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In this study, the Legit.Health tool, developed by AI LABS GROUP S.L., which utilizes artificial intelligence to optimize clinical flow and patient care processes for skin conditions, will be evaluated. The purpose of this tool is to automatically prioritize patients with greater urgency, assign the type of consultation (dermatological or aesthetic), enhance diagnostic capability and detection of malignant pigmented lesions in auxiliary staff, and provide a visual record (photograph) of the condition for later review by external experts.
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Thus, the main objective of this study is to validate that Legit.Health, based on Artificial Intelligence, improves efficiency in clinical flow and patient care processes, thereby reducing time and cost of patient care through enhanced diagnostic accuracy and severity determination.
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The secondary objectives focus on measuring the diagnostic performance of Legit.Health:
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Demonstrate that Legit.Health enhances healthcare professionals\' ability to detect malignant or suspicious pigmented lesions.
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Demonstrate that Legit.Health improves healthcare professionals\' ability and precision in measuring the degree of involvement in patients with female androgenetic alopecia.
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Demonstrate that Legit.Health improves healthcare professionals\' ability and precision in measuring the degree of involvement in patients with acne.
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Additionally, the study aims to assess the utility of this tool:
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Automate the triage/initial assessment process in patients presenting with pigmented lesions.
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Evaluate the reduction in healthcare resources usage by the center by reducing the number of triage consultations and directing the patient directly to the appropriate consultation (esthetic or dermatological).
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Evaluate Legit.Health\'s usability by the patient. Demonstrate that Legit.Health increases specialist satisfaction. Evaluate the reduction in healthcare resources usage by reducing the number of triage consultations and directing the patient directly to the appropriate consultation, whether in aesthetic or dermatological settings.
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Methodology Study Design Type This is an observational study, both prospective with a longitudinal character and retrospective case series.
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Study Period This study estimates a recruitment period of 3 months. The total study duration is estimated at 6 months, including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing, data analysis, and preparation of the final study report.
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The total study duration for each participant with pigmented lesions will be 1-3 months. The duration for patients with acne and alopecia will be 1 day.
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Study Population Adult patients (≥ 18 years) with skin pathologies treated at the Dermatology Unit of IDEI. conditions: Acne conditions: Acne Vulgaris conditions: Alopecia, Androgenetic conditions: Pigmented Lesions conditions: Pigmented Skin Lesion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 150 type: ESTIMATED measure: Concordance between the physician's diagnosis and that of the tool. measure: Agreement of detected malignancy between the dermatologist and Legit.Health tool measure: Acne severity measure: Severity of alopecia sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IDEI Hospital status: RECRUITING city: Madrid zip: 28009 country: Spain name: Miguel Sánchez-Viera, PhD role: CONTACT phone: +34 915740990 email: [email protected] name: Miguel Sánchez-Viera, PhD role: PRINCIPAL_INVESTIGATOR name: Concetta Alessandro, MD role: SUB_INVESTIGATOR name: Alejandra Capote, MD role: SUB_INVESTIGATOR name: Pablo López-Andina, MD role: SUB_INVESTIGATOR name: Allison Marie Bell-Smythe Sorg, MD role: SUB_INVESTIGATOR name: Alejandra Vallejos, MD role: SUB_INVESTIGATOR name: Isabel del Campo, MD role: SUB_INVESTIGATOR name: Juliana Machado, MD role: SUB_INVESTIGATOR name: Raúl Lucas-Escobar, MD role: SUB_INVESTIGATOR name: Beatriz Torres role: SUB_INVESTIGATOR name: Alfonso Medela, MsC role: SUB_INVESTIGATOR name: Taig Mac Carthy, MsC role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06263400 id: randomized trial briefTitle: Recovery Levels of Depression Patients and Caregiver Psychoeducation overallStatus: RECRUITING date: 2022-09-01 date: 2024-12-30 date: 2024-12-30 date: 2024-02-16 date: 2024-02-16 name: Aydin Adnan Menderes University class: OTHER briefSummary: To determine the effect of psychoeducation given to patients and caregivers on patients' depression and recovery levels, caregivers' emotional expression and family burden levels. conditions: Psychoeducation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In randomization, among the patients who volunteered to participate in the study, the odd number of patients and their caregivers in the list made according to the order of hospitalization constituted the study group, and the even number of patients and their caregivers formed the control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 92 type: ESTIMATED name: psychoeducation and follow-up study measure: to patients before training measure: pre-training caregivers measure: after training measure: after training sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing status: RECRUITING city: Aydın state: Aydın/Turkey zip: 09000 country: Turkey name: şerife öztaban, MsC role: CONTACT phone: +905557130105 email: [email protected] name: Filiz ADANA, Phd role: SUB_INVESTIGATOR lat: 37.84501 lon: 27.83963 hasResults: False
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<|newrecord|> nctId: NCT06263387 id: FILObsLAM_VENAZA briefTitle: Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine acronym: VENAZA overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-11-30 date: 2025-03-30 date: 2024-02-16 date: 2024-04-18 name: French Innovative Leukemia Organisation class: OTHER name: Acute Leukemia French Association briefSummary: Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.
