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<|newrecord|> nctId: NCT06261177 id: 22-175 briefTitle: Take-home Functional Electrical Stimulation for MDD overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-04 date: 2024-12 date: 2025-03 date: 2024-02-15 date: 2024-02-15 name: Unity Health Toronto class: OTHER briefSummary: The purpose of this study is to learn whether Functional Electrical Stimulation (FES) of the facial muscles is effective in treating major depressive disorder (MDD) and to develop a model for take-home delivery. conditions: MDD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Functional Electrical Stimulation (FES) name: Sham FES measure: Feasibility of the FES for MDD measure: Tolerability and safety of the FES for MDD measure: Improvement in symptoms of depression-17-item Hamilton Depression Rating Scale (HAM-D-17) measure: Improvement in symptoms of depression-16-Item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16) measure: Improvement in symptoms of anxiety- General Anxiety Disorder (GAD-7) measure: Improvement in well-being-World Health Organization-5 Well-Being Index (WHO-5) measure: Improvement in sleep quality- Pittsburgh Sleep Quality Index (PSQI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Michael's Hospital city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06261164 id: 01-19-373- 2/23 briefTitle: Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients overallStatus: RECRUITING date: 2024-01-31 date: 2024-12-31 date: 2025-01-31 date: 2024-02-15 date: 2024-02-15 name: University Clinical Centre of Republic of Srpska class: OTHER briefSummary: The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents. conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Cytosorb® and Oxiris® adsorbents measure: Development of population pharmacokinetic model sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Medical Intensive Care Medicine status: RECRUITING city: Banja Luka zip: 78000 country: Bosnia and Herzegovina name: Nikolina Spiric, MPharm role: CONTACT phone: +38751342295 email: [email protected] name: Pedja Kovacevic, Prof. role: SUB_INVESTIGATOR lat: 44.77842 lon: 17.19386 hasResults: False |
<|newrecord|> nctId: NCT06261151 id: Zhongshan-HHY-03 briefTitle: Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-03-31 date: 2024-02-15 date: 2024-02-15 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Elderly GC patients face several challenges during treatment, such as comorbidities, organ dysfunction, immunosuppression, and delayed recovery. Advanced age is associated with a higher rate of postoperative complications shortly after surgical treatment, and lower 5-year overall survival as long-term outcome. |
In China, the prevalence of malnutrition in hospitalized patients is around 12.6% to 46.19%. Malnutrition is one of the great risk factors of adverse clinical outcomes in elderly patients with GC. The nutritional status at the time of diagnosis was independently associated with postoperative complications, overall survival, and disease-free survival. The condition can be caused by mechanical obstruction of the digestive tract or anorexia-cachexia syndrome, leading to insufficient protein or energy intake and absorption disorder. Nutrition screening, assessment, and intervention are important steps in nutritional management. |
Previous studies mostly focused on hospitalized internal medical patients. Only a few studies focused on surgical patients regardless of age. Therefore, in this retrospective study, we are going to investigate the nutritional status and perioperative nutritional support of geriatric surgical patients with GC, and provide a basis for implementing an effective nutritional intervention. conditions: Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing Gastrectomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Clinical data collection measure: The preoperative nutritional status of elderly patients underwent gastrectomy sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06261138 id: RSR-HCC-2019-001 briefTitle: Survival Analysis: TACE vs. Combination Therapy in HCC overallStatus: COMPLETED date: 2019-02-01 date: 2023-03-31 date: 2023-10-31 date: 2024-02-15 date: 2024-02-15 name: Zhejiang University class: OTHER briefSummary: This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable HCC. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 279 type: ACTUAL name: Transarterial chemoembolization name: Systemic treatment measure: Progression Free Survival (PFS) per mRECIST measure: 12 months PFS rate measure: Overall survival (OS) measure: Objective Response Rate (ORR) per mRECIST measure: Disease Control Rate (DCR) per mRECIST measure: Adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Medical College of Zhejiang University city: Hangzhou state: Zhejiang zip: 310003 country: China lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06261125 id: SL-B2023-718 briefTitle: Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401) acronym: HSBRT2401 overallStatus: RECRUITING date: 2024-03-10 date: 2026-06-30 date: 2028-06-30 date: 2024-02-15 date: 2024-03-12 name: Mian XI class: OTHER briefSummary: Abdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective response rate of 5% to 30%. Previous studies have demonstrated that stereotactic body radiotherapy (SBRT) is an effective local treatment for HCC with abdominal LNM, with a high response rate of 60% to 80%. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients, suggesting radiotherapy should be combined with systematic treatment. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC. The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib in HCC patients with portal abdominal LNM. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Stereotactic body radiotherapy name: Adebrelimab name: Lenvatinib measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Overall response rate (ORR) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Treatment-related adverse events measure: Correlation between serum cytokines and overall survival and immune-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mian Xi status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Mian Xi, MD role: CONTACT phone: +862087343385 email: [email protected] name: Mian Xi, MD role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06261112 id: B.30.2.ATA.01.11/285 briefTitle: The Effect of Using a Kaleidoscope on Fear and Pain in Children overallStatus: RECRUITING date: 2022-05-07 date: 2024-05-01 date: 2024-05-01 date: 2024-02-15 date: 2024-02-15 name: Mihriban Culha class: OTHER briefSummary: The research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health Research and Application Center and referred to the Orthopedic clinic, and decided to undergo a cast procedure for treatment. The sample of the research consisted of a total of 70 children and their parents, including 35 control groups and 35 kaleidoscope groups, who met the research criteria from this universe. The children in the kaleidoscope group were shown the kaleidoscope. No intervention other than routine application was applied to the control group. "Introductory Information Form", "Wong-Baker Facial Expressions Rating Scale and Child Fear Scale were used in the collection of data. conditions: Fracture; Complication Orthopedic Procedure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assigment primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: single /investigatör) whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: kaleidescope measure: Child Fear Scale (CFS) measure: Facial Expressions Rating Scale sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Ataturk University status: RECRUITING city: Erzurum zip: 25240 country: Turkey name: Mihriban ÇULHA role: CONTACT phone: 05070926243 email: [email protected] lat: 39.90861 lon: 41.27694 hasResults: False |
<|newrecord|> nctId: NCT06261099 id: 037 briefTitle: Telerehabilitation-Based Early Upper Extremity Training in Stroke Patients overallStatus: RECRUITING date: 2024-02-08 date: 2025-02-27 date: 2025-11-27 date: 2024-02-15 date: 2024-02-15 name: Suleyman Demirel University class: OTHER briefSummary: Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic. conditions: Stroke, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: prospective double-blind, randomized controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sealed envelopes will be prepared in advance for randomization and will be marked with numbers 1 and 2, indicating whether they are a study group or a control group. Randomization will be done by a third party unaware of the study content. Randomization order tracking will be done with sequentially numbered containers. Patients participating in the study will be blinded to which treatment group they will be included in. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: control + working group measure: Mini Mental Test measure: Fugl Meyer Motor Function Scale measure: Laser-pointer Assisted Angle Reproduction Test measure: Modified Barthel Index measure: Reaching Performance Scale sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Güler Ertuğrul status: RECRUITING city: Kocaeli state: İ̇zmi̇t country: Turkey name: GÜLER ERTUĞRUL role: CONTACT phone: +90 531 950 05 90 email: [email protected] lat: 39.62497 lon: 27.51145 facility: Suleyman Demirel University status: RECRUITING city: Isparta state: Merkez country: Turkey name: MEHMET DURAY role: CONTACT phone: +90 506 473 11 65 email: [email protected] lat: 37.76444 lon: 30.55222 hasResults: False |
<|newrecord|> nctId: NCT06261086 id: soh-med-24-01-06MS briefTitle: Evaluation of Pyroptosis-related Indicators in the Pathogenesis of Vitiligo:Across-sectional Comparative Study overallStatus: NOT_YET_RECRUITING date: 2024-02-24 date: 2024-08-24 date: 2024-08-24 date: 2024-02-15 date: 2024-02-15 name: Sohag University class: OTHER briefSummary: Vitiligo is an acquired pigmentary disorder on skin and/or mucosae, which is characterized by death of melanocytes (MCs), affecting 0.5%-2% of the population worldwide (1). It doesn't affect the health of patients but it has marked social pressure and greatly interfere with their quality of life (2,3). It presents with well circumscribed milky white patches that occur secondary to destruction of melanocyte, it may appear at any age and affect both sexes equally. |
It can affect ethnic groups and people of all skin types with no predilection (4). |
Clinically, several types of vitiligo are distinguished according to the distribution of the achromic lesions. One or more lesions in a dermatomal pattern are characteristic for segmental vitiligo (SV) while this segmental distribution is absent in non-segmental vitiligo (NSV). The latter variety includes both the focal type and the generalized type (5). Numerous previous studies tried to illustrate the pathogenesis behind the disease, but the exact pathophysiology is still not fully understood. It is a multifactorial disease. Factors include, neural theory, oxidative stress theory, autoimmune hypothesis, intrinsic theory, melanocytorrhagy hypothesis (6). Many theories tried to explain the mechanisms of MC destruction in vitiligo. Apoptosis is one of the most widely studied cell death pathways. In addition, the other two forms of cell death, conventional necrosis and autophagy seem to be involved in the death of vitiligo MCs under certain situations. Moreover, new types of regulated cell death including necroptosis, pyroptosis, and ferroptosis may also participate in the pathogenesis (7). Pyroptosis is a highly inflammatory form of necrosis cell death NCD regulated mainly by caspase-1, which is initiated following large supramolecular complex ermed inflammasome activation (8). The inflammasome-activated Caspases then cleave the pyroptosis-inducing protein Gasdermin D (GSDMD), which forms a pore in the plasma membrane and causes cell lysis as well as the secretion of IL-1β typically (9). Another study suggests that inflammasome activation could be a useful marker for assessing disease progression of vitiligo (10). However, the link between vitiligo and inflammasome activation is still unclear. The inflammasome regulates cell death and inflammation via activation of caspase-1 (11). The activation of caspase-1 promotes the secretion of proinflammatory cytokines IL-1β and IL-18, as well as the initiation of pyroptosis (12). So, evaluation of pyroptosis-related indicators (GASDM-D, IL 1β \& IL-18) may help understanding the obscure inflammasome pathway involvement in the pathogenesis of Vitiligo. conditions: Vitiligo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ESTIMATED name: evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18) measure: GASDM-D measure: IL 1β measure: IL-18 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06261073 id: Soh-Med-24-01-08MS briefTitle: Evaluation of Serum and Tissue Cathepsin L in Non-segmental Vitiligo Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-01 date: 2025-03-01 date: 2024-02-15 date: 2024-02-15 name: Sohag University class: OTHER briefSummary: Introduction Vitiligo is an autoimmune disease of the skin that targets pigment producing melanocytes and results in patches of depigmentation that are visible as white spots (Frisoli et al., 2020) Vitiligo is a relatively common acquired pigmentation disorder that can cause significant psychological stress (Leung AKC et al., 2021). The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic (Majumder et al, 1993), with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide (Krüger et al, 2012). |
