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The second objective is to determine the extent to which the general population is prepared to use technological tools as part of their rehabilitation. The aim is to gain a better understanding of the profile of people who could potentially benefit from tele-rehabilitation. Accessibility to the technologies, their expectations and barriers will also be explored as part of this study. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 1000 type: ESTIMATED name: Conducting questionnaires measure: ATI - affinity technology interaction scale measure: Scale for assessing a person's readiness to use technological tools as part of their rehabilitation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Universitaires Saint-Luc status: RECRUITING city: Brussel state: Woluwé-Saint-Lambert zip: 1200 country: Belgium name: Thierry Lejeune, MD, PhD role: CONTACT phone: +3227641648 email: [email protected] name: Mathilde Van Durme role: CONTACT phone: +3227641675 email: [email protected] lat: 50.85045 lon: 4.34878 hasResults: False |
<|newrecord|> nctId: NCT06363266 id: 190211_1 briefTitle: A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-08-31 date: 2028-08-31 date: 2024-04-12 date: 2024-04-12 name: St. Mary's Research Center, Canada class: OTHER name: Princess Margaret Hospital, Canada name: University of Calgary name: Sunnybrook Health Sciences Centre name: University of British Columbia name: McGill University name: Simon Fraser University name: Université de Sherbrooke name: Memorial University of Newfoundland name: Université de Montréal name: Centre intégré de santé et de services sociaux (CISSS) de Laval briefSummary: Men with prostate cancer and their family caregivers face many physical and emotional challenges from the cancer itself and its treatment(s), which often lead to high anxiety. The pandemic has highlighted the importance of protecting our physical and mental health, and the complex responsibilities that caregivers have in supporting their loved ones. To improve the health of men with prostate cancer and of their caregivers, the research team developed TEMPO: a self-directed Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram. TEMPO was developed with men with prostate cancer and their caregivers over the past 8 years. It also combines the investigators' research conducted over the past decade on providing the best support to those affected by cancer. Because the cancer care workforce is already overstretched, the research team designed TEMPO to be used without guidance from a health care professional. TEMPO is one-of-a kind in its support of both patients and caregivers, and the integration of coping skills training on a wide range of cancer challenges along with a home-based exercise program. Patients and caregivers who have used TEMPO said they improved their communication, learned new skills to cope with both physical and emotional challenges of cancer, and increased their physical activity. The present project builds on this work to further evaluate the cost and impact of TEMPO on men's and caregivers' health. Men with prostate cancer and their caregivers will be assigned by chance to one of two groups a) TEMPO or b) monitor their anxiety for 12 weeks. After 12 weeks, patients' and caregivers' needing more support will be identified based on an assessment of their anxiety level. For those already using TEMPO and needing more support, non-health care professional guidance might be offered. All those in the monitoring group needing more support will now have access to TEMPO. All participants complete surveys to determine whether TEMPO led to improved health outcomes. conditions: Cancer of the Prostate conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Using a stepped care approach, TEMPO will be provided across two intervention stages with variations on timing (initial vs. delayed) and intensity (self-directed vs. guided). All dyads will continue to access usual care (a co-intervention measure is included). primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 376 type: ESTIMATED name: TEMPO name: Active Monitoring dyads' anxiety measure: HADS-Anxiety measure: TEMPO's key mechanisms of action sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Mary's Research Centre city: Montreal state: Quebec zip: H3T1M5 country: Canada name: Sylvie Lambert, PhD role: CONTACT phone: 514-398-3685 email: [email protected] lat: 45.50884 lon: -73.58781 facility: St Mary's Hospital Research Centre city: Montréal country: Canada name: Manon de Raad role: CONTACT email: [email protected] lat: 45.50884 lon: -73.58781 hasResults: False |
<|newrecord|> nctId: NCT06363253 id: CIRB Ref: 2023/2073 briefTitle: Pilot Study of the Human Metagenome in Metabolic Diseases overallStatus: RECRUITING date: 2023-08-14 date: 2026-12-31 date: 2027-12-31 date: 2024-04-12 date: 2024-04-12 name: Sengkang General Hospital class: OTHER name: Singapore General Hospital name: Lee Kong Chian School of Medicine, Nanyang Technological University name: Duke-NUS Graduate Medical School briefSummary: This is a cohort study to understand the role of the human metagenome, and associated metabolites, in health and in various diseased states, in particular obesity as well as sarcopenia. |
