pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Brief Mindfulness Intervention for Pain Before an In-clinic Orthopedic Procedure
NCT Number: NCT06471075
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Chronic Pain|Acute Pain
Interventions: BEHAVIORAL: Mindful Pain Management|BEHAVIORAL: Pain Psychoeducation
Sponsor: Florida State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-22
Completion Date: 2025-09-11
Locations: Tallahassee Orthopedic Clinic (TOC), Tallahassee, Florida, 32308, United States

Summary:
This project is a single-site, randomized controlled trial designed to investigate the impact of a 7-minute mindfulness intervention on pain among patients undergoing kyphoplasty or radiofrequency ablation.

Primary Outcome Measures: Change in Pain Unpleasantness Numeric Rating Scale, Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness., Immediately before to after 7-minute audio recording
Secondary Outcome Measures: Acute Pain, Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity., Immediately before to after 7-minute audio recording|Anxiety, Change in anxiety from baseline will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety., Immediately before to after 7-minute audio recording|Treatment Satisfaction, Treatment satisfaction at the visit's end will be measured with three, validated items (1. How satisfied are you with your medical care today?, 2. Was the visit/procedure tolerable?, 3. Would you have the same procedure again?), each scored on an 11-point, Likert-type scale ranging from 0 to 10. Higher scores represent greater treatment satisfaction, At the end of the medical provider visit - approximately 1 hour.
Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors
NCT Number: NCT06470997
Acronym: Pro-CHILI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Immune-mediated Hepatitis
Interventions: BIOLOGICAL: Blood sample collection|PROCEDURE: Liver biopsy
Sponsor: University Hospital, Montpellier
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-06-01
Locations: CHU de Montpellier, Montpellier, 34295, France

Summary:
Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.

Primary Outcome Measures: Determination of the area under the ROC (Receiver Operation characteristic) curve for hepatitis., Sensitivity/specialty curve of blood biomarkers identification and expression level by proteomic analysis, specific to immunotherapy-induced hepatitis (CHILI group), versus idiopathic autoimmune hepatitis (control group)., Baseline
Secondary Outcome Measures: Determination of the area under the ROC (Receiver Operation characteristic) curve for treatment response, Sensitivity/specialty curve of blood biomarkers identification and expression level by proteomic analysis, specific to response to treatments corticosteroids, UDCA (Ursodeoxycholic acid) established as part of the care)., Baseline, day 14, day 28, month 3, month 6|Responses to treatments, Response to corticosteroid and UDCA (Ursodeoxycholic acid) treatments being defined as a reduction in liver tests of 50%, Day 28
Ethics Education to Support Nurse Leaders in HealthCare
NCT Number: NCT06470984
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knowledge, Attitudes, Practice
Interventions: BEHAVIORAL: Educational intervention
Sponsor: OSF Healthcare System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2025-12-31

Summary:
Using an exploratory study design with an educational intervention, a pre/post evaluation of ethical confidence and competence will be completed for nursing leaders working in either acute care or post-acute care with primary purpose to increase ethical competency and confidence in decision making for nursing leaders in a clinical role.

Primary Outcome Measures: Ethical Competence Support Questionnaire, The ethical competence support questionnaire contains 27 items addressing four subcategories: encouragement of ethical activity, provision of information on ethical issues, dealing with ethical issues, and conversational support. A 5-point Likert Scale is used for measurement: Strong disagree to Strongly Agree. Minimum value = 1 maximum value =5., change from baseline in the ethical competence measure at 6-weeks.|Ethical Safety Questionnaire, The ethical safety questionnaire contains11 items addressing four subcategories: general ethical safety, ethical autonomy, ethical respect, and ethical competence. A 5-point Likert Scale is used for measurement: Strong disagree to Strongly Agree. Minimum value = 1 maximum value =5., change from baseline in the ethical safety measure at 6-weeks.
Secondary Outcome Measures: Ethical Confidence Assessment, Confidence as a nurse leader for ethical decision making is rated on a 1-10 scale. 0=not confident 10= very confident, change from baseline in the ethical competence measure at 6-weeks and at 3 mos.
Color Stability of Sectional and Full Glass Ceramic Laminate Veneer
NCT Number: NCT06470945
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spacing of Anterior Teeth
Interventions: PROCEDURE: Glass ceramic sectional veneer|PROCEDURE: Glass ceramic laminate veneer
Sponsor: October University for Modern Sciences and Arts
Sex: ALL
Age: ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2025-05-01
Locations: October University for Modern Sciences & Arts, Giza, Giza,6th October City, 12451, Egypt

Summary:
The aim of the study is to evaluate the color stability of full and sectional glass ceramic laminate veneer as esthetic failure is reported to be common failure in laminate following clinical service.

