hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06295731 id: INBRX106-01-201 id: EU CT type: OTHER domain: 2024-511323-34 briefTitle: INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2029-05 date: 2024-03-06 date: 2024-03-06 name: Inhibrx, Inc. class: INDUSTRY briefSummary: This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20. conditions: Head and Neck Squamous Cell Carcinoma (HNSCC) studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Phase 2: open label; Phase 3: double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 410 type: ESTIMATED name: INBRX-106 name: Pembrolizumab measure: Phase 2: Objective Response Rate (ORR) measure: Phase 3: Progression-Free Survival (PFS) measure: Phase 3: Overall Survival (OS) measure: Phase 3: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Clinical Benefit Rate (CBR) measure: Phase 3: Time to Chemotherapy (TTCtx) measure: Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference measure: TTCD in physical functioning (PF) measure: TTCD in role functioning (RF) measure: TTCD in Global Health Status/quality of life (GHS/QoL) measure: Incidence and severity of Adverse Events (AEs) measure: Number of patients who experienced abnormalities in vital signs and clinical laboratory parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06295718 id: 2023/51 briefTitle: Tele-assessment of Functional Performance and Quality of Life in Patients With Duchenne Muscular Dystrophy: Validity and Reliability Study overallStatus: ENROLLING_BY_INVITATION date: 2023-07-01 date: 2024-03-02 date: 2024-05-10 date: 2024-03-06 date: 2024-03-06 name: Sahra Şirvan class: OTHER briefSummary: Thanks to tele-assessment methods, it may be possible to evaluate DMD patients without traveling to clinical centers. In recent years, the applicability of remote assessment methods in DMD patients, as in many populations, is being investigated. However, studies have generally focused on a single evaluation parameter such as physical function, a special evaluation method or a special evaluation tool. The aim of this study is to investigate whether remote assessment of functional performance and quality of life in DMD patients is valid and reliable. If a valid and reliable tele-evaluation method that includes functional performance and quality of life parameters is found to be valid and reliable, the travel burden on patients and caregivers can be eased, patients\' stress and anxiety related to travel can be reduced, caregivers can save time and energy and provide patients with the best possible treatment. conditions: Duchenne Muscular Dystrophy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED measure: Timed Performance Tests measure: Brooke Upper Extremity Functional Classification (BUEFS) measure: Vignos Lower Extremity Functional Classification (VAEFS) measure: PedsQL-3.0 Neuromuscular Module by PedsQL Multidimensional Fatigue Scale sex: MALE minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: İstanbul University - Cerrahpaşa city: Istanbul zip: 34758 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06295705 id: 5230588 briefTitle: Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD) acronym: ASD overallStatus: RECRUITING date: 2024-04-02 date: 2025-04 date: 2025-04 date: 2024-03-06 date: 2024-04-11 name: Loma Linda University class: OTHER briefSummary: This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Hip-Hop Dance measure: Child Description of Impact on Social-Emotional Health measure: Parent Perspective of Impact on Social-Emotional Health measure: Change in Social-Emotional Behavior sex: ALL minimumAge: 7 Years maximumAge: 11 Years stdAges: CHILD facility: Loma Linda University Health status: RECRUITING city: Loma Linda state: California zip: 92350 country: United States name: Julie Kugel, OTD role: CONTACT phone: 909-558-4628 phoneExt: 47473 email: jkugel@llu.edu lat: 34.04835 lon: -117.26115 hasResults: False
nctId: NCT06295666 id: 26.12.2018/901 briefTitle: Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta overallStatus: COMPLETED date: 2019-02-19 date: 2019-11-25 date: 2020-01-20 date: 2024-03-06 date: 2024-03-06 name: Akdeniz University class: OTHER briefSummary: Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis conditions: Periodontitis conditions: Gingival Crevicular Fluid conditions: Interleukin 1-beta conditions: Bactericidal Permeability Protein studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ACTUAL measure: Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Akdeniz Üniversitesi Diş Hekimliği Fakültesi city: Antalya country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False
nctId: NCT06295653 id: 7-23 briefTitle: Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-30 date: 2025-04-30 date: 2024-03-06 date: 2024-03-06 name: Tanta University class: OTHER briefSummary: The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement. conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 26 type: ESTIMATED name: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane measure: measure changes in periimplant mucosal thickness measure: mid-buccal keratinized mucosal width sex: ALL minimumAge: 30 Years maximumAge: 55 Years stdAges: ADULT facility: Faculity of Dentistry Tanta University city: Tanta state: Elgarbia zip: 6620012 country: Egypt name: Faten a Seddiq, Faculty Dean role: CONTACT phone: 3335631 phoneExt: +20 email: dean_dent@unv.tanta.edu.eg name: ahmed a abdelsayed role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-03 uploadDate: 2024-03-03T10:57 filename: Prot_SAP_000.pdf size: 472866 hasResults: False
nctId: NCT06295640 id: 300/2022 briefTitle: Relative Contribution of Brain Insulin Action for Postprandial Metabolism acronym: BrainInsPPM overallStatus: RECRUITING date: 2024-03-18 date: 2025-12 date: 2026-01 date: 2024-03-06 date: 2024-03-27 name: University of Ulm class: OTHER briefSummary: The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women.
Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray. conditions: Glucose Metabolism Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, controlled, cross-over design for men. Randomized, controlled, 2x2 factorial cross-over design for women taking the menstrual cycle phase into account. primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Oral glucose tolerance test with double-tracer dilution and intranasal insulin spray name: Oral glucose tolerance test with double-tracer dilution and intranasal placebo spray measure: Endogenous glucose production measure: Rate of glucose disappearance measure: Proglucagon cleavage products measure: Glucose tolerance measure: Whole-body insulin sensitivity measure: Insulin secretion measure: Post-absorptive energy expenditure measure: Sex differences measure: Menstrual cycle effects measure: Autonomic nervous system activity sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Universityhospital Ulm status: RECRUITING city: Ulm zip: 89081 country: Germany name: Julia Hummel, Phd role: CONTACT phone: +4973150044744 email: julia.hummel@uniklinik-ulm.de name: Rebecca Spies, MD role: CONTACT email: rebecca.spies@uniklinik-ulm.de lat: 48.39841 lon: 9.99155 hasResults: False
nctId: NCT06295627 id: SYSKY-2024-115-01 briefTitle: The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies overallStatus: COMPLETED date: 2023-01-30 date: 2023-09-30 date: 2024-01-15 date: 2024-03-06 date: 2024-03-06 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: To explore the analysis of factors causing indwelling urinary catheter-related infections in ICU patients and their nursing strategies, and to provide reference for clinical nursing work. 291 patients with indwelling urinary catheters in the second area of ICU of our hospital from January 1, 2023 to September 30, 2023 were selected as research subjects. They were divided into infection group and non-infection group according to the presence or absence of urinary tract infection. Non-infection group The first group consisted of patients without urinary tract infection (278 cases), and the infection group consisted of patients with urinary tract infection (13 cases). A retrospective analysis method was used to analyze the causes of catheter-related urinary tract infection and the infecting bacteria of the two groups of patients. A single factor analysis was performed on various factors and other related factors, and corresponding nursing strategies were summarized and proposed. conditions: Catheter-associated Urinary Tract Infection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 291 type: ACTUAL name: There were no interventions in retrospective analysis measure: How many patients in the infected group and how many patients in the non-infected group had bladder irrigation measure: How many patients in the infected group and how many patients in the non-infected group were given enema measure: How many times the indwelling catheter was changed in patients in the infected group and patients in the non-infected group respectively measure: How many patients in the infected group and the non-infected group had co-diabetes sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital city: Canton state: Guangdong zip: 510030 country: China lat: 23.11667 lon: 113.25 hasResults: False
nctId: NCT06295614 id: SPARKL briefTitle: Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease acronym: SPARKL overallStatus: RECRUITING date: 2024-03-01 date: 2029-04-01 date: 2029-04-01 date: 2024-03-06 date: 2024-03-12 name: Ecole Polytechnique Fédérale de Lausanne class: OTHER briefSummary: The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-site, single-arm, non-blinded, non-randomized, interventional primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: ARC-IM System implantation measure: Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system. measure: 10-meter walk test measure: 6-minute walk test measure: Timed up and Go and its cognitive version measure: Freezing of gait circuit measure: Kinematic analysis measure: Muscle analysis measure: Mini Balance Evaluation Systems Test (mini-BESTest) measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III measure: King's Parkinson's disease Pain Scale (KPPS) measure: The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV. measure: Parkinson's Disease Questionnaire-39 (PDQ-39) measure: Activities specific Balance Confidence Questionnaire (ABC-Q) measure: The Freezing of Gait Questionnaire (FOG-Q) measure: Home-use kinematic monitoring measure: Daily falls tracking measure: Satisfaction questionnaire measure: User Evaluation of Satisfaction with technology (QUEST 2.0) measure: System Usability Scale (SUS) measure: Nerve conduction studies (NCS) measure: Somato-sensory evoked potential (SSEP) measure: Cortical signal recording measure: Kinematic analysis in different therapeutic conditions measure: Muscle analysis in different therapeutic conditions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Universitaire Vaudois (CHUV) status: RECRUITING city: Lausanne state: Vaud zip: 1011 country: Switzerland name: Jocelyne Dr Bloch, Prof. Dr. role: CONTACT lat: 46.516 lon: 6.63282 hasResults: False
