: Caroline TOURTE, role: CONTACT, phone: +33161693150, email: [email protected], geoPoint lat: 48.60603, lon: 2.48757, hasResults: False |
protocolSection identificationModule nctId: NCT06294691, orgStudyIdInfo id: infusion time & aGVHD-002, briefTitle: Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Anhui Provincial Hospital, class: OTHER_GOV, descriptionModule briefSummary: To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT), conditionsModule conditions: Acute Graft-versus-host Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 198, type: ESTIMATED, armsInterventionsModule interventions name: Time of stem cell infusion, outcomesModule primaryOutcomes measure: The cumulative incidence of grade III to IV aGVHD, secondaryOutcomes measure: The cumulative incidence of grade II to IV aGVHD, secondaryOutcomes measure: The cumulative incidence of neutrophil engraftment at 28 days after transplantation, secondaryOutcomes measure: The cumulative incidence of platelet recovery at 100 days after transplantation, secondaryOutcomes measure: The cumulative incidence of transplant-related mortality at 180 days after transplantation, secondaryOutcomes measure: The cumulative incidence of transplant-related mortality at 360 days after transplantation, secondaryOutcomes measure: The cumulative incidence of chronic GVHD at 360 days after transplantation, secondaryOutcomes measure: The probability of GVHD-free, relapse-free survival(GRFS), secondaryOutcomes measure: The probability of disease-free survival(DFS), secondaryOutcomes measure: The probability of overall survival(OS), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), city: Hefei, state: Anhui, zip: 230036, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False |
protocolSection identificationModule nctId: NCT06294678, orgStudyIdInfo id: infusion time & aGVHD-001, briefTitle: Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Anhui Provincial Hospital, class: OTHER_GOV, descriptionModule briefSummary: To observe the effect of stem cell infusion on the development of acute graft-versus-host disease (aGVHD) in patients with malignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT), conditionsModule conditions: Acute Graft-versus-host Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 198, type: ESTIMATED, armsInterventionsModule interventions name: Time of stem cell infusion, outcomesModule primaryOutcomes measure: The incidence of grade III to IV aGVHD, secondaryOutcomes measure: The incidence of grade II to IV aGVHD, secondaryOutcomes measure: The cumulative incidence of neutrophil engraftment at 28 days after transplantation, secondaryOutcomes measure: The cumulative incidence of platelet recovery at 100 days after transplantation, secondaryOutcomes measure: The cumulative incidence of transplant-related mortality at 180 days after transplantation, secondaryOutcomes measure: The cumulative incidence of transplant-related mortality at 360 days after transplantation, secondaryOutcomes measure: The cumulative incidence of chronic GVHD at 360 days after transplantation, secondaryOutcomes measure: The probability of GVHD-free, relapse-free survival(GRFS), secondaryOutcomes measure: The probability of disease-free survival(DFS), secondaryOutcomes measure: The probability of overall survival(OS), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), city: Hefei, state: Anhui, zip: 230036, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False |
protocolSection identificationModule nctId: NCT06294665, orgStudyIdInfo id: MD113/2023, briefTitle: Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries, conditionsModule conditions: Hip Fractures, conditions: Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pericapsular Nerve Group (PENG) Block, outcomesModule primaryOutcomes measure: The time to the first request of analgesia, secondaryOutcomes measure: Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively, secondaryOutcomes measure: Occurrence of side effects of drugs., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ain Shams University, status: RECRUITING, city: Cairo, zip: 11122, country: Egypt, contacts name: Fatma Ebeid, role: CONTACT, phone: +201095569596, email: [email protected], contacts name: Mohamed Salama, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06294652, orgStudyIdInfo id: AGMT_Lymphoma_Reg, briefTitle: AGMT Austrian Lymphoma Registry, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2033-12-31, completionDateStruct date: 2033-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Arbeitsgemeinschaft medikamentoese Tumortherapie, class: OTHER, descriptionModule briefSummary: Lymphomas are a group of cancers that originate in the lymphatic system, a key component of the immune system. They can be broadly categorized into two main types: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).There are different subtypes of HL, including classical Hodgkin lymphoma (cHL) and nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). The subtypes of cHL include nodular sclerosis, mixed cellularity, lymphocyte-rich, and lymphocyte-depleted.Non-Hodgkin lymphomas are more diverse and comprise a wide range of subtypes, each with distinct genetic, molecular, and clinical features. Common subtypes of NHL include Diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL), myeloma, and other rarer subgroups.Many of these diseases typically present with lymph node enlargement, bone marrow infiltration, general and lymphoma subtype specific symptoms and laboratory abnormalities.Novel agents have improved the prognosis of high-risk lymphoma patients in the front-line and relapsed setting and more accurate prognostic tools enable less intensive treatment for low-risk patients, while maintaining their good prognosis.Lymphoma disease have not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of epidemiology, clinical course and molecular and other biologic data of this disease. As lymphomas are a very heterogeneous group, not all subtypes will always be documented simultaneously in this registry. Which lymphoma subtype is to be documented can change over time, depending on which clinical question is currently in focus., conditionsModule conditions: Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 4000, type: ESTIMATED, outcomesModule primaryOutcomes measure: General Characteristics, primaryOutcomes measure: Genetic Profiling, primaryOutcomes measure: Proportion of lymphoma patients in Austria that require treatment, primaryOutcomes measure: Proportion of lymphoma patients in Austria under active surveillance, primaryOutcomes measure: Number of patients with concomitant diseases, primaryOutcomes measure: Number of treatment and outcome of treatment, primaryOutcomes measure: Patient Outcome, primaryOutcomes measure: Toxicities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitätsklinik für Innere Medizin III, PMU Salzburg, status: RECRUITING, city: Salzburg, zip: 5020, country: Austria, contacts name: Richard Greil, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.79941, lon: 13.04399, hasResults: False |
protocolSection identificationModule nctId: NCT06294639, orgStudyIdInfo id: XJA-20240224, briefTitle: ED50 of Esketamine for Laser Treatment in Children, acronym: ESCALATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-03-27, completionDateStruct date: 2025-04-27, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Air Force Military Medical University, China, class: OTHER, descriptionModule briefSummary: There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. We explore the effective dose of esketamine combined with alfentanil for the inhibition of body movement during facial laser treatment in pediatric patients., conditionsModule conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: The Biased coin method is used, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: Esketamine will be prepared by an investigator who is not involved in anesthesia and outcome assessment. For all participants, esketamine will be diluted to the same volume., enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Esketamine, outcomesModule primaryOutcomes measure: half effective dose of inhibition of body movement, secondaryOutcomes measure: number of patients with agitation during awake, secondaryOutcomes measure: number of patients with dizzy during awake, secondaryOutcomes measure: number of patients with nausea and vomiting during awake, secondaryOutcomes measure: number of patients with apnea during awake, secondaryOutcomes measure: satisfaction score of the parents to the anesthesia, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294626, orgStudyIdInfo id: ISozeri, briefTitle: Examination of Neuromotor Development of Cases Diagnosed With Scaphocephaly, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Acıbadem Atunizade Hospital, class: OTHER, descriptionModule briefSummary: It's an observational study. Purpose of the study: To evaluate the neuromotor development of scaphocephaly cases.21 infants diagnosed with scaphocephaly aged 2-17 months were included.* Is there any delay in the neuromotor development of scaphocephaly cases?* If delay is observed, in which area is it most common?Denver-II Developmental Screening Test and Alberta Motor Infant Scale were applied to the participants., conditionsModule conditions: Craniosynostosis, Sagittal, conditions: Scaphocephaly, conditions: Developmental Delay, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 21, type: ACTUAL, armsInterventionsModule interventions name: Group 1, outcomesModule primaryOutcomes measure: Denver-II Developmental Screening Test, primaryOutcomes measure: Alberta Infant Motor Scale, eligibilityModule sex: ALL, minimumAge: 2 Months, maximumAge: 17 Months, stdAges: CHILD, contactsLocationsModule locations facility: Acıbadem Altunizade Hospital, city: Istanbul, state: Uskudar, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06294613, orgStudyIdInfo id: CIV-23-07-043672, briefTitle: A Prospective, Open-label, Single-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Acusurgical, class: INDUSTRY, descriptionModule briefSummary: Prospective, interventional, open-label, non-controlled, monocentric study in Belgium of Luca, of up to 7 evaluable subjects, undergoing vitreoretinal surgery to treat intravitreal hemorrhage and macular pucker.Only one eye per subject can be enrolled., conditionsModule conditions: Vitreoretinal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 7, type: ESTIMATED, armsInterventionsModule interventions name: vitreoretinal surgery, outcomesModule primaryOutcomes measure: Safety Outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Gent, status: RECRUITING, city: Gent, state: East Flanders, zip: 9000, country: Belgium, contacts name: Bart Leroy, PhD, role: CONTACT, phone: +32 9 33 25791, email: [email protected], geoPoint lat: 51.05, lon: 3.71667, hasResults: False |
protocolSection identificationModule nctId: NCT06294600, orgStudyIdInfo id: REACT, secondaryIdInfos id: 2023-507295-40, type: EUDRACT_NUMBER, briefTitle: Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT), acronym: REACT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-11-05, completionDateStruct date: 2026-01-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Hellenic Institute for the Study of Sepsis, class: OTHER, descriptionModule briefSummary: The primary objective of the REACT randomized clinical trial (RCT) is to optimize the clinical benefit from adjunctive clarithromycin treatment shown in the ACCESS trial and to provide evidence for the clinical benefit of early start of adjunctive oral clarithromycin guided by suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia (CAP) at risk. This can be achieved by endpoints incorporating clinical benefit with the effect of treatment on the improvement of the immune dysregulation of CAP. The secondary objectives of REACT are to investigate the impact of early adjunctive treatment with clarithromycin on the resolution of CAP at the test-of-cure (TOC) visit., conditionsModule conditions: Community-acquired Pneumonia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, 1:1 randomized, double-blind, placebo-controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Clarithromycin 500mg, interventions name: Tablets, outcomesModule primaryOutcomes measure: Change of baseline respiratory symptoms score, primaryOutcomes measure: Change of baseline total sequential organ failure assessment (SOFA) score, primaryOutcomes measure: Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio, secondaryOutcomes measure: The number of patients that succeeded the resolution of CAP at the test of cure (TOC) visit., secondaryOutcomes measure: Need for up-escalation of the SoC administered antibiotics., secondaryOutcomes measure: Survival, secondaryOutcomes measure: Change of baseline sequential organ failure assessment (SOFA) score, secondaryOutcomes measure: Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio, secondaryOutcomes measure: Cytokine production, secondaryOutcomes measure: 28-Day Mortality, secondaryOutcomes measure: 90-Day Mortality, secondaryOutcomes measure: Cost, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming", status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: Nikolaos Tsokos, MD, PhD, role: CONTACT, phone: 6973388487, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki, status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: Simeon Metallidis, MD, PhD, role: CONTACT, phone: 6944361931, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital, status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: Theano Kontopoulou, MD, PhD, role: CONTACT, phone: 6944690525, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital, status: RECRUITING, city: Athens, country: Greece, contacts name: Georgios Adamis, MD, PhD, role: CONTACT, phone: 6937463999, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 1st Department of Internal Medicine, General University Hospital of Ioannina, status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: Charalampos Milionis, MD, PhD, role: CONTACT, phone: 6944521512, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital, status: RECRUITING, city: Athens, country: Greece, contacts name: Vassiliki Tzavara, MD, PhD, role: CONTACT, phone: 6944849808, phoneExt: 0030, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 1st Department of Internal Medicine, THRIASIO General Hospital of Elefsis, status: RECRUITING, city: Athens, country: Greece, contacts name: Styliani Sympardi, MD, PhD, role: CONTACT, phone: 6971863078, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens, status: RECRUITING, city: Athens, country: Greece, contacts name: Petros Bakakos, MD, PhD, role: CONTACT, phone: 6974748113, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 