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This study is expected to include a total of approximately 17-42 participants. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 17 type: ESTIMATED name: KH801 measure: MTD measure: DLT measure: RP2D measure: AE measure: Cmax measure: Tmax measure: T1/2 measure: AUC0-t measure: CL measure: AUC0-inf measure: anti-drug antibody (ADA) measure: Objective Response Rate（ORR） measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Median Progression-Free Survival (mPFS) measure: Overall Survival（OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Cancer Hospital city: Peking state: Beijing country: China name: Lin Shen role: CONTACT name: Lin Shen role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University city: Guangzhou state: Guangdong country: China name: ErWei Song role: CONTACT phone: 18982182468 email: [email protected] name: ErWei Song role: PRINCIPAL_INVESTIGATOR name: Junyan Wu role: PRINCIPAL_INVESTIGATOR name: Herui Yao role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Central Hospital Affiliated To Shandong First Medical University city: Jinan state: Shandong country: China name: Meili Sun role: CONTACT name: Meili Sun role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: West China Second University Hospital,Sichuan University/West China Women's and Children's Hospital city: Chengdu state: Sichuan zip: 610000 country: China name: Rutie Yin role: CONTACT name: Rutie Yin role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False |
<|newrecord|> nctId: NCT06364488 id: 295721 briefTitle: TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2025-07-31 date: 2024-04-15 date: 2024-04-15 name: BlueSkeye AI class: INDUSTRY name: Institute of Mental Health Nottingham name: Nottinghamshire Healthcare NHS Trust name: Nottingham University Hospitals NHS Trust briefSummary: This trial will assess the safety, feasibility, acceptability, usability and agreement with validated scales of an automated mood monitoring App (TrueBlue), in adult, perinatal participants (recruited between 12 weeks of pregnancy and 12 weeks post-partum), recruited across multiple sites in Nottinghamshire, United Kingdom (UK). An initial within-study pilot phase will assess key aspects of the study including recruitment rate, usability issues and a detailed understanding of any device related adverse events; prior to full recruitment of a total 125 participants over a total 14-month period. conditions: Depression conditions: Depression, Postpartum conditions: Anxiety in Pregnancy conditions: Anxiety conditions: Anhedonia conditions: Perinatal Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 125 participants, of whom 12 will enter the initial 5-month within-study pilot phase aimed at understanding any device-related adverse events and usability issues. primaryPurpose: OTHER masking: NONE count: 125 type: ESTIMATED name: TrueBlue App measure: The rate of device related adverse events measure: Rate of initial use (assessing feasibility and acceptability) measure: Rate of New Depression or Risk (Suicidality) events measure: Rate of referral to Perinatal Psychiatry services measure: Rate of acceptance of referrals to Perinatal Psychiatry measure: Diagnosis rate for depression, or other mental health problems, during the period of study. measure: Continued use (acceptability) measure: Loss to follow-up measure: Usability (quantitative measure) measure: Agreement between TrueBlue generated score and validated scales measure: Thematic results sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nottingham University Hospitals NHS Trust city: Nottingham state: Nottinghamshire zip: NG7 2UH country: United Kingdom name: Nia Jones role: CONTACT email: [email protected] role: CONTACT email: [email protected] name: Nia Jones role: PRINCIPAL_INVESTIGATOR lat: 52.9536 lon: -1.15047 facility: Nottinghamshire Healthcare NHS Foundation Trust city: Nottingham zip: NG3 6AA country: United Kingdom name: Bonnie MILLAR role: CONTACT email: [email protected] role: CONTACT email: [email protected] name: Neil Nixon, MBBS, DM role: PRINCIPAL_INVESTIGATOR name: Deepa Bagepalli Krishnan role: SUB_INVESTIGATOR name: Zaib un Nisa role: SUB_INVESTIGATOR name: Amy Au-Yong role: SUB_INVESTIGATOR name: Christina Kelly role: SUB_INVESTIGATOR lat: 52.9536 lon: -1.15047 hasResults: False |
<|newrecord|> nctId: NCT06364475 id: BezmialemVU-TF-AÖ-1 briefTitle: Could a Time-restricted Diet Compete With a Calorie-restricted 6-meal Diet? overallStatus: COMPLETED date: 2021-11-01 date: 2022-07-01 date: 2022-09-01 date: 2024-04-15 date: 2024-04-15 name: Bezmialem Vakif University class: OTHER briefSummary: The prevalence of obesity and obesity-related diseases are on the rise worldwide. The widely accepted approach in dietary treatment of obesity is the calorie-restricted three meals-three snacks a day diet; however, alternative approaches are needed. This study was conceived with a view to comparing time-restricted eating, a method which can be easily conveyed and applied in overcoming obesity, to a six meals a day diet. 174 participants aged between 18-65 with a BMI\>25 kg/m2 were included. Diet lists with similar calorie, macro counts suitable for their respective group were prepared. Anthropometric measurements, blood pressure, blood tests were analyzed before the study and at the end of the 8-week. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One group 16:8 time-restricted intermittent fasting and the other group energy-restricted six-meal eating. Both of groups with an eating plan suitable with their groups and 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein). primaryPurpose: PREVENTION masking: NONE count: 137 type: ACTUAL name: 16:8 Time-Restricted Intermittent Fasting Group name: Energy-Restricted Six-Meal Group measure: Weight measured in kilogram measure: Body composition measure: Body mass index measure: Waist-to-height ratio (WHtR) measure: Waist circumference in centimetres sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İstanbul Sabri Artam Vakfi Family Medicine Center city: İ̇stanbul zip: 34473 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06364462 id: ZLRK202301 briefTitle: Precise Evaluation Criteria for Histological Regression of NASH Fibrosis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-03-09 date: 2027-04-01 