pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Association of Near Infrared Spectroscopy With Interstage Outcomes
NCT Number: NCT06538571
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Single-ventricle
Interventions: DIAGNOSTIC_TEST: Near infrared spectroscopy
Sponsor: Advocate Hospital System
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-01
Completion Date: 2026-07-01
Locations: Advocate Childrens Hospital, Oak Lawn, Illinois, 60453, United States

Summary:
The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)/arterial pulse oximetry value) with need for inpatient admission or intervention. Secondary aims will be to determine the correlation of the oxygen extraction ratio with weight gain, neurodevelopment, unexpected admissions, systemic ventricular strain by echocardiography, and Glenn hospitalization admission characteristics.

Primary Outcome Measures: Unexpected admissions, The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected admissions during the interstage period., 1 year|Unexpected interventions, The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected need for interventions such as cardiac catheterization interventions or surgical interventions, 1 year
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
NCT Number: NCT06538558
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Opioid Use Disorder
Interventions: DRUG: Tezampanel|DRUG: Placebo
Sponsor: Proniras Corporation
Collaborators: Indiana University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10-14
Completion Date: 2025-11-30

Summary:
This study is examining the use of Tezampanel (TZP) for treatment of Opioid Withdrawal Syndrome (OWS) in participants with Opioid Use Disorder (OUD). Participants will receive TZP or placebo (PBO) daily on Days 2 - 7 during a 7-day inpatient stay at the research center to determine safety, pharmacokinetic (PK) assessment, and efficacy of TZP for OWS.

Primary Outcome Measures: To evaluate systemic tolerability and safety of intravenous tezampanel administration., Monitoring incidence of dose-limiting toxicities, incidence and severity of treatment emergent adverse events., First Dose through Day 10 visit
Secondary Outcome Measures: To characterize Cmax (maximum concentration) of tezampanel, Samples will be collected and analyzed at various timepoints per protocol, Day 2 and Day 5 (multiple pre and post dose timepoints)|To characterize Area Under the Curve (AUC) concentration of tezampanel, Samples will be collected and analyzed at various timepoints per protocol, Day 2 and Day 5 (multiple pre and post dose timepoints)
The Effect Of Sitting Position On The Labor Process
NCT Number: NCT06538545
Acronym: POSİTİON
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy|Bleeding|Pain
Interventions: BEHAVIORAL: Sitting position is used in Experimental Arms 1-2
Sponsor: Cumhuriyet University
Sex: FEMALE
Age: ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-05-02
Completion Date: 2024-04-04
Locations: Hilal Güveri, Sivas, Sivas Merkez, 58000, Turkey|Cumhuriyet Üniversitesi, Sivas, 58000, Turkey

Summary:
This study was conducted to determine the effect of sitting position on the labor process. The randomized controlled experimental study was conducted in the delivery room of Sivas Numune Hospital.

Primary Outcome Measures: Visual analog scale is applied starting from the 1st stage of labor and until the end of the 2nd stage.If the VAS value is 10, it means there is a lot of pain, and if it is 0, it means there is no pain., The effect of sitting positions of pregnant women in the 38-42nd weeks of pregnancy on the birth process, 1 years
Anticariogenic Properties of Zamzam Water
NCT Number: NCT06538532
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Caries,Dental|Caries Active
Interventions: OTHER: Zamzam water
Sponsor: Al-Azhar University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-06-01
Completion Date: 2024-06-01
Locations: Faculty of Dental medicine for Girls Al Azhar university, Cairo, 4434103, Egypt

Summary:
The present study aims to evaluate and compare the effect of Zamzam water as mouthwashes in high caries-risk patients regarding:

i. Streptococcus mutans (S. mutans) count. ii. Oral pH. After 3 and 6 months interval.

Primary Outcome Measures: Streptomutans count, measurements of Colony forming unit (CFU) will be performed using blood agar and mitis salivarius-bacitracin agar (MSBA)., 3 months and 6 months|Salivary PH level, using pH meter, 3 months and 6 months|caries risk level, According to ADA, 3 months and 6 months
Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty.
NCT Number: NCT06538519
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hip Osteoarthritis
Interventions: PROCEDURE: total hip replacement using lateral approach|PROCEDURE: total hip replacement using anterior approach|DEVICE: gait analysis at 6wks, 3 months and 18 months
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2021-01-03
Completion Date: 2023-07-10
Locations: Ain Shams University Hospitals, Cairo, Abbasia, Egypt

Summary:
The goal of this Prospective Randomized Study is to confirm presence or absence of differences in gait mechanics in direct anterior and lateral approaches for total hip arthroplasty. and to compare the clinical outcomes of both approaches.

