pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Gastroesophageal Reflux Disease Diagnostic Trial
NCT Number: NCT06504134
Acronym: GERDT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastroesophageal Reflux Disease
Interventions: DIAGNOSTIC_TEST: the Novel Esophageal Cell Collection Device
Sponsor: Changhai Hospital
Collaborators: West China Hospital|Ruijin Hospital|Tongji Hospital|Wuhan Union Hospital, China|Shanghai Tongji Hospital, Tongji University School of Medicine|The Second Affiliated Hospital of Baotou Medical College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2027-12-31

Summary:
Gastroesophageal reflux disease (GERD) is a very common condition in clinical practice. In China, GERD affects nearly 150 million patients, whose quality of life are seriously impacted. Currently, the diagnosis of GERD primarily depends on the results of 24h reflux monitoring. However, such examination is under a quite low acceptability. As a result, a large number of patients were not diagnosed timely and accurately, and serious social problems are induced, such as drug abuse of proton pump inhibitor. Our team has previously developed a novel device for esophageal cell enrichment and established an internationally pioneering method of cytological screening for esophageal cancer based on cutting-edge deep learning technology. This project aims to develop multiple deep learning algorithms and establish an innovative method for diagnosis of GRED, using the novel esophageal cell enrichment technology. The research includes: 1) constructing deep learning algorithms for automatic esophageal inflammatory cells recognition and classification; 2) mining and extracting the key features of esophageal squamous cells and inflammatory cells under physician-AI interaction; 3) establishing a prediction model for GERD by integrating digital features of squamous cells and inflammatory cells and building a cloud-based automatic diagnosis system; 4) investigating the immuno-infiltration atlas of GERD and its diagnostic value based on the enriched inflammatory cells. The ultimate goal is to solve current clinical problems and realize rapid, convenient, and accurate diagnosis of GERD.

Primary Outcome Measures: Diagnostic accuracy, sensitivity and specificity, 60 minutes
The Effect of Flipped Classroom Teaching Method on Medical Error Tendencies
NCT Number: NCT06504095
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Students|Education
Interventions: OTHER: intervention group (Flipped Teaching Method Group)
Sponsor: Aydin Adnan Menderes University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-15
Completion Date: 2024-12-30

Summary:
This study aimed to determine the effect of the flipped classroom teaching method on the medical error tendencies of intern nurses.

Primary Outcome Measures: "Determination of students' tendency towards medical errors [To be determined at the end of the study (4 weeks later)]", "The 'Medical Error Proneness Scale', developed to measure the tendency towards medical errors, will be applied to both the experimental and control group students.. Determining and comparing the medical error proneness levels of the experimental and control groups.", To be measured at the end of the study (4 weeks later)
Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy
NCT Number: NCT06504082
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ectopic Pregnancy
Interventions: DRUG: Letrozole|DRUG: Methotrexate
Sponsor: Yuzuncu Yıl University
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-06-01
Completion Date: 2023-06-01
Locations: Yuzuncu Yil University, Van, Tuşba, 06145, Turkey

Summary:
The objective of the study is to compare the effectiveness of single-dose methotrexate and letrozole + single-dose methotrexate in treating ectopic pregnancy, focusing on treatment success, changes in ß-hCG levels, hemogram and biochemical markers, surgical intervention due to rupture, fertility preservation, and reduction of maternal morbidity, mortality, and healthcare costs. This is a prospective study conducted on 60 ectopic pregnancy patients at Van Yuzuncu Yil University from June 2021 to September 2022. Thirty patients received single-dose methotrexate, while the other thirty received letrozole + single-dose methotrexate. Inclusion criteria were ß-hCG \<5000 mIU/mL, ectopic mass \<3-4 cm, no persistent abdominal pain, no fetal cardiac activity, and no contraindications to the treatments. Outcomes measured included treatment success, blood parameter changes, and the need for surgical intervention.

Primary Outcome Measures: Decrease in β-hCG levels, Serum β-hCG titration was monitored on days 1, 4, and 7 using the same laboratory kit., On day 1, 4 and 7
Secondary Outcome Measures: Need of surgical interventions, On the days of admission.|Hospitalization Days, Through study completion, an average of 3 weeks
Risk Stratification and Early Prevention Strategies for Non-compaction of Ventricular Myocardium (CAPTAIN)
NCT Number: NCT06504056
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Isolated Noncompaction of the Ventricular Myocardium
Interventions: BIOLOGICAL: Diagnosis of NVM|BIOLOGICAL: Diagnosis of NVM|BIOLOGICAL: Diagnosis of NVM
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-30
Completion Date: 2030-09-01
Locations: First Affiliated Hospital of Xi'an Jiantong University, Xi'an, Shaanxi, 710061, China

Summary:
This study intends to retrospectively-prospectively enroll NVM patients from multiple centers to establish a natural population cohort of NVM patients. By collecting clinical data and biological samples from surgical patients, the investigators will construct a prognosis prediction system for NVM, optimize risk stratification, explore new strategies for the early prevention and treatment of NVM, and improve the efficiency of clinical treatment of NVM patients.

