pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Transforming Care Experiences of Support Workers and Managers
NCT Number: NCT06508853
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Learning Disabilities|Behavioural Problem
Interventions: OTHER: Qualitative research (no intervention)
Sponsor: King's College London
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-05
Locations: Kings College London, London, United Kingdom

Summary:
* What research question is being addressed? What is the experience of support workers, and managers, supporting people with learning disabilities who have moved from inpatient to community settings as part of the Transforming Care Agenda.
* How is it of relevance and importance to patients and public? In 2011 serious abuse of people with learning disabilities was uncovered at Winterbourne View, an independent hospital for people with learning disabilities. The Transforming Care Agenda was set out by the UK government in 2012 in response to this abuse. A key part of the action plan included moving people with learning disabilities out of inappropriate hospital settings, into the community.

Support workers and managers are key mediators in approaches to ensure that people with learning disabilities are able to achieve a good quality of life in the community, however so far there is limited research looking into their experiences.

* Broadly what area (disease, therapy or service) is being studied? For therapeutic studies what is the drug, device or procedure being tested? The area being studied is support for people with learning disabilities who have moved from inpatient settings to community settings.
* Who would be eligible? Support workers and managers who have worked with people with learning disabilities who have moved from inpatient to community settings within the past three years will be eligible to be interviewed as part of this study. 4 to 6 support workers, and 4 to 6 managers will be interviewed in total.
* The type of sites where the study will be conducted Participants (support workers and managers) will be recruited through NHS sites (community learning disability teams) who have identified individuals with learning disabilities who have moved from hospital to community settings (as part of the Transforming Care Agenda) within the past 3 years.
* How long will the study last and what will the participants undergo? The study will last approximately 1.5 years. If they consent, participants will be invited to take part in an interview, lasting up to one hour. The interview will focus on their experience of supporting someone with a learning disability who has moved from a hospital setting, into a community setting, within the past three years.

Primary Outcome Measures: No formal outcome measures - qualitative analysis of data from interviews., Data will be analysed using IPA, 1
Pilot Trial of Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma
NCT Number: NCT06508827
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Anemia, Iron Deficiency|Melanoma
Interventions: DRUG: Iron dextran 1000 mg IV
Sponsor: Mateusz Opyrchal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-06
Locations: Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, 46202, United States

Summary:
Anemia is a common complication among cancer patients and is negatively associated with overall prognosis and therapeutic outcomes. The purpose of this study is to see if giving a dose of iron prior to any standard of care chemotherapy treatment will affect the cells that are believed to make treating melanoma harder, making melanoma more responsive to the standard of care immunotherapy.

Primary Outcome Measures: Erythroid progenitor cells (EPCs) detection in patient's blood, Whether the erythroid progenitor cells (EPCs) can be detected at baseline in patient's blood in 3 out of 5 evaluable patients, Baseline, 1 week post iron infusion, 21 days post iron infusion
Secondary Outcome Measures: Iron dose tolerance, At least 50% of patients consented successfully receive \>50% of planned iron infusion, baseline
Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy
NCT Number: NCT06508814
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain
Interventions: PROCEDURE: Lower Insufflation Pressure|PROCEDURE: Standard Insufflation Pressure
Sponsor: University of Tennessee
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2025-06-10
Locations: University of Tennessee Health Science Center, Memphis, Tennessee, 38103, United States

Summary:
The purpose of this study is to determine the effect of decreased insufflation pressure on postoperative pain, analgesic use, and surgical safety and feasibility for laparoscopic hysterectomy.

Primary Outcome Measures: Pain on postoperative day 1, All participants will be asked to rate their pain using the Visual Analog Scale (VAS) approximately 24 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain., 24 hours following surgery
Secondary Outcome Measures: Preoperative pain, All participants will be asked to rate their pain using the Visual Analog Scale (VAS) upon their arrival before surgery. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain., Within 2 hours before surgery|Postoperative pain while in PACU, All participants will be asked to rate their pain using the Visual Analog Scale (VAS) while they are recovering in PACU, approximately 2 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain., Approximately 2 hours after surgery completion|Postoperative pain at follow-up visit, All participants will be asked to rate their pain using the Visual Analog Scale (VAS) at their 2-week postoperative follow-up visit. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain., Approximately 2 weeks after surgery completion|Opioid use after discharge, All participants will be asked about the number of prescription opioid pills they took following discharge., Within 2 weeks after surgery
Combination of the Vaginal Laser With a Moisturizing and Repairing Niosomal Gel in the Treatment of Genitourinary Syndrome in Oncology Patients
NCT Number: NCT06508788
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Genitourinary Syndrome of Menopause
Interventions: DEVICE: CO2 laser
Sponsor: Hospital Universitari de Bellvitge
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-07-01
Locations: Carlos, Hospitalet de Llobregat, Cataluña, 08907, Spain

