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protocolSection identificationModule nctId: NCT06349759, orgStudyIdInfo id: OPI-NYXDLD-302, briefTitle: Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances, acronym: LYNX-2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Ocuphire Pharma, Inc., class: INDUSTRY, collaborators name: Viatris Inc., descriptionModule briefSummary: Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances., conditionsModule conditions: Mesopic Vision, conditions: Night Vision Loss, 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: 200, type: ESTIMATED, armsInterventionsModule interventions name: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 15, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: United States, California, status: RECRUITING, city: Newport Beach, state: California, zip: 92663, country: United States, geoPoint lat: 33.61891, lon: -117.92895, locations facility: United States, North Carolina, status: RECRUITING, city: Garner, state: North Carolina, zip: 27529, country: United States, geoPoint lat: 35.71126, lon: -78.61417, locations facility: United States, Rhode Island, status: RECRUITING, city: Warwick, state: Rhode Island, zip: 02888, country: United States, geoPoint lat: 41.7001, lon: -71.41617, hasResults: False
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protocolSection identificationModule nctId: NCT06349746, orgStudyIdInfo id: collage of physical therapy, briefTitle: Cervical Unilateral Antero-posterior Mobilization and Thoracic Central Postro-anterior Mobilization in Treatment of Shoulder Impingement Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Egyptian Chinese University, class: OTHER, collaborators name: Benha University, descriptionModule briefSummary: Shoulder impingement syndrome (SIS) is a complex, multi-factorial problem that is treated with a variety of different conservative options. The conservative option that has shown effectiveness is manual therapy of the cervical and thoracic spine, conditionsModule conditions: Shoulder Impingement, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: this study will be conducted to compare one group receiving selected therapeutic exercises and other group recieve cervical and thoracic mobilization added to selected therapeutic exercise Program on pain intensity, Pain-free shoulder flexion and scaption active ROM, muscle strength of external rotator and abductors, shoulder functional status in patients with Shoulder Impingement Syndrome., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: patients and outcomes assessor will be masked about the grouping of the study, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: therapeutic exercises, interventions name: mobilization exercise, outcomesModule primaryOutcomes measure: pain intensity, primaryOutcomes measure: shoulder flexion and abduction range of motion, primaryOutcomes measure: muscle strength, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349733, orgStudyIdInfo id: MR-37-23-008382, briefTitle: Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration", statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-23, primaryCompletionDateStruct date: 2023-11-10, completionDateStruct date: 2024-04-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: Each year, millions of burn, trauma, or surgical patients worldwide suffer from scarring that severely affects their quality of life and social functioning. In order to prevent and treat diseases related to abnormal scar hyperplasia, clinicians and researchers have adopted various methods, such as scar grinding, surgical resection, drug injection in scar tissue, cryotherapy, laser and so on. However, these methods can not effectively inhibit the abnormal proliferation of scars and improve the adverse effects of existing scars on patients. To date, there is no accepted gold standard for the effective treatment and improvement of abnormal scar tissue., conditionsModule conditions: Scar, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Botulinum toxin type A, outcomesModule primaryOutcomes measure: The modified Stony Brook Scar Evaluation Scale, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu Hospital of Shandong University Dezhou Hospital, city: Dezhou, state: Shandong, zip: 253000, country: China, geoPoint lat: 37.45127, lon: 116.31046, hasResults: False
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protocolSection identificationModule nctId: NCT06349720, orgStudyIdInfo id: KF-2023-355, briefTitle: Investigating Long-term Health Effects and Complications in COVID-19 Recoveries, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-07, primaryCompletionDateStruct date: 2024-06-07, completionDateStruct date: 2024-06-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Zhaohui Tong, class: OTHER, descriptionModule briefSummary: Clarify the incidence of functional impairments in cured COVID-19 patients and identify influencing factors. Build a multi-omics database for COVID-19 patients in the recovery period to elucidate the biological biomarkers and targets associated with functional impairments. Comprehensive exploration of the long-term prognosis, complications, sequelae, and risk factors of COVID-19 patients after Omicron infection, as well as their immune characteristics. Compare the impact of different strains of the COVID-19 virus on prognosis and immune response. Develop comprehensive rehabilitation intervention strategies for COVID-19 patients with functional impairments and evaluate the impact of different intervention methods on their prognosis. Based on clinical data, multi-omics data, and precise rehabilitation assessment data, construct predictive models for prognosis and rehabilitation effectiveness in COVID-19, providing scientific evidence for the implementation of effective COVID-19 rehabilitation measures., conditionsModule conditions: COVID-19 Patients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 17000, type: ESTIMATED, armsInterventionsModule interventions name: respiratory rehabilitation, outcomesModule primaryOutcomes measure: Immunological characteristics associated with functional impairments in COVID-19 convalescent patients, primaryOutcomes measure: Changes in laboratory examination indicators, primaryOutcomes measure: High-resolution CT of the chest, primaryOutcomes measure: Pulmonary function test, primaryOutcomes measure: Multi-omics changes and characteristics associated with functional impairments in COVID-19 convalescent patients, primaryOutcomes measure: Inflammatory factors related to body dysfunction in COVID-19 rehabilitation patients, primaryOutcomes measure: Regular rehabilitation assessment following respiratory rehabilitation intervention in COVID-19 patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Institute of Respiratory Medicine, status: RECRUITING, city: Beijing, state: Beijing, zip: 100027, country: China, contacts name: Zhaohui Tong, Dr, role: CONTACT, phone: +86 010 8523 1000, email: 13910930309@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06349707, orgStudyIdInfo id: 2023PI112, briefTitle: Multiplex PCR for Severe Respiratory Infections During the COVID-19 Pandemic, acronym: VirCoV+, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: The hypothesis was that a retrospective investigation of the molecular virological tests in a University hospital could be informative, with the aim to identify non-COVID-19 respiratory viruses during the circulation of SARS-CoV-2, according to systematic population data for public health knowledge., conditionsModule conditions: Viral Pneumonia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: other: Observational, outcomesModule primaryOutcomes measure: Occurrence of positive viral PCR assays (not COVID-19) from hospitalizations for respiratory infections., secondaryOutcomes measure: Real-life features of patients in Intensive care (from the whole population - Outcome 1) with positive viral PCR during infectious pneumonia., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Schvoerer, city: Vandoeuvre Les Nancy, zip: 54511, country: France, geoPoint lat: 48.65, lon: 6.18333, hasResults: False
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protocolSection identificationModule nctId: NCT06349694, orgStudyIdInfo id: PamukkaleU.ftr-NYıldız-001, briefTitle: Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated.The main questions we aim to answer are:Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied., conditionsModule conditions: Urinary Bladder, Overactive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous MPN stimulation (T-MPNS), interventions name: Transcutaneous tibial nerve stimulation (TTNS), interventions name: BT (Control group), outcomesModule primaryOutcomes measure: Improvement in incontinence episodes (positive response rate), secondaryOutcomes measure: The severity of incontinence, secondaryOutcomes measure: Symptom severity, secondaryOutcomes measure: Frequency of voiding, nocturia, number of pads, secondaryOutcomes measure: Quality of life (IIQ7), secondaryOutcomes measure: The Hospital Anxiety and Depression Scale (HAD), secondaryOutcomes measure: FSFI, secondaryOutcomes measure: Cure-improvement rates, secondaryOutcomes measure: Treatment satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamukkale University, city: Denizli, country: Turkey, geoPoint lat: 37.77417, lon: 29.0875, hasResults: False
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protocolSection identificationModule nctId: NCT06349681, orgStudyIdInfo id: CONOXBird, briefTitle: Describe Relations Between qCON and qNOX Indicies During Propofol-Remifentanil General Anesthesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Padova, class: OTHER, descriptionModule briefSummary: CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bewtween the 2 indicies., conditionsModule conditions: Anesthesia Brain Monitoring, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 14, type: ESTIMATED, outcomesModule primaryOutcomes measure: Correlation between qCON and qNOX, secondaryOutcomes measure: Correlation between qCON and concentrations of Propofol(CeP), secondaryOutcomes measure: Correlation between qNOX and concentrations of Remifentanil (CeR), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Treviso Regional Hospital, status: RECRUITING, city: Treviso, state: TV, zip: 31100, country: Italy, contacts name: Federico Linassi, role: CONTACT, email: federico.linassi@gmail.com, geoPoint lat: 45.66673, lon: 12.2416, hasResults: False
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protocolSection identificationModule nctId: NCT06349668, orgStudyIdInfo id: 2023-505941-21-00, briefTitle: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery, acronym: SMILe, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Hans Bahlmann, class: OTHER, collaborators name: Linkoeping University, descriptionModule briefSummary: The goal of this clinical trial is to learn whether the addition of spinal analgesia leads to superior recovery in patients undergoing robotic-assisted laparoscopic upper urinary tract surgery under general anesthesia. The main questions it aims to answer are:* Is the decrease in wellbeing as quantified by the patient-centered outcome scale "Quality of Recovery 15" (QoR-15), from baseline to the first day after surgery (POD 1), at least 8.0 points less in patients receiving spinal analgesia in addition to general anesthesia?* Does spinal analgesia result in improved recovery as quantified by QoR-15 at POD 7, the incidence of postoperative pain at rest and at mobilization, nausea and vomiting, the need for opioid analgesics, time out-of-bed, length of stay and the incidence of complications?* Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery?* Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery?Participants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively.QoR-15 and other markers of recovery will be registered using structured interviews preoperatively, at POD1 and POD7. In addition, patients will record pain at rest and at mobilization three times daily in a diary.In a subgroup of patients advanced hemodynamic parameters will be recorded using pulse-contour analysis before, during and after surgery. Blood samples will also be collected in these patients at fixed intervals and analyzed for amongst others inflammation and cardiac dysfunction., conditionsModule conditions: Other Specified Disorders of Kidney and Ureter, conditions: Benign Neoplasm of Ureter, conditions: Calculus of Kidney and Ureter, conditions: Ureter Cancer, conditions: Ureteric Reflux, conditions: Congenital Ureteric Anomaly, conditions: Benign Renal Neoplasm, conditions: Renal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: spinal analgesia with morphine and bupivacaine, interventions name: lidocaine infusion, outcomesModule primaryOutcomes measure: QoR-15 score at postoperative day 1, secondaryOutcomes measure: QoR-15 score preoperatively, secondaryOutcomes measure: QoR-15 score at postoperative day 7, secondaryOutcomes measure: Pain (NRS) in rest and during motion 2hrs after arrival to the PACU, secondaryOutcomes measure: Pain (NRS) on POD 1-3, secondaryOutcomes measure: Pain (NRS) in rest and during motion at POD 7, secondaryOutcomes measure: Time from arrival in the OR to start of surgery, secondaryOutcomes measure: Time from end of surgery until leaving the OR, secondaryOutcomes measure: Incidence of unplanned termination of the lidocaine infusion, secondaryOutcomes measure: Amount of remifentanil in patients given remifentanil, secondaryOutcomes measure: Amount of intraoperative opioids in patients not receiving remifentanil, secondaryOutcomes measure: Length of stay at the PACU, secondaryOutcomes measure: Amount of opioids administred at the PACU, secondaryOutcomes measure: Percentage of patients with PONV requiring treatment at 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay, secondaryOutcomes measure: "Time out-of-bed" on POD 1-3, secondaryOutcomes measure: Amount of opioids administered during the first 24 hours at the ward, secondaryOutcomes measure: First POD passing gases, secondaryOutcomes measure: First POD passing stool, secondaryOutcomes measure: Incidence of pruritus, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: DAOH30, secondaryOutcomes measure: Postoperative complications untill POD 30, secondaryOutcomes measure: Requirement for opioids after discharge, secondaryOutcomes measure: Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours of induction of anesthesia, secondaryOutcomes measure: Intraoperative fluid balance, secondaryOutcomes measure: Time with low blood pressure during anesthesia, secondaryOutcomes measure: Lowest MAP within 10 minutes after induction of anesthesia, secondaryOutcomes measure: Highest MAP within 10 minutes of abdominal insufflation, secondaryOutcomes measure: Fraction of patients needing norepinephrine before start of surgery, secondaryOutcomes measure: Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of surgery), secondaryOutcomes measure: Average infusion rate of norepinephrine, in patients receiving norepinephrine, before start of surgery, secondaryOutcomes measure: Average infusion rate of norepinephrine, in patients receiving norepinephrine, after start of surgery, secondaryOutcomes measure: Intraoperative Cardiac Index, secondaryOutcomes measure: Intraoperative Stroke Volume Index, secondaryOutcomes measure: Intraoperative Cardiac Power Index, secondaryOutcomes measure: Intraoperative dPmx, secondaryOutcomes measure: Intraoperative Pulse Pressure Variation, secondaryOutcomes measure: Intraoperative Stroke Volume Variation, secondaryOutcomes measure: Intraoperative Systemic Vascular Resistance Index, secondaryOutcomes measure: Intraoperative heart rate, secondaryOutcomes measure: Biochemical markers of inflammation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Linköping, status: RECRUITING, city: Linköping, country: Sweden, contacts name: Martin Holmberg, MD, role: CONTACT, phone: +46101033932, email: martin.holmberg@regionostergotland.se, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False
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protocolSection identificationModule nctId: NCT06349655, orgStudyIdInfo id: 2023-KY-0865-001, briefTitle: The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-05, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-03-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Zhengzhou University, class: OTHER, collaborators name: Henan Provincial Chest Hospital, collaborators name: The Affiliated Infectious Disease Hospital of Zhengzhou University, collaborators name: The Fifth People's Hospital of Anyang, collaborators name: Shangqiu Municipal Hospital, collaborators name: Nanyang Central Hospital, collaborators name: Luoyang Central Hospital, collaborators name: Guangshan County People's Hospital, collaborators name: Fengqiu County People's Hospital, descriptionModule briefSummary: To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection., conditionsModule conditions: COVID-19, conditions: Azvudine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 32864, type: ACTUAL, armsInterventionsModule interventions name: Azvudine, interventions name: Paxlovid, outcomesModule primaryOutcomes measure: All-cause death, secondaryOutcomes measure: Composite disease progression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Zhengzhou University, city: Zhengzhou, state: Henan, zip: 450052, country: China, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False
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protocolSection identificationModule nctId: NCT06349642, orgStudyIdInfo id: MC230901, secondaryIdInfos id: 23-008413, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: NCI-2024-02979, type: REGISTRY, domain: CTRP (Clinical Trials Reporting Program), briefTitle: Predicting Response to Immune Checkpoint Inhibitors Across Solid Tumors Using a Live Tumor Diagnostic Platform, acronym: CYBRID-04, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The primary purpose of this study is to determine the sensitivity of CYBRID Score for predicting in-vivo clinical response based on surgical response or RECIST 1.1 for neoadjuvant and locally advanced/metastatic patients, respectively. The secondary purposes is to determine the sensitivity of the CYBRID Score for predicting in-vivo clinical response based on surgical response or RECIST 1.1 for neoadjuvant and locally advanced/metastatic patients, respectively., conditionsModule conditions: Early Stage Triple-Negative Breast Carcinoma, conditions: Locally Advanced Bladder Urothelial Carcinoma, conditions: Locally Advanced Cervical Carcinoma, conditions: Locally Advanced Clear Cell Renal Cell Carcinoma, conditions: Locally Advanced Colorectal Carcinoma, conditions: Locally Advanced Endometrial Carcinoma, conditions: Locally Advanced Esophageal Carcinoma, conditions: Locally Advanced Liver Carcinoma, conditions: Locally Advanced Lung Non-Small Cell Carcinoma, conditions: Locally Advanced Malignant Skin Neoplasm, conditions: Locally Advanced Triple-Negative Breast Carcinoma, conditions: Metastatic Bladder Urothelial Carcinoma, conditions: Metastatic Cervical Carcinoma, conditions: Metastatic Clear Cell Renal Cell Carcinoma, conditions: Metastatic Colorectal Carcinoma, conditions: Metastatic Endometrial Carcinoma, conditions: Metastatic Esophageal Carcinoma, conditions: Metastatic Liver Carcinoma, conditions: Metastatic Lung Non-Small Cell Carcinoma, conditions: Metastatic Malignant Skin Neoplasm, conditions: Metastatic Malignant Solid Neoplasm, conditions: Metastatic Triple-Negative Breast Carcinoma, conditions: Resectable Bladder Urothelial Carcinoma, conditions: Resectable Colorectal Carcinoma, conditions: Resectable Lung Non-Small Cell Carcinoma, conditions: Resectable Malignant Liver Neoplasm, conditions: Resectable Skin Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Tissue Collection, outcomesModule primaryOutcomes measure: Accuracy of cytoplasmic hybrid (Cybrid) Score for predicting in-vivo clinical response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32224, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Dev Mukhopadhyay, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False
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protocolSection identificationModule nctId: NCT06349629, orgStudyIdInfo id: 20240401, briefTitle: The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: Perimarticular fracture bone defect is a common and complicated clinical disease. The current treatment for this type of injury is anatomical reduction of the fracture, where the bone defect is filled with artificial, autologous or allogeneic bone in granular form, and then fixed with plates and screws. However, these bone filler materials exist in a loose accumulation state and cannot form an effective overall support force for the joint. The applicant realized three dimensional (3D) printing of WE43 magnesium alloy with personalized design and porous overall structure, and developed high-temperature heat treatment technology to slow its degradation, which effectively realized the dual stability of degradation rate of magnesium alloy support body and overall structure during the bone repair period. This project will optimize the design of 3D printed WE43 magnesium alloy full-structure in-bone support, and establish a metamaterial pore structure design platform that regulates the physical properties and degradation behavior of porous implants. Fracture from proximal humerus, distal radius and tibial plateau, conditionsModule conditions: Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 3D printed WE43 magnesium alloy, outcomesModule primaryOutcomes measure: Detection of Magnesium alloy metabolism, primaryOutcomes measure: Degradation of 3D printed magnesium alloy prosthesis, primaryOutcomes measure: New bone regeneration, primaryOutcomes measure: Evaluation of shoulder joint function, primaryOutcomes measure: Evaluation of wrist joint function, primaryOutcomes measure: Evaluation of knee joint function, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Haidian, country: China, contacts name: Bingchuan Liu, role: CONTACT, phone: +86 18310188678, email: liubc@bjmu.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospita, status: RECRUITING, city: Beijing, zip: 100083, country: China, contacts name: Yun Tian, M.D, role: CONTACT, phone: +8613701053505, email: tiany@bjmu.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06349616, orgStudyIdInfo id: STUDY24458, briefTitle: Cooling Strategies for Older Adults in the Heat, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Penn State University, class: OTHER, descriptionModule briefSummary: The earth's climate is warming, and the number of heat waves has increased in recent years. At the same time, the number of adults over the age of 65 is growing. Humans sweat and increase blood flow to the skin to cool their body when they get hot. Older adults do not do this as well as young adults. This makes it harder to safely be in warm and/or humid conditions. It is important to learn about cooling strategies for older adults to safely be in warm and/or humid conditions.There is compelling evidence that intermittent hand and forearm cold-water immersion effectively reduces the rise of core temperature during heat stress in older adults. However, it is still unknown if this is an effective cooling strategy for older adults. Furthermore, our laboratory has shown that folic acid supplementation improves blood flow responses in older adults. This may be beneficial to older adults during heat stress., conditionsModule conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Subjects participate in 4 experiments, 2 for each treatment (folic acid supplementation and placebo). The order of treatment is random., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent cold-water hand and forearm immersion, interventions name: No intermittent cold-water hand and forearm immersion, outcomesModule primaryOutcomes measure: Core temperature, primaryOutcomes measure: Heart rate, primaryOutcomes measure: Blood Pressure, secondaryOutcomes measure: Body Mass, secondaryOutcomes measure: Skin Temperature, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 100 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Noll Laboratory, city: University Park, state: Pennsylvania, zip: 16802, country: United States, contacts name: W. Larry Kenney, Ph.D., role: CONTACT, phone: 814-863-1672, email: w7k@psu.edu, contacts name: Rachel Cottle, MS, role: CONTACT, email: rmc5808@psu.edu, geoPoint lat: 40.80201, lon: -77.85639, hasResults: False
