pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients With a Primary Malignancy of the Central Nervous System
NCT Number: NCT06485310
Acronym: TECAP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Central Nervous System Cancer|Psychological Distress
Interventions: OTHER: Teleconsultation for psychological support
Sponsor: Centre Hospitalier Universitaire de la Réunion
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-24
Completion Date: 2026-12-31
Locations: University Hospital of Reunion Island - Neurosurgery department, St Pierre, Reunion, 97410, France

Summary:
The goal of this clinal trial is to compare the effectiveness of nurse-led teleconsultation with usual care (intervention group) on psychological distress in patients with primary malignant tumors of the central nervous system between diagnosis and first anti-cancer treatment, versus usual care alone (control group).

Participants will be randomized into two groups :

* group A) intervention: usual care + nurse teleconsultation for psychological support
* group B) control: usual care alone

Enrolment = Day0 (D0)

Participants will :

* groups A and B: D0: complete 4 questionnaires (Quality of Life, Screening for Distress, Screening for Anxiety and Depression, Social Support Questionnaire)
* Group A : D0+2/4 das : nursing teleconsultation for psychological support
* Groups A and B: D0+10days : telephone call to complete the same 4 questionnaires as at inclusion
* Group A : D0+15days: semi-directive interview, at home, for voluntary patients.

Primary Outcome Measures: Distress thermometer, Comparison of the change in psychological distress score, measured using the psychological distress screening tool (from National Comprehensive Cancer Network) between the 2 groups between inclusion (T0) and before the first anti-cancer therapy (T1)., 10 days
Effect Tunnel in Oral Medicine
NCT Number: NCT06485297
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Psychological
Interventions: OTHER: questionnary
Sponsor: Centre Hospitalier Universitaire de Nice
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-18
Completion Date: 2024-04-18
Locations: CHU NICE, Nice, Alpes Maritimes, 0600, France

Summary:
Evaluate whether there are differences in knowledge between practitioners and students regarding the tunnel effect, to validate the benefit of teaching it in oral medicine. Main objective: to evaluate the state of knowledge relating to the tunnel effect concerning the performance of a surgical procedure, of a cohort of odontologists of different professional levels. Secondary objectives: evaluate the nature of the means they propose in order to counter the effects of this cognitive bias.

Primary Outcome Measures: Evaluation of the state of knowledge relating to the tunnel effect concerning the performance of a surgical procedure, of a cohort of odontologists of different professional levels., Questionnaire: 6 items. Main objective: to evaluate the state of knowledge relating to the tunnel effect concerning the performance of a surgical procedure, of a cohort of odontologists of different professional levels. The responses were compared to each other, following interpretation of the relevant data by Diana Neponoceno. Discrepancies in responses or inconsistencies were supported by studies confirming or refuting the results, At the inclusion
Secondary Outcome Measures: Evaluation of the nature of the means proposed to combat the tunnel effect, Secondary objectives: evaluate the nature of the means they propose in order to counter the effects of this cognitive bias. The responses were compared to each other, following interpretation of the relevant data by Diana Neponoceno. Discrepancies in responses or inconsistencies were supported by studies confirming or refuting the results, At the inclusion
A Real-world Study of Camrelizumab Alone or in Combination With Apatinib/Chemotherapy for Advanced Gastric Cancer
NCT Number: NCT06485271
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer|RWS|PD-1 Immunotherapy
Interventions: DRUG: Camrelizumab|DRUG: apatinib|DRUG: chemotherapy
Sponsor: Changzhi People's Hospital Affiliated to Changzhi Medical College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 504
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-01
Completion Date: 2026-10
Locations: Changzhi People's Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China

Summary:
The purpose of this observational study is to evaluate the safety and efficacy of camrelizumab and apatinib in patients with advanced gastric cancer under real-life conditions, particularly in various subgroups of gastric cancer patients, with a view to providing information about the treatment modalities and efficacy of the treatment in real-life gastric cancer patients and to explore the possible predictive biomarkers of prognosis.Patients, who had both decided to be treated with camrelizumab or apatinib prior to enrollment, were entered into one of the following three cohorts at the discretion of the investigator, based on their disease stage and prior treatment

