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Patient Reported Experience Measures (PREMs) ask patients about their healthcare service experience. It gives them a voice to share their views. PREMs allow healthcare providers (HCPs) to see where care is good, and where they could improve. Vascular surgery is a surgical speciality looking after people's blood vessels (arteries and veins).
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There is no PREM available for vascular patients. The research team want to create a PREM for this patient group.
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WHY IT IS IMPORTANT:
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A PREM allows HCPs to record and understand patients' experiences of their treatment. It gives patients a way to provide feedback on their healthcare experience. PREMs can help HCPs make changes to patients' care, identifying areas of good practice and areas for improvement. The Welsh Government is keen to support the use of PREMs.
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AIMS:
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To develop a PREM specific to vascular surgery patients.
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RESEARCH PLAN:
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The research team will summarise the literature about PREMs in surgery. The research team will then run focus groups and interviews with patients and staff to create a 'draft' PREM for vascular patients in Wales. The 'draft' PREM will be translated into Welsh.
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In the second phase, a larger number of vascular patients (100-300 depending on how long the 'draft' PREM is) from hospitals across Wales will complete the questionnaire. Statistical tests will look at the results to see if the questionnaire works well to capture patients' experiences. Based on these results, small changes will be made to make the 'draft' PREM better. This will make sure the 'final PREM' is ready for widespread use in Wales and beyond.
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PATIENT AND PUBLIC INVOLVEMENT:
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The patients' experience team at CAVUHB has reviewed our patients' materials. Our research team includes PPI co-applicants (DC and AH). DC a double amputee who has had many vascular operations. DC has experience raising awareness about vascular disease through public forums like the Limbless Association Charity and BBC Radio Wales. AH has issues with her leg due to smoking and had a keyhole operation to help with that. She had some problems after the procedure This is her first time as a PPI representative. DC and AH supported our research design and will be steering group members. Also, our research focuses on giving patients a voice and will include patients across Wales. A diverse group of patients will be involved across all stages of the PREM development. conditions: Vascular Diseases conditions: Patient Empowerment conditions: Patient Satisfaction conditions: Patient Engagement conditions: Surgery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 330 type: ESTIMATED measure: Degree of Validity of the PREM measure: Degree of Reliability of the PREM measure: Degree of Responsiveness of the PREM measure: Degree of Feasibility of implementing the PREM in clinical practice sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southeast Wales Vascular Network-Cardiff and Vale University Health Board city: Cardiff state: Wales country: United Kingdom lat: 51.48 lon: -3.18 hasResults: False
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<|newrecord|> nctId: NCT06363162 id: LRR202404 briefTitle: Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery overallStatus: RECRUITING date: 2022-12-01 date: 2025-06-30 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Beijing Tiantan Hospital class: OTHER name: West China Hospital name: The First Affiliated Hospital of Zhengzhou University name: Capital Medical University name: Jiangsu Raman Medical Equipment Co., Ltd. briefSummary: To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the results of Immunohistochemistry or genetic test on the same brain tissue samples. conditions: Glioma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The same sample was diagnosed using Raman spectroscopy and immunohistochemistry or genetic test, respectively. Calculate the AUC, the accuracy, the sensitivity and specificity of a Raman analyzer using immunohistochemistry or genetic test results as the gold standard. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: Blind assessment: Researchers using Raman analyzer during surgery are not aware of the subjects' preoperative diagnostic results, while researchers conducting immunohistochemistry or genetic test after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer. count: 200 type: ESTIMATED name: Immunohistochemistry or genetic test measure: Area Under the Curve measure: Accuracy measure: Sensitivity measure: Specificity measure: Kappa coefficient measure: Time consumption for the Raman analyzer in detection measure: Adverse Event Incidence Rate measure: Serious Adverse Event Incidence Rate measure: Operator adverse events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing state: Beijing zip: 100071 country: China name: Yinyan Wang, MD and PhD role: CONTACT phone: +86 13581698953 email: tiantanyinyan@126.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06363149 id: 2024-11-DM-136 briefTitle: Disseminated Intravascular Coagulation (DIC) Score and Organ Dysfunction in Septic Shock Patients overallStatus: RECRUITING date: 2024-04-12 date: 2025-09 date: 2025-09 date: 2024-04-12 date: 2024-04-16 name: Sanjay Gandhi Postgraduate Institute of Medical Sciences class: OTHER_GOV briefSummary: Septic shock is common complication in patients with critical illnesses, with higher incidence in low and medium income countries like ours. Disseminated intravascular coagulation (DIC) is also common in patients presenting to intensive care units. Further DIC is common coexisting condition seen in many patients presenting with sepsis and septic shock.
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Both DIC and septic shock individually are associated with very high mortality and morbidity and coexistence of both increase risk manifold. Organ dysfunction is a complication of both septic shock and DIC individually and in presence of coexistence risk further multiply. DIC scoring of every patient at risk as in patients presenting with septic shock help us to predict about patients having more chances to convert to overt DIC.
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Understanding effects of DIC on organ dysfunction in septic shock patients can help to prognosticate and guide towards early intervention. Also, there is paucity of literature on effect of DIC score changes on organ dysfunction in patients with septic shock. conditions: Septic Shock conditions: Disseminated Intravascular Coagulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 7 measure: Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 14 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences status: RECRUITING city: Lucknow state: Uttar Pradesh zip: 226014 country: India name: Mohan Gurjar, MD, PDCC role: CONTACT name: Dinesh Chandra, MD, DM role: CONTACT name: Mohan Gurjar, MD, PDCC role: PRINCIPAL_INVESTIGATOR name: Sanjay Chaudhary, MD role: SUB_INVESTIGATOR name: Dinesh Chandra, MD, DM role: PRINCIPAL_INVESTIGATOR lat: 26.83928 lon: 80.92313 hasResults: False
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<|newrecord|> nctId: NCT06363136 id: 14.06.2023-111176 briefTitle: Foot Posture, Strength, Performance, and Postural Control in Isolated Gastrocnemius Tightness overallStatus: RECRUITING date: 2024-02-01 date: 2024-05-30 date: 2024-06-30 date: 2024-04-12 date: 2024-04-12 name: Bezmialem Vakif University class: OTHER briefSummary: Studies on gastrocnemius tightness in healthy children are limited, but there is evidence that ankle dorsiflexion decreases with increasing age in children. It is not known whether gastrocnemius tightness is a normal finding in children, but recurrent leg pain is common in children. It is also known that flexible flatfoot is a normal observation in developing children and that the medial longitudinal arch develops during the first decade of life. Both foot morphology and ankle dorsiflexion change in developing children; however, it is not known whether there is a relationship between them or not.
