pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Creation of a Syncope Channel for Patients Admitted to the Emergency Department for Loss of Consciousness and Not Hospitalized: Etiological Predictivity (Before/After Study)
NCT Number: NCT06503653
Acronym: Sync'Hope
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Syncope
Interventions: DIAGNOSTIC_TEST: syncope channel|DIAGNOSTIC_TEST: routine care
Sponsor: Versailles Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-03-31
Completion Date: 2024-12-31
Locations: centre hospitalier de Versailles, Le Chesnay, Yvelines, 78390, France

Summary:
The main aim of this study is to assess the value of creating a "syncope pathway" to optimize diagnostic performance in patients admitted to the emergency department for syncope and not hospitalized, compared with the previous pre-syncope pathway situation.

Primary Outcome Measures: etiological diagnosis of synchope, Percentage of patients for whom at least one etiological diagnosis of syncope was identified., 3 months
Coronary Microvascular Dysfunction in Angina Patients With Non-obstructive Coronary Artery Disease (ANOCA-CMD)
NCT Number: NCT06503640
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Angina Patients With Non-obstructive Coronary Artery Disease|Coronary Microvascular Dysfunction|Index of Microvascular Resistance
Sponsor: China-Japan Friendship Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-01
Completion Date: 2025-12-31
Locations: China-Japan Friendship Hospital, Beijing, Beijing, 100029, China

Summary:
The goal of this observational study is to explore the incidence and effect on prognosis of coronary microvascular dysfunction in patients present of stable anginal symptoms, a clinical indication for invasive coronary angiography, and no hemodynamically significant epicardial coronary artery disease, defined as fractional flow reserve (FFR) \>0.80.

Primary Outcome Measures: MACE in 12 months, major adverse cardiovascular events 12 months, including cardiac death, myocardial infarction, and readmission for angina., 12 months
The Impact of Genetic Polymorphism on the Echocardiographic Parameters and Cardiac Fibrosis Markers in Response to Empagliflozin Treatment Among Patients With Heart Failure
NCT Number: NCT06503601
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 92
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-30
Completion Date: 2025-10-01
Locations: Ain shams university, Cairo, 11315, Egypt

Summary:
It is important to assess the implications of genetic variants of the TGF-β1 gene in patients with HFrEF and the association of this polymorphism with treatment response to SGLT2I. Therefore, by correlating the pharmacogenetics hand in hand with the mechanistic markers involved in the pathogenesis of HF, this can aid in the development of individualized, therapeutic strategies and improve the patient's drug response.

Primary Outcome Measures: Genetic polymorphism and echocardiographic parameters, To detect association between a TGFβ1 gene polymorphism variants and echocardiographic outcome of patients with HFrEF in response to empagliflozin., 3-6 months
Secondary Outcome Measures: Cardiac fibrosis biochemical markers, • To detect association between serum TGFβ1, MMP-2 and TNF-α levels (cardiac fibrosis biochemical marker) and echocardiographic parameters of patients with HFrEF in response to empagliflozin, 3-6 months
Ureteral Stent Exchange Abstention in Urinary Tract Infections
NCT Number: NCT06503588
Acronym: JJ-change-UTI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Urinary Tract Infections|Urinary Catheterization
Interventions: OTHER: Guidelines promoting surgical abstention
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-03
Locations: Nancy university hospital, Nancy, Lorraine, 54000, France

Summary:
The Committee of Infectiology of the French Association of Urology (CIAFU) provided, for the first time in 2020, comprehensive guidelines for ureteral stent-associated urinary tract infections (USAUTI) prevention, diagnosis and treatment. Since evidence lacked in terms of appropriate treatment, guidelines could not support systematic change of US in case of USAUTI.

This study aims to evaluate whether "after guidelines group" patients treated for USAUTI had different occurrence of at least one relapse or recurrence than "before guidelines group".

Primary Outcome Measures: Relapse OR recurrence of urinary tract infection, 1 year
Secondary Outcome Measures: Nephro-urologic complication, Acute kidney injury ; hematuria ; pain ; stent migration or incrustation, 1 year|Infectious complication, Sepsis or septic shock, 1 year|In-hospital and 1-year mortality, all cause death, 1 year|Resort to Watch or Reserve antibiotics, antibiotics' WHO classifcation, 1 year
A Study to Assess Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization in Chinese Participants Receiving Upadacitinib for Atopic Dermatitis (AD) Through Chart Review
NCT Number: NCT06503536
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atopic Dermatitis (AD)
Sponsor: AbbVie
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-06
Completion Date: 2024-11-10
Locations: Huashan Hospital affiliated to Fudan University /ID# 268259, Shanghai, Shanghai, 200040, China

Summary:
Atopic Dermatitis (AD) is a common, chronic, and flaring systemic inflammatory skin disorder characterized by intensely pruritic and distressing skin eruptions. This study will assess treatment patterns, treatment outcomes, healthcare resource utilization in Chinese participants receiving Upadacitinib for Atopic Dermatitis (AD) undergoing chart review.

