pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Long Term Follow-up for RGX-202
NCT Number: NCT06491927
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Duchenne Muscular Dystrophy
Interventions: GENETIC: No Intervention
Sponsor: REGENXBIO Inc.
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 19
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-08
Completion Date: 2029-12-01
Locations: Arkansas Children's Hospital, Little Rock, Arkansas, 72202, United States|Stanford School of Medicine/Division of Neuromuscular Medicine, San Carlos, California, 94070, United States|Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, 60611, United States

Summary:
RGX-202-5101 is a long-term follow up study that evaluates the long term safety and efficacy of RGX-202 in participants who have received RGX-202 (a gene therapy designed to deliver a transgene for novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain) in a separate parent study.

Primary Outcome Measures: Evaluation of long-term safety of RGX-202, Incidences of AEs and SAEs over time, 5 years inclusive of parent study
Secondary Outcome Measures: Efficacy measured by change in Functional Assessment, Longitudinal trajectory (mean and change from baseline) in North Star Ambulatory Assessment (NSAA) raw and linear score, 5 years inclusive of parent study
A Single-Arm Study of Aflibercept 8 mg Dosed in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
NCT Number: NCT06491914
Acronym: ELARA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Neovascular Age-Related Macular Degeneration|Diabetic Macular Edema
Interventions: DRUG: Aflibercept 8 mg
Sponsor: Regeneron Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2027-05-30
Locations: Retina Group of New England, Waterford, Connecticut, 06385, United States|Retina Vitreous Associates of Florida, Saint Petersburg, Florida, 33711, United States|Retina Consultants of Texas, Bellaire, Texas, 77401, United States

Summary:
This study is researching an experimental drug called aflibercept 8 mg, referred to as "study drug". The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.

The aim of the study is to see how safe and effective aflibercept 8 mg injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.

Primary Outcome Measures: Occurrence of treatment-emergent adverse events (TEAEs), Through week 24|Occurrence of serious TEAEs, Through week 24
Oligoantigenic Diet and Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).
NCT Number: NCT06491836
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Attention Deficit Disorder
Interventions: DIETARY_SUPPLEMENT: oligoantigenic diet|OTHER: Food regimen without food restrictions.
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-04

Summary:
Fifty patients who diagnosed as ADHD syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) Criteria aged from 6 to 16 years old will be assigned randomly into 2 arms: arm 1: the patients will follow food regimen that cover recommended daily allowance (RDA) for macronutrients and micronutrients suitable for their ages without any food restriction, arm 2: the patients will follow food regimen that cover (RDA) for macronutrients and micronutrients suitable for their ages based on Oligoantigenic diet (OAD). Psychiatric assessment will be done before intervention and after 3 months of intervention.

Primary Outcome Measures: Conner's Parent Rating Scales-Revised (CRS-R), This tool is used to assess the profile and severity of symptoms, response to treatment and follow up studies. Items will be scored on 14 subscales of symptoms including opposition, cognitive problems, inattention and hyperactivity. It is usually considered normal when T-scores are less than 60, while scores above 60 are signs of academic, behavioral or social issues., 3 months|Child Behavior Checklist (CBCL/6-18), It is designed to obtain parents'/caregivers' reports of their children's problems and it is a reliable tool for assessing the traits associated with childhood mental health issues., 3 months|The Continuous Performance Test (CPT), It is a measurement of sustained attention deficits. It requires participants to respond to predesignated targets among stimuli that will be presented at a rapid fixed rate., 3 months|Clinical Global Impression, Scale is designed to assess the effectiveness of a particular treatment: CGI-severity scale (CGI-S) assessing illness severity and CGI-C assessing global improvement or change. CGI-S will measure illness severity at baseline and after treatment on a scale of seven points, 3 months
EXTRA-Meso (EXercise TheRApy in Mesothelioma) Feasibility
NCT Number: NCT06491784
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mesothelioma
Interventions: OTHER: Exercise Therapy
Sponsor: NHS Greater Glasgow and Clyde
Collaborators: University of Surrey|Manchester University NHS Foundation Trust|Mesothelioma UK
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-01-25
Completion Date: 2025-07-31
Locations: Queen Elizabeth University Hospital, Glasgow, G51 4TF, United Kingdom|Wythenshawe Hospital, Manchester, M23 9LT, United Kingdom

