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<|newrecord|> nctId: NCT06362668 id: RCV-0006-EU briefTitle: EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU) acronym: FASTR-EU overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2024-10-01 date: 2024-12-31 date: 2024-04-12 date: 2024-04-12 name: Reprieve Cardiovascular, Inc class: INDUSTRY briefSummary: The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence. conditions: Acute Decompensated Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Reprieve Decongestion Management System name: Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide) measure: Total sodium loss (in mmol of sodium) per 24 hours measure: Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency. measure: Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours measure: Weight loss per 24 hours at end of randomized therapy measure: Time on IV loop diuretic measure: Number of participants with ≥ 0.3 mg/dL increase in serum creatinine sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen city: Groningen country: Netherlands name: Kevin Damman, MD role: CONTACT lat: 53.21917 lon: 6.56667 facility: Wroclaw Medical University city: Wrocław country: Poland name: Jan Biegus, MD role: CONTACT lat: 51.1 lon: 17.03333 hasResults: False
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<|newrecord|> nctId: NCT06362655 id: ANID/FONDECYT 2013/1230801 briefTitle: ACTIBESE Project - Active Behaviour in School Education acronym: ACTIBESE overallStatus: ENROLLING_BY_INVITATION date: 2023-04-01 date: 2023-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Pontificia Universidad Catolica de Valparaiso class: OTHER name: Universidad de La Frontera briefSummary: The ACtive BEhaviour in School Education (ACTIBESE) project aims to assess and intervene in Chilean schoolchildren's active behaviours by examining the influence of personal, interpersonal, and school factors. This study includes a cross-sectional and intervention study involving 152 schools in the Valparaíso and Araucanía Regions, representing urban and rural areas. Participants, divided into children (8-11 years old) and adolescents (12-17 years old), will undergo a comprehensive evaluation, including sociodemographic characteristics, physical activity (PA) levels, parental and peer support, teaching styles of the teachers, and school environment characteristics.
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For the cross-sectional study, questionnaires, interviews, accelerometry, and pedometry will be used to collect data on various factors influencing PA in schoolchildren. In the intervention study, a 5-month continuous training program for teachers will be implemented, focusing on improving teaching styles and enhancing teaching competencies related to physical education and health classes. The program aims to positively affect schoolchildren's PA indirectly through improved teaching practices.
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The research will use mixed models, ANCOVA (Analysis of Covariance) , and logistic regressions for data analysis, incorporating multilevel logistic regressions to account for school-level dependencies. The study's outcomes will contribute valuable insights into the complex interactions between school, interpersonal, and personal factors influencing schoolchildren's PA, aiding the development of targeted interventions. This comprehensive approach aligns with the project's goal of fostering a physically active lifestyle among Chilean schoolchildren. conditions: Physical Inactivity conditions: Child Behavior conditions: Family Support studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention Study primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: No apply count: 144 type: ESTIMATED name: Intervention measure: Physical activity levels sex: ALL minimumAge: 9 Years maximumAge: 17 Years stdAges: CHILD facility: IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile. city: Viña Del Mar state: Valparaiso zip: 2300000 country: Chile lat: -33.02457 lon: -71.55183 hasResults: False
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<|newrecord|> nctId: NCT06362642 id: PMV-586-105 briefTitle: A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants overallStatus: RECRUITING date: 2024-03-28 date: 2024-08 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: PMV Pharmaceuticals, Inc class: INDUSTRY briefSummary: The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: The treatments will be: Day 1: single oral dose of PC14586, Day 20: oral dose of itraconazole BID, Day 21-22: single oral dose of itraconazole QD, Day 23: single oral dose of PC14586 and single oral dose of itraconazole, Day 24-27: single oral dose of itraconazole QD. primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: PC14586 name: Itraconazole measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure (AUC0-inf) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the time to peak drug concentration (Tmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the half-life (t1/2) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Identification of the incidence of treatment emergent adverse events (TEAE) of PC14586 when administered alone and co-administered with itraconazole in healthy participants. measure: Identification of vital sign abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. measure: Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. measure: Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea status: RECRUITING city: Madison state: Wisconsin zip: 53704 country: United States name: Christine Hale, MD role: CONTACT email: Christine.Hale@fortrea.com lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06362629 id: WCH240407 briefTitle: AI App for Management of Atopic Dermatitis overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-12-31 date: 2029-08-31 date: 2024-04-12 date: 2024-04-12 name: West China Hospital class: OTHER briefSummary: Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurrent rashes and itching, which seriously affects the quality of life of patients and brings heavy economic burden to society. The Treat to Target (T2T) strategy was proposed to guide optimal use of systemic therapies in patients with moderate to severe AD, and it is emphasized patients' adherence and combined evaluation from both health providers and patients. While effective treatments for AD are available, non-adherence of treatment is common in clinical practice due to the patients' unawareness of self-evaluation and lack of concern about the specific follow-up time points in clinics, which leads to the treatment failure and repeated relapse of AD.
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Hypothesis: An Artificial Intelligence assistant decision-making system (AIADMS) with implementation of the T2T framework could help control the disease progression and improve the clinical outcomes for AD.
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Overall objectives:
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We aim to develop an AIADMS in the form of smartphone app to integrate T2T approach for both clinicians and patients, and design clinical trials to verify the effectiveness and safety of the app. Methods: This project consists of three parts, AI training model for diagnosis and severity grading of AD based on deep learning, development of Artificial Intelligence assistant decision-making system (AIADMS) in the form of app, and design of a randomized controlled trial to verify the effectiveness and safety of AIADMS App for improvement of the clinical outcomes in AD patients.
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Expected results: With application of AIADMS based app, the goal of T2T for patients with AD could be realized better, the prognosis could be improved, and more satisfaction could be achieved for both patients and clinicians.
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Impact: This is the first AIADMS based app for AD management running through thediagnosis, patients' self-participation, medical follow-up, and evaluation of achievement of goal of T2T. conditions: Atopic Dermatitis conditions: Artificial Intelligence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 232 type: ESTIMATED name: Artificial Intelligence assistant decision-making system (AIADMS) App measure: The overall efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI at 12 weeks after treatment measure: The seperated efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI measure: The economic consumption measure: Satisfaction evaluation sex: ALL minimumAge: 1 Year maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362616 id: N23PBD briefTitle: Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer acronym: PAPBI-3 overallStatus: RECRUITING date: 2024-04-12 date: 2026-10-11 date: 2027-04-11 date: 2024-04-12 date: 2024-04-18 name: The Netherlands Cancer Institute class: OTHER briefSummary: This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 31 type: ESTIMATED name: Preoperative accelerated partial breast irradiation name: Breast conserving surgery name: Sentinel node procedure name: Biopsy track removal measure: Acute post-treatment toxicity measure: Fibrosis/induration measure: Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30 measure: Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23 measure: Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis measure: Cosmetic outcome according to the BCCT.core software program sex: FEMALE minimumAge: 51 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Netherlands Cancer Institute status: RECRUITING city: Amsterdam zip: 1066CX country: Netherlands name: Astrid Scholten, MD PhD role: CONTACT phone: +31205129111 email: a.scholten@nki.nl lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06362603 id: FB2022NIH briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-12 date: 2024-04-12 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06362590 id: LV-SPIND-001 briefTitle: Expanded Access Use of Ladiratuzumab Vedotin in Advanced Solid Tumors overallStatus: AVAILABLE date: 2024-04-12 date: 2024-04-12 name: Seagen Inc. class: INDUSTRY briefSummary: The purpose of this study is to provide the option of Ladiratuzumab Vedotin treatment to eligible patients in studies SGNLVA-005. studyType: EXPANDED_ACCESS name: ladiratuzumab vedotin stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362577 id: TSC202202 briefTitle: Clinical Study of HIFU for Localized Prostate Cancer acronym: HIFU overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-11-30 date: 2026-12-31 date: 2024-04-12 date: 2024-04-12 name: RenJi Hospital class: OTHER briefSummary: In this study, the safety and effectiveness data of Sonablate system, a transrectal high-intensity focused ultrasound therapeutic instrument, in the treatment of localized prostate cancer were collected, and the treatment conditions of patients with other methods (such as radical prostatectomy) were compared and analyzed. Observe the differences in treatment effect, survival rate, postoperative PSA, recurrence and complications.
