pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats
NCT Number: NCT06491394
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Rhabdomyolysis
Interventions: DRUG: Lactoferrin|DIAGNOSTIC_TEST: iron|DIAGNOSTIC_TEST: MDA, TAC, and GSH|DIAGNOSTIC_TEST: Nrf2|DIAGNOSTIC_TEST: AMPK|DIAGNOSTIC_TEST: HO-1|DRUG: glycerin
Sponsor: Aswan University Hospital
Sex: MALE
Age: CHILD
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-01-01

Summary:
This study focuses on detecting the possible beneficial effect of Lactoferrin (Lf) administration on the kidney and the heart of glycerol-induced rhabdomyolysis (RM) in rats and its relation to ferroptosis and AMPK/Nrf2/ HO-1 signalling pathway. The main questions it aims to answer are:

1. Is Lf administration 15 min. before or after RM induction in rats beneficial to kidneys and heart?
2. When administered to glycerol-induced rats, does Lf act by upregulating the AMPK/Nrf2/ HO-1 signalling pathway and inhibiting ferroptosis?

Primary Outcome Measures: Nrf2 expression, Nrf2 expression in heart and kidney tissues, 2 months|AMPK levels, AMPK levels in kidney and heart tissue homogenate, 2 months|HO-1 levels, HO-1 levels in kidney and heart tissue homogenate, 2 months
Secondary Outcome Measures: iron levels, Iron levels in heart and kidney tissue homogenate, 2 months|MDA levels, MDA levels in heart and kidney tissue homogenate, 2 months|TAC levels, TAC levels in heart and kidney tissue homogenate, 2 months|GSH levels, GSH levels in heart and kidney tissue homogenate, 2 months
Post Cesarian Section Wound Infections at Emergency Room
NCT Number: NCT06491381
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Surgical Wound Infection
Interventions: PROCEDURE: Cesarean delivery
Sponsor: Al-Azhar University
Sex: FEMALE
Age: ADULT
Enrollment: 220
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-01
Completion Date: 2024-08-01
Locations: Al-Hussein University Hospital, Cairo, 11633, Egypt

Summary:
The goal of this observational study is to compare the incidence of post-cesarean section wound infections between emergency and elective cesarean deliveries at El-hussien Hospital. The main questions it aims to answer are:

Is there a difference in surgical site infection rates between emergency and elective cesarean sections? What are the other outcome measures associated with emergency versus elective cesarean deliveries?

Participants will be 220 patients undergoing cesarean section, divided into two groups:

110 patients undergoing emergency cesarean delivery in the Emergency Unit 110 patients undergoing elective cesarean delivery

Researchers will compare the emergency cesarean group to the elective cesarean group to see if there are differences in surgical site infection rates and other relevant outcome measures.

Primary Outcome Measures: Post Caesarian Section Wound Infections, * The wounds will be inspected. The presence of minor or major wound infection will be recorded on an audit form.
* Wound infection will be defined as:

Purulent discharge present within or exuding from the wound. Painful spreading erythema indicative of cellulitis.

• An infection will be defined as minor if deep tissue destruction or lymphangitis is absent, and major if these elements, wound dehiscence or systemic symptoms, is present., 6 weeks after surgery.
Secondary Outcome Measures: Wound Healing Complications, We will assess the occurrence of other wound-related complications, such as wound dehiscence (separation of wound edges), seroma (accumulation of fluid), or hematoma (collection of blood)., 6 weeks after surgery.|Length of Hospital Stay, We will measure the duration of hospitalization for patients who undergo a cesarean section at the emergency unit and hospital., 6 weeks after surgery.|Surgical Site Pain, We will evaluate the intensity and duration of pain experienced by patients at the surgical site following a cesarean section., 6 weeks after surgery.|Antibiotic Usage, We will measure the frequency, type, and duration of antibiotic administration to treat post-cesarean section wound infections., 6 weeks after surgery.|Patient Satisfaction, We will assess the level of satisfaction reported by patients regarding their overall experience with the cesarean section procedure and subsequent wound healing., 6 weeks after surgery.|Keloid formation, We will assess formation of keloid after the surgery/, 6 months after the surgery
Optimal Interval Between Consecutive Cesarean Sections
NCT Number: NCT06491368
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cesarean Section Complications
Interventions: PROCEDURE: Cesarean Delivery
Sponsor: Al-Azhar University
Sex: FEMALE
Age: ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-10
Completion Date: 2025-03-01
Locations: Al-Hussein University Hospital, Cairo, 11633, Egypt