Summary:
The goal of this clinical trial is to learn whether running an exercise study in patients with mesothelioma is feasible. The main question(s) it aims to answer are:

1. Is it feasible to recruit patients to a randomised clinical trial of exercise therapy
2. What are the barriers to study recruitment
3. What are the barriers to study retention

Participants who decide to take part in the study will be randomly allocated one of two study arms:

1. Standard of care, where the participant will undergo their usual clinical follow-up
2. Exercise therapy, where the participant will receive a personalised 12 week exercise, nutrition and wellbeing programme Participants in both study arms will be asked to complete quality of life questionnaires and a basic fitness assessment at the start and end of the study follow-up period.

Participants will be asked if they would be happy to conduct a short interview with a member of the research team, to assess their views on the study. This interview will be audio recorded and the audio recording will be transcribed anonymously to allow researchers to improve future study design.

Primary Outcome Measures: Number of patients recruited, Number of patients recruited to the study, 12 months
Secondary Outcome Measures: Proportion of screened patients who are ineligible, Proportion of screened patients who are ineligible for the study, 12 months|Study drop-out rate, Proportion of patients who enter the study who withdraw prior to study completion, 12 months|Intervention adherence rate, Proportion of patients randomised to the intervention arm who complete the exercise programme, 12 months|Health-related Quality of Life questionnaire completion rate, Number of Health-related Quality of Life questionnaires completed by participants in the study (higher numbers of completed questionnaires equates to better outcome), 18 months|Framework analysis from qualitative interviews, Framework analysis from qualitative interviews with study participants, 12 months
A Cryotherapy With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma
NCT Number: NCT06491771
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cryotherapy Effect
Interventions: DEVICE: TargetCool
Sponsor: Mahidol University
Sex: ALL
Age: ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-07-01
Locations: Department of Dermatology, Siriraj Hospital, Mahidol University, Bangkok, 10700, Thailand

Summary:
This study aimed to evaluate the effectiveness of a precision cryotherapy via boosting mode combined with tranexamic acid versus normal saline in the treatment of melasma. Eighteen patients aged 25 to 60 years diagnosed with epidermal-typed melasma sized equal to or more than 2 cm on both cheeks were included. The patients were treated with a precision cryotherapy via boosting mode combined with tranexamic acid and normal saline on each side of cheek for 4 times every 1 week. Then, they were follow up at 1 and 3 months after the last treatment. Subjective assessment of physician and patient improvement were evaluated. Moreover, Melasma Area and Severity Index (MASI), melanin and erythema index using Mexameter were also recorded.

Primary Outcome Measures: The change of Melasma Area and Severity Index score, Two blind dermatologists evaluated Melasma Area and Severity Index score on each side of cheek in every visits (0-48; best to worse), Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Secondary Outcome Measures: Physician improvement score, Using quartile scale (\<0% = worsen; 0% = no change; 1-25% = mild improvement; 26-50% = moderate improvement; 51-75% = marked improvement; 76-100% = complete improvement), 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment|Overall improvement by patients, Using quartile scale (\<0% = worsen; 0% = no change; 1-25% = mild improvement; 26-50% = moderate improvement; 51-75% = marked improvement; 76-100% = complete improvement), 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment|the changes in melanin index, Using Mexameter, Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment|the changes in erythema index, Using Mexameter, Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment|Side effects, After treatment on both sides, Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
EIM Via the Myolex mScan as an ALS Biomarker
NCT Number: NCT06491732
Acronym: ElectricALS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Amyotrophic Lateral Sclerosis
Interventions: DEVICE: Electrical Impedance Myography
Sponsor: Beth Israel Deaconess Medical Center
Collaborators: United States Department of Defense
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-09-30
Locations: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States

Summary:
Amyotrophic lateral sclerosis (ALS) has been traditionally considered incurable and untreatable. But starting in the 1990s with the introduction of Riluzole, therapies are being discovered and ultimately approved for slowing disease progression. Many pharmaceutical companies continue to seek new therapeutic approaches. One critical aspect of all clinical trials is the need track to progression sensitively to identify the impact of therapy. Tools to track ALS progression must be convenient, objective, require minimal training, be easily standardized, cost-efficient, and have the potential to be applied effectively at home. There has been a push to identify accurate, objective biomarkers of ALS progression. In this study, the investigators propose to use Electrical impedance myography (EIM) to evaluate the progression of the disease. Work has shown that the EIM 50 kilohertz (kHz) phase value from one or more muscles, followed sequentially, can serve as an effective overall biomarker for assessing the rate of ALS progression for a single person.