The main questions it aims to answer are:

if the anterior approach to the hip is faster recovery than lateral approach? if the anterior approach to the hip has better gait mechanics than lateral approach?

Participants will:

undergo one of the two approaches for total hip arthroplasty. All patients will be followed up at 2 weeks, 6 weeks, 3 months and 18 months. gait analysis will be done at 6wks, 3m, and 18months.

Primary Outcome Measures: surgery time, by ''Minute'' as the unit, no special description., intraoperative time starting from skin incision to skin closure|hemoglobin drop, hemoglobin drop level between pre and postoperative., postoperative day one|hospital stays, by ''Day'' as the unit, no special description. postoperative stay days from operation day to discharge day., immediately after the procedure|pain score, using visual analogue scale (VAS) from 0-10 the more scale the worst the pain, 2 weeks 6 weeks 3 months 18 months|Harris hip score, for measuring hip function from 0-100 the more the score the better hip function, 2 weeks 6 weeks 3 months 18 months
Secondary Outcome Measures: gait analysis, A single experienced physical medicine specialist will perform the gait analysis in a gait lab. Three-dimensional kinematic and kinetic data will be collected using eight high-speed infrared cameras (Quality motion analysis system, oqus 1 cameras), which can capture 240 frames per second, two force plates (Advanced Mechanical Technology Incorporated, AMTI), and 26 ten-millimeter passive retroreflective markers fixed on the subject using a double-face tape in specific landmarks on the subject in accordance to the modified institute Orthopedic Rizzoli (IOR ) model for full body marker set., at 6 weeks, 3 months, 18 months
Jumpstarting Advance Care Planning With ANAI People
NCT Number: NCT06538493
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Advance Care Planning
Interventions: BEHAVIORAL: JUMPSTART-ANAI
Sponsor: Southcentral Foundation
Collaborators: University of Arkansas|University of Washington|University of Colorado, Denver|Alaska Native Tribal Health Consortium|University of Alaska Fairbanks
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-01-01
Completion Date: 2027-05-30
Locations: Southcentral Foundation, Anchorage, Alaska, 99508, United States

Summary:
The older Alaska Native/American Indian (ANAI) population is increasing at twice the rate of the general population with a higher burden of serious illness. Older ANAI adults with serious illness are half as likely to have advance directives (AD), indicating a need for improved access to and utilization of advance care planning (ACP) to ensure that medical care aligns with the values, goals, and preferences of ANAI patients and their families throughout the illness trajectory. The major goals of this cluster randomized trial (CRT) are to (1) evaluate the comparative effectiveness of usual care and JUMPSTART- ANAI, a culturally tailored ACP communication intervention, for prompting patient-driven ACP conversations between ANAI adults and primary care providers and to (1) identify key factors to successfully implement the intervention in health systems serving ANAI adults with serious illness.

Primary Outcome Measures: Number of Participants with an Advance Directive in the Electronic Health Record (EHR), New advance directive scanned into EHR, Baseline, 3 months, 6 months, 12 months
Confirmatory Study of PRGN-2012 in Patients With RRP
NCT Number: NCT06538480
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Recurrent Respiratory Papillomatosis|Papillomavirus Infection|Papillomaviridae
Interventions: DRUG: PRGN-2012
Sponsor: Precigen, Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-11
Completion Date: 2029-03-01
Locations: National Institute of Health, Bethesda, Maryland, 20892, United States|University of Cincinnati, Cincinnati, Ohio, 45267, United States

Summary:
The purpose of this confirmatory study is to provide further demonstration of the efficacy of PRGN-2012 for the treatment of RRP in adults.

Primary Outcome Measures: Determine the percentage of subjects with a complete response following treatment with PRGN-2012, A complete response is defined as no requirement for surgical intervention in the 12 months after treatment, 1 year
Secondary Outcome Measures: Safety and tolerability, Incidence and severity of adverse events will be assessed through capture of adverse events, lab assessments and vital signs. Adverse events will be evaluated for causality, grade (Common Terminology Criteria for Adverse Events (CTCAE) v 5.0) and seriousness., 1 year
Dynamic Pattern of Etiology, Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia
NCT Number: NCT06538441
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Severe Pneumonia
Sponsor: Shanghai General Hospital, China
Collaborators: First Affiliated Hospital of Chongqing Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-12-30
Locations: Mei Kang, Shanghai, Shanghai, 200080, China

Summary:
The goal of this longitudinal observational study is to investigate the pathogen spectrum composition of severe pneumonia (SP) in different disease stages and to study the changes of immune inflammatory factors in patients with SP in different course of disease during and after the COVID-19 pandemic. The main questions it aims to answer is:

What is the pathogenic profile of SP patient admitted in intensive care unit (ICU) during and after COVID-19 pandemic? What is the dynamic pattern of etiology and immunoinflammatory factors of SP progression during the period in ICU? Are those indexes mentioned above associated with the prognosis of SP?