Primary Outcome Measures: Number of participants who achieve a composite endpoint post-index score of Eczema Area and Severity Index (EASI) < =7, Eczema Area and Severity Index (EASI): Clear=0, Almost clear=0.1-1.0, Mild=1.1-7.0, Moderate=7.1-21.0, Severe=21.1-50.0, Very severe=50.1-72.0, Up to 3 months|Number of participants who achieve a composite endpoint post-index score of Investigator's Global Assessment (IGA) × Body Surface Area (BSA) < = 30, Investigator's Global Assessment (IGA) × Body Surface Area (BSA): Mild=0-30, Moderate=30.1-130, Severe=130.1-400, Up to 3 months
A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer
NCT Number: NCT06503497
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Pancreatic Cancer Non-resectable
Interventions: BIOLOGICAL: chemotherapy sequential CAR-NK cell infusion
Sponsor: Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2026-07-31

Summary:
This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of second-line systemic chemotherapy sequential NKG2D CAR-NK cell therapy for pancreatic cancer

Primary Outcome Measures: Maximum tolerated dose, Determine the optimal agent for NKG2D CAR-NK at maximum tolerated dose, within 28 days after NKG2D CAR-NK treatment|Dose limiting toxicity, Describe the adverse events of limiting further increases in the dose of NKG2D CAR-NK, From enrollment of the first subject to completion of follow-up of the last subject up to 2 years
Secondary Outcome Measures: Effectiveness evaluation, Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1, At weeks 4、8 and months 3、6、9、12、16、20 and 24 after treatment
SCLife®-UT hUC-MSCs Advanced Therapy Medicinal Products (hUC-MSCs ATMPs) for Patients With Thin Endometrial Infertility
NCT Number: NCT06503471
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Infertility, Female
Interventions: BIOLOGICAL: human umbilical cord mesenchymal stem cell complex collagen|PROCEDURE: intrauterine injection
Sponsor: Sclnow Biotechnology Co., Ltd.
Sex: FEMALE
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2026-08-31
Locations: Changsha Reproductive Medicine Hospital (Changsha Ning 'er Maternity Hospital), Changsha, Hunan, 410217, China

Summary:
To explore the therapeutic effect and safety of human umbilical cord mesenchymal stem cells on thin endometrial infertility and to explore whether human umbilical cord mesenchymal stem cells using collagen as the carrier can promote endometrial growth, reduce the recurrence rate of intrauterine adhesion, increase the clinical pregnancy rate, improve the pregnancy outcome, and study its safety.

Primary Outcome Measures: Pregnancy outcome, Pregnancy status is tracked for pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate and live birth rate., 12 months
A Low-Interventional Study of an Electronic Sickle Cell Disease Patient Reported Outcomes in Sickle Cell Participants
NCT Number: NCT06503458
Status: TERMINATED
Study Type: OBSERVATIONAL
Conditions: Sickle Cell Disease|Sickle Cell Anemia
Sponsor: Sanguine Biosciences
Collaborators: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-19
Completion Date: 2024-04-10
Locations: Sanguine Biosciences, Woburn, Massachusetts, 01801, United States

Summary:
The purpose of this study is to learn more about painful crisis in people with Sickle Cell Disease. For this reason, Pfizer is conducting a study to understand how people with Sickle Cell Disease feel on a daily basis, treat these painful episodes including if they treat themselves at home or go to a doctor's office/emergency room, as well as the types of medications that are taken during these episodes.

Primary Outcome Measures: Primary Objective #1:, To assess whether the effect of HU on frequency of physician-reported MU VOC is observed in the study population, the annualized rate reduction in those on HU as compared to matched participants in control group will be evaluated. The null hypothesis is that the annualized physician-reported MU VOC rate in HU treatment group is not different from one in control group., 6 months|Primary Objective #2, To assess whether the effect of HU on frequency of patient-reported crisis rates (VOC Day rate and Patient-reported VOC Event rate) calculated using SCD ePRO is observed in the study population, the annualized rates reduction in HU treatment group as compared to matched participants in control group will be evaluated. The corresponding null hypotheses are that the annualized patient-reported crisis rates in HU treatment group are not different from ones in control group., 6 months
Secondary Outcome Measures: Association Between Patient-Reported Crisis Rates and Physician-Reported MU VOC rate, Patient-reported crisis rates are determined by VOC Day rate and patient-reported VOC Event rate and is calculated using the SCD ePRO. These will be compared to physician-reported MU VOC rate to assess if there is an association between them. The assessment will be done in the matched sample, as well as in those in HU treatment group and in matched control group participants. The corresponding null hypotheses are that the annualized patient-reported crisis rates are not associated with physician-reported MU VOC., 6 months
The Effects of Programmed Death-ligand 1 on Postoperative Pain for Lung Cancer Patients
NCT Number: NCT06503432
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer|Postoperative Pain
Sponsor: Peking University People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-03

Summary:
The concentration of plasma programmed death-ligand 1(PD-L1) for lung cancer patients before video-assisted thoracoscopic surgery is detected. According to the distribution of plasma concentration, patients are divided into high or low expression of PD-L1. Differences in acute and chronic postoperative pain are compared between two groups of patients. And effects of PD-L1 expresion on postoperative pain in lung cancer patients are explained.