2nd Department of Internal Medicine, Attikon University Hospital, status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: Eleni Mpoutati, MD, PhD, role: CONTACT, phone: 6932434399, phoneExt: 0030, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 2nd Department of Internal Medicine, THRIASIO General Hospital of Elefsis, status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: Zoi Alexiou, MD, PhD, role: CONTACT, phone: 6944820763, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 2nd Department of Internal Medicine, TZANEIO Piraeus General Hospital, status: RECRUITING, city: Athens, country: Greece, contacts name: Georgios Chrysos, MD, PhD, role: CONTACT, phone: 6945432120, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis, status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: Periklis Panagopoulos, MD, PhD, role: CONTACT, phone: 6944410495, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital, status: RECRUITING, city: Athens, country: Greece, contacts name: Ilias Skopelitis, MD, PhD, role: CONTACT, phone: 6944688196, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO- BENAKEIO E.E.S., status: RECRUITING, city: Athens, country: Greece, contacts name: Maria Chini, MD, PhD, role: CONTACT, phone: 6944576476, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 3rd University Department of Internal Medicine, SOTIRIA Athens General Hospital of Chest Diseases, status: RECRUITING, city: Athens, country: Greece, contacts name: Garyfallia Poulakou, MD, PhD, role: CONTACT, phone: 6945597583, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 4th Department of Internal Medicine, Attikon University Hospital, status: RECRUITING, city: Athens, country: Greece, contacts name: Antonios Papadopoulos, MD, PhD, role: CONTACT, phone: 6977302400, phoneExt: 0030, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: 6th Pulmonary Medicine Department, SOTIRIA General Hospital of Chest Diseases of Athens, status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: Ioannis Dimitroulis, MD, PhD, role: CONTACT, phone: 6932666007, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: Department of Chest Medicine, EVANGELISMOS Athens General Hospital, status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: Paraskevi Katsaounou, MD, PhD, role: CONTACT, phone: 2132033384, phoneExt: 0030, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: Department of Internal Medicine, Larissa University General Hospital, status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: George Dalekos, MD, PhD, role: CONTACT, phone: 6937759699, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: Department of Internal Medicine, Patras University General Hospital, status: RECRUITING, city: Athens, country: Greece, contacts name: Karolina Akinosoglou, MD, PhD, role: CONTACT, phone: 6977762897, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: Department of Pulmonary Medicine, General Hospital of Kerkira, status: NOT_YET_RECRUITING, city: Athens, country: Greece, contacts name: Ilias Papanikolaou, MD, PhD, role: CONTACT, phone: 6974305925, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: Emergency Department, TZANEIO Piraeus General Hospital, status: RECRUITING, city: Athens, country: Greece, contacts name: Styliani Gerakari, MD, PhD, role: CONTACT, phone: 6973308684, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, hasResults: False |
protocolSection identificationModule nctId: NCT06294587, orgStudyIdInfo id: IRB-300012407, briefTitle: Evaluation of Free Gingival Graft Timing, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft., conditionsModule conditions: Ridge Augmentation, conditions: Alveolar Mucosa, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: FGG Before GBR, interventions name: FGG after GBR, outcomesModule primaryOutcomes measure: Volumetric outcome assessment, primaryOutcomes measure: Buccal soft tissue profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unversity of Alabama at Birmingham, School of Dentistry, city: Birmingham, state: Alabama, zip: 35294-0007, country: United States, contacts name: Hussein Basma, DDS, MS, role: CONTACT, phone: 205-975-2888, email: [email protected], contacts name: Sarah Startley, DMD, role: CONTACT, phone: 205-975-8711, email: [email protected], contacts name: Hussein Basma, DDS, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False |
protocolSection identificationModule nctId: NCT06294574, orgStudyIdInfo id: 300011943, briefTitle: Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: Mammotome, descriptionModule briefSummary: The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK., conditionsModule conditions: Breast Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: HydroMARK Plus Clip, outcomesModule primaryOutcomes measure: Retrieval rate of the HydroMARK Plus clip., secondaryOutcomes measure: Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Kirklin Clinic, city: Birmingham, state: Alabama, zip: 35249, country: United States, contacts name: Quenteeria Mooney, role: CONTACT, phone: 205-996-1082, email: [email protected], contacts name: Ceren Yalniz, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False |
protocolSection identificationModule nctId: NCT06294561, orgStudyIdInfo id: TGRX-326-1003, briefTitle: TGRX-326 Pharmacokinetic Drug Interaction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Shenzhen TargetRx, Inc., class: INDUSTRY, collaborators name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, descriptionModule briefSummary: This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitor/inducer drugs on pharmacokinetic profiles of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer., conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Itraconazole+TGRX-326, interventions name: Efavirenz+TGRX-326, outcomesModule primaryOutcomes measure: Plasma Tmax, primaryOutcomes measure: Plasma Cmax, primaryOutcomes measure: Plasma AUC(0-t), primaryOutcomes measure: Plasma AUC(0-inf), primaryOutcomes measure: T1/2, primaryOutcomes measure: Plasma volume of distribution (Vz/F), primaryOutcomes measure: Plasma clearance (CL/F), secondaryOutcomes measure: Adverse events/serious adverse events, secondaryOutcomes measure: Corrected QT Interval, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nanjing Drug Tower Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Juan Li, MD, role: CONTACT, phone: +862583105910, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06294548, orgStudyIdInfo id: IRB-300012272 (UAB 23152), briefTitle: A Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2027-05-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: This is a phase Ib/II, dose escalation and dose expansion study of valemetostat (DS-3201) with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma (HCC) who did not receive prior systemic therapy for advanced HCC., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Valemetostat, interventions name: Atezolizumab, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: Phase 1b, primaryOutcomes measure: Phase II, secondaryOutcomes measure: Safety and pharmacokinetics (PK), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Margaret Thomas, MPH, role: CONTACT, email: [email protected], contacts name: Mehmet S Akce, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False |
protocolSection identificationModule nctId: NCT06294535, orgStudyIdInfo id: 2024, briefTitle: The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-11, primaryCompletionDateStruct date: 2024-05-18, completionDateStruct date: 2024-06-06, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap., conditionsModule conditions: Orbital Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: patient select randomly from closed label, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: reconstruction of orbital walls, outcomesModule primaryOutcomes measure: restoring the accurate position of eye, primaryOutcomes measure: motility of eye, primaryOutcomes measure: volume of orbit, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Tanta University, city: Tanta, zip: 3111, country: Egypt, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False |
protocolSection identificationModule nctId: NCT06294522, orgStudyIdInfo id: 1984, briefTitle: Reconstruction of Nasal Floor for Three-dimensional Repair of Alveolar Cleft, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-20, primaryCompletionDateStruct date: 2024-01-06, completionDateStruct date: 2024-02-16, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: reconstruction of alveolar cleft with autogenous bone after elevation of mucoperiosteal flap and suturing of nasal floor and palatal flap, conditionsModule conditions: Alveolar Cleft, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: reconstruction of alveolar cleft, outcomesModule primaryOutcomes measure: recurrence of oronasal fistula, primaryOutcomes measure: volume of alveolar cleft after reconstruction, primaryOutcomes measure: density of bone, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Tanta University, city: Tanta, zip: 3111, country: Egypt, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False |
protocolSection identificationModule nctId: NCT06294509, orgStudyIdInfo id: SMTaVNS 2024, secondaryIdInfos id: 2024-00039, type: REGISTRY, domain: BASEC, briefTitle: taVNS Application Timing During Robotic Sensorimotor Task, acronym: SMTaVNS2024, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Olivier Lambercy, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the feasibility and effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in enhancing sensorimotor learning and adaptation. This study will focus on healthy individuals performing a robotic sensorimotor task.Main Questions it Aims to Answer:How does taVNS, with different timing protocols, affect the feasibility and effectiveness of performing a robotic sensorimotor task? What is the impact of taVNS on sensorimotor learning and adaptation?Participants Will:Be pseudo-randomly assigned to one of five experimental groups with different taVNS stimulation timings.Perform a sensorimotor task multiple times across sessions, spanning a maximum of two weeks or until achieving 70% accuracy in two successive sessions.Have kinematic data collected by a robot during the task. Have physiological data measured using external sensors. Fill out questionnaires about the feasibility of taVNS and other subjective measures after each session.Comparison Group:Researchers will compare the four experimental groups to each other to see if different taVNS stimulation timings affect sensorimotor learning outcomes, as well as to a control group that will receive no stimulation., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single-blinded, pseudo-randomised, exploratory, single-centre, national, longitudinal study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: in-house developed transcutaneous auricular Vagus Nerve Stimulation device, outcomesModule primaryOutcomes measure: Subjectively perceived tolerance of taVNS and perceived difficulty of motor task, primaryOutcomes measure: Success of the sensorimotor challenge, primaryOutcomes measure: Mean Change from Baseline in Galvanic Skin Response (GSR), primaryOutcomes measure: Mean Change from Baseline in Heart Rate (HR), primaryOutcomes measure: Mean Change from Baseline in Pupil Diameter (PD), primaryOutcomes measure: Mean Change from Baseline in electroencephalogram (EEG), secondaryOutcomes measure: Subjectively perceived positive effects of taVNS on motor performance, secondaryOutcomes measure: Change of movement parameters from baseline, secondaryOutcomes measure: Associations between outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294496, orgStudyIdInfo id: 2023YFS0274, briefTitle: Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Sichuan Provincial People's Hospital, class: OTHER, descriptionModule briefSummary: Ischemic stroke affects 2.5 to 3 million people annually in China, ranking as the leading cause of death and disability. Cervical artery stenosis is a significant contributor to this problem, with about 50% of patients experiencing cognitive impairment due to reduced cerebral blood flow. Two main surgical approaches, carotid endarterectomy (CEA) and carotid artery stenting (CAS), are used to treat severe cervical artery stenosis, but their effects on various factors remain unclear.This project collects multimodal imaging data, including CT perfusion and angiography, to create 3D models of cervical artery stenosis. Computational fluid dynamics and AI analysis are used to assess hemodynamics. By monitoring blood flow, oxygen levels, and evaluating postoperative outcomes, the goal is to tailor surgical approaches for better patient outcomes and improved quality of life., conditionsModule conditions: Carotid Stenosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: CEA/CAS, outcomesModule primaryOutcomes measure: Perioperative cardio-cerebrovascular adverse events, secondaryOutcomes measure: Compute fluid dynamics parameters, secondaryOutcomes measure: Clinical outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Provincial People's Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610072, country: China, contacts name: Li Xiong, Master, role: CONTACT, phone: 028-87393020, email: [email protected], contacts name: Chaoqun Zeng, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06294483, orgStudyIdInfo id: Soh-Med-24-01-09MS, briefTitle: Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus., statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: The present study aims to:Compare clinical features, hematological indices and disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: CBC, interventions name: Antinuclear Antibody tests (ANA), interventions name: Rest of ANA profile, interventions name: C3 and C4 complement level., interventions name: Anti phospholipid marker, interventions name: Serum creatinine and Alb/create ratio, interventions name: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus., interventions name: SLEDAI scores, outcomesModule primaryOutcomes measure: Evaluate the hematological indices as (mean platelet volume) of our SLE patient., primaryOutcomes measure: Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient., primaryOutcomes measure: Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient., primaryOutcomes measure: Compare the degree of disease activity between the early-onset and late-onset patients with systemic lupus erythematosus., primaryOutcomes measure: Evaluate the correlation between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university hospital, city: Sohag, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False |
