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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: ncimo_referrals@nih.gov name: Micaela Ganaden, M.D. role: CONTACT phone: (240) 858-3654 email: ncicar@mail.nih.gov 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: huangj97@mail.sysu.edu.cn 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: huangj97@mail.sysu.edu.cn 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: e.elzinga@113.nl name: Saskia Mérelle, dr role: CONTACT phone: 020 3113883 email: s.merelle@113.nl 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: laura.stewart@unco.edu 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: mkang@unmc.edu 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: istep@uncg.edu 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: nkjgu@uib.no 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: yanrui4112@163.com 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: jxa01998@btch.edu.cn name: Jinzhe Liu, physician role: CONTACT phone: 18810831618 email: ljza02528@btch.edu.cn 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:
A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University.
Population of study:
192 pregnant women at the age range from 20 to 35 years, with BMI \< 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age \>39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan) and candidate for elective cesarean delivery (Previous one or two cesarean section) were included in our study. Patients with uterine over distension as due to multiple pregnancies or polyhydramnios, multipara (parity ≥3), women with uterine fibroids, antepartum hemorrhage presentation such as placenta previa, placental abruption or vasa previa, moderate to severe anemia with hemoglobin level \<9mg/dl, patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias, hypertension, cardiovascular, DM, hepatic, or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone, antacids containing magnesium were excluded from our study. conditions: Postpartum Hemorrhage studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 192 type: ACTUAL name: Misoprostol measure: The amount of blood loss measure: Changes in hematocrit values in both groups after delivery measure: Changes in Hemoglobin level measured by gm/dl in both groups after delivery measure: Incidence of side effects of study medications sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Faculty of medicine, Kasr Alainy city: Cairo state: Al Manyal zip: 11956 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06364085 id: DBS2024 briefTitle: Enhancing Epilepsy Management With Precision Deep Brain Stimulation acronym: EPI-BOOST overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-06 date: 2024-04-15 date: 2024-04-15 name: Nova Scotia Health Authority class: OTHER briefSummary: The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study. conditions: Epilepsy, Drug Resistant studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Neuromodulation programming measure: Seizure reduction measure: Change in disease score on Patient Weighted Quality Of Life In Epilepsy measure: Change in depression score on Neurological Disorders Depression Inventory in Epilepsy measure: Change in anxiety score on Anxiety General Anxiety Disorder-7 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Elizabeth Health Science Centre city: Halifax state: Nova Scotia zip: B3H 3A7 country: Canada name: Lutz Weise role: CONTACT lat: 44.64533 lon: -63.57239 hasResults: False
<\|newrecord\|> nctId: NCT06364072 id: PDC 01-0202 id: 2023-504023-63-00 type: CTIS briefTitle: Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-15 date: 2024-09-20 date: 2024-04-15 date: 2024-04-15 name: Cessatech A/S class: INDUSTRY briefSummary: The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children. conditions: Pain studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: CT001 measure: To assess the safety and tolerability measure: To evaluate the analgesic effect measure: To assess medication errors sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06364059 id: aSDH-TT briefTitle: A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-11 date: 2024-04-15 date: 2024-04-15 name: Charles University, Czech Republic class: OTHER name: Military University Hospital, Prague briefSummary: Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes. conditions: Acute Subdural Hematoma conditions: Acquired Brain Injury studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Decompressive craniectomy with evacuation of subdural hematoma measure: Level of consciousness at time of injury measure: Initial size of subdural hematoma measure: Initial midline shift measure: Chronic use of anti-clotting medication measure: Trauma severity analyzed using Injury Severity Score (ISS). measure: Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II) measure: The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC). measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months. measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months. measure: Number of revisions. measure: Time from injury to surgery. measure: Time of operation. measure: The need for reversal of the effects of anticoagulants. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Military University Hospital Prague city: Praha zip: 16209 country: Czechia name: Michal Soták, M.D., Ph.D. role: CONTACT phone: +420973202999 email: michal.sotak@uvn.cz name: Tomáš Tyll, M.D., Ph.D. role: CONTACT phone: +420973202999 email: tomas.tyll@uvn.cz name: Tomáš Tyll, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 hasResults: False
<\|newrecord\|> nctId: NCT06364046 id: ZJLS-KLDMIR-22006 briefTitle: Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-15 date: 2024-04-15 name: The Central Hospital of Lishui City class: OTHER briefSummary: This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice. conditions: Carcinoma conditions: Small Cell Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Drug-eluting beads bronchial arterial chemoembolization name: Serplulimab name: Intravenous chemotherapy measure: Objective response rate measure: Progression Free Survival measure: Overall Survival measure: Time to tumor untreatable progression measure: Disease Control Rate measure: Duration of Overall Response measure: Tumor biomarkers measure: Tumor biomarkers measure: Tumor biomarkers measure: Tumor biomarkers measure: Eastern Cooperative Oncology Group Score measure: Recurrence rate of hemoptysis measure: Quality of life Questionare-Core score measure: The incidence of adverse events and serious adverse events measure: Pain assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lishui central hospital city: Lishui state: Zhejiang zip: 323000 country: China lat: 28.46042 lon: 119.91029 hasResults: False
