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protocolSection identificationModule nctId: NCT06361459, orgStudyIdInfo id: NL83858.058.12, briefTitle: Stop Smoking in Spine Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-06, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, collaborators name: Medical Center Haaglanden, collaborators name: Haga Hospital, collaborators name: Alrijne Hospital, collaborators name: Spaarne Gasthuis, descriptionModule briefSummary: Patients that are subjected to a medium complex surgical intervention in neck (posterior) or lumbar spine (posterior) with instrumentation are motivated to stop smoking. The outcome data of patients that stop and that continue smoking will be compared. A group of non smokers is evaluated as a control group. Particularly clinical outcome is evaluated, as well as radiological outcome., conditionsModule conditions: Smoking Cessation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: three study groups: group that does not smoke, group that smokes and stops, group that smokes and does not stop, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Stop smoking, outcomesModule primaryOutcomes measure: ODI or NDI, secondaryOutcomes measure: VAS leg or arm pain, secondaryOutcomes measure: HADS, secondaryOutcomes measure: EuroQol, secondaryOutcomes measure: perceived recovery, secondaryOutcomes measure: radiological evaluation for fusion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leiden University Medical Centre, status: RECRUITING, city: Leiden, state: Zuid Holland, zip: 2300RC, country: Netherlands, contacts name: carmen vleggeert-lankamp, MD MSc PhD, role: CONTACT, phone: +31630925428, email: [email protected], geoPoint lat: 52.15833, lon: 4.49306, hasResults: False
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protocolSection identificationModule nctId: NCT06361446, orgStudyIdInfo id: 023098816, briefTitle: Zonisamide Versus Propranolol in Migraine, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-04-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: Investigators aim to compare the effect of zonisamide versus propranolol in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency, conditionsModule conditions: Migraine, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We will assess The number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either zonisamide and acetaminophen or propranolol and acetaminophen from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included zonisamide and acetaminophen, and Drug B included propranolol and acetaminophen. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Zonisamide 50 MG, interventions name: Propranolol, outcomesModule primaryOutcomes measure: The change in migraine days per 28 days, secondaryOutcomes measure: The total number of migraine days after three months of treatment, secondaryOutcomes measure: The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency., secondaryOutcomes measure: HIT-6 score absolute change in each group after three months of treatment, secondaryOutcomes measure: The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months., eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Kafr Elsheikh University Hospital, status: RECRUITING, city: Kafr Ash Shaykh, zip: 33511, country: Egypt, contacts name: mohamed G. Zeinhom, MD, role: CONTACT, phone: 2001009606828, email: [email protected], geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
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protocolSection identificationModule nctId: NCT06361433, orgStudyIdInfo id: R5-11, briefTitle: Intracerebral Transplantation of Autologous MSC Combined With Scaffold Product for Chronic Intracerebral Hemorrhage, acronym: RAINBOW-Hx, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Hokkaido University Hospital, class: OTHER, collaborators name: Japan Agency for Medical Research and Development, descriptionModule briefSummary: The goal of this clinical trial is to test intracerebral transplantation of stem cell product in patient with chronic intracerebral hemorrhage. The main questions aims to answer are:* The safety of the product* The efficacy of the product, conditionsModule conditions: Intracerebral Hemorrhage, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: HUFF-01, outcomesModule primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, secondaryOutcomes measure: Change in mRS examination, secondaryOutcomes measure: Change in NIHSS examination, secondaryOutcomes measure: Change in FIM examination, secondaryOutcomes measure: Change in Fugl-Myer examination, secondaryOutcomes measure: Change in Barthal index examination, secondaryOutcomes measure: Change in FDG-PET examination, secondaryOutcomes measure: Change in IMZ-SPECT examination, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hokkaido University Hospital, status: RECRUITING, city: Sapporo, state: Hokkaido, zip: 0608638, country: Japan, contacts name: Masahito Kawabori, role: CONTACT, phone: +81117065987, email: [email protected], geoPoint lat: 43.06667, lon: 141.35, hasResults: False
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protocolSection identificationModule nctId: NCT06361420, orgStudyIdInfo id: 2023YF051-01, briefTitle: Driving Pressure-guided Lung Protective Ventilation, acronym: DPV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Yong Lin, PhD, class: OTHER, descriptionModule briefSummary: The study, named as "The Efficacy of Driving Pressure-guided Lung Protective Ventilation in Surgical Repair of Acute Type A Aortic Dissection: an open-label, randomized control clinical trial", aims to investigate whether driving pressure-guided lung protective ventilation can reduce postoperative oxygenation function in patients who have undergone surgical repair of acute type A aortic dissection. The primary outcomes is the incidence of postoperative hypoxemia (a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93% at any concentration of inspiratory oxygen) within 7 days after the surgery., conditionsModule conditions: Hypoxemia, conditions: Ventilator Lung, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: open, randomised control trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ESTIMATED, armsInterventionsModule interventions name: Driving pressure-guided positive end expiratory pressure, interventions name: Optimal oxygenation-guided positive end expiratory pressure, interventions name: Ventilation strategy, interventions name: Management of hypoxemia, outcomesModule primaryOutcomes measure: The incidence of postoperative hypoxemia, secondaryOutcomes measure: The trend of perioperative oxygenation function, secondaryOutcomes measure: Postoperative pulmonary complications except hypoxemia, secondaryOutcomes measure: Early/late death, secondaryOutcomes measure: Vasoactive-inotropic score at the end of surgery, secondaryOutcomes measure: Postoperative adverse cardiovascular events, secondaryOutcomes measure: Length of stay in intensive care unit, secondaryOutcomes measure: Ventilation assistance time, secondaryOutcomes measure: Postoperative extrapulmonary complications, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian medical university union hospital, status: RECRUITING, city: Fuzhou, state: Fujian, zip: 350001, country: China, contacts name: Yong Lin, MD, role: CONTACT, phone: 13805064575, email: [email protected], geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
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protocolSection identificationModule nctId: NCT06361407, orgStudyIdInfo id: 2023-A02464-41, briefTitle: Sensory and Cognitive Predictions, and Their Disruptions in Schizophrenia, acronym: SensoSchiz, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2028-02-28, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Centre Psychothérapique de Nancy, class: OTHER, collaborators name: Institut National de la Santé Et de la Recherche Médicale, France, descriptionModule briefSummary: Disturbances in the sense of self and time could play an important role in the development of psychotic symptoms. Previous work has shown that patients have difficulty preparing to process information on the scale of a second, but are abnormally disturbed by slightly asynchronous information on the millisecond scale. In both cases, the anomalies could explain the patients' unusual experience of time. The hypothesis in neurotypical patients is that small delays or asynchronies asynchronies are treated as irrelevant information and ignored and ignored, whereas in patients suffering from schizophrenia they would disrupt the flow of time. This hypothesis is tested with a new visual illusion., conditionsModule conditions: Schizophrenia, conditions: Sensory Processing Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Individuals with schizophrenia will be tested in parallel with neurotypicals, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: The group will be masked at the stage of data analysis. It cannot be masked at the prior stages, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Illusion task, outcomesModule primaryOutcomes measure: Effect of a millisecond-level trajectory perturbation, secondaryOutcomes measure: Baseline rate of illusion, secondaryOutcomes measure: Effect of a rebound (top-down, conscious influence), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06361394, orgStudyIdInfo id: CORPFIN0021, briefTitle: The Impacts of Mindfulness on Psychological Wellbeing Among Nursing Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-07-25, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Chang Gung University of Science and Technology, class: OTHER, descriptionModule briefSummary: The aims of this study are to develop a mindfulness-based course for nursing students. As well as, to verify the effects on psychological well-being (mindfulness, stress, and anxiety) and nursing professional related competences (empathy, clinical practicum stress, nursing competency) among nursing students., conditionsModule conditions: Students, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The experimental group will enroll in the elective course named "Mindfulness and Happiness," which will consist of 2 hours every week for a continuous period of 18 weeks. The comparison group will not participate in this course., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: mindfulness course, outcomesModule primaryOutcomes measure: perceived stress at baseline, primaryOutcomes measure: perceived stress at T0, primaryOutcomes measure: perceived stress at T1, primaryOutcomes measure: perceived stress at T2, primaryOutcomes measure: anxiety disorder at baseline, primaryOutcomes measure: anxiety disorder at T0, primaryOutcomes measure: anxiety disorder at T1, primaryOutcomes measure: anxiety disorder at T2, primaryOutcomes measure: mindful attention awareness at baseline, primaryOutcomes measure: mindful attention awareness at T0, primaryOutcomes measure: mindful attention awareness at T1, primaryOutcomes measure: mindful attention awareness at T2, primaryOutcomes measure: empathy at baseline, primaryOutcomes measure: empathy at at T0, primaryOutcomes measure: empathy at at T1, primaryOutcomes measure: empathy at at T2, primaryOutcomes measure: practicum stress at T1, primaryOutcomes measure: practicum stress at T2, primaryOutcomes measure: Nursing Competence at T1, primaryOutcomes measure: Nursing Competence at T2, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ya-Chu Hsiao, status: RECRUITING, city: Taoyuan City, state: N/A = Not Applicable, zip: 333 03, country: Taiwan, contacts name: ya-chu hsiao, EdD, role: CONTACT, phone: +886939740890, email: [email protected], geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
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protocolSection identificationModule nctId: NCT06361381, orgStudyIdInfo id: 24-01-281, briefTitle: The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Hartford, class: OTHER, descriptionModule briefSummary: Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy subjects. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive modality that modulates the vagus nerve by stimulating its auricular branches. The effects of the combination of TENS and TaVNS on producing an analgesic response have not been studied. Considering that TENS and TaVNS both stimulate similar analgesic pathways but through different means of activation, the investigators can hypothesize that a combination of both methods can produce a more pronounced analgesic response. Therefore, the objective of this study is to assess the hypoalgesic effect of a combination of TENS and TaVNS in pain-free subjects.The study will be a simple crossover design conducted at the University of Hartford. Subjects will be recruited from the University of Hartford population via oral communication, digital flyers, and posters on campus. Thirty participants will undergo two sessions in a crossover manner with one week in between. During one session, the participants will receive TENS with active TaVNS and the other session will be a placebo procedure (TENS with placebo TaVNS). The order of these sessions will be randomized. Importantly, the pressure pain threshold (PPT) and heat pain threshold (HPT) assessors will be blinded to the treatment category. For active TaVNS, a frequency of 25 Hz will be applied with a pulse duration of 200 µs. For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. High frequency TENS of 100Hz will be applied in both sessions, with a pulse duration of 200 µsec, asymmetrical biphasic square waveform, and intensity of maximal tolerance without pain. TENS and TaVNS will be turned on for 30 minutes after a baseline measurement of outcomes. TENS and TaVNS will then be turned off, but the electrodes will remain on until completion of post-treatment assessment. Pressure pain threshold, heat pain threshold, blood pressure, oxygen saturation and heart rate will be tested 4 times: Once pre-intervention, once during intervention, once immediately after the intervention and once 15 minutes post-intervention., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS), interventions name: Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS), interventions name: Transcutaneous Electrical Nerve Stimulation, outcomesModule primaryOutcomes measure: Pressure Pain Threshold, secondaryOutcomes measure: Heat Pain Threshold, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Oxygen saturation, secondaryOutcomes measure: Blood pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Hartford, city: West Hartford, state: Connecticut, zip: 06117, country: United States, geoPoint lat: 41.76204, lon: -72.74204, hasResults: False
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protocolSection identificationModule nctId: NCT06361368, orgStudyIdInfo id: NYCU112174AF, briefTitle: Efficacy Assessment of Probiotics in Improving Sleep Indices, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: National Yang Ming University, class: OTHER, collaborators name: Bened Biomedical Co., Ltd., descriptionModule briefSummary: To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions., conditionsModule conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: PS150, interventions name: Placebo, outcomesModule primaryOutcomes measure: Polysomnography (PSG), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: Insomnia Severity Index (ISI), secondaryOutcomes measure: Beck Depression Inventory-Second Edition (BDI-II), secondaryOutcomes measure: Beck Anxiety Inventory (BAI), secondaryOutcomes measure: VAS-Sleep, secondaryOutcomes measure: Epworth Sleepiness Scale (ESS), secondaryOutcomes measure: Standford Sleepiness Scale (SSS), secondaryOutcomes measure: Visual Analogue Scale for gastrointestinal symptoms (VAS-GI), secondaryOutcomes measure: Saliva Melatonin, secondaryOutcomes measure: Saliva Cortisol, secondaryOutcomes measure: Saliva IL-6, secondaryOutcomes measure: Saliva Total Antioxidant Capacity (TAC), secondaryOutcomes measure: Saliva Serotonin, secondaryOutcomes measure: Saliva GABA, secondaryOutcomes measure: Saliva Orexin, secondaryOutcomes measure: Urine 6-sulfatoxymelatonin, secondaryOutcomes measure: Urine Norepinephrine, secondaryOutcomes measure: Actigraphy, secondaryOutcomes measure: Sleep Diary, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Institute of Brain Science National Yang Ming Chiao Tung University, city: Taipei, zip: 112304, country: Taiwan, contacts name: Yu En Kuo, Master, role: CONTACT, phone: +886 975231262, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06361355, orgStudyIdInfo id: CMAB807-I-002, briefTitle: Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-02, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Taizhou Mabtech Pharmaceutical Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #Denosumab# in healthy male subjects after a single dose, conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Biological: Post-change CMAB807, Prolia, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Post-change CMAB807, interventions name: Prolia, outcomesModule primaryOutcomes measure: Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time, primaryOutcomes measure: Maximum Concentration of Denosumab, secondaryOutcomes measure: Time to Maximum Concentration of Denosumab, secondaryOutcomes measure: Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3000 Hours, secondaryOutcomes measure: Half-time, secondaryOutcomes measure: Clearance Rate, secondaryOutcomes measure: Apparent Volume, secondaryOutcomes measure: Serum type 1 C-telopeptide (CTX1), secondaryOutcomes measure: anti-drug antibodies(ADA), secondaryOutcomes measure: Neutralization antibodies(Nab), otherOutcomes measure: Percentage and Severity of Participants with Adverse Events, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Second Hospital of Anhui Medical University, status: RECRUITING, city: Hefei, state: Anhui, country: China, contacts name: Hu Wei, Doctor, role: CONTACT, phone: 0551-65997164, email: [email protected], geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
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protocolSection identificationModule nctId: NCT06361342, orgStudyIdInfo id: 23-003633, briefTitle: Smartphones Aggravating Anxiety Symptoms, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The goal of this study is to assess if excessive use of smartphone apps of social media can impact a person's mental health. The study is aimed at improving the usage of smartphones which might help improve the mental health of patients. The goal is not to discourage the use of smartphones but instead to utilize smartphones in a way that they do not impact lives., conditionsModule conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: General decrease in smartphone use, interventions name: Avoiding Social Media Apps, outcomesModule primaryOutcomes measure: Change in anxiety, secondaryOutcomes measure: Change in depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic Minnesota, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06361329, orgStudyIdInfo id: 20240030C, briefTitle: Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Zhejiang University, class: OTHER, descriptionModule briefSummary: ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients., conditionsModule conditions: ETP-ALL, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 81, type: ESTIMATED, armsInterventionsModule interventions name: Homoharringtonine, interventions name: venetoclax, interventions name: Cytarabine, interventions name: G-CSF, interventions name: Vindesine, interventions name: Daunorubicin, interventions name: cyclophosphamide, interventions name: Dexamethasone, interventions name: L-ASP, outcomesModule primaryOutcomes measure: 1-year EFS, secondaryOutcomes measure: CR/CRi, secondaryOutcomes measure: OS, secondaryOutcomes measure: MRD, secondaryOutcomes measure: Safety of induction therapy, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital, College of Medicine, Zhejiang University, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, contacts name: Jie Jin, PhD&MD, role: CONTACT, phone: 13705716779, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06361316, orgStudyIdInfo id: CSPC-DEY-PC-JS01, briefTitle: Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-03-25, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Kuirong Jiang, class: OTHER, collaborators name: CSPC Ouyi Pharmaceutical Co., Ltd., descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer., conditionsModule conditions: Pancreatic Cancer, conditions: Adjuvant Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: Irinotecan liposome injection, outcomesModule primaryOutcomes measure: Disease Free Survival, DFS, secondaryOutcomes measure: Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE, secondaryOutcomes measure: Overall Survival, OS, secondaryOutcomes measure: Quality of life, QOL, secondaryOutcomes measure: The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy, secondaryOutcomes measure: he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: FirstNanjingMU, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 025, country: China, contacts name: KuiRong Jiang, archiater, role: CONTACT, phone: 15312995688, email: [email protected], contacts name: Min Tu, associate doctor, role: SUB_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06361303, orgStudyIdInfo id: PS230001, secondaryIdInfos id: PS230001 / PSS001, type: OTHER, domain: US FDA, briefTitle: The Happiest Baby, Inc. SNOO Postmarket Surveillance Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-29, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Happiest Baby, Inc., class: INDUSTRY, descriptionModule briefSummary: This postmarket surveillance study will evaluate the safety of the SNOO Smart Sleeper Bassinet when used for infants who are at high risk for Sudden Unexpected Infant Death (SUID). This study will survey 1000 caregivers of high-risk infants to examine the frequency of death or serious injury occurring in the SNOO Bassinet., conditionsModule conditions: Infant Death, conditions: Serious Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: SNOO Bassinet, outcomesModule primaryOutcomes measure: Serious Injury, primaryOutcomes measure: Infant death, secondaryOutcomes measure: Infant age during SNOO use, secondaryOutcomes measure: Degree of SNOO use, secondaryOutcomes measure: Weaning rationale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Happiest Baby, Inc., status: RECRUITING, city: Los Angeles, state: California, zip: 90064, country: United States, contacts name: Christopher Laine, PhD, role: CONTACT, phone: 310-476-4440, email: [email protected], contacts name: Sarah Chang, MPH, role: CONTACT, phone: 310-476-4440, email: [email protected], contacts name: Christopher Laine, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06361290, orgStudyIdInfo id: APHP231703, briefTitle: Diaphyseal Reconstruction of Malignant Tumors in Children, acronym: RDTM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Primary malignant bone tumors represent 5% of malignant tumors in children, 90% of which are osteosarcomas or Ewing sarcomas.The objective of oncological resection is local control of the disease. Excision of the entire tumor should make it possible to maintain good function of the limb, minimizing morbidity, and promoting acceptance by the patient.Biological reconstructions offer the best long-term functional results. Several possibilities are then available: the Induced Membrane technique, the Vascularized Fibula and Vascularized Fibula associated with an Allograft.Until today, no reconstruction technique in children has proven its superiority over another and no decision-making algorithm for therapeutic care has been determined based on the importance of the bone resection and the affected segment in diaphyseal tumor reconstruction surgery of the lower limb.The aim of the present research is to compare the three techniques concerning the consolidation aspect, the reoperation rates, the rates of bone complications, septic, and the functional results by the study of the medical files of approximately 90 patients operated between 1986 and 2017., conditionsModule conditions: Childhood Malignant Tumors of Lower Limbs, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Data collection from hospital medical records, outcomesModule primaryOutcomes measure: Duration of bone consolidation period, secondaryOutcomes measure: Rate of surgical re-intervention, secondaryOutcomes measure: Short- and long-term complication rates, secondaryOutcomes measure: Long-term functional results, secondaryOutcomes measure: Relationship between radiotherapy and biological reconstruction result, eligibilityModule sex: ALL, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hôpital Armand-Trousseau, city: Paris, zip: 75012, country: France, contacts name: Franck Fitoussi, MD-PhD, role: CONTACT, phone: 679693634, phoneExt: +33, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Necker-Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Edouard Haumont, MD, role: CONTACT, phone: 486587192, phoneExt: +32, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06361277, orgStudyIdInfo id: JW22104, briefTitle: To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-03, primaryCompletionDateStruct date: 2023-11-20, completionDateStruct date: 2023-11-27, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: JW Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions, conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Reference Drug or Test Drug, outcomesModule primaryOutcomes measure: AUCt, primaryOutcomes measure: Cmax, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Trial Center, Jeonbuk National University Hospital, city: Jeonju, country: Korea, Republic of, geoPoint lat: 35.82194, lon: 127.14889, hasResults: False