Primary Outcome Measures: Objective response rate, The percentage of subjects achieving complete or partial response in a real-world clinical setting., 24 months
Secondary Outcome Measures: Progression free survival, From date of admission until the date of first documented progression in the real-world setting or date of death from any cause, whichever came first, assessed up to 24 months., 24 months|Disease control rate, The percentage of subjects achieving complete response, partial response, or disease stability in a real-world clinical setting., 24 months|Overall survival, From date of admission until the date of death from any cause, assessed up to 24 months., 24 months
Universal CAR-T Cells in Patients With Refractory Autoimmune Diseases of the Nervous System.
NCT Number: NCT06485232
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Neuromyelitis Optica Spectrum Disorders|Myasthenia Gravis, Generalized|Multiple Sclerosis|Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Interventions: DRUG: Universal BCMA CAR-T|DRUG: Universal CD19 CAR-T|DRUG: Universal BCMA CAR-T; Universal CD19 CAR-T
Sponsor: Xuanwu Hospital, Beijing
Collaborators: Bioray Laboratories
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-12-31
Locations: Xuanwu Hospital, Capital Medical University, Beijing, Beijing, 100053, China

Summary:
This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.

Primary Outcome Measures: Incidence of dose-limiting toxicities(DLTs), Incidence of dose-limiting toxicities(DLTs), First 28 days after infusion|Incidence of adverse events(AEs) and severe adverse, Incidence of adverse events(AEs) and severe adverse events(SAEs)., Up to 12 months after infusion
Secondary Outcome Measures: Concentrations of UCAR-T cells, The concentration of BCMA UCAR T cells and CD19 UCAR-T cells in peripheral blood after infusion, 3 months|B cell levels in peripheral blood, The change of B cell levels in peripheral blood after infusion, 3 months|Changes of pathogenic antibody titers after infusion, The changes of pathogenic antibody titers in peripheral blood or cerebrospinal fluid., 1, 3, 6 ,12months|NMOSD: Annualized relapse rate, ARR is defined as the number of relapses divided by the total participant-years after infusion, 6, 12months|gMG: Changes of Myasthenia Gravis Activities if Daily Living (MG-ADL) Score, MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe gMG., 1, 3, 6, 12months|CIDP:Changes of Inflammatory Neuropathy Cause and Treatment (INCAT) Score after infusion., The INCAT score assesses the functionality of the arms and legs by giving a 0-5 score for arms and legs, with 0 representing no disability and 5 representing no arm function or inability to stand/walk., 1, 3, 6, 12months|MS: Changes of the number of Gd-enhancing T1 Lesions, The changes of enhancing Lesions as detected by brain Magnetic Resonance Imaging (MRI), 6, 12months|MS: Changes of the number of Number of New or Enlarging T2 Lesions, Number of new/enlarging T2 lesions on last available MRI scan compared to baseline., 6, 12months
A Phase IIa Clinical Study of Puesta Mesylate for Injection in Patients With T-Cell Lymphoma and Cutaneous T-Cell Lymphoma
NCT Number: NCT06485219
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)|Cutaneous T-cell Lymphoma (CTCL)
Interventions: DRUG: 11.2 mg/m2 Purinostat Mesylate|DRUG: 15 mg/m2 Purinostat Mesylate
Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-22
Completion Date: 2025-12-22
Locations: Ruijin Hospital, Shanghai Jiaotong University School Of Medicine, Shanghai, Shanghai, 200000, China|West China Hospital Sichuan University, Chengdu, Sichuan, 610000, China

Summary:
Primary Objective To evaluate the preliminary efficacy of puesta mesylate for injection in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) patients. Secondary Objectives

1. to evaluate the efficacy of puesta mesylate for injection in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) patients;
2. to evaluate the safety and tolerability of puesta mesylate for injection in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).

(PTCL) and cutaneous T-cell lymphoma (CTCL) population pharmacokinetic profile.

Exploratory Objective:

To evaluate the relationship between tumor biomarkers and the therapeutic efficacy and safety of puesta mesylate injection.

Primary Outcome Measures: Objective remission rate (ORR), Defined as the proportion of subjects with an overall efficacy response of complete remission (CR) or partial remission (PR) after at least one baseline evaluation during the trial period, Evaluated every two cycles after medication (Each cycle is 21 days)
Secondary Outcome Measures: Complete Remission Rate (CRR), Defined as the proportion of subjects with an overall efficacy response of CR after at least one baseline evaluation during the trial;, Evaluated every two cycles after medication (Each cycle is 21 days)|Disease Control Rate (DCR), Defined as the proportion of subjects with an overall efficacy response of CR, PR, and stable disease (SD) after at least one baseline evaluation during the trial;, Evaluated every two cycles after medication (Each cycle is 21 days)|Duration of remission (DOR), Duration of first remission (PR and above) to disease progression or death;, Evaluated every two cycles after medication (Each cycle is 21 days)|Time to Tumor Remission (TTR), Time from first dose to the onset of PR and beyond;, Evaluated every two cycles after medication (Each cycle is 21 days)
The Innate Immune Response and Enteric Nervous System in Crohn's Disease.
NCT Number: NCT06485193
Status: TERMINATED
Study Type: OBSERVATIONAL
Conditions: Crohn Disease
Interventions: DIAGNOSTIC_TEST: Immunohistochemistry
Sponsor: Aalborg University Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-04
Completion Date: 2024-06-01
Locations: Aalborg University Hospital, Aalborg, Northern Region, 9000, Denmark