<\|newrecord\|> nctId: NCT06364033 id: CLL2624 briefTitle: Biological and Clinical Efficacy of Shingrix in Patients With CLL overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-11 date: 2028-10 date: 2024-04-15 date: 2024-04-15 name: Gruppo Italiano Malattie EMatologiche dell'Adulto class: OTHER briefSummary: This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix. conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma conditions: CLL-like MBL conditions: Varicella-zoster Virus Reactivation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 312 type: ESTIMATED name: serologic response evaluation measure: Serologic response evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC Ematologia ASST dei Sette Laghi city: Varese country: Italy name: Marta Coscia role: CONTACT lat: 45.82058 lon: 8.82511 hasResults: False
<\|newrecord\|> nctId: NCT06364020 id: APHP230067 briefTitle: Assessment of Risk Factors in Patients With Non-carious Cervical Lesions acronym: LACIS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-15 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: In the management of patients with noncarious cervical lesions (NCCL), we observe that they frequently present signs of anxiety, traumatic brushing, bruxism or eating disorders. These multifactorial and interrelated etiologies make diagnosis and management difficult. Furthermore, in the literature, there is a lack of studies that evaluate the relationship between these risk factors and NCCL. A better understanding of the etiology and risk factors would help to optimize patient management and direct patients to the most appropriate therapies. conditions: Anxiety conditions: Stress conditions: Non-carious Cervical Lesions studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: To investigate the association between anxiety/stress and the presence of NCCL. measure: To investigate the association between bruxism and the presence of NCCL. measure: To investigate the association between eating disorders and the presence of NCCL. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hôpital Rothschild - Service Odontologie city: Paris zip: 75012 country: France name: Caroline Mocquot, MCU-PH role: CONTACT phone: +33622971627 email: caroline.mocquot@aphp.fr name: Maria Clotilde Carra, Professor role: CONTACT phone: +33630746555 email: mariaclotilde.carra@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06364007 id: SLiu0401 briefTitle: HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC overallStatus: RECRUITING date: 2024-03-03 date: 2025-12-31 date: 2026-03-31 date: 2024-04-12 date: 2024-04-12 name: Sulai Liu class: OTHER briefSummary: The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: HAIC+STRIDE+Len measure: ORR measure: PFS measure: OS measure: DCR measure: AE sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University) status: RECRUITING city: Changsha state: Hunan country: China name: Chuang Peng, PhD role: CONTACT phone: 15200850489 email: pengchuangcn@163.com lat: 28.19874 lon: 112.97087 hasResults: False
<\|newrecord\|> nctId: NCT06363994 id: ICP-CL-00128 briefTitle: A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL overallStatus: NOT_YET_RECRUITING date: 2024-05-25 date: 2034-12-25 date: 2035-12-25 date: 2024-04-12 date: 2024-04-12 name: InnoCare Pharma Inc. class: INDUSTRY briefSummary: Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL) conditions: Mantle Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 490 type: ESTIMATED name: Orelabrutinib name: Bendamustine Injection name: Rituximab name: Orelabrutinib Placebo measure: Dose-limiting toxicity (DLT) measure: Progression-free Survival (PFS) for Arm A vs. Arm C sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06363981 id: JagiellonianU72 briefTitle: Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-04 date: 2024-04-12 date: 2024-04-15 name: Jakub Antczak class: OTHER name: Andrzej Frycz Modrzewski Krakow University briefSummary: Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression. conditions: Unipolar Depression conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Placebo intervention will be delivered with a programmable coil for magnetic stimulation, which can be switched by a third person between modes of active (therapeutic) and sham stimulation. In the sham-mode coil elicits similar sounds as in the active stimulation, but induces only negligible magnetic field. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Active rTMS over the left DLPFC and over the left DMPFC name: Active rTMS over the left DLPFC name: Sham rTMS measure: Beck Depression Inventory 2 measure: Froward digit span measure: Language part of Addenbrooke's Cognitive Examination measure: Dimensional Anhedonia Rating Scale measure: Athens Insomnia Scale measure: Pittsburgh Sleep Quality Index measure: Epworth Sleepiness Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Education of Research and Development Center, Babinski Clinical Hospital city: Cracovia zip: 30393 country: Poland name: Wojciech Korzeniowski, MD role: CONTACT phone: +48 12 652 42 00 email: wojciech.korzen@gmail.com name: Jakub Antczak, MD role: CONTACT phone: +48 12 25 50 email: jakub.antczak@uj.edu.pl lat: 50.06143 lon: 19.93658 hasResults: False
<\|newrecord\|> nctId: NCT06363968 id: 1743326 briefTitle: Biomarkers in the Retina for Prognosticating Mental Health Treatments acronym: BRIGHT overallStatus: RECRUITING date: 2024-02-12 date: 2025-09-01 date: 2030-09-01 date: 2024-04-12 date: 2024-04-12 name: VA Puget Sound Health Care System class: FED briefSummary: Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot study
Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are:
1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD?