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protocolSection identificationModule nctId: NCT06361264, orgStudyIdInfo id: Karanahan, briefTitle: Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-11-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: KARANAHAN, class: OTHER, descriptionModule briefSummary: The goal of this study is to evaluate the safety and clinical efficacy of personalized chemotherapy with low doses of cyclophosphamide administered taking into account the reparative cycle of tumor cells in participants with breast cancer (stage IV or disease progression). The main question it aims to answer is: Does personalized chemotherapy of breast cancer with low doses of cyclophosphamide, taking into account the reparative cycle of tumor cells, lead to a significant reduction in tumor size and improvement in the visual status of controlled tumor foci relative to their initial state? During the preparatory stage, a tumor sample from participant is harvested intraoperatively. The primary culture is obtained from this tumor tissue sample. Repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle G2/M phase is identified. The schedule of administering cyclophosphamide and DNAmix complex composite preparation is calculated according to the resulting time points. According to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days., conditionsModule conditions: Stage IV Breast Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Karanahan, outcomesModule primaryOutcomes measure: The size of tumor foci, secondaryOutcomes measure: The quality of life score, secondaryOutcomes measure: The immunomodulatory effect, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karanahan Llc, status: RECRUITING, city: Novosibirsk, state: Novosibirsk Region, zip: 630090, country: Russian Federation, contacts name: Anastasia Proskurina, role: CONTACT, email: [email protected], contacts name: Sergey Sidorov, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False
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protocolSection identificationModule nctId: NCT06361251, orgStudyIdInfo id: CS5_10, briefTitle: Interventional, Monocentric, Double-blind Randomized Category 2b Study Evaluating the Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post -Inflammatory Hyperpigmentation (Pih)) on the Face, acronym: CS5_10, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Cryonove Pharma, class: INDUSTRY, collaborators name: Dermatech, descriptionModule briefSummary: The goal of this clinical trial is to compare the 2 different prototype of cytoselectivecryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are:* the tolerance of 2 prototypes of cyto-selective cryotherapy treatments* the performance of 2 prototypes of cyto-selective cryotherapy treatments Participants will be treated for each spots with a definied prototype during 6 treatment visits.Researchers will compare the tolerance and performance of the 3 prototypes., conditionsModule conditions: Lentigo, conditions: Solar Lentigo, conditions: Post Inflammatory Hyperpigmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Proof of concept study concerning 2 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double blind (participant and care provider), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: CRYONOVE (EC14_4osc), interventions name: CRYONOVE (EC05osc), outcomesModule primaryOutcomes measure: Tolerance, secondaryOutcomes measure: Performance (Acquisitions C-cube), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University, city: Pretoria, country: South Africa, geoPoint lat: -25.74486, lon: 28.18783, hasResults: False
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protocolSection identificationModule nctId: NCT06361238, orgStudyIdInfo id: 2023-LCYJ-PY-21, briefTitle: Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, descriptionModule briefSummary: This study aims to clarify the preventive effect of perioperative liraglutide application on postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery., conditionsModule conditions: Delirium, Postoperative, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Liraglutide injection, interventions name: Placebo injection, outcomesModule primaryOutcomes measure: The incidence of delirium, secondaryOutcomes measure: The severity of delirium, secondaryOutcomes measure: Cognitive function, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Duration of ICU stay, secondaryOutcomes measure: Mechanical ventilation time, secondaryOutcomes measure: Duration of hospital stay, secondaryOutcomes measure: In-hospital mortality, secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Rate of major cardiovascular adverse events, secondaryOutcomes measure: Serum levels of NSE, secondaryOutcomes measure: Serum levels of CRP, secondaryOutcomes measure: Serum levels of IL-1α, secondaryOutcomes measure: Serum levels of TNF-α, secondaryOutcomes measure: Serum levels of C3, secondaryOutcomes measure: Serum levels of LDH, secondaryOutcomes measure: Serum levels of CK, secondaryOutcomes measure: Serum levels of CK-MB, secondaryOutcomes measure: Serum levels of AST, secondaryOutcomes measure: Serum levels of cTNT, secondaryOutcomes measure: Serum levels of BNP, secondaryOutcomes measure: Serum levels of C1q, secondaryOutcomes measure: Serum levels of IL-1β, secondaryOutcomes measure: Serum levels of IL-6, secondaryOutcomes measure: Serum levels of S100β, secondaryOutcomes measure: Left Ventricular Posterior Wall Thickness in Diastole (LVPWTd), secondaryOutcomes measure: Left Ventricular End-Diastolic Dimension (LVDd), secondaryOutcomes measure: Left Ventricular End-Systolic Diameter (LVDs), secondaryOutcomes measure: Left Atrial Diameter (LAD), secondaryOutcomes measure: Ejection Fraction (EF), secondaryOutcomes measure: Fractional Shortening (FS), secondaryOutcomes measure: Early Diastolic Velocity/Atrial Diastolic Velocity (E/A), secondaryOutcomes measure: Interventricular Septum Thickness in Diastolic (IVSTd), eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06361225, orgStudyIdInfo id: 0075-24-MMC, briefTitle: Routine Use of RUSH Protocol in the Intensive Care Unit, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Meir Medical Center, class: OTHER, descriptionModule briefSummary: The RUSH protocol has been used for several years for the rapid evaluation of a patient admitted to the emergency room with shock. Traditionally, its use was especially common in trauma victims, but later its use was extended to patients admitted to the emergency room with shock from any reason. The protocol includes rapid assessment with the guideness of ultrasound of heart contraction, assessment for pleural effusions, assessment of intra-abdominal blood (FAST), diagnosis of venous thrombosis (DVT), and rulling out hydronephrosis. It can also add a pupil size assessment and an evaluation of the gallbladder and bile ducts, as well as the size of the bladder. In intensive care, we use this protocol (or part of it) for the evaluation of a patient who is deteriorating in the ICU for an unknown reason . In some patients we use this protocol as a routine part of the physical examination as part of the daily patient evaluation.We would like to investigate whether the routine use of the RUSH protocol as part of the daily patient evaluation in the general intensive care unit will lead to any change in the patient's management., conditionsModule conditions: RUSH Protocol, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: evaluation with RUSH protocol, outcomesModule primaryOutcomes measure: Change of patient medical therapy, primaryOutcomes measure: Performing unplanned laboratory tests, primaryOutcomes measure: Performing unplanned image tests, primaryOutcomes measure: Performing unplanned invasive procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Meir Medical Center, city: Kfar Saba, country: Israel, geoPoint lat: 32.175, lon: 34.90694, hasResults: False
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protocolSection identificationModule nctId: NCT06361212, orgStudyIdInfo id: BJXH-2022-002, briefTitle: Ethoximod Pharmacokinetics In Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2022-09-20, completionDateStruct date: 2024-01-12, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Longevity Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects. The main questions it arms to answer are:1. to evaluate the safety and tolerance of Ethoximod in healthy subjects after single or repeated doses.2. to assess the pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects after single or repeated doses.3. to evaluate of the effect of food on the pharmacokinetics of Ethoximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples., conditionsModule conditions: Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 65, type: ACTUAL, armsInterventionsModule interventions name: Ethoximod, outcomesModule primaryOutcomes measure: Peak plasma concentration (Cmax), primaryOutcomes measure: Time to peak plasma concentration (Tmax), primaryOutcomes measure: The lowest plasma concentration (Cmin), primaryOutcomes measure: Half-life (t1/2), primaryOutcomes measure: Number of adverse events and number of participants with adverse events, secondaryOutcomes measure: Lymphocyte count, secondaryOutcomes measure: Percentage of CD3+CD4+ and CD3+CD8+ T cells, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The first hospital of Jilin University, city: Changchun, state: Jilin, country: China, geoPoint lat: 43.88, lon: 125.32278, hasResults: False
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protocolSection identificationModule nctId: NCT06361199, orgStudyIdInfo id: BJXH-2021-001, briefTitle: Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-16, primaryCompletionDateStruct date: 2022-02-16, completionDateStruct date: 2023-10-08, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Longevity Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects and patients with rheumatoid arthritis. The main questions it arms to answer are:1. to evaluate the safety and tolerance of Proximod in health subjects after repeated doses.2. to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses.3. to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis.4. to evaluate the pharmacokinetics and pharmacodynamics of Proximod in patients with rheumatoid arthritis.Participants will receive test tablets or placebo at the indicated date and collect blood samples., conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Proximod, interventions name: Placebo, outcomesModule primaryOutcomes measure: Peak plasma concentration (Cmax), primaryOutcomes measure: Time to peak plasma concentration (Tmax), primaryOutcomes measure: The lowest plasma concentration (Cmin), primaryOutcomes measure: Half-life (t1/2), primaryOutcomes measure: Area under the plasma concentration versus time curve (AUC), primaryOutcomes measure: Number of adverse events and number of participants with adverse events, secondaryOutcomes measure: Lymphocyte count, secondaryOutcomes measure: Percentage of CD3+CD4+ and CD3+CD8+T cells, secondaryOutcomes measure: ACR20 score in Patients With Rheumatoid Arthritis, secondaryOutcomes measure: Disease Activity Score（DAS28-CRP）in Patients With Rheumatoid Arthritis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The first hospital of Jilin University, city: Changchun, state: Jilin, country: China, geoPoint lat: 43.88, lon: 125.32278, hasResults: False
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protocolSection identificationModule nctId: NCT06361186, orgStudyIdInfo id: BJXH-2017-001, briefTitle: Proximod Pharmacokinetics In Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-09-14, primaryCompletionDateStruct date: 2017-11-01, completionDateStruct date: 2021-06-22, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Longevity Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects. The main questions it arms to answer are:1. to evaluate the safety and tolerance of Proximod in healthy subjects after single or repeated doses.2. to learn the pharmacodynamics of Proximod in healthy subjects after single or repeated doses.3. to evaluation of the effect of food on the pharmacokinetics of Proximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples., conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 134, type: ACTUAL, armsInterventionsModule interventions name: Proximod, interventions name: Placebo, outcomesModule primaryOutcomes measure: Peak plasma concentration (Cmax), primaryOutcomes measure: Time to peak plasma concentration (Tmax), primaryOutcomes measure: The lowest plasma concentration (Cmin), primaryOutcomes measure: Half-life (t1/2), primaryOutcomes measure: Number of adverse events and number of participants with adverse events, secondaryOutcomes measure: Lymphocyte count, secondaryOutcomes measure: Percentage of CD3+CD4+ and CD3+CD8+ T cells, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The first hospital of Jilin University, city: Changchun, state: Jilin, country: China, geoPoint lat: 43.88, lon: 125.32278, hasResults: False
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protocolSection identificationModule nctId: NCT06361173, orgStudyIdInfo id: STUDY00004127, briefTitle: Spanish BMT4me Usability & Acceptability, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Nationwide Children's Hospital, class: OTHER, collaborators name: Columbia University, descriptionModule briefSummary: The objective of this project is to trans-create, conduct user testing of a previously developed and piloted mHealth app, and user acceptability with parents of children in the acute phase post-allogeneic hematopoietic stem cell transplant (HSCT). Nationwide Children's Hospital (NCH) will be the primary data collection site and Columbia University Irving Medical Center will be a secondary site., conditionsModule conditions: Bone Marrow Transplant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: BMT4me, outcomesModule primaryOutcomes measure: Assess app usability using the System Usability Scale (SUS), eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Columbia University Irving Medical Center, city: New York, state: New York, zip: 10027, country: United States, contacts name: Melissa Beauchemin, role: CONTACT, email: [email protected], geoPoint lat: 40.71427, lon: -74.00597, locations facility: Nationwide Children's Hospital, city: Columbus, state: Ohio, zip: 43215, country: United States, contacts name: Bianca Franklin, BS, role: CONTACT, contacts name: Micah Skeens, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
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protocolSection identificationModule nctId: NCT06361160, orgStudyIdInfo id: D23-P037, briefTitle: Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation, acronym: HALLUSTIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier St Anne, class: OTHER, descriptionModule briefSummary: Approximately 1% of the general population will be affected by schizophrenia over the course of their lives, with life expectancy being reduced by 20 years on average and quality of life being severely diminished in affected individuals. One third of patients suffering from schizophrenia will evolve towards a resistant form of the disease, amongst which many will suffer from auditory-verbal hallucinations (AVH) that current therapeutic approaches struggle to alleviate. Previous work from our team has demonstrated the possibility of robustly inferring the periods of occurrence of AVH from fMRI data, paving the way for the development of a closed-loop neuromodulation system comprised of an electrode array positioned in Broca's area, which would detect AVH in real time, and effector electrodes which would stimulate the temporo-parietal cortex to interrupt them. The aim of this project is to assess the feasibility of this system. To do so, we will first test the ability of transcranial magnetic stimulation of the "continuous theta burst" (cTBS) type, applied at the time of AVH onset, to reduce their duration and intensity, and assess whether this is associated with therapeutic response to the current gold standard rTMS protocol for AVH reduction through neuroplasticity induction. Demonstrating the feasibility of acute suppression of AVH by cortical neurostimulation is an essential element in the feasibility of a closed-loop reactive neuromodulation system.The research project comprises two phases:-Phase 1: randomized controlled clinical trial (1 weekly session per patient over 12 weeks: 6 active stimulation sessions and 6 sham sessions) evaluating the phasic effects of rTMS on AVHs as they appear during the sessions.Phase 2: open-label study offering patients a routine rTMS protocol which has demonstrated its effects on AVH (10 TMS sessions over one workweek - twice daily with 1-hour intervals, MULTIMODHAL study, NCT01373866)., conditionsModule conditions: Treatment Resistant Schizophrenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Patients (20) suffering from resistant schizophrenia will be enrolled over a 12-month period and will be randomized in a (1:1) ratio to start with either active or sham Transcranial Magnetic Stimulation (TMS) for the first of their 12 sessions, which will then alternate from one condition to the other for each patient., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Only the person conducting the experiment will know which condition each patient is in., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Active Transcranial Magnetic Stimulation (TMS), interventions name: Sham Transcranial Magnetic Stimulation (TMS), outcomesModule primaryOutcomes measure: Duration of auditory-verbal hallucinations, secondaryOutcomes measure: Clinical scales scores, secondaryOutcomes measure: Measure of the duration and/or intensity of HAV (in seconds) during active phasic stimulation sessions compared to sham sessions (phase 1) among TMS responders and non-responders in phase 2, secondaryOutcomes measure: Intensity of auditory-verbal hallucinations, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06361147, orgStudyIdInfo id: 3764/2-10-2019, briefTitle: Psychoeducation of Adult Siblings of ASD People (Autism Spectrum Disorder)., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Hellenic Mediterranean University, class: OTHER, descriptionModule briefSummary: The aim of this study is to apply a psychoeducational program in adult siblings of people with ASD as a means to provide knowledge related to the disorder and improving their quality of life.The psycho-educational program will be implemented in adult siblings of people with ASD and its effectiveness will be assessed.Participation in this program is expected to contribute in the improvement of the quality of life of the participants, their siblings with ASD and those related to them. No risk is identified., conditionsModule conditions: Autism Spectrum Disorder, conditions: Sibling Relations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Interventional groups and Control groups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 88, type: ACTUAL, armsInterventionsModule interventions name: Cygnet program for ASD, outcomesModule primaryOutcomes measure: Psychoeducation effectiveness on siblings of ASD, primaryOutcomes measure: Psychoeducation effectiveness on the knowledge of ASD, primaryOutcomes measure: Psychoeducation effectiveness on siblings relationship, primaryOutcomes measure: Psychoeducation effectiveness on resilience of siblings of ASD, primaryOutcomes measure: Psychoeducation effectiveness on the well-being of siblings of ASD, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hellenic Mediterranean University, city: Heraklion, state: Crete, zip: 82102, country: Greece, geoPoint lat: 35.32787, lon: 25.14341, hasResults: False
