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The study comprises two phases. In the first phase, mental health professionals working on addiction services of the Spanish National Health System will be randomly assigned to receive training in one intervention and then the other (DBT-SUD and UP) and will be evaluated before and after each training. In the second phase, participants will be randomly assigned to implement one intervention first and then the other in their workplaces with people with alcohol addiction and will be also assessed before and after the implementation. Qualitative and quantitate outcome measures will be analyzed using a Mixed- Methods-Design. conditions: Implementation Science studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are assigned to two groups in parallel for the duration of the study. The specific design is an reverse counterbalanced (ABBA) intrasubject experimental study where participants will be randomly assigned to first (and then the other) receive DBT-SUD or UP online training in the phase 1 of the study, and randomly assigned to first implement DBT-SUD or UP intervention in the phase two. A balanced randomization (1:1) will be conducted in order to eliminate possible biases and ensure equivalence between groups. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 160 type: ESTIMATED name: Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD) name: Unified Protocol (UP) measure: Acceptability and Intention to Use Survey measure: Measures of Acceptability, Appropriateness and Feasibility of the intervention (AIM, IAM & FIM) measure: Normalization MeAsure Development Questionnaire (NoMAD) measure: Copenhagen Burnout Inventory (CBI) measure: Brief Scale of Understanding Substance Abuse (SUSS) measure: Implementation Climate Scale (ICS) measure: Organizational Readiness for Implementing Change (ORIC) measure: Evidence-Based Practice Attitudes Scale (EBPAS) measure: Program sustainability assessment tool (PASAT) measure: Barriers to Implementation Inventory (BTI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Zaragoza status: RECRUITING city: Teruel state: Aragón zip: C/ Ciudad Escolar S/N44003 country: Spain name: María Vicenta Navarro Haro, PhD role: CONTACT phoneExt: 861145 email: [email protected] lat: 40.3456 lon: -1.10646 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-02 uploadDate: 2024-04-09T12:23 filename: ICF_000.pdf size: 419669 hasResults: False |
<|newrecord|> nctId: NCT06366087 id: BP-C-24-001 briefTitle: Sublingual Atropine Bioequivalence by Route of Administration (SABER) acronym: SABER overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-24 date: 2024-05-24 date: 2024-04-15 date: 2024-04-15 name: Biomedical Advanced Research and Development Authority class: FED name: Rho Federal Systems Division, Inc. name: Allucent briefSummary: A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult volunteers. conditions: Atropine Bioequivalence studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Atropine Sulfate Ophthalmic Solution USP, 1% name: Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL) measure: The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to infinity (AUCinf). measure: The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to time of last quantifiable data point (AUCt). measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by area under the analyte concentration versus time curve to time 45, 60, 90, 120, 150, and 240 minutes (AUC45, AUC60, AUC90, AUC120, AUC150, and AUC240, respectively) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by maximum measured plasma concentration (Cmax) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by time to Cmax (tmax) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by apparent terminal elimination half-life (t1/2) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by terminal elimination rate constant (λz) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by volume of distribution (Vd/F) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by total body clearance (CL/F) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by absorption rate constant (Ka) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johnson County Clin-Trials (JCCT) city: Lenexa state: Kansas zip: 66219 country: United States name: Carlos A Fierro, MD role: CONTACT phone: 913-825-4400 email: [email protected] name: Mazen Zari role: CONTACT phone: 913-825-4400 email: [email protected] name: Carlos A Fierro, MD role: PRINCIPAL_INVESTIGATOR lat: 38.95362 lon: -94.73357 hasResults: False |
<|newrecord|> nctId: NCT06366074 id: HUM00252120 briefTitle: Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-15 date: 2024-04-15 name: University of Michigan class: OTHER name: Transtimulation Research, Inc briefSummary: This project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device. |
This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prevalence of delayed Chemotherapy-induced nausea, emesis, and dyspeptic symptoms (CINEDS) is 75% in women vs 51% in men (60% to 40% ratio). Therefore, every effort will be made to recruit at least 60% female subjects into the clinical study. primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Watch-TEA group name: Tethered TEA device measure: Usability of the device for both groups day 3 measure: Number of adverse events related to the device noted on the safety questionnaire measure: Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days measure: Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level measure: Number of non-treatment TEA adverse events for both groups sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Colin Burnett role: CONTACT phone: 734-647-2806 email: [email protected] name: Jiande Chen, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False |
<|newrecord|> nctId: NCT06366061 id: 2020-02868 briefTitle: A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING overallStatus: RECRUITING date: 2022-05-14 date: 2024-07-01 date: 2024-12-01 date: 2024-04-15 date: 2024-04-15 name: Eckhard Mauermann class: OTHER briefSummary: This study aims to examine the correlation and agreement of regional and global measurements of ventricular function in the apical 4 chamber and subcostal 4 chamber view. Additionally, we will explore limitations of the technology and explore the effect of left lateral positioning. conditions: Cardiac Functional Disturbances During Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: S'Tissue Doppler Index (TDI) AP4C supine vs. S'STE SC4C supine measure: Global longitudinal strain (GLS), AP4C supine vs. GLS, SC4C supine, i.e. clinical questions: can we use the SC4C for global markers of ventricular function? measure: Comparison of high Frame Rate (FR) vs. low FR of the following measures: [ i) S'STE AP4C supine, ii) GLS AP4C supine, iii) SR AP4C supine] measure: Comparison of the measured values in the cardiological gold standard (Left lateral decubitus (LLD)) vs. supine, for the following values [ i) S'TDI AP4C, ii) S'STE AP4C, iii) GLS] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel status: RECRUITING city: Basel state: Basel Stadt zip: 4000 country: Switzerland name: Michael Lampart, Prakt. med. role: CONTACT phone: +41764006180 email: [email protected] lat: 47.55839 lon: 7.57327 hasResults: False |
