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<|newrecord|> nctId: NCT06381336 id: TRAKSILVER2022 briefTitle: A Digital Home-Based Physiotherapy Program for Active Aging acronym: TRAK overallStatus: COMPLETED date: 2022-03-23 date: 2022-11-07 date: 2022-11-07 date: 2024-04-24 date: 2024-04-25 name: Trak Health Solutions S.L. class: INDUSTRY name: Basque Health Service name: University of the Basque Country (UPV/EHU) briefSummary: This clinical trial will aim to understand the effects of the TRAK-SILVER digital platform on pre-frail and older adults living at home, assessing its impact on physical activity level, emotional variables, and overall quality of life. Participant satisfaction with the digital treatment will also be evaluated.
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This research will provide insight into the utility and acceptance of the digital platform as a personalised and accessible digital physiotherapy program for this population, advancing understanding in the field.
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The participants will undergo a 3-month physiotherapy program using the TRAK-SILVER platform or a paper guide based on their assigned group. Additionally, weekly uploads of health-promoting audiovisual content will enhance the intervention's holistic approach to improving older adults' well-being and functional capacity. conditions: Frail Elderly Syndrome conditions: Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized two-group design with pretest-posttest assessment was used to analyse the effectiveness of the TRAK-SILVER application. Seventy-two adults aged 65 and above were stratified by gender and physical functioning capacity (SPBB) and then randomly assigned to either the experimental (EG) or control group (CG). EG received the TRAK-SILVER platform as a treatment methodology. The CG did not have access to the platform and was instructed to continue with the standard care program through exercise sheets. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 72 type: ACTUAL name: TRAK-SILVER platform measure: Short Physical Performance Battery (SPPB measure: Gait Speed measure: Timed Up and Go Test measure: 6-minute walk test (6MWT) measure: Berg Balance Scale measure: Number of steps count measure: Geriatric Depression Scale-15 (GDS) measure: De Jong Gierveld Loneliness Scale (JGLS) measure: Quality of life (QoL) questionnaire measure: Client Satisfaction Questionnaire (CSQ) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Social Center of Orio (Zahartzaroa) city: Orio state: Basque Country zip: 20810 country: Spain lat: 43.2787 lon: -2.12537 hasResults: False
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<|newrecord|> nctId: NCT06381323 id: PA2024 briefTitle: The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism overallStatus: RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2027-04-01 date: 2024-04-24 date: 2024-04-24 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism. conditions: Primary Aldosteronism conditions: Finerenone conditions: Mineralocorticoid Receptor Antagonist studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 55 type: ESTIMATED name: Finerenone measure: 24h systolic BP drop value measure: The change of diastolic BP from the baseline level after Finerenone treatment measure: Hypertension remission rate measure: Change of serum potassium level measure: Change of plasma renin activity measure: Change of ARR measure: Change of UACR measure: Change of eGFR measure: Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Dalong Zhu, MD,PhD role: CONTACT phone: 86-25-83-105302 email: [email protected] name: Ping Li, MD,PhD role: CONTACT phone: 86-25-83-105302 email: [email protected] name: Dalong Zhu, MD,PhD role: PRINCIPAL_INVESTIGATOR name: Ping Li, MD,PhD role: SUB_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06381310 id: 202310077DINB briefTitle: Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access overallStatus: RECRUITING date: 2024-02-26 date: 2024-10-30 date: 2024-10-30 date: 2024-04-24 date: 2024-04-24 name: National Taiwan University Hospital class: OTHER name: National Taiwan University Hospital Bei-Hu Branch briefSummary: Patients with ESRD are able to maintain life by undergoing renal replacement therapy, including hemodialysis (HD), peritoneal dialysis (PD) or kidney transplantation. HD continues to be the primary option. Arteriovenous fistula (AVF) and arteriovenous graft (AVG) are the common access sites for hemodialysis (HD) patients. AVF is the best access for dialysis , which is known as the lifeline of hemodialysis patients, but requires 6 to 8 weeks to maturate. Long-term use of an AVF for dialysis requires the ability of the dialysis staff to cannulate it successfully with large-bore needles thrice weekly. With increasing AVF prevalence as well as aging and more obese populations in the developed world, increasing numbers of difficult-to-cannulate AVFs are being encountered in practice.
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Traditionally, after maturation, cannulation of new AVF/AVG was performed by trained renal nurses through physical examination, namely listening to bruits and feeling for thrills to guide needle placement, known as "blind" cannulatio. However, physical examination is not reliable for first and difficult access cannulation (e.g., small or partial stenosis, deep-seated AVF/AVG, presence of clots, after multiple failed attempts with hematoma /swelling, and/or immature access with small vessel caliber), rendered higher rate of cannulation failure and lower AVF and AVG survival. Unfortunately, cannulation failure result in access damage, vessel intimal lining damage leading to stenosis, thrombosis, or aneurysm formation contributing to AVF failure, treatment delay and increased requirement for central venous access devices (CVAD). Patients with early AVF failure have much higher mortality risk, particularly if they are older and female. Van Loon et al. revealed that up to 90% of the first cannulation had complications (i.e., infiltration including hematoma formation and missed cannulation). With a high rate of AVF maturation failure (38-60%) in general, cannulation failure may be avoidable if a more in-depth assessment was done before the attempt.
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Ultrasound (US) guided cannulation effective in identifying access location and patency. Roshan et al. reported a case study on bedside ultrasonography for AVF cannulation. The study showed decreased cannulation failure, vessel wall damage, thrombosis, and hematoma formation risks also reduced missed cannulation and increased staff confidence in performing cannulation.
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Therefore, this study aims to explore the effects of ultrasound technology on arteriovenous access successful cannulation for patients with end-stage kidney disease to provide reliable research integration evidence as the basis for future clinical care. conditions: Successful Cannulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: asus-handheld-ultrasound LU710L measure: cannulation success rate measure: cannulation satisfaction sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital Bei-Hu Branch status: RECRUITING city: Taipei City country: Taiwan name: Tsuei-Wun Chang role: CONTACT phone: 886-23717101 phoneExt: 218501 lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06381297 id: OndokusMU id: Ondokuz Mayıs University type: REGISTRY domain: Clinical research ethics committee briefTitle: Speech in Noise Discrimination Skills in Multiple Sclerosis Patients. overallStatus: COMPLETED date: 2020-10-09 date: 2023-03-23 date: 2023-04-23 date: 2024-04-24 date: 2024-04-24 name: Asuman Kucukoner class: OTHER briefSummary: The aim of this clinical trial was to determine the effect of multiple sclerosis on speech reception and discrimination in noise and to compare the effects on the medial olivocochlear reflex, which is thought to affect speech intelligibility in noise, with a control group.