Primary Outcome Measures: In-hospital mortality, Number of Participants with fatal outcomes out of all participants, up to 3 months
Secondary Outcome Measures: length of stay in ICU, Number of days since admitted to ICU for each patient, through study completion, an average of 38 days|duration of mechanical ventilation, Number of days of mechanical ventilation treatment for each patient, through study completion, an average of 25 days
Methylation Patterns of the NUPR1, MGMT, NDRG2, and GLI1 Genes and Their Impact on Therapeutic Outcome of GBM Patients
NCT Number: NCT06538428
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: GBM
Interventions: GENETIC: DNA methylation profiling
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-09-01
Completion Date: 2022-12-09
Locations: Ain shams university hospital, Cairo, Egypt

Summary:
The study aimed to investigate the role of promoter methylation of MGMT, NUPR1, NDRG2, and GLI1 genes in glioblastoma multiforme (GBM) patients. Tissue samples were collected from GBM patients and individuals with non-neurooncological diseases (NND). The methylation status of the four genes was analyzed, and the clinical characteristics and survival of GBM patients were evaluated.

Primary Outcome Measures: GBM prognosis, Determine the prognostic and predictive significance of the DNA methylation patterns of the examined genes in Egyptian GBM patients. Using the EpiTect Methyl II PCR Kit, The methylation levels of four genes: MGMT, NUPR1, NDRG2, and GLI1 were measured. Then, using Spearman correlation, their levels were correlated with GBM progression and therapeutic response to the chemotherapeutic drug \[temozolomide\]., two years
Secondary Outcome Measures: Survival analysis, Obtained correlation between the studied epigenetic events and survival pattern may hopefully in the future direct the clinician to predict the response to standard treatment and provide a guide for proper management of GBM, two years
Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome
NCT Number: NCT06538415
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: Pulse Diet|OTHER: Control Rice Diet
Sponsor: University of Florida
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-09-01

Summary:
Skin health is influenced by the microbiome, lipids, oxidative stress, inflammation, and UV exposure. A 14-week trial with 50 women aged 45-65 will test if polyphenol-rich pulses improve skin health by affecting these factors. Using a white rice control diet, the study will measure skin parameters and analyze correlations with changes in lipids and microbiome, potentially proving the benefits of pulses.

Primary Outcome Measures: Change from baseline Skin color after UV radiation, Irradiation will be applied to dorsal skin (back, scapular region not typically exposed to the sun) with 2 times of minimal erythema dose using an FDA approved UVB phototherapy light and a UV light meter. At baseline, after 56 and 112 days, skin color will be measured before and 24 hours after irradiation. Skin color will be evaluated by a colorimeter using the 3-dimensional color system with L\*, a\*, and b\*-values. L\* and b\* values assess lightness and browning effects, respectively. The a\*-value (red/green-axis) is a measure for reddening (erythema)., 100 days|Change from baseline skin transepidermal water loss, Skin transepidermal water loss will be measured using a Tewameter to evaluate the water barrier function of the skin. The Tewameter measures the density gradient of the water evaporation from the skin (g/h/m\^2)., 100 days|Change from baseline skin erythema and melanin index, Skin erythema and melanin index ((Arbitrary Mexameter Units on a scale of 0-999) will be assessed with Mexameter. These two components are mainly responsible for the color of the skin. They are measured by reflectance., 100 days|Change from baseline skin pH plus, Skin pH will be measured using a Skin-pH-Meter., 100 days|Change from baseline skin hydration, Skin hydration (Arbitrary Units (AU) on a scale of 0-120) will be measured using a Skin Corneometer., 100 days|Change in skin microbiome, For skin swabbing, a 3x3-cm square on a forearm will be swabbed with a cotton swab soaked in 0.9% sodium chloride with 0.1% Tween-20 in a Z-stroke manner, 100 days|Change in oxidative stress, Concentration of Malondialdehyde (nmol/mL) in plasma will be determined as a marker of lipid peroxidation using a photometric method., 100 days|Change in inflammation, * Plasma concentration levels (pg/mL) of IL-6 proteins will be analyzed as inflammation biomarkers using ELISA kits.
* Plasma concentration levels (mg/mL) of C-reactive proteins will be analyzed as inflammation biomarkers using ELISA kits., 100 days
Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis: An Assessor-blinded, Randomized Controlled Trial
NCT Number: NCT06538402
Acronym: TESTIMONY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ulcerative Colitis|Familial Adenomatous Polyposis
Interventions: PROCEDURE: 10 cm pouch|PROCEDURE: 15 cm pouch
Sponsor: Odense University Hospital
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2038-09-01
Locations: Aarhus University Hospital, Aarhus, Denmark|Hvidovre Hospital, Hvidovre, Denmark

Summary:
The aim of this randomized controlled trial is to compare outcome after construction of an ileal (J-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery.