Summary:
Vaginal laser together with the use of moisturizing and repairing gels could be an effective therapy for the treatment of genitourinary syndrome in women with a history of neoplasia in whom the use of estrogens is not recommended.

The purpose of this study is to evaluate the effectiveness of vaginal laser together with adjuvant treatment with a hydrating and repairing niosomal gel as a beneficial treatment in this group of patients.

Primary Outcome Measures: Effectiveness, To evaluate the effectiveness of CO2 vaginal laser together with adjuvant treatment with a hydrating and repairing niosomal gel as a beneficial treatment in patients with a history of neoplasia in whom the use of estrogens is not recommended, 12 months
Secondary Outcome Measures: Security, To determine the safety (side effects) of vaginal laser therapy, 12 months|Duration, To determine the durability of the effects produced by vaginal laser therapy, 12 months
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
NCT Number: NCT06508775
Acronym: LONGSAFE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Melanoma Stage III|B-cell Non Hodgkin Lymphoma|Pediatric ALL|Childhood Non-Hodgkin Lymphoma|Acute Lymphatic Leukemia|Chronic Lymphatic Leukemia|Melanoma Stage IV
Interventions: BIOLOGICAL: MB-CART19.1|BIOLOGICAL: MB-CART20.1|BIOLOGICAL: MB-CART2019.1
Sponsor: Miltenyi Biomedicine GmbH
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-05-05
Completion Date: 2040-12-31
Locations: Universitätsklinikum Köln, Cologne, 50937, Germany|Universitätsmedizin Göttingen, Göttingen, 37075, Germany|Universitätsklinikum Münster, Münster, 48149, Germany|Universitäts-Kinderklinik Würzburg, Würzburg, 97080, Germany

Summary:
The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.

Primary Outcome Measures: Adverse Events, Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies, through study completion, up to 14 years
Secondary Outcome Measures: Lymphocyte count, B and T lymphocyte count, through study completion, up to 14 years|Height, Height, through study completion, up to 14 years|Weight, Weight, through study completion, up to 14 years|Tanner staging for pediatric patients, Tanner staging for pediatric patients, through study completion, up to 14 years|Menstruation status for pediatric patients, Did the patient experience their first menstrual cycle (menarche)? If yes, enter date, through study completion, up to 14 years|RCL, Percentage of patients with detectable replication-competent lentivirus (RCL) (if results of 2 consecutive years are negative for an individual patient, further sampling will not be continued for this patient; if results of all samples in first year of primary trial were negative for an individual patient, sampling will not be continued for this patient in this long-term follow-up trial), through study completion, up to 14 years|Relapse / Progression, Percentage of patients who relapse or progress since enrollment and rate of surviving patients, through study completion, up to 14 years|Detectable Transgene levels, Percentage of patients with detectable transgene levels (if results of 2 consecutive years are negative for an individual patient, further sampling will be stopped for this patient), through study completion, up to 14 years
A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-993
NCT Number: NCT06508762
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pain
Interventions: DRUG: VX-993
Sponsor: Vertex Pharmaceuticals Incorporated
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-26
Completion Date: 2024-09
Locations: ICON Salt Lake City, Salt Lake City, Utah, 84124, United States

Summary:
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-993 in healthy adult participants.

