hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06331312 id: CAIN457C22301E1 id: 2023-508077-85-00 type: OTHER domain: EU CT number briefTitle: Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR) acronym: REPLENISH-EXT overallStatus: RECRUITING date: 2024-04-10 date: 2028-03-13 date: 2028-05-08 date: 2024-03-26 date: 2024-04-16 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica. conditions: Polymyalgia Rheumatica studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Secukinumab measure: Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs) sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis Investigative Site status: RECRUITING city: Parramatta zip: 2150 country: Australia lat: -33.81667 lon: 151.0 hasResults: False
nctId: NCT06331299 id: BL013 briefTitle: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer acronym: UTOPIA overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-03 date: 2026-03 date: 2024-03-26 date: 2024-04-19 name: UroGen Pharma Ltd. class: INDUSTRY briefSummary: This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC). conditions: Bladder Cancer conditions: Urothelial Carcinoma conditions: Urothelial Carcinoma Bladder studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 87 type: ESTIMATED name: UGN-103 measure: Complete response rate (CRR) measure: Duration of response (DOR) measure: Durable complete response (DCR) rate measure: Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology and serum chemistry) measure: Mitomycin plasma concentrations measure: Mitomycin maximum plasma concentration (Cmax) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06331286 id: IIT20230091C-R1 briefTitle: The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity overallStatus: RECRUITING date: 2023-09-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: First Affiliated Hospital of Zhejiang University class: OTHER briefSummary: The primary objective of this study is to investigate the effect of dulaglutide adjuvant treatment in patients with bipolar disorder with obesity, in addition to exploring the effect of GLP-1RA on cognition of bipolar disorder. conditions: Bipolar Disorder conditions: Obesity conditions: Cognition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: dulaglutide injection measure: weight measure: Concentration of blood glucose in blood measure: Concentration of total cholesterol in blood measure: Concentration of high density lipoprotein in blood measure: Concentration of low density lipoprotein in blood measure: Concentration of triglyceride in blood measure: CBCT test results measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score measure: Treatment Emergent Symptom Scale (TESS) Score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Psychiatry, First Affiliated Hospital of Zhejiang University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Hu ShaoHua role: CONTACT phone: 13957162903 email: dorhushaohua@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False
nctId: NCT06331273 id: CT2024-ZJU-OBS3 briefTitle: Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2028-04-01 date: 2024-03-26 date: 2024-03-26 name: Zhejiang University class: OTHER name: Shulan (Hangzhou) Hospital briefSummary: The "no-touch" technique has been one of the most important principles of oncological surgery and aimed to prevent seeding and tumor cell dissemination. Previous studies in hepatectomy have shown that no-touch technique surgery can reduce HCC recurrence and improve the survival of patients. However, there is no consensus on whether the no-touch technique in LT for HCC improves the outcomes. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant clinical information, post-transplant pathological records and exploring and clarify the correlation between "no-touch" technique and the prognosis of LT patients. conditions: Liver Transplantation conditions: No-touch Technique conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Liver transplantation with "No-touch" technique measure: Recurrence free surviavl rate measure: Overall survival rate measure: Tumor recurrence rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06331260 id: CT2024-ZJU-OBS2 briefTitle: Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2028-04-01 date: 2024-03-26 date: 2024-03-26 name: Zhejiang University class: OTHER name: Shulan (Hangzhou) Hospital briefSummary: As key biomarkers in HCC, AFP and PIVKA-II reflects biological features of tumor and has been widely applied for clinical diagnosis. Previous studies reported preoperative AFP and PIVKA-II are related to HCC recipient long-term survival after liver transplantation. However, there is no prospective study supporting these conclusions. This study aims to prospective collect liver transplantation cases from multiple transplant centers and further evaluate the prognostic role of preoperative AFP and PIVKA-II in liver transplantation for HCC. conditions: Liver Transplantation conditions: Hepatocellular Carcinoma conditions: Alpha-Fetoprotein conditions: Protein Induced by Vitamin K Absence or Antagonist-II studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Recurrence free survival rate measure: Overall survival rate measure: Tumor recurrence rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06331247 id: 20230520-2 briefTitle: MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II overallStatus: RECRUITING date: 2024-03-18 date: 2025-12-31 date: 2025-12-31 date: 2024-03-26 date: 2024-04-04 name: Zhejiang University class: OTHER briefSummary: A 6-month pilot randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet + usual medical care versus usual medical care on cognitive change and several other secondary outcomes through a randomized controlled trial in 60 mild stroke patients aged 35-70 years without dementia. conditions: Dementia conditions: Stroke conditions: Cognitive Change conditions: Cerebrovascular; Disorder, Thrombotic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a two-arm parallel design, with one arm being the control arm (usual medical care) and the other being the intervention arm (MIND diet intervention + usual medical care). primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcome assessors will be masked from the assignment of the participants. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: General dietary advice name: Localized MIND diet intervention name: Routine medical care measure: Change in global cognitive function measure: Change in MIND diet score measure: Change in Montreal Cognitive Assessment (MoCA) score measure: Change in Mini-Mental State Examination (MMSE) score measure: Change in brain MRI markers measure: Change in memory function measure: Change in language function measure: Change in executive function measure: Change in visuospatial function measure: Change in the ability of daily life measured using the Activities of Daily Living Scale (ADL) measure: Change in the ability of daily life measured using the Instrumental Activities of Daily Living Scale (IADL) measure: Change in depressive status measured using the Patient Health Questionnaire (PHQ-9) measure: Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7) measure: Changes in plasma metabolic profiles measured using metabolome analysis measure: Changes in plasma inflammatory biomarker panel measure: Changes in the intestinal microbiome sex: ALL minimumAge: 35 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310058 country: China name: Lusha Tong, PhD role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False
nctId: NCT06331234 id: VCI briefTitle: Effects of Vena Cava Inferior Measurements on AKI and Mortality. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-01 date: 2024-12-01 date: 2024-03-26 date: 2024-04-23 name: Inonu University class: OTHER briefSummary: Fluid overload is harmful in critically ill patients; In addition to increasing mortality, it may increase the incidence of acute kidney injury (AKI), length of ICU stay, and duration of mechanical ventilation by causing end-organ damage. (1-3) Mortality attributable to AKI is 20% and is an independent determinant of mortality. (4) Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. When the IVC diameter is \< 2 cm, it means there is no congestion and VEXUS is 0. Mild congestion: In addition to the IVC measuring approximately 2 cm, normal patterns such as the systolic wave being greater than the diastolic wave in the hepatic vein PW-doppler, pulsatility below 30% in the portal vein Doppler, continuous flow in the renal vein PW-doppler, or slightly abnormal patterns, i.e. hepatic The systolic wave in vein PW-doppler is smaller than the diastolic wave, the pulsatility in portal PW-doppler is between 30-50%, and the renal vein PW-doppler is accompanied by biphasic flow, and VEXUS is scored as 1. Moderate congestion is scored as VEXUS 2, which is measured as IVC 2 cm or more, plus inversion of the systolic wave on hepatic vein PW-doppler, pulsatility greater than 50% on portal PW-doppler, and discontinuous monophasic flow with only the diastolic phase on renal vein PW-doppler. It is accompanied by one of the serious abnormal patterns such as There is severe congestion, that is, VEXUS 3: IVC diameter of 2 cm or more and the presence of at least two seriously abnormal PW-Doppler morphologies. (5) The primary aim of this study is to describe the prevalence of venous congestion based on VExUS in general ICU patients. Secondary outcomes were to evaluate the association between VExUS, AKI, and 28-day mortality. conditions: Intensive Care Unit conditions: Acute Kidney Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Vena cava inferior diameter measure: acute kidney injury measure: mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06331221 id: JSA_Fatigue_FADEUP briefTitle: Effects of Different Concentric and Eccentric Muscle Fatigue Protocols on the Knee Joint Position Sense overallStatus: RECRUITING date: 2023-11-02 date: 2024-05-15 date: 2024-06-01 date: 2024-03-26 date: 2024-03-26 name: Universidade do Porto class: OTHER briefSummary: The aim of this study was to investigate the effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense of healthy individuals. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 20 type: ESTIMATED name: Muscle fatigue Protocol measure: Absolute angular error measure: Relative angular error measure: Variable angular error sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculdade de Desporto, Universidade do Porto status: RECRUITING city: Porto zip: 4200 country: Portugal name: Joana Azevedo, MSc role: CONTACT phone: +351917910094 email: azevedojoana311@gmail.com lat: 41.14961 lon: -8.61099 hasResults: False
nctId: NCT06331208 id: LUNG-HF:16181/21; G-21-57 briefTitle: Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure acronym: LUNG-HF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-30 date: 2026-12-30 date: 2024-03-26 date: 2024-03-26 name: Institute for Clinical and Experimental Medicine class: OTHER_GOV briefSummary: Heart failure (HF) patients often develop pulmonary hypertension (PH) that leads to transition into a biventricular HF with poor prognosis.
There are two PH components: 1) passive transmission of increased left atrial pressure, 2) heart failure (HF) related pulmonary vascular dysfunction (PVD) with increased vascular resistance. Intriguingly, only some, but not all HF patients develop heart failure-related PVD. The mechanisms and non-invasive detection of HF-PVD are poorly understood and are the focus of the current grant application. Development of PVD is linked to insufficiently characterized metabolic factors that may be mediators of HF-PVD.
Part A of the project aims to identify novel metabolites associated with the presence of PVD in patients with HF that can serve as biomarkers or targets and will provide biologic insights into PVD. Part C will assess the effects of reverting of metabolic alterations (identified in part A) by a drug/diet on pulmonary vasculature in experimental HF-related PVD. The "gold standard" for the detection of PVD is right heart catheterization, which is invasive and risky. Heart failure-related PVD is therefore often diagnosed late.