date: 2024-04-15 date: 2024-04-15 name: Beijing Friendship Hospital class: OTHER briefSummary: It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements. conditions: NASH conditions: Liver Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 220 type: ESTIMATED name: lifestyle intervention measure: Regression of NASH fibrosis measure: Dynamic changes of liver stiffness measurements (LSM) measure: Dynamic changes of CAP measure: Dynamic changes of MRE measure: Dynamic changes of MRI-PDFF measure: Dynamic changes of non-invasive liver fibrosis models measure: Dynamic changes of non-invasive liver fibrosis models measure: Dynamic changes of non-invasive liver fibrosis models measure: Dynamic changes of non-invasive liver fibrosis models measure: Dynamic changes of non-invasive liver fibrosis models measure: Dynamic changes of metabolic markers measure: Dynamic changes of metabolic markers measure: Dynamic changes of metabolic markers measure: Incidence of liver-related events measure: Incidence of extrahepatic related events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364449 id: 202309052RIND briefTitle: Clinical Decision Tree Analysis of Hemodialysis Arteriovenous Access Choices and Creations - a Multiple-center Retrospective Cohort Study overallStatus: RECRUITING date: 2023-10-13 date: 2024-05-07 date: 2024-05-31 date: 2024-04-15 date: 2024-04-15 name: National Taiwan University Hospital class: OTHER briefSummary: Our study aim was to utilize a decision tree analysis (DTA) model to gain insight into the decision-making process within a multiple-center cohort. conditions: Decision Tree Analysis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 600 type: ESTIMATED name: No intervention measure: predicted AV access choices measure: to determine factors affecting clinical use of the targeted AV access over a variable timeframe sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei country: Taiwan name: Chih-Yang Chan, MD Phd role: CONTACT lat: 25.04776 lon: 121.53185 hasResults: False |
<|newrecord|> nctId: NCT06364436 id: AksarayU1 briefTitle: Distant Reiki Therapy on Postpartum Period Fatigue and Depression overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-03 date: 2024-03-18 date: 2024-04-10 date: 2024-04-15 date: 2024-04-15 name: Aksaray University class: OTHER briefSummary: This research was conducted to evaluate the effect of Reiki therapy applied to women in the postpartum period on the risk of fatigue and postpartum depression. conditions: PostPartum Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 85 type: ESTIMATED name: Reiki energy therapy measure: Visual Analog Scale for Fatigue (VAS-F) measure: Edinburgh Postnatal Depression Scale (EPDS) sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Aksaray University city: Aksaray state: Merkez country: Turkey lat: 38.37255 lon: 34.02537 hasResults: False |
<|newrecord|> nctId: NCT06364423 id: 10001599 id: 001599-C briefTitle: Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-07-01 date: 2030-07-01 date: 2024-04-15 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: Background: |
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. CD19 is a protein often found on the surfaces of these cancer cells. Researchers can modify a person's own immune cells (T cells) to target CD19. When these modified T cells are returned to the body-a treatment called anti-CD19 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells. |
Objective: |
To test anti-CD19 CAR T cell therapy in people with CLL or SLL. |
Eligibility: |
People aged 18 years and older with CLL or SLL that has not been controlled with standard drugs. |
Design: |
Participants will be screened. They will have imaging scans and tests of their heart function. If a sample of tissue from their tumor is not available, a new one may be taken; the sample will be tested for CD19. |
Participants will receive a drug to reduce the leukemia cells in their blood. Then they will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be gene edited to make them attack cells with CD19. |
Participants will take drugs to prepare them for treatment for 3 days. These drugs will start 5 days before the treatment. Then their own modified CAR T cells will be returned to their bloodstream. Participants will stay in the hospital for at least 9 days after the treatment. |
Follow-up visits will continue for 5 years. conditions: B-Cell Chronic Lymphocytic Leukemia conditions: Leukemia, Lymphocytic, Chronic, B-Cell conditions: B-Lymphocytic Leukemia, Chronic studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Autologous HuCD19 ( Anti-CD19)CAR T cells name: Cyclophosphamide name: Fludarabine name: Rituximab measure: Phase I: Determine the safety of administering T-cells expressing a fully-human anti-CD19 CAR to participants with advanced CLL or SLL. measure: Phase II: Determine the overall response rate (ORR) of T cells expressing an anti-CD19 CAR with a fully-human single chain variable fragment (scFv) to participants with advanced CLL measure: Phase I: Assess overall response rate measure: Phase I+II: Assess complete response rate measure: Phase I+II: Assess duration of responses measure: Phase I+II: Determine the ORR for re treatment with rituximab, chemotherapy and CAR T cells in eligible patients measure: Phase II: Determine the frequency of grade 3-4 adverse events at the Optimal Dose sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: NCI Medical Oncology Referral Office role: CONTACT phone: 240-760-6050 email: [email protected] name: Micaela Ganaden, M.D. role: CONTACT phone: (240) 858-3654 email: [email protected] lat: 38.98067 lon: -77.10026 hasResults: False |