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The main questions it aims to answer are:
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Does MS disease affect the ability to discriminate speech in noise? Does MS affect contralateral suppression results assessing medial olivocochlear function? Is there a correlation between the ability to discriminate speech in noise and contralateral suppression skills of MS patients? Data from MS patients and healthy participants will be compared. Thirty relapsing remitting MS patients and 30 healthy participants admitted to the clinic will be evaluated. conditions: Multiple Sclerosis-Relapsing-Remitting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Multiple sclerosis patient group and healthy control group. primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ACTUAL name: Hearing test name: Speech in noise discrimination test name: Montreal Cognitive Assessment Scale name: Symbol Number Modalities Test (SDMT) measure: Pure tone Audiometry Test measure: Speech Audiometry measure: Speech Discrimination in Noise Test measure: Otoacoustic Emission Test measure: Contralateral Suppression Test measure: Montreal Cognitive Assessment Scale measure: Symbol Digit Modalities Test sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Ondokuz Mayıs University city: Samsun zip: 55300 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False
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<|newrecord|> nctId: NCT06381284 id: MG-001 briefTitle: Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired With a Self-moderated Assessment overallStatus: RECRUITING date: 2024-03-28 date: 2024-05-27 date: 2025-05-27 date: 2024-04-24 date: 2024-04-26 name: ZS Associates class: INDUSTRY name: University of California, San Francisco briefSummary: This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The main study objective is to evaluate the feasibility of a social media recruitment campaign tied to a participant reported symptom survey and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected Myasthenia Gravis (MG). conditions: Myasthenia Gravis conditions: Neuromuscular Manifestations conditions: Neuromuscular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Social media recruitment name: Self-Assessment name: Follow-up measure: Social media recruitment feasibility measure: MG Exercise Assessment Tool validity measure: Time to diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ZS Associates status: RECRUITING city: Evanston state: Illinois zip: 60201 country: United States name: Ananda V Pandurangadu, MD role: CONTACT phone: 1-847-448-1001 email: [email protected] name: Ananda Vishnu Pandurangadu, MD role: PRINCIPAL_INVESTIGATOR name: Pritikanta Paul, MD role: SUB_INVESTIGATOR lat: 42.04114 lon: -87.69006 hasResults: False
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<|newrecord|> nctId: NCT06381271 id: TRUST TAVR Registry briefTitle: Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation overallStatus: RECRUITING date: 2018-10-30 date: 2034-10 date: 2034-10 date: 2024-04-24 date: 2024-04-24 name: Xijing Hospital class: OTHER briefSummary: The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected conditions: Aortic Valve Regurgitation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Transcatheter aortic valve replacement measure: Combined clinical efficacy outcomes measure: Combined early safety and clinical efficacy outcomes measure: Rate of technical success measure: Rate of device success measure: Combined clinical efficacy outcomes measure: Rate of all-cause mortality measure: Valve-related long-term clinical efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital status: RECRUITING city: Xi'an state: Shannxi zip: 710032 country: China name: Rutao Wang, M.D., Ph.D. role: CONTACT phone: +86-15091095796 email: [email protected] name: Ruining Zhang, BSc role: CONTACT phone: +86-15802990370 email: [email protected] name: Ling Tao, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 hasResults: False
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<|newrecord|> nctId: NCT06381258 id: SDF briefTitle: Fetal Cardiac Function overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-11 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: The aim of our study is to evaluate the effect of PE and FGR on fetal cardiac function. Pregnancies with preeclampsia and FGR, and preeclampsia with normal fetal growth are evaluated by echocardiography and compared with uncomplicated pregnancies. conditions: Fetal Growth Retardation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 32 type: ESTIMATED name: Ultrasound measure: Cardiac systolic function measure: Cardiac diastolic function sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381245 id: KB/265/2023 briefTitle: First-time Ablation of Atrial Fibrillation Registry acronym: DIPE overallStatus: RECRUITING date: 2023-12-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-24 date: 2024-04-24 name: Medical University of Warsaw class: OTHER briefSummary: Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success.
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The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers. conditions: Atrial Fibrillation conditions: Arrhythmia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: PPG-based remote heart rhythm/rate monitoring name: ECG-based remote heart rhythm/rate monitoring name: Transthoracic and transesophageal echocardiography examination name: Liver ultrasound examination name: Rotational angiography with three-dimensional reconstruction name: Blood-derived biomarker analysis name: Mobile health-based spirometry measure: Late AF recurrence measure: Late recurrence of AF or atrial tachycardia or atrial flutter measure: Early recurrence of AF measure: Early recurrence of AF or atrial tachycardia or atrial flutter measure: Time to AF recurrence and the impact of early recurrence on late AF recurrence measure: The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring measure: Progression or regression of AF measure: Modification of treatment, including antiarrhythmic treatment measure: AF-related quality of life and symptoms measure: Periprocedural complications measure: Heart rate variability and rate measure: Blood biomarker levels measure: Ablation procedure parameters measure: Cardiac remodelling sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Warsaw status: RECRUITING city: Warsaw country: Poland name: Monika Gawałko, MD, PhD role: CONTACT phone: 22 599 19 58 phoneExt: +48 email: [email protected] name: Monika Gawałko, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Paweł Balsam, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Piotr Lodziński, MD, PhD role: SUB_INVESTIGATOR name: Michał Marchel, MD, PhD role: SUB_INVESTIGATOR name: Michał Peller, MD, PhD role: SUB_INVESTIGATOR name: Bartosz Krzowski, MD, PhD role: SUB_INVESTIGATOR name: Cezary Maciejewski, MD, PhD role: SUB_INVESTIGATOR name: Maria Boszko, MD role: SUB_INVESTIGATOR name: Michał Gawlik, MD role: SUB_INVESTIGATOR name: Karolina Mitrzak, MD role: SUB_INVESTIGATOR name: Alicja Skrobucha, MD role: SUB_INVESTIGATOR name: Mateusz Wawrzeńczyk, MD role: SUB_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False
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<|newrecord|> nctId: NCT06381232 id: VIOME-001 briefTitle: Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population overallStatus: RECRUITING date: 2018-07-23 date: 2028-07-23 date: 2028-07-23 date: 2024-04-24 date: 2024-04-24 name: Viome class: INDUSTRY briefSummary: The purpose of the study is to collect and analyze physiological, physical, and molecular data from a diverse population to increase our understanding of how such parameters are associated with health and disease. conditions: General Health conditions: Wellness studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 20000 type: ESTIMATED name: No Intervention measure: Molecular Determinants of Health and Disease sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Viome Life Sciences status: RECRUITING city: Bothell state: Washington zip: 98011 country: United States name: Momchilo Vuyisich role: CONTACT phone: 425-300-6933 email: [email protected] lat: 47.76232 lon: -122.2054 hasResults: False
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<|newrecord|> nctId: NCT06381219 id: s67001 briefTitle: Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial overallStatus: RECRUITING date: 2023-12-19 date: 2026-12-31 date: 2028-12-31 date: 2024-04-24 date: 2024-04-24 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: The objective of the study is to study whether the introduction of heated food products (more specifically heated hen's egg and/or cow's milk) in children with EoE would be possible without re-occurrence of the eosinophilic inflammation, while the intake of less heated products might cause disease recidive. Moreover, we would like to study whether the gradual re-introduction of less heated products after the most heated form is tolerated, could lead to tolerance induction in EoE. conditions: Eosinophilic Esophagitis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Implementation of cow's milk in decreasingly heated forms name: Implementation of hen's egg in decreasingly heated forms measure: Maintained remission of EoE measure: Maintained remission only in step 1 of the diet measure: Association of remission with circulating IgG4 levels measure: Association of remission with IgG4 levels on biopsy measure: In vitro B cell test to mimic B cell activation after stimulation measure: Correlation between QoL and remission measure: Associated atopy measure: Associated food allergies sex: ALL minimumAge: 12 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: UZ Leuven Gasthuisberg status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Dominique Bullens, Prof. Dr. role: CONTACT phone: 0032 16 34 38 01 email: [email protected] name: Marleen Jannis role: CONTACT phone: 0032 16 34 38 01 email: [email protected] lat: 50.87959 lon: 4.70093 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-07-05 uploadDate: 2023-10-25T10:35 filename: Prot_000.pdf size: 696874 hasResults: False
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<|newrecord|> nctId: NCT06381206 id: No 475 briefTitle: Silodosin in Management of Lower Ureteral Stones overallStatus: COMPLETED date: 2022-10-20 date: 2023-10-20 date: 2023-10-25 date: 2024-04-24 date: 2024-04-24 name: Syrian Private University class: OTHER briefSummary: This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the side effects of silodosin. conditions: Stone, Kidney studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: Silodosin measure: Stone expulsion (yes) measure: Stone expulsion (no) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus university city: Damascus zip: 1 country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 hasResults: False
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<|newrecord|> nctId: NCT06381193 id: ESTR-01-2022 briefTitle: Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics overallStatus: COMPLETED date: 2023-03-03 date: 2023-07-10 date: 2023-07-10 date: 2024-04-24 date: 2024-04-24 name: Centros de Investigación de Nutrición y Salud class: OTHER name: Nutribiotica briefSummary: The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are:
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* To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks.