Primary Outcome Measures: Maximum Observed Plasma Concentration (Cmax) of VX-993, From Day 1 up to Day 28|Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993, From Day 1 up to Day 28|Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993, From Day 1 up to Day 28
Secondary Outcome Measures: Maximum Observed Plasma Concentration (Cmax) of VX-993 Metabolite, From Day 1 up to Day 28|Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993 Metabolite, From Day 1 up to Day 28|Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993 Metabolite, From Day 1 up to Day 28|Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), From Day 1 up to Day 28
Cyberbullying, Empathy, and Storytelling in Adolescents
NCT Number: NCT06508736
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cyberbullying
Interventions: BEHAVIORAL: Storytelling|BEHAVIORAL: Training
Sponsor: Gazi University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-07-30

Summary:
The type of this study is a randomized controlled experimental study. The aim of this study is to determine the effect of storytelling method on cyberbullying and empathy level in adolescents. The population of the study consisted of 5th and 6th grade middle school students. The sample of the study will consist of students involved in cyberbullying. The sample will be selected through randomization and stratified selection will be made according to gender. The students in the intervention group will receive 4 sessions of storytelling intervention. The active control group will receive 4 sessions of cyberbullying training. Questions that the research aims to answer:

Is there a difference between the intervention group and the control group in terms of cyberbullying level? Is there a difference between the intervention groups and the control group in terms of empathy level?

Participants:

The intervention group will participate in 4 sessions of storytelling intervention.

The control group will participate in 4 sessions of cyberbullying training.

Primary Outcome Measures: cyberbullying, It is expected that cyberbullying will decrease with storytelling. These measurements will be made with the Cyberbullying Triangle Scale. Cyberbullying Triangle Scale and Bullying, Victimization and Cyber Bystander subscales will be used in the evaluation. The assessment is done by categorizing students into various categories. These categories are: "not involved in cyberbullying, only cyber victim, only cyber bully, only cyber bystander, cyber bully and cyber victim, cyber bystander and cyber victim, cyber bystander and cyber bully, cyber bully, cyber victim and cyber bystander"., 6 months
Secondary Outcome Measures: empathy, Empathy parameter is expected to increase with storytelling. Empathy will be assessed with the Cognitive, Affective, Behavioral Empathy Scale. The Empathy Scale consists of 30 questions and three sub-factors: cognitive, affective and bodily empathy. The scale has a 3-point Likert (0 and 2) type rating. The score that can be obtained from the scale varies between 0 and 60 and the higher the score, the higher the empathy tendency., 6 months
Comparison of Dental Implants With Different Surface Properties
NCT Number: NCT06508723
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implant Failed|Peri-Implantitis
Interventions: PROCEDURE: Dental implant placement
Sponsor: Kutahya Health Sciences University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-04-05
Completion Date: 2025-09-05
Locations: Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology, Kütahya, 43100, Turkey

Summary:
This controlled, parallel clinical study aims to compare the effect of fixed prosthetic restorations placed in the posterior region with different implant surfaces on clinical and peri-implant marginal bone loss.

The main question(s) it aims to answer are:

Is there a difference between peri-implant marginal bone loss levels in dental implants with two different surfaces placed in the posterior region? Is there a difference in peri-implant clinical parameters in dental implants with two different surfaces placed in the posterior region? The study includes a test group (implant with Ti-Ulta surface) and a control group (implant with Ti-Unite surface).

Two implants with different surfaces will be placed in the bone following the same routine implant placement protocol.

Primary Outcome Measures: Peri-implant marginal bone loss, The primary outcome was the assessment of marginal bone loss on radiographs at 1-year follow-up., 1-year follow-up of all implants after prosthetic loading
CT-Angiography Plaque Characteristics and Events in Deferral Patients by Invasive Fractional Flow Reserve
NCT Number: NCT06508697
Acronym: CAPTURE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Patient Preference
Interventions: DIAGNOSTIC_TEST: invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement
Sponsor: Fujita Health University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: Fujita Health University, Toyoake, Aichi, 470-1192, Japan

Summary:
Fractional flow reserve (FFR)-guided PCI for chronic coronary syndromes (CCS) is reported to improve the outcomes compared with angiography-guided PCI. However, cardiac-events still occur in FFR-deferral patients in long-term follow-up. Coronary computed tomography angiography (CTA)-defined high-risk-plaque (HRP) is known to relate future cardiac events. We hypothesized that CTA might identify plaque features linked to future cardiac events in deferral patients.