protocolSection identificationModule nctId: NCT06294470, orgStudyIdInfo id: 01-2023, briefTitle: Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2023-12-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Universidad Central de Venezuela, class: OTHER, descriptionModule briefSummary: The objective of this study is to assess the efficiency of the procedure for hemorrhoidal prolapse and pexia in alleviating symptoms of defecatory obstruction among patients with grade II to IV mucohemorrhoidal prolapse., conditionsModule conditions: Hemorrhoids, conditions: Defecation Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: Ballon expulsion test, interventions name: Colonic transit time, interventions name: Stapled hemorrhodopexy, outcomesModule primaryOutcomes measure: Postoperative improvement of symptoms of defecatory obstruction, secondaryOutcomes measure: Postoperative change of the balloon expulsion test, secondaryOutcomes measure: Postoperative change of the colonic transit time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Domingo Luciani, city: Caracas, state: Miranda, zip: 1073, country: Venezuela, geoPoint lat: 10.48801, lon: -66.87919, hasResults: False |
protocolSection identificationModule nctId: NCT06294457, orgStudyIdInfo id: CI-2024-480, briefTitle: Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, descriptionModule briefSummary: ObjectivesMain objective:Assess the effectiveness of non-invasive neuromodulation treatment (NESA) for the management of constipation in patients without diagnosed pathology in SpainSecondary objectives:Evaluate the improvement in sleep quality Analyze the improvement in blood pressure quality Measure the improvement in cortisol quality Determine if there is an improvement in heart rate, conditionsModule conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: The device will be placed with no current. This type of neuromodulation gives no feeling at all to the patient while administred, so there is no way for the patient to know if the apparatus is connected or not., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Non-Invasive Neuromodulation NESA, outcomesModule primaryOutcomes measure: Quality of life by constipation (CVE-20), secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Cardiac Frecuency, secondaryOutcomes measure: Arterial pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06294444, orgStudyIdInfo id: REC/RCR&AHS/23/0741, briefTitle: Comparison of Constraint Induced Movement Therapy and Mirror Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. The aim of this study will be the to know the effect of mCIMT with and without mirror therapy on upper limb function in children with hemiplegic cerebral palsy. A randomized control trial will be conducted at Sheikh Zayed Hospital, RYK through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with mCIMT and Group B will be treated with mCIMT and mirror therapy. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. mCIMT with and without mirror therapy will be applied in patients with hemiplegic cerebral palsy to see the effect on upper limb function., conditionsModule conditions: Hemiplegic Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trial, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Participants will get separate treatment protocol and possible efforts will be put to mask the both groups about their treatment, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Constraint Induced Movement Therapy, interventions name: Mirror therapy, outcomesModule primaryOutcomes measure: fine motor skills, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Imran Amjad, status: RECRUITING, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, contacts name: Muhammad Asif Javed, MS, role: CONTACT, phone: 923224209422, email: [email protected], contacts name: Imran Amjad, PhD, role: CONTACT, phone: 923224390125, email: [email protected], contacts name: Hurriya Sehar, MS*, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.558, lon: 74.35071, locations facility: Riphah International University, status: RECRUITING, city: Lahore, state: Punjab, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False |
protocolSection identificationModule nctId: NCT06294431, orgStudyIdInfo id: RADX-P-2406, briefTitle: Radicle Clarity 24: A Study of Health and Wellness Products on Cognitive Function and Related Health Outcomes, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Radicle Science, class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on cognitive function and related health outcomes, conditionsModule conditions: Cognitive Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be stratified based on their gender assigned at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 1001, type: ESTIMATED, armsInterventionsModule interventions name: Placebo Control Form 1, interventions name: Clarity Active Study Product 1.1 Usage, interventions name: Placebo Control Form 2, interventions name: Clarity Active Study Product 2.1 Usage, outcomesModule primaryOutcomes measure: Change in cognitive function, secondaryOutcomes measure: Change in fatigue, secondaryOutcomes measure: Change in sleep-related impairment, secondaryOutcomes measure: Minimal clinical importance difference (MCID) in cognitive function, otherOutcomes measure: Change in mood (emotional distress-depression), otherOutcomes measure: Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radicle Science, Inc, city: Del Mar, state: California, zip: 92014, country: United States, geoPoint lat: 32.95949, lon: -117.26531, hasResults: False |
protocolSection identificationModule nctId: NCT06294418, orgStudyIdInfo id: 1-037-23, briefTitle: FCI in Post-operative Low Grade Gliomas, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: NHS Grampian, class: OTHER_GOV, collaborators name: University of Aberdeen, descriptionModule briefSummary: The aim of this pilot study is to explore the utility of a new imaging technique, called Field Cycling Imaging (FCI), in postoperative low grade gliomas.The main question it aims to answer is if FCI can differentiate subtypes of low grade gliomas. Participants will have one FCI scan., conditionsModule conditions: Glioma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Field Cycling Imaging (FCI), outcomesModule primaryOutcomes measure: Differentiation of sub-types of low grade glioma assessed by Field Cycling Imaging (FCI) T1 dispersion profiles, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aberdeen Royal Infirmary, status: RECRUITING, city: Aberdeen, zip: AB25 2ZD, country: United Kingdom, contacts name: Arnab K Rana, Dr, role: CONTACT, phone: +441224438363, email: [email protected], geoPoint lat: 57.14369, lon: -2.09814, hasResults: False |
protocolSection identificationModule nctId: NCT06294405, orgStudyIdInfo id: 24-0010, briefTitle: Intraocular Lens Implant Registry Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2029-02-14, completionDateStruct date: 2029-02-14, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University Hospital Augsburg, class: OTHER, descriptionModule briefSummary: The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery., conditionsModule conditions: Intraocular Lens Complication, conditions: Intraocular Lens Rotation, conditions: Intraocular Lens Associated Postoperative Inflammation, conditions: Lens Opacities, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Intraocular lens Implantation, outcomesModule primaryOutcomes measure: Functional results with different Intraocular lenses, primaryOutcomes measure: Contrast sestivitiy with different Intraocular lenses, primaryOutcomes measure: Anatomical results., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Augsburg, status: RECRUITING, city: Augsburg, country: Germany, contacts name: Isabella Baur, MD, role: CONTACT, geoPoint lat: 48.37154, lon: 10.89851, hasResults: False |
protocolSection identificationModule nctId: NCT06294392, orgStudyIdInfo id: 90FA3010, briefTitle: KEEP Connecting Kin, acronym: KEEP-CK, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Oregon Social Learning Center, class: OTHER, collaborators name: Office of Planning, Research & Evaluation, descriptionModule briefSummary: The current study provides a unique opportunity to conduct a summative evaluation of the KEEP Connecting Kin (KEEP-CK) program by leveraging extant relationships with Oregon's Child Welfare System (CWS), Self-Sufficiency Program (SSP), and our community partners to address the needs of informal kinship families and the youth in their care. Specifically, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to evaluate the immediate (post-intervention) and sustained (10 month) impacts of the KEEP-CK program on child, adult, and service utilization outcomes, and prevention of entry into the CWS., conditionsModule conditions: Internalizing Behavior, conditions: Externalizing Behavior, conditions: Child Permanency, conditions: Parenting, conditions: Parent Stress, conditions: Service Utilization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Informal kinship caregivers will be randomly assigned to receive the KEEP-CK program either immediately or after waiting 10 months using a randomized blocked design. Blocking factors include: (a) the length of time that the child has been living in informal kinship care (\<=6 months, 7 months to \<2 years, or \>=2 years); (b) child age (4 to 12 years, or 13+ years); and (c) low (or not low) resource families, defined by an annual household income below (or above) 150% of the federal poverty level., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: KEEP-CK, outcomesModule primaryOutcomes measure: Mean change in youth well-being (i.e., behavioral and emotional functioning, including child internalizing and externalizing behaviors), primaryOutcomes measure: Mean change in child permanency (i.e., placement stability and permanency of placements), primaryOutcomes measure: Mean change in parenting practices and parent/caregiver stress., primaryOutcomes measure: Mean change in parent/caregiver stress., primaryOutcomes measure: Mean change in parenting practices., primaryOutcomes measure: Mean change in parents' use of services from multiple systems (financial, educational, mental health, medical, legal), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Oregon Center Learning Center, status: RECRUITING, city: Eugene, state: Oregon, zip: 97401, country: United States, contacts name: Courtenay Padgett, role: CONTACT, phone: 541-485-2711, email: [email protected], geoPoint lat: 44.05207, lon: -123.08675, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2023-07-11, uploadDate: 2024-02-27T15:36, filename: SAP_000.pdf, size: 239212, hasResults: False |
protocolSection identificationModule nctId: NCT06294379, orgStudyIdInfo id: OUH_SDM, briefTitle: Shared Decision Making in Melanoma Patients Receiving Adjuvant Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: University of Copenhagen, collaborators name: Aarhus University Hospital, collaborators name: Aalborg University Hospital, descriptionModule briefSummary: This study aims to develop test and evaluate a Patient Decision Aid called "The Decision Helper" among melanoma patients eligible for adjuvant treatment.* Is the Decision Helper an acceptable tool for patients and clinicians and is it feasible in clinical practice?* Are there any differences in the levels of decisional regret in the patients who have not used the Decision Helper (pre-implementation) compared to the ones who have (post-implementation?, conditionsModule conditions: Malignant Melanoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: Development of a Patient Decision Aid "The Decision Helper" for melanoma patients receiving adjuvant theory, primaryOutcomes measure: Evaluation of the "The Decision Helper", eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Odense University Hospital, status: RECRUITING, city: Odense C, zip: 5000, country: Denmark, contacts name: Lærke Tolstrup, role: CONTACT, phone: 40295129, email: [email protected], geoPoint lat: 55.39594, lon: 10.38831, hasResults: False |
protocolSection identificationModule nctId: NCT06294366, orgStudyIdInfo id: MenoufiaU2022, briefTitle: Bipolar Transurethral Enucleation Versus Resection in the Treatment of Benign Prostatic Hyperplasia: a Comparative Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-12, primaryCompletionDateStruct date: 2024-04-12, completionDateStruct date: 2024-06-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Menoufia University, class: OTHER, descriptionModule briefSummary: Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men .Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH .Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26% Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP, conditionsModule conditions: Prostatic Hyperplasia, conditions: Prostate Enucleation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Bipolar Bowa device, outcomesModule primaryOutcomes measure: Assessing and comparing the safety, the surgical efficacy and peri-operative morbidity of bipolar enucleation of the prostate and bipolar transurethral resection of the prostate for the treatment of patients with symptomatizing prostates., eligibilityModule sex: MALE, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of medicine, status: RECRUITING, city: Shibīn Al Kawm, state: Menoufia, zip: 32866, country: Egypt, contacts name: Baher M Abdelraouf, MD, role: CONTACT, phone: +201069973254, email: [email protected], geoPoint lat: 30.55258, lon: 31.00904, hasResults: False |