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* To evaluate the stool consistency after 8 weeks (Bristol scale).
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* To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks.
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Participants are randomized into the following groups:
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* Group A: 20 assigned to probiotic + placebo
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* Group B: 20 assigned to prebiotic + placebo
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* Group C: 20 assigned to probiotic + prebiotic
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* Group D: 20 assigned to the placebo + placebo
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Participants took 4 units of product per day (2 of each assigned product) for 2 months. conditions: Functional Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ACTUAL name: Probiotic name: Prebiotic name: Probiotic + Prebiotic name: Placebo measure: 1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation. measure: To evaluate the stool consistency (Bristol scale). measure: To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20) measure: To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale). sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centros de Investigación en Nutrición y Salud SL. (Clínica CINUSA) city: Madrid zip: 28036 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06381180 id: Warrior CARE: CBH briefTitle: Warrior CARE: Cannabis Behavioral Health acronym: CBH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2030-12-31 date: 2030-12-31 date: 2024-04-24 date: 2024-04-24 name: Wayne State University class: OTHER briefSummary: This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation. conditions: Post Traumatic Stress Disorder conditions: Cannabis Use conditions: Suicide conditions: Veterans conditions: Marijuana studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 500 type: ESTIMATED name: Tetrahydrocannabinol name: Cannabidiol name: Placebo measure: Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment. measure: Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment measure: Assessing Suicidality over time using the C-SSRS assessment. measure: Assessing Suicidality throughout the study using the SBQ-R assessment. measure: Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires. measure: Assess emotional state pre- and post-treatment using the PANAS questionnaire. measure: Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment. measure: Assess childhood and lifetime trauma pre- and post-treatment using the ACE, CTQ, and PCTI questionnaires. measure: Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments. measure: Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales. measure: Assess ethnic-racial discrimination pre- and post-treatment using the CERIS-A and TSDS Questionnaires. measure: Assess demographics using a self-report assessment measure: Assess toxicant exposure commonly experienced during war using the KGWIC and BPE assessments. measure: Assess smoking habits and history using the FTND assessment measure: Assess general health and history pre- and post-treatment using the SF-36 assessment. measure: Assess healthcare utilization throughout the study. measure: Assess pain pre- and post-treatment using the BPI assessment. measure: Assess sleepiness pre- and post-treatment using the ESS questionnaire. measure: Assess overall quality of life pre- and post-treatment using the QOL questionnaire. measure: Assess substance use throughout the study using the TLFB assessment. measure: Assess neurocognitive and executive function pre- and post-treatment using the WCST, WMS, CVLT, HMDD, WCS, IGT tasks measure: Assess physiological measures throughout the study as a safety check measure: Assess biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD. sex: ALL minimumAge: 19 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wayne State University city: Detroit state: Michigan zip: 48201 country: United States name: Nareen Sadik, B.S. role: CONTACT lat: 42.33143 lon: -83.04575 hasResults: False
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<|newrecord|> nctId: NCT06381167 id: Endoscopic decompression briefTitle: Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-10 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis. conditions: Lumbar Spinal Stenosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Endoscopic Decompressive Laminectomy measure: Oswestry Disability Index ODI scores for low back pain and neuropathic pain measure: visual analog scale (VAS) score for low back and lower extremity radiating pain measure: European Quality of Life-5 Dimensions (EQ-5D) score measure: painDETECT score sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381154 id: MC230404 id: NCI-2024-03078 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-009036 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230404 type: OTHER domain: Mayo Clinic id: P01CA084203 type: NIH link: https://reporter.nih.gov/quickSearch/P01CA084203 id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 briefTitle: Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2029-07-04 date: 2029-07-04 date: 2024-04-24 date: 2024-04-24 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase II trial tests how well photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy works in treating patients with pancreatic cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Photoradiation uses light activated drugs, such as verteporfin, that become active when exposed to light. These activated drugs may kill tumor cells. Vertoporfin may also increase tumor response to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy may kill more tumor cells in patients with unresectable, locally advanced or metastatic pancreatic cancer. conditions: Locally Advanced Pancreatic Adenocarcinoma conditions: Metastatic Pancreatic Adenocarcinoma conditions: Stage II Pancreatic Cancer AJCC v8 conditions: Stage III Pancreatic Cancer AJCC v8 conditions: Stage IV Pancreatic Cancer AJCC v8 conditions: Unresectable Pancreatic Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Endoscopic Ultrasound name: Fluorouracil name: Irinotecan name: Leucovorin name: Lymph Node Biopsy name: Magnetic Resonance Imaging name: Oxaliplatin name: Pembrolizumab name: Photodynamic Therapy name: Positron Emission Tomography name: Questionnaire Administration name: Verteporfin measure: Overall response rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Incidence of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Vinay Chandrasekhara, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06381141 id: CLN-619-002 briefTitle: A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2027-03 date: 2024-04-24 date: 2024-04-24 name: Cullinan Therapeutics Inc. class: INDUSTRY briefSummary: A Phase 1b, Multicenter, Open-Label, Study to Investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CLN-619 measure: Proportion of participants reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Changes in Eastern Cooperative Oncology Group (ECOG) performance measure: Incidence of Dose-Limiting toxicity (DLTs) measure: Best Overall Response (BOR) per patient measure: Overall Response Rate (ORR) measure: Duration of Response (DoR) measure: Clinical Benefit Rate (CBR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381128 id: CAA by CT in children with CHD briefTitle: Coronary Arteries Anomalies by CT in Children With CHD overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2026-01-01 date: 2029-12-31 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction. conditions: Cardiac Congenital Defects studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Cardiac CT measure: Detection of coronary arteries anomalies by computed tomography angiography in children with congenital heart disease sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06381115 id: 23-006685 briefTitle: App-Based Optimization of Long-Term CPAP Adherence and Quality of Life overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-11 date: 2024-04-24 date: 2024-04-24 name: Mayo Clinic class: OTHER name: Arizona State University (ASU) briefSummary: The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: SleepWell24 Application measure: CPAP Adoption measure: Change in Quality of Life measure: Change in sleep time measure: Change in physical activity measure: Change in sedentary time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona city: Scottsdale state: Arizona zip: 85259 country: United States lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06381102 id: 20240134 briefTitle: Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1 overallStatus: RECRUITING date: 2024-04-13 date: 2024-10-01 date: 2024-10-01 date: 2024-04-24 date: 2024-04-24 name: University of Miami class: OTHER briefSummary: The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: transcutaneous auricular vagus nerve stimulation 30/30 name: transcutaneous auricular vagus nerve stimulation 10/10 measure: Tolerability measured by tolerability questionnaire measure: Tolerability measured by self-report measure: Change in heart rate variability (HRV) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Gabriel Gonzalez, DPT role: CONTACT phone: 305-243-8117 email: [email protected] name: Marlon Wong, PT, PhD role: PRINCIPAL_INVESTIGATOR name: Gabriel Gonzalez, DPT role: SUB_INVESTIGATOR name: Jessica Bolanos, DPT role: SUB_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False
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<|newrecord|> nctId: NCT06381089 id: VNS004 briefTitle: Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients acronym: ERRVNS overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-07-10 date: 2024-08-10 date: 2024-04-24 date: 2024-04-24 name: SEFA HAKTAN HATIK class: OTHER briefSummary: This study was conducted in patients with ischemic stroke; This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patient's functional level and autonomic nervous system.