Primary Outcome Measures: Cardiac events in patient level, a composite of cardiac death, non-fatal acute coronary syndrome (ACS), and ischemia-driven revascularization for patient-level analysis, From 2018 to 2026|Cardiac events in lesion level, lesion-level ACS and lesion-level ischemia-driven revascularization, From 2018 to 2026
Current Status of BTKi Treatment for CLL/SLL in China
NCT Number: NCT06508684
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: CLL/SLL
Interventions: DRUG: BTK inhibitor
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-13
Completion Date: 2025-07-12
Locations: Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjin, Jiangsu, 210029, China

Summary:
BTKi has become the standard treatment regimen for CLL/SLL，there is a lack of large-scale real-world studies on the use status and related influencing factors of BTK inhibitors. Therefore, we plan to conduct this multicenter retrospective cross-sectional study to understand the current situation of BTK inhibitor treatment for CLL/SLL patients in China and the related influencing factors, and to explore more suitable treatment patterns based on this.

Primary Outcome Measures: Patient characteristics of those receiving BTKi treatment, Describe the patient characteristics of those receiving BTKi treatment, including age, gender, etc, up to one year
Secondary Outcome Measures: overall response rate, Assessed according to the iwCLL2018 criteria, up to one year|Incidence of adverse reactions, Assessed according to the CTCAE 5.0 criteria, up to one year
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT Number: NCT06508658
Acronym: EPCORE DLBCL-4
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Diffuse Large B-Cell Lymphoma
Interventions: DRUG: Epcoritamab|DRUG: Rituximab|DRUG: Lenalidomide|DRUG: Oxaliplatin|DRUG: Gemcitabine
Sponsor: Genmab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2028-01-17

Summary:
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Around 320 adult participants with R/R DLBCL will be enrolled in approximately 165 sites across the world.

Participants in arm A will receive subcutaneous (SC) injections of epcoritamab plus oral lenalidomide capsules (E-Len) for up to 12 cycles (each cycle is 28 days). Participants "in arm B will receive intrav... (IV) infused R-GemOx for up to 4 cycles (each cycle is 28 days)

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Primary Outcome Measures: Progression-Free Survival (PFS), PFS is defined as the duration from the date of randomization to the date of disease progression determined per Lugano 2014 criteria as assessed by an independent review committee (IRC), or death, whichever occurs first., Up to 4 Years
Secondary Outcome Measures: Percentage of Participants Who Achieve Complete response (CR), CR is defined as the percentage of participants who achieve CR determined by Lugano 2014 criteria, as assessed by an IRC that is blinded to treatment arm prior to the initiation of new anti-lymphoma therapy., Up to 4 Years|Overall Survival (OS), OS is defined as the time from randomization to death from any cause., Up to 4 Years|Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate, The MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of new anti-lymphoma therapy., Up to 4 Years
Study to Evaluate the Safety/Tolerability, PK and PD After Intravenous DWJ1521 Administration in Healthy Volunteers
NCT Number: NCT06508645
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: DWP14012 injection
Sponsor: Daewoong Pharmaceutical Co. LTD.
Sex: ALL
Age: ADULT
Enrollment: 33
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-01-10
Completion Date: 2022-04-06
Locations: Seoul-National University Hospital, Seoul, 03080, Korea, Republic of

Summary:
A randomized, double-blind, placebo-controlled, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy volunteers

Primary Outcome Measures: AUC0-24h of Fexuprazan, Pharmacokinetics parameter following DWP14012 injection, Part1 for 8 days, Part2 for 5 days|24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%), Parmacodynamics parameter following DWP14012 injection, Part1 for 8 days, Part2 for 4 days
The Effect of Mandala on Nausea, Vomiting, Pain and Anxiety in Chemotherapy Patients
NCT Number: NCT06508632
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Anxiety
Interventions: BEHAVIORAL: Mandala group
Sponsor: Cukurova University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-07
Completion Date: 2025-01-31
Locations: Çukurova University Balcalı Training and Research Hospital, Adana, Balçalı, 01250, Turkey

Summary:
To determine the effect of mandala art therapy (coloring) on nausea, vomiting, pain and anxiety in children receiving outpatient chemotherapy. The concept of cancer is used to describe a group of diseases that start from a single cell and show uncontrolled growth, proliferation and spread to surrounding tissues. The cooperation of the family and the healthcare team plays a major role in the success of the treatment. Surgical treatment, radiotherapy and chemotherapy are applied in its treatment. Art therapy, a method of distraction, is used to prevent pediatric oncology patients from focusing on the pain and stressful life events they experience. By having children do artistic activities in the hospital room, nurses can reduce symptom management, social isolation, and long-term negative social effects.