2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment?
Participants will be asked to:
* Undergo ERG recordings before and after a single dose of sertraline.
* Provide relevant clinical information related to PTSD symptoms and treatment history.
Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording. conditions: PTSD conditions: Posttraumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 50 type: ESTIMATED name: RETeval measure: ERG b-wave amplitude response to SSRI measure: Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score measure: Total PTSD Checklist for DSM-5 (PCL-5) sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Puget Sound Health Care System status: RECRUITING city: Seattle state: Washington zip: 98108 country: United States name: Rebecca C Hendrickson, MD, PhD role: CONTACT phone: 206-277-5054 email: rebecca.hendrickson@va.gov name: Katharine J Liang, MD, PHD role: SUB_INVESTIGATOR name: Rebecca C Hendrickson, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06363955 id: INTM-PMCF-UNIMOUTH id: 750/13.02.2023 type: OTHER domain: National and Kapodistrian University of Athens briefTitle: Assessing the Efficacy of a Hydrogen Peroxide Mouthwash for Oral Wound Healing, Oral Hygiene and Xerostomia Relief overallStatus: COMPLETED date: 2023-04-25 date: 2024-04-01 date: 2024-04-01 date: 2024-04-12 date: 2024-04-26 name: National and Kapodistrian University of Athens class: OTHER name: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. briefSummary: The aim of this study is to evaluate the efficacy and safety of a hydrogen carbamide/peroxide mouthwash, named UNISEPT® MOUTHWASH, regarding oral wound healing, postoperative symptoms, xerostomia (dry mouth) and oral hygiene improvement. Study participants have reported dry mouth and are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögren's Syndrome, following consultation with their rheumatologist. This is a standardized diagnostic procedure that leads to healing by primary intention (i.e. wound edges are closely re-approximated with sutures).
Researchers are comparing this mouthwash with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving dry mouth and/or oral hygiene. Participants randomly get the hydrogen carbamide/peroxide mouthwash or the placebo one to use for 14 days after the biopsy. The investigators will not know which one they are providing as the bottles will be identical.
Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation), improvement of dry mouth and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial consultation and the biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (such as measuring saliva) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed. conditions: Wound Heal conditions: Oral Dryness conditions: Postoperative Pain conditions: Sjogren's Syndrome conditions: Biopsy Wound conditions: Mouth; Wound conditions: Mouth Dryness conditions: Dental Plaque conditions: Gingival Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial is designed as a prospective, randomized, placebo-controlled, triple blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of a hydrogen carbamide/peroxide mouthwash or placebo mouthwash, made by the same manufacturer. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ACTUAL name: Hydrogen Carbamide/Peroxide Mouthwash name: Placebo mouthwash measure: Assessment of wound healing based on the modified Landry Healing Index on day 14 measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 14 measure: Assessment of wound healing based on the modified Landry Healing Index on day 7 measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 7 measure: Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home) measure: Postoperative symptoms (pain, eating and speech difficulty) on day 7 measure: Postoperative symptoms (pain, eating and speech difficulty) on day 14 measure: Wound healing based on the incision/wound length measure: Subjective oral dryness symptoms (8-item VAS questionnaire) measure: Observed (objective) signs of oral dryness measure: Change in Unstimulated Saliva Flow Rate measure: Oral Hygiene - Dental Plaque: Full-Mouth Plaque Index measure: Oral Hygiene - Gingival Inflammation: Full Mouth Gingival Index measure: Oral Health Related Quality of Life measure: Assessment of swelling in the biopsy area measure: Adverse Events measure: Participant's comments and satisfaction regarding the provided treatment/use of the products measure: Compliance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens city: Athens state: Attiki zip: 11527 country: Greece lat: 37.97945 lon: 23.71622 hasResults: False
<\|newrecord\|> nctId: NCT06363942 id: 2024-5973 briefTitle: A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2026-04-15 date: 2024-04-12 date: 2024-04-12 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not. conditions: Fall Injury conditions: Frailty conditions: Old Age; Atrophy conditions: Age-Related Atrophy conditions: Age-Related Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: SAFE program (exercise intervention) measure: Objective 1 measure: Objective 2 measure: Objective 4 sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Royal Victoria Hospital - Glen site city: Montréal state: Quebec zip: H4A 3J1 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06363929 id: 341-23 briefTitle: Continuous Glucose Monitoring in Neonatal Hyperinsulinism overallStatus: RECRUITING date: 2023-06-01 date: 2025-06-01 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: MemorialCare Health System class: OTHER name: DexCom, Inc. briefSummary: The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly. conditions: Hyperinsulinism conditions: Hypoglycemia Neonatal studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Dexcom G6 continuous glucose monitor measure: Mean absolute relative difference (MARD) measure: Mean absolute difference (MAD) sex: ALL minimumAge: 24 Hours maximumAge: 3 Months stdAges: CHILD facility: Miller Children's Hospital status: RECRUITING city: Long Beach state: California zip: 90806 country: United States name: Erin Okawa role: CONTACT phone: 310-825-6244 email: eokawa@memorialcare.org lat: 33.76696 lon: -118.18923 hasResults: False
<\|newrecord\|> nctId: NCT06363916 id: 2023-A00335-40 briefTitle: Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System acronym: SEECLOOP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-11 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: Medtrum France class: INDUSTRY name: Axonal-Biostatem briefSummary: The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study.
The main question it aims to answer is :
• Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ?
Participants will be :
* Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system
* Randomized to the Open Loop or Closed Loop group
* Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire status
Researchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group. conditions: Type 1 Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED name: Insulin Management System in Manual mode of operation name: Insulin Management System in Automatic mode of operation measure: Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups measure: Evolution of TIR measure: Evolution of coefficient of glycemic variation measure: Superiority in Glycated Haemoglobin (HbA1c) improvement measure: Evolution of Time spent Above Range (TAR) measure: Evolution of Time spent Below Range (TBR) measure: Body Mass Index change measure: Glucose sensor measurement change measure: Percentage of patients with TIR > 70% measure: Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1% measure: Evolution of glucose management indicator (GMI) measure: Evolution of dosage of insulin measure: Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop) measure: Evolution of Self-administered Questionnaires scores measure: Evolution of Diabetes Treatment Satisfaction score measure: Safety Events measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TIR measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on glucose sensor measurements measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TAR measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TBR measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on GMI measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on dosage of insulin measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on Self-administered Questionnaires scores sex: ALL minimumAge: 7 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Angers city: Angers country: France name: Regis COUTANT role: CONTACT name: Regis COUTANT role: PRINCIPAL_INVESTIGATOR lat: 47.46667 lon: -0.55 facility: CHU Besançon city: Besançon country: France name: Sophie BOROT role: CONTACT name: Sophie BOROT role: PRINCIPAL_INVESTIGATOR lat: 47.24878 lon: 6.01815 facility: CHU Bordeaux city: Bordeaux country: France lat: 44.84044 lon: -0.5805 facility: CHU Caen city: Caen country: France name: Michael JOUBERT role: CONTACT name: Michael JOUBERT role: PRINCIPAL_INVESTIGATOR lat: 49.18585 lon: -0.35912 facility: Centre Hospitalier Sud-Francilien city: Corbeil-Essonnes country: France name: Freddy PENFORNIS role: CONTACT name: Freddy PENFORNIS role: PRINCIPAL_INVESTIGATOR name: Thanh-Lan DANG DUY role: PRINCIPAL_INVESTIGATOR lat: 48.60603 lon: 2.48757 facility: Centre Hospitalier de Gonesse city: Gonesse country: France name: Jennifer ALLAIN role: CONTACT name: Jennifer ALLAIN role: PRINCIPAL_INVESTIGATOR lat: 48.98693 lon: 2.44892 facility: Centre Hospitalier Saint-Louis city: La Rochelle country: France name: Didier GOUET role: CONTACT name: Didier GOUET role: PRINCIPAL_INVESTIGATOR lat: 46.16667 lon: -1.15 facility: Hôpital Hôtel-Dieu city: Le Creusot country: France name: Sylvaine CLAVEL role: CONTACT name: Sylvaine CLAVEL role: PRINCIPAL_INVESTIGATOR lat: 46.80714 lon: 4.41632 facility: Hospices Civils de Lyon city: Lyon country: France lat: 45.74848 lon: 4.84669 facility: Hôpital Européen city: Marseille country: France name: Denis RACCAH role: CONTACT name: Denis RACCAH role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Hôpital La Timone city: Marseille country: France name: Rachel REYNAUD role: CONTACT name: Rachel REYNAUD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: CHU Montpellier city: Montpellier country: France name: Fabienne DALLA VALE role: CONTACT name: Fabienne DALLA VALE role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: CHU Nantes city: Nantes country: France lat: 47.21725 lon: -1.55336 facility: Hôpital Lariboisière city: Paris country: France name: Jean-Pierre RIVELINE role: CONTACT name: Jean-Pierre RIVELINE role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Necker city: Paris country: France name: Jacques BELTRAND role: CONTACT name: Jacques BELTRAND role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Robert Debré city: Paris country: France name: Elise BISMUTH role: CONTACT name: Elise BISMUTH role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Rangueil city: Toulouse country: France name: Vincent MELKI role: CONTACT name: Vincent MELKI role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False
<\|newrecord\|> nctId: NCT06363903 id: 2022-MMC-051 briefTitle: ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation overallStatus: RECRUITING date: 2022-05-09 date: 2024-05 date: 2025-05 date: 2024-04-12 date: 2024-04-12 name: Maxima Medical Center class: OTHER name: Amsterdam UMC name: Maastricht University Medical Center briefSummary: In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics. conditions: Autoimmunity conditions: Inguinal Hernia conditions: Stress Urinary Incontinence conditions: Pelvic Organ Prolapse conditions: Implant Complication conditions: Systemic Autoimmune Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: mesh allergy test name: blood tests name: Mesh removal measure: Positive diagnostic tests measure: Autoimmune complaints and objective findings in immunologic blood test measure: Autoimmune complaints and objective findings in mesh allergy test (MAT) measure: Mesh removal and subjective complaints measure: Mesh histopathology measure: Patient demographics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Centre status: ACTIVE_NOT_RECRUITING city: Maastricht state: Limburg zip: 6229HX country: Netherlands lat: 50.84833 lon: 5.68889 facility: Maxima Medical Centre status: RECRUITING city: Veldhoven state: Noord-Brabant zip: 5504DB country: Netherlands name: Willem AR Zwaans, MD PhD role: CONTACT phone: +31408888550 email: willem.zwaans@mmc.nl name: Maurits JC Gielen, MD role: SUB_INVESTIGATOR lat: 51.41833 lon: 5.40278 facility: Amsterdam UMC status: NOT_YET_RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: Prof. Dr. J.P. Roovers role: CONTACT lat: 52.37403 lon: 4.88969 hasResults: False
<\|newrecord\|> nctId: NCT06363890 id: TD02 briefTitle: Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia acronym: AusTD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-10-01 date: 2025-12-01 date: 2024-04-12 date: 2024-04-12 name: Lumen Bioscience, Inc. class: INDUSTRY briefSummary: The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population. conditions: Travelers Diarrhea studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED name: TAQMan Array Card measure: Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06363877 id: 5220078 briefTitle: Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-10 date: 2025-11 date: 2024-04-12 date: 2024-04-12 name: Loma Linda University class: OTHER briefSummary: This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds. conditions: Surgical Site Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 1100 type: ESTIMATED name: Povidone-Iodine name: Normal Saline measure: Surgical Site Infection measure: Readmission measure: Return to the Operating Room measure: Ileus measure: Small Bowel Obstruction sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Loma Linda University Health city: Loma Linda state: California zip: 92354 country: United States name: Martin G Rosenthal, MD role: CONTACT email: mrosenthal@llu.edu name: Martin Rosenthal, MD role: PRINCIPAL_INVESTIGATOR name: Mohamed H El-Farra, MD role: SUB_INVESTIGATOR lat: 34.04835 lon: -117.26115 hasResults: False