Vitiligo results in white macules and patches on the body. Initial lesions occur most frequently on the hands, forearms, feet, and face, favoring a periocular or perioral distribution (Ahmed jan N et al., 2023). Vitiligo lesions are classified into 2 major categories: segmental vitiligo (SV) and non-segmental vitiligo (NSV) (Relke et al ., 2019). Segmental vitiligo is characterized by its early onset, rapid stabilization, and unilateral distribution (Van Geel et al., 2017). Non-segmental vitiligo comprises of generalized (vitiligo vulgaris), acrofacial, mucosal (multifocal), and universal vitiligo (Kovacevic et al., 2016). Non-segmental vitiligo (NSV) is the most common form of vitiligo (Benzekri et al., 2013). Multiple mechanisms are involved in melanocyte disappearance, namely genetic predisposition, environmental triggers, metabolic abnormalities, impaired renewal, and altered inflammatory and immune responses (Boniface K et al ., 2018). |
The results of some studies indicate a frequent association of vitiligo with autoimmune diseases. A number of studies have established a higher prevalence of autoimmune endocrine diseases in women, as well as in non-segmental vitiligo patients and in cases of family history of vitiligo and/or other autoimmune diseases. In addition, it was shown that the prevalence of endocrine diseases increases with increasing area of depigmentation (Troshina EA et al., 2020). Autoimmunity in vitiligo is driven by the IFN-γ-CXCL10 cytokine signaling pathway. Activated melanocyte-specific CD8+ T cells secrete IFN-γ, which signals through the IFN-γ receptor (IFN-γR) to activate JAK1/2 and STAT1. This induces the production of CXCL9 and CXCL10, which signal through their receptor CXCR3 to recruit more auto-reactive T cells to the epidermis, resulting in widespread melanocyte destruction (Harris JE et al., 2017). |
The lysosomal cysteine proteinases of the papain family are involved in lysosomal bulk proteolysis, major histocompatibility complex class II-mediated antigen presentation, pro-hormone processing, and extracellular matrix remodeling. conditions: Vitiligo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 40 type: ESTIMATED name: blood sample and tissue biopsy measure: Cathepsin L sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06261060 id: 2023-0918 id: NCI-2024-01333 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Low-Dose Sirolimus to Increase Hematopoietic Function in Patients With RUNX1 Familial Platelet Disorder overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2026-06-11 date: 2028-06-11 date: 2024-02-15 date: 2024-03-07 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn about the safety and effects of low-dose sirolimus in participants with RUNX1-FPD. conditions: Familial Platelet Disorder conditions: Hematopoietic studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Sirolimus measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Courtney DiNardo, MD role: CONTACT phone: 713-794-1141 email: [email protected] name: Courtney DiNardo, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False |
<|newrecord|> nctId: NCT06261047 id: SDZLEC2023-389-02 briefTitle: Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-02-15 date: 2024-02-15 name: Shandong Cancer Hospital and Institute class: OTHER briefSummary: Recent years have seen significant advancements in the treatment landscape of advanced hepatocellular carcinoma (HCC), with the emergence of targeted and immunotherapy strategies reshaping first-line therapy. Sorafenib, a multi-targeted tyrosine kinase inhibitor, initially set the standard, followed by approvals for lenvatinib, regorafenib, cabozantinib, and ramucirumab. Immunotherapy, particularly combinations like atezolizumab with bevacizumab, has shown superior efficacy over sorafenib. Despite these advances, second-line therapies offer limited progression-free survival (mPFS: 2-3 months), necessitating new approaches. Radiotherapy, bolstered by technological advancements, has shown promise. Techniques like stereotactic body radiotherapy (SBRT) combined with PD-1 inhibitors achieve significant response rates and survival benefits. Combining radiotherapy with targeted immunotherapy has also demonstrated improved outcomes. Radiotherapy, especially in oligometastatic HCC, is increasingly favored due to its ability to enhance local control without increasing toxicity. These developments underscore the evolving landscape of HCC treatment towards personalized and multimodal approaches. conditions: Hepatocellular Carcinoma conditions: Radiotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: radiotherapy measure: Progression free survival measure: Overall response rate measure: Overall survial measure: Disease control rate measure: Duration of control sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinbo Yue status: RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: jinbo yue role: CONTACT phone: +86053167626442 email: [email protected] lat: 36.66833 lon: 116.99722 hasResults: False |
<|newrecord|> nctId: NCT06261034 id: 23-008765 id: 8K12AR084222-15 type: NIH link: https://reporter.nih.gov/quickSearch/8K12AR084222-15 briefTitle: A Study of Sex Differences in Neurocirculatory Control overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-03 date: 2027-03 date: 2024-02-15 date: 2024-04-10 name: Mayo Clinic class: OTHER name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) briefSummary: The purpose of this study is to investigate potential sex differences in neurocirculatory control of blood pressure in patients with untreated obstructive sleep apnea (OSA). conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Blood pressure measure: Arterial stiffness measure: Endothelial function measure: Sympathetic nerve burst frequency measure: Sympathetic nerve burst incidence measure: Sympathetic nerve burst amplitude (AU) measure: Total muscle sympathetic nerve activity (MSNA) measure: Cerebral autoregulation measure: Sympathetic action potentials per burst measure: Sympathetic action potential clusters per burst measure: Sympathetic action potential conduction latency of each cluster measure: Immune function measure: Urinary Extracellular Vesicle Presence and Content measure: Plasma Extracellular Vesicle Presence and Content sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Joshua Bock, PhD role: CONTACT phone: 507-422-0768 email: [email protected] name: Ian Greenlund, PhD role: CONTACT phone: (507) 422-3411 email: [email protected] name: Virend Somers, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False |
<|newrecord|> nctId: NCT06261021 id: INNO-6051 briefTitle: Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus overallStatus: RECRUITING date: 2024-04-19 date: 2025-02 date: 2025-02 date: 2024-02-15 date: 2024-04-25 name: Innovaderm Research Inc. class: OTHER briefSummary: This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus. conditions: Discoid Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intra-individual primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This study will be single-blinded. Only the efficacy assessor will be blinded in this study (for subjects with randomized areas). The assessor will only assess efficacy and will not have any other interactions with the subject. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Ruxolitinib 1.5% cream name: Application without occlusion in Area 1 name: Application under occlusion at night in Area 2 name: Application under occlusion at night in Area 1 name: Application without occlusion in Area 2 measure: Change from baseline in target lesion CLASI-A score measure: Change from baseline in target lesion CLASI-A score measure: Proportion of subjects with an erythema score of 0 (absent) measure: Change from baseline in target lesion SADDLE-A measure: Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear) measure: Dermatology Life Quality Index (DLQI) measure: Cutaneous Lupus Erythematosus Quality of Life (CLEQol) measure: Numeric Rating Scale(NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Innovaderm Research Inc. status: RECRUITING city: Montréal state: Quebec zip: H2X 2V1 country: Canada name: Fareheen Chowdhury, MSc role: CONTACT phone: 514-521-4285 phoneExt: 341 email: [email protected] name: Robert Bissonnette role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False |
<|newrecord|> nctId: NCT06261008 id: 2023.553 briefTitle: Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-26 date: 2026-06-26 date: 2024-02-15 date: 2024-02-16 name: Chinese University of Hong Kong class: OTHER briefSummary: In Hong Kong, Colorectal cancer ranks second in both cancer incidence and mortality. The government-subsidized population-based CRC screening program (the Program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial FIT screenings. A subsidized follow-up colonoscopy is offered to participants with positive FIT results. Participants are advised to repeat the FIT screening 2 years after receiving a negative result. An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program. Nonadherence to repeat FIT screening is caused by forgetfulness and is associated with an individual's psychological health behaviour. conditions: CRC, Colorectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patient will be randomized into either standard care or telehealth intervention group primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: There will no masking count: 370 type: ESTIMATED name: TI group measure: adherence rate measure: the number of days to repeat FIT measure: costs incurred in each study arm measure: uptake rate in positive FIT measure: detection rate in positive FIT measure: qualitative factors associated with repeat FIT adherence sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre of Digestive Health, Prince of Wales Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False |
<|newrecord|> nctId: NCT06260995 id: Ref: 230603 briefTitle: The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Study Protocol overallStatus: RECRUITING date: 2023-09-01 date: 2024-05-31 date: 2024-06-30 date: 2024-02-15 date: 2024-02-21 name: University of Dublin, Trinity College class: OTHER briefSummary: Intermediaries help people to connect to community-based services and supports, including physical activity and exercise groups (physical activities). They do this by acting as a link person. After receiving a referral or self-referral, they conduct an assessment, connect people to services in the community, and follow-up with people over time. |
This project will investigate if connecting to physical activities through an intermediary can improve health and wellbeing. It will also investigate people's experiences of working with an intermediary. This project is a pilot feasibility study, which means the investigators are evaluating the measures used and the way the trial is designed to see if they are suitable for a larger study in the future. conditions: Physical Inactivity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Social Prescribing Link Worker Intermediary Intervention name: Local Sports Partnership Community Development Officer Intervention measure: International Physical Activity Questionnaire - Short Form measure: Self-Efficacy for Exercise Scale measure: Short Warwick Edinburgh Mental Well-being Scale measure: Demographics and Health Status measure: Semi-structured Interviews - Intervention Participants measure: Overall Acceptability of the Intervention measure: Gatekeeper Recruitment Logs measure: Semi-structured Interviews - Gatekeepers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Dublin, Trinity College Dublin status: RECRUITING city: Dublin 8 zip: D08 W9RT country: Ireland name: Megan O'Grady role: CONTACT phone: 018963613 email: [email protected] lat: 53.33306 lon: -6.24889 hasResults: False |
<|newrecord|> nctId: NCT06260982 id: 2021PI148 briefTitle: Cognitive Disorders in Hereditary Spastic Paraplegia Type 4 acronym: SPG-TEP overallStatus: RECRUITING date: 2022-01-01 date: 2025-01 date: 2025-01-02 date: 2024-02-15 date: 2024-02-15 name: Central Hospital, Nancy, France class: OTHER briefSummary: Hereditary spastic paraplegia type 4 is the most frequent mutation of hereditary spastic paraplegias. It is commonly described as pure, with progressive weakness of the lower limbs, pyramidal syndrome and vesico-sphincter disorders. However, cognitive disorders have been reported for over 20 years, but remain poorly characterized. conditions: Spastic Paraplegia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: 18-FDG-PET measure: cognitive testing measure: Correlations between neuropsychological tests, clinical examination, PET and general data. measure: Genotype/Phenotype correlations sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centre hospitalier régional universitaire status: RECRUITING city: Nancy zip: 54000 country: France name: Mathilde Renaud, MD, PhD role: CONTACT email: [email protected] lat: 48.68439 lon: 6.18496 hasResults: False |
