pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer
NCT Number: NCT06518135
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sentinel Lymph Node Biopsy
Interventions: OTHER: SLNB group
Sponsor: Henan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 508
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-30
Completion Date: 2028-03-31
Locations: Henan cacer hospital, Henan, Henan, 450008, China

Summary:
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies.

Primary Outcome Measures: Axillary recurrence-free survival, The time from surgery to axillary recurrence or last follow-up, 5th year after surgery
Secondary Outcome Measures: regional lymph node recurrence-free survival, The time from surgery to the occurrence of regional lymph node recurrence, metastasis, or last follow-up, 5th year after surgery|Disease-free survival, The time from surgery to the occurrence of recurrence, metastasis, or last follow-up, 5th year after surgery|Overall survival, The time from surgery to patient death or last follow-up, 5th year after surgery|The incidence of postoperative upper limb lymphedema, By using the circumference method, the styloid process of the ulna is taken as the starting point, with an interval of 10cm and measured up to 40cm. The circumference is measured, and the volume of the affected limb is ≥ 10% or\>200ml., 5th year after surgery|EORTC-QLQ-C30 V3 rating, The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) core 30 items (C30) and breast cancer 23 items (BR23) four scales to assess the impact of different surgical methods on patients' lives, 5th year after surgery
A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers
NCT Number: NCT06518122
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: HCP1306|DRUG: RLD2302|DRUG: RLD2102
Sponsor: Hanmi Pharmaceutical Company Limited
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-01
Locations: Jeonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of

Summary:
The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers.

Primary Outcome Measures: AUCtau, Pharmacokinetic evaluation, [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration|Css,max, Pharmacokinetic evaluation, [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Secondary Outcome Measures: Css,min, Pharmacokinetic evaluation, [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration|Css,av, Pharmacokinetic evaluation, [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration|Tss,max, Pharmacokinetic evaluation, [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration|t1/2, Pharmacokinetic evaluation, [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration|CLss/F, Pharmacokinetic evaluation, [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration|Vdss/F, Pharmacokinetic evaluation, [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration|Fluctuation[(Css,max-Css,min)/Css,av], Pharmacokinetic evaluation, [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration|Swing[(Css,max-Css,min)/Css,min], Pharmacokinetic evaluation, [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Caregivers of Children With Autism Spectrum Disorder
NCT Number: NCT06518109
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Autism Spectrum Disorder|Caregiver Burden|Exercise|Physical Activity
Interventions: OTHER: Zarit Caregiver Burden Scale
Sponsor: Gulhane School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-15
Completion Date: 2024-06-15
Locations: University of Health Sciences, Ankara, 06018, Turkey

Summary:
This study aims to examine the relationship between caregiving burden and physical activity, exercise self-efficacy, and perceived exercise benefits and barriers in caregivers of Caregivers of children with autism spectrum disorder (CwASD).The study population consisted of primary caregivers of a CwASD for at least 1 year. Caregiving burden was assessed using the Zarit Caregiver Burden Scale, physical activity using the International Physical Activity Questionnaire-Short form (IPAQ-SF), exercise self-efficacy using the Exercise Self-Efficacy Scale, and perceived exercise benefit using the Exercise Benefits/Barriers Scale. The relationship between caregiver burden and other parameters was analysed.

Primary Outcome Measures: The Zarit Caregiver Burden Scale, The Zarit Caregiver Burden Scale (ZCBS) is a widely used instrument for assessing the burden experienced by caregivers of individuals requiring long-term care. It consists of 22 items and the total score ranges from 0 to 88 (low/no burden to severe burden), 10 minutes
Prediction Model of Microvascular Ischemic Ocular Motor Nerve Palsy and Inflammatory Ocular Motor Nerve Palsy in Chinese Patients
NCT Number: NCT06518096
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Neuro-Ophthalmology
Sponsor: Beijing Tongren Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 299
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-01-01
Completion Date: 2024-04-30
Locations: Tongren Hospital, Beijing, Beijing, 102600, China

Summary:
This study aimed to train and validate deep learning systems (DLS) to differentiate between microvascular ischemic ocular motor nerve palsy (v-OMNP) and inflammatory ocular motor nerve palsy (i-OMNP). The method involves using clearly diagnosed v-OMNP and i-OMNP patients from the Department of Neurology database at Beijing Tongren Hospital for further DLS validation, aiding in the differential diagnosis of the aforementioned diseases.