Primary Outcome Measures: Change in the incidence of mortality rate, The survival status will be obtained from the medical records and phone calls to patients or their family members., At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3 year.
Modified DEP Regimens for the Treatment of Hemophagocytic Lymphohistiocytosis
NCT Number: NCT06504030
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hemophagocytic Lymphohistiocytoses
Interventions: DRUG: modified-DEP
Sponsor: The First Affiliated Hospital of Soochow University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-02-01

Summary:
This study is trying to evaluate the efficacy and safety of modified DEP regimens for the treatment of active hemophagocytic lymphohistiocytosis.

Primary Outcome Measures: Response rate of modified-DEP, Rates of complete response, partial response, improvement, 2 weeks, 4 weeks, 6 weeks, 8 weeks|Incidence of Treatment-Emergent Adverse Events, Rates of adverse events, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary Outcome Measures: Survival of patients, The disease outcomes, 3-month and 6-month survival rates, and median survival, 3 months, 6 months, 1 year
FUS-TB VS COG-TB in Small Lesions of Prostate Cancer
NCT Number: NCT06504017
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer
Interventions: PROCEDURE: COG-TB: Cognitive Fusion guided prostate targeted Biopsy|PROCEDURE: FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Collaborators: Huai'an First People's Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2025-08

Summary:
To compare the positive detection rates of COG-TB vs FUS-TB for prostate cancer with PI-RADS 4 small lesions.

Primary Outcome Measures: detection rate of any PCa, detection rate of any prostate cancer, 1 week (after pathology）
Secondary Outcome Measures: detection rate(cs PCa and PCa) of TBx, detection rate for PI-RADS 4 small lesion (\<5mm) under MRI-TRUS fusion, 1 week (after pathology）
Acute Coronary Syndrome KCMC_1
NCT Number: NCT06503991
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypertension|HIV
Interventions: BEHAVIORAL: Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP)|BEHAVIORAL: Control of Blood Pressure and Risk Attenuation (COBRA)
Sponsor: Duke University
Collaborators: National Institutes of Health (NIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-10-31

Summary:
To adapt and assess the implementation and preliminary effectiveness of an integrated COBRA and CHAMP multi-component community health worker-delivered hypertension intervention in improving blood pressure control among PLWH in northern Tanzania.

Primary Outcome Measures: Feasibility as measured by the proportion of total scheduled intervention sessions (CHW counseling sessions, doctor's visits, phone calls) attended, The primary measure of feasibility for this study will the proportion of total scheduled intervention sessions (CHW counseling sessions, doctor's visits, phone calls) attended by the 100 study participants over the course of the 6-month intervention., 6 Months
Secondary Outcome Measures: Proportion of participants reporting adherence to an anti-hypertensive medication at 6-month follow-up, 6 Months|Proportion of participants with controlled blood pressure at 6-month follow-up, Controlled blood pressure (BP) is defined as systolic BP\<140 mmHg and diastolic BP \<90 mmHg., 6 Months|Hypertension Knowledge-Level Scale (HK-LS) scores at 6-month follow-up, The HK-LS is used to measure knowledge about hypertension among adults. It has 22 items with six sub-dimensions. The maximum score is 22 for the entire scale, 2 for "definition", 4 for "medical treatment", 4 for "drug compliance", 5 for "lifestyle", 2 for "diet", and 5 for "complications" sub-dimensions. A higher score indicates greater hypertension knowledge., 6 Months
Tunisian Registry of Trans Catheter Aortic Valve Implantation
NCT Number: NCT06503965
Acronym: TAVI-TN
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tunisian Patients Already Implanted With a TAVI
Sponsor: Les Laboratoires des Médicaments Stériles
Collaborators: Tunisian Society of Cardiology and Cardiovascular Surgery
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-23
Completion Date: 2025-12-31
Locations: Hôpital militaire principal d'instruction de Tunis, Tunis, Tunisia

Summary:
Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement. Despite its increasing adoption worldwide, there re-mains a paucity of data regarding TAVI outcomes in Tunisian patients. In response to this gap in knowledge, the investigators propose the establishment of the Tunisian TAVI Registry, a multicenter initiative aimed at comprehensively documenting the clinical characteristics, procedural de-tails, and short- and long-term outcomes of TAVI procedures across Tunisia. The TAVI.TN registry will enroll consecutive patients undergoing TAVI procedures at participating centers across Tunisia, between 2013 and 2024 with a retrospective arm and a prospective arm. The TAVI-TN Registry represents a significant step towards enhancing our understanding of TAVI outcomes in the Tunisian population. By systematically capturing real-world data, this initiative aims to inform clinical decision-making, improve patient care, and contribute to the advancement of TAVI practices in Tunisia and beyond.

