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Participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery.
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Intervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment).
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Main outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480).
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Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\' and health professionals\' experiences on health care, as well as improve patients\' health. conditions: PROMs conditions: PREMs conditions: Implementation Research conditions: Impact Evaluation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1440 type: ESTIMATED name: PROMs and PREMs name: PREMs name: Control name: Healthcare professionals measure: Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals measure: Health-related quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital del Mar Reseach Institute status: RECRUITING city: Barcelona state: Catalonia zip: 08003 country: Spain name: Olatz Garin role: CONTACT phone: +34 636210255 email: [email protected] name: Olatz Garin role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06272539 id: 2023 101435 briefTitle: Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-01 date: 2026-01-01 date: 2024-02-22 date: 2024-02-28 name: Fundación Universidad Católica de Valencia San Vicente Mártir class: OTHER name: Instituto de Investigación Biomédica de Salamanca briefSummary: Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Administration of high doses of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in failed back surgery syndrome (FBSS) patients. Methods/Materials. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area (protocol number PI 2023 101435 in (24/01/2024) in accordance with the ethical guidelines of the Helsinki declaration. Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.4 (partial η2 = 0.40, α = .05, power = 0.90), resulting in a total of 28 patients. Assuming a 30% dropout rate, 36 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception. conditions: Failed Back Surgery Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: By doing so, we will aim to eliminate or reduce potential biases due to the order of patients and any transference effects that might occur if one profile clinical patients will influence the performance in several evaluations. Specifically, each patient will complete a sequence of allocation in the order of A, B, B, A, where 'A' represents SCS treatment isolated and 'B' denotes combined treatment. Subsequently, the average of the two 'A' conditions was calculated, and the same process was applied for the 'B' conditions whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Exercise name: Spinal Cord Stimulation measure: Disability (Oswestry Disability Index) measure: Perception Pain (Visual analogue scale) measure: Quality of life (Short Form 36 Health Survey, SF36) measure: Patient's satisfaction measure: Strength (Sorensen Test) measure: Fear of Movement (Tampa Scale of Kinesiophobia, TSK) measure: Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale) measure: Catastrophic thinking (Pain Catastrophizing Scale) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Juan Vicente-Mampel city: Torrent state: Valencia zip: 46900 country: Spain lat: 39.43705 lon: -0.46546 hasResults: False
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<|newrecord|> nctId: NCT06272526 id: SOCIALANX_1 briefTitle: Internet-Based Self-Help Intervention for Social Anxiety Symptoms overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-01 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Anadolu University class: OTHER briefSummary: This study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. Participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist.
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The intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in Turkey. Participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Internet Based Intervention - GUIDED measure: Liebowitz Social Anxiety Scale (LSAS) Turkish Form measure: Social Appearance Anxiety Scale (SAAS) Turkish Form measure: Patient Health Questionnaire-9 (PHQ-9) Turkish Form measure: Generalized Anxiety Disorder-7 (GAD-7) Turkish Form measure: Sociodemographic Information Form measure: System Usability Scale (SUS-10) Turkish Form measure: Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form measure: Adherence to Intervention measure: Guide Evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272513 id: ProAct-HNC-02 briefTitle: Influencing Factors for Physical Activity in People With Head and Neck Cancer acronym: ProAct-HNC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03-31 date: 2025-06-30 date: 2024-02-22 date: 2024-02-26 name: Kantonsspital Winterthur KSW class: OTHER name: Eastern Switzerland University of Applied Sciences name: University of Applied Sciences of Western Switzerland name: UMC Utrecht name: University of Lausanne name: Zurich University of Applied Sciences briefSummary: The goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others.
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Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions:
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* What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience?
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* What motivates people with advanced head and neck cancer to be physically active?
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* How do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer?
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The interviews will be transcribed verbatim and analysed with a structuring content analysis approach. conditions: Advanced Head and Neck Squamous Cell Carcinoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: interview transcripts measure: personal information of participants sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-09 uploadDate: 2024-02-15T04:21 filename: Prot_000.pdf size: 1702659 hasResults: False
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<|newrecord|> nctId: NCT06272500 id: 2024-KY-0146-001 briefTitle: Exploring Methods for Treating Hypergastrinemia in Patients With Autoimmune Gastritis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-31 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: Jianning Yao class: OTHER briefSummary: Autoimmune atrophic gastritis (AAG) is an organ-specific autoimmune disease that primarily affects the gastric body and fundus while sparing the antrum. Its characteristics include destruction of gastric wall cells, loss of intrinsic factors, and atrophy of the gastric mucosa. Endoscopic examination reveals features of reverse atrophy, with significant atrophy in the gastric body and fundus, appearing as a mosaic of red and white patches. Currently, AAG is believed to result from a pathological CD4+ T-cell-mediated autoimmune response against the gastric H+/K+-ATPase. CD4+ T lymphocytes target the parietal cells' H+/K+-ATPase, stimulating plasma cells to secrete autoantibodies, including parietal cell antibodies (PCA) and intrinsic factor antibodies (IFA). The former plays a key role in parietal cell destruction and glandular atrophy. AAG is considered a premalignant condition, with the potential development of gastric dysplasia, cancer, and type 1 gastric neuroendocrine tumours (type 1 g-NET).
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Gastric neuroendocrine tumors (g-NETs), also known as gastric carcinoids, account for approximately 23% of gastrointestinal and pancreatic neuroendocrine tumors. Clinically, g-NETs are mainly classified into three types. Type III is typically sporadic tumors associated with normal gastrin levels and poor prognosis. Although type 1 g-NETs caused by AAG are usually well-differentiated, studies have reported that 8%-23% of type 1 g-NETs extending into the deep submucosal layer may metastasize to regional lymph nodes or even to the liver. Furthermore, 3% of patients may develop neuroendocrine carcinoma, highlighting the need for appropriate attention.
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Due to the destruction of gastric glands (including parietal and chief cells) in AAG patients, there is a deficiency in intrinsic factor, gastric acid, and a decrease in pepsinogen I (PG-I) levels. Insufficient gastric acid secretion leads to a compensatory increase in gastrin secretion by G cells in the gastric antrum, which acts on receptors present in enterochromaffin-like cells (ECL) in the gastric body and fundus, promoting ECL cell proliferation. Prolonged stimulation by hypergastrinemia can result in the development of ECL cell tumors, namely type 1 g-NETs. Considering the close association between type 1 g-NETs and AAG, primarily related to hypergastrinemia resulting from reduced gastric acid secretion, it is hypothesized that supplementation with gastric acid could provide negative feedback regulation of gastrin, reducing the risk of type 1 g-NET development in AAG patients. This study aims to investigate the impact of oral apple cider vinegar on gastrin levels in AAG patients, thus exploring a simple and cost-effective method to reduce the risk of type 1 g-NETs in AAG patients. conditions: Autoimmune Gastritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: oral administration of a compound digestive enzyme capsule name: oral administration of apple cider vinegar name: oral administration of both the compound digestive enzyme capsule and apple cider vinegar measure: serum gastrin levels measure: serum gastrin levels measure: the adverse reaction rates sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-30 uploadDate: 2024-02-15T10:32 filename: Prot_SAP_000.pdf size: 152941 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-30 uploadDate: 2024-02-15T10:32 filename: ICF_001.pdf size: 156619 hasResults: False
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<|newrecord|> nctId: NCT06272487 id: ALN-AGT01-007 briefTitle: Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3) acronym: KARDIA-3 overallStatus: RECRUITING date: 2024-02-29 date: 2025-03-20 date: 2025-12-19 date: 2024-02-22 date: 2024-04-18 name: Alnylam Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications. conditions: High Cardiovascular Risk conditions: Hypertension studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 390 type: ESTIMATED name: Zilebesiran name: Placebo measure: Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) measure: Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) measure: Change from Baseline at Month 6 in Mean Seated Office SBP measure: Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM measure: Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 measure: Proportion of Patients with 24-hour Mean SBP assessed by ABPM <130 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 measure: Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM measure: Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP measure: Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM measure: Change from Baseline Over Time in Serum Angiotensinogen (AGT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Trial Site status: RECRUITING city: Flint state: Michigan zip: 48504 country: United States lat: 43.01253 lon: -83.68746 hasResults: False
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<|newrecord|> nctId: NCT06272474 id: 0266-07/2021 - 18/07/2021 briefTitle: Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments overallStatus: COMPLETED date: 2022-09-11 date: 2023-12-09 date: 2023-12-09 date: 2024-02-22 date: 2024-02-22 name: Hams Hamed Abdelrahman class: OTHER briefSummary: Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Recently, new methods based on mandibular motion tracking using optical devices have been introduced for integrating individual functional movement into occlusal morphology.
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The aim of this study: This study will clinically assess the reliability of the virtual reproduction of mandibular movement for detecting occlusal interferences and adjustments of designed and milled CAD-CAM zirconia crowns using a digital occlusal analyzer.