The null hypothesis is that there will be no apparent change in color stability between full and sectional veneer over one year of clinical service

Primary Outcome Measures: Color change, assessment of color change using spectrophotometer, Baseline,3,6,9,12 months
Secondary Outcome Measures: shade match, assessment of shade match using Modified USPHS, Baseline,3,6,9,12 months
Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure
NCT Number: NCT06470932
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Respiratory Diseases
Interventions: DIAGNOSTIC_TEST: Follow-up consult
Sponsor: University Hospital, Grenoble
Sex: ALL
Age: CHILD, ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-11
Completion Date: 2026-11

Summary:
This study aims to assess the quality of life of patients six months after admission to a pediatric intensive care unit for acute respiratory failure. Children's quality of life will be assessed using the PedsQL scale at 6 months. This is a prospective cohort diagnostic and prognostic study.

Primary Outcome Measures: Quality of life at 3 months, Quality of life at 3 months measured by PEDS QL (Pediatric Quality of Life) scale, scoring from 0 (good quality of life) to 92 (poor quality of life), 3 months
Online Exposure Therapy for Obsessive-Compulsive Disorder (OCD) Study
NCT Number: NCT06470893
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obsessive-Compulsive Disorder
Interventions: BEHAVIORAL: OCD-NET
Sponsor: University of Miami
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-15
Completion Date: 2025-09-01
Locations: University of Miami, Miami, Florida, 33136, United States

Summary:
The overarching goal of this protocol is to investigate mechanisms that influence symptom outcomes of exposure and response prevention (ERP) therapy for OCD. Mechanisms may include affective processes, learning factors, cognitive factors, or other constructs that could influence treatment outcomes. The study team will conduct this research within the context of an effective online treatment for OCD called OCD-NET. OCD-NET is bibliotherapy with coaching and its content is reflective of standard care for OCD.

Primary Outcome Measures: Change in OCD Symptoms Measured by Yale-Brown Obsessive Compulsive Scale-Second Edition (YBOCS-II), YBOCS-II scores range from 0-50, and higher scores indicate more severe illness, Baseline, up to 12 months (end of treatment)
Randomized Controlled Effectiveness Trial of VA S.A.V.E.
NCT Number: NCT06470867
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicide Prevention
Interventions: BEHAVIORAL: VA S.A.V.E.|BEHAVIORAL: Control training
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 710
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2025-04-01
Completion Date: 2028-03-31
Locations: VA Portland Health Care System, Portland, OR, Portland, Oregon, 97207-2964, United States

Summary:
Veterans are most likely to disclose suicidal thoughts to their close supports such as family and friends. These loved ones are, in turn, very interested in learning how to help a Veteran in need. Close supports are uniquely poised to provide a meaningful contribution to suicide prevention, if they can learn how to effectively promote Veterans' connection to care. VA S.A.V.E. (Signs; Ask; Validate; Encourage and Expedite) is a suicide prevention gatekeeper training specifically tailored to the Veteran community that teaches close supports how to identify signs of suicide risk and how to connect the at-risk person to professional treatment. The primary objective of this study is to evaluate the effectiveness of VA S.A.V.E. and to explore factors impacting its potential widespread implementation.

Primary Outcome Measures: Count of Gatekeeper Behaviors Used, Number of gatekeeper behaviors used (sum): Gatekeeper behaviors are comprised of three survey items: 1) ask if having suicidal thoughts ("\[In the past month\] how many times did you directly ask a person if they were having suicidal thoughts?"); 2) recommend professional treatment ("How many times did you tell a person having suicidal thoughts to see their doctor, go to the emergency room, call 911, or get any other professional treatment?"); and 3) provide suicide prevention hotline information ("How many times did you give a person having suicidal thoughts information about a suicide prevention hotline such as 988, the Veterans Crisis Line or Military Crisis Line?").