<|newrecord|> nctId: NCT06366048 id: EHBHKY2022-K-025 briefTitle: A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF) acronym: RNLV overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-01 date: 2024-05-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-18 name: National Natural Science Foundation of China class: OTHER_GOV briefSummary: The post-hepatotectomy liver failure (PHLF) is still the most worrisome complication of hepatic resection. Surgeons have always been making efforts to preoperatively predict PHLF using kinds of techniques, scoring systems, and variables. The investigators of this study tried to create an individual predictive model based on the variable, resected normal parenchymal volume (RNLV), then assessing the performance and value of the model in clinical practice. conditions: Liver Failure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1133 type: ACTUAL name: the different definitions of PHLF according to 50-50 criteria and ISGLS criteria measure: Probability of PHLF was predicted with our individual model based on RNLV. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Third Affiliated Hospital of Naval Medical University city: Shanhai state: Shanghai zip: 201800 country: China hasResults: False |
<|newrecord|> nctId: NCT06366035 id: NMRR ID-24-00924-HPO briefTitle: LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression acronym: LoVE4MUM overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-06-03 date: 2024-10-01 date: 2024-04-15 date: 2024-04-16 name: National Institutes of Health, Ministry of Health Malaysia class: OTHER briefSummary: Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions. conditions: Postpartum Depression conditions: Maternal Behavior conditions: mHealth Intervention conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single Blinded, Pilot Randomized Control Trial primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 64 type: ESTIMATED name: LoVE4MUM mobile application measure: Postpartum Depression measure: Postpartum Mental Health Literacy measure: Automatic Negative Frequency sex: FEMALE minimumAge: 19 Years maximumAge: 50 Years stdAges: ADULT facility: Hospital Tengku Ampuan Rahimah city: Klang state: Selangor zip: 41586 country: Malaysia name: Noor Fadzleeyanna Mohd Yahaya, MOG role: CONTACT phone: 03-3375 7000 name: Noor Fadzleeyanna Mohd Yahaya, MOG role: PRINCIPAL_INVESTIGATOR name: Shalisah Sarip, PhD role: SUB_INVESTIGATOR name: Norfazilah Ahmad, PhD role: SUB_INVESTIGATOR lat: 3.03333 lon: 101.45 facility: Hospital Shah Alam city: Shah Alam state: Selangor zip: 40000 country: Malaysia name: Siti Sabrina Kamarudin role: CONTACT phone: 0355263000 phoneExt: 3305 email: [email protected] name: Siti Sabrina Kamarudin, MBBS role: PRINCIPAL_INVESTIGATOR name: NNurul Syuhaida Abdul Razak, MOG role: SUB_INVESTIGATOR name: Idayu Badilla Idris, PhD role: SUB_INVESTIGATOR lat: 3.08507 lon: 101.53281 hasResults: False |
<|newrecord|> nctId: NCT06366022 id: Warsaw.06 briefTitle: Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft overallStatus: RECRUITING date: 2023-05-30 date: 2024-05-30 date: 2024-05-30 date: 2024-04-15 date: 2024-04-15 name: Medical University of Warsaw class: OTHER briefSummary: Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. The aim of this study is to compare the results of the modified tunneling technique with subepithelial connective tissue graft in gingival recessions placed with the inner side towards the flap cover graft and the outer side towards the flap cover graft. conditions: Gingival Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: The tunnel technique for root coverage with CTG with inner side of the graft name: The tunnel technique for root coverage with CTG with outer side of the graft measure: Clinical attachment level (CAL) measure: Recession height (RH) measure: Recession width (RW) measure: Width of keratinized tissue (KTW) measure: Thickness of keratinized tissue (GT measure: Average recession coverage (ARC) measure: Complete recession coverage measure: Probing pocket depth (PPD) measure: Root coverage esthetic score (RES) measure: Post surgical pain and swelling measure: Patient's satisfaction with treatment sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw status: RECRUITING city: Warsaw state: MAzowsze zip: 00-246 country: Poland name: Bartłomiej Górski, PhD role: CONTACT phone: 48225022099 lat: 52.22977 lon: 21.01178 hasResults: False |
<|newrecord|> nctId: NCT06366009 id: Warsaw Study briefTitle: Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-07-31 date: 2024-07-31 date: 2024-04-15 date: 2024-04-15 name: Przemyslaw Kunert class: INDUSTRY name: NaoX Technologies name: Warsaw Medical University Clinical Center name: Departments and Clinics of Emergency Medicine of the Medical University of Gdańsk briefSummary: The study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE). conditions: Epilepsy conditions: Focal Epilepsy conditions: Drug Resistant Epilepsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: NaoX in-ear EEG system measure: determination of the starting point of focal temporal epileptic seizures measure: Identification of subgroups of epileptic patterns measure: Assessment of ease-of-use and comfort of use of the NAOX in-ear EEG system by patients and the EEG technician sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kliniki Neurochirurgii CSK UCK WUM city: Warsaw country: Poland name: Przemysław Kunert, Prof. role: CONTACT name: Maja Kopytek-Beuzen, Dr. role: CONTACT lat: 52.22977 lon: 21.01178 hasResults: False |
<|newrecord|> nctId: NCT06365996 id: Core set geriatric ICF briefTitle: Development and Validation of the Polish Geriatric Core Set. overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-12-15 date: 2025-12-15 date: 2024-04-15 date: 2024-04-15 name: University of Rzeszow class: OTHER briefSummary: Population ageing is a global problem. With ageing, involutionary changes and multimorbidity increase, leading to limitations in the performance of daily activities and disability. Proposed by the World Health Organisation (WHO), the geriatric core set is a set of categories of the International Classification of Functioning, Disability and Health (ICF) that allows for a comprehensive assessment of a person of geriatric age. In Poland, the geriatric core set has not yet been adapted and validated. Therefore, the aim of this study is the cultural adaptation and validation of the Polish version of the ICF-based categorical profile for the assessment of older people. conditions: Aging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 800 type: ESTIMATED measure: ICF Geriatric core set measure: Sociodemographic data of the sample measure: Disability - WHODAS 2.0 v 36 item sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Rzeszow city: Rzeszów state: Podkarpacie zip: 35-959 country: Poland name: Agnieszka Sozańska, professor role: CONTACT phone: 530172857 email: [email protected] lat: 50.04132 lon: 21.99901 hasResults: False |
<|newrecord|> nctId: NCT06365983 id: UFRGS-Cassio briefTitle: Comparison of Free Gingival Graft and Linear Incision for Connective Tissue overallStatus: RECRUITING date: 2023-04-28 date: 2025-04-28 date: 2026-04-28 date: 2024-04-15 date: 2024-04-15 name: Federal University of Rio Grande do Sul class: OTHER briefSummary: A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. |
Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap (Zucchelli and De Sanctis) in both groups. The donor areas for connective tissue will be the hard palate region, with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side. |
Each patient will undergo a preparatory phase for study inclusion, consisting of supragingival scaling, polishing, and oral hygiene instructions at least 3 weeks before study inclusion. Patients will be instructed on personalized and proper use of toothbrush, dental floss, and/or interdental brush. |
All surgical procedures in both groups will be performed by the same operator (CCO). Randomization will determine the side to be operated on first. The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques. |
Outcomes evaluated at 3, 6, 9, and 12 months include: gingival recession depth, probing depth, visible plaque, bleeding on probing, width of keratinized tissue, three-dimensional tissue assessment from intraoral scanning, and quality of life related. Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis. |
INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions. |
EXCLUSION CRITERIA |
Individuals will not be considered eligible if they: |
* Present any form of immunological compromise; |
* Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases; |
* Present active periodontitis, defined by presence of \>=10% subgingival bleeding and probing depth and clinical attachment loss proximal \>4mm (Tonetti et al. 2018); |
* Are current or ex-smokers; |
* Have allergies to ibuprofen and chlorhexidine digluconate. |
Research Objective: |
PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage. |
SECONDARY OBJECTIVE |
Compare the two grafts in terms of clinical outcomes of root coverage; Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography; Compare the two grafts in terms of patient-centered outcomes. conditions: Connective Tissue conditions: Gingiva conditions: Gingival Recession conditions: Humans studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: All sample randomization procedures will be carried out by a researcher not involved in treatments and clinical examinations. An external researcher not affiliated with the study will be responsible for maintaining participant allocation confidentiality. Sides will be identified by numbers stored in opaque, sealed envelopes with the randomization sequence. Outcome assessors will be blinded to the experimental group to which participants belong. whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Connective Tissue with Free Gingival Graft name: Connective Tissue with Linear Incision measure: Percentage of root coverage measure: Recession depth sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alex Nogueira Haas status: RECRUITING city: Porto Alegre state: RS zip: 95780000 country: Brazil name: Cássio Cardona Orth role: CONTACT phone: 11999791876 email: [email protected] lat: -30.03306 lon: -51.23 hasResults: False |
<|newrecord|> nctId: NCT06365970 id: HCC 23-056 briefTitle: Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-05-31 date: 2027-05-31 date: 2024-04-15 date: 2024-04-15 name: Ibrahim Halil Sahin class: OTHER name: GlaxoSmithKline briefSummary: The second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC. This study will examine the combination of niraparib and dostarlimab for a synergistic antitumor effect for patients with MSI-H CRC. conditions: MMR-D/MSI-H Colorectal Cancers studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Niraparib name: Dostarlimab measure: Objective response rate (ORR) measure: Adverse Events Related to Treatment measure: Progression-free Survival (PFS) measure: Duration of Response (DoR) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC Hillman Cancer Center city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Debra Diecks, MSN role: CONTACT phone: 412-623-8364 email: [email protected] name: Ibrahim Sahin, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False |
<|newrecord|> nctId: NCT06365957 id: BSERE24-APP001-FED briefTitle: Acute Effects of Exercise Combined With Ketone Ester Supplement overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-04 date: 2024-04-15 date: 2024-04-22 name: University of Macau class: OTHER briefSummary: To examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults. conditions: Overweight and Obesity conditions: Cognitive Change conditions: Ketoses, Metabolic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Ketone monoester supplementation name: High-intensity interval exercise name: Moderate-intensity continuous exercise name: Placebo measure: Maximal Oxygen Uptake measure: Systolic Blood Pressure measure: Diastolic Blood Pressure measure: Concentration of Blood Lipid measure: Concentration of Blood Glucose measure: Concentration of Blood Beta-Hydroxybutyrate measure: Concentration of Blood Lactic Acid measure: Concentration of Blood Insulin measure: Reaction Time of Stroop Task measure: Accuracy of Stroop Task measure: Reaction Time of N-back Task measure: Accuracy of N-back Task measure: Cerebral Hemoglobin Concentration measure: Arousal Level sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06365944 id: CHUBX 2023/73 briefTitle: Concussion in French Non-professional Handball League : Efficiency of a Concussion Protocol, the White Card Process acronym: PRECCOCE overallStatus: RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2026-04-20 date: 2024-04-15 date: 2024-04-24 name: University Hospital, Bordeaux class: OTHER briefSummary: Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol. conditions: Brain Concussion conditions: Cerebral Concussion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Proportion, as a percentage, of participant declaring no medical care while being estimated at risk of having a concussion (assessed by answers to the questionnaire) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bordeaux University Hospital status: RECRUITING city: Bordeaux country: France name: Quentin LHUAIRE role: CONTACT lat: 44.84044 lon: -0.5805 hasResults: False |
<|newrecord|> nctId: NCT06365931 id: 160224 briefTitle: Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-16 date: 2024-02-16 date: 2024-04-30 date: 2024-04-15 date: 2024-04-15 name: University of Extremadura class: OTHER briefSummary: INTRODUCTION: Clubfoot, drop foot or clubfoot, is a disorder that prevents reaching 100º of dorsiflexion actively. Its etiology is varied, and may be due to congenital problems, direct alteration of the bone structure, spasticity or shortening of the posterior musculature (triceps suralis), a neurological factor or a combination of several. Thus, we can differentiate between congenital clubfoot and acquired clubfoot. Stroke is one of the main causes of acquired clubfoot, which is due to paralysis of the dorsiflexor musculature and/or spasticity of the plantar flexor musculature. Electrical stimulation is able to increase muscle activation by depolarization of the motor plate and modulation of nerve conduction. This can be done transcutaneously, through surface electrodes or percutaneously through needles, so neuromodulation is presented as a tool applicable to the pathology of the equine foot, if we take into account the increased activation of the dorsiflexors of the foot. |
OBJECTIVE: The main objective is to evaluate which of the techniques, percutaneous or transcutaneous, is more effective for the approach of clubfoot in post-stroke patients. |