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Materials and methods: Intraoral optical impression will be made for thirteen selected patients with endodontically treated maxillary first premolars after abutment preparation followed by buccal and lateral interocclusal records taking. Two zirconia crowns will be fabricated for each patient following regular digital workflow with twenty six zirconia crowns, which will be allocated according to the virtual method of adjustment of occlusal interferences into two groups (Group I: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record (n=13) and Group II: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal and lateral interocclusal records (n=13)). Then milling and sintering of all crowns will be performed following the manufacturer's instructions. The occlusion of all crowns will be analyzed using an electronic pressure analyzer. All data will be statistically analyzed and discussed in light of the results obtained. conditions: Dental Occlusion studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Single group is receiving the two interventional arms primaryPurpose: DIAGNOSTIC masking: NONE count: 26 type: ACTUAL name: CAD-CAM zirconia crowns using buccal interocclusal record. name: CAD-CAM zirconia crowns using lateral interocclusal records. measure: Static occlusal interference measure: Dynamic occlusal interference sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Alexandria Faculty of Dentistry city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06272461 id: UTEM ELKI briefTitle: Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery overallStatus: RECRUITING date: 2023-10-01 date: 2024-05-30 date: 2024-06-30 date: 2024-02-22 date: 2024-04-16 name: University Tunis El Manar class: OTHER briefSummary: Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).
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For the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours.
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For the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours.
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Plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively. conditions: Colorectal (Colon or Rectal) Cancer conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intravenous Lidocaine vs intravenous ketamine primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Lidocaine IV name: Ketamine Injectable Solution measure: The variation of Interleukin-6 levels measure: Pain assessed by Numerical Rating Scale (NRS) measure: Post-operative nausea and vomiting measure: Bowel function. measure: Hospital length of stay. measure: Post-operative complications. sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tunisia status: RECRUITING city: Nabeul zip: 8000 country: Tunisia name: BEN ALI MECHAAL role: CONTACT phone: 53890987 phoneExt: 00216 email: [email protected] lat: 36.45606 lon: 10.73763 hasResults: False
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<|newrecord|> nctId: NCT06272448 id: CERM2022-27 21042022 briefTitle: teleRehabilitation for pAtients With ParkInson's Disease at Any mOment acronym: RAPIDO overallStatus: RECRUITING date: 2022-11-15 date: 2024-05-31 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: Università Politecnica delle Marche class: OTHER name: Universita di Verona briefSummary: The goal of this clinical trial is to test the feasibility and safety of a telerehabilitation and telemonitoring approach in people with Parkinson's disease at any stage. The main questions it aims to answer are: will patients with Parkinson's disease comply with the recommended level of training at home using an ad hoc developed telerehabilitation platform? • Will this training be safe and impact the patient's well-being perception? Participants will be given a tablet and instructed to access an online platform to observe different motor tasks presented in as many video clips by experienced therapists.They will be requested to perform the motor tasks per a predetermined protocol over 3 months. Their compliance with the recommended training will be checked by physiotherapists every 15 days during phone calls, whereas their daily level of motor activity will be recorded by a smartwatch. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Before-after study with one follow-up at 3 months of treatment end primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Telerehabilitation measure: Compliance with the telerehabilitation system measure: Perceived usability of system measure: Incidence of treatment-emergent adverse events measure: User satisfaction measure: Compliance with the monitoring system measure: Feasibility of telemonitoring approach measure: Motor symptom and disability progression measure: Non motor symptom progression measure: Patients' Quality of life measure: Caregiver's burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurorehabilitation Clinic status: RECRUITING city: Ancona zip: 60126 country: Italy name: Elisa Andrenelli, Dr role: CONTACT phone: 0715965794 email: [email protected] lat: 43.5942 lon: 13.50337 facility: Università di Verona status: RECRUITING city: Verona zip: 37100 country: Italy name: Marialuisa Gandolfi, Prof role: CONTACT phone: +39 045 812 4943 email: [email protected] lat: 45.4299 lon: 10.98444 hasResults: False
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<|newrecord|> nctId: NCT06272435 id: PRO-FY2024-64 briefTitle: Beverage Hydration Index: Assessment of Four Rehydration Solutions overallStatus: RECRUITING date: 2023-12-23 date: 2024-05-31 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: University of Memphis class: OTHER briefSummary: No studies to date to evaluate the effects of the three different liquid IV electrolyte products on the beverage hydration index (BHI). Therefore, the purpose of this study is to determine the impact of three different LIV products (Hydration multiplier, Sugar Free formulation with Amino Acids, and Sugar Free with allulose) on hydration status in young and active men and women compared to a control (water). The study will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and BHI (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance, as well as determining electrolyte concentrations, osmolality, specific gravity, and sodium and potassium in urine. conditions: Hydration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Semi-blinded, placebo controlled, crossover design primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Treatments will be labeled A-D. Subjects will be provided prepared beverages prepared in cup. whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: Multiplier name: Sugar Free name: Sugar Free with Amino Acids name: Water measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Net Fluid Balance measure: Net Fluid Balance measure: Net Fluid Balance measure: Net Fluid Balance measure: Net Fluid Balance measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Sodium balance measure: Sodium balance measure: Sodium balance measure: Sodium balance measure: Sodium balance measure: Potassium balance measure: Potassium balance measure: Potassium balance measure: Potassium balance measure: Potassium balance measure: Body Mass measure: Body Mass measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Center for Nutraceutical and Dietary Supplement Research status: RECRUITING city: Memphis state: Tennessee zip: 38152 country: United States name: Jackie Pence, Ph.D. role: CONTACT phone: 901-678-1547 email: [email protected] name: Richard J Bloomer, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 35.14953 lon: -90.04898 hasResults: False
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<|newrecord|> nctId: NCT06272422 id: 2022/0472 id: 2023-A00358-37 type: OTHER domain: IDRCB - ANSM ID briefTitle: Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning acronym: HIP3D overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-03 date: 2024-02-22 date: 2024-02-22 name: University Hospital, Lille class: OTHER briefSummary: The study will analyze hip biomechanical parameters using EOS radiographic measurements pre- and post-operatively (3 months) and post-operatively (3 months) CT scans after total hip replacement (THR), neck-preserving THR of the Minihip type or hip resurfacing (HR). Clinical results will be assessed at 3 months and 1 year after surgery.