A higher score indicates a better outcome., 6-month follow-up
Secondary Outcome Measures: Ask if having suicidal thoughts, Count of Gatekeeper Behavior 1) Ask if having suicidal thoughts. A higher score indicates a better outcome., 6-month follow-up|Recommend professional treatment, Count of Gatekeeper Behavior 2) Recommend professional treatment. A higher score indicates a better outcome., 6-month follow-up|Provide suicide prevention hotline information, Count of Gatekeeper Behavior 3) Provide suicide prevention hotline information. A higher score indicates a better outcome., 6-month follow-up|Suicide Prevention Skills, 6-item, coder/clinician-administered scale that assesses: 1) Recognizing Signs of suicide risk; 2) Asking about presence of suicidal thoughts; 3) Validating the Veteran?s experience ; 4) Encouraging professional treatment and Expediting getting; 5) Asking about lethal means safety; and 6) empathy/expression of care, 3-month follow-up
Effect of Nebulized Dexmedetomidine on Post-dural Puncture Headache
NCT Number: NCT06470854
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post-Dural Puncture Headache
Interventions: DRUG: Nebulized Dexmedetomidine|PROCEDURE: Bilateral greater occipital nerve block
Sponsor: Tanta University
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2024-03-22
Locations: Tanta University, Tanta, El Gharbyia, 13511, Egypt

Summary:
Dural puncture during neuroaxial procedures is the most frequent major complication that causes the development of post-dural puncture headache (PDPH) in 16%-86% of cases. PDPH could be defined as severe positional headache that usually presents during the first 72-h following accidental dural puncture.

Dexmedetomidine (DXM) is a potent and highly selective α2-adrenergic agonist that was approved for ICU and procedural sedation in adults. Additionally, DXM has pleiotropic effects for its sympatholytic, amnestic, and analgesic properties. Regarding routes of administrations, DXM allows high flexibility and can be administered through intravenous (IV), intramuscular, buccal, intranasal and inhalational routes.

Nebulized DXM at 1 µg/kg is a favorable alternative to the intravenous route in short duration surgeries because it attenuates heart rate response to laryngoscopy. However, the effects of nebulized DXM on blood pressure are controversial.

it was assured that it has a role in reduction of the intraoperative anesthetic requirements and analgesic consumption.

The prophylactic and management strategies for PDPH are heterogeneous because of the absence of clear guidelines and protocols for the management of PDPH. However, the general plan for PDPH management consists of conservative treatment and if failed invasive procedures such as blood patch were applied.

Primary Outcome Measures: The extent of reduction of consumed analgesia, Efficacy of both modalities for relieve of Post Dural Puncture Headache in the women who included in the study., 5 Months
CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML
NCT Number: NCT06470841
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Myeloid Leukemia
Interventions: DRUG: CHG Combined With Venetoclax and Azacytidine
Sponsor: Navy General Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-20
Completion Date: 2028-12
Locations: Navy General Hospital, Beijing, Beijing, 100048, China

Summary:
The goal of this phase 2 trial is to test the safety and efficacy of CHG Combined With Venetoclax in treating patients with newly diagnosed AML.

Primary Outcome Measures: Overall Response Rate (ORR), ORR was defined as the proportion of patients who achieved CR or PR as their best response, 1 year
Secondary Outcome Measures: Overall Survival (OS), OS was defined as time from diagnosis to death from any cause or the last follow-up, through study completion, an average of 3 years|Progression Free Survival (PFS), For patients in morphologic remission, documented relapse was considered progression. Relapse following complete remission(CR) is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse., 2 years
ROADSTER 3 Extended Follow-up Sub-Study
NCT Number: NCT06470815
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Carotid Artery Diseases
Interventions: PROCEDURE: Transcarotid Artery Revascularization (TCAR)
Sponsor: Silk Road Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2029-07
Locations: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|Abbott Northwestern, Minneapolis, Minnesota, 55407, United States|Lancaster General Hospital, Lancaster, Pennsylvania, 17602, United States

Summary:
The study objective is to evaluate long-term outcomes for participants enrolled in the ROADSTER 3 study and treated with the ENROUTE Transcarotid Stent System (TSS) and ENROUTE Transcarotid Neuroprotection System (NPS).

Primary Outcome Measures: Ipsilateral Stroke, Ipsilateral stroke at 2-years, 3-years, 4-years, and 5-years following the index procedure, 2-years, 3-years, 4-years, and 5-years following the index procedure|Ipsilateral Stroke Mortality, Ipsilateral stroke mortality at 2-years, 3-years, 4-years, and 5-years following the index procedure, 2-years, 3-years, 4-years, and 5-years following the index procedure|In-stent Restenosis, In-stent restenosis ≥70% at 2-years and 5-years, 2-years and 5-years following the index procedure
Intervention of Shoulder Blood Flow Restriction Training on Shoulder Joint Pain and Function of Judo Athletes
NCT Number: NCT06470789
Acronym: whsu
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Dislocation|Blood Flow Restriction Training
Interventions: BEHAVIORAL: Shoulder blood restriction training
Sponsor: Yang Liu
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-09-15
Completion Date: 2024-05-30
Locations: YangLiu, Wuhan, Hubei, 430000, China

Summary:
To observe the effect of shoulder low load blood flow restriction training on pain, function, strength and joint motion of the subjects with shoulder joint dysfunction.