Summary:
The study aims to explore the relationships between inflammation, nerve changes, and the expression of interferon-stimulated proteins in inflamed and non-inflamed bowel areas from patients with Crohn's disease. Crohn's disease is a chronic inflammatory condition with complex causes and mechanisms that remain uncertain despite extensive research.

Methods and Procedures This exploratory study utilizes tissue samples from a clinical biobank at Aalborg University Hospital. The samples are paraffin-embedded blocks from which tissue sections are prepared for immunohistochemical and histological staining. The study focuses on assessing the expression of interferon-stimulated proteins through optimized immunohistochemical staining methods, ensuring reproducibility via automated machines. The protein expressions are then analyzed qualitatively and semi-quantitatively and compared with structural changes in the bowel tissues.

Primary Outcome Measures: MxA expression, Immunohistochemical Mxa expression, June 1 2024
Secondary Outcome Measures: Enterovirus positivity, pan-enterovirus immunohistochemistry, June 1 2024
Comparative Effectiveness of Uterine Repair Surgery on Preventing Recurrence of Cesarean Sar Pregnancy
NCT Number: NCT06485180
Acronym: CECS
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy Complications
Interventions: PROCEDURE: Active comparator
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Collaborators: Peking University
Sex: FEMALE
Age: ADULT
Enrollment: 606
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-01-01
Completion Date: 2024-06-01
Locations: Women's hospital, school of medicine, zhejiang university, Hangzhou, Zhejiang, 310006, China

Summary:
The goal of this observational study is to learn about the long-term effects of resection surgery which is cesarean scar pregnancy(CSP) excision plus hysterotomy closure in CSP patients to treat their CSP. The main question it aims to answer is:

Does resection surgery lower next recurrence of CSP than conservative surgery which leaves the uterine niche alone? Participants already underwent resection surgery or conservative surgery will answer survey questions about their next pregnancy for 3 years.

Primary Outcome Measures: effectiveness, The incidence rate of non-CSP, up to 3 years
Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease
NCT Number: NCT06485128
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Kidney Diseases|Diastolic Heart Failure|Small Vessel Disease|Glaucoma
Interventions: DIAGNOSTIC_TEST: Optical coherence tomography(-angiography) OCT(A)|DIAGNOSTIC_TEST: Fundus pictures|DIAGNOSTIC_TEST: DVA 3.0|DIAGNOSTIC_TEST: Hyperspectral retinal images|DIAGNOSTIC_TEST: SphygmoCor|DIAGNOSTIC_TEST: Sphygmomanometer|DIAGNOSTIC_TEST: Blood sample|DIAGNOSTIC_TEST: Skin biopsy|DIAGNOSTIC_TEST: Neuropsychological examination
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2021-07-06
Completion Date: 2024-12-31
Locations: Universitaire Ziekenhuizen UZ/KU Leuven, Leuven, Vlaams-Brabant, 3000, Belgium

Summary:
To explore the distribution of retinal vasculature parameters in patients with different subtypes of cardiovascular and ocular disease.

Primary Outcome Measures: Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations., 3 years
Secondary Outcome Measures: Diagnostic performance of the aforementioned parameters to distinguish the different subpopulations., 3 years|The association between these parameters and (1) the presence of risk factors for cardiovascular disease (including biomarkers) and (2) risk factors for disease progression and (3) neuropsychological functioning, 3 years|Physiological behaviour of retinal vasculature under cardiovascular stress., 3 years|Histopathological correlates in dermal microvasculature, 3 years
Differences of the Postoperative Outcome for Carotid Surgery Patients Treated by Either Male or Female Surgeons
NCT Number: NCT06485102
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Carotid Stenosis
Interventions: PROCEDURE: Carotid Surgery in patients with symptomatic or asymptomatic stenosis
Sponsor: University Hospital Augsburg
Collaborators: Epidemiology, Faculty of Medicine, University of Augsburg
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-01
Completion Date: 2024-12-31
Locations: University Hospital Augsburg, Augsburg, 86156, Germany

Summary:
This research will focus on the differences of the postoperative outcome for carotid surgery patients treated by either male or female surgeons. Since 2012, in Germany, the surgical treatment of carotid stenosis has an established quality assurance, making the thematic especially suitable for testing the surgical results of either male or female surgeons.