Primary Outcome Measures: the incidence of chronic pain after surgery, Patients were followed up by the Brief Pain Inventory questionnaire about the details of chronic pain., 3 months after surgery
A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
NCT Number: NCT06503406
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Wound|Burns|Trauma Injury
Interventions: DEVICE: SupraSDRM®|DEVICE: NovoSorb® BTM
Sponsor: The Metis Foundation
Collaborators: The University of Texas Medical Branch, Galveston
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09

Summary:
This is a prospective, randomized, controlled, multi-center clinical study comparing SupraSDRM® to standard of care wound dressing, BTM, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.

Primary Outcome Measures: Number of days between the application of the dermal substitute to when the dermal substitute is deemed suitable for grafting by the treatment care team., This endpoint is based on the ability of the dermal substitute to rapidly vascularize and allow for placement of a skin graft., up to 5 weeks
Secondary Outcome Measures: Clinical incidence of skin substitute infection, Incidence of infections and inflammatory response and scar development, up to 5 weeks|Days of skin graft application from time of SupraSDRM® or SoC application, The wounds will be assessed for their readiness for grafting by their treating surgeon at minimum weekly, up to 5 weeks|Percentage graft survival as assessed 7 days after skin graft application, Percent of graft survival will be measured by clinical assessment, 7 days|Number of return trips to the OR, The wounds will be assessed by their care team as part of standard care procedures. Research personal will document any areas of concern or additional surgeries required., up to 1 year|Skin graft contraction, Patient and Observer Scar Assessment Scale (POSAS) Questionnaire will be used to assess scaring and contraction. This scale uses a 1-10 rating scale with 1 being normal and 10 being worst imaginable outcome., up to 1 year|Wound Pain scale 1-10, Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) at each visit, up to 1 year|Cost-effectiveness, looking at the overall length of stay in the hospital, the number of trips to the operating room and cost of skin substitute will help determine if the study dressing is more or less cost affective, up to 1 year
Real-world Study on the Management of Hematological Toxicities Associated With Targeted Therapies for Breast Cancer
NCT Number: NCT06503380
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hematological Toxicity|Targeted Therapy|Breast Cancer
Interventions: OTHER: No intervenrion.
Sponsor: Fudan University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2027-06-10
Locations: Zhi-Ming Shao, Shanghai, Not US/Canada, 200032, China

Summary:
This multicenter, real-world, observational study will retrospectively and prospectively collect real-world data related to the investigational drugs. We plan to observe 1000 patients and collect data on treatment cycles N and N+1 of the targeted therapies. Retrospective data collection is based on existing patient diagnosis and treatment records, collecting information on patients who have completed two treatment cycles before January 1, 2024. Prospective data collection is based on routine clinical treatment during the study period, collected until the end of the next cycle of treatment or early termination of the study. To observe the disease characteristics and management mode of hematological toxicity related to targeted therapies of breast cancer, and explore the possible related factors of hematological toxicity, such as age, disease subtype, cancer stage, targeted therapy regimens, etc. This study will respect the medication choices of researchers in the study, without specifying which medication to choose for treatment, dosage, mode of administration (including single drug, combination therapy, or sequential therapy), and duration of administration.

Primary Outcome Measures: Incidence of cancer treatment induced neutropenia (CIN), The occurrence, prevention, treatment of neutropenia associated with targeted therapies. The influence of different baseline characteristics of patients on treatment outcomes and efficacy and safety of drugs., Approximately 2 years
Secondary Outcome Measures: Incidence of cancer therapy induced thrombocytopenia (CTIT), Characteristics and management of thrombocytopenia induced by targeted therapies of breast cancer., Approximately 2 years|Incidence of cancer related anemia (CRA), Characteristics and management of anemia induced by targeted therapies in breast cancer patients in the real world., Approximately 2 years
Observation Study in Patients Age 0-5 Years With LAMA2-related Congenital Muscular Dystrophy
NCT Number: NCT06503367
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: LAMA2-MD \(Merosin Deficient Congenital Muscular Dystrophy, MDC1A\)
Sponsor: Nationwide Children's Hospital
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)|Ann & Robert H Lurie Children's Hospital of Chicago|Children's Hospital Medical Center, Cincinnati|University of Iowa|Washington University School of Medicine|Stanford University|University of Utah|University of Rochester|University of Pittsburgh|University of Texas, Southwestern Medical Center at Dallas|University of Minnesota|UCLA Ronald Reagan Medical Center|Boston Children's Hospital
Sex: ALL
Age: CHILD
Enrollment: 44
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2028-09
Locations: Nationwide Children's Hospital, Columbus, Ohio, 43205, United States

Summary:
The goal of this observational study is to understand how young children with LAMA2-related dystrophy move and change over time. We will also learn about how this condition impacts other body systems.