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protocolSection identificationModule nctId: NCT06361134, orgStudyIdInfo id: 14574941-302,08,01-, briefTitle: Efficacy of Supporting SAFE Early Intervention, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-15, primaryCompletionDateStruct date: 2022-05-15, completionDateStruct date: 2022-11-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, descriptionModule briefSummary: Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention., conditionsModule conditions: Infant Development, conditions: Physiotherapy, conditions: Early Intervention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: SAFE Early İntervention, interventions name: NDT based therapy, outcomesModule primaryOutcomes measure: Test of Infant Motor Profile, secondaryOutcomes measure: Bayley Scales of Infant and Toddler Development, Third Edition,, secondaryOutcomes measure: Infant/Toddler Sensory Profile 2, secondaryOutcomes measure: Infant/Toddler HOME Inventory, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule locations facility: Erzurum Technical University, city: Erzurum, country: Turkey, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
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protocolSection identificationModule nctId: NCT06361121, orgStudyIdInfo id: D361, briefTitle: Mid-point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block in Posterolateral Thoracotomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Fayoum University Hospital, class: OTHER, descriptionModule briefSummary: The ultrasound guided Thoracic paravertebral (TPV) block in the context of posterolateral thoracotomy offers targeted pain relief by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL)Costach et al introduced the mid-point transverse process to pleura block (MTP) as a modification of conventional paravertebral block by placing the LA posterior to the (SCTL) under ultrasound guidence achieving an effective block without the necessity to approach the pleura and the attendant risks.In recent studies ,the ultrasound guided MTP block provided an effective analgesia in various surgical procedures including mastectomy, video-assisted thoracic surgeries and cardiac surgeries.In our study we hypothesized that the mid-point transverse process to pleura (MTP) block can provide an effective analgesia comparable with thoracic paravertebral (TPV) block in adult patients undergoing posterolateral thoracotomy incisions., conditionsModule conditions: Bronchiectasis, conditions: Lung Neoplasm, conditions: Emphysematous Bleb of Lung, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The patients will be randomized into two groups: MTP block group and TPV block group in a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided MTP and TPV block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection are blinded from the group assignments, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: mid-point transverse process to pleura (MTP) block, interventions name: Thoracic Paravertebral Block, outcomesModule primaryOutcomes measure: The total postoperative fentanyl consumption, secondaryOutcomes measure: Demographic data, secondaryOutcomes measure: visual analogue scale score both during rest and with cough, secondaryOutcomes measure: intra operative fentanyl consumption, secondaryOutcomes measure: Duration of surgery, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Oxygen saturation, secondaryOutcomes measure: complications related to the block, secondaryOutcomes measure: complications related to IV opioids, secondaryOutcomes measure: Hospital length of stay in days, secondaryOutcomes measure: Participant satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fayoum University Hospital, status: RECRUITING, city: Fayoum, zip: 63514, country: Egypt, contacts name: Mohamed A Hamed, MD, role: CONTACT, phone: 01010509736, phoneExt: +20, email: [email protected], contacts name: Mohamed A Hamed, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.30995, lon: 30.8418, hasResults: False
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protocolSection identificationModule nctId: NCT06361108, orgStudyIdInfo id: YJ001-103, briefTitle: Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of YJ001 for Spray Use in Patients With Diabetic Peripheral Neuropathic Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Zhejiang Hanmai Pharmaceutical Technology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center.In this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects.Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11., conditionsModule conditions: Diabetic Peripheral Neuropathic Pain, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blinded with regard to the study treatment that subjects receive,without the investigator, the sponsor, or the subjects being aware of wether YJ001 or the placebo is administered. All decisions concerning dose escalation will be made in a blinded manner by the safety review committee.The Safety Review Committee (SRC), comprised of the Principal Investigator, Medical Monitor, and Sponsor's qualified designee, will convene after completion of each cohort to evaluate available safety, PK, and other relevant data.The SRC will determine whether to proceed to the next planned dose level, continue with the study and add additional safety evaluations, expand the number of subjects at the current level, reduce the dose, or stop the study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: YJ001 for Spray Use, interventions name: Placebo of YJ001 for Spray Use, outcomesModule primaryOutcomes measure: Safety Assessments - AEs, primaryOutcomes measure: Safety Assessments -Number of Participants With Abnormal Laboratory Values, primaryOutcomes measure: Safety Assessments - Skin Reaction, secondaryOutcomes measure: Pharmacokinetics-AUC, secondaryOutcomes measure: Pharmacokinetics- Cmax, secondaryOutcomes measure: Pharmacokinetics - tmax, secondaryOutcomes measure: Pharmacokinetics - tlag, secondaryOutcomes measure: Pharmacokinetics - t1/2, secondaryOutcomes measure: Pharmacokinetics - CLr/f,ss, secondaryOutcomes measure: Efficacy evaluation indicator, secondaryOutcomes measure: Efficacy evaluation indicators - ADSIS, secondaryOutcomes measure: Efficacy evaluation indicators - SF-MPQ, secondaryOutcomes measure: Efficacy evaluation indicators - VPT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Trials of Texas,LLC, city: Fredericksburg, state: Texas, zip: 78229, country: United States, contacts name: Douglas Scott Denham, role: CONTACT, phone: 210-949-0122, geoPoint lat: 30.2752, lon: -98.87198, hasResults: False
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protocolSection identificationModule nctId: NCT06361095, orgStudyIdInfo id: R01GABM, briefTitle: Confirmatory Efficacy Trial of Attention Bias Modification for Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Texas at Austin, class: OTHER, collaborators name: Arcade Therapeutics, descriptionModule briefSummary: The goal of this clinical trial is to compare the efficacy of two related, but different ABM (Attention Biased Modification) treatments for depression in adults with elevated symptoms of depression. The main aims are:* Aim 1:examine whether gamified ABM leads to greater change in the primary and secondary outcomes than sham ABM* Aim 1: establish that gamified ABM is at least as effective as traditional ABM.* Aim 2: identify moderators of ABM efficacy and mechanisms responsible for its efficacy.* Aim 3: Identify the durability of ABM on depression symptoms during short-term follow-upParticipants will complete self-report questionnaires, complete eye-tracking tasks, and be clinically assessed through interviews by clinician researchers.If there is a comparison group: Researchers will compare sham, traditional, and gamified treatment groups to see if they moderate symptoms of depression., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Traditional Attention Bias Modification, interventions name: Gamified Attention Bias Modification, interventions name: Sham Attention Bias Modification, outcomesModule primaryOutcomes measure: QIDS (Quick Inventory of Depression Symptoms) SR-16, secondaryOutcomes measure: Sheehan Disability Scale (SDS), secondaryOutcomes measure: Snaith-Hamilton Pleasure Scale (SHAPS), secondaryOutcomes measure: Hamilton Depression Rating Scale (HAM-D), secondaryOutcomes measure: Generalized Anxiety Disorder (GAD-7), secondaryOutcomes measure: Perseverative Thinking Questionnaire (PTQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Mental Health Research, city: Austin, state: Texas, zip: 78705, country: United States, contacts name: Christopher G Beevers, PhD, role: CONTACT, email: [email protected], contacts role: CONTACT, email: [email protected], geoPoint lat: 30.26715, lon: -97.74306, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-05, uploadDate: 2024-04-08T12:13, filename: ICF_000.pdf, size: 143608, hasResults: False
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protocolSection identificationModule nctId: NCT06361082, orgStudyIdInfo id: CORPG5N0061, briefTitle: Ultrasonic Backscatter Imaging for ACL Reconstruction and Shoulder Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: This study explores ultrasonic scattering imaging technology in patients undergoing anterior cruciate ligament (ACL) reconstruction and those with shoulder musculoskeletal disorders. Ultrasonography, widely utilized for diagnosing musculoskeletal conditions, faces limitations due to factors like operator experience and equipment settings, often lacking in quantifiable disease metrics. Nakagami imaging, employing the backscattering statistical distribution model, offers a quantitative assessment method that minimizes subjective interpretation by extracting tissue properties through the interaction between ultrasound and tissue microstructure. The Nakagami model effectively describes tissue scattering statistics, enabling the identification and classification of tissue features based on specific scattering conditions.ACL reconstruction is commonly performed, with postoperative complications including joint stiffness and muscle strength decline, associated with changes in muscle quality and volume. Similarly, soft tissue injuries around the shoulder and ankle are prevalent in sports medicine, with ultrasound used to assess the severity of injuries to soft tissues such as the rotator cuff tendons/muscles and surrounding ligaments of the shoulder, as well as the medial and lateral ligament complexes of the ankle. Preliminary findings suggest that Nakagami imaging can differentiate layers within normal tendons, proposing its potential for visualizing and quantifying soft tissue lesions post-ultrasound, aiming for standardized diagnostic criteria.The results of this project could significantly improve the diagnostic efficacy of musculoskeletal ultrasound, facilitating earlier treatment and reducing the socio-economic impacts. Academically, it positions the investigating team as pioneers in the application of ultrasound inverse scattering imaging technology., conditionsModule conditions: ACL Injury, conditions: ACL Reconstruction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: ACL reconstruction, outcomesModule primaryOutcomes measure: MRI of affected limb- Cross sectional area measured in squared cm of quadriceps muscles, primaryOutcomes measure: Ultrasound Nakagami back scattering analysis- Nakagami index, secondaryOutcomes measure: Physical examination of limbs- Angles of Range of Motion of knee, secondaryOutcomes measure: MRI of affected limb- Quality of knee structures documented with descriptions for MR signals, secondaryOutcomes measure: Physical examination of limbs- Laxity of knee ligaments of subjects number with any positive knee physical findings, secondaryOutcomes measure: Ultrasound of affected limb- Cross sectional area measured in squared cm of quadriceps muscles, secondaryOutcomes measure: Ultrasound of affected limb- Quality of knee structures documented with descriptions for echogenicity, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06361069, orgStudyIdInfo id: aslıakdeniz, briefTitle: Reducing Anxiety in Children Undergoing Day Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Bilecik Seyh Edebali Universitesi, class: OTHER, descriptionModule briefSummary: Aim: This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery.Methods: The study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. The study was conducted between April 2023 and January 2024 with children aged 6-12 years who were admitted to the pediatric clinic of a hospital for day surgery. A total of 85 children (including 20 children in the control group, 22 children in the finger puppet intervention group, 21 children in the distraction cards intervention group, and 22 children in the kaleidoscope intervention group) who were hospitalized in the pediatric clinic between April 2023 and January 2024 and who met the inclusion criteria were included in the study. Descriptive statistics, Mann Whitney U test, Kruskal Wallis and regression analysis were used in the evaluation of the data., conditionsModule conditions: Anxiety, conditions: Child, Only, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ACTUAL, armsInterventionsModule interventions name: distraction cards, kaleidoscope and finger puppet, outcomesModule primaryOutcomes measure: Anxiety, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Bilecik Şeyh Edebali University, city: Bilecik, country: Turkey, geoPoint lat: 40.14192, lon: 29.97932, hasResults: False
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protocolSection identificationModule nctId: NCT06361056, orgStudyIdInfo id: LCCC2140, briefTitle: Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-02, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: This study explores the overall feasibility, impact, and satisfaction of using the "mHealth app" on clinic workflow for Black or African American women diagnosed with breast cancer.The "mHealth app" which can be used as a platform to share clinical trial education and communication, was created and tested in previous steps of this study., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Survey, interventions name: mHealth app, outcomesModule primaryOutcomes measure: Feasibility of Mobile Health Application (mHealth app)- subjects, primaryOutcomes measure: Feasibility of Mobile Health Application (mHealth app) - Clinicians and staff, secondaryOutcomes measure: Overall satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UNC Lineberger Comprehensive Cancer Center, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27514, country: United States, contacts name: Lauren Matthews, role: CONTACT, phone: 919-843-5321, email: [email protected], contacts name: Marjory Charlot, MD, MPH, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
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protocolSection identificationModule nctId: NCT06361043, orgStudyIdInfo id: 2023-01833, briefTitle: Conebeam CT-based Online Adaptive Radio-Therapy for Esophageal Cancer (ARTEC), acronym: ARTEC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, descriptionModule briefSummary: Despite multimodal therapy, patients with esophageal cancer have poor prognosis with 5-year overall survival around 25%. Considering tumor-related death as main reason for high mortality rate in those patients, treatment-related cardio-pulmonary toxicities could also play a role in this regard. Online adaptive radiotherapy offers the possibility for daily re-planning and therefore helps radiation oncologists to better spare the organs at risk and reduce radiation-induced toxicity. Tha aim of ARTEC is to assess the pulmonary toxicity in patients with esophageal cancer treated with online adaptive radiotherapy., conditionsModule conditions: Esophageal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of patients with pulmonary toxicity, secondaryOutcomes measure: Number of patients with pathological complete response, secondaryOutcomes measure: Dosimetrical analysis between scheduled and adaptive plans, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inselspital, University of Berne, Deparftment of Radio-Oncology, status: RECRUITING, city: Berne, zip: 3010, country: Switzerland, contacts name: Hossein Hammatazad, MD, role: CONTACT, phone: +41 31 632 26 32, email: [email protected], contacts name: Timo Nannen, role: CONTACT, phone: +41 31 632 90 74, email: [email protected], geoPoint lat: 46.94809, lon: 7.44744, hasResults: False
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protocolSection identificationModule nctId: NCT06361030, orgStudyIdInfo id: HMPL-012-C2-PC01, briefTitle: Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of surufatinib combined with gemcitabine plus nab-paclitaxel in patients with locally advance d pancreatic cancer, conditionsModule conditions: Pancreatic Cancer, conditions: Pancreatic Cancer Non-resectable, conditions: Pancreatic Ductal Adenocarcinoma, PDAC, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: surufatinib combined with gemcitabine plus nab-paclitaxel, outcomesModule primaryOutcomes measure: Surgical conversion rate, secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: R0 surgical conversion rate, secondaryOutcomes measure: progression free survival(PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Adverse Event, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Heshui Wu, role: CONTACT, phone: +86 137-2011-7761, email: [email protected], contacts name: Heshui Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06361017, orgStudyIdInfo id: QNPY2022007, briefTitle: The Prediction of Hemorrhage Transformation by Cerebral Autoregulation in AIS Patient After Endovascular Thrombectomy, acronym: PHASE, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcome.Patients: patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT.dCA Examination: dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT.The objectives of the study were as follows: The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed. So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes., conditionsModule conditions: Acute Ischemic Stroke, conditions: Endovascular Thrombectomy, conditions: Dynamic Cerebral Autoregulation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: endovascular thrombectomy, outcomesModule primaryOutcomes measure: The occurrence of hemorrhage transformation, primaryOutcomes measure: Patients without hemorrhage transformation, primaryOutcomes measure: The occurrence of unfavorable outcome, primaryOutcomes measure: The occurrence of favorable outcome, secondaryOutcomes measure: The occurrence of long-term unfavorable outcome, secondaryOutcomes measure: The occurrence of long-term favorable outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University, city: Beijing, state: Beijing, zip: 100053, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06361004, orgStudyIdInfo id: DBS for TR-TS, briefTitle: Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) in patients with Treatment-refractory Tourette's syndrome (TR-TS) implantation targeting the Antero-medial globus pallidus interna (GPi), Antero-medial globus pallidus interna (amGPi), Postero-ventrolateral GPi (pvGPi), Centromedian nucleus, substantia periventricularis and nucleus ventro-oralis internus (Cm-Spv-Voi), Centre median nucleus and nucleus ventro-oralis (Cm-Voi), or Nucleus Accumbens/ Anterior Limb of Internal Capsule (NA-ALIC), or other unreported nuclei targets., conditionsModule conditions: Tourette's Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients with Treatment-refractory Tourette's syndrome (TR-TS), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Deep Brain Stimulation (DBS), outcomesModule primaryOutcomes measure: Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 6 months, secondaryOutcomes measure: YGTSS-Total Motor: Change in YGTSS-Total Motor at week 2, month 3, month 6, and month 12., secondaryOutcomes measure: YGTSS-Total Phonic: Change in YGTSS-Total phonic at week 2, month 3, month 6, and month 12., secondaryOutcomes measure: YGTSS: remission, and response rate, secondaryOutcomes measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change in Y-BOCS at week 2, month 3, month 6, and month 12., secondaryOutcomes measure: Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the HAMA total score., secondaryOutcomes measure: Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 3 months, 6 months, and 12 months., secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 3, Month 6, and Month 12., secondaryOutcomes measure: Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in Clinical Global Impression-Severity (CGI-S), secondaryOutcomes measure: Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12., secondaryOutcomes measure: EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 3, Month 6, and Month 12 in EQ-5D-5L., secondaryOutcomes measure: Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12., secondaryOutcomes measure: Safety as indicated by the number of Adverse Events: Week 2, Month 3, Month 6, and Month 12., secondaryOutcomes measure: Change from baseline in the Verbal Fluency Test (COWAT), secondaryOutcomes measure: Change from baseline in the Trailmaking Test A&B, secondaryOutcomes measure: Change in Rey-Osterrieth Complex Figure Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, zip: 100053, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06360991, orgStudyIdInfo id: DBS for TR-OCD, briefTitle: DBS for Treatment-resistant Obsessive-compulsive Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) implantation targeting the anteromedial region of subthalamic nucleus (amSTN), or nucleus accumbens (NAc), or bed nucleus of the stria terminalis (BNST), or ventral capsule/ventral striatum (VC/VS), or the ventral anterior limb of the internal capsule (vALIC) in patients with treatment-resistant obsessive-compulsive disorder (TR-OCD)., conditionsModule conditions: Obsessive-Compulsive Disorder (OCD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Deep brain stimulation (DBS), outcomesModule primaryOutcomes measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): the change from baseline to 1 year in the Y-BOCS total score., secondaryOutcomes measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): remission, response, and partial response rate, secondaryOutcomes measure: Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in the HAMA total score., secondaryOutcomes measure: Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year., secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 1, Month 3, Month 6, and Month 1., secondaryOutcomes measure: Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in Clinical Global Impression-Severity (CGI-S), secondaryOutcomes measure: Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12., secondaryOutcomes measure: EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12 in EQ-5D-5L., secondaryOutcomes measure: Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12., secondaryOutcomes measure: Safety as indicated by the number of Adverse Events Week 2, Month 1, Month 3, Month 6, and Month 12., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, zip: 100053, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06360978, orgStudyIdInfo id: docetaxel as a radiosenstizer, briefTitle: Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The overall incidence of HNC continues to rise, with a predicted 30% increase annually by 2030., this increase has been recorded across both developed and developing countries.Approximately 90% of HNCs are squamous cell carcinoma . The major risk factors of head and neck squamous cell carcinoma (HNSCC) are tobacco and heavy alcohol use and human papillomavirus infection . There has been a significant decline in smoking in high-income countries during the last few decades, which has led to a sharp decline in smoking related HNSCC . While increase in global incidence of human papillomavirus (HPV)-associated or positive (+) HNSCC Head and neck squamous cell carcinoma (HNSCC) is a highly challenging cancer, despite the advancements in treatment, the overall prognosis for HNSCC remains poor, with a five-year survival rate of around 50%.Chemoradiation is one of the treatment options for locally advanced head and neck cancers, the drug of choice for radiosensitization is cisplatin Although cisplatin-based chemoradiotherapy (CRT) is the standard of care for locally advanced head and neck squamous cell carcinoma (LAHNSCC), cisplatin is contraindicated in many patients because of age, diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group.The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC., conditionsModule conditions: Head and Neck Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Docetaxel, outcomesModule primaryOutcomes measure: progression free survival, secondaryOutcomes measure: incidence of treatment adverse events, secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06360965, orgStudyIdInfo id: Shoufa2024-3-7045, briefTitle: Clinical Trial of Acupoint Application in Improving the Sequelae of Pelvic Inflammatory Disease and Chronic Pelvic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Beijing Hospital of Integrated Traditional Chinese and Western Medicine, class: OTHER, descriptionModule briefSummary: Chronic Pelvic Pain is one of the common gynecological symptoms, characterized by persistent and non periodic pain in the pelvic cavity and surrounding tissues. It is often seen as a sequelae of pelvic inflammatory diseases caused by the failure to receive timely and correct treatment. This study compares the effectiveness of warm meridians and relieve pain plaster in relieving the sequelae of pelvic inflammatory disease and chronic pelvic pain symptoms, and evaluates the safety of improved patches and traditional patches, further promoting it to community grassroots hospitals., conditionsModule conditions: Pelvic Inflammatory Disease, conditions: Chronic Pelvic Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Improved warm meridians and relieve pain plaster, interventions name: Traditional warm meridians and relieve pain plaster, interventions name: Placebo plaster, outcomesModule primaryOutcomes measure: Main symptoms (lower abdominal pain) improvement level (visual analogue scale), secondaryOutcomes measure: TCM syndrome score scale, secondaryOutcomes measure: Local physical sign rating scale, secondaryOutcomes measure: Pelvic masses and fluid accumulation, secondaryOutcomes measure: EuroQol Five Dimensions Questionnaire, secondaryOutcomes measure: Recurrence of abdominal pain during 1-month menstrual cycle was followed up., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Hospital of Integrated Traditional Chinese and Western Medicine, status: RECRUITING, city: Beijing, country: China, contacts name: YuNa Liu, role: CONTACT, phone: 86-010-88223667, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06360952, orgStudyIdInfo id: T23-03, briefTitle: A Comparator Study of a Tasso Device Blood Sample to Traditional Venous Blood Sample for CBC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Tasso Inc., class: INDUSTRY, collaborators name: The Leukemia and Lymphoma Society, descriptionModule briefSummary: This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.This investigation will include a minimum of 40 sample sets from unique patients., conditionsModule conditions: Leukopenia, conditions: Leukocytosis, conditions: Neutropenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Tasso+ CBC, outcomesModule primaryOutcomes measure: Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count, secondaryOutcomes measure: Agreement between capillary and venous blood in the measurement of secondary biomarkers, otherOutcomes measure: Patient acceptance of Tasso device, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lineberger Comprehensive Cancer Center, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
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protocolSection identificationModule nctId: NCT06360939, orgStudyIdInfo id: ETH02659, briefTitle: Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease, acronym: Radioablate, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-04-15, completionDateStruct date: 2027-04-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Western Sydney Local Health District, class: OTHER, collaborators name: University of Sydney, collaborators name: National Heart Foundation, Australia, descriptionModule briefSummary: The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are:* What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months* What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care)., conditionsModule conditions: Ventricular Tachycardia, conditions: Cardiomyopathies, conditions: Arrhythmias, Cardiac, conditions: Ventricular Arrythmia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: SBRT, interventions name: CA, outcomesModule primaryOutcomes measure: VT burden, secondaryOutcomes measure: Recurrent sustained VT, secondaryOutcomes measure: VT storm, secondaryOutcomes measure: Absolute VT burden, secondaryOutcomes measure: Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI), secondaryOutcomes measure: ICD shocks, secondaryOutcomes measure: Hospitalization, secondaryOutcomes measure: All cause mortality, secondaryOutcomes measure: Cardiovascular Mortality, secondaryOutcomes measure: Composite outcome of VT recurrence/hospitalisation/death/ cardiac transplantation, secondaryOutcomes measure: Ventricular function, secondaryOutcomes measure: Quality of Life as per Short Form - 36 (SF-36) Score, secondaryOutcomes measure: Quality of Life as per Implantable Cardioverter Defibrillator Concerns Questionnaire (ICDC) score, secondaryOutcomes measure: Number of AADs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360926, orgStudyIdInfo id: 2024-A00526-41, briefTitle: Improvement Image Quality for SuperSonic® MACH Ultrasound System, acronym: MACH IQ, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: SuperSonic Imagine, class: INDUSTRY, descriptionModule briefSummary: The aim of this Study is to collect radiologist feedback to support the further development and improvement of the imaging modes implemented on the embedded software in the SuperSonic® Ultrasound System (including the probe)., conditionsModule conditions: Diagnosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: SuperSonic® Ultrasound System, outcomesModule primaryOutcomes measure: Qualitative assessment of image quality, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06360913, orgStudyIdInfo id: 2023/09AOU/346, briefTitle: Blood Spot and Urine Metabolomic Screening Applied to Rare Diseases, acronym: BUSARD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-03, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain, class: OTHER, descriptionModule briefSummary: The primary goal of this study is to establish a biobank of dried blood spots and urines from a large control cohort and collect several cohorts as large as possible of patients affected or suspected of being affected by rare diseases (mainly hereditary metabolic diseases) or by autism spectrum disorders.A metabolomic database using a high-resolution mass spectrometer (i.e. the "Device") will be generated and specific biomarkers for the diseases will be confirmed or uncovered. The ultimate goal is to facilitate and improve the diagnosis and screening of the patients affected by these disorders, but also to improve the knowledge about the biochemical mechanisms involved over the course of the selected pathologies.High-resolution mass spectrometry allows the measurement of thousands of metabolites in a single analysis. The current biochemical tests used for the diagnosis of hereditary metabolic diseases are only using a combination of maximum a few dozens of biomarkers in one analysis.Objectives Unravel new biomarkers for diagnosis (+/- explore the altered pathways...) Uncover and/or validate newborn screening biomarkers through retrospective analysis of preserved newborn DBS from confirmed patients (useful for first or second tier biochemical NBS testing!) Validation of LC-MS qTOF for metabolomics screening as first line diagnostic test (thousands of metabolites) using diagnostic algorithms (modified z-scores) \& continuous optimization by adding new cases and new controls in the database Generation of a biobank of urines and DBS from rare diseases (IEMs) \& from a large reference population useful for other research applications, conditionsModule conditions: Inborn Errors of Metabolism, conditions: Rare Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 3 groups:1. Control subjects2. Confirmed patients (rare diseases)3. Suspected patients (rare diseases), primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 2286, type: ESTIMATED, armsInterventionsModule interventions name: High resolution mass spectrometry, outcomesModule primaryOutcomes measure: Uncover new biomarkers in dried blood spots and urines samples able to improve the diagnosis of rare diseases, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Universitaire des enfants Reine Fabiola (HUDERF-ULB), status: NOT_YET_RECRUITING, city: Brussels, zip: B-1020, country: Belgium, contacts name: Lionel Marcélis, MSc, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Aurélie Empain, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Corinne De Laet, M.D., Ph.D., role: SUB_INVESTIGATOR, contacts name: Ebru Surgun, M.D., role: SUB_INVESTIGATOR, contacts name: Céline Morelli, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Cliniques universitaires Saint Luc, status: RECRUITING, city: Brussels, zip: B-1200, country: Belgium, contacts name: Joseph P. Dewulf, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Marie-Cécile Nassogne, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Xavier Stephenne, M.D., Ph.D., role: SUB_INVESTIGATOR, contacts name: Nicole Revencu, M.D., Ph.D., role: SUB_INVESTIGATOR, contacts name: Stéphanie Paquay, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Institut de Pathologie et de Génétique (IPG), status: NOT_YET_RECRUITING, city: Charleroi, zip: B-6041, country: Belgium, contacts name: Dominique Roland, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Damien Lederer, M.D., Ph.D., role: SUB_INVESTIGATOR, contacts name: Isabelle Maystadt, M.D., Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 50.41136, lon: 4.44448, locations facility: CHU Liege, status: NOT_YET_RECRUITING, city: Liège, zip: B-4000, country: Belgium, contacts name: François-Guillaume Debray, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: François Boemer, Pharm D PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Caroline Dadoumont, MD, role: SUB_INVESTIGATOR, geoPoint lat: 50.63373, lon: 5.56749, hasResults: False
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protocolSection identificationModule nctId: NCT06360900, orgStudyIdInfo id: 2024P000849, briefTitle: Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Spaulding Rehabilitation Hospital, class: OTHER, descriptionModule briefSummary: The primary aims of this randomized, single-blinded, 2x2 sham-controlled trial are to 1) evaluate synergistic impact of 8-weeks of transcutaneous auricular vagus nerve stimulation (taVNS) + cognitive-behavioral therapy (CBT) on post-meal gut-brain communication; 2) determine the sequential relationship between treatment-associated changes in gastrointestinal-related anxiety and both clinical functional dyspepsia (FD) improvements and meal-induced physiological outcomes; 3) investigate whether post-treatment changes in gut-brain physiology mediate improvements in FD clinical outcomes. Using a fully non-invasive framework including gastric and brain magnetic resonance imaging (MRI) and taVNS, the investigators aim to evaluate the potential synergy of taVNS and CBT in FD, by assessing the gut-brain physiological response to prandial challenge, linking physiological with symptom improvements., conditionsModule conditions: Functional Dyspepsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: taVNS, interventions name: CBT, interventions name: Education Control, interventions name: Sham taVNS, outcomesModule primaryOutcomes measure: Nepean Dyspepsia Index (NDI), primaryOutcomes measure: Visceral Sensitivity Index (VSI), secondaryOutcomes measure: Gastric peristaltic velocity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360887, orgStudyIdInfo id: DRKS00030614, briefTitle: Management of Proximal Humerus Fractures in Adults: a Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-01-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Regional Hospital of Bolzano, class: OTHER, descriptionModule briefSummary: Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment., conditionsModule conditions: Shoulder Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 351, type: ESTIMATED, armsInterventionsModule interventions name: Conservative, interventions name: ORIF, interventions name: CRPP, outcomesModule primaryOutcomes measure: Oxford Shoulder Score, secondaryOutcomes measure: The visual analogue scale, secondaryOutcomes measure: Rate of complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Academic Hospital of Bolzano (SABES-ASDAA), city: Bolzano, state: Alto Adige, zip: 39100, country: Italy, contacts name: Malte Nikolas Witte, Dr., role: CONTACT, phone: 00393885787726, email: [email protected], geoPoint lat: 46.49067, lon: 11.33982, hasResults: False
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protocolSection identificationModule nctId: NCT06360874, orgStudyIdInfo id: ND003-I-06, briefTitle: A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Shenzhen NewDEL Biotech, Co., Ltd, class: INDUSTRY, collaborators name: Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd., descriptionModule briefSummary: The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults, conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: ND-003 40mg, interventions name: ND-003 placebo 40mg, interventions name: ND-003 80mg, interventions name: ND-003 placebo 80mg, interventions name: ND-003 160mg, interventions name: ND-003 placebo 160mg, interventions name: ND-003 240mg, interventions name: ND-003 placebo 240mg, interventions name: ND-003 300mg, interventions name: ND-003 placebo 300mg, interventions name: MAD_ND003_Dose 1, interventions name: MAD_placebo_Dose 1, interventions name: MAD_ND003_Dose 2, interventions name: MAD_placebo_Dose 2, interventions name: MAD_ND003_Dose 3, interventions name: MAD_ placebo_Dose 3, interventions name: Food effect_Cohort 1, interventions name: Food effect_Cohort 2, outcomesModule primaryOutcomes measure: Adverse Events (AE), secondaryOutcomes measure: maximum concentration (Cmax), secondaryOutcomes measure: Time to maximum concentration (Tmax), secondaryOutcomes measure: Elimination Half-life (t1/2), secondaryOutcomes measure: Clearance (CLz/F), secondaryOutcomes measure: AUC from time 0 to last time of quantifiable concentration (AUC0-t), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360861, orgStudyIdInfo id: 1400-1-233-51589, secondaryIdInfos id: IR.TUMS.MEDICINE.REC.1400.197, type: OTHER_GRANT, domain: Tehran University of Medical Sciences, briefTitle: Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis, acronym: MS, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-07-23, primaryCompletionDateStruct date: 2024-03-04, completionDateStruct date: 2024-03-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Tehran University of Medical Sciences, class: OTHER, descriptionModule briefSummary: To assess the safety and of a single dose of IV infusion of placenta derived Mesenchymal Stem Cells (PLMSCs) in patients with secondary progressive Multiple Sclerosis (SPMS) disease.Monitoring will be encompassed baseline assessments and follow-ups over subsequent months, evaluating clinical signs, Expanded Disability Status Scale (EDSS), cytokines, diffusion tensor imaging (DTI), functional MRI (fMRI), cognitive \& psychological evaluations, and flow cytometry for B cell markers., conditionsModule conditions: Multiple Sclerosis, conditions: Secondary-Progressive Multiple Sclerosis, conditions: Mesenchymal Stem Cells, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open-label phase 1, single-center, pre-post comparison study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ACTUAL, armsInterventionsModule interventions name: Allogenic placenta derived mesenchymal stem cells, outcomesModule primaryOutcomes measure: Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability]., secondaryOutcomes measure: Number of participants with a change in disability as measured by Expanded Disability Status Scale ., secondaryOutcomes measure: Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test ., secondaryOutcomes measure: Number of participants with a change in cognitive performance as measured by Persian version of minimal assessment of cognitive function in MS battery., secondaryOutcomes measure: Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging ., secondaryOutcomes measure: Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging ., secondaryOutcomes measure: Number of participants with a change in processing and motor speed as assessed by the Symbol Digit Modalities Test ., secondaryOutcomes measure: Number of participants with evaluation of verbal learning and memory deficits as measured by the California Verbal Learning Test second edition ., secondaryOutcomes measure: Proportion of patients with change in CD20 / CD19 B cells surface markers, secondaryOutcomes measure: Biological Assessments including IL-10, IL-6, IL-17, and TNFα levels of cytokines., secondaryOutcomes measure: Proportion of patients with change in T2 lesion volume on brain MRI., secondaryOutcomes measure: Proportion of patients with change in brain volume on MRI., secondaryOutcomes measure: Proportion of patients for assessment of visuospatial learning as measured by the Brief Visuospatial Memory Test-Revised ., secondaryOutcomes measure: Proportion of patients for assessment of visuospatial ability as measured by Judgment of Line Orientation Test ., secondaryOutcomes measure: Proportion of patients for evaluation of executive functions as measured by the Delis-Kaplan Executive Function System Sorting and descriptive tests., secondaryOutcomes measure: Proportion of patients for measuring verbal fluency as measured by the Controlled Oral Word Association Test ., secondaryOutcomes measure: Proportion of patients for psychological assessment as measured by the validated Persian version of Symptom Checklist-90-Revised ., secondaryOutcomes measure: Proportion of patients for evaluation of fatigue as measured by was examined by the Persian version of Fatigue Severity Scale ., secondaryOutcomes measure: Proportion of patients for assessment of visuospatial ability as measured by the brief visuospatial memory test-revised test., secondaryOutcomes measure: Proportion of patients for assessment of visuospatial ability as measured by the California Verbal Learning Test Second Edition test., eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Tehran University of Medical Sciences,Tehran, Iran, city: Tehran, country: Iran, Islamic Republic of, geoPoint lat: 35.69439, lon: 51.42151, hasResults: False
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protocolSection identificationModule nctId: NCT06360848, orgStudyIdInfo id: IRB00001192, briefTitle: Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases), statusModule overallStatus: COMPLETED, startDateStruct date: 2005-01-01, primaryCompletionDateStruct date: 2021-01-01, completionDateStruct date: 2021-01-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Ibn Jazzar Hospital, class: OTHER, descriptionModule briefSummary: Pseudarthrosis of the humerus is a serious complication of humerus fractures, of particular interest to subjects young working people with pseudoarthrogenic risk factors (tobacco++). It represents a real problem therapeutic given the long period of treatment, its disabling socio-professional repercussions and the cost which resulting.The aim of our work is to evaluate the anatomical and functional results of different surgical techniques. used., conditionsModule conditions: Humerus Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 53, type: ACTUAL, armsInterventionsModule interventions name: surgery, outcomesModule primaryOutcomes measure: Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients), primaryOutcomes measure: Distribution of hypertrophic pseudarthrosis according to technique surgical procedure used (in Number of patients), primaryOutcomes measure: Time to consolidation depending on the type of pseudarthrosis (in months), primaryOutcomes measure: Average Constant score postoperatively according to the means of restraint, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06360835, orgStudyIdInfo id: IRB00001193, briefTitle: Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases), statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01-01, primaryCompletionDateStruct date: 2021-12-01, completionDateStruct date: 2021-12-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Ibn Jazzar Hospital, class: OTHER, descriptionModule briefSummary: Osteosyntheses employed in treating fractures at the upper end of the femur play a critical role in facilitating a swift recovery by minimizing immobilization periods and enabling early rehabilitation of the affected joints, thereby promoting a speedy return to normal walking function.Osteosynthesis alters the mechanical dynamics of the bone segment, which undergoes continual changes during the consolidation and mobilization phases of recovery. Throughout these stages, a range of mechanical complications may arise, posing challenges despite the successful prevention of infections. Non-infectious complications associated with the presence of osteosynthesis materials, especially in weight-bearing areas like the lower limb, remain a concern.In light of these considerations, surgeons must exercise meticulous care in selecting synthetic materials to mitigate the risk of osteosynthesis failures. In cases where internal fixation fails, the standard recourse often involves converting to total hip arthroplasty (THA).However, it is essential to note that THA subsequent to complications arising from proximal femur osteosynthesis presents a higher incidence of both intraoperative and postoperative complications compared to the implantation of primary total hip prostheses. Thus, while osteosynthesis remains a valuable intervention for femur fractures, careful attention to material selection and postoperative management is crucial in optimizing patient outcomes and minimizing complications., conditionsModule conditions: Proximal Femur Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: total hip arthroplasty, outcomesModule primaryOutcomes measure: Surgical Approach, primaryOutcomes measure: Preparation of the Patient, primaryOutcomes measure: Anesthesia, primaryOutcomes measure: Type of Surgical Revision, primaryOutcomes measure: Types of Prosthesis, secondaryOutcomes measure: Age Distribution, secondaryOutcomes measure: Distribution by Sex, secondaryOutcomes measure: Distribution According to Affected Side, secondaryOutcomes measure: Distribution According to Circumstances of Trauma, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IBN jazzar hospital, city: Kairouan, zip: 3190, country: Tunisia, geoPoint lat: 35.6781, lon: 10.09633, hasResults: False