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To analyze and compare the clinical outcome, postoperative complications and tumor control of HIFU and robot-assisted laparoscopic radical prostatectomy for localized prostate cancer, and to explore the effectiveness and safety of HIFU in the treatment of localized prostate cancer, so as to provide an alternative treatment for localized prostate cancer. conditions: Localized Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG measure: Incidence of postoperative complications measure: The time to reach the lowest point of PSA measure: Assessment of quality of life and sexual function spontaneously reported at 2, 6, and 12 months after surgery measure: The negative rate of tumor exclusion was evaluated by imaging (mainly mp-MRI) at 2 and 12 months after surgery measure: The incidence of biochemical recurrence that requires remedial or systemic treatment 12 months after surgery measure: Postoperative overall survival rate sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362564 id: CIPL-LBE-0101 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-12 date: 2024-04-12 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06362551 id: INC-GS-2024-002 briefTitle: Oocyte Donor Application Discrepancies overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-25 date: 2024-05 date: 2025-05 date: 2024-04-12 date: 2024-04-12 name: Inception Fertility, LLC class: INDUSTRY name: GeneScreen Counseling, LLC briefSummary: Retrospective observational study comparing information received on Inception Central Donor Recruitment's standardized online egg donor application compared to information reported during a genetic risk assessment consultation with a certified genetic counselor with contracted third party genetic counseling service, GeneScreen. All donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included. conditions: Infertility studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Rate of additional information measure: Rate of applicant decline sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Inception Fertility LLC city: Houston state: Texas zip: 77081 country: United States lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06362538 id: MCH-ProCardioPrev briefTitle: The Cardiovascular Prevention Program overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2027-04-15 date: 2024-04-12 date: 2024-04-16 name: Maria Cecilia Hospital class: OTHER briefSummary: Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. In Europe, mortality per year is equal to 2.2 million women and 1.9 million men, representing 47% and 37% of all deaths respectively. In Italy, the situation in terms of deaths due to cardiovascular diseases it is in line with the world ranking and European, being responsible for 44% of all deaths. The only interventional or pharmacological approach is neither effective nor sustainable. The most deaths from cardiovascular diseases are due to atherothrombotic events, which are attributable to a series of risk factors, most of which are modifiable. Turns out itself as a targeted action on these factors with the aim of safeguarding the state of health cardiovascular, may represent the best applicable strategy. It is therefore necessary structure and activate prevention programs aimed at the general population and groups of subjects at higher risk. conditions: Cardiovascular Prevention studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: International Physical Activity Questionnaire name: Six minute walking test name: SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21. name: MEDAS name: Intima-media thickness (IMT) name: Blood sampling name: Stool Sample Culture Test measure: measure of body mass index measure: Adherence to the Mediterranean diet measure: blood test to check cholesterol levels measure: blood pressure measurement measure: blood glucose test sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06362525 id: 2022-389 briefTitle: Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room overallStatus: RECRUITING date: 2023-10-09 date: 2025-09-30 date: 2027-09-30 date: 2024-04-12 date: 2024-04-12 name: University of Liege class: OTHER name: Centre Hospitalier Universitaire de Liege briefSummary: This observational study aims to describe the incidence of episodes of disconnected consciousness (including near-death experience (NDE)) and episodes of connected consciousness in patients admitted to the resuscitation room, who survived a critical condition and who meet at least one of these criteria during their stay in the resuscitation room: (1) deep sedation, (2) intubation, (3) cardiopulmonary resuscitation, or (4) (non-drug-induced) Glasgow Coma Scale score = 3. We also investigate the potential (neuro)physiological markers and biomarkers. In order to help determine the potential risk factors of such episodes, cognitive factors such as dissociative propensity are also investigated. Unexpected visual and auditory stimuli will be displayed. In addition, we assess the evolution of memory, as well as short- and long-term consequences on quality of life, anxiety, and attitudes towards care.
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Memory of patients who did not meet the above-mentioned criteria are also investigated. A group of 15 healthy participants will be invited to test the stimuli display.
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Finally, (neuro)physiological parameters of a subsample of dying patients are also investigated. conditions: Critical Illness conditions: Near-Death Experience conditions: Consciousness, Loss of conditions: Quality of Life conditions: Emergencies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Detection of potential episodes of disconnected consciousness measure: Detection of potential episodes of connected consciousness measure: Risk factors measure: Quality of life assessment measure: Memory content and evolution assessment measure: Detection of post-traumatic stress disorder (PTSD) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU of Liège status: RECRUITING city: Liège zip: 4000 country: Belgium lat: 50.63373 lon: 5.56749 hasResults: False
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<|newrecord|> nctId: NCT06362512 id: Marco_PANG_2024 briefTitle: Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes. acronym: COGMOTION overallStatus: RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-12 date: 2024-04-16 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The purpose of this study is to evaluate a cognitive-motor exercise on dual-task interference during dual-task ankle movement and the corresponding alterations of brain activity. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After stratification according to gender and walking speed, the participants will be randomly allocated to one of three groups: (1) dual-task training, (2) single-task training, and (3) control intervention, using a 1:1:1 allocation ratio. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This will be a single-blinded randomized controlled trial . The assessor will be blinded during assessments. The participants and investigators (trainers) are not possible to be blinded as it is an exercise intervention. whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Dual-task training name: Single-task training name: Upper limb strengthening exercise measure: Dual-task step frequency measure: Dual-task cognitive performance accuracy measure: Blood oxygenation level changes of the brain measure: Single-task walking speed measure: Dual-task walking performance measure: Mini Balance Evaluation Systems Test measure: Activities-specific Balance Confidence Scale measure: Trail Making Test measure: Digit Span Test measure: Montreal Cognitive Assessment measure: Fall incidence measure: Dual-task ankle movement degree measure: Dual-task cognitive performance time sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong zip: 000000 country: China name: Marco Yiu Chung Pang, PhD role: CONTACT lat: 22.39407 lon: 114.13737 hasResults: False
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<|newrecord|> nctId: NCT06362499 id: 01 briefTitle: Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients. overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-31 date: 2024-07-31 date: 2024-04-12 date: 2024-04-17 name: Universidade Federal do Rio Grande do Norte class: OTHER briefSummary: Dysfunctional breathing and persistent hypocapnia can be associated with many of the symptoms experienced by patients such as dyspnea, fatigue, chest pain and palpitations. The identification of dysfunctional breathing and hypocapnia in these patients is important as it may represent a target for treatment.