Summary:
The goal of this observational study is to determine the best time interval between consecutive cesarean sections and compare maternal and neonatal outcomes in women with a history of previous cesarean sections. The main questions it aims to answer are:

* What is the optimal time interval between consecutive cesarean sections for minimizing maternal intraoperative complications, blood transfusions, and intra- and postoperative bleeding?
* What are the differences in fetal and neonatal outcomes based on different time intervals between cesarean sections?

Participants will be divided into five subgroups based on the time interval since their last cesarean section: 0-12 months, 12-24 months, 25-36 months, 37-48 months, and more than 48 months. Each participant will undergo an elective cesarean section and provide data on maternal and neonatal outcomes.

Researchers will compare these subgroups to see if varying time intervals between consecutive cesarean sections affect maternal and neonatal outcomes.

Primary Outcome Measures: Intraoperative complications, Occurrences of injuries to the bladder or bowel during surgery, injury of uterine artery, extension of uterine incision., Withen the surgery.
Secondary Outcome Measures: Intraoperative and postoperative bleeding (quantify blood loss, Measurement of blood loss before and after surgery using complete blood count (CBC)., withen the surgery and up to 24 hours after the sutgery.|Blood transfusions, Instances of maternal blood transfusions during or after surgery., withen the surgery and up to 24 hours after the sutgery.|ICU admissions, Number of mothers admitted to the Intensive Care Unit (ICU) postoperatively., 1 week after the surgery.|Fetal distress, Instances of fetal distress noted during labor or delivery, during and 24 hours after the surgery.|Neonatal Apgar scores, Apgar scores measured at 1 minute and 5 minutes after birth, assessing newborn health., 5 minutes after birth.|NICU admissions, Number of neonates admitted to the Neonatal Intensive Care Unit (NICU)., during and 24 hours after the surgery.|Neonatal morbidity and mortality, Incidence of health issues and deaths among newborns within a specific timeframe post-delivery., during and 2 weeks after the surgery.
First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer
NCT Number: NCT06491355
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Efficacy, Self|Safety Issues|Colo-rectal Cancer
Interventions: DRUG: mfolfox6 and hlx04 regimen and Serplulimab|DRUG: mfolfox6 and hlx04 regimen
Sponsor: Sir Run Run Shaw Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-06-30
Locations: Sir Run Run Shao hospital, Hanzhou, Zhejiang, 310016, China

Summary:
This is a prospective, multi-center, randomized controlled clinical intervention study, aiming to explore the effectiveness and safety of mfolfox6 and hlx04 regimens combined with slulimumab as first-line treatment for MSS-type initial unresectable metastatic colorectal cancer after induction therapy. This study plans to include a total of 72 patients with untreated MSS-type initial unresectable metastatic colorectal cancer.

This study randomly allocated groups through a randomization system, and entered the following treatment groups at a ratio of 1:1: (1) Experimental group: mfolfox6 and hlx04 regimen induction therapy followed by slulimab treatment (36 cases); (2) Control group Group: mfolfox6 and hlx04 regimen treatment (36 cases).