METHODOLOGY: a clinical trial with randomized probabilistic assignment in four groups is proposed: G1 (percutaneous neuromodulation): patients will receive a needle circuit approaching the deep peroneal nerve in an ultrasound-guided manner. They will receive a 20-30Hz symmetrical biphasic current; G2 (transcutaneous neuromodulation): patients will have a superficial electrode circuit placed over the belly of the tibialis anterior muscle. They will receive a symmetrical biphasic current of 20-30Hz; G3 (placebo-percutaneous group): in which the patients will receive the neuromodulation circuit with needles at 0 intensity; G2 (placebo-transcutaneous group): the patients will receive the electrodes at 0 intensity over the belly of the tibialis anterior muscle. |
The variables to be analyzed are: anthropometric variables (age, weight, height, BMI), muscle oxygenation (SatO2, O2Hb, HHb and THb), muscle strength of the foot dorsiflexors measured with dynamometer, muscle activation by surface electromyography, active and passive joint balance with goniometry or inclinometer, assessment of gait and balance, assessment of load distribution by static and dynamic pressure platform, spasticity and questionnaire on quality of life and functionality. The acute effects after one intervention session (pre-post intervention of one session) and the effects after a 10-session program will be analyzed. conditions: Stroke/Brain Attack studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ACTUAL name: Percutaneous neuromodulation name: Transcutaneous neuromodulation name: Placebo-percutaneous name: Placebo-transcutaneous name: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional) measure: Muscle activity measure: Displacement of the center of pressures (CoP) measure: Articular amplitude measure: Balance measure: Balance measure: Gait measure: Tissue oxygen in muscle measure: Muscular strength measure: Functionality measure: quality of life index measure: Spasticity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mª Dolores Apolo Arenas city: Badajoz country: Spain lat: 38.87789 lon: -6.97061 hasResults: False |
<|newrecord|> nctId: NCT06365918 id: 2023-0836 id: NCI-2024-03236 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2028-03-22 date: 2030-03-22 date: 2024-04-15 date: 2024-04-15 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To find the recommended dose of the investigational drug VG2025 that can be given intraperitoneally (given directly into the abdominal cavity) to participants with advanced solid tumors. conditions: Advanced Solid Tumor conditions: Carcinomatosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: VG2025 measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Siqing Fu, MD,PHD role: CONTACT phone: 713-792-4318 email: [email protected] name: Siqing Fu, MD,PHD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False |
<|newrecord|> nctId: NCT06365905 id: 23-011680 id: NCI-2024-02550 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-011680 type: OTHER domain: Mayo Clinic in Rochester briefTitle: Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding overallStatus: RECRUITING date: 2024-06-01 date: 2027-06-30 date: 2027-06-30 date: 2024-04-15 date: 2024-04-16 name: Mayo Clinic class: OTHER briefSummary: This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions. conditions: Endometrial Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Non-Interventional Study measure: Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS) sex: FEMALE minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: NOT_YET_RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Kristina A. Butler, M.D., M.S. role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida status: NOT_YET_RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Christopher C. DeStephano, M.D., M.P.H. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Gretchen E. Glaser, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False |
<|newrecord|> nctId: NCT06365892 id: 22-36548 briefTitle: Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-01-01 date: 2026-01-01 date: 2024-04-15 date: 2024-04-15 name: University of California, San Francisco class: OTHER briefSummary: This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years. conditions: Adolescent Idiopathic Scoliosis (AIS) studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Both arms - Open-label Placebo (COLP) and Treatment As Usual (TAU) primaryPurpose: TREATMENT masking: NONE maskingDescription: Blinding of patients and providers will not be feasible due to the nature of the study. count: 64 type: ESTIMATED name: open-label placebo name: Treatment as usual measure: The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery measure: Weekly level of mobility and change from baseline in mobility on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Pediatric Mobility Short Form 7a at week 6. measure: Weekly level of anxiety and change from baseline in anxiety levels on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Anxiety Short Form 8a at week 6. measure: Weekly level of depressive symptoms and change from baseline in depressive symptoms on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Depressive Symptoms Short Form 8a at week 6. measure: The duration of time in days following surgery until patients establish Independence with Physical Therapy measure: The length of time in days following surgery until discharge from the hospital measure: The length of time in days following surgery until participant returns to school measure: Whether participants experience urinary retention following surgery. measure: Whether participants experience constipation measured by the number of days between surgery and first bowel movement measure: Whether participants experience an oxygen requirement and the duration of the requirement following surgery. sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of California, San Francisco city: San Francisco state: California zip: 94158 country: United States lat: 37.77493 lon: -122.41942 hasResults: False |
<|newrecord|> nctId: NCT06365879 id: CMAB007-003 briefTitle: To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-11-01 date: 2026-05-01 date: 2024-04-15 date: 2024-04-15 name: Taizhou Mabtech Pharmaceutical Co.,Ltd class: INDUSTRY briefSummary: This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair® in patients with refractory chronic spontaneous urticaria conditions: Chronic Spontaneous Urticaria studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 392 type: ESTIMATED name: CMAB007 name: Xolair measure: Change From Baseline of the Itch Severity Score (ISS7) Score At Week 12 measure: Change From Baseline of Urticaria Activity Score (UAS7) At Week 12 measure: Change From Baseline of Number of Hives Score (NHS7) At Week 12 measure: Time to ISS7 MID Response by Week 12 measure: Percentage of Patients With UAS7≤6 at Week 12 measure: Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12 measure: Change From Baseline of Urticaria Control Test (UCT) at Week 12 measure: Percentage of Patients With UCT≥12 at Week 12 measure: Percentage of Complete Controls (UCT=16) at Week 12 measure: Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12 measure: Percentage of Complete Responders (UAS7=0) at Week 12 measure: Percentage of