<|newrecord|> nctId: NCT06364410 id: NCI-2024-02982 id: NCI-2024-02982 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 10554 type: OTHER domain: University of Texas MD Anderson Cancer Center LAO id: 10554 type: OTHER domain: CTEP id: UM1CA186688 type: NIH link: https://reporter.nih.gov/quickSearch/UM1CA186688 briefTitle: Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-08-30 date: 2026-03-31 date: 2026-03-31 date: 2024-04-15 date: 2024-04-25 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone. conditions: Clinical Stage III Gastric Cancer AJCC v8 conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 conditions: Clinical Stage IV Gastric Cancer AJCC v8 conditions: Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 conditions: Locally Advanced Gastric Carcinoma conditions: Locally Advanced Gastroesophageal Junction Adenocarcinoma conditions: Locally Advanced Malignant Solid Neoplasm conditions: Metastatic Gastric Carcinoma conditions: Metastatic Gastroesophageal Junction Adenocarcinoma conditions: Metastatic Malignant Solid Neoplasm conditions: Unresectable Gastric Carcinoma conditions: Unresectable Gastroesophageal Junction Adenocarcinoma conditions: Unresectable Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Azenosertib name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Echocardiography name: Magnetic Resonance Imaging name: Multigated Acquisition Scan name: Trastuzumab Deruxtecan measure: Maximum tolerated dose measure: Recommended phase 2 dose measure: Incidence of dose limiting toxicities (DLTs) measure: Incidence of adverse events (AEs) measure: Objective response rate (ORR) measure: Progression free survival (PFS) measure: Duration of response measure: Pharmacodynamic effects in the tumor measure: Predictors of response and acquired resistance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364397 id: ESPRIT202403 briefTitle: Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis acronym: ESPRIT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-05 date: 2024-04-15 date: 2024-04-18 name: Changhai Hospital class: OTHER name: Peking Union Medical College Hospital name: First People's Hospital of Hangzhou briefSummary: The goal of this clinical trial is to learn if endoscopic retrograde cholangiopancreatography (ERCP) works to treat idiopathic recurrent pancreatitis (IRAP) in adults. It also clarify the efficacy of ERCP in the diagnosis of IRAP. The main questions it aims to answer are: |
Does ERCP reduce the frequency of pancreatitis episodes in IRAP patients? Does ERCP contribute to identify the etiology of IRAP patients? |
Participants will be randomly allocated to receive ERCP (pancreatic sphincterotomy and pancreatic stent placement) or conservative treatment and be followed for 1 year. conditions: Recurrent Acute Pancreatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 158 type: ESTIMATED name: ERCP name: Health education and conservative management of clinical routines measure: Recurrence rate of AP measure: Ratio of reduced AP episodes measure: Proportion of patients with reduced AP episodes measure: Severity of AP measure: Evaluation of quality of life measure: Evaluation of psychological condition measure: Proportion of patients diagnosed by ERCP. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai Hospital city: Shanghai state: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06364384 id: E2024074 briefTitle: Radical Synchronous Chemoradiotherapy With DDP/5-FU and PD-1 for Non-metastatic Rectal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-04-20 date: 2024-04-20 date: 2027-02-28 date: 2024-04-15 date: 2024-04-15 name: Sixth Affiliated Hospital, Sun Yat-sen University class: OTHER briefSummary: The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are: |
Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime？ Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs. |
Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY. conditions: Rectal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: PD-1 and CRT measure: 1-year tumor-free survival(DFS) measure: 1-year overall survival (OS) measure: 1-year relapse-free survival (RFS) measure: 1-year metastasis free survival (DMFS) measure: Incidence of chemotherapy and immunotherapy-related adverse reactions measure: Complete response rate (CRR) measure: 1-year stoma-free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sixth Affiliated Hospital, Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Jun Huang, MD role: CONTACT phone: +86-13926451242 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06364371 id: E2023210 briefTitle: Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer overallStatus: RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2026-06-01 date: 2024-04-15 date: 2024-04-15 name: Sixth Affiliated Hospital, Sun Yat-sen University class: OTHER briefSummary: The goal of this observational study is to establish a dynamic multi-omics integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer, providing support for subsequent patient selection for the watch-and-wait strategy. The main question it aims to answer is: |
What is the predictive value of this model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment? Eligible patients will be prospectively enrolled, and the clinical features of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative will be collected and annotated. conditions: Predictive Cancer Model conditions: Pathologic Complete Response studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 106 type: ESTIMATED name: Medical examination measure: Area under curve(AUC) measure: Sensitivity measure: Specificity measure: Negative predictive value(NPV) measure: Positive predictive value(PPV) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Sixth Affiliated Hospital, Sun Yatsen University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Jun Huang role: CONTACT phone: 13926451242 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06364358 id: IRB23-0385 id: 5R21DK121262 type: NIH link: https://reporter.nih.gov/quickSearch/5R21DK121262 briefTitle: Interactive Computer-adaptive Chronic Kidney Disease Education Program acronym: ICCKD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-04 date: 2024-04-15 date: 2024-04-15 name: University of Chicago class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC conditions: Chronic Kidney Diseases conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Computerized CKD Education name: Usual Hospital Care measure: Change in CKD Knowledge baseline to post patient education intervention measure: Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention measure: Change in ESKD Treatment Preferences from baseline to 1 day post-intervention measure: Change in Patient Activation Measure from Baseline to 30 days Post-intervention measure: Increase in Health Intent baseline to post intervention (at 1 day and 30 day follow-up) measure: CKD Self-Management from baseline to 30 day post-intervention sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago Medical Center city: Chicago state: Illinois zip: 60637 country: United States lat: 41.85003 lon: -87.65005 hasResults: False |