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Venetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN/AZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. Early access to treatment in France is close to real-life setting condition. conditions: AML, Adult studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 230 type: ESTIMATED measure: characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort measure: characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort measure: characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort measure: characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life measure: describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amiens CHU city: Amiens country: France lat: 49.9 lon: 2.3 facility: Angers CHU city: Angers country: France lat: 47.46667 lon: -0.55 facility: Avignon CH city: Avignon country: France lat: 43.94834 lon: 4.80892 facility: Bayonne CH city: Bayonne country: France lat: 43.48333 lon: -1.48333 facility: Besançon CHU city: Besançon country: France lat: 47.24878 lon: 6.01815 facility: Brest CHU city: Brest country: France lat: 48.3903 lon: -4.48628 facility: Caen CHU city: Caen country: France lat: 49.18585 lon: -0.35912 facility: CERGY PONTOISE - CH René Dubos city: Cergy-Pontoise country: France lat: 49.03894 lon: 2.07805 facility: Hôpital d'Instruction des Armées PERCY city: Clamart country: France lat: 48.80299 lon: 2.26692 facility: CHU Estaing city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 facility: Corbeil-Essonnes - Ch Sud Francilien city: Corbeil-Essonnes country: France lat: 48.60603 lon: 2.48757 facility: Créteil CHU HENRI MONDOR city: Créteil country: France lat: 48.78333 lon: 2.46667 facility: Dijon CHU city: Dijon country: France lat: 47.31667 lon: 5.01667 facility: Grenoble CHU city: Grenoble country: France lat: 45.16667 lon: 5.71667 facility: Le Mans CH city: Le Mans country: France lat: 48.0 lon: 0.2 facility: CHU Lille city: Lille country: France lat: 50.63297 lon: 3.05858 facility: Limoges CHU city: Limoges country: France lat: 45.83153 lon: 1.25781 facility: Lyon sud CHU city: Lyon country: France lat: 45.74848 lon: 4.84669 facility: Marseille IPC city: Marseille country: France lat: 43.29551 lon: 5.38958 facility: Meaux CH de l'Est francilien city: Meaux country: France lat: 48.96014 lon: 2.87885 facility: METZ-THIONVILLE CHR- Hôpital de Mercy city: Metz country: France lat: 49.11911 lon: 6.17269 facility: Montpellier - Chu Saint Eloi city: Montpellier country: France lat: 43.61092 lon: 3.87723 facility: Nantes CHU city: Nantes country: France lat: 47.21725 lon: -1.55336 facility: Nice CHU city: Nice country: France lat: 43.70313 lon: 7.26608 facility: Nimes CHU city: Nîmes country: France lat: 43.83333 lon: 4.35 facility: Paris La Pitié salpetrière city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Paris Necker city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Paris Saint Louis city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Bordeaux CHU city: Pessac country: France lat: 44.81011 lon: -0.64129 facility: Reims CHU city: Reims country: France lat: 49.25 lon: 4.03333 facility: Rennes CHU city: Rennes country: France lat: 48.11198 lon: -1.67429 facility: roubaix CH city: Roubaix country: France lat: 50.69421 lon: 3.17456 facility: Centre de Lutte Contre le Cancer H. Becquerel city: Rouen country: France lat: 49.44313 lon: 1.09932 facility: Institut de Cancérologie Lucien Neuwirth city: Saint-Priest-en-Jarez country: France lat: 45.47501 lon: 4.37614 facility: Saint Quentin CH city: Saint-Quentin country: France lat: 49.84889 lon: 3.28757 facility: ICANS - Institut de cancérologie de strasbourg europe city: Strasbourg country: France lat: 48.58392 lon: 7.74553 facility: Toulouse - IUCT Oncopole - Service d'Hématologie city: Toulouse country: France lat: 43.60426 lon: 1.44367 facility: Tours CHU city: Tours country: France lat: 47.38333 lon: 0.68333 facility: Troyes CH city: Troyes country: France lat: 48.3 lon: 4.08333 facility: Nancy CHU city: vandoeuvre les Nancy country: France lat: 48.65 lon: 6.18333 facility: Versailles CH city: Versailles country: France lat: 48.8 lon: 2.13333 facility: Villejuif IGR city: Villejuif country: France lat: 48.7939 lon: 2.35992 hasResults: False
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<|newrecord|> nctId: NCT06263374 id: 69HCL21_0355 briefTitle: Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery acronym: MAXIMAND overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-09-30 date: 2028-03-31 date: 2024-02-16 date: 2024-02-16 name: Hospices Civils de Lyon class: OTHER briefSummary: Dento-maxillary dysmorphoses are defined as an anomaly in the relative growth of the maxilla and/or mandible. They lead to functional disorders (i.e., disturbances in chewing or oral communication) and aesthetic issues with psychological repercussions on self-esteem, affecting the quality of life of these patients. The multidisciplinary treatment involves orthodontics (duration = 18-24 months), orthognathic surgery involving the maxillary and/or mandibular bone (at 12 months), immediately followed by physiotherapy (duration = 3 months). One main goal after surgery is the recovery of month opening to restore an appropriate orofacial function. Motor imagery (mental rehearsal of a movement without actually moving) is effectively used in athletes and in rehabilitation mainly neurological but so far has not been investigated in maxillofacial rehabilitation. Considering that the effectiveness of rehabilitation is increased when physical and mental practices are combined, this leads to propose this study aiming to investigate whether the addition of motor imagery of the maxillofacial region to maxillofacial physiotherapy (based on a practice of physical therapeutic exercises) modifies the recovery of maximum mouth opening, other ranges of motion, jaw function, and quality of life in patients after orthognathic surgery compared to the addition of a control cognitive task \[watching a non-emotional content film or filling out a crossword or Sudoku grid\] to maxillofacial physiotherapy. conditions: Maxillofacial Abnormalities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-centric randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: A randomization list will be centrally generated by an independent methodologist for each center and integrated into the electronic case report form. The physiotherapist will disclose the allocation to the participant during the inclusion visit, following clear, transparent, and appropriate information, and obtaining the participant's consent to participate in the study. This disclosure occurs after all measurements have been completed. The inclusion visit is scheduled 30 days ± 8 before the surgery. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Motor imagery of the jaw name: Control task (Sudoku or Crossword puzzle) measure: Maximal mouth opening measured in millimeters using a caliper measure: Active maximum mouth opening in millimeter using a vernier caliper measure: Active jaw range of motion (ROM) other than maximal opening measure: Maxillofacial pain measure: Body weight mass (kilograms) measure: Orthodontic associated treatment measure: Compliance with physiotherapy and intervention measure: Orofacial function measure: Maxillofacial quality of life measure: Level of achievement of the goals set by the patient before surgery measure: Motor imagery capability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cabinet Bataille city: Lyon zip: 69003 country: France name: Guillaume Nainani role: CONTACT phone: 0478011908 phoneExt: +33 email: [email protected] lat: 45.74848 lon: 4.84669 facility: Cabinet de kinésithérapie Saint Alexandre city: Lyon zip: 69005 country: France name: Caroline Alvarado-Faysse role: CONTACT phone: 0437410332 phoneExt: +33 email: [email protected] lat: 45.74848 lon: 4.84669 facility: Hôpital Henry Gabrielle city: Saint-Genis-Laval zip: 69230 country: France name: Sébastien Matéo role: CONTACT phone: 0478865066 phoneExt: +33 email: [email protected] lat: 45.69558 lon: 4.7934 hasResults: False
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<|newrecord|> nctId: NCT06263361 id: NCH02-2021 briefTitle: Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma. overallStatus: RECRUITING date: 2021-10-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-16 date: 2024-02-16 name: IRCCS San Raffaele class: OTHER briefSummary: Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. The aim of this study is to evaluate the MRI imaging characteristics of the peritumoral area (PTA) and to correlate this information to pathological findings. conditions: Cerebral Lymphoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: MRI imaging name: Cerebral biopsy measure: MRI imaging measure: MRI imaging measure: MRI imaging measure: MRI imaging measure: Define immunopathological features measure: Accuracy of fluoresceine guided stereotactic biopsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele Scientific Institute status: RECRUITING city: Milan zip: 20132 country: Italy name: Laura Sincinelli role: CONTACT phone: 003926435568 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06263348 id: HMM0601 briefTitle: A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-12-20 date: 2026-04-30 date: 2026-04-30 date: 2024-02-16 date: 2024-02-16 name: Hua Medicine Limited class: INDUSTRY name: Shanghai Branch, KunTuo Medical Research and Development (Beijing) Co., Ltd. briefSummary: The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin. conditions: Type2diabetes studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The marketed product - Dorzagliatin tablet (HuaTangNing®) is used as the study drug. During this study, the dosage and administration of Dorzagliatin tablets will be completely in accordance with the investigator's judgment based on the package insert and the patient's condition. primaryPurpose: TREATMENT masking: NONE count: 2000 