Primary Outcome Measures: VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint, * All-cause mortality
* All stroke (disabling and non-disabling)
* Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
* NYHA (New York Heart Association) class III or IV functional classification of heart failure
* Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, Effective Orifice Area (EOA) ≤0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) \<0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation, From 30 days post procedure to completion of at least 2 years of follow up
Secondary Outcome Measures: VARC defined 'Device success' composite endpoint, * Absence of procedural mortality
* Correct positioning of a single prosthetic heart valve into the proper anatomical location
* Intended performance of the prosthetic heart valve (no prosthesis - patient mismatch and mean aortic valve gradient ,20 mmHg or peak velocity ,3 m/s, no moderate or severe prosthetic valve regurgitation), 30 days
Impact of Uterine Immune Profiling and Personalized Treatments in Patients Receiving a Single Blastocyst: a Matched Controlled Study
NCT Number: NCT06503952
Acronym: UTIMPROSET
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Infertility|Repeated Embryos Implantation Failures|Success Rate of Assisted Reproductive Therapy
Interventions: COMBINATION_PRODUCT: Personalized care in function of the immune profile
Sponsor: Matricelab Innove
Sex: FEMALE
Age: ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-01-01
Completion Date: 2024-04-30
Locations: Hopital des Bluets- centre de procreation Médicalement assisté, Paris, Ile De, 75012, France

Summary:
Previous Randomised controlled study and cohort studies suggested that personalization of care based on the uterine immune profiling performed before an embryo transfer increase subsequent Live birth rate. The weakness of previous studies relies on the fact that the transfer policy applied had some possibly impact on the subsequent live birth rate observed. Indeed, it is well known that day-3 and Day-5 embryos do not have the same implantation rate and that the number of embryos transferred may also impact the subsequent live birth rate.

To complete previous studies, the present study aims to select a population who had an uterine immune profiling between January 1st 2020 and June 30th 2023 and an single Day-5 fresh or freeze-thawed embryo transfer (SET) within the next nine months following the uterine immune profiling This population will be matched on age, number of previous embryo transfer and type of transfer (fresh of freeze-thawed) to a population who did not had any uterine immune profiling the nine months before the single Day-5 embryo transfer The outcome is the subsequent Live birth rate following the Day-5 SET among the population who benefitted of an immune profiling before SET and the control population who did not benefited of a uterine immune profile before SET

Primary Outcome Measures: Live birth rate following the single Day-5 embryo transfer (ET), Live birth rate following the Day-5 ET between the case and control groups, 9 months after the ET
Secondary Outcome Measures: Implantation rate following the Day-5 ET, Implantation rate following the Day-5 ET between the case and control groups, one month after ET|Clinical pregnancy rate after the Day-5 ET, Clinical pregnancy rate after the Day-5 ET between the case and control groups, two weeks after ET|Ongoing PR after the day-5 ET, Ongoing PR after the day-5 ET between the case and control groups, 12 weeks after ET
Etiology Analysis of Chronic Cough After COVID-19 Infection and Research on the Efficacy of ICS or ICS/LABA
NCT Number: NCT06503939
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Chronic Cough
Sponsor: Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2024-12-31
Locations: Xiangya Hospital Central South University, Changsha, Hunan, 410008, China

Summary:
This study collected 600 patients, evaluated whether patients had airway hyperreactivity, airway inflammation, specific types and allergic reactions, comprehensively analyzed and classified the causes of chronic cough in patients, and evaluated and compared the improvement of cough symptoms and quality of life after ICS or ICS/LABA treatment.

Primary Outcome Measures: The etiology of chronic cough was comprehensively analyzed and classified., 2023.09-2024.12
Secondary Outcome Measures: To evaluate and compare cough symptoms and quality of life improvement after ICS or ICS/LABA treatment., 2023.09-2024.12
Long Term Impact of Covid-19 Vaccination on Adolescence
NCT Number: NCT06503926
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: SARS CoV 2 Vaccination
Interventions: OTHER: SARS-COV-2 vaccination
Sponsor: Sinai University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 270
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-06
Completion Date: 2024-07-01
Locations: Sinai University, Ismailia, 11749, Egypt

Summary:
Long term impact of COVID 19 vaccination on dizziness-related disability and balance in adolescence