Primary Outcome Measures: Pouch dysfunction score, Ranges from 0 to 7.5, where a low score indicates good bowel function will little to no impact on quality of life, 1, 3, 5 and 10 years after surgery
Secondary Outcome Measures: Short Inflammatory Bowel Disease Questionnaire, Consists of 10 questions with a total score range from 10 (poor health-related quality of life) to 70 (good health-related quality of life), 1, 3, 5 and 10 years after surgery|Short-form (SF)-36, Consists of questions relating to 8 domains of life with a total score ranging from 0-100, with lower numbers indicating worse health status, 1, 3, 5 and 10 years after surgery|Postoperative complications using the Comprehensive Complication Index (CCI), The CCI is a continuous scale, where each postoperative complication as defined by Clavien-Dindo is assigned a weigth based on its severity. A total summarized score taking all complications into account is thus generated., 90 days after surgery|Pouch failure, Hazard ratio of pouch failure defined as an intended permanent ileostomy with or without pouch excision, 1, 3 and 5 years after surgery
Running Online Injury Prevention Feasibility Study
NCT Number: NCT06538363
Acronym: ROIPF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Musculoskeletal Injury
Interventions: BEHAVIORAL: Education|BEHAVIORAL: Generic Education
Sponsor: Simon Fraser University
Collaborators: Natural Sciences and Engineering Research Council, Canada
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-01-01
Locations: Simon Fraser University, Burnaby, British Columbia, V5A 1S6, Canada

Summary:
The main purpose of this study is to test the feasibility of a larger scale interventional study. The investigators want to understand whether data can be reliably collected data various different streams while participants follow a standard 12-week half-marathon training program, and whether participants follow training recommendations.

Primary Outcome Measures: Recruitment Rate, - The number of participants enrolled versus the target number., 4 weeks|Data Collection Compliance, * The percentage of participants who complete the online eligibility questionnaire, demographic intake questionnaire, weekly injury questionnaire, and exit questionnaire.
* The percentage of participants who reliably upload data from the shoe-embedded sensors after each run.
* The percentage of participants who consistently track their menstrual cycle with the MyNormative app.
* The percentage of participants who regularly record their runs with their GPS-enabled smartwatch and upload data to Strava., 12 weeks|Attendance, - Attendance rate at the initial in-person orientation session and optional in-person group runs., 16 weeks|Adherence to Training Recommendations, - Percentage of participants in the intervention group who follow the individualized training recommendations., 12 weeks|Training Program Compliance, - Percentage of completed prescribed training runs per week during the 12-week half-marathon training program., 12 weeks|Satisfaction and Usability, * Participant feedback on the ease of use and satisfaction with the shoe-embedded sensors, MyNormative app, and Strava integration. Measured during the exit questionnaire.
* Participant feedback on the clarity and usefulness of the training recommendations (both individualized and generic). Measured during the exit questionnaire., 12 weeks|Barriers and Facilitators, - Reasons provided by participants in the intervention group for following or not following the individualized training advice, as captured in the exit questionnaire., 12 weeks
Secondary Outcome Measures: Injury incidence, - Incidence and severity of running-related injuries reported weekly via the injury questionnaire. Injuries are defined according to the consensus definition of running injuries by Yamato et al ("musculoskeletal (originating from the bones, muscles, joints) that has restricted your ability to run in any way (distance, speed, duration) for at least 7 days or for 3 consecutive training sessions")., 12 weeks
Response to an Intervention With Omega-3 (RIO - Study)
NCT Number: NCT06538324
Acronym: RIO
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overweight|Hypertriglyceridemia
Interventions: DIETARY_SUPPLEMENT: Omega-3|DIETARY_SUPPLEMENT: HOSO
Sponsor: Universidad San Sebastián
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-30
Completion Date: 2025-12-31
Locations: Universidad San Sebastián, Valdivia, Los Ríos, 5090000, Chile

Summary:
The RIO-Study project is a randomized, controlled, double-blind, crossover trial aimed at determining the effectiveness of omega-3 fatty acids at nutritional doses on lipid metabolism and inflammation in overweight and hypertriglyceridemic individuals in Chile.