Primary Outcome Measures: Shoulder strength, In this study, a muscle force tester was used to measure the maximum force of the subjects' shoulders. During the measurement, the subjects were required to maintain supine and standing positions, and the maximum force of shoulder joint push, abduction, internal rotation and external rotation was measured in different positions. The strength test of each exercise session needs to be completed three times, each measurement interval of 30 seconds, and finally the average value of the three maximum strength values is taken., 6week|Shoulder joint range of motion Angle measurement, The measurement of shoulder joint range of motion mainly includes measuring the range Angle of shoulder joint abduction, external rotation and internal rotation under different postures (standing posture, supine posture)., 6week|Shoulder VAS score, In this study, the quantification of shoulder joint pain was carried out using the Visual Analogue Scale (VAS) . VAS is a common tool used to assess the level of pain or discomfort, including shoulder pain., 6week|Shoulder Constant-Murley scale, Shoulder Constant-Murley scale is a clinical evaluation tool used to evaluate shoulder function and severity of shoulder diseases, and is often used to evaluate the efficacy and rehabilitation progress before and after shoulder surgery. The scale includes assessments of shoulder joint range of motion, muscle strength, pain and function of daily living., 6week
Chatbot Counselling for Smoking Cessation in Youths
NCT Number: NCT06470776
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Use|Smoking Cessation
Interventions: BEHAVIORAL: Chatbot counselling|BEHAVIORAL: Peer counselling
Sponsor: The University of Hong Kong
Collaborators: Health and Medical Research Fund
Sex: ALL
Age: CHILD, ADULT
Enrollment: 154
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-07
Completion Date: 2025-10-31
Locations: HKU Youth Quitline, Hong Kong, Hong Kong

Summary:
The goal of this pilot trial is to develop and examine the trial feasibility and acceptability of a chatbot for smoking cessation in youth smokers. Specific aims include:

1. To assess how many youth smokers accept the invitation to participate in the trial
2. To assess the retention of the participants through 6 months after treatment initiation
3. To assess the acceptability of the chatbot in terms of participants' compliance and usability rating of the chatbot.
4. To estimate the intervention effect on abstinence outcomes
5. To explore the participants' perception and experiences in the chatbot

Primary Outcome Measures: Biochemically-validated tobacco abstinence, Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL), 6 months after randomisation|Recruitment rate, Number of participants divided by the number of eligible subjects, Through recruitment completion, about 9 months|Retention rate, Number of participants completed the follow-up divided by the number of participants, 6 months
Secondary Outcome Measures: Self-reported 7-day point-prevalence tobacco abstinence, Being completely smoke-free in the past 7 days, 3 months after randomisation|Self-reported 7-day point-prevalence tobacco abstinence, Being completely smoke-free in the past 7 days, 6 months after randomisation|Self-reported 30-day point-prevalence tobacco abstinence, Being completely smoke-free in the past 30 days, 3 months after randomisation|Self-reported 30-day point-prevalence tobacco abstinence, Being completely smoke-free in the past 30 days, 6 months after randomisation|Self-reported 24-hour quit attempt, Serious attempt to quit smoking for 24 hours or longer in daily smokers, 3 months after randomisation|Self-reported 24-hour quit attempt, Serious attempt to quit smoking for 24 hours or longer in daily smokers, 6 months after randomisation|Self-reported 50% smoking reduction, Smoking reduction by at least half of the baseline daily number of cigarettes in continued smokers, 3 months after randomisation|Self-reported 50% smoking reduction, Smoking reduction by at least half of the baseline daily number of cigarettes in continued smokers, 6 months after randomisation
A Study Evaluating ANV600 Single Agent or in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (EXPAND-1)
NCT Number: NCT06470763
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Solid Tumor
Interventions: DRUG: ANV600|DRUG: ANV600 + pembrolizumab (KEYTRUDA®)
Sponsor: Anaveon AG
Collaborators: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-02
Locations: Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States|Oncopole Claudius Regaud, Toulouse, Toulouse, France|START Madrid CIOCC, Madrid, Spain|Ente Ospedaliero Cantonale - Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland|Cantonal Hospital St Gallen, St Gallen, Switzerland

Summary:
The purpose of study ANV600-001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity and antitumor activity of ANV600 administered as a single agent or in combination with pembrolizumab in adult participants with advanced solid tumors.