Primary Outcome Measures: Impact on Balance, The pediatric balance scale is used to assess balance (Lowest score =0 " worst"- Maximum score is 56 " Perfect Balance", Through study completion, an average of 1 day - 1 year after taking the vaccine|Functional Disability, The Dizziness Handicap Inventory is used to assess functional disability related to dizziness, Through study completion, an average of 1 day - 1 year after taking the vaccine
Secondary Outcome Measures: Emotional Disability, The Dizziness Handicap Inventory is used to assess emotional disability related to dizziness, Through study completion, an average of 1 day - 1 year after taking the vaccine|Physical Disability, The Dizziness Handicap Inventory is used to assess physical disability related to dizziness, Through study completion, an average of 1 day - 1 year after taking the vaccine
Cognitive Muscular Therapy for Patients With Long-COVID and Breathing Pattern Disorder
NCT Number: NCT06503913
Acronym: COMLOC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long COVID|Respiratory Disease
Interventions: BEHAVIORAL: Cognitive Muscular Therapy|BEHAVIORAL: Breathing visualisation
Sponsor: University of Salford
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-25
Completion Date: 2025-12-31
Locations: University of Salford, Manchester, Greater Manchester, M6 6PU, United Kingdom

Summary:
The aim of the study is to test a treatment known as "Cognitive Muscular Therapy (CMT)" for reducing breathlessness and improving autonomic function in patients with long-COVID.

Primary Outcome Measures: Change in Nijmegen Questionnaire, Used to capture breathlessness symptoms associated with hyperventilation disorder. Score 0 - 60 (0 = no hyperventilation symptoms, 60 severe symptoms of hyperventilation)., Change from Baseline to two months (post intervention)
Secondary Outcome Measures: Change in Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale, Used to capture breathlessness symptoms associated with long-COVID compared to pre-acute infection. Score 0 - 45 (0 = no long-COVID symptoms, 45 severe symptoms of long-COVID)., Change from Baseline to two months (post intervention)|Change in Dyspnea-12 questionnaire, Used to capture breathlessness symptoms. Score 0 - 36 (0 = no breathlessness symptoms, 36 severe breathlessness)., Change from Baseline to two months (post intervention)|Change in Self-evaluation of breathing questionnaire, Used to capture breathlessness symptoms associated with dysfunctional breathing. Score 0 - 75 (0 = no dysfunctional breathing symptoms, 60 severe symptoms of dysfunctional breathing)., Change from Baseline to two months (post intervention)|Change in Composite Autonomic Symptom Score, Used to capture symptoms associated with autonomic dysfunction. 31 questions rating the symptoms associated with autonomic dysfunction., Change from Baseline to two months (post intervention)|Change in EQ-5D-5L, Used to capture an individual's quality of life through their ability to complete daily living activities. Each heading is rated from no problems through to unable to complete the task., Change from Baseline to two months (post intervention)|Change in WHO Disability Assessment Schedule (12-item), Used to capture an individual's ability to perform daily living activities. Each point is rated from No difficulty performing a task to extreme difficulty/cannot complete the task., Change from Baseline to two months (post intervention)
COVID-19 and Intestinal Microbiota in Children
NCT Number: NCT06503887
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, Children
Interventions: OTHER: Stool sample collection
Sponsor: Saint-Joseph University
Collaborators: Université Paris Cité
Sex: ALL
Age: CHILD
Enrollment: 86
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-04-01
Completion Date: 2023-09-25
Locations: Saint Joseph university, Beirut, Lebanon

Summary:
SARS-CoV-2 is the causative agent of the COVID-19 pandemic. It appears to cause only mild to moderate upper respiratory symptoms in children, in addition to gastrointestinal symptoms resulting from its penetration into intestinal cells. Viral respiratory infections are often accompanied by a change in the composition of the gut microbiota (GM). Additionally, intestinal metabolites and integrity appear to be altered. This work aims to study the composition of the GM of Lebanese children, currently (n=14) and previously (n=33) infected with SARS-CoV-2 and to compare it to pre-pandemic controls (n=39). Furthermore, the correlation between the composition of the GM and the intestinal homeostasis are evaluated. Clinical data and stool samples were collected from children aged 1 month to 12 years. The bacterial profile is determined by quantitative PCR and 16S rRNA sequencing. Levels of secretory immunoglobulin A (sIgA), fecal calprotectin, beta defensin type 2 (hBD-2), short-chain fatty acids (SCFAs), tryptophan derivatives, and bile acids are also evaluated. Given the well-established relationship between the GM and the immune system, the results of this study could serve as a potential basis for the implementation of personalized nutrition and biotic supplementations aimed at restoring the host-microbiota symbiosis, pointing to the prevention and treatment of COVID-19

Primary Outcome Measures: Analysis of the gut microbiota in covid-19 children, Quantify and analyse the composition of the gut microbiota if Lebanese infected Children, june 2024
Secondary Outcome Measures: Effect on covid infection on mucosal barrier, Evaluation of the consequences of the infection on the mucosal barrier, june 2024|correlation between gut microbiota and mucosal response, examine the correlation between the composition of the gut microbiota and the mucosal response, september 2024
Improving Attention in Individuals With Long COVID-19
NCT Number: NCT06503874
Acronym: LongCovAtten
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long Covid
Interventions: OTHER: Attention Training|OTHER: Music Group
Sponsor: Shirley Ryan AbilityLab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-22
Completion Date: 2027-03-01
Locations: Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States

Summary:
This study is to find out if the Attention Processing Training program is a potential treatment for brain fog symptoms, reported by people with Long-Covid. Also investigating the feasibility of completing this program virtually.