<|newrecord|> nctId: NCT06364345 id: INOVA_POCAD_1 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-15 date: 2024-04-15 name: [Redacted] hasResults: False |
<|newrecord|> nctId: NCT06364332 id: ChatsafeNL id: 2023.0348 type: OTHER domain: Medical Ethics Committee VUmc briefTitle: #Chatsafe Netherlands: a Social Media Intervention to Improve Dutch Young People's Safe Communication About Suicide Online acronym: CSNL overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2024-12 date: 2025-03 date: 2024-04-15 date: 2024-04-15 name: 113 Suicide Prevention class: OTHER name: Orygen name: Mind briefSummary: Suicide is the leading cause of death among young people (YP) aged 10 to 25 years in the Netherlands. In addition, YP report high rates of suicidal ideation (16%). While suicidal behavior is a complex phenomenon with many factors and causes, the role of social media is becoming more prominent, especially for YP. Social media has been shown to be a source where YP can find support, but it's also a place where suicidal behavior is glorified or normalized, which can be triggering or harmful to other social media consumers. |
The #Chatsafe guidelines were developed by Orygen Australia to better equip young people to communicate safely about suicide on social media. These guidelines are supported by a social media campaign to make the content of the guidelines more accessible to them. The #Chatsafe intervention consists of both the guidelines and the social media campaign. A small-scale Australian feasibility study showed promising results in terms of the acceptance and safety of the campaign, and safety regarding communicating about suicide on social media platforms. Currently, in Australia it is tested to what extent these results hold up in a Randomized Controlled Trial (RCT) (Robinson et al., 2023). |
With funding from the Dutch National Agenda for Suicide Prevention, a contextualized replication study is conducted. The aim of this study is to determine whether the #Chatsafe intervention has an effect on the way in which Dutch YP communicate online about suicide. conditions: Suicide Prevention conditions: Communication conditions: Social Media studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are randomized to the intervention or the control group using block randomization with varying block sizes (block sizes vary from 2 to 16). The distribution key will be 1:1. The randomization schedule is computer generated by a researcher who will not be part of the analysing researchers. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The research team will be kept blind to randomization. A safety procedure is drawn up in which a senior researcher is appointed who will be unblinded if absolutely necessary. Principally, this will not be needed, since the study psychologists are independently alerted when a subject wants to get in touch. whoMasked: INVESTIGATOR count: 400 type: ESTIMATED name: Social Media campaign measure: Safe communication about suicide online measure: Confidence when communicating about suicide online measure: Willingness to intervene against suicide online measure: Self-efficacy online measure: Safety of the #ChatsafeNL materials measure: Acceptability of the #ChatsafeNL intervention measure: Safety of the #ChatsafeNL intervention sex: ALL minimumAge: 16 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: 113 Suicide Prevention city: Amsterdam state: Noord Holland zip: 1105 BP country: Netherlands name: Elke Elzinga, dr role: CONTACT phone: 020 3113883 email: [email protected] name: Saskia Mérelle, dr role: CONTACT phone: 020 3113883 email: [email protected] lat: 52.37403 lon: 4.88969 hasResults: False |
<|newrecord|> nctId: NCT06364319 id: 2024PHD002-001 briefTitle: Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-12-31 date: 2028-06-30 date: 2024-04-15 date: 2024-04-15 name: Peking University People's Hospital class: OTHER briefSummary: The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will be randomly assigned to either the Anti-CD25 rhMAb treatment group or the traditional treatment group. The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver. conditions: cGVHD studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 118 type: ESTIMATED name: anti-CD25 rhMAb name: Prednisone name: Ruxolitinib name: Cyclosporine measure: overall response rate (ORR) measure: duration of response（DOR） measure: patient-reported outcomes (PRO) measure: disease-free survival (DFS) measure: failure-free survival (FFS) measure: non-relapse mortality (NRM) measure: overall survival （OS） measure: adverse drug reactions (ADR) sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364306 id: 12032024 briefTitle: oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias acronym: PRIOR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2031-12-31 date: 2024-04-15 date: 2024-04-17 name: University Hospital, Basel, Switzerland class: OTHER name: St. Clara Hospital, Basel, Switzerland name: Klinikum Kempten, Kempten, Germany briefSummary: This study investigates on the effect of two different operative techniques to treat large abdominal wall defects. |
The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR). |
The main questions it aims to answer are: |
length of stay after the operation rate of complications rate of recurrence and reoperations quality of life. |
Participants will: |
Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes. conditions: Ventral Hernia conditions: Incisional Hernia conditions: Abdominal Wall Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients are blinded to their treatment allocation until hospital discharge criteria according to the primary endpoint are fulfilled. After discharge, blinding is difficult to be ensured because there is no control, if dressing have been removed or modified. To ensure patient blinding during hospital stay, patients from both treatment arms will receive identical dressings as if an open and minimal-invasive access had been performed. In case the dressing must be changed during the hospital stay, this will be performed while the patient is blinded using a cover. |