Primary Outcome Measures: The diagnosis of acute bilateral diplopia, microvascular ischemic ocular motor nerve palsy or inflammatory ocular motor nerve palsy., This study aimed to train and validated deep learning systems to differentiate between v-OMNP and i-OMNP. Clinical information, including sex, age at onset, clinical manifestations, inflammatory factors (including C-reactive protein, erythrocyte sedimentation rate, autoimmune antibody in the cerebrospinal fluid), cavernous sinus MRIs, and prognosis, was obtained from hospitalization and follow-up records. The following information was recorded: (1) intracavernous sinus: abnormal side, thickness of cavernous sinus, thickening enhancement, enlargement and enhancement of CN III, CN IV and CN VI, and narrowing of intracavernous internal carotid artery and (2) extracavernous sinus: enhancing adjacent lesions, lacrimal prolapsus, orbital fascial lipocele, eyeball protrusion, thickened eyelids, and dilatation of superior orbital veins., 6 months
The Relation Between Triglyceride- Glucose Index, Procalcitonin and Cardiac Affection in Septic Shock.
NCT Number: NCT06518083
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Septic Shock
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-07-31

Summary:
The study is carried out to demonstrate the relation between Triglyceride -glucose index and cardiac affection in the patients admitted to the ICU with septic shock.

Primary Outcome Measures: 1- To evaluate the effect of TyG index of on mortality of patients with septic shock.., follow up the effect of elevated TyG index on increased mortality, 3 months
Results Comparison of Cervical Cancer Early Detection Using Cerviray With VIA Test
NCT Number: NCT06518070
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cervical Cancer
Interventions: DIAGNOSTIC_TEST: Cerviray AI
Sponsor: Universitas Padjadjaran
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-01
Completion Date: 2023-10-31
Locations: Padjajaran University, Bandung, Indonesia

Summary:
Cervical cancer, primarily caused by Human Papilloma Virus (HPV), is a significant global health concern, ranking as the fourth most common cancer in women worldwide. In Indonesia, it stands as the second most frequent cancer among women. This study investigates the performance of Cerviray® AI and Cerviray® AI Evaluation, an artificial intelligence (AI) technology for diagnosing cervical cancer, aiming to compare its sensitivity, specificity, positive predictive value (PPV), and area under the receiver operating characteristic curve (AUC ROC) with the Visual Inspection with Acetic Acid (VIA) test.

Primary Outcome Measures: Cerviray AI, The target population screened using Cerviray AI tools and Cerviray AI evaluation and will be compared to VIA test and confirmed by the anatomical pathology examination. The data will be shown as analytical results of the Cerviray AI tool., 1 day
NAC for Hematopoietic Recovery in SAA
NCT Number: NCT06518044
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Aplastic Anemia
Interventions: DRUG: N Acetyl L Cysteine
Sponsor: Peking University People's Hospital
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2025-07-01

Summary:
This is a prospective single-arm clinical study to evaluate the role of NAC among patients with severe aplastic anemia (SAA) can promote hematopoietic recovery after haploidentical transplantation.

Primary Outcome Measures: The incidence of prolonged thrombcytopenia (PT), which was assessed at +2M post-HSCT., PT was defined as platelet count less than 20×109/L or a dependence on platelet transfusion with the engraftment of other cell lines(ANC\>0.5×109/L and hemoglobin\>70 g/L without transfusion support) beyond day +60 post-HSCT in the presence of complete donor chimerism (CDC)., Two months post-HSCT.|The incidence of poor graft function (PGF), which was assessed at +2M post-HSCT., PGF was defined as the presence of 2 or 3 cytopenic counts (ANC≤0.5×109/L, platelet≤20×109/L, or hemoglobin≤70 g/L) for at least 3 consecutive days beyond day +28 post-HSCT with a transfusion requirement, related with hypoplastic-aplastic BM, in the presence of complete donor chimerism (CDC)., Two months post-HSCT.
Secondary Outcome Measures: The cumulative incidences of transplantation related mortality (TRM)., Number of participants suffered TRM will be calculated., Two months post-HSCT.|The cumulative incidences of Thrombotic Microangiopathy (TMA)., Number of participants suffered TMA will be calculated., Two months post-HSCT.|The cumulative incidences of graft versus host disease (GvHD)., Number of participants suffered GvHD will be calculated., Two months post-HSCT.|The cumulative incidences of overall survival (OS)., Number of participants survived for 1 year post diagnosed will be calculated., One year post-HSCT.|Adverse reactions, Liver function, renal function, respiratory syndrom assessed by CTCAE v4.0 during oral administration of NAC., Two months post-HSCT.
The Effects of Meditation on Stress and Fatigue
NCT Number: NCT06518031
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intensive Care Nurses
Interventions: OTHER: meditation
Sponsor: Osmaniye Korkut Ata University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2021-12-19
Completion Date: 2022-01-30
Locations: Songül GÜNGÖR, Merkez, Osmani̇ye, 80010, Turkey

Summary:
A randomized controlled trial was conducted with nurses practicing meditation for six weeks, compared to a control group with no intervention. Stress and fatigue levels were measured using validated scales at baseline and post-intervention.