Primary Outcome Measures: Phase I dose escalation: Incidence of Dose Limiting Toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab combination with pembrolizumab, Day 1 up to 24 months|Phase I dose escalation: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab, Day 1 up to 24 months|Phase II: Objective Response Rate (ORR) using RECIST v1.1, Day 1 up to 24 months|Phase II: Duration of Response (DOR) using RECIST v1.1, Day 1 up to 24 months
Secondary Outcome Measures: Phase I Dose escalation: Serum concentration of ANV600 following a single dose and after repeated dosing, Day 1 up to 24 months|Phase I Dose escalation: Immunogenicity as indicated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (nAb), Day 1 up to 24 months|Phase I Dose escalation: Objective response rate (ORR) using RECIST v1.1, Day 1 up to 24 months|Phase I Dose escalation: Duration of response (DOR) using RECIST v1.1, Day 1 up to 24 months|Phase II: Progression-free survival (PFS), Day 1 up to 24 months|Phase II: Overall Survival (OS), Day 1 up to 24 months|Phase II: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab, Day 1 up to 24 months|Phase II: PK parameters based on ANV600 serum levels following a single dose and after repeated dosing, Day 1 up to 24 months|Phase II: Immunogenicity as indicated by the incidence of antidrug antibodies (ADA) and neutralizing antibodies (nAb), Day 1 up to 24 months
Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) With Advanced Prostate Cancer (CaP)
NCT Number: NCT06470750
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Advanced Prostate Adenocarcinoma|Metastatic Prostate Adenocarcinoma|Stage III Prostate Cancer AJCC v8|Stage IVB Prostate Cancer AJCC v8
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 77
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2026-07-30
Locations: Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States

Summary:
This study evaluates the possibility of patient-centered home care as a new model of cancer care to reduce disparities and improve health related quality of life and patient-reported outcomes in Black patients with advanced prostate cancer.

Primary Outcome Measures: Feasibility of Patient-centered Home Care (PCHC), Participants will be asked to fill in a brief questionnaire regarding: patient preference for location of therapy (at the infusion center or in the home); perceived difficulties (isolation, less contact with hospital staff and other patients, feeling less secure with less back-up outside the hospital setting, the possibility of equipment malfunctions and complications in the home setting); and advantages (less travelling to specialized medical facilities, reduced risk of hospital acquired infections or blood clots, the ability to receive treatment in the comfort and security of the home, less disruption to family life, increased feeling of control over treatment and illness). Feasibility will be assessed based on responses to the questionnaire., Up to 6 months
Secondary Outcome Measures: Time to emergency room visit, Time to first emergency room visit will be recorded., Up to 6 months|Time to hospital visit, The time to first hospitalization will be recorded., Up to 6 months
Mapping of Electrical Properties in the Brain
NCT Number: NCT06470711
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Malignant Glioma
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2026-11-30
Locations: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States

Summary:
This study evaluates imaging methods for monitoring neural and electrical activity in the brain for improving clinical diagnosis.

Primary Outcome Measures: Identify diffusion MRI metrics [using conductivity tensor imaging (CTI)] that inform of regional electrical properties in the brain, At least 4 normal white matter regions of the brain will be analyzed. Fractional anisotropy (FA) and optimized diagnostic imaging (ODI) values will be compared to determine alignment within normal healthy white matter tracts (e.g. cortical spinal tract, corpus callosum)., Baseline
Prophylactic Prostatectomy for Prostate Cancer (PPPC)
NCT Number: NCT06470685
Acronym: PPPC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer|Genetic Predisposition to Disease|BRCA Mutation
Interventions: BEHAVIORAL: Qualitative Research Interviews
Sponsor: Royal Marsden NHS Foundation Trust
Collaborators: Institute of Cancer Research, United Kingdom
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-24
Completion Date: 2025-06-24

Summary:
Prostate cancer affects 1-in-8 people assigned male at birth in the UK and kills almost 12,000 annually. Half the cases occur due to genetic factors. These include rare highly-penetrant mutations such as BRCA2 as well as a combination of common genetic variants. A 'polygenic risk score' can be used to identify people who may develop more aggressive forms of the disease. Prophylactic, or 'risk-reducing' mastectomy and oophorectomy has been shown to prevent mortality and be acceptable for healthy women with known genetic risks. There is no such evidence as yet of the benefits of similar surgery for people at a higher genetic risk of developing prostate cancer. However, this question is often posed in clinic by people who carry pathogenic variants in BRCA2. In the future we propose to develop a feasibility study offering prophylactic prostatectomy to people based on their high genetic risk.