Primary Outcome Measures: Progression free survival（PFS）, The time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Secondary Outcome Measures: objective response rate(ORR), It refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, through study completion, an average of 1 year|disease control rate(DCR), Refers to the proportion of patients with best overall assessment of complete response, partial response, or stable disease., through study completion, an average of 1 year|overall survival(OS), Overall survival (os) is defined as the date from randomization to death from any cause., 5 years
Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease
NCT Number: NCT06491342
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fatty Liver, Nonalcoholic
Interventions: DIETARY_SUPPLEMENT: Probiotic|DIETARY_SUPPLEMENT: Placebo
Sponsor: Phramongkutklao College of Medicine and Hospital
Collaborators: Thailand Institute of scientific and technological research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-25
Completion Date: 2025-05-28
Locations: Division of gastroenterology and hepatology, Ratchathewi, Bangkok, 10400, Thailand

Summary:
Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial

Primary Outcome Measures: Liver steatosis by MRI, Hepatic steatosis with MRI-PDFF (the percent ratio of the density of mobile protons from triglycerides and the total density of protons from mobile triglycerides and mobile water). Outcome Measures was report as percent, 12 weeks|Liver steatosis by fibroscan, Shear wave velocity with controlled attenuation parameter (CAP) unit in decibels per meter (dB/m), 12 weeks|Liver stiffness by fibroscan, Fibroscan- transient elastography in kilopascals (kPa), 12 weeks
Secondary Outcome Measures: Liver inflammation, Evaluated alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), gamma-glutamyl transferase (GGT; U/L), and alkaline phosphatase (ALP; U/L), 12 weeks|Metabolic profile, Fasting plasma glucose (FPG) in mg/dL, 12 weeks|Metabolic profile, HbA1C in percent, 12 weeks|Metabolic profile: HOMA IR, Fasting plasma glucose and serum insulin level will be combined to report in HOMA IR in mg/dl x mIU/L, 12 weeks|Metabolic profile: serum lipid profiles, Total cholesterol in mg/dL, low-density lipoprotein (LDL) cholesterol in mg/dL, high-density lipoprotein (HDL) in mg/dl, cholesterol in mg/dL, and triglyceride in mg/dL, 12 weeks|Inflammatory marker, hsCRP level in mg/L, 12 weeks|Inflammatory marker, Interleukin 6 (IL-6) in pg/mL, 12 weeks|Anthropomorphic evaluation: BMI, Weight and height will be combined to report BMI in kg/m\^2, 12 weeks|Anthropomorphic evaluation: composition analysis, Body fat in percentage, 12 weeks|Anthropomorphic evaluation, Body muscle in kilogram, 12 weeks
Other Outcome Measures: Fecal SCFA, Fecal SCFA (acetate, propionate and butyrate) in microgram/ml metagenomic sequencing (Next-generation sequencing), 12 weeks
Results of Cross-leg Free Vascularized Fibular Graft
NCT Number: NCT06491316
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tibial Fractures
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-20
Completion Date: 2024-10-30
Locations: Assiut University Hospital, Assiut, 71515, Egypt

Summary:
This study aims to evaluate the new technique of cross-leg vascularized fibular graft for reconstruction of post-traumatic long tibial bone defects in terms of restoring normal anatomy and function of the traumatized limb in a series of cases admitted in Assiut University hospital, Orthopedics and trauma surgery department.

Primary Outcome Measures: Number of cases of Flap survival, Flap intake and vascularization without necrosis, 6 weeks from operation|Number of cases of Bone healing, Radiological evaluation, 1 year from operation
Secondary Outcome Measures: Number of cases with accepted Limb alignment, Long film x-ray of both lower limbs to assess bone alignment, 1 year
Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy
NCT Number: NCT06491303
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neutropenia|Thrombocytopenia|Aplastic Anemia|Anemia|Epilepsy
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2025-12-01

Summary:
Low therapeutic index of established antiepileptic drugs (AEDs) coupled with better understanding of the pathophysiology of seizure has encouraged the development of several novel AEDs. The conventional antiepileptics like phenytoin, phenobarbitone, valproate and