Angioedema-free Days From Week 4 to Week 12 measure: Incidence of adverse events measure: Immunogenicity measure: AUC0-t measure: AUC0-inf measure: Half time measure: Cmax measure: Tmax measure: Clearance Rate measure: Apparent Volume of Distribution measure: Level of Total IgE and Free IgE sex: ALL minimumAge: 15 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06365866 id: 2022-06-008B briefTitle: Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer. overallStatus: RECRUITING date: 2024-02-19 date: 2024-12 date: 2024-12 date: 2024-04-15 date: 2024-04-15 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: The purpose of this study is to observe the safety and effectiveness of the add-on of intraluminal brachytherapy with BRAXX esophageal brachytherapy applicator after definitive CCRT in patients with thoracic esophageal cancer. conditions: Esophageal Neoplasms conditions: Head and Neck Neoplasms conditions: Gastrointestinal Neoplasms conditions: Digestive System Diseases conditions: Digestive System Neoplasms conditions: Esophageal Diseases conditions: Neoplasms by Site conditions: Gastrointestinal Diseases conditions: Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Add-on treatment to standard treatment (fixed doses allowing dose reduction or dose delay according to the tolerability of individual patients); No control group. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: "BRAXX" Esophageal Brachytherapy Applicator. name: Add-on of intraluminal brachytherapy measure: To estimate the local control rate at primary tumor site. measure: To estimate overall response rate. measure: To estimate distant metastasis rate. measure: To estimate progression-free survival rate. measure: To estimate overall survival status. measure: To estimate toxicity analysis. measure: To estimate adverse event. sex: ALL minimumAge: 20 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei zip: 11217 country: Taiwan name: Pin-I Huang, Ph.D. role: CONTACT phone: +886 955-275-822 email: [email protected] name: Pin-I Huang, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 hasResults: False |
<|newrecord|> nctId: NCT06365853 id: IMGN853-0424 id: 2023-505617-24-00 type: CTIS briefTitle: A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-05-26 date: 2027-05-26 date: 2024-04-15 date: 2024-04-15 name: ImmunoGen, Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the incidence rate and severity of pre-specified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \[PSOC\] or platinum-resistant ovarian cancer \[PROC\]) with high folate receptor alpha (FRα) expression. conditions: Recurrent Ovarian Cancer conditions: Folate Receptor-Alpha Positive studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Mirvetuximab Soravtansine name: Lubricating Eye Drops name: Prednisolone acetate ophthalmic suspension 1% eye drops name: Brimonidine tartrate ophthalmic solution eye drops measure: Number of Participants With MIRV-related Corneal AEs (≥ Grade 2) in Asymptomatic Participants measure: Number of Participants With All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis measure: Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Asymptomatic Versus Symptomatic Participants measure: Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis measure: National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score measure: Area Under the Curve (AUC) of MIRV measure: Maximum Serum Concentration (Cmax) of MIRV measure: Trough Concentration (Ctrough) of MIRV sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP) city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Yale School of Medicine - Yale Gynecologic Oncology city: New Haven state: Connecticut zip: 06510 country: United States lat: 41.30815 lon: -72.92816 facility: Holy Cross Hospital city: Silver Spring state: Maryland zip: 20910 country: United States lat: 38.99067 lon: -77.02609 facility: Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology city: Springfield state: Massachusetts zip: 01107 country: United States lat: 42.10148 lon: -72.58981 facility: New York Oncology Hematology city: Albany state: New York zip: 12208 country: United States lat: 42.65258 lon: -73.75623 facility: Women's Cancer Care Associates, LLC city: Albany state: New York zip: 12208 country: United States lat: 42.65258 lon: -73.75623 facility: New York-Presbyterian/Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) - Herbert Irving Pavilion city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 facility: Duke Cancer Institute (DCI) - Duke Cancer Center city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 facility: University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic city: Dallas state: Texas zip: 75235 country: United States lat: 32.78306 lon: -96.80667 facility: Monash University - Monash Medical Centre (MMC) - Clayton city: Clayton state: Victoria country: Australia lat: -37.91667 lon: 145.11667 facility: Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek city: Edegem state: Antwerp country: Belgium lat: 51.15662 lon: 4.44504 facility: AZ Sint-Lucas - Campus Sint-Lucas - Borstkliniek city: Gent state: East Flanders country: Belgium lat: 51.05 lon: 3.71667 facility: Universitair Ziekenhuis Gent (UZ Gent) city: Gent state: East Flanders country: Belgium lat: 51.05 lon: 3.71667 facility: McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre city: Montreal state: Quebec country: Canada lat: 45.50884 lon: -73.58781 facility: Universite de Montreal - Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame city: Montreal state: Quebec country: Canada lat: 45.50884 lon: -73.58781 facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud city: Pierre Benite country: France lat: 45.7009 lon: 4.82511 facility: Bon Secours Hospital - Dublin city: Dublin country: Ireland lat: 53.33306 lon: -6.24889 facility: Mater Misericordiae University Hospital (MMUH) (START Dublin) city: Dublin country: Ireland lat: 53.33306 lon: -6.24889 facility: Istituto Europeo di Oncologia (IEO) (European Institute of Oncology) city: Milan country: Italy lat: 45.46427 lon: 9.18951 facility: Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location city: Badalona state: Barcelona country: Spain lat: 41.45004 lon: 2.24741 facility: Parc Taulí city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Vall d'Hebron Institut d'Oncologia city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen) city: Jaen country: Spain lat: 37.76922 lon: -3.79028 hasResults: False |