Participants will undergo:

* Neuromuscular assessments
* Blood collections
* Swallowing and breathing assessments
* Questionnaires

Primary Outcome Measures: Validate the change over 24 months using the Neuromuscular Gross Motor Outcome, The Neuromuscular GRO is a 50-item assessment that measures a child's gross motor function when lying down, sitting, crawling, walking, jumping, and climbing stairs., 24 months|Validate the change over 24 months using the Bayley Scales of Infant and Toddler Development™ 4th Ed (BayleyTM-4), The Bayley assess four areas of development: Gross Motor, Fine Motor, Speech and Language, and Social. These results are compared to typically developing children ages 15 days to 42 months. The entire assessment takes between 1 and 3 hours, with breaks., 24 months|Validate the change over 24 months using the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders, The CHOP-Intend includes 16-items to measure a child's ability to move their body in a lying down position, supported sitting, and assisted rolling., 24 months|Validate the change over 24 months using the Motor Function Measure Scale-Short Form, The MFM-20 contains 20 items to assess a child's motor function in sitting, lying down, standing, and completing tabletop activities., 24 months|Validate the change over 24 months using the World Health Organization motor milestones, A child will be asked to complete 6 items to assess attainment of gross motor milestones including sitting without support, crawling, standing, and walking with and without assistance., 24 months
Other Outcome Measures: Validate CK Biomarkers, Blood will be drawn at each in-person visit to test Creatine Kinase, a muscle enzyme, and to store biomarkers for future research., From enrollment to the end of observation at 2 years.|Muscle Ultrasound, Biceps or Quadriceps thickness will be measured in the middle of the muscle using standard ultrasound guidance., 24 months
Gait Metric Validation of the Cionic Neural Sleeve
NCT Number: NCT06503354
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Validation Study
Interventions: DEVICE: Neural Sleeve and Zeno walkway
Sponsor: Cionic, Inc.
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-08
Completion Date: 2024-12-31
Locations: Cleveland State University, Department of Health Sciences and Human Performance, Cleveland, Ohio, 44115-2214, United States

Summary:
The purpose of this study is to determine the validity of the Neural Sleeve gait metrics compared to gait parameters assessed with a Protokinetics Zeno pressure sensitive walkway. The spatiotemporal gait parameters obtained from the Zeno walkway have been rigorously validated and will represent the "gold standard" ground truth measurements in the proposed protocol. Confirming the validity of the Neural Sleeve metrics offers benefit to individuals who utilize the device by providing confidence that calculated gait reports are accurate and can be used to inform usage of the device and associated gait changes over time. Findings of innaccuracy would still offer benefit in the form of knowing that the Neural Sleeve metrics need to be used with caution and/or updated to provide correct outcomes to users.

Primary Outcome Measures: Gait speed, Time one takes to walk a specified distance (expressed as a ratio between distance and time, in centimeters per second), A walking session of up to 5 minutes|Stride length, Distance (centimeters) covered when one takes two steps, one with each foot, measured from ipsilateral heel contact to the next ipsilateral heel contact (right-to-right or left-to-left heel) (centimeters), A walking session of up to 5 minutes|Cadence, Number of steps per minute (steps per minute), A walking session of up to 5 minutes
A Hospital-Based Registry of Preventive Cardiology Clinics
NCT Number: NCT06503341
Acronym: PREVENT-CARD
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiovascular Morbidity|Cardiovascular Risk Assesment|Primary Prevention CVD
Interventions: OTHER: Cardiovascular risk assesment
Sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-17
Completion Date: 2041-06
Locations: National Institute of Cardiovascular Diseases, Karachi, Sindh, 75510, Pakistan

Summary:
More research is needed to articulate the most effective ways to use these tools as screening tests in cardiovascular risk assessments and how they ultimately affect CVD mortality and morbidity outcomes. Clinicians are encouraged to continue sharing decision-making with patients to combine their unique cardiovascular risk factors and develop a comprehensive, effective treatment plan.

