hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06388252 id: ERID-KSOPR-0049/2023 id: 0120-297/2023/3 type: OTHER domain: National Medical Ethics Committee of the Republic of Slovenia briefTitle: Electrochemotherapy Induces Changes in the Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma overallStatus: ENROLLING_BY_INVITATION date: 2023-11-10 date: 2025-09-30 date: 2025-11-30 date: 2024-04-29 date: 2024-04-29 name: Institute of Oncology Ljubljana class: OTHER name: Slovenian Research and Innovation Agency briefSummary: In the last 10 years, the treatment of metastatic cutaneous melanoma has changed dramatically. The new systemic treatment with immunotherapy has led to a dramatic improvement in quality of life and overall survival. Systemic treatment means that the patient receives the drug as an infusion into a vein. Unfortunately, we know that immunotherapy is not equally successful in all patients. Recent studies have shown that the success of the treatment is not only influenced by the cellular composition of the metastasis, but also by its surroundings. This is called tumor microenvironment. Depending on the differences in the composition of this microenvironment, some metastases can be described as immunologically hot and others as immunologically cold. Immunologically hot metastases respond better to immunotherapy than immunologically cold metastases.
Studies have shown that with some interventions we can change the tumor microenvironment from being immune-cold to being immune-hot. Electrochemotherapy is one of the interventions that might improve the efficacy of immunotherapy in cutaneous melanoma. Electrochemotherapy is an established method for the local treatment of tumors, in which only a certain tumor is treated with special electrodes, to which a weak electric current is applied. We hypothesize that electrochemotherapy stimulates the body's own immune response and enables more effective treatment. Since immunotherapy also stimulates the body's own immune response to cutaneous melanoma cells, the interaction of the two drugs could be even more successful. Recent research results support this assumption.
The results will help us to better understand the synergistic effects of electrochemotherapy and immunotherapy on cutaneous melanoma metastases. The combination of systemic immunotherapy and electrochemotherapy could become an important treatment method for patients with metastatic melanoma. conditions: Cutaneous Malignant Melanoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Electrochemotherapy with intratumoural cysplatin is recommended for smaller (less than 3 cm) and fewer tumours (up to 10 lesions), while electrochemotherapy with intravenous bleomycin is preferable for multiple and larger tumours. primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Electrochemotherapy with Intratumoral Cysplatin name: Electrochemotherapy with Intravenous Bleomycin measure: Changes in the tumor microenvironment of cutaneoys and subcutaneousm melanoma metastases induced by electrochemotherapy measure: Diferrent changes in the tumor microenvironment induced by electrochemotherapy with bleomycin or cysplatin sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Oncology Ljubljana city: Ljubljana zip: 1000 country: Slovenia lat: 46.05108 lon: 14.50513 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-10 uploadDate: 2024-03-20T00:20 filename: ICF_000.pdf size: 356929 hasResults: False
nctId: NCT06388239 id: BE24-006 briefTitle: Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-08-26 date: 2024-09-14 date: 2024-09-23 date: 2024-04-29 date: 2024-04-29 name: International Bio service class: NETWORK briefSummary: The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects. Twenty-eight (28) subjects will be randomly assigned to receive either generic apixaban 5 mg film-coated tablets (1 x 5 mg; Test) or ELIQUISTM (1 x 5 mg; Reference) in Period 1 and after the washout period they will receive the other formulation as a crossover fashion in Period 2. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Apixaban 5MG name: ELIQUIS measure: Plasma Area Under the Curve (AUC(0 to 36hr)) for Apixaban measure: Peak Plasma Concentration (Cmax) of Apixaban sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