Primary Outcome Measures: STRESS LEVELS, PERCEIVED STRESS SCALE, after 6 weeks|FATIGUE LEVELS, FATIGUE SEVERITY SCALE, after 6 weeks
Efficacy and Safety of High-Dose Rate Brachytherapy with Immunotherapy and Chemotherapy As Second-Line Treatment for Advanced Non-Small Cell Lung Cancer
NCT Number: NCT06518018
Acronym: HIBIC-NSCLC
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Advanced Stage NSCLC|Second-line Treatment|Patients Without Targetable Driver Mutations
Sponsor: The First People's Hospital of Neijiang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2025-09-01

Summary:
This is a single-center, retrospective, propensity score-matched study exploring the efficacy and safety of high-dose rate (HDR) brachytherapy combined with immune checkpoint inhibitors (ICIs) and chemotherapy as a second-line treatment for advanced non-small cell lung cancer (NSCLC).

The study will compare two groups:

Study group: HDR brachytherapy (30Gy single fraction) + ICIs (pembrolizumab) + chemotherapy (docetaxel) Control group: ICIs (pembrolizumab) + chemotherapy (docetaxel) alone Primary objective: To assess the objective response rate (ORR)

Secondary objectives: To evaluate progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety.

The study aims to address the unmet clinical need for effective treatments in advanced NSCLC patients who have progressed after immunotherapy. It will investigate whether the addition of HDR brachytherapy to immunotherapy and chemotherapy can improve treatment outcomes.

This research is significant as it explores a novel treatment combination, potentially offering new options for second-line treatment of advanced NSCLC. It also aims to contribute to the understanding of how radiotherapy doses affect immunotherapy responses and may help identify biomarkers for treatment response prediction.

Primary Outcome Measures: Objective Response Rate (ORR), The proportion of patients achieving either a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria, Every 8 weeks from baseline up to 24 months or until disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurs first
Secondary Outcome Measures: Progression-Free Survival (PFS), Time from treatment initiation to disease progression or death from any cause, Progression-Free Survival was assessed from the date of treatment initiation until the date of first documented disease progression or death from any cause, whichever occurred first, assessed up to 24 months.
Other Outcome Measures: Overall Survival (OS), Time from treatment initiation to death from any cause, Overall Survival was measured from the date of treatment initiation until death from any cause or patients who were still alive at the last follow-up were censored at that time point, assessed up to 36 months.
Collaborative cOMMUNIty Care for Metastatic breAsT cancEr Patients in inDonesia (Communicated)
NCT Number: NCT06517992
Acronym: Communicated
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metastatic Breast Cancer|Cancer
Interventions: OTHER: Health education for cadre (communicated project)
Sponsor: Gadjah Mada University
Collaborators: Pfizer|Queensland University of Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Primary Health Center, Yogyakarta, Daerah Istimewa Yogyakarta, 55581, Indonesia|Primary Health center, Bali, Indonesia

Summary:
The current study aims to empower local cadres in providing care for metastatic breast cancer (mBC) patients in 2 provinces in Indonesia (Bali and Yogyakarta).