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To this end, two types of examination are carried out, both of which are used in current practice:
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* Pre-operatively: EOS radiography
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* Post-operatively: EOS radiograph and CT scan
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Inclusion (m-3; m-1) :
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* Patient information at pre-operative visit
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* Non-opposition of patient, family member or legal guardian, if applicable
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* Questionnaires and clinical examination (standard management)
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* EOS during anesthetic consultation
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Follow-up visit (m+3):
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- Post-operative follow-up consultation EOS and CT scan (1 week prior to visit) + questionnaire and clinical examination
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Follow-up visit (m+12):
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- Post-operative check-up, questionnaire and clinical examination conditions: Coxarthrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 165 type: ESTIMATED name: hip arthroplasty measure: Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty. measure: Compare the anatomical restoration of frontal and axial parameters between the 3 types of intervention (PTH, Minihip and RSA). measure: Compare clinical outcomes and patient satisfaction between the 3 procedures (PTH, Minihip and RSA). measure: Correlate restoration of hip femoral offset and patient functional outcome at 3 months. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272409 id: DEP114-III-0123 briefTitle: Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children. acronym: SIERRA overallStatus: NOT_YET_RECRUITING date: 2025-02-15 date: 2025-03-15 date: 2027-04-15 date: 2024-02-22 date: 2024-02-22 name: EMS class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years. conditions: Allergic Rhinitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 318 type: ESTIMATED name: DEP114 name: Desloratadine 0.5 MG/ML measure: To demonstrate the superiority of DEP114 in relation to desloratadine 0.5 mg/mL in relieving the nasal symptoms of moderate to severe persistent allergic rhinitis in children, five days after starting treatment. measure: To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment. measure: Evaluate the efficacy of DEP114 to relieve nasal obstruction present in moderate to severe persistent allergic rhinitis in children through the treatment. measure: Evaluate the efficacy of DEP114 to relieve coryza present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment. measure: Evaluate the efficacy of DEP114 to relieve nasal itching present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment. measure: Evaluate the efficacy of DEP114 to relieve sneezing present in persistent allergic rhinitis moderate to severe in children, three and five days after the start of treatment. measure: Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the perception of the person responsible for the participant. measure: Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the investigator's perception. sex: ALL minimumAge: 6 Years maximumAge: 11 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06272396 id: CHUBX 2023/64 briefTitle: Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch acronym: ECG-MC overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2027-03-20 date: 2028-03-20 date: 2024-02-22 date: 2024-02-22 name: University Hospital, Bordeaux class: OTHER briefSummary: Over the past few years, various systems have been developed to record ECG traces on an ambulatory basis. The latest connected watch models feature 2-electrode ECG recording. This single or six derivations can be used to derive a wealth of information about the heart's rhythm. The information that can be derived from an ECG recording with a derivation goes far beyond̀ simple differentiation between atrial fibrillation and sinus rhythm. In contrast, in various clinical situations, a tracing restricted to an ICD may prove falsely normal, wrongly reassuring a patient and delaying management. The primary objective of the study is to evaluate the sensitivity of ECG-1D or 6D recordings from a connected watch in measuring electrical parameters, compared with a standard ECG-12D, also to obtain a bank of tracings, to create and validate an artificial intelligence algorithm for the automatic analysis of ECG tracings recorded with a connected watch and also to validate the feasibility and sensitivity of recording an ECG tracing with a connected watch in children. conditions: Arrhythmias, Cardiac studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 3000 type: ESTIMATED name: Smart watch measure: Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude measure: Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration measure: Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude measure: Comparison of electrical parameters measured using the 2 ECG methods: QRS duration measure: Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc measure: Creation of bank of anormal ECG trace measure: Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG measure: Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home measure: Validate the feasibility of recording an ECG trace with a connected watch for a child measure: Validate the sensibility of an ECG trace with a connected watch for a child sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Haut-Lévèque city: Pessac zip: 33604 country: France name: Pierre BORDACHAR role: CONTACT lat: 44.81011 lon: -0.64129 hasResults: False
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<|newrecord|> nctId: NCT06272383 id: HS26166 (B2023:092) briefTitle: Croup Dosing Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-02-22 date: 2024-02-22 name: University of Manitoba class: OTHER briefSummary: Croup is a common childhood respiratory disease that often leads to frequent emergency department visits. It is a viral infection that causes cough, throat, and airway swelling, making breathing difficult. Dexamethasone is a medication that helps to reduce swelling, making breathing easier for children. A standard dose of 0.6mg/kg is used in children. However, a lower amount (due to side effects of steroids in children) has been suggested. We will examine whether 25% less than the standard dose is equally effective in treating croup. Investigators will conduct a clinical study with the support of patients with lived experience (which, in this case, are the parents of the children) to better care for children with croup. If proven, this study can improve the outcome in children with croup. conditions: Croup studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an internal double-blinded vanguard randomized controlled trial (RCT), which will be conducted at the Winnipeg Children's Hospital (WCH). Computerized randomization will be performed by a statistician at the George and Fay Yee Centre for HealthCare Innovation to generate the randomization list. Investigators will perform a computerized randomization stratified by age. Investigators will do a block randomization with random blocks of undisclosed block sizes over the seasons to ensure temporal distribution of croup cases is captured. Investigators will randomly assign patients to either the intervention or control in ratio 1:1. While croup is common between 6 months and 5 years, a typical croup affects children between 6 months and 3 years. Based on this, we will randomize such that this age category (6 months-3years) has almost similar distribution in each arm. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: 0.15 mg/kg dexamethasone measure: Return visits or readmissions to the hospital measure: Adverse events sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06272370 id: PLACER-2021C3-24737-IC briefTitle: Individualizing Treatment for Asthma in Primary Care acronym: iTREAT-PC overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-09-30 date: 2024-02-22 date: 2024-02-22 name: DARTNet Institute class: OTHER_GOV name: Penn State University name: Icahn School of Medicine at Mount Sinai name: University of Colorado, Denver name: RAND name: University of Washington name: Rutgers University name: University of North Carolina name: Brigham and Women's Hospital name: Reliant Medical Group name: Kelsey Research Foundation name: Wake Forest University Health Sciences briefSummary: This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care, rescue inhaled corticosteroids, azithromycin and both rescue inhaled corticosteroids and azithromycin. Participants in all arms will be offered access to an online asthma symptom monitoring system. conditions: Asthma conditions: Bronchial Diseases conditions: Respiratory Tract Infections conditions: Lung Diseases, Obstructive conditions: Lung Diseases conditions: Respiratory Hypersensitivity conditions: Immune System Diseases studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: patient randomized trial of three different drug combinations primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 125 type: ESTIMATED name: Asthma Symptom Monitoring online tools name: Inhaled Steroids name: Azithromycin Pill measure: The annualized rate of major asthma exacerbations (a hospitalization for asthma or 72+ hours of oral/parenteral steroids). measure: Asthma control as measured by the Asthma Control Test measure: Asthma Quality of Life as measured by the Juniper Mini Asthma Quality of Life Questionnaire measure: Days Per Year Lost from Work or School/Days Unable to Carry Out Usual Activities Due to Asthma. sex: ALL minimumAge: 12 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: DARTNet Insitute status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Brian K Manning, MPH role: CONTACT phone: 800-434-0278 phoneExt: 82 email: [email protected] name: Joel Shields, MA role: CONTACT phone: 80004340278 phoneExt: 84 email: [email protected] name: Michelle Hernandez, MD role: PRINCIPAL_INVESTIGATOR name: Kari Stephens, PhD role: PRINCIPAL_INVESTIGATOR name: John Valenta, PhD role: PRINCIPAL_INVESTIGATOR name: Juan Wisniveski, MD role: PRINCIPAL_INVESTIGATOR name: Lipika Samal, MD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06272357 id: Antiarrhythmic drugs briefTitle: The Use of Antiarrhythmic Drugs in Pediatrics overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-03-31 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital, a clinical audit conditions: Antiarrhythmic Drug Adverse Reaction studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 158 type: ESTIMATED name: Antiarrhythmic drugs measure: Detect the rate of use of antiarrhythmic drugs in pediatrics and the different indications for them other than the control of arrhythmia. sex: ALL minimumAge: 30 Days maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06272344 id: CHUBX 2022/38 briefTitle: Remote Programming of Cardiac Implantable Electronic Devices 2 acronym: REACT 2 overallStatus: RECRUITING date: 2023-04-24 date: 2024-10-24 date: 2024-10-24 date: 2024-02-22 date: 2024-02-22 name: University Hospital, Bordeaux class: OTHER briefSummary: Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full CIED check-up and reprogramming is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. In this study we aim to evaluate our previously validated remote programming solution (REACT study, NCT05366660) in outpatient device clinics which are close to the patient's home but remote from the CIED expert. conditions: Pacemaker conditions: Defibrillator conditions: Telemedecine studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single-center, single-arm, pairwise comparison trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 50 type: ESTIMATED name: Teleconsultation measure: assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital measure: Time saving for patient measure: Savings on medical transport measure: Costs associated with teleconsultation measure: safety of teleconsultation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bordeaux University Hospital status: RECRUITING city: Pessac zip: 33604 country: France name: Sylvain MD Ploux role: CONTACT phone: (0)5 57 65 64 71 phoneExt: +33 email: [email protected] name: Estel HUGOT role: CONTACT phone: (0)5 57 62 32 26 phoneExt: +33 email: [email protected] name: Sylvain MD Ploux role: PRINCIPAL_INVESTIGATOR lat: 44.81011 lon: -0.64129 hasResults: False
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<|newrecord|> nctId: NCT06272331 id: NL83162.091.22 briefTitle: Milk and Plant Protein Digestion acronym: MAPP-D overallStatus: RECRUITING date: 2024-01-15 date: 2024-07-01 date: 2024-07-01 date: 2024-02-22 date: 2024-02-22 name: Wageningen University class: OTHER name: FrieslandCampina briefSummary: The goal of this study is to explore the effect of protein quantity and quality in plant-based drinks. Healthy normal-weight males aged between 18 and 45 years will be included in the study.
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The main objectives are to examine the differences in postprandial amino acid profiles, and to examine differences in gastric behavior between cow's milk and plant based drinks.
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Participants will visit after an overnight fast three times and have blood draws before and after consumption one of the study drinks. There will be MRI scans of the stomach before and after consumption of the drink to assess gastric behavior. conditions: Food Digestion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 12 type: ESTIMATED name: Low-protein plant-based drink name: High-protein plant-based drink name: Cow's milk measure: Postprandial plasma amino acid profile as characterized by the peak height and iAUC measure: Gastric behavior measure: Postprandial plasma response measure: Verbal ratings of wellbeing measure: MRI markers of digestion sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Human Research Unit - Division of Human Nutrition and Health status: RECRUITING city: Wageningen zip: 6708WE country: Netherlands name: Paul Smeets, PhD role: CONTACT phone: + 31317484681 email: [email protected] name: Paul Smeets, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.97 lon: 5.66667 hasResults: False
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<|newrecord|> nctId: NCT06272318 id: 74131 briefTitle: Vital Signs Blood Pressure Trial overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-06-30 date: 2026-12-31 date: 2024-02-22 date: 2024-02-22 name: Stanford University class: OTHER briefSummary: The purpose of this study is collect subject vitals with a blood pressure cuff, electrocardiogram (ECG), and photoplethysmogram (PPG). This data can then be used to develop a reliable, accurate, noninvasive, and continuous blood pressure monitoring device. conditions: Cardiovascular Diseases conditions: Hypertension conditions: Blood Pressure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Blood Pressure Cuff, EKG, PPG measure: Collection of Subject Name (optional) measure: Collection of Subject Height measure: Collection of Subject Weight measure: Collection of Subject Age measure: Collection of Subject Medical Comorbidities measure: Blood Pressure Measurement measure: Collection of ECG Waveforms measure: Collection of PPG Waveforms sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06272305 id: 49RC21_0301 briefTitle: TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis acronym: TREC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-06-01 date: 2024-06-01 date: 2024-02-22 date: 2024-02-22 name: University Hospital, Angers class: OTHER_GOV briefSummary: Restenosis due to myo-intimal hyperplasia remains a concern after carotid endarterectomy. It occurs in around 6% of cases. Several risk factors for restenosis have already been identified, such as smoking, hypertension, female gender, diabetes, dyslipidemia and small carotid diameter. The main objective of this prospective multicenter study was to determine whether the technical characteristics of the eversion technique have an influence on the rate of restenosis at 1 year.