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40 people over the age of 18 participated in the study. They were randomly divided into two groups: robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation. While the robotic rehabilitation group received Lokomat and neurological rehabilitation, the other group received stimulation with the Vagustim device, which is applied non-invasively through the ear, in addition to Lokomat and neurological rehabilitation. Spasticity, autonomic nervous system, walking speed, motor function, quality of life, muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment. In the study, significance was evaluated at p\<0.05 level. conditions: Ischemic Stroke conditions: Vagus Nerve Stimulation conditions: Robotic Rehabilitation conditions: Autonomic Nervous System studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Robotic Rehabilitation name: Transcutaneous Auricular Vagal Nerve Stimulation measure: Numerical Pain Rating Scale measure: Stroke Specific Quality of Life Scale measure: 10 Meter Walk Test measure: Fugl-Meyer Assessment Lower Extremity measure: Modified Ashworth Scale measure: Electromyography measure: Autonomic Nervous System sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381076 id: IRB202400087 briefTitle: Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis. overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-12 date: 2025-12 date: 2024-04-24 date: 2024-04-26 name: University of Florida class: OTHER briefSummary: A 12-week double-blind randomized control trial will be conducted among adults on hemodialysis (n=15) to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress. Participants will be randomized via a computer-generator into either the control or intervention group. Participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks. At baseline, weeks 8 and 12, participants will have blood sampled and complete a 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day) and a quality of life survey. conditions: Chronic Kidney Disease 5D studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized comparator-controlled trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants will receive a 3-digit coded product that either contains 7 mls of liposomal curcumin or food colorant. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Liposomal curcumin name: Food colorant measure: high-sensitivity C-reactive protein measure: Advanced glycation end products measure: fatty acid byproduct - 4-hydroxynon-enal measure: fatty acid byproduct - malondialdehyde measure: fatty acid byproduct - 8-F2 isoprostanes measure: Klotho sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381063 id: PI2023_843_0152 briefTitle: Non-steroidal Anti-inflammatory in Cardiac Surgery acronym: KETOPAIN overallStatus: RECRUITING date: 2024-03-27 date: 2027-03 date: 2027-07 date: 2024-04-24 date: 2024-04-24 name: Centre Hospitalier Universitaire, Amiens class: OTHER name: University Hospital, Rouen name: University Hospital, Lille briefSummary: Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication. conditions: Acute Postoperative Pain conditions: Non-steroidal Anti-inflammatory Drugs conditions: Cardiac Surgery conditions: Pain Intensity conditions: Multimodal Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 238 type: ESTIMATED name: pain management name: ketoprofen name: PLacebo measure: reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery measure: NSAIDs reduce postoperative at rest at 24 hours from the end of surgery measure: Change in pain trajectory during the first 7 days after cardiac surgery measure: Change in cumulative opioid within 48 hours after surgery measure: Change in pulmonary postoperative complications within 7 days after surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens Picardie status: RECRUITING city: Amiens country: France name: Osama ABOU ARAB role: CONTACT email: [email protected] name: Emmanuel BESNIER, MD role: PRINCIPAL_INVESTIGATOR name: Mouhamed MOUSSA, MD role: PRINCIPAL_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False
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<|newrecord|> nctId: NCT06381050 id: SHR-7631-101 briefTitle: The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2027-04 date: 2024-04-24 date: 2024-04-24 name: Suzhou Suncadia Biopharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: SHR-7631 measure: Maximum tolerated dose (MTD) or maximum administered dose (MAD) measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0) measure: PK parameter: Tmax measure: PK parameter: Cmax measure: PK parameter: AUC0-t measure: PK parameter: AUC0-∞ measure: PK parameter: t1/2 measure: PK parameter: MRT (mean residence time) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381037 id: PID2021-127986OB-I00 briefTitle: Quality of Life and Psychological Strengths of Older People acronym: QUALIFRAG overallStatus: RECRUITING date: 2023-09-01 date: 2026-01-31 date: 2026-08-31 date: 2024-04-24 date: 2024-04-24 name: CEU San Pablo University class: OTHER briefSummary: As the 2019 coronavirus pandemic (COVID-19) overspreads around the world, and scientists try to elucidate about the complexity of the virus, there is clear potential for it to become a long-lasting global illness. In this picture, Spain has emerged as one of the most affected countries with a high prevalence rate. The possibility of illness or even death, the uncertainty of the future, or the required physical estrangement, make this epidemic a highly stressful situation with potential long-term consequences on the physical and psychological wellbeing of the population, just isolation raises the probability of health problems like depression and anxiety. However, the same event does not affect everybody equally. The ultimate effect of a stressor will depend on its appraisal as a threat and the resources the person counts on to copy and several biopsychosocial variables could play an important role, as risk or protective factors. conditions: Quality of Life conditions: Skills, Coping studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Quantitative, observational and longitudinal study with three measurements (pre-intervention, post-intervention and monitoring). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 110 type: ESTIMATED name: "How to improve your strengths and quality of life". measure: Quality of life measure: Psychological wellbeing measure: Loneliness measure: Anxiety and depression Anxiety and depression measure: Gratitude measure: Experiential acceptance measure: Resilience measure: Family functioning sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Pablo CEU University (Campus Montepríncipe) status: RECRUITING city: Alcorcón state: Madrid zip: 28925 country: Spain name: Leyre Galarraga Cristóbal role: CONTACT phone: 913724700 phoneExt: 14607 email: [email protected] name: Gema Pérez Rojo role: CONTACT phone: 913724700 phoneExt: 14999 email: [email protected] lat: 40.34582 lon: -3.82487 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2023-12-01 uploadDate: 2023-12-11T03:43 filename: SAP_000.pdf size: 70923 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-01 uploadDate: 2023-12-11T03:42 filename: ICF_001.pdf size: 71559 hasResults: False
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<|newrecord|> nctId: NCT06381024 id: 2022 A02702-41 briefTitle: A Study of Telemonitoring in Cancer Patients acronym: MINERVA overallStatus: RECRUITING date: 2023-04-04 date: 2024-12-30 date: 2024-12-30 date: 2024-04-24 date: 2024-04-24 name: Centre Hospitalier de Bligny class: OTHER name: Exystat name: Cureety name: Pharmaspecific name: ProPens briefSummary: The goal of this prospective, randomized, unblinded, single-centre, interventional study is to assess the effectiveness of standard of care with Cureety, compared to standard of care alone, to reduce the number of all telephone calls during the first 4 months of oral or intravenous cancer treatment for patients older than 18 years of age, initiating oral or intravenous cancer treatment at the Centre Hospitalier de Bligny.