Primary Outcome Measures: cardiovascular risk assesesment, risk stratification of Cardiovascular diseases (CVD) in patients without established CVD but with CVD co morbids.we are using Atherosclerotic Cardiovascular Diseases (ASCVD) Risk Score and World Heart Organization(WHO) Risk Score for CVD Risk Assesment. In ASCVD Risk Score, we categorize population into low risk ( score \<5), borderline(score between 5 and 7.4) ,intermediate( score between 7.5 an 19.9) and high risk (score\>20), using all parameters for risk assesment. For WHO risk score calculation we are using WHO Risk score system for South Asia. https://cdn.who.int/media/docs/default-source/cardiovascular-diseases/south-asia.pdf?sfvrsn=c5b0d9a3_2, Ten years
Secondary Outcome Measures: Cardiovascular risk reduction, CVD risk reduction in patients with or without established CVD but with CVD co morbids., Ten years|Cardiovascular related deaths, Estimation of patients who expired in their follow up despite CVD risk factors management., Ten years.
Role of Specific microRNAs in Cluster Headache
NCT Number: NCT06503328
Acronym: 5*1000
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cluster Headache
Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-01
Completion Date: 2025-06-30
Locations: IRCCS Mondino Foundation, Pavia, 27100, Italy

Summary:
Cluster headache (CH) is a primary headache included in the trigeminal autonomic cephalalgias (TACs) according to the International Calssification of Headache Disorder, Third Edition. CH is characterized by a multifaceted and incompletely understood pathophysiology. Recent experimental evidence has increasingly emphasized the role of specific microRNAs (miRNAs) in the pathophysiology of primary headaches, including migraine.

In a recent study, we observed an upregulation in the gene expression of two miRNAs, miR-382-5p and miR-34a-5p, in peripheral blood mononuclear cells (PBMCs) of subjects with chronic migraine (CM). These miRNAs are involved in inflammation modulation and the release of γ-aminobutyric acid (GABA). Notably, this upregulation correlated with the migraine phenotype and its severity.

Several neuropeptides have been established to play an active role in CH. Studies by the Danish group have demonstrated that intravenous administration of CGRP, PACAP, or VIP can induce CH attacks in at least 50% of participants in the active phase of the disease.

However, no data currently exists regarding the potential involvement of miRNAs in CH. Given this context, the primary aim of this study is to investigate the gene expression of specific miRNAs (miR-382-5p, miR-34a-5p, and miR-155) in PBMCs and plasma levels of neuropeptides (CGRP, PACAP, VIP) in subjects with episodic CH in the active phase (eCH-act), episodic CH in the remission phase (eCH-rem), chronic CH (cCH), and healthy control subjects (HCs).

Primary Outcome Measures: PBMCs gene expression of miR-382-5p, miR-382-5p gene expression in PBMCs will be evaluated by real-time reverse transcription (RT-PCR). This assessment will be then normalized with U6 (a type of small nuclear RNA used as housekeeping gene) and expressed as Relative Quantification (RQ)., Single evaluation at study visit - baseline (T0)
Secondary Outcome Measures: PBMCs gene expression of miR-34a-5p and miR-155, miR-34a-5p and miRNA-155 gene expression will be evaluated by real-time reverse transcription (RT-PCR). This assessment will be then normalized with U6 (a type of small nuclear RNA used as housekeeping gene) and expressed as Relative Quantification (RQ)., Single evaluation at study visit - baseline (T0)|Plasma levels of CGRP alpha, PACAP and VIP, Plasma levels of CGRP alpha, CGRP beta, PACAP and VIP will be measured using validated commercial ELISA kits., Single evaluation at study visit - baseline (T0)|Score of MIDAS, HIT-6, and CHIQ, MIDAS, HIT-6, CHIQ represent validated clinical scales to rate CH related disability., Single evaluation at study visit - baseline (T0)
Myoglobin Removal With CytoSorb in Rhabdomyolysis
NCT Number: NCT06503289
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury|Rhabdomyolysis|Endothelial Dysfunction
Interventions: DEVICE: Cytosorb therapy
Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-01-28
Locations: Sisli etfal research and training hospital, Istanbul, 34371, Turkey

Summary:
The aim of this observational study is to assess whether myoglobin removal with CytoSorb® ameliorates endothelial damage in severe rhabdomyolysis patients who are admitted to the intensive care unit. The primary objective of the study is:

- Does myoglobin removal with CytoSorb® reduces glycocalyx degradation markers?

Patients with severe rhabdomyolysis will receive the intervention and blood samples will be obtained in regular intervals.

Primary Outcome Measures: Syndecan-1, Reduction in Syndecan-1 with CS therapy, 12 hour
Secondary Outcome Measures: glycocalyx markers, Sustained reduction in other glycocalyx markers after CS therapy, 12 hour|myoglobin, Reduction in myoglobin levels with CS therapy, 12 hours
The Treatment of Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma by Orelabrutinib and Radiotherapy
NCT Number: NCT06503276
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Extranodal Marginal Zone B-cell Lymphoma
Interventions: DRUG: Orelabrutinib|RADIATION: Ultra-low dose radiotherapy
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2028-10-31
Locations: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, Shanghai, 200011, China