Primary Outcome Measures: Number of participants who successfully completed at least 80% of the study tasks sessions, Recording the number of participants who completed at least 80% of the study sessions out of the number of all participants who enrolled in the study., 2 years
Secondary Outcome Measures: Change of scores in objective attention tests (i.e, CPT 3), pre- and post -intervention, The Conners Continuous Performance Test Third Edition™ (Conners CPT 3™), 2 year
Other Outcome Measures: Change of scores in objective attention tests (i.e, Digit Span), pre- and post -intervention, Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) - Digit Span Subtest, 2 year
Community-designed Food Is Medicine for Adults With Diabetes
NCT Number: NCT06503861
Acronym: FarmtoHealth
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus
Interventions: BEHAVIORAL: Food Is Medicine intervention
Sponsor: Indiana University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 61
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-06-15
Completion Date: 2021-09-12
Locations: Southern Indiana Community Health Care, Paoli, Indiana, 47454, United States

Summary:
The goal of this clinical trial is to learn if an educational intervention can affect clinical outcomes in adults with diabetes. The main question it aims to answer is:

Can a Food Is Medicine intervention affect obesity and/or diabetes markers in adults?

Researchers will compare a Food Is Medicine arm to a control arm to answer the research question.

Participants will provide biometrics and questionnaire responses at three time points. Those in the Food Is Medicine arm will receive regular free meal kits combined with cooking and nutritional education.

Primary Outcome Measures: Participants' diabetes level or severity, Participants' glycated hemoglobin - Hemoglobin A1c (HbA1c), Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)|Participants' obesity level or severity, Body mass index (BMI), Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Secondary Outcome Measures: Dietary behaviors, Self-reported food consumption frequencies, Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (MAMBO) Phase I
NCT Number: NCT06503848
Acronym: MAMBO
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine Disorders
Interventions: DRUG: Sumatriptan
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Collaborators: Instituto de Salud Carlos III
Sex: ALL
Age: ADULT
Enrollment: 108
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-25
Completion Date: 2024-12
Locations: Hospital Universitari Vall d'Hebron, Barcelona, Spain

Summary:
The goal of this observational study is to identify differential traits in spontaneous migraine attacks that can help us predict the response to treatment with sumatriptan.

Participants will be asked to register the headache characteristics before and after taking sumatriptan and whether the treatment was effective or not during four migraine attacks.

Primary Outcome Measures: Response to sumatriptan, Relief of pain from moderate-severe to mild or absent at 2 hours and 24 hours in 3 out of 4 migraine attacks.

The response will be evaluated via questionnaire., 24 hours
Secondary Outcome Measures: Migraine characteristics, Patients will complete a questionnaire describing the characteristics of migraine attacks in the beginning of the attack, and at timepoints 2 and 24 hours after taking sumatriptan., 24 hours
Efficacy of Transforaminal Epidural Steroid and Its Combination With Ozone in Lumbar Radiculopathy
NCT Number: NCT06503835
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Low Back Pain|Radiculopathy Lumbar|Hernia|Disk Herniated Lumbar
Interventions: PROCEDURE: Fluoroscopy Guided Transforaminal Epidural Ozone Injection|PROCEDURE: Fluoroscopy Guided Transforaminal Epidural Steroid Injection
Sponsor: Ibn Sina Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-06-01
Completion Date: 2021-12-31
Locations: Ankara University Faculty of Medicine, İbni Sina Hospital, Ankara, 06230, Turkey

Summary:
This retrospective study aimed to assess the clinical effectiveness and safety of transforaminal epidural injections of steroid and ozone mixture versus steroid alone in low back and radicular leg pain related to disk herniation.