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Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:
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* In-person care alone (Standard of care group).
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* In-person care with Cureety telemonitoring (Standard of care with Cureety group).
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Participants will:
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* be monitored with digital application Cureety (Standard of care with Cureety group)
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* fill out quality of life questionnaire (baseline, 2 months, 4 months)
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* fill out satisfaction questionnaire (2 months, 4 months)
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* have the ongoing and incoming phone calls logged (duration and type) conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:
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* In-person care alone (Standard of care group).
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* In-person care with telemonitoring (Standard of care with Cureety group).
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The randomization will be stratified by:
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• Oral versus intravenous cancer treatment. The number of patients initiating oral treatment at randomization will be restricted to 20 patients. primaryPurpose: TREATMENT masking: NONE count: 82 type: ESTIMATED name: remote patient monitoring measure: Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment measure: Duration of all telephone calls during the first 4 months of oral or intravenous cancer treatment measure: Numbers of telephone calls during the first 4 months of cancer treatment in subgroups measure: Hospital-free survival rate measure: Quality of life at 2 and 4 months after initiation of cancer treatment. measure: Patient satisfaction with the healthcare provided measure: CH Bligny staff satisfaction with the healthcare provided sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Bligny status: RECRUITING city: Briis-sous-Forges zip: 91640 country: France name: Ingrid Alexandre, MD role: CONTACT phone: +33169263138 email: [email protected] name: Ingrid Alexandre, MD role: PRINCIPAL_INVESTIGATOR lat: 48.62399 lon: 2.12112 hasResults: False
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<|newrecord|> nctId: NCT06381011 id: BEUFTR-4 briefTitle: Local Vibration in Cervical Radiculopathy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-01 date: 2024-09-01 date: 2024-04-24 date: 2024-04-24 name: Bitlis Eren University class: OTHER briefSummary: The aim of this study is to evaluate the effect of local vibration application on the upper extremity pain, paresthesia, neck pain, and limitations in cervical joint range of motion experienced by patients with cervical radiculopathy. conditions: Cervical Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The evaluator and the researcher administering the local vibration application will be different. Patients will be blinded to their group assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 34 type: ESTIMATED name: Local Vibration measure: Neck Pain measure: Upper Limb Pain measure: Paresthesia measure: Cervical Range of Motion measure: The Change in the Pressure Pain Threshold of the Upper Trapezius measure: The Change in the Viscoelastic Properties of the Upper Trapezius sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bitlis Eren University city: Bitlis state: Merkez zip: 13000 country: Turkey name: Ömer Dursun, Asst. Prof. role: CONTACT phone: 5426088687 phoneExt: +90 email: [email protected] name: Erhan Dincer, M.Sc. role: CONTACT phone: 5442543857 phoneExt: +90 email: [email protected] lat: 38.40115 lon: 42.10784 hasResults: False
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<|newrecord|> nctId: NCT06380998 id: EPCPHCFAPAEWPSPSWAG briefTitle: Effects of Petroleum Compounds on Psychological Health and Cognitive Functions overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-10-01 date: 2027-10-01 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: Over the last decade, awareness of the effects of hydrocarbon fuels on neurodegenerative disorders has increased significantly, as they are ubiquitous environmentally toxic chemicals that affect the central nervous system and result in irreversible neuronal damage, as many hydrocarbons can cross the blood-brain barrier through multiple pathways and cause direct toxicity. conditions: Cognitive Deterioration studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 196 type: ESTIMATED name: whey protien measure: Effects of petroleum compounds on psychological health and cognitive functions of petrol station workers in Assiut measure: To explore the relation between the level of petroleum hydrocarbon metabolites and the severity of psychological heath and cognitive functions disturbance of petrol station workers measure: To explore the role of supplements with whey protein in ameliorating these effects measure: To assess the relationship between the psychological effects, cognitive functions, and nutritional status of petroleum station workers sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of medicine city: Assiut state: Assiut University zip: 71515 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06380985 id: NURA-009-23F id: 1I01CX002715-01A1 type: OTHER_GRANT domain: Clinical Science Research & Development briefTitle: Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury acronym: TABM overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-06-30 date: 2027-12-31 date: 2024-04-24 date: 2024-04-26 name: VA Office of Research and Development class: FED briefSummary: The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI. conditions: Alcohol Use Disorder conditions: Mild-Moderate Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a Phase II double-blind, randomized, sham-controlled clinical trial. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The identity of ApBM and Sham will not be known to investigators or patients. To maintain the blind, the participant and the research coordinator (naïve to ApBM) administering the participant's training will be blind to whether "1" or "2" is ApBM or Sham. The research coordinator will receive the patient assignment from statistical software at time of randomization. The key that determines assignment of ApBM or Sham to condition "1" or "2" will be known by an addiction research program affiliate PI otherwise uninvolved in the current study. They will document this key in a locked electronic file. The study blind will be broken on completion of the study and after the study database has been locked. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Personalized VR Alcohol Approach Bias Modification (ApBM) Condition name: Sham Condition measure: Percent of Heavy Drinking Days measure: Cue-induced fMRI BOLD-signal craving activation contrasts measure: Cognitive flexibility sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Francisco VA Medical Center, San Francisco, CA city: San Francisco state: California zip: 94121-1563 country: United States name: David L Pennington role: CONTACT phone: 415-221-4810 phoneExt: 24504 email: [email protected] name: Yim Fan Wong, BS role: CONTACT phone: (415) 221-4810 phoneExt: 22329 email: [email protected] name: David L Pennington role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 hasResults: False
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<|newrecord|> nctId: NCT06380972 id: HDM6009A-301 briefTitle: A Prospective, Randomized, No-treatment Controlled, Evaluator-blinded Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-09 date: 2025-10 date: 2024-04-24 date: 2024-04-24 name: AQTIS Medical B.V. class: OTHER briefSummary: A Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour conditions: Forehead Contouring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: the method of endpoint blind evaluation is adopted, that is, it's blinded for the evaluator. whoMasked: OUTCOMES_ASSESSOR count: 189 type: ESTIMATED name: Polycaprolactone (PCL) Based Facial Injectable measure: The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS) measure: The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS) measure: The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS) measure: The global aesthetic improvement rate assessed by the injection investigator based on the Global Aesthetic Improvement Scale (GAIS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Second Provincial General Hospital city: Guangzhou state: Guangdong zip: 510317 country: China name: Shengkang Luo role: CONTACT phone: 02089168071 email: [email protected] name: WEIJIN HONG role: CONTACT phone: 02089168071 name: shengkang luo role: PRINCIPAL_INVESTIGATOR name: weijin hong role: SUB_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06380959 id: 223K879 briefTitle: Art-based Activities in Stroke Patients overallStatus: COMPLETED date: 2023-10-02 date: 2023-12-31 date: 2024-02-29 date: 2024-04-24 date: 2024-04-29 name: Ege University class: OTHER briefSummary: Introduction and Aim: Life after stroke begins a difficult period in which functional capacity is very limited. Disability persists for a long time, and various problems such as hemiparesis, hemiplegia, dysarthria, dysphagia, urinary and bowel incontinence, which are frequently encountered after stroke, can affect the quality of life in the long term. As non-pharmacological approaches, especially non-invasive methods, have gained attention, creative arts-based therapies have often been recommended for stroke survivors because they have an arts-based approach without side effects. It is thought that the study conducted will contribute to the literature as there are not many studies in the literature. The aim of this study is to examine the effects of art-based activities on stroke patients' hope and self-efficacy levels. Its sub-purpose is to reveal the feelings and thoughts that arise with art objects obtained from art-based activities applied to stroke patients.