type: ESTIMATED name: Dorzagliatin tablets measure: Incidences of ADRs and SAEs measure: Blood glucose indicators measure: Response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China name: Wenying Yang, MD,PhD role: CONTACT lat: 39.9075 lon: 116.39723 facility: China-Japan Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China name: Bo Zhang, MD,PhD role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06263335 id: Fatima Jinnah Women University briefTitle: MBI for Psychological Distress, SI and NSSI Among Young Adults overallStatus: COMPLETED date: 2022-02-28 date: 2022-05-28 date: 2022-05-28 date: 2024-02-16 date: 2024-02-16 name: Fatima Jinnah Women University class: OTHER briefSummary: Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups. conditions: Psychological Distress conditions: Suicidal Ideation conditions: Non-Suicidal Self Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Mindfulness Based Stress Reduction Intervention measure: Psychological Distress measure: Suicidal Ideation measure: Non-Suicidal Self-Injury (NSSI) sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT facility: Fatima Jinnah Women University city: Rawalpindi state: Punjab zip: 46000 country: Pakistan lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06263322 id: IRB202200419 id: R21AG073769 type: NIH link: https://reporter.nih.gov/quickSearch/R21AG073769 briefTitle: The ROAMM-EHR Study acronym: ROAMM-EHR overallStatus: RECRUITING date: 2023-11-16 date: 2026-10-17 date: 2026-10-17 date: 2024-02-16 date: 2024-02-16 name: University of Florida class: OTHER name: National Institute on Aging (NIA) briefSummary: In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes. conditions: Peripheral Arterial Disease conditions: Chronic Limb-Threatening Ischemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Randomized Clinical trial. Comparison study to test the feasibility of patient generated health data compared to standard of care post-surgical observation. primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE maskingDescription: Participants are masked to whether their PGHD are being sent to their care provider. Care providers are masked to who receives standard of care. Investigators (except for one who will be the point person for randomization) will be masked to intervention assignments. Staff assessors will be masked to whether PGHD are being sent to their care provider. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Actionable remotely generated health data name: Non-Actionable remotely generated health data measure: 6-min walk distance measure: self-reported quality of life sex: ALL minimumAge: 60 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Aging status: RECRUITING city: Gainesville state: Florida zip: 32611 country: United States name: Institute_of_Aging role: CONTACT phone: 352-273-5919 email: [email protected] name: HOBI_Department role: CONTACT phone: 352.627.9467 email: [email protected] lat: 29.65163 lon: -82.32483 hasResults: False
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<|newrecord|> nctId: NCT06263309 id: Femoralneckfracture briefTitle: Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis overallStatus: COMPLETED date: 2022-06-01 date: 2023-06-01 date: 2023-09-01 date: 2024-02-16 date: 2024-02-16 name: Istanbul University class: OTHER briefSummary: OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes.
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METHODS:
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Design: Retrospective cohort study. Setting: Academic Level I Trauma Center. Patient Selection Criteria: Included were patients with femoral neck fractures treated with DHS or cannulated screws, with follow-up data available.
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Outcome Measures and Comparisons: Main outcomes were femoral neck shortening, incidence of AVN, and Harris Hip Score (HHS) for functional assessment. conditions: Femoral Neck Fractures conditions: Femoral Neck Shortening studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 10 type: ACTUAL name: Femoral neck shortening measurement measure: Harris Hip score sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University city: İstanbul zip: 34093 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06263296 id: UW 24-055 briefTitle: Smartphone Assisted Self-management Education for Adult Burn Patient at Aftercare overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2025-06-28 date: 2025-09-30 date: 2024-02-16 date: 2024-03-05 name: Queen Mary Hospital, Hong Kong class: OTHER briefSummary: Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general population
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There is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care.
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The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report:
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1. Higher level of health-related quality of life,
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2. Higher level of self-efficacy
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3. Higher level of score in Burn Rehabilitation Knowledge
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4. Lower pain level, as measured by Numeric Pain Rating Scale; and
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5. Lower level of itchiness
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The desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period. Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care. After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.
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For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required. conditions: Burns conditions: Self Efficacy conditions: Burn Second Degree conditions: Burns Third Degree conditions: Quality of Life conditions: Adherence, Treatment conditions: Burn Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pilot Randomized Controlled Trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Only subject will be single blinded to the intervention provided whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Self Management Education measure: Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12 measure: Change from Baseline in the Generic Quality of life at Week 4 & Week 12 measure: Change from Baseline in the Burn Rehabilitation Knowledge Questionnaire measure: Change from Baseline in the Self efficacy at Week 4 & Week 12 measure: Change from Baseline in the Itchiness of life at Week 4 & Week 12 measure: Change from Baseline in the Pain level at Week 4 & Week 12 measure: Percentage in the Burn related out-patient clinic attendance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LIU Siu Kwong city: Hong Kong country: China name: Siu Kwong LIU, ANC role: CONTACT phone: 852 22557610 email: [email protected] lat: 22.39407 lon: 114.13737 hasResults: False
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<|newrecord|> nctId: NCT06263283 id: PROICM 2023-04 KYO briefTitle: Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer acronym: KYOCOL overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-02-16 date: 2024-02-16 name: Institut du Cancer de Montpellier - Val d'Aurelle class: OTHER briefSummary: Every year in France, nearly 3,000 women develop a cervical cancer. The average age of women diagnosed is 51. Uterovaginal brachytherapy is one of the reference treatments.
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To allow this treatment, an applicator is first placed under general anaesthesia in the vaginal zone. Then, the pulsed Dose Rate (PDR) or high dose rate (HDR) uterovaginal brachytherapy requires 2-5 days hospitalization in an isolated room. Uterovaginal brachytherapy requires strict bed rest without movements allowed for the pelvic area until the applicator is removed.
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Prolonged immobilization, the context of the illness and the intimacy of the area to be treated are all recognized sources of anxiety. According to a study, 40% of patients have post-traumatic stress at 3 months of treatment. A Danish team highlights the significant decrease in physical capacity during and after treatment.
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Thus, as a recent literature review concludes, there is a real need to develop Non-Pharmacological-Interventions (NPI) to limit the aftereffects. It also seems important to provide support for self-management of symptoms.
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Among NPI of interest, Yoga is a mind-body practice that can decrease perceived stress. A systematic review confirms that yoga can reduce stress during cancer treatment. This underlines the importance of proposing this practice for patients treated for all types of cancers and further evaluations on the effects of respiratory and meditation exercises. Another team showed the feasibility of respiratory exercise intervention in patients undergoing chemotherapy while also talking about mental health benefits. Finally, a reduction in perceived stress was achieved in women treated with radiotherapy for breast cancer through yoga intervention. A lot of work has been done with promising results without the result of a consensus applicable to all care situations.
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Moreover, educational requirements are high in women treated to gynecological cancer.
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Meeting these needs helps to improve quality of life, pain management and drug use.
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Integrating Patient Educational Project (PEP) therefore seems relevant as an additional tool in patient empowerment. In addition, the fact that a combined Physiotherapy-Yoga-PEP intervention is feasible in women treated for breast cancer allows us to offer adjusted version in patients with brachytherapy.