Primary Outcome Measures: Pain Rating scale, It is a visual analog scale used to evaluate the intensity of pain. This scale includes six different facial expressions scored from 0 to 10. 0 means "no pain," while 10 means "most severe pain." The scale is used to diagnose pain in children aged 3-18. Pain scores are given according to the numerical values given to the faces on the scale. The lowest score is "1" and the highest score is "5". As the score from the scale increases, pain tolerance decreases, and as the score decreases, tolerance increases., Approximately 2 hours from start
Secondary Outcome Measures: Nausea and Vomiting Thermometer in Children with Cancer, The Nausea and Vomiting Thermometer Scale in Children with Cancer is a tool used to evaluate the frequency and severity of nausea and vomiting in children with cancer aged 0-18 years. The structure of the scale consists of 2 subscales: Nausea: 0 (no nausea) - 10 (most severe nausea), Vomiting: 0 (no vomiting) - 10 (most severe vomiting), Visuals using 5 different colors and emojis for each subscale. A thermometer was created., Approximately 2 hours from start
AK117 (Anti-CD47) + Anti-EGFR for R/M HNSCC
NCT Number: NCT06508606
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: AK117|DRUG: anti-EGFR
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-08-01

Summary:
The administration of first-line pembrolizumab monotherapy or combined chemotherapy has been shown to improve survival among patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). However, over 80% of the patients still experience disease progression within a year. Upon progression, treatment options are notably constrained, typically comprising methotrexate, docetaxel, and cetuximab. The median progression-free survivaland overall survival following chemotherapy, targeted therapy, or their combination are dismally low, ranging from 2-3 months and 6-8 months, respectively. The clinical trials CheckMate 141 and KEYNOTE 040 have led to the approval of Nivolumab and Pembrolizumab as second-line treatments for R/M HNSCC. Nevertheless, the response rates to immune monotherapy are limited, ranging from 10% to 35%. Even after receiving standard second-line immunotherapy, over 80% of patients encounter disease progression within 6 months, and more than 60% succumb to the disease within a year. Therefore, there is a dearth of a standardized treatment for R/M HNSCC after the failure of first- or second-line PD-1 (L1) inhibitors and/or platinum-based therapy

Primary Outcome Measures: Number of patients with Adverse Events (AEs), Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs, Up to approximately 1 years|OS, overall survival, Up to approximately 1 years
Secondary Outcome Measures: ORR, Objective response rate, Up to approximately 1 years|PFS, Progression Free Survival, Up to approximately 1 years|DCR, Disease control rate, Up to approximately 1 years|DoR, Duration of Response, Up to approximately 1 years
Metabolomics Analysis of Acute Kidney Injury and Delirium After Cardiac Surgery
NCT Number: NCT06508593
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: AKI - Acute Kidney Injury|Delirium, Postoperative
Interventions: DIAGNOSTIC_TEST: Serum metabolic profile
Sponsor: Xijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-20
Completion Date: 2024-12-31
Locations: Xijing Hospital, Xi'an, Shaanxi, 710032, China

Summary:
Clinical evidence suggests that renal injury leads to changes in the structure of the cerebral cortex in patients, suggesting the existence of the renal brain axis. Therefore, some scholars have proposed that AKI may be an important cause of secondary injuries such as delirium. Approximately 60% of AKI patients in clinical practice experience delirium.Although the underlying mechanism associated with acute renal injury and delirium is still unclear, it has been recognized that it increases incidence rate and mortality, prolongs hospital stay, and accelerates long-term cognitive decline. The investigators assume that the serum metabolic profiles of patients with delirium and AKI after cardiac surgery, with delirium only, with AKI only, and without delirium or AKI after surgery can be compared separately to explore the mechanisms of complications and the interaction mechanisms between organ damage after extracorporeal circulation cardiac surgery, and to identify metabolic markers specific to complications, identify patients with increased susceptibility, and provide reference for early diagnosis of complications and basis for early intervention.