Primary Outcome Measures: Visual Analog Scale (VAS), The VAS score for pain assessment ranges between 0-10 ( (0=no pain, 5=moderate pain, 10=extremely severe pain)., 24th hours, 1st, 3rd, 6th, and 12th months
Secondary Outcome Measures: Oswestry Disability Questionnaire (ODI), ODI is a questionnaire in which the level of disability increases as the total score increases. Total scores vary between 0 and 50., 1st, 3rd, 6th, and 12th months|MacNab Scale Scores, The MacNab scale scores were used for success in pain decrease and include excellent, good, fair, and poor. The "excellent" and "good" results were accepted as favorable outcomes, and the "fair" and "poor" results were considered unsatisfactory, 1st and 12th months
Comparison of Application Effects Between Long- and Standard Short- Peripheral Venous Catheters
NCT Number: NCT06503822
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hospitalized Patients
Interventions: DEVICE: Long peripheral venous catheter|OTHER: Control group (Short peripheral venous catheter)
Sponsor: Shenzhen Third People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-12-05
Completion Date: 2024-12-31
Locations: Deng Qiuxia, Shenzhen, Guangdong, China

Summary:
Short PIVC (intravenous indentation needle) accounts for more than 50% of clinical infusion tools, but long PIVC is rarely used and studied in China. This study aims to explore the application characteristics and application effects of long PIVC in China. It provides reference for the correct selection of infusion tools, and promotes the clinical application and promotion of new intravenous therapy tools.

The study nurse will work with the responsible physician to assess the eligibility for enrollment and sign the informed consent. Were randomly assigned to the control group (to receive a new 24G/22G (0.7mm\*19mm/0.9mm\*25mm) short PIVC (closed needle protected venous catheter system) puncture) or the intervention group (to insert a new 3F (8cm) or 4F(10cm) long PIVC) for daily routine maintenance until catheter removal, General demographic data, laboratory-related data, catheter-related data, catheter-related complications (unplanned extubation, phlebitis, catheter blockage, catheter-related thrombosis, catheter-related bloodstream infection, exudation, etc.) and patient satisfaction were collected.

Primary Outcome Measures: Unplanned extubation, Any complications of catheter removal before completion of IV therapy or before the recommended time of catheter use. Removal of the catheter at the end of intravenous infusion therapy is not considered catheter failure., Up to 2 months
Antiviral Therapy in Infants With HBV Infection
NCT Number: NCT06503796
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: HBV
Interventions: DRUG: Lamivudine|DRUG: Interferon
Sponsor: Beijing 302 Hospital
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-11
Locations: the Fifth Medical Center of PLA, Beijing, China

Summary:
This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. HBV-infected infants in the treatment group were treated with LAM before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for HBV DNA and/or HBsAg after reaching the age of 1 year. The control group was followed up synchronously. Follow-up was conducted every 3 months during the study period. The main efficacy evaluation indexes: HBsAg conversion (functional cure) rate, HBeAg conversion rate, HBeAg seroconversion rate, HBV DNA conversion rate, HBsAg seroconversion rate, and ALT reversion rate at the end of 12 months of treatment and at 2 years of age.

Primary Outcome Measures: The rate of HBsAg loss, The rate of HBsAg loss in 12months after intervention, 2 years old, 12months after intervention, 2 years old
Secondary Outcome Measures: The rate of HBsAg seroconversion, The rate of HBsAg seroconversion in 12months after intervention, 2 years old, 12months after intervention, 2 years old|The rate of HBV DNA loss, The rate of HBV DNA loss in 12months after intervention, 2 years old, 12months after intervention, 2 years old|The rate of HBeAg loss, The rate of HBeAg loss in 12months after intervention, 2 years old, 12months after intervention, 2 years old|The rate of HBeAg seroconversion, The rate of HBeAg seroconversion in 12months after intervention, 2 years old, 12months after intervention, 2 years old|ALT reversion rate, ALT reversion rate in 12months after intervention, 2 years old, 12months after intervention, 2 years old|Incidence of Treatment-Emergent Adverse Events, Safety and Tolerability of Antiviral Therapy in infants, 12months after intervention, 2 years old
A Retrospective Chart Review Study of Patients With Chronic Lung Allograft Dysfunction-Bronchiolitis Obliterans Syndrome (CLAD-BOS) Post Lung Transplantation
NCT Number: NCT06503770
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bronchiolitis Obliterans Syndrome Due to and After Lung Transplantation (Disorder)
Sponsor: Zambon SpA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-27
Completion Date: 2024-12-31
Locations: Cleveland Clinic Main Campus, Cleveland, Ohio, 44195, United States|Baylor Scott and White Health Advanced Lung Disease Specialists, Columbus, Ohio, 43210, United States|Baylor Scott and White Health Advanced Lung Disease Specialists, Dallas, Texas, 75246, United States|Universitaire Ziekenhuizen Leuven (UZ Leuven) Campus Gasthuisberg, Leuven, 3000, Belgium|Hospital Universitario Reina Sofia, Córdoba, Andalucia, 14004, Spain|Universidad de Cantabria (UC) Hospital Universitario Marques de Valdecilla (HUMV), Santander, Cantabria, 39008, Spain

Summary:
The aim of this study is to describe the forced expiratory volume in 1 second (FEV1) decline and natural disease evolution in patients affected by CLAD-BOS after lung transplantation and receiving an immunosuppressive therapy as standard of care.