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Between September 2021 and November 2022, we followed all patients undergoing carotid endarterectomy by eversion in 8 French hospitals. Demographic data, operative indications and technical characteristics of the endarterectomies performed were collected. These were defined by the circumferential nature of the carotid bulb according to 3 types (TREC A, B or C), and the length and depth of the endarterectomy according to anatomopathological reports. Post-operative complications were collected as much as doppler ultrasonography at three months and 1 year to quantify restenosis. conditions: Hyperplasia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED name: This research does not require any specific investigation and does not imply any modification of treatment. measure: Rate of restenosis measure: Morbidity and mortality rate measure: Major cardiological event measure: Minor neurological events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272292 id: S66441 briefTitle: Biomechanical Investigation of Symptomatic FAI and Two Groups of Asymptomatic Controls acronym: CAM-FAI adult overallStatus: RECRUITING date: 2022-07-28 date: 2024-03-01 date: 2024-03-01 date: 2024-02-22 date: 2024-02-22 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Femoroacetabular impingement (FAI) is an orthopaedic condition that is primarily characterized by the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum resulting in an abnormal contact between the two during hip motion, especially in positions of increased hip flexion and rotation, ultimately leading to hip pain. Unfortunately, a FAI diagnosis is frequently only made once symptoms have become severe to an extent that they limit everyday life activities. Moreover, another important aspect that has been consistently overlooked in past FAI movement studies is the influence muscle strength and activation can have on movement pattern and symptom presentation. The diagnosis and management of FAI needs to be addressed through a more wholesome investigation of the biomechanical influence on the manifestation of symptoms.
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This project aims to further unravel the link between spinopelvic anatomy, its biomechanical contribution to femoro-pelvic motion and the manifestation of femoroacetabular impingement in adult male population. By, for the first time, integrating three-dimensional (3D) instrumented motion analysis with state-of-the-art full-body biplanar X-ray imaging (EOS imaging, Paris France), we will more specifically investigate the presence of an association between spinopelvic kinematics and the link to symptomatic FAI morphology, as well as investigate the presence of differences in these measures between symptomatic and asymptomatic subjects with comparable femoral morphology. conditions: Femoroacetabular Impingement studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cross-sectional, case-control prospective clinical study primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: 3 study groups, based on clinical examination and medical imaging:
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* symptomatic CAM-FAI patients
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* asymptomatic CAM controls
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* healthy controls whoMasked: PARTICIPANT count: 99 type: ESTIMATED name: EOS name: 3D motion lab analysis measure: The presence of CAM morphology in combination with symptoms measure: The Copenhagen Hip and Groin Outcome Score (HAGOS) measure: Radiographic spinopelvic parameters measure: 3D motion analysis parameters sex: MALE minimumAge: 21 Years maximumAge: 35 Years stdAges: ADULT facility: University Hospitals of Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Stijn Ghijselings, MD role: CONTACT phone: +32 16 33 88 18 email: [email protected] name: Orthopedic Research role: CONTACT phone: +32 16 33 88 18 email: [email protected] lat: 50.87959 lon: 4.70093 hasResults: False
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<|newrecord|> nctId: NCT06272279 id: HS23666(B2020:015) briefTitle: Neuromodulation With Spinal Stimulation Methods overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-02-01 date: 2024-02-22 date: 2024-02-22 name: University of Manitoba class: OTHER briefSummary: This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed. conditions: Spinal Cord Injuries conditions: Spinal Cord Injury at C5-C7 Level conditions: Paraplegia, Spinal conditions: Paraplegia, Incomplete studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Semi-blinded, randomized block entry design, crossover intervention study. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: The participant will be connected to the stimulation device(s) but will not know if it has been turned on during each trial. In addition, the person analyzing the outcome data will not be aware of the stimulation status of the participant. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: spinal stimulation-DCS name: spinal stimulation-sham DCS name: spinal stimulation-EPS name: sham spinal stimulation-EPS measure: Motor response measure: Motor evoked potentials measure: Blood pressure sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Manitoba status: ENROLLING_BY_INVITATION city: Winnipeg state: Manitoba zip: R3E 0J9 country: Canada lat: 49.8844 lon: -97.14704 facility: University of Manitoba status: RECRUITING city: Winnipeg state: Manitoba zip: R3E 0J9 country: Canada name: Katinka Stecina, Ph.D. role: CONTACT phone: 2047893761 email: [email protected] name: Kristine Cowley, Ph.D. role: CONTACT phone: 2047893305 email: [email protected] lat: 49.8844 lon: -97.14704 hasResults: False
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<|newrecord|> nctId: NCT06272266 id: 2021/03-26 briefTitle: The Aerobic Exercise Capacity and Muscle Strenght in Individuals With COVID-19 overallStatus: COMPLETED date: 2022-04-20 date: 2022-05-30 date: 2023-02-15 date: 2024-02-22 date: 2024-02-22 name: Selda Sarıkaya class: OTHER name: Zonguldak Bulent Ecevit University briefSummary: The subject of the project is the impact of COVID-19 on the exercise capacity of patients. The long-term sequelae of COVID-19 infection are still unknown. It is not yet clear whether pulmonary sequelae, which may be a consequence of the disease, are associated with a measurable functional deficit. In this project, the aerobic capacity of healthy people will be compared with individuals who have experienced Covid-19, and the amount of increase in aerobic capacity will be determined at the end of 15 sessions by applying a rehabilitation program including bicycle ergometry to individuals who have experienced Covid-19 Detailed description : In December 2020, in the pneumonia epidemic in which the city of Wuhan, China is the center, pneumonia developed due to the newly defined SARS-CoV-2 factor was defined as Coronavirus disease 2019 (COVID-19). It has been observed that clinical findings of SARS-CoV-2 infection in patients hospitalized in Wuhan range from mild manifestations such as asymptomatic disease and mild upper respiratory tract infection to severe viral pneumonia accompanied by respiratory failure and may result in death.The long-term sequelae of COVID19 are still unknown. Pulmonary sequelae that impair physical fitness have been predominantly defined for hospitalized patients with COVID-19. Although lung lesions have been identified as asymptomatically in infected individuals, it is not yet clear whether these observations are related to a measurable functional deficit in physical fitness. They measured the change in the predicted maximum aerobic capacity (VO2 max) of non-infected,asymptomatically infected, and recovering COVID-19 individuals with a well-established and validated physical fitness test before and after the COVID-19 outbreak among young Swiss adults.They demonstrated decreased aerobic capacity in young adults 1 to 2 months after symptomatic COVID-19 without physical strength being affected. In their study, 19% of young adults who recovered after COVID-19 had a VO2 max decrease of more than 10% compared to baseline before infection. It has been identified that decreased VO2 max value is the hallmark of interstitial lung disease. SARS-CoV-2 infection causes lung damage even in asymptomatic cases.
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A total of 64 people, including 32 people in 2 groups between the ages of 18-55, who have or have not had corona virus infection, who applied to Bülent Ecevit University Faculty of Medicine Physical Therapy and Rehabilitation or Infectious Diseases outpatient clinics for different reasons, will be included in our project. The research start date is February 2021 and the end date is February 2023. At the beginning of the study, demographic information of the individuals such as gender, age,height, weight, occupation, education, body mass index, physical activity level (international physical activity index-IPAQ), the most used hand (dominant hand) in daily life activities will be recorded. In the control group, resting heart rate, blood pressure, saturation measurement, ECG will be performed before exercise. In addition, in order to evaluate their muscle strength, microFET3 manual muscle measurement device will be used to measure the triceps muscle strength in the upper extremity they actively use, and the quadriceps muscle strength of the same side will be measured, and their grip strength will be measured with the JAMAR hydraulic hand dynamometer. Using the international physical activity index(IPAQ), activity status in daily life will be assessed. The exercise capacity of all individuals will be measured with the aid of the COSMED Quark CPET device using the bicycle ergometry test recommended by the American Society of Cardiovascular and Pulmonary Rehabilitation. In this test, submaximal exercise test will be performed by providing 25 W increase in 2 minutes periods after the warm-up period at 0 load (W) for 2 minutes. In addition, the borg scale obtained at the end of the test, metabolic equivalent of task (MET) and maximum work (W), test duration, maximum heart rate parameters will also be recorded in order to evaluate the exercise capacity.