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The literature review thus invites us to propose the educational intervention Kine-Yoga-PEP in the very particular context of brachytherapy. conditions: Cervical Cancer conditions: Brachytherapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control Group: Standard care according to the modalities of each center (concomitant treatment prescription, psychological support, physiotherapy or dietetic are supports that can be proposed if needed) Experimental Group: Standard support with Daily realization of a session of Kine-Yoga supervised by a physiotherapist at J2, J3 and J4 of uterovaginal brachytherapy. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: session of Kine-Yoga measure: Evaluation of the Kine-Yoga-PEP intervention to standard care during the uterovaginal brachytherapy on perceived stress at 15 days of treatment initiation in patients treated for cervical cancer. measure: assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention measure: Evaluation of the immediate effect of the Kine-Yoga-PEP intervention in the experimental group on perceived stress, pain (overall and due to immobility) and the evolution of these parameters during brachytherapy. measure: Evaluation of the evolution of fatigue during uterovaginal brachytherapy measure: assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy measure: Description of the use of anxiolytics by group (experimental vs control) measure: Description of the experiences of patients treated for cervical cancer during uterovaginal brachytherapy receiving a Kine-Yoga-PEP intervention (approximately 20 patients in the experimental group sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06263270 id: 12-2023-01 briefTitle: Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-04-16 name: Cytonics Corporation class: INDUSTRY name: Southern Star Research Pty Ltd. briefSummary: The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are:
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1. are two doses of CYT-108, delivered 12 weeks apart, safe when injected directly into the joint?
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2. does administration of CYT-108 result in a reduction in pain, stiffness, and improvement in daily physical function?
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Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify "disease modification" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment. conditions: Osteoarthritis, Knee conditions: Osteoarthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The Phase 1a trial will be a multicenter, double-blind, randomized, placebo-controlled clinical study to evaluate the safety of two doses of CYT-108 (given at Day 1 and Day 85) in participants with mild to moderate primary OA of the knee, followed out to 26 weeks. A Screening Visit will be performed between twenty-eight days to two days before the first dose, (i.e., Days -28 to -2), and if eligible, participants will attend baseline evaluation on Day 1 to confirm eligibility before randomisation to treatment. The first and second doses will be administered on Day 1 and Day 85 (12 weeks post-first dose, with six follow-up visits on Days 8, 29, 57, 85, 113, and 183; Weeks 1, 4, 8, 12, 16, and 26 weeks post-first dose respectively). primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: This study is double-blind, placebo-controlled. Neither the investigator, care providers, patients, nor study sponsor have knowledge of the interventions assigned to each participant. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: CYT-108, a recombinant protease inhibitor name: Phosphate Buffered Saline (PBS) measure: Adverse Events measure: Blood Pressure measure: Heart Rate measure: Respiratory Rate measure: Body Temperature measure: Titer of Human Anti-Drug Antibody measure: Change in WOMAC Scores (Pain, Stiffness, and Difficulty Performing Daily Activities) measure: Time of Onset measure: Concentration of Cartilage Degradation Fragments in Blood Plasma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emeritus Research city: Camberwell state: Victoria zip: 3124 country: Australia name: Stuart Game, MD role: CONTACT phone: +61 3 9509 6166 email: [email protected] lat: -37.84205 lon: 145.0694 hasResults: False
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<|newrecord|> nctId: NCT06263257 id: 2023-631 briefTitle: The Effect of Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-10 date: 2025-04 date: 2024-02-16 date: 2024-04-16 name: Busra Nur Temur class: OTHER briefSummary: The aim of this study is to evaluate the impact of mandala art therapy on the anxiety and comfort levels of living kidney transplant recipients. While kidney transplantation improves the recipients' quality of life, it may also expose them to psychological, physical, and social challenges post-transplant. This situation can increase recipients' levels of anxiety, making them cope with psychiatric issues and affecting their comfort levels. Feeling psychologically and physiologically comfortable is a crucial component of a successful recovery process for recipients.
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Mandala art therapy is known as an effective method that supports the mental health, physical functioning, and social and emotional well-being of individuals with health issues. Mandalas can contribute to comfort by promoting inner peace, focusing attention, and encouraging creative expression. This study aims to investigate the impact of mandala art therapy on anxiety and comfort levels in kidney transplant recipients. To achieve this goal, a mixed-methods study using a randomized controlled and nested experimental design is planned.
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The results of this study will provide valuable insights to healthcare providers by elucidating the impact of mandala art therapy on comfort and anxiety levels in living kidney transplant recipients. This information may guide healthcare professionals in enhancing kidney transplant recipients' psychological and emotional well-being, reducing stress, and promoting higher levels of comfort through mandala art therapy.
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H0a: There is no effect of Mandala Art Therapy on the perceived anxiety level in living kidney transplant recipients.
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H0b: There is no effect of Mandala Art Therapy on the comfort level of living kidney transplant recipients. conditions: Anxiety conditions: Transplant;Failure,Kidney conditions: Transplant Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: For the intervention group, the first measurement (afternoon of the day before surgery) will include State-Trait Anxiety Inventory and General Comfort Questionaire, the second measurement (Postoperative Day 5 - discharge day) will include State Anxiety Inventory and General Comfort Questionaire. The sessions of the Mandala Art Therapy training program for the intervention group will be conducted as follows: Session 1 on Postoperative Day 5 - discharge day (after the scales), Session 2 on 1st Control (1 week after surgery), Session 3 on 2nd Control (2 weeks after surgery), and the third measurement at 3rd Control (1 month after surgery). For the Control Group, the third measurement (1 month after surgery) will be collected through self-reporting for State Anxiety Inventory and General Comfort Questionaire. This stage aims to conduct a randomized controlled study. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Blinding In this study, blinding of participants and the statistician is planned. Blinding of the researcher implementing the intervention will not be possible. Since participants will not know to which group they are assigned, participant blinding is considered feasible. Data related to the scales (post-test) will be coded as 'A' and 'B' without indicating whether they belong to the intervention or control group. The coded data will be analyzed by a statistician, without knowledge of group allocation. After the statistical analyses are completed, the coding for the intervention and control groups will be revealed. This blinding technique is intended to minimize statistical bias. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: Mandala Art Therapy measure: Reduction in anxiety levels measure: Increasing comfort level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06263244 id: NL83403.018.22 briefTitle: Specifying the Anti-inflammatory Effects of Ziltivekimab acronym: SPIDER overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-16 date: 2024-03-25 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics. conditions: Atherosclerosis conditions: Inflammation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, double blind, placebo-controlled trial primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: After informed consent has been obtained, patients will be randomized via computer randomization to either 15 mg ziltivekimab (n=20) or placebo (n=20). On the eCRFs or other documents subjects will be identified by subject ID and randomization number only. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ziltivekimab name: Placebo measure: TBRmax coronary arteries measure: monocyte activation marker protein expression measure: delta PCAT measure: Correlation delta TBRmax and CCTA derived plaque characteristics measure: delta SUVmax bone marrow measure: delta TBRmax ascending aorta measure: changes monocyte phenotype measure: changes in hsCRP measure: changes plasma cytokine and chemokine levels (pg/mL) measure: changes plasma cytokine and chemokine levels (ng/mL) sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06263231 id: IT-03 briefTitle: A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) acronym: INVINCIBLE-3 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2028-12 date: 2024-02-16 date: 2024-02-16 name: Intensity Therapeutics, Inc. class: INDUSTRY name: Premier Research Group plc briefSummary: To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen. conditions: Sarcoma,Soft Tissue studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 333 type: ESTIMATED name: INT230-6 name: Eribulin name: Trabectedin name: Pazopanib measure: Overall Survival (OS) measure: Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with leiomyosarcoma measure: Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with liposarcoma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06263218 id: CCR-2023-200344 briefTitle: Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil overallStatus: ENROLLING_BY_INVITATION date: 2023-10-01 date: 2024-07-30 date: 2024-12-29 date: 2024-02-16 date: 2024-02-22 name: Hospital do Rim e Hipertensão class: OTHER briefSummary: This is a single-center, non-interventional, retrospective study of data, at the level of the individual without identification, extracted from medical records of adult patients undergoing a kidney transplant procedure after 1st from January 2018 until reaching the sample size enrollment (around 500 individuals); this refers to the period of verification of individuals' eligibility for entry into the study. Individuals under strategy preemptive patients who developed CMV infection/disease within 12 months after transplantation. The data will be collected from date of transplant (including pre-transplant clinical history) until completion of at least 12 months after transplantation, or until graft loss, or recipient death or loss to follow-up, when/if applicable. conditions: CMV Infection conditions: CMV Viremia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 500 type: ESTIMATED measure: Incidence of infection, CMV disease, and tissue invasive disease. measure: Incidence recurrent CMV infection/disease measure: Incidence of refractory CMV infection/disease sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital do Rim city: São Paulo zip: 04038-002 country: Brazil lat: -23.5475 lon: -46.63611 hasResults: False
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<|newrecord|> nctId: NCT06263205 id: Dressing briefTitle: Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques acronym: Dressing overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-24 date: 2026-12-24 date: 2024-02-16 date: 2024-04-02 name: Fudan University class: OTHER name: Shanghai Changzheng Hospital name: Changhai Hospital name: Shanghai East Hospital briefSummary: The goal of this clinical trial is to assess the effectiveness and safety of non-dressing (exposed wound) versus dressing techniques in postoperative wound management for patients with gastrointestinal tumors. The main questions it aims to answer are:
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1. Does non-dressing of postoperative wounds in gastrointestinal tumor surgery provide equivalent or better wound healing compared to traditional dressing techniques?
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2. Can non-dressing of postoperative wounds reduce patient pain and healthcare costs? Participants in this study, who are diagnosed with gastrointestinal tumors and undergoing surgery, will be randomly assigned to either the non-dressing group or the dressing group. The non-dressing group will have their surgical wounds left exposed after initial postoperative care, while the dressing group will receive regular wound dressing changes every 48-72 hours. Researchers will compare these two groups to see if there are differences in the rate of wound complications, pain levels, and overall healthcare costs.
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This study aims to provide evidence-based recommendations for postoperative wound care in gastrointestinal tumor surgeries, potentially improving patient outcomes and reducing medical expenses. conditions: Gastrointestinal Tumors conditions: Surgical Wound Infection conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 816 type: ESTIMATED name: Non-Dressing of Surgical Wound name: Regular Dressing Change of Surgical Wound measure: Rate of Postoperative Wound Healing Complications measure: Patient Pain Levels measure: Medical Costs Associated with Wound Care sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center city: Shanghai state: Shanghai zip: 2000000 country: China name: Dazhi Xu, MD,PHD role: CONTACT phone: 021-64175590 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06263192 id: AMH-IUI briefTitle: Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles overallStatus: COMPLETED date: 2020-10-01 date: 2022-12-01 date: 2023-05-01 date: 2024-02-16 date: 2024-02-16 name: Jose Antonio Moreno class: OTHER name: Universitat Autonoma de Barcelona briefSummary: The goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (IAD) in non-sterile women with plasma AMH levels \> and \< 1.1 ng/mL. conditions: Infertility, Female conditions: Anti-Mullerian Hormone Deficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 342 type: ACTUAL name: Intrauterine insemination measure: Cummulative pregnancy rate sex: FEMALE minimumAge: 25 Years maximumAge: 39 Years stdAges: ADULT facility: Fertty International city: Barcelona zip: 08010 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06263179 id: STUDY00007706 id: UL1TR001412 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR001412 briefTitle: Feasibility of Aerobic Exercise for Recovery From Work-related Concussion overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-14 date: 2024-12-30 date: 2024-02-16 date: 2024-04-08 name: State University of New York at Buffalo class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion. conditions: Concussion, Brain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Target Heartrate Aerobic Exercise primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Target Heartrate Aerobic Exercise measure: Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed. measure: Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale measure: Change in Patient Health Questionnaire-9 (PHQ-9) measure: Change in Generalized Anxiety Disorder-7 (GAD-7) measure: Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5) measure: Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) measure: Work Climate Questionnaire - 6-Item Version measure: Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) measure: Time to return to work measured in days measure: Rate of adverse Events as assessed by questioning the participant sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-26 uploadDate: 2024-01-29T12:18 filename: ICF_000.pdf size: 252809 hasResults: False
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<|newrecord|> nctId: NCT06263166 id: 5535 briefTitle: The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels: A Randomized Controlled Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-12 date: 2024-02-16 date: 2024-02-16 name: Ondokuz Mayıs University class: OTHER briefSummary: Women who will undergo vaginal examinations randomly assigned to intervention (n = 44) and control (n = 44) groups at a public hospital in Turkey will participate in the study. Stress ball application before vaginal examination will be explained to women in the intervention group. These women will be asked to tighten and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed. Data regarding pain and anxiety outcomes will be collected before and after the examination.
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The main questions it aims to answer are:
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* question 1: What is the effect of stress ball application on women's anxiety level during vaginal examination?