Primary Outcome Measures: EIM phase change over time, Mean and standard deviation in rate of change in EIM phase values compared to mean and standard deviation in rate of change in ALSFRS-R over 8 months, 8 months
A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT
NCT Number: NCT06491719
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome|EBV|Hemophagocytic Lymphohistiocytoses
Interventions: OTHER: NCR300（Allogenic Ipsc-derived Natural Killer cells ）
Sponsor: Beijing Friendship Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2026-07-15
Locations: Beijing Friendship Hospital, Capital Medical University, Beijing, China

Summary:
To evaluate the efficacy and safety of iNK cells infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)

Primary Outcome Measures: Disease-free survival time (DFS), Assessment of CAEBV, EBV-HLH systemic disease status and peripheral blood EBV-DNA levels, 1 year|complete remission rate (CR), EBV-DNA negative rate in relapsed/non-remitting patients, 1 year|Recurrence rate (RT), EBV-DNA reactivation rate for high-risk patients, 1 year
Secondary Outcome Measures: cytomegalovirus DNA, Incidence of post-transplant infection-related comorbidities, 1 year|Adverse Event（AE）, Assess the frequency and extent of adverse events, 1 year
Long-term Outcomes in Older Patients With Physical Restraint
NCT Number: NCT06491706
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Physical Restraint|Biological Sex Diffrences|Morality
Interventions: OTHER: the was no intervention
Sponsor: Beaujon Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 149
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-11-01
Completion Date: 2022-10-30
Locations: Hopital BEAUJON, Clichy, 92110, France

Summary:
The worldwide population is ageing. Biological sex is first and foremost a genetic modifier of disease. To prevent self-arm many techniques can be used in older patients. Among them coercive measure consisting of physical restraint (PR) is one of the techniques.

This study aims to assess the effects of the biological sex on the long-term survival after PR in geriatric patients during the initial emergency department (ED) visit.

This retrospective study included patients between November 2019 to March 2021. All consecutive hospitalized patients after emergency department visit older than 75 years with PR were included.

The population was compared according to the biological sex. One-year all-cause mortality was plotted with the Kaplan-Meier curve. Hazard ratios (HRs) for 1-year mortality were calculated using a Cox proportional hazards regression model. Mortality was monitored over a 3-year period.

Primary Outcome Measures: one year mortaliy, ONE year
Can Optic Nerve Sheath Diameter Detect Norological Morbidities for Patients Undergoing Carotis Endarterectomy
NCT Number: NCT06491693
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Optic Nerve Sheath Diameter Measurements for Carotis Endarterectomy
Sponsor: Başakşehir Çam & Sakura City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-01-01
Locations: BasaksehirCamveSakuraSehirH, Istanbul, Turkey

Summary:
The main purpose of this study is to investigate the contribution of changes in Optic Nerve Sheath Diameter (OSNC) measured at different periods during Carotid Endarterectomy (CEA) operations to the prediction of neurological problems detected in the postoperative period. The secondary aim of the study is to examine the relationship between optic nerve sheath diameter measurement and other routinely used perioperative follow-up parameters in terms of predicting neurological problems.

Primary Outcome Measures: The aim is to investigate the contribution of changes in Optic Nerve Sheath Diameter (OSNC) measured at different periods during Carotid Endarterectomy (CEA) operations to the prediction of neurological problems detected in the postoperative period., Optic nerve sheath diameter measurement with USG is made using a high-frequency linear probe after the system settings are made suitable for the lens retina and vitreous body. It is performed by applying gel to the upper eyelid and placing the transducer in the temporal part of the eye, with the patient in a supine position with the head and body elevated 20-30 degrees.Optic nerve sheath diameter measurement with USG is made using a high-frequency linear probe after the system settings are made suitable for the lens retina and vitreous body. It is performed by applying gel to the upper eyelid and placing the transducer in the temporal part of the eye, with the patient in a supine position with the head and body elevated 20-30 degrees., 4 months
Evaluation of the Cardioprotective Effect of Dapagliflozin on Anthracyclines-Induced Cardiotoxicity in Breast Cancer Patients
NCT Number: NCT06491680
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Breast Cancer
Interventions: DRUG: Dapagliflozin 10mg Tab
Sponsor: Helwan University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2025-10

Summary:
The goal of this clinical trial is to learn if dapagliflozin drug has a cardioprotective effect against anthracyclines-induced cardiotoxicity. It will also learn about the safety of dapagliflozin drug.