<|newrecord|> nctId: NCT06260969 id: TJHH-2023-WM13 briefTitle: Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis overallStatus: RECRUITING date: 2022-09-01 date: 2025-09-30 date: 2025-09-30 date: 2024-02-15 date: 2024-02-15 name: Tianjin Huanhu Hospital class: OTHER briefSummary: The study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Patients who met the general inclusion criteria underwent thrombectomy and the necessary remedial treatment. conditions: Large Vessel Occlusion conditions: Intracranial Artery Occlusion With Cerebral Infarction conditions: Endovascular Treatments conditions: Acute Ischemic Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 470 type: ESTIMATED name: balloon dilatation measure: Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days measure: Proportion of patients with a good prognosis early after treatment measure: Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR measure: Vascular recanalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Huanhu Hospital status: RECRUITING city: Tianjin state: Tianjin country: China name: Ming Wei role: CONTACT phone: 13502182903 email: [email protected] lat: 39.14222 lon: 117.17667 hasResults: False |
<|newrecord|> nctId: NCT06260956 id: U01-ROC-001 id: 1U01AI173032 type: NIH link: https://reporter.nih.gov/quickSearch/1U01AI173032 briefTitle: Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg acronym: ESCAPE overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2029-09 date: 2024-02-15 date: 2024-02-15 name: University of Rochester class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding. conditions: Allergy and Immunology conditions: Peanut and Nut Allergy conditions: Egg Allergy conditions: Food Allergy in Infants conditions: Food Allergy Peanut studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: National, parallel, two arm (one-to-one allocation), single blinded, randomized controlled trial. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Due to the nature of the intervention, the subjects must know which arm they are assigned to, however, biostatistician and investigators will be blinded to study assignment. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Avoidance name: Consumption measure: Egg sensitization measure: Peanut and egg specific IgG and IgG4 measure: Antibodies in maternal blood measure: Egg allergy measure: Antigen concentrations measure: Exploratory: Peanut sensitization measure: Exploratory: Symptoms measure: Exploratory: Peanut sensitization sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Rochester city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 hasResults: False |
<|newrecord|> nctId: NCT06260943 id: 20221220 id: NCI-2024-00566 type: REGISTRY domain: NCI Clinical Trials Reporting Program (CTRP) briefTitle: Targeted Navigation in Hepatocellular Carcinoma (HCC) overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-10-31 date: 2026-10-31 date: 2024-02-15 date: 2024-02-15 name: University of Miami class: OTHER name: The V Foundation briefSummary: The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment. conditions: Hepatocellular Carcinoma conditions: Cholangiocarcinoma conditions: Hepatobiliary Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Target Navigation Pilot Program measure: Number of Days to First Contact measure: Number of Hours for Each Contact measure: Number of Days to First Appointment measure: Number of Days to First Treatment measure: Number of Months of Total Navigation measure: Number of Participants that Die Within One Year measure: Proportion of Participants Enrolled in Clinical Research sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States name: Gloria Figueroa role: CONTACT phone: 305-243-0779 email: [email protected] name: Patricia Jones, MD role: CONTACT phone: (305) 243-0779 email: [email protected] name: Patricia Jones, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False |
<|newrecord|> nctId: NCT06260930 id: Value of chest ultrasonography briefTitle: Value of Chest Ultrasonography in ILD Screening overallStatus: COMPLETED date: 2017-01 date: 2019-09 date: 2019-12 date: 2024-02-15 date: 2024-02-15 name: Aswan University class: OTHER briefSummary: The main aim of this study is to detect the value of transthoracic ultrasonography in the diagnosis and assessment of ILDs in correlation to chest X- ray, blood gases, pulmonary function test and echocardiography and to compare it with high resolution CT (HRCT) as a golden diagnostic investigation. conditions: Interstitial Lung Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 80 type: ACTUAL measure: Sensitivity and specificity of the lung sonography for interstitial lung disease screening sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06260917 id: E2-23-4148 briefTitle: The Effect of Urinating Through the Zipper or by Pulling Down the Trousers on Uroflowmetry Parameters in LUTS overallStatus: COMPLETED date: 2023-11-01 date: 2023-12-31 date: 2023-12-31 date: 2024-02-15 date: 2024-02-15 name: Ankara City Hospital Bilkent class: OTHER briefSummary: There are many factors that affect uroflowmetry parameters. One of these is the urination position. Research has mostly focused on standing and sitting urination positions. However, those who prefer the standing position as a habit can urinate by opening the zipper or lowering the trousers. Although the effect of these two applications on uroflowmetry parameters in healthy men has been investigated in only one study, their effect on patients with lower urinary tract symptoms has not been examined. conditions: Benign Prostatic Hyperplasia conditions: Micturition Disorder conditions: Urinary Obstruction conditions: Urinary Tract Disease conditions: Urologic Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 80 type: ACTUAL name: position of urination measure: Qmax measure: PVR measure: Qave measure: Duration of voiding sex: MALE minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bilkent City Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06260904 id: AIIMS BBSR/PGThesis/23-24/112 briefTitle: Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2025-01-31 date: 2025-05-31 date: 2024-02-15 date: 2024-02-15 name: All India Institute of Medical Sciences, Bhubaneswar class: OTHER briefSummary: Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. A prolonged treatment with steroids is required for clinical improvement, which increases the chances of long-term adverse effects. So, there is a need for newer, effective treatment modalities, such as retinoids, methotrexate, Janus kinase inhibitors, PDE4 inhibitors, etc. |
Of these, methotrexate is a dihydrofolate reductase inhibitor that inhibits the replication and function of T and B lymphocytes. It has shown a good response to OLP (around 83%) in a study by Lajevardi et al. and can be considered a treatment option in patients with moderate to severe OLP. Apremilast is a drug with a novel immunomodulatory mechanism of action. It inhibits phosphodiesterase type IV, which increases levels of cyclic adenosine monophosphate (cAMP), thus activating protein kinase A and inhibiting various inflammatory mediators. Based on a pilot study by Paul et al., apremilast is associated with clinical improvement in lichen planus. |
Among the various treatment options, there is a lack of head-on trials. Methotrexate is an immunosuppressant with various systemic adverse effects and requires close monitoring. Whereas apremilast is a non-immunosuppressive drug with a better safety profile, it does not show such adverse effects. These drugs can be used as an add-on to low-dose steroids in view of reducing the adverse effects associated with steroid therapy. To the best of our knowledge, there is no randomized controlled trial comparing these two drugs to date. Hence, the present study has been planned to evaluate the safety and efficacy of methotrexate versus apremilast as an add-on to the standard steroid therapy in OLP patients. conditions: Oral Lichen Planus studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, add-on, active-controlled, open-label, parallel-design clinical trial primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Prednisolone name: Apremilast name: Methotrexate measure: Pain by Visual Analogue Scale (VAS) score measure: Severity by Physician global assessment of disease (PGA) score measure: Severity and pain by oral mucosal disease severity score measure: serum IL 6 level measure: Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 ) measure: Incidence of treatment-emergent adverse events of both test and control group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AIIMS Bhubaneswar city: Bhubaneswar state: Odisha zip: 751019 country: India name: Monalisa Jena, MD role: CONTACT phone: 09438884193 email: [email protected] name: Biswanath Behera, MD role: CONTACT phone: 07978351200 email: [email protected] name: Biswanath Behera role: SUB_INVESTIGATOR name: Madhusmita Sethy role: PRINCIPAL_INVESTIGATOR name: Mowdharani PS role: PRINCIPAL_INVESTIGATOR lat: 20.27241 lon: 85.83385 hasResults: False |
<|newrecord|> nctId: NCT06260891 id: ZnSCD briefTitle: Zinc Supplementation in Sickle Cell Disease acronym: ZnSCD overallStatus: NOT_YET_RECRUITING date: 2025-04-01 date: 2026-09-30 date: 2026-09-30 date: 2024-02-15 date: 2024-03-13 name: University of California, San Francisco class: OTHER name: American Society Hematology, Research Collaborative name: Children's Hospital of Philadelphia name: Johns Hopkins University name: Baylor College of Medicine name: Children's National Research Institute name: Children's Hospital Medical Center, Cincinnati name: Newark Beth Israel Medical Center name: University of Pennsylvania briefSummary: The goal of this short term prospective Phase II study is to compare the effects of two alternate daily doses of zinc (25 and 40 mg/day) in 34 randomly assigned homozygous Sickle Cell Disease (SCD-SS) patients aged 15-35 years old. The main question it aims to answer is: Which biomarkers are most responsive to zinc supplementation, and what is the maximum tolerated zinc dose that induces the desired changes in biomarkers of bone turnover? Participants will be recruited from 7 American Society Hematology Research Collaborative SCD Centers. Eligible SCD subjects will be invited to participate in the 16-week study, involving 2 baseline blood draws 4 weeks apart, followed by a 12-week zinc intervention. The findings from this study will be used to determine the dosage of zinc to be used in a larger, future study on the long term impact of zinc supplementation on bone health in SCD-SS. conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a delayed start parallel design where all subjects will have a usual care period, 2 baseline samples 4 weeks apart, followed by a 12 week zinc intervention, with samples at 8 and 12 weeks. primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: n/a the 2 zinc capsule dosages (25 and 40 mg) will be compounded to look identical whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: 25 mg/day zinc name: 40 mg/day zinc measure: Biomarker of Bone Formation (PINP) measure: Biomarker of Bone Resorption (CTx) measure: Biomarker of Bone Formation (BSAP) measure: Biomarker of Bone Resorption (TRAP 5b) sex: ALL minimumAge: 15 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: UCSF Benioff Children's Hospital Oakland city: Oakland state: California zip: 94609 country: United States name: Ellen Fung, PhD role: CONTACT phone: 510-428-3885 phoneExt: 4939 email: [email protected] name: Beth Anne Martin role: CONTACT email: [email protected] lat: 37.80437 lon: -122.2708 hasResults: False |