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protocolSection identificationModule nctId: NCT06349603, orgStudyIdInfo id: S2023, briefTitle: Physiotherapy Approach for Susac Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-13, primaryCompletionDateStruct date: 2023-04-01, completionDateStruct date: 2023-04-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Rehabilitation Centre Zivot, class: OTHER, descriptionModule briefSummary: Susac's syndrome is a rare autoimmune disorder characterised by a triad of encephalopathy (brain dysfunction), branch retinal artery occlusion (loss of vision) and sensorineural hearing loss. This study presents the case of a patient undergoing intensive physiotherapy intervention following an injury, focusing on assessments such as volume and range of motion measurements, manual muscle tests, and pain intensity evaluations using various scales., conditionsModule conditions: Susac Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1, type: ACTUAL, outcomesModule primaryOutcomes measure: Mobility and Muscle Strength Improvement, primaryOutcomes measure: Muscle Strength Improvement Outcome Measure, primaryOutcomes measure: Pain Intensity Outcome Measure, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rehabilitation centre Život, city: Mostar, zip: 88000, country: Bosnia and Herzegovina, geoPoint lat: 43.34333, lon: 17.80806, hasResults: False
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protocolSection identificationModule nctId: NCT06349590, orgStudyIdInfo id: IRB24-0373, briefTitle: Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery, acronym: DIET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized plant-based low fat/ high-fiber meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Plant-Based Meals, outcomesModule primaryOutcomes measure: Change of the presence of active-urokinase-type plasminogen activation (uPA) stool samples before and after diet intervention using western blot and zymography., secondaryOutcomes measure: Change of the presence of active- Matrix Metalloproteinase-9 (MMP9) in stool samples before and after diet intervention using western blot and zymography., secondaryOutcomes measure: Change of the presence of plasminogen in stool samples before and after diet intervention using western blot and zymography., secondaryOutcomes measure: Change of the stool associated metagenomics in subjects before and after intervention., secondaryOutcomes measure: Change of the levels of short-chain fatty acids and bile acids between pre- and post- intervention stool samples., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Chicago, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Benjamin Shogan, MD, role: CONTACT, phone: 773-732-2260, email: bshogan@bsd.uchicago.edu, contacts name: Leila Yazdanbakhsh, role: CONTACT, phone: 773-834-6087, email: leila.yazdanbakhsh@bsd.uchicago.edu, contacts name: Benjamin Shogan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06349577, orgStudyIdInfo id: 23-0921, secondaryIdInfos id: 5K23HL151882, type: NIH, link: https://reporter.nih.gov/quickSearch/5K23HL151882, briefTitle: Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass., conditionsModule conditions: Acute Kidney Injury, conditions: Hemolysis, conditions: Thrombocytopenia, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1100, type: ESTIMATED, armsInterventionsModule interventions name: Non-pulsatile blood flow, interventions name: Pulsatile blood flow, outcomesModule primaryOutcomes measure: Acute kidney injury, secondaryOutcomes measure: Acute kidney injury risk score, secondaryOutcomes measure: Red blood cell units transfused, secondaryOutcomes measure: Platelet nadir, secondaryOutcomes measure: Discontinuation rate of cardiopulmonary bypass mode, secondaryOutcomes measure: 30-day mortality, otherOutcomes measure: Myocardial infarction, otherOutcomes measure: Stroke, otherOutcomes measure: Renal failure requiring renal replacement therapy, otherOutcomes measure: Re-exploration for bleeding, otherOutcomes measure: Sepsis, otherOutcomes measure: New onset atrial fibrillation, otherOutcomes measure: Duration of mechanical ventilation, otherOutcomes measure: Post-operative delirium, otherOutcomes measure: Post-operative hospital length of stay, otherOutcomes measure: New requirement for mechanical circulatory support, otherOutcomes measure: Intra-operative red blood cell transfusion in units, otherOutcomes measure: Post-operative red blood cell transfusion in units, otherOutcomes measure: Post-operative platelet transfusion in units, otherOutcomes measure: Post-operative plasma transfusion in units, otherOutcomes measure: Post-operative cryoprecipitate transfusion in units, otherOutcomes measure: Intra-operative platelet transfusion in units, otherOutcomes measure: Intra-operative plasma transfusion in units, otherOutcomes measure: Intra-operative cryoprecipitate transfusion in units, otherOutcomes measure: New onset of acute lung injury, otherOutcomes measure: New onset of left ventricular systolic dysfunction, otherOutcomes measure: New onset of right ventricular systolic dysfunction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Hospital, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False
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protocolSection identificationModule nctId: NCT06349564, orgStudyIdInfo id: 23-01443, briefTitle: Implementing Virtual Reality (VR) to Reduce Sedation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time., conditionsModule conditions: Sedative During Endoscopy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Pico 4 Enterprise headset with noise cancelling headphones, outcomesModule primaryOutcomes measure: Total amount of sedative drugs administered during the procedure, secondaryOutcomes measure: Patient-reported discomfort or pain (using 0-10 pain scale), secondaryOutcomes measure: Duration of the procedure, secondaryOutcomes measure: Overall patient satisfaction scores, secondaryOutcomes measure: Number of events of complications from VR, secondaryOutcomes measure: Number of technical failures, secondaryOutcomes measure: Troubleshooting time, secondaryOutcomes measure: PACU length of stay, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Brooklyn, city: Brooklyn, state: New York, zip: 11220, country: United States, geoPoint lat: 40.6501, lon: -73.94958, hasResults: False
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protocolSection identificationModule nctId: NCT06349551, orgStudyIdInfo id: RC23_0586, briefTitle: Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling., acronym: SECU-BIO2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: After blood sampling from an arterial catheter, the reinjection of the clearing fluid (a mixture of saline solution and blood) is proposed to limit blood loss. However, the status of coagulation in this clearing liquid remains poorly documented., conditionsModule conditions: Intensive Care Units, conditions: Arterial Lines, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 211, type: ESTIMATED, armsInterventionsModule interventions name: Patients of intensive care unit, outcomesModule primaryOutcomes measure: Composite score of the coagulation activation over time in the clearing fluid during blood sampling from an arterial catheter, secondaryOutcomes measure: Concentration of prothrombin over time in the clearing fluid during blood sampling from an arterial catheter, secondaryOutcomes measure: Concentration of factor II over time in the clearing fluid during blood sampling from an arterial catheter, secondaryOutcomes measure: Concentration of factor V over time in the clearing fluid during blood sampling from an arterial catheter, secondaryOutcomes measure: Concentration of fibrin monomer over time in the clearing fluid during blood sampling from an arterial catheter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantes university hospital, status: RECRUITING, city: Nantes, state: Loire-atlantique, zip: 44093, country: France, contacts name: Jerôme Dauvergne, role: CONTACT, phone: +33240165289, email: jerome.dauvergne@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Hospital center, status: NOT_YET_RECRUITING, city: Saint-Nazaire, zip: 44606, country: France, contacts name: Damien Muller, Dr, role: CONTACT, phone: 02 72 27 89 89, email: dmuller.med@gmail.com, geoPoint lat: 47.28333, lon: -2.2, hasResults: False
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protocolSection identificationModule nctId: NCT06349538, orgStudyIdInfo id: 35-435 ex 22/23, briefTitle: Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2034-04-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about epidemiology, biologic markers, disease subtypes and possible prognostic factors in essential tremor (ET) patients. The main question\[s\] it aims to answer are:* The prevalence of ET-plus compared to ET in a prospectively collected ET population.* To assess in detail the heterogenous group of ET patients using comprehensive clinical (motor and non-motor scales, questionnaires), imaging \[magnetic resonance imaging (MRI), sonography of substantia nigra and cerebral vessels\], neurophysiological (tremor analysis, digital spiral drawing) and laboratory markers (sGFAP, sNfL, routine laboratory parameters).* To assess possible non-invasive markers of neurodegeneration in ET patients (optic coherence tomography, alpha-synuclein in olfactory mucosa)Participants will be asked to undergo the above mention evaluation at baseline and at follow-up approx. 5 years later.Researchers will compare the findings within the ET group to independently existing cohorts of healthy controls and/or patients with other movement disorders like Parkinson's disease., conditionsModule conditions: Essential Tremor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab., outcomesModule primaryOutcomes measure: Prevalence of ET-plus, secondaryOutcomes measure: Age of ET patients, secondaryOutcomes measure: Sex of ET patients, secondaryOutcomes measure: Family history, secondaryOutcomes measure: Symptom leading to ET-plus classification, secondaryOutcomes measure: current and former medication for essential tremor, secondaryOutcomes measure: subjective disease course of ET, secondaryOutcomes measure: responsivity to alcohol, secondaryOutcomes measure: presence of cardiovascular risk factors, secondaryOutcomes measure: MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease Rating Scale) parts I-IV, secondaryOutcomes measure: modified Essential Tremor Rating Assessment Scale (mTETRAS), secondaryOutcomes measure: Scale for the assessment and rating of ataxia (SARA), secondaryOutcomes measure: Verbal fluency animals (part of the CERAD-plus test battery), secondaryOutcomes measure: Boston Naming Test (part of the CERAD-plus test battery), secondaryOutcomes measure: Mini Mental State Examination Test (MMSE; part of the CERAD-plus test battery), secondaryOutcomes measure: word list learning (part of the CERAD-plus test battery), secondaryOutcomes measure: constructive praxis (part of the CERAD-plus test battery), secondaryOutcomes measure: word list recall (part of the CERAD-plus test battery), secondaryOutcomes measure: word list recognition (part of the CERAD-plus test battery), secondaryOutcomes measure: constructive praxis recall (part of the CERAD-plus test battery), secondaryOutcomes measure: Trail Making Test A (part of the CERAD-plus test battery), secondaryOutcomes measure: Trail Making Test B (part of the CERAD-plus test battery), secondaryOutcomes measure: s-words (part of the CERAD-plus test battery), secondaryOutcomes measure: Frontal Assessment Battery (FAB), secondaryOutcomes measure: Geriatric Depression Scale (GDS), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Non-Motor Symptoms Scale for Parkinson's Disease (NMSS), secondaryOutcomes measure: RBD Screening Questionnaire, secondaryOutcomes measure: Global Physical Activity Questionnaire (GPAQ), secondaryOutcomes measure: Quality of Life in Essential Tremor Questionnaire (QUEST), secondaryOutcomes measure: University of Pennsylvania Smell Identification Test (UPSIT), secondaryOutcomes measure: Montreal Cognitive Assessment (MOCA), secondaryOutcomes measure: Auditory verbal learning test, secondaryOutcomes measure: Symbol Digit Modalities Test (SDMT), secondaryOutcomes measure: Brief Visuospatial Memory Test, secondaryOutcomes measure: Comprehensive trail making test 4, secondaryOutcomes measure: Comprehensive trail making test 5, secondaryOutcomes measure: Regensburg word fluency test, secondaryOutcomes measure: EQ-5D, secondaryOutcomes measure: resilience scale (RS-13), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: Digital Spiral Drawing, secondaryOutcomes measure: Schellong Test, secondaryOutcomes measure: serum glial fibrillary acidic protein (sGFAP), secondaryOutcomes measure: serum neurofilament light (sNfL), secondaryOutcomes measure: Transcranial sonography, secondaryOutcomes measure: tremor analysis, secondaryOutcomes measure: cerebral MRI, secondaryOutcomes measure: cerebral MRI, secondaryOutcomes measure: cerebral MRI, secondaryOutcomes measure: cerebral MRI, secondaryOutcomes measure: cerebral MRI, secondaryOutcomes measure: cerebral MRI, secondaryOutcomes measure: optic coherence tomography (OCT), secondaryOutcomes measure: optic coherence tomography (OCT), secondaryOutcomes measure: optic coherence tomography (OCT), secondaryOutcomes measure: optic coherence tomography (OCT), secondaryOutcomes measure: Olfactory mucosa swab, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Graz, city: Graz, zip: 8036, country: Austria, geoPoint lat: 47.06667, lon: 15.45, hasResults: False
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protocolSection identificationModule nctId: NCT06349525, orgStudyIdInfo id: DU-2021-00103, briefTitle: Retention of Telescopic Versus Locator Attachments, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-01, primaryCompletionDateStruct date: 2023-07-05, completionDateStruct date: 2023-10-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Delta University for Science and Technology, class: OTHER, descriptionModule briefSummary: Forty patients ( 24female and16 male )with completely edentulous maxilla and mandible . All patients received implant supported mandibular and maxillary overdentures. The patients were randomly divided into two groups according to attachments retaining Max IOD that supported by four axial implants in maxilla . The TA was used to retain group I (GrI) MaxIOD, while that of group II (Gr II) was retained by LA. MaxIOD retention and MBL(vertical and horizontal) around implants of both groups was recorded at time of insertion (R0) ,then twelve(R12)and (R24) months following insertion of the prosthesis., conditionsModule conditions: Jaw, Edentulous, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: telescopic overdenture, interventions name: Locator overdenture, outcomesModule primaryOutcomes measure: Retention, secondaryOutcomes measure: Marginal bone loss, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Delta University for Science & Technology, city: Mansoura, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06349512, orgStudyIdInfo id: IC 2022-07, secondaryIdInfos id: 2023-507860-37-00, type: CTIS, briefTitle: 68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT), acronym: FAP-IT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2027-07-30, completionDateStruct date: 2027-07-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Institut Curie, class: OTHER, descriptionModule briefSummary: Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC., conditionsModule conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-FAPI-46 PET/CT imaging, outcomesModule primaryOutcomes measure: Area under the ROC curve, secondaryOutcomes measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances, secondaryOutcomes measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances, secondaryOutcomes measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances, secondaryOutcomes measure: Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349499, orgStudyIdInfo id: CIIPCL-AMD-MAG-23, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
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protocolSection identificationModule nctId: NCT06349486, orgStudyIdInfo id: KMUHIRB-F(II)-20230179, briefTitle: Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Kaohsiung Medical University, class: OTHER, descriptionModule briefSummary: 1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments., conditionsModule conditions: Helicobacter Pylori Eradication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1. bismuth-amoxicillin-vonoprazan triple therapy2. vonoprazan-amoxicillin dual therapy3. proton pump inhibitor-based standard triple therapy, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 780, type: ESTIMATED, armsInterventionsModule interventions name: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate, interventions name: vonoprazan, amoxicillin, interventions name: rabeprazole, amoxicillin, clarithromycin, outcomesModule primaryOutcomes measure: the eradication rate of Helicobacter pylori, secondaryOutcomes measure: genotype analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaohsiung Medical University Hospital, status: RECRUITING, city: Kaohsiung, zip: 807, country: Taiwan, contacts name: Deng-Chyang Wu, MD,PHD, role: CONTACT, phone: 886-7-3121101, phoneExt: 7451, email: dechwu@yahoo.com, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False
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protocolSection identificationModule nctId: NCT06349473, orgStudyIdInfo id: SR604-1, briefTitle: A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-09-27, completionDateStruct date: 2025-09-27, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Equilibra Bioscience LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604 in participants with severe Hemophilia A or Hemophilia B, with or without inhibitors (Part B)., conditionsModule conditions: Healthy Participants, conditions: Hemophilia A, conditions: Hemophilia B, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: SR604, interventions name: Placebo, outcomesModule primaryOutcomes measure: Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), primaryOutcomes measure: Parts A and B: Number of Participants with Clinical Abnormal Changes in Coagulations Markers, secondaryOutcomes measure: Part A: Area Under the Serum Concentration-time Curve from time Zero to the Last Quantifiable Time Point (AUC[0-t]), secondaryOutcomes measure: Part A: Area Under the Serum Concentration-time Curve from time Zero Extrapolated to Infinity (AUC[0-inf]), secondaryOutcomes measure: Parts A and B: Maximum Concentration (Cmax) of SR604, secondaryOutcomes measure: Parts A and B: Time to Maximum Concentration (tmax) of SR604, secondaryOutcomes measure: Parts A and B: Terminal Half-life (T1/2) of SR604, secondaryOutcomes measure: Part A: Clearance Following Extravascular Administration (CL/F) of SR604, secondaryOutcomes measure: Part A: Volume of Distribution in Terminal Phase Following Extravascular Administration (Vz/F) of SR604, secondaryOutcomes measure: Parts B: Concentration before the next dose administration (Ctrough), secondaryOutcomes measure: Parts B: Area Under the Serum Concentration-time Curve within One Dosing Interval (AUCtau), secondaryOutcomes measure: Parts B: Accumulation Ratio (R) of SR604, secondaryOutcomes measure: Parts B: Number of Bleeding Events, secondaryOutcomes measure: Parts B: Annualized Bleeding Rate (ABR) in Body and Targeted Joints, secondaryOutcomes measure: Parts A and B: Number of Participants with Positive Antidrug Antibodies (ADAs), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: California Clinical Trials Medical Group (CCTMG), status: RECRUITING, city: Glendale, state: California, zip: 91206, country: United States, contacts name: Esther Yoon, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.14251, lon: -118.25508, hasResults: False
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protocolSection identificationModule nctId: NCT06349460, orgStudyIdInfo id: STU00216998, secondaryIdInfos id: R01DK133300, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK133300, briefTitle: A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence., conditionsModule conditions: Binge Eating, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: In this micro-randomized trial, participants will have 2 consecutive, independent micro-randomizations at the time of target selection each week for 16 weeks: namely, 1 of 5 treatment targets will be randomly delivered, either as a recommended or assigned target, to each user, of equal probability per randomization., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: FoodSteps behavioral intervention, outcomesModule primaryOutcomes measure: Weekly change in binge eating, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern University Feinberg School of Medicine, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Andrea K Graham, PhD, role: CONTACT, phone: 312-503-5266, email: andrea.graham@northwestern.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06349447, orgStudyIdInfo id: KY2021-771, briefTitle: Pilot Study of LED for PIE and PIH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-05-10, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Yanjun Dan, class: OTHER, descriptionModule briefSummary: The aim of this study is to explore the effect of medical LEDs (830 nm and 590 nm) in the prevention and treatment of PIE and PIH., conditionsModule conditions: Hyperpigmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 308 nm LED light was utilized to induce an vivo PIE/PIH model on the thigh of subjects. The irradiation dose was 1.5 MED. Five circular experimental lesions measuring 1.5 × 1.5 cm were selected on the thighs, categorizing into five groups: control group, 830 nm LED treatment group, 590 nm LED treatment group, 830 nm LED prevention group and 590 nm LED prevention group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: LED, interventions name: without any LED exposition, outcomesModule primaryOutcomes measure: melanin index, primaryOutcomes measure: erythema index, secondaryOutcomes measure: transepidermal water loss (TEWL), secondaryOutcomes measure: elasticity, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huashan Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Yanjun Dan, role: CONTACT, phone: +86 159 0194 0897, email: danyanjun@126.com, contacts name: Leihong Xiang, role: CONTACT, phone: +86 13818252671, email: flora_xiang@vip.163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06349434, orgStudyIdInfo id: R-1215-23, briefTitle: The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-15, primaryCompletionDateStruct date: 2028-10-01, completionDateStruct date: 2028-10-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Kessler Foundation, class: OTHER, descriptionModule briefSummary: To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study., conditionsModule conditions: SCI - Spinal Cord Injury, conditions: Upper Extremity Dysfunction, conditions: Upper Extremity Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Randomized Clinical Trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: MyoMo, interventions name: conventional therapy, outcomesModule primaryOutcomes measure: GRASSP, primaryOutcomes measure: Range of motion of hands and arms, primaryOutcomes measure: Muscle strength measurement, secondaryOutcomes measure: Spasticity measurement, secondaryOutcomes measure: Brain signals measurement, secondaryOutcomes measure: CUE-Q, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kessler Foundation, status: RECRUITING, city: West Orange, state: New Jersey, zip: 07052, country: United States, contacts name: Ghaith J Androwis, Ph.D., role: CONTACT, phone: 201-968-6110, email: gandrowis@kesslerfoundation.org, geoPoint lat: 40.79871, lon: -74.23904, hasResults: False