protocolSection identificationModule nctId: NCT06294353, orgStudyIdInfo id: WCTP-ED-B-01, briefTitle: Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-29, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: WELT corp, class: INDUSTRY, descriptionModule briefSummary: The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders.The main questions it aims to answer are:* Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders?* Is the WELT-ED safe for use in the target population without causing adverse effects?Participants will:* Undergo assessments to determine their baseline health status and severity of eating disorder symptoms.* Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks).* Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects., conditionsModule conditions: Eating Disorders, conditions: Binge Eating, conditions: Binge-Eating Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 134, type: ESTIMATED, armsInterventionsModule interventions name: WELT-ED (CBT based DTx), interventions name: Standard Treatment, outcomesModule primaryOutcomes measure: Binge Eating Frequency, secondaryOutcomes measure: Eating Disorder Examination Questionnaire (EDE-Q), secondaryOutcomes measure: Clinical Impairment Assessment (CIA), secondaryOutcomes measure: Patient health questionnaire-9 (PHQ-9), secondaryOutcomes measure: Generalized anxiety disorder 7-item scale (GAD-7), secondaryOutcomes measure: The EuroQol Visual Analogue Scale (EQ-VAS), secondaryOutcomes measure: Clinical Global Impression of Improvement (CGI-I), secondaryOutcomes measure: Clinical Global Impression of Severity (CGI-S), otherOutcomes measure: Adherence (Compliance) to WELT-ED (applicable only to WELT-ED Group), otherOutcomes measure: BMI (Body Mass Index), otherOutcomes measure: WELT-ED App Usage Satisfaction (applicable only to WELT-ED Group), otherOutcomes measure: App-Based Lifestyle and Eating Data (applicable only to WELT-ED Group), otherOutcomes measure: Change in Regular Meal Frequency (applicable only to WELT-ED Group), eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, status: RECRUITING, city: Seoul, zip: 03080, country: Korea, Republic of, contacts name: soohee Choi, role: CONTACT, phone: 0215885700, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, locations facility: Severance Hospital, status: RECRUITING, city: Seoul, zip: 03722, country: Korea, Republic of, contacts name: Young Chul Jung, MD, role: CONTACT, phone: 82-2-2228-1622, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06294340, orgStudyIdInfo id: 1322-IX/42, briefTitle: Noise, Oxidative Stress and Cardiovascular System, acronym: NOXYCARD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Belgrade, class: OTHER, descriptionModule briefSummary: Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity., conditionsModule conditions: Noise; Adverse Effect, conditions: Noise Exposure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Exposure to loud pre-recorded road traffic noise, outcomesModule primaryOutcomes measure: Systolic blood pressure, primaryOutcomes measure: Concentration of stress hormone, secondaryOutcomes measure: Diastolic blood pressure, secondaryOutcomes measure: Concentration of inflammation parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine, University of Belgrade, city: Belgrade, state: Beograd, zip: 11040, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False |
protocolSection identificationModule nctId: NCT06294327, orgStudyIdInfo id: EC23027, briefTitle: RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Vitaz, class: OTHER, collaborators name: University Ghent, descriptionModule briefSummary: Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%).The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research \& Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings.This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period \> 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher., conditionsModule conditions: Pressure Injury, conditions: Pressure Ulcer, conditions: Decubitus Ulcer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 308, type: ESTIMATED, armsInterventionsModule interventions name: Reactive static air support surfaces, outcomesModule primaryOutcomes measure: Incidence of pressure ulcer, category > I, secondaryOutcomes measure: Cost of alternating air pressure mattress compared to reactive static air support surfaces, secondaryOutcomes measure: Patient comfort, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vitaz (General Hospital), status: RECRUITING, city: Sint-Niklaas, state: East Flanders, zip: 9100, country: Belgium, contacts name: Brecht Serraes, PhD, role: CONTACT, phone: +3237602039, email: [email protected], contacts name: Peter Desmet, MD, role: CONTACT, geoPoint lat: 51.16509, lon: 4.1437, hasResults: False |
protocolSection identificationModule nctId: NCT06294314, orgStudyIdInfo id: 1982669-3, briefTitle: Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2026-08-01, completionDateStruct date: 2028-07-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Marshall University, class: OTHER, collaborators name: Arthrex, Inc., descriptionModule briefSummary: The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information., conditionsModule conditions: Anterior Cruciate Ligament Rupture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Fertilized ACL, outcomesModule primaryOutcomes measure: Return to play, primaryOutcomes measure: Biomechanics testing, secondaryOutcomes measure: MRI findings, otherOutcomes measure: Rerupture, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 26 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Marshall University, status: RECRUITING, city: Huntington, state: West Virginia, zip: 25755, country: United States, contacts name: chad d lavender, md, role: CONTACT, phone: 304-552-6514, email: [email protected], contacts name: Kara Cipriani, np, role: CONTACT, phone: 304-541-5316, email: [email protected], geoPoint lat: 38.41925, lon: -82.44515, hasResults: False |
protocolSection identificationModule nctId: NCT06294301, orgStudyIdInfo id: P10-LP005-01, briefTitle: A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-19, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Longbio Pharma, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD)., conditionsModule conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: LP-005 Dose 1 (Single), interventions name: LP-005 Dose 2 (Single), interventions name: LP-005 Dose 3 (Single), interventions name: LP-005 Dose 4 (Single), interventions name: LP-005 Dose 5 (Single), interventions name: LP-005 Dose 6 (Single), interventions name: Placebo (Single), interventions name: LP-005 Dose 7 (Multiple), interventions name: LP-005 Dose 8 (Multiple), interventions name: LP-005 Dose 9 (Multiple), interventions name: Placebo (Multiple), outcomesModule primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Time to peak concentration (Tmax) of LP-005, secondaryOutcomes measure: Maximum concentration (Cmax) of LP-005, secondaryOutcomes measure: Elimination half-life (t1/2) of LP-005, secondaryOutcomes measure: Area under the concentration-time curve (AUC0-t) of LP-005, secondaryOutcomes measure: Apparent clearance rate (CL/F) of LP-005, secondaryOutcomes measure: Assessment of immunogenicity, secondaryOutcomes measure: Assessment of complement C5 activity, secondaryOutcomes measure: Assessment of complement C3b activity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Public Health Clinical Center, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Yun Ling, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06294288, orgStudyIdInfo id: P-10-LP003-2022-01, briefTitle: A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-07-01, primaryCompletionDateStruct date: 2023-09-03, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Longbio Pharma, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-003 and Part 2, multiple ascending dose (MAD)., conditionsModule conditions: Chronic Spontaneous Urticaria, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: LP-003 Dose 1 (Single), interventions name: LP-003 Dose 2 (Single), interventions name: LP-003 Dose 3 (Single), interventions name: LP-003 Dose 4 (Single), interventions name: LP-003 Dose 5 (Single), interventions name: Placebo (Single), interventions name: LP-003 Dose 6 (Multiple), interventions name: LP-003 Dose 7 (Multiple), interventions name: LP-003 Dose 8 (Multiple), interventions name: Placebo (Multiple), outcomesModule primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Time to peak concentration (Tmax) of LP-003, secondaryOutcomes measure: Maximum concentration (Cmax) of LP-003, secondaryOutcomes measure: Elimination half-life (t1/2) of LP-003, secondaryOutcomes measure: Area under the concentration-time curve (AUC0-t) of LP-003, secondaryOutcomes measure: Apparent clearance rate (CL/F) of LP-003, secondaryOutcomes measure: Assessment of immunogenicity, secondaryOutcomes measure: Assessment of total immunoglobulin E (IgE), secondaryOutcomes measure: Assessment of free IgE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai General Hospital, city: Shanghai, state: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06294275, orgStudyIdInfo id: P-10-LP001-2022-01, briefTitle: A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-09-16, primaryCompletionDateStruct date: 2024-01-02, completionDateStruct date: 2024-04-06, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Longbio Pharma, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-001 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-001 and Part 2, multiple ascending dose (MAD)., conditionsModule conditions: Myelodysplastic Syndrome (MDS), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: LP-001 Dose 1 (Single), interventions name: LP-001 Dose 2 (Single), interventions name: LP-001 Dose 3 (Single), interventions name: LP-001 Dose 4 (Single), interventions name: LP-001 Dose 5 (Single), interventions name: LP-001 Dose 6 (Single), interventions name: Placebo (Single), interventions name: LP-001 Dose 7 (Multiple), interventions name: LP-001 Dose 8 (Multiple), interventions name: Placebo (Multiple), outcomesModule primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Time to peak concentration (Tmax) of LP-001, secondaryOutcomes measure: Maximum concentration (Cmax) of LP-001, secondaryOutcomes measure: Elimination half-life (t1/2) of LP-001, secondaryOutcomes measure: Area under the concentration-time curve (AUC0-t) of LP-001, secondaryOutcomes measure: Apparent clearance rate (CL/F) of LP-001, secondaryOutcomes measure: Assessment of immunogenicity, secondaryOutcomes measure: Assessment of hemoglobin (Hb) change, secondaryOutcomes measure: Assessment of red blood cell (RBC) count change, secondaryOutcomes measure: Assessment of reticulocyte (Rtc) count change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Public Health Clinical Center, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06294262, orgStudyIdInfo id: 2023-508230-33-00, briefTitle: Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine, acronym: TETRALITE-Ib, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: LiteVax BV, class: INDUSTRY, collaborators name: University Hospital, Ghent, collaborators name: HarmonyCR, Melle, Belgium, descriptionModule briefSummary: The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants. Local and systemic adverse events, and humoral and cellular immune responses will be determined at different time intervals after a single administration. Mode of action of LiteVax Adjuvant will examined by detailed genetic analysis and omics approaches such as transcriptomics, proteomics and metabolomics., conditionsModule conditions: Vaccination Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: TETRALITE, outcomesModule primaryOutcomes measure: Characterise local and systemic AEs, and SAEs, pIMDs and AESIs to TETRALITE, primaryOutcomes measure: Characterise clinical hematology and biochemistry to TETRALITE, secondaryOutcomes measure: Characterise HI antibody response to the four vaccine strains of TETRALITE in serum, secondaryOutcomes measure: Characterise MN antibody response to the four vaccine strains of TETRALITE in serum, otherOutcomes measure: Characterise mechanisms of action of LiteVax Adjuvant, otherOutcomes measure: Characterise T-cell responses to TETRALITE in PBMCs, otherOutcomes measure: Characterise B-cell response to TETRALITE in PBMCs, otherOutcomes measure: Characterise molecular features of vaccine-induced immunity by RNA sequencing, otherOutcomes measure: Characterise antibody response to influenza virus antigens other than hemaglutunin of the vaccine strains of TETRALITE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Gent, status: RECRUITING, city: Ghent, zip: 9000, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, hasResults: False |
protocolSection identificationModule nctId: NCT06294249, orgStudyIdInfo id: 20045125, briefTitle: Pain Severity in Flapless Dental Implant Placement Using Laser, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-04, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Shiraz University of Medical Sciences, class: OTHER, collaborators name: Shahid Beheshti University of Medical Sciences, descriptionModule briefSummary: The goal of this split-mouth randomized clinical trial study was to investigate the effect of using a laser on pain and discomfort following flapless dental implant surgery. It was hypothesized that laser did not have any impact on post-op pain. Therefore, the study aimed to compare pain and discomfort following flapless dental implant surgeries with or without a laser., conditionsModule conditions: Jaw, Edentulous, Partially, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Laser-induced Incision, interventions name: Punch Incision, interventions name: Implant Placement, outcomesModule primaryOutcomes measure: Pain Severity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: shiraz University of medical sciences, city: Shiraz, state: Fars, country: Iran, Islamic Republic of, geoPoint lat: 29.61031, lon: 52.53113, hasResults: False |
protocolSection identificationModule nctId: NCT06294236, orgStudyIdInfo id: SC291-102, briefTitle: Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Sana Biotechnology, class: INDUSTRY, descriptionModule briefSummary: SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases., conditionsModule conditions: Lupus Erythematosus, conditions: Systemic Lupus Erythematosus, conditions: SLE (Systemic Lupus), conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, conditions: Granulomatous Polyangiitis, conditions: Microscopic Polyangiitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: SC291, outcomesModule primaryOutcomes measure: Evaluate safety and tolerability of SC291, secondaryOutcomes measure: Evaluate preliminary clinical response to SC291, secondaryOutcomes measure: Evaluate preliminary clinical response to SC291, secondaryOutcomes measure: Evaluate preliminary clinical response to SC291, secondaryOutcomes measure: Evaluate preliminary clinical response to SC291, secondaryOutcomes measure: Evaluate preliminary clinical response to SC291 (LN and ERL Cohorts), secondaryOutcomes measure: Evaluate preliminary clinical response to SC291 (LN Cohort), secondaryOutcomes measure: Evaluate preliminary clinical response to SC291 (ERL Cohort), secondaryOutcomes measure: Evaluate preliminary clinical response to SC291 (AAV Cohort), secondaryOutcomes measure: Evaluate preliminary clinical response to SC291 (AAV Cohort), secondaryOutcomes measure: Evaluate cellular kinetics and persistence of SC291, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Swedish Medical Center, status: RECRUITING, city: Seattle, state: Washington, zip: 98122, country: United States, contacts name: Richie Satira, RN, role: CONTACT, phone: 206-386-2000, email: [email protected], contacts name: Danna Caceres-Reyes, RN, role: CONTACT, phone: 206-386-2000, email: [email protected], contacts name: Philip J. Mease, MD, MACR, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False |