Primary Outcome Measures: The impact of surgeons' gender, team gender and patients gender on postoperative apoplexy, stroke \[observed in a time frame of 30 days after the operation\], 0-30 days|The impact of surgeons' gender team gender and patients gender on postoperative peripheral nerve lesions, Impairment of peripheral cervial nerves \[observed in a time frame of 30 days after the operation\], 0-30 days|The impact of surgeons' gender team gender and patients gender on reinterventions, Number of patients with surgical revision, 0-30 days|The impact of surgeons' gender team gender and patients gender on procedure related death, Number of patients who died following surgery, 0-30 days
Secondary Outcome Measures: The impact of surgeons' gender team gender and patients gender on procedure time, Duration of surgery measured in minutes, 0-30 days|The impact of surgeons' gender team gender and patients gender on the length of stay, length of stay in days, 0-30 days
Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers
NCT Number: NCT06485089
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obesity|Breast Cancer Risk
Sponsor: University of Kansas Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-12
Locations: University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|University of Kansas Medical Center Breast Cancer Prevention Center, Westwood, Kansas, 66208, United States

Summary:
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.

Primary Outcome Measures: Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months, Accrual defined as signed consent and ompleting baseline proceedures, 12 months|Completion rate of 70% or more, Completion of procedures for biomarker assessment after 3-6 months of tirzeptide, 6 months
Secondary Outcome Measures: Change in mammographic fibroglandular volume, as measured by Volpara software baseline and 6 months, 6 months|Change in benign breast tissue proliferation, Difference in baseline and off study Ki-67 in women with baseline Ki-67 of 1 % or higher, 3-6 months|Change in benign breast tissue estrogen response and ELF5 gene expression, Difference in baseline and off study mRNA, 3-6 months|Assessment of GIP-R expression in breast tissue, GIP- R mRNA and protein, 3-6 months|Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho, change in blood levels with assays primarily by ELISA, 3-6 months
Effect of Modeling Resin on Anterior Direct Composite Veneer
NCT Number: NCT06485024
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Wear|Dental Decay
Interventions: DEVICE: Modeling Resin
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2025-08

Summary:
the study will be conducted to evaluate the clinical performance of direct Nanohybrid resin composite veneer restorations applied with or without modeling resin

Primary Outcome Measures: comparison of Color stability with and without the intervention, by using Spectrophotometer to measure the color considering the intervention, baseline and after one year
Secondary Outcome Measures: comparing the effect of the intervention on color match, using the modefied USPHS criteria, baseline and after one year|comparing the effect of the intervention on anatomical form, using the modefied USPHS criteria, baseline and after one year|comparing the effect of the intervention on surface texture, using the modefied USPHS criteria, baseline and after one year|comparing the effect of the intervention on marginal adaptation, using the modefied USPHS criteria, baseline and after one year|comparing the effect of the intervention on marginal discoloration, using the modefied USPHS criteria, baseline and after one year|comparing the effect of the intervention on retention rate, using the modefied USPHS criteria, baseline and after one year|comparing the effect of the intervention on postoperative sensitivity, using the modefied USPHS criteria, baseline and after one year|comparing the effect of the intervention on recurrent caries, using the modefied USPHS criteria, baseline and after one year
Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing
NCT Number: NCT06485011
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Acute Postoperative
Interventions: PROCEDURE: Paltysma suturing|PROCEDURE: Without Platysma suturing
Sponsor: Children Hospital and Institute of Child Health, Lahore
Sex: ALL
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-01-01
Completion Date: 2021-09-01
Locations: The Children Hospital, Lahore, Punjab, 42000, Pakistan

Summary:
Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing in terms of wound scar and pain.

Primary Outcome Measures: Post operative Pain, Pain assessed on visual analogue scale. higher the VAS score means more pain and lower score mean less pain, 48 hours
Relationship Between Children's Colour Preferences and Their Dental Anxiety
NCT Number: NCT06484998
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Anxiety|Child Development
Interventions: BEHAVIORAL: Dental anxiety level and child's compomer colors selection
Sponsor: Bulent Ecevit University
Sex: ALL
Age: CHILD
Enrollment: 275
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2024-01-01
Locations: Bülent Ecevit Univercity, Zonguldak, Kozlu, 67600, Turkey

Summary:
The objective of this study was to examine the relationship between children's color preferences and their dental anxiety. It aims to answer are:

1. Is there a relationship between children's compomer restoration colour preferences and dental anxiety?
2. Do children's compomer restoration colour preferences vary according to age and gender?
3. Are children's compomer restoration colour preferences the same as their favourite colours?