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protocolSection identificationModule nctId: NCT06349421, orgStudyIdInfo id: 202401078RINE, briefTitle: Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Bone quality stands as a crucial determinant impacting the success rate of dental implants, exerting influence on both implant primary stability and the efficacy of osseointegration. While radiographic images can partially reveal bone quality, experienced surgeons often rely on tactile sensation during bone drilling to assess it. Subsequently, based on the diagnosed bone quality, distinct implant designs and surgical protocols have been invented to enhance survival rates.Technological advancements now enable the preoperative design of implant placement through a comprehensive guide, merging CBCT DICOM files with digital oral scanning data. This "fully guided" approach enhances the precision, stability, and safety of implant placement surgery. However, the use of a fully guided surgical guide introduces an additional factor-the friction between the drill and guide-potentially impacting the surgeon's tactile feedback.This study aims to assess the difference in bone quality evaluation by tactile sensation between freehand drilling and drilling with a fully guided surgical guide, using test blocks of different bone density. The discussion will explore the pros and cons of employing a fully guided guide to optimize outcomes in implant treatment., conditionsModule conditions: Dentistry, conditions: Education, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: VAS scale at the same density of sawbone, eligibilityModule sex: ALL, minimumAge: 24 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349408, orgStudyIdInfo id: CIBI3001A101, briefTitle: IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2027-05-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Innovent Biologics (Suzhou) Co. Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. It includes a Phase 1 section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3001, and a Phase 2 section to explore and confirm the efficacy, safety and tolerability of IBI3001 at its RP2D., conditionsModule conditions: Locally Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: IBI3001, outcomesModule primaryOutcomes measure: Number of subjects with adverse events, primaryOutcomes measure: Number of subjects with clinically significant changes in physical examination results, primaryOutcomes measure: Number of subjects with clinically significant changes in vital signs, primaryOutcomes measure: MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs), secondaryOutcomes measure: Plasma concentration (Cmax) of IBI3001, secondaryOutcomes measure: Area under the curve (AUC) of IBI3001, secondaryOutcomes measure: Time to maximum concentration (Tmax) of IBI3001, secondaryOutcomes measure: Clearance (CL) of IBI3001, secondaryOutcomes measure: Volume of distribution (V) of IBI3001, secondaryOutcomes measure: Half-life (T1/2) of IBI3001, secondaryOutcomes measure: Immunogenicity of IBI3001, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Time to response (TTR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wollongong Public, city: Wollongong, state: New South Wales, zip: 2500, country: Australia, contacts name: Daniel Brungs, role: CONTACT, email: Daniel.brungs@health.nsw.gov.au, geoPoint lat: -34.424, lon: 150.89345, hasResults: False
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protocolSection identificationModule nctId: NCT06349395, orgStudyIdInfo id: NisantasiU, briefTitle: The Effect of Mindfulness-Based Stress Reduction Training Before Mastectomy on Postoperative Pain in Early Period, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-06-29, completionDateStruct date: 2024-07-29, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Istanbul Nisantasi University, class: OTHER, descriptionModule briefSummary: This research aims to investigate the effect of mindfulness-based stress reduction training given before mastectomy on postoperative early period pain and the fear of movement caused by pain. According to the World Health Organization, 18.1 million new cancer diagnoses are made each year, with breast cancer being the most common type among women, accounting for 24.2% of all cancers diagnosed. In Turkey, the incidence of breast cancer was determined as 22,345 in 2018. Breast cancer significantly affects women's quality and length of life. Surgical intervention is the most commonly chosen treatment method for cases of localized breast cancer. Pain and limited movement are among the most common problems encountered after surgery. Non-pharmacological methods have been shown to be effective in pain management, with the mindfulness-based stress reduction technique being one of these methods. This technique is described as an effective treatment for conditions such as pain, depression, and addiction, with high levels of mindfulness being associated with greater self-esteem, optimism, and empathy, whereas low levels of mindfulness are linked to depression, anxiety, chronic pain, and acute pain., conditionsModule conditions: Pain Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2 parallel groups randomized controlled study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: MBSR surgical nursing care, outcomesModule primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: The Tampa Scale of Kinesiophobia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University - Cerrahpasa, status: RECRUITING, city: Istanbul, zip: 34160, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06349382, orgStudyIdInfo id: CALAS, briefTitle: CArbohydrate Loading in Aortic Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Belgrade, class: OTHER, descriptionModule briefSummary: The adverse effects of overnight fasting before surgery have been well-documented in the contemporary literature. Still, due to the possibility of pulmonary aspiration of gastric contents, many clinicians worldwide still employ this practice. On the other hand, the benefits of preoperative oral carbohydrate loading (OCHL) have been shown in various patient groups. Studies examining the usefulness of preoperative OCHL in aortic surgery are lacking. In particular, no randomized control trials have specifically examined the impact of preoperative OCHL on the postoperative course in patients undergoing open abdominal aortic surgery., conditionsModule conditions: Abdominal Aortic Aneurysm, conditions: Leriche Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to receive preoperative OCHL (the experimental group) or no intervention (the control group) in a 1:1 ratio. Randomization will be performed using computer-generated randomization codes, which will be held in sealed envelopes. Patients in the experimental group (OCHL group) will receive a high-carbohydrate beverage (12.6% carbohydrates, 50 kcal/100 mL, 285 mOsm/kg; PreOp®, Nutricia, Zoetermeer, The Netherlands) 800 mL on the evening before surgery (between 9 p.m. and 11 p.m.), and 400 mL 2 hours before the induction of anesthesia. Participants in the no-intervention (control) group will be fasted from midnight until surgery. All other aspects of perioperative patient care will be the same for all participants, as per the standardized Institutional protocol for the treatment of abdominal aortic aneurysms and Leriche Syndrome., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: carbohydrate-rich beverage, outcomesModule primaryOutcomes measure: The ICU length of stay, primaryOutcomes measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), primaryOutcomes measure: Insulin sensitivity index (HOMA-ISI), primaryOutcomes measure: Homeostasis model assessment of β-cell function (HOMA-β), primaryOutcomes measure: Six aspects of subjective well-being according to the visual analog scale, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: 30-day mortality rate, secondaryOutcomes measure: The incidence of local wound infections, secondaryOutcomes measure: The incidence of postoperative surgical complications, secondaryOutcomes measure: The incidence of postoperative non-surgical complications, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia, city: Belgrade, zip: 11000, country: Serbia, contacts name: Igor Koncar, MD, Ph.D., role: CONTACT, phone: +381668300290, email: dr.koncar@gmail.com, contacts name: Igor Koncar, MD, Ph.D., role: SUB_INVESTIGATOR, contacts name: Ksenija Jovanovic, MD, Ph.D., role: SUB_INVESTIGATOR, contacts name: Ranko Trailovic, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False
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protocolSection identificationModule nctId: NCT06349369, orgStudyIdInfo id: PG Thesis/2023-24/105, briefTitle: Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia, acronym: tDCS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-12-09, completionDateStruct date: 2026-04-09, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: All India Institute of Medical Sciences, Bhubaneswar, class: OTHER, descriptionModule briefSummary: The study is a randomized, double-blind, parallel-arm, sham-controlled trial that aims to compare the effects of transcranial direct current stimulation (tDCS) versus sham stimulation on inflammatory markers (IL-6 and TNF-alpha) and clinical outcomes (PANSS, AHRS, CGI-SCH, GAF) in patients with chronic schizophrenia over 10 days of treatment. The primary objective is to assess changes in IL-6 levels, while secondary objectives include evaluating changes in TNF-alpha, symptom scales, and adverse events. The study will be conducted at the psychiatry department of AIIMS Bhubaneswar, with 60 patients aged 18-60 years with moderate-to-severe schizophrenia symptoms randomized to receive either active tDCS (cathode over left temporo-parietal junction, anode over left dorsolateral prefrontal cortex) or sham stimulation. The researchers hope to elucidate the potential immunomodulatory effects of tDCS and its impact on symptoms in chronic schizophrenia, which may lead to more targeted, multifaceted interventions to improve patient outcomes., conditionsModule conditions: Chronic Schizophrenia, 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: 60, type: ESTIMATED, armsInterventionsModule interventions name: transcranial direct current stimulation, outcomesModule primaryOutcomes measure: Change in the IL-6 levels, secondaryOutcomes measure: Change in the TNF alpha levels., secondaryOutcomes measure: Change in the Positive and Negative syndrome Scale, secondaryOutcomes measure: Change in the Auditory hallucination rating scale, secondaryOutcomes measure: Change in the Clinical global impression- Schizophrenia scale, secondaryOutcomes measure: Change in the Global Assessment of Functioning scale, secondaryOutcomes measure: To compare the adverse events reported in both control and intervention groups., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: AIIMS Bhubaneswar, status: RECRUITING, city: Bhubaneswar, state: Odisha, zip: 751019, country: India, contacts name: Ashutosh Biswas, role: CONTACT, geoPoint lat: 20.27241, lon: 85.83385, hasResults: False
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protocolSection identificationModule nctId: NCT06349356, orgStudyIdInfo id: FDACSTIM0012023, secondaryIdInfos id: IRB00000533, type: OTHER, domain: WCG IRB, briefTitle: Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease", statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-28, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Quantel Medical, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of C.STIM, an intense pulsed light device to treat signs and symptoms of dry eye disease. The main question it aims to answer is:• Difference of the evolution of Tear Break-Up time (TBUT) between the 2 arms of the study (placebo and treated).Researchers will compare treated group and placebo to respond to the main question.Participants will assess to an inclusion visit (disease evaluation purpose) and then four IPL treatment visit to finish with the last visit (disease evaluation purpose)., conditionsModule conditions: Dry Eye Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: MULTI-CENTER, PROSPECTIVE, RANDOMIZED, SHAM-CONTROLLED, SUPERIORITY, NON-SIGNIFICANT RISK, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Intense pulsed light with C.STIM device, outcomesModule primaryOutcomes measure: Tear Break-Up Time evolution, secondaryOutcomes measure: dry eye signs and symptoms, secondaryOutcomes measure: dry eye signs and symptoms, secondaryOutcomes measure: dry eye signs and symptoms, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], secondaryOutcomes measure: Meibum quality, secondaryOutcomes measure: Meibum Expressibility, secondaryOutcomes measure: Use of artificial tear drops, secondaryOutcomes measure: Use of artificial tear drops, secondaryOutcomes measure: Glaucoma, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Visionary Consultants Inc., status: RECRUITING, city: Lexington, state: Kentucky, zip: 40517, country: United States, contacts name: Dr. KARPECKI, role: CONTACT, phone: 463-210-6618, email: karpecki@karpecki.com, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Triangle Eye Consultants, status: ACTIVE_NOT_RECRUITING, city: Raleigh, state: North Carolina, zip: 27617, country: United States, geoPoint lat: 35.7721, lon: -78.63861, locations facility: Toyos Clinic, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37215, country: United States, contacts name: Dr. TOYOS, role: CONTACT, phone: 615-327-4015, email: rostar80@gmail.com, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Eye Centers of Racine & Kenosha, status: RECRUITING, city: Kenosha, state: Wisconsin, zip: 53142, country: United States, contacts name: Dr SINGH, role: CONTACT, phone: 312-371-4335, email: ipsingh@amazingeye.com, geoPoint lat: 42.58474, lon: -87.82119, hasResults: False
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protocolSection identificationModule nctId: NCT06349343, orgStudyIdInfo id: UHCT230949, briefTitle: CD19/BCMA HLA-independent TCR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) human leukocyte antigen (HLA)-independent T cell receptor (TCR) -T therapy in refractory/moderate-to-severe systemic lupus erythematosus(SLE)., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: CD19/BCMA Hi-TCR-T cell therapy, outcomesModule primaryOutcomes measure: Safety and tolerability, secondaryOutcomes measure: Proportion of subjects with SRI-4 response, secondaryOutcomes measure: Changes in the Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from baseline, secondaryOutcomes measure: Changes in the BILAG-2004 score from baseline, secondaryOutcomes measure: Changes in the Physician Global Assessment (PGA) score from baseline, secondaryOutcomes measure: Pharmacokinetics (PK), secondaryOutcomes measure: Pharmacodynamics (PD), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349330, orgStudyIdInfo id: 2022/00908, briefTitle: The Immediate Effectiveness of a 3D Intraoral Scanner as an Oral Hygiene Educational Tool, acronym: 3D scanner, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-07, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: National University Hospital, Singapore, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled clinical trial is to compare the immediate effectiveness of 3D intra-oral scanners and standard oral hygiene instructions in improving the oral hygiene of 52 subjects. The main question\[s\] it aims to answer are:* Does a 3D intra-oral scanner facilitate the improvement of oral hygiene in subjects?* Does a 3D-rendered image of plaque-stained teeth confer better visualization to subjects?Prospective Open Cohort study: Patients referred to NUCOHS Periodontology Department will be invited to participate in the study. Included participants will be randomized into the 3D scanner (test) and standard oral hygiene (control) group. Subsequently, both groups will receive personalized oral hygiene instructions before brushing their teeth. The participants will receive plaque disclosing again to compare the differences between baseline and post-intervention.Routine periodontal parameters will be recorded at baseline and researchers will compare the percentage improvement in full mouth plaque scores to see if the test group performed better than the control group.A questionnaire will be given to subjects in the test and control group for qualitative analysis.The study will require 1 visit., conditionsModule conditions: Periodontal Diseases, conditions: Plaque Induced Gingival Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a parallel-arm randomized controlled trial and subjects are randomized into test and control groups via block randomization.To investigate the immediate effectiveness on the use of 3D intraoral scanner in the improvement of oral hygiene in two (2) parallel arm study with 52 subjects (n=52). The study will take place over 1 visit., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Test: 3D intra-oral scanner, interventions name: Control: Standard oral hygiene, outcomesModule primaryOutcomes measure: Full mouth plaque score (%), secondaryOutcomes measure: Patient's satisfaction of 3D scanner and standard oral hygiene group based on 5-point Likert Scale, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National University Hospital, Singapore, status: RECRUITING, city: Singapore, country: Singapore, contacts name: Xiao Tong, Jacinta Lu, BDS, role: CONTACT, phone: 6716 2233, email: jacinta_lu@nuhs.edu.sg, contacts name: Xiao Tong, Jacinta Lu, MDS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
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protocolSection identificationModule nctId: NCT06349317, orgStudyIdInfo id: 2024-005, briefTitle: Neoadjuvant IMRT Combined With Camrelizumab and Apatinib for Resectable HCC With PVTT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Yongyi Zeng, class: OTHER, descriptionModule briefSummary: This study is an open-label, single-arm prospective clinical trial that evaluates the efficacy and safety of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in the treatment of resectable hepatocellular carcinoma with portal vein tumor thrombus., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib, outcomesModule primaryOutcomes measure: 1-year Event-Free Survival (EFS) rate, secondaryOutcomes measure: Event-Free Survival (EFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease-Free Survival (DFS), secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: Overall Objective Response of primary liver tumor and PVTT, otherOutcomes measure: Surgical safety, otherOutcomes measure: Safety of radiotherapy, camrelizumab and apatinib treatment, otherOutcomes measure: Exploratory Endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349304, orgStudyIdInfo id: S25, briefTitle: Impact of Grape Powder Consumption on Eye Health and Glycemic Status in Singapore Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: National University of Singapore, class: OTHER, collaborators name: California Table Grape Commission, descriptionModule briefSummary: The purpose of this study is to understand the impacts of regular consumption of freeze-dried table grape powder on eye health and regulation of advanced glycation end products in Singapore older adults. The investigators hypothesize that regular consumption of freeze-dried table grape powder will promote improvements in eye health and lower levels of advanced glycation end products when compared to the placebo group., conditionsModule conditions: Macula; Degeneration, conditions: Aging, conditions: Advanced Glycation End Products, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Freeze-dried table grape powder, interventions name: Placebo grape powder, outcomesModule primaryOutcomes measure: Macular pigment optical density, primaryOutcomes measure: Visual acuity, primaryOutcomes measure: Photostress recovery time, primaryOutcomes measure: Visual function questionnaire 25, primaryOutcomes measure: Skin advanced glycation end products levels, primaryOutcomes measure: Dietary advanced glycation end products level, primaryOutcomes measure: Blood advanced glycation end products levels, primaryOutcomes measure: Contrast sensitivity, secondaryOutcomes measure: Concentration of tumour necrosis factor-α, secondaryOutcomes measure: Concentration of interleukin-6, secondaryOutcomes measure: Concentration of high-sensitivity C-reactive protein, secondaryOutcomes measure: Concentration of fasting blood glucose, secondaryOutcomes measure: Concentration of malondialdehyde, secondaryOutcomes measure: Concentration of 8-isoprostaglandin-F2α, secondaryOutcomes measure: Skin carotenoid status, secondaryOutcomes measure: Concentration of insulin, secondaryOutcomes measure: Percentage of glycated hemoglobin, otherOutcomes measure: Measurement of height, otherOutcomes measure: Measurement of blood pressure, otherOutcomes measure: Measurement of weight, otherOutcomes measure: Measurement of waist circumference, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349291, orgStudyIdInfo id: 0074-24-MMC, briefTitle: Venous Thrombosis After Removal of Central Venous Catheter, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Meir Medical Center, class: OTHER, descriptionModule briefSummary: Insertion of intravenous catheter is a very common operation in patients in the general intensive care unit. These catheters are used for a variety of purposes - administration of inotropics/pressors, intravenous nutrition, concentrated electrolytes and performing dialysis.There are several known complications of central venous catheter insertion, such as thrombosis and pulmonary embolism. In a literature review, there are no clear data regarding the rate of intravenous thrombosis in patients after removal of a central venous catheter. These findings are often discovered randomly, when the patient undergoes imaging for a different indication. There is no recommendation for an active search for intravenous thrombi at the catheter insertion sites in these patients, and it is not entirely clear whether it is mandatory to administer anticoagulant treatment in these patients if thrombi are randomly discovered at the catheter insertion sites.In this study, we aim to check the proportion of patients who developed thrombosis at the central catheter insertion sites after its removal, to check whether there are catheter insertion sites that are at a higher risk of developing thrombosis than other sites, and to check whether there are predictive characteristics for the development of this type of thrombosis., conditionsModule conditions: Thrombosis, Venous, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Detection of venous thrombosis via US, outcomesModule primaryOutcomes measure: Rate of DVT after removal of central venous catheter, 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: NCT06349278, orgStudyIdInfo id: 2024-7276, briefTitle: Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX, acronym: PDAC-LIV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2026-01-16, completionDateStruct date: 2029-01-16, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Laval University, class: OTHER, descriptionModule briefSummary: This is a prospective, pilot study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough, standard of care assessment for both pancreatic primary and liver metastases resectability with blood tumor markers (CEA, CA 19-9 and CA-125), triphasic CT-scan and liver magnetic resonance imaging (MRI), patients with resectable pancreatic ductal adenocarcinoma primary and three or less resectable liver metastases will be prospectively included in the study. PET-scan may be added to the investigation depending on CT-scan or MRI results to prove metastatic disease or rule out extrahepatic metastases. Patients will receive a total of 12 cycles of perioperative FOLFIRINOX (FFX), with first reassessment with triphasic CT-scan to monitor tumor response after the first six cycles. Every patient will receive at least 6 cycles of FFX before surgery. The remaining six cycles will be received either preoperatively or postoperatively, depending on patient tolerance and tumor response at reassessment. Patients with liver metastases only visible on MRI will also have liver MRI at reassessment, which is also standard of care. Patients with evidence of tumor response on both imaging using RECIST V.1.1 criteria (stable disease or partial response), and blood tumor markers (≥ 80% decrease and/or normalization of all tumor markers) will then undergo pancreatic resection, either distal pancreatectomy or pancreatoduodenectomy depending on tumor side, with liver metastases excision. Each case will be followed with blood tumor markers and CT-scan every three months for two years, and every four months afterwards or until recurrence, which is standard of care for patients with metastatic PDAC. For patients without evidence of tumor response on imaging, or \< 80% decrease of all tumor markers, the standard palliative systemic treatment will be continued., conditionsModule conditions: Pancreas Adenocarcinoma, conditions: Pancreas Metastases, conditions: Pancreas Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: One group will undergo intervention prospectively., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Pancreatic resection and non-anatomic liver resections., outcomesModule primaryOutcomes measure: Morbidity and mortality, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Québec, status: RECRUITING, city: Quebec City, state: Quebec, zip: G1R 2J6, country: Canada, contacts name: Alexandre Brind'Amour, role: CONTACT, phone: +14185254444, phoneExt: 15925, email: godonco@chudequebec.ca, contacts name: Jean-François Ouellet, MD, role: SUB_INVESTIGATOR, contacts name: Jean-François Berthin Ouellet, MD, role: SUB_INVESTIGATOR, contacts name: Isabelle Deshaies, MD, role: SUB_INVESTIGATOR, contacts name: Carl Daigle, MD, role: SUB_INVESTIGATOR, contacts name: Félix Couture, MD, role: SUB_INVESTIGATOR, contacts name: Maxime Chénard-Poirier, MD, role: SUB_INVESTIGATOR, contacts name: Anne-Julie Simard, role: SUB_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False