<\|newrecord\|> nctId: NCT06363864 id: LL-IRB-2401 briefTitle: Investigation of Metabolomics Differences Between Metabolic Syndrome and Healthy Individuals in Taiwan overallStatus: NOT_YET_RECRUITING date: 2024-04-14 date: 2029-10-31 date: 2029-10-31 date: 2024-04-12 date: 2024-04-12 name: Leeuwenhoek Laboratories Co. Ltd. class: INDUSTRY briefSummary: The prevalence of metabolic syndrome in Taiwan has been increasing yearly. In this project, the database of blood test results from healthy and metabolic syndromes individuals will be analyzed to identify the small molecules related to the severity of metabolic syndrome. These identified small molecules could be used as biomarkers to predict the development of metabolic syndromes in the future. conditions: Metabolic Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED measure: Concentration changes of small molecules in blood. sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06363851 id: Kylo-11-I-C01 briefTitle: Single-ascending Dose Study of Kylo-11 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-05-31 date: 2025-11-30 date: 2024-04-12 date: 2024-04-12 name: Kylonova (Xiamen) Biopharma co., LTD. class: INDUSTRY briefSummary: This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects. conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Kylo-11 name: Placebo measure: Incidence of adverse events measure: Incidence of adverse events measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax) measure: PK parameter of time of maximum observed concentration (Tmax) measure: PK parameter of area under the concentration time curve (AUC) measure: Change in serum Lp(a) over time measure: Percent change in serum Lp(a) over time sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Chengdu Xinhua Hospital city: Chengdu state: Sichuan zip: 610000 country: China name: Xiaolan Yong role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06363838 id: ordu eah briefTitle: Evaluation of Neuromuscular Morphometry of the Vaginal Wall overallStatus: COMPLETED date: 2019-12-01 date: 2020-06-25 date: 2020-06-30 date: 2024-04-12 date: 2024-04-12 name: Gaziosmanpasa Research and Education Hospital class: OTHER_GOV name: T.C. ORDU ÜNİVERSİTESİ briefSummary: In this prospective study, women aged between 40 and 75 years who had not undergone any vaginal surgery and had not undergone any abdominal prolapse surgery were included. Thirty-one women diagnosed with rectocele on examination were included in the study group. Thirty-one patients who underwent vaginal intervention and hysterectomy for reasons other than rectocele (colposcopy, conization, etc.) without anterior or posterior wall prolapse were included in the control group. conditions: Pelvic Organ Prolapse studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 62 type: ACTUAL measure: epithelial thickness measure: smooth muscle density sex: FEMALE minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hakan Timur city: Ordu country: Turkey lat: 40.97782 lon: 37.89047 hasResults: False
<\|newrecord\|> nctId: NCT06363825 id: MRCTA,ECFAH Of FMU[2024]373 briefTitle: A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-04-12 date: 2026-04-11 date: 2027-05-11 date: 2024-04-12 date: 2024-04-17 name: Fujian Medical University class: OTHER briefSummary: To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load conditions: Advanced Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: camrelizumab measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Progression-free survival (PFS) measure: Tumor progression time (TTP) measure: Overall survival (OS) measure: AE sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinhua Chen status: RECRUITING city: Fuzhou country: China name: Yiping Chen role: CONTACT phone: 13805066904 lat: 26.06139 lon: 119.30611 hasResults: False
<\|newrecord\|> nctId: NCT06363812 id: The POST briefTitle: Probability of OncotypeDx to Reallocate as Low or High Risk of Recurrence Breast Cancer Patients With Uncertain Biology overallStatus: ACTIVE_NOT_RECRUITING date: 2018-03-08 date: 2021-05-15 date: 2024-12-31 date: 2024-04-12 date: 2024-04-15 name: Fondazione Sandro Pitigliani class: OTHER name: Genomic Health®, Inc. name: Istituto Toscano Tumori briefSummary: In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 258 type: ACTUAL measure: the proportion of tumor samples with a useful OncotypeDx measure: the proportion of patients in which the result of the test has induced a modification in the initial treatment plan measure: the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital of Prato city: Prato zip: 59100 country: Italy lat: 43.8805 lon: 11.09699 hasResults: False