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Materials and Methods: The study was conducted as a randomised controlled design. After the groups were determined, art-based activities module was applied to the intervention group for one week, while no additional intervention was made to the control group. Research data were collected using "Individual Introduction Form", "Herth Hope Index", "Generalized Self-Efficacy Scale. Data were analyzed with Statistical Package for the Social Sciences 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Controlled primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ACTUAL name: Art Based Activity measure: Herth Hope Index measure: Generalized Self-Efficacy Scale measure: Individual Introduction Form measure: Art Object Concretization Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: Bornova state: İzmir zip: 35100 country: Turkey lat: 38.47921 lon: 27.2399 hasResults: False
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<|newrecord|> nctId: NCT06380946 id: 978/91 briefTitle: Influence of Injectable Platelet Rich Fibrin on Different Orthodontic Tooth Movements During Clear Aligner Therapy overallStatus: ENROLLING_BY_INVITATION date: 2024-06-01 date: 2024-10-01 date: 2024-11-01 date: 2024-04-24 date: 2024-04-24 name: Al-Azhar University class: OTHER briefSummary: The aim of this prospective clinical project will be to assess the effect of platelet rich fibrin on the rate of different orthodontic tooth movements during clear aligner therapy. conditions: Effect of Platelet Rich FibrinDuring Clear Aligner Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 78 type: ESTIMATED name: iPRF measure: Influence of injectable platelet rich fibrin rate of different orthodontic tooth movements by millimeter sex: ALL minimumAge: 15 Years maximumAge: 22 Years stdAges: CHILD stdAges: ADULT facility: AlAzhar university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06380933 id: B11103008 briefTitle: The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort overallStatus: COMPLETED date: 2022-09-01 date: 2022-09-01 date: 2024-02-28 date: 2024-04-24 date: 2024-04-24 name: Dalin Tzu Chi General Hospital class: OTHER briefSummary: Purposes: Describe the background information and clinical characteristics of respirator-dependent patients, verify the sleep and comfort effects of respirator-dependent patients whether or not they receive a lavender essential oil warm water foot bath, and compare changes of the sleep, comfort, heartbeat, and blood pressure in respirator-dependent patients before and after receiving a lavender essential oil warm water foot bath. conditions: Sleep Quality conditions: Comfort studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: two-group crossover design trial and block randomly assigns groups after gender stratification. The experimental group first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days; the control group first received routine care for 3 days, then rested for 3 days, and then received lavender essential oil 41-42C warm water foot bath for 20 minutes for 3 days. primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 94 type: ACTUAL name: experimental group measure: Richards-Campbell Sleep Questionnaire measure: Numerical Rating of Comfort sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hsu Mei-Lian city: Chiayi City country: Taiwan lat: 23.47917 lon: 120.44889 hasResults: False
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<|newrecord|> nctId: NCT06380920 id: Digital Health App briefTitle: Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-24 date: 2024-04-25 name: National Cheng-Kung University Hospital class: OTHER briefSummary: This project anticipates addressing the obesity epidemics problem which has caused unhealthy lifestyle in billions of obesities and overweight people worldwide. The investigators propose on digital health solution in providing healthcare-on-demand, for personalized health, healthy lifestyle and weight management. This study proposes on using Cognitive Behavior Therapy (CBT) in decreasing individual's food craving, which is administered through AI (Assistive Intelligence) tracking. As with any new medicine, uncertain long-term effects and high costs of these new drugs are also critical factors considered by physicians and policy makers worldwide. Researchers have also reported on 85% of people re-gaining premedication weight after 5 years. There is no easily available self-controlled monitoring strategy/intervention for the unhealthy lifestyle is believed to be one of the main problems. Therefore, the investigators propose on the research and development of self-managing digital health APP (application) for 12 months over two phases, with three months to design APP and nine months to confirm the clinical validation. During the first phase, the investigators propose on design of an "AI Mindful Eating" App, to enhance individual's healthy lifestyle with subsequent weight-loss. Based on "gut-brain-axis", this is anticipated to be achieved by using CBT and AI is used to recognize nutrition and mood within mobile images. This facilitates fulfilling lifestyle and long-term weight-loss. Finally, the study proposes to complete function definition and clinical validation for our AI Humanity APP. By scheduled check-up program by monitoring and analyzing body weight, body fat, anthropometric and metabolic change data between case and control groups. The investigators intend to disclose the effect of the AI assistant APP in weight management and metabolic disease prevention. conditions: Weight Loss conditions: Body Fat Rate Loss conditions: Body Composition Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: "AI Mindful Eating" App name: Outpatient regular follow-up measure: weight change measure: Parameters of Metabolic syndrome sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06380907 id: ZL-1102-002 briefTitle: A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-02-28 date: 2026-03 date: 2024-04-24 date: 2024-04-26 name: Zai Lab (Hong Kong), Ltd. class: INDUSTRY name: Zai Lab (US) LLC briefSummary: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis conditions: Plaque Psoriasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: ZL-1102 1% w/w gel BID for 16 weeks name: ZL-1102 3% w/w gel BID for 16 weeks name: ZL-1102 3% w/w gel QD for 16 weeks name: Placebo ZL-1102 0% w/w gel BID for 16 weeks name: Placebo ZL-1102 0% w/w gel QD for 16 weeks measure: Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16. measure: The proportion of patients achieving IGA treatment success. measure: The proportion of patients achieving IGA score of 0 or 1. measure: The percent change from baseline in mPASI score. measure: The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20. measure: The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20. measure: Time to achieve mPASI 50/75/90. measure: Time to achieve IGA score of 0 or 1. measure: Time to achieve 1- or 2-point improvement in IGA. measure: Incidence of Treatment Related Adverse Events through Week 20. measure: Mean local tolerability scores (LTS) measure: Serum concentration of ZL-1102. measure: Anti-drug antibody (ADA) of ZL-1102. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zai Lab Site 5013 city: Phillip state: Australian Capital Territory zip: 2606 country: Australia lat: -31.13333 lon: 150.85 facility: Zai Lab Site 5016 city: Kotara state: New South Wales zip: 2289 country: Australia lat: -32.95 lon: 151.68333 facility: Zai Lab Site 5017 city: Woolloongabba state: Queensland zip: 4102 country: Australia lat: -27.48855 lon: 153.03655 facility: Zai Lab Site 5014 city: Carlton state: Victoria zip: 3053 country: Australia lat: -37.8 lon: 144.96667 facility: Zai Lab Site 5002 city: Melbourne E. state: Victoria country: Australia lat: -37.81667 lon: 144.9879 facility: Zai Lab Site 5015 city: Melbourne state: Victoria zip: 3124 country: Australia lat: -37.814 lon: 144.96332 hasResults: False