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protocolSection identificationModule nctId: NCT06349265, orgStudyIdInfo id: 02, briefTitle: Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-02, primaryCompletionDateStruct date: 2024-02-02, completionDateStruct date: 2024-03-02, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Kastamonu University, class: OTHER, descriptionModule briefSummary: This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models., conditionsModule conditions: Carpal Tunnel Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 33, type: ACTUAL, armsInterventionsModule interventions name: Carpal Tunnel Hydrodissection with %5 dextrose in water injection, outcomesModule primaryOutcomes measure: Visual Analogue Scale(VAS), secondaryOutcomes measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), secondaryOutcomes measure: Dolour Neuropathique en 4 Questions (DN4) questionnaire, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gamze Gül Güleç, city: Kastamonu, zip: 37150, country: Turkey, geoPoint lat: 41.37805, lon: 33.77528, hasResults: False
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protocolSection identificationModule nctId: NCT06349252, orgStudyIdInfo id: LUNGTNM, briefTitle: Survival Validation and Gene Mutations of N Descriptors in the Ninth Edition of the TNM Classification for Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: The International Association for the Study of Lung Cancer Staging Committee recently unveiled the ninth edition of TNM staging system for lung cancer. This study aims to explore survival outcomes, stage grouping, and gene mutations in N descriptors of this new classification system., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1263, type: ESTIMATED, armsInterventionsModule interventions name: Radical resection, outcomesModule primaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Chen Haiquan, MD, role: CONTACT, phone: +86-21 64175590, phoneExt: 1707, email: hqchen1@yahoo.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06349239, orgStudyIdInfo id: 24Hemato01, briefTitle: Oral Azacitidine Maintenance Post-CPX 351, acronym: ORAZ-351, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: Approximately 10% of patient develop AML after chemotherapy or radiation for unrelated disease (t-AML) and 20% have AML with an antecedent hematologic disorder (AML-MRC). CPX-351 (Vyxeos), a liposomal formulation of a fixed molar ratio (1:5) daunorubicin and cytarabine, has been approved for treatment of adults with newly diagnosed t-AML or AML-MRC. CPX-351 significantly improved median overall survival.Although induction chemotherapy results in remission in many older patients with AML, relapse is common and overall survival is poor. For patients not eligible for HSCT, maintenance therapies are needed to reduce the risk of relapse and prolong overall survival without causing undue adverse effects or compromising health-related quality of life. Oral azacitidine (ONUREG) has been approved by FDA on September, 2020, to treat adult patients with AML who achieved CR or CRi following intensive induction chemotherapy with or without consolidation and who are not able to complete intensive curative therapy (not candidate to HSCT).The use of oral azacitidine maintenance is an integral part of clinical practice for AML patients who have achieved a first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after intensive ""3+7"" induction chemotherapy and who are unable to complete intensive curative therapy.But there are few data on its efficacy as a post-CPX-351 maintenance agent in patients with newly diagnosed t-AML or AML-MRC or de novo AML.THe aim of this study is to show the improvement of overall survival with use of oral Azacitidine as maintenance for patients with de novo AML including t-AML or AML-MRC who achieved complete remission or complete remission with incomplete blood count recovery after CPX-351. Long-term product safety is also being studied, conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: overall survival, secondaryOutcomes measure: Safety and tolerance, eligibilityModule sex: ALL, minimumAge: 64 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Nice, status: RECRUITING, city: Nice, country: France, contacts name: CLUZEAU thomas, role: CONTACT, geoPoint lat: 43.70313, lon: 7.26608, hasResults: False
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protocolSection identificationModule nctId: NCT06349226, orgStudyIdInfo id: DISCOLAB, briefTitle: Identification of Biomarkers and Molecular Targets Involved on Intervertebral Disc Degeneration and Discogenic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-05-22, primaryCompletionDateStruct date: 2025-05-21, completionDateStruct date: 2025-05-21, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Low back pain, associated with intrinsic disorders of the spine, is a very frequent clinical condition that is accompanied by high morbidity with effects both on psychosocial aspects, and health care system. It occurs in approximately 80% of the population throughout their lives. Most low back pain is associated with intervertebral disc degeneration (IDD) associated with neuroinflammation and pain. In this context, the study of sphingolipid metabolism can play an important role in the identification of new molecules responsible for the degenerative process. Sphingolipids, in fact, are a class of molecules that are implicated in multiple signal pathways, such as proliferation, degradation of the extracellular matrix, inflammatory state, apoptosis and migration. In particular, sphingosine-1-phosphate (S1P), an intermediate of sphingolipid metabolism, acts as a pro-inflammatory mediator, predominantly in the extracellular environment, regulating important cellular properties related to inflammatory potential and pain. The objective of this study is to characterize the degenerative process in cells isolated from degenerated human intervertebral discs from both at cellular and molecular levels in order to identify new targets implicated in degenerative processes, including sphingolipid signaling pathway., conditionsModule conditions: Intervertebral Disc Degeneration, conditions: Discogenic Pain, conditions: Discogenic Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: cell isolation from intervertebral disc tissue and biomarker investigation, outcomesModule primaryOutcomes measure: Characterization of degenerated intervertebral disc cells, secondaryOutcomes measure: Development of cellular model platform, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, zip: 20122, country: Italy, contacts name: Giovanni Marfia, MD, Phd, role: CONTACT, phone: 0255035502, phoneExt: +39, email: giovanni.marfia@policlinico.mi.it, contacts name: Stefania E Navone, PhD, role: CONTACT, phone: 0255034268, phoneExt: +39, email: stefania.navone@policlinico.mi.it, contacts name: Mauro Pluderi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Giovanni Marfia, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Stefania E Navone, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Guarnaccia, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Begani, MSc, role: SUB_INVESTIGATOR, contacts name: Marco Locatelli, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Stefano Borsa, MD, role: SUB_INVESTIGATOR, contacts name: Giulio Bertani, MD, role: SUB_INVESTIGATOR, contacts name: Claudia Fanizzi, MD, role: SUB_INVESTIGATOR, contacts name: Giorgio Fiore, MD, role: SUB_INVESTIGATOR, contacts name: Luigi Schisano, MD, role: SUB_INVESTIGATOR, contacts name: Manuela Caroli, MD, role: SUB_INVESTIGATOR, contacts name: Antonella Ampollini, MD, role: SUB_INVESTIGATOR, contacts name: Elena Pirola, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06349213, orgStudyIdInfo id: C23-19, secondaryIdInfos id: 2023-A02263-42, type: OTHER, domain: Secondary ID, briefTitle: Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive Time, acronym: TIMES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2030-11-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Institut National de la Santé Et de la Recherche Médicale, France, class: OTHER_GOV, descriptionModule briefSummary: Time processing, the ability to process and encode temporal information, is essential for cognitive functioning and for a large number of daily life activities. In particular, the processing of durations of several seconds is central to cognition, impaired in several pathologies, and has been associated with cognitive changes with advancing age. While behavioral studies have been conducted to specify the neural bases of temporal cognition and their association with other cognitive functions, the mechanisms underlying age-related changes, and individual differences, remain unknown. The project will characterize ageing effects on timing mechanisms and their neural underpinnings. Building on recent advances from neuroscience and age-related cognitive changes, the project focuses on the precision of duration processing, that declines with age, and the associated neural bases. Participants will perform a duration judgement task while (a) electroencephalography, and (b) functional magnetic resonance imaging activity are simultaneously recorded to investigate age effects on structural and functional network connectivity. In addition, striatal dopamine will be measured using a FDOPA PETscan. Evaluation of other temporal cognition processes and general cognition will also be performed. This combination offers a unique opportunity to accurately specifying the neurophysiological underpinning of aging effects on time processing changes. This project will further our understanding of the variability of cognitive performance with advancing age, and contribute to identifying new measures of temporal impairments., conditionsModule conditions: Healthy Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: FDOPA injection before PET imaging, interventions name: Time perception tasks, interventions name: fMRI imaging, interventions name: EEG imaging, interventions name: 3 year follow-up, outcomesModule primaryOutcomes measure: EEG phase lag index differences between group, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349200, orgStudyIdInfo id: 3197, briefTitle: Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Dow University of Health Sciences, class: OTHER, descriptionModule briefSummary: Many patients suffer from dental anxiety and don't go to dentists for regular checkups. This can lead to the initiation and progression of dental caries, which, if not controlled at the right time, can lead to the loss of the tooth itself. Many forms of distraction have been used to overcome this; music is also one of them. The main objective of this study is to compare the effectiveness of binaural beats and 432 Hz music in reducing preoperative dental unease and anxiety among adult patients undergoing root canal treatment in a dental teaching hospital. The null hypothesis is that both binaural beats and 432 Hz-frequency music are not effective in reducing preoperative dental anxiety among patients undergoing routine endodontic therapy in a dental teaching hospital. A total of three groups will be a part of this study, with a total sample size of 99 participants (33 participants in each group). Group A will listen to 432 Hz music for 10 minutes before the procedure, Group B will listen to binaural beats for 10 minutes before the procedure; and Group C (active control group) will listen to white noise for 10 minutes before the procedure. The Visual Analog Scale for Anxiety will be used to assess the anxiety levels before local anesthesia administration, after local anesthesia administration, and 10 minutes after listening to sounds. Then root canal treatment will be completed as a routine procedure., conditionsModule conditions: Dental Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 99, type: ESTIMATED, armsInterventionsModule interventions name: 432 Hz music, interventions name: Binaural beats, interventions name: White noise, outcomesModule primaryOutcomes measure: Change in Pre-operative Dental Anxiety score using Visual Analog Scale for Anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dow University of Health Sciences, status: RECRUITING, city: Karachi, state: Sindh, zip: 74200, country: Pakistan, contacts name: Dr. Hafsa Zaki, role: CONTACT, phone: +923462746052, email: hafsazaki99@hotmail.com, contacts name: Dr. Shahbaz Ahmed, role: CONTACT, phone: +923212000873, email: saj119@googlemail.com, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06349187, orgStudyIdInfo id: dsc002, briefTitle: Digital Competencies of the Doctors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-05-10, completionDateStruct date: 2024-06-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Limited Liability Company "Docstarclub", class: OTHER, descriptionModule briefSummary: The role of digital technologies in healthcare is growing. Therefore, the roles and responsibilities of medical professionals are constantly changing and there is a need for continuous professional development. However, according to some authors, today's generation of doctors can be considered as "digital aborigines" \[Aungst, Patel, 2020\]. Low literacy in the field of e-health has become a major obstacle to digital transformation in developed countries, so digital skills training for healthcare professionals has gradually been introduced in the USA \[Adler-Milstein, et al., 2014\], Europe \[Schreiweis, et al., 2019\], Australia \[Evolution of eHealth in Australia, 2016\].The most common methodologies for determining a doctor's digital literacy level are HITCOMP and TIGER. In particular, HITCOMP includes 5 areas of expertise: administration, research/biomedicine, direct patient care, computer science, engineering/information systems/information and communication technologies, as well as several levels: basic, basic, intermediate, advanced, expert \[EU\*US eHealth Work Project, 2020\].However, in our opinion, the digital competence of a doctor is not only the ability to work at a computer and use software. The successful development of the digital world is preceded by some psychological and emotional processes.It all starts with digital trust, that is, with people's confidence in the reliability and security of digital systems, processes and technologies. Without the conviction that the implementation and active use of certain IT services will be useful and will not bring harm, the successful launch of such technologies will be impossible.Provided that there is digital trust, a person in his daily life gradually gets experience using various technologies: payments, appointments with specialists, purchases, etc. Thus, basic digital literacy appears in conjunction with the rules of behavior in the online space (digital culture). And only after that, having skills positively supported by experience, the doctor begins to master digital competencies in his workplace.Computerization and automation of the healthcare system began relatively recently, traditional (paper) document management in medicine is familiar to everyone, but not optimal from the point of view of system management. Therefore, universal digitalization is perceived as something artificially imposed, increasing the workload of doctors, distracting from their main work and shifting the focus from truly therapeutic activities to filling out documentation. As a result, doctors have a range of negative emotions: fear, annoyance, anxiety, despondency, refusal of further contacts, etc., which lead to an aggravation of emotional burnout. The ability to recognize and live through these states, to come to an inner balance, to accumulate an internal resource for further development of new technologies - all this is possible under the condition of the development of emotional intelligence. By developing so-called soft skills, the doctor will be emotionally stable, capable of further advancement and learning new skills, and will easily cope with temporary difficulties and setbacks.And the final stage, having gained the opportunity to overcome internal obstacles, the doctor is ready to begin mastering specialized digital skills directly related to medical activities: work in medical information systems, remote monitoring, artificial intelligence, medical decision support systems.The result of the development of a doctor within this model will be not only digital literacy, but also the development of an internally stable personality that easily overcomes any obstacles not only in training, but also in communication with patients and colleagues., conditionsModule conditions: Digital Competences, conditions: Emotional Intelligence, conditions: Emotional Burnout, conditions: Doctor Patient Relation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Interview, outcomesModule primaryOutcomes measure: Completing the survey, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349174, orgStudyIdInfo id: 2024-valve-1, briefTitle: Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: A Prospective Pilot Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: China-Japan Friendship Hospital, class: OTHER, descriptionModule briefSummary: The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?Participants will:undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery., conditionsModule conditions: Emphysema, conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: bronchoscopic lung volume reduction surgery using endobronchial valve, outcomesModule primaryOutcomes measure: Percentage change in FEV1 relative to baseline, secondaryOutcomes measure: Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators, secondaryOutcomes measure: Percentage change in RV relative to baseline, secondaryOutcomes measure: Percentage change in TLC relative to baseline, secondaryOutcomes measure: Percentage change in DLCO relative to baseline, secondaryOutcomes measure: Percentage change in SGRQ score relative to baseline, secondaryOutcomes measure: Percentage change in mMRC grade relative to baseline, secondaryOutcomes measure: Percentage change in 6MWD relative to baseline, secondaryOutcomes measure: the incidence of surgical-related adverse events, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China-Japan Friendship Hospital, city: BeiJing, state: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06349161, orgStudyIdInfo id: 1451_02/BVNTW-VNCSKTE, briefTitle: Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience, statusModule overallStatus: COMPLETED, startDateStruct date: 2011-05, primaryCompletionDateStruct date: 2013-06, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: National Children's Hospital, Vietnam, class: OTHER, descriptionModule briefSummary: Open surgical dismembered pyeloplasty has traditionally been the preferred method for treating ureteropelvic junction obstruction (UPJO), with a success rate exceeding 94%. However, it is associated with drawbacks such as increased postoperative pain, extended hospital stays, and visible scarring. Minimally invasive alternatives, including laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP), have gained popularity since their introduction in 1993, offering comparable success rates to open surgery while providing cosmetic benefits and shorter hospital stays. Nevertheless, these techniques present challenges in pediatric patients, including limited working space, technical complexities, and prolonged operative times. The retroperitoneoscopic one-trocar-assisted pyeloplasty (OTAP) method, introduced in 2007, combines the advantages of minimally invasive surgery with the success rates of standard dismembered pyeloplasty. Despite favorable outcomes reported by several researchers, comprehensive studies regarding long-term follow-up and clinical outcomes are lacking. This study aims to evaluate the long-term outcomes of OTAP, addressing this gap in the medical literature., conditionsModule conditions: Ureteropelvic Junction Obstruction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: One-trocar-assisted pyeloplasty, outcomesModule primaryOutcomes measure: Operative time, primaryOutcomes measure: Conversion to open, primaryOutcomes measure: Extension of skin incision, primaryOutcomes measure: Postoperative complications, primaryOutcomes measure: Median length of hospital stays, primaryOutcomes measure: Median follow up length, primaryOutcomes measure: Post-operative mean APD, primaryOutcomes measure: Post-operative mean DRF, primaryOutcomes measure: Mean incision length, primaryOutcomes measure: Recurrence, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: The National Hospital of Pediatrics, city: Hanoi, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, hasResults: False
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protocolSection identificationModule nctId: NCT06349148, orgStudyIdInfo id: NESTLE2022QN-0007, briefTitle: The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: SHUANGZHENGJIA, class: OTHER, descriptionModule briefSummary: The goal of this open-label randomized control trial is to study the effect of immunonutrition in locally advanced cervical cancer (LACC) with standard concurrent chemoradiotherapy. LACC patients undergoing radical synchronous chemoradiotherapy will be randomized into the experimental group receiving enteral immunonutrition therapy and the control group receiving standard enteral nutrition support.The main purpose it aims to answer are:1）Can immunonutrition therapy improve patients' dose-limiting toxicity(DLT) and DLT-free survival? 2）Can immunonutrition therapy improve patients' nutritional status and quality of life?, conditionsModule conditions: Cervical Cancers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: enteral immunonutrition, interventions name: standard oral enteral nutrition, outcomesModule primaryOutcomes measure: Dose-limiting toxicity, primaryOutcomes measure: DLT-free survival, secondaryOutcomes measure: compliance, secondaryOutcomes measure: Prevalence of malnutrition, secondaryOutcomes measure: Prevalence of sarcopenia, secondaryOutcomes measure: QoL (Quality of life), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: 2-year overall survival, secondaryOutcomes measure: 2-year progression-free survival, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital, Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijing, zip: 100021, country: China, contacts name: SHUANGZHENG JIA, PhD, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06349135, orgStudyIdInfo id: A.Ayman OMFS, briefTitle: Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Aya Ayman Ahmed, class: OTHER, descriptionModule briefSummary: Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures via Intraoral Versus Extraoral Approaches: Prospective Cohort Study, conditionsModule conditions: Mandibular Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2, type: ESTIMATED, armsInterventionsModule interventions name: Open Reduction & Internal Fixation, outcomesModule primaryOutcomes measure: IL-17, primaryOutcomes measure: OPG, secondaryOutcomes measure: Blood Loss, secondaryOutcomes measure: Operative time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06349122, orgStudyIdInfo id: 2023-509421-41-00, briefTitle: Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth, acronym: AUTOP2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Assistance Publique Hopitaux De Marseille, class: OTHER, descriptionModule briefSummary: Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis.The main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth.The hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%., conditionsModule conditions: Bacterial Vaginosis, conditions: Vaginal Dysbiosis, conditions: Premature Delivery, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1292, type: ESTIMATED, armsInterventionsModule interventions name: Vaginal flora abnormalities screening and quantification using molecular biology technique, interventions name: Azithromycine, interventions name: Ceftriaxone, interventions name: Metronidazole, interventions name: Clotrimazole, Vaginal, interventions name: Usual Care, outcomesModule primaryOutcomes measure: The rate of preterm birth, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06349109, orgStudyIdInfo id: PA-WPW, briefTitle: Physical Activity in Children With Wolff-Parkinson-White Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Karamanoğlu Mehmetbey University, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate the level of physical activity and its determinants in children with WPW., conditionsModule conditions: Wolff-Parkinson-White Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cardiopulmonary exercise test, interventions name: Atrial-Ventricular Strain Analysis, interventions name: Arterial Stiffness Measurement, interventions name: Physical Activity Level, interventions name: Physical Activity Barriers Assesment, outcomesModule primaryOutcomes measure: The Physical Activity Questionnaire for Older Children Score, secondaryOutcomes measure: VO2peak, secondaryOutcomes measure: aPWV, secondaryOutcomes measure: GLS, secondaryOutcomes measure: LASr, secondaryOutcomes measure: LASct, secondaryOutcomes measure: LAScd, secondaryOutcomes measure: Physical activity barriers (Parent) scale score, secondaryOutcomes measure: Physical Activity Outcome Expectancies (Child) scale score, secondaryOutcomes measure: Physical Activity Home Environment (Child) scale score, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Haluk Tekerlek, PhD, role: CONTACT, phone: +905355915009, email: haluktekerlek@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06349096, orgStudyIdInfo id: ALM-HAR-CLL-23-01, briefTitle: Safety And Efficacy Investigation Of The Effects Of ClearLift Q-Switched Nd:Yag 1064nm Laser Module In The Treatment Of Facial Skin Wrinkles, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Alma Lasers, class: INDUSTRY, descriptionModule briefSummary: Alma Lasers ClearLift is a fractional non-ablative Q-Switched laser, allowing practitioners to use the benefits of a high intensity QS laser for the treatment of aged skin. Alma Harmony ClearLift uses a fractional QS laser to achieve a deep mechanical effect beneath the epidermis via a photoacustic effect. This creates a controlled dermal wound while leaving the epidermis intact. The wound healing process stimulates growth of new collagen, skin contracture and tightening. This procedure is virtually painless with no downtime and is safe for all skin types.Based on this background, we have considered an interest to design a study aimed at assessing the efficacy and safety of a treatment course with ClearLift Module in patients with facial skin wrinkles, conditionsModule conditions: Facial Skin Wrinkles, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Alma Harmony, outcomesModule primaryOutcomes measure: Primary endpoint, secondaryOutcomes measure: Secondary endpoint, secondaryOutcomes measure: Secondary endpoint, secondaryOutcomes measure: Secondary endpoint, otherOutcomes measure: Safety & Tolerability, otherOutcomes measure: Safety & Tolerability, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: San Luca Medical Clinic, city: Tirana, country: Albania, contacts name: Arminda Avdulaj, MD, role: CONTACT, phone: 694488000, phoneExt: +355, email: avdulajarminda@gmail.com, contacts name: Arminda Avdulaj, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.3275, lon: 19.81889, hasResults: False