<|newrecord|> nctId: NCT06365840 id: IMC-001-202 briefTitle: A Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor acronym: TMB-H overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2027-12 date: 2024-04-15 date: 2024-04-15 name: ImmuneOncia Therapeutics Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients. conditions: TMB-H conditions: Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: IMC-001 measure: ORR sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06365827 id: AZ293/20 briefTitle: Perioperatively Assessed Biomarker I-FABP Level for Prediction of Acute Mesenteric Ischemia and Its Correlation With Acute Kidney Injury, Followed by Extracorporeal Circulation (aMIKI) acronym: aMIKI overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-01 date: 2023-12-31 date: 2024-07-31 date: 2024-04-15 date: 2024-04-22 name: University of Giessen class: OTHER briefSummary: Acute mesenteric ischemia (AMI) is a severe condition that might occur after cardiovascular surgery. Several risk factors for AMI, such as multimorbidity, the use of vasopressors, and an increase in inflammatory markers have been identified in the past. However, these risk factors also seem to influence the blood and urine levels of I-FABP. This prospective pilot study intends to evaluate the value of perioperatively assessed I-FABP levels and to correlate these values with clinical or angiographic findings in mesenteric ischemia to improve a standardised diagnosis. conditions: Cardiac Surgery With Cardiopulmonary Bypass conditions: Acute Mesenteric Ischemia conditions: Acute Kidney Injury conditions: Non-Occlusive Mesenteric Ischaemia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 500 type: ACTUAL name: observational study measure: Concentration of I-FABP values with/and without acute mesenteric ischemia measure: Time interval to mesenteric ischemia measure: Overall mortality rate measure: Correlation of I-FABP with biomarkers of acute kidney injury measure: Association of mesenteric ischemia with hypercoagulable states measure: Incidence of stroke measure: Association of I-FABP level and multi-organ failure or cardiovascular mortality sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Giessen, Cardiovascular surgery city: Giessen state: Hessen zip: 35392 country: Germany lat: 50.58727 lon: 8.67554 hasResults: False |
<|newrecord|> nctId: NCT06365814 id: ERASforNACT briefTitle: ERAS for Gastric Cancer Patients After NACT overallStatus: COMPLETED date: 2023-10-01 date: 2024-04-01 date: 2024-04-01 date: 2024-04-15 date: 2024-04-15 name: The Affiliated Hospital of Qingdao University class: OTHER briefSummary: Background: Gastric cancer patients receiving neoadjuvant chemotherapy (NACT) are more vulnerable to perioperative stress. Enhanced recovery after surgery (ERAS) is widely used in surgical patients aiming at reducing stress responses. However, whether this approach is safe and feasible for gastric cancer patients received minimally invasive radical gastrectomy after NACT remained determined. So, the objective of this study is to investigate the effects of ERAS for this special group of gastric cancer patients. |
Materials and Methods: The data of gastric cancer patients who underwent minimally invasive radical gastrectomy after NACT were collected in this retrospective cohort study. Patients were divided into an ERAS group and a conventional group based on whether they received perioperative ERAS management. Propensity score matching was conducted to eliminate bias. Pre- and postoperative inflammatory and nutritional marker levels, postoperative complications, recovery indices and 3-year OS and RFS were observed. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 252 type: ACTUAL name: enhanced recovery after surgery name: conventional perioperative management measure: postoperative infectious complications measure: postoperative recovery parameter measure: blood test result measure: 3-year overall survival measure: 3-years recurrence-free survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital city: Qingdao state: Shandong zip: 266000 country: China lat: 36.06488 lon: 120.38042 hasResults: False |
<|newrecord|> nctId: NCT06365801 id: 2022YFC3500401-IBS briefTitle: Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-15 date: 2024-04-15 name: The Third Affiliated hospital of Zhejiang Chinese Medical University class: OTHER briefSummary: Irritable bowel syndrome (IBS) is a common functional disorder of the digestive system characterized by recurrent abdominal pain associated with bowel movements or changes in bowel habits. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS manifestations make treatment difficult. By detecting and exploring the biological characteristics presented by the relevant meridian point reaction, this project clarified the specificity and regularity of the connection between the acupoint and the Zangfu reflected by this phenomenon, and conducted correlation analysis based on the intestinal flora, tryptophan metabolite levels and related scales of patients with IBS. conditions: Irritable Bowel Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Pain sensitivity measure: Thermal radiation characteristics measure: Microcirculation characteristics measure: Electrical characteristics measure: Biological ultra-weak luminescence measure: Intestinal flora measure: Tryptophan metabolites measure: Bristol Fecal Traits Grading Scale measure: Severity of IBS (IBS-SSS) measure: IBS Quality of Life (IBS-QOL ) measure: TCM Constitution Survey measure: Gastrointestinal Symptoms Rating Scale (GSRS) measure: Self-Rating Anxiety Scale (SAS) measure: Self-Rating Depression Scale (SDS) measure: Pittsburgh Sleep Quality Index (PSQI) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06365788 id: S66466 id: 2022-502272-23-00 type: OTHER domain: EU CT Number briefTitle: Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer acronym: ABBICAR overallStatus: RECRUITING date: 2024-04-08 date: 2027-12 date: 2027-12 date: 2024-04-15 date: 2024-04-15 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: Kom Op Tegen Kanker name: Eli Lilly and Company name: Teva Pharma briefSummary: This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer. conditions: Triple Negative Breast Neoplasms studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: Abemaciclib name: Bicalutamide measure: Number of participants with disease control at 16 weeks measure: Number of participants with (serious) adverse events, death and clinical abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measure: HRQoL change from baseline as measured by EORTC QLQ-C30 measure: Number of participants with disease control at 16 weeks in subgroup with androgen receptor (AR) positivity on immunohistochemistry (IHC) in ≥10% of cells. measure: Number of participants with disease control at 16 weeks in subgroups A, B, C and D separate measure: Number of participants with disease control at 24 weeks measure: Number of participants with partial or complete response at 16 weeks measure: Duration of response measure: Months of progression free survival measure: Months of overall survival sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antwerp University Hospital status: NOT_YET_RECRUITING city: Antwerp country: Belgium name: Sevilay Altintas, MD, PhD role: CONTACT phone: +3238213250 email: [email protected] name: Sevilay Altintas, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.21989 lon: 4.40346 facility: Gasthuiszusters Antwerpen status: NOT_YET_RECRUITING city: Antwerp country: Belgium name: Kevin Punie, MD role: CONTACT phone: +3234433737 email: [email protected] name: Kevin Punie, MD role: PRINCIPAL_INVESTIGATOR lat: 51.21989 lon: 4.40346 facility: University Hospital Brussels status: NOT_YET_RECRUITING city: Brussel country: Belgium name: Christel Fontaine, MD role: CONTACT phone: +3224776040 email: [email protected] name: Christel Fontaine, MD role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: Ghent University Hospital status: NOT_YET_RECRUITING city: Ghent country: Belgium name: Hannelore Denys, MD, PhD role: CONTACT phone: +3293322692 email: [email protected] name: Hannelore Denys, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: Jessa Ziekenhuis status: NOT_YET_RECRUITING city: Hasselt country: Belgium name: Annelies Requilé, MD role: CONTACT phone: +3211337979 email: [email protected] name: Annelies Requilé, MD role: PRINCIPAL_INVESTIGATOR lat: 50.93106 lon: 5.33781 facility: University Hospitals Leuven status: RECRUITING city: Leuven country: Belgium name: Patrick Neven, MD, PhD role: CONTACT phone: +3216344750 email: [email protected] name: Kristien Borremans, MD role: CONTACT phone: +3216347795 email: [email protected] name: Patrick Neven, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False |