<|newrecord|> nctId: NCT06260878 id: REB23-0625 briefTitle: Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis acronym: STRIPE overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-12-31 date: 2028-06-30 date: 2024-02-15 date: 2024-02-15 name: University of Calgary class: OTHER briefSummary: This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative. conditions: Post-ERCP Acute Pancreatitis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 505 type: ESTIMATED name: Intravenous Ringer's lactate measure: Serum amylase measure: Pancreatitis measure: Bleeding measure: Cholangitis measure: Cardiorespiratory adverse event measure: Serum lipase measure: Electrolytes measure: Creatinine measure: Brain natriuretic peptide sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06260865 id: E-ETH-01K-CI02 briefTitle: A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-07-31 date: 2024-08-30 date: 2024-02-15 date: 2024-02-15 name: EverEx Inc. class: INDUSTRY briefSummary: This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome. conditions: Patellofemoral Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 216 type: ESTIMATED name: MORA Cure name: Treatment as Usual measure: Usual pain severity assessed by the Visual Analogue Scale (VAS) measure: Usual pain severity assessed by the Visual Analogue Scale (VAS) measure: Worst pain severity assessed by the Visual Analogue Scale (VAS) measure: Functional disability assessed by the Kujala Patellofemoral Scale measure: Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D) measure: Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) measure: Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS) measure: Flexion and extension strength of knee measure: Treatment adherence sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Myongji Hospital city: Goyang-si state: Gyeonggi-do zip: 10475 country: Korea, Republic of lat: 37.65639 lon: 126.835 facility: Hanyang University Guri Hospital city: Guri-si state: Gyeonggi-do zip: 11923 country: Korea, Republic of lat: 37.5986 lon: 127.1394 facility: CHA Bundang Medical Center city: Seongnam-si state: Gyeonggi-do zip: 13496 country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: Inha University Hospital city: Junggu state: Incheon-si zip: 22332 country: Korea, Republic of lat: 37.69175 lon: 126.60024 facility: Chung-Ang University Hospital city: Dongjak state: Seoul zip: 06973 country: Korea, Republic of lat: 35.15713 lon: 126.8166 facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center city: Dongjak state: Seoul zip: 07061 country: Korea, Republic of lat: 35.15713 lon: 126.8166 facility: Kyung Hee University Hospital at Gangdong city: Gangdong state: Seoul zip: 05278 country: Korea, Republic of facility: The Catholic University of Korea Seoul St. Mary's Hospital city: Seocho state: Seoul zip: 06591 country: Korea, Republic of lat: 37.49056 lon: 127.02 facility: Seoul National University Bundang Hospital city: Gyeonggi-do zip: 13620 country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Asan Medical Center city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False |
<|newrecord|> nctId: NCT06260852 id: ES20/Th8/23-11-2023 briefTitle: Identification of Minimum Focal Points in Vision Curve Formation overallStatus: RECRUITING date: 2024-02-01 date: 2024-08 date: 2024-08 date: 2024-02-15 date: 2024-03-07 name: Democritus University of Thrace class: OTHER briefSummary: The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery. conditions: Presbyopia conditions: Pseudophakia conditions: Cataract conditions: Refractive Errors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Diagnostic Test: Visual Acuity Assessment measure: Visual curves interpolation measure: Area of the curve (AOC) assessment measure: Visual acuity assessment sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology, University Hospital of Alexandroupolis status: RECRUITING city: Alexandroupolis state: Evros zip: 68100 country: Greece name: Georgios Labiris, MD, PhD role: CONTACT phone: 00302551030405 email: [email protected] lat: 40.84995 lon: 25.87644 hasResults: False |
<|newrecord|> nctId: NCT06260839 id: KY20232442-F-1 briefTitle: the Effect of Minimally Invasive Technique Assisted by Magnetic Resonance Neurography overallStatus: RECRUITING date: 2024-02-16 date: 2024-12-01 date: 2024-12-31 date: 2024-02-15 date: 2024-02-26 name: He Xiang class: OTHER briefSummary: The goal of this clinical trial is to to compare the therapeutic effect of minimally invasive surgery guided by magnetic resonance neurography(MRN) compared with non-magnetic resonance assisted minimally invasive surgery in patients with moderate to severe gluteal muscle contracture(GMC). The main question it aims to answer are: magnetic resonance neurography can better help optimize the surgical path of minimally invasive surgery in the treatment of gluteal muscle contracture. |
Participants will underwent preoperative magnetic resonance examination according to different groups, and then the experimental group designed individualized surgical approach and MRN-assisted minimally invasive release according to the imaging findings. In the control group, preoperative magnetic resonance examination was only used to assist in the diagnosis and evaluation of gluteal muscle contracture, and the magnetic resonance results were not used to assist in the design of surgical approach. In the control group, non-MRN-assisted minimally invasive release was performed. The researchers will compare the intraoperative surgery-related indicators and postoperative hip function scores and complications of patients in different groups to see if magnetic resonance-assisted surgery has a better postoperative effect. conditions: Orthopedic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: magnetic resonance neurography name: no magnetic resonance neurography measure: Hip joint outcome score(HOS) scale measure: Objective hip function scoring scale measure: Hip joint function of patients measure: Imaging data of patients with gluteal muscle contracture measure: Record the duration of the patient 's surgery measure: The record of the length of the surgical incision of the patient measure: Measurement of intraoperative blood loss measure: The first ambulation time after operation measure: postoperative pain score measure: Postoperative patients were satisfied with the appearance measure: The record of postoperative wound infection measure: The occurrence of postoperative wound fat liquefaction measure: Postoperative wound peripheral nerve vascular injury measure: Postoperative incision hematoma formation measure: Gluteal muscle contracture severity ZHAO 's classification measure: Demographic characteristics of patients sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital, the Fourth Military Medical University status: RECRUITING city: Xian state: Shaanxi zip: 710032 country: China name: Xiang He, MS role: CONTACT phone: 8684771013 email: [email protected] name: Long Bi, Prof. role: CONTACT phone: 8684771013 email: [email protected] name: Long Bi, Prof. role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 hasResults: False |
<|newrecord|> nctId: NCT06260826 id: 3977/QĐ-HVQY briefTitle: CPAP on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery acronym: CPAP overallStatus: COMPLETED date: 2021-12-01 date: 2022-08-20 date: 2022-08-30 date: 2024-02-15 date: 2024-02-15 name: Nguyen Dang Thu class: OTHER briefSummary: Postoperative continuous positive airway pressure (CPAP) can improve lung function. The risk of pulmonary complications is high after major abdominal surgery but may be reduced by prophylactic postoperative noninvasive ventilation using CPAP. This study compared the effects of auto-CPAP via a nasal mask (JPAP) and constant-CPAP via a facial mask (O2-Max Trio) on oxygenation and pulmonary function in elderly patients after major open abdominal surgery. conditions: Continuous Positive Airway Pressure conditions: Pulmonary Function conditions: Older People studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients were randomly assigned in a 1:1 ratio to either the O2-Max Trio or JPAP group through a computer-generated randomization list . primaryPurpose: TREATMENT masking: NONE maskingDescription: the treatment allocation was unblinded to both the patient and the staffs count: 60 type: ACTUAL name: Auto CPAP via nasal mask (JPAP machine) name: Constant CPAP via facial mask (O2-Max Trio system) measure: The oxygenation-PaO2/FiO2 measure: The forced vital capacity (FVC) measure: The forced expiratory volume in the first second-FEV1 measure: The FEV1/FVC ratio measure: The peak expiratory flow-PEF sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VietXo Friendship Hospital city: Hanoi zip: 12108 country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False |
<|newrecord|> nctId: NCT06260813 id: S66277 briefTitle: Biomechanical and Morphological Characterization of PTTD acronym: PTTD overallStatus: RECRUITING date: 2022-08-22 date: 2028-08-01 date: 2028-08-01 date: 2024-02-15 date: 2024-02-15 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Posterior tibial tendon dysfunction (PTTD) is a progressive condition of the tendon of the tibialis posterior muscle with symptoms of tendinopathy or even rupture. Functionally, it is associated with the inability to lock the mid foot and thus manifests itself as a main contributor to adult acquired flatfoot deformity. |
Concerning treatment, clinical decision making is currently based on a classification integrating various parameters as pain, flexibility of the foot joints, the condition of the posterior tibial tendon assessed through ultrasound imaging and radiographic assessment of arthritic changes. Surprisingly, this classification does not consider any morphologic characteristics (the shape of a bone or joint) or functional, biomechanical characteristics of the foot and ankle, i.e. based on kinematics (e.g. range of motion) and/or kinetics (center of pressure, angular velocity, moment, power absorption and power generation of a joint). |
Detailed biomechanical characteristics of the foot and ankle can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform. Kinematic studies in the field of PTTD typically considered the foot as a structure consisting of three segments: hind foot, forefoot and hallux. Consequently, the mid foot segment (the Chopart and Lisfranc joints) has been neglected, although it is this segment that is particularly affected in PTTD patients. |
The aim of this research is to overcome the limitations of the current classification system and treatment of PTTD patients, by complementing the current standard-of-care clinical assessment with better insight in the pathologic changes that occur in PTTD patients. conditions: Posterior Tibial Tendon Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective interventional study that includes PTTD patients (PTTD I, II and III) and a healthy control group. primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: PTTD patients (PTTD I, II and III) and a healthy control group. whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Radiography name: Ultrasound name: MRI name: CT-scan name: Gait analysis measure: Kinematic characteristics during Gait analysis measure: Center of pressure during Gait analysis measure: Angular velocity during Gait analysis measure: Moment during Gait analysis measure: Power absorption during Gait analysis measure: Power generation during Gait analysis measure: Bone morphology measure: American Orthopaedic Foot & Ankle Society (AOFAS) score measure: European Foot and Ankle Society (EFAS) score measure: 36-item Short Form Health Survey (SF36) measure: Visual Analogue Scale (VAS) pain measure: Visual Analogue Scale (VAS) satisfaction sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Sander Wuite role: CONTACT phone: +32 16 33 83 29 email: [email protected] name: Kevin Deschamps role: CONTACT phone: +32 16 33 88 27 email: [email protected] lat: 50.87959 lon: 4.70093 hasResults: False |
<|newrecord|> nctId: NCT06260800 id: PI 23-3405 briefTitle: Spanish Version of Credibility and Expectancy Questionnaire in Patients With Musculoskeletal Injuries overallStatus: RECRUITING date: 2024-01-08 date: 2024-07-01 date: 2024-11-30 date: 2024-02-15 date: 2024-02-15 name: University of Valladolid class: OTHER briefSummary: Physiotherapy treatment of musculoskeletal injuries should be performed following the main clinical guidelines of person-centered care. Patients' perception of the abilities and facilities provided by physiotherapists boost a convenient therapeutic relationship. This relation is linked with more satisfaction and adherence during the treatment, as well as credibility and expectancy of the patient related to the treatment. Thus, Credibility and Expectancy questionnaire is normally used to assess that point. CEQ presents good psychometric properties when used in Physisiotherapy interventions, but there is not a spanish version of this questionaire. conditions: Validation Study studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Validation CEQ measure: Content validity measure: Construct validity measure: Reliability measure: Criterion validity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Silvia Lahuerta Martín status: RECRUITING city: Soria zip: 42004 country: Spain lat: 41.76401 lon: -2.46883 hasResults: False |
<|newrecord|> nctId: NCT06260787 id: OBGY-202401.01 briefTitle: Clinical Profiles And In Vitro Fertilization Success overallStatus: COMPLETED date: 2023-01-01 date: 2023-03-31 date: 2023-12-31 date: 2024-02-15 date: 2024-02-15 name: Universitas Padjadjaran class: OTHER briefSummary: This research was carried out to determine if the IVF patients' clinical profile were connected with how successful in their getting pregnant. This was a cross-sectional study which recruited all patients, performed at a major fertility clinic in Indonesia. Our data collection period spanned between January 2017 and December 2021. conditions: in Vitro Fertilisation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 223 type: ACTUAL name: In Vitro Fertilisation measure: Pregnancy rate sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran city: Bandung state: Jawa Barat zip: 40161 country: Indonesia lat: -6.92222 lon: 107.60694 hasResults: False |