Primary Outcome Measures: anxiety level, To determine the child's anxiety, the Modified Child Dental Anxiety Scale-faces version(MCDAS f) was administered to the children before restorative treatment. According to the MCDASf, a score was obtained by summing the scores of each question expressed with faces ranging from 1 "relaxed", 2 "slightly anxious", 3 "anxious", 4 "very anxious" and 5 "extremely anxious" according to 8 questions. A total score of less than 19 points was categorised as low anxiety, 19-31 points as moderate anxiety and 32-40 points as high anxiety., before dental treatment to 30 minutes|colour preference, The children were asked to choose from a new scale consisting of 9 colours (pink, blue, gold, silver, orange, yellow, green, purple, white) by adding white compomer (Dyract XP) to the colored compomer colour scale (Voco Twinky Star) for the compomer restoration color selections. During the color selection of the patients, it was ensured that the patients saw all the colors at the same time in order not to cause any guidance., before dental treatment to 30 minutes|favorite color, The patients were asked what their favourite color was after the compomer restoration color selection so that the previous question would not have any effect on the child's restoration color selection and the data obtained were recorded., before dental treatment to 30 minutes
Study of AXT-1003 in Subjects With Advanced Malignant Tumors.
NCT Number: NCT06484985
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Non-Hodgkin Lymphoma|Advanced Solid Tumor
Interventions: DRUG: AXT-1003
Sponsor: Axter Therapeutics (Beijing) Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-09
Locations: Beijing Cancer Hospital, Beijing, China|Hunan Cancer Hosptial, Changsha, China|Fujian Cancer Hospital, Fuzhou, China|Sun Yat-Sen University Cancer Center, Guangzhou, China|Fudan University Shanghai Cancer Center, Shanghai, China

Summary:
This is a Phase I study of AXT-1003 to assess the safety, tolerability, and pharmacokinetics in patients with advanced malignancies.

Primary Outcome Measures: Number of Participants With Dose-Limiting Toxicity (DLT) (Dose Escalation), Dose Escalation only: to characterize the dose limiting toxicities (DLTs) of AXT-1003., Up to 28 days|Number of Participants with Adverse Events (AEs), Laboratory test ,ECG, vital signs, physical examination, Baseline up to 30 days after the last dose of study
Secondary Outcome Measures: Overall response rates (ORR), ORR is defined as the proportion of subjects with a CR or PR., Up to 3 years|Duration of response(DOR), DOR is defined as the time from the initial objective response to progression of disease (PD) or death after the response, whichever occurs first., Up to 3 years|Progression free survival (PFS), Progression-free survival is defined as the time from the first dose of study treatment to the first PD or death for any reason in the absence of documented PD, whichever occurs first., Up to 3 years|Time to response (TTR), Time to response is defined as the time from first dose of study treatment to the first objective tumor response., Up to 3 years|Disease control rate (DCR), Disease control rate is defined as the proportion of subjects with a CR, PR, or stable disease(SD)., Up to 3 years|Maximum observed concentration (Cmax) of AXT-1003, Pharmacokinetics of AXT-1003, Up to 15 days|Time of maximum observed concentration (tmax) of AXT-1003, Pharmacokinetics of AXT-1003, Up to 15 days|Area under the curve from the time of dosing to the time of the last measurable concentration (AUCtau) of AXT-1003, Pharmacokinetics of AXT-1003, Up to 15 days|Minimum observed concentration (Cmin) of AXT-1003, Pharmacokinetics of AXT-1003, Up to 15 days|Terminal elimination half-life (t1/2) of AXT-1003, Pharmacokinetics of AXT-1003, Up to 15 days|Total body clearance (CL/F) of AXT-1003, Pharmacokinetics of AXT-1003, Up to 15 days
Pediatric Aquatic Occupational Therapy for Children With Sensory Processing Challenges
NCT Number: NCT06484946
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sensory Processing Disorder|Autism Spectrum Disorder|ADHD
Interventions: OTHER: aquatic occupational therapy
Sponsor: Kristen Pataki
Sex: ALL
Age: CHILD
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-02-19
Completion Date: 2024-04-09
Locations: Seven Hills Recreation Center, Seven Hills, Ohio, 44131, United States

Summary:
Children with sensory processing challenges participated in an 8-week play-based aquatic program addressing goals on behavior, sensory, and participation. It is expected that after the 8-week group, the child's goals will improve demonstrating an effective intervention to address sensory difficulties.