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protocolSection identificationModule nctId: NCT06349083, orgStudyIdInfo id: 23-01227, briefTitle: Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2029-01, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, interventions name: Inactive Placebo, interventions name: Supportive therapy sessions, outcomesModule primaryOutcomes measure: Percent change in the alcohol cue-induced Blood-oxygen-level dependent (BOLD) signal in the lateral prefrontal cortex (PFC), primaryOutcomes measure: Percent change in the alcohol cue-induced BOLD signal change in the caudate, primaryOutcomes measure: Percent change in alcohol cue-induced BOLD signal change in the ventromedial PFC (vmPFC), primaryOutcomes measure: Percent change in alcohol cue-induced BOLD signal change in the insula, primaryOutcomes measure: Percent change in negative affective cue-induced BOLD signal change in the dorsomedial PFC (dmPFC), primaryOutcomes measure: Percent change in negative affective cue-induced BOLD signal change in the supramarginal gyrus, primaryOutcomes measure: Percent change in negative affective cue-induced BOLD signal change in the amygdala, primaryOutcomes measure: Percent change in negative affective cue-induced BOLD signal change in the insula, primaryOutcomes measure: Percent change in alcohol cue-induced functional connectivity in prespecified regions of interest (ROI), primaryOutcomes measure: Percent change in negative affective cue-induced functional connectivity in prespecified regions of interest (ROI), primaryOutcomes measure: Percent change in the frequency of failed response inhibition, primaryOutcomes measure: Change in discounting rate (log(k)), primaryOutcomes measure: Change in number of set-shifting errors, primaryOutcomes measure: Average number of no heavy drinking days, primaryOutcomes measure: Change in phosphatidyl ethanol (PEth) blood levels, primaryOutcomes measure: Change in carbohydrate-deficient transferrin (CDT) blood levels, primaryOutcomes measure: Change in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score, primaryOutcomes measure: Change in PSQI global score, primaryOutcomes measure: Change in patient's self-assessed quality of life (by the SF-36 Questionnaire), primaryOutcomes measure: Change in Alcohol craving score, primaryOutcomes measure: Change in negative affect score, primaryOutcomes measure: Change in impulsivity score (Barratt impulsivity scale by the subscales and by the total score), secondaryOutcomes measure: Average number of no drinking days, secondaryOutcomes measure: Percentage of heavy drinking days, secondaryOutcomes measure: Average number of drinks per day, secondaryOutcomes measure: Percentage of abstinent days, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06349070, orgStudyIdInfo id: 23-00404, briefTitle: RESTORE - Phase II, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2027-01-30, completionDateStruct date: 2027-03-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity, 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies., conditionsModule conditions: Maternal Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The study is a hybrid type III implementation-effectiveness trial using a longitudinal cluster-randomized trial with a modified stepped wedge design. In Year 1, all 10 clinics start with the low touch strategy, followed by randomization of clinics in Year 2 to either low touch (5 clinics) or high touch (5 clinics), and finally in Year 3, all 10 clinics will transition to the high touch strategy. Starting in Year 2, we will enroll a subsample of subjects into the a prospective cohort of pregnant persons who will participate in surveys at baseline and postpartum., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: Low Touch - Text Messaging Implementation Strategy, interventions name: High Touch - Community Health Worker (CHW) Implementation Strategy, outcomesModule primaryOutcomes measure: Percent adoption of the program, secondaryOutcomes measure: Mean number of videos viewed, secondaryOutcomes measure: Mean number of sessions completed, secondaryOutcomes measure: Level of adherence, secondaryOutcomes measure: Adequacy of Prenatal Care Utilization Index Score, secondaryOutcomes measure: Number of postpartum follow-up visits attended, secondaryOutcomes measure: Number of subjects who had a pre-term delivery, secondaryOutcomes measure: Number of subjects with post-partum depression, secondaryOutcomes measure: Mean gestational weight gain, secondaryOutcomes measure: Percent sustainability (continued adoption) following the M-CHW implementation period, secondaryOutcomes measure: Program Costs, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYC Health + Hospitals/Bellevue, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: NYU Langone Health, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06349057, orgStudyIdInfo id: AnkaraCHBilkent.1, briefTitle: The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: Many drugs have anticholinergic activity. This means that it blocks the muscarinic binding of the neurotransmitter acetylcholine.In this study, the anticholinergic burden of the patients in the perioperative period will be calculated with the Anticholinergic Cognitive Burden Scale (ACBS) and patients with a score of 1 or above will be included in the study. Anticholinergic load of drugs used in the intraoperative period; Its effect on postoperative hospital stay, morbidity and mortality following elective heart surgery will be investigated., conditionsModule conditions: Mortality, conditions: Postoperative Complications, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: reducing anticholinergic burden, outcomesModule primaryOutcomes measure: Mortality, secondaryOutcomes measure: Effects on postoperative recovery, secondaryOutcomes measure: Effects on postoperative recovery, secondaryOutcomes measure: Postoperative complication, otherOutcomes measure: Length of stay in hospital and intensive care unit, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seda Kurtbeyoğlu, status: RECRUITING, city: Çankaya, state: Ankara, zip: 06800, country: Turkey, contacts name: Seda Kurtbeyoğlu, role: CONTACT, phone: +905388342776, email: kurtbeyogluseda@gmail.com, geoPoint lat: 39.9179, lon: 32.86268, hasResults: False
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protocolSection identificationModule nctId: NCT06349044, orgStudyIdInfo id: BASIMA, briefTitle: A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy/Stereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +/- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, descriptionModule briefSummary: Based on the interaction between radiation therapy and immunotherapy and the potential potentiation of Probio-M9 for the treatment of ICIs, this study is planned to design an integrated treatment protocol for the first-line treatment of advanced gastrointestinal tumors through the use of macrofractionated radiotherapy as a means of immune activation, combined with the synergistic effect of Probio-M9 microbial agents and PD-1 inhibitors., conditionsModule conditions: Gastroesophageal Junction Adenocarcinoma, conditions: Liver Cancer Stage IV, conditions: Biliary Tract Cancer, conditions: Pancreatic Adenocarcinoma, conditions: Colorectal Cancer, conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Hypofractionated radiotherapy/SBRT（5-8 Gy/fx，3-5 fx）, interventions name: Anti-PD-1 monoclonal antibody, interventions name: Oxaliplatin and Capecitabine, interventions name: Anti-VEGF 15mg/kg, interventions name: Anti-VEGF 7.5mg/kg, interventions name: Gemcitabine and Cisplatin, interventions name: Gemcitabine and Albumin paclitaxel, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: ORR, secondaryOutcomes measure: adverse effects rate, secondaryOutcomes measure: Qol, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: Qol, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhengjiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, contacts name: Ji Zhu, role: CONTACT, phone: 13501978674, email: zhuji@zjcc.org.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06349031, orgStudyIdInfo id: IEC/IMS.SH/SOA/2024/683, briefTitle: Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Institute of Medical Sciences and SUM Hospital, class: OTHER, descriptionModule briefSummary: Childhood constipation is a common but serious gastrointestinal disorder prevalent worldwide. In 90-95% of children, it is of functional origin. Thirty to seventy-five percent of children with functional constipation also have fecal impaction. The treatment strategy for functional constipation includes fecal disimpaction and maintenance therapy to ensure regular bowel movements.Polyethylene glycol (PEG) based laxatives have been recommended as the first-line therapeutic agents. The commonly used formulations are PEG 3350 with a molecular weight between 3200- 3700 g/mol and PEG 4000 with molecular weight of 4000 g/mol. Both are shown to be effective in pediatric constipation management in placebo-controlled trials. PEG 3350 + Electrolyte (E) is more widely used than PEG 4000 for the management of constipation. This might be because of the perception that PEG 3350 + E is safer in terms of preventing electrolyte imbalance. However, because of the inclusion of electrolytes, PEG 3350+ E solution taste saltier than PEG 4000. Many patients struggle to tolerate the unpleasant taste resulting in the high incidence of non-compliance. To date, no pediatric trials have compared PEG 4000 versus PEG 3350+E for management of Fecal disimpaction.Present study has been planned to evaluate the efficacy \& tolerability of PEG 4000 versus PEG 3350+ E for fecal disimpaction in pediatric functional constipation. Patients between age 1-16 years having functional constipation (as per ROME IV criteria) with fecal impaction will be included. Subjects will be randomly assigned to either PEG 4000 or PEG 3350+E at a ratio of 1:1. They will be stratified into 3 different age groups: 1-5 years, 6-11 years, and 12-16 years. They will receive either of the PEG solutions (as per allocation) at a dose of 1.5 gm/kg/day for 6 consecutive days or till the resolution of fecal impaction whichever is earlier. The resolution of fecal impaction is defined as the passage of clear liquid stool and the disappearance of palpable abdominal fecolith.Primary outcome is defined as the proportion of subjects achieving fecal disimpaction in each arm.Secondary outcomes are defined as follows:1. Total no of Days required to achieve fecal disimpaction in each arm2. Cumulative dose of PEG required for fecal disimpaction in each arm3. Proportion of subjects (\> 5 years age) reporting palatability issues in each arm4. Proportion of subjects discontinuing the treatment due to palatability issues in each arm, conditionsModule conditions: Functional Constipation, conditions: Fecal Impaction, conditions: Constipation - Functional, conditions: Constipation Chronic Idiopathic, conditions: Pediatric Functional Constipation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: One member of the research group will do the treatment allocation and will not be involved in clinical evaluation and collection of outcome data. Both study medications will be provided by him/her in opaque bottles with identical packaging and labeling. Neither the participants nor the rest of the study personnel will be aware of the treatment allocation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Administration of Polyethylene Glycol (PEG) 4000 as per treatment allocation to participants, interventions name: Administration of Polyethylene Glycol (PEG) 3350 + Electrolyte as per treatment allocation to participants, outcomesModule primaryOutcomes measure: Proportion of subjects achieving fecal disimpaction in Each Arm, secondaryOutcomes measure: Total no of Days required to achieve fecal disimpaction in each arm, secondaryOutcomes measure: Cumulative PEG dose required for fecal disimpaction in each arm, secondaryOutcomes measure: Proportion of subjects reporting palatability issues in each arm, secondaryOutcomes measure: Proportion of subjects discontinuing the treatment due to palatability issues in each arm, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute of Medical Sciences (IMS) and SUM Hospital, city: Bhubaneswar, state: Odisha, zip: 751003, country: India, contacts name: Kalpana Panda, MD, DM, role: CONTACT, phone: 91-9717133189, email: drkalpanapanda@gmail.com, contacts name: J Bikrant kumar Prusty, MD, role: CONTACT, phone: 91-9090205041, email: princejammy142@gmail.com, contacts name: Mrutunjay Dash, MD, role: SUB_INVESTIGATOR, contacts name: Basudev Biswal, MD, role: SUB_INVESTIGATOR, contacts name: Mamta Devi Mohanty, MD, role: SUB_INVESTIGATOR, contacts name: Prasant Saboth, MD, role: SUB_INVESTIGATOR, geoPoint lat: 20.27241, lon: 85.83385, hasResults: False
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protocolSection identificationModule nctId: NCT06349018, orgStudyIdInfo id: IRB-2023-972, briefTitle: Effects of Isotonic Beetroot Supplementation on Sprint Interval Exercise Performance, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Nanyang Technological University, class: OTHER, descriptionModule briefSummary: This study aims to examine the effects of dietary nitrate supplementation via beetroot juice on sprint interval cycling exercise performance. Twenty-four participants (male or female) will undertake a randomized, crossover trial where they consume either (i) an isotonic beetroot juice drink containing nitrate (12.9 mmol) for 5 days or (ii) an isotonic sports drink (no nitrate) for 5 days. On Day 5 of each trial, participants will come to the laboratory and 2 hours after consuming their allocated drink will complete a 6 bouts of sprint interval exercise. Power output during cycling will be measured as the primary outcome measure. Salivary and plasma measures of nitrate and nitrite will be taken over the course of the morning on Day 5. After a 5-day washout period participants will crossover and begin their second trial., conditionsModule conditions: Exercise Performance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Both isotonic drinks (high nitrate or no nitrate) are deidentified and labelled (coded) by a third party not involved with the research. Randomization and allocation are completed by a third party not involved in the testing., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Dietary Supplement: High nitrate isotonic drink, interventions name: Dietary Supplement: No nitrate isotonic drink, outcomesModule primaryOutcomes measure: Power output during maximal sprint cycling, secondaryOutcomes measure: Salivary nitrate, secondaryOutcomes measure: Plasma nitrate and nitrite, secondaryOutcomes measure: Muscle oxygenation, secondaryOutcomes measure: Sensory evaluation (Acceptance and Preference Test Evaluation by Meilgaard et al 2007), secondaryOutcomes measure: Stroop test, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University, status: RECRUITING, city: Singapore, zip: 637616, country: Singapore, contacts name: Stephen Burns, PhD, role: CONTACT, phone: 65 67903354, email: stephen.burns@nie.edu.sg, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
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protocolSection identificationModule nctId: NCT06349005, orgStudyIdInfo id: 111, briefTitle: Laryngoscopy and Coronary Artery Bypass Graft Surgery, acronym: VL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Konya Meram State Hospital, class: OTHER, descriptionModule briefSummary: In this prospective, randomized, controlled trial, the purpose is to compare Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope in terms of hemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG)., conditionsModule conditions: Videolaryngoscopy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Tracheal intubation using Storz VL, interventions name: Tracheal intubation using Macintosh laryngoscopy, interventions name: Tracheal intubation using MacGrath VL, interventions name: Tracheal intubation using EzVision VL, outcomesModule primaryOutcomes measure: Hemodynamic response, primaryOutcomes measure: Hemodynamic response, secondaryOutcomes measure: Intubation time, secondaryOutcomes measure: Visualization of the glottis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Betul Kozanhan, city: Konya, zip: 42005, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06348992, orgStudyIdInfo id: HMUDQ20240318001, briefTitle: ACT Combined Yoga for Parental Burnout in Parents With Autistic Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Harbin Medical University, class: OTHER, descriptionModule briefSummary: OBJECTIVE: To explore the intervention effect of ACT combined with a yoga intervention program on parenting burnout in parents with ASD.METHODS: This study used a combination of qualitative research and quantitative analysis to examine the intervention effects of an ACT-centered intervention program on parenting burnout in parents of children with ASD, and to clarify the evaluations and perceptions of parents with ASD about the research program through qualitative research.RESULTS AND CONCLUSION: To clarify the intervention effect of ACT combined with yoga intervention program on parenting burnout of ASD parents., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Acceptance commitment therapy and yoga, interventions name: Active Comparator: Mental Health Education Group, outcomesModule primaryOutcomes measure: Measuring parental Burnout Levels, primaryOutcomes measure: Measuring parenting stress Levels, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System adult profile-57, PROMIS-57, secondaryOutcomes measure: Medical Outcomes Study 36-Item Short-Form Health Survey, MOS SF-36, secondaryOutcomes measure: Acceptance and Action Questionnaire-II, AAQ-II, secondaryOutcomes measure: Cognitive Fusion Questionnaire，CFQ-F, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Harbin Medical University Hospital, status: RECRUITING, city: Daqing, state: None Selected, zip: 043300, country: China, contacts name: Jiayi Chen, Master, role: CONTACT, phone: 15765962070, email: cjy071949@163.com, geoPoint lat: 46.58333, lon: 125.0, hasResults: False
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protocolSection identificationModule nctId: NCT06348979, orgStudyIdInfo id: CEBD 5/2021, briefTitle: Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area., conditionsModule conditions: Dental Caries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ACTUAL, armsInterventionsModule interventions name: Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns, interventions name: all ceramic Endocrowns (emax), outcomesModule primaryOutcomes measure: clinical Fracture, secondaryOutcomes measure: clinical performance marginal adaptation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 38 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06348966, orgStudyIdInfo id: predictors of readmission, briefTitle: Predictors of Hospital Readmission for Chronic Obstructive Pulmonary Disease Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This study is aimed to determine the risk factors for hospital readmission within 6 months in COPD patients, conditionsModule conditions: Hospital Radmission for COPD Patients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 188, type: ESTIMATED, outcomesModule primaryOutcomes measure: assessment of potential predictors of readmission among COPD patients, secondaryOutcomes measure: development of early warning model for hospital readmission in COPD patients, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348953, orgStudyIdInfo id: Bioactive restorative system, briefTitle: Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This research study delves into the effectiveness of bioactive and non-bioactive restorative systems in deep carious permanent molars treated with selective caries removal. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue. The study investigates how the choice of restorative material influences the outcomes of selective caries removal procedures in deep carious lesions. By assessing factors such as restoration integrity, pulpal response, and long-term success rates, the research seeks to provide evidence-based insights into the comparative performance of bioactive and non-bioactive restorative systems in this clinical context., conditionsModule conditions: Dental Caries, conditions: Dental Diseases, conditions: Deep Caries, conditions: Tooth Diseases, conditions: Tooth Decay, conditions: Teeth; Lesion, conditions: Caries; Dentin, conditions: Dental Restoration Failure of Marginal Integrity, conditions: Tooth Demineralization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: selective caries removal and conventional non-bioactive restorative system, interventions name: selective caries removal and bioactive restorative system, outcomesModule primaryOutcomes measure: Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5, secondaryOutcomes measure: Functional properties - fracture&retention-marginal adaptation-Radiographic Examination"when applicable"-Scoring system Ordinal 1-5, secondaryOutcomes measure: Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5), secondaryOutcomes measure: Success or Failure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06348940, orgStudyIdInfo id: 83242392, briefTitle: Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-12, primaryCompletionDateStruct date: 2024-06-12, completionDateStruct date: 2024-06-12, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Anhui Medical University, class: OTHER, descriptionModule briefSummary: The majority of cancer patients experience varying degrees of psychological distress and physical symptoms due to the presence of cancer or the process of treatment. These symptoms are closely associated with inflammatory markers and patient prognosis, highlighting the urgent need for effective psychological intervention methods. Behavioral activation, an emerging psychological intervention approach, requires further investigation regarding its potential in alleviating negative emotions among cancer patients. Therefore, the investigators conducted a randomized controlled trial (RCT) to investigate whether (1) behavioral activation can ameliorate negative emotions and physical symptoms in cancer patients; (2) behavioral activation can contribute to improved survival outcomes for these patients; and (3) behavioral activation can enhance NLR levels and other clinical indicators among individuals with cancer.The investigators aimed to recruit a total of 390 cancer patients, comprising 170 individuals diagnosed with esophageal and gastric cancer, 100 individuals with colorectal cancer, and 120 individuals with lung cancer. These patients were recruited from the Department of Oncology at the Second Affiliated Hospital of Anhui Medical University between March 2023 and November 2023. They were randomly allocated into two groups: an intervention group (behavioral activation+care as usual, BA+CAU) and a control group (care as usual, CAU). The intervention group underwent an eight-week behavioral activation program (see Detailed Description) designed to promote engagement in meaningful activities that are physically and emotionally rewarding while reducing involvement in maladaptive emotional cycles. Both the intervention group and the control group received standard care along with conventional treatment for their respective cancers.This study aims to demonstrate the significant efficacy of behavioral activation in improving negative emotions, somatic symptoms, quality of life, and clinical inflammatory indicators among cancer patients. Furthermore, it may potentially enhance patient survival rates, thereby offering a novel approach for psychological intervention in cancer patients and contributing to multidisciplinary treatment and management strategies. The intervention measures employed in this study do not involve any pharmacological treatments or hazardous activities. For illiterate or less educated patients, the informed consent process and questionnaire collection will be conducted using methods that ensure their full comprehension (e.g., verbal explanations, visual aids). Additionally, patients with evident cognitive impairments were excluded from the study.The investigators have implemented a questionnaire system on the WJX website (https://www.wjx.cn/) to collect patient information through both paper and electronic questionnaires. The psychological measurement questionnaires are stored electronically, while socio-demographic data and clinical indicators are collected in the hospital's medical record management system. Subsequently, all data is summarized and saved in local Excel files and SPSS files for specialized analysis by data analysts. Patient names are anonymized within the database, ensuring strict confidentiality of personal information such as contact details and home address.Possible statistical methods include descriptive statistical analysis, generalized estimating equation or repeated measures analysis of variance, structural equation modeling, correlation analysis and regression, survival analysis, etc., conditionsModule conditions: Cancer Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 390, type: ESTIMATED, armsInterventionsModule interventions name: behavioral activation, outcomesModule primaryOutcomes measure: Sociodemographic data, primaryOutcomes measure: Status of Tumor, primaryOutcomes measure: Body Mass Index, BMI, primaryOutcomes measure: Biochemical index, primaryOutcomes measure: Blood Pressure, BP, primaryOutcomes measure: Nutritional Risk Screening, NRS, primaryOutcomes measure: Visual Analogue Scale, VAS, primaryOutcomes measure: Karnofsky Performance Status Scale, KPS, primaryOutcomes measure: Psychological Distress Thermometer (DT), primaryOutcomes measure: Hospital anxiety and depression scale (HADS), primaryOutcomes measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), primaryOutcomes measure: Pittsburgh sleep quality index (PSQI), primaryOutcomes measure: Revised Piper Fatigue Scale (PFS-R), primaryOutcomes measure: International physical activity questionnaire (IPAQ), primaryOutcomes measure: Brief Resilient Coping Scale (BRCS), primaryOutcomes measure: Multidimensional Scale of Perceived Social Support (MSPSS), primaryOutcomes measure: General Self-Efficacy Scale (GSES), primaryOutcomes measure: The activation subscale of Behavioral Activation for Depression Scale (BADS-A), primaryOutcomes measure: Social Impact Scale (SIS), primaryOutcomes measure: Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF), primaryOutcomes measure: The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog), primaryOutcomes measure: Time of Progression-free survival (PFS), primaryOutcomes measure: Time of Time to progression (TTP), primaryOutcomes measure: Concentration of C-reactive protein (CRP), primaryOutcomes measure: Value of Neutrophils to lymphocytes ratio (NLR), primaryOutcomes measure: Value of Platelet-lymphocyte ratio (PLR), primaryOutcomes measure: Value of Monocyte-lymphocyte ratio (MLR), primaryOutcomes measure: Value of Systemic immune inflammation index (SII), primaryOutcomes measure: Value of Pan-immune inflammation value (PIV), primaryOutcomes measure: Concentration of Carcinoembryonic antigen (CEA), primaryOutcomes measure: Concentration of Carbohydrate antigen 19-9 (CA19-9), primaryOutcomes measure: Concentration of Carbohydrate antigen 72-4 (CA72-4), primaryOutcomes measure: Concentration of Neuron-specific enolase (NSE), primaryOutcomes measure: Concentration of Squamous cell carcinoma associated antigen (SCC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Affiliated Hospital of Anhui Medical University, city: Hefei, state: Anhui, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
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protocolSection identificationModule nctId: NCT06348927, orgStudyIdInfo id: DZ2023EI004, briefTitle: Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC, acronym: WUKONG-32, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Hunan Province Tumor Hospital, class: OTHER, descriptionModule briefSummary: This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.Condition or disease Intervention/treatment Phase Non-Small Cell Lung Cancer Drug: sunvozertinib Drug: anlotinib Phase 2, conditionsModule conditions: Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: sunvozertinib in combination with Anlotinib, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Adverse events (AEs) according to CTCAE 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 410013, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06348914, orgStudyIdInfo id: 6991, briefTitle: Knowledge of Vital Pulp Therapy in Permanent Teeth Among a Group of Dental Students in Egypt, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-10, primaryCompletionDateStruct date: 2024-11-10, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Conducting this questionnaire will help in collecting information about the extent of knowledge of vital pulp therapy in permanent teeth among dental students in Egypt. This will aid in identifying the knowledge gap, interest, and challenges regarding utilization of vital pulp therapy in permanent teeth., conditionsModule conditions: Vital Pulp Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 323, type: ESTIMATED, armsInterventionsModule interventions name: Knowledge assessment, interventions name: Educational Material, outcomesModule primaryOutcomes measure: Knowledge of vital pulp therapy, secondaryOutcomes measure: Knowledge after awareness about vital pulp therapy, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348901, orgStudyIdInfo id: 2021-09-001, briefTitle: Clinical Utility of Oxford Cognitive Screen Test to Screen Cognitive Impairment in Post Stroke Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Bundang CHA Hospital, class: OTHER, descriptionModule briefSummary: The goal of this type of study: clinical trial is to assess K-OCS clinical utility in participant population. The main aims:validate the reliability and validity of the Korean version of the Oxford Cognitive Screen (K-OCS) analyze its sensitivity, specificity, and diagnostic accuracy, and compare its examination participation rates with existing assessment tools to determine the effectiveness of K-OCS in detecting post-stroke cognitive impairment., conditionsModule conditions: Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Measurement of K-OCS, secondaryOutcomes measure: Measurement of Korean version of mini-mental state examination (K-MMSE), secondaryOutcomes measure: Measurement Korean Version of the Oxford cognitive screen (K-OCS), secondaryOutcomes measure: Measurement of national institute of health care stroke scale (NIHSS), secondaryOutcomes measure: Measurement of fuctional independence meausure (FIM), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center, status: RECRUITING, city: Seongnam-si, state: Gyeonggi-do, zip: 13496, country: Korea, Republic of, contacts name: Eunyoung Cho, role: CONTACT, phone: +82-10-2753-0285, email: a220242@chamc.co.kr, geoPoint lat: 37.43861, lon: 127.13778, hasResults: False
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protocolSection identificationModule nctId: NCT06348888, orgStudyIdInfo id: 22250, briefTitle: A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, 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 EGFR and 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 with people who have 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.BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced.The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' bloodThe study will have 2 treatment groups.In Group 1, participants will take:* BAY2927088 as a single dose on Days 1 and 8.* Itraconazole once daily on Days 5 to 11.In Group 2, participants will take:* BAY2927088 as a single dose on Days 1 and 14.* Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2.Participants will visit the study clinic:* at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study* on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2* once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check upDuring the study, the doctors and their study team will:* perform physical examinations* collect blood samples from the participants to measure the levels 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 having An adverse event is any medical problem that a participant has during a study. The 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: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: BAY2927088, interventions name: Itraconazole, interventions name: Carbamazepine, outcomesModule primaryOutcomes measure: AUC of BAY2927088 with and without itraconazole, primaryOutcomes measure: Cmax of BAY2927088 with and without itraconazole, primaryOutcomes measure: AUC of BAY2927088 with and without carbamazepine, primaryOutcomes measure: Cmax of BAY2927088 with and without carbamazepine, secondaryOutcomes measure: Number of participants with TEAEs, secondaryOutcomes measure: Severity of TEAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348875, orgStudyIdInfo id: CLN-PLAN-102v1, briefTitle: Clinical Evaluation of Radiation Reduction for Optimized Safety, acronym: CERROS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Angiowave Imaging, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques., conditionsModule conditions: Coronary Artery Disease, conditions: Myocardial Infarction, conditions: Coronary Disease, conditions: Coronary Stenosis, conditions: Angina Pectoris, conditions: Chest Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Segment-level percent diameter stenosis (%DS), secondaryOutcomes measure: Stenosis severity, secondaryOutcomes measure: Diagnostic quality, secondaryOutcomes measure: Radiation dose - SOC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Corewell Health West, city: Grand Rapids, state: Michigan, zip: 49503, country: United States, contacts name: Ryan Madder, MD, role: CONTACT, phone: 616-391-4327, email: Ryan.Madder@corewellhealth.org, contacts name: Timothy Joseph, MD, role: CONTACT, phone: 616-391-4327, email: stacie.vanoosterhout@corewellhealth.org, contacts name: Ryan Madder, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Timothy Joseph, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.96336, lon: -85.66809, hasResults: False
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protocolSection identificationModule nctId: NCT06348862, orgStudyIdInfo id: 323/REC/2023, briefTitle: Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Al-Quds University, class: OTHER, descriptionModule briefSummary: The aim of the current study is to analyze the effect of listening to Quran or music or natural sounds on anxiety and stress level among patients undergoing MRI., conditionsModule conditions: Anxiety, conditions: Stress, conditions: MRI Contrast Media Adverse Reaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Double blinded, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Listening to either Quran, Music, and or Natural sound, outcomesModule primaryOutcomes measure: Level of Anxiety among patients who underwent MRI, primaryOutcomes measure: Level of Stress, secondaryOutcomes measure: Sociodemographic, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06348849, orgStudyIdInfo id: 0797-11/2023, briefTitle: The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: The aim of the current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy., conditionsModule conditions: Molar Incisor Hypomineralization, conditions: Hypersensitivity, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, outcomesModule primaryOutcomes measure: Desensitising effect in hypersensitive MIH molars, secondaryOutcomes measure: Change in the plaque index scores, secondaryOutcomes measure: Change in children's frequency of toothbrushing, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348836, orgStudyIdInfo id: 2123624-1/2, briefTitle: The Effects of Open Chain Versus Closed Chain Strengthening on Dynamic Valgus During a Step Down Test, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Alvernia University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the effects of different exercises programs in individuals with abnormal knee motion. The main question it aims to answer are:* In individuals with abnormal knee motion and without knee pain, does a weight-bearing exercise program reduce abnormal knee motion during a step-down test better than a non weight-bearing exercise program? Participants will* Perform a stepdown test while undergoing motion analysis and electromyograph (EMG) recording.* Participants will then be placed either into a weight-bearing or non weight-bearing exercise group. Exercises will be performed 3 times per week for 6 weeks.* Further motion analysis and EMG data will be collected to test for differences. Researchers will compare individual results before and after exercise, and between-group results before and after exercise to see if one exercise program helps improved abnormal knee motion more than the other., conditionsModule conditions: Dynamic Knee Valgus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to either a closed-chain (weightbearing) exercise group or an open-chain (non-weightbearing) exercise group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Electromyographic activity of gluteus medius muscle during step-down test, primaryOutcomes measure: Electromyographic activity of quadriceps muscle during step-down test, primaryOutcomes measure: Electromyographic activity of hamstring muscles during step-down test, secondaryOutcomes measure: Amount of dynamic knee valgus during step-down test measured with motion analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alvernia University, status: RECRUITING, city: Reading, state: Pennsylvania, zip: 19607, country: United States, contacts name: James M O'Donohue, DPT, role: CONTACT, phone: 610-334-1162, email: jim@odfamily.com, geoPoint lat: 40.33565, lon: -75.92687, hasResults: False
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protocolSection identificationModule nctId: NCT06348823, orgStudyIdInfo id: BritishUE, briefTitle: Relationship Between Soft Tissue Volume and Gingival Phenotype: A Novel Classification System, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, collaborators name: British University In Egypt, descriptionModule briefSummary: Different classifications to describe alveolar ridge defects have been published over the past years but no single classification has been developed concerning soft tissue volume around teeth or dental implants. Moreover, while several studies investigated the effect of various augmentation techniques and materials on soft tissue volume change and volume stability there is a real gap of knowledge regarding how to evaluate the available soft tissue volume and when to consider it sufficient or deficient which would definitely improve clinical decision making and treatment planing. Therefore, our primary aim was to assess the application of a novel classification system based on the correlation between buccal soft tissue volume and gingival biotypes and, also to assess the sensitivity of such novel method., conditionsModule conditions: Gingival Biotype, conditions: Soft Tissue, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: volume survey, outcomesModule primaryOutcomes measure: soft tissue volume - biotype correlation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ahmed Hamdy, status: RECRUITING, city: Cairo, zip: 11234, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06348810, orgStudyIdInfo id: DTT2024, briefTitle: Dual-Task Training for People With Mild Cognitive Impairment and Mild Dementia, acronym: DTT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Taipei Medical University, class: OTHER, descriptionModule briefSummary: Evidence shows that people with dementia have a higher prevalence of sleep disturbance, cognitive decline, behavioral disturbance, and experience motor dysfunction. These symptoms are interrelated. However, few randomized controlled trial (RCT) studies implement dual-task training for mild cognitive impairment and mild dementia, especially for those who experience sleep problems and behavioral disturbances.Therefore, this study aims to analyze the effect of dual-task training in improving global cognitive function, executive function, working memory, sleep, behavioral disturbances, balance, and flexibility among people with mild cognitive impairment and mild dementia.The main questions it aims to answer are:1. . Does dual-task training affect primary outcomes (global cognitive function, executive function, and working memory)2. . Does dual-task training affect secondary outcomes (including sleep quality, behavioral disturbances, balance, and flexibility) for people with mild cognitive impairment and mild dementia?"The length of dual-task training is 6 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 18. While the control group receives the usual care. Researchers will compare the experiment and control groups to see the effect of the dual-task training., conditionsModule conditions: Dementia, conditions: Mild Cognitive Impairment, conditions: Older Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: eksperimental group receive dual-task training, while control group receive usual care and both conduct at the same time, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Outcomes Assessor will be blind, so they didnt know which is intervention group or control group, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dual-task training, interventions name: Usual care, outcomesModule primaryOutcomes measure: Global cognitive function, primaryOutcomes measure: Executive function, primaryOutcomes measure: Working memory, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Behavioral disturbance, secondaryOutcomes measure: Balance, secondaryOutcomes measure: Flexibility, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nursing Home, city: Malang, state: Jawa Timur, zip: 65216, country: Indonesia, contacts name: Nur Aini, MSc, role: CONTACT, phone: +6285234727354, email: d432110003@tmu.edu.tw, geoPoint lat: -7.9797, lon: 112.6304, hasResults: False
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protocolSection identificationModule nctId: NCT06348797, orgStudyIdInfo id: BHP01-01, briefTitle: Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Sichuan University, class: OTHER, collaborators name: Chengdu Brilliant Pharmaceutical Co., Ltd., descriptionModule briefSummary: A study to evaluate the safety and feasibility of α-PD-L1/4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with/without bridge radiotherapy., conditionsModule conditions: Small Cell Lung Cancer Extensive Stage, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: α-PD-L1/4-1BB DLL3 CAR-T (BHP01), outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Overall-Survival (OS), secondaryOutcomes measure: CAR-T cell numbers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348784, orgStudyIdInfo id: 11, briefTitle: Screening for Ovarian Malignancy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-01-01, completionDateStruct date: 2023-01-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ain Shams Maternity Hospital, class: OTHER, descriptionModule briefSummary: Ovarian cancer is the second most common gynecologic malignancy. In 2008, it was the seventh leading cause of cancer deaths in women worldwide. Estimating the risk of malignancy is essential in the management of adnexal masses and several mathematical models and scoring systems have been developed to be used for discrimination between benign and malignant adnexal masses. Knowledge of the specific type of adnexal pathology before surgery is likely to improve patient triage with high accuracy, and it also makes it possible to optimize treatment. The correct identification of stage I cancer is particularly important, conditionsModule conditions: Early Detection of Ovarian Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Assesment of Different NEoplasias in the adenexa model, interventions name: Risk of malignancy index, interventions name: Histopathologic examination, outcomesModule primaryOutcomes measure: Sensitivity, specificity, positive predictive, and negative predictive value of Assessment of Different NEoplasias in the adneXa model for differentiating between benign and malignant ovarian tumors, eligibilityModule sex: FEMALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AinShams university maternity hospital, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06348771, orgStudyIdInfo id: Pro2023001579, briefTitle: Postprandial Inflammation and Nuts (PIN) in Older Adults, acronym: PIN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Rutgers, The State University of New Jersey, class: OTHER, descriptionModule briefSummary: The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice, but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain and inflammation. Given these findings, this study will examine the postprandial effects of meals with 2 levels of saturated fatty acids (SFA) on metabolic endotoxemia, inflammation and satiety, using a randomized cross-over design. The low SFA meal includes peanuts that are high in monounsaturated fatty acids (MUFA) and this will be compared to a high SFA meal. The results of this study have the potential to provide valuable insights into the role of peanuts in promoting health and preventing disease in at-risk older adults., conditionsModule conditions: Healthy Aging, conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Higher SFA meal vs higher MUFA (nut) meal in individuals with overweight and obese, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: monounsaturated fatty acids (MUFA) peanut meal, outcomesModule primaryOutcomes measure: Concentration of Endotoxin, primaryOutcomes measure: Concentration of Interleukin-6, secondaryOutcomes measure: Concentration of Glucose and Insulin, secondaryOutcomes measure: Concentration of Triglyceride, secondaryOutcomes measure: Appetite, secondaryOutcomes measure: Concentration of Inflammatory markers, otherOutcomes measure: Concentration of zonulin, otherOutcomes measure: Lipid Profile, otherOutcomes measure: Characterization of the Microbiome, otherOutcomes measure: Concentration of incretin hormones, otherOutcomes measure: Concentration of Bone regulating markers, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Foran Hall, status: RECRUITING, city: New Brunswick, state: New Jersey, zip: 08901, country: United States, contacts name: Sue Shapses, PhD, role: CONTACT, phone: 848-932-9403, email: shapses@rutgers.edu, contacts name: Rebecca Serrano, RD MPH, role: CONTACT, phone: 848-932-9403, email: rcjs@cinj.rutgers.edu, geoPoint lat: 40.48622, lon: -74.45182, locations facility: Rutgers University - NJ Inst Food Nutrition & Health, status: RECRUITING, city: New Brunswick, state: New Jersey, zip: 08901, country: United States, contacts name: Sue A Shapses, role: CONTACT, phone: 848-932-9403, email: shapses@rutgers.edu, geoPoint lat: 40.48622, lon: -74.45182, hasResults: False