<|newrecord|> nctId: NCT06260774 id: TTX-MC138-002 briefTitle: Study of TTX-MC138 in Subjects With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2026-02-01 date: 2027-02-01 date: 2024-02-15 date: 2024-04-09 name: TransCode Therapeutics class: INDUSTRY briefSummary: A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX MC138 in Subjects with Advanced Solid Tumors conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Dose Escalation Study Design primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: TTX-MC138 measure: Dose Escalation - Adverse Events measure: Dose Escalation - Overall Response Rate (ORR) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06260761 id: Dh3108103/64 briefTitle: MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT overallStatus: COMPLETED date: 2021-10-05 date: 2023-02-05 date: 2023-02-05 date: 2024-02-15 date: 2024-02-15 name: Police General Hospital, Thailand class: OTHER briefSummary: The goal of this clinical trial is to compare the Minimally Invasive Plate Osteosynthesis (MIPO) approach with conventional methods in volar locking plate treatment for distal end radius fractures under the Wide Awake Local Anesthesia No Tourniquet (WALANT) technique. The main question it aims to answer is: Does the MIPO approach provide better pain control than the conventional approach of volar locking plate fixation in distal radius fractures under WALANT? Participants will be requested to record their pain on the Visual Analog Scale (VAS), assess their functional scores, and undergo postoperative radiographic evaluations. Researchers will compare the MIPO group and the conventional group to determine the postoperative pain VAS scores, shedding light on the comparative effectiveness of the two approaches. conditions: Radius; Fracture, Lower or Distal End studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The data collector, an orthopedic resident unaware of the surgical technique used, obtained information after operation. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 68 type: ACTUAL name: MIPO name: Conventional measure: Pain Visual analogue scale measure: Quick Disabilities of the Arm, Shoulder and Hand measure: Grip strength measure: Pinch strength measure: Range of motion measure: Aesthetics measure: Satisfy measure: Volar tile measure: ulnar variance measure: radial inclination measure: operation time measure: skin incision measure: morphine IV use measure: complication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Police general hospital city: Pathum Wan state: Bangkok zip: 10330 country: Thailand lat: 13.73649 lon: 100.5239 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-10-05 uploadDate: 2024-02-04T06:00 filename: Prot_SAP_000.pdf size: 1309374 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2021-10-05 uploadDate: 2024-02-04T06:05 filename: ICF_001.pdf size: 80882 hasResults: False |
<|newrecord|> nctId: NCT06260748 id: LBI-CDCA-001 id: 2023-505759-29-00 type: OTHER domain: EU Clinical Trials Register briefTitle: A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-30 date: 2025-12-31 date: 2024-02-15 date: 2024-02-15 name: Leadiant Biosciences, Inc. class: INDUSTRY briefSummary: This study is designed to demonstrate the beneficial effect of CDCA in the treatment of CTX-associated diarrhea in approximately 10 participants aged 2-75 years old with newly diagnosed CTX or suspected CTX who have never received treatment with CDCA. conditions: Cerebrotendinous Xanthomatoses studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Chenodeoxycholic acid name: Chenodeoxycholic acid Placebo measure: Change from baseline at Week 4 in average number of stools with a BSS score of 6 or 7 per day measure: Change in plasma cholestanol levels from baseline to Week 12 measure: Change in urine and/or plasma bile alcohol levels from baseline to Week 12 measure: Incidence of, severity/intensity of, and relationship to study drug of AEs measure: Incidence of, severity/intensity of, and relationship to study drug of SAEs measure: Incidence of, severity/intensity of AESIs measure: Incidence of, severity/intensity of, and changes in laboratory values measure: Incidence of, severity/intensity of, and changes in physical examination measure: Incidence of, severity/intensity of, and changes in vital signs measure: Number of participants with discontinuations due to AEs sex: ALL minimumAge: 2 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06260735 id: HS25897 (H2023:073) id: URGP#51472 type: OTHER_GRANT domain: University of Manitoba id: RGPIN-2015-05703 type: OTHER_GRANT domain: NSERC briefTitle: Non-invasive Spinal Cord Stimulation After Spinal Cord Injury acronym: SCI-ES-WALK overallStatus: RECRUITING date: 2023-06-15 date: 2024-08-15 date: 2024-11-15 date: 2024-02-15 date: 2024-02-15 name: University of Manitoba class: OTHER briefSummary: Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols. |
This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods. conditions: Spinal Cord Injuries conditions: Spinal Cord Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Trans-spinal electrical stimulation name: Electrical muscle activation name: Treadmill walking measure: Neurophysiological markers or stepping measure: Electromyography (EMG) of ankle extensor muscles measure: Metabolic function testing measure: 6 Min Walk Test measure: SCIM-Spinal Cord Independence Measure- Mobility scores measure: Autonomic scores measure: Rate or Perceived Exertion (RPE) of Submaximal VO2 testing sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Manitoba status: RECRUITING city: Winnipeg state: Manitoba zip: R3E 0W2 country: Canada name: Katinka Stecina role: CONTACT phone: 204-789-3761 email: [email protected] lat: 49.8844 lon: -97.14704 hasResults: False |
<|newrecord|> nctId: NCT06260722 id: 18805 id: J1I-MC-GZBZ type: OTHER domain: Eli Lilly and Company briefTitle: Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2) overallStatus: RECRUITING date: 2024-02-21 date: 2026-12-11 date: 2027-03-30 date: 2024-02-15 date: 2024-04-17 name: Eli Lilly and Company class: INDUSTRY briefSummary: The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1250 type: ESTIMATED name: Retatrutide name: Semaglutide measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%) measure: Change from Baseline in HbA1c (%) measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% measure: Percentage of Participants Who Achieve HbA1c < 5.7% measure: Percent Change from Baseline in Body Weight measure: Change from Baseline in Body Weight measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 5% measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 10% measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 15% measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction measure: Percent Change from Baseline in Triglycerides measure: Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol measure: Change from Baseline in Systolic Blood Pressure (SBP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama - Department of Nutrition Sciences status: RECRUITING city: Birmingham state: Alabama zip: 35294 country: United States name: William Garvey role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: Neighborhood Healthcare Institute of Health status: RECRUITING city: Escondido state: California zip: 92025 country: United States name: James Schultz role: PRINCIPAL_INVESTIGATOR lat: 33.11921 lon: -117.08642 facility: Long Beach Research Institute status: RECRUITING city: Long Beach state: California zip: 90805 country: United States name: Ashley Duzik role: PRINCIPAL_INVESTIGATOR lat: 33.76696 lon: -118.18923 facility: Rancho Cucamonga Clinical Research status: RECRUITING city: Rancho Cucamonga state: California zip: 91730 country: United States name: Steven Barag role: PRINCIPAL_INVESTIGATOR lat: 34.1064 lon: -117.59311 facility: University of Colorado Anschutz Medical Campus status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Neda Rasouli role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Arrow Clinical Trials status: RECRUITING city: Daytona Beach state: Florida zip: 32117 country: United States name: David Billmeier role: PRINCIPAL_INVESTIGATOR lat: 29.21081 lon: -81.02283 facility: New Age Medical Research Corporation status: RECRUITING city: Miami state: Florida zip: 33186 country: United States name: Janet Gersten role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: South Broward Research status: RECRUITING city: Miramar state: Florida zip: 33027 country: United States name: Kenneth Blaze role: PRINCIPAL_INVESTIGATOR lat: 25.98731 lon: -80.23227 facility: Clinical Research of Central Florida status: RECRUITING city: Winter Haven state: Florida zip: 33880 country: United States name: Eduardo Torres role: PRINCIPAL_INVESTIGATOR lat: 28.02224 lon: -81.73286 facility: Herman Clinical Research status: RECRUITING city: Suwanee state: Georgia zip: 30024 country: United States name: Lee Herman role: PRINCIPAL_INVESTIGATOR lat: 34.05149 lon: -84.0713 facility: Pacific Diabetes & Endocrine Center status: RECRUITING city: Honolulu state: Hawaii zip: 96813 country: United States name: ALAN PARSA role: PRINCIPAL_INVESTIGATOR lat: 21.30694 lon: -157.85833 facility: Rocky Mountain Clinical Research status: RECRUITING city: Idaho Falls state: Idaho zip: 83404 country: United States name: Kevin Prier role: PRINCIPAL_INVESTIGATOR lat: 43.46658 lon: -112.03414 facility: Deaconess Clinic - Gateway Health Center status: NOT_YET_RECRUITING city: Newburgh state: Indiana zip: 47630 country: United States name: Renee Galen role: PRINCIPAL_INVESTIGATOR lat: 37.94449 lon: -87.40529 facility: IMA Clinical Research Monroe - Armand status: RECRUITING city: Monroe state: Louisiana zip: 71201 country: United States name: Clinton Guillory role: PRINCIPAL_INVESTIGATOR lat: 32.50931 lon: -92.1193 facility: MedStar Health Research Institute (MedStar Physician Based Research Network) status: RECRUITING city: Hyattsville state: Maryland zip: 20782 country: United States name: Jean Park role: PRINCIPAL_INVESTIGATOR lat: 38.95594 lon: -76.94553 facility: Brigham and Women's Hospital Diabetes Program status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Vanita Aroda role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: NECCR PrimaCare Research status: RECRUITING city: Fall River state: Massachusetts zip: 02721 country: United States name: Ehab Sorial role: PRINCIPAL_INVESTIGATOR lat: 41.70149 lon: -71.15505 facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division status: RECRUITING city: Troy state: Michigan zip: 48098 country: United States name: Neil Fraser role: PRINCIPAL_INVESTIGATOR lat: 42.60559 lon: -83.14993 facility: Palm Research Center Tenaya status: RECRUITING city: Las Vegas state: Nevada zip: 89128 country: United States name: Samer Nakhle role: PRINCIPAL_INVESTIGATOR lat: 36.17497 lon: -115.13722 facility: NYC Research INC status: RECRUITING city: Long Island City state: New York zip: 11106 country: United States name: Anastasios Manessis role: PRINCIPAL_INVESTIGATOR lat: 40.74482 lon: -73.94875 facility: Medication Management status: RECRUITING city: Greensboro state: North Carolina zip: 27405 country: United States name: James Franklin role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 facility: Remington Davis Clinical Research status: RECRUITING city: Columbus state: Ohio zip: 43215 country: United States name: Elena Christofides role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Intend Research, LLC status: RECRUITING city: Norman state: Oklahoma zip: 73069 country: United States name: Lisa Connery role: PRINCIPAL_INVESTIGATOR lat: 35.22257 lon: -97.43948 facility: Central States Research status: RECRUITING city: Tulsa state: Oklahoma zip: 74136 country: United States name: Sarah Land role: PRINCIPAL_INVESTIGATOR lat: 36.15398 lon: -95.99277 facility: The Corvallis Clinic, P.C. status: RECRUITING city: Corvallis state: Oregon zip: 97330 country: United States name: Brian Curtis role: PRINCIPAL_INVESTIGATOR lat: 44.56457 lon: -123.26204 facility: Thomas Jefferson University Hospital status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Serge Jabbour role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: Dallas Diabetes Research Center status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Julio Rosenstock role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Valley Institute of Research - Fort Worth status: RECRUITING city: Fort Worth state: Texas zip: 76164 country: United States name: alex guevara role: PRINCIPAL_INVESTIGATOR lat: 32.72541 lon: -97.32085 facility: Juno Research status: RECRUITING city: Houston state: Texas zip: 77040 country: United States name: Damaris Vega role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: Southern Endocrinology Associates status: RECRUITING city: Mesquite state: Texas zip: 75149 country: United States name: Sumana Gangi role: PRINCIPAL_INVESTIGATOR lat: 32.7668 lon: -96.59916 facility: Texas Valley Clinical Research status: RECRUITING city: Weslaco state: Texas zip: 78596 country: United States name: Eduardo Luna role: PRINCIPAL_INVESTIGATOR lat: 26.15952 lon: -97.99084 facility: Medrasa Clinical Research status: RECRUITING city: Wylie state: Texas zip: 75098 country: United States name: Tanvir Ahmad role: PRINCIPAL_INVESTIGATOR lat: 33.01512 lon: -96.53888 facility: Central Washington Health Services Association d/b/a Confluence Health status: RECRUITING city: Wenatchee state: Washington zip: 98801 country: United States name: Anton Grasch role: PRINCIPAL_INVESTIGATOR lat: 47.42346 lon: -120.31035 facility: Exemplar Research status: RECRUITING city: Morgantown state: West Virginia zip: 26505 