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<|newrecord|> nctId: NCT06380894 id: 2020/2239 briefTitle: Virtual Reality Cognitive Training for Mild Cognitive Impairment overallStatus: COMPLETED date: 2021-01-27 date: 2022-09-30 date: 2023-01-31 date: 2024-04-24 date: 2024-04-24 name: Changi General Hospital class: OTHER briefSummary: This study aims to assess the feasibility and efficacy of a 10-weekly multi-domain VRCT program on the cognitive function (i.e. attention, memory, and executive functioning) of older adults with MCI. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Virtual Reality Cognitive Training name: Active Control measure: Change from Baseline in Memory Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests at Week 11 measure: Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11 measure: Change from Baseline in Attention Performance on the Colour Trails Test 1 at Week 11 measure: Change from Baseline in Executive Function Performance on the Frontal Assessment Battery (FAB) at Week 11 measure: Change from Baseline in Executive Function Performance on the Colour Trails Test 2 at Week 11 sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Changi General Hospital city: Singapore country: Singapore lat: 1.28967 lon: 103.85007 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-01-27 uploadDate: 2024-04-15T09:12 filename: Prot_SAP_000.pdf size: 384298 hasResults: False
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<|newrecord|> nctId: NCT06380881 id: SHR-2017-102 briefTitle: PK/PD Study of SHR-2017 Injection in Patients With Bone Metastases overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-07 date: 2024-04-24 date: 2024-04-24 name: Suzhou Suncadia Biopharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: To evaluate the pharmacokinetic characteristics, pharmacodynamic characteristics, safety, tolerability and immunogenicity of SHR-2017 injection in patients with bone metastases, and to evaluate the efficacy of SHR-2017 injection in the treatment of skeletal-related event and cancer pain. conditions: Patients With Bone Metastases studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: SHR-2017 measure: The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax measure: The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax measure: The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t measure: The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞ measure: The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2 measure: The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F measure: The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr measure: The pharmacodynamic parameter of SHR-2017 after administration include β-CTX measure: The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time measure: Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing measure: Incidence of skeletal-related event measure: Average daily total opioids consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Huiping Li role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06380868 id: Nanjing-2 briefTitle: IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus acronym: IVI-DIABETES overallStatus: ENROLLING_BY_INVITATION date: 2024-06-10 date: 2026-06-01 date: 2027-07-20 date: 2024-04-24 date: 2024-04-24 name: Nanjing First Hospital, Nanjing Medical University class: OTHER name: Shanxi Provincial People's Hospital briefSummary: Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent (DES) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by IVUS, as opposed to angiography guidance, resonating with findings from the IVUS-XPL study, OCTOBER trial, and RENOVATE COMPLEX PCI trial, further confirmed by more recent IVUS-ACS trial.
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Optical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI.
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Regrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus. However, several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial. conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will undergo 1:1 randomization to either intravascular imaging (including intravascular ultrasound or optical coherence tomography)-guided DES implantation which will be the treatment group or Angio-guided DES implantation which will be the control group, stratified by research sites. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Randomization will be performed in the catheter laboratory by an invasive nurse. Staff in the catheter laboratory will be not blinded to the treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 1332 type: ESTIMATED name: Intravascular imaging-guided PCI name: Angiography-guided PCI group measure: Rate of target vessel failure (TVF) measure: Rate of target vessel failure without procedure-related MI measure: Rate of cardiac death measure: Rate of all-cause death measure: Rate of procedure-related myocardial infarction (PMI) measure: Rate of spontaneous myocardial infarction (SMI) measure: Rate of clinically-driven revascularization measure: Rate of stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospital city: Nanjing state: Jiangsu zip: 210006 country: China lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06380855 id: GIHSYSU-34 briefTitle: Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME) overallStatus: RECRUITING date: 2022-08-24 date: 2025-08-24 date: 2025-08-24 date: 2024-04-24 date: 2024-04-24 name: Sun Yat-sen University class: OTHER briefSummary: The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury. conditions: Rectal Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 5 type: ESTIMATED name: Flexible colonoscope assisted hybrid transanal total mesorectal resection measure: Success rate of operation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Liang Kang, MD, PhD role: CONTACT phone: 008613602886833 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06380842 id: 2023HX1970 briefTitle: Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-12-30 date: 2026-12-30 date: 2024-04-24 date: 2024-04-24 name: Chunling Jiang class: OTHER briefSummary: The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy. conditions: Necrotizing Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Necrotizing Pancreatitis patients' organ dysfunction progression measure: Measure organ dysfunction change after open necrosectomy with respect to time measure: incidence of a composite of major complications measure: Incidence of ICU mortality measure: Incidence of hospital mortality measure: Incidence of 28-day mortality measure: Incidence of one year mortality measure: ICU length of hospital stay measure: Length of hospital stay measure: The pancreatic symptoms score measure: The levels of inflammatory factor CRP measure: The levels of inflammatory cytokines IL-6 measure: The levels of inflammatory procalcitonin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06380829 id: Adnan Menderes briefTitle: Psychometric Properties of the Self-Care Assessment Scale for 3-6 Year Old Children With Cerebral Palsy-Parent Form overallStatus: COMPLETED date: 2023-06-05 date: 2023-12-05 date: 2024-02-10 date: 2024-04-24 date: 2024-04-24 name: Aydin Adnan Menderes University class: OTHER briefSummary: This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability.
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Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a reliable scale? conditions: Cerebral Palsy conditions: Self Care studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 127 type: ACTUAL name: Questionnaire measure: To asses Turkish validity and reliability of Self-Care Assessment Scale for Children with CP aged 3-6 years sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Bircan Kahraman Berberoğlu city: Aydın zip: 0900 country: Turkey lat: 37.84501 lon: 27.83963 hasResults: False
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<|newrecord|> nctId: NCT06380816 id: CRUKD/24/001 id: ISRCTN26628699 type: REGISTRY domain: ISRCTN briefTitle: A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-11 date: 2029-11 date: 2024-04-24 date: 2024-04-24 name: Cancer Research UK class: OTHER name: UCB Biopharma SRL briefSummary: This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.
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The four main aims of the clinical trial are to find out:
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1. The best dose of UCB4594 that can be given safely to participants in the trial.
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2. What the side effects of UCB4594 are and how they can be managed.
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3. What happens to UCB4594 inside the body and how it affects cancer cells.