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* question 2: What is the effect of stress ball application on women's pain level during vaginal examination? conditions: Anxiety State conditions: Pain conditions: Exanimation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 88 type: ESTIMATED name: Stress ball intervention measure: Anxiety change measure: Pain level sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06263153 id: OSU-23329 id: NCI-2024-00002 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-16 date: 2024-03-13 name: Yuanquan Yang class: OTHER name: Gateway for Cancer Research briefSummary: This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy. conditions: Bladder Urothelial Carcinoma conditions: Muscle Invasive Bladder Carcinoma conditions: Stage II Bladder Cancer AJCC v8 conditions: Stage IIIA Bladder Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Durvalumab name: Futibatinib name: Magnetic Resonance Imaging name: Radical Cystectomy measure: Complete pathologic response rate measure: Incidence of adverse events (AEs) measure: Pathologic down-staging rate to non-muscle invasive disease measure: Overall survival measure: Progression free survival measure: Frequency and severity of adverse events, including delay in cystectomy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Yuanquan Yang, MD, PhD role: CONTACT phone: 614-366-2485 email: [email protected] name: Yuanquan Yang, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
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<|newrecord|> nctId: NCT06263140 id: Chula-ARC 001/21 briefTitle: Vitamin D Levels in Non-immediate Drug Hypersensitivity Case-control Study overallStatus: COMPLETED date: 2021-05-30 date: 2022-01-15 date: 2022-02-01 date: 2024-02-16 date: 2024-02-16 name: Chulalongkorn University class: OTHER briefSummary: Serum vitamin D levels in drug-induced non-immediate reactions conditions: Stevens-Johnson Syndrome conditions: Drug Reaction With Eosinophilia and Systemic Symptom conditions: Maculopapular Exanthem conditions: Vitamin D Deficiency conditions: Drug-Induced Rash studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ACTUAL measure: Serum vitamin D levels sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Chulalongkorn University city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
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<|newrecord|> nctId: NCT06263127 id: CMUH112-REC2-104 briefTitle: Sensory Motor Interventions on Preterm Infants overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2026-01-10 date: 2026-01-10 date: 2024-02-16 date: 2024-02-16 name: China Medical University Hospital class: OTHER briefSummary: Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants. conditions: Preterm Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: oral stimulation name: infants massage measure: Oral intake measure: Transition time of oral feeding measure: weight gain measure: Hospital stay measure: Neonatal Neurobehavioral Examination-Chinese Version(NNE-C) measure: Infant/Toddler Sensory Profile-Chinese Version(ITSP-C) measure: Premature Bottle Feeding Questionnaire(PBFQ) sex: ALL maximumAge: 34 Weeks stdAges: CHILD facility: China Medical University Hospital city: Taichung zip: 404 country: Taiwan name: Yu-Rou Chiang, Bachelor role: CONTACT phone: 0910-897-089 email: [email protected] name: Pei-Yu Yang, Master role: CONTACT phone: 0975-681-610 email: [email protected] name: Pei-Yu Yang, Master role: PRINCIPAL_INVESTIGATOR name: Yea-Shwu Hwang, ScD role: SUB_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False
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<|newrecord|> nctId: NCT06263114 id: 00002826 briefTitle: Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2027-01-01 date: 2024-02-16 date: 2024-02-16 name: Children's Mercy Hospital Kansas City class: OTHER name: Eurofins briefSummary: Liver transplant rejection is when the body's immune system attacks and damages the liver of a transplant recipient. Currently the best way to see if that is happening is with a liver biopsy. The purpose of this research study is to see if a simple blood test can diagnose if a transplanted liver is being rejected. conditions: Liver Transplant; Complications conditions: Liver Failure, Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: TruGraf® Liver gene expression panel (GEP) measure: Correlation of the TruGraf® Liver GEP with rejection activity index (RAI) on surveillance and for-cause biopsy. measure: Comparison of the GEP to non-rejection injury found on biopsy measure: Utility of the GEP for monitoring liver injury sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: Children's Mercy Hospitals and Clinics status: RECRUITING city: Kansas City state: Missouri zip: 64108 country: United States name: Corey Schurman, MA role: CONTACT phone: 816-802-1167 email: [email protected] name: Amber Bagherian, MD role: CONTACT phone: 816-234-3016 name: Ryan Fischer, MD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-01-03 uploadDate: 2024-01-08T15:14 filename: Prot_000.pdf size: 353012 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-23 uploadDate: 2024-02-14T12:08 filename: ICF_001.pdf size: 244224 hasResults: False
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<|newrecord|> nctId: NCT06263101 id: ChaoyangHospital briefTitle: Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery overallStatus: RECRUITING date: 2024-02-21 date: 2024-10-01 date: 2024-10-01 date: 2024-02-16 date: 2024-04-10 name: Chaoyang Hospital of China Medical University class: OTHER_GOV briefSummary: Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI) after colorectal surgery, is characterized by symptoms such as nausea, vomiting, abdominal distension, and delayed bowel movements. The incidence of this issue varies among medical institutions, impacting patient nutrition, prolonging hospital stays, and increasing healthcare costs.
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The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD. Studies have demonstrated changes in inflammatory cells and factors in the abdominal fluid following abdominal surgery, emphasizing the clinical significance of analyzing drainage fluid to predict postoperative gastrointestinal function.
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This study analyzes inflammatory markers in drainage fluid following laparoscopic colorectal cancer surgery. The aim is to enhance the accuracy of predicting gastrointestinal recovery outcomes and contribute to the evolving field of Enhanced Recovery After Surgery (ERAS). conditions: Postoperative Gastrointestinal Dysfunction (POGD) studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 63 type: ESTIMATED name: Biochemical testing of abdominal drainage fluid name: Cytological examination of abdominal drainage fluid name: Peripheral blood cytology tests measure: Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1 measure: Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3 measure: Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 1 measure: Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 3 measure: Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 1. measure: Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 3. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chaoyang Central Hospital of China Medical University status: RECRUITING city: Chaoyang state: Liaoning country: China name: Xinao Fu role: CONTACT phone: +8618238692250 email: [email protected] lat: 41.57028 lon: 120.45861 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-01-08 uploadDate: 2024-02-12T01:53 filename: Prot_000.pdf size: 182027 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-08 uploadDate: 2024-02-12T01:52 filename: SAP_001.pdf size: 154895 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-08 uploadDate: 2024-02-12T01:37 filename: ICF_002.pdf size: 277845 hasResults: False
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<|newrecord|> nctId: NCT06263088 id: CASE15223 briefTitle: EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-06-30 date: 2026-06-30 date: 2024-02-16 date: 2024-02-20 name: Case Comprehensive Cancer Center class: OTHER briefSummary: This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).
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This study has 3 components as follows-
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1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment.
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2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant.
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3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational/informational material appropriate for participant's diagnosis. conditions: Gastrointestinal Cancer conditions: Colon Cancer conditions: Rectal Cancer conditions: Anal Cancer conditions: Esophageal Cancer conditions: Stomach Cancer conditions: Appendix Cancer conditions: Pancreas Cancer conditions: Liver Cancer conditions: Neuroendocrine Tumors studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm study to address the existing disparities faced by Black participants with gastrointestinal (GI) cancer in accessing crucial biomarker testing, receiving evidence-based care, and participating in clinical trials. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 200 type: ESTIMATED name: EQUITY GI measure: Biomarker testing rate of Black participants diagnosed with GI cancer measure: Clinical trial enrollment rate among black participants diagnosed with GI cancer measure: Change in Health literacy test among black participants diagnosed with GI cancer measure: Change in Health literacy score among black participants diagnosed with GI cancer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center city: Cleveland state: Ohio zip: 44106 country: United States name: Sakti Chakrabarti, MD role: CONTACT phone: 216-844-3951 email: [email protected] lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06263075 id: 717/2023/Oss/AOUBo id: 6822 type: OTHER domain: SirER (Emilia-Romagna Research Information System) platform briefTitle: Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM) acronym: CRASY-PRAM overallStatus: RECRUITING date: 2023-12-13 date: 2025-12 date: 2026-06 date: 2024-02-16 date: 2024-02-16 name: IRCCS Azienda Ospedaliero-Universitaria di Bologna class: OTHER briefSummary: Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated.
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Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses.