country: United States name: WARD PAINE role: PRINCIPAL_INVESTIGATOR lat: 39.62953 lon: -79.9559 facility: CARE - Centro de Alergia y Enfermedades Respiratorias status: NOT_YET_RECRUITING city: Ciudad Autónoma de Buenos Aires state: Buenos Aires zip: 1414 country: Argentina name: Hernan Finkelstein role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Stat Research S.A. status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1023AAB country: Argentina name: Lucas Gutnisky role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: CIPREC status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1061AAS country: Argentina name: Cesar Zaidman role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Médico Viamonte status: RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1120AAC country: Argentina name: Diego Aizenberg role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Mautalen Salud e Investigación status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1128AAF country: Argentina name: José Fretes role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: CEMEDIAB status: NOT_YET_RECRUITING city: C.a.b.a. state: Ciudad Autónoma De Buenos Aires zip: C1205AAO country: Argentina name: Alejandro Chertkoff role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Instituto Centenario status: NOT_YET_RECRUITING city: Caba state: Ciudad Autónoma De Buenos Aires zip: 1204 country: Argentina name: SUSANA SALZBERG role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada status: NOT_YET_RECRUITING city: Ciudad Autonoma de Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1425AGC country: Argentina name: Antonela Mainardi role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Medico Privado San Vicente Diabetes status: NOT_YET_RECRUITING city: Cordoba state: Córdoba zip: 5006 country: Argentina name: Cecilia Luquez role: PRINCIPAL_INVESTIGATOR lat: -31.4135 lon: -64.18105 facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes status: RECRUITING city: Godoy Cruz state: Mendoza zip: 5501 country: Argentina name: Pedro Rosario Fabian Calella role: PRINCIPAL_INVESTIGATOR lat: -32.92863 lon: -68.8351 facility: Centro de Investigaciones Clínicas Baigorria status: RECRUITING city: Granadero Baigorria state: Santa Fe zip: 2152 country: Argentina name: Juan Escalante role: PRINCIPAL_INVESTIGATOR lat: -32.85683 lon: -60.71754 facility: Instituto de Investigaciones Clinicas Rosario status: NOT_YET_RECRUITING city: Rosario state: Santa Fe zip: S2000CVD country: Argentina name: Maximiliano Sicer role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: Fundación Respirar status: RECRUITING city: Buenos Aires zip: C1426ABP country: Argentina name: Maria De Salvo role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro de Investigaciones Metabólicas (CINME) status: NOT_YET_RECRUITING city: Ciudad Autónoma de Buenos Aires zip: C1056ABJ country: Argentina name: Federico Perez Manghi role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Diabetológico Dr. Waitman status: NOT_YET_RECRUITING city: Córdoba zip: 5000 country: Argentina name: JOSE POZZI role: PRINCIPAL_INVESTIGATOR lat: -31.4135 lon: -64.18105 facility: University of Calgary - Clinical Trials Unit status: NOT_YET_RECRUITING city: Calgary state: Alberta zip: T2T 5C7 country: Canada name: Ronald Sigal role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: Alberta Diabetes Institute status: NOT_YET_RECRUITING city: Edmonton state: Alberta zip: T6G 2E1 country: Canada name: Peter Senior role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 facility: Aggarwal and Associates Limited status: RECRUITING city: Brampton state: Ontario zip: L6T 0G1 country: Canada name: Naresh Aggarwal role: PRINCIPAL_INVESTIGATOR lat: 43.68341 lon: -79.76633 facility: Dr. Steven V. Zizzo Medicine Professional Corporation status: RECRUITING city: Hamilton state: Ontario zip: L8J 0B6 country: Canada name: Steven Zizzo role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: Wharton Medical Clinic status: NOT_YET_RECRUITING city: Hamilton state: Ontario zip: L8L 5G8 country: Canada name: Sean Wharton role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: Hamilton Medical Research Group status: RECRUITING city: Hamilton state: Ontario zip: L8M 1K7 country: Canada name: Richard Tytus role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: Bluewater Clinical Research Group Inc. status: NOT_YET_RECRUITING city: Sarnia state: Ontario zip: N7T 4X3 country: Canada name: John O'Mahony role: PRINCIPAL_INVESTIGATOR lat: 42.97866 lon: -82.40407 facility: Prime Health Clinical Research status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M4S 1Y2 country: Canada name: Iris Shasha Gorfinkel role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Maple Leaf Research status: RECRUITING city: Toronto state: Ontario zip: M5G 1K2 country: Canada name: Graham Smith role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Private Practice - Dr. Nigel Jagan status: RECRUITING city: Whitby state: Ontario zip: L1N 2L1 country: Canada name: Nigel Jagan role: PRINCIPAL_INVESTIGATOR lat: 43.88342 lon: -78.93287 facility: 9109-0126 Quebec Inc. status: RECRUITING city: Montreal state: Quebec zip: H4N 2W2 country: Canada name: Ronald Akhras role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 facility: RM Pharma Specialists status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 03100 country: Mexico name: Mariana Crespo role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Hospital de Jésus, I.A.P. status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 06090 country: Mexico name: Efrain Villeda Espinosa role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 11650 country: Mexico name: Melchor Alpizar Salazar role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Diseno y Planeacion en Investigacion Medica status: NOT_YET_RECRUITING city: Guadalajara state: Jalisco zip: 44130 country: Mexico name: Cesar Calvo role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario status: NOT_YET_RECRUITING city: Guadalajara state: Jalisco zip: 44670 country: Mexico name: Maria Arechavaleta Granell role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Instituto de Diabetes, Obesidad y Nutricion status: NOT_YET_RECRUITING city: Cuernavaca state: Morelos zip: 62250 country: Mexico name: Leobardo Sauque Reyna role: PRINCIPAL_INVESTIGATOR lat: 18.9261 lon: -99.23075 facility: Cardiolink Clin Trials status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 64060 country: Mexico name: Elías García role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Clínica García Flores SC status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 64610 country: Mexico name: Pedro Garcia role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Enclifar Ensayos Clínicos Farmacológicos Sc status: NOT_YET_RECRUITING city: Chihuahua zip: 31110 country: Mexico name: Luis Nevarez role: PRINCIPAL_INVESTIGATOR lat: 28.63528 lon: -106.08889 facility: Instituto Veracruzano en Investigación Clínica S.C. status: NOT_YET_RECRUITING city: Veracruz zip: 91851 country: Mexico name: Rosa Luna Ceballos role: PRINCIPAL_INVESTIGATOR lat: 19.18095 lon: -96.1429 facility: Advanced Clinical Research, LLC status: RECRUITING city: Bayamón zip: 00959 country: Puerto Rico name: Angel Comulada-Rivera role: PRINCIPAL_INVESTIGATOR lat: 18.39856 lon: -66.15572 facility: GCM Medical Group, PSC - Hato Rey Site status: RECRUITING city: San Juan zip: 00917 country: Puerto Rico name: Gregorio Cortes-Maisonet role: PRINCIPAL_INVESTIGATOR lat: 18.46633 lon: -66.10572 hasResults: False |
<|newrecord|> nctId: NCT06260709 id: NN6019-7565 id: 2022-502605-15-00 type: OTHER domain: European Medical Agency (EMA) id: U1111-1284-5820 type: OTHER domain: World Health Organization (WHO) briefTitle: A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis overallStatus: RECRUITING date: 2024-02-20 date: 2028-02-29 date: 2028-02-29 date: 2024-02-15 date: 2024-04-26 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years). conditions: Transthyretin Amyloid Cardiomyopathy (ATTR CM) studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: NNC6019-0001 measure: Number of Treatment Emergent Adverse Events measure: Change in 6-Minute Walk Test (6MWT) measure: Change in N-terminal-pro brain natriuretic peptide (NT-proBNP) measure: Change in Myocardial Extracellular Volume (ECV) measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) measure: Change in Troponin I measure: Change in Global Longitudinal Strain (GLS) on Echocardiography sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Arizona status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85054 country: United States lat: 33.44838 lon: -112.07404 facility: Cedars-Sinai Medical Center_Los Angeles status: NOT_YET_RECRUITING city: Beverly Hills state: California zip: 90211 country: United States lat: 34.07362 lon: -118.40036 facility: Stanford Hlth Cre-Boswell Clin status: RECRUITING city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 facility: Mayo Clinic Jacksonville status: NOT_YET_RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States lat: 30.33218 lon: -81.65565 facility: NW Univ-Bluhm Cardiovasc Inst status: NOT_YET_RECRUITING city: Evanston state: Illinois zip: 60208 country: United States lat: 42.04114 lon: -87.69006 facility: Univ of MD Schl of Med status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States lat: 39.29038 lon: -76.61219 facility: Mayo Clinic Rochester status: NOT_YET_RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 facility: University of Calgary_Cardiology status: NOT_YET_RECRUITING city: Calgary state: Alberta zip: T2N 4Z6 country: Canada lat: 51.05011 lon: -114.08529 facility: Ctr for Cardiovascular Innovation status: NOT_YET_RECRUITING city: Vancouver state: British Columbia zip: V5Z 1M9 country: Canada lat: 49.24966 lon: -123.11934 facility: II. interni klinika VFN - Kardiologie a angiologie status: NOT_YET_RECRUITING city: Praha 2 zip: 12808 country: Czechia lat: 50.08804 lon: 14.42076 facility: Ap-Hp-Hopital Henri Mondor status: NOT_YET_RECRUITING city: Créteil zip: 94000 country: France lat: 48.78333 lon: 2.46667 facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 status: NOT_YET_RECRUITING city: Toulouse Cedex 9 zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie status: NOT_YET_RECRUITING city: Heidelberg zip: 69120 country: Germany lat: 49.40768 lon: 8.69079 facility: LMU Klinikum München Klinik und Poliklinik 1 status: NOT_YET_RECRUITING city: München zip: 81377 country: Germany lat: 48.13743 lon: 11.57549 facility: Uniklinik Münster, Klinik für Kardiologie I status: NOT_YET_RECRUITING city: Münster zip: 48149 country: Germany lat: 51.96236 lon: 7.62571 facility: Universitatsklinikum Wurzburg AöR status: NOT_YET_RECRUITING city: Würzburg zip: 97078 country: Germany lat: 49.79391 lon: 9.95121 facility: Fondazione CNR-Regione Toscana Gabriele Monasterio status: NOT_YET_RECRUITING city: Pisa state: Pi zip: 56124 country: Italy lat: 43.70853 lon: 10.4036 facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo status: NOT_YET_RECRUITING city: Pavia state: PV zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 facility: UMC Groningen status: NOT_YET_RECRUITING city: Groningen zip: 9713 GZ country: Netherlands lat: 53.21917 lon: 6.56667 facility: Universitair Medisch Centrum Utrecht status: NOT_YET_RECRUITING city: Utrecht zip: 3584 CX country: Netherlands lat: 52.09083 lon: 5.12222 facility: Hospital da Senhora da Oliveira - Guimarães status: NOT_YET_RECRUITING city: Guimarães zip: 4835-044 country: Portugal lat: 41.44443 lon: -8.29619 facility: Centro Hospitalar de Trás-os-Montes e Alto Douro status: NOT_YET_RECRUITING city: Vila Real zip: 5000-508 country: Portugal lat: 41.30062 lon: -7.74413 facility: Hospital Universitario Puerta de Hierro Majadahonda status: NOT_YET_RECRUITING city: Majadahonda state: Madrid zip: 28222 country: Spain lat: 40.47353 lon: -3.87182 hasResults: False |
<|newrecord|> nctId: NCT06260696 id: DAS-7626 id: U1111-1282-5512 type: OTHER domain: World Health Organization (WHO) briefTitle: Assessing Health-Related Quality of Life and Willingness to Pay for Weight Management in Asia-Pacific by Gender acronym: ASPECT - APAC overallStatus: COMPLETED date: 2023-08-10 date: 2023-10-05 date: 2023-10-05 date: 2024-02-15 date: 2024-02-15 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The purpose of this survey is to collect information for scientific research and to identify the impact of overweight and obesity on health-related quality of life. conditions: Overweight conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 3000 type: ACTUAL name: No treatment is given measure: Score on IWQOL-Lite validated sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novo Nordisk Investigational Site city: Dubai country: United Arab Emirates lat: 25.0657 lon: 55.17128 hasResults: False |