protocolSection identificationModule nctId: NCT06294223, orgStudyIdInfo id: SaglikBilU, briefTitle: Upper Extremity and Muscle Oxygenation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: The aim of this study was to measure the acute change in oxygen saturation of skeletal muscle during resistance exercise in the upper extremity using near-infrared spectroscopy., conditionsModule conditions: Near-infrared Spectroscopy, conditions: Muscle Oxygenation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Exercise follow up with near-infrared spectroscopy, outcomesModule primaryOutcomes measure: Determination of Blood Pressure, primaryOutcomes measure: Saturation Measurement, primaryOutcomes measure: Muscle Oxygenation Measurement, primaryOutcomes measure: Determination of Heart Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Saglik Bilimleri University, status: RECRUITING, city: Istanbul, zip: 34010, country: Turkey, contacts name: Esra Pehlivan, Ass Prof, role: CONTACT, phone: 05058527913, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06294210, orgStudyIdInfo id: REC202307012, briefTitle: Supporting Secondary School Student Wellbeing Through a Mobile App and Wearable Biofeedback, acronym: EWSSS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Royal College of Surgeons, Ireland, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effects of an app and wearable device on the wellbeing of secondary school students. The app will offer support for stress management, sleep improvement, and time management. Additionally, it will provide access to educational resources, text-based coaching, and biofeedback monitoring through the wearable device. The device, worn around the wrist, will measure heart rate variability as an indicator of stress response. Throughout the study, students will complete bi-monthly surveys on sleep, stress, and overall wellbeing. To assess the specific impact of each feature, the app features will be released incrementally over the course of a year. The intervention group, comprising students in their last two years of secondary school, will have access to the app and wearable device, while a control group within the same class will not use the system but will complete the same wellness surveys. Coaches on this platform will come from the Centre for Positive Health Sciences MSc in Positive Health Coaching as part of their continued training in coaching. Coaching will be asynchronous so that students can post questions at any time during the day, but coaches will respond within 24 hours, during office hours. It will be made clear that this is not a therapeutic service and will be directed to other resources for these services. Coaches will file an incident report if a risk arises from a message with participants. Participants will be given guidelines for the type of questions they can ask such as asking for advice for setting goals related to their digital habits and sleeping better. The study\'s findings will provide valuable insights into the effectiveness of the app and wearable device in enhancing student wellbeing leading up to their leaving certification exams., conditionsModule conditions: No Disease or Condition is Being Studied, conditions: Stress Psychological, conditions: Overall Wellness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A group of students will be using the mobile app and wrist-monitor to support their wellbeing while a control group of students will be followed at the same time who will not be using the app or wearable. The survey wellbeing, stress, and sleep scores will be compared between these groups., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Mobile app and wrist-worn monitor, outcomesModule primaryOutcomes measure: Wellbeing Survey Results, secondaryOutcomes measure: Heart Rate Variability Metrics, secondaryOutcomes measure: Routine check-ins, secondaryOutcomes measure: App Engagement, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294197, orgStudyIdInfo id: PhD Thesis, briefTitle: Examination of the Effects of Pelvic Floor Exercises on Vaginal and Sexual Health in Postmenopausal Women., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-13, primaryCompletionDateStruct date: 2024-07-13, completionDateStruct date: 2024-12-13, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Hatice Gulsah Kurne, class: OTHER, descriptionModule briefSummary: The purpose of this study; To investigate the effects of pelvic floor muscle exercises on vaginal and sexual health in postmenopausal women. Vaginal symptoms such as vaginal dryness, burning and dyspareunia occur in the postmenopausal period. Vaginal symptoms affect sexual function, leading to a decrease in quality of life. In our study, we plan to evaluate vaginal dryness, one of the vaginal symptoms, using Schirmer's Test. Also in our study; Severities of vaginal dryness, burning and dyspareunia will be evaluated with the visual analog scale (VAS), sexual function will be evaluated with the Post-Menopausal Sexuality Questionnaire and Female Sexual Function Scale, vaginal aging will be evaluated with the Daily Effect of Vaginal Aging Scale, and the presence/severity of pelvic floor symptoms will be evaluated with the Pelvic Floor Distress Inventory-20. The cases will be randomized into two groups and pelvic floor exercises will be given to one group. After the exercises are given, vaginal pH and moistness will be evaluated for acute effect. In the other group, vaginal PH and moisture will be measured after 5 minutes. The cases will be followed without any intervention to the control group. After 12 weeks, the same evaluations will be made to both groups and the results will be compared. The data will be compared using appropriate statistical methods (statistical significance value will be taken as p\<0.05) and discussed with the literature., conditionsModule conditions: Sexual Dysfunction, conditions: Postmenopausal Symptoms, conditions: Pelvic Floor Muscle Weakness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment Randomized Healthy Participants, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Pelvic Floor Exercises, outcomesModule primaryOutcomes measure: Schirmer's Test, secondaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: Female Sexual Function Index (FSFI), secondaryOutcomes measure: Postmenopausal Sexuality Questionnaire (PMSQ), secondaryOutcomes measure: Vaginal Daily Impact of Aging Scale (VDIAS), secondaryOutcomes measure: Disturbing Pelvic Floor Inventory-20, secondaryOutcomes measure: Evaluation of Pelvic Floor Muscle Strength, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Training and Research Hospital, status: RECRUITING, city: Istanbul, state: Fatih, zip: 34098, country: Turkey, contacts name: Nebahat Uzunay, MD, role: CONTACT, phone: +905052609436, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06294184, orgStudyIdInfo id: Guangzhou PH tDCS in SD, briefTitle: tDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Guangzhou Psychiatric Hospital, class: OTHER_GOV, descriptionModule briefSummary: The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out., conditionsModule conditions: Subthreshold Depression, conditions: Young People, conditions: Transcranial Direct Current Stimulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: tdcs lDLPFC, interventions name: tdcs rVLPFC, interventions name: Sham, outcomesModule primaryOutcomes measure: The effect of tDCS in alleviating subthreshold depressive symptoms, secondaryOutcomes measure: Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms, secondaryOutcomes measure: To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Guangzhou Brain hospital(Guangzhou Huiai Hospital), status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510370, country: China, contacts name: Kangguang Lin, M.D;Ph.D, role: CONTACT, phone: 86-13560360144, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06294171, orgStudyIdInfo id: Modified Alveolar Bone Cut, briefTitle: Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-15, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-11-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Baghdad, class: OTHER, descriptionModule briefSummary: The aim of the study is to determine the efficacy of modified piezosurgery with osseodensification drills in expanding narrow alveolar bone., conditionsModule conditions: Dental Implant Failed, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: measurement of alveolar ridge width, outcomesModule primaryOutcomes measure: expansion rate, primaryOutcomes measure: expansion rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Baghdad College of Dentistry, city: Baghdad, zip: 10011, country: Iraq, geoPoint lat: 33.34058, lon: 44.40088, hasResults: False |
protocolSection identificationModule nctId: NCT06294158, orgStudyIdInfo id: LANYARD-ICU-1.1, briefTitle: Light and Noise: Objectively Assessing Environmental Risk Factors for Delirium in the ICU, acronym: LANYARD-ICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, descriptionModule briefSummary: Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in critically ill patients, is a relatively recent development. However, research into delirium prevention and treatment is now in focus of scientific efforts internationally.Knowledge of intensive care unit (ICU) environment as a potential modifiable risk factor for delirium is insufficient to this date. This study thus seeks to evaluate, whether potentially modifiable environmental factors, such as noise or dazzling, are associated with development of delirium. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future.This project is planned to be carried out as an observational pilot study at three perioperative ICUs at the University Medical Centre Graz. Adult patients shall be screened for inclusion, if not deeply sedated. Suitable patients shall be included into the study after written informed consent or deferred consent if they can be expected to remain in the ICU for at least another two days, if they are not already in delirium, if the ICU environment is not actively modified for therapeutic reasons and if no treatment limitations are in place. Over a study duration of one year, 250 to 300 patients are expected to be enrolled into the study. Of those, 60 to 120 patients are likely to develop delirium.Baseline data known to be of relevance for outcome prediction in critically ill patients and factors known to predispose for development of delirium during ICU and hospital stay will be collected. Study equipment will be deployed to measure noise levels and illumination repeatedly over the day. Daily assessments for delirium using the Confusion Assessment Method in Intensive Care Units (CAM-ICU) will be performed. Vital status, physiologic parameters and parameters of ongoing treatment will concomitantly be documented on a daily basis.Data on light and noise levels are then to be unified with parameters of physiology and treatment, vital status, and results of daily assessments for delirium. Statistical analysis using methods of descriptive and comparative statistics as well as both unadjusted and adjusted logistic regression analysis will be performed to identify factors significantly associated with the development of delirium (i.e., risk factors)., conditionsModule conditions: Delirium, conditions: Critical Illness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Brightness measurement, interventions name: Sound level measurement, outcomesModule primaryOutcomes measure: Delirium, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Centre Graz, Dept. of Anaesthesiology and Intensive Care Medicine, city: Graz, state: Styria, zip: 8036, country: Austria, contacts name: Andrea Berghofer, Mag, role: CONTACT, phone: +43 316 385 0, phoneExt: 84663, email: [email protected], contacts name: Paul Zajic, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Philipp G. H. Metnitz, MD PhD, role: SUB_INVESTIGATOR, contacts name: Andreas Münch, MD, role: SUB_INVESTIGATOR, contacts name: Andreas Waltensdorfer, MD, role: SUB_INVESTIGATOR, contacts name: Gabriel Honnef, MD PhD, role: SUB_INVESTIGATOR, contacts name: Christian Regvar, MD, role: SUB_INVESTIGATOR, contacts name: Barbara Hallmann, MD, role: SUB_INVESTIGATOR, contacts name: Martin Rief, MD PhD, role: SUB_INVESTIGATOR, contacts name: Alexander Pichler, MD, role: SUB_INVESTIGATOR, contacts name: Michael Eichlseder, MD, role: SUB_INVESTIGATOR, geoPoint lat: 47.06667, lon: 15.45, hasResults: False |
protocolSection identificationModule nctId: NCT06294145, orgStudyIdInfo id: U24AG072699, type: NIH, link: https://reporter.nih.gov/quickSearch/U24AG072699, briefTitle: Effects of a Wellbeing Intervention on Inflammation Through Reward and Threat Processes, acronym: SAVOR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, collaborators name: Network for Emotional Wellbeing, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: This study aims to evaluate how savoring influences reward and threat processes and downstream inflammation. Savoring is designed to enhance positive affect, which may blunt stress responses and reduce downstream inflammation. The investigators aim to examine changes in the brain following the savoring intervention. The investigators are particularly interested in changes in brain activity that are correlated with changes in inflammation-related markers in the blood. In this single-armed pilot trial, the investigators will assess how savoring alters reactivity to rewarding and threatening experiences, and then examine related changes in downstream inflammation. The investigators intend to recruit 20 undergraduate students to complete a 7-week standardized savoring intervention. Participants will complete brain scans, daily diaries, questionnaires, a behavioral task, and blood collection at pre- and post-intervention assessments., conditionsModule conditions: Low Positive Affect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All 20 participants will be assigned to the same 7-week savoring intervention., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Savoring Intervention, outcomesModule primaryOutcomes measure: Positive affect, secondaryOutcomes measure: Negative affect, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Perceived stress, secondaryOutcomes measure: Psychological wellbeing, secondaryOutcomes measure: Emotions, secondaryOutcomes measure: Reward, secondaryOutcomes measure: Savoring strategies, secondaryOutcomes measure: Interoception, secondaryOutcomes measure: Inflammation, secondaryOutcomes measure: Sustained Attention, secondaryOutcomes measure: Neural Reward Activity, secondaryOutcomes measure: Neural Threat Activity, secondaryOutcomes measure: Daily diary, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 22 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California, Los Angeles, status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Robin B Blades, role: CONTACT, phone: 510-520-5780, email: [email protected], contacts name: Julienne Bower, PhD, role: CONTACT, phone: 310-825-3004, email: [email protected], contacts name: Julienne Bower, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Chloe Boyle, PhD, role: SUB_INVESTIGATOR, contacts name: Naomi Eisenberger, PhD, role: SUB_INVESTIGATOR, contacts name: Steve Cole, PhD, role: SUB_INVESTIGATOR, contacts name: Michelle Craske, PhD, role: SUB_INVESTIGATOR, contacts name: Aileen Echiverri, PhD, role: SUB_INVESTIGATOR, contacts name: Robin Blades, role: SUB_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False |