In case for any reason the patient has been unblinded to his treatment allocation (accidental or intentional dressing removal, bed-side wound opening, other) all outcome data are assessed regardless and unblinding is documented and reported in the final report. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Robotically-assisted ventral hernia repair (RVHR) name: Open ventral hernia repair (OVHR) measure: Primary outcome: length of stay measure: Comprehensive complication index (CCI) measure: Adverse events measure: pain after surgery measure: Functional recovery measure: Quality of life using SF-12 form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364293 id: KY2023-261-01 briefTitle: An Early Warning Model of Unfavorable Outcomes Following Endovascular Interventional Treatment of Intracranial Aneurysm overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-15 date: 2024-04-15 name: Beijing Tiantan Hospital class: OTHER name: National Natural Science Foundation of China briefSummary: Endovascular treatment has become one of the primary treatment methods for intracranial aneurysms. The unfavorable outcomes during follow-up included aneurysm recurrence and long-term incomplete-occlusion, which would bring a high risk of rebleeding and retreatment. Previous studies have tried to predict the outcomes of aneurysms following endovascular treatment based on aneurysm characteristics including morphology, embolization packing degree, etc, but the conclusion was inconsistent. Hemodynamics of aneurysms and parent artery played a greater role in predicting outcomes following endovascular treatments. Investigators also found that the outcomes were determined by many factors, in which the demography, clinical indicators, treatment methods, and material selection can not be ignored, and the mechanism of unfavorable imaging outcomes should be explored using large samples of clinical cases and numerous variable parameters. The pre-experiment of investigators confirmed that artificial intelligence technology can meet the calculation requirements for deep mining and analysis of large sample data. This study aims to use the deep learning model to identify relevant risk factors and weights, establish a stable and accurate prediction model, then incorporate the prospective study to verify the model. The results will be very helpful in accurately predicting the adverse outcomes such as recurrence and long-term non-occlusion after endovascular treatment and help to improve the therapeutic strategy and avoid risk factors. Besides, the occurrence of ischemic or hemorrhagic complications during follow-up may affect the final follow-up outcome, so the analysis was included as one of the outcome events to evaluate the prognosis after intervention. conditions: Intracranial Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 750 type: ESTIMATED name: Observational design does not include interventional behavior. measure: Unfavorable imaging outcome measure: Hemorrhagic or ischemic complication occurred during the follow-up sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06364280 id: 2023X0135 id: UG3HL165019 type: NIH link: https://reporter.nih.gov/quickSearch/UG3HL165019 id: U24HL165014 type: NIH link: https://reporter.nih.gov/quickSearch/U24HL165014 briefTitle: Pediatric Prehospital Airway Resuscitation Trial acronym: Pedi-PART overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-08-31 date: 2029-09-30 date: 2024-04-15 date: 2024-04-15 name: Ohio State University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) name: University of Utah briefSummary: This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: \[BVM-only\] or \[BVM followed by SGA\]. The \[winner of Stage I\] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between \[BVM followed by ETI\] vs. \[Winner of Stage I\]. conditions: Heart Arrest, Out-Of-Hospital conditions: Wounds and Injuries conditions: Respiratory Insufficiency in Children conditions: Child, Only conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The trial uses a Bayesian Adaptive Sequential Platform Trial (BASIC-PT) framework. |
The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\]. |
The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: \[BVM-only\] or \[BVM followed by SGA\]. The \[winner of Stage I\] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between \[BVM followed by ETI\] vs. \[Winner of Stage I\]. |
The interventions will be quasi-randomized using alternate day assignment. primaryPurpose: TREATMENT masking: NONE count: 3000 type: ESTIMATED name: BVM name: SGA name: ETI measure: 30-day ICU-free survival measure: Neurologic outcome upon hospital discharge sex: ALL minimumAge: 24 Hours maximumAge: 17 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06364267 id: BabyTears briefTitle: Babytam vs Babyexe in Post-menopausal Women at High Risk for Breast Cancer. acronym: BabyTears overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-09-01 date: 2026-09-01 date: 2024-04-15 date: 2024-04-15 name: Andrea DeCensi class: OTHER name: Dana-Farber/Brigham and Women's Cancer Center name: Herbert Irving Comprehensive Cancer Center name: Istituto Europeo di Oncologia name: Breast Cancer Research Foundation briefSummary: The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: Tamoxifen 10 MG name: Exemestane 25 MG measure: Quality of life MEnQol measure: Other domains measure: PMAS questionnaire measure: Customer Satisfaction questionnaire measure: BPI measure: Sex hormones biomarkers measure: Insulin biomarker measure: Bone biomarker sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: E.O. Ospedali Galliera city: Genova zip: 16128 country: Italy lat: 44.40478 lon: 8.94438 hasResults: False |
<|newrecord|> nctId: NCT06364254 id: 2311054791 briefTitle: Effects of CBD on 2 Mile Run Time Trial Performance overallStatus: RECRUITING date: 2023-11-11 date: 2024-05-30 date: 2024-05-30 date: 2024-04-15 date: 2024-04-15 name: University of Northern Colorado class: OTHER briefSummary: Individuals who engage in endurance events tend to experience higher levels of stress within the body, mind, and gut, that often lead to impairment of performance. Based on previous studies, CBD has the potential relieve gut distress, and reduce pre-race anxiety thus resulting in an improvement in sport performance. Given the current research on the use of CBD in active individuals, the aim of this pilot study is to explore the effects of CBD compared to a placebo on anxiety, GI distress and a 2-mile running performance in a moderately active population identifying as female. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Cannabidiol Capsules measure: Difference in Time Trial Times measure: Difference in Anxiety Measured with the State Trait Anxiety Inventory measure: Difference in Blood Lactate Concentrations measure: Difference in Gastrointestinal Distress measure: Different in Heart Rate Variability sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University Of Northern Colorado status: RECRUITING city: Greeley state: Colorado zip: 80639 country: United States name: Laura K Stewart, PhD role: CONTACT phone: 970-351-1891 email: [email protected] lat: 40.42331 lon: -104.70913 hasResults: False |