Primary Outcome Measures: Fasting TG (mg/dL), Baseline serum levels of circulating triglycerides, up to 6 weeks
Secondary Outcome Measures: Postprandial TG (mg/dL), Triglyceride concentration (mg/dL) measured by enzymatic colorimetric assay at baseline (fasting) and at 2, 4, and 6 hours after consumption of a standardized 50 g fat meal., up to 6 weeks|Change in mRNA expression levels of lipid metabolism genes in Peripheral Blood Mononuclear Cells (PBMCs), Fold change in mRNA expression of genes of lipid metabolism in PBMCs at 0h and 4h, measured by RT-qPCR, up to 6 weeks|Change in concentrations (pg/mL) of pro-inflammatory cytokines TNF-α and IL-6, Serum concentrations (pg/mL) of tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) measured by enzyme-linked immunosorbent assay (ELISA) at fasting (0h) and 4 hours postprandial following a standardized test meal, up to 6 weeks|Fasting serum Low-Density Lipoproteins, High-Density Lipoproteins, Very Low-Density Lipoproteins (mg/dL), Fasting levels before and after intake of omega-3 or HOSO, up to 6 weeks|Fasting plasma glucose concentration (mg/dL), Fasting levels before and after intake of omega-3 or HOSO, up to 6 weeks
Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease
NCT Number: NCT06538311
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Alzheimer Disease|Mild Cognitive Impairment|Logopenic Progressive Aphasia|Amnestic Symptoms
Interventions: DEVICE: Active rTMS|DEVICE: Sham rTMS
Sponsor: Massachusetts General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-05-01
Completion Date: 2025-03-01
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02129, United States

Summary:
In this research study we want to learn more about the effects of non-invasive brain stimulation on memory and brain-network function in cognitively unimpaired older adults and in patients with amnestic mild cognitive impairment (aMCI).

This study will use a form of non-invasive brain stimulation called repetitive Transcranial Magnetic Stimulation (rTMS). rTMS will slightly alter activity in an area of your brain that controls memory. Changes resulting from this stimulation will be measured with behavioral tests of memory and general cognition, as well as by taking images of your brain with Magnetic Resonance Imaging (MRI).

Participants will come in for one baseline visit followed by 10 days of daily rTMS study visits (Monday through Friday) and an evaluation visit. Then, there will be a 2-week break. After this break, they will return for another baseline visit, an additional 10 days of rTMS, and a final evaluation visit.

Primary Outcome Measures: Changes in Memory, This will include observed changes in memory as a result of the stimulation through neuropsychological testing., Baseline and post-treatment Day 11|Changes in Brain Network Connectivity, This will include observed changes in resting-state functional connectivity as a result of the stimulation., Baseline and post-treatment Day 11
Study to Investigate the Chemotherapy-Induced Peripheral Neuropathy (CIPN) Onset-Suppressing Effect and Safety of ONO-2910 in Patients With Breast Cancer Receiving Weekly Paclitaxel
NCT Number: NCT06538272
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy
Interventions: DRUG: ONO-2910|DRUG: Placebo
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-08-31
Completion Date: 2025-06-30
Locations: Fujita Health University Hospital, Aichi, Japan|Nagoya City University Hospital, Aichi, Japan|Nagoya University Hospital, Aichi, Japan|Funabashi Municipal Medical Center, Chiba, Japan|Medical Corporation Tesshokai Kameda Medical Center, Chiba, Japan|National Cancer Center Hospital East, Chiba, Japan|Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center, Fukuoka, Japan|Gunma Prefectural Cancer Center, Gunma, Japan|University of Tsukuba Hospital, Ibaraki, Japan|Social Medical Corporation Hakuaikai Sagara Hospital, Kagoshima, Japan|Nippon Medical School Musashikosugi Hospital, Kanagawa, Japan|Tokai University Hospital, Kanagawa, Japan|Kumamoto Shinto General Hospital, Kumamoto, Japan|Kumamoto University Hospital, Kumamoto, Japan|Okayama University Hospital, Okayama, Japan|Nahanishi Clinic, Okinawa, Japan|Osaka Breast Clinic, Osaka, Japan|Osaka Prefectural Hospital Organization Osaka International Cancer Institute, Osaka, Japan|Osaka Rosai Hospital, Osaka, Japan|Osaka University Hospital, Osaka, Japan|Yodogawa Christian Hospital, Osaka, Japan|Japanese Saitama Red Cross Hospital, Saitama, Japan|Saitama Medical University International Medical Center, Saitama, Japan|Shizuoka General Hospital, Shizuoka, Japan|Center Hospital of the National Center for Global Health and Medicine, Tokyo, Japan|National Cancer Center Hospital, Tokyo, Japan|Nippon Medical School Hospital, Tokyo, Japan|St. Luke's International Hospital, Tokyo, Japan|Tokyo Metropolitan Komagome Hospital, Tokyo, Japan|Toranomon Hospital, Tokyo, Japan

Summary:
To investigate the safety and CIPN onset-suppressing effect of ONO-2910 in participants receiving paclitaxel (PTX) weekly as chemotherapy for breast cancer in Japan.