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In the literature, there is no study evaluating foot posture, muscle strength, functional performance, and postural control in children with isolated gastrocnemius muscle tightness. It was planned to evaluate postural control using computerized dynamic posturography (Biodex Balance System), lower extremity muscle strength using a hand-held dynamometer, foot posture using the Foot Posture Index (FPI-6), and functional performance using single-foot-double-foot jump tests in healthy children with isolated gastrocnemius muscle tightness. conditions: Gastrocnemius Tightness conditions: Postural Control conditions: Muscle Strength conditions: Functional Performance conditions: Foot Posture studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 28 type: ESTIMATED measure: Postural Control Assessment measure: Lower extremity muscle strength measurement measure: Foot posture assessment measure: Functional performance assessment sex: ALL minimumAge: 7 Years maximumAge: 16 Years stdAges: CHILD facility: Bezmialem Vakif University status: RECRUITING city: Istanbul country: Turkey name: Deniz Tuncer, PhD, PT role: CONTACT name: Fatma Eren, PT role: CONTACT name: Fatma Eren, PT role: SUB_INVESTIGATOR name: Deniz Tuncer, PhD, PT role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06363123 id: BFHHZML20240009 briefTitle: Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis overallStatus: RECRUITING date: 2024-03-29 date: 2024-10 date: 2025-04 date: 2024-04-12 date: 2024-04-15 name: Beijing Friendship Hospital class: OTHER briefSummary: The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from multi-cancer patients using advanced mass spectrometry detection technology, in conjunction with metabolomics approaches. The goal is to construct a plasma metabolite database for multi-cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early multi-cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of multi-cancer. conditions: Lung Cancer conditions: Breast Cancer conditions: Colorectal Cancer conditions: Thyroid Cancer conditions: Gastric Cancer conditions: Cervical Cancer conditions: Liver Cancer conditions: Pancreatic Cancer conditions: Cholangiocarcinoma conditions: Prostate Cancer conditions: Esophageal Cancer conditions: Ovarian Cancer conditions: Renal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2700 type: ESTIMATED measure: Plasma metabolite content sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Yibin Xie, Ph.D. role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Li Min, Ph. D. role: CONTACT phone: +86 13552652141 email: minli@ccmu.edu.cn name: Bilian Kang, Ph.D. role: CONTACT phone: +86 18001218793 email: kbl@mail.ccmu.edu.cn lat: 39.9075 lon: 116.39723 facility: Hebei Tumor Hospital status: RECRUITING city: Shijiazhuang state: Hebei zip: 050010 country: China name: Lianmei Zhao, Ph.D. role: CONTACT lat: 38.04139 lon: 114.47861 facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310022 country: China name: Qian Song, Ph.D. role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06363110 id: 22724 briefTitle: An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States acronym: HOVER overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-10 date: 2024-06-30 date: 2024-06-30 date: 2024-04-12 date: 2024-04-16 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which data already collected from people with chronic heart failure with reduced ejection fraction (HFrEF) are studied.
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In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare.
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Chronic HFrEF is a long-term condition in which the heart becomes weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen, which the body requires to function properly.
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The study treatment, vericiguat, works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow. As a result, the heart can pump better.
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It is already approved for doctors to prescribe to people with chronic HFrEF in the United States (US) who are stabilized after a recent "decompensation event". The treatment with vericiguat starts at a low dose, which should be increased gradually to the target dose based on how a patient tolerates the treatment.
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The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors.
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The main purpose of the study is to learn more about the dosage pattern of vericiguat in people with chronic HFrEF in the US. To do this, researchers will collect the following information for 3 months after participants' first dose of vericiguat:
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* starting dose of vericiguat
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* daily changes in dosage pattern
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* time taken to reach the target dose
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* number and percentage of participants:
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* with specific changes in dosage pattern
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* reaching the target dose of vericiguat
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They will also collect information on how often low blood pressure or fainting occurs, which are well known events in people with chronic HFrEF.
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The data will come from the participants' information stored in a database called the HealthVerity HF dataset. Data collected will be from people with chronic HFrEF who started taking vericiguat between January 2021 and April 2023.
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Researchers will only look at the health records of participants in the US.
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Researchers will track participants' data and will collect information for a maximum of 6 months before and 3 months after their first dose of vericiguat.
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In this study, only available data from routine care are collected. No visits or tests are required as part of this study. conditions: Chronic Heart Failure With Reduced Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1400 type: ESTIMATED name: Vericiguat (Verquvo, BAY1021189) measure: Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index date measure: Number of patients having daily dose of 10 mg/day within the 90 days after vericiguat initiation measure: Days from index date to first occurrence of 10 mg/day dose measure: Number of patients who received a dose of 2.5 mg/day, 5 mg/day and 10 mg/day, or discontinued drug therapy each day over the 90-day follow-up period measure: Number of patients having any Vericiguat up-titration within the 90 days after vericiguat initiation measure: Number of patients having specific titration scenarios within the 90 days after vericiguat initiation measure: Number of patients having hypotension or syncope in the entire 90 days after vericiguat initiation and by 30 days intervals sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer city: Whippany state: New Jersey zip: 07981 country: United States lat: 40.82454 lon: -74.4171 hasResults: False
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<|newrecord|> nctId: NCT06363097 id: ΔΔ5032 briefTitle: Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease overallStatus: RECRUITING date: 2023-09-04 date: 2024-12 date: 2025-06 date: 2024-04-12 date: 2024-04-12 name: Aristotle University Of Thessaloniki class: OTHER briefSummary: In chronic kidney disease (CKD), hypertension is characterized by the phenomenon of sodium-sensitivity, i.e., the disproportionate increase in blood pressure (BP) due to an increase in dietary sodium consumption to maintain homeostasis through urinary sodium excretion. Impaired renal circulation, blunt suppression of renin-angiotensin-aldosterone system, sympathetic nervous system overactivity, paradoxically reduced levels of atrial natriuretic peptide and hyperinsulinemia represent the main pathophysiologic mechanisms. Accumulated evidence has suggested that uromodulin plays a central role in the development of sodium-sensitive hypertension. Uromodulin is a kidney-specific glycoprotein which is exclusively produced by the epithelial cells lining the thick ascending limb and early distal convoluted tubule. It is currently recognized as a multifaceted player in kidney physiology and disease, with discrete roles for intracellular, urinary, interstitial and serum uromodulin. Among these, urinary uromodulin modulates renal sodium handling through regulating tubular transporters that reabsorb sodium and are targeted by diuretics, i.e., the loop diuretic-sensitive Na+-K+-2Cl- cotransporter type 2 (NKCC2) and the thiazide-sensitive Na+/Cl- cotransporter (NCC). Given these roles, the contribution of uromodulin to sodium-sensitive hypertension has been proposed. In preclinical models, uromodulin deficiency causes decreased BP that is resistant to dietary salt, while uromodulin overexpression causes hypertension due to increased tubular sodium reabsorption that is responsive to furosemide. Genetic human studies have identified robust associations of specific UMOD gene variants with sodium sensitivity and incident hypertension risk, while comprehensive Mendelian randomization studies have affirmed these associations by highlighting the causal relationship between UMOD variants, urinary uromodulin levels and hypertension. Furthermore, clinical studies in both healthy individuals and hypertensive patients have indicated a link between sodium sensitivity and uromodulin, directly affecting mean BP levels and BP response to salt intake. With regards to CKD population, solid data on the link of uromodulin with sodium sensitivity are currently missing from the literature. There is only a pediatric study in the setting of CKD (stages 2-3), which failed to show an association between urinary uromodulin levels indexed to urinary creatinine (UMOD/uCr) and either 24-hour or office BP; however, this study has several limitations, and its results should be interpreted with caution. To best of our knowledge, there is no study up to date investigating the effect of dietary sodium intake on 24-hour ambulatory blood pressure depending on urinary uromodulin levels in adult CKD patients. conditions: Chronic Kidney Disease conditions: Hypertension studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 130 type: ESTIMATED measure: Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory systolic blood pressure. measure: Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory diastolic blood pressure. measure: Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory systolic blood pressure. measure: Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory diastolic blood pressure. measure: Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory systolic blood pressure. measure: Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory diastolic blood pressure. measure: The difference in 24-hour ambulatory brachial SBP/DBP between patients with high and low urinary uromodulin excretion. measure: The difference in 24-hour ambulatory brachial SBP/DBP standard deviation (SD) between patients with high and low urinary uromodulin excretion. measure: The difference in 24-hour ambulatory brachial SBP/DBP weighted SD (wSD) between patients with high and low urinary uromodulin excretion. measure: The difference in 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV) between patients with high and low urinary uromodulin excretion. measure: The difference in 24-hour ambulatory brachial SBP/DBP average real variability (ARV) between patients with high and low urinary uromodulin excretion. measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD). measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD). measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV). measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV). measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD). measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD). measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV). measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV). measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP standard deviation (SD). measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD). measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV). measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP average real variability (ARV). measure: Effect of 24-hour urinary sodium excretion on hydration status (US-B lines). measure: Effect of nighttime/daytime ratio of urinary sodium excretion on hydration status (US-B lines). measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on hydration status (US-B lines). measure: Effect of 24-hour urinary sodium excretion on MMSE score. measure: Effect of nighttime/daytime ratio of urinary sodium excretion on MMSE score. measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on MMSE score. measure: Effect of 24-hour urinary sodium excretion on PSQI score. measure: Effect of nighttime/daytime ratio of urinary sodium excretion on PSQI score. measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on PSQI score. measure: Effect of 24-hour urinary sodium excretion on ESS score. measure: Effect of nighttime/daytime ratio of urinary sodium excretion on ESS score. measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on ESS score. measure: Effect of 24-hour urinary sodium excretion on nocturnal urinations. measure: Effect of nighttime/daytime ratio of urinary sodium excretion on nocturnal urinations. measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on nocturnal urinations. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1st Department of Nephrology status: RECRUITING city: Thessaloníki state: Central Macedonia zip: 54642 country: Greece name: Artemios G Karagiannidis, MD, MSc role: CONTACT phone: +30 6970362392 email: artemiskaragiannidis@gmail.com lat: 40.64361 lon: 22.93086 hasResults: False
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<|newrecord|> nctId: NCT06363084 id: IST-Nim-PC-6 briefTitle: A Retrospective Study for Nimotuzumab Plus Postoperative Adjuvant Chemotherapy for Resectable Pancreatic Cancer overallStatus: COMPLETED date: 2016-05-01 date: 2022-07-31 date: 2023-06-30 date: 2024-04-12 date: 2024-04-12 name: Ruijin Hospital class: OTHER briefSummary: This trial is a retrospective, observational study, patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS). conditions: Resectable Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 64 type: ACTUAL name: Nimotuzumab measure: overall survival (OS） measure: disease-free survival (DFS) measure: locoregional recurrence-free survival (LRRFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06363071 id: 202000495A3 briefTitle: APA and PAS Training for Gait Initiation in Parkinson's Disease overallStatus: RECRUITING date: 2022-06-13 date: 2025-03-31 date: 2025-05-31 date: 2024-04-12 date: 2024-04-12 name: Chang Gung University class: OTHER briefSummary: Our research focused on understanding the interplay between brain excitability and balance function in patients with Parkinson's disease (PD), alongside evaluating effective physical therapy methods. It highlights the prevalence of non-motor disorders and cognitive impairments among PD patients, including balance and postural issues, cognitive function decline, and gait instability. Additionally, it notes that PD patients exhibit abnormal electrophysiological responses, indicating altered central excitability. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Weight shift training and APA feedback name: Paired associative stimulation measure: Balance Performance measure: COP Path Length in Balance Tasks measure: COP Displacement in Balance Tasks measure: Motor Evoked Potentials (MEPs) measure: Intracortical Facilitation (ICF) measure: Intracortical Inhibition (ICI) measure: Walking Speed measure: Step Length measure: Step Time measure: COP Velocity in Balance Tasks measure: COP Area in Balance Tasks measure: Double Support Time measure: Single Support Time measure: Swing Time measure: Stance Time measure: Cadence sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University status: RECRUITING city: Taoyuan zip: 333 country: Taiwan name: Ya-Ju Chang, PhD role: CONTACT phone: 88632118800 phoneExt: 5515 email: yjchang@mail.cgu.edu.tw lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06363058 id: 201902166B0 briefTitle: Electrical Stimulation Cycling Training Effects on SCA overallStatus: RECRUITING date: 2022-04-08 date: 2025-07-31 date: 2025-07-31 date: 2024-04-12 date: 2024-04-17 name: Chang Gung University class: OTHER briefSummary: To focuses on the challenges faced by individuals with spinocerebellar ataxia (SCA), highlighting the major clinical sign of ataxia that affects their stability and ability to perform daily activities, thereby impacting their quality of life. It outlines the concept of neural plasticity, which is the brain's ability to adapt through changes in excitability, and notes that these changes are more enduring in the central nervous system (CNS) than in the peripheral nervous system (PNS). This adaptability, crucial for memory and motor learning, is compromised in SCA patients due to impaired brain areas and pathways. The summary further delves into motor learning, distinguishing between explicit and implicit learning, and points out that SCA patients exhibit deficiencies in procedural learning and cerebellar function. It also introduces the concept of priming as a preparatory mechanism that can enhance the effectiveness of physical therapy by modifying subsequent responses to stimuli. The document suggests that cycling, as an aerobic exercise, could prime the brain for improved blood flow and oxygenation, thereby supporting synaptic plasticity and the release of beneficial neurotrophic factors. Finally, the project aims to deepen the understanding of motor performance and learning mechanisms in SCA patients and apply these insights to clinical rehabilitation strategies. conditions: Spinocerebellar Ataxia (SCA) studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 145 type: ESTIMATED name: ES Cycling Training measure: Overall Response Time measure: Overall Error Rate measure: Motor Evoked Potentials (MEPs) measure: Intracortical Facilitation (ICF) measure: Intracortical Inhibition (ICI) measure: Total Scale for the Assessment and Rating of Ataxia (SARA) Score measure: Total Berg Balance Scale (BBS) Score measure: Total Time to Complete the Time Up and Go test (TUG test) measure: Walking Speed measure: Step Length measure: Step Time measure: Double Support Time measure: Single Support Time measure: Swing Time measure: Stance Time measure: Cadence sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University status: RECRUITING city: Taoyuan zip: 333 country: Taiwan name: Ya-Ju Chang, PhD role: CONTACT phone: 88632118800 phoneExt: 5515 email: yjchang@mail.cgu.edu.tw lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06363045 id: NIDEK-TONOREF-UK-0001 briefTitle: Comparative Study of the NIDEK TONOREF III With Predicate Devices overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-11 date: 2024-04-12 date: 2024-04-17 name: Nidek Co. LTD. class: INDUSTRY briefSummary: The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices. conditions: Intraocular Pressure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 220 type: ESTIMATED name: NIDEK TONOREF III name: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER name: NIDEK CEM-530 measure: Equivalent to legally-marketed devices measure: Equivalent to the pachymeter function measure: The numbers of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aston University city: Birmingham zip: B4 7ET, UK country: United Kingdom lat: 52.48142 lon: -1.89983 hasResults: False
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<|newrecord|> nctId: NCT06363032 id: 202110104RINB briefTitle: Elastography in Predicting Renal Outcome overallStatus: RECRUITING date: 2021-12-27 date: 2024-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: National Taiwan University Hospital class: OTHER briefSummary: There are two types of elastography: strain elastography assesses the degree of strain when applying a given amount of force to the skin. Shear-wave elastography assesses the velocity of shear wave propagation within the target lesion. A part of the tissue is deformed by a "push pulse", the velocity of the shear waves propagating within the tissue is detected, and the stiffness of the tissue is assessed based on the detected shear velocity. Shear-wave elastography has been intensively studied in thyroid, breast, liver, cervical lymph nodes, and musculoskeletal diseases with promising result.
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Transthoracic shear-wave ultrasound is also used for the prediction of lung malignancy.
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In progressive renal disease, renal function decline correlates with the extent of interstitial fibrosis, irrespective of the original pathology. Experience and research in using shear-wave elastography to study the stiffness of renal parenchyma and renal fibrosis are scanty. The investigators will conduct a prospective observational study. This study aims to provide the information of tissue elasticity in different etiologies of renal diseases and to validate the predictive value of shear-wave elastography in predicting renal function and renal fibrosis.