Aim of the study:

Evaluate cardioprotective effect and safety of dapagliflozin against anthracyclines-induced cardiotoxicity.

The main questions it aims to answer are:

1. Does the drug lower the cardiotoxicity which induced by anthracyclines?
2. What medical problems do participants have when taking dapagliflozin drug?

Treatment

1. Anthracyclines by 4 cycles included doxorubicin 50-60 mg/m2 with cyclophosphamide 600 mg as a combination or epirubicin 90-100 mg/m2 with cyclophosphamide 600 mg as a combination.
2. Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose.

Primary Outcome Measures: N-terminal pro-B-type natriuretic peptide (NT-pro BNP) testing, Monitoring the serum at Baseline and after the last cycle of anthracyclines ., Baseline and after the last cycle of anthracyclines ( 0 and 2 to 3 months )
Secondary Outcome Measures: Echocardiography by measuring left ventricular ejection fraction, LVEF will be assessed using MM and 2D eye balling performed by an experienced operator blind of the patients history.

Measure at Baseline, after the last cycle of anthracycline, 3 months after the end of chemotherapy and PRN for any symptomatic patients, Measure at Baseline, after the last cycle of anthracycline, 3 months after the end of chemotherapy ( 5 to 6 months )|Make a questionnaire to asses side effects of anthracyclines, This questionnaire is made by patients complains and patients reported outcomes, 6 months
NLR AND CRP Useful as Cost-Effective Preliminary Prognostic Markers in ST-Elevation Myocardial Infarction
NCT Number: NCT06491667
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: STEMI
Interventions: DIAGNOSTIC_TEST: CBC|DIAGNOSTIC_TEST: C-reactive protein
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-12-01
Locations: Sohag university hospital, Sohag, Egypt

Summary:
Acute myocardial infarction (AMI) is a serious and fatal cardiovascular emergency and considered the leading cause of mortality worldwide.

Atherosclerosis of coronary arteries which takes decades to manifest clinically, is the primary predisposing pathologic factor responsible for the development of coronary heart disease It has been shown that A complex immune and inflammatory pathophysiological process is thought to be crucial for in the initiation and progression of atherosclerotic plaques.

Inflammation is one of the main mechanisms in the pathogenesis of atherosclerosis , Destabilization of chronic artery plaques and development of thrombosis, which are the main mechanisms in the pathophysiology of ST-segment elevation myocardial infarction (STEMI).

, and the interest to the evaluation of inflammatory biomarkers in coronary artery disease (CAD) has been increasing over the last decade .

Although numerous inflammatory markers, including troponin T/I, lactate dehydrogenase (LDH), and creatine kinase (CK-MB), are linked to worsened clinical outcomes in both ST elevation and non-ST elevation myocardial infarction (NSTEMI), there is an unmet need for a cost-effective biomarker for impoverished countries of the world .

The neutrophil-to-lymphocyte ratio (NLR), and C-reactive protein (CRP) ; has emerged as an important inflammatory markers for cardiovascular risk stratification.

And are relatively cheap inflammatory markers, can act as a bridge to mitigate the gap in assessing the cardiovascular risk and outcomes

Primary Outcome Measures: Neutrophil-lymphocyte ratio, Explore the role of Neutrophil-lymphocyte ratio in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction, 6 months|C-reactive protein, C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction, 6 months
The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Newborn
NCT Number: NCT06491641
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Comfort Theory|Hemodynamic Variables
Interventions: OTHER: Care based on Kolcaba's comfort theory
Sponsor: Cukurova University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-26
Completion Date: 2024-12-31
Locations: Tatvan Devlet Hastanesi, Bi̇tli̇s, tATATVAN/BİTLİS, 13200, Turkey

Summary:
It was planned to determine the effect of nursing care based on Kolcaba's Comfort Theory on newborns' comfort, pain and hemodynamic variables for babies admitted to the neonatal intensive care unit.