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Individuals who have been confirmed by the previous SARS-COV 2 real-time reverse transcriptase polymerase chain reaction (RT-PCR) test to have coronovirus infection after the test will be included in a treatment program of 15 sessions, at least 3 sessions per week, with bicycle ergometry. After 15 sessions, exercise capacity will be re-evaluated using the cycling test, the aforementioned triceps and grip muscle strengths, V02 max, maximum conjugate (MET), maximum work (w), borg scale, maximum heart rate, test time parameters will be saved again after treatment. conditions: COVID-19 Pneumonia conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 41 type: ACTUAL name: Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system) name: Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). name: Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.) name: Aerobic exercise training (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.) measure: Assessment of Triceps muscle strength by using the Micro FET3 muscle strength device measure: Assessment of Maximum work (watts) ın the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of Metabolic Equivalent (MET) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of VO2peak (ml/kg/min) in the exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of VO2peakpredictive (%) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of Hand grip strength (kg) by using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). measure: Assessment of Exchange Ratio(RER ) by using cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Anaerobik Treshold (VAT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Maximum Oxygen Capacity (VO2peak) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Maximum Oxygen Capacity at Ventilatory Anaerobic Threshold (VO2AT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Carbon Dioxide Ventilatory Equivalent (VE/CO2) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Heart Rate Recovery (HRR) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Heart Rate Recovery at first minute (HRR1) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of quadriceps muscle strength by using the Micro FET3 muscle strength device measure: Assessment of Physical activity by using the International Physical Activity Questionnaire (IPAQ) measure: Assessment of Test Duration (min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of Perceived Difficulty by using the Borg Scale measure: Assessment of Maximum heart rate (beats/min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of Systolic and diastolic blood pressure (mmHg) by using a blood pressure monitor measure: Assessment of resting heart rate (beats/min) by using a a pulse oximeter sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Zonguldak Bülent Ecevit University city: Zonguldak zip: 67100 country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False
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<|newrecord|> nctId: NCT06272253 id: UNAIR-MP-INAKTIF-R-010 briefTitle: UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-19 date: 2024-03-19 date: 2024-07-19 date: 2024-02-22 date: 2024-02-22 name: Dr. Soetomo General Hospital class: OTHER_GOV name: Indonesia-MoH name: Universitas Airlangga name: PT Biotis Pharmaceuticals, Indonesia briefSummary: This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.
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The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports. conditions: COVID-19 Pandemic conditions: COVID-19 Vaccines studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 250 type: ACTUAL name: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg measure: Humoral Immune Response (Neutralizing antibody) measure: Incidence of Adverse Events measure: Humoral Immune Response - The neutralizing antibody measure: Humoral Immune Response-IgG SARS-CoV-2 neutralizing titer by CLIA measure: Exploratory Endpoints-Whole Genome Sequencing sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Dr. Soetomo General Hospital city: Surabaya state: Jawa Timur zip: 67161 country: Indonesia lat: -7.24917 lon: 112.75083 hasResults: False
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<|newrecord|> nctId: NCT06272240 id: 17380 briefTitle: Tumor Microenvironment in Ovarian Cancer acronym: MICO overallStatus: RECRUITING date: 2024-01-02 date: 2024-07 date: 2027-01 date: 2024-02-22 date: 2024-02-22 name: University of Udine class: OTHER briefSummary: A detailed understanding of molecular mechanism of cancer genesis is fundamental to develop innovative and personalized therapies. The new frontier in biomedical research is represented by organoids, a three-dimensional cell culture system obtained from a tissue fragment that accurately reproduces the essential properties of the original tissue in vitro, which could provide a valuable model for explanation of ovarian cancers pathogenesis and will allow to predict the response to a specific therapy. With this research project, we expect to generate ovarian cancer organoids to characterize in vitro interactions and molecular pathway among tumor cells, immune cells, and resident microbiota (intratumoral bacteria and/or microbial-derived molecules). conditions: Ovarian Cancer Stage III conditions: Ovarian Cancer Stage IV studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Ovarian Cancer Organoids measure: • Composition of the tumor microenvironment (including the immune system and intratumoral microbiota). • Generate organoids sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Università degli Studi di Udine status: RECRUITING city: Udine state: UD zip: 33100 country: Italy lat: 46.0693 lon: 13.23715 hasResults: False
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<|newrecord|> nctId: NCT06272227 id: 4-2023-0986 briefTitle: Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients overallStatus: NOT_YET_RECRUITING date: 2024-02-13 date: 2025-09-01 date: 2025-09-01 date: 2024-02-22 date: 2024-02-22 name: Yonsei University class: OTHER briefSummary: This study aims to investigate the potential improvement in muscle function, compared to the placebo group, through the concurrent administration of denosumab and alfacalcidol over a one-year period in postmenopausal women with functional sarcopenia and osteoporosis aged 65 and older. The study is planned as a double-blinded randomized controlled trial, intending to recruit a total of 340 participants. Primary outcome is the improvement in SPPB score of 0.5 or more compared to the control group. conditions: Sarcopenia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 340 type: ESTIMATED name: alfacalcidol name: placebo name: Denosumab measure: Improvement in SPPB score of 0.5 or more compared to the control group sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: Division of Endocrinology, Department of internal Medicine, Yonsei University College of Medicine, Severance Hospital city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06272214 id: ZJCCRT005 briefTitle: Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma in the Era of Immunotherapy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2029-03-01 date: 2024-02-22 date: 2024-02-22 name: Zhejiang Cancer Hospital class: OTHER briefSummary: This study is a multicenter, prospective, randomized phase II trial aimed at exploring the value of adjuvant radiotherapy in patients at high risk of recurrence after neoadjuvant chemoradiotherapy for esophageal cancer. The study primarily includes patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy and surgery and did not achieve complete pathological response (non-pCR) postoperatively and were defined as preoperative clinical stage at T3-4N+M0.
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Eligible patients will be randomized in a 1:1 ratio into two groups: the observation group and the adjuvant radiotherapy group. The control group consists of patients who receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer, followed by maintenance therapy with PD1/PDL1 inhibitors for up to 1 year or until tumor progression. The adjuvant radiotherapy group receives additional adjuvant radiotherapy on top of the control group's treatment. The specific treatment process involves receiving 2 cycles of neoadjuvant chemotherapy combined with immunotherapy (PD1/PDL1 inhibitors) before potentially curative esophageal cancer surgery. The chemotherapy regimen includes paclitaxel in combination with platinum agents, with a preference for albumin-bound paclitaxel (280mg/m2 on Day 1, or 100mg on Days 1, 8, and 15) in combination with carboplatin (AUC=5). Following surgery, patients start adjuvant radiotherapy 4-6 weeks after the operation, with a radiation dose of 45Gy/25F/5W, completed no later than 8 weeks post-surgery. Two weeks after completing radiotherapy, patients continue with immunotherapy maintenance therapy for up to 1 year or until tumor progression. Subsequently, follow-up visits are scheduled every 3-4 months for the first 3 years, every 6 months for the next 2 years, and annually thereafter. The primary endpoint is 2-year disease-free survival (DFS), and secondary endpoints include overall survival (OS), local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), recurrence patterns, and safety assessment. Additionally, the study will explore biomarkers predicting treatment efficacy and adverse reactions in subjects, including PD-L1 expression, ctDNA clearance status, infiltrating immune cell types and quantities, cytokine expression, and other tumor biomarkers. This exploration aims to guide stratified precision treatment for patients. conditions: Adjuvant Radiotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 146 type: ESTIMATED name: Adjuvant radiotherapy name: Observation measure: 2-year DFS measure: OS measure: LRFS measure: DMFS measure: HRQoL measure: Adverse effects recorded during radiotherapy and PD1/PDL1 inhibitors maintaince period measure: Incidence of Recurrence sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang country: China name: YANG YANG, M.D. role: CONTACT phone: +8657188128182 email: [email protected] name: Youhua Jiang role: PRINCIPAL_INVESTIGATOR name: Yongling Ji role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06272201 id: 50620 TPR briefTitle: Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study acronym: INSPIRO overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2026-08 date: 2026-08 date: 2024-02-22 date: 2024-02-22 name: USGI Medical class: INDUSTRY briefSummary: This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP). conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 186 type: ESTIMATED name: POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors measure: Percentage of total body weight loss (%TBWL) following randomization measure: Responder rate of at least 50% in the POSE2.0 treatment group measure: Safety- Incidence of device and procedure related adverse events through 12 months sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272188 id: 09.2023.1435 briefTitle: Preconception Care for Couples Planning Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-07-15 date: 2025-08-15 date: 2024-02-22 date: 2024-02-22 name: Yuzuncu Yıl University class: OTHER name: Marmara University name: Kocaeli University name: Kastamonu University name: Maltepe University name: Izmir Katip Celebi University briefSummary: Preconception care is to optimize health, address modifiable risk factors, and eliminate or reduce health-threatening factors for the woman, fetus, and newborn by working with couples to achieve a healthy pregnancy. Preconception care is the best way to protect against risks in pregnancy and plan risk management. Preconception care offers women and their partners the opportunity to gain healthy lifestyle behaviors, make conscious choices, and gain awareness of factors that threaten health before, during and after pregnancy. However, the rate of receiving preconception care is only 12.3% in our country.