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In many of these patients, tachypnea at low levels of exertion suggests increased respiratory muscle activity, which can lead to the sensation of dyspnea. Sympathetic hyperactivity leads to excessive and irregular ventilation during exercise. In this way, inspiratory muscle training can improve symptoms (dysfunctional breathing), possibly by attenuating the metaboreflex (vagal modulation-attenuation of the sympathetic response) of the inspiratory muscle in post-covid-19 subjects, reducing ventilatory variability. conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Experimental Group measure: Ventilation variability and ventilation efficiency measure: Respiratory muscle strength measure: Pulmonary function measure: Quality of life - Medical Outcomes Study 36-Item Short Health Form Survey (SF-36) measure: Peripheral muscle strength measure: Functional capacity measure: Adverse effects and adherence sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Federal University of Rio Grande do Norte status: RECRUITING city: Natal state: Rio Grande Do Norte zip: 59082-100 country: Brazil name: Gabriely Azevêdo role: CONTACT phone: 84999390004 email: gabrielyazevedo.ga@gmail.com name: Patrícia Nogueira role: CONTACT lat: -5.795 lon: -35.20944 facility: Patrícia Nogueira status: RECRUITING city: Natal state: Rio Grande Do Norte country: Brazil name: Patrícia Nogueira role: CONTACT name: Gabriely Azevêdo role: CONTACT phone: 5584999390004 email: gabrielyazevedo.ga@gmail.com lat: -5.795 lon: -35.20944 hasResults: False
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<|newrecord|> nctId: NCT06362486 id: SIGNATURE briefTitle: Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment overallStatus: ACTIVE_NOT_RECRUITING date: 2021-08-01 date: 2023-08-01 date: 2024-08-01 date: 2024-04-12 date: 2024-04-12 name: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla class: OTHER briefSummary: The Covid19 pandemic, paradoxically, represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge about the relationship between inflammation, brain development and an increased risk of suffering from neuropsychiatric disorders or alterations. In addition, the current availability of sophisticated biological techniques and evaluation procedures represents an unique option for this purpose.
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Here, we propose a cohort study of sars-cov-2 (type 2 coronavirus causing severe acute respiratory syndrome) infected pregnant women and newborns. We will try to answer the following questions: (i) what is the inflammatory / immune status of newborns (NBs) of mothers infected by Covid19 like?; (ii) is there a relationship between the clinical characteristics of the maternal infection (severity / moment / of infection) and the inflammatory status of the newborn?; (iii) could these features increase the vulnerability to developing central nervous system (CNS) alterations at an early age, and at some point during adult life ?; (iv) How is the Covid19 infected mother's placenta altered? Do the placental alterations Covid19 mediated contribute to develop CNS alterations?; (v) is the infection associated with phenotypes obtained through neurological and neurodevelopmental clinical evaluation (hypotonia, clumsiness, impaired communication and sociability) in children at 6 months and 12 months?
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Our main objective is to explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn, which is associated with neurodevelopmental disorders and which confers a greater risk of developing neuropsychiatric disorders. The biological information of the umbilical cord (fetus blood) and peripheral blood of the mother obtained after childbirth was provided by the cohort of women during the Covid19 pandemic monitored during their pregnancy, delivery, childbirth and postpartum. These samples and the clinical characterisation of the cohort of mothers and newborns, of which we will be able to do an exhaustive longitudinal follow-up, are tremendously valuable at this time. There is a need to establish new research strategies to understand the pathophysiology of neuropsychiatric diseases, and to discover new molecular and cellular mechanisms involved in the development of the CNS. conditions: Covid19 and Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Severity of infection, time of infection. name: Mental health assessment name: biological measure: explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Virgen del Rocío city: Sevilla zip: 41013 country: Spain lat: 37.38283 lon: -5.97317 hasResults: False
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<|newrecord|> nctId: NCT06362473 id: LIPIGEN-001 briefTitle: Lipid Transport Disorder Italian Genetic Record (LIPIGEN) acronym: LIPIGEN overallStatus: RECRUITING date: 2015-08-04 date: 2026-09-30 date: 2026-09-30 date: 2024-04-12 date: 2024-04-12 name: Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi) class: OTHER briefSummary: LIPIGEN is an observational study involving Italian physicians and researchers in the field of diseases related to blood lipid levels. This study aims to improve the diagnosis and treatment of people with familial dyslipidaemias, including very common conditions such as familial hypercholesterolaemia (FH) and less common ones such as familial chylomicronidaemic syndrome (FCS).
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What does the study do?
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It collects information on Italian patients with Familial Hypercholesterolaemia (FH), following them in their normal clinical examination without adding extra procedures.
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It uses the data collected to further our understanding of diseases such as familial hypercholesterolaemia, examining how it is diagnosed clinically and by genetic testing, and evaluating the effectiveness of different treatments.
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It seeks to identify the genetic mutations that cause familial hypercholesterolaemia and other dyslipidaemias, helping to choose the most effective treatments.
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It evaluates the impact of long-term treatments and patient adherence to medication, as well as monitoring the incidence of cardiovascular events and other important outcomes.
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Who can participate?
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The study is aimed at people of all ages, from children to adults, with familial hypercholesterolaemia or other genetic dyslipidaemia.
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More than 50 centres throughout Italy are involved, making the study accessible to many.
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What does participation entail?
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Participants will continue with their normal clinical practice.
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Data such as family history, personal clinical findings and genetic information will be collected, without additional procedures.
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For some, further evaluations, such as ultrasounds, may be required to better study their condition.