* Does nursing care based on comfort theory reduce the comfort and pain levels of newborn babies?
* Does nursing care based on comfort theory have an effect on babies' vital signs?

Primary Outcome Measures: Neonatal Infant Pain Scale-Nips, The scale developed by Lawrence et al. is used for premature and newborns. In the neonatal pain scale, 5 (five) behavioral groupings (facial expression, crying, movements of arms and legs, state of wakefulness) and a physiological parameter (respiratory pattern) are evaluated and measured. Total score varies between 0-7. A high score on this scale indicates that the intensity of the pain is high. ., It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.|Newborn Comfort Behavior Scale, It is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. M. Each item in the scale is scored from 1 to 5. It is evaluated based on the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale (YKDS) is 6 and the highest score is 30. If the total score of the scale is between 14-30, it is emphasized that the baby is in pain or distress, is uncomfortable and needs interventions to provide comfort. Scoring 4-6 on the Numerical Rating Scales indicates moderate pain and distress, while scoring 7-10 indicates severe pain and distress., It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
Liver Function Abnormalities in Patients With Acute Heart Failure
NCT Number: NCT06491628
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Heart Failure
Interventions: BEHAVIORAL: Avoiding the risk factors
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-08
Locations: Sohag university, Sohag, Egypt

Summary:
The aim of this study is to evaluate liver function test abnormalities and to identify associated cardiac and non cardiac factors mediating hepatic impairment in acute heart failure patients

Primary Outcome Measures: Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals, assessment the LFTs abnormalities and factors mediating hepatic impairment in patients with AHF, baseline
Secondary Outcome Measures: Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals, assessment the LFTs abnormalities and factors mediating hepatic impairment in patients with AHF, 1 year
A Study of Clinical Characteristics ,Risk Factors and Outcome of Lupus Nephritis Among Children With Systemic Lupus Erthromatousus in Sohag Univeristy Hospital
NCT Number: NCT06491602
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lupus Nephritis
Interventions: DIAGNOSTIC_TEST: renal biobsy
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-24
Completion Date: 2025-06-24
Locations: Sohag university Hospital, Sohag, Sohag, Egypt

Summary:
systemic lupus erthrematosus is an inflamatory and autoimmune condition characterized by multisystem affection and chronic course with unpredictable flares despite potentially afffecting every oragan . kidney involvment are the most common

Primary Outcome Measures: remission of LN, acute on top of chronic, 1 year|progress to CKD, affection of kidney become perment, 1 year
Feasibility and Outcomes of Endovascular Aneurysm Repairs (EVARs) Without Arterial Line Monitoring
NCT Number: NCT06491589
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Abdominal Aortic Aneurysm
Sponsor: Nova Scotia Health Authority
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-12-01
Locations: QEII Health Sciences Center, Halifax, Nova Scotia, B3H 3A7, Canada

Summary:
Endovascular Aortic Aneurysm Repairs (EVARs) are typically performed with arterial line monitoring, however our institution has successfully omitted this practice in select cases without complications or patient safety concerns. To investigate this further, our planned study will compare patients undergoing EVAR with and without arterial line monitoring. Data will be collected on pre-operative characteristics (patient age, sex, comorbidities), intraoperative details (procedural time, need for emergent intra-operative arterial monitoring or blood draws), and postoperative outcomes (complications, time in post-operative recovery unit). Operating room staff satisfaction and acceptability will be measured using a survey developed by our team. The findings from this study hold promise for improvement the treatment of aortic aneurysms, as well as enhancing patient safety and experience.