Prior to this, we wish to undertake this pilot qualitative study to better understand patients' perspectives on the acceptability of the procedure. Prostatectomy carries risks, with potential impact on erectile function and urinary continence. In this year-long project we will conduct up to 20 semi-structured interviews with patients and public to explore acceptability and to identify informational and support needs envisaged by men contemplating prophylactic prostatectomy. We will invite people aged over 18 to take part. We will include a wide range of perspectives including those at higher genetic risk or a strong family history of prostate cancer, as well as those with unknown or normal genetic risk factors. We will include people from different socio-economic backgrounds and those of black ethnicity who carry a higher risk. They will be recruited from existing prostate cancer screening studies and from community organisations with expertise in working with under-served communities.

Primary Outcome Measures: What would be the uptake of prophylactic prostatectomy?, To explore people's understandings, views and opinions on hypothetical prophylactic prostatectomy for those at high genetic risk of developing prostate cancer., Opinions collected and analysed over 12 months
Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer
NCT Number: NCT06470672
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Advanced Breast Cancer|Hormone-receptor-positive Breast Cancer|Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Interventions: DRUG: SHR-A1921|DRUG: Adebrelimab
Sponsor: Fudan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-07
Locations: Fudan Cancer Hospital, Shanghai, Shanghai, 200230, China

Summary:
Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.

Primary Outcome Measures: ORR by investigator, ORR (Objective response rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1., At baseline, at the time point of every 6 weeks, up to 2 years
Secondary Outcome Measures: DCR by investigator, DCR (Disease control rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1., At baseline, at the time point of every 6 weeks, up to 2 years|DoR (Duration of Response), DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression., Up to 2 years|PFS (Progression-Free Survival), PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression)., Up to 2 years|OS (Overall Survival), OS is the time from the date of first dose until the date of death by any cause., Up to 2 years|Safety (incidence rate of adverse event), An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experienced an adverse event and discontinued study drug due to an AE., From time of informed consent provided to 3 months after the last dose of study therapy
Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.
NCT Number: NCT06470646
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hemodialysis Access Failure
Interventions: PROCEDURE: Endovascular therapy
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2026-12-31
Locations: Renji Hospital, Shanghai, Shanghai, China

Summary:
This study is a prospective, single-center real-world research, aiming to understand the clinical intervention effects and health economics value of various endovascular treatment methods for arteriovenous graft fistula failure in the real world. The target lesion is defined as the inflow tract (artery, anastomosis, bend), middle segment, and outflow vein of the dialysis pathway. The study will recruit 240 patients with arteriovenous graft fistula failure at a single center from September 2023 to December 2024. Depending on different treatment methods, patients will be divided into several subgroups, such as the simple balloon dilation group, drug balloon group, stent implantation group, etc. As this is a real-world study, the main observations will be the technical success rate of various endovascular treatment methods, major adverse events during the perioperative period, and the symptom-driven target lesion re-intervention rate, target vessel patency rate, and total hospital expenditure related to target lesions at 1, 6, 12, 18, and 24 months postoperatively.

Primary Outcome Measures: Clinically-driven target lesion re-intervention, Clinically-driven target lesion re-intervention refers to a repeat procedure performed on a previously treated lesion due to the recurrence of symptoms or other clinical indications, rather than being routinely scheduled., 1-month、6-month、12-month、18-month、24-month
Secondary Outcome Measures: target lesion primary patency, Target lesion primary patency refers to the treated lesion site remaining open and unobstructed without the needfor any additional revascularization procedure during the follow-up period., 1-month、6-month、12-month、18-month、24-month|target lesion assisted primary patency, Target lesion assisted primary patency refers to the treated lesion site remaining patent(open) during the follow-up period,but requiring an additional revascularization procedure,such as percutaneous transluminal angioplasty,to maintain patency of the target lesion., 1-month、6-month、12-month、18-month、24-month
To Evaluate the Efficacy of Adebrelimab Combined With Chemotherapy After HIFU Induction Neoadjuvant Therapy HR+/HER2- Breast Cancer
NCT Number: NCT06470633
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer|HR+/HER2- Breast Cancer
Interventions: DRUG: Adebrelimab|PROCEDURE: High Intensity Focused Ultrasoun（HIFU）|DRUG: Cyclophosphamide|DRUG: Epirubicin|DRUG: Docetaxel
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Collaborators: Jiangsu Hengrui Pharmaceuticals Co.,Ltd
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-31

Summary:
To explore the efficacy and safety of adebrelimab combined with chemotherapy (epirubicin + cyclophosphamide →docetaxel) neoadjuvant therapy early HR+/HER2- breast cancer with high risk factors after the induction treatment of HIFU and adebrelimab.