Primary Outcome Measures: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire - Breast Cancer (EORTC QLQ-BR23), Questionnaire to measure Quality of Life of Breast Cancer Patients. This consists of 23 items with 2 domains: symptom scales (systemic therapy side effects, upset by hair loss, Arm symptoms and Breast symptoms) and functional scale (body image, future perspective, sexual functioning, and sexual enjoyment). The questionnaire uses likert scale 1-4. The options are not at all, a little, quite a bit, and very much. An option for "Not applicable (N/A)" is also offered for an item of sexual enjoyment. This instrument has been translated to Bahasa Indonesia. The scale ranges in score from 0-100 with a higher score for the functional scale represents a high or healthy level of functioning. On the other hand, the high score for symptom scale represents frequent problems., 2-3 months
Secondary Outcome Measures: Symptom Management Self Efficacy Scale - Breast Cancer (SMSES-BC), This instrument consists of 27 items related to self-efficacy in the symptom management relevant to chemotherapy for patients with breast cancer. The items is offering rating from 0 not at all confident) to 10 (completely confident). The higher score represents higher perceived of symptom-management self-efficacy., 2-3 months|Preparedness for caregiving scale (PCS), PCS consists of 8 items and 1 open ended question. This is a family caregiver instrument to self-rated how well are of becoming caregivers with the domain of providing physical care, emotional support, setting up in-home support services and dealing with caregiver's stress. Responses are ranging from 0 (not at all prepared) to 5 (very well prepared)., 2-3 months|Resilience Scale Specific to Cancer (RS-SC-10), tThis instrument is a brief and validated instrument for family caregivers of patient with cancer \[44\] which consists of 10 items. RS-SC developed using MRIT analysis and consists of 2 domains: generic and Shift-Persist. The score ranges from 10-50 with the higher score represents higher resilience., 2-3 months
Development and Prospective Validation of a Digital Pathology-based Artificial Intelligence Diagnostic Model for Pan-cancer Lymphatic Metastasis
NCT Number: NCT06517979
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer|Lymphatic Metastasis
Interventions: DIAGNOSTIC_TEST: Artificial intelligence (AI)-based diagnostic model
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-26
Completion Date: 2027-06-30
Locations: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510120, China

Summary:
The goal of this diagnostic test is to develop an artificial intelligence (AI)-based pan-cancer universal diagnostic model for detecting pathological lymph node metastasis (LNM), and prospectively evaluate its apllication value in the real-world clinical practice.

Investigators will compare the diagnostic performance (sensitivity, specificity, etc.) of the AI model and routine pathological report issued by pathologists, to see if the AI model can improve the clinical workflow of pathological evaluation of cancer LNM in in the real world.

Primary Outcome Measures: sensitivity, the number of correctly diagnosed positive slides (with lymphatic metastasis), to be divided by the number of positive slides in total, For each enrolled patient, the diagnosis results of AI model will be obtained in servel days after lymph node dissection, and the sensitivity of the AI model will be evaluated through study completion, an average of 3 year.
Secondary Outcome Measures: specificity, the number of correctly diagnosed negative slides (without lymphatic metastasis), to be divided by the number of negative slides in total, For each enrolled patient, the diagnosis results of AI model will be obtained in servel days after lymph node dissection, and the sensitivity of the AI model will be evaluated through study completion, an average of 3 year.
Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations
NCT Number: NCT06517953
Acronym: IcomBine
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-small Cell Lung Cancer Metastatic|EGFR G719X|EGFR L861Q|EGFR S768I
Interventions: DRUG: Icotinib|DRUG: Befotertinib
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 23
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-17
Completion Date: 2027-12-24
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
This research study aims to explore the combination of two targeted drugs as first-line treatment for Non-Small Cell Lung Cancer (NSCLC) with uncommon EGFR mutation.

Primary Outcome Measures: Objective Response Rate （ORR）, ORR, per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR)., 24 months
Secondary Outcome Measures: Progression-free survival（PFS）, PFS, defined as time from study drug administration to progression or death due to any cause., 12 months|Disease control rate（DCR）, DCR, defined as proportion of complete response, partial response, and disease stabilization to the proportion of patients with evalueable tumors., 12 months|Overall survival （OS）, OS, defined as the time from study drug administration until the date of death due to any cause., 24 months
A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP)
NCT Number: NCT06517940
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Retinitis Pigmentosa
Sponsor: Sumitomo Pharma America, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2026-02-28

Summary:
The natural history in individuals with severe retinitis pigmentosa (RP) is variable and there remains an unmet need to better understand disease progression in this population. The goal of this study is to determine which visual assessments individuals with RP and low visual acuity can reliably perform and to evaluate the annual decline of visual function in severe RP.

Primary Outcome Measures: Reliability (test-retest variability within subjects), Reliability (test-retest variability within subjects) on:

* Total visual area (degrees squared) on kinetic perimetry using V4e stimulus (excluding temporal islands) (Time frame: 12 months)
* Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) Log of Minimum Angle of Resolution (LogMAR) equivalent (or Low Vision Test, as applicable) (Time frame: 12 months)
* Retinal light sensitivity on Full-field Stimulus Threshold test (Time frame: 12 months)
* Retinal sensitivity and fixation stability on microperimetry (Time frame: 12 months), 12 months
Prevalence of Long-term Dental Effects of Chemotherapy in Childhood Cancer Survivors Diagnosed With Cancer Before the Age of 10
NCT Number: NCT06517927
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chemotherapy Effect|Dental Caries|Malocclusion|Childhood Cancer|Tooth Defect
Interventions: DIAGNOSTIC_TEST: Clinical and radiographic dental examination
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sex: ALL
Age: CHILD, ADULT
Enrollment: 142
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-05-03
Completion Date: 2026-05-03
Locations: Cliniques universitaires Saint-Luc, Brussels, 1200, Belgium

Summary:
To date, there are no methods for assessing the risk of oral developmental defects that could predict long-term adverse effects in cancer survivors. Having such a method at our disposal would enable us to better assess the risk and develop new prevention and treatment strategies to ensure the patient's healthy oral development.