<|newrecord|> nctId: NCT06364241 id: 331760 id: 226706/Z/22/Z type: OTHER_GRANT domain: Wellcome Trust briefTitle: Focus Groups on Cognitive Function in Psychosis acronym: PRECOGNITION overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-07 date: 2026-09 date: 2024-04-15 date: 2024-04-15 name: King's College London class: OTHER name: South London and Maudsley NHS Foundation Trust briefSummary: Cognitive deficits are commonly observed in people with mental disorders. In psychosis, these impairments are frequently present early in the course of the disorder and have a substantial impact on functional outcomes. This project will gain insight into the cognitive deficits that people with lived experience of psychosis and their carers perceive to be the most troublesome. To achieve this, the investigators will conduct two sets of focus groups. During the first set of focus groups, the investigators will aim to identify the cognitive deficits that individuals with psychosis and their carers consider to be the most impairing. |
The findings of these focus groups will provide important information about what areas of cognition and functioning should be considered in future analyses of large fully anonymised datasets collected in the past from individuals with psychosis. The focus groups will not form part of those analyses, but will provide input from people with lived experience of psychosis on what problems with thinking skills are the most important for them and that should be considered by further research. |
The second set of focus groups will enable the investigators to determine the participants' perception of potential risks and benefits associated with the dissemination of findings on cognitive function in psychosis, to ensure this is done in a manner that is sensitive to the wishes and needs of people with lived experience of psychosis. |
Each participant will be asked to attend one focus group, which will last approximately one hour. Focus groups will take place at the South London and Maudsley (SLaM) Trust or at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, although provision will be made for participants to also participate online. conditions: Psychosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 32 type: ESTIMATED name: Focus group measure: Individual perception of impairments due to cognitive deficits associated with psychosis sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364228 id: 0133-24-FB briefTitle: Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-04 date: 2026-04 date: 2024-04-15 date: 2024-04-15 name: University of Nebraska class: OTHER briefSummary: The proposed study is a double-blind, randomized, placebo-controlled study of intranasal oxytocin (OXT) to determine its efficacy in improving quality of life and reducing stress in caregivers to persons with dementia. Planned enrollment is 32 subjects over 2 years. conditions: Stress studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: Placebo name: Oxytocin Intranasal Spray 12 International Unit (12IU) name: Oxytocin Intranasal Spray 24 International Unit (24IU) name: Functional MRI measure: Participants' chronic stress levels in the past thirty days. measure: Participant Quality of Life survey measure: Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and EmpaTom task. sex: FEMALE minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Nebraska Medical Center, Department of Psychiatry city: Omaha state: Nebraska zip: 61898-5581 country: United States name: Minjoo Kang, MEd role: CONTACT phone: 402-552-6239 email: [email protected] name: Soonjo Hwang, MD role: PRINCIPAL_INVESTIGATOR name: Janelle N Beadle, PhD role: SUB_INVESTIGATOR lat: 41.25626 lon: -95.94043 hasResults: False |
<|newrecord|> nctId: NCT06364215 id: 2024P000883 briefTitle: Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation acronym: (SMILE-AF) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-04-15 date: 2024-04-22 name: Brigham and Women's Hospital class: OTHER name: Boston Scientific Corporation briefSummary: Compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF). conditions: Atrial Fibrillation Paroxysmal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 450 type: ESTIMATED name: Pulmonary Vein Isolation alone name: Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation measure: Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period. measure: The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure. measure: Freedom from atrial arrhythmias medication measure: Procedural time measure: Procedure-related Recurrencies measure: Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT). measure: Use of amiodarone measure: Complications. measure: fluoroscopy time. measure: Pulsed field ablation (PFA) applications during procedure. measure: first-pass pulmonary vein isolation (PVI). sex: ALL minimumAge: 21 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Obadah Aloum, MD role: CONTACT phone: 617-525-7047 name: Fernando Moreno role: CONTACT phone: 6175257047 name: Jorge E Romero, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06364202 id: 1928368 briefTitle: Effects of Peanut Butter on Sleep Quality and Daily Energy Levels in Fire Fighters overallStatus: COMPLETED date: 2022-08-01 date: 2023-11-01 date: 2023-11-01 date: 2024-04-15 date: 2024-04-15 name: Augusta University class: OTHER briefSummary: The purpose of this study is to examine the possible benefits of peanut butter consumption prior to bedtime on sleep and energy levels among fire fighters. Fire fighters require high levels of energy to perform their occupational tasks but commonly lack sleep as well as the amount of dietary protein and fat suggested for tactical athletes. By addressing this gap, we expect that if peanut butter consumption is shown to improve sleep and/or energy, this lifestyle change (peanut butter consumption) may be appealing to fire fighters because of the ease and low cost of peanut butter. Aim 1: Determine if consuming peanut butter prior to bedtime alters measures of sleep quality and quantity in fire fighters. It is hypothesized that firefighters who consume the peanut butter will have positive impacts in measure of sleep quality and energy levels. |