protocolSection identificationModule nctId: NCT06294132, orgStudyIdInfo id: 4016601, briefTitle: Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-10-21, completionDateStruct date: 2024-10-28, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Ithaca College, class: OTHER, descriptionModule briefSummary: Background / Purpose:There is an ongoing debate regarding the ability of physical therapists to manually sense intervertebral motion. Physical therapists use intervertebral hypomobility as a clinical indicator for spinal manipulation. Also in question is the mechanism of improvement observed after spinal manipulation. Some argue that the improvement is purely neurophysiologic and unrelated to changes in intervertebral motion. This study aimed to determine the diagnostic accuracy of a physical therapist's manual assessment of lumbar intervertebral motion compared to ultrasound imaging and the effect of lumbar manipulation on intervertebral motion, pain, and disability,Methods:Subjects will complete a Numeric Pain Rating Scale (NPR),Oswestry Disability Index (ODI), and a Central Sensitization Inventory before arriving for the study via Qualtrics survey tool. They will be screened for contraindications to manipulation and neurological signs and symptoms. Active forward bending will be quantified by measuring the distance of the subject's fingertips to the floor. Two experienced physical therapists will evaluate the subject's lumbar intervertebral mobility. They will identify the lumbar segment with the least motion or hypomobility. The subjects will be imaged from L1 to S1 with a 5 MHz curvilinear transducer (Edge II MSK ultrasound unit, SonoSite, Inc, Bothell, WA) in the sidlying position with their trunk and hips flexed to end-range. The examiner will save the sagittal image and then place a digital caliper to measure the distance between the spinous processes from the peak of the hyperechoic curvature of the caudal spinous process to the peak of the hyperechoic curvature of the cranial spinous process of each lumbar segment (L5-S1, L4-L5, L3-L2,L2-L1). Subjects will then be randomized to receive a high-velocity low amplitude thrust manipulation or a sham manipulation. The lumbar spine will be reimaged. The ultrasound examiner will be blinded to the manipulation and the caliper measurements. Finally, subjects will be asked for their Global Rating of Change (GROC) and to actively bend forward to remeasure the distance of their fingertips to the floor. One week later, patients will receive an e-mail containing links to repeat the NPR, GROC, and ODI., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to either receive lumbar manipulation or a sham lumbar manipulation., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Participant: the participants will not know whether they received the lumbar manipulation or sham lumbar manipulation.Care Provider: the care providers (those who perform the lumbar manipulation and sham lumbar manipulation) will not be involved in collecting any outcome data.Investigator: all investigators collecting outcome measures will not know which subjects received the lumbar manipulation or sham lumbar manipulation.Outcome assessor: the outcome assessors will not be involved in collecting data., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Lumbar Manipulation, interventions name: Sham Lumbar Manipulation, outcomesModule primaryOutcomes measure: Diagnostic Ultrasound, secondaryOutcomes measure: Trunk Flexion Range Of Motion Measurement, secondaryOutcomes measure: Oswestry Disability Questionnaire, secondaryOutcomes measure: Numeric Pain Rating Scale, secondaryOutcomes measure: Global Rating of Change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ithaca College, status: RECRUITING, city: Ithaca, state: New York, zip: 14850, country: United States, contacts name: John Winslow, role: CONTACT, phone: 607-229-8792, email: [email protected], contacts name: Michael Costello, role: CONTACT, email: [email protected], geoPoint lat: 42.44063, lon: -76.49661, hasResults: False |
protocolSection identificationModule nctId: NCT06294119, orgStudyIdInfo id: MANCAVA, secondaryIdInfos id: 2022SLB5MX, type: OTHER_GRANT, domain: Italian Ministry of Research, briefTitle: Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2026-02-08, completionDateStruct date: 2026-02-08, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: IRCCS Policlinico S. Donato, class: OTHER, descriptionModule briefSummary: MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression.In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression.Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states., conditionsModule conditions: Cardiac Disease, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Major Cardiac surgery, outcomesModule primaryOutcomes measure: Autoregulation index (ARI), primaryOutcomes measure: number of patients developing depression, primaryOutcomes measure: Baroreflex sensitivity, primaryOutcomes measure: Cortical activity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Policlinico San Donato, status: RECRUITING, city: San Donato Milanese, state: Milan, zip: 20097, country: Italy, contacts name: Vlasta Bari, PhD, role: CONTACT, phone: +390252774381, email: [email protected], contacts name: Pavandeep Singh, role: CONTACT, email: [email protected], contacts name: Marco Ranucci, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Vlasta Bari, PhD, role: SUB_INVESTIGATOR, contacts name: Alberto Porta, PhD, role: SUB_INVESTIGATOR, contacts name: Francesca Gelpi, Ms, role: SUB_INVESTIGATOR, contacts name: Beatrice Cairo, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.41047, lon: 9.26838, hasResults: False |
protocolSection identificationModule nctId: NCT06294106, orgStudyIdInfo id: 24-212, briefTitle: eTMS for Veterans and First Responders With PTSD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Virginia Polytechnic Institute and State University, class: OTHER, collaborators name: Wave Neuroscience, descriptionModule briefSummary: A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial., conditionsModule conditions: Post Traumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 10 participants will receive eTMS treatment 10 participants will receive sham eTMS treatment, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: eTMS coil will have an 'active' and 'sham' side and the application will look identical to the participant. The technician will not know which side of the coil is which and will additionally be blinded., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS), outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Report of Symptoms, secondaryOutcomes measure: PCL-5, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fralin Biomedical Research Institute, city: Roanoke, state: Virginia, zip: 24016, country: United States, contacts name: Jessica Florig, MPH, role: CONTACT, phone: 540-526-2261, email: [email protected], contacts name: Wynn Legon, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.27097, lon: -79.94143, hasResults: False |
protocolSection identificationModule nctId: NCT06294093, orgStudyIdInfo id: 026/24, briefTitle: Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-02-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Haifa, class: OTHER, collaborators name: Zinman College of Physical Education and Sports Sciences, descriptionModule briefSummary: this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners., conditionsModule conditions: Achilles Tendon Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: ultrasound tissue characterized, primaryOutcomes measure: Balance test, primaryOutcomes measure: Proprioception test, primaryOutcomes measure: muscle strength test, primaryOutcomes measure: endurance test gastrocnemius muscle, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294080, orgStudyIdInfo id: DfH2023, briefTitle: Effects of Dance and Tai Chi on Balance and Wellbeing on Healthy Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Wolverhampton, class: OTHER, descriptionModule briefSummary: The aim of the proposed randomised controlled study is to compare the effects and efficacy between a dance, a Tai Chi and a waiting list control group intervention over an eight-week period on physical functions and mental benefits among non-clinical adults aged between 18 and 59. The study's primary outcome is mental wellbeing and secondary parameters are physical functional and mood. A tertiary outcome will examine how the physical and mental parameters change during the learning and practice phases, conditionsModule conditions: General Population, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Random Controlled Trial: Blind, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Data collection carried out by RAs blinded to participants' group allocation Statistician blinded to the group and test parameters, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Dance, interventions name: Tai Chi, outcomesModule primaryOutcomes measure: Well-being, secondaryOutcomes measure: Leg strength, secondaryOutcomes measure: Balance, secondaryOutcomes measure: Mood, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Wolverhampton, city: Walsall, state: West Midlands, zip: WS1 3BD, country: United Kingdom, geoPoint lat: 52.58528, lon: -1.98396, hasResults: False |
protocolSection identificationModule nctId: NCT06294067, orgStudyIdInfo id: 43261, briefTitle: A Dose Response Investigation of Docosahexaenoic Acid (DHA), acronym: DRI-DHA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Toronto, class: OTHER, collaborators name: Unity Health Toronto, descriptionModule briefSummary: Docosahexaenoic acid (DHA) is an omega-3 polyunsaturated fatty acid (n-3 PUFA), commonly consumed from fish, that regulates many critical functions within the body including the brain, eye, and heart. While the metabolic precursor to DHA, alpha-linolenic acid (ALA) is considered nutritionally essential and has a set Dietary Reference Intake (DRI), DHA has not yet been deemed essential and does not have a set DRI. Currently, research suggests an intake range of dietary DHA to be anywhere from 0 to over 500mg/d. The aim of our study is to further investigate a feedback mechanism or accumulation that occurs with eicosapentaenoic acid (EPA) as a result of increased dietary DHA to provide insight for potential Recommended Dietary Intake (RDI) values.Hypothesis: The dietary DHA dose at which blood EPA levels increase is the point at which elongation slows, indicating a significant negative feedback pathway is present.Objectives: 1: To determine the dose-response for DHA to increase blood EPA levels in a mixed vegetarian and vegan population. 2: Investigate the DHA dose and time at dose that increases EPA using natural abundance delta carbon-13 (δ13C) as a tracer. 3: To measure DHA turnover and loss rates. 4: Provide data for exploratory analyses related to PUFA metabolism and the effect of DHA on disease related biomarkers.Method: During an 8-week trial, 72 healthy vegan or vegetarian males and females (18-50 years) will be supplemented with 1 of 6 algal-oil based DHA doses: 0, 100, 200, 400, 800 or 1000 mg/d. Blood will be collected at days 0, 3, 7, 14, 28 and 56 and will be analyzed for changes in blood EPA levels as the primary outcome and plasma δ13C EPA signature as the secondary outcome.Significance: Investigating this negative feedback pathway is of great importance in providing evidence to support n-3 PUFA DRIs. EPA and DHA are ecologically sensitive with their major source coming from unsustainably farmed fish stocks and having a set DRI may help to limit the overconsumption of these nutrients., conditionsModule conditions: Nutrition, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blinded, randomized, control, dose-response supplementation trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: For randomization we will use the Research Electronic Data Capture (REDCap) program. Following successful completion of informed consent, the questionnaire and anthropometric assessment participants will be randomized into groups, of a possible six, using a blocked (Latin squares) randomization. These groups will represent DHA0 (0mg/d), DHA1 (100mg/d), DHA2 (200mg/d), DHA3 (400mg/d), DHA4 (800mg/d), and DHA5 (1000mg/d) groups. The Latin square sequences will be randomly allocated to participants with a similar number of participants allocated to each treatment sequence. The participants will only be randomized once all information is collected, informed consent has been obtained and questionnaires have been filled out following the first study call/zoom meeting. Then following their first study in person visit and post blood sample extraction they will be given their DHA capsules, which have been organized by a lab member not directly involved in the study., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: docosahexaenoic acid (DHA), interventions name: soybean oil placebo, outcomesModule primaryOutcomes measure: Changes in omega-3 polyunsaturated fatty acid (n-3 PUFA) blood levels, secondaryOutcomes measure: Changes in the delta carbon 13 (δ13C) n-3 PUFA signatures, secondaryOutcomes measure: Measure of n-3 LC PUFA turnover rates, secondaryOutcomes measure: Measure of n-3 LC PUFA half-lives, otherOutcomes measure: Increased intake of dietary α-Linolenic acid (ALA) and the inhibition of long chained omega-3 polyunsaturated fatty acids (LC n-3 PUFA) synthesis, otherOutcomes measure: Comparing the potential change in omega-3 long chained polyunsaturated fatty acids (n-3 LC PUFA) levels between male and female participants, otherOutcomes measure: Comparing the potential change in n-3 LC PUFA δ13C signatures between male and female participants, otherOutcomes measure: Comparing the potential change in n-3 LC PUFA levels between genetic variations, otherOutcomes measure: Comparing the potential change in n-3 LC PUFA δ13C signatures between genetic variations, otherOutcomes measure: Changes in cardiovascular disease (CVD) biomarkers (BMI in kg/m^2), otherOutcomes measure: Changes in cardiovascular disease (CVD) biomarkers (Waist circumference in cm/inch), otherOutcomes measure: Changes in cardiovascular disease (CVD) biomarkers (blood pressure in mmHg), otherOutcomes measure: Changes in cardiovascular disease (CVD) biomarkers (heart rate in beats per minute), otherOutcomes measure: Changes in cardiovascular disease (CVD) biomarkers (blood lipid profile changes in mmol/L), otherOutcomes measure: Changes in δ13C DHA signature levels to document adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Nutrition and Risk Factor Modification Centre, status: RECRUITING, city: Toronto, state: Ontario, zip: M5C 2T2, country: Canada, contacts name: Amy Symington, PhD student, role: CONTACT, email: [email protected], contacts name: John Sievenpiper, MD, PhD, FRCPC, role: CONTACT, email: [email protected], contacts name: Richard Bazinet, PhD, role: SUB_INVESTIGATOR, contacts name: John Sievenpiper, MD, PhD, FRCPC, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06294054, orgStudyIdInfo id: 2021/0393/HP, briefTitle: Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy, acronym: SELECT, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, collaborators name: Institut Curie, descriptionModule briefSummary: This study will allow the investigators to better assess the efficiency of neoadjuvant chemotherapy before cystectomy by training a predictive model on different patient cohorts with bladder cancer., conditionsModule conditions: Bladder Cancer, conditions: Genomic Instability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 707, type: ESTIMATED, armsInterventionsModule interventions name: neoadjuvant chemotherapy with cisplatine, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre de lutte contre le cancer François Baclesse, city: Caen, country: France, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Centre de recherche des Cordeliers, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Saint-Louis AP-HP, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Institut Curie Centre de Recherche, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Institut Curie, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Institut Gustave Roussy, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Mines ParisTech, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06294041, orgStudyIdInfo id: UEC23/52, briefTitle: INvestigating the Value of Early Sleep Therapy, acronym: INVEST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Strathclyde, class: OTHER, collaborators name: University of Oxford, collaborators name: University of Glasgow, collaborators name: NHS Greater Glasgow and Clyde, collaborators name: NHS Grampian, descriptionModule briefSummary: Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Insomnia interferes with daily activities and may cause other mental and physical health problems. It also makes it more difficult to cope with cancer treatment and makes recovery more challenging. For these reasons, it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia.Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake. Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment. However, it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance, who are undergoing cancer treatment.This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education (SHE) control intervention. The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future, larger study. Throughout, the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise., conditionsModule conditions: Acute Insomnia (Disorder), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Due to the nature of the SRT intervention, the research nurse, patients and most of the study team cannot be blinded to treatment allocation. However, the statistician will be blinded to treatment allocation (i.e., SRT or SHE) until after analysis is complete, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Sleep Restriction Therapy (SRT), interventions name: Sleep Hygiene Education (SHE), outcomesModule primaryOutcomes measure: Recruitment rates, primaryOutcomes measure: Retention rates, primaryOutcomes measure: Intervention fidelity: Therapist adherence, primaryOutcomes measure: Intervention fidelity: Patient engagement, primaryOutcomes measure: Intervention fidelity: Control group contamination, primaryOutcomes measure: Outcome measure completion, primaryOutcomes measure: Intervention acceptability, secondaryOutcomes measure: Improvement in insomnia severity, secondaryOutcomes measure: Improvement in mental health [depression], secondaryOutcomes measure: Improvement in mental health [anxiety], secondaryOutcomes measure: Improvement in rest-activity rhythms [fatigue]Fatigue (FACT-F), secondaryOutcomes measure: Improvement in rest-activity rhythms, secondaryOutcomes measure: Improvement in sleep [estimates of subjective sleep], secondaryOutcomes measure: Measure of health related quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294028, orgStudyIdInfo id: RC31/21/0338, briefTitle: International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction, acronym: VIVA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator., conditionsModule conditions: Ischemic Heart Disease, conditions: Ventricular Tachycardia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 268, type: ESTIMATED, armsInterventionsModule interventions name: Adverse events collection, interventions name: Quality of life questionnaire EQ-5D-5L, interventions name: Medical-economic evaluation, outcomesModule primaryOutcomes measure: Monitoring for the occurrence of at least one serious event during the 36 months of follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294015, orgStudyIdInfo id: 2023-5009, briefTitle: Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Université de Sherbrooke, class: OTHER, descriptionModule briefSummary: Introduction: Glaucoma is the second leading cause of blindness globally. Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. Autologous serum eye drops (ASED), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. This study investigates the efficacy of 20% ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops.Methods: The present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment.The primary outcome is the comparison of National Eye Institute (NEI) scores between autologous serum drops and placebo-treated eyes at two months. Secondary outcomes include Schirmer's test scores, visual acuity, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, intraocular pressure, and complication rates.The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue., conditionsModule conditions: Corneal Epitheliopathy, conditions: Glaucoma, conditions: Corneal Disease, conditions: Dry Eye, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: 20% ASED + AT, interventions name: 0.9% NS + AT, outcomesModule primaryOutcomes measure: National Eye Index Scores, secondaryOutcomes measure: Schirmer Test, secondaryOutcomes measure: Visual Acuity, secondaryOutcomes measure: Tear Break Up Time, secondaryOutcomes measure: Ocular Surface Disease Index, secondaryOutcomes measure: Intraocular Pressure, secondaryOutcomes measure: Complication rates, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06294002, orgStudyIdInfo id: 46-06-04/2020-1, briefTitle: Neuromuscular Training & Postural Stability, acronym: STABLEFIT, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-15, primaryCompletionDateStruct date: 2022-02-20, completionDateStruct date: 2022-06-25, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Novi Sad, class: OTHER, descriptionModule briefSummary: Background: Postural stability (PS) is a vital function that helps maintain equilibrium during standing still, locomotion, and any activities requiring high balance performance. Under static and dynamic conditions, PS is a fundamental factor for the quality of movement in everyday activities or sports. PS and adaptive ability are required in sports due to the interactions between the sensory and motor systems, which regulate postural adjustments by processing information from the visual, vestibular, and somatosensory systems, as reported by previous studies. The interest in using different exercises and protocols for improving PS in sports and physiotherapy has grown in the last few decades. Experts have proposed various training modalities to increase neuromuscular stability, balance, postural control, and general stability. Dynamic Neuromuscular Stabilization (DNS) is a complex of correction exercises with a neuromuscular approach based on improving breathing, fundamental movements, and principles of developmental kinesiology. Whole body vibration training (WBV) is a neuromuscular training approach that has recently become very popular among researchers and practitioners in health and sport. It is usually used as an additional method in a conventional training routine. Designing the training program to achieve the optimal benefits for PS in healthy young adults is important in general personal health management. Although different training protocols have improved PS and general stability in everyday activities, there is still considerable debate regarding the optimal exercise modalities within an exercise program. Aim: The purpose of this study is to determine the effects of dynamic neuromuscular stabilisation (DNS), whole-body vibration (WBV), and a combination of DNS and WBV (MIX) training modalities on postural stability (PS) in healthy recreation participants. Method and materials: 180 gender-balanced groups were divided into four groups, MIX, DNS, VIBRO and CONTROL and underwent two months of treatment. The single and double-leg Center of Force (COF) parameters were collected on the Forceplate., conditionsModule conditions: Postural Stability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: Dynamic neuromuscular stabilisation group, interventions name: Whole body vibration group, interventions name: Dynamic neuromuscular stabilisation with whole body vibration group, outcomesModule primaryOutcomes measure: Double-leg static postural stability sway area, primaryOutcomes measure: Double-leg static postural stability center of force traveled way, primaryOutcomes measure: Double-leg static postural stability medio-lateral displacement, primaryOutcomes measure: Double-leg static postural stability anterior-posterior displacement, primaryOutcomes measure: Single-leg static postural stability sway area, primaryOutcomes measure: Single-leg static postural stability center of force traveled way, primaryOutcomes measure: Single-leg static postural stability anterior-posterior displacement, primaryOutcomes measure: Single-leg static postural stability medio-lateral displacement, secondaryOutcomes measure: Sex, secondaryOutcomes measure: Date of birth, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Body Mass Index (BMI), secondaryOutcomes measure: Adherence, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 26 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of sport and Physical Education, University of Novi Sad, city: Novi Sad, state: Vojvodina, zip: 21000, country: Serbia, geoPoint lat: 45.25167, lon: 19.83694, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-19, uploadDate: 2024-02-27T09:25, filename: Prot_000.pdf, size: 468513, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-19, uploadDate: 2024-02-27T09:26, filename: ICF_001.pdf, size: 167182, hasResults: False |
protocolSection identificationModule nctId: NCT06293989, orgStudyIdInfo id: Emergency department, briefTitle: Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo, acronym: Vertigo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Monastir, class: OTHER, descriptionModule briefSummary: This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED, conditionsModule conditions: Vertigo, Peripheral, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Diazepam 5mg, interventions name: Diazepam 10 mg, interventions name: Placebo, outcomesModule primaryOutcomes measure: Visual analogue scale (VAS)-3H, secondaryOutcomes measure: the Delta-VAS, secondaryOutcomes measure: the time required to reach the resolution of the vertigo crisis, secondaryOutcomes measure: Patients satisfaction, secondaryOutcomes measure: number of patients with adverse effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293976, orgStudyIdInfo id: 4506, briefTitle: Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study, acronym: SEVERE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Unity Health Toronto, class: OTHER, descriptionModule briefSummary: Background: Reverse triggering (RT) is a frequent phenomenon observed in sedated patients under a mechanical ventilation mode called assist-control ventilation. RT is when the ventilator would trigger the patient's respiratory effort instead of the correct order of the patient's respiratory effort triggering the ventilator. Reverse triggering can have negative consequences (loss of protective lung ventilation, and causing double breaths - with the ventilator giving two consecutive breaths and not allowing the patient to exhale) but also offer some protective effects (avoid diaphragm disuse atrophy). The balance of its negative vs positive effects depends on its frequency and magnitude of its associated respiratory effort. Respiratory entrainment is the most often referred mechanism involving a change in patient's rate of breathing effort from that of patient's intrinsic rate to the rate of mechanical insufflation. The specific ventilatory settings associated with or responsible for RT remains unknown.Aims: To assess in mechanically ventilated critically ill patients the influence of the set respiratory rate (RR) and tidal volume (Vt) on the presence/development of RT and to describe the pattern of respiratory muscle activity during Reverse Triggering (RT).Methods. 