The aims of this study are:

* Assess the caries risk in childhood cancer survivors compared with a control group.
* Assess the dental development defects risk in childhood cancer survivors compared with a control group.

Primary Outcome Measures: Assessment of the caries experience by using the Decay Missing Filled Teeth score (DMFT), Assess the impact of the chemotherapy agents on the risk of ulterior caries development, Thoughout the entire study, approximately during 2 years
Secondary Outcome Measures: Assessment of the prevalence of dental development defects (DDD), Assess the impact of the chemotherapy agents on the risk of ulterior dental development defect, Thoughout the entire study, approximately during 2 years
Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
NCT Number: NCT06517901
Acronym: FOCUS-PC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer|Diagnosis
Interventions: PROCEDURE: Software fusion prostate biopsy|PROCEDURE: Cognitive fusion prostate biopsy
Sponsor: Albany Medical College
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 1312
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-15
Completion Date: 2026-12-30

Summary:
The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques:

1. Software-based fusion of MRI and ultrasound images (software fusion) or
2. Visually estimated MRI-informed (cognitive fusion) technique

To date, there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy. This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI (mp-MRI) of prostate.

Primary Outcome Measures: Detection of clinically significant prostate cancer, Compare the overall detection of clinically significant prostate cancer following fusion vs cognitive MRI-targeted biopsy, 1 year
Secondary Outcome Measures: Detection of clinically significant prostate cancer in the targeted cores, systematic biopsy cores, and combined, Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy, 1 year|Detection of clinically significant prostate cancer based on lesion size (< 0.5 cm; 0.5 cm to 1 cm; > 1.1 cm etc), Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy, 1 year|Detection of clinically significant prostate cancer at various lesion location (anterior, posterior, apex, base), Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy, 1 year|Detection rate of overall prostate cancer of any grade, Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy, 1 year|Detection rate of clinically insignificant (low grade) prostate cancer, Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy, 1 year|Detection rate of clinically significant prostate cancer based on PSA density (PSA level / prostate volume), Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy, 1 year
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
NCT Number: NCT06517888
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Vestibular Schwannoma
Interventions: COMBINATION_PRODUCT: AAVAnc80-antiVEGF via Akouos Delivery Device
Sponsor: Akouos, Inc.
Collaborators: Eli Lilly and Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-08
Locations: Mayo Clinic, Rochester, Minnesota, 55905, United States

Summary:
This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.

Primary Outcome Measures: Frequency of Adverse Events (AEs), AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery device), through trial completion, approximately one year
Secondary Outcome Measures: Tumor Volume, Change from baseline in tumor size via MRI (volumetric analysis), through trial completion, approximately one year|Performance of Akouos Delivery Device, Performance based on the frequency of device deficiencies observed during delivery of AAVAnc80-antiVEGF to the intracochlear space, through trial completion, approximately one year
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
NCT Number: NCT06517875
Acronym: ODYSSEY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Primary Myelofibrosis|Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Interventions: DRUG: Momelotinib|DRUG: Luspatercept
Sponsor: GlaxoSmithKline
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-17
Completion Date: 2026-08-25

Summary:
The purpose of this Phase 2 study is to evaluate the efficacy and safety of momelotinib (MMB) in combination with luspatercept (LUSPA) in participants with transfusion dependence (TD) primary myelofibrosis (PMF) or Post-polycythemia vera (PV)/ essential thrombocythemia (ET) myelofibrosis (MF) who are either janus kinase (JAK) inhibitor (JAKi) naïve or experienced.

