hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06285227, orgStudyIdInfo id: CM313-100001, briefTitle: Study of CM313 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Keymed Biosciences Co.Ltd, class: INDUSTRY, descriptionModule briefSummary: This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: CM313 injection, outcomesModule primaryOutcomes measure: Adverse event, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06285201, orgStudyIdInfo id: TJ202001BE104, briefTitle: Study of Felzartamab in Healthy Adult Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: TJ Biopharma Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design), conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: T, interventions name: R, outcomesModule primaryOutcomes measure: Primary PK Endpoint, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Hospital of Jilin University, status: RECRUITING, city: Jilin, state: Changchun, country: China, contacts name: Xiaojiao Li, Doctor, role: CONTACT, phone: +8613514314089, email: xingxingsuo123456@126.com, geoPoint lat: 43.85083, lon: 126.56028, hasResults: False
protocolSection identificationModule nctId: NCT06285188, orgStudyIdInfo id: APHP221174, secondaryIdInfos id: 2023-A01398-37, type: REGISTRY, domain: ID-RCB, briefTitle: Immunomonitoring of Mold Invasive Infections, acronym: IMMUNOFIL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Mold invasive infections are associated with an important mortality despite optimization of the antifungal treatment. In a few case reports, immune checkpoints inhibitors, initially developed for neoplastic diseases, have shown a potential beneficial effect in such devastating infections by restoring an efficient immune response. The investigators propose a longitudinal monitoring of the adaptative immune response, notably immune checkpoint expression on T cells, during mold invasive infections to help identify the patients who could benefit from the adjunction of immunotherapy and the optimal timing of such strategy., conditionsModule conditions: Invasive Fungal Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Immune checkpoint expression on T cells, secondaryOutcomes measure: Aspergillus/Mucorales FLUOROSPOT, secondaryOutcomes measure: T cell proliferation, secondaryOutcomes measure: Immune checkpoint expression on monocytes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Necker Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Alexandra SERRIS, MD, role: CONTACT, phone: +33 6 68 80 24 92, email: alexandra.serris@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06285175, orgStudyIdInfo id: APP-22-04497, briefTitle: REINVENT: A Brain and Muscle Computer Interface for Stroke, acronym: REINVENT, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, descriptionModule briefSummary: Stroke is a leading cause of adult disability in the United States. High doses of repeated task-specific practice have shown promising results in restoring upper limb function in chronic stroke (\>6 months after onset). However, it is currently challenging to provide such doses in standard clinical practice. At-home telerehabilitation services supervised by a clinician are a potential solution to provide higher-dose interventions. However, telerehabilitation systems developed for repeated task-specific practice typically require a minimum level of active movement. Therefore, severely impaired people necessitate alternative therapeutic approaches. Measurement and feedback of electrical muscle activity via electromyography (EMG) have been previously implemented in the presence of minimal or no volitional movement to improve motor performance in people with stroke. Specifically, muscle neurofeedback training to reduce unintended co-contractions of the impaired hand may be a targeted intervention to improve motor control in severely impaired populations. In this study, we examine the effects of a low-cost, portable, and modular EMG biofeedback system (Tele-REINVENT) for supervised and unsupervised upper limb telerehabilitation after stroke during a 6-week home-based training program that reinforces activity of the wrist extensor muscles while avoiding coactivation of flexor muscles via computer games., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: Tele-REINVENT, outcomesModule primaryOutcomes measure: Fugl Meyer Assessment - Upper Extremity, primaryOutcomes measure: Maximum EMG activity, primaryOutcomes measure: Corticomuscular coherence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Southern California, city: Los Angeles, state: California, zip: 90033, country: United States, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
protocolSection identificationModule nctId: NCT06285162, orgStudyIdInfo id: 69HCL23_1372, secondaryIdInfos id: 2024-A00294-43, type: OTHER, domain: ID-RCB, briefTitle: Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy, acronym: UFANI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: The Analgesia Nociception Index (ANI) reflects the balance between sympathetic and parasympathetic tone. It is based on a specific interpretation of the R-R interval variation. During fluid removal by net ultrafiltration in patients with fluid overload and continuous renal replacement therapy, some data suggest that haemodynamic variation could be induced by the autonomic nervous system. The study aims to investigate ANI variations in this context and their association with the haemodynamic variations observed., conditionsModule conditions: Critically Ill, conditions: Renal Replacement Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Percentage of changes in ANI., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel, city: Bron, zip: 69500, country: France, contacts name: Martin RUSTE, MD, role: CONTACT, phone: +33472118956, phoneExt: +33, email: martin.ruste@chu-lyon.fr, contacts name: Martin RUSTE, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Matthias JACQUET-LAGREZE, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, hasResults: False