Summary:
Extranodal marginal zone B-cell lymphoma (EMZL) is the most common lymphoma of the ocular adnexa (OA), accounting for approximately 60%. As a special part of the body, there is no consensus on the optimal treatment strategy for OA-EMZL. Studies have shown that patients who wait for postoperative observation have a 5-year PFS of approximately 80% and a 10-year PFS of 63%. Therefore, radiotherapy remains an important treatment for stage I/II OA-EMZL patients, but the dosage of radiotherapy remains controversial. In 2014, Hoskin PJ et al. found that the complete response rate and effective rate of patients in the standard 24Gy radiation dose group were 71% and 91%, while those in the 4Gy radiation dose group were 55% and 87%, respectively. Meanwhile, the PFS of patients with 4Gy radiation dose was lower than that of the group with 24Gy radiation dose, but there was no significant difference in OS between the two groups. However, in a study conducted by Chelius M et al. in 2021, they found that the incidence of both early and late toxic effects was significantly higher in the\>4Gy radiation dose group than in the\<4Gy radiation dose group. These toxic effects inevitably affect the quality of life of patients. Therefore, investigators plan to adopt a combination of ultra-low dose radiotherapy and drug therapy, which not only reduces the side effects of radiotherapy, but also improves the complete response rate of treatment and reduces disease progression or recurrence. However, studies have shown that radiotherapy combined with rituximab cannot improve the disease-specific survival rate of OA-EMZL. Therefore, BTK inhibitors (BTKi), as a novel targeted drug for the treatment of EMZL, have been used to treat relapsed and refractory EZML by interfering with BCR signals. Based on the above research, investigators plan to explore the efficacy of combination therapy with Orelabrutinib and ultra-low dose radiotherapy (4Gy) in the treatment of stage I/II OA-EMZL.

Primary Outcome Measures: Complete Response Rate, Percentage of participants with complete response was determined on the basis of investigator assessments, End of treatment (4 months after administration)
Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL
NCT Number: NCT06503263
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Interventions: DRUG: Zanubrutinib plus Lenalidomide as Maintenance Therapy
Sponsor: Navy General Hospital, Beijing
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2030-12-30
Locations: Navy General Hospital, Beijing, Beijing, 100048, China

Summary:
The goal of this phase 2 trial is to test the safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with DLBCL.

Primary Outcome Measures: EFS, EFS was defined as the time from treatment initiation to progression, relapse, new treatment, or death by any cause, whichever occurred first., 2 years
Secondary Outcome Measures: PFS, PFS was defined as the time from study entry until disease progression or death by any cause, 2 years|OS, OS was defined as the time from treatment initiation to death by any cause., 2 years
Safety and Efficacy of SWK002 in Patients With D2T-Rheumatoid Arthritis
NCT Number: NCT06503237
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rheumatoid Arthritis
Interventions: DRUG: Anti-CD19 CART cells will be given IV at split doses.
Sponsor: The First Affiliated Hospital of University of Science and Technology of China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-26
Completion Date: 2026-03
Locations: Hunan Siweikang Therapeutic Co.Ltd, Changsha, Hunan, 410119, China

Summary:
This is an open label, single-site, dose-escalation study in up to 18 participants with refractory rheumatoid arthritis. This study aims to evaluate the safety and efficacy of the treatment with Anti-CD19 CART.

Primary Outcome Measures: Safety Outcome, All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set., up to 2 years
Secondary Outcome Measures: The persistence, accumulation, and migration of Anti-CD19 CART cells, Assessing the trafficking of Anti-CD19 CART cells in the peripheral blood at the time of each infusion as well as at each time of follow-up by Quantitative Real-time Polymerase Chain Reaction or flow cytometry. Peripheral blood will be collected prior to the initial infusion and will be set as baseline., Day-1, 1, 3, 5, 7, 9, 11, 14, 21, 28 and Month 2, 3, 6, 9, 12|Erythrocyte Sedimentation Rate, To evaluate RA disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12|American College of Rheumatology (ACR) criteria 20, 50, 70 response rate, To evaluate RA disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12|Swollen and tender joint count, To evaluate RA disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12|Visual Analogue Scale, To evaluate RA disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12
On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Lymphoma
NCT Number: NCT06503211
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Recurrent or Refractory B-cell Non Hodgkin's Lymphoma
Interventions: BIOLOGICAL: UTAA09 injection
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-12-31
Locations: PersonGen.Anke Cellular Therapeutice Co., Ltd., Hefei, Anhui, 230088, China

Summary:
The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.