Primary Outcome Measures: Assess acceptability of no art-line EVAR., Acceptability (user satisfaction, perceived appropriateness, perceived positive or negative effects on organization) will be determined by a Likert scale survey circulated to treating staff., 12 months|Assess technical feasibility of no art-line EVAR., Technical feasibility (time required for pre-op prep and setup; duration of procedure), 12 months|Asess safety of no art-line EVAR., Although this has already been established to be a safe and viable surgical technique, it would still be interesting to collect data on the incidence of intra-op and post-op complications., 12 months
Secondary Outcome Measures: Assess complication rates of no art-line EVAR as compared to traditional EVAR procedures using arterial line monitoring., Assess the overall complication rates (incidence) of the no art-line approach to EVAR., 12 months
Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)
NCT Number: NCT06491563
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: For Treatment of Chronic Hepatitis B Virus Infection
Interventions: BIOLOGICAL: BRII-179|DRUG: BRII-835 (VIR-2218)|BIOLOGICAL: PEG-IFNα
Sponsor: Brii Biosciences Limited
Collaborators: Vir Biotechnology, Inc.
Sex: ALL
Age: ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-06
Locations: Investigative Site 86004, Beijing, Beijing, 100000, China|Investigative Site 86009, Beijing, Beijing, 100000, China|Investigative Site 86006, Chongqing, Chongqing, 400000, China|Investigative Site 86015, Xiamen, Fujian, 361000, China|Investigative Site 86012, Foshan, Guangdong, 528000, China|Investigative Site 86001, Guangzhou, Guangdong, 510000, China|Investigative Site 86013, Guangzhou, Guangdong, 510000, China|Investigative Site 86002, Shenzhen, Guangdong, 518000, China|Investigative Site 86010, Wuhan, Hubei, 430000, China|Investigative Site 86003, Shanghai, Shanghai, 200000, China|Investigative Site 86008, Shanghai, Shanghai, 200000, China|Investigative Site 86007, Chengdu, Sichuan, 610000, China|Investigative Site 86011, Chengdu, Sichuan, 610000, China|Investigative Site 86014, Chengdu, Sichuan, 610000, China|Investigative Site 86005, Hangzhou, Zhejiang, 310000, China

Summary:
This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Primary Outcome Measures: Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint, 24 weeks post end of treatment
Secondary Outcome Measures: Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint (in participants with lower baseline HBsAg levels), 24 weeks post end of treatment|Percentage of participants with treatment-emergent adverse events (TEAEs), 24 weeks post NRTI discontinuation|Percentage of participants with serious adverse events (SAEs), 24 weeks post NRTI discontinuation|Percentage of participants with abnormalities in hematology, chemistry, and/or coagulation parameters, 24 weeks post NRTI discontinuation
Disposable 7.5Fr Electronic Flexible Ureteroscope Combined 10Fr Ureteral Access Sheath for Treatment of Renal Stone <2cm
NCT Number: NCT06491524
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ureteroscopy|Urolithiasis
Interventions: DEVICE: Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm
Sponsor: Ningbo No. 1 Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 23
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-04-20
Completion Date: 2023-10-28
Locations: Ningbo First hospital, Ningbo, Zhejiang, 315010, China

Summary:
Observation efficacy and safety of disposable f7.5 electronic flexible ureteroscope combined f10 ureteral guide sheath for treatment of renal stone \<2cm.

Primary Outcome Measures: Success rate of Accessing, success rate of UAS placement (SRUP), 1 day
Secondary Outcome Measures: Evaluation of intraoperative ureteral injury, Evaluation of intraoperative ureteral injury according to the standards proposed by Traxer et. al., 1 day|Stone free rate, stone free rate (SFR), 1 and 30 days|overactive bladder symptom score (OABSS), Overactive bladder symptom score (OABSS) before and after the operation, 1 month|Quality of life (QOL) questionnaire, Quality of life (QOL) before and after the operation, 1 month
Repetitive Phrenic Nerve Stimulation in Critically Ill Patients Under Mechanical Ventilation
NCT Number: NCT06491511
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Phrenic Nerve|Electrical Stimulation
Interventions: PROCEDURE: Transcutaneous, repetitive phrenic nerve electrical stimulation
Sponsor: Seoul National University Hospital
Collaborators: National Research Foundation of Korea
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-17
Completion Date: 2025-01-31
Locations: Seoul National University Hospital, Seoul, 03080, Korea, Republic of

Summary:
Subjects: Patients aged 19 and older who are currently in the ICU and undergoing invasive mechanical ventilation.

Methods: The study involves performing non-invasive repetitive phrenic nerve stimulation in ICU patients on mechanical ventilation.

Stimulation protocol: The intensity and position of phrenic nerve stimulation were individualized. The frequency was set to 10Hz, 15Hz, and 20Hz. The duration of stimulation was adjusted according to the set inspiration time of mechanical ventilation.