Primary Outcome Measures: tpCR, total pathologic complete response rate（lymph node and breast）, 6 months
Secondary Outcome Measures: bpCR, breast pathologic complete response rate, 6 months
The Relationship Between Pelvic Floor Muscle Function and Hip Pain Among Women
NCT Number: NCT06470620
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Incontinence Stress|Incontinence|Hip Pain Chronic
Interventions: DIAGNOSTIC_TEST: pelvic floor muscle assessment
Sponsor: University of Haifa
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-06
Locations: Haifa University, Department of PHysical Therapy, Haifa, 31905, Israel

Summary:
This study examines the relationship between pelvic floor muscle (PFM) function and self-perception of PFM contraction with hip pain, their severity, and hip muscle strength.

In addition, it will examines the association between PFM function, and anxiety.

Primary Outcome Measures: International Consultation on Incontinence Questionnaire, evaluating the frequency, severity and impact on quality of life of urinary incontinence. The score ranges from 0-21, with a higher score indicating greater severity, baseline|pelvic floor muscle function assessed as correct movement of the urinary bladder, upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound. Upward movement is considered the correct direction describing good function of pelvic floor muscles, baseline|urinary bladder displacement in millimeters, bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool, baseline|pelvic floor muscles endurance of contraction in seconds, The participant is instructed to contract pelvic floor muscle and hold the contraction as long as possible. bladder status on ultrasound is assessed. When the bladder starts to move downward from its position the examination ends. (measured in sec)., baseline
Secondary Outcome Measures: muscle strength, hip muscle abduction sill be measure via hand held dynamometer, baseline|hip function assessment, International Hip Outcome Tool 12 questionnaire. range 0-100, with a high score indicates a high quality of life, baseline|self-reporting of fear and anxiety of hip pain regarding quality of life, Hospital Anxiety \& Depression Scale, baseline|hip range of motion, range of motion will be assessed with goniometer, baseline|function assesment, single leg squat, baseline
The Lymphocytic Infiltrate of Lung Tumors.
NCT Number: NCT06470607
Acronym: TREGILC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer|Immune System
Sponsor: Scientific Institute San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-20
Completion Date: 2028-01-31
Locations: Scientific Institute Ospedale San Raffaele, Milan, 20132, Italy

Summary:
The study is configured as a monocentric observational transversal biological study.

The main objective of the study is the reconstruction of the molecular organization of tumors of the thoracic cavity, in particular non-small cell lung cancer (NSCLC).

The study involves the collection of clinical data and biological material (blood and tumor tissue) from 70 subjects diagnosed with thoracic tumors.

Primary Outcome Measures: LYMPHOCYTE ISOLATION, the collection of lymphocytes, and their sequencing and analysis of differentially expressed genes., from enrollment in the study to surgery at 15 days
Secondary Outcome Measures: Lymphocyte gene expression, Analysis of gene expression and translational activity of lymphocyte cells (CD4+), from surgery to processing within 48 hours
Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes
NCT Number: NCT06470594
Acronym: ESPRIMO-CCR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Endometriosis
Sponsor: University of Campania "Luigi Vanvitelli"
Sex: FEMALE
Age: ADULT
Enrollment: 138
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-29
Completion Date: 2026-06
Locations: University of Campania Luigi Vanvitelli, Napoli, 80138, Italy

Summary:
Primary aim of this study is to evaluate the change in systemic inflammation parameters after surgery for superficial, ovarian or deep endometriosis. Secondary objectives focus on correlating these parameters to clinical outcomes, in patients with pelvic pain, and reproductive outcomes, in women desiring offspring.