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protocolSection identificationModule nctId: NCT06360822, orgStudyIdInfo id: 19317, briefTitle: Increasing Equity in Lung Cancer Screening, acronym: LUCARE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, collaborators name: Eskenazi Health, descriptionModule briefSummary: The overall objective of this mixed methods study is to: 1) Refine the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders; 2) pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ED-LCS intervention for future refinement., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: ED-LCS, outcomesModule primaryOutcomes measure: Rate of patients receive Lung Cancer Screening, secondaryOutcomes measure: Patients ratings of intervention, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eskenazi Health, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Nicholas Pettit, MD, role: CONTACT, phone: 317-962-5975, email: [email protected], geoPoint lat: 39.76838, lon: -86.15804, hasResults: False
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protocolSection identificationModule nctId: NCT06360809, orgStudyIdInfo id: 2024 PARINEFC 00001, briefTitle: Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC), acronym: PEP_BC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Institut Nacional d'Educacio Fisica de Catalunya, class: OTHER, collaborators name: ICFO - The Institute of Photonics Sciences, collaborators name: Hospital Clinic of Barcelona, collaborators name: Institut d'Investigacions Biomèdiques August Pi i Sunyer, collaborators name: Universidad San Jorge, descriptionModule briefSummary: To improve the health and quality of life of breast cancer (BC) patients, researchers are focusing on prehabilitation strategies like physical exercise, preparing patients both mentally and physically for clinical and surgical procedures, potentially reducing complications. Physical exercise is also recognized as pivotal in optimizing chemotherapy. It can improve blood flow and oxygen supply in the microenvironment of the tumor (MT), potentially enhancing chemotherapy effectiveness. Although previous research has shown the benefits of preoperative exercise combined with chemotherapy in various cancer types, including BC, further investigation is needed into the exact effects of prehabilitation exercise (PE) on MT physiology.This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment. The hypothesis is that PE in BC patients will improve their quality of life, reduce fatigue, increase muscle mass, decrease fat mass, and enhance physical fitness. Additionally, beneficial acute hemodynamic changes, particularly increased blood flow following PE sessions, and hemodynamic adaptations involving higher levels of oxygenated hemoglobin, increased blood flow, greater oxygen saturation, and a higher metabolic rate of oxygen, are expected.The study will include 76 participants aged 18-65 years, meeting specific criteria such as a diagnosis of hormone receptor-positive BC, no medical contraindications for exercise, no metastatic cancer, and no structured exercise in the last six months. These participants will be randomly assigned to a PE group or a control group. The study will consist of three phases: Phase 1 involves pre-intervention assessments, Phase 2 includes a 4-week PE intervention with three weekly sessions, and Phase 3 encompasses post-intervention and post-surgery assessments. The 4-week PE intervention in Phase 2 will include strength and aerobic training. Quality of life and fatigue assessments will use questionnaires, and measurements will be made for fat mass, lean mass, bone density, and cardiorespiratory fitness. Strength measurements will be taken, and shoulder mobility will be evaluated. Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Prehabilitation exercise program, outcomesModule primaryOutcomes measure: Quality of life score, primaryOutcomes measure: Cancer quality of life score, primaryOutcomes measure: Cancer-related fatigue, primaryOutcomes measure: Body composition, primaryOutcomes measure: Bone density, primaryOutcomes measure: Cardiorespiratory fitness, primaryOutcomes measure: Maximum isometric manual grip strength, primaryOutcomes measure: Upper body maximum strength, primaryOutcomes measure: Lower body maximum strength, primaryOutcomes measure: Shoulder range of motion, primaryOutcomes measure: Relative oxyhemoglobin concentration ([02Hb]) in the microenvironment of the tumor, primaryOutcomes measure: Relative deoxyhemoglobin concentration ([HHb]) in the microenvironment of the tumor, primaryOutcomes measure: Oxygen saturation (StO2) in the microenvironment of the tumor, primaryOutcomes measure: Blood flow (BF) in the microenvironment of the tumor, secondaryOutcomes measure: Height, secondaryOutcomes measure: Body mass, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Wait circumference, secondaryOutcomes measure: Anthropometric measurements, secondaryOutcomes measure: Bioimpedance measurements, secondaryOutcomes measure: Maximal heart rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínic, status: RECRUITING, city: Barcelona, zip: 08036, country: Spain, contacts name: Eduard Mension, MD, role: CONTACT, email: [email protected], contacts name: Albert Busquets, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lucia Sagarra-Moreno, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Esther Valera, MSc, role: SUB_INVESTIGATOR, contacts name: Graciela Martínez-Pallí, MD, role: SUB_INVESTIGATOR, contacts name: Raquel Sebio, PhD, role: SUB_INVESTIGATOR, contacts name: Blai Ferrer-Uris, PhD, role: SUB_INVESTIGATOR, contacts name: Turgut Durduran, PhD, role: SUB_INVESTIGATOR, contacts name: Mireia Mora, MD, role: SUB_INVESTIGATOR, contacts name: Eduard Mension, MD, role: SUB_INVESTIGATOR, contacts name: Helena Castillo, MD, role: SUB_INVESTIGATOR, contacts name: Rosa Angulo-Barroso, PhD, role: SUB_INVESTIGATOR, contacts name: Alfredo Irurtia, PhD, role: SUB_INVESTIGATOR, contacts name: Marta Carrasco-Marginet, PhD, role: SUB_INVESTIGATOR, contacts name: Alex Cebrián-Ponce, MSc, role: SUB_INVESTIGATOR, contacts name: Ferran Faixat, role: SUB_INVESTIGATOR, contacts name: Quim Rosales, role: SUB_INVESTIGATOR, contacts name: Raquel Martinez-Reviejo, MSc, role: SUB_INVESTIGATOR, contacts name: Paula Bonay, BS, role: SUB_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06360796, orgStudyIdInfo id: 2023-ADC189-I-010, briefTitle: Study of Pharmacokinetics and Metabolism on [(14)C]ADC189, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-24, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Jiaxing AnDiCon Biotech Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants., conditionsModule conditions: Pharmacokinetics, conditions: Metabolism, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: [(14)C]ADC189, outcomesModule primaryOutcomes measure: The Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites, primaryOutcomes measure: The Maximum Plasma Concentration [Cmax] of [(14)C]ADC189 and its metabolites, primaryOutcomes measure: The whole blood and serum concentrations of total radioactivity of [(14)C]ADC189 (about 100 μCi), primaryOutcomes measure: The urinary and fecal recovery of total radioactivity of [(14)C]ADC189 (about 100 μCi), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Affilicated Hospital of Bengbu Medical University, status: RECRUITING, city: Bengbu, state: Anhui, zip: 233004, country: China, contacts name: Huan Zhou, role: CONTACT, phone: +8613665527160, email: [email protected], geoPoint lat: 32.94083, lon: 117.36083, hasResults: False
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protocolSection identificationModule nctId: NCT06360783, orgStudyIdInfo id: Pro00111388, briefTitle: COVID-19 Quick Start - Test and Treat in Africa, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: Duke Clinical Research Institute, collaborators name: Clinton Health Access Initiative, Nigeria, descriptionModule briefSummary: Duke University and the Clinton Health Access Initiative (CHAI), in partnership with the Ministries of Health (MoH) of Ghana, Malawi, Rwanda, Zambia, and Zimbabwe, aim to assess the implementation and impact of COVID-19 test -and -treat (T\&T) demonstration programs, conditionsModule conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Stakeholder Perspectives, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke Global Health Institute, city: Durham, state: North Carolina, zip: 27705, country: United States, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
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protocolSection identificationModule nctId: NCT06360770, orgStudyIdInfo id: NIRSCovidSBCelje, briefTitle: Assessement of Microcirculation With NIRS Predicts Sepsis Development in Patients With Severe Covid-19 Pneumonia, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-01, primaryCompletionDateStruct date: 2023-02-28, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: General and Teaching Hospital Celje, class: OTHER, descriptionModule briefSummary: Sepsis and septic shock are among main causes of death in patients with severe Covid-19 pneumonia. A few factors are proven to predict sepsis in these patients. WIth near infrared spectroscopy it is possible to detect microcirculatory changes typical for sepsis early in the course of disease. The hypothesis that changes in tissue oxygene saturation during vasoocclusive test predict sepsis as well as mortality in mechancally ventilated patients withe severe Covid-19 pneumonia will be tested., conditionsModule conditions: Sepsis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 35, type: ACTUAL, outcomesModule primaryOutcomes measure: sepsis development, secondaryOutcomes measure: mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SB Celje, city: Celje, zip: 3000, country: Slovenia, geoPoint lat: 46.23092, lon: 15.26044, hasResults: False
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protocolSection identificationModule nctId: NCT06360757, orgStudyIdInfo id: DHF-21-2141-1, briefTitle: Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: QIAGEN Gaithersburg, Inc, class: INDUSTRY, descriptionModule briefSummary: A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems., conditionsModule conditions: SARS-CoV-2 Acute Respiratory Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1432, type: ESTIMATED, armsInterventionsModule interventions name: NeuMoDx SARS-CoV-2 Assay, outcomesModule primaryOutcomes measure: Sensitivity as compared to the comparator method, secondaryOutcomes measure: Specificity, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: QIAGEN Gaithersburg, Inc, status: RECRUITING, city: Manchester, zip: M130BH, country: United Kingdom, contacts name: Sarah G Johnson, role: CONTACT, phone: 44 7825866041, email: [email protected], contacts name: Helen Green, role: CONTACT, phone: 44 7825866041, email: [email protected], geoPoint lat: 53.48095, lon: -2.23743, hasResults: False
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protocolSection identificationModule nctId: NCT06360744, orgStudyIdInfo id: ENFORCE PLUS, briefTitle: A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-05, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Jens D Lundgren, MD, class: OTHER, collaborators name: Ministry of the Interior and Health, Denmark, descriptionModule briefSummary: A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.The Danish Medicines Agency has approved the vaccine from J\&J for use in Denmark, however it is not currently part of the national vaccine programme.The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent)., conditionsModule conditions: SARS CoV 2 Infection, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: Johnson & Johnson, outcomesModule primaryOutcomes measure: Assessment of the J& J vaccine, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aarhus Universitetshospital, Skejby, city: Aarhus, state: Aarhus N, zip: 8200, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Aalborg Universitetshospital Syd, city: Aalborg, zip: 8000, country: Denmark, geoPoint lat: 57.048, lon: 9.9187, locations facility: Hvidovre Hospital, city: Hvidovre, zip: 2600, country: Denmark, geoPoint lat: 55.65719, lon: 12.47364, locations facility: Odense Universitetshospital, city: Odense, zip: 5000, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Sjællandsuniversitetshospital, city: Roskilde, zip: 4000, country: Denmark, geoPoint lat: 55.64152, lon: 12.08035, hasResults: False
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protocolSection identificationModule nctId: NCT06360731, orgStudyIdInfo id: 1018, briefTitle: The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: The goal of this study is to evaluate the effect of 4-7-8 breathing exercise on tinnitus handicap, psychological factors and sleep quality.There will be a parallel-group randomized controlled trial study and consists of two groups.Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks. Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory, and perceived stress scale will be applied before and after the application., conditionsModule conditions: Tinnitus, Subjective, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study employs a parallel group randomised controlled trial design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: In the study, patients do not know which group they were in. Therefore, blinding is performed among the participants. To prevent bias in the study, blinding is also performed between the researchers. Researchers (S.B. and A.O. from both clinics) make the pre- and post-test evaluations without knowing which group the patients are in., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: 4-7-8 breathing exercise technique and informative session on tinnitus, interventions name: Informative session on tinnitus, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: Tinnitus Handicap Inventory (THI), primaryOutcomes measure: Tinnitus Handicap Inventory (THI), primaryOutcomes measure: Insomnia severity index (ISI), primaryOutcomes measure: Insomnia severity index (ISI), primaryOutcomes measure: Perceived stress scale -10 (PSS-10), primaryOutcomes measure: Perceived stress scale -10 (PSS-10), primaryOutcomes measure: Trait Anxiety Scale (TAS), primaryOutcomes measure: Trait Anxiety Scale (TAS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gokce Saygi Uysal, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Audiology Unit of the Department of Otorhinolaryngology, Ege University Faculty of Medicine Hospital, city: Izmir, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06360718, orgStudyIdInfo id: CHLA-23-00170, briefTitle: Effects of Using a Storybook, to Explain Leukemia to Children Versus the Standard Child Life Intervention, on Parental Stress., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-03, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Children's Hospital Los Angeles, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to measure the effects of using a storybook versus standard child life intervention with parents of children newly diagnosed with leukemia on parental stress.The main questions it aims to answer are:* What effect will the storybook have on parent/legal guardian stress at three timepoints: baseline, discharge, and follow up?* Will this storybook impact parent/legal guardian comfort levels and improve their child's understanding?Participants will be asked to complete surveys at three timepoints, prior to and following child life intervention and about 3.5 months later. During child life interventions, participants will receive resources and support to explain leukemia to their school aged, 3-16-year-old, child (patient or sibling).Researchers will compare Intervention and Control Groups to see if parental stress is lower in those who received the storybook in addition to the standard child life intervention versus the standard child life intervention alone., conditionsModule conditions: Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: "Who is Luke Eemia?" Storybook, outcomesModule primaryOutcomes measure: Parental Stress, prior to and following child life intervention, secondaryOutcomes measure: Parent perception of the child's stress, secondaryOutcomes measure: Parent's Comfort Explaining Aspects of Leukemia Diagnosis, secondaryOutcomes measure: Parent comfort, readiness, and importance, explaining aspects of the diagnosis at the discharge (1-week post baseline)., secondaryOutcomes measure: Parental Impression of the Storybook Tool using a Likert scale (1-week post baseline)., eligibilityModule sex: ALL, minimumAge: 3 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Children's Hospital Los Angeles, status: RECRUITING, city: Los Angeles, state: California, zip: 90027, country: United States, contacts name: Erin Shields, MA, role: CONTACT, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06360705, orgStudyIdInfo id: CVVD003, briefTitle: StrataMGT for the Treatment of Vulvar Lichen Sclerosus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Center for Vulvovaginal Disorders, class: OTHER, collaborators name: Stratpharma AG, descriptionModule briefSummary: This study is designed to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus., conditionsModule conditions: Vulvar Lichen Sclerosus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: StrataMGT, outcomesModule primaryOutcomes measure: Histopathologic Inflammation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centers for Vulvovaginal Disorders, status: RECRUITING, city: New York, state: New York, zip: 10036, country: United States, contacts name: Andrew Goldstein, MD, role: CONTACT, phone: 4102790209, email: [email protected], contacts name: Andrew Goldstein, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Leia Mitchell, PA-C, MMSc, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06360692, orgStudyIdInfo id: Marta Lluesma Vidal Carden, briefTitle: Impact of Nipple Micropigmentation in Mastectomized Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Cardenal Herrera University, class: OTHER, descriptionModule briefSummary: This will be a multicenter prospective descriptive case series study following a cohort.The micropigmentation/tattoo procedure will be carried out following the protocol established in each center (see annex x). The present investigation only involves measuring the impact that this technique has on the patients by collecting data in digital format before and after the CAP micropigmentation/tattoo that motivated their visit to the clinical service.CAP micropigmentation/tattooing is usually performed between 6 and 12 months after the breast reconstructive surgery has been completed, sufficient time for healing to complete and the breast to stabilize, although it can be performed from 2 months after the intervention. Nurses are responsible for performing micropigmentation/tattooing of the areola and nipple in mastectomized women., conditionsModule conditions: Body Image, conditions: Female Sexual Function, conditions: Self Esteem, conditions: Intimacy With Your Partner, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Body imagen, secondaryOutcomes measure: Self-esteem, secondaryOutcomes measure: Sexual Function, secondaryOutcomes measure: Intimacy with the partner, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360679, orgStudyIdInfo id: CIP000004, briefTitle: Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: BariaTek Medical, class: INDUSTRY, descriptionModule briefSummary: Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic gastric restriction and biliodigestive diversion, outcomesModule primaryOutcomes measure: Safety of the BariTon™, primaryOutcomes measure: Safety of the BariTon™, secondaryOutcomes measure: Safety of the BariTon™, secondaryOutcomes measure: Safety of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: BMI Clinic Double Bay, status: RECRUITING, city: Sydney, state: New South Wales, zip: 2028, country: Australia, contacts name: Adrian Sartoretto, Dr, role: CONTACT, phone: 0290534688, phoneExt: 61, email: [email protected], geoPoint lat: -33.86785, lon: 151.20732, locations facility: BMI Clinic Liverpool, status: RECRUITING, city: Sydney, state: New South Wales, zip: 2170, country: Australia, contacts name: Adrian Sartoretto, Dr, role: CONTACT, phone: 0290534688, phoneExt: 61, email: [email protected], geoPoint lat: -33.86785, lon: 151.20732, hasResults: False
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protocolSection identificationModule nctId: NCT06360666, orgStudyIdInfo id: Neurax1, briefTitle: Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia, acronym: NEURAX, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Asst Melegnano e Martesana, class: OTHER_GOV, descriptionModule briefSummary: The goal of this observational study is to learn about postoperative mortality and postoperative length of stay outcomes after abdominal laparoscopic major surgery. The main question it aims to answer is:Does general anesthesia lower complications compared to loco-regional anesthesia (keeping the patient spontaneously breathing and sedated) in laparoscopic abdominal major surgery? Participants are followed for neurological sequelae for 90 days following surgery, conditionsModule conditions: Mortality, conditions: Surgical Complication, conditions: Neurological Complication, conditions: Respiratory Complication, conditions: Cardiovascular Complication, conditions: Nephrotoxicity, conditions: Metabolic Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Mortality, primaryOutcomes measure: Morbidity, secondaryOutcomes measure: Surgical revisions, secondaryOutcomes measure: organ dysfunctions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST Melegnano e Martesana - Ospedale Vizzolo Predabissi, city: Vizzolo Predabissi, state: Milan, zip: 20070, country: Italy, geoPoint lat: 45.35587, lon: 9.34815, hasResults: False