Primary Outcome Measures: To evaluate the FEV1 trajectory of patients diagnosed with CLAD-BOS, Change in FEV1 trajectory over time, Up to 12 years
ILD In Obese Patients With OSA
NCT Number: NCT06503757
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: ILD
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-20
Completion Date: 2025-01-20

Summary:
Assess the impact of obesity and OSA on the interpretation of high-resolution computed tomography (HRCT) findings in patients with ILD.

Identify specific challenges or confounding factors that may contribute to the misinterpretation of HRCT findings in this population.

Evaluate the potential consequences of misinterpretation, including delayed or inaccurate diagnosis, inappropriate treatment decisions, and suboptimal patient outcomes.

Primary Outcome Measures: the prevalence of misinterpretation of interstitial lung disease (ILD) on high-resolution computed tomography (HRCT) scans in obese patients with obstructive sleep apnea (OSA)., determined by assessing the agreement between radiologists' interpretations of HRCT findings related to ILD in this specific patient population., Baseline
Transthoracic vs Transbronchial Ablation for Lung Cancer
NCT Number: NCT06503744
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer Stage IA
Interventions: PROCEDURE: ablation
Sponsor: Shanghai Chest Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-04
Completion Date: 2028-12
Locations: Shanghai Chest Hospital, Shanghai, Shanghai, 200030, China

Summary:
The aim of this study is to investigate the efficacy and safety of transthoracic versus transbronchial ablation in the treatment of early stage peripheral lung cancer.

Primary Outcome Measures: Complete ablation rate at 6 months post-procedure, This refers to the number of lesions completely ablated 6 months after ablative treatment as a proportion of the total number of ablative treated lesions., Up to 6 months
Secondary Outcome Measures: Success rate of technique implementation, Defined as the number of lesions reached by the ablation needle and successfully treated by ablation as a proportion of the total number of lesions to be ablated, as assessed by imaging immediately after ablation., Immediate postoperative|Complete ablation rate at 12 months post-procedure, This refers to the number of lesions completely ablated 12 months after ablative treatment as a proportion of the total number of ablative treated lesions., Up to 12 months|Local control rate at 1, 2 and 3 years post-procedure, This refers to the number of completely ablated and incompletely ablated lesions at 1, 2 and 3 years after ablative treatment as a proportion of the total number of ablative treated lesions., Up to 36 months|Progression-free survival, Refers to the duration between the subject's study procedure and the first occurrence of disease progression or death from any cause, recorded through follow-up for up to 3 years., Up to 36 months|Overall survival, Refers to the duration between the subject's study procedure and the subject's death, recorded through follow-up for up to 3 years., Up to 36 months|Safety, Assessment of the incidence of device or procedure-related adverse events that occurred during the study., Up to 6 months
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)
NCT Number: NCT06503731
Acronym: Shamrock
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Antibody-mediated Rejection
Interventions: COMBINATION_PRODUCT: Efgartigimod PH20 SC - prefilled syringe|OTHER: Placebo PH20 SC - prefilled syringe
Sponsor: argenx
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-22
Completion Date: 2027-09

Summary:
The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation.

After a screening period of up to 6 weeks, eligible participants will be randomized in a 1:1:1 ratio. The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, steroids) during the treatment period (48 weeks). At the end of the treatment period, the participants will enter an observational/follow-up period (approximately 24 weeks). The participants will be in the study for up to 78 weeks.

Primary Outcome Measures: Incidence of Adverse Events (AEs), Up to 78 weeks|Percentage of participants with permanent treatment discontinuation due to adverse events (AEs), Up to 48 weeks
Secondary Outcome Measures: Changes from baseline (slope) of the estimated glomerular filtration rate (eGFR), Up to 72 weeks|Histological changes in kidney biopsy, Up to 72 weeks|Urine protein creatinine ratio (UPCR), Up to 72 weeks|Graft and participant survival, Up to 72 weeks|Percentage change from baseline in total IgG levels in serum over time, Up to 60 weeks|Efgartigimod serum concentration-time profile and PK parameter Ctrough, Up to 48 weeks|Incidence of antidrug antibodies (ADA) against efgartigimod in serum over time, Up to 72 weeks|Incidence of antibodies against rHuPH20 in plasma over time, Up to 72 weeks
Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents
NCT Number: NCT06503718
Acronym: FFD
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tibial Fractures
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: CHILD
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-03
Completion Date: 2024-12-31
Locations: Service de Chirurgie Pédiatrique - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
Most displaced tibial shaft fractures in pediatric patients have traditionally been treated after reduction by cast immobilization with good long-term results. Recently, there has been a growing trend towards surgical intervention by osteosynthesis from the outset. This study aims to describe the results of orthopedic treatment and osteosynthesis from the outset.