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By assuming a power of 0.8, a two-side p value of 0.05, a ratio of 0.2 (sample sizes in negative/positive groups) to detect the difference between area under ROC curve and null hypothesis value (0.8 and 0.7), a target sample of 273 (with a 5% cushion, 260\~290) patients is required. conditions: Kidney Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: elastography measure: collect medical record of blood urea nitrogen and Creatinine sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei country: Taiwan name: Fan-Chi Chang role: CONTACT phone: 886-0223123456 email: leiny.fc@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06363019 id: 2023/00158 briefTitle: Supporting At-Risk Mothers Across Perinatal Period acronym: SMART overallStatus: RECRUITING date: 2024-02-26 date: 2025-02-26 date: 2026-07-06 date: 2024-04-12 date: 2024-04-12 name: National University of Singapore class: OTHER name: Ministry of Health, Singapore briefSummary: The SMART app is a mobile application based psychosocial parenting intervention containing educational materials (articles, videos, audios, podcasts) on parenting, an integrated peer support chat function with experienced mothers and an integrated forum for interaction with other mother participants.
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The goal of this interventional study is to test the effectiveness of a mobile-app health based intervention, SMART, mothers in the perinatal period.
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The main questions this study aims to answer are:
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1. What is the effect of a mobile-based health intervention, SMART, on maternal outcomes?
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2. What is the effect of a mobile-based health intervention, SMART, on infant outcomes?
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3. What is the cost-effectiveness of using SMART as compared to standard routine care?
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Researchers will compare results with a control group that will undergo standard routine care. conditions: Perinatal Depression conditions: Parents conditions: Anxiety conditions: Self Efficacy conditions: Stress conditions: Infant Development studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-group parallel-armed randomized controlled trial with a pretest and repeated post-test experimental design primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 200 type: ESTIMATED name: Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile application measure: Postnatal depression measure: Infant physical development measure: Infant cognitive development measure: Infant emotional development measure: Anxiety measure: Perceived stress measure: Perceived social support measure: Maternal-infant bonding measure: Parental satisfaction measure: Parental efficacy measure: Objective stress measure: Emotional availability measure: Health services and utilization measure: Infant Physical Development measure: Infant Social Development measure: Infant Social Development measure: Infant Social Development measure: Infant Emotional Development sex: FEMALE minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alice Lee Centre for Nursing Studies, National University of Singapore status: RECRUITING city: Singapore zip: 117597 country: Singapore name: Shefaly Shorey, PhD role: CONTACT phone: 66011294 phoneExt: +(65) email: nurssh@nus.edu.sg lat: 1.28967 lon: 103.85007 facility: National University of Singapore status: RECRUITING city: Singapore zip: 117597 country: Singapore name: Shefaly Shorey role: CONTACT phone: +6566011294 email: nurssh@nus.edu.sg lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06363006 id: K23C3280 briefTitle: Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer overallStatus: RECRUITING date: 2024-03-11 date: 2026-01-01 date: 2027-01-01 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of cardonilizumab injection combined with TKI in second-line treatment of advanced hepatocellular carcinoma. The main questions it aims to answer are:
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* Objective response rate (ORR) for evaluation
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* Disease Control Rate (DCR); Duration of relief (DoR); Progression free survival (PFS); Total survival time (OS); Safety。 conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: TKI+Cardunilimab measure: ORR Full single-arm, open, multicenter prospective clinical study measure: Progression-free Survival (PFS) measure: Disease Control Rate (DCR) measure: Overall Survival (OS) measure: Duration of Response (DOR) measure: Stable Disease (SD) measure: Progression free survival rate measure: Any adverse events related with treatment with TKI plus Cardonizumab. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH) status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Haitao Zhao, Professor role: CONTACT phone: +861069156042 email: zhaoht@pumch.cn lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362993 id: STUDY00021561 briefTitle: Breast Cancer Screening in Ghana overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11 date: 2025-03 date: 2024-04-12 date: 2024-04-15 name: Penn State University class: OTHER name: University of Ghana briefSummary: This study is designed to test the feasibility of two intervention on promoting early screening for breast cancer in rural Ghana. In one intervention, screening for breast cancer, diabetes and hypertension will be offered together. In another intervention, a series of sessions with men will be conducted with a goal to change gender attitudes and increase support to women. The investigators' long-term goal is to test these interventions in a large-scale randomized controlled trial. The specific aims of this feasibility study are to: 1) refine the study materials, including the curriculum for the sessions with men, by consulting with an expert advisory committee and a local committee, and 2) determine the feasibility of the two interventions in four clinic zones in Yilo-Krobo district in eastern Ghana (1 clinic in control, 1 clinic in the first intervention, and 2 in the second intervention). This trial registration is for the second specific aim. conditions: Breast Cancer Female studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: Bundling name: MEGH measure: Clinical breast exam (CBE) utilization at the local clinic sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362980 id: BPI-1178-IIT01 briefTitle: A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations acronym: EGFR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-04-12 date: 2024-04-12 name: National Cancer Center, China class: OTHER briefSummary: BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: BPI-1178 name: Osimertinib measure: Number of patients with dose-limiting toxicity (DLT) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DoR) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Intracranial ORR (iORR) measure: Intracranial DCR (iDCR) measure: Intracranial DoR (iDoR) measure: Intracranial Time to Progression (iTTP) measure: Intracranial PFS (iPFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362967 id: Anti-HLA antibody briefTitle: The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-06-30 date: 2024-04-12 date: 2024-04-12 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation conditions: High Titers of Anti-HLA Antibody (MFI ≥5000) studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG measure: Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment measure: Incidence of primary graft failure measure: Incidence of TRM after allo-HSCT measure: Incidence of ineffective platelet transfusion after allo-HSCT measure: Cumulative incidence of neutrophil engraftment after allo-HSCT measure: Cumulative incidence of II-IV° acute GVHD measure: Cumulative incidence of relapse at 1 year post-transplant measure: Probability of overall survival post transplantation measure: Incidence of allergies and allergic reactions measure: Incidence of haemorrhagic events measure: Incidence of viral, bacterial and fungal infections measure: Incidence of hypocalcaemia sex: ALL minimumAge: 14 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) city: Hefei state: Anhui zip: 230036 country: China lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06362954 id: AnkaraMedipolU-FTR-SS-01 briefTitle: The Relationship Between Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients overallStatus: RECRUITING date: 2023-12-31 date: 2024-04-01 date: 2024-06-01 date: 2024-04-12 date: 2024-04-12 name: Ankara Medipol University class: OTHER name: Gazi University briefSummary: Conditions such as hemiparesis, sensory and motor impairment, perceptual impairment, cognitive impairment, aphasia, and dysphagia may be observed after stroke. Motor impairment after stroke may occur due to damage to any part of the brain related to motor control. There is much clinical evidence that damage to different parts of the sensorimotor cortex in humans affects other aspects of motor function. Loss of strength, spasticity, limb apraxia, loss of voluntary movements, Babinski sign, and motor neglect are typical motor deficits following a cortical lesion (upper motor neuron lesion). Post-stroke spasticity can be seen in 19% to 92% of stroke survivors. Post-stroke hemiparesis is a significant cause of morbidity and disability, along with abnormal muscle tone. It has also been recognized that post-stroke hemiparesis may occur without spasticity. Spasticity seen after stroke causes loss of movement control, painful spasms, abnormal posture, increased muscle tone, and a general decrease in muscle function, and may affect limb blood flow. Studies in the literature show that spasticity can affect limb blood flow.