<\|newrecord\|> nctId: NCT06363799 id: OST1_010 briefTitle: Osteopathic Protocol for Insomnia in College Students overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-29 name: Escola Superior de Tecnologia da Saúde do Porto class: OTHER briefSummary: In this randomized controlled experimental trial, it is aimed to determine the effectiveness of an osteopathic protocol treatment for insomnia in college students. In this study, will be used the Compression of 4th ventricle (CV4) and the diaphragmatic breathing technique. conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: 4th ventricle compression technique and diaphragmatic breathing name: Sham Technique measure: Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score sex: ALL minimumAge: 18 Years maximumAge: 28 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06363786 id: GOOSEBERRY briefTitle: Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-30 date: 2024-09-30 date: 2024-04-12 date: 2024-04-12 name: Essity Hygiene and Health AB class: INDUSTRY briefSummary: The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and qPCR. In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of pathces. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with approproate statistical tests on 5% level for varaibles. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed. conditions: Incontinence-associated Dermatitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Healthy volunteers get patches carrying a low pH or control formula applied to the forearms. The patches are carried over two days and the skin parameteres and skin mictrobiome is measured on day 3. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Test patches measure: Changes in skin microbiome as measured by molecular sequencing measure: Changes in skin microbiome diversity as measured by qPCR measure: Skin surface pH measure: Change in Trans Epidermal Water loss measure: Change in skin hydration measure: Change in Skin water profile measure: Presence of low pH formula on the skin sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Essity Study Site city: Gothenburg zip: SE40503 country: Sweden name: Fredrik Agholme, PhD role: CONTACT phone: +46730323634 email: fredrik.agholme@essity.com name: Ulrika Husmark, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False
<\|newrecord\|> nctId: NCT06363773 id: RESTO-IMMUNO id: 2023-A02451-44 type: OTHER domain: ANSM briefTitle: A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer. acronym: RESTO-IMMUNO overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2026-06 date: 2024-04-12 date: 2024-04-17 name: Elsan class: OTHER briefSummary: This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (\> 6 months) and displaying disease progression.
In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7). The radiotherapy device itself is not the subject of this study and will be used in accordance with its CE mark and indications.
The objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. In particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases. conditions: Metastatic Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot, exploratory, prospective, monocentric study primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Stereotactic Radiotherapy measure: Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. measure: Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with progression after initial response to immunotherapy. measure: Objective Response Rate according to iRECIST criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. measure: Objective Response Rate according to RECIST 1.1 criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. measure: Duration until new systemic treatment start. measure: Incidence of Adverse Events (safety) measure: Progression-Free Survival measure: Overall Survival measure: Objective Response Rate according to iRECIST criteria on the irradiated lesion only. measure: Objective Response Rate according to RECIST 1.1 criteria on the irradiated lesion only. measure: Objective Response Rate according to iRECIST criteria on all untreated lesion(s) (abscopal effect). measure: Objective Response Rate according to RECIST 1.1 criteria on all untreated lesion(s) (abscopal effect). measure: Objective Response Rate according to iRECIST criteria on each untreated lesion taken independently from others (abscopal effect). measure: Objective Response Rate according to RECIST 1.1 criteria on each untreated lesion taken independently from others (abscopal effect). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Clinical city: Soyaux state: Charente zip: 16800 country: France lat: 45.65 lon: 0.2 hasResults: False
<\|newrecord\|> nctId: NCT06363760 id: EDIT-301-LTFU-001 briefTitle: A Long-Term Follow-Up Study of Participants With Sickle Cell Disease or Transfusion Dependent β-Thalassemia Who Received EDIT-301 overallStatus: NOT_YET_RECRUITING date: 2024-06-04 date: 2040-08 date: 2040-08 date: 2024-04-12 date: 2024-04-12 name: Editas Medicine, Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the long-term safety and efficacy of EDIT-301 in participants with severe sickle cell disease (SCD) or transfusion-dependent β-thalassemia (TDT) who have received EDIT-301. conditions: Sickle Cell Disease conditions: Transfusion-dependent Beta-Thalassemia conditions: Hemoglobinopathies studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: Safety and efficacy assessments measure: Adverse events of special interest (AESI) measure: Adverse events of interest (AEI) measure: All-cause mortality measure: Adverse events (AEs) related to EDIT-301 measure: Serious adverse events (SAEs) measure: Proportion of SCD participants with severe vaso-occlusive events (sVOEs) over time post-EDIT-301 infusion measure: Proportion of SCD participants with vaso-occlusive events (VOEs) over