Primary Outcome Measures: Small molecule metabolites specific to complications after extracorporeal circulation cardiac surgery, Non biased detection of all small molecule metabolites associated with complications after extracorporeal circulation cardiac surgery, and screening of differential metabolites, 1 week
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
NCT Number: NCT06508567
Acronym: SHAPE-PSMA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer Recurrent|Prostate Cancer
Interventions: RADIATION: High Dose Rate Brachytherapy
Sponsor: University Health Network, Toronto
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2031-03-01

Summary:
This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.

Primary Outcome Measures: Dosimetry Parameters, As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints, 5 Years|Acute toxicity assessed by CTCAE V5.0 (Grade ≥3), Determine the number of patients with late genitourinary, gastrointestinal and/or sexual toxicities as a result of salvage HDR Brachytherapy treatment at a grade ≥3, 5 Years
Secondary Outcome Measures: Biochemical Control assessed by PSA, Determine the number of patients demonstrating biochemical control of PSA following salvage HDR Brachytherapy treatment., 5 Years|Local Disease Control, Assessed by MRI/PSMA-PET imaging at 2 years, 2 Years|Changes in Quality of Life, Assessed with EPIC Quality of Life scores yearly for 5 years., 5 years
The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery
NCT Number: NCT06508541
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colorectal Cancer
Sponsor: Shanghai Tong Ren Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 235
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2024-09-01
Locations: Shanghai Tongren Hospital, Changning, Shanghai, 200336, China

Summary:
Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging

Primary Outcome Measures: disease-free survival(DFS), the duration from radical surgery to the confirmation of recurrence or metastasis by regular or telephone follow-up, 1 month
Secondary Outcome Measures: the number of harvested lymph nodes, the number of harvested lymph nodes including positive and negative ones, 1month
Intervention of Growth Mindset for Intern Nursing Students
NCT Number: NCT06508528
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Growth, Psychological
Interventions: BEHAVIORAL: a 12-week growth mindset intervention|OTHER: Hospital mentoring
Sponsor: Huzhou University
Collaborators: Hangzhou Normal University|The Affiliated Hospital of Hangzhou Normal University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-09-05
Completion Date: 2022-11-27
Locations: Hangzhou Normal University, Hangzhou, China

Summary:
This is a 12-week growth mindset intervention for the nursing students during clinical rotation practice. It aims at promoting the core self-evaluation and professional self-efficacy for them.

Primary Outcome Measures: growth mindset, Growth mindset in recent one week measured by the growth mindset scale , ranging from 6-36, with higher score reflects higher level of growth mindset., We will measure the score of growth mindset before the training, 6 weeks of training, and 12 weeks of training.|core self-evaluation, Core self-evaluation in recent one week measured by the core self-evaluation scale, ranging from 10-50, with higher score reflects higher level of core self-evaluation., We will measure the score of core self-evaluation before the training, 6 weeks of training, and 12 weeks of training.|professional self-efficacy, Professional self-efficacy in recent one week measured by the professional self-efficacy questionnaire for nursing students, ranging from 27-135, with higher score reflects higher level of professional self-efficacy., We will measure the score of professional self-efficacy before the training, 6 weeks of training, and 12 weeks of training.
Pancreatitis - Microbiome as Predictor of Severity II
NCT Number: NCT06508502
Acronym: P-MAPS II
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Pancreatitis|Acute Pancreatitis With Infected Necrosis
Sponsor: University Medical Center Goettingen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2027-12-31
Locations: University Medical Center Goettingen, Göttingen, Lower Saxony, 37075, Germany

Summary:
The goal of this observational study is to evaluate the orointestinal microbiome and microbial derived metabolome in patients suffering from acute pancreatitis as a biomarker for severity. The main questions it aims to answer are:

* Can the orointestinal microbiome robustly predict the course of acute pancreatitis?
* How does the microbiome impact the severity of an acute pancreatitis?

Buccal/ rectal swabs, plasma and stool is collected from patients with acute pancreatitis within 48h after hospital admission.