<|newrecord|> nctId: NCT06260683 id: OSU-22240 id: NCI-2023-04102 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: R01DA057327 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA057327 briefTitle: A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2027-04-29 date: 2027-04-29 date: 2024-02-15 date: 2024-04-03 name: Ohio State University Comprehensive Cancer Center class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) to non-tobacco flavored ECs on smoking behavior in current cigarette smokers to use of nicotine replacement therapy (patches and lozenges). ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use, and learn how ECs affect smoking behaviors and health. conditions: Cigarette Smoking-Related Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1500 type: ESTIMATED name: Nicotine Replacement name: Questionnaire Administration name: Vaping name: Vaping measure: Biochemically verified 7-day point prevalence abstinence from cigarettes measure: Switching rate measure: Cigarettes smoked per day measure: Change in nicotine dependence measure: Changes in cigarette craving and nicotine withdrawal measure: Number of days used measure: Product appeal measure: Continued purchase and use of ECs sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Theodore L. Wagener, PhD role: CONTACT email: [email protected] name: Theodore L. Wagener, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False |
<|newrecord|> nctId: NCT06260670 id: CP0004 briefTitle: FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation acronym: FLOW EVAL-AF overallStatus: COMPLETED date: 2022-09-01 date: 2022-10-28 date: 2022-10-28 date: 2024-02-15 date: 2024-02-15 name: Ablacon, Inc. class: INDUSTRY briefSummary: FLOW EVAL-AF is a prospective, observational, single center pilot trial. The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the activation patterns observed from concomitant high density mapping of those regions. conditions: Persistent Atrial Fibrillation conditions: Longstanding Persistent Atrial Fibrillation conditions: Atrial Fibrillation, Persistent conditions: Arrhythmias, Cardiac studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ACTUAL name: Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter measure: Descriptive correlation of electrogram patterns sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Herz-und Diabeteszentrum NRW (Clinic of Ruhr University of Bochum) city: Bad Oeynhausen state: North Rhine-Westphalia zip: 32545 country: Germany lat: 52.20699 lon: 8.80365 hasResults: False |
<|newrecord|> nctId: NCT06260657 id: 2021PI124 briefTitle: Search for Olfactory Cells Within the Fetal Ethmoid Epithelium acronym: COEF overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-10 date: 2025-10 date: 2024-02-15 date: 2024-02-15 name: Central Hospital, Nancy, France class: OTHER briefSummary: The recent rhinological functional approach known as "Evo-Devo" leads us to consider the nose not as a single organ, but as the construction of a specifically olfactory organ within which functional respiratory structures have developed over the course of species evolution in the same way they develop during human embryogenesis. |
In adult humans, the olfactory structures are limited to two narrow regions situated at the upper part of the nasal passages known as olfactory clefts. Nevertheless, phylogenetic evidence indicates that these olfactory clefts are vestiges of an olfactory organ that once occupied the entire ethmoid bone in the front of the skull base. |
The hypothesis of this study posits that, during the embryological development of the ethmoid bone, it would initially be covered with olfactory mucosa, which would gradually diminish as the lateral masses of the ethmoid formed, eventually persisting exclusively within the olfactory clefts of the ethmoid by the conclusion of the first trimester (end of organogenesis). Besides their fundamental interest, the results of this study could help understand the still unknown pathogenesis of nasal polyposis, a chronic anosmic disease with a prevalence of 2 to 4% in the French and European population. |
This study requires a series of ethmoidal samples from human fetuses at various ages between 7 and 15 weeks of gestational age. Specific immunohistological labeling techniques under standard optical microscopy will be used to search for and quantify olfactory nerve cells within the fetal ethmoidal mucosa. conditions: Fetal Ethmoidal Mucosa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Histological analysis on fetal ethmoids measure: Immunohistological positive signal of primary olfactive neurons measure: Concentration of primary olfactory neurons immunohistological signals sex: ALL minimumAge: 7 Weeks maximumAge: 15 Weeks stdAges: CHILD facility: Centre Hospitalier Régional Universitaire - Service ORL city: Nancy country: France name: Roger Jankowski, MD/PhD role: CONTACT email: [email protected] lat: 48.68439 lon: 6.18496 hasResults: False |
<|newrecord|> nctId: NCT06260644 id: Repairing defective composite briefTitle: Evaluation of Using Self-adhering Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial) overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-01 date: 2025-09 date: 2025-10 date: 2024-02-15 date: 2024-02-15 name: Cairo University class: OTHER briefSummary: This research proposal is evaluating the clinical performance of using self-adhering flowable resin composite in repairing old occlusal defective resin composite versus conventional flowable resin composite restoration over 18 months. conditions: Occlusal Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: double ( participants, outcomes assessor) participants and both assessors will be blind to the type of material used whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: VertiseTM flowable composite (Kerr,USA) measure: Restoration clinical performance using FDI criteria sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Faculty of Dentistry city: Cairo zip: 113311 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06260631 id: P.T.REC/012/004807 briefTitle: Efficacy of High-intensity Laser Acupuncture in Patients With Chronic, Non-specific Low Back Pain overallStatus: RECRUITING date: 2024-02-25 date: 2024-08 date: 2024-08 date: 2024-02-15 date: 2024-04-26 name: Cairo University class: OTHER name: King Khalid University briefSummary: The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture on peak torque, power of trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic nonspecific low back pain (CNLBP). conditions: Chronic Nonspecific Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: high-intensity laser acupuncture and exercise therapy program primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: random generator whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: high-intensity laser acupuncture and Exercise therapy program name: Sham laser acupuncture measure: peak torque measure: peak torque measure: Average Power measure: Average Power measure: Pain Intensity measure: Pain Intensity measure: lumbar flexion and extension ROM assessment measure: lumbar flexion and extension ROM assessment measure: Disability measure: Disability measure: patient Satisfaction measure: patient Satisfaction sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Doaa Ayoub Elimy status: RECRUITING city: Giza zip: 11251 country: Egypt name: Doaa A Elimy, lecturer role: CONTACT phone: 00201066474654 email: [email protected] lat: 30.00808 lon: 31.21093 hasResults: False |
<|newrecord|> nctId: NCT06260618 id: 2021/HRE00065 briefTitle: Effect of Chitodex Gel in Tympanoplasty Surgery overallStatus: RECRUITING date: 2021-11-20 date: 2024-05-13 date: 2024-05-13 date: 2024-02-15 date: 2024-02-20 name: Central Adelaide Local Health Network Incorporated class: OTHER_GOV name: University of Adelaide briefSummary: The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty procedures to close tympanic membrane perforations (TMP). conditions: Tympanic Membrane Perforation conditions: Tympanic Membrane Inflammation conditions: Surgery conditions: Otitis Media studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single blinded randomised clinical trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Masked: The people receiving the treatment/s, The people analysing the results/data Unmasked: The surgeon administering the treatment. whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: Gelfoam name: Chitodex measure: Number of participants with tympanic membrane closure measure: rate of tympanic membrane closure measure: Number of participants with improved hearing measure: Number of participants with improved eardrum function measure: Ease of use of product compared to active comparator - surgeon feedback measure: Time taken to complete surgery measure: Number of Participants with improved quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Queen Elizabeth Hospital status: RECRUITING city: Adelaide state: South Australia zip: 5011 country: Australia name: Prof Peter John Wormald, MD role: CONTACT phone: +61 8 8222 7158 email: [email protected] name: Emma Barry, BSc (Hons) role: CONTACT phone: +61 8 8222 7158 email: [email protected] name: Prof Peter John Wormald, MD role: PRINCIPAL_INVESTIGATOR lat: -34.92866 lon: 138.59863 facility: The Memorial Hospital status: RECRUITING city: North Adelaide state: South Australia zip: 5006 country: Australia name: Prof Peter John Wormald, MD role: CONTACT phone: +61 8 8222 7158 email: [email protected] lat: -34.90733 lon: 138.59141 hasResults: False |
<|newrecord|> nctId: NCT06260605 id: Burcu Bayrak 1 id: Burcu type: REGISTRY domain: Bayrak briefTitle: Complications of Diabetes With Puzzles acronym: Diabetes with overallStatus: COMPLETED date: 2023-12-19 date: 2024-02-20 date: 2024-03-04 date: 2024-02-15 date: 2024-03-07 name: Bilecik Seyh Edebali Universitesi class: OTHER briefSummary: In this study, it was aimed to investigate the effect of diabetes complications training on endocrine system diseases and nursing care in the Internal Medicine Nursing course on the knowledge level of nursing students. conditions: Diabetes Complications studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 110 type: ACTUAL name: Education measure: Education sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Bilecik Şeyh Edebali University city: Bilecik state: Merkez country: Turkey lat: 40.14192 lon: 29.97932 hasResults: False |
<|newrecord|> nctId: NCT06260592 id: Aysun Acun 4 briefTitle: Ethical Attitude and Humanistic Acting Skills of Intensive Care Nurses overallStatus: RECRUITING date: 2024-02-06 date: 2024-03 date: 2024-03 date: 2024-02-15 date: 2024-02-15 name: Bilecik Seyh Edebali Universitesi class: OTHER briefSummary: Today, rapidly developing technology and changing treatment and care conditions increase the tendency towards ethical values both as an intellectual concept and as a moral guide. The nursing profession, which focuses on people in ethical terms, is also performed by people. This situation brings with it many ethical dilemmas in areas where health care services are provided. In ICUs, long and critical treatments of patients, differences of opinion between the medical team and the institution, non-compliance with patient rights, difficulties in terminal patient care, procedures performed without the patient\'s consent, distribution of limited medical resources, unethical attitudes and attitudes of nurse colleagues, Many issues such as long-term exposure to stressors and constant alarm sounds can cause mental distress and negative emotions in intensive care nurses. One of the effective ways to increase the quality of care provided by nurses is humanistic practice ability. The presence of humanistic practice ability provides more realistic, human-centered nursing care, improves the quality of life of patients, and also positively affects health expenditures. conditions: Humanistic Care Skills studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED measure: Ethical compliance of nurses in the intensive care unit measure: Humanistic care skills of nurses in the intensive care unit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bilecik Şeyh Edebali University status: RECRUITING city: Bilecik zip: 11000 country: Turkey name: Aysun Acun, PhD role: CONTACT phone: +905072104506 email: [email protected] name: Aysun Acun, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.14192 lon: 29.97932 hasResults: False |
<|newrecord|> nctId: NCT06260579 id: S-number 66153 id: S006722N type: OTHER_GRANT domain: Research Foundation Flanders - SBO project briefTitle: Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity acronym: PHOENIX-Kidney overallStatus: RECRUITING date: 2022-11-14 date: 2025-09-30 date: 2029-12 date: 2024-02-15 date: 2024-02-15 name: KU Leuven class: OTHER name: University Ghent briefSummary: This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent. conditions: Physical Activity conditions: Exercise Training conditions: Kidney Transplantation conditions: Physical Fitness conditions: Cardiovascular Health conditions: Gut Microbiome conditions: Health-related Quality of Life conditions: Implementation conditions: Cost-effectiveness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel group randomized controlled trial primaryPurpose: OTHER masking: SINGLE maskingDescription: Outcome assessors are blinded to the group allocation of the patients. Due to the nature of the intervention, blinding of the patients is not possible. However, a sham training intervention is provided to the control group. whoMasked: OUTCOMES_ASSESSOR count: 147 type: ESTIMATED name: Exercise/physical activity measure: Changes in peak oxygen consumption (VO2peak) measure: Health-related physical fitness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Ghent status: RECRUITING city: Ghent zip: 9000 country: Belgium name: Calders Patrick, PhD role: CONTACT lat: 51.05 lon: 3.71667 facility: UZ Leuven status: RECRUITING city: Leuven zip: 3000 country: Belgium name: Amaryllis Van Craenenbroeck, MD, PhD role: CONTACT lat: 50.87959 lon: 4.70093 hasResults: False |