time post-EDIT-301 infusion measure: Frequency of SCD-related transfusions over time post-EDIT-301 infusion for SCD participants measure: Proportion of TDT participants with sustained transfusion independence (TI) over time measure: Proportion of TDT participants with sustained transfusion reduction (TR) over time measure: Frequency of TDT-related transfusions over time post-EDIT-301 infusion for TDT participants measure: SCD and TDT: Percent of peripheral red blood cells (RBCs) containing HbF (F-cells) over time measure: SCD and TDT: Total hemoglobin (Hb) concentration (g/dL) over time measure: SCD and TDT: Proportion of alleles with intended genetic modification present in peripheral blood nucleated cells and bone marrow derived CD34+ over time measure: Average HbF (pg) per RBC over time for SCD participants measure: Complete Blood Count (CBC) red cell indices assay over time for SCD participants measure: Average HbF (pg) per F-cell over time for SCD participants measure: HbF and HbS concentration (g/dL) over time for SCD participants measure: The level of HbF production determined by fractionation of different forms of Hb (including but not limited to HbA, HbA2, HbC, HbD, HbE, and HbS) over time for SCD participants. measure: Percentage of HbF over total non-transfused total Hb (non-transfused total Hb refers to the total g/dL of all Hb variants, excluding HbA) over time for TDT participants. measure: HbF concentration (g/dL) over time for TDT participants measure: Iron overload of TDT participants measure: Proportion of TDT participants receiving iron chelation therapy over time. sex: ALL minimumAge: 12 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06363747 id: 123456 briefTitle: The Medically Reproducing Bariatric Surgery (MRB) II Study overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2025-06-03 date: 2025-06-03 date: 2024-04-12 date: 2024-04-15 name: Durham VA Medical Center class: FED name: Société des Produits Nestlé (SPN) briefSummary: Roux-en-Y (RYGB) gastric bypass reduces the size and capacity of the stomach and bypasses a portion of the small intestine which leads to decreased food intake and higher levels of a gut hormone called GLP-1 (glucagon-like-peptide-1). These changes lead to weight loss, improved blood sugars and often remission of type 2 diabetes but most patients do not qualify or want surgery. The investigators are searching for ways to make the beneficial effects of RYGB available to most type 2 diabetes patients rather than a select few that undergo RYGB.
The investigators believe that parts of RYGB can be medically reproduced through a combination of diet and medicine. Once weekly injectable GLP-1 medicine that leads to weight loss and improved blood sugar control in type 2 diabetes are now FDA approved. Optifast is a medically supervised diet that safely reduces calorie intake to 800 calories per day for three months by replacing normal meals with specially prepared bars and shakes which leads to weight loss and improved blood sugar control in type 2 diabetes. Normal meals are then gradually reintroduced over 6 weeks and the bars/shakes are stopped. The investigators hypothesize that Optifast (diet) + once weekly GLP-1 will lead to weight loss and improvement in blood sugar control in type 2 diabetes similar to what is seen after RYGB. conditions: Type 2 Diabetes conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control--\[GLP-1 agonist +/- DM2 meds + medical management + nutritional/behavioral counseling\] Experimental---\[Optifast + GLP-1 agonist + medical management + nutritional/behavioral counseling\] primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Very Low Calorie Diet measure: Glycemic Control measure: Weight lost measure: Medication Intensity measure: Health Related Quality of Life measure: Symptom Item Checklist sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Greenville VA Health Care Center city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 hasResults: False
<\|newrecord\|> nctId: NCT06363734 id: DAL20240409 briefTitle: Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial overallStatus: RECRUITING date: 2024-04-09 date: 2025-12-15 date: 2026-12-31 date: 2024-04-12 date: 2024-04-16 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4/6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI. conditions: Non-small Cell Lung Cancer conditions: EGFR Activating Mutation conditions: Cell Cycle Deregulation conditions: EGFR-TKI Resistant Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Osimertinib plus Dalpiciclib measure: Objective Response Rate (ORR) measure: disease control rate (DCR) measure: Duration of Response (DoR) measure: Progression Free Survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Thoracic Medical Oncology, Tianjin Medical University Cancer Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300060 country: China name: Peng Chen, M.D. role: CONTACT phone: +86-22-23340123 phoneExt: 3201 email: chenpeng@tjmuch.com name: Peng Chen, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False
<\|newrecord\|> nctId: NCT06363721 id: DFH00125 briefTitle: A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health overallStatus: RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: Designs for Health class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the impact of a commercially-available oil rinse product (PerioPull™) on parameters of dental health among a sample of adults. PerioPull™ is commercially available and sold primarily from clinicians' offices.

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