<|newrecord|> nctId: NCT06365775 id: TJ-IRB20221229 briefTitle: Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2026-11-23 date: 2026-11-23 date: 2024-04-15 date: 2024-04-15 name: Dan Bing class: OTHER briefSummary: The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are: |
* if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls |
* if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls |
* to find out which factor from multi-omics data relates to outcomes of SSNHL |
* to develop the best prognostics model based on the multi-omics data. |
Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model. conditions: Sudden Sensorineural Hearing Loss conditions: Hearing Loss, Sensorineural conditions: Hearing Loss, Sudden studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Pure tone audiometry (PTA) measure: Speech reception thresholds measure: Speech discrimination scores measure: Variant detection efficiency measure: Exome coverage measure: Genome-wide variant distribution measure: Head MRI measure: Inner Ear MRI sex: ALL minimumAge: 4 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06365762 id: CK-0103 briefTitle: The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract overallStatus: COMPLETED date: 2006-01-01 date: 2006-12-31 date: 2007-04-30 date: 2024-04-15 date: 2024-04-16 name: Livionex Inc. class: INDUSTRY briefSummary: The study objectives were: |
* To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity; |
* To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and |
* To determine the optimal clinical dose of EDTA ophthalmic solution (C-KAD) which to proceed into pivotal study(s). conditions: Age Related Cataracts studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 111 type: ACTUAL name: EDTA Ophthalmic Solution 2.6% name: EDTA Ophthalmic Solution 1.3% name: Saline Solution (Placebo) measure: Contrast Sensitivity (Mesopic) Responder Analysis measure: Cumulative Improvement in Contrast Sensitivity (Mesopic) measure: Mean Change in Contrast Sensitivity (Mesopic) measure: Mean Change in Best-Corrected Visual Acuity (BCVA) measure: Pentacam Imaging sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Mary's Eye Specialists, Inc. city: San Francisco state: California zip: 94117 country: United States lat: 37.77493 lon: -122.41942 facility: Hunkeler Eye Institute city: Overland Park state: Kansas zip: 66210 country: United States lat: 38.98223 lon: -94.67079 facility: The Johns Hopkins Hospital & Health System, Wilmer Eye Institute city: Lutherville state: Maryland zip: 21093 country: United States lat: 39.42122 lon: -76.62608 facility: Harvard Medical School, Massachusetts Eye and Ear Infirmary city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: Charlotte Eye, Ear, Nose, and Throat Associates city: Charlotte state: North Carolina zip: 28210 country: United States lat: 35.22709 lon: -80.84313 facility: University of Utah, John Moran Eye Center city: Salt Lake City state: Utah zip: 84132 country: United States lat: 40.76078 lon: -111.89105 hasResults: False |
<|newrecord|> nctId: NCT06365749 id: TJ-IRB20221228 briefTitle: Genetic Feature of Congenital Hearing Loss in Chinese Population overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2026-11-23 date: 2026-11-23 date: 2024-04-15 date: 2024-04-15 name: Dan Bing class: OTHER briefSummary: Congenital hearing loss, as well as hearing loss present at birth, is one of the most common chronic conditions in children, with a prevalence of permanent bilateral hearing loss of 2.83 per 1000 children of primary school age, which is mainly caused by genetic factors. The goal of this observational study is to learn about novel causative genes in infants with hearing loss in the Chinese population. The main problem it aims to deal with are: |
* to present the genetic characteristics of the infant with hearing loss in the Chinese population |
* to build up a prognostic model base on diverse data. |
Participants will be asked to receive audiological tests and collection of the peripheral blood sample. conditions: Congenital Hearing Loss conditions: Congenital Deafness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Whole exome sequencing data measure: TEOAE-based otoacoustic emissions test outcome measure measure: Auditory brainstem response testing measure: Acoustic impedance measure: Audiogram sex: ALL maximumAge: 6 Months stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06365736 id: 240310 briefTitle: The Effect of a Contemplative Nature-based Intervention on Spiritual Well-being overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-09-04 date: 2024-09-04 date: 2024-04-15 date: 2024-04-15 name: University of Twente class: OTHER briefSummary: The goal of this randomized control trial is to test if contemplating in nature could benefit spiritual well-being in general adults. The main question it aims to answer is: |
Does a 2-week contemplative nature intervention improve spiritual well-being? |
Researchers will compare intervention conditions to active control (walking in nature) and passive control (waitlist) conditions to see if contemplating in nature works to improve spirituality. |
Participants in the intervention condition will walk for 10 minutes and then choose a nice spot to sit for 10 minutes. During these minutes they will be asked to be silently present and observe trees, plants, flowers, or other aspects of nature and contemplate their connectedness to nature and their own awareness. Then walk back 10 minutes. |
Participants in the active control condition will walk for 30 minutes without further instruction. conditions: Spiritual Well-being conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Contemplating in nature name: Walking in nature measure: Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) measure: Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) measure: Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) measure: Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) measure: Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) measure: Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) measure: Client satisfaction of intervention condition assessed by Client Satisfaction Questionnaire (CSQ-8) measure: Client satisfaction of active control condition assessed by Client Satisfaction Questionnaire (CSQ-8) measure: Client satisfaction of passive control condition assessed by Client Satisfaction Questionnaire (CSQ-8) measure: Nature connectedness assessed by Connectedness to Nature Scale (CNS) measure: Nature connectedness assessed by Connectedness to Nature Scale (CNS) measure: Nature connectedness assessed by Connectedness to Nature Scale (CNS) measure: Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS) measure: Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS) measure: Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS) measure: Well-being assessed by Mental Health Continuum-Short Form (MHC-SF) measure: Well-being assessed by Mental Health Continuum-Short Form (MHC-SF) measure: Well-being assessed by Mental Health Continuum-Short Form (MHC-SF) measure: Psychological well-being assessed by Brief INSPIRE-O measure: Psychological well-being assessed by Brief INSPIRE-O measure: Psychological well-being assessed by Brief INSPIRE-O measure: Stress assessed by Perceived Stress Scale (PSS) measure: Stress assessed by Perceived Stress Scale (PSS) measure: Stress assessed by Perceived Stress Scale (PSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Twente city: Enschede state: Overijssel zip: 7522NB country: Netherlands name: TALITHA RUARUS-BLANKERT role: CONTACT phone: +31534891289 email: [email protected] name: Ernst Bohlmeijer, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 52.21833 lon: 6.89583 hasResults: False |