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This study aims to investigate the relationship between muscle oxygenation and spasticity in post-stroke hemiparetic patients based on the idea that oxygenation may be insufficient as a result of restriction of blood flow on the affected side due to spasticity in stroke patients. conditions: Stroke conditions: Hemiparesis;Poststroke/CVA conditions: Spasticity as Sequela of Stroke studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 18 type: ESTIMATED name: Assessment measure: Plantar Flexors Muscle Oxygenation measure: Spasticity measure: Motor Function measure: 6-Minute Walk Test measure: Stair Climbing Test measure: Adipose tissue thickness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation status: RECRUITING city: Ankara state: Çankaya country: Turkey name: Gökhan Yazıcı, Assos. Prof. role: CONTACT phone: +90 506 316 0572 email: gokhanyazici38@hotmail.com name: Gökhan Yazıcı, Assos. Prof. role: PRINCIPAL_INVESTIGATOR name: Taylan Altıparmak, Asst. Prof. role: SUB_INVESTIGATOR name: Çağla Çağatay role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06362941 id: NW-HGN-01 briefTitle: Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-01 date: 2025-03-30 date: 2024-04-12 date: 2024-04-18 name: Nutraceutical Wellness Inc. class: INDUSTRY briefSummary: A single-center, open-label, prospective study to demonstrate the efficacy of an oral supplement to improve the strength and support the growth of thinning hair in men and women with self-perceived hair thinning. conditions: Hair Thinning studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment 6-month, single-center, prospective interventional study primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Nutrafol Women's Hair Growth Supplemnt name: Nutrafol Women's Balance Hair Growth Supplement name: Nutrafol Women's Vegan Hair Growth Supplement name: Nutrafol Women's Postpartum Hair Growth Supplement name: Nutrafol Men's Hair Growth Supplement measure: Change in hair shaft diameter compared to baseline at Day 180. measure: Change in hair shaft diameter compared to baseline at Day 90. measure: Change in broken hairs recovered from the hair pull test compared to baseline at Day 180 measure: Change in broken hairs recovered from the hair pull test compared to baseline at Day 90 measure: Change in hair breakage during the hair pull test compared to baseline at Day 180 measure: Change in hair breakage during the hair pull test compared to baseline at Day 90 measure: Change in the number of hairs recovered from the hair pull test compared to baseline at Day 180 measure: Change in the number of hairs recovered from the hair pull test compared to baseline at Day 90 measure: Subject Self-Perceived Improvement in Hair Quality at Day 180 measure: Subject Self-Perceived Improvement in Hair Quality at Day 90 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dermatology Consulting Services city: High Point state: North Carolina zip: 27262 country: United States name: Zoe Draelos role: CONTACT phone: 336-841-2040 email: zdraelos@northstate.net lat: 35.95569 lon: -80.00532 hasResults: False
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<|newrecord|> nctId: NCT06362928 id: CP-60005 briefTitle: Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-06 date: 2025-08 date: 2024-04-12 date: 2024-04-12 name: Akura Medical class: INDUSTRY briefSummary: This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE). conditions: Pulmonary Embolism Acute studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: ATC System measure: Effectiveness measure: Safety: Composite of Major Adverse Device-Related Events measure: Safety: Composite of Major Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362915 id: FMASUR66/2024 briefTitle: Analgesic Effect of Illiohypogastic & Ilioinguinal Nerve Block in TAVR - TF (Prospective Randomized Study) overallStatus: RECRUITING date: 2024-01-02 date: 2024-07-15 date: 2024-08-30 date: 2024-04-12 date: 2024-04-12 name: Ain Shams University class: OTHER briefSummary: The purpose of the study is to compare the effect of illiohypogastric and ilioinguinal nerve block with the local infiltration with lidocaine in patients undergoing TAVI conditions: Anesthesia, Local studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: * Group (A): will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1% (9).
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* Group (B): will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivicane 0.25% by an experienced anesthesiologist. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: Lidocaine name: Bupivacain measure: Extra Demand of sedation measure: Patient and surgeon satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: maha sadek El Derh status: RECRUITING city: Cairo state: Heliopolis zip: 11721 country: Egypt lat: 30.06263 lon: 31.24967 facility: Ain Shams University status: RECRUITING city: Cairo country: Egypt name: maha S elDerh, Ass.prof role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06362902 id: NOSES-VIII B briefTitle: Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2025-09-01 date: 2024-04-12 date: 2024-04-12 name: National Cancer Center, China class: OTHER briefSummary: The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients. conditions: Colon Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Laparoscopic right hemicolectomy with transrectal specimen extraction measure: The rate of postoperative complications measure: Operating time measure: Estimated blood loss measure: The time of first flatus measure: Postoperative hospitalization sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Haitao Zhou, M.D. role: CONTACT phone: +8613381167333 email: zhouhaitao01745@163.com name: Yueyang Zhang, M.D. role: CONTACT phone: +8613552910035 email: yyzhang0129@163.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362889 id: HealMD-CBD-1 briefTitle: Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-10 date: 2024-11 date: 2024-04-12 date: 2024-04-12 name: Rejuva Medical Aesthetics class: OTHER name: HealMD, LLC briefSummary: This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne. conditions: Acne Vulgaris (Disorder) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Microneedling with CBD measure: Primary efficacy endpoints measure: Secondary efficacy endpoints sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rejuva Medical Aesthetics city: Los Angeles state: California zip: 90025 country: United States name: LaRyel A Waldon, B.S. role: CONTACT phone: 424-644-2400 email: laryel@rejuvamedical.org name: Margaux Oldfield role: CONTACT phone: 4246442400 email: margaux@rejuvamedical.org lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06362876 id: BAlis briefTitle: The Effect of Breastfeeding Counseling Based on Motivational Interviewing overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-15 date: 2024-08-15 date: 2024-12-15 date: 2024-04-12 date: 2024-04-12 name: Mersin University class: OTHER briefSummary: This research was planned to determine the effect of breastfeeding counseling based on motivational interviewing method and standard breastfeeding counseling on breastfeeding self-efficacy and breastfeeding results in women who had a cesarean section. conditions: Breastfeeding Counseling Based on Motivational Interviewing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 74 type: ESTIMATED name: Breastfeeding Counseling Based on Motivational Interviewing name: Standard Breastfeeding Consultancy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Breastfeeding Results Evaluation Form measure: Breastfeeding Results Evaluation Form measure: Breastfeeding Results Evaluation Form measure: Breastfeeding Results Evaluation Form sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Mersin University city: Mersin zip: 33180 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False
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<|newrecord|> nctId: NCT06362863 id: WDRY2024-K027 briefTitle: Evaluation of Enteral Nutrition Biscuits for Inducing Remission in Moderate-to-severe Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: Ping An class: OTHER briefSummary: By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess patient adherence to enteral nutrition biscuits and the timing of their application; to assess the role of enteral nutrition biscuits in biologically refractory patients; and to assess the role of enteral nutrition biscuits in the remission of perianal, small bowel, and colonic lesions. conditions: Crohn's Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective randomized controlled study divided into intervention and control groups. primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: enteral nutrition biscuits measure: Crohn's disease activity index, CDAI measure: Induced remission success rate measure: Gastrointestinal Symptom Rating Scale (GSRS) score measure: Gastrointestinal symptom remission measure: Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics measure: Incidence and severity of perianal lesions in both groups measure: Rate of endoscopic remission of small bowel and colon lesions in both groups measure: Changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups measure: Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362850 id: 1253/2023 briefTitle: Tele-Support for Emergency Medical Technicians acronym: POHCA overallStatus: RECRUITING date: 2024-04-08 date: 2024-04-18 date: 2024-12-01 date: 2024-04-12 date: 2024-04-12 name: Medical University of Vienna class: OTHER name: Ludwig Boltzmann Institute Digital Health and Patient Safety briefSummary: In this manikin-based simulation study the impact of tele-support during a simulated pediatric out-of-hospital cardiac arrest scenario on emergency medical technicians' guideline adherence, on gaze behavior as well as on performance of resuscitation management and cognitive load will be analyzed. conditions: Cardiac Arrest studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In a manikin-based simulation study, the participants will be randomized to either performing the scenario with tele-support or without tele-support (80 participants 40 groups, 20 groups with tele-support, 20 groups without tele-support). primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Tele-support measure: guideline adherence measure: gaze behavior measure: teamwork performance measure: cognitive load measure: Performance of cardiopulmonary resuscitation measure: Technical feasibility measure: Usability sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Christina Hafner, MD, PhD role: CONTACT phone: 004314040041020 email: christina.hafner@meduniwien.ac.at lat: 48.20849 lon: 16.37208 hasResults: False