There is a need for noninvasive tests that may help to detect PVD in early stages and can be done repeatedly. Recent advances in artificial intelligence (AI)-assisted automated quantitative analysis of lung texture from low-dose contrast-free high-resolution CT images allow to quantify lung water content, interstitial changes or vessel volume, and may provide clues for detection of heart failure-related PVD. Such an approach, not tested yet, will be utilized for the detection of HF-PVD (part B). Clinical and functional characteristics of lung circulation (exercise hemodynamics, diffusion capacity, perfusion) will be analyzed in relation to quantitative CT data. conditions: Heart Failure conditions: Pulmonary Hypertension conditions: Pulmonary Vascular Resistance Abnormality studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 230 type: ESTIMATED name: non-contrast chest CT name: spirometry with diffusing lung capacity for carbon monoxide (DLCO) analysis name: Omics analysis of blood plasma obtained from pulmonary artery or peripheral blood name: supine bike exercise during right heart catheterisation name: Lung ventilation/perfusion SPECT measure: biomarker of pulmonary vasculopathy in HF measure: CT characteristics of pulmonary vasculopathy in HF measure: CT characteristics of presence of heart failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Clinical and Experimental Medicine - IKEM city: Prague zip: 140 21 country: Czechia name: Vojtech Melenovsky, MD, PhD role: CONTACT phone: 420 236055190 email: vome@ikem.cz lat: 50.08804 lon: 14.42076 hasResults: False
nctId: NCT06331195 id: DICA-HF_MAIN briefTitle: An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH) acronym: DICA-FH overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-12 date: 2024-03-26 date: 2024-03-26 name: Hospital do Coracao class: OTHER name: University of Sao Paulo name: National Institute of Cardiology, Laranjeiras, Brazil name: Instituto Dante Pazzanese de Cardiologia briefSummary: The main objective of this randomized clinical trial is to evaluate the effects of the adapted Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) according to the the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ whole genome sequencing (WGS); to evaluate the effects of the interventions on lipid profile biomarkers; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; to identify the prevalence of subclinical atherosclerosis; to perform pharmacogenomic analysis; and to evaluate adherence rates according to study groups. In this study, 300 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to the FH context (DICA-FH) + phytosterol placebo + krill oil placebo (control group); 2) DICA-FH + 2g/day of phytosterol + krill oil placebo; 3) DICA-FH + phytosterol placebo + 2g/day of krill oil; and 4) DICA-FH + 2g/day of phytosterol + 2g/day of krill oil.
Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up. conditions: Familial Hypercholesterolemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Placebo phytosterol name: Placebo krill oil name: Phytosterol name: Krill oil measure: LDL-c measure: Lp(a) measure: TC measure: HDL-c measure: TG measure: VLDL measure: NHDL measure: CI I measure: CI II measure: TG/HDL-c measure: AI measure: ox-LDL measure: APOAI measure: APOB100 measure: AE measure: Adherence sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06331182 id: 36264PR552/2/24 briefTitle: Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain overallStatus: RECRUITING date: 2024-03-26 date: 2024-08-01 date: 2024-08-01 date: 2024-03-26 date: 2024-03-27 name: Tanta University class: OTHER briefSummary: The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain. conditions: Dexmedetomidine conditions: Ketamine conditions: External Oblique Intercostal Plane Block conditions: Post Thoracotomy Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ketamine name: Dexmedetomidine name: Bupivacaine measure: Time to the 1st rescue analgesia measure: Intraoperative fentanyl consumption measure: Total morphine consumption in the 1st 24hr and 48 hr measure: Degree of pain measure: Heart rate measure: Mean arterial blood measure: The incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University status: RECRUITING city: Tanta state: ElGharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Saad A Moharam, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False
nctId: NCT06331169 id: ALTER-BC-Ib-01 briefTitle: Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-06-30 date: 2024-03-26 date: 2024-03-26 name: Fudan University class: OTHER briefSummary: A Prospective Phase Ib Study of Anlotinib with Trastuzumab Deruxtecan for HER2-Low Unresectable and/or Metastatic Breast Cancer conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Anlotinib name: Trastuzumab deruxtecan measure: Determination of the RP2D of anlotinib in combination with trastuzumab deruxtecan measure: Objective Response Rate (ORR) measure: Duration of Response (DCR) measure: Duration of Response (DOR) measure: Progression-free Survival (PFS) measure: Overall Survival (OS) measure: Number of Participants With Adverse Events (AEs) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jian Zhang city: Shanghai state: Shanghai zip: 200433 country: China name: Jian Zhang, MD,PhD role: CONTACT phone: +8664175590 phoneExt: 85000 email: syner2000@163.com lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06331143 id: 36264PR551/2/24 briefTitle: Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion overallStatus: RECRUITING date: 2024-03-28 date: 2024-09-01 date: 2024-09-01 date: 2024-03-26 date: 2024-03-29 name: Tanta University class: OTHER briefSummary: The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery. conditions: Mid-Transverse Process Block conditions: Intrathecal Morphine conditions: Idiopathic Scoliosis conditions: Posterior Spinal Fusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block name: Morphine measure: Degree of pain measure: Heart rate measure: Mean arterial pressure measure: Patient satisfaction measure: Complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University status: RECRUITING city: Tanta state: ElGharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Saad A Moharam, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False