<|newrecord|> nctId: NCT06365723 id: SPH-2023-32410 briefTitle: Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial overallStatus: NOT_YET_RECRUITING date: 2025-01-15 date: 2030-06-15 date: 2032-06-15 date: 2024-04-15 date: 2024-04-15 name: University of Minnesota class: OTHER briefSummary: Approximately 92 million U.S. adults (\~38% of population) have prediabetes (PreD). Because people with PreD are at high risk CMD, they are a target population for diabetes prevention programs. The focus is people with PreD because of their high risk for developing CMD and large numbers, providing an opportunity to investigate behavioral and environmental approaches as preventive measures in a well-defined population. Urbanization affords challenges and opportunities to public health that include exposure to obesogenic environments, air pollution, and psychosocial stressors. In healthy adults suggest exposure to nature has health benefits relative to exposure to built environments. Hypothesized mechanisms for health benefits of Greenspace exposure include increased physical activity (PA), attention restoration, stress reduction, and reduced exposure to pollution. Many of the health benefits are associated with reduced psychological and physiological stress leading to better autonomic functioning as assessed by heart rate variability (HRV) and other biomarkers. Multiple studies suggest that PA and exposure to natural environments may act together to improve health. Yet, aside from our preliminary studies, we are not aware of any studies that examined how physical activity may interact with exposure to urban Greenspace ('Green') compared with built urban environments ('Gray'), to reduce stress and improve health. The purpose of this proposed study is to conduct a randomized crossover trial comparing differences in the psychosocial and physiological effects of walking in urban Green and Gray spaces in adults with PreD. conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study is a randomized crossover trial with a 4-week washout period. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 216 type: ESTIMATED name: Green Walk name: Gray Walk measure: Measure of Anxiety measure: Perceived stress assessment measure: Mood assessment measure: Heart Rate variability measure: Salivary cortisol levels measure: Ambient Particulate Matter measure: Black Carbon levels measure: CMD risk measure: State and Trait anxiety sex: ALL minimumAge: 25 Years maximumAge: 64 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06365710 id: HUS/206/2022 briefTitle: Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture overallStatus: RECRUITING date: 2022-11-24 date: 2025-01-31 date: 2026-01-31 date: 2024-04-15 date: 2024-04-15 name: Töölö Hospital class: OTHER briefSummary: Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture. |
Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation. |
Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE). conditions: Orthopedic Procedures, Physical Therapy Modalities, Postoperative Care, Rehabilitation, Wrist Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: Telerehabilitation name: Traditional physiotherapy measure: Patient-Rated Wrist Evaluation (PRWE) measure: Grip strength measure: Quick Disabilities of the arm, shoulder, and hand measure: Pain (Visual Analogue Scale) measure: Wrist range of motion (ROM) measure: Adverse events measure: Global improvement measure: Patient-rated Quality of Life (EQ-5D) measure: Cost-utility analysis sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Division of Musculosceletal and Plastic Surgery, Hand Surgery Unit, Helsinki University Hospital status: RECRUITING city: Helsinki state: Uusimaa zip: 00029 country: Finland name: Samuli Aspinen, M.D., Ph.D. role: CONTACT phone: +358406360546 email: [email protected] lat: 60.16952 lon: 24.93545 hasResults: False |
<|newrecord|> nctId: NCT06365697 id: ZHTQ202301 briefTitle: Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11 date: 2025-10 date: 2024-04-15 date: 2024-04-15 name: Zhuhai Tonbridge Medical Tech. Co., Ltd. class: INDUSTRY briefSummary: The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis. conditions: Carotid Artery Stenosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 188 type: ESTIMATED name: Ton-bridge carotid stent name: WALLSTENT carotid stent measure: Incidence of non-MAE(major adverse events) within 30 days post-procedure measure: Technical success measure: Procedural success measure: Target lesion revascularization (TLR) measure: Ipsilateral stroke between 31 days and 1 year post-procedure measure: In-stent restenosis measure: mRS score measure: Device deficiency measure: Incidence of MAE measure: Incidence of Adverse events (AE) measure: Incidence of Serious adverse events (SAE) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The People's Hospital of Liaoning Province city: Shenyang state: Liaoning country: China name: Peizhuo Zang role: PRINCIPAL_INVESTIGATOR lat: 41.79222 lon: 123.43278 facility: Linyi People's Hospital city: Linyi state: Shandong country: China name: Hongxing Han role: PRINCIPAL_INVESTIGATOR lat: 35.06306 lon: 118.34278 facility: Qingdao Central Hospital city: Qingdao state: Shandong country: China name: Haicheng Yuan role: PRINCIPAL_INVESTIGATOR lat: 36.06488 lon: 120.38042 facility: The Affiliated Hospital of Qingdao University city: Qingdao state: Shandong country: China name: Yong Zhang role: PRINCIPAL_INVESTIGATOR lat: 36.06488 lon: 120.38042 facility: Central Hospital Affiliated to Shangdong First Medical University city: Jinan state: Shangdong country: China name: Liqun Jiao role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: Lishui Central Hospital city: Lishui state: Zhejiang country: China name: Xueli Cai role: PRINCIPAL_INVESTIGATOR lat: 28.46042 lon: 119.91029 facility: Xuanwu Hospital, Capital Medical University city: Beijing country: China name: Bin Yang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06365684 id: 133548 id: 2023-507823-52 type: EUDRACT_NUMBER briefTitle: Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4 acronym: LIBRAL overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-05-01 date: 2025-05-01 date: 2024-04-15 date: 2024-04-24 name: Leiden University Medical Center class: OTHER name: AstraZeneca briefSummary: Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease. |
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