nctId: NCT06388226 id: IRB # 16143 briefTitle: Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2026-07-31 date: 2026-07-31 date: 2024-04-29 date: 2024-04-29 name: Indiana University class: OTHER name: Purdue University briefSummary: The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF. conditions: Heart Failure With Preserved Ejection Fraction studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Leg heat therapy name: Leg sham therapy measure: Change in time to exhaustion during treadmill exercise measure: Change in maximal pulmonary oxygen uptake during treadmill exercise measure: Change in triceps surae microvascular oxygenation during treadmill exercise measure: Change in systolic blood pressure measure: Change in diastolic blood pressure measure: Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score measure: Change in triceps surae microvascular oxygenation during reactive hyperemia measure: Change in triceps surae volume measure: Change in triceps surae intramuscular fat content measure: Change in the time constant for phosphocreatine recovery after dynamic exercise measure: Change in maximal plantar flexor strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06388213 id: GLP-1 RA patients GE by GUS briefTitle: Investigation of the Evolution of Gastric Emptying by Gastric Ultra Sonography in Patients Treated With GLP-1 Receptor Agonists on a 7 Days Pausing Period. overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2026-05 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Geneva class: OTHER briefSummary: Glucagon-like-peptide-1 is a hormone released by the gut enteroendocrine cells. Its secretion occurs after each meal to enable production of insulin and inhibits the production of glucagon to lower after meal glycemia. It also inhibits gastric emptying and food intake. GLP-1 RA plays a role on GLP-1 receptors present on islet beta cells and delta cells of the pancreas to control insulin. GLP-1 receptors are also present in multiple region of the central nervous system such as the hypothalamus and hindbrain where it results in reducing food intake. For anesthesiologist it is important to understand how GLP-1 RA influence gastric emptying. Indeed, respecting a fasting period (6 hours for solid and 2 hours for liquid) before each surgery is one of the cornerstones of anesthesiology to significantly reduce the risk of pulmonary aspiration. One of the side effects of GLP-1 RA is slowing gastric emptying and increasing the risk of regurgitation in patient that observed a recommended fasting period. During 2023 a lot of cases reports have emerged of pulmonary aspiration or the presence of a full stomach in patient treated by GLP-1 RA for a type 2 diabetes. Despite recommendations made by the American Society of Anesthesiology, it is still unkown what is the best fasting period and how long patients should pause a long acting GLP-1 RA before surgery. In this observational study, we would like to determine the effect of GLP-1 RA on gastric emptying in patient scheduled for general anesthesia. We will measure and compare residual gastric content with gastric ultrasonography in patients treated by GLP-1 RA and in those who are not. We will also do these comparisons in a group of patients with type 2 diabetes treated by weekly GLP-1 RA at different days after the injection of the medication. Our hypothesis is that we will observe a reduction in gastric residue in patients who stopped weekly GLP-1 RA 7 days prior the examination compared to those who have stopped less days considering the same fasting period. This would lead us to propose an optimal duration of stopping time for GLP-1 inhibitors in the preoperative period. conditions: Diabetes Mellitus, Type 2 conditions: Anesthesia conditions: Pulmonary Aspiration of Gastric Contents studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Gastric Ultrasonography measure: Reduction of 5.5 cm2 of the CSA in patients pausing 7 days their GLP-1 RA treatment. measure: Correlation between a full stomach evaluated on gastric ultrasonography and gastric symptoms such as nausea and bloating. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06388200 id: OCU400-301 briefTitle: A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa acronym: liMeliGhT overallStatus: RECRUITING date: 2024-04-26 date: 2025-06-30 date: 2026-10-30 date: 2024-04-29 date: 2024-04-29 name: Ocugen class: INDUSTRY briefSummary: This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP.