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<|newrecord|> nctId: NCT06362837 id: P0117910-001 briefTitle: Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services acronym: REACTS-IN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-06-30 date: 2030-05-24 date: 2024-04-12 date: 2024-04-12 name: McGill University class: OTHER name: World Vision Canada name: Global Affairs Canada briefSummary: This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention and comparison communities, schools, and health facilities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators. conditions: Stunting conditions: Gender Equality conditions: Acceptability of Health Care conditions: Diet; Deficiency conditions: Empowerment studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a quasi-experimental design for the evaluation of an intervention that is in the community (including schools) as well as in the local health service facilities. The data collection at baseline, midline, and end-line will occur simultaneously in the intervention and comparison selected communities. primaryPurpose: OTHER masking: NONE count: 13500 type: ESTIMATED name: Education intervention on nutrition, gender equity, WASH, sexual and reproductive health rights name: school-based iron-folic acid supplement program name: Health service training on equitable access to nutrition, health, and sexual and reproductive services name: bio-fortified crops measure: Gender equality measure: Child anthropometry measure: Antenatal care measure: Contraception use by women and partners measure: Child diet measure: Sexual and reproductive health services for adolescents measure: Gender equitable health services for nutrition, health, and sexual and reproductive health sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Brac University city: Dhaka country: Bangladesh name: Malay K Mridha, PhD role: CONTACT email: malay.mridha@bracu.ac.bd lat: 23.7104 lon: 90.40744 facility: Connar Consultants city: Nairobi country: Kenya name: Elizabeth Kamau, PhD role: CONTACT email: ekambu@gmail.com lat: -1.28333 lon: 36.81667 facility: Ifakara Health Institute city: Ifakara country: Tanzania name: Ester Elisaria, PhD role: CONTACT email: eelisaria@ihi.or.tz lat: -8.13333 lon: 36.68333 hasResults: False
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<|newrecord|> nctId: NCT06362824 id: 2094138 briefTitle: Promoting Physical Activity in Older Hispanic/Latino(a) Adults overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2028-09-30 date: 2029-09-30 date: 2024-04-12 date: 2024-04-15 name: Kaiser Permanente class: OTHER name: University of California, San Diego briefSummary: In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week). conditions: Sedentary Behavior conditions: Physical Inactivity conditions: Alzheimer Disease, Protection Against studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: De Pie Intervention name: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD) measure: Change in Moderate Intensity Physical Activity (MIPA) minutes/day measure: Meet MIPA guidelines of 150 minutes physical activity per week sex: ALL minimumAge: 55 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California San Diego city: San Diego state: California zip: 92093 country: United States name: Zvinka Z Zlatar, PhD role: CONTACT email: zzlatar@health.ucsd.edu name: Zvinka Z Zlatar, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 hasResults: False
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<|newrecord|> nctId: NCT06362811 id: 483730 briefTitle: Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-12 date: 2024-04-16 name: Istanbul University class: OTHER briefSummary: The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia. conditions: Analgesia conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ACTUAL name: Sacral Erector Spinae Plane Block measure: Postoperative pain scores measure: Analgesia requirement measure: Complications sex: ALL minimumAge: 1 Day maximumAge: 5 Years stdAges: CHILD facility: Istanbul University Cerrahpasa city: Istanbul zip: 34098 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06362798 id: IRB22-0729 id: 1R01HD109293-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HD109293-01 id: 6-23FY-0012 type: OTHER_GRANT domain: March of Dimes briefTitle: Effect of Support for Low-Income Mothers of Preterm Infants overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-12-01 date: 2024-04-12 date: 2024-04-15 name: Harvard School of Public Health (HSPH) class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 33 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development. conditions: Preterm Birth conditions: Low; Birthweight, Extremely (999 Grams or Less) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-arm single-blind 1:1 randomized controlled trial of financial transfers ($160 per week) versus usual care. Mothers in the intervention arm will access videos that explain the impact of the cash on their availability for benefits and social supports. They will also be able to ask questions to a benefits counselor about how the transfers affect their benefits during the trial. primaryPurpose: OTHER masking: DOUBLE maskingDescription: Enrolled mothers who are assigned to the intervention group will be informed to not discuss the financial transfers with anyone on the NICU care team (i.e., physicians, nurses, etc.) whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 420 type: ESTIMATED name: Financial Transfers measure: Provision of breast milk (proportion) measure: Provision of skin-to-skin care measure: Duration of mother's milk expression measure: Gestational weight-for-age measure: Gestational length-for-age z-score measure: Gestational head circumference measure: Necrotizing enterocolitis (NEC) measure: Late-onset bacterial or fungal sepsis (LOS) measure: NICU Visitation measure: Postpartum Bonding measure: Provision of breast milk (volume) measure: Breastfeeding episode measure: Maternal physical health measure: Maternal mental health (anxiety) measure: Maternal mental health (depression) measure: Reaction Time Modified Flanker Task measure: Accuracy Performance Modified Flanker Task measure: Reaction Time Psychomotor Vigilance Task measure: Accuracy Psychomotor Vigilance Task measure: Happiness measure: Life satisfaction measure: Sleep measure: Routine postpartum care measure: Financial distress measure: Financial hardship measure: Food insecurity measure: Housing instability measure: Housing insecurity measure: Transportation insecurity measure: Length of stay measure: Mother readmission between 4-8 weeks post-discharge measure: Baby readmission between 4-8 weeks post-discharge measure: Mother emergency department visit between 4-8 weeks post-discharge measure: Baby emergency department visit between 4-8 weeks post-discharge measure: Sleep position measure: Sleep location measure: Breastfeeding expression continuation measure: Skin-to-skin care knowledge measure: Breastfeeding knowledge measure: Perception of hospital experience sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Healthcare of Atlanta and Emory University city: Atlanta state: Georgia zip: 30322 country: United States name: Michelle-Marie Peña, MD role: CONTACT email: michelle.marie.pena@emory.edu lat: 33.749 lon: -84.38798 facility: Boston Medical Center city: Boston state: Massachusetts zip: 02118 country: United States name: Gabriela Cordova Ramos, MD role: CONTACT email: gabriela.CordovaRamos@bmc.org lat: 42.35843 lon: -71.05977 facility: Baystate Medical Center city: Springfield state: Massachusetts zip: 01199 country: United States name: Laura Madore, MD role: CONTACT email: laura.Madore@baystatehealth.org lat: 42.10148 lon: -72.58981 facility: UMass Memorial Medical Center city: Worcester state: Massachusetts zip: 01605 country: United States name: Margaret Parker, MD role: CONTACT email: margaret.Parker@umassmemorial.org lat: 42.26259 lon: -71.80229 hasResults: False
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<|newrecord|> nctId: NCT06362785 id: Virtual Reality-Seniors briefTitle: Musculoskeletal Pain, Motor Control, Risk of Falls and Virtual Reality overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2026-06 date: 2024-04-12 date: 2024-04-12 name: Universidade da Coruña class: OTHER name: Centre for Information and Communications Technology Research (CITIC) briefSummary: The goal of this clinical trial is to learn about musculoskeletal pain, functionality, and risk of falls in community-dwelling adults aged 60 years and older. The main questions it aims to answer are:
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* What are the characteristics of a community-dwelling population over 60 years and older in terms of musculoskeletal pain, functionality, and risk of falls?
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* Does an intervention with virtual reality lower musculoskeletal pain, raise functionality and prevent falls in community-dwelling adults aged 60 years and older, compared to a control group that does not receive such intervention?