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The LIPIGEN study not only helps to better understand diseases related to high cholesterol but also aims to improve patients\' lives through more precise diagnosis and personalised treatments. conditions: Familial Hypercholesterolemia conditions: Genetic Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 10000 type: ESTIMATED name: Lipid-lowering treatments measure: Lipid profile of patients with genetic dyslipidemia measure: Genetic profile of patients with genetic dyslipidemia sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Multimedica status: RECRUITING city: Sesto san Giovanni state: Milano zip: 20099 country: Italy name: Fabio Pellegatta, MD role: CONTACT phone: 00390224209593 email: lipigen@sisa.it name: Fabio Pellegatta, MD role: PRINCIPAL_INVESTIGATOR lat: 45.53329 lon: 9.22585 hasResults: False
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<|newrecord|> nctId: NCT06362460 id: RAY1216-23-03 briefTitle: Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China overallStatus: COMPLETED date: 2023-09-18 date: 2023-11-01 date: 2023-11-15 date: 2024-04-12 date: 2024-04-16 name: Guangdong Raynovent Biotech Co., Ltd class: INDUSTRY briefSummary: This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \[14C\]RAY1216 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of RAY1216. conditions: Pharmacokinetics studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 6 type: ACTUAL name: [14C] RAY1216 measure: Total radioactivity in plasma PK measure: Total radioactivity in plasma PK measure: Total radioactivity in plasma PK measure: Total radioactivity in plasma PK measure: Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae) measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The First Affiliated Hospital of Bengbu Medical College city: Bengbu country: China lat: 32.94083 lon: 117.36083 hasResults: False
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<|newrecord|> nctId: NCT06362447 id: RC31/22/0320 briefTitle: Efficacy of Injectable Gentamicin in Hereditary Ichthyosis acronym: GENTIC overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2026-04-01 date: 2027-04-01 date: 2024-04-12 date: 2024-04-12 name: University Hospital, Toulouse class: OTHER briefSummary: This study will evaluate the efficacy and safety of intravenous gentamicin in congenital ichthyosis due to a non-sens mutation. The primary objective is the severity of scales and erythema at the third month, compared to baseline. Secondary objectives will include: the importance of itching, trans epidermal water loss, cutaneous expression of the targeted protein, the security of the drug and patients' satisfaction. conditions: Ichthyosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 26 type: ESTIMATED name: Gentamicin Injectable Solution measure: Gentamicin efficacity measure: Gentamicin efficacity measure: Gentamicin efficacity on quality of life sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Saint-Louis APHP city: Paris zip: 75010 country: France name: BOURRAT Emmanuelle, MD role: CONTACT phone: 01 42 49 90 90 phoneExt: 33 email: emmanuelle.bourrat@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU de Toulouse city: Toulouse zip: 31059 country: France name: SEVERINO-FREIRE Maella, MD role: CONTACT phone: 05 67 77 81 41 phoneExt: 33 email: severino-freire.m@chu-toulouse.fr name: TEXIER Hélène role: CONTACT phone: 05 67 77 81 80 phoneExt: 33 email: texier.h@chu-toulouse.fr name: MAZEREEUW-HAUTIER Juliette, MD, PhD role: SUB_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False
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<|newrecord|> nctId: NCT06362434 id: UHN-HHREHAB-24-xxxx briefTitle: Visual Telerehabilitation in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour acronym: HHREHAB overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-01 date: 2027-06-01 date: 2024-04-12 date: 2024-04-12 name: University Health Network, Toronto class: OTHER name: Alberta Children's Hospital name: St. Justine's Hospital name: The Hospital for Sick Children name: British Columbia Children's Hospital briefSummary: Brain malignancies are the most common cause of death from cancer in the pediatric population and a major source of morbidity amongst survivors. Many children with a brain tumour often suffer from visual field defects (hemianopia) dramatically impacting their daily life with poorer social interaction, difficulties learning, playing sports and engaging with peers. Practically, they bump into people and objects and have problems in finding their way in unfamiliar places and in detecting incoming objects in their blind field. There is growing recognition of the diverse and deep impact of hemianopia on physical and mental health, quality of life, and social outcomes of the affected individuals and their family. However, despite the frequent impact of brain tumours on the visual function and functional vision, ophthalmologic evaluations are not standard of care for all brain tumour patients and there are no standardized protocols of vision loss management in the pediatric population with hemianopia. There is an unmet need of restoring perception in the blind field in individuals with hemianopia consecutive to pediatric brain tumor.
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Our laboratory has developed a visual rehabilitation procedure based on the combination of adaptative audio and visual target tracking in a 3D environment in virtual reality. Participants perform audiovisual stimulation at home in a headset, with remote control from the laboratory. Preliminary on data on paediatric patients with hemianopia consecutive to a brain tumour indicate feasibility and potential effectiveness of a 6-week Re:Vision program on visual fields, visual perception and quality of life.
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Our objective is to evaluate the effectiveness of Re:Vision, an 8-week visual telerehabilitation program, on visual perception in 50 individuals aged 10-40 years old with hemianopia consecutive to a pediatric brain tumor in a phase IIa/b multi-centric clinical study across Canada.
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This intervention provides more equitable access to individuals, with the ability to receive rehabilitation therapy at home without supervision by a healthcare professional, meaning that Canadians living outside urban centres could take advantage of specialized therapies with remote supervision. This is the first study that could lead to a major change in the management of these patients. It could open the door for visual rehabilitation strategies to other population of visually impaired children, significantly impacting public health strategies. conditions: Hemianopsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Audiovisual stimulation measure: Binocular Visual Field measure: Patient-related Outcome Measures - National Eye Institute - Visual Function Questionnaire - 25 measure: Patient-related Outcome Measures - World Health Organization - Quality of Life questionnaire - BREF measure: Reading Speed measure: Fixation Stability measure: Contrast Sensitivity measure: Brain Activity - Visually-evoked potentials measure: Retinal Integrity measure: Brain imaging - Tractography measure: Brain imaging - Retinotopy measure: Head tracking measure: Eye tracking sex: ALL minimumAge: 10 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Alberta Children's Hospital city: Calgary state: Alberta zip: T3B 6A8 country: Canada name: Lucie Lafay-Cousin, MD role: CONTACT phone: 403-955-7272 email: llafayco@ucalgary.ca name: Lucie Lafay-Cousin, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: British Columbia Children's Hospital city: Vancouver state: British Columbia zip: V6H 3N1 country: Canada name: Sylvia Cheng, MD role: CONTACT phone: 604-875-2406 email: sylvia.cheng@cw.bc.ca name: Sylvia Cheng, MD role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 facility: The Hospital for Sick Children city: Toronto state: Ontario zip: M5G 1E8 country: Canada name: Eric Bouffet, MD role: CONTACT phone: 416-813-7500 email: eric.bouffet@sickkids.ca name: Eric Bouffet, MD role: PRINCIPAL_INVESTIGATOR name: Uri Tabori, MD role: SUB_INVESTIGATOR name: Inci Yaman Bajin, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Centre Hospitalier Universitaire Sainte-Justine city: Montreal state: Quebec zip: H3T 1C5 country: Canada name: Sebastien Perreault, MD role: CONTACT phone: 514-345-2372 email: s.perreault@umontreal.ca name: Sebastien Perreault, MD role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 facility: CHU de Québec city: Québec state: Quebec zip: G1J 1Z4 country: Canada name: Valerie Larouche, MD role: CONTACT phone: 418-654-2282 email: valerie.larouche@fmed.ulaval.ca name: Valerie Larouche, MD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False
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<|newrecord|> nctId: NCT06362421 id: ONC-HN-2402 briefTitle: Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-07 date: 2024-04-12 date: 2024-04-12 name: Wake Forest University Health Sciences class: OTHER name: InnoTech Precision Medicine briefSummary: The purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer. In this study, the methods required to detect human papillomavirus will be developed and tested in samples collected from patients with oropharyngeal squamous cell carcinoma and compared to samples collected from participants without cancer. conditions: Oropharyngeal Squamous Cell Carcinoma conditions: Human Papillomavirus Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Pre-Radiation Dental Evaluation/Sample Collection name: Pre-Study Visit name: Oral Medicine Consultation Visit/Sample Collection measure: Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB measure: Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB measure: Overall Accuracy - All Participants sex: ALL minimumAge: 39 Years maximumAge: 59 Years stdAges: ADULT facility: Hayworth Cancer Center city: High Point state: North Carolina zip: 27262 country: United States name: Study Coordinator role: CONTACT phone: 336-713-1790 email: cbynum@wakehealth.edu lat: 35.95569 lon: -80.00532 facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Study Coordinator role: CONTACT phone: 336-713-1790 email: cbynum@wakehealth.edu name: Muhammad A Shazib, DMD role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 hasResults: False
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<|newrecord|> nctId: NCT06362408 id: PLAGH-DEX-PSM/IPTW-001 briefTitle: Effect of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients overallStatus: COMPLETED date: 2022-06-01 date: 2023-05-25 date: 2023-06-01 date: 2024-04-12 date: 2024-04-12 name: Chinese PLA General Hospital class: OTHER name: Beijing Tiantan Hospital name: First Affiliated Hospital of Guangxi Medical University name: The Affiliated Hospital Of Guizhou Medical University name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School name: Wuhan Union Hospital, China name: Fudan University briefSummary: China's aging population is causing an increase in the number of senior persons undergoing surgery. More and more clinicians are paying attention to the postoperative survival and mental health of elderly surgical patients.