<|newrecord|> nctId: NCT06260566 id: H-52570 briefTitle: Tolerability of Enteral NAC in Infants overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-02 date: 2027-02 date: 2024-02-15 date: 2024-04-15 name: Sanjiv Harpavat class: OTHER name: Baylor College of Medicine briefSummary: Biliary atresia (BA) is a neonatal liver disease characterized by impaired bile flow and is the most common indication for pediatric liver transplantation. BA can be treated with the Kasai portoenterostomy (KP), a procedure that attempts to restore bile flow and slow disease progression. However, success of the KP procedure is quite variable, and lack of adjuvant medical therapies following KP is a major gap in pediatric hepatology. |
This study begins to explore oral N-acetylcysteine (NAC) as a potential medical therapy in BA by determining whether an oral formulation can be given to infants. The primary objective is to determine tolerability of the oral NAC formulation. The primary outcome is tolerating at least 3 out of 4 total doses without emesis. The Bayesian Optimal Interval Design (BOIN) trial design will be used to determine the maximum tolerated dose of oral NAC. Our secondary objective is to assess palatability of the oral NAC formulation by comparing facial expressions when taking oral NAC versus other medications commonly given to cholestatic infants. conditions: Biliary Atresia studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study consists of two parts: |
* Administering applesauce alone (lead-in): In study days 1-2, infants will receive one infant spoon (approximately ½ teaspoon) of plain applesauce by mouth twice a day. If the infant tolerates 3-4 of 4 total doses without emesis, the infant will progress to the final two days of the study. |
* Administering applesauce plus NAC (for infants who tolerate applesauce in study days 1-2): In study days 3-4, infants will receive an individualized dose of powdered oral NAC mixed into one infant spoon of applesauce by mouth twice a day for a maximum of four doses of NAC medication. primaryPurpose: OTHER masking: NONE maskingDescription: N/A. No Masking count: 12 type: ESTIMATED name: N-Acetylcysteine measure: No emesis within 30 minutes of administration of at least 3 of 4 total doses of oral NAC measure: Oral NAC palatability compared to clinically indicated medications using the facial expression scale measure: Oral NAC-specific adverse event evaluation sex: ALL minimumAge: 122 Days maximumAge: 273 Days stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06260553 id: SCOG008 briefTitle: Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC overallStatus: ENROLLING_BY_INVITATION date: 2024-02-07 date: 2025-02-07 date: 2025-08-07 date: 2024-02-15 date: 2024-02-15 name: Fujian Cancer Hospital class: OTHER_GOV briefSummary: To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy. conditions: EGFR/ ALK-negative Advanced NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: tislelizumab and metronomic oral vinorelbine measure: PFS measure: ORR measure: DCR measure: AE sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian cancer hospital city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 hasResults: False |
<|newrecord|> nctId: NCT06260540 id: Core Endurance briefTitle: Core Endurance in Healthy Young Adults overallStatus: RECRUITING date: 2024-02-01 date: 2024-02-29 date: 2024-04-29 date: 2024-02-15 date: 2024-03-26 name: Karabuk University class: OTHER briefSummary: This study aimed to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time in healthy young adults. The "core" region functions as a connection point between the upper and lower extremities and enables the transfer of force from this region to the extremities. This region is a basic structure where the force required for all movements is generated and transmitted from the proximal segments to the distal segments. "Core" stabilization has a significant impact on limb functionality, and stabilization of the proximal segments is necessary to maintain the mobility and function of the distal segments. To establish a stable base during functional activities, the "core" muscles are activated before the upper and lower extremity muscles. This ensures force production and transfer of resulting forces, thus supporting the mobility of the distal segments. Increasing core stabilization increases force production in the extremities, and control of core strength, balance and movement maximizes upper and lower extremity functions. Any impairment in core stabilization reduces the quality of movement and increases the risk of injury to the upper extremity. Therefore, it has been stated that "core" stabilization has a significant effect on athletic performance and upper extremity functions. There are not enough studies in the literature investigating this effect in healthy young adults. Most existing studies focus on the role of core endurance on athlete performance. |
The aim of this study is not only to investigate core endurance levels in healthy young adults but also to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time. conditions: Health Risk Behaviors studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 104 type: ESTIMATED measure: Side bridge test measure: Prone bridge test (plank) test measure: Trunk flexion endurance test measure: Sorensen test measure: Purdue Pegboard test measure: Isometric hand dynamometer for muscle strength measure: Nelson hand reaction test sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Karabuk University status: RECRUITING city: Karabuk zip: 78000 country: Turkey lat: 41.20488 lon: 32.62768 hasResults: False |
<|newrecord|> nctId: NCT06260527 id: ARTS-011-101 briefTitle: Safety and Pharmacokinetic Study of ARTS-011 in Chinese Healthy Volunteers overallStatus: RECRUITING date: 2023-08-30 date: 2024-05-30 date: 2024-09-30 date: 2024-02-15 date: 2024-02-15 name: Allorion Therapeutics Inc class: INDUSTRY briefSummary: This single- and multiple-ascending dose study is a Phase 1, first in human study of ARTS-011. The goal of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of ARTS-011 after single and multiple oral doses of ARTS-011 in Chinese healthy volunteers. conditions: Chinese Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Single ascending dose (SAD) following by multiple ascending dose (MAD) and food effect study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 76 type: ESTIMATED name: ARTS-011 name: Placebo measure: Incidence of Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs measure: Number of Adverse Events (AEs) according to severity measure: Number of participants with change from baseline in vital signs (blood pressure, pulse rate, oral temperature) measure: Number of participants with change from baseline in 12-Lead Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) measure: Number of participants with change from baseline physical examination measure: Incidence and magnitude of treatment emergent clinical laboratory abnormalities measure: Number of participants with change in 24-hour creatine clearance from baseline measure: Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Plasma Decay Half-Life (t1/2) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Apparent Volume of Distribution (Vz/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Apparent Clearance (CL/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) if data permit measure: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ARTS-011 in Single Ascending Dose (SAD) measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of ARTS-011 in Multiple Ascending Dose (MAD) measure: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of ARTS-011 in Single Ascending Dose (SAD) measure: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of ARTS-011 in Multiple Ascending Dose (MAD) measure: Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Food Effect Cohort measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Food Effect Cohort measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of ARTS-011 in Food Effect Cohort measure: Plasma Decay Half-Life (t1/2) of ARTS-011 in Food Effect Cohort measure: Apparent Clearance (CL/F) of ARTS-011 in Food Effect Cohort if data permit measure: Apparent Volume of Distribution (Vz/F) of ARTS-011 in Food Effect Cohort if data permit sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Ruihua Dong, MD role: CONTACT phone: 010-80839386 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06260514 id: APR-1051-001 briefTitle: Study of APR-1051 in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2028-06 date: 2024-02-15 date: 2024-02-15 name: Aprea Therapeutics class: INDUSTRY briefSummary: The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 79 type: ESTIMATED name: APR-1051 measure: Treatment-related adverse events measure: Recommended dose of APR-1051 measure: Pharmacokinetics: Cmax/Cmin of APR-1051 measure: Pharmacokinetics: Tmax of APR-1051 measure: Pharmacokinetics: AUC of APR-1051 measure: Pharmacokinetics: t1/2 of APR-1051 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06260501 id: ATADEK-2023-13/463 briefTitle: Wetting Solution-ideal Body Weight Ratio in Liposuction Procedures overallStatus: COMPLETED date: 2021-09-01 date: 2023-09-30 date: 2023-10-30 date: 2024-02-15 date: 2024-02-15 name: Acibadem University class: OTHER briefSummary: Although the use of wetting solutions during high-volume liposuction is a standard approach, it is unclear how to optimize wetting solutions and components and their effect on postoperative complications.. Since the super-wet technique (aspiration of 1 cc per 1 cc of infiltrate) was introduced in 1986, it has become one of the most frequently applied techniques worldwide . Adrenaline and lidocaine are often added to WS due to their hemostatic and analgesic effects One of the major advantages of super-wet technique is that blood loss is quite low. However, potential cardiovascular side effects of WS and the amounts of epinephrine and lidocaine they contain, such as volume overload, local anesthetic toxicity, hypertension, arrhythmia, and tachycardia, are still a scoop of investigation. In this study, we examined the WS and the medications it contains from a different perspective to understand the possible cause of these adverse outcomes. Despite the most suitable candidates for liposuction are patients with a BMI\<30 kg/m2 and low comorbidity and age, the patient group undergoing liposuction is often obese, and overweight individuals require that obesity-related pathophysiological changes be taken into consideration. Therefore, we analyzed the patients by dividing them into two groups according to the amount of WS applied according to their IBW (WS/IBW≤90ml/kg: group I and WS/IBW\>90ml/kg: group I). In this study we aimed to evaluate the effect of wetting solutions and components calculated according to ideal body weight (IBW) on postoperative complications conditions: Liposuction conditions: Obesity conditions: Postoperative Complications studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 192 type: ACTUAL name: super-wet technique measure: Mean arterial pressure (MAP) was measured to detect hypertension and hypotension. measure: The Numerical Pain Rating Scale (NRS) was used to assess postoperative pain level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Acibadem Altunizade Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06260488 id: 8925 briefTitle: Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence acronym: CTPred overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-06-15 date: 2025-08-15 date: 2024-02-15 date: 2024-02-15 name: University Hospital, Strasbourg, France class: OTHER briefSummary: The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements. Endovascular surgery is considered to be the treatment of choice for the peripheral arterial disease, the results of which depend on the physiological forces on the arterial wall, the anatomy of the vessels and the characteristics of the lesions being treated. The atheromatous disease includes, in a simple way, 3 categories of plaques: calcified, fibrous, and lipidic. The study of these plaques and their differentiation in imaging and histology in the FPAS has already been the subject of research. To treat them, there are angioplasty balloons and stents with different designs and components, with different mechanical properties and different impregnated molecules. |
There is no non-invasive method (imaging) to accurately differentiate lesions along the FPAS. The analysis is performed from the preoperative CT scan, but there are high-resolution scanners that allow a quasi-histological analysis of the tissue. |
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