Primary Outcome Measures: Percentage of Participants with TI Response by Week 24, TI response is defined as not requiring red blood cell (RBC) transfusion (except in the case of clinically overt bleeding) for any ≥12-week interval., Up to Week 24
Secondary Outcome Measures: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation, Up to approximately 36 weeks|Number of Participants with Clinically Important Changes in Laboratory Parameters, Vital Signs, and Eastern Cooperative Oncology Group (ECOG) Performance Status, Up to Week 24|Percentage of Participants with TI at the End of Week 24, TI was defined as not requiring RBC transfusion (except in the case of clinically overt bleeding) for ≥12 weeks preceding Week 24, with all hemoglobin (Hgb) levels during the ≥12-week interval of ≥8 g/dL (except in the case of clinically overt bleeding)., Up to Week 24|Plasma Concentration of MMB, Up to Week 24|Plasma Concentration of Morpholino Lactam (M21), Up to Week 24
Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia
NCT Number: NCT06517862
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Neonatal Hyperbilirubinemia
Interventions: DRUG: Zinc sulfate|DRUG: Ursodeoxycholic acid
Sponsor: Amira Adel Fouly
Collaborators: Egyptian Chinese University|Ain Shams University
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2024-12-01
Locations: Neonatal Intensive Care Unit (NICU) of Ain Shams University Hospitals, Cairo, Egypt

Summary:
Neonatal jaundice, or neonatal hyperbilirubinemia, is a common medical issue in the first two weeks of life, causing prolonged hospitalization and readmissions. It results from elevated total serum bilirubin (TSB) and is manifested as yellowish discoloration of the skin, sclera, and mucous membrane. Clinical jaundice appears in about 60% of term neonates and 80% of preterm infants within the first week of life. Pathologic hyperbilirubinemia occurs when bilirubin levels increase by more than 5 mg/dL/day or 0.2 mg/dL/hour, or when jaundice lasts longer than two to three weeks in full-term infants. In preterm infants, unconjugated hyperbilirubinemia is of particular concern due to their permeable blood-brain barrier and underdeveloped brain. Phototherapy is widely used to reduce or prevent the rise of serum unconjugated bilirubin levels and reduce the need for exchange transfusions. However, phototherapy has both immediate and long-term side effects, and it can only decrease accumulated UCB but does not prevent its accumulation. There is a growing potential to explore novel adjuvant treatments to increase bilirubin clearance, decrease phototherapy duration, and decrease exchange transfusion rate.

Primary Outcome Measures: serum bilirubin level., Assessing the effect of oral administration of zinc sulfate (at low and high doses) and ursodeoxycholic acid on serum bilirubin levels during the treatment of neonatal non-hemolytic unconjugated hyperbilirubinemia., 10 days|duration of phototherapy needed., Assessing the effect of oral administration of zinc sulfate (at low and high doses) and ursodeoxycholic acid on the duration of phototherapy during the treatment of neonatal non-hemolytic unconjugated hyperbilirubinemia., 10 days
Secondary Outcome Measures: monitoring adverse effects, assessing the possible side effects of both drugs, 10 days|serum zinc level, evaluate the level of serum zinc before and after interventions., 10 days|length of NICU stay., assess if the intervention will affect the duration of the NICU stay., 10 days
Automated Screening Device to Detect MTMROP
NCT Number: NCT06517836
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Retinopathy of Prematurity|ROP
Interventions: DEVICE: iROP DL
Sponsor: Siloam Vision
Collaborators: National Eye Institute (NEI)
Sex: ALL
Age: CHILD
Enrollment: 1284
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-03-20
Completion Date: 2024-12-01
Locations: Oregon Health and Sciences University, Portland, Oregon, 97239, United States

Summary:
The purpose of the study is to evaluate the i-ROP DL system for autonomous ROP screening. To demonstrate the sensitivity and specificity of the i-ROP DL system on images obtained by healthcare providers in the neonatal intensive care unit (NICU) setting to detect more than mild ROP (MTMROP), defined as type 2 or worse (as defined by the Early Treatment for ROP \[ETROP\] study), or pre-plus, compared to an image-based reference standard diagnosis (RSD).

This study will utilize a large multicenter dataset of images obtained as part of the Multicenter Telemedicine Approaches to Evaluating Acute-phase ROP (e-ROP) Study, a National Institute of Health multicenter study.

Primary Outcome Measures: sensitivity and specificity of the i-ROP DL system, sensitivity and specificity of the I-ROP DL system for more than mild ROP and treatment requiring (type 1) ROP, 6 months
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
NCT Number: NCT06517810
Acronym: SAVE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury|Acute Kidney Injury Due to Sepsis
Interventions: DEVICE: QUELIMMUNE (SCD-PED)
Sponsor: SeaStar Medical
Sex: ALL
Age: CHILD, ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2026-05
Locations: Cincinnati Children's Hospital, Cincinnati, Ohio, 45229, United States

Summary:
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.