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The aim of this project is to examine the effect of online preconception counseling on information and care practices for couples planning pregnancy for healthy starts.
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Materials and Methods:
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The randomized controlled experimental study will be conducted between February 1, 2024 and February 1, 2026 in the provinces of Istanbul, Izmir, Kastamonu, Ankara and Van. The population of the research will consist of all couples who applied to the marriage offices in the above provinces between February 1, 2024 and February 1, 2026. In the sample calculation, it was calculated that at least 80 couples (experimental group: 40 couples, control group: 40 couples) should be included in the study. Couples that meet the sampling criteria will be assigned to the experimental or control group according to the random numbers table. Online preconception care counseling will be provided to couples in the experimental group 1 month after their wedding date. Preconception care counseling, consisting of 17 titles, was prepared in line with the relevant literature and standardized by the researchers. After the counseling, the couples will be introduced to the preconception care website, which they can use if they need it, and will be given login information.
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Data will be obtained before and in the 3rd month after counseling with the Introductory Information Form (TBF), Preconceptional Period Risk Assessment Form, Preconceptional Care Health Literacy Scale and Preconceptional Period Health Behavior Scale. The data will be transferred to the SPSS 22 program and evaluated by the researchers. Chi-square test, t-test, Mann Whitney-U Test, Wilcoxon test and paired simple t test will be used to analyze the data. conditions: Preconception Care, Preconception Risk studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We do not use a model primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 160 type: ESTIMATED name: web-based online preconceptional counselling measure: Identifying Information Form measure: Preconceptional Period Risk Assessment Form measure: Preconceptional Care Health Literacy Scale measure: Preconceptional Period Health Behavior Scale sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Van Yuzuncu Yil University city: Van country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False
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<|newrecord|> nctId: NCT06272175 id: 10102023 briefTitle: Immediate Effects of Open and Closed Kinetic Chain Exercises on Upper Extremity in Stroke Patients. overallStatus: RECRUITING date: 2024-03-04 date: 2024-09-30 date: 2024-12-30 date: 2024-02-22 date: 2024-03-07 name: Istinye University class: OTHER briefSummary: Stroke is a sudden disruption of blood flow to the brain, resulting in physical and mental disabilities. It's a global health issue affecting millions each year, often leading to paralysis, altered muscle tone, and loss of motor control and balance. This study aims to examine the immediate effects of open and closed kinetic chain activites on upper extremity spasticity and motor dexterity in hemiplegic patients. This study will be conducted simultaneously at İstinye University Hospital Medical Park Gaziosmanpaşa and İstinye University Physiotherapy and Rehabilitation Application and Research Center (İSÜFİZYOTEM). 50 stroke patients will be included in the study, and all participants will be asked to sign an informed consent form. At the beginning of the session, all participants will be evaluated for their socio-demographic characteristics by a questionnaire created by the researchers, muscle viscoelastic properties by MyotonPRO, upper extremity muscle tone by Modified Ashworth Scale, upper extremity motor dexterity by Box and Block Test, and upper extremity joint range of motion by goniometer and by a phone application named as PhysioMaster. After the assessment, participants will be randomly assigned to two groups: open kinetic chain activity group and closed kinetic chain activity group. After performing the exercises, all evaluations will be conducted again. Thus, the aim is to understand the immediate effects of two different group exercises on the evaluated parameters. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Open Kinetic Chain Activity name: Closed Kinetic Chain Activity measure: MyotonPRO digital palpation device measure: Box and Block Test measure: Modified Ashworth Scale measure: Goniometer measure: PhysioMaster sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istinye University Hospital Medical Park Gaziosmanpasa status: RECRUITING city: Istanbul country: Turkey name: Mehmet Salih Baran, Assist. Prof. role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06272162 id: NL85622.041.24 id: 15030 type: OTHER_GRANT domain: KWF id: 23U-0725 type: OTHER domain: NedMec briefTitle: Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy acronym: LAPSTAR overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2030-01 date: 2030-01 date: 2024-02-22 date: 2024-02-22 name: UMC Utrecht class: OTHER name: Amsterdam UMC, location VUmc name: Radboud University Medical Center name: Catharina Ziekenhuis Eindhoven name: Centre for Human Drug Research, Netherlands name: Dutch Pancreatic Cancer Group (DPCG) briefSummary: A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC). conditions: Locally Advanced Pancreatic Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: MR guided radiotherapy measure: HRQoL deterioration-free survival measure: Overall survival measure: Patient reported Quality of Life EORTC QLQ-PAN26 measure: Patient reported Quality of Life EORTC QLQ-C30 measure: Patient reported Quality of Life EQ5D-5L measure: The need of subsequent treatments measure: Treatment response assessed on CT-imaging (graded according to RECIST guidelines) measure: CA 19.9 response measure: Trial@home monitoring related outcome: feasibility Withings Steel HR smartwatch measure: Trial@home monitoring related outcome: feasibility Body+ scale measure: Trial@home monitoring related outcome: feasibility Whitings Sleep measure: Trial@home monitoring related outcome: feasibility ePRO application measure: Trial@home monitoring related outcome: digital biomarkers measure: Intervention arm related outcome toxicity measure: Intervention arm related outcome, completion of therapy measure: Intervention arm related outcome diffusion weighted images sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Catharina Hospital city: Eindhoven state: Noord- Brabant zip: 5623 EJ country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: [email protected] name: H. M.U. Peulen, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.44083 lon: 5.47778 facility: Amsterdam University Medical Center, VUmc city: Amsterdam state: Noord-Holland zip: 1081 HV country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: [email protected] name: A. M.E. Bruynzeel, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Radboud University Medical Center city: Nijmegen zip: 6525 GA country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: [email protected] name: H. D. Heerkens, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 facility: University Medical Center Utrecht city: Utrecht zip: 3584CX country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: [email protected] name: L. A. Daamen, MD, PhD role: PRINCIPAL_INVESTIGATOR name: M. P.W. Intven, MD, PhD role: SUB_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False
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<|newrecord|> nctId: NCT06272149 id: VGN-R08b-001 briefTitle: An Exploratory Clinical Trial of VGN-R08b in Patients With Type II Gaucher Disease overallStatus: RECRUITING date: 2023-03-01 date: 2025-01-15 date: 2029-02-28 date: 2024-02-22 date: 2024-02-22 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER name: Shanghai Vitalgen BioPharma Co., Ltd. briefSummary: This exploratory trial is to prove the tolerability and safety of VGN-R08b to treat infants with type II Gaucher disease. conditions: Type II Gaucher Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: VGN-R08b measure: Number of Adverse Events (AEs), Serious Adverse Events (SAEs) measure: Long-term safety follow-up measure: Survival ratio at age of 24 months measure: Changes in the activity of glucose cerebroside lipase (GCase) measure: Changes in the activity of glucose cerebroside (GC) levels measure: Changes in the activity of glucose sphingosine (Lyso GL1) levels in peripheral blood and CSF after medication measure: Immunogenicity measure: Changes in the genomic level of VGN-R08b vector in peripheral blood after medication sex: ALL minimumAge: 0 Months maximumAge: 24 Months stdAges: CHILD facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200097 country: China name: Zhang Huiwen, Dr. role: CONTACT phone: 18117165075 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06272136 id: SPN-007 briefTitle: Spiden Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM) overallStatus: RECRUITING date: 2024-02-23 date: 2024-11-30 date: 2024-12-31 date: 2024-02-22 date: 2024-02-28 name: Spiden AG class: INDUSTRY name: Profil Institut für Stoffwechselforschung GmbH briefSummary: This is a single-centre, multiple sequential-cohort, open study. conditions: Type 1 Diabetes conditions: Type2diabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Clinical Demo 2.0 measure: Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Profil for Stoffwechselforschung GmbH status: RECRUITING city: Neuss state: Nordrhein-Westfallen zip: 41460 country: Germany name: Marc Stoffel, MD role: CONTACT phone: 0049213140180 lat: 51.19807 lon: 6.68504 hasResults: False
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<|newrecord|> nctId: NCT06272123 id: 20D.776 briefTitle: Endotypic Stability in CRS overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-31 date: 2026-01-31 date: 2024-02-22 date: 2024-02-22 name: Thomas Jefferson University class: OTHER name: GlaxoSmithKline briefSummary: A Case control study with 150 cases and 50 controls will be conducted. Immunologic (cytokines measurements in nasal secretions and sinonasal tissues), histopathologic (tissue eosinophilia) and clinical parameters (Lund-Mackay and Lund-Kennedy score, lung function tests), surveys (SNOT- 22, SF-36 quality of life survey) will be compared between different groups of patients conditions: Chronic Sinusitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 200 type: ESTIMATED name: no intervention measure: Endotypic markers measure: SF-36 measure: SNOT-22 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thomas Jefferson University Department of Otolaryngology status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Elizabeth Kangas, RN, BSN role: CONTACT phone: 215-955-6784 email: [email protected] lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06272110 id: 22-01303 briefTitle: Promoting Equitable Access to Language Services in Health and Human Services overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-07 date: 2025-08 date: 2024-02-22 date: 2024-02-22 name: NYU Langone Health class: OTHER name: Department of Health and Human Services briefSummary: This is a community-based study that will engage community and health care stakeholders to develop, implement, and evaluate a Health Literacy (HL)-informed, culturally- and linguistically- sensitive approach to improving language access services for patients with limited English proficiency (LEP) to promote health equity and reduce disparities in preventive health services use and health outcomes in New York City (NYC). This study will have a total of 4 phases that include a preparatory work phase (Non-Human Subjects Research), a pre-implementation phase, an implementation phase, and a post-implementation phase.