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protocolSection identificationModule nctId: NCT06348758, orgStudyIdInfo id: KAP towards AI, briefTitle: Knowledge, Attitudes, And Perceptions of a Group of Egyptian Dental Students Towards Artificial Intelligence, acronym: AIKnowledge, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-11, primaryCompletionDateStruct date: 2024-06-07, completionDateStruct date: 2024-08-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: In the context of this ongoing AI revolution, it is essential to ensure that current and future clinical practitioners are up to date regarding this technology's current state and potential. It is valuable to assess the current attitude of clinical dentists and undergraduate students in dentistry regarding the future role of AI.To the best of the author's knowledge, there is no study about Egyptian dental students' views and attitudes regarding the application of AI in dental practice. Therefore, this study aimed to evaluate the attitudes and perceptions of a group of dental students in Egypt towards AI., conditionsModule conditions: Health Knowledge, Attitudes, Practice, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 384, type: ESTIMATED, armsInterventionsModule interventions name: questionnaire, outcomesModule primaryOutcomes measure: knowledge, attitudes, and perceptions about artificial intelligence in Dentistry, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University- Faculty of Dentistry, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06348745, orgStudyIdInfo id: diaphragmatic ultrasound, briefTitle: Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: * Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.* Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function.* Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator., conditionsModule conditions: Diaphragm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: ultrasound, outcomesModule primaryOutcomes measure: diaphragmatic function, secondaryOutcomes measure: pulmonary function ., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06348732, orgStudyIdInfo id: biomarkers in cardiomyopathy, briefTitle: Diagnostic and Prognostic Role of Troponin and Brain Natriuretic Peptide in Pediatric Patients With Cardiomyopathy in Correlation to Echocardiography Findings, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This study aims to assess the the role of cardiac biomarkers (troponin and ProBNP) in pediatric Patients with all types of cardiomyopathy in correlation with echocardiography findings ., conditionsModule conditions: Cardiomyopathies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 65, type: ESTIMATED, outcomesModule primaryOutcomes measure: Diagnostic and Prognostic Role of Troponin and Pro BNP in Pediatric Patients with Cardiomyopathy in correlation to Echocardiography findings ., eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348719, orgStudyIdInfo id: 35RC21_9732_ROBOT-ECO-GYN, briefTitle: Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer., acronym: ROBOT-ECO-GYN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-10, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Rennes University Hospital, class: OTHER, descriptionModule briefSummary: The standard treatment for endometrial cancer is surgery, as long as the stage of the disease and the patient's condition allow. It consists of hysterectomy (TSH) with bilateral adnexectomy. The recommended surgical approach is the minimally invasive or laparoscopic route, whose oncological safety has been demonstrated by the LAP2 study.Since 2010 and the arrival of robotic surgery in gynaecology, the robot-assisted laparoscopic approach has gradually been used for endometrial cancer Hysterectomy.Several studies have suggested that the cost and effectiveness of laparoscopy may vary according to the age and body mass index of the patient.The investigators therefore hypothesise that robot-assisted laparoscopy may be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France.The investigators therefore hypothesise that robot-assisted laparoscopy could be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France. The investigators will also test the efficiency of the surgical technique as a function of age and Body mass Index., conditionsModule conditions: Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: As part of this project, we are proposing an original approach by combining a randomized controlled trial with a prospective observational cohort and a retrospective cohort.This research will therefore consist of 3 complementary studies :A multicenter, parallel-group, open-label, randomized controlled superiority trial (ratio 1:1) comparing two groups:* Group 1: laparoscopic robot-assisted hysterectomy* Group 2: conventional laparoscopic hysterectomy A prospective cohort based on the randomized controlled trial A retrospective cohort, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 1680, type: ESTIMATED, armsInterventionsModule interventions name: Robot-assisted laparoscopy, interventions name: conventional laparoscopy, interventions name: Prospective cohort study, interventions name: Retrospective cohort study, interventions name: information and consent, interventions name: randomization, interventions name: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence, interventions name: Surgical data collection, interventions name: Biological data collection, interventions name: Collection of histological data from the surgical specimen, interventions name: Phone calls, interventions name: Pain assessment, interventions name: Collect of data on non-reimbursed transport, interventions name: Collect of everyday help, interventions name: Collection of the business resumption date, interventions name: SF36 questionnaire, interventions name: Questionnaire EQ5D-5L, interventions name: FIGO Stadium, interventions name: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.), interventions name: Collection of adjuvant treatments, interventions name: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one, interventions name: Collection of data, outcomesModule primaryOutcomes measure: Cost-utility ratio expressed in terms of costs / QALY, secondaryOutcomes measure: Operating time, secondaryOutcomes measure: Conversion rate, secondaryOutcomes measure: Rate and nature of intraoperative complications, secondaryOutcomes measure: Post-operative complication rate and nature at D42 (Clavien-Dindo classification), secondaryOutcomes measure: Post-operative complication rate and nature at M6 (Clavien-Dindo classification), secondaryOutcomes measure: Volume of intraoperative blood loss, secondaryOutcomes measure: Number of RBC, FFP, PC transfused during hospital stay, secondaryOutcomes measure: Visual analogue scale (VAS) of pain 6h after surgery, secondaryOutcomes measure: Visual analogue scale (VAS) of pain 24h after surgery, secondaryOutcomes measure: Visual analogue scale (VAS) of pain D3 after surgery, secondaryOutcomes measure: Analgesic consumption at D1 after surgery, secondaryOutcomes measure: Analgesic consumption at D3 after surgery, secondaryOutcomes measure: Analgesic consumption at D7 after surgery, secondaryOutcomes measure: Analgesic consumption at D42 after surgery, secondaryOutcomes measure: EQ-5D-5L at inclusion after surgery, secondaryOutcomes measure: EQ-5D-5L at D1 after surgery, secondaryOutcomes measure: EQ-5D-5L at D3 after surgery, secondaryOutcomes measure: EQ-5D-5L at D7 after surgery, secondaryOutcomes measure: EQ-5D-5L at D14 after surgery, secondaryOutcomes measure: EQ-5D-5L at D21 after surgery, secondaryOutcomes measure: EQ-5D-5L at D42 after surgery, secondaryOutcomes measure: EQ-5D-5L at M3 after surgery, secondaryOutcomes measure: EQ-5D-5L at M6 after surgery, secondaryOutcomes measure: SF-36 at baseline after surgery, secondaryOutcomes measure: SF-36 at D3 after surgery, secondaryOutcomes measure: SF-36 at D7 after surgery, secondaryOutcomes measure: SF-36 at D42 after surgery, secondaryOutcomes measure: SF-36 at M6 after surgery, secondaryOutcomes measure: Consumption of care: average length of hospital stay, secondaryOutcomes measure: Consumption of care: average of number of re-hospitalizations,, secondaryOutcomes measure: Consumption of care: average of emergency room visits, secondaryOutcomes measure: Consumption of care: average of number of gynecologist consultations, secondaryOutcomes measure: Consumption of care: quantity of analgesic(s), secondaryOutcomes measure: Consumption of care:, secondaryOutcomes measure: Consumption of care: average of number of work stoppage(s)., secondaryOutcomes measure: Time to initiate adjuvant treatment when indicated, secondaryOutcomes measure: Vital status at 6 months, secondaryOutcomes measure: Gas recovery time, secondaryOutcomes measure: QALYs from a collective perspective at D42, secondaryOutcomes measure: QALYs from a collective perspective at M6., secondaryOutcomes measure: Number of patients who underwent each approach, secondaryOutcomes measure: QALYs and average costs in relation to care consumption of patients included in the prospective cohort and in the randomized controlled trial according to the approach used and subgroups defined by age (<or> to 75 years) and BMI <or> to 30 kg/m2)., secondaryOutcomes measure: Surgical teams' perception of the benefits and limitations of robotic surgery in this indication, as well as perceived barriers and levers to the deployment of robot-assisted surgery in low- or intermediate-risk endometrial cancer., secondaryOutcomes measure: Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale, secondaryOutcomes measure: Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX, secondaryOutcomes measure: Total annual costs of the foreseeable spread of robot-assisted surgery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Lille, Hôpital Jeanne de Flandre, city: Lille, zip: 59000, country: France, contacts name: Yohan Kerbage, role: CONTACT, geoPoint lat: 50.63297, lon: 3.05858, locations facility: CHU LIMOGES, Hôpital Mère-Enfant, city: Limoges, zip: 87042, country: France, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Hôpital Lariboisière/Hôpital Saint Louis, city: Paris, zip: 75010, country: France, contacts name: Cyrille Huchon, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Cochin, city: Paris, zip: 75014, country: France, contacts name: Bruno Borghese, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Européen Georges Pompidou, city: Paris, zip: 75015, country: France, contacts name: Henri Azaïs, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Bichat, city: Paris, zip: 75018, country: France, contacts name: Martin Koskas, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Tenon AP-HP, city: Paris, zip: 75020, country: France, contacts name: Yohann Dabi, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Pitié Salpêtrière, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Lyon Sud - Hospices Civils de Lyon, city: Pierre-Bénite, zip: 69495, country: France, contacts name: Pierre-Adrien Bolze, role: CONTACT, geoPoint lat: 45.7009, lon: 4.82511, locations facility: Hôpital privé des côtes d'Armor, city: Plerin, zip: 22190, country: France, contacts name: Isabelle Jaffré, role: CONTACT, geoPoint lat: 48.54249, lon: -2.77983, locations facility: CHU de Rennes, Hôpital Sud, city: Rennes, zip: 35200, country: France, contacts name: Vincent Lavoue, role: CONTACT, geoPoint lat: 48.11198, lon: -1.67429, locations facility: CHU de Rouen, city: Rouen, zip: 76031, country: France, contacts name: Morgane Perrin, role: CONTACT, geoPoint lat: 49.44313, lon: 1.09932, locations facility: CHU de Saint Etienne, city: Saint Etienne, zip: 42055, country: France, contacts name: Céline Chauleur, role: CONTACT, geoPoint lat: 45.43389, lon: 4.39, locations facility: CHU de Strasbourg - Hôpital de Hautepierre, city: Strasbourg, zip: 67200, country: France, geoPoint lat: 48.58392, lon: 7.74553, locations facility: CHU de Tours - Hôpital Bretonneau, city: Tours, zip: 37044, country: France, contacts name: Lobna OULDAMER, role: CONTACT, geoPoint lat: 47.38333, lon: 0.68333, hasResults: False
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protocolSection identificationModule nctId: NCT06348706, orgStudyIdInfo id: Ain Shams University25032024, briefTitle: Effect of Dipeptidyl Peptidase- 4 Inhibitors on Non-Alcoholic Steatohepatitis and Type 1 Diabetes, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-10, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2024-01-15, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Background: Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD) that can precipitate to advanced fibrosis and leads to cardiovascular morbidity and mortality. Many patients with type 1 diabetes mellitus (T1DM) had histological evidence of steatosis and met the histological criteria for NASH. Matrix metalloproteinase-14 (MMP-14) is a type 1 transmembrane proteinase expressed in liver fibrosis and is involved in the development of atherosclerosis and cardiovascular disease. Hepatic dipeptidyl peptidase-4 (DPP-4) expression in NAFLD may be directly associated with hepatic lipogenesis and liver injury. Some studies showed the beneficial effect of dipeptidyl peptidase-4 (DDP-4) inhibitors in NAFLD/NASH for their role in improving hepatic glucose metabolism. Vildagliptin, a DPP-4 inhibitor, could be promising therapeutic agents for NAFLD/NASH.To the best of our knowledge, no previous study assessed the role of DPP-4 inhibitors in adolescent patients with T1DM and NASH.Objectives: This randomized-controlled clinical trial assessed the impact of the oral DPP-4 inhibitor, vildagliptin, as an add-on therapy on NASH in adolescents with T1DM as well as its effect on glycemic control, lipid profile, MMP-14 levels and CIMT as a marker for subclinical atherosclerosis.Methods: This study included 60 adolescents with T1DM and NASH with a mean age 15.6 ± 2.08 years and disease duration ≥ 5 years. Forty age- and sex-matched healthy subjects with a mean age 14.9 ± 3.2 years were enrolled as healthy controls to compare MMP-14 levels. T1DM patients were randomly assigned to receive oral vildagliptin (50 mg daily) with lunch meal for six months or not. Fasting and 2 hours post-prandial blood glucose levels, HbA1c, liver function tests, fasting lipid profile, hepatic steatosis index and triglyceride glucose (TyG) index were assessed. MMP-14 levels were measured by enzyme-linked immunosorbent assay among all patients and healthy controls. CIMT was assessed using Doppler ultrasound and transient elastography with controlled attenuation parameter (CAP) was performed to assess liver stiffness and steatosis stage., conditionsModule conditions: Diabetes Mellitus, Type 1, conditions: NASH, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Dipeptidyl peptidase 4 (DPP-4) inhibitor, outcomesModule primaryOutcomes measure: Number of participants with treatment-related effect on NASH status in adolescents with type 1 diabetes mellitus, secondaryOutcomes measure: Number of participants with treatment-related Matrix metalloproteinase-14 (MMP-14) level change, secondaryOutcomes measure: Number of participants with treatment-related Glycemic control (HbA1c%) level change, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Nancy Elbarbary, city: Cairo, zip: 11361, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06348693, orgStudyIdInfo id: Gliotherapy, briefTitle: Development of Therapeutic Approaches Modulating Molecular Targets Implicated on Cancer Stem Cell-related Aggressiveness, statusModule overallStatus: RECRUITING, startDateStruct date: 2017-04-19, primaryCompletionDateStruct date: 2025-11-21, completionDateStruct date: 2025-11-21, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Experimental evidence suggests that cancer stem cells (CSCs) may play a key role in the malignancy of these tumors. In fact, due to the hypoxic tumor microenvironment, these cells are able to create compensatory pathways that confer stem-like, angiogenic and pro-tumoral functions. Furthermore, it has been demonstrated that brain tumor stem cells are radio- and chemo-resistant and therefore not treatable with the therapeutic protocols currently in use. To date, in fact, there are no definitive treatments for the eradication of brain tumors. In this scenario, sphingolips, a class of lipid deputized to several physiological functions, are also involved in tumor onset, progression, drug resistance, and aggressiveness. In hypoxic tumor microenvironment, CSCs present a modified rheostat in the metabolism of sphingolipid, in favor of Sphingosine-1-phosphate (S1P).S1P is an intermediate of sphingolipid metabolism, formed from sphingosine through the action of sphingosine kinases (SK). Increasing evidence suggests that S1P acts as a tumor-promoting signal, predominantly in the extracellular environment, regulating important cellular properties correlated with tumor potential.The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment., conditionsModule conditions: Glioblastoma, conditions: Glioma, conditions: Glioma Glioblastoma Multiforme, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: cell isolation from tumor biopsies and biomarker investigation, outcomesModule primaryOutcomes measure: Investigation of molecular and metabolic signature of cancer stem cells to assess specific markers related to gliomagenesis and cancerogenesis., secondaryOutcomes measure: Biomarker investigation, secondaryOutcomes measure: Cellular response to pharmacological treatments, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, zip: 20122, country: Italy, contacts name: Stefania E Navone, PhD, role: CONTACT, phone: 0255034268, phoneExt: +39, email: stefania.navone@policlinico.mi.it, contacts name: Giovanni Marfia, MD, PhD, role: CONTACT, phone: 0255034268, phoneExt: +39, email: giovanni.marfia@policlinico.mi.it, contacts name: Stefania Navone, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Giovanni Marfia, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Guarnaccia, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Begani, MSc, role: SUB_INVESTIGATOR, contacts name: Marco Locatelli, Md, PhD, role: SUB_INVESTIGATOR, contacts name: Claudia Fanizzi, MD, role: SUB_INVESTIGATOR, contacts name: Luigi Schisano, MD, role: SUB_INVESTIGATOR, contacts name: Antonella Ampollini, MD, role: SUB_INVESTIGATOR, contacts name: Manuela Caroli, MD, role: SUB_INVESTIGATOR, contacts name: Giulio Bertani, MD, role: SUB_INVESTIGATOR, contacts name: Giorgio Fiore, MD, role: SUB_INVESTIGATOR, contacts name: Antonio D Ammando, MD, role: SUB_INVESTIGATOR, contacts name: Elena Scagliotti, MSc, role: SUB_INVESTIGATOR, contacts name: Giorgia Abete Fornara, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06348680, orgStudyIdInfo id: AmasyaU-betuluzun-004, briefTitle: The Effect of Video-assisted Episiotomy Repair Training on Anxiety and Self-efficacy Levels in Midwifery Students, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-04-05, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Amasya University, class: OTHER, descriptionModule briefSummary: The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training., conditionsModule conditions: Episiotomy Wound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 31, type: ESTIMATED, armsInterventionsModule interventions name: Video assisted episiotomy repair training, outcomesModule primaryOutcomes measure: State Anxiety Scale, primaryOutcomes measure: Episiotomy Skills Self-Efficacy Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06348667, orgStudyIdInfo id: 3184794, briefTitle: Effects of a Short- and Long-term 'Blackboard' Intervention on Ankle Stability in Older Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-06-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to assess the effectiveness of adding specific Blackboard Training (BB) exercises to conventional physiotherapy in improving foot and ankle parameters essential for fall prevention among older adults.The main questions it aims to answer are:1. Can the addition of BB exercises improve ankle dorsiflexion mobility?2. Can the addition of BB exercises enhance single-leg stability and control of mediolateral displacement of the center of pressure?Participants will be divided into control and intervention groups. Both groups will receive their usual conventional physiotherapy exercises. The intervention group will undergo a 5-week program comprising 10 sessions of BB exercises targeting ankle mobility and balance.Participants will be asked to:* Perform 3 sets of 15 repetitions for assisted ankle dorsiflexion mobility.* Engage in 5 rounds of 40-second balance exercises using the BB.Researchers will compare the intervention group's outcomes with those of the control group to determine the effectiveness of adding BB exercises in improving foot and ankle parameters related to fall prevention., conditionsModule conditions: Fall, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Specific ankle stability exercises, interventions name: Conventional physiotherapy exercises program, outcomesModule primaryOutcomes measure: Foot and ankle pain, primaryOutcomes measure: Foot and ankle strength, primaryOutcomes measure: Foot and ankle ROM, primaryOutcomes measure: Ankle dorsiflexion under load, primaryOutcomes measure: Center of pressures variations (anteroposterior and mediolateral center of pressure displacement, velocity, and total surface), primaryOutcomes measure: Monopodal stability, primaryOutcomes measure: Functional stability, eligibilityModule sex: ALL, minimumAge: 75 Years, maximumAge: 95 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rodrigo Martin-San Agustin, status: RECRUITING, city: Valencia, country: Spain, contacts name: Rodrigo Martin-San Agustin, role: CONTACT, phone: +34 963 983 853, email: rodrigo.martin@uv.es, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06348654, orgStudyIdInfo id: 6392, briefTitle: New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer, acronym: InPERSON, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The goal of the InPerson study is to employ all resources in a digital listening platform to benefit the quality of life of patients (QoL) with advanced HER2-negative breast cancer.The care pathway of patients with this type of disease represents an optimal setting for the implementation of an innovative narrative medicine pathway that, aided by integrative therapies, aims to support and accompain them in their treatment journey with a continuum of care. Moreover, the narrative medicine platform will implement the actual "static" way to define QoL with the classic Patient-Reported Outcomes (PROs) questionnaires, that reflect the patient status at a certain time point and not as a dinamic entity. It is on the basis of these assumptions that the present application project on the use of the DNMLAB digital narrative diary in the oncology department of the Fondazione Policlinico Gemelli was born., conditionsModule conditions: Breast Cancer, conditions: Narrative Medicine, conditions: HER2-negative Breast Cancer, conditions: Patient Satisfaction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: introduction of digital listening may improve the quality of life of patients withe breast cancer, outcomesModule primaryOutcomes measure: Standardized quality-of-life measurement, primaryOutcomes measure: Perceived quality of life, primaryOutcomes measure: Personalization of the care pathway, primaryOutcomes measure: Quality of the patient-physician relationship., secondaryOutcomes measure: Interaction between multidisciplinary teams, secondaryOutcomes measure: Patient involvement and compliance in the care pathway, secondaryOutcomes measure: lifestyles best suited to positively affect quality of life, secondaryOutcomes measure: Awareness of disease condition, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348641, orgStudyIdInfo id: 2011-KAEK-25 2022/12-11, briefTitle: Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-04-20, completionDateStruct date: 2025-04-20, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Nurgül Tekin, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn.This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups.Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist.The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant.The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines., conditionsModule conditions: Pain, conditions: Retinopathy of Prematurity, conditions: Premature Baby 26 to 32 Weeks, conditions: Premature Baby 33 to 36 Weeks, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: baby massage, outcomesModule primaryOutcomes measure: Pain during examination for retinopathy of prematurity, secondaryOutcomes measure: Comfort during retinopathy of prematurity examination, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 40 Days, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348628, orgStudyIdInfo id: P/38/04/2021, briefTitle: Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-05-31, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Madunil Anuk Niriella, class: OTHER, descriptionModule briefSummary: The goal of this study is to assess if motivational counselling works to reduce the weight in participants with Non Alcoholic Fatty Liver Disease (NAFLD)., conditionsModule conditions: Non-Alcoholic Fatty Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 231, type: ACTUAL, armsInterventionsModule interventions name: Motivational Interview, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in weight after 1 year compared to baseline, primaryOutcomes measure: Change in Aspartate aminotransferase (AST) level and Alanine aminotransferase (ALT) level after 1 year compared to baseline, primaryOutcomes measure: Change in platelet count after 1 year compared to baseline, primaryOutcomes measure: Change in waist circumference and hip circumference after 1 year compared to baseline, primaryOutcomes measure: Change in total fat percentage and visceral fat percentage after 1 year compared to baseline, secondaryOutcomes measure: Change in motivation for weight loss after 1 year compared to baseline, secondaryOutcomes measure: Change in depression, anxiety and stress after 1 year compared to baseline, secondaryOutcomes measure: Change in quality of life after 1 year compared to baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, University of Kelaniya, city: Ragama, state: Western Province, zip: 11010, country: Sri Lanka, geoPoint lat: 7.0292, lon: 79.917, hasResults: False