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Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. DEX has the potential to prevent and treat postoperative anxiety and depression in elderly patients undergoing non-cardiac surgery.
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Further exploration of evidence for evidence-based medicine is needed. Based on the above research background, this hypothesis is proposed: in elderly patients undergoing noncardiac surgery, intraoperative DEX is associated with a reduction in short-term postoperative mental disorders and a reduction in long-term postoperative mortality. conditions: Cohort Studies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 6000 type: ACTUAL name: Dexmedetomidine measure: Postoperative mortality rate measure: The incidence of postoperative delirium measure: The incidence of postoperative anxiety measure: The incidence of postoperative depression measure: Postoperative sleep disorders measure: Surgical related complications measure: Postoperative quality of life evaluation sex: ALL minimumAge: 65 Years maximumAge: 110 Years stdAges: OLDER_ADULT facility: Chinese PLA General Hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362395 id: 24-5022 briefTitle: Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction acronym: ULTRAS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2030-06 date: 2030-06 date: 2024-04-12 date: 2024-04-12 name: University Health Network, Toronto class: OTHER briefSummary: This international multi-centre phase 3 randomized control trial investigates whether giving a very high dose of radiation in a single treatment session (ultra-high dose: experimental) using advanced technology called MR-Linac is more effective than a high dose (control) for treating liver tumors that have spread from other parts of the body (liver metastases). This study also aims to identify predictors of treatment response and side effects by analyzing various factors such as imaging markers and genetic profiles.
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Liver metastases are common in several cancers, but surgery is often not feasible for many patients. Stereotactic body radiotherapy (SBRT), which delivers focused radiation to tumors, is an alternative treatment option. Previous studies have shown promising results with SBRT, but the optimal radiation dose for liver metastases is still uncertain.
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This study will look at patients with specific types of primary cancers known to respond well to SBRT. Treatment effectiveness will be assessed by monitoring tumor control, overall survival, and quality of life.
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By comparing ultra-high dose SBRT with standard high dose, the study aims to determine if the former can provide better tumor control with fewer side effects. If successful, this approach could offer a significant advancement in the treatment of liver metastases, potentially improving outcomes and quality of life for patients. conditions: Liver Metastases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 114 type: ESTIMATED name: Magnetic resonance (MR)-guided stereotactic ablative single-fraction (SBRT) measure: Local control (LC) of treated target lesion compared to high dose MR-guided stereotactic single-fraction radiation. measure: Overall survival (OS) measure: Progression free survival (PFS) measure: Intra-hepatic progression measure: Widespread progression. measure: Physician-assessed toxicities: National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5. measure: Patients-reported toxicity: Patient Reported Outcomes - Common Terminology Criteria of Adverse Events (PRO CTCAE) V.1. measure: Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, Core 15 for Palliative Care (EORTC QLQ-C15-PAL) measure: Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, liver metastases (EORTC QOQ-LM21). measure: Changes in the levels of circulating biomarkers (cell-free tumor DNA) in response to SBRT. measure: Changes in the levels of circulating biomarkers (cytokines) in response to SBRT. measure: Changes in the levels of circulating biomarkers (metabolites) in response to SBRT. measure: Changes in the levels of circulating biomarkers (immune cell populations) in response to SBRT. measure: Identification of MR imaging biomarkers in response to SBRT. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362382 id: 2024-zxm-01 briefTitle: Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-04-22 date: 2026-05-01 date: 2024-04-12 date: 2024-04-12 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn the effectiveness of remote home-based exercise rehabilitation using mobile Internet technology for patients with pulmonary hypertension，especically providing early and mid-term results of its effectiveness. The main questions it aims to answer are:
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Dose tele-rehabilitation training improves prognostic function and quality of life in patients with pulmonary hypertension？ Researchers will compare tele-rehabilitation training group to a control group (receive health propaganda and education, and then follow their daily routine after discharge from the hospital) to see if tele-rehabilitation training works to improve prognosis.
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Participants will:
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During their stay in the hospital, the patients of tele-rehabilitation training group were accompanied by a rehabilitation trainer and a psychotherapist for a complete cycle of (7 days ± 3 days 1 week/times) standardized training. The scheme of rehabilitation is impedance training. A specialized professional team including cardiologists, rehabilitation trainers, psychotherapists and radiologists were involved. After discharge from the hospital, patients in the rehabilitation group underwent 3-5 weekly daily training sessions and intensive supervision and management by the online community at least once a week.
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Visit the clinic at the 3rd month of the study. Extended follow-up up to 6 months may be considered if patients are cooperative and could complete the training program in the first 3 months. conditions: Pulmonary Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: tele-rehabilitation training name: health propaganda and education measure: changes in 6MWD after 3 months measure: changes in muscle mass after 3 months measure: peak VO2 measure: VO2peak% measure: VE/VCO2 slope measure: PET CO2 measure: Changes in muscle mass evaluated by CT measure: Changes in grip strength measure: the time for 5 sit-to-stand test measure: Quality of life measured by SF-36 after 3 months measure: Quality of life measured by SF-36 after 6 months measure: Quality of life measured by emPHasis-10 after 3 months measure: Quality of life measured by emPHasis-10 after 6 months measure: Changes in WHO Cardiac Function Classification measure: Change in NT-proBNP measure: Change in TAPSE by cardiac doppler ultrasound measure: Changes in hemodynamic indice after 6 months measure: Changes in sleep quality score after 3 months measure: Changes in sleep quality score after 6 months measure: Changes in psychosocial score after 3 months measure: Changes in psychosocial score after 6 months measure: All-cause mortality in 3 months measure: All-cause mortality in 6 months measure: The occurrence rate of primary events in pulmonary hypertension in 3 months measure: The occurrence rate of primary events in pulmonary hypertension in 6 months sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Fuwai Hospital city: Beijing state: Beijing zip: 100037 country: China name: Xiaoming Zhou, MD role: CONTACT phone: +86 88396992 email: zhouxmcmu@163.com name: Xiaoming Zhou, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362369 id: 7HP-111 briefTitle: A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-12-31 date: 2028-12-31 date: 2024-04-12 date: 2024-04-12 name: 7 Hills Pharma, LLC class: INDUSTRY briefSummary: This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.