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Findings from the preparatory work and pre-implementation phase and discussions with key partners will inform the co-design of intervention strategies and endpoints for the later phases (implementation and post-implementation phase). conditions: Appropriate Use of Language Across Services studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 17500 type: ESTIMATED name: System level Language Access (LA) intervention measure: Percentage of appropriate interpreter use measure: Percentage of appropriate interpreter use measure: Percentage of patients up to date with preventive screenings and vaccinations measure: Percentage of patients up to date with preventive screenings and vaccinations measure: Percentage of patients with knowledge of federal rights related to LA services measure: Percentage of patients with knowledge of federal rights related to LA services measure: Percentage using untrained interpreters measure: Percentage using untrained interpreters measure: Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back) measure: Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back) measure: Percentage of patients with satisfaction with LA services preventive health services utilization measure: Percentage of patients with satisfaction with LA services preventive health services utilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health + Hospitals Diagnostic/Treatment Centers city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: NYC Health + Hospitals/Bellevue city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: NYC Health + Hospitals/Woodhull city: New York state: New York zip: 11206 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06272097 id: 201328 briefTitle: Postoperative Difficult-to-Heal Wounds of Clinical Trial Registration overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-11-15 date: 2024-02-22 date: 2024-02-22 name: Danni Feng class: OTHER briefSummary: This study aims to investigate the effectiveness of an optimized care management protocol for refractory postoperative wounds based on the TIME CDST tool. Through a randomized controlled trial approach, the investigators will conduct a rigorous comparative analysis of the experimental group and the control group. The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change, while the control group receive a routine wound care program of wound cleaning and dressing changes at each dressing change. The main research objective is to evaluate the superiority of the experimental group compared with the control group in terms of wound healing time, healing quality, and patient satisfaction. Through the implementation of this study, the investigators expect to provide an effective optimization scheme for the management of refractory postoperative wounds in clinical practice, thereby improving patient outcomes and quality of life. conditions: Wound Heal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Intervention program based on TIME-CDST tool led by wound specialist nurses name: A routine wound care program measure: Wound healing time measure: The wound healing rate measure: The rate of wound area reduction measure: The Pressure Ulcer Scale for Healing (PUSH) measure: The positive rate of bacterial culture measure: The pain intensity measure: Patient comfort score measure: Patient satisfaction score measure: The levels of albumin measure: The number of dressing changes measure: Medical costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272084 id: CRRT-TPE-01-DE briefTitle: Analysis of TPE Treatments With multiFiltratePRO acronym: TPEopt overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-12 date: 2024-02-22 date: 2024-04-19 name: Fresenius Medical Care Deutschland GmbH class: INDUSTRY name: X-act Cologne Clinical Research GmbH briefSummary: Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments. conditions: Autoimmune Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 60 type: ESTIMATED name: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO measure: Total amount of exchange plasma (prescribed vs achieved exchange volume) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum Aschaffenburg-Alzenau city: Aschaffenburg state: Bavaria zip: 63739 country: Germany name: Stefan Büttner, Dr. med. role: CONTACT email: [email protected] lat: 49.97704 lon: 9.15214 hasResults: False
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<|newrecord|> nctId: NCT06272071 id: 2023YFC2308802-01 briefTitle: A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Severe Hepatitis (Liver Failure) Complicated With Infection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2026-11 date: 2024-02-22 date: 2024-03-04 name: Zhejiang University class: OTHER name: Beijing Ditan Hospital name: Beijing YouAn Hospital name: Huashan Hospital name: Qilu Hospital of Shandong University briefSummary: The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with severe hepatitis (liver failure). The main questions it aims to answer are:
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* Mapping of infectious agents in patients with severe hepatitis (liver failure)
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* Constructing early warning predictive models to explore how to give an individualized regimen of integrated immune function. conditions: Liver Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 4 weeks, including site of infection and pathogen of infection. measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 8 weeks, including site of infection and pathogen of infection. measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 12 weeks, including site of infection and pathogen of infection. measure: qSOFA score at 8 weeks measure: qSOFA score at 12 weeks sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272058 id: 1366-0034 briefTitle: A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems overallStatus: RECRUITING date: 2024-03-20 date: 2024-10-01 date: 2024-10-01 date: 2024-02-22 date: 2024-03-25 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to people with and without severe liver problems. People can join the study if they are 18 to 80 years of age and have a body mass index (BMI) between 18.5 and 42 kg/m2.
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Avenciguat (BI 685509) is a medicine that is being developed to treat high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether having liver problems influences how Avenciguat (BI 685509) is taken up in the body. All participants take Avenciguat (BI 685509) once as a tablet.
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Participants are in the study for slightly longer than 1 month. Following the screening period of about 4 weeks, they stay at the study site for 4 nights. Afterwards, there are 2 visits to the study site. The site staff measures the amount of Avenciguat (BI 685509) in the blood. The doctors also regularly check participants' health and take note of any unwanted effects. conditions: Healthy conditions: Liver Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Avenciguat (BI 685509) measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) measure: Maximum measured concentration of the analyte in plasma (Cmax) measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orlando Clinical Research Center status: RECRUITING city: Orlando state: Florida zip: 32809 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: [email protected] lat: 28.53834 lon: -81.37924 hasResults: False
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<|newrecord|> nctId: NCT06272045 id: IRB00398712 id: 5U24HL163114-02 type: NIH link: https://reporter.nih.gov/quickSearch/5U24HL163114-02 briefTitle: Early Intervention to Promote Cardiovascular Health of Mothers and Children acronym: ENRICH overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-09 date: 2028-07 date: 2024-02-22 date: 2024-03-12 name: JHSPH Center for Clinical Trials class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung \& Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors. conditions: Cardiovascular Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: cluster randomized at the home visiting supervisor level, stratified within home visiting agencies whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 6400 type: ESTIMATED name: Enriched home visiting name: Routine home visiting measure: Parent physical activity measure: Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale measure: Parent body mass index measure: Parent blood pressure measure: Child body mass index sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: California Polytechnic Institute city: San Luis Obispo state: California zip: 93407 country: United States name: Noemi Alarcon role: CONTACT phone: 805-756-5694 email: [email protected] name: Suzanne Phelan role: PRINCIPAL_INVESTIGATOR lat: 35.28275 lon: -120.65962 facility: Colorado University city: Aurora state: Colorado zip: 80045-7464 country: United States name: Katharine Gamalski role: CONTACT phone: 720-499-4501 email: [email protected] name: Mandy Allison role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Northwestern University city: Chicago state: Illinois zip: 60208 country: United States name: Danielle Lorch role: CONTACT phone: 630-222-2194 email: [email protected] name: Darius Tandon role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Washington University city: Saint Louis state: Missouri zip: 63130 country: United States name: Cindy Schwartz role: CONTACT phone: 314-346-7101 email: [email protected] name: Debra Haire-Joshu role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Wake Forest University city: Winston-Salem state: North Carolina zip: 27109 country: United States lat: 36.09986 lon: -80.24422 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15260 country: United States lat: 40.44062 lon: -79.99589 facility: Pennsylvania State University city: State College state: Pennsylvania zip: 16801 country: United States lat: 40.79339 lon: -77.86 facility: Lifespan city: Providence state: Rhode Island zip: 02903 country: United States name: Angelica McHugh role: CONTACT phone: 401-793-8978 email: [email protected] name: Rena Wing role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 hasResults: False