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protocolSection identificationModule nctId: NCT06348615, orgStudyIdInfo id: DEFBODY, briefTitle: Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medical Device, acronym: DEFBODY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2024-04-23, completionDateStruct date: 2024-06-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: ICIM International S.r.l. a socio unico, class: INDUSTRY, descriptionModule briefSummary: Post-marketing clinical study conducted on a CE medical device, named Defense Body, cellulite treatment, edematous fibrosclerotic panniculopathy (2nd and 3rd stage pathology), reducing draining cream-gel, to verify its effectiveness and tolerability on a panel of 56 subjects females affected by 2nd and 3rd degree PEF. The effectiveness of the device is measured in terms of reduction in thigh circumference, improvement in the appearance of the skin with reduction of the orange peel appearance and improvement in skin smoothness., conditionsModule conditions: Cellulite, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Anti-cellulite cream-gel Medical Device (DEFBODY), outcomesModule primaryOutcomes measure: First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments, primaryOutcomes measure: First day of study initiation: BMI, primaryOutcomes measure: First day of study initiation: Measurement of waist circumference, hip circumference and thigh circumference, primaryOutcomes measure: First day of study initiation: digital photographs of the area to be treated, primaryOutcomes measure: First day of study initiation: skin profilemetry of the thigh, primaryOutcomes measure: First day of study initiation: pinch test, secondaryOutcomes measure: After 28 days of treatment: recording of any concomitant pharmacological treatments that have occurred., secondaryOutcomes measure: After 28 days of treatment: BMI, secondaryOutcomes measure: After 28 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference, secondaryOutcomes measure: After 28 days of treatment: digital photographs of the area to be treated, secondaryOutcomes measure: After 28 days of treatment: skin profilemetry of the thigh, secondaryOutcomes measure: After 28 days of treatment: pinch test, secondaryOutcomes measure: After 28 days of treatment: AE or AED or Drop-off, secondaryOutcomes measure: After 28 days of treatment: satisfaction evaluation and compliance, secondaryOutcomes measure: After 56 days of treatment: recording of any concomitant pharmacological treatments that have occurred., secondaryOutcomes measure: After 56 days of treatment: BMI, secondaryOutcomes measure: After 56 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference, secondaryOutcomes measure: After 56 days of treatment: digital photographs of the area to be treated, secondaryOutcomes measure: After 56 days of treatment: skin profilemetry of the thigh, secondaryOutcomes measure: After 56 days of treatment: pinch test, secondaryOutcomes measure: After 56 days of treatment: AE or AED or Drop-off, secondaryOutcomes measure: After 56 days of treatment: evaluation of compliance, secondaryOutcomes measure: After 56 days of treatment: overall rating of product satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dermatology Unit - I.R.C.C.S. Ospedale San Raffaele, status: RECRUITING, city: Milano, country: Italy, contacts name: Santo Raffaele Mercuri, role: CONTACT, contacts name: Vittoria Giulia Bianchi, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06348602, orgStudyIdInfo id: PI23-00201, briefTitle: Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Hospital Universitario Dr. Jose E. Gonzalez, class: OTHER, descriptionModule briefSummary: Chronic GVHD (cGVHD) is a predominant cause of mortality and disability not related to relapse; it occurs in 30 to 70% of patients. The majority of patients with cGVHD present with ocular involvement with a reported incidence of 40-60%. Symptoms can range from mild dry eye syndrome to severe epithelial defects that can generate corneal perforation and loss of vision. The most accepted pharmacological modality is the topical application of cyclosporine A; on the other hand, tacrolimus has shown greater immunosuppressive power when used in ocular GVHD. However, this effectiveness is limited since by the time the manifestations appear, there is already permanent damage to the lacrimal gland due to the lymphocytic infiltration; so it is necessary to use a prevention strategy before these manifestations appear. Previously, the employment of ocular cyclosporine drops as ocular GVHD prophylaxis was assessed to evaluate safety and effectiveness, showing that it is well tolerated and can limit the appearance of severe dry eye manifestations in a small group of patients. The purpose of this work is to compare the two modalities currently accepted for the treatment of the disease, but in a prophylactic way; topical ciclosporin A against topical tacrolimus, to determine the safety and efficiency of each of them as a preventive measure to limit the risk of developing the appearance of ocular cGVHD and the permanent consequences that this generates., conditionsModule conditions: Ocular Graft-versus-host Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental, prospective, randomized, unblinded., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cyclosporine ophthalmic solution 0.1%, interventions name: Tacrolimus ophthalmic ointment 0.03%, outcomesModule primaryOutcomes measure: Incidence of ocular graft-versus-host disease in patients undergoing allo-HSCT receiving topical prophylaxis with Cyclosporine A or Tacrolimus as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease., secondaryOutcomes measure: Incidence of ocular graft-versus-host disease in patients undergoing allo-HSCT receiving topical prophylaxis with Cyclosporine A or Tacrolimus as assessed by the National Institutes of Health Consensus Development Projects on Chronic GVHD scoring system., secondaryOutcomes measure: Prevalence of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease, secondaryOutcomes measure: Severity of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease., secondaryOutcomes measure: Prevalence of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the National Institutes of Health Consensus on Chronic GVHD scoring system., secondaryOutcomes measure: Severity of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the National Institutes of Health Consensus on Chronic GVHD scoring system., secondaryOutcomes measure: Number of participants requiring adjuvant treatment for ocular GVHD in patients receiving prophylactic tacrolimus or cyclosporine for ocular GVHD., secondaryOutcomes measure: Prevalence of Dry Eye Disease prior to the HSCT., secondaryOutcomes measure: Subtypes of Dry Eye Disease prior to the HSCT, secondaryOutcomes measure: Number of participants requiring adjuvant treatments for the Dry Eye Disease, secondaryOutcomes measure: Incidence of other manifestations of acute and chronic GVHD, local or systemic, in patients receiving prophylactic treatment for ocular GVHD., secondaryOutcomes measure: Number of participants with topical tacrolimus related adverse events as assessed by a questionnaire for evaluation of adverse drug events, secondaryOutcomes measure: Number of participants with topical cyclosporine related adverse events as assessed by a questionnaire for evaluation of adverse drug events, otherOutcomes measure: Incidence of ocular GVHD in patients receiving prophylactic treatment for ocular GVHD., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario de la U.A.N.L., status: RECRUITING, city: Nuevo León, state: Monterrey, zip: 66640, country: Mexico, contacts name: Olga Graciela Cantú Rodriguez, MD, role: CONTACT, phone: 8186939257, email: ogcantur@yahoo.com.mx, contacts name: David Gómez Almaguer, MD, role: CONTACT, phone: 8186756718, email: dgomezalmaguer@gmail.com, hasResults: False
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protocolSection identificationModule nctId: NCT06348589, orgStudyIdInfo id: 2023-05959-01, briefTitle: Orthostatic Hypotension and Blood Pressure Variability in Persons Undergoing Hemodialysis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Vrinnevi Hospital, class: OTHER, collaborators name: Linkoeping University, descriptionModule briefSummary: High blood pressure is a risk factor for end-stage renal disease and is common in patients undergoing maintenance hemodialysis. Intradialytic hypotension is associated with an adverse prognosis. More knowledge is needed to identify patients at high risk for intradialytic hypotension and dialysis-associated hypotensive episodes. The aim of this observational single-center pilot study is to evaluate whether point-of-care ultrasound measurements may predict intradialytic hypotension and orthostatic blood pressure falls, in patients with chronic kidney disease who undergo maintenance hemodialysis., conditionsModule conditions: Chronic Kidney Disease Requiring Chronic Dialysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Intra-dialytic systolic blood pressure fall of 20 mmHg or larger, primaryOutcomes measure: Post-dialytic orthostatic systolic blood pressure fall of 20 mmHg or larger, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348576, orgStudyIdInfo id: AD-209P3, briefTitle: Phase III Study to Evaluate the Efficacy and Safety of AD-209, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Addpharma Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of AD-209, conditionsModule conditions: Hypertension,Essential, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: AD-209, interventions name: AD-2091, interventions name: AD-209 Placebo, interventions name: AD-2091 Placebo, outcomesModule primaryOutcomes measure: Change rate of MSSBP, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Korea University Guro Hospital, city: Seoul, country: Korea, Republic of, contacts name: Chang Gyu Park, M.D., Ph.D, role: CONTACT, contacts name: Chang Gyu Park, M.D., Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06348563, orgStudyIdInfo id: 7437787981, briefTitle: AGED Diagnostics Liver Disease Assessment, acronym: AGEDDX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-09-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Active Genomes Expressed Diagnostics, Corp, class: INDUSTRY, collaborators name: Arizona Clinical Trials, collaborators name: Walter Reed National Military Medical Center, descriptionModule briefSummary: Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood. The first assessment is to conduct test method verification to expand sample size to several hundred samples through whole genome sequencing methods. The second assessment is focused on biomarker validation by comparing targeted sequencing from patient plasma. Several sub- assessments will be conducted to support overall biomarker development efforts., conditionsModule conditions: NASH With Fibrosis, conditions: NAFLD, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: AGED Multiple Target Assay in Healthy Controls, interventions name: AGED Multiple Target Assay in NAFLD Participants, interventions name: AGED Multiple Target Assay in Fibrosis Participants, outcomesModule primaryOutcomes measure: Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma, secondaryOutcomes measure: Biomarker Validation, Targeted Epigenetic Sequencing Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AGED Diagnostics, city: Bethesda, state: Maryland, zip: 20002, country: United States, contacts name: Rachel Zayas, role: CONTACT, phone: 617-777-7971, email: rachel@ageddiagnostics.com, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
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protocolSection identificationModule nctId: NCT06348550, orgStudyIdInfo id: BFMKP 01, briefTitle: Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-30, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, collaborators name: Foundation IRCCS San Matteo Hospital, descriptionModule briefSummary: The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl., conditionsModule conditions: Dyslipidemias, conditions: Dysglycemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Berberol® K, interventions name: Placebo, outcomesModule primaryOutcomes measure: Variation of LDL cholesterol, secondaryOutcomes measure: Variation of lipid profile, secondaryOutcomes measure: Change in glycemic status, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Policlinico S. Matteo Foundation, status: RECRUITING, city: Pavia, zip: 27100, country: Italy, contacts name: Giuseppe Derosa, MD, PhD, role: CONTACT, email: giuseppe.derosa@unipv.it, contacts name: Pamela Maffioli, MD, role: CONTACT, email: p.maffioli@smatteo.pv.it, contacts name: Giuseppe Derosa, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Pamela Maffioli, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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protocolSection identificationModule nctId: NCT06348537, orgStudyIdInfo id: Polyphenol-Fibromyalgia, briefTitle: Effects of Olive Polyphenols in Fibromyalgia Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-20, primaryCompletionDateStruct date: 2021-04-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Universidad de Granada, class: OTHER, collaborators name: Solvitae Medical, S.L, collaborators name: University of Jaén, descriptionModule briefSummary: To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Olive Polyphenols, interventions name: Placebo, outcomesModule primaryOutcomes measure: Plasma proteome, primaryOutcomes measure: Lipid peroxidation, secondaryOutcomes measure: Aldolase, secondaryOutcomes measure: C-reactive protein (CRP), secondaryOutcomes measure: Impact of fibromyalgia, secondaryOutcomes measure: Quality of Life, secondaryOutcomes measure: Red blood cells, secondaryOutcomes measure: Haemoglobin, secondaryOutcomes measure: Fibrinogen, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Cholesterol ratio, secondaryOutcomes measure: LDL cholesterol, secondaryOutcomes measure: Cortisol, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Jaén, city: Jaén, zip: 23071, country: Spain, geoPoint lat: 37.76922, lon: -3.79028, hasResults: False
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protocolSection identificationModule nctId: NCT06348524, orgStudyIdInfo id: ferumoxytol_2015, briefTitle: Ferumoxytol-enhanced Magnetic Resonance Imaging, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-03, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Transmed Solutions, class: OTHER, descriptionModule briefSummary: There are no current alternatives to diagnostic contrast-requiring imaging for patients with an eGFR \<30mL/min due to the association of gadolinium-based imaging modalities to nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury. Ferumoxytol-enhanced imaging may offer an alternative approach., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Ferumoxytol injection, outcomesModule primaryOutcomes measure: Detect the absence of ≥50% stenosis in the coronary artery tree, secondaryOutcomes measure: Detect stenosis in proximal and distal segments of the coronary artery tree, secondaryOutcomes measure: Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06348511, orgStudyIdInfo id: 0165-22-TLV, briefTitle: XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Tel-Aviv Sourasky Medical Center, class: OTHER_GOV, descriptionModule briefSummary: The investigators developed a neuroscientifically-informed gamified tic-therapy platform. The investigators previously identified tic-triggering elements in movies and video games. Next, the investigators employed these elements to generate and validate a gamified intervention protocol, which is based on a video game the investigators designed (called XTics). The study tests the efficacy of the gamified tool integrated in an exposure and response prevention (ERP) protocol to enhance both patient's compliance and clinical outcome., conditionsModule conditions: Tic Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study tested the impact of contingent and immediate reward (ICR) given by the game in respect to the participant's tic frequency relative to a random and non-contingent delayed reward (DR) provided by the end of the training day. Each participant underwent three training days in each of the the modes during one week. The training days included 3 (first day) or 4 (second and third days) game sessions. The order of the training modes was random., primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: Personnel who interact directly with the study subjects were not aware of the assigned treatments. Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group., whoMasked: INVESTIGATOR, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: XTics, outcomesModule primaryOutcomes measure: The Tic Yale Global Tic Severity Scale (YGTSS), primaryOutcomes measure: The Parent Tic Questionnaire (PTQ), primaryOutcomes measure: Premonitory Urge for Tic Scale (PUTS), primaryOutcomes measure: The Subjective Units of Distress Scale (SUDS), primaryOutcomes measure: The "Urge Thermometer", primaryOutcomes measure: Rush Videotape Protocol, primaryOutcomes measure: Tic-to-tic interval, secondaryOutcomes measure: The Screen for Child Anxiety Related Emotional Disorders (SCARED), secondaryOutcomes measure: The Children Depression Inventory (CDI), secondaryOutcomes measure: The Conners' Parent Rating Scale-Revised Long Form (CRS:RL), secondaryOutcomes measure: Obsessive Compulsive Inventory-Child Version (OCI-CV), secondaryOutcomes measure: The Behavior Rating Inventory of Executive Function (BRIEF), secondaryOutcomes measure: The Emotion Regulation Questionnaire (ERQ), secondaryOutcomes measure: User Engagement Scale (UES), eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sagol Brain Institute, Tel Aviv Sourasky Medical Center, city: Tel Aviv, country: Israel, geoPoint lat: 32.08088, lon: 34.78057, hasResults: False
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protocolSection identificationModule nctId: NCT06348498, orgStudyIdInfo id: TSL-TCM-JSP-Ⅰb, briefTitle: Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Tasly Pharmaceutical Group Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Jia Shen Tablet, outcomesModule primaryOutcomes measure: Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax), primaryOutcomes measure: Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (Tmax), primaryOutcomes measure: Plasma PK analysis: Area under curve at steady state (AUCss), secondaryOutcomes measure: NT-proBNP, secondaryOutcomes measure: 6-Minutes-Walking-Test (6MWT), secondaryOutcomes measure: Echocardiogram results, secondaryOutcomes measure: NYHA classification, secondaryOutcomes measure: AEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, city: Tianjin, state: Tianjin, country: China, contacts name: Yuhong Huang, role: CONTACT, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
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protocolSection identificationModule nctId: NCT06348485, orgStudyIdInfo id: VGHTCCTC_NPCbleeding001, briefTitle: Massive Nasal Bleeding in Patients With NPC Received Curative RT, statusModule overallStatus: COMPLETED, startDateStruct date: 1994-12-01, primaryCompletionDateStruct date: 2019-04-30, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Taichung Veterans General Hospital, class: OTHER, descriptionModule briefSummary: To investigate the incidence, predictive markers, and survival impact of massive nasal bleeding in nasopharyngeal carcinoma (NPC) patients who received curative radiotherapy (RT) with/without chemotherapy. A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. Investigators analyzed the occurrence rates of massive nasal bleeding between different characteristics and tried to identify important predictive factors. Investigators compared overall survival between patients with and without massive nasal bleeding by Kaplan-Meier method., conditionsModule conditions: Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1327, type: ACTUAL, armsInterventionsModule interventions name: Patients without massive nasal bleeding, interventions name: Patients with massive nasal bleeding, outcomesModule primaryOutcomes measure: Massive Nasal Bleeding Rate, secondaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taichung Veterans General Hospital, city: Taichung, zip: 407, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
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protocolSection identificationModule nctId: NCT06348472, orgStudyIdInfo id: 0004-24-SHA, briefTitle: The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Shalvata Mental Health Center, class: OTHER, descriptionModule briefSummary: Despite a range of treatments for posttraumatic stress disorder (PTSD), only a small proportion of patients reach full symptomatic remission. Recent developments in the field of neuroscience have been providing compelling evidence to suggest that neurobiological determinants might influence not only the emergence of PTSD, but also its resistance to treatment. Immune-inflammation regulatory processes were found to be active during recovery from PTSD, potentially through interactive relationship with the oxytocin secretion system. This innovative longitudinal study aims to examine the role of inflammatory biomarkers and their interactive effect with the oxytocin (OT) system on the development of PTSD and on treatment response among patients with PTSD symptoms undergoing psychotherapy treatment. Patients (N = 100) suffering from trauma-related distress will be recruited from the trauma clinic in Shalvata Mental Health Center. Participants will be followed for 12 weeks of once-a-week psychotherapy sessions. They will be measured for endogenous OT level and cytokines levels in saliva before and after sessions 1, 6, and 12, and will complete psychotherapy outcome self-report questionnaires following each of these sessions., conditionsModule conditions: Posttraumatic Stress Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Oxytocin Secretion, primaryOutcomes measure: Inflammatory Response: IL-1β, primaryOutcomes measure: Inflammatory Response: IL-6, primaryOutcomes measure: Inflammatory Response: TNF-α, primaryOutcomes measure: Posttraumatic stress disorder symptoms, primaryOutcomes measure: Depression severity, primaryOutcomes measure: General anxiety symptoms, secondaryOutcomes measure: Psychological resilience, secondaryOutcomes measure: Working Alliance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shalvata Mental health Center, status: RECRUITING, city: Hod HaSharon, country: Israel, contacts name: Omer Sedoff, MA, role: CONTACT, email: omerse@clalit.org.il, geoPoint lat: 32.15934, lon: 34.8932, hasResults: False
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