Aim 2: Examine the effects of peanut butter consumption on morning and evening energy levels conditions: Sleep conditions: Body Composition conditions: Blood Pressure conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Peanut Butter measure: Body composition measure: Body composition measure: Sleep measure: Blood pressure measure: Blood pressure measure: Physical activity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Augusta University city: Augusta state: Georgia zip: 30909 country: United States lat: 33.47097 lon: -81.97484 hasResults: False |
<|newrecord|> nctId: NCT06364189 id: FY22-119 id: R61AG084479 type: NIH link: https://reporter.nih.gov/quickSearch/R61AG084479 briefTitle: Inspiring Seniors Toward Exercise Promotion acronym: iSTEP overallStatus: RECRUITING date: 2024-04-15 date: 2025-04-30 date: 2025-04-30 date: 2024-04-15 date: 2024-04-15 name: University of North Carolina, Greensboro class: OTHER name: National Institute on Aging (NIA) briefSummary: The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults. |
To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 min/day) and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing \>150min/week AE and 3 days/week of ST for 30 min/day. conditions: Cognitively Normal Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Music name: Exercise measure: Physical activity (objective) measure: Ecological Momentary Assessment (EMA): Affective response to PA measure: Ecological Momentary Assessment (EMA): Perceived autonomy measure: Ecological Momentary Assessment (EMA): Perceived exertion measure: Ecological Momentary Assessment (EMA): Behavioral intention measure: Ecological Momentary Assessment (EMA): Physical Activity setting measure: Ecological Momentary Assessment (EMA): Anticipated, remembered, and incidental affect measure: Ecological Momentary Assessment (EMA): Social Support for Exercise measure: Physical activity (self-report) measure: Cognitive performance - General measure: Cognitive performance - Tower of London measure: Cognitive performance - NIH Toolbox Oral Reading Recognition Test measure: Cognitive performance - NIH Toolbox List Sort Working Memory Test measure: Cognitive performance - NIH Toolbox Picture Sequence Test measure: Cognitive performance - NIH Toolbox Dimensional Change Card Sort Test measure: Cognitive performance - NIH Toolbox Flanker Inhibitory Control and Attention Test measure: Cognitive performance - Mnemonic Similarity Task measure: Cognitive performance - Perceptual Discrimination Task measure: Health Related Quality of Life measure: Physical activity (subjective) measure: Music Reward Experience measure: Treatment Satisfaction measure: Body Mass Index measure: Waist/Hip/Leg Circumference measure: Sagittal Diameter measure: Blood Pressure measure: Handgrip Strength measure: Timed Up and Go (TUG) measure: 10-Meter Walk measure: 4-Stage Balance Test measure: 6-Minute Walk Test (6MWT) measure: 30-second Chair Stand sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of North Carolina at Greensboro status: RECRUITING city: Greensboro state: North Carolina zip: 27402-6170 country: United States name: Project Coordinator, MS role: CONTACT phone: 336-334-4765 email: [email protected] name: Jennifer L Etnier, PhD role: PRINCIPAL_INVESTIGATOR name: Shin Park, PhD role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 hasResults: False |
<|newrecord|> nctId: NCT06364176 id: STUDY00149479 briefTitle: Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-10 date: 2024-04-15 date: 2024-04-22 name: University of Kansas Medical Center class: OTHER briefSummary: The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy. |
Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 42 type: ESTIMATED name: Losartan name: Placebo measure: Sweat chloride measure: Lung function - absolute measure: Lung function - relative measure: Transforming growth factor (TGF)-beta1 - airway measure: TGF-beta1 - systemic measure: Inflammatory mediators - airway measure: Inflammatory mediators - systemic measure: CFQ-R measure: Adverse events sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States name: Charles Bengtson, MD, MSc role: CONTACT phone: 913-588-6000 name: Carolina Aguiar role: CONTACT phone: 9139459295 name: Matthias Salathe, M.D. role: SUB_INVESTIGATOR name: Andreas Schmid, M.D. role: SUB_INVESTIGATOR lat: 39.11417 lon: -94.62746 hasResults: False |
<|newrecord|> nctId: NCT06364163 id: 697716 briefTitle: Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults overallStatus: NOT_YET_RECRUITING date: 2024-08-12 date: 2026-12-31 date: 2027-12-31 date: 2024-04-15 date: 2024-04-15 name: University of Bergen class: OTHER name: The Norwegian Seafood Research Fund briefSummary: High cholesterol concentration is a major risk factor for cardiovascular disease (CVD), and consumption of fish has been associated with a lower CVD risk in several studies. The beneficial health effects of consuming fish have traditionally been ascribed to the long-chain PUFA (LC-PUFA) EPA (C20:5n-3) and DHA (C22:6n-3), although consumption of fish oils or concentrates with high EPA and DHA contents does not affect the cholesterol concentration in humans and lowers the cholesterol concentration in rats and mice only when given in very high doses. Fish oils contain a plethora of fatty acids besides EPA and DHA, and in recent years, increased focus has been on the long-chain MUFA (LC-MUFA) cetoleic acid (C22:1n-11). Cetoleic acid is found in high amounts in oils from certain fish species such as herring, which has relatively low contents of both EPA and DHA. The investigators have recently summarised and meta-analysed the available literature that investigates the effects of diets containing fish oils or fish oil concentrates