protocolSection identificationModule nctId: NCT06285149, orgStudyIdInfo id: AKLD-22, briefTitle: Tace With Icaritin in First-line Treatment of Middle and Advanced HCC in Child Grade B Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus, TACE+Icaritin may potentially optimize treatment strategies for patients with poor liver function reserve., conditionsModule conditions: HCC, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Icaritin, outcomesModule primaryOutcomes measure: ORR, primaryOutcomes measure: PFS, secondaryOutcomes measure: Overall survival，OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06285136, orgStudyIdInfo id: SHEN-PJ-KE-2024-15, briefTitle: Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital of Kunming Medical University, class: OTHER, collaborators name: Institute of hematology hospital,Chinese Academy of Medical Sciences, collaborators name: Handan Central Hospital, collaborators name: Taian City Central Hospital, collaborators name: Tianjin People's Hospital, collaborators name: Guizhou Provincial People's Hospital, collaborators name: Central South University, collaborators name: Western Theater General Hospital, collaborators name: First Affiliated Hospital of Guangxi Medical University, collaborators name: Chengdu Jingdongfang Hospital, descriptionModule briefSummary: This study proposes to conduct a prospective, multicenter, single-arm study to explore the efficacy and safety of venetoclax in combination with high-dose decitabine (DEC3-VEN) in new diagnosed adult patients with AML, and to provide evidence for the optimal selection of clinical treatment regimens, which is planned to be conducted in 10 research centers across the country., conditionsModule conditions: Acute Myeloid Leukemia, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: DEC3-VEN, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Kunming Medical University., city: Kunming, state: Yunnan, country: China, geoPoint lat: 25.03889, lon: 102.71833, hasResults: False
protocolSection identificationModule nctId: NCT06285084, orgStudyIdInfo id: VALETUDO Trial (L4195), briefTitle: Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility, acronym: VALETUDO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2025-11-02, completionDateStruct date: 2027-02-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: The goal of this observationl study is to evaluate the possibility of building a Deep Learning (DL) model capable of analyzing electrocardiographic traces of athletes and providing information in the form of a probability stratification of cardiovascular disease.Researchers will enroll a training cohort of 455 participants, evaluated following standard clinical practice for eligibility in competitive sports. The response of the clinical evaluation and ECG traces will be recorded to build a DL model.Researchers will subsequently enroll a validation cohort of 76 participants. ECG traces will be analyzed to evaluate the accuracy of the model to discriminate participants cleared for sports eligibility versus participants who need further medical tests, conditionsModule conditions: Sports Cardiology, conditions: Preventive Cardiology, conditions: Electrocardiogram, conditions: Artificial Intelligence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 531, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: DL model accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ospedale Galeazzi-Sant'Ambrogio, status: RECRUITING, city: Milano, state: Lombardy, zip: 20157, country: Italy, contacts name: davide marchetti, MD, role: CONTACT, phone: +390283506734, email: davide.marchetti@grupposandonato.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06285071, orgStudyIdInfo id: NN7415-7557, secondaryIdInfos id: U1111-1274-4740, type: OTHER, domain: World Health Organization (WHO), briefTitle: Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2030-04-30, completionDateStruct date: 2030-04-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years., conditionsModule conditions: Haemophilia A, conditions: Haemophilia B, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Concizumab, outcomesModule primaryOutcomes measure: Number of adverse reaction (AR), secondaryOutcomes measure: Number of serious adverse reaction (SAR), secondaryOutcomes measure: Number of serious adverse event (SAE), secondaryOutcomes measure: Number of thromboembolic adverse event (AE), secondaryOutcomes measure: Number of shock/anaphylaxis AE, secondaryOutcomes measure: Number of treated spontaneous and traumatic bleeding episodes, secondaryOutcomes measure: Number of treated spontaneous and traumatic target joint bleeding episodes, secondaryOutcomes measure: Number of all treatment requiring bleeding episode, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novo Nordisk Investigational Site, city: Toshima, state: Tokyo, country: Japan, hasResults: False
protocolSection identificationModule nctId: NCT06285058, orgStudyIdInfo id: LUNAI, briefTitle: Deep Learning Model Predicts Pathological Complete Response of Lung Cancer Following Neoadjuvant Immunochemotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: This study presents the development and validation of an artificial intelligence (AI) prediction system that utilizes pre-neoadjuvant immunotherapy plain scans and enhanced multimodal CT scans to extract deep learning features. The aim is to predict the occurrence of pathological complete response in non-small cell lung cancer patients undergoing neoadjuvant immunochemotherapyy., conditionsModule conditions: Deep Learning Model, conditions: Pathological Complete Response, conditions: Non-small Cell Lung Cancer, conditions: Neoadjuvant Chemoimmunotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: No interventions, outcomesModule primaryOutcomes measure: the accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of predicting model, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06285045, orgStudyIdInfo id: 2060302-1703-05, briefTitle: Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-10-01, primaryCompletionDateStruct date: 2019-08-31, completionDateStruct date: 2019-08-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of Roujin Formula in the treatment of fibromyalgia syndrome(FMS)patients with blood deficiency and liver depression through a randomized,single-blind,placebo-parallel controlled exploratory clinical trial study,and to provide reliable clinical evidence for the treatment of fibromyalgia syndrome with Roujin Formula. 48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data., conditionsModule conditions: Fibromyalgia Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Roujin Formula, outcomesModule primaryOutcomes measure: The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline, primaryOutcomes measure: The change of the Visual Analogue Scale (VAS) for pain from baseline, secondaryOutcomes measure: The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline, secondaryOutcomes measure: The change of the Beck depression inventory(BDI) from baseline, secondaryOutcomes measure: The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Juan Jiao, city: Beijing, state: Beijing, zip: 100053, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False