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This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements. conditions: Craniosynostoses conditions: Hypovolemia conditions: Hemorrhage conditions: Hemodynamic Instability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Intraoperative monitoring measure: Hemodynamic events occurring during surgery measure: Evaluation of changes in volemic status measure: Evaluation of changes in volemic status measure: Evaluation of changes in systemic vascular resistance measure: Evaluation of changes in cardiac function measure: Evaluation of changes in cardiac function sex: ALL minimumAge: 3 Months maximumAge: 8 Months stdAges: CHILD facility: IRCCS AOU of Bologna Policlinico Sant'Orsola status: RECRUITING city: Bologna state: BO zip: 40138 country: Italy name: Luigia Scudeller, MD role: CONTACT phone: 051 2141402 phoneExt: +39 email: [email protected] name: Barbara Lotito, MD role: CONTACT phone: 051 2141296 phoneExt: +39 email: [email protected] name: Lorena Pasini, MD role: SUB_INVESTIGATOR name: Fabio Caramelli, MD role: SUB_INVESTIGATOR name: Rosario Ruga, Student role: SUB_INVESTIGATOR name: Andrea La Placa, MD role: SUB_INVESTIGATOR lat: 44.49381 lon: 11.33875 hasResults: False
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<|newrecord|> nctId: NCT06263062 id: women undergoing colposcopy briefTitle: Management With Fear of Cancer in Women Undergoing Colposcopy: Randomized Controlled Study overallStatus: RECRUITING date: 2021-01-07 date: 2024-06-15 date: 2024-06-15 date: 2024-02-16 date: 2024-02-16 name: Alanya Alaaddin Keykubat University class: OTHER briefSummary: Cervical cancer is the fourth most common cancer in women worldwide. Due to advances in early diagnosis and treatment, the number of survivors of cancer has increased over the past 50 years. Therefore, the current standard of care for the detection of cervical neoplasm, a Papanicolaou smear and then a colposcopic biopsy, requires a high degree of diagnostic accuracy. In particular, the fear of developing cancer after cancer screening tests is becoming an increasingly significant problem, with an impact on psychosocial health in individuals. For people who are afraid of cancer, meditation and awareness training can make it easier for emotions to self-regulate in times of distress and pain. This study aim to conducted to determine the impact of the Awareness-Based Initiation Program on cancer fear and level of awareness in women undergoing colonoscopy. conditions: Cancer Fear conditions: Cervical Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Awareness-Based Coping with Fear of Cancer Programme measure: The Cancer Worry Scale measure: Philadelphia Mindfulness Scale sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alanya Alaaddin Keykubat University status: RECRUITING city: Alanya zip: 7400 country: Turkey name: fatma ozlem uner, MSc role: CONTACT phone: +905062972749 email: [email protected] lat: 36.54375 lon: 31.99982 hasResults: False
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<|newrecord|> nctId: NCT06263049 id: ejaculation post TURP briefTitle: Is Ejaculation Preservation TURis the Natural Evolution of the "Gold Standard". overallStatus: COMPLETED date: 2023-05-01 date: 2024-01-01 date: 2024-02-01 date: 2024-02-16 date: 2024-04-24 name: Ain Shams University class: OTHER briefSummary: evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 106 type: ACTUAL name: transurethral resection of prostate measure: post operative antegrade ejaculation measure: post operative urine continence sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ain shams university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06263036 id: Bilgen S briefTitle: Morphometric Examination of the Larynx overallStatus: COMPLETED date: 2013-01-10 date: 2013-06-10 date: 2013-06-10 date: 2024-02-16 date: 2024-02-16 name: Acibadem University class: OTHER briefSummary: Objective: To measure laryngeal dimensions in a sample of Turkish cadavers including males and females of various ages and heights.
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Patients and Methods: Morphological measurement was performed on 102 laryngeal specimens. Laryngeal cartilages were collected from human cadavers. All dimensions of the cartilages were measured using a thread and vernier calipers. Age, sex, and height were recorded. Results for men and women were compared. conditions: Laryngeal Dimensions in Males and Females studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 102 type: ACTUAL name: Men name: Women measure: To measure laryngeal dimensions in cadavers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06263023 id: 34L-CP-02-009 briefTitle: A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation acronym: OPTIMAL overallStatus: RECRUITING date: 2024-04-19 date: 2025-03 date: 2025-09 date: 2024-02-16 date: 2024-04-24 name: 34 Lives, PBC class: INDUSTRY name: Indiana University Health name: University of Miami name: MOUNT SINAI HOSPITAL name: University of Wisconsin, Madison briefSummary: This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals. conditions: Organ Preservation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Sub-Normothermic Machine Preservation and Assessment measure: Transplant Allocation Success measure: 7-Day Delayed Graft Function (DGF) measure: Graft Survival measure: Patient Survival measure: Serum Creatinine (sCr) measure: eGFR measure: Long term data collection- Graft Survival measure: Long term data collection- Patient Survival measure: Long term data collection- Serum Creatinine measure: Long term data collection- eGFR sex: ALL minimumAge: 16 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Miami Transplant Institute, University of Miami Miller School of Medicine status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Giselle Guerra, MD role: CONTACT name: Giselle Guerra, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Indiana University Health status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States name: William Goggins, MD role: CONTACT name: William Goggins, MD role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 facility: The Mount Sinai Hospital status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Matthew Holzner, MD role: CONTACT name: Matthew Holzner, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: University of Wisconsin School of Medicine and Public Health status: NOT_YET_RECRUITING city: Madison state: Wisconsin zip: 53792 country: United States name: Jacqueline Garonzik Wang, MD role: CONTACT name: Jacqueline Garonzik Wang, MD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06263010 id: CIBS-2023-01 briefTitle: Allopregnanolone as a Regenerative Treatment for Parkinson's Disease acronym: Allo-PD overallStatus: RECRUITING date: 2024-01-12 date: 2024-09 date: 2024-12 date: 2024-02-16 date: 2024-02-20 name: Roberta Brinton class: OTHER briefSummary: The goal of this open-label, pilot clinical trial is to test allopregnanolone as a regenerative treatment in patients with Parkinson's disease (PD). The main questions this study aims to answer are:
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1. Is a large-scale clinical trial testing how well it works in patients with PD feasible?
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2. Is allopregnanolone safe and well-tolerated in patients with PD.
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3. Can we see any signals of changes in imaging and clinical scales?