that have a high content of cetoleic acid but low or no content of EPA and DHA on cholesterol concentration in rodents, showing that cetoleic acid-rich fish oils and concentrates prevent high cholesterol concentration. conditions: High Cholesterol studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Herring oil concentrate name: Control measure: Serum concentration of LDL-cholesterol measure: Serum concentration of HDL-cholesterol measure: Serum concentration of total cholesterol measure: Serum concentrations of apolipoproteins measure: Serum concentrations of amino acids metabolites measure: Serum concentration of one-carbon pathway metabolites measure: Fatty acid composition in leukocytes measure: Serum concentration of glucose measure: Serum concentration of insulin measure: Urine concentrations of cystatin C measure: Urine concentrations of T cell immunoglobulin mucin-1 (TIM-1) measure: Body composition sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bergen city: Bergen country: Norway name: Oddrun A Gudbrandsen, PhD role: CONTACT phone: 55975553 phoneExt: 47 email: [email protected] lat: 60.39299 lon: 5.32415 hasResults: False |
<|newrecord|> nctId: NCT06364150 id: MAGIC6 briefTitle: Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction acronym: MAGICcell6 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-08-01 date: 2024-04-15 date: 2024-04-15 name: Seoul National Hospital class: OTHER_GOV briefSummary: This study will evaluate the efficacy and safety of "Therapeutic Use of Autologous-Primed Autologous Peripheral Blood Stem Cell Treatment for Myocardial Regeneration in Acute Myocardial Infarction". conditions: Acute Myocardial Infarction studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single arm, open label interventional study primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Autologous Peripheral Blood Stem Cell injection measure: Left ventricular systolic function measure: Regional wall motion score index measure: B-natriuretic peptide level measure: 6-minute walk test measure: All-cause death measure: Target lesion Revascularization measure: Readmssion measure: Cardiovascular death measure: non-Target lesion Revascularization sex: ALL minimumAge: 19 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364137 id: 73203 briefTitle: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings - Pilot RCT overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-06-30 date: 2025-06-30 date: 2024-04-15 date: 2024-04-15 name: Stanford University class: OTHER name: National Institute of Mental Health (NIMH) name: MainSquare Co. (dba 'Teleo') briefSummary: The research study will examine engagement in telehealth for children undergoing psychotherapy. The study in Phase I entails a pilot randomized trial with a goal to enroll 42 families, examining patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing. |
Engagement will be assessed using well-established measures - PRIME-O (modified) video coding, MTT-Y/MTTCG and attendance data (sessions 1-4). Clinicians in the study will deliver therapy to clients for 4 sessions, providing opportunity to measure temporal sustainment of any engagement differences. conditions: Anxiety Disorders conditions: Mood Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 42 type: ESTIMATED name: Teleo name: Standard videoconferencing measure: PRIME-O Video Coding Score measure: My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores measure: My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores measure: Attendance during Psychotherapy Sessions sex: ALL minimumAge: 5 Years maximumAge: 14 Years stdAges: CHILD facility: Stanford University city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 hasResults: False |
<|newrecord|> nctId: NCT06364124 id: Beijing_LH_CCU2024 briefTitle: Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction overallStatus: RECRUITING date: 2023-06-01 date: 2024-06-01 date: 2025-06-01 date: 2024-04-15 date: 2024-04-18 name: Beijing Luhe Hospital class: OTHER briefSummary: Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies. conditions: STEMI studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: evolocumab name: Atorvastatin measure: Average percent change from baseline in LDL-C levels to discharge and day 30 measure: Average percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A and apolipoprotein B to discharge and day 30 measure: Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30 measure: Number of cardiovascular events to day 30 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing luhe hospital status: RECRUITING city: Beijing country: China name: rui yan role: CONTACT phone: 17746570262 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06364111 id: Vibrabot Capsule briefTitle: Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation overallStatus: RECRUITING date: 2024-01-08 date: 2025-06-14 date: 2025-08-30 date: 2024-04-15 date: 2024-04-15 name: Beijing Tsinghua Chang Gung Hospital class: OTHER briefSummary: This is a single-center trial that enrolls 20 18 to 85-year-old patients with moderate to severe FC to study the efficacy of Vibrabot capsule (dosage: 5 capsules/week) and polyethylene glycol, as well as the mechanism of action of the Vibrabot capsule. conditions: Chronic Functional Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Vibrabot capsule name: polyethylene glycol measure: The proportions of responders to the three therapies during the treatment period. measure: Evaluation of intestinal motility measure: Assessment of neurotransmitters in peripheral blood measure: Assessment of changes in intestinal flora measure: Evaluation of the treatment cycle of Vibrabot Capsules sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: XuanJiang status: RECRUITING city: Beijing state: Beijing zip: 102218 country: China name: Xuan Jiang, professor role: CONTACT phone: 13671006525 email: [email protected] name: Jinzhe Liu, physician role: CONTACT phone: 18810831618 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06364098 id: prevention of PPH briefTitle: Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections overallStatus: COMPLETED date: 2022-01-01 date: 2023-02-01 date: 2023-02-01 date: 2024-04-15 date: 2024-04-15 name: Cairo University class: OTHER briefSummary: Study design: |
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