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4. Whether UCB4594 can cause cancer to shrink. conditions: Advanced Solid Tumours conditions: Squamous Cell Carcinoma of Head and Neck conditions: Carcinoma, Non-Small-Cell Lung conditions: Colorectal Neoplasms conditions: Triple Negative Breast Neoplasms conditions: Carcinoma, Renal Cell (Clear Cell Only) conditions: Esophageal Neoplasms conditions: Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors) conditions: Uterine Cervical Neoplasms conditions: Ovarian Neoplasms conditions: Pancreatic Neoplasms studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 167 type: ESTIMATED name: UCB4594 measure: Recommended Phase 2 dose (RP2D) of UCB4594 measure: Frequency of adverse events (AEs) considered at least possibly related to UCB4594 (up to 18 cycles). measure: Number of patients achieving a complete response (CR)/immune CR (iCR) or partial response (PR)/immune PR (iPR) to UCB4594 (all modules). measure: Maximum concentration of UCB4594 (monotherapy modules; Modules A and B). measure: Minimum concentration of UCB4594 (monotherapy modules; Modules A and B). measure: Area under the curve of UCB4594 (monotherapy modules; Modules A and B). measure: Steady state volume of distribution of UCB4594 (monotherapy modules; Modules A and B). measure: Clearance of UCB4594 (monotherapy modules; Modules A and B). measure: Frequency of AEs considered at least possibly related to UCB4594 (up to end of AE reporting period). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Christie NHS Foundation Trust city: Manchester country: United Kingdom name: Fiona Thistlethwaite, Prof role: CONTACT phone: +44 (0)161 9187672 email: [email protected] lat: 53.48095 lon: -2.23743 facility: University Hospital Southampton NHS Foundation Trust city: Southampton country: United Kingdom name: Ioannis Karydis, Prof role: CONTACT email: [email protected] lat: 50.90395 lon: -1.40428 hasResults: False
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<|newrecord|> nctId: NCT06380803 id: 4-2020-1385 briefTitle: Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence acronym: ROMCAPO+AI overallStatus: RECRUITING date: 2021-04-29 date: 2025-01-26 date: 2025-01-26 date: 2024-04-24 date: 2024-04-24 name: Severance Hospital class: OTHER name: National Research Foundation of Korea briefSummary: The goal of this prospective study is to investigate the satisfaction, NASA-Task Load Index (TLX), and surgical proficiency of a robotic breast surgery education program using cadaver or porcine models, as well as to develop an AI-based surgical guide for utilization within the educational program in trainees for robotic breast surgery.
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The main question\[s\]it aims to evaluate :
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* Satisfaction questionnaire of a educational program
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* NASA-TLX of a educational program
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* global evaluative assessment of robotic skills (GEARS) of a robotic breast surgery for surgical proficiency
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Participants will participate the educational program and fill out a satisfaction questionnaire and NASA-TLX.
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The tutor evaluates GEARS for 15 minutes at the beginning and end of training.
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After the development of the surgical guide based on AI, researchers will compare a training group with or without surgical guide to see the effect of the surgical guide. conditions: Breast Neoplasms conditions: Surgery conditions: Educational Problems conditions: Surgical Procedure, Unspecified studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: A educational program measure: Satisfaction questionnaire of a educational program measure: NASA-Task Load index of a educational program measure: Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency measure: The comparison of satisfaction questionnaire of a educational program between the group with the surgical guide and without the surgical guide measure: The comparison of NASA-Task Load index of a educational program between the group with the surgical guide and without the surgical guide measure: The comparison of Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency between the group with the surgical guide and without the surgical guide sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University College of Medicine status: RECRUITING city: Seoul zip: 120-752 country: Korea, Republic of name: Hyung Seok Park, MD, PhD role: CONTACT phone: +82-2228-2100 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06380790 id: 8423 briefTitle: Effect of Laser-aided Csf on the Rate of Leveling and Alignment of Mandibular Anterior Crowding overallStatus: RECRUITING date: 2023-05-01 date: 2024-05 date: 2024-10 date: 2024-04-24 date: 2024-04-24 name: Cairo University class: OTHER briefSummary: To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment conditions: Orthodontics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 26 type: ESTIMATED name: Laser-aided csf name: placebo laser-aided csf measure: Rate of tooth movement measure: Pain level measure: Periodontal health sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Faculty of dentistry cairo university status: RECRUITING city: Cairo country: Egypt name: Cairo University role: CONTACT phone: 0223638755 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06380777 id: DDT system for sarcopenia briefTitle: Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia overallStatus: RECRUITING date: 2023-09-01 date: 2028-12-31 date: 2028-12-31 date: 2024-04-24 date: 2024-04-24 name: Peking Union Medical College Hospital class: OTHER briefSummary: The goal of this observational study is to establish a digital diagnosis and treatment system for sarcopenia, integrating research outcomes into a unified approach encompassing a digital vaccine (early warning screening model), digital drug (intervention model associated with pathogenesis), and digital rehabilitation (preventive system combining early warning and treatment). This aims to create a digital visual tertiary prevention network for sarcopenia.
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Research aims:
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Evaluate the effectiveness of the digital vaccine through a cross-sectional epidemiological survey.
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Establish a specialized cohort for sarcopenia through a longitudinal investigation, implementing the digital drug and digital rehabilitation interventions.
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Participants will:
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Engage in screening and assessment based on inclusion and exclusion criteria.
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Be monitored longitudinally, with tailored interventions for those with muscle atrophy and regular follow-ups for at-risk individuals.
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Key outcomes will focus on sarcopenia indicators, serum biomarkers, and clinical endpoints such as fracture rates, weakness classification, and quality of life. conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED measure: Appendicular skeletal muscle mass index measure: Hand grip strength measure: Gait speed measure: Concentration of insulin measure: Concentration of adiponectin measure: Concentration of leptin measure: Concentration of insulin like growth factor -1(IGF-1) measure: Concentration of interleukin 18 (IL-18) measure: Concentration of tumor necrosis factor - α (TNF-α) measure: Concentration of TNF-like weak inducer of apoptosis (TWEAK) measure: Concentration of fibroblast growth factor -19 (FGF-19) measure: Concentration of myostatin measure: Concentration of chemoattractant protein-1 (MCP-1) measure: Concentration of activin sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Kang Yu, MD role: CONTACT phone: +86 010-69155550 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06380764 id: RC.11.3.2024 briefTitle: Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache overallStatus: COMPLETED date: 2023-03-02 date: 2023-07-25 date: 2023-12-01 date: 2024-04-24 date: 2024-04-24 name: Benha University class: OTHER briefSummary: Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.
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Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region. conditions: Postdural Puncture Headache studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 152 type: ACTUAL name: Greater Occipital Nerve Block name: Bilateral suboccipital intramuscular injection name: Epidural Blood Patch name: Normal Saline 10 mL Injection name: Lidocaine 2% Injectable Solution measure: The extent of reduction of consumed analgesia sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT facility: Benha university city: Banhā state: El Qalyoubia zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False
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<|newrecord|> nctId: NCT06380751 id: D9722C00001 briefTitle: Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer acronym: EvoPAR-BR01 overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2029-03-30 date: 2030-07-18 date: 2024-04-24 date: 2024-04-24 name: AstraZeneca class: INDUSTRY briefSummary: The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer. conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label count: 500 type: ESTIMATED name: Saruparib (AZD5305) name: Camizestrant name: Abemaciclib name: Ribociclib name: Palbociclib name: Fulvestrant name: Letrozole name: Anastrozole name: Exemestane measure: Progression-Free Survival measure: Overall Survival measure: Progression Free Survival 2 measure: Time to chemotherapy measure: Objective Response Rate measure: Duration of Response measure: Participant-reported tolerability measure: Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) measure: Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) measure: Plasma concentrations of saruparib (AZD5305) measure: Plasma concentrations of camizestrant measure: Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study. sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Toronto state: Ontario zip: M5G 2M9 country: Canada lat: 43.70011 lon: -79.4163 facility: Research Site city: Montreal state: Quebec zip: H3T 1E2 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Montréal state: Quebec zip: H2X 0A9 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Saskatoon state: Saskatchewan zip: S7N 4H4 country: Canada lat: 52.13238 lon: -106.66892 facility: Research Site city: Toronto zip: M4N 3M5 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False
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