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Participants will:
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* Answer questionnaires.
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* Perform physical laboratory tests through a camera-based motion capture system.
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* Execute task-based exercises in a virtual environment through virtual reality.
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Researchers will compare community-dwelling adults aged 60 years and older who execute task based exercises in a virtual environment through virtual reality and community-dwelling adults aged 60 years and older without any intervention to see if virtual reality improves musculoskeletal pain, functionality, and lowers fall risk. conditions: Musculoskeletal Pain conditions: Task Performance and Analysis conditions: Accidental Falls conditions: Virtual Reality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 110 type: ESTIMATED name: Virtual Reality measure: Presence of musculoskeletal pain measure: Pain Intensity measure: Initial positioning measure: Final positioning measure: Angular velocity measure: Acceleration measure: Movement execution time measure: Range of joint movement measure: Neck disability measure: Lower back disability measure: Kinesiophobia measure: Falls history measure: General health status measure: Date of birth measure: Gender measure: Height measure: Weight measure: Body mass index (BMI) measure: Depressive symptoms measure: Cognitive capacity measure: Amount and type of medication consumed measure: Existence of comorbidity sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362772 id: MR-36-24-010944 briefTitle: Clinical Efficacy of 125I Seed Implantation in the Treatment of Refractory Differentiated Thyroid Cancer overallStatus: COMPLETED date: 2015-01-01 date: 2022-02-01 date: 2023-04-01 date: 2024-04-12 date: 2024-04-12 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: A retrospective analysis was conducted on RAIR-DTC patients who underwent radioactive 125I seed implantation from January 2015 to February 2022 at Jiangxi Cancer Hospital. Prescription dose: 80\~120 Gy. All cases were followed up at 1, 3, and 5 months postoperatively to monitor changes in tumor size, serum thyroglobulin (Tg), and serum anti-thyroglobulin antibody levels in thyrotropin-inhibited states, pain scores, and postoperative adverse reactions. The data were processed and analyzed using IBM SPSS 26.0. Pairwise comparisons were conducted using the Wilcoxon signed-rank test, and a p-value of less than 0.05 indicated statistical significance. conditions: Thyroid Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 36 type: ACTUAL name: Iodine-125 brachytherapy measure: Tumor size measure: Serological assessment measure: Pain score measure: Adverse event sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362759 id: TOUR006-C01 briefTitle: A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP acronym: TRANQUILITY overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2026-02 date: 2024-04-12 date: 2024-04-12 name: Tourmaline Bio, Inc. class: INDUSTRY briefSummary: This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 in participants with chronic kidney disease and elevated hs-CRP. conditions: Chronic Kidney Diseases conditions: Chronic Kidney Insufficiency conditions: Chronic Renal Diseases conditions: Chronic Renal Insufficiency conditions: Kidney Insufficiency, Chronic conditions: C-Reactive Protein conditions: High Sensitivity C-Reactive Protein conditions: Hs-CRP conditions: hsCRP studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: TOUR006 - 50 MG name: TOUR006 - 25 MG name: TOUR006 - 15 MG name: Placebo measure: Evaluate the effects of TOUR006 compared with placebo on hs-CRP measure: Evaluate the effects of TOUR006 compared with placebo on hs-CRP measure: Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006 measure: Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362746 id: FORPE-2 briefTitle: Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2028-06-01 date: 2028-12-01 date: 2024-04-12 date: 2024-04-12 name: Supergene, LLC class: INDUSTRY briefSummary: Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE) conditions: Pulmonary Embolism studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: At clinical sites patients will be equally randomized into two groups to receive non-immunogenic recombinant staphylokinase or placebo.
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Non-immunogenic recombinant staphylokinase or placebo will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. All patients will be examined for 30 days. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Neither patient nor investigator knows treatment assignment. All eligible patients will be randomized in two equal groups for administration of non-immunogenic recombinant staphylokinase or placebo. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 486 type: ESTIMATED name: Non-immunogenic recombinant staphylokinase name: Placebo measure: Composite of death from any cause or hemodynamic collapse or recurrent PE measure: Right/left ventricular (RV/LV) end-diastolic diameter ratio measure: RV/LV end-diastolic diameter ratio measure: RV/LV end-diastolic diameter ratio measure: Right ventricular (RV) end-diastolic volume measure: Qanadli index measure: Systolic pulmonary artery pressure measure: In hospital death from all causes (assessed up to day 7) measure: Death from all causes measure: Safety endpoint - hemorrhagic stroke measure: Safety endpoint - BARC type 3 and 5 bleeding measure: Safety endpoint - number and severity of adverse events (AEs) and serious AEs in organs and systems sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: V.F. Dolgopolov Vyselki Central District Hospital city: Vyselki state: Krasnodar Region zip: 353100 country: Russian Federation name: Valerii V. Makukhin, PhD role: CONTACT phone: (86199) 123-53 phoneExt: +7 email: makuhinv@mail.ru name: Valerii V. Makukhin, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.58128 lon: 39.66409 facility: I.P. Pavlov Ryazan State Medical University city: Ryazan' state: Ryazan zip: 390026 country: Russian Federation name: Denis S. Yunevich, PhD role: CONTACT phone: (4912) 46-63-90 phoneExt: +7 email: yunevichden@ya.ru name: Denis S. Yunevich, PhD role: PRINCIPAL_INVESTIGATOR lat: 54.6269 lon: 39.6916 facility: Belgorod Regional Clinical Hospital of St. Joseph city: Belgorod zip: 308007 country: Russian Federation name: Sergei L Konstantinov, MD role: CONTACT email: konstantinov5@yandex.ru name: Sergei L Konstantinov, MD role: PRINCIPAL_INVESTIGATOR lat: 50.61074 lon: 36.58015 facility: Kuzbass Cardiology center city: Kemerovo zip: 650002 country: Russian Federation name: Vasilii V. Kashtalap, MD, PhD role: CONTACT phone: +7 (3842) 64-22-41 email: v_kash@mail.ru name: Vasilii V. Kashtalap, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.33333 lon: 86.08333 facility: City Clinical Hospital №1 city: Kirov zip: 610035 country: Russian Federation name: Oleg V. Solovyev, PhD role: CONTACT phone: (8332) 56-35-74 phoneExt: +7 email: ckn@medkirov.ru name: Oleg V. Solovyev, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.59665 lon: 49.66007 facility: Regional Clinical Hospital №2 city: Krasnodar zip: 350012 country: Russian Federation name: Tamara A. Chirva, MD role: CONTACT phone: (861) 222-000-2 phoneExt: +7 email: makuhinv@mail.ru name: Tamara A. Chirva, MD role: PRINCIPAL_INVESTIGATOR lat: 45.04484 lon: 38.97603 facility: S.S. Yudin City Clinical Hospital city: Moscow zip: 115446 country: Russian Federation name: Bogdan B Orlov, MD, PhD role: CONTACT phone: 7 (499) 612-45-66 email: bborlov@mail.ru name: Bogdan B Orlov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: V.V. Vinogradov City Clinical Hospital city: Moscow zip: 117292 country: Russian Federation name: Imad Merai, MD, PhD role: CONTACT phone: +7 (495) 103 46 66 email: imadmerai@yahoo.com name: Imad Merai, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: S.P. Botkin City Clinical Hospital city: Moscow country: Russian Federation name: Yuri V. Karabach, PhD role: CONTACT phone: (499) 490-03-03 phoneExt: +7 email: yu.karabach@ya.ru name: Yuri V. Karabach, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: N.N. Burdenko Penza Regional Clinical hospital city: Penza zip: 440026 country: Russian Federation name: Valentin E. Oleynikov, MD, PhD role: CONTACT phone: +7 (8412) 54-84-07 email: oleynikof@gmail.com name: Valentin E. Oleynikov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 53.20066 lon: 45.00464 facility: G.A. Zakharyin Clinical hospital №6 city: Penza zip: 440071 country: Russian Federation name: Elena S. Panina, PhD role: CONTACT phone: (8412) 98-33-55 phoneExt: +7 email: panina.es@mail.ru name: Elena S. panina, PhD role: PRINCIPAL_INVESTIGATOR lat: 53.20066 lon: 45.00464 facility: City Clinical Hospital №4 city: Perm zip: 614107 country: Russian Federation name: Oleg M. Lapin, PhD role: CONTACT phone: 342-263-01-06 phoneExt: +7 email: heparin@yandex.ru name: Oleg M. Lapin, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.01046 lon: 56.25017 facility: V.P. Polyakov Samara Regional Clinical Cardiology Dispensary city: Samara zip: 443070 country: Russian Federation name: Dmitrii V Duplyakov, MD, PhD role: CONTACT phone: 8 (846) 373-70-63 email: duplyakov@yahoo.com name: Dmitrii V Duplyakov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 53.20007 lon: 50.15 hasResults: False
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<|newrecord|> nctId: NCT06362733 id: IRB-74165 briefTitle: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2026-06-01 date: 2024-04-12 date: 2024-04-12 name: Stanford University class: OTHER briefSummary: The purpose of this open label trial is to examine the preliminary effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and child-focused intervention. conditions: Autism Spectrum Disorder conditions: Restricted Behavior conditions: Autism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth measure: Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB). measure: Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings. measure: Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment. measure: Change from Baseline in Parent-Rated Irritability as captured by the Aberrant Behavior Checklist (ABC), Irritability Subscale. measure: Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R). measure: Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS). measure: Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD). measure: Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7). measure: Change from Baseline in Caregiver Self-Report on the Warwick-Edinburg Mental Wellbeing Scales (WEMWS). measure: Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21). measure: Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). measure: Caregiver Report Executive Functioning Scale (EFS). measure: Daily Living Skills Scale (DLSS). sex: ALL minimumAge: 4 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06362720 id: 720/2566(IRB2) briefTitle: The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen acronym: CMV overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-12-31 date: 2024-04-12 date: 2024-04-12 name: Siriraj Hospital class: OTHER briefSummary: The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. The main questions it aims to answer are:
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* How do CMV infection and reactivation differ between Allo-SCT patients who received a standard regimen versus those who received a Post-transplant Cyclophosphamide-based regimen?