Primary Outcome Measures: Goal Attainment Scaling (GAS), Goals were written on behavior, engagement/participation, and sensory on a scale from -2 (worse outcome) to +2 (better outcome). Each week scores on each goal were documented., Scores were tracked weekly for 8 weeks of each program.|Parent Surveys, Survey with quantitative and qualitative questions about their child's experience and differences seen in the aquatic group, Parents were given a post-survey at the 8th week.
Secondary Outcome Measures: Sensory Processing Measure (SPM: Preschool version: SPM-P, newer edition: SPM-2) Assessment Scores, Assessment given to parents to fill out before their child could start the aquatic group. Gives information on different sensory systems. Categories are: vision, hearing, touch, taste and smell, body awareness, balance and motion, sensory total, planning and ideas, and social participation. Interpretive range is: Typical, Moderate difficulties, and Severe difficulties., Parents completed SPM on their child before the 8-week group began.
Risk Management in Primary Care
NCT Number: NCT06484933
Acronym: eGERISSEP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Primary Care
Interventions: BEHAVIORAL: Focus groups of health professionals and users of primary care
Sponsor: Hospices Civils de Lyon
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-05
Completion Date: 2026-06-01
Locations: Cabinet Medical, Oullins, 69600, France

Summary:
The proposed research is a prospective, non-comparative study based on a qualitative method, comprising a literature review followed by 2 successive series of Focus Groups with users and healthcare professionals of primary care in the French AURA region. The 2 Focus Group phases will make it possible to :

* propose an operational definition of the notion of a professional team in primary care (validation by consensus between the participants of the first 4 Focus Groups based on the definitions in the literature)
* describe the ways in which risks are managed in primary care teams (qualitative analysis of the contributions made by the participants in the next 12 Focus Groups organized in 12 primary care teams)

Primary Outcome Measures: Operational definition of the notion of a professional team in primary care in the France, by means of focus groups and validation by consensus., This definition will be based on data from a literature review adapted to the context of French primary care and the practices/experience of professionals and users by means of focus groups including professionals and users from the primary care teams., up to 23 months
A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL
NCT Number: NCT06484920
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Relapsed Hodgkin Lymphoma|Refractory Hodgkin Lymphoma|Relapsed Non-Hodgkin Lymphoma|Refractory Non-Hodgkin Lymphoma|B-cell Lymphoma
Interventions: DRUG: ATRA|DRUG: Pembrolizumab
Sponsor: Rita Assi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2030-12
Locations: Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, 46202, United States|Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, 46202, United States

Summary:
This is a Phase II single-center open label trial of the combination of ATRA and pembrolizumab treatment in patients with histologically proven, relapsed or refractory Hodgkin Lymphoma or B-Non-Hodgkin-lymphoma.

Primary Outcome Measures: Incidence of Adverse Events, Safety will be assess by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0, from start of treatment through 90 days safety follow-up visit
Secondary Outcome Measures: Overall Response Rate, Screening to up to 2 years post last therapy|Complete Remission Rate, Screening to up to 2 years post last therapy|Patient derived myeloid-derived suppressor cells (MDSC), Assessing the anti-tumor effect of the combination of pembrolizumab and ATRA on the reduction in myeloid-derived suppressor cells (MDSC) frequency and suppressive function through in vitro experiments using patient-derived MDSCs., Screening, before cycle 2, before cycle 4, and within 60 days after cycle 4 day 1
Investigation of Other Predictive Properties of the ACTA PORT Score
NCT Number: NCT06484907
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Disease|Blood Transfusion|Acute Kidney Injury
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-11-01
Locations: Ankara Bilkent City Hospital, Ankara, 06800, Turkey

Summary:
In the scope of this study, it will be determined whether the ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) scoring system can predict the incidence of events in other organ systems, and the feasibility of conducting multiple assessments using a single simple score will be investigated.