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Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b conditions: Advanced Cancer conditions: Advanced Solid Tumor conditions: Melanoma conditions: Metastasis conditions: Pleural Mesothelioma conditions: Renal Cell Carcinoma conditions: MSI-High conditions: Mismatch Repair Deficiency conditions: Colorectal Cancer conditions: Hepatocellular Carcinoma conditions: Hepatocellular Cancer conditions: Renal Cell Cancer conditions: Kidney Cancer conditions: Skin Cancer conditions: Non Small Cell Lung Cancer conditions: NSCLC conditions: Anaplastic Lymphoma Kinase Genomic Tumor Aberrations conditions: ALK Genomic Tumor Aberrations studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE maskingDescription: Phase 1b - Open Label count: 126 type: ESTIMATED name: Alintegimod name: Ipilimumab name: Nivolumab measure: Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0 measure: Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0 measure: Define RPTDs for Alintegimod measure: Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Maximum Plasma Concentration (Cmax) measure: Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Area Under the Curve (AUC) measure: Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Maximum Plasma Concentration (Cmax) measure: Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Area Under the Curve (AUC) measure: Determine Progression Free Survival (PFS) response in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 tumor assessment criteria. measure: Determine Overall Response Rate (ORR) in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 response assessment criteria. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Florida Cancer Specialists city: Lake Mary state: Florida zip: 32746 country: United States name: Study Coordinator role: CONTACT phone: 407-804-6133 name: Alexander Philipovskiy, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 28.75888 lon: -81.31784 facility: Dartmouth Hitchcock city: Lebanon state: New Hampshire zip: 03756 country: United States name: Study Coordinator role: CONTACT phone: 603-650-6345 name: Konstantin H Dragnev, MD role: PRINCIPAL_INVESTIGATOR lat: 43.64229 lon: -72.25176 facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Study Coordinator role: CONTACT phone: 713-792-4259 name: Apostolia-Maria Tsimberidou, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06362356 id: 24-106 briefTitle: Microbial Metabolites and Outcomes of Pregnancy Study acronym: MMOPS overallStatus: RECRUITING date: 2024-03-05 date: 2026-12-31 date: 2026-12-31 date: 2024-04-12 date: 2024-04-18 name: The Cleveland Clinic class: OTHER briefSummary: Emerging data connect diet, the gut microbiota and its metabolites in cardiometabolic disease. Hypertensive disorders of pregnancy (HDP) are common and are a leading cause of maternal and neonatal morbidity. HDP likely share similar pathophysiology as cardiometabolic disease in non-pregnant people with a yet unrevealed role of diet and the gut microbiota, including systemic inflammation and endothelial dysfunction.
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Despite high biological plausibility that nutrition, the gut microbiota and its metabolites may play a role in health and disease in pregnancy, there is a paucity of data regarding these associations, thus limiting advancement of the field. Similar to the proposed pathogenesis for diet, gut microbiota and the microbial metabolite trimethylamine-N-oxide (TMAO) in cardiovascular disease, we hypothesize that the interplay between maternal diet, the gut microbiota and its associated microbial metabolites play a mechanistic role in HDP. We propose to test this hypothesis in a racially-diverse US cohort to determine association with adverse pregnancy outcomes, specifically future development of HDP. We propose to prospectively collect plasma and urine TMAO throughout pregnancy from a cohort of 200 pregnant participants.
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Through 1) characterizing plasma and urine TMAO levels across each trimester of pregnancy, and 2) assessment of this microbial metabolite as a predictor of development of HDP, we have the potential to identify a biomarker that would allow us to identify people at risk of HDP early in pregnancy and provide new opportunities for therapeutic interventions to improve maternal and neonatal outcomes. conditions: Hypertensive Disorder of Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: TMAO level measure: TMAO level measure: TMAO level sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Cara Dolin, M.D. role: CONTACT phone: 440-312-2229 email: dolinc@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06362343 id: PUMCH-Rivaroxaban-Monitoring briefTitle: The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics overallStatus: RECRUITING date: 2024-01-01 date: 2026-10-30 date: 2027-01-30 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER name: Ruijin Hospital name: Xiangya Hospital of Central South University name: China-Japan Friendship Hospital briefSummary: 1. Integrate pharmacokinetic-pharmacodynamic (PK-PD) modeling and pharmacogenomics techniques to develop a population PK-PD model, aiming to explore monitoring and dose guidance schemes for Direct Oral Anticoagulants (DOACs).
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2. Investigate the factors influencing PK-PD of DOACs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes.
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3. Explore the correlation between drug concentrations, coagulation indices, and clinical outcomes of DOACs, defining the indications for DOACs testing and the overall monitoring process. conditions: Pulmonary Embolism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Rivaroxaban measure: Bleeding events measure: Recurrent thromboembolic events sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Juhong Shi, M.D role: CONTACT phone: +8613701178492 email: shijh@pumch.cn name: Min Peng, M.D role: CONTACT phone: +8613581888792 email: pengmin@pumch.cn lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362330 id: 2022-SR-471 briefTitle: Multi-parametric MRI in Patients of Bladder Cancer overallStatus: RECRUITING date: 2021-07-01 date: 2024-05-30 date: 2024-06-30 date: 2024-04-12 date: 2024-04-12 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Accurate preoperative detection of muscle-invasive bladder cancer remains a clinical challenge. The investigators aimed to develop and validate a knowledge-guided causal diagnostic network for the detection of muscle-invasive bladder cancer with multiparametric magnetic resonance imaging(MRI). conditions: Muscle-invasive Bladder Cancer conditions: Artificial Intelligence studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: magnetic resonance imaging measure: Muscle-invasive bladder cancer measure: Non-muscle-invasive bladder cancer sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Yu-Dong Zhang status: RECRUITING city: Nanjing zip: 210029 country: China name: Yu-Dong Zhang, MD;PHD role: CONTACT phone: 15805151704 email: njmu_zyd@163.com lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06362317 id: K5247 briefTitle: Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer overallStatus: RECRUITING date: 2024-03-06 date: 2025-03-06 date: 2026-03-06 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER briefSummary: Explore the impact of the first-line application of Toripalimab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers conditions: Biliary Tract Neoplasms Immunotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Toripalimab name: Lenvatinib name: Gemox Chemotherapy（Gemox or GC） measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Progression-free survival (PFS) measure: Overall survival measure: Duration of response measure: Clinical benefit rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH) status: RECRUITING city: Beijing state: Beijing zip: 100005 country: China name: Haitao Zhao, Professor role: CONTACT phone: +861069156042 email: zhaoht@pumch.cn lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362304 id: 2024-DG-01 briefTitle: 99mTc-CNDG SPECT/CT in Brain Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-04 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER briefSummary: The goal of this clinical trial is to evaluate the value of 99mTc-CNDG for diagnosis of brain tumors by comparing it with 18F-FDG-PET. The main questions it aims to answer are:
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1. What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG?
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2. What is the correlation between the SUVmax value of 99mTc-CNDG and tumor type?
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Participants will:
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Receive18F-FDG-PET and 99mTc-CNDG examination within 2 weeks before surgery. Obtain pathological diagnosis by surgery or biopsy as the gold standard. conditions: Intracranial Tumor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: 99mTc-CNDG SPECT/CT measure: SUVmax sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362291 id: 2023IR27 briefTitle: Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial overallStatus: RECRUITING date: 2023-08-01 date: 2024-07-31 date: 2025-04-30 date: 2024-04-12 date: 2024-04-12 name: Peking University First Hospital class: OTHER briefSummary: The goal of this clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are:
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Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy?
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Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.
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Participants will:
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Receive AI-cTB or routine cTB. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 340 type: ESTIMATED name: MRI-AI guided cognitive prostate targeted biopsy name: Routine cognitive prostate targeted biopsy measure: The clinically significant prostate cancer (csPCa) detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (SB) measure: The PCa detection rate measure: The Gleason score (GS) of the biopsy sample measure: The GS of radical prostatectomy (RP) specimens sex: MALE minimumAge: 45 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Baowei Zhang role: CONTACT phone: +86 83572466 email: bdyyll@126.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362278 id: 026 briefTitle: A Multi-omics Study of "Healthy" Premature CAD Patients overallStatus: RECRUITING date: 2024-03-20 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The goal of this multi-center observational clinical trial is to investigate the genetic risk factors of patients with premature CAD and none traditional CAD risk factors through a multi-omics approach.