This is a multicenter, assessor blinded and randomized study which will enroll 150 subjects. conditions: Retinitis Pigmentosa studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This is outcome assessor blinded study whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Sub-Retinal Administration of OCU400-301 measure: Number of participants with change in functional vision in the study eye of RP subjects as assessed by LDNA measure: Number of participants with change in functional vision in the study eye in Gene Agnostic group as assessed by LDNA measure: Number of participants with change in functional vision in the all treated eyes of RP subjects as assessed by LDNA measure: Number of participants with change in functional vision in the all treated eyes of subjects in Gene Agnostic Arm as assessed by LDNA measure: Number of participants with change in visual function in subjects with RHO mutation as assessed by LLVA letter score measure: Number of participants with change in visual function in Gene Agnostic Arm as assessed by LLVA letter scores measure: Ocular and non-ocular Events measure: Patients Global Impression of Change (PGIC) score sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Associated Retina Consultants status: RECRUITING city: Phoenix state: Arizona zip: 85020 country: United States name: Mallory Mintert, MS role: CONTACT phone: 480-999-5458 email: Mallory.mintert@doctrials.com name: Jillian Bollinger, BS role: CONTACT phone: 480-999-5458 email: Jillian.bollinger@doctrials.com name: Benjamin Bakall role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Retina Consultants of Texas status: NOT_YET_RECRUITING city: Bellaire state: Texas zip: 77401 country: United States name: Rebbeca C Taing role: CONTACT phone: 713-524-3434 email: rebbecca.taing@retinaconsultantstexas.com name: Kenneth C Fan, M.D, MBA role: PRINCIPAL_INVESTIGATOR lat: 29.70579 lon: -95.45883 hasResults: False
nctId: NCT06388174 id: S2022-0336 briefTitle: Idiopathic Generalized Epilepsy Syndromes overallStatus: RECRUITING date: 2023-01-01 date: 2026-12-31 date: 2033-12-31 date: 2024-04-29 date: 2024-04-29 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: The idiopathic generalized epilepsies (IGEs) have historically included the syndromes childhood absence epilepsy (CAE), juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and epilepsy with generalized tonic-clonic seizures alone (GTCA). Recognition of the IGEs is important for clinical care, as it informs diagnosis, prevents unnecessary investigation, allows optimal selection of anti-seizure medications (ASMs), and provides prognostic guidance.
According to the new ILAE definition in 2022, the study aims to describe the clinical features, electroencephalographic, imaging findings and long-term prognosis. conditions: Epilepsy conditions: Epilepsy, Idiopathic Generalized studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: The proportion of drug-resistent epilepsy measure: The proportion of seizure freedom measure: The proportion of psychiatric comorbidity measure: The proportion of psychosocial outcome measure: The proportion of seizure relapse after antiseizure medication withdrawn sex: ALL minimumAge: 4 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Chunhong Shen role: CONTACT phone: +86 0571 87783872 email: shen_neurology@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False
nctId: NCT06388161 id: Yan2022-0336 briefTitle: Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology overallStatus: RECRUITING date: 2023-08-01 date: 2025-12-31 date: 2030-12-31 date: 2024-04-29 date: 2024-04-29 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER name: Sir Run Run Shaw Hospital name: Ningbo Medical Center Lihuili Hospital name: Shaoxing People's Hospital briefSummary: Seizure is one of the most common symptoms in autoimmune encephalitis with neuronal surface-mediated antibodies. Interestingly, some patients may exhibit new-onset seizures as the initial manifestation without fulminant sign of encephalitis, particularly in the early stage.
It is essential to recognize these patients early and to perform antibody testing, as studies have reported early immunotherapy can improve their clinical outcomes. At the same time, it is important to limit the number of patients who require testing, for the sake of specificity and cost effectiveness. Thus, this prospective, multicenter study aims to identify neural antibodies in patients with focal seizures of unknown etiology, and to create a score to preselect patients requiring autoantibody testing. conditions: Epilepsy conditions: Encephalitis Autoimmune studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Detectable serum neural autoantibodies measure: Neuronal surface antibodies-mediated autoimmune- encephalitis measure: The proportion of seizure freedom measure: The proportion of drug-resistent epilepsy measure: Clinical severity and recovery sex: ALL minimumAge: 14 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China status: RECRUITING city: Hangzhou state: Zhejiang country: China name: Chun-Hong Shen role: CONTACT phone: +86 0571 87783872 email: shen_neurology@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False
nctId: NCT06388148 id: XL STROKE-2 briefTitle: Endovascular Treatment for eXtra-Large Ischemic Stroke acronym: XL STROKE-2 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-10-31 date: 2027-01-31 date: 2024-04-29 date: 2024-04-29 name: Zhongming Qiu class: OTHER name: The First Affiliated Hospital, University of South China name: Xiangtan Central Hospital name: Zhejiang University name: Longyan First Affiliated Hospital of Fujian Medical University briefSummary: The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion. conditions: Stroke, Acute Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 286 type: ESTIMATED name: Medical management name: Endovascular thrombectomy measure: Modified Rankin Scale score measure: Rate of successful reperfusion measure: Rate of excellent outcome measure: Rate of functional independence measure: Rate of independent ambulation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xiangtan Central Hospital city: Xiangtan state: Hunan zip: 421001 country: China lat: 27.85 lon: 112.9 facility: Xingguo County People's Hospital city: Ganzhou state: Jiangxi country: China hasResults: False
nctId: NCT06388135 id: SNC-01 briefTitle: Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05 date: 2027-05 date: 2024-04-29 date: 2024-04-29 name: Yang Jianjun, PhD class: OTHER briefSummary: Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC).
The efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated. Methods and analysis: A prospective, single-center, open-label cohort study will enroll 80 patients, with 40 patients allocated to the experimental group and 40 patients to the control group. Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab, cisplatin, and nab-paclitaxel, while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel. The primary efficacy endpoint will be the assessment of pathological complete response (pCR) following neoadjuvant therapy. Secondary efficacy endpoints will include major pathological response (MPR), disease-free survival, objective response rate (ORR), and monitoring of adverse events (AEs).
Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20242052-C-1). conditions: Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Serplulimab Combined With Nab-paclitaxel and Cisplatin name: nab-paclitaxel，Cisplatin measure: pCR measure: MPR measure: DFS measure: ORR measure: AEs sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06388122 id: 23-009689 id: NCI-2024-03405 type: REGISTRY domain: CTRP (Clinical Trials Reporting Program) id: MC240301 type: OTHER domain: Mayo Clinic briefTitle: DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2026-06-15 date: 2026-06-15 date: 2024-04-29 date: 2024-04-29 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor. conditions: HER2-negative Breast Cancer conditions: Hormone-receptor-positive Breast Cancer conditions: Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Biospecimen Collection measure: DiviTum®TKa assay as an early predictor of primary treatment resistance sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Pooja Advani, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False
nctId: NCT06388109 id: IRB15-00741 briefTitle: Positive Peers Intervention Clinical Trial acronym: PoPIT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-11 date: 2024-04-29 date: 2024-04-29 name: MetroHealth Medical Center class: OTHER name: Kent State University briefSummary: The goal of this clinical trial is to learn if the Positive Peers mobile app intervention increases rates of viral suppression in young (13-34 y/o) persons with HIV.
* complete online surveys at enrollment, 3 mo, 6, mo, 9 mo and 12 months. conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control trial with observational cohort for eligible patients who decline participation primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 250 type: ESTIMATED name: Positive Peers mobile app measure: Viral suppression measure: Correlates of app use and viral suppression measure: Correlates of app use and retention in care measure: Correlates of app use and HIV related perceived stigma sex: ALL minimumAge: 13 Years maximumAge: 34 Years stdAges: CHILD stdAges: ADULT facility: Northeast Valley Health Corporation city: Van Nuys state: California zip: 91405 country: United States name: Edgar Banuelos role: CONTACT email: edgarbanuelos@nevhc.org name: Herberth Osorio, MPH role: PRINCIPAL_INVESTIGATOR lat: 34.18667 lon: -118.44897 facility: Infectious Disease Practice- Rutgers University city: Newark state: New Jersey zip: 07103 country: United States name: Jared Khan role: CONTACT email: khanjj@njms.rutgers.edu name: Shoba Swaminathan, MD role: PRINCIPAL_INVESTIGATOR lat: 40.73566 lon: -74.17237 facility: Equitas Health city: Cincinnati state: Ohio zip: 45206 country: United States name: Tania Slack-Peterson role: CONTACT email: TaniaSlack@equitashealth.com name: Kelly Wesp, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Equitas Health city: Columbus state: Ohio zip: 43203 country: United States name: Tania Slack-Peterson role: CONTACT email: TaniaSlack@equitashealth.com name: Kelly Wesp, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Thomas Street Clinic city: Houston state: Texas zip: 77004-8004 country: United States name: Ernesto Linares Pineda role: CONTACT email: Ernesto.LinaresPineda@bcm.edu name: Shital Patel, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: UW Madison Clinic at Harborview city: Seattle state: Washington zip: 98104 country: United States name: Tala Mahmoud role: CONTACT email: talam2@uw.edu name: H Nina Kim, MD, MPH role: PRINCIPAL_INVESTIGATOR name: Raaka Kumbhakar, MD role: SUB_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False