Primary Outcome Measures: KDIGO AKI Staging, KDIGO is in the process of developing the Clinical Practice Guideline for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD). ///// Stage 1: Serum creatinine 1.5-1.9 times baseline or ≥0.3 mg/dl (≥26.5 mmol/l) increase or Urine output \<0.5 ml/kg/h for 6-12 hours ////// Stage 2: Serum creatinine 2.0-2.9 times baseline or \<0.5 ml/kg/h for ≥12 hours /////// Stage 3: Serum creatinine 3.0 times baseline or Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l) or Initiation of renal replacement therapy or in patients \<18 years, decrease in eGFR to \<35 ml/min per 1.73 m² or Urine output \<0.3 ml/kg/h for ≥24 hours or anuria for ≥12 hours, Preoperative (last week before operation) and daily after the operation for 7 days
Secondary Outcome Measures: Mechanical Ventilation Duration, The duration the patient remains intubated from surgery to extubation, the duration after surgery up to a month|Intensive Care Duration, The duration the patient remains in intensive care unit after surgery, the duration after surgery up to a month|Hospital Stay Duration, The duration the patient stays in the hospital after surgery until discharge, the duration after surgery up to a month|Mortality, If the patient dies within 1 month or not, the duration after surgery up to a month|Complications, Cardiac, Pulmonary, Neurological, Infectious, Thrombotic complications and Presence of MODS (Multiple Organ Dysfunction Syndrome) / SIRS (Systemic Inflammatory Response Syndrome), the duration after surgery up to a month|Reoperation Necessity, The need for reoperation due to bleeding, the duration after surgery up to a month
The Effect of Refractive Errors on Central Corneal Thickness by Using Pentacam and IOL Master
NCT Number: NCT06484894
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Central Corneal Thickness
Interventions: DEVICE: Pentacam and IOL master
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-08

Summary:
To evaluate the impact of refractive errors on the central corneal thickness obtained by Pentacam and intraocular lenses (IOL) master in eyes with different refractive errors.

Primary Outcome Measures: To find if there a correlation between refractive errors and the central corneal thickness, Study the effect of refractive errors on central corneal thickness, Baseline
Secondary Outcome Measures: To study if there a difference between measurement by pentacam and measurement of IOL master, Study which device is more accurate in measuring the central corneal thickness and if there is any difference between the two devices, Baseline
Clinical Study of Probiotic Treatment for Androgenetic Alopecia
NCT Number: NCT06484881
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Androgenetic Alopecia|Female Pattern Baldness
Interventions: DIETARY_SUPPLEMENT: Daniel Alain Probiotic Treatment for Androgenetic Alopecia|DRUG: Topical minoxidil 5%
Sponsor: Applied Biology, Inc.
Collaborators: Follea International Limited
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-06-15

Summary:
The primary objective of the study is to assess the efficacy of DA-001 as an oral supplement for treatment of female pattern hair loss.

Primary Outcome Measures: Target Area Hair Counts, Target Area Hair Counts, Week [0,12]
Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
NCT Number: NCT06484868
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Partial Lipodystrophy
Interventions: DRUG: Metreleptin
Sponsor: Amryt Pharma
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-08
Completion Date: 2027-09
Locations: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez, Lille, France|Hopital Pitie-Salpetriere, Paris, France|Hôpital Saint-Antoine, Paris, France|Centre Hospitalier Lyon-Sud, Pierre-Bénite, France|Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM), Berlin, Germany|Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin, Ulm, Germany|Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna, Italy|Universitá degli Studi "Magna Graecia" di Catanzaro, Catanzaro, Italy|Azienda Ospedaliero Universitaria Maggiore della Carità di Novara, Novara, Italy|Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello, Pisa, Italy|A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia, Udine, Italy|Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital, Cambridge, United Kingdom

Summary:
This is an Open Label, Phase IV, Post Authorisation Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in people with Partial Lipodystrophy

Primary Outcome Measures: Number of patients with decrease of at least 0.5% in glycated haemoglobin (HbA1c) at Month 12 compared to Baseline or HbA1c <6.5 % at Month 12, in patients with baseline HbA1c ≥6.5%., To evaluate the efficacy (HbA1c) of metreleptin treatment in patients with PL, 12 months|Number of patients with decrease of at least 30% in triglycerides (TG) at Month 12 compared to Baseline, in patients with baseline TG levels ≥500 mg/dL (5.65 mmol/L), To evaluate the efficacy (TG) of metreleptin treatment in patients with PL, 12 months
Secondary Outcome Measures: Number of patients with decrease of at least 0.5% in HbA1c at Month 24 compared to Baseline or HbA1c <6.5 % at Month 24, in patients with baseline HbA1c ≥6.5%., To evaluate the long-term efficacy of metreleptin treatment in patients with PL, 24 months|Number of patients with decrease of at least 30% in TG levels at Month 24 compared to Baseline, in patients with baseline TG levels ≥500 mg/dL (5.65 mmol/L)., To evaluate the long-term efficacy of metreleptin treatment in patients with PL, 24 months|Change from baseline in liver volume at Month 12 and Month 24, To assess changes in liver volume., 12 months and 24 months|Incidence of, Treatment emergent adverse events (TEAEs), Deaths and other serious adverse events (SAEs), Treatment related adverse events (AEs), AEs of special interest (AESIs) and AEs leading to study drug discontinuation, To evaluate the safety of metreleptin treatment in patients with PL, 24 months
Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome
NCT Number: NCT06484855
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Primary Sjögren's Syndrome
Interventions: DRUG: IBI355|DRUG: IBI355 placebo
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-14
Completion Date: 2025-08-08
Locations: The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, 230001, China

Summary:
This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in primary Sjogren's syndrome (pSS) patients. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in pSS patients.