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protocolSection identificationModule nctId: NCT06360653, orgStudyIdInfo id: 76CIVICO2023, briefTitle: a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer, acronym: SISTER-RAY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: ARNAS Civico Di Cristina Benfratelli Hospital, class: OTHER, descriptionModule briefSummary: The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer, conditionsModule conditions: Endometrial Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic Post-operative Radiotherapy for Endometrial Cancer, outcomesModule primaryOutcomes measure: Acute G3 or higher Gastrointestinal and Genitourinary Toxicity, secondaryOutcomes measure: Late Gastrointestinal and Genitourinary Toxicity, secondaryOutcomes measure: Distant Progression Free Survival, secondaryOutcomes measure: Local Control, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Overall Quality of Life, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ARNAS Civico Hospital, city: Palermo, state: PA, zip: 90100, country: Italy, contacts name: FRANCESCO CUCCIA, MD, role: CONTACT, phone: +393334393336, email: [email protected], geoPoint lat: 38.13205, lon: 13.33561, hasResults: False
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protocolSection identificationModule nctId: NCT06360640, orgStudyIdInfo id: APC148-001, secondaryIdInfos id: 2023-507939-38-00, type: OTHER, domain: EU Trial no, briefTitle: A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: AdjuTec Pharma AS, class: INDUSTRY, collaborators name: CTC Clinical Trial Consultants AB, descriptionModule briefSummary: The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Placebo-controlled, 6 sequential cohorts., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: This is a double-blind trial., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: APC148 and Placebo, outcomesModule primaryOutcomes measure: Incidence and intensity of adverse events (AEs), primaryOutcomes measure: Incidence and intensity of serious adverse events (SAEs), primaryOutcomes measure: Incidence and intensity of infusion-related AEs, primaryOutcomes measure: Time course of local tolerability reactions, primaryOutcomes measure: Changes from baseline in blood pressure, primaryOutcomes measure: Changes from baseline in respiratory rate, primaryOutcomes measure: Changes from baseline in body temperature, primaryOutcomes measure: Changes from baseline in heart rate, primaryOutcomes measure: Changes from baseline in PQ/PR interval, primaryOutcomes measure: Changes from baseline in QRS interval, primaryOutcomes measure: Changes from baseline in QT interval, primaryOutcomes measure: Changes from baseline in QTcF interval, primaryOutcomes measure: Changes from baseline in Clinical Laboratory Profile, primaryOutcomes measure: Changes from baseline in physical examination, secondaryOutcomes measure: APC148 plasma concentrations, secondaryOutcomes measure: APC148 urine concentrations, secondaryOutcomes measure: Pharmacokinetic (PK) parameter in plasma - Area under curve (AUC) 0-24, secondaryOutcomes measure: PK parameter in plasma - AUC0-inf, secondaryOutcomes measure: PK parameter in plasma - AUC0-last, secondaryOutcomes measure: PK parameter in plasma - Cmax, secondaryOutcomes measure: PK parameter in plasma - Tmax, secondaryOutcomes measure: PK parameter in plasma - T1/2, secondaryOutcomes measure: PK parameter in plasma - Clearance (CL), secondaryOutcomes measure: PK parameter in plasma - Vz, secondaryOutcomes measure: PK parameter in plasma - Vss determination of plasma concentrations will be collected., secondaryOutcomes measure: PK parameters in urine - A(e), secondaryOutcomes measure: PK parameters in urine - fe, secondaryOutcomes measure: PK parameter in urine - renal clearance (CLr), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Trial Consultants AB, city: Uppsala, country: Sweden, contacts name: Erik Rein-Hedin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.85882, lon: 17.63889, hasResults: False
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protocolSection identificationModule nctId: NCT06360627, orgStudyIdInfo id: 2022_D0008, briefTitle: Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-20, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, descriptionModule briefSummary: Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT, conditionsModule conditions: Radiation Exposure, conditions: Lung Embolism, conditions: Lung Cancer, conditions: Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Computed Tomography, outcomesModule primaryOutcomes measure: Dose Reduction by new scanner, primaryOutcomes measure: stable Image Quality in reduced dose scans, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zurich - Diagnostic Radiology, status: RECRUITING, city: Zurich, zip: 8091, country: Switzerland, contacts name: Thomas Frauenfelder, PD MD, role: CONTACT, phone: 0041442551111, email: [email protected], contacts name: Marga Rominger, Prof MD, role: CONTACT, phone: 0041442551111, email: [email protected], contacts name: Thomas Frauenfelder, PD MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06360614, orgStudyIdInfo id: 2024s01, briefTitle: The Effect of Hand Massage Applied to Palliative Care Oncology Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: murat koç, class: OTHER_GOV, collaborators name: Istanbul Sultanbeyli State Hospital, descriptionModule briefSummary: World Health Organization (WHO) palliative care is defined as "an approach that aims to reduce or prevent suffering by early identification, evaluation and treatment of the physical, psychosocial and spiritual problems of patients and families accompanying life-threatening diseases, and thus to increase their quality of life." Palliative care is a multidisciplinary approach that provides appropriate health care for oncology patients, who have a wide variety of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply.Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means. The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. is located. Studies in the literature have found that hand massage reduces anxiety levels, stress and agitation levels, pain levels, and increases comfort and sleep levels. As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients., conditionsModule conditions: Hand Massage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Before the application, data will be collected and recorded through a face-to-face interview (8-10 minutes) by a nurse who does not know which group the patients are in. Sleep times of patients will be measured with a smart bracelet. At this stage, the same procedure will be continued for the intervention and control groups.Hand massage will be applied to the intervention group for 4 weeks, 2 days a week (Monday and Friday), 2 sessions each day. The control group will receive routine monitoring and nursing care for 4 weeks.In the intervention and control groups, VAS-Pain, General Comfort Scale and Pittsburgh Sleep Quality were assessed by a face-to-face interview by a nurse who did not know which group the patients were in, on the 7th day (Monday), 14th day (Monday) and 28th day (Monday). Index measurement tools will be applied and patients' sleep times will be measured with a smart bracelet., primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Hand massage application, interventions name: routine monitoring and nursing care, outcomesModule primaryOutcomes measure: İndividual Information Form, primaryOutcomes measure: Patient Follow-up Form, primaryOutcomes measure: General Comfort Scale, primaryOutcomes measure: Pittsburgh Sleep Quality Index, primaryOutcomes measure: Smart Bracelet, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sultanbeyli State Hospital, city: Istanbul, zip: 34000, country: Turkey, contacts name: Murat Koç, role: CONTACT, phone: +905436725093, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06360601, orgStudyIdInfo id: 36264PR589/3/24, briefTitle: Intravenous Labetalol Versus Hydralazine in Preeclampsia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: We study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome, conditionsModule conditions: Preeclampsia Severe, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Labetalol Injection, interventions name: HydrALAZINE Injection, outcomesModule primaryOutcomes measure: Cerebral blood flow, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, city: Tanta, zip: 3511, country: Egypt, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
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protocolSection identificationModule nctId: NCT06360588, orgStudyIdInfo id: NCI-2024-01141, secondaryIdInfos id: NCI-2024-01141, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAY131-Z1G, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: EAY131-Z1G, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180820, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180820, briefTitle: Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-06-19, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: The phase II MATCH treatment trial tests how well copanlisib works to treat patients with cancer with PTEN loss. Copanlisib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth., conditionsModule conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Copanlisib, interventions name: Radiologic Examination, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: 6-month progression-free survival (PFS) rate, secondaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ECOG-ACRIN Cancer Research Group, city: Philadelphia, state: Pennsylvania, zip: 19103, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06360575, orgStudyIdInfo id: NCI-2024-01127, secondaryIdInfos id: NCI-2024-01127, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAY131-C2, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: EAY131-C2, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180820, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180820, briefTitle: Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2016-05-30, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II MATCH treatment trial tests how well crizotinib works to treat patients with cancers with MET exon 14 deletion genetic changes. Crizotinib is in a group of medications called tyrosine kinase inhibitors. It works by blocking enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow., conditionsModule conditions: Advanced Lymphoma, conditions: Advanced Malignant Solid Neoplasm, conditions: Refractory Lymphoma, conditions: Refractory Malignant Solid Neoplasm, conditions: Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Crizotinib, interventions name: Radiologic Examination, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: 6-month progression-free survival (PFS) rate, secondaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ECOG-ACRIN Cancer Research Group, city: Philadelphia, state: Pennsylvania, zip: 19103, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06360562, orgStudyIdInfo id: 2020P002418, briefTitle: Reconnecting to Ourselves and Others in Virtual Meetings (ROOM), statusModule overallStatus: RECRUITING, startDateStruct date: 2020-09-15, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2025-04-25, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality., conditionsModule conditions: Mood Disorders, conditions: Anxiety Disorders, conditions: Psychotic Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 174, type: ESTIMATED, armsInterventionsModule interventions name: Resilience Training, outcomesModule primaryOutcomes measure: Discomfort with Others, primaryOutcomes measure: Intervention Feasibility and Acceptability, primaryOutcomes measure: Penn Emotion Recognition Test, primaryOutcomes measure: Stop Distance Paradigm, secondaryOutcomes measure: Beck Depression Inventory, secondaryOutcomes measure: Spielberger State-Trait Anxiety Inventory, secondaryOutcomes measure: Prodromal Questionnaire- Brief, secondaryOutcomes measure: Connor-Davidson Resilience Scale, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts name: Daphne J Holt, MD, PhD, role: CONTACT, phone: 617-726-7618, email: [email protected], contacts name: Nicole DeTore, PhD, role: CONTACT, phone: 617-726-2065, email: [email protected], geoPoint lat: 42.37787, lon: -71.062, hasResults: False
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protocolSection identificationModule nctId: NCT06360549, orgStudyIdInfo id: TJ-IRB202403019, briefTitle: Effect of Percutaneous Acupoint Electrical Stimulation on Delirium, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Qin Zhang, class: OTHER, collaborators name: National Natural Science Foundation of China, descriptionModule briefSummary: This study is a multicenter, prospective, randomized controlled clinical trial that aims to observe the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on plasma TK/MMP3 in a randomized controlled setting. The intervention group received percutaneous acupoint electrical stimulation, whereas the control group underwent conventional treatment. The primary objective is to enhance the management of postoperative delirium, specifically focusing on the occurrence and severity of delirium following thoracoscopic pulmonary resection. Additionally, various perioperative inflammatory markers, cognitive function, recovery quality, pain levels, anxiety, sleep patterns, postoperative complications, and overall hospital stay duration were monitored to elucidate the mechanisms through which percutaneous acupoint electrical stimulation improves postoperative delirium., conditionsModule conditions: Delirium, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention group was percutaneous acupoint electrical stimulation treatment group, and the control group was conventional treatment group.Inclusion criteria:1. Voluntarily sign informed consent;2. Age ≥18 years old;3. Patients undergoing thoracoscopic pneumonectomy;4. ASA Grade I-III;, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 238, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous Electrical Acupoint Stimulation, outcomesModule primaryOutcomes measure: Delirium (using the Delirium Rating Scale, DRS), secondaryOutcomes measure: Mini-Mental State Examination (MMSE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Hospital of Traditional Chinese Medicine, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Jiemin Deng, role: CONTACT, phone: 2780, email: [email protected], contacts name: Jiemin Deng, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Qin Zhang, phd, role: CONTACT, phone: 15717154768, email: [email protected], contacts name: Qin Zhang, phd, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06360536, orgStudyIdInfo id: IRB-300012634, secondaryIdInfos id: P50MD017338, type: NIH, link: https://reporter.nih.gov/quickSearch/P50MD017338, briefTitle: Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women, acronym: OVERCOME-IT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The purpose of this study is to collect preliminary data on the feasibility, acceptability, and potential effects of a novel, remotely delivered resistance training program., conditionsModule conditions: Overweight or Obesity, conditions: Prediabetes or Diabetes, conditions: Prehypertension (Elevated Blood Pressure) or Hypertension, conditions: Resistance Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Resistance Training, outcomesModule primaryOutcomes measure: Feasibility of recruitment, primaryOutcomes measure: Feasibility of retention, primaryOutcomes measure: Intervention adherence, secondaryOutcomes measure: Change in resistance training behaviors, secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in HbA1C, secondaryOutcomes measure: Change in body composition, secondaryOutcomes measure: Change in handgrip strength, secondaryOutcomes measure: Change in the number of chair stands, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Jackie Grant, role: CONTACT, phone: 205-975-7108, email: [email protected], contacts name: Amber Kinsey, role: CONTACT, phone: 205-934-9851, email: [email protected], contacts name: Amber W Kinsey, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False
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protocolSection identificationModule nctId: NCT06360523, orgStudyIdInfo id: CRE-2024.141, briefTitle: To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-07-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 102 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy., conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: AI modal, outcomesModule primaryOutcomes measure: Prostate Cancer detection rate of ISUP grade group ≥2, secondaryOutcomes measure: Diagnosis of any grade of prostate cancer, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Wales Hospital, Chinese University of Hong Kong, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06360510, orgStudyIdInfo id: 44, briefTitle: Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-05-05, primaryCompletionDateStruct date: 2024-05-05, completionDateStruct date: 2024-05-05, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, class: OTHER, descriptionModule briefSummary: The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS)., conditionsModule conditions: Carpal Tunnel Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: %5 dextrose injection, interventions name: betamethasone injection, outcomesModule primaryOutcomes measure: vas, secondaryOutcomes measure: boston carpal tunnel syndrome questionnaire, secondaryOutcomes measure: median nerve cross sectional area, secondaryOutcomes measure: tinnel test positivity, secondaryOutcomes measure: phalen test positivity, secondaryOutcomes measure: duruöz hand index, secondaryOutcomes measure: global evaluation of treatment outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06360497, orgStudyIdInfo id: 202206090070, briefTitle: The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-03, primaryCompletionDateStruct date: 2022-10-09, completionDateStruct date: 2022-10-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Beijing Normal University, class: OTHER, descriptionModule briefSummary: The purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory., conditionsModule conditions: MM Group, conditions: LKCM Group, conditions: Waitlist Group, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 152, type: ACTUAL, armsInterventionsModule interventions name: mindfulness meditation intervention and loving-kindness and compassion meditation intervention, outcomesModule primaryOutcomes measure: The Depression Anxiety Stress Scale, primaryOutcomes measure: The Philadelphia Mindfulness Scale, primaryOutcomes measure: The Sensitivity to Punishment and Sensitivity to Reward Questionnaire, secondaryOutcomes measure: The Emotional Word Lists, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 56 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xianglong Zeng, city: Beijing, state: Beijing, zip: 100875, country: China, geoPoint lat: 39.9075, lon: 116.39723, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-27, uploadDate: 2024-03-27T06:37, filename: Prot_SAP_000.pdf, size: 125410, hasResults: False
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protocolSection identificationModule nctId: NCT06360484, orgStudyIdInfo id: PrevelanceHDVSudan, briefTitle: Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2022-09-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: National Center for Gastroentestinal and Liver Disease, class: OTHER, descriptionModule briefSummary: Background: Sudan has a high prevalence of hepatitis B surface antigen (HBsAg), exceeding 8%. The prevalence of hepatitis B varies across different regions of Sudan, ranging from 6.8% in central Sudan to as high as 26% in southern Sudan. Hepatitis B virus (HBV) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Hepatitis D virus (HDV) relies on HBV for replication and can accelerate the progression of HBV-related liver diseases, leading to more severe outcomes. This study aims to determine the prevalence of HDV infection among Sudanese patients with HBV-related liver diseases and to investigate the clinical characteristics of patients with HBV/HDV co-infection.Design/Method: This descriptive cross-sectional hospital-based study was conducted at Ibn Sina Specialized Hospital in Sudan between June and September 2022. Ninety HBV patients aged 16 years and above were included. Patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. Investigations included liver function tests, abdominal ultrasounds, and ELISA for Ant-HDV-IgG, conditionsModule conditions: Hepatitis B, conditions: Hepatitis D, conditions: Viral Hepatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: investigations for Hepatitis D virus, outcomesModule primaryOutcomes measure: the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases., eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Center for Gastrointestinal and Liver Diseases, city: Khartoum, zip: 15004, country: Sudan, geoPoint lat: 15.55177, lon: 32.53241, hasResults: False