Primary Outcome Measures: Evaluation of the result of orthopedic treatment and osteosynthesis from the outset, Use of the functional score for this assessment :

Scores :

* 95-100 : Excellent
* 75-94 : Good
* 51-74 : Fair
* 0-50 : Poor, Up to 6 months
Obstacles and Facilitators to the Treatment of Police Officers With Mental Health Disorders
NCT Number: NCT06503705
Acronym: BASP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mental Disorders
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-08
Completion Date: 2025-07-08
Locations: Service de Pathologie Professionnelle - Médecine du Travail - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
Police officers are subject to various professional risk factors that can contribute to the occurrence of mental health difficulties such as depression, anxiety, and post-traumatic stress disorder. In previous work, low use of specialized care structures was noted. Added to this is the carrying of a weapon which represents an element facilitating the passage to self-aggressive action.

The objective of the study is to identify and describe the barriers and facilitators to the treatment of police officers facing mental health difficulties.

Primary Outcome Measures: To identify and describe the barriers and facilitators to the treatment of police officers facing mental health difficulties., * The analysis of the interviews with the police officers will be carried out using a method inspired by grounded theory; with first a deductive approach, then inductive; thirdly, links will be sought between the different categories of analysis to try to develop a synthetic representation of the barriers and facilitators to the treatment of police officers with mental health disorders.
* Grounded theory research assumes that data, rather than existing theories or hypotheses, determine what knowledge is revealed. By systematically analyzing qualitative data, it seeks to understand the social phenomena studied., Up to 1 year
A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Cytochrome P450 3A4 and 2C8 Substrates in Healthy Participants
NCT Number: NCT06503679
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: LY4100511 (DC-853) Dose 1|DRUG: LY4100511 (DC-853) Dose 2|DRUG: Midazolam|DRUG: Repaglinide
Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-10
Completion Date: 2024-10
Locations: Fortrea Clinical Research Unit Inc., Dallas, Texas, 75247, United States

Summary:
The main purpose of this study is to assess the safety and tolerability and pharmacokinetics of LY4100511 (DC-853) when administered alone or in the presence of cytochrome P450 substrates in healthy participants.

Primary Outcome Measures: Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Midazolam and 1-Hydroxymidazolam and Repaglinide, PK parameters of midazolam and 1-hydroxymidazolam and repaglinide in the absence or presence of steady-state LY4100511, Day 1 and Day 9: Predose, Up to 48 Hours Post Dose|PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Midazolam and 1-Hydroxymidazolam and Repaglinide, PK parameters of midazolam and 1-hydroxymidazolam and repaglinide in the absence or presence of steady-state LY4100511, Day 1 and Day 9: Predose, Up to 48 Hours Post Dose|PK: Maximum Observed Concentration (Cmax) of Midazolam and 1-Hydroxymidazolam and Repaglinide, PK parameters of midazolam and 1-hydroxymidazolam and repaglinide in the absence or presence of steady-state LY4100511, Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults
NCT Number: NCT06503666
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV Infections|Sexually Transmitted Diseases
Interventions: BEHAVIORAL: ZAIMARA|BEHAVIORAL: Health Promotion
Sponsor: Centre for Infectious Disease Research in Zambia
Collaborators: University of Illinois at Chicago|University of Alabama at Birmingham
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-05

Summary:
The proposed hybrid effectiveness-implementation study will systematically adapt the Informed, Motivated, Aware, Responsible Adolescent Girls and Adults (IMARA) curriculum that was previously adapted for South Africa (IMARA-SA) to use in Zambia (will be renamed Zambian Informed, Motivated, Aware, Responsible Adolescent Girls and Adults (ZAIMARA) and evaluate the impact of ZAIMARA on improving adolescent girls and young women HIV testing, HIV and STI incidence, PrEP uptake and sexual risk behaviour. The study will also assess the impact of monthly mental health screening with referral versus a monthly nutrition and exercise screening on peer leaders job retention. We will also examine implementation factors and outcomes associated with ZAIMARA across five sites.

Primary Outcome Measures: AGYW HIV testing uptake, Proportion of AGYW testing for HIV at 6 months, Within 6 months following delivery of ZAIMARA & HP curriculum
Secondary Outcome Measures: Incident HIV infection and STIs, PrEP uptake, and AGYW sexual risk behavior, Proportion of AGYW testing positive for HIV \& STIs , Proportion requesting for PrEP and Proportion of AGYW engaging in sexual risk behaviour, Within 6, 12, 18 and 24 months following delivery of ZAIMARA & HP curriculum|AGYW HIV testing at 12, 18, and 24-months, Proportion of AGYW testing for HIV, Within 12, 18 and 24 months following delivery of ZAIMARA & HP curriculum