30 adult patients (15 in each group), sedated and under assist-controlled ventilation will be included. Ventilator settings will be modified to modulate the frequency and magnitude of reverse triggering. Initially, with the ventilator on a mode called volume control, which means the ventilator controls the amount of air (tidal volume) and the number of breaths the patients gets every minute (respiratory rate \[RR\]). The tidal volume will be set at the current standard clinical practice setting (6 ml/kg of predicted body weight). The presence of an intrinsic respiratory rate will be assessed with an end-expiratory occlusion maneuver. Next, the number of breaths the ventilator gives per minute (RR) will be changed from 6 breaths less to 6 breaths more, in steps of 2 breaths every minute. The protocol will be repeated again changing the amount of air the patients gets (tidal volume) from 4, 5, 7 and 8 ml/kg. Continuous recordings of airway pressure, flow, esophageal pressure, electrical activity of the diaphragm, main accessory muscles and frontal electroencephalography will be obtained during the protocol and baseline clinical and physiological characteristics and outcomes will be recorded. A validated software will be used to detect RT and measure the intensity and timing of each muscle electrical activity and the magnitude of the inspiratory effort during RT., conditionsModule conditions: Respiration, Artificial, conditions: Reverse Triggering, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Changes in the ventilator respiratory rate and tidal volume, outcomesModule primaryOutcomes measure: The rate of of reverse triggered breaths occurring after each change in the ventilator respiratory rate and tidal volume., primaryOutcomes measure: The magnitude of the effort, measured by the drop in the esophageal pressure in cmH2O, associated with the reverse triggered breaths after each change in the ventilator respiratory rate and tidal volume, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unity Health Toronto - St. Michael's Hospital, status: RECRUITING, city: Toronto, state: Ontario, zip: M5B 1T8, country: Canada, contacts name: Audery Kim, role: CONTACT, phone: 416-864-5686, email: [email protected], contacts name: Antenor Rodrigues, role: SUB_INVESTIGATOR, contacts name: Laurent Brochard, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06293963, orgStudyIdInfo id: 24-0300a, briefTitle: Front-of-package Label Effects in Latine and Limited English Proficiency Populations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Duke University, collaborators name: Stanford University, descriptionModule briefSummary: The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are:What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and less healthy food products?What front-of-package label design is most effective in helping Latino and low English proficiency consumers choose healthier food products?Additionally, this experiment also aims to answer the following question:Do the benefits of front-of-package label designs differ by English proficiency and parental status?Participants will be randomly assigned to 1 of 4 types of front-of-package label designs and view their assigned label design on 3 sets of products. Each set will display 3 similar products, each high in either 1, 2, or 3 nutrients of concern. For each set, participants will select the product that they believe to be the healthiest, least healthy, and the product that they would most want to consume. Researchers will compare results across label designs., conditionsModule conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: Guideline Daily Amounts label, interventions name: Interpretive text-only label, interventions name: Interpretive magnifying glass icon label, interventions name: Separated interpretive magnifying glass icon label, outcomesModule primaryOutcomes measure: Selection of healthiest product for purchase, secondaryOutcomes measure: Correct identification of healthiest product, secondaryOutcomes measure: Correct identification of least healthy product, secondaryOutcomes measure: Correct identification of products high in nutrients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Marissa G Hall, PhD, role: CONTACT, phone: 919-445-1310, email: [email protected], geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06293950, orgStudyIdInfo id: AUTISM, briefTitle: Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-09, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Jordan, class: OTHER, descriptionModule briefSummary: Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities., conditionsModule conditions: Autism, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: WJMSC, outcomesModule primaryOutcomes measure: safety profile lab tests, secondaryOutcomes measure: efficacy change in Adult ADHD Self-Report Scale (ASRS), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cell Therapy Center, status: RECRUITING, city: Amman, zip: 00962, country: Jordan, contacts name: Hanan Jafar, PhD, role: CONTACT, phone: 00962798871087, email: [email protected], contacts name: Abdallah Awidi, MD, role: CONTACT, phone: 0096265355000, phoneExt: 23960, email: [email protected], geoPoint lat: 31.95522, lon: 35.94503, hasResults: False |
protocolSection identificationModule nctId: NCT06293937, orgStudyIdInfo id: 24-0300b, briefTitle: Impact of Front-of-package Labels on Weight Bias Among Latines, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Duke University, collaborators name: Stanford University, descriptionModule briefSummary: The goal of this experiment is to examine the effects on explicit weight bias of a selection task using 4 different types of front-of-package food labels to select healthy or unhealthy foods among a sample of Latine and low English proficiency adults. The main questions this experiment aims to answer are:* Does the use of different front-of-package label designs in a selection task lead to different effects on explicit weight bias among Latine and low English proficiency consumers?* Does the use of different front-of-package label designs in a selection task lead to different effects on attribution of personal responsibility for body weight among Latine and low English proficiency consumers?Participants will be randomly assigned to 1 of 4 types of front-of-package label designs. They will view 3 sets of products (frozen meals, frozen pizzas, and frozen desserts), shown in random order. For each product set, participants will view 3 products shown in random arrangement, each with participants' randomly assigned label shown on the front of package. After viewing all 3 product types, participants will answer questions about explicit weight bias and attribution of responsibility for body weight. Researchers will compare results across label designs., conditionsModule conditions: Weight Prejudice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: Numerical label, interventions name: Interpretive text-only label, interventions name: Interpretive magnifying glass icon label, interventions name: Separated interpretive magnifying glass icon label, outcomesModule primaryOutcomes measure: Explicit weight bias, mean score, secondaryOutcomes measure: Attribution of personal responsibility for body weight, mean score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Aline D'Angelo Campos, MPP, role: CONTACT, phone: 919-966-3215, email: [email protected], geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06293924, orgStudyIdInfo id: The PEFLANA Trial, briefTitle: Pericardial Fluid Analysis in Recurrent Pericarditis, acronym: PEFLANA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2029-02, completionDateStruct date: 2031-02, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: ASST Fatebenefratelli Sacco, class: OTHER, descriptionModule briefSummary: This clinical trial aims to examine the biochemical and cytological features of pericardial effusion during acute and recurrent pericarditis and to understand the molecular factors responsible for pathogenesis. The primary objective of this study is to identify and validate diagnostic criteria in pericardial fluid analysis that can differentiate patients with acute and recurrent pericarditis from those with only pericardial fluid but no inflammation.This study will enroll patients with acute pericarditis who require pericardiocentesis for either diagnostic or therapeutic purposes. Two control groups will also be included: one consisting of patients who need cardiac surgery with a collection of pericardial fluid, and the other consisting of patients who require pericardiocentesis for non-inflammatory pericardial effusion. The purpose of the study is to compare the cell activation status and cytokines present in pericardial fluid during acute pericarditis with those present during other pericardial pathologies., conditionsModule conditions: Acute Pericarditis, conditions: Pericardial Effusion, conditions: Pericardial Disease, conditions: Pericardial Fluid Exudate, conditions: Autoinflammatory Disorders, conditions: Autoinflammatory Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 432, type: ESTIMATED, armsInterventionsModule interventions name: Pericardiocentesis, interventions name: Pericardiotomy, interventions name: Cytofluorometry and Gene expression analysis, outcomesModule primaryOutcomes measure: Differences in cell counts among inflammatory and non-inflammatory pericardial effusion., primaryOutcomes measure: Difference in biochemical parameters among inflammatory and non-inflammatory pericardial effusion, secondaryOutcomes measure: Difference of IL-1 expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion, secondaryOutcomes measure: Differences of inflammatory cytokine expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion, secondaryOutcomes measure: Differences of gene expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion, secondaryOutcomes measure: Differences of gene expression in pericardial fluid and blood cells during pericarditis, secondaryOutcomes measure: Differences in cytokine and other molecule concentrations between pericardial fluid and blood cells in pericarditis, secondaryOutcomes measure: Correlation of inflammatory mediators in pericardial fluid and clinical features during pericarditis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06293911, orgStudyIdInfo id: 2024-POSTBIOTICSDOWNSYNDROME, briefTitle: Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-07-17, completionDateStruct date: 2025-07-28, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: The aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with Down syndrome.Patients will be enrolled at the S.C. Odontostomatologia dell'Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, Italy. After the collection of the periodontal clinical indexes (BoP%, PCR%, dental mobility, mMGI, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders.Then, they will be randomly divided into two groups according to the home treatment:* in the Trial group Biorepair Plus Parodontgel Intensive (containing microRepair®, hyaluronic acid, Lactobacillus Ferment and Aloe Barbadensis Leaf Juice Powder) will be used once a day for all the duration of the study* in the Control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study.Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint., conditionsModule conditions: Down Syndrome, conditions: Gingival Bleeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Biorepair Plus Parodontgel Intensive, interventions name: Placebo gel, outcomesModule primaryOutcomes measure: Change in Bleeding on Probing (BOP%), primaryOutcomes measure: Change in Plaque Control Record (PCR%), primaryOutcomes measure: Change in Dental mobility, primaryOutcomes measure: Change in Modified Gingival Index, primaryOutcomes measure: Change in compliance, primaryOutcomes measure: Change in product satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino", city: Turin, zip: 10128, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False |
protocolSection identificationModule nctId: NCT06293898, orgStudyIdInfo id: BL-M07D1-ST-101, briefTitle: Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2025-08-24, completionDateStruct date: 2027-08-24, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: SystImmune Inc., class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors., conditionsModule conditions: Endometrial Cancer, conditions: Cervical Cancer, conditions: Ovarian Cancer, conditions: Urothelial Carcinoma, conditions: Biliary Tract Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: BL-M07D1, outcomesModule primaryOutcomes measure: Summary of safety, primaryOutcomes measure: To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SystImmune Recruiting Site, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: SystImmune, role: CONTACT, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06293885, orgStudyIdInfo id: PLUG-II, briefTitle: Pleurodesis Using Hypertonic Glucose, acronym: PLUG-II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, descriptionModule briefSummary: Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection., conditionsModule conditions: Air Leak From Lung, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Dextrose 50, interventions name: Standard of Care - No Dextrose 50, outcomesModule primaryOutcomes measure: Prolonged Air Leak, secondaryOutcomes measure: Duration of Chest Tubes, secondaryOutcomes measure: Home with Chest Tube, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: London Health Sciences Centre, city: London, state: Ontario, zip: N6A 5W9, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False |
protocolSection identificationModule nctId: NCT06293872, orgStudyIdInfo id: IZC miniscrew, briefTitle: Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-25, primaryCompletionDateStruct date: 2023-07-10, completionDateStruct date: 2023-12-28, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Baghdad, class: OTHER, descriptionModule briefSummary: Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability, pain perception, sinus penetration, secondary stability and failure rate., conditionsModule conditions: Orthodontic Appliance Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: 12*2 mm length miniscrew, outcomesModule primaryOutcomes measure: failure rate, secondaryOutcomes measure: primary stability, secondaryOutcomes measure: secondary stability, secondaryOutcomes measure: pain perception, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Baghdad College of Dentistry, city: Baghdad, zip: 10011, country: Iraq, geoPoint lat: 33.34058, lon: 44.40088, hasResults: False |
protocolSection identificationModule nctId: NCT06293859, orgStudyIdInfo id: 5047292, briefTitle: Effect of 12-week Probiotic Consumption Immobilized on Oat Flakes on Blood and Urine Biomarkers and Human Microbiome, acronym: FOODBIOMES CT2, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2023-07-07, completionDateStruct date: 2023-07-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of the Aegean, class: OTHER, collaborators name: Democritus University of Thrace, descriptionModule briefSummary: The purpose of this clinical trial was to evaluate the effects Lactococcus cremoris spp. im-mobilized on oat flakes on human microbiome and blood and urine biomarkers of associated with human health., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Probiotic oat flakes, interventions name: Conventional oat flakes, outcomesModule primaryOutcomes measure: Inflammatory biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of the Aegean, city: Myrina, state: Limnos/Lesvos, zip: 81 400, country: Greece, geoPoint lat: 39.87483, lon: 25.06359, hasResults: False |
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