nctId: NCT06295601 id: 2024/5591 briefTitle: Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-02-15 date: 2025-08-15 date: 2024-03-06 date: 2024-03-06 name: Inonu University class: OTHER briefSummary: This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 10 type: ESTIMATED name: Traditional rehabilitation name: Action observation therapy and motor imagery measure: Berg Balance Scale measure: Berg Balance Scale measure: Muscle strength and functional mobility measure: Muscle strength and functional mobility measure: Fatigue Severity Scale measure: Fatigue Severity Scale measure: Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire measure: Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06295588 id: STUDY00009135 id: T32CA102618 type: NIH link: https://reporter.nih.gov/quickSearch/T32CA102618 briefTitle: Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-03-06 date: 2024-03-06 name: University of Rochester class: OTHER name: National Cancer Institute (NCI) briefSummary: To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation. conditions: Fatigue conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Fucoidan extracted from F. Vesiculosus name: Fucoidan extracted from U. Pinnatifida measure: percentage of participants who are randomized to the study out of all participants approached measure: percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention measure: percentage of participants who take at least 80% of the fucoidan pills during the study measure: mean change in Brief Fatigue Inventory measure: mean change in plasma viscosity in blood measure: mean change in erythrocyte sedimentation rate in blood measure: mean change in thyroid stimulating hormone in blood measure: mean change in C-reactive protein in blood measure: mean change in leptin in blood measure: mean change in D Dimer in blood measure: mean change in TNF alpha in blood measure: mean change in neopterin in blood measure: mean change in lactase dehydrogenase in blood measure: mean change in procalcitonin in blood measure: mean change in frailty using a modified Fried's Frailty questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 hasResults: False
nctId: NCT06295575 id: ZZhang briefTitle: Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass overallStatus: COMPLETED date: 2021-06-01 date: 2022-07-01 date: 2022-07-01 date: 2024-03-06 date: 2024-03-06 name: Nanjing Children's Hospital class: OTHER briefSummary: A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora. conditions: Congenital Heart Disease conditions: Intestinal Disease conditions: Dysbiosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: probiotics containing Bifidobacterium infantis and Lactobacillus name: placebos containing lactose measure: incidence of morbidity measure: gastrointestinal functional recovery indicators measure: biomarkers measure: microbiome sex: ALL minimumAge: 1 Month maximumAge: 1 Year stdAges: CHILD facility: Children's Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210093 country: China lat: 32.06167 lon: 118.77778 hasResults: False
nctId: NCT06295562 id: CMUH112-REC3-201 briefTitle: Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-07-31 date: 2025-07-31 date: 2024-03-06 date: 2024-03-07 name: China Medical University Hospital class: OTHER briefSummary: This study will recruit 66 patients with obstructive sleep apnea, comprising 33 men and 33 women, who have been referred to the sleep center by their doctors for polysomnograms (PSG). The subjects will undergo two overnight sleep PSG sessions at the sleep center. The interval between the two examinations will be at least 7 days, during which they will receive both a placebo and medication conditions, administered 1 hour before bedtime. The study drugs will include: (1) atomoxetine 80 mg and oxybutynin 5 mg; or (2) venlafaxine 37.5 mg; or (3) atomoxetine 80 mg and trazodone 100 mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters. conditions: Obstructive Sleep Apnea of Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 66 type: ESTIMATED name: Atomoxetine 80mg combined with oxybutynin 5mg name: Venlafaxine 37.5mg name: Atomoxetine 80mg combined with trazodone 100mg name: Placebo measure: Physiological parameter measure: Endotypic traits measure: Sleep quality measure: Waking sleepiness sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06295549 id: LB2304-0001 briefTitle: Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma overallStatus: RECRUITING date: 2024-03-25 date: 2026-06-30 date: 2028-06-30 date: 2024-03-06 date: 2024-03-06 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER name: Nanjing Legend Biotech Co. briefSummary: A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma conditions: Relapsed and Refractory B-cell Non-Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: LUCAR-G39P cells product measure: Incidence, severity and type of TEAEs measure: Pharmacokinetics in peripheral blood measure: Pharmacokinetics in bone marrow measure: The recommended Phase II dose (RP2D) for this cell therapy measure: Overall Response Rate (ORR) measure: Progression-free survival (PFS) measure: Overall Survival (OS) measure: Time to Response (TTR) measure: Duration of Response (DoR) measure: Immunogenicity assessment of LUCAR-G39P cells sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital status: RECRUITING city: Nanjin state: Jiangsu zip: 210029 country: China name: Huayuan Zhu, PhD，MD role: CONTACT phone: 86 25 68306034 email: huayuan.zhu@hotmail.com name: Yeqin Sha, MD role: CONTACT email: yeqinsha@njmu.edu.cn hasResults: False