Primary Outcome Measures: The incidence of dose limiting toxicity (DLT ), The incidence, severity, and types of dose limiting toxicity, 28 days after infusion|The incidence of TEAEs, The incidence, severity, and types of adverse events that occur during treatment, 28 days after infusion
Secondary Outcome Measures: ORR, Evaluate the overall response rate based on the efficacy criteria of Lugano 2014, 24 months after infusion|PFS, Evaluate the progression free survival based on the efficacy criteria of Lugano 2014, 24 months after infusion|OS, Evaluate the overall survival based on the efficacy criteria of Lugano 2014, 24 months after infusion
Whole Grain Job's Tear, Muscle Health, Blood Glucose and Lipid Level
NCT Number: NCT06503172
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Sarcopenia|Frailty|Hyperglycemia|Hyperlipidemia
Interventions: BIOLOGICAL: Taiwanese whole grain job's tear (red job's tear)|BIOLOGICAL: White job's tear
Sponsor: Taipei Veterans General Hospital, Taiwan
Collaborators: Taichung District Agricultural Research and Extension Station, Ministry of Agriculture, Taiwan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-14
Completion Date: 2024-12
Locations: Taipei Veterans General hospital, Taipei, 112, Taiwan

Summary:
Background: This investigation aims to explore efficacy of Taiwanese whole grain job's tear on muscle health and blood glucose and lipid levels in community-dwelling older adults.

Methods: An open-label, 16-week, randomized controlled, cross-over trial involving participants with subject complaint of slower gait or weakness or fall in last year were recruited. The intervention group consumed Taiwanese whole grain job's tear (red job's tear) or white job's tear. Assessments included laboratory tests, functional assessments, and body composition.

Primary Outcome Measures: Changes of appendicular skeletal muscle index(ASMI), ASMI=appendicular skeletal muscle mass(kg)/(height(m)2), 0, 8, 16 week|Changes of handgrip strength, Maximal handgrip strength of dominant hand (kg), 0, 8, 16 week|Changes of gait speed, Usual gait speed measured by 6-meter walking (m/s), 0, 8, 16 week|Changes of time required to finish timed up and go(TUG) test, Changes of time required to finish timed up and go(TUG) test, 0, 8, 16 week
Secondary Outcome Measures: Changes of inflammation marker, defined by hsCRP, 0, 8, 16 week|Changes of insulin resistance, Measured by HOMA-IR, 0, 8, 16 week|Changes of LDL, Changes of LDL, 0, 8, 16 week|Changes of muscle biomarker 1, Measured by serum myostatin, 0, 8 week|Changes of muscle biomarker 2, Measured by serum follistatin, 0, 8 week|Changes of muscle biomarker 3, Measured by serum activin A, 0, 8 week
Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study
NCT Number: NCT06503159
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaping Teens|Healthy Volunteers
Interventions: BEHAVIORAL: Mindfulness-based Stress Reduction (MBSR) Program
Sponsor: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-10
Completion Date: 2026-06-05
Locations: National Institute on Drug Abuse, Baltimore, Maryland, 21224, United States

Summary:
The purpose of this translational bench-to-bedside study is to examine the neurobiological effects of an evidence-based technology-delivered mindfulness training (MT) program on vaping-related rsFC alterations in hippocampal networks and testing whether changes in rsFC ((Delta)rsFC) in these networks predict reduction in tobacco vaping behaviors in adolescents. The study also aims to test the accessibility and feasibility of using this mindfulness-based stress reduction (MBSR) platform as an implementation for widespread MT in adolescents.

Primary Outcome Measures: To characterize rsFC changes ((Delta)rsFC) in hippocampal networks and d-rsFC following a technology-delivered MBSR program in nicotine vaping adolescents., Hippocampal connectivity and d-rsFC measures are related to both nicotine exposure and MBSR training, 5.5-7 months|To characterize static and dynamic rsFC differences in hippocampal networks related to nicotine vaping in adolescents., Hippocampal networks are related to nicotine exposure, especially in adolescence., 5.5-7 months
Secondary Outcome Measures: To assess other imaging metrics such as resting connectivity from alternative sites related to mindfulness meditation and nicotine dependence (e.g., dACC) and task-based activation differences between vaping and non-vaping teens and pre-/post-MB..., These metrics will provide a fuller understanding of teen vaping and the effects of MBSR training., 5.5-7 months|To assess engagement with a smoking cessation app and changes in various behaviors following MBSR training., Understanding feasibility and acceptability as well as efficacy is important in assessing potential for development of MBSR training as a new therapeutic intervention for vaping-related TUD in youth., 5.5-7 months
Crohn's Disease - Inflammation and Microbial Proteolytic Activity
NCT Number: NCT06503081
Acronym: CIMPA
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn's Disease of Both Small and Large Intestine
Interventions: PROCEDURE: Colonoscopy
Sponsor: McMaster University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-12-01
Completion Date: 2025-01-10
Locations: McMaster University, Hamilton, Ontario, L8N 3Z5, Canada

Summary:
This study postulates that altered microbiota associated with areas of mucosal inflammation in CD, can be characterized by an increased proteolytic profile. This is clinically important as it may be possible to modulate the proteolytic activity of the CD-associated bacteria by using other bacteria that produce protease inhibitors, such as serpins.