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The main questions it aims to answer are:
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* Genetic risk factors \& metabolic fingerprints of patients with premature CAD and none traditional CAD risk factors remain unknown.
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* How to optimize current primary prevention strategy for this rare CAD subgroup？ conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 160 type: ESTIMATED name: multi-omics studies measure: common & rare variants associated with "healthy" pre-mature CAD phenotype measure: Unique metabolomic fingerprints associated with "healthy" pre-mature CAD phenotype sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Chunjian Li, Phd、MD role: CONTACT phone: +86 13701465229 email: lijay@njmu.edu.cn lat: 32.06167 lon: 118.77778 facility: Qilu Hospital of Shangdong University status: ACTIVE_NOT_RECRUITING city: Jinan state: Shandong zip: 250012 country: China lat: 36.66833 lon: 116.99722 facility: The Second Affiliated Hospital of Zhejiang University Medical College status: ACTIVE_NOT_RECRUITING city: Hangzhou state: Zhejiang zip: 310009 country: China lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06362265 id: 18437 id: I8H-MC-BDDB type: OTHER domain: Eli Lilly and Company briefTitle: A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-11 date: 2026-11 date: 2024-04-12 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 22 type: ESTIMATED name: LY3209590 measure: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590 measure: PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590 measure: Change from Baseline in Fasting Glucose sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Honor Health Research Institute city: Scottsdale state: Arizona zip: 85258 country: United States lat: 33.50921 lon: -111.89903 facility: Children's Hospital Los Angeles city: Los Angeles state: California zip: 90027 country: United States lat: 34.05223 lon: -118.24368 facility: Children's Healthcare of Atlanta - Center for Advanced Pediatrics city: Atlanta state: Georgia zip: 30329 country: United States lat: 33.749 lon: -84.38798 facility: University of Louisville, Norton Children's Research Institute city: Louisville state: Kentucky zip: 40202 country: United States lat: 38.25424 lon: -85.75941 facility: Johns Hopkins University School of Medicine city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 facility: Joslin Diabetes Center city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: UBMD Pediatrics city: Buffalo state: New York zip: 14203 country: United States lat: 42.88645 lon: -78.87837 facility: NYU Langone city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States lat: 39.12713 lon: -84.51435 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06362252 id: DS7300-189 id: 2023-509629-36 type: OTHER domain: EU CT briefTitle: A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03) overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2026-11-30 date: 2026-12-30 date: 2024-04-12 date: 2024-04-12 name: Daiichi Sankyo class: INDUSTRY name: Merck Sharp & Dohme LLC briefSummary: This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting. conditions: Extensive Stage-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 149 type: ESTIMATED name: Ifinatamab deruxtecan name: Atezolizumab name: Carboplatin name: Etoposide measure: Number of Participants Reporting Dose-limiting Toxicities Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A) measure: Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Duration of Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Clinical Benefit Rate as Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Time to Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Overall Survival Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Pharmacokinetic Parameter Maximum Serum Concentration of I-DXd measure: Pharmacokinetic Parameter Time to Maximum Serum Concentration of I-DXd measure: Pharmacokinetic Parameter Area Under the Concentration Curve of I-DXd measure: The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362239 id: STUDY00003853 briefTitle: Prospective Home-Based Palliative Care and Hospice Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-10 date: 2027-10 date: 2024-04-12 date: 2024-04-12 name: Steven Smith class: OTHER name: Akron Children's Hospital name: Medical University of South Carolina name: Nemours Children's Hospital name: Baylor College of Medicine briefSummary: The purpose of this study is to test the hypothesis that the addition of home-based hospice and palliative care (HBHPC) will provide a reduction in health care utilization, improve quality of life, and facilitate goal-concordant care that is superior to inpatient and clinic pediatric palliative care (PPC) alone. conditions: Pediatric Palliative Care studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Study Surveys measure: Hospital Utilization Differences measure: Demographic Differences measure: Location of death differences sex: ALL maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06362226 id: HM20029491 briefTitle: OPTIMIZING OCULAR OUTCOMES: A DUAL-ARMED STUDY FOR PERIORBITAL BURN MANAGEMENT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-08 date: 2026-10 date: 2024-04-12 date: 2024-04-12 name: Virginia Commonwealth University class: OTHER briefSummary: The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& antibiotic ointment with vitamin E as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns. conditions: Periorbital Burns studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Steroid/Antibiotic name: 5-FU/Kenalog measure: Comparison of wound healing time measure: Comparison of infection rate measure: Comparison of complication rates measure: Comparison of pain level measure: Comparison of quality of life measure: Comparison of cosmetic outcome through the Vancouver scar scale (VSS) measure: Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362213 id: NL76924.029.22 briefTitle: Gaining Insight Into Dual Sensory Loss acronym: DSL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04 date: 2025-04 date: 2024-04-12 date: 2024-04-12 name: Amsterdam UMC, location VUmc class: OTHER name: Royal Dutch Visio briefSummary: The goal of this observational study is to explore difficulties in information access, mobility, communication and fatigue in people with combined vision and hearing impairments. The main question it aims to answer is:
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• What influence do varying severities of vision and hearing loss have on information access, mobility, communication and fatigue.