Primary Outcome Measures: Maximum diaphragm thickness during phrenic nerve repetitive stimulation, Maximum diaphragm thickness (mm), Measured one time between 48 hours after intubation and before extubation.|Change in diaphragm thickness before and during phrenic nerve repetitive stimulation, Change of diaphragm thickness (mm), Measured one time between 48 hours after intubation and before extubation.
Secondary Outcome Measures: Amplitude of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulation, CMAP amplitude (mV), Measured one time between 48 hours after intubation and before extubation.|Area of the phrenic nerve compound motor action potential during phrenic nerve repetitive stimulation, CMAP area (ms\*mV), Measured one time between 48 hours after intubation and before extubation.
Hemidiaphragmatic Paralysis Following Supraclavicular Brachial Plexus Blockade.
NCT Number: NCT06491498
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Respiratory Depression
Interventions: DIAGNOSTIC_TEST: Supraclavicular Brachial Plexus Blockade
Sponsor: Sohag University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-02-01

Summary:
The supraclavicular block is a regional anesthetic technique used as an alternative or adjunct to general anesthesia or used for postoperative pain control for upper extremity surgeries (mid-humerus through the hand). First introduced in 1911 by Kulenkampff as a landmark-based approach, the associated risk of pneumothorax was likely responsible for the technique falling out of favor. With the advent of ultrasonography, La Grange described the utilization of the Doppler probe to identify arteries in 1978. Contemporarily, Kapral and colleagues advocated for the dynamic use of ultrasound to guide needle advancement in the supraclavicular position. Colloquially known as the "spinal of the arm," the supraclavicular block is advantageous as the brachial plexus nerves are tightly packed in this approach and speed of onset is often rapidly achieved. However, because of this consolidated relationship, consider restricting volumes of local anesthesia to as low as possible to achieve goals, as compression ischemia may occur.

Primary Outcome Measures: incidences of hemi diaphragmatic paralysis following ultrasound-guided supraclavicular plexus blockade, By Using M-mode Ultrasonography showing the limitation of diaphragmatic motion before and after supraclavicular brachial plexus blockade, 2 hours
Secondary Outcome Measures: Evaluation of post operative pain by visual analog scale, effect on vital signs, 2 hours|Evaluation of oxygen saturation by pulse oximeter, effect on vital signs, 2 hours
Postoperative Analgesia in Laparoscopic Gynecological Surgeries
NCT Number: NCT06491485
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Postoperative Pain
Interventions: DRUG: Group M (lidocaine with Magnesium sulfate)|DRUG: Group B (lidocaine with Sodium bicarbonate)|DRUG: Group C (lidocaine with saline)
Sponsor: Assiut University
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-12-01

Summary:
The aim of this study is to compare intraperitoneal instillation of magnesium sulfate versus sodium bicarbonate as an adjuvant to lidocaine 1% , on reducing postoperative pain in laparoscopic gynecological surgeries.

Primary Outcome Measures: first rescue analgesia, The first request for analgesia will be recorded by the nurse, and in case of pain in VAS more than 3, 1 gm of paracetamol will be administrated as a rescue analgesic if failed fentanyl 100mic will be added, 24 hour postoperative
Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer
NCT Number: NCT06491472
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Cancer
Interventions: DRUG: Ivonescimab|DRUG: Gemcitabine|DRUG: Nab paclitaxel|RADIATION: SBRT
Sponsor: Wuhan Union Hospital, China
Collaborators: Akesobio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2027-07-15
Locations: Wuhan Union Hospital of China, Wuhan, China

Summary:
This study is an open-label, single-arm Phase II clinical study to evaluate the efficacy and safety of ivonescimab(AK112/SMT112) in combination with stereotactic body radiation therapy and chemotherapy in patients with pancreatic cancer

Primary Outcome Measures: Objective Response Rate(ORR), ORR is the proportion of subjects with CR or PR , based on RECIST v1.1., Up to approximately 2 years
Secondary Outcome Measures: Progression-free Survival (PFS), PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first)., Up to approximately 2 years|Overall Survival(OS), OS is the time from the date of randomization or first dosing date to death due to any cause., Up to approximately 2 years|Disease Control Rate (DCR), DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1, Up to approximately 2 years|Adverse event (AE), Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results, Up to approximately 2 years|Duration of Response(DOR), Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first, Up to approximately 2 years
Predicting Postoperative Pulmonary Infection in Elderly Patients Undergoing Major Surgery: a Study Based on Logistic Regression and Machine Learning Models
NCT Number: NCT06491459
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Postoperative Pulmonary Infection in Elderly Patients
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: OLDER_ADULT
Enrollment: 9481
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-06-01
Locations: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China

Summary:
Although a number of clinical predictive models were developed to predict postoperative pulmonary infection, few predictive models have been used in elderly patients. In this study, the researchers aim to compare different algorithms to predict postoperative pulmonary infection in elderly patients and to assess the risk of postoperative pulmonary infection in elderly patients.