Primary Outcome Measures: Efficacy evaluation：Proportion of participants with peripheral sensory neuropathy (NP)# of Grade 2 or higher by 12 weeks after the start of intervention, 12 week|Number of Participants with AE, Up to 101 days|Weight, Up to 87 days|body temperature, Up to 87 days|pulse rate, Up to 87 days|blood pressure, Up to 87 days|ECG heart rate, Up to 87 days|ECG RR interval, Up to 87 days|ECG PR interval, Up to 87 days|ECG QRS complex, Up to 87 days|ECG QT interval, Up to 87 days|ECG QTcF, Up to 87 days|Hematology, Up to 87 days|Clinical chemistry, Up to 87 days|Blood coagulation, Up to 87 days|Urinalysis, Up to 87 days|Pregnancy test, Up to 101 days|Viral test, baseline
Effects of tDCS Combined With Retrieval Practice on Semantic Memory in Patients With Schizophrenia
NCT Number: NCT06538259
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenic Patients
Interventions: DEVICE: Transcranial direct current stimulation (tDCS)-anodal group|DEVICE: Transcranial direct current stimulation (tDCS)-sham group
Sponsor: Northeast Normal University
Sex: ALL
Age: ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-07-24
Completion Date: 2024-04-15
Locations: Northwest Normal University, Lanzhou, Gansu, 730070, China

Summary:
The semantic processing deficit stands as a central feature of cognitive abnormalities in schizophrenia. Both transcranial direct current stimulation (tDCS) and retrieval practice have been demonstrated as external techniques capable of ameliorating the semantic processing deficit in individuals with schizophrenia. The inquiry examines whether the combined effect of tDCS and retrieval practice, following tDCS intervention targeting the left dorsolateral prefrontal cortex (L-DLPFC) in patients with schizophrenia, contributes to the preservation of semantic memory in these individuals.

Investigators recruited 52 patients diagnosed with schizophrenia from hospitals. After five consecutive days of tDCS intervention (2 mA × 20 mins, twice per day), Investigators administered a word list memorization task comparing retrieval practice and restudy strategies. Subsequently, Investigators observed their immediate and delayed memory performance through tests.

Primary Outcome Measures: The correct recall rate of word lists, The correct recall rate of word lists was calculated for each subject by the experimental assistant., 5mins to 24 hours|Adjusted Ratio of Clustering (ARC), Free recall organization was measured by the Adjusted Ratio of Clustering (ARC) scores, 5mins to 24 hours
Pain After Buffered Vs Non Buffered Articaine
NCT Number: NCT06538233
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pain
Interventions: DRUG: Buffered articaine|DRUG: Non buffered articaine
Sponsor: Cleveland Dental Institute
Sex: ALL
Age: ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2025-01-31
Locations: Clevland Dental Institute, Cleveland, Ohio, 44128, United States

Summary:
Pain after buffered versus non buffered articaine.

Primary Outcome Measures: Numerical Rate Scale (NRS), Pain during injection of buffered versus non-buffered articaine local anesthetic will be measured using NRS from 0 to 10, where 0 is no pain and 10 is the most unbearable pain ., Immediate
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer
NCT Number: NCT06538207
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Metastatic Pancreatic Cancer
Interventions: DRUG: ONO-4578|DRUG: ONO-4538|DRUG: Oxaliplatin|DRUG: Levofolinate|DRUG: Irinotecan|DRUG: Fluorouracil|DRUG: Gemcitabine|DRUG: Nab-Paclitaxel
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-01-13
Completion Date: 2024-11-30
Locations: National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan|Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan|Seirei Hamamatsu General Hospital, Hamamatsu-shi, Shizuoka, Japan|Juntendo University Hospital, Bunkyō-Ku, Tokyo, Japan|The University of Tokyo Hospital, Bunkyō-Ku, Tokyo, Japan|National Cancer Center Hospital, Chuo Ku, Tokyo, Japan|The Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo, Japan|Kyorin University Hospital, Mitaka-shi, Tokyo, Japan|Keio University Hospital, Shinjuku-Ku, Tokyo, Japan

Summary:
This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic cancer.