Recruited participants will have their fecal, salivary, urine, serum, and in certain instances, mucosal samples taken, for metagenomic sequencing and metabolite testing. |
We hope to uncover various differences and signatures in the metagenome and metabolome in various diseased states, with potential future therapeutic applications in personalised medicine. conditions: Obesity conditions: Sarcopenia conditions: Sarcopenic Obesity conditions: Chronic Inflammation conditions: Metabolic Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: No specific intervention measure: Metagenomic alterations measure: Metabolomic alterations sex: ALL minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sengkang General Hospital status: RECRUITING city: Singapore zip: 544886 country: Singapore name: Koy Min Chue role: CONTACT phone: 69305000 email: [email protected] lat: 1.28967 lon: 103.85007 hasResults: False |
<|newrecord|> nctId: NCT06363240 id: CBBLCIP001 briefTitle: Evaluation of Broadband Light Treatment for Solar Lentigines overallStatus: RECRUITING date: 2024-03-12 date: 2024-12-20 date: 2025-01-30 date: 2024-04-12 date: 2024-04-12 name: Sciton class: INDUSTRY briefSummary: Broadband light treatment for Solar Lentigines conditions: Solar Lentigo studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Broadband Light measure: Changes in skin post treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sanctuary Plastic Surgery status: RECRUITING city: Boca Raton state: Florida zip: 33431 country: United States name: Jonathan Cook, MD role: CONTACT lat: 26.3669 lon: -80.13033 hasResults: False |
<|newrecord|> nctId: NCT06363227 id: ANEST-0003 briefTitle: Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients acronym: PAIN overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-04 date: 2024-04-12 date: 2024-04-16 name: Schulthess Klinik class: OTHER briefSummary: The aim of this study is to examine the impact of implementing a standardized pain therapy protocol and their components on postoperative pain trajectories and postoperative outcomes such as increased opioid consumption and to compare it for different orthopaedic operations, i.e. major shoulder, hip, knee und spine surgery. conditions: Postoperative Pain, Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 12000 type: ESTIMATED name: Standardized pain management measure: Perioperative pain trajectories measure: Increased risk for postoperative pain measure: Total amount of opioids administered measure: Correlation of pain trajectories and patient reported outcome measures (e.g. postoperative nausea and vomiting) sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06363214 id: ANEST-0002 briefTitle: Impact of Patient Blood Management (PBM) at the Schulthess Clinic acronym: PBM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-04 date: 2024-04-12 date: 2024-04-16 name: Schulthess Klinik class: OTHER briefSummary: Aim of this study is to analyze the transfusion requirements of allogenic blood products at the Schulthess Clinic for patients that had major orthopedic or major spine surgery between 2019 and 2024 order to identify patients at risk for transfusion. Moreover, impact of transfusion requirements and other measures of PBM on patient outcomes will be assessed. These data are required to further improve PBM at the Schulthess Clinic. conditions: Patient Blood Management studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 16000 type: ESTIMATED name: Patient blood management measure: Perioperative transfusion rates measure: Risk factors for perioperative transfusion Risk factors for perioperative transfusion Risk factorsfor perioperative transfusion measure: Perioperative rates of coagulation products administered measure: Clinical outcomes sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06363201 id: CAT2024/PED01 briefTitle: Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours overallStatus: NOT_YET_RECRUITING date: 2024-04-28 date: 2024-12-15 date: 2025-12-15 date: 2024-04-12 date: 2024-04-12 name: Catalysis SL class: INDUSTRY briefSummary: Exploratory study to evaluate the effect and safety of the use of Ocoxin® oral solution on the quality of life of paediatric patients with advanced stage solid tumours. conditions: Advanced Cancer conditions: Advanced Solid Tumor conditions: Lymphoma, Hodgkin conditions: Central Nervous System Tumor conditions: Sarcoma conditions: Germ Cell Tumor conditions: Pediatric Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Ocoxin Oral solution measure: Quality of Life measure: Degree of toxicity related to oncospecific treatment measure: Nutritional Status measure: Presence of Adverse Events (AE) measure: Metabolic Status measure: Physical Status measure: Response to oncospecific treatment sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hospital Escuela, Tegucigalpa (Honduras) city: Tegucigalpa state: Francisco Morazan zip: 504 country: Honduras name: Ingrid C. Arambú Elvir, Dr. role: CONTACT phone: 50498878486 email: [email protected] name: Ingrid C. Arambú Elvir, Dr. role: PRINCIPAL_INVESTIGATOR name: Alejandra Elonor Zapata, Dr. role: SUB_INVESTIGATOR name: Clarissa L. Aguilar Molina, Dr. role: SUB_INVESTIGATOR name: Darío Vinicio Cáceres, Dr. role: SUB_INVESTIGATOR name: Gerardo Ismael Castro, Dr. role: SUB_INVESTIGATOR lat: 14.0818 lon: -87.20681 hasResults: False |