Participants already scheduled for surgery as part of their endometriosis care will be followed regarding the abovementioned outcomes after calculation of pre and postsurgical systemic inflammation markers (neutrophil to lymphocyte ratio; platelet to lymphocyte ratio and lymphocyte to monocyte ratio)

Primary Outcome Measures: Neutrophil to lymphocyte ratio, Measured before and after (24 to 72 hours) surgery
Secondary Outcome Measures: Platelet to lymphocyte ratio, Measured before and after (24 to 72 hours) surgery|Lymphocyte to monocyte ratio, Measured before and after (24 to 72 hours) surgery
MACE in Different Drug-Eluting Stents
NCT Number: NCT06470529
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease|Stent Restenosis
Interventions: DEVICE: drug eluting stents
Sponsor: Shiraz University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4159
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-03-01
Completion Date: 2021-07-01
Locations: Shiraz University of Medical Sciences, Shiraz, Fars, 713481433, Iran, Islamic Republic of

Summary:
In this retrospective cohort study, all patients from Iranian registry were recruited and follow up after 5 years were recorded for MACE, and its relation to type and demographic data were evaluated

Primary Outcome Measures: Major adverse coronary events, Total sum of Myocardial infarction (MI), Hospital admission, Death, reoperation or re PCI,, 5 years
Effect of Psycho-Educational Program and Relaxation Training on Resilience Among Women With Breast Cancer
NCT Number: NCT06470490
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Women With Breast Cancer
Interventions: BEHAVIORAL: psychoeducational
Sponsor: Abeer Abd Elwahed Almowafy
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-01-07
Completion Date: 2024-05-02
Locations: Faculty of Nursing, Assiut, Egypt

Summary:
Aim: To evaluate the effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer.

Design: Randomized controlled trials used a pretest and posttest design to determine the effect of psychoeducational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer presenting to breast clinics in Assiut, Egypt. The women were randomly allocated to the intervention group and control group.

Method: Data collection took place at the outpatient clinic at the Assiut University in South Egypt Cancer Institute. The study involved a total of 100 participants diagnosed with breast cancer recruited using a purposive sampling method, who were categorized into two groups, each comprising 50 women. Group 1 received a psychoeducational program and relaxation training, while Group 2 received only routine care without the psychoeducational program. Inclusion criteria were age ranging from 20 to 60 years, consent to research participation, and nonmetastatic breast cancer diagnosis. The investigators excluded failing to engage regularly in the psychoeducational program, suffering from a significant illness other than breast cancer, having a history of persistent psychological illnesses, and using psychiatric medications.

Primary Outcome Measures: Measurement tool: questionnaire The psychoeducational intervention employed was effective in enhancing resilience and self-esteem while changing psychological distress among women diagnosed with breast cancer, The effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer, 5 months
Molecular Characteristics of Phlegm-heat Syndrome in Ischemic Stroke
NCT Number: NCT06470477
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ischemic Stroke, Acute
Interventions: DRUG: Guideline-based treatment
Sponsor: Dongzhimen Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2024-12-31
Locations: Dongzhimen Hospital, Beijing, Beijing, 100700, China

Summary:
The molecular characteristics of ischemic stroke with phlegm-heat syndrome and candidate biomarkers were identified based on multi-omics data. The main purpose of this study is to validate the molecular characteristics and biomarkers of phlegm-heat syndrome in ischemic stroke, and to demonstrate the association of biomarkers with clinical outcomes.

Primary Outcome Measures: Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke, Sensitivity, specificity, and area under the ROC curve of molecular features of Phlegm-heat syndrome in ischemic stroke.

The molecular characteristics of phlegm-heat syndrome in ischemic stroke include but are not limited to matrix metalloproteinase 9, mitogen-activated protein kinase 1, interleukin 6, and tumor necrosis factor., Baseline
Secondary Outcome Measures: Proportion of patients independent, Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2., 90 days|National Institute of Health Stroke Scale, The National Institute of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurological deficits., Baseline, 7 days and 10 days after stroke onset.
Thalidomide Combined With Chemotherapy in the Treatment of Relapsed or Refractory Yolk Sac Tumor
NCT Number: NCT06470464
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Germ Cell Tumor|Yolk Sac Tumor
Interventions: DRUG: Thalidomide combined with TGA chemotherapy (nab-paclitaxel + gemcitabine+ epirubicin)
Sponsor: Shandong First Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-11-11
Completion Date: 2024-06-16
Locations: Shandong Cancer Hospital and Institute, Jinan, Shandong, 250117, China

Summary:
Remarkable progress has been made in treating germ-cell tumor (GCT) through the use of platinum-based regimens. However, part of yolk sac tumor (YST) with cisplatin resistance or recurrence is nevertheless prone to relapse after second-line treatment. This leaves a gap in effective treatment, which needs to be filled by novel therapeutic approaches. This paper is the first one to report the treatment combining thalidomide with nab-paclitaxel, gemcitabine, and epirubicin (T-TGA) for children with repeated relapsed or refractory yolk sac tumor (rrrYST).

Primary Outcome Measures: AFP, alpha fetoprotein, 3 weeks
Secondary Outcome Measures: imageological examination, imageological examination, 6 weeks