Primary Outcome Measures: Dose-limiting toxicities（DLT）, 28 days|Adverse event(AE), UP to 28 days after the last dose
Secondary Outcome Measures: Pharmacokinetics (Plasma concentration for ONO-4578), Up to 28 days after the last dose|Pharmacokinetics (Serum concentration for ONO-4538), Up to 28 days after the last dose|Overall response rate (ORR), Up to 2 years|Disease control rate (DCR), Up to 2 years|Overall survival (OS), Up to 2 years|Progression-free survival (PFS), Up to 2 years|Duration of response (DOR), Up to 2 years|Time to response (TTR), Up to 2 years|Best overall response (BOR), Up to 2 years|Percentage of change in the sum of tumor diameters of target lesions, Up to 2 years|Maximum percentage of change in the sum of tumor diameters of target lesions, Up to 2 years|Changes in tumor markers (CEA and CA19-9), Up to 2 years
Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis
NCT Number: NCT06538194
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lateral Epicondylitis
Interventions: PROCEDURE: Mesotherapy
Sponsor: Haydarpasa Numune Training and Research Hospital
Sex: ALL
Age: ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2024-08-01
Locations: Health Science University Haydarpasa Numune Research and Training Hospital, Istanbul, Uskudar, 34668, Turkey

Summary:
A total of 84 patients with lateral epicondylitis were included in the study. The patients were randomly assigned to 3 treatment groups: mesotherapy (n = 28), prolotherapy (n = 28), and control (n = 28). Patients were evaluated before treatment and at the 3rd and 8th weeks of treatment for pain severity measured with the Visual Activity Scale (VAS) during resting, activity, and at night, and for functional status with a short version of the upper limb-specific disabilities of the arms, shoulder, and hand (Quick-Dash) and Oxford Elbow Score.

Primary Outcome Measures: VAS, Measurement of Pain Severity. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')., All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.|short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash), Measurement of Functional Disability. The possible score ranges from 0 to 100 points. 0 points represent a complete, unrestricted function of the upper extremities, while 100 points represent the greatest possible functional impairment. The DASH score is one of the most established questionnaires for disorders of the upper limb., All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.|Oxford Elbow Score, Measurement of Functional Disability. The outcome can be interpreted based on a 48-point scale: 0-19, poor; 20-29, fair; 30-39, good; and 40-48, excellent, All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
Eye Soft Surgery for Facial Sinkynesis
NCT Number: NCT06538103
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Facial Paralysis|Sinkynesis
Interventions: PROCEDURE: Eye soft surgery|OTHER: Physical Rehabilitation
Sponsor: University of Catania
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2022-01-18
Completion Date: 2023-11-30
Locations: Arianna Di Stadio, Catania, Sicily, 95121, Italy

Summary:
Facial synkinesis (FS) is a distressing sequela of facial palsy (FP) characterized by involuntary, simultaneous movements of facial muscles occurring during voluntary facial expressions. Treatment of synkinesis is challenging, and preventive methods are needed.

This study evaluates the efficacy of physical facial nerve rehabilitation (PFNR) therapy alone versus PNFR with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis.

25 outpatients are randomized to receive either PFNR alone (neuromuscular retraining and Kabat proprioceptive neuromuscular facilitation) or PNFR and early (90 days after FP onset) eyelid surgery (involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion). Comprehensive otolaryngological assessments and Magnetic Resonance Imaging (MRI) will be conducted. Synkinesis progression was measured using Another Disease Scale (ADS) at baseline, 3 months 6 months, 12 months, and 24-months post-treatment. The data were analyzed with ANOVA, t-test, Chi-Square analyses.

Primary Outcome Measures: Sinkinesis, Presence or absence, 3, 6, 12, 24 months
Secondary Outcome Measures: Recovery of Facial motility, ADS will be used to evaluate the recovery of facial motility, 3, 6, 12, 24 months|Time to recover facial motility, Evaluation of months needed to recover, 3, 6, 12, 24 months
The Effect of Lying Position on Hemodynamic Parameters in Patients With Mechanical Ventilated and Spontaneously Breathing.
NCT Number: NCT06538051
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Position Sense Disorders|Hemodynamic Instability
Interventions: OTHER: lying positions
Sponsor: Aydin Adnan Menderes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-11-15
Completion Date: 2022-05-15
Locations: Sevil Olğun, Aydın, 09010, Turkey

Summary:
Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing.

Material and Methods: The research was carried out semi-experimentally with a single-group posttest design, between November 2021 and May 2022 in the Internal Medicine Intensive Care (ICU) Unit a University Hospital. The study of the sample consisted of 60 patients in the ICU. Data were collected with the patient identification form and the hemodynamic parameters follow-up form. The patients were given different lying positions for 3 days. Hemodynamic parameters were measured and recorded at the 10th minute, 1st hour and 2nd hour after position changes. The measurement results obtained were compared with one-way ANOVA test.