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Participants will receive a weekly infusion in their vein of allopregnanolone for a total of 12 weeks. There is no placebo so everyone receives allopregnanolone and "Open-label" means the study is not blinded so both the participant and investigators know the assigned treatment. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Allopregnanolone measure: Study completion measure: Adverse Events measure: Infusion Reactions measure: Pharmacokinetics: Peak Plasma Concentration (Cmax) measure: Pharmacokinetics: Time of peak concentration (tmax) measure: Pharmacokinetics: Half-life (t1/2) measure: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) measure: Dopamine transporter (DaT) SPECT imaging measure: MRI: Regional brain volumes measure: MRI: Fractional Anisotropy measure: MRI: Quantitative anisotropy measure: MRI: Functional connectivity measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part I (non-motor EDL) measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part II (motor EDL) measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part III (motor examination) measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part IV (motor complications) measure: Mean rate of change in the Unified Dyskinesia Rating Scale (UDysRS) total score measure: Change from baseline in Montreal Cognitive Assessment (MoCA) score measure: Change from baseline in Parkinson's disease Questionnaire (PDQ-39). measure: Change from baseline in Hamilton Depression Rating Scale (HAM-D) measure: Cambridge Cognition's Paired Associates Learning (PAL) Test measure: Cambridge Cognition's Motor Screening Task (MOT) measure: Cambridge Cognition's One Touch Stockings of Cambridge (OTS) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Arizona Clinical & Translational Science Research Center status: RECRUITING city: Tucson state: Arizona zip: 85721 country: United States name: Dakota Darby role: CONTACT email: [email protected] lat: 32.22174 lon: -110.92648 hasResults: False
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<|newrecord|> nctId: NCT06262997 id: TU-FTR-AMUTLU-2 briefTitle: Effectiveness of Pilates and Taping in Office Workers With Neck Pain overallStatus: RECRUITING date: 2024-02-15 date: 2025-02-15 date: 2025-02-15 date: 2024-02-16 date: 2024-02-23 name: Tarsus University class: OTHER briefSummary: The aim of this study is to investigate the effectiveness of pilates and kinesiotape applications in office workers with neck pain. In this direction, neck pain and disability, pain threshold, muscle strength, range of motion, core endurance, postural awareness and quality of life will be evaluated. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One group will receive only pilates training. Other group participants will receive kinesiobant application in addition to pilates training. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The researcher who will do the pilates training and taping and the other researcher who will do the pre-test and post-test are blinded. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Pilates name: Pilates and Kinesiotape measure: Neck Disability Index measure: Pain PressureThreshold measure: Muscle Strength measure: Range of Motion measure: Prone Bridge Test measure: Sits Up Test: measure: Postural Habits and Awareness Scale measure: Short Form 36 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tarsus University status: RECRUITING city: Mersin country: Turkey name: Ali Mutlu role: CONTACT name: Ali MUTLU role: PRINCIPAL_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False
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<|newrecord|> nctId: NCT06262984 id: 2023/21-754 briefTitle: Therapeutic Play Before Nasopharyngeal Swabbing in Children overallStatus: COMPLETED date: 2024-02-19 date: 2024-03-13 date: 2024-03-13 date: 2024-02-16 date: 2024-03-15 name: Maltepe University class: OTHER briefSummary: The study will be conducted with the randomized controlled experimental method. Children who apply to the Child Health and Diseases Polyclinic and Child Health and Diseases Service and who will have nasopharyngeal swab applied will be divided into two groups by drawing lots. After the randomization children in the therapeutic play group the nasal swab will be shown on the doll to the child by the researcher before being taken. The child is then allowed to play with the doll accompanied by the researcher. No intervention will be performed on children in the control group. The parents will also be found next to their children in both groups during the procedure. conditions: Behavior, Coping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 68 type: ACTUAL name: Therapeutic Play measure: Children's emotional manifestation sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Maltepe University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06262971 id: PCI-LM-Registry-2018 briefTitle: Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital overallStatus: COMPLETED date: 2018-06-01 date: 2022-12-31 date: 2023-12-31 date: 2024-02-16 date: 2024-02-16 name: Medipol University class: OTHER briefSummary: This hospital-based registry study at Istanbul Medipol University Hospital focuses on documenting and analyzing the clinical and demographic characteristics, procedural-related aspects, and both short and long-term outcomes of patients undergoing left main coronary artery percutaneous coronary intervention (PCI). The study aims to identify predictors for adverse clinical outcomes in patients treated for left main coronary artery disease. conditions: Coronary Artery Disease conditions: Left Main Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3620 type: ACTUAL name: Percutaneous coronary intervention measure: Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI measure: Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR) measure: Procedure-Related Complications Within 30 Days of PCI measure: Health-Related Quality of Life (HRQoL) Scores One Year After PCI measure: Rate of stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06262958 id: KUH5703459 briefTitle: Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent acronym: REAL-SMART overallStatus: RECRUITING date: 2017-08-07 date: 2030-06-01 date: 2030-06-01 date: 2024-02-16 date: 2024-02-16 name: Kuopio University Hospital class: OTHER briefSummary: ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it conditions: Alcoholism conditions: Substance Abuse conditions: Alcohol Dependence conditions: Alcohol-Related Disorders conditions: Substance Use Disorders conditions: Adolescent Behavior conditions: Adolescent Problem Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clients are randomized into two groups: 1) those receiving TAU and 2) those receiving a mini-intervention for substance and alcohol use an add-on treatment. primaryPurpose: TREATMENT masking: NONE count: 800 type: ESTIMATED name: ASSIST name: Treatment as usual measure: Decreased consumption of alcohol, tobacco or substances measure: BDI scores measure: GAD scores sex: ALL minimumAge: 14 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Kuopio University Hospital status: RECRUITING city: Kuopio zip: 70110 country: Finland name: Sanna Voutilainen, Res. nurse role: CONTACT phone: +358447175351 email: [email protected] lat: 62.89238 lon: 27.67703 hasResults: False
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<|newrecord|> nctId: NCT06262945 id: YDU/2024/120-1808 briefTitle: Comperasion the Postoperative Effect of Low Laser Therapy and Platelet Rich Fibrin on Mandibular Third Molar Surgery. overallStatus: COMPLETED date: 2024-01-02 date: 2024-02-06 date: 2024-02-07 date: 2024-02-16 date: 2024-02-16 name: Beste Erismen class: OTHER briefSummary: The aim of this study was investigate the comparison of postoperative effects of low laser treatment and platelet-rich fibrin application on mandibular impacted third molar tooth extraction. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 4 randomly separated groups. In group 1, PRF was applied to the tooth socket. In group 2, PRF was applied to the tooth socket combined with Low Laser Treatment extraorally to the extraction area for three days within surgery day In group 3, Low Laser Treatment was applied to the extraorally to the extraction area for three days within surgery day. In group 4 (control group), tradional osteomy was made. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation. All of the 4 groups patients were prescribed an 875/125 mg amoxicillin/clavulanic acid tablet twice daily for five days. conditions: Impacted Third Molar Tooth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 60 type: ACTUAL name: Diagnoses name: traditional osteotomies name: platelet rich fibrin name: Antibiotics, Penicillin name: low laser therapy, bicure laser name: Analgesic measure: Visual analogue scale (VAS) measure: Visual analogue scale (VAS) measure: Visual analogue scale (VAS) measure: Visual analogue scale (VAS) measure: Trismus measure: Trismus measure: Trismus measure: Trismus measure: Swelling measure: Swelling measure: Swelling measure: Swelling measure: the number of analgesic tablets measure: the number of analgesic tablets measure: the number of analgesic tablets measure: the number of analgesic tablets sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Near East University city: Nicosia state: Lefkosa zip: 99138 country: Cyprus lat: 35.17531 lon: 33.3642 hasResults: False
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<|newrecord|> nctId: NCT06262932 id: RADS regimen briefTitle: Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-04-08 name: Police General Hospital, Thailand class: OTHER briefSummary: The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen
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* Repeated dosing regimen
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* Standard dosing regimen conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Amiodarone measure: Heart rate measure: Normal sinus rhythm at 24 hours measure: Heart rate measure: Major adverse cardiovascular events measure: Phlebitis measure: Changed in heart rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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