<|newrecord|> nctId: NCT06363188 id: effect of ESWT on fractures briefTitle: The Impact of ESWT on Healing of Fractured Mandible overallStatus: RECRUITING date: 2024-02-01 date: 2024-08-01 date: 2025-08-30 date: 2024-04-12 date: 2024-04-12 name: Cairo University class: OTHER briefSummary: studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws. conditions: Fractured Mandible Due to Trauma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: Radial Extracorporeal shockwave measure: bone healing (denisty of bone) measure: pain sensation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo Univeristy status: RECRUITING city: Cairo country: Egypt name: khloud nasr eldin, GP role: CONTACT phone: 01014919174 email: [email protected] name: Emad Saied, prof. role: CONTACT phone: 01222117986 lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06363175 id: 8737 id: 343073 type: OTHER domain: Integrated Research Application system (IRAS) briefTitle: PREMs In Vascular SurgERy Enhancement Study acronym: PREMIERE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-08-01 date: 2026-06-01 date: 2024-04-12 date: 2024-04-15 name: Cardiff and Vale University Health Board class: OTHER_GOV name: Welsh Value in Health Centre (WViHC) name: Centre for Healthcare Evaluation, Device Assessment, and Research (CEDAR) briefSummary: THE PROBLEM: |
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). |
There is no PREM available for vascular patients. The research team want to create a PREM for this patient group. |
WHY IT IS IMPORTANT: |
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. |
AIMS: |
To develop a PREM specific to vascular surgery patients. |
RESEARCH PLAN: |
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. |
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. |
PATIENT AND PUBLIC INVOLVEMENT: |
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 |
<|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: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|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. |
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. |
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 |
<|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. |
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 |
<|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: [email protected] name: Bilian Kang, Ph.D. role: CONTACT phone: +86 18001218793 email: [email protected] 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 |
<|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. |
In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare. |
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. |
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. |
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. |
The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors. |
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: |
* starting dose of vericiguat |
* daily changes in dosage pattern |
* time taken to reach the target dose |
* number and percentage of participants: |
* with specific changes in dosage pattern |
* reaching the target dose of vericiguat |
They will also collect information on how often low blood pressure or fainting occurs, which are well known events in people with chronic HFrEF. |
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. |
Researchers will only look at the health records of participants in the US. |
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. |
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 |
<|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: [email protected] lat: 40.64361 lon: 22.93086 hasResults: False |
<|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 |
<|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: [email protected] lat: 24.95233 lon: 121.20193 hasResults: False |
<|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: [email protected] lat: 24.95233 lon: 121.20193 hasResults: False |
<|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 |
<|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. |
Transthoracic shear-wave ultrasound is also used for the prediction of lung malignancy. |
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. |
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: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False |
<|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. |
The goal of this interventional study is to test the effectiveness of a mobile-app health based intervention, SMART, mothers in the perinatal period. |
The main questions this study aims to answer are: |
1. What is the effect of a mobile-based health intervention, SMART, on maternal outcomes? |
2. What is the effect of a mobile-based health intervention, SMART, on infant outcomes? |
3. What is the cost-effectiveness of using SMART as compared to standard routine care? |
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: [email protected] 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: [email protected] lat: 1.28967 lon: 103.85007 hasResults: False |
<|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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