Primary Outcome Measures: Incidence of adverse events and serious adverse events, up to week 24
Secondary Outcome Measures: Area under the Curve(AUC) of multi-dose of IBI355, Up to week 16|Peak serum concentration(Cmax) of multi-dose of IBI355, Up to week 16|Clearance (CL) of multi-dose of IBI355, Up to week 16|Half-life (t1/2) of multi-dose of IBI355, Up to week 16|The ratio of Anti-drug antibody of multi-dose of IBI355, Up to week 24
NW-301 TCR-T in Patients With Advanced Solid Tumor
NCT Number: NCT06484790
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Tumor, Solid
Interventions: DRUG: NW-301V|DRUG: NW-301D
Sponsor: Ting Deng
Collaborators: Neowise Biotechnology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-08
Completion Date: 2027-04-07
Locations: Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China

Summary:
An open label, two cohorts, multiple dose exploratory clinical study to independently evaluate the safety, efficacy, and pharmacokinetics of autologous anti-KRAS G12V/G12D mutation T-cell Receptor T cell in advanced solid tumor

Primary Outcome Measures: Dose-limiting toxicity (DLT), Safety, 28 days of single infusion
A Clinical Study of SHR-9539 in Patients With Multiple Myeloma
NCT Number: NCT06484777
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Multiple Myeloma
Interventions: DRUG: SHR-9539 for injection
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 138
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2027-07-31
Locations: West China Hospital of Sichuan University, Chengdu, Sichuan, 610000, China

Summary:
This study is a multicenter, open-label, dose-escalation/dose-expansion clinical Phase I trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy profile of SHR-9539 Injection in patients with multiple myeloma.

Primary Outcome Measures: RP2D of SHR-9539 injection, Determination of the recommended phase 2 dose (RP2D) of SHR-9539 injection in patient with multiple myeloma., Approximately 24 months
Secondary Outcome Measures: Incidence and severity of AE, Assessing the incidence of adverse events (AEs) mainly using the Common Terminology Criteria for Adverse Events (CTCAE Version 5), and CRS and ICANS were graded according to ASTCT standards., Up to follow-up period, approximately 24 months|Cmax, Maximum serum concentration, Up to follow-up period, approximately 24 months|Tmax, Time to reach maximum plasma concentration., Up to follow-up period, approximately 24 months|Overall Response Rate (ORR), ORR assessed by the IMWG response criteria., Up to follow-up period, approximately 24 months
Alberta Rehabilitation Advice Line SelfBack Study
NCT Number: NCT06484751
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Low-back Pain
Interventions: DEVICE: SelfBack
Sponsor: University of Alberta
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-15
Completion Date: 2026-07-01
Locations: Alberta rehabilitation advice line, Edmonton, Albertta, Canada

Summary:
Recurrent and persistent low back pain (LBP) is a massive problem in Canada that causes a substantial pain, disability, cost, and even premature death.

The good news is that treatments for recurrent and persistent LBP are available. Many guidelines now recommend education and exercise as the best intervention for chronic LBP. Unfortunately, education and exercise programs are not publicly funded in Canada-only Canadians with extended health benefits can access these programs.

As a result, the 50% of Canadians who do not have extended health benefits often seek care for LBP from their publicly funded physicians. Physicians, in turn, have little choice but to reach for what they have available, including opioids, x-rays and referrals to specialists. Not only are these interventions unhelpful for chronic LBP, they are often harmful, sometimes deadly, and disproportionately affect lower socio-economic status households.

A possible solution to this problem exists in a validated app (SelfBack) that provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of treatment plans to individuals is achieved by using case-based reasoning methodology which is a branch of artificial intelligence.

This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through the Rehabilitation Advice Line, a telephone service open Monday to Friday and provides rehabilitation advice and general health information for Albertans of any age.

The results of this study will help us understand the barriers and facilitators of distributing and using the app in the general pollution of Alberta. This information will be used to apply for funding for a larger study to understand the effectiveness of the app as an intervention for persistent and recurrent LBP.

Primary Outcome Measures: The percentage of patients who utilize the SelfBack app, Success will be defined as 50% of patients using the app, 12 months