The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE

Primary Outcome Measures: Safety, New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner, 28 days or through hospital discharge, whichever is sooner
One-Year Study of S1B-509 vs Placebo for Weight Loss
NCT Number: NCT06517797
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obesity
Interventions: DRUG: S1B-509
Sponsor: S1 Biopharma, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-15
Completion Date: 2026-12-15

Summary:
This is a study to test whether S1B-509 given orally daily helps people with overweight or obesity to lose more weight than with placebo over a year.

Primary Outcome Measures: Per cent weight change, 100 (Weight at follow-up) - (weight at baseline)/(weight at baseline), 48 weeks|Proportion losing at least 5% body weight, (number of subjects (no. ss) per group losing at least 5% body weight)/(total no. ss/group, 48 weeks
Secondary Outcome Measures: Waist circumference, measured waist in inches or centimeters, 48 weeks|Proportion losing 10%, per cent of patients per group losing ten percent weight, a substantial amount, 48 weeks|Proportion losing 15%, per cent of patients per group losing a highly substantial amount of weight, 48 weeks|Change in systolic blood pressure, average gain in systolic blood pressure per group, 48 weeks|Change in diastolic blood pressure, average change in diastolic pressure per group, 48 weeks|Change in Hemoglobin A1c, change in glycosylated hemoglobin, a measure of diabetes; normal is less than 6.5%, 48 weeks|Change in Columbia suicidality screener, 6 yes/no items, patient-rated screener on suicide ideation and behavior, "no" on each is best, 48 weeks|Change in Personal Health Questionnaire, 9-item version, depression screener. Sum of 9 self-rated items from 0 (best) to 3 (worst)., 48 weeks|Adverse events, Change in subjective (answer to "how have you felt" or objective findings, 4 weeks|Change in Female Sexual Function Index, Female, 19-item self-rated scale on sexual response, sum of ratings from 0 or 1 (worst) to 5 (best), 4 weeks|Change in International Index of Erectile Function, 5-item version, 5-item self-rated scale on erectile function, sum of items rated from 1 (worst) to 5 (best), 4 weeks|Edmonton Obesity Staging System, Single-item categorical rating from 0 (normal) to 4 (severe), 4 weeks
Insulin Initiation and Adherence Behaviours: a Cross Sectional Survey of Indian HCPs & Patients With Type 2 Diabetes
NCT Number: NCT06517784
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Type 2 Diabetes
Interventions: OTHER: No treatment given
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 752
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-05
Completion Date: 2024-08-16
Locations: Novo Nordisk India, Bangalore, India

Summary:
This is a cross-sectional study planned among patients with Type 2 Diabetes (T2D) and Health Care Providers (HCPs) who treat T2D patients. Study participants will be recruited through existing databases/panels to complete a 30-minute self-administered online survey. The purpose of the study is to understand the insulinization barriers and the insulin adherence behaviours of both HCPs and patients.

Primary Outcome Measures: The barriers toward insulin initiation among HCPs & patients, Barriers to insulin initiation = Likert scale: 1=Strongly disagree, 5=Strongly agree, At time of data abstraction (Day 1)
Effect of Prone Positionning in Non Intubated Patients
NCT Number: NCT06517745
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: SARS-CoV 2 Pneumonia|Acute Respiratory Distress Syndrome|Prone Positioning
Interventions: PROCEDURE: Prone positioning
Sponsor: Mongi Slim Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2021-10-30
Locations: Mongi Slim hospital, Tunis, 2046, Tunisia

Summary:
Retrospective single center study on the effect of awake prone positioning in ICU patients with severe hypoxemia related to SARS-COV2

Primary Outcome Measures: Intubation, invasive mechanical ventilation requirement, at day 7|Intubation, invasive mechanical ventilation requirement, at day 14
Secondary Outcome Measures: ICU mortality, observed mortality rate in the ICU, at Day 14
Brain Research and Integrative Neuroscience Network for COVID-19
NCT Number: NCT06517706
Acronym: BRAINN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Training|Transcranial Direct Current Stimulation
Interventions: COMBINATION_PRODUCT: Combination of tDCS (device) with cognitive training (behavioral)|BEHAVIORAL: Categorization Program
Sponsor: University of Cyprus
Sex: FEMALE
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12-31
Locations: University of Cyprus, Nicosia, 1678, Cyprus

Summary:
The aim of the experimental study is to investigate two interventions for the management of cognitive symptoms resulting from long COVID. Participants will be randomly assigned into two interventions. 1. Categorization Program (CP) training with active tDCS or 2. Categorization Program training with sham tDCS.