Primary Outcome Measures: Respiratory rate, The patients' respiratory rate were measured and compared separately in the supine semi-fowler's and lateral positions., Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.|oxygen saturation, The patients' oxygen saturation were measured and compared separately in the supine semi-fowler's and lateral positions., Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.|Arterial blood pressure, The patients' arterial blood pressure were measured and compared separately in the supine semi-fowler's and lateral positions., Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.|pulse rate, The patients' pulse rate were measured and compared separately in the supine semi-fowler's and lateral positions., Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
NCT Number: NCT06538038
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non Small Cell Lung Cancer|Epidermal Growth Factor Receptor Gene Mutation|Stage III Lung Cancer|Stage IV Lung Cancer
Interventions: DRUG: Osimertinib|DRUG: Osimertinib + Chemotherapy
Sponsor: PrECOG, LLC.
Collaborators: ECOG-ACRIN Cancer Research Group
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 538
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2029-08

Summary:
The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens.

Primary Outcome Measures: real-world Progression-Free Survival (rwPFS), Time from initiating therapy to progression or death without documented progression, From initiation of therapy to progression or death, up to 3 years
Secondary Outcome Measures: real-world Overall Survival (rwOS), Time from initial therapy to death from any cause., From initiation of therapy to death, up to 3 years|real-world time to treatment discontinuation (rwTTD), Time from treatment initiation (osimertinib or osimertinib + chemotherapy) to discontinuation of osimertinib., From initiation of therapy to discontinuation of osimertinib, up to 3 years
Other Outcome Measures: Patient-Reported Outcomes (PRO), Functional Assessment of Cancer Therapy-G7+1 Version 4 (FACT-G7+1), 3 years
TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer
NCT Number: NCT06538012
Acronym: BAH2472
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Lung Cancer|Lung Cancer Metastatic|Lung Cancer, Non-small Cell|Lung Cancer Recurrent
Interventions: BIOLOGICAL: Tumor Infiltrating Lymphocytes (TIL)|DRUG: Cyclophosphamide|DRUG: Fludarabine|DRUG: Interleukin-2|DRUG: Pembrolizumab
Sponsor: Essen Biotech
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2026-12-28
Locations: District One Hospital, Beijing, Beijing, 086-373, China

Summary:
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory lung cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to lung cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.

Primary Outcome Measures: Adverse Events, To characterize the safety profile of (TIL) and natural autologous TIL in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events., 6 months
Secondary Outcome Measures: Objective Response Rate (ORR), Proportion of patients with response per Response Evaluation Criteria in Solid Tumors, Up to 36 months|Disease Control Rate (DCR）, Percentage of patients that meet CR, PR and SD criteria set in this study, Up to 36 months|Duration of Response (DOR), The time length between the first confirmed objective response to the treatment and the subsequent disease progression, Up to 36 months|Progression-Free Survival (PFS), The time length between TIL infusion and confirmed subsequent disease progression, Up to 36 months
Anti-PD-1/PD-L1 Antibodies Plus Anti-VEGF Antibody Treatment in Patients With Advanced-Stage HCC
NCT Number: NCT06537908
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: Anti-PD-1/PD-L1 antibodies|DRUG: Anti-VEGF
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2029-12-31
Locations: Zhongshan Hospital Fudan university, Shanghai, China

Summary:
This study is being done to analyze the safety, tolerability, and efficacy of treatment using combination of anti-VEGF and anti-PD-1/PDL1 antibodies for patients with advanced hepatocellular carcinoma.

Primary Outcome Measures: Incidence of adverse events, Safety will be monitored by addressing and recording all adverse events (AEs), serious adverse events (SAEs) and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute Common Safety will be monitored by addressing and recording all adverse events (AEs), serious adverse events (SAEs) and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0., Up to 30 days after last treatment dose
Secondary Outcome Measures: Objective response rate(ORR), Evaluated by researchers based on the RECIST 1.1 standard, 5 years|Progression free survival(PFS), Evaluated by researchers based on the RECIST 1.1 standard, 5 years|To the relief time (TOR), Evaluated by researchers based on the RECIST 1.1 standard, 5 years|Duration of relief(DOR), Evaluated by researchers based on the RECIST 1.1 standard, 5 years|Disease Control Rate (DCR), Evaluated by researchers based on the RECIST 1.1 standard, 5 years|6-month survival rate, Evaluated by researchers based on the RECIST 1.1 standard, 6-month|12-month survival rate, Evaluated by researchers based on the RECIST 1.1 standard, 12-month