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Participants will fill out questionnaires and the researchers will measure their vision and hearing functions. conditions: Dual Sensory Impairment of Vision and Hearing studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 300 type: ESTIMATED measure: information access measure: mobility measure: communication measure: fatigue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC, location VUmc city: Amsterdam state: Noord Holland zip: 1081 HV country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06362200 id: LYG20230083 briefTitle: The Validation and Biological Index Studies on the Improved Social Function of ASD by 40 Hz tACS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-12-31 date: 2028-12-31 date: 2024-04-12 date: 2024-04-12 name: Central South University class: OTHER briefSummary: In this proposed study, tACS will be used to intervene in the autism spectrum disorders of children and adolescents, and the efficacy of this intervention method will be evaluated, as well as the internal mechanism of adolescents' autism spectrum disorders will be discussed. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: 40 Hz tACS intervention measure: Autism assessment assessment index measure: EEG physiological detection index measure: Magnetic resonance detection index measure: Eye movement index measure: Emotion recognition index measure: Understanding of social interaction index measure: Understanding of thoughts and intentions index measure: Social Communication Changes index measure: Stereotyped behavior index measure: Sensory index measure: Abnormal behavior indicator measure: Sleep index measure: Plasma Metabolite Levels Assessment measure: Safety evaluation SAFTEE indicator sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06362187 id: STUDY00003238 briefTitle: VR Pilot for Pancreatitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2026-05 date: 2024-04-12 date: 2024-04-12 name: Cedars-Sinai Medical Center class: OTHER briefSummary: The purpose of the research is to test the feasibility and preliminary impact of a home-based, standardized, gut-directed, virtual reality cognitive behavioral therapy (VR CBT) on clinical and functional outcomes of patients with chronic pancreatitis (CP) and recurrent acute pancreatitis (RAP) pain. The primary research procedures are questionnaires and biometric Fitbit data. The study will enroll adult patients with CP or RAP. conditions: Chronic Pancreatitis conditions: Recurrent Pancreatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, controlled primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Gut Directed VR name: Sham Control VR measure: Feasibility of home-based VR measure: Impact of home-based VR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marissa Podell city: Los Angeles state: California zip: 90048 country: United States lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06362174 id: SHEBA-22-9902-SBH-CTIL briefTitle: Capsule & Omics for pRedicting Exacerbation of Crohn's Disease acronym: CORE-CD overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-07 date: 2025-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Sheba Medical Center class: OTHER_GOV briefSummary: The research group have previously evaluated the benefit of serial consecutive capsule endoscopy as monitoring tool for Crohn's disease in remission, demonstrating its superior accuracy for disclosing inflammation and for prediction of flares in comparison to other diagnostic modalities such as magnetic resonance enterography and inflammatory biomarkers. Subsequently, deep learning algorithms had developed to provide excellent accuracy for identification and grading of ulcers and intestinal strictures on capsule endoscopy still images. The investigators will advance this knowledge using a parallel two-parts approach. conditions: Crohn's Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 62 type: ACTUAL measure: Crohn's Disease Activity Index score (CDAI) measure: Disease related complications measure: disease related hospitalization measure: Change of crohn's disease medications measure: opinion of the principle investigator (PI) or the treating physician measure: The rate of clinical flare accompanied by objective signs of mucosal inflammation. measure: The rate of inflammatory worsening with/without accompanying clinical symptoms sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sheba Medical Center city: Tel-Hashomer country: Israel lat: 32.04195 lon: 34.85623 hasResults: False
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<|newrecord|> nctId: NCT06362161 id: IRB-300011066 briefTitle: Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-12-31 date: 2024-04-12 date: 2024-04-12 name: University of Alabama at Birmingham class: OTHER briefSummary: The purpose of this study is to help providers develop an interdisciplinary treatment pathway for functional neurological disorder (FND) at University of Alabama at Birmingham (UAB), and will involve psychiatry, speech therapy, physical therapy, and occupational therapy. The study will also help providers to evaluate the treatment pathway and publish results regarding the process and outcomes. conditions: Functional Neurological Disorder conditions: Convulsion, Non-Epileptic conditions: Functional Seizure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1100 type: ESTIMATED measure: Patient Demographic Information measure: Hospital Anxiety and Depression Scale (HADS) measure: ASM 121 functional assessment definitions measure: SF-36 (subjective health and wellbeing) measure: Work and Social Adjustment Scale (WSAS) measure: Patient Health Questionnaire 15 measure: Dizziness Handicap Inventory measure: Dizziness Symptom Profile measure: Adult Tic Questionnaire (ATQ) measure: Child Self-Report Tic Questionnaire measure: Parent Tic Questionnaire (PTQ) measure: Seizure Questionnaire measure: Level 2-Somatic Symptom report measure: Revised Children's Anxiety and Depression Scale (RCADS) measure: Functional Disability Inventory (FDI) measure: Impact on the Family Scale measure: Pediatric Quality of Life (Peds-QL) measure: Healthcare Utility Questionnaire measure: Assessment of control over symptoms sex: ALL minimumAge: 8 Years maximumAge: 89 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Michelle Bumpers role: CONTACT lat: 33.52066 lon: -86.80249 hasResults: False
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<|newrecord|> nctId: NCT06362148 id: 1-10-72-134-23 briefTitle: Circulating Tumor DNA in Peripheral T-cell Lymphomas acronym: CIRCULATE overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2030-12 date: 2024-04-12 date: 2024-04-22 name: University of Aarhus class: OTHER name: Aarhus University Hospital briefSummary: The aim of this study is to evaluate the feasibility of circulating tumor DNA (ctDNA) measurement in blood plasma for the applicability in prognostication, treatment evaluation and measurable residual disease (MRD) surveillance in a cohort of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphomas (PTCL). conditions: Peripheral T-cell Lymphoma conditions: NK/T-Cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assay name: 18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) measure: ctDNA occurrence measure: ctDNA quantification measure: Progression free survival measure: Overall survival measure: Radiographic assessment by PET/CT measure: Comparison of molecular and radiographic response measure: Spatial and temporal mutational homo- or heterogeneity measure: Fragment pattern analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Hematology, Aarhus University Hospital status: RECRUITING city: Aarhus state: Central Denmark Region zip: 8200 country: Denmark name: Patrick R Noerhave, MD role: CONTACT phone: +4551543715 email: panoer@rm.dk name: Francesco A d'Amore, MD, DMSc role: CONTACT phone: +4523708527 email: frandamo@rm.dk name: Patrick R Noerhave, MD role: PRINCIPAL_INVESTIGATOR name: Martin B Pedersen, MD, PhD role: SUB_INVESTIGATOR name: Francesco A d'Amore, MD, DMSc role: SUB_INVESTIGATOR lat: 56.15674 lon: 10.21076 hasResults: False
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<|newrecord|> nctId: NCT06362135 id: 0733 briefTitle: Virtual Home Visits for Stroke Patients and Their Caregivers acronym: INHABASAEV overallStatus: RECRUITING date: 2023-08-01 date: 2024-12-01 date: 2025-03-01 date: 2024-04-12 date: 2024-04-15 name: The Scientific and Technological Research Council of Turkey class: OTHER briefSummary: The primary aim of this study is to evaluate the effectiveness of virtual home care for stroke patients and their caregivers. The secondary purpose is to evaluate the usability of the application by developing a mobile application for use in virtual home visits.
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The study will be carried out using the mixed research model, in which quantitative and qualitative methods are used together. The population of the research will consist of patients and caregivers with the diagnosis of hemorrhage, infarction, cerebrovascular accident and cerebral infarction, who applied to the Antalya Provincial Health Directorate Antalya Training and Research Hospital Home Health Unit, where the study is planned to be conducted. The sample of the study will consist of stroke patients and caregivers who meet the criteria for inclusion in the study. The first phase of the study was designed as a parallel group, single center and single blind randomized controlled trial to evaluate the effectiveness of virtual home visits in terms of time, cost and caregiver competence. The experimental group was the patient/patient relative group who made a virtual home visit, the control group will consist of 48 patients/patient relatives who have been visited face-to-face. In the second phase of the study, semi-structured interview method will be used to determine the views of patients/patient relatives about virtual home visits. In order to evaluate the usability of the developed application, a usability survey will be applied to the group that has visited the virtual home.
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With the results of this study, telemedicine applications in home care services will help to increase accessibility to home care services and reduce health care costs.considered to contribute. At the same time, it is expected that the results of the study will contribute to the scientific literature in the field of design and application of telemedicine services, which are developing and spreading conditions: Stroke conditions: Caregiver conditions: Virtual conditions: Home Visit studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment Virtual visit with stroke patient and their caregiver primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Telephone support or virtual meeting during the research process will be provided by an independent interviewer. whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Virtual Home Visit name: Control Group measure: Effect of Virtual and Face to face to home visit measure: Level of competence of stroke caregiver measure: Frequency of unplanned hospital readmission measure: Effect of the virtual home visit sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasemin Demi̇r Avci̇ status: RECRUITING city: Antalya zip: 07058 country: Turkey name: Yasemin Demir Avcı, PhD role: CONTACT phone: +905514028492 email: ydemir@akdeniz.edu.tr lat: 36.90812 lon: 30.69556 hasResults: False
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