Primary Outcome Measures: Altered microbiota associated with areas of mucosal inflammation in CD, is characterized by an increased proteolytic profile, Increase proteolytic activity profile influenced by microbiota composition in inflamed areas comprared with non-inflamed areas in a context of Crohn's disease, December 2019 - January 2025
Impact of NAFLD vs MAFLD Stigma on Quality of Life in Egyptian Patients
NCT Number: NCT06503068
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: NAFLD
Interventions: OTHER: Questionnaire
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2024-12-15
Locations: Tropical medicine department, Tanta University Hospitals, Tanta, Gharbyea, 31527, Egypt

Summary:
Non-alcoholic fatty liver disease (NAFLD) has become the leading cause of liver disease worldwide. The global burden of NAFLD is about 30% of the population, With a higher prevalence in Egypt about 47.5 %. The prevalence increases significantly with the presence of type 2 diabetes and obesity.

NAFLD is commonly associated with metabolic dysfunction and the development of cardiovascular disease. However, the NAFLD definition excludes other causes. It is not correlated with metabolic dysfunction and cardiovascular risk, so in 2020, the term metabolic-dysfunction-associated fatty liver disease (MAFLD) was suggested to replace the term NAFLD.

The nomenclature change was partly related to the stigma associated with the term NAFLD. As the words "alcoholic" and "fatty" were considered stigmatizing. A recent global survey showed that 26% of patients (57% in the USA and 7% in MENA) felt stigmatized relating to overweight/obesity and 8% of patients (22 % in the USA and 3% in MENA) felt stigmatized by the term NAFLD. While 34% and 38% of physicians considered the words "non-alcoholic" and "fatty" stigmatizing, respectively.

There is a discrepancy between the different regions of the world and between patients and providers regarding the perception of NAFLD/ MAFLD stigma. This study aims to assess the perception and stigmatization of various diagnostic terms (fatty liver, NAFLD \& MAFLD) among Egyptian patients and physicians. Also, to assess the impact of stigma on the quality of life and the motivations and barriers for lifestyle modification which is the cornerstone of NAFLD/MAFLD management.

Primary Outcome Measures: Awareness of NAFLD/MAFLD stigma in Egypt, Using a questionnaire to assess awareness of stigma related to various diagnostic terms such as "fatty liver", "NAFLD", "MAFLD", and Metabolic dysfunction-associated steatotic liver disease "MASLD" in patients and in NAFLD/NASH treating physicians in Egypt., till August 2024|Perception of NAFLD/MAFLD stigma in Egypt, Using a questionnaire to assess perception of stigma related to various diagnostic terms such as "fatty liver", "NAFLD", "MAFLD", and "MASLD" in patients and in NAFLD/NASH treating physicians in Egypt., till August 2024
Secondary Outcome Measures: impact on quality of life, Using a questionnaire to understand the impact of NAFLD vs MAFLD stigma on the quality of life in Egyptian patients, till August 2024|Motivations to lifestyle changes, Using a questionnaire to evaluate the motivation for lifestyle changes in Egyptian patients, till August 2024|Barriers to lifestyle changes, Using a questionnaire to evaluate the barriers for lifestyle changes in Egyptian patients, till August 2024
Antibiotic Abuse Patterns in Gharbia, Egypt
NCT Number: NCT06503055
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Antibiotic Abuse
Interventions: OTHER: Questionnaire
Sponsor: Rania Mamdouh Elkafoury
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2024-12-15
Locations: Tropical medicine department, Tanta University Hospitals, Tanta, Gharbyea, 31527, Egypt

Summary:
Antimicrobial resistance (AMR) represents a serious problem described by the World Health Organization (WHO) as "a global public health concern". Research from around the globe indicates high rates of practices related to injudicious use of antibiotics as leftover antibiotics, antibiotic non-adherence, the pressure made by patients who request antibiotics from clinicians, unwarranted provision of antibiotics by physicians and pharmacists, antibiotic abuse and misuse in the form of overuse or underuse.

Moreover, many patients believe they have the right to self-prescribe an antibiotic or get one from friends and family. About 50% of antibiotic use is done improperly using the wrong agent, dose, or duration.

In Egypt, antibiotic misuse and overuse led to a high prevalence of multidrug-resistant (MDR) bacteria among the population.

The current work aims to assess the prevalence of antibiotic abuse among medical field professionals and the public and understand the factors leading to antibiotic misuse, thus evaluating awareness levels regarding antibiotic resistance.

Primary Outcome Measures: prevalence of antibiotic abuse, using a questionnaire to assess prevalence of antibiotic abuse among both medical field professionals and the public., till August 2024
Secondary Outcome Measures: factors leading to antibiotic misuse, using a questionnaire to understand the factors leading to antibiotic misuse., till August 2024|awareness of antibiotic resistance, using a questionnaire to evaluate awareness levels about antibiotic use and antibiotic resistance., till August 2024