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<|newrecord|> nctId: NCT06272032 id: 2023KFKT001 briefTitle: Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in Allergic Rhinitis overallStatus: RECRUITING date: 2023-08-01 date: 2025-07-31 date: 2025-07-31 date: 2024-02-22 date: 2024-02-22 name: Chongqing Medical University class: OTHER briefSummary: Allergic rhinitis (AR) is a common condition, with nearly 300 million affected individuals in China, significantly impacting the quality of life. Despite standardized drug treatments, approximately 20% of AR patients experience inadequate control and require surgical intervention. AR manifests as nasal itching, sneezing, clear nasal discharge, nasal congestion, primarily associated with inflammation-induced hypertrophy of nasal turbinates and a heightened neurogenic state of the nasal mucosa. Surgical treatment focuses on "reducing hypertrophy" of nasal turbinates and "desensitizing" neurogenic hyperreactivity.High-intensity focused ultrasound (HIFU), as a minimally invasive therapeutic modality in AR, is still in its early stages of application and requires further multicenter clinical studies and widespread adoption. This project collaborates with six established institutions proficient in ultrasound treatment for AR. It aims to conduct a prospective multicenter observational study and subsequent dissemination, emphasizing the application of "reduction of hypertrophy" and "desensitization" in AR.Through standardized case selection, subjective and objective measures such as subjective symptom scores, quality of life assessments, nasal reflex, and nasal resistance tests before and after treatment will be employed to evaluate the effectiveness and safety of HIFU in "reducing hypertrophy" and "desensitizing" aspects of AR. Simultaneously, building on our established Otolaryngology Head and Neck Surgery Alliance and Southwest Allergy Alliance, the research results will be promoted through lectures, hands-on guidance, training sessions, academic conferences, and other means to facilitate the application of HIFU in AR and benefit a larger population of AR patients. conditions: Allergic Rhinitis studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: High-intensity focused ultrasound (HIFU) name: intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines measure: Nasal Symptom Score measure: daily medication score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing country: China name: Shen Yang, Doctoral role: CONTACT phone: 15111953398 email: [email protected] lat: 29.56278 lon: 106.55278 hasResults: False
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<|newrecord|> nctId: NCT06272019 id: HREC-DCU 2023-074 briefTitle: Alternative Application Methods of Pre-procedural Povidone Iodine Mouthrinse overallStatus: COMPLETED date: 2023-09-01 date: 2024-04-20 date: 2024-04-20 date: 2024-02-22 date: 2024-04-23 name: Chulalongkorn University class: OTHER briefSummary: To compare the iodine remaining in saliva between gargle method and swab method conditions: The Retention of Iodine in Saliva Over the Time conditions: The Comparison of Iodine in Saliva Between Gargle and Swab studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: the participant will use iodine gargle in 2 method primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 25 type: ACTUAL name: Iodine gargle measure: The rate of retention of iodine in saliva measure: The comparison of the retention of iodine between gargle and swab sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of Dentistry, Chulalongkorn University city: Bangkok country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
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<|newrecord|> nctId: NCT06272006 id: Anatomical recession briefTitle: The Comparison of Different Root Coverage Techniques Using the Anatomical Recession Area Approach overallStatus: NOT_YET_RECRUITING date: 2024-02-24 date: 2025-03-04 date: 2025-04-05 date: 2024-02-22 date: 2024-02-22 name: Hacettepe University class: OTHER briefSummary: The goal of this clinical trial is to compare the effectiveness of two treatments for gingival recession. The main questions it aims to answer are:
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Which treatment method, Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft, is more effective in treating gum recession? How does the Anatomical Recession Rate, a new measurement technique, help in evaluating the success of these treatments?
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The patients will be treated with coronally advanced flap or modified coronally advanced tunnel + connective tissue graft to see which method is more effective in reducing gum recession, as measured by using anatomical recession rate. conditions: Gingival Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This randomized controlled trial compares two gingival recession treatments: Coronally Advanced Flap (CAF) with Connective Tissue Graft (CTG) versus Modified Coronally Advanced Tunnel (MCAT) with CTG. Participants are randomized 1:1 to either intervention. Outcomes assessors are blinded to allocation, ensuring unbiased evaluation of the primary outcome, Anatomical Recession Rate (ARR), and secondary clinical outcomes over a 12-month follow-up. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: This study implements single-blind masking where outcomes assessors are unaware of participants' group assignments to minimize bias. While blinding participants and care providers is not feasible due to the nature of surgical interventions, strict protocols ensure assessors remain blinded to treatment allocation throughout the study, enhancing outcome evaluation objectivity. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Coronally Positioned Flap with Connective Tissue Graft name: Modified Coronally Advanced Tunnel with Connective Tissue Graft measure: Anatomical Recession Rate (ARR) measure: Clinical Attachment Level (CAL) measure: Gingival Thickness (GT) measure: Keratinized Tissue Thickness (KTT) measure: Wound healing index (WHI) measure: Tissue appearance measure: Aesthetic evaluation measure: Dentin hypersensitivity sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hacettepe University city: Ankara zip: 06100 country: Turkey name: Abdullah Akman, PHD role: CONTACT phone: +905327609139 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06271993 id: 23-233 briefTitle: SPT for Sensitization of Collagen Dressing overallStatus: RECRUITING date: 2024-02-08 date: 2024-02-16 date: 2024-03-15 date: 2024-02-22 date: 2024-02-23 name: Covalon Technologies Inc. class: INDUSTRY name: ALS Beauty and Personal Care briefSummary: The goal of this clinical trial is to determine the sensitization (contact allergy) potential of the test product ColActive Plus Collagen Matrix Dressing after a skin prick test on the skin of healthy human subjects. The main question it aims to answer is:
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• Does the product induce any sensitization (contact allergy) after a skin prick using a UniTest PC (pain control) device in healthy human subjects? Participants will have the test product and both positive and negative controls applied, and skin response will be evaluated by an allergist at 15 minutes, 6 hours, and 24-48 hours post-application to see if sensitization occurs. conditions: Allergy Skin conditions: Allergic Skin Reaction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This will be a single center, with no randomization or blinding, study design in 20 healthy adult subjects, age 18-70 years. Based on prior experience approximately 30 subjects will be enrolled to ensure 20 subjects complete the study. primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: ColActivePlus Collagen Matrix Dressing measure: Wheal measurement measure: Wheal measurement measure: Wheal measurement sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ALS Beauty and Personal Care status: RECRUITING city: Torrance state: California zip: 90501 country: United States name: Ashley Glavis, BS role: CONTACT phone: 424-307-5900 email: [email protected] name: Jordan DeSantis, MHI, BS role: PRINCIPAL_INVESTIGATOR lat: 33.83585 lon: -118.34063 hasResults: False
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<|newrecord|> nctId: NCT06271980 id: 23228/ENCORE briefTitle: Early-Onset Colorectal Cancer Recurrence acronym: ENCORE overallStatus: COMPLETED date: 2023-04-15 date: 2024-02-01 date: 2024-02-01 date: 2024-02-22 date: 2024-03-12 name: City of Hope Medical Center class: OTHER name: IRCCS San Raffaele Hospital, Milan, Italy name: Institute of Biomedical Research of Salamanca, Salamanca, Spain briefSummary: Survivors of early-onset colorectal cancer (diagnosed before age 50) may experience colorectal cancer recurrence several years after curative-intent treatments, but clinical guidelines provide unclear guidance on endoscopic surveillance.
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This study aims to predict recurrence-free survival and overall survival, in survivors of early-onset colorectal cancer, using a tumor-based molecular assay based on microRNA (ribonucleic acid) conditions: Colorectal Cancer Recurrent conditions: Colorectal Cancer conditions: Colorectal Neoplasms conditions: Colorectal Adenocarcinoma conditions: Colorectal Cancer Stage I conditions: Colorectal Cancer Stage II conditions: Colorectal Cancer Stage III studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 177 type: ACTUAL name: ENCORE measure: Recurrence Free Survival measure: Overall Survival sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: City of Hope Medical Center city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 hasResults: False
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<|newrecord|> nctId: NCT06271967 id: ABT-CIP-10518 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-02-22 date: 2024-02-22 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06271954 id: 202300096A3 briefTitle: The Relationship Between Emotion Regulation and Psychiatric Disorder in Youth overallStatus: RECRUITING date: 2023-03-27 date: 2025-03-26 date: 2025-03-26 date: 2024-02-22 date: 2024-03-26 name: Chang Gung Memorial Hospital class: OTHER name: National Taiwan University Hospital briefSummary: According to the increasing worldwide prevalence rate of psychiatric disorders in youth, the mental health of youth is becoming more and more important.
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Taiwan's Ministry of Health and Welfare reported the clibing suicide rate of youth in past five years and showed the prevention work and related intervention for youth's mental health was noteable. The definition of emotion regulation was "consists of the extrinsic and intrinsic processes responsible for monitoring, evaluating, and modifying emotional reactions, especially their intensive and temporal features, to accomplish one's goals." Emotion regulation strategies including "rumination", "avoidance", "suppression", "Problem-solving", "reappraisal", "acceptance", "social support", and "distraction".
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