Primary Outcome Measures: Categorization Program Test 1, Semantic knowledge and classification behavior, Administered pre & post training with the Categorization Program, at 6 weeks|Categorization Program Test 2, Decision-Making and Rule based learning, Administered pre & post training with the Categorization Program, at 6 weeks|Probe Tasks, Decision-Making and Rule based learning, Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks|WHO BREF Quality of Life, general quality of life, before and after training, at 6 weeks|Dysexecutive Questionnaire, Test of everyday executive functioning behaviors; self and informant reports, pre and post training, at 6 weeks
Other Outcome Measures: Cognitron Cognitive Assessment Battery, Tests of memory, reaction time, and executive Functioning, Pre & Post Testing, after completion of training at 6 weeks|fNIRS, Functional spectroscopy of oxygenated and deoxygenated hemodynamic responses, pre and post training testing, after completion of training at 6 weeks
Tight Control for Rotator Cuff Tendinopathy
NCT Number: NCT06517680
Acronym: GREAT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rotator Cuff Tendinopathy
Interventions: OTHER: tight control management|OTHER: standard follow-up
Sponsor: Nantes University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2027-09-15
Locations: CHU de Nantes, Nantes, 44093, France

Summary:
The main objective of the study is to determine whether tight management of patients in early rotator cuff tendinopathy would lead to better clinical improvement than standard management. In a randomized study, we propose to compare two types of management, with a tight control group having one consultation per month for the first 3 months, in order to readapt or intensify management, whereas the control group will only be seen at 3 months after inclusion. We hypothesize that this close follow-up will lead to more rapid clinical improvement and reduce the transition to chronicity and the associated costs (inclusion of a medico-economic analysis taking into account, in particular, healthcare consumption and time off work).

Primary Outcome Measures: Oxford Shoulder Score, Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48), 6 months
Secondary Outcome Measures: Oxford Shoulder Score, Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48), 3 months and 12 months|pain at motion, Visual Analogic Scale / 100 mm, 3 Months, 6 months, 12 months|Pain Self-Efficacy Questionnaire, 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain., 3 Months, 6 months, 12 months|Insomnia Severity Index, 7 item auto-questionnaire, 3 Months, 6 months, 12 months|number of shoulder surgeries, patients requiring shoulder surgery to manage their shoulder pain and/or disability, 12 months|medico-economic study, Incremental cost-utility ratio (cost per QALY, Quality- Adjusted Life-Years), 12 months
Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye
NCT Number: NCT06517667
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Dry Eye
Interventions: DRUG: Icross tear substitute|DRUG: Hyabak tear substitute
Sponsor: University of Seville
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2024-06-01
Locations: Novovision ophthalmologic clinic, Murcia, 30009, Spain

Summary:
The objective of the study is to compare the efficacy and safety of different hyaluronic acid tear substitutes formulations in patients with evaporative dry eye. For this purpose, a randomized, single-blind clinical trial has been designed.

Primary Outcome Measures: Lipid layer thickness (LLT), The Lipiview® (Johnson \& JohsonVision Care, San Francisco, CA, USA) II ocular surface interferometer evaluates LLT automatically assesses LLT with nanometer precision by recording a 20 s video of the tear film interference pattern and then displays the data in interferometric color units (ICU), where1 ICU reflects approximately 1 nm of LLT., This outcome measure was analyzed at baseline, 1 months and 3 months.
Secondary Outcome Measures: Ocular surface disease index questionnaire, The OSDI questionnaire were employed to assess the severity of DED symptoms, with scores ranging from 0 (indicating no ocular surface disease) to 100 (indicating severe ocular surface disease) points. This questionnaire was provided during consultations at each follow-up visit., This outcome measure was analyzed at baseline, 1 months and 3 months.|Non-invasive tear film break-up time, Tear film stability was automatically assessed using NIBUT by projecting Placido rings from the Sirius device (CSO, Florence, Italy) onto the corneal surface. The time interval between the last blink and the initial distortion of the ring pattern was defined as first NIBUT. This variable was always measured at least 12 hours after administration of the study medication and the average of 3 consecutive measurements was calculated for statistical analysis., This outcome measure was analyzed at baseline, 1 months and 3 months.|Schirmer I test without anesthesia, During the test, the patient is instructed to look upward while the test strip is carefully positioned between the palpebral conjunctiva of the lower eyelid and the bulbar conjunctiva. Subsequently, the patient is asked to keep their eyes gently closed for five minutes. After this period, the test strip is removed, and the Schirmer test score is determined by measuring the length of the moistened area on the strip., This outcome measure was analyzed at baseline, 1 months and 3 months.