Primary Outcome Measures: Microbiome classifier, AUROC of an updated classifier for revised Atlanta classification and severity based on the previously published classifier., up to 90 days
Secondary Outcome Measures: Metabolome classifier, Assessing differentially produced metabolites obtained from corresponding plasma and stool samples using high-performance liquid chromatography/mass spectrometry (HPLC/MS) between mild, moderate severe and severe acute pancreatitis., up to 90 days|New classifier, AUROCs of new classifiers that can utilize features that were not available in our previous studies (e.g. the metabolome) and features that were not used for the previously published classifier (e.g. the buccal microbiome)., up to 90 days|Differential abundances, Assessing differential abundances between mild, moderate severe and severe acute pancreatitis and comparison with previous published differential abundant species, up to 90 days|Mortality, Association of mortality with microbiome and metabolome applying alpha-, beta-diversity and differential abundances., up to 90 days|Length of hospital stay, Association of length of hospital stay with microbiome and metabolome applying alpha-, beta-diversity and differential abundances., up to 90 days
The Efficacy of Amnion Chorion Allograft in Management of Gingival Recession.
NCT Number: NCT06508476
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Gingival Recession, Localized
Interventions: BIOLOGICAL: Amnion Chorion membrane|PROCEDURE: connective tissue graft
Sponsor: Minia University
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-02
Locations: faculty of dentistry, Minia University, Minya, Other, 61111, Egypt

Summary:
the main goal of this clinical trial is to test the efficacy of amnion Chorion allograft in managing gingival recession. The main questions it aims to answer are: Is it effective in treating gingival recession, and how it compares to connective tissue graft.

Primary Outcome Measures: recession depth, recession depth is measured from CEJ to the gingival margin in millimeters., changes in millimeters from base line to follow up after 6 months
Secondary Outcome Measures: Recession Width, it is measured at the widest point from the mesial gingival margin to the distal gingival margin in millimeters, changes in millimeters from base line to follow up after 6 months|the height of keratinized gingiva, it is measured in millimeters as the distance from the mucogingival junction to the gingival margin, with the mucogingival junction location determined using a visual method., changes in millimeters from base line to follow up after 6 months|Probing pocket depth, it is measured as the distance from the gingival margin to base of pocket., changes in millimeters from base line to follow up after 6 months|percentage of root coverage, it will be calculated as \[pre-operative gingival recession depth - post-operative recession depth\]/ \[preoperative recession depth\] \* 100%, changes in percentile from base line to follow up after 6 months
Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
NCT Number: NCT06508463
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Peripheral T Cell Lymphoma|Relapsed Peripheral T-Cell Lymphoma|Peripheral T-Cell Lymphoma, Not Otherwise Specified|Anaplastic Large Cell Lymphoma|Mycosis Fungoides|Relapsed Anaplastic Large Cell Lymphoma|Relapsed Mycosis Fungoides
Interventions: PROCEDURE: Biopsy|PROCEDURE: Biospecimen Collection|PROCEDURE: Bone Marrow Biopsy|PROCEDURE: Computed Tomography|PROCEDURE: Positron Emission Tomography|BIOLOGICAL: Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter|PROCEDURE: Single Photon Emission Computed Tomography|BIOLOGICAL: Cemiplimab|BIOLOGICAL: Ipilimumab
Sponsor: Mayo Clinic
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-05
Completion Date: 2032-04-01
Locations: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States|Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus (VSV) carrying the human (h) sodium iodide symporter (NIS) and Interferon (IFN) beta (β) genes (VSV-hIFNβ-NIS) in combination with ipilimumab and cemiplimab in patients with T-cell lymphoma. A virus, called VSV-hIFNβ-NIS, which has been changed in a certain way, may be able to kill cancer cells without damaging normal cells. Immunotherapy with ipilmumab and cemiplimab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

Primary Outcome Measures: Incidence of adverse events of grade 3 or higher, Assessed by the Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by cohort and overall). Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The rate of grade 3 or higher non-hematologic adverse events, and the rate of grade 4 or higher adverse event (hematologic and non-hematologic) will be computed each with a 95% exact binomial confidence., Up to 2 years
Secondary Outcome Measures: Clinical response, The number of responses \[complete response (CR) or partial response (PR)\] will be summarized by simple descriptive summary statistics., Up to 2 years|Progression-free survival, The distribution of survival time will be estimated using the method of Kaplan-Meier (overall, by dose level, and by disease type)., From registration to disease progression or death due to any cause, assessed up to 2 years|Overall survival, The distribution of survival time will be estimated using the method of Kaplan-Meier (overall, by dose level, and by disease type)., From registration to death due to any cause, assessed up to 2 years
A Mental Health Services Engagement Program for Racial and Ethnic Minority Young Adults
NCT Number: NCT06508450
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psychosis|Bipolar and Related Disorders|Depressive Disorder
Interventions: BEHAVIORAL: Just Do You|BEHAVIORAL: Component A|BEHAVIORAL: Component B|BEHAVIORAL: Component C
Sponsor: New York University
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2027-01
Locations: Jewish Board of Family and Children's Services, Bronx, New York, 10457, United States