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* progression-free survival, Median overall survival, cumulative incidence of relapse, non-relapsed mortality (NRM) and GvHD at 2 years after Allo-SCT
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* The impact of CMV infection and CMV reactivation on progression-free survival, overall survival, and NRM
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* Averse events of GVHD prophylaxis medication Participants will be collected the data of treatment and treatment response during transplant until 2 years after transplant from hospital medical record. conditions: CMV Infection or Reactivation After Allogenic HSCT studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 158 type: ESTIMATED measure: Number of participants with CMV infection and reactivation measure: progression-free survival measure: Median overall survival measure: cumulative incidence of relapse measure: non-relapsed mortality measure: GvHD measure: Averse events sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362707 id: 2023161001 briefTitle: Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD) acronym: FEAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-10-01 date: 2026-10-01 date: 2024-04-12 date: 2024-04-15 name: Helse Stavanger HF class: OTHER_GOV name: University of Exeter briefSummary: The goal of this placebo-controlled double-blind Phase 2 clinical trial is to test in people with early Alzheimer's Disease.
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The main questions it aims to answer are:
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* Does treatment with fasudil, a ROCK-inhibitor, lead to significant improvement in working memory (based on computer-based working memory composite scores) compared to placebo in individuals with early Alzheimer's disease (AD) over 12 months?
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* What is the effect of fasudil treatment for 12 months on other cognitive functions, brain metabolism measured by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and other relevant clinical functions and biomarkers in individuals with early Alzheimer's disease (AD)?
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* Treatment will be escalated to a maintenance dose of 120 mg total daily dose for up to 50 weeks, with regular clinic visits for efficacy and safety evaluations.
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* Assessments will include cognitive tests, FDG-PET scans, and biomarker analyses, with follow-up by the Data and Safety Monitoring Board for ongoing safety review.
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The study will compare participants receiving fasudil with those receiving placebo to see if fasudil treatment leads to improvements in cognitive functions, brain metabolism measured by FDG-PET. conditions: Cognitive Decline, Mild conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Fasudil name: Placebo measure: Cognition measure: Brain metabolism measure: Plasma levels of ptau217 measure: Plasma levels of nfl measure: Levels of cerebrospinal Aβ1-40 and Aβ1-42 measure: Levels of cerebrospinal tau and p-tau measure: Blood pressure (Safety assessments) measure: Pulse (Safety assessments) measure: Urine testing (Safety assessments) measure: Blood urea nitrogen (BUN) (Safety assessments) measure: Potassium (Safety assessments) measure: Sodium (Safety assessments) measure: Calcium (Safety assessments) measure: Glucose (Safety assessments) measure: Hemoglobin (Safety assessments) measure: Creatinine (Safety assessments) measure: Total and direct bilirubin (Safety assessments) measure: CRP (C-reactive protein) (Safety assessments) measure: Aspartate aminotransferase (AST) (Safety assessments) measure: Serum glutamic-oxaloacetic transaminase (SGOT) (Safety assessments) measure: Alanine aminotransferase (ALT) (Safety assessments) measure: Serum glutamic-pyruvic transaminase (SGPT) (Safety assessments) measure: Alkaline phosphatase (Safety assessments) measure: Electrocardiogram (ECG) (Safety assessments) measure: Columbia Suicide Severity Rating Scale (C-SSRS) (Safety assessments) sex: ALL minimumAge: 50 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362694 id: 34 briefTitle: Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy overallStatus: RECRUITING date: 2024-03-25 date: 2026-03-25 date: 2026-06-25 date: 2024-04-12 date: 2024-04-12 name: Saint Petersburg State University, Russia class: OTHER briefSummary: This pilot phase 2 study evaluates the effectiveness and safety of the Rechallenge concept in patients with BRAF-positive anaplastic thyroid cancer after progression on anti-BRAF therapy. Patients with BRAF-positive anaplastic thyroid cancer who were previously treated with dabrafenib and trametinib (with a clinical or objective response at the start of treatment) and later with tumor progression during anti-BRAF therapy and subsequent lines of chemotherapy are scheduled to undergo targeted therapy (repeated administration of dabrafenib and trametinib in standard doses) and evaluate the outcomes according to the primary and secondary endpoints. conditions: Anaplastic Thyroid Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Dabrafenib + Trametinib measure: Objective response rate measure: Progression-Free Survival measure: Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events) measure: Overall survival measure: The assessment of conversion to resectability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Petersburg State University Hospital status: RECRUITING city: Saint Petersburg zip: 190020 country: Russian Federation name: Ernest Dzhelialov role: CONTACT phone: +7(911)134-50-44 email: ernest.dzhelialov@gmail.com lat: 59.93863 lon: 30.31413 hasResults: False
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<|newrecord|> nctId: NCT06362681 id: CF-2023-I-13 briefTitle: Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-30 date: 2026-03-30 date: 2024-04-12 date: 2024-04-12 name: Universidad Nacional Autonoma de Mexico class: OTHER briefSummary: The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinpro™ White Varnish and pastes containing CPP-ACP in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with Molar Incisor Hypomineralization (MIH) in schoolchildren 6-12 years-old in Mexico. conditions: Molar Incisor Hypomineralization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months. primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: using a block randomization technique in which a computer-generated sequence would be used to assign each participant to a particular group in the allocation ratio of 1:1. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Fluoride measure: Mineral Density sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Alvaro Garcia Pérez status: RECRUITING city: San Pedro Apatlaco state: Morelos country: Mexico lat: 18.79306 lon: -98.95972 hasResults: False
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