Primary Outcome Measures: the incidence of postoperative pulmonary infection during hospitalization, the incidence of postoperative pulmonary infection during hospitalization, through study completion, an average of 30 days
Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
NCT Number: NCT06491446
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Human Papillomavirus Infection
Interventions: DRUG: ABI-2280|DRUG: Placebo
Sponsor: Antiva Biosciences
Sex: FEMALE
Age: ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-27
Completion Date: 2026-02-28
Locations: PARC Clinical Research, Royal Adelaide Hospital, Adelaide, South Australia, Australia

Summary:
This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.

Primary Outcome Measures: For sentinel cohorts: Incidence and Severity of Adverse Events, For sentinel cohorts: for each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo, Week 24|For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline, Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders., Week 12
Secondary Outcome Measures: For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events, For fully expanded cohorts, including sentinel: for each dose/dosing regimen, incidence and severity of AEs, relationship of AEs to IP, and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo., Week 24|Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders, For fully expanded cohorts, including sentinel: For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 24, Week 24
Clinical Trial of H2-BP Electronic Sphygmomanometer
NCT Number: NCT06491433
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Blood Pressure|Normal Blood Pressure|Prehypertension|Hypertension
Interventions: DEVICE: H2-BP
Sponsor: Gangnam Severance Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-04-27
Completion Date: 2024-12-09
Locations: Gangnam Severance Hospital,, Seoul, Korea, Republic of

Summary:
The study compares H2-BP, a wristband blood pressure monitor, with an auscultatory sphygmomanometer. Both devices are used on the same arm. After confirming wrist and upper arm circumference, H2-BP is operated by one measurer, while the auscultatory sphygmomanometer is simultaneously operated by two other measurers. Each subject undergoes alternating measurements of H2-BP on one wrist and the auscultatory sphygmomanometer on the same arm until three valid measurement pairs are obtained per subject, with a maximum of eight repetitions allowed. The two auscultatory sphygmomanometer measurers operate independently and cannot see each other's measurements during the test. Measurements are repeated for 10 to 30 minutes until three valid blood pressure values are obtained and recorded. Validity assessment variables are derived from the recorded values to evaluate the accuracy of H2-BP.

Primary Outcome Measures: Mean and Standard Deviation of Differences Between H2-BP Device and aneroid Sphygmomanometer Measurements., Average difference between blood pressure measurements obtained with the test medical device and the comparator.

Standard deviation of the difference between blood pressure measurements obtained with the test medical device and the comparator (based on the number of measurements)., serial assessment during 1 day
Secondary Outcome Measures: Standard Deviation of Differences Between H2-BP Device and aneroid Sphygmomanometer Measurements., Standard deviation of the difference in blood pressure measurements between the test device and the comparator (based on the number of participants), secondary outcome will be out in 1 day
Is There a Role for Hip Arthroscopy in Patients With Femoral Head Fractures?
NCT Number: NCT06491420
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Femur Head Fracture|Arthroscopy
Interventions: OTHER: fixation with arthroscopy
Sponsor: Kasr El Aini Hospital
Sex: ALL
Age: ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2024-12-01
Locations: Kasr Al Ainy-Cairo University- Faculty of Medicine, Cairo, Manial, 11956, Egypt

Summary:
Femoral head fractures, often caused by high-energy trauma, pose significant challenges due to complications like avascular necrosis, post-traumatic osteoarthritis, and sciatic nerve damage. While traditionally treated with open reduction and internal fixation (ORIF) or total hip replacement (THR), hip arthroscopy has emerged as a minimally invasive alternative that reduces surgical trauma, offers direct fracture visualization and manipulation, and may result in shorter recovery times and fewer complications.

Primary Outcome Measures: Non Arthritic Hip Score, The Following five questions concern the amount of pain: 1 Walking on a flat surface? 2 Going up or down stairs? 3 At night while in bed? 4 Sitting or lying? 5 tanding upright? the scoring for each question is from 0 to 4, 6 months