Summary:
Researchers aim to test a brief culturally-responsive young adult orientation program for community mental health services. They will conduct a 24-month randomized trial with 80 young adults from racial and ethnic minority groups in a community-based mental health clinic.

Primary Outcome Measures: Participant acceptability questionnaire, Self-report measure for assessing intervention acceptability from the perspectives of intervention recipients. Based on the theoretical framework of acceptability. Items are scored from 1 to 5. Possible total scores range from 9 to 45, with higher scores indicating greater acceptability., Immediately after the intervention|Qualitative interviews, Interviews with participants to assess acceptability of Components A, B, and C, Immediately after the intervention|Intervention adherence, Provider reported rate of intervention components completed by participants., Baseline through study completion, an average of 2 years; repeated measure to assess change through study completion
Secondary Outcome Measures: Service utilization, Provider reported service utilization. Total number of contacts between participant and service providers starting 1 month before baseline though 3-month follow up to assess change in participant engagement., Assessed 3 months after baseline|Client Engagement in Child Protective Services Scale, This scale is altered to measure young adult engagement in mental health services. The scale includes 8 questions and responses will be summed. The range for the scale is 8 to 40, with higher scores indicating higher levels of engagement., Assessed immediately after the intervention and 3 months after baseline
Topical Thymoquinone in Psoriasis Vulgaris
NCT Number: NCT06508372
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psoriasis Vulgaris
Interventions: DRUG: Topical thymoquinone Ointment|DRUG: topical placebo ointment
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-01

Summary:
A previous trial found that N. sativa oil was more effective as an antipsoriatic agent, particularly when taken as both a cream and a pill. This confirmed that N. sativa possesses antipsoriatic properties and can alleviate psoriasis symptoms

Primary Outcome Measures: Psoriasis severity score (TES) assessment, Psoriasis severity score (TES): It is a physician-based, four-point scoring system in which the thickness, erythema, and scales within each plaque will be rated from 0 (none) to 3 (severe)at baseline and to evaluate the therapeutic outcome of topical thymoquinone ointment in each follow up visit., 3 months
Secondary Outcome Measures: Evaluation of treatment adverse effects, Any local or systemic side effects will be reported to evaluate the safety of Thymoquinone ointment for treatment of localized plaque psoriasis, 3 months
Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension.
NCT Number: NCT06508359
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Outcome
Interventions: DRUG: Norepinephrine|DRUG: Phenylephrine
Sponsor: General Hospital of Ningxia Medical University
Sex: FEMALE
Age: ADULT
Enrollment: 2000
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-03-01
Completion Date: 2027-02-28

Summary:
This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section.

Primary Outcome Measures: pH, From umbilical arterial blood gases., Immediately after delivery|Base excess (BE), From umbilical arterial blood gases., Immediately after delivery
Secondary Outcome Measures: The incidence of post-spinal anesthesia hypotension, Systolic blood pressure (SBP) \< 80% of the baseline, 1-15 minutes after spinal anesthesia|The incidence of severe post-spinal anesthesia hypotension, Systolic blood pressure (SBP) \< 60% of the baseline, 1-15 minutes after spinal anesthesia|The incidence of bradycardia, Heart rate \< 60 beats/min, 1-15 minutes after spinal anesthesia|The incidence of nausea and vomiting, Presence of nausea and vomiting in patients after spinal anesthesia, 1-15 minutes after spinal anesthesia|The incidence of hypertension, Systolic blood pressure (SBP) \>120% of the baseline., 1-15 minutes after spinal anesthesia|Partial pressure of oxygen (PO2), From umbilical arterial blood gases., Immediately after delivery|APGAR score, A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration, 1 min after delivery|APGAR score, A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration, 5 min after delivery