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protocolSection identificationModule nctId: NCT06360471, orgStudyIdInfo id: FS-FMC, briefTitle: Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2027-10-01, completionDateStruct date: 2032-10-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy.This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.Statistical analysis of the data will be performed., conditionsModule conditions: Fertility Issues, conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2800, type: ESTIMATED, armsInterventionsModule interventions name: fertility preservation, outcomesModule primaryOutcomes measure: 5-year cumulative live birth rate, secondaryOutcomes measure: Ovarian function(AMH levels), secondaryOutcomes measure: Ovarian function(AFC counts), secondaryOutcomes measure: Newborn malformation rate, secondaryOutcomes measure: Tumor recurrence rate, secondaryOutcomes measure: Tumor survival rate, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Xiang Ma, MD. PHD, role: CONTACT, phone: +8618001581878, email: [email protected], contacts name: Nan Lu, role: CONTACT, phone: +8615950476023, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06360458, orgStudyIdInfo id: MRCTA,ECFAH of FMU[2024]368, briefTitle: Methylprednisolone Adjunctive to Endovascular Treatment for Stroke, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Wan-Jin Chen, class: OTHER, descriptionModule briefSummary: The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction., conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 735, type: ESTIMATED, armsInterventionsModule interventions name: Methylprednisolone, outcomesModule primaryOutcomes measure: Mortality at 90 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360445, orgStudyIdInfo id: HD1912BE202201, briefTitle: Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-26, primaryCompletionDateStruct date: 2022-08-21, completionDateStruct date: 2022-08-21, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: CSPC Ouyi Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects were administered a single dose of 100 mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting conditions or 150mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting and Fed conditions. Venous blood samples were collected at pre-dose (0 h), and up to 72 h post dose. This study was to evaluate the bioequivalence and safety of the test formulation and the reference formulation of Olaparib Tablets in healthy subjects., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 2-period Crossover Assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open label, enrollmentInfo count: 102, type: ACTUAL, armsInterventionsModule interventions name: Olaparib Tablet test formulation 100mg, interventions name: Olaparib Tablet reference formulation 100mg, interventions name: Olaparib Tablet test formulation 150mg, interventions name: Olaparib Tablet reference formulation 150mg, outcomesModule primaryOutcomes measure: Cmax Description: Maximum observed plasma concentration, primaryOutcomes measure: AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time, primaryOutcomes measure: AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration, secondaryOutcomes measure: Time of maximum observed plasma concentration (Tmax), secondaryOutcomes measure: Terminal elimination half-life (T1/2), secondaryOutcomes measure: Apparent total body clearance (Cl/F), secondaryOutcomes measure: Apparent volume of distribution (V/F), secondaryOutcomes measure: Number of participants with Adverse Events, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06360432, orgStudyIdInfo id: HSEARS20240214001, briefTitle: Effects of the EatWelLog App on Diet Management for Older Adults With Sarcopenic Obesity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: Sarcopenic obesity, characterised by concurrent reduced muscle mass and excess body fat, affects 11% of older adults worldwide, rising to 23% in those over 75. Considering the negative synergistic impact on health, promoting muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies for managing SO. Exercise and nutrition are the primary interventions recommended for SO.This project aims to evaluate the effects of the EatWellLog App developed by the investigators' team for local older adults, in improving:* their sarcopenic obesity status, measured by all four diagnostic criteria, including grip strength, muscle mass, physical performance and body fat mass (primary outcome), and,* nutritional self-efficacy, nutritional status, dietary quality, health-related quality of life, and adherence to diet and exercise regimens (secondary outcomes), by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group.The EatWellLog App, designed for older adults with SO, incorporating Klasnja and Pratt's five-strategy framework for mobile health (mHealth) applications development to facilitate health behavioural change. This App supports users with SO in managing daily diets that promote gradual weight loss and muscle mass preservation, adhering to the dietary regimen for this population.Forty older adults with SO will be recruited from local community health centres and then randomized to either m-health or control groups. Both groups will receive an 8-week supervised programme separately. The programme consists of personalised dietary modification programme and group-based exercise training which have been tested and used in the investigators' pilot and General Research Fund (GRF) project. Additionally, only the m-health group will be instructed to use the App for daily diet self-management.Participants will be assessed on a variety of outcomes immediately after the 8-week supervised programme (T1), which will be compared to the baseline (T0). To explore the possible long-term effects of the intervention, other measurements will be conducted at 3-(T2) and 6-(T3) months after the supervised programme, which will be compared with those conducted at T0., conditionsModule conditions: Sarcopenic Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A two-arm, assessor-blinded, parallel design pilot randomized control trial (RCT) consisting of a M-health and a control group will be adopted to evaluate the effectiveness of the EatWellLog App in improving older adults' sarcopenic obesity (SO) status and other SO-related parameters by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: An independent assessor who is blinded to the group allocations will assess the participants' outcomes., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Dietary modification program, interventions name: Exercise training, interventions name: The EatWellLog App, outcomesModule primaryOutcomes measure: Changes of muscle strength, primaryOutcomes measure: Changes of muscle mass, primaryOutcomes measure: Changes of body mass index, primaryOutcomes measure: Changes of waist circumference, primaryOutcomes measure: Changes of fat mass, primaryOutcomes measure: The Short Physical Performance Battery (SPPB) scale, secondaryOutcomes measure: Mini Nutritional Assessment (MNA) Short-form, secondaryOutcomes measure: Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale, secondaryOutcomes measure: Dietary Quality Index-International (DQI-I), secondaryOutcomes measure: EuroQoL 5D (EQ-5D), secondaryOutcomes measure: Diet Adherence, secondaryOutcomes measure: Exercise Adherence, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, city: Hong Kong, country: Hong Kong, contacts name: Amy Cheung, MA, role: CONTACT, phone: +852 27664145, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06360419, orgStudyIdInfo id: SOL-MDD-301, briefTitle: Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol, acronym: PARADIGM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Axsome Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Solriamfetol 300 mg, interventions name: Placebo, outcomesModule primaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale (MADRS), primaryOutcomes measure: Incidence of treatment-emergent adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Site, status: RECRUITING, city: Encino, state: California, zip: 91316, country: United States, geoPoint lat: 34.15917, lon: -118.50119, locations facility: Clinical Research Site, status: RECRUITING, city: Lemon Grove, state: California, zip: 91945, country: United States, geoPoint lat: 32.74255, lon: -117.03142, locations facility: Clinical Research Site, status: RECRUITING, city: Oceanside, state: California, zip: 92056, country: United States, geoPoint lat: 33.19587, lon: -117.37948, locations facility: Clinical Research Site, status: RECRUITING, city: Redlands, state: California, zip: 92374, country: United States, geoPoint lat: 34.05557, lon: -117.18254, locations facility: Clinical Research Site, status: RECRUITING, city: Riverside, state: California, zip: 92506, country: United States, geoPoint lat: 33.95335, lon: -117.39616, locations facility: Clinical Research Site, status: RECRUITING, city: Sherman Oaks, state: California, zip: 91403, country: United States, geoPoint lat: 34.15112, lon: -118.44925, locations facility: Clinical Research Site, status: RECRUITING, city: Upland, state: California, zip: 91786, country: United States, geoPoint lat: 34.09751, lon: -117.64839, locations facility: Clinical Research Site, status: RECRUITING, city: Cromwell, state: Connecticut, zip: 06416, country: United States, geoPoint lat: 41.5951, lon: -72.64537, locations facility: Clinical Research Site, status: RECRUITING, city: Hialeah, state: Florida, zip: 33012, country: United States, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Clinical Research Site, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32256, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Clinical Research Site, status: RECRUITING, city: Orlando, state: Florida, zip: 32801, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Clinical Research Site, status: RECRUITING, city: Orlando, state: Florida, zip: 32806, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Clinical Research Site, status: RECRUITING, city: Orlando, state: Florida, zip: 32807, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Clinical Research Site, status: RECRUITING, city: Chicago, state: Illinois, zip: 60634, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Clinical Research Site, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02131, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Clinical Research Site, status: RECRUITING, city: Saint Charles, state: Missouri, zip: 63304, country: United States, geoPoint lat: 38.78394, lon: -90.48123, locations facility: Clinical Research Site, status: RECRUITING, city: Las Vegas, state: Nevada, zip: 89102, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Clinical Research Site, status: RECRUITING, city: Brooklyn, state: New York, zip: 11235, country: United States, geoPoint lat: 40.6501, lon: -73.94958, locations facility: Clinical Research Site, status: RECRUITING, city: Rochester, state: New York, zip: 14609, country: United States, geoPoint lat: 43.15478, lon: -77.61556, locations facility: Clinical Research Site, status: RECRUITING, city: Hickory, state: North Carolina, zip: 28601, country: United States, geoPoint lat: 35.73319, lon: -81.3412, locations facility: Clinical Research Site, status: RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73118, country: United States, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Clinical Research Site, status: RECRUITING, city: Media, state: Pennsylvania, zip: 19063, country: United States, geoPoint lat: 39.91678, lon: -75.38769, locations facility: Clinical Research Site, status: RECRUITING, city: Memphis, state: Tennessee, zip: 38119, country: United States, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Clinical Research Site, status: RECRUITING, city: Wichita Falls, state: Texas, zip: 76309, country: United States, geoPoint lat: 33.91371, lon: -98.49339, locations facility: Clinical Research Site, status: RECRUITING, city: Everett, state: Washington, zip: 98201, country: United States, geoPoint lat: 47.97898, lon: -122.20208, hasResults: False
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protocolSection identificationModule nctId: NCT06360406, orgStudyIdInfo id: D1346R00009, briefTitle: Real-World Treatment Study of Koselugo (Selumetinib), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2031-09-30, completionDateStruct date: 2031-09-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea.This study will provide information on the Korean patient population that is treated with the study drug., conditionsModule conditions: Neurofibromatosis 1, conditions: Neurofibroma, Plexiform, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: Adverse events (AEs) rate, primaryOutcomes measure: Physeal dysplasia occurance rate, secondaryOutcomes measure: Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360393, orgStudyIdInfo id: 17384, briefTitle: Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients With Severe Asthma on Biologics, acronym: OUTERSPACE-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: Trudell Medical International, descriptionModule briefSummary: Severe refractory asthma affects about 3.5% of asthma patients, often necessitating biologic therapy in addition to standard treatment. However, little is understood about maintenance and reliever inhalation medication adherence in these cases which might impact overall biologic response. Objectively monitoring inhalation medication adherence remains a significant challenge. The Smart AeroChamber® device, capable of measuring adherence and inhalation technique, is untested in severe asthma patients on biologics, presenting a potentially cost-effective solution to monitor adherence and better understand treatment response.This study aims to assess the feasibility of the Smart AeroChamber® device in severe asthma patients on biologic therapy, with objectives to:1. Evaluate inhalation medication adherence patterns and inhaler technique, and comparing that adherence data with traditional measures e.g. the Test of Adherence to Inhalers (TAI), and an inhalation technique checklist.2. Investigate the association between inhaled medication adherence and clinical outcomes such as exacerbations, short-acting beta-agonists (SABA) use, oral corticosteroids use (OCS), Fractional Exhaled Nitric Oxide (FeNO), blood eosinophil count, and Asthma Control Questionnaire (ACQ) scores.3. Assess patient and healthcare provider satisfaction and usability of the Smart AeroChamber® device.The study design is prospective and observational, with a sample size of 110 adult patients diagnosed with severe asthma using biologic therapy. Participants will be followed for 12 months, during which they will receive Smart AeroChamber® devices. These devices will measure medication adherence and inhaler technique, and undergo assessments of clinical outcomes at regular intervals. Usability and satisfaction will also be evaluated using the Systems Usability Scale (SUS) in patients and healthcare professionals.The study will be conducted across five severe asthma clinics in the Netherlands. Data analysis will involve comparing the inhalation medication adherence data with traditional measures for adherence and inhalation technique, assessing clinical outcomes, and evaluating usability and satisfaction. The findings from this study will provide insights into the feasibility and effectiveness of using digital devices like the Smart AeroChamber® to support medication adherence and possibly improve outcomes in patients with severe asthma on biologic therapy., conditionsModule conditions: Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Smart spacer, outcomesModule primaryOutcomes measure: Comparative analysis of smart spacer medication adherence and inhaler technique against Test of Adherence to Inhalers (TAI-12), primaryOutcomes measure: Comparison of smart spacer medication adherence patterns (adherence and inhaler technique) with inhaler checklist examined by pulmonologist or pulmonary nurse, secondaryOutcomes measure: Assessing the association of smart spacer assessed adherence with annual exacerbation rate, secondaryOutcomes measure: Assessing the association of smart spacer assessed adherence with reliever inhaler use (e.g. SABA), secondaryOutcomes measure: Assess the association of smart spacer assessed adherence with oral corticosteroids use, secondaryOutcomes measure: Assess the association of smart spacer assessed adherence with FeNO results, secondaryOutcomes measure: Assess the association of smart spacer assessed adherence with blood eosinophils, secondaryOutcomes measure: Assess the association of smart spacer assessed adherence with asthma control (ACQ-6), secondaryOutcomes measure: Assess the association of smart spacer assessed adherence with spirometry results, otherOutcomes measure: Assess usability and patient satisfaction using the System Usability Scale, otherOutcomes measure: Assess usability and healthcare provider satisfaction using the System Usability Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medisch Centrum Leeuwarden, city: Leeuwarden, state: Friesland, zip: 8934AD, country: Netherlands, contacts name: Akke-Nynke van der Meer, MD, PhD, role: CONTACT, phone: +31 58 286 3875, email: [email protected], geoPoint lat: 53.20139, lon: 5.80859, locations facility: Isala, city: Zwolle, state: Overijssel, zip: 8025AB, country: Netherlands, contacts name: Niels Patberg, MD, role: CONTACT, email: [email protected], geoPoint lat: 52.5125, lon: 6.09444, locations facility: Stichting Sint Franciscus Vlietland Groep, city: Rotterdam, state: Zuid-Holland, zip: 3118JH, country: Netherlands, contacts name: Yasemin Türk, MD, PhD, role: CONTACT, phone: +31 10 461 6161, email: [email protected], geoPoint lat: 51.9225, lon: 4.47917, locations facility: University Medical Center Groningen, city: Groningen, zip: 9713GZ, country: Netherlands, contacts name: Maarten van den Berge, MD, PhD, role: CONTACT, phone: +31 6 24450194, email: [email protected], contacts name: Titia Klemmeier, RN, role: SUB_INVESTIGATOR, contacts name: Huib Kerstjens, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Foundation Martini Hospital, city: Groningen, zip: 9728NT, country: Netherlands, contacts name: Marjolein J van Es, MD, PhD, role: CONTACT, phone: +31 50 524 5245, email: [email protected], geoPoint lat: 53.21917, lon: 6.56667, hasResults: False
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protocolSection identificationModule nctId: NCT06360380, orgStudyIdInfo id: AQP-CLP-004, briefTitle: Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System, acronym: REFORM-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-03, primaryCompletionDateStruct date: 2024-11-03, completionDateStruct date: 2024-12-29, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: AquaPass Medical Ltd., class: INDUSTRY, descriptionModule briefSummary: The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.Patients will wear a lightweight suit that helps remove excess fluids through their sweat.We want to see if AquaPass can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.Participants will select if to be treated at their home or in the outpatient clinic., conditionsModule conditions: Chronic Heart Failure, conditions: CKD Stage 3, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A prospective, multicenter, single-arm, within-patient-controlled, pivotal trial, enrolling patients with decompensated heart failure and/or CKD stage 2-3 inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥40 mg furosemide or equivalent., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: AquaPass System, outcomesModule primaryOutcomes measure: AquaPass Performance Evaluation, secondaryOutcomes measure: AquaPass Safety Evaluation, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06360367, orgStudyIdInfo id: 2023-00060, briefTitle: mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2024-10-22, completionDateStruct date: 2024-10-22, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Hawaii, class: OTHER, collaborators name: United States Department of Agriculture (USDA), collaborators name: Pennington Biomedical Research Center, descriptionModule briefSummary: The goal of this 8-week clinical trial is to learn whether the PortionSize Ed mobile app helps to improve healthy eating habits among early adolescents in the Hawai'i-Food and Lifeskills for Youth (HI-FLY) program.PortionSize Ed is a dietary assessment and nutrition education mobile app, that provides real-time feedback on adherence to tailored dietary recommendations. HI-FLY is a healthy lifestyle program delivered in schools throughout Hawaii. PortionSize Ed also contains educational videos.Participants in this study will be randomly assigned to either the HI-FLY only group (HI-FLY), where they will receive the standard HI-FLY program or to the HI-FLY + PortionSize Ed app (HI-FLY + PSEd) group where they will receive the standard HI-FLY program and a study iPhone with the PortionSize Ed app for the 8-week study. This will allow us to evaluate the effect of the PortionSize Ed app among early adolescents in HI-FLY., conditionsModule conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: HI-FLY Curriculum, interventions name: HI-FLY Curriculum + PortionSize Ed app, outcomesModule primaryOutcomes measure: Feasibility- Study enrollment, primaryOutcomes measure: Acceptability- User Satisfaction Survey (USS) scores and qualitative responses, primaryOutcomes measure: Acceptability- Computer System Usability Questionnaire (CSUQ) scores, primaryOutcomes measure: Acceptability- PortionSize Ed app usage data, primaryOutcomes measure: Acceptability- Reason for study drop out, primaryOutcomes measure: Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score, primaryOutcomes measure: Efficacy- Change in HEI-2020 component scores, primaryOutcomes measure: Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey, primaryOutcomes measure: Feasibility- Study Attrition, secondaryOutcomes measure: Change in body weight, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Hawaii at Manoa, status: RECRUITING, city: Honolulu, state: Hawaii, zip: 96822, country: United States, contacts name: Chloe P Lozano, PhD, role: CONTACT, phone: 808-956-7095, email: [email protected], geoPoint lat: 21.30694, lon: -157.85833, hasResults: False
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protocolSection identificationModule nctId: NCT06360354, orgStudyIdInfo id: 20230223, briefTitle: A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-06-29, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers., conditionsModule conditions: Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 282, type: ESTIMATED, armsInterventionsModule interventions name: AMG 193, interventions name: Gemcitabine, interventions name: Nab-paclitaxel, interventions name: Cisplatin, interventions name: Pembrolizumab, interventions name: Modified FOLFIRINOX, outcomesModule primaryOutcomes measure: Number of Participants Experiencing Dose Limiting Toxicities (DLT), primaryOutcomes measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE), primaryOutcomes measure: Number of Participants Experiencing Serious Adverse Events (SAE), secondaryOutcomes measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), secondaryOutcomes measure: Disease Control (DC) per RECIST v1.1, secondaryOutcomes measure: Duration of Response (DOR) per RECIST v1.1, secondaryOutcomes measure: Time to Response (TTR) per RECIST v1.1, secondaryOutcomes measure: Overall Survival (OS) per RECIST v1.1, secondaryOutcomes measure: Progression-free Survival (PFS) per RECIST v1.1, secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) of AMG193, secondaryOutcomes measure: Time to Maximum Plasma Concentration (tmax) of AMG193, secondaryOutcomes measure: Area Under the Plasma Concentration-time Curve (AUC) of AMG 193, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope National Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, hasResults: False
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protocolSection identificationModule nctId: NCT06360341, orgStudyIdInfo id: 202301946, briefTitle: Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, descriptionModule briefSummary: The proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). The proposed research has significant potential to improve self-efficacy (the confidence in one's ability to manage their condition) which is one of the most potent factors for improved health outcomes., conditionsModule conditions: Low Back Pain, Mechanical, conditions: Acute Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Individuals in the pilot randomized controlled trial (RCT) intervention will be randomized to either the intervention or routine discharge care (RC) using REDCap randomizer and assigned to RC or Emergency Department Digital Pain Self-Management Intervention (EDPSI) + RC., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Randomization to RC or Intervention group will not be masked to the Principal Investigator (PI), co-PI, or to participants., enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Emergency Department Digital Pain Self-Management Intervention (EDPSI), interventions name: Routine Discharge Care, outcomesModule primaryOutcomes measure: Improving Self-Management Health Outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UF Health Shand's Adult Emergency Department, city: Gainesville, state: Florida, zip: 32608, country: United States, contacts name: Alexandria A Carey, MSN, MBA-HC, role: CONTACT, phone: 661-607-1702, email: [email protected], contacts name: Angela R Starkweather, PhD, role: CONTACT, phone: (352) 273-6323, email: [email protected], geoPoint lat: 29.65163, lon: -82.32483, hasResults: False
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protocolSection identificationModule nctId: NCT06360328, orgStudyIdInfo id: 033-2024, briefTitle: Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial), acronym: JuniorDoc-VL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-08-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University Hospital Heidelberg, class: OTHER, descriptionModule briefSummary: Securing the airway through endotracheal intubation (ETI) is a fundamental skill for anaesthetists. It is used during surgery, in the intensive care unit, during periprocedural anaesthesia and in emergency medicine. The clinical relevance of airway management is demonstrated in particular by the fact that the main cause of serious anaesthesia-related complications lies in the area of airway management. increasing technological developments in recent years (e.g. video laryngoscopy \[VL\]) aim to reduce the complication rate in the area of airway management. however, there are currently a large number of VLs available, which differ massively in their application. Therefore, it is essential to systematically collect data and develop structured training in airway management, taking into account current technological developments.While endotracheal intubation is traditionally performed with a direct laryngoscope, indirect video laryngoscopy, with chip-based camera technology at its tip, has been introduced across the board in recent years and is now part of standard clinical and preclinical equipment. Doctors in advanced training are trained with a focus on direct laryngoscopy; the use of and training in indirect video laryngoscopy does not follow any standards; in addition, the decision as to which method of securing the airway is chosen has so far been the responsibility of the individual doctor in anaesthesiology, although there is a tendency for the VL to be associated with a higher success rate in the first intubation attempt, the so-called "first-pass success".The main aim of this clinical prospective, randomised controlled trial is to train anaesthetists in advanced training in conventional direct laryngoscopy on the one hand and indirect video laryngoscopy (VL) on the other, with a focus on tracking the progress of their skills after 200 intubations with regard to first-pass success., conditionsModule conditions: Intubation Complication, conditions: Intubation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Control group = direct laryngoscopy Intervention group = video laryngoscopy, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: video laryngoscopy, outcomesModule primaryOutcomes measure: Rate of Successful tracheal intubation on the first attempt (First-Pass-Success)., secondaryOutcomes measure: Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma., secondaryOutcomes measure: Specify the number of attempts made during laryngoscopy., secondaryOutcomes measure: Compare the level of training with intubation success., secondaryOutcomes measure: Mention any failures or transitions to other rescue techniques., secondaryOutcomes measure: Specify the use of Optimal External Laryngeal Manipulation (OELM) techniques such as backward, upward and rightward pressure (BURP) Cricoid Pressure (CP) or adjustment of the participant's head and neck position., secondaryOutcomes measure: When using VL, record the occurrence of fogging., secondaryOutcomes measure: Assess the glottic view using the Cormack-Lehane-Score (I - IV). (I = good view), secondaryOutcomes measure: assess the glottic view using the Percentage of Glottic Opening Score (POGO) (0%-100%). (0%= no view, 100% best view), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,, status: RECRUITING, city: Heidelberg, state: Baden-Wuerttemberg, zip: 69120, country: Germany, contacts name: Davut Deniz Uzun, MD, role: CONTACT, phone: 0049 62215639349, email: [email protected], contacts name: Felix Schmitt, MD, role: CONTACT, phone: 0049 62215639421, email: [email protected], geoPoint lat: 49.40768, lon: 8.69079, hasResults: False
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protocolSection identificationModule nctId: NCT06360315, orgStudyIdInfo id: 202201265, briefTitle: Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: Heart failure affects more than 1.5 million people in France, resulting in over 70,000 deaths and more than 165,000 hospitalizations each year. Viral and bacterial infections are frequently associated with episodes of acute heart failure in patients with chronic heart failure (CHF). Lower respiratory tract infections, such as influenza and pneumococcus, are common causes of hospitalization for decompensated heart failure, leading to increased morbidity and mortality. Studies have shown that pneumococcal vaccination can reduce the risks of heart attack or stroke in patients with heart failure. However, despite vaccination recommendations, coverage rates remain low, especially for pneumococcus. In this study, we will evaluate the impact of an incentive letter for pneumococcal vaccination on one-year hospitalization rate in patients with heart failure., conditionsModule conditions: Chronic Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 12000, type: ESTIMATED, armsInterventionsModule interventions name: Incentive letter for pneumococcal vaccination to the patient and to the GP, outcomesModule primaryOutcomes measure: 1-year Pneumococcus vaccination rate, secondaryOutcomes measure: 1-year all-cause hospital admission rate, secondaryOutcomes measure: 1-year specific hospital admission rate, secondaryOutcomes measure: 1-year all-cause mortality rate, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montpellier University Hospital, city: Montpellier, zip: 34090, country: France, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False
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protocolSection identificationModule nctId: NCT06360302, orgStudyIdInfo id: RECHMPL22_0505, briefTitle: Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients, acronym: KREBSome-IRC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: This prospective, multicenter, cross-sectional, repeated-measures comparative study compared functional and biochemical response profiles to exercise between 2 groups of chronically ill patients (chronic renal failure dialysis patients and patients with metabolic syndrome) and a group of healthy subjects.The hypothesis is that the addition of plasma metabolic intermediates associated with energy disorders linked to insulin resistance, will improve the sensitivity of the assessment of muscle oxidative metabolism abnormalities, as reported in exercise intolerant subjects.In this way, the metabolomics approach during exercise would provide a biological and functional "signature" of insulin resistance of muscular origin, discriminating between insulin-resistant patients, healthy control subjects and dialysis patients, with an exercise metabolic profile approaching that observed in insulin-resistant patients. A better understanding of metabolic abnormalities could guide muscle rehabilitation.Participants will be asked to perform an exercise test, with several blood samples taken at different exercise intensities.Researchers will compare the metabolic profile of three groups: patients with chronic kidney disease, patients with metabolic syndrome and healthy subjects:* V'O2-adjusted lactate at rest and during exercise* The combination of exercise energy metabolism intermediates reflecting insulin resistance among Krebs cycle cofactors/substrates, ß-oxidation cofactors/substrates, amino acids, conditionsModule conditions: Metabolic Syndrome, conditions: Dialysis; Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cross-sectional comparative study with repeated measures, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Exercise test, interventions name: Blood sample, interventions name: Impedancemetry, outcomesModule primaryOutcomes measure: Compare V'O2-adjusted plasma lactate profile at rest and during exercise (metabolic stress test), between chronic renal failure patients, patients with metabolic syndrome and healthy subjects., secondaryOutcomes measure: Compare between the 3 groups their metabolic profile (Krebs cycle cofactors/substrates) adjusted to V'O2 at rest and during exercise., secondaryOutcomes measure: Compare between the 3 groups their metabolic profile (ß-oxidation cofactors/substrates) adjusted to V'O2 at rest and during exercise., secondaryOutcomes measure: Compare between the 3 groups their metabolic profile (amino acids) adjusted to V'O2 at rest and during exercise., secondaryOutcomes measure: Compare between the 3 groups their metabolic profile (acyl-carnitine profiles) adjusted to V'O2 at rest and during exercise., secondaryOutcomes measure: Anthropometry Comparison between the 3 groups, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie, city: Montpellier, zip: 34295, country: France, contacts name: Jean-Paul CRISTOL, Prof, role: CONTACT, phone: +33(0)4 67 33 83 15, email: [email protected], geoPoint lat: 43.61092, lon: 3.87723, locations facility: Montpellier University Hospital, city: Montpellier, zip: 34295, country: France, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False
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protocolSection identificationModule nctId: NCT06360289, orgStudyIdInfo id: ALN-TTR-NT-003, briefTitle: Observational Study of Neurofilament Light Chain (NfL) as a Biomarker in Asymptomatic Carriers of the Transthyretin (TTR) Variants and Patients With Hereditary Transthyretin-mediated (hATTR) Amyloidosis With Polyneuropathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Alnylam Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This is a single-center observational study evaluating the potential value of NfL as a biomarker for diagnosis, detection of disease onset, monitoring of disease progression, and treatment response in asymptomatic carriers of TTR variants and symptomatic hATTR amyloidosis patients with polyneuropathy., conditionsModule conditions: Hereditary Amyloidosis, Transthyretin-Related, conditions: Asymptomatic Carrier State, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Standard of Care, outcomesModule primaryOutcomes measure: NfL Levels in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline, primaryOutcomes measure: Change in NfL Levels Over Time in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy, secondaryOutcomes measure: Correlation Between the NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline, secondaryOutcomes measure: Correlation Between the Change in NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy, secondaryOutcomes measure: Comparison of the Measured NfL Levels to the Normal Levels Expected to be Seen in the General Population by Using the Existing Reference Ranges and Databases, secondaryOutcomes measure: Time to Onset of Active Disease in Asymptomatic Carriers of TTR Variants, secondaryOutcomes measure: Disease Progression in Symptomatic hATTR Amyloidosis Patients with Polyneuropathy, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Universitaire (CHU) Le Kremlin-Bicêtre Assistance Publique-Hôpitaux de Paris (APHP), city: Paris, state: Île-de-France, zip: 94270, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06360276, orgStudyIdInfo id: 14012021, briefTitle: Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-14, primaryCompletionDateStruct date: 2022-08-02, completionDateStruct date: 2022-08-12, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: This study aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.Hypotheses for research:1. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit less fatigue than those who do not.2. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit improved coping behaviors than those who do not.A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping., conditionsModule conditions: Fatigue, conditions: Coping Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Seated Exercises, interventions name: Psychoeducational Rehabilitation, interventions name: Routine Care, outcomesModule primaryOutcomes measure: Piper Fatigue Scale, primaryOutcomes measure: Mini-Mental Adjustment to Cancer Scale, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Nursing, city: Alexandria, zip: 56321, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
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protocolSection identificationModule nctId: NCT06360263, orgStudyIdInfo id: #1-6/2023, briefTitle: OSSEODENSIFICATION BY DENSAH BURS WITH ACTIVATED PLASMA ALBUMIN GEL FOR SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-11, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Esraa Salem Kamal, class: OTHER, descriptionModule briefSummary: Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement., conditionsModule conditions: Bone Loss, Alveolar, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Densah bur in combination with activated plasma albumin gel, outcomesModule primaryOutcomes measure: Postoperative pain, primaryOutcomes measure: Implant stability, primaryOutcomes measure: Vertical bone height gain, primaryOutcomes measure: Bone density around implant, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Alexandria University, status: RECRUITING, city: Alexandria, country: Egypt, contacts name: Esraa S Kamal, BDS, role: CONTACT, phone: 106 054 3345, phoneExt: +20, email: [email protected], geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
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protocolSection identificationModule nctId: NCT06360250, orgStudyIdInfo id: B2001-F20220601, briefTitle: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Changchun BCHT Biotechnology Co., class: INDUSTRY, collaborators name: The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, collaborators name: Anning City First People's Hospital, descriptionModule briefSummary: To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation, conditionsModule conditions: Clostridium Tetanus, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation, interventions name: Tetanus human immunoglobulin (HTIG), interventions name: Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo, interventions name: Adsorbed tetanus vaccine (TT), outcomesModule primaryOutcomes measure: Safety evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PK evaluation index, secondaryOutcomes measure: PD evaluation index, secondaryOutcomes measure: PD evaluation index, secondaryOutcomes measure: PD evaluation index, secondaryOutcomes measure: Immunogenicity evaluation index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360237, orgStudyIdInfo id: ISIS 678354, briefTitle: Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS), statusModule overallStatus: AVAILABLE, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Ionis Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome (FCS)., conditionsModule conditions: Familial Chylomicronemia Syndrome, designModule studyType: EXPANDED_ACCESS, armsInterventionsModule interventions name: Olezarsen, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360224, orgStudyIdInfo id: CASES, briefTitle: Collect Flow and Ultrasound Images of Coronary Bypass Grafts, acronym: CASES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2029-05-15, completionDateStruct date: 2029-05-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Medistim ASA, class: INDUSTRY, descriptionModule briefSummary: This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG)., conditionsModule conditions: Cardiac Bypass Surgery (CABG), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes, outcomesModule primaryOutcomes measure: Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360211, orgStudyIdInfo id: 22251, briefTitle: A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2024-06-11, completionDateStruct date: 2024-06-11, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called Epidermal growth factor receptor (EGFR) and Human epidermal growth factor receptor 2 (HER2) mutations.Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2 that cause uncontrolled cell growth and increased spread of cancer.In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies on people with advanced NSCLC with EGFR or HER2 mutations.BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.Researchers think that BAY2927088 might affect an enzyme (called CYP3A4) that breaks down drugs in the body. This might make the effects of some drugs weaker or stronger. Midazolam is a drug that is broken down by CYP3A4. By studying the level of midazolam in the blood, researchers can understand how BAY2927088 might influence this enzyme's activity.The main purpose of this study is to find out how BAY2927088, taken as a single dose and as multiple doses, affects the level of another drug, called midazolam, in the blood of healthy participants. To achieve this goal, researchers will measure the following for midazolam when participants take it with or without BAY2927088:* Area under the curve (AUC): a measure of the total amount of midazolam in participants' blood over time* Maximum observed concentration (Cmax): the highest amount of midazolam in participants' bloodThe study will have 3 treatment periods:Period 1 (Day 1 to Day 2): On Day 1, participants will take midazolam Period 2 (Day 3 to Day 4): On Day 3, participants will take midazolam with BAY2927088 Period 3 (Day 5 to Day 15): On Days 5 to 13, participants will take BAY2927088 On Day 14, participants will take midazolam with BAY2927088Participants will be part of the study for about 8 weeks with at least 3 visits to the study clinic.Participants will visit the study clinic:* More than/at least once, within 2 to 28 days before the treatment starts* Once on the day before the treatment starts and will stay in the clinic until Day 15 of the treatment* Once, within 7 to 10 days after they finish treatment for a health checkupDuring the study, the doctors and their study team will:* do physical examinations* collect blood samples from the participants to measure the blood levels of midazolam and of BAY2927088* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)* ask the participants questions about how they are feeling and what adverse events they are havingAn adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment., conditionsModule conditions: Advanced Non-small Cell Lung Cancer, conditions: EGFR Mutation, conditions: HER2 Mutation, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: BAY2927088, interventions name: Midazolam, outcomesModule primaryOutcomes measure: Cmax of midazolam when given with and without BAY2927088, primaryOutcomes measure: AUC of midazolam when given with and without BAY2927088, secondaryOutcomes measure: Number of participants with TEAEs, secondaryOutcomes measure: Severity of TEAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: PAREXEL International, Baltimore, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21225, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06360198, orgStudyIdInfo id: 2022-874/08, briefTitle: The Relationship Between Posture, Sense of Position, Musculoskeletal Discomfort and Anxiety, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-30, primaryCompletionDateStruct date: 2022-11-30, completionDateStruct date: 2022-12-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: It is known that posture is affected by various factors such as somatosensation, visual perception and cognition. In addition, it is also thought to affect conditions such as stress and anxiety through receptors. The aim of this study was to investigate the relationship between postural changes such as thoracic kyphosis, musculoskeletal problems, trunk position sense and anxiety in young individuals who were asymptomatic in terms of musculoskeletal problems., conditionsModule conditions: Kyphosis Postural Thoracic, conditions: Proprioception, conditions: Musculoskeletal System, conditions: Anxiety, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 67, type: ACTUAL, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Throcic Kyphosis, secondaryOutcomes measure: Trunk Position Sense, secondaryOutcomes measure: Musculoskeletal Discomfort, secondaryOutcomes measure: Anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Yıldırım Beyazıt University, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06360185, orgStudyIdInfo id: Asthma V2 October 2023, briefTitle: Retrospective Study of Patients With Acute Presentation for Asthma to an Emergency Department in UK (RAPAE), acronym: RAPAE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Norfolk and Norwich University Hospitals NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: Study team will obtain a list of all patients who have been seen in A+E over the past 6 years with a discharge diagnosis of asthma. Their history will be reviewed from their A+E notes. Team will obtain weight and height from Electronic prescribing tool and will obtain compliance information and past medical history from participant's GP records. Team will use participant's postcode to word out socio economic status quintile using office of national statistics tool. The following information will be taken from hospital documentation and from GP records., conditionsModule conditions: Asthma Acute, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Change in body weight, primaryOutcomes measure: Change in body height, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06360172, orgStudyIdInfo id: 3-2024, briefTitle: The Feasibility of Motivational Interviewing on Emotional Authenticity, Dispositional Optimism, And Academic Motivation Among Nursing Students: A Randomized Controlled Trial, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: Motivational interviewing, or MI, is a collaborative, person-centered counseling technique to uncover and enhance a person\'s motivation for behavior change . MI was first created for the treatment of substance dependence, but it has since been successfully implemented in several fields, including healthcare and education (. Given the vital role that nursing students play in the healthcare system, Saudi Arabia, like many other nations, has realized how important it is to improve the motivation and well-being of its nursing students, conditionsModule conditions: Nursing Students, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Motivational Interviewing, outcomesModule primaryOutcomes measure: Kernis-Goldman Authenticity Inventory, primaryOutcomes measure: The Life Orientation Test-Revised form for Adolescents, primaryOutcomes measure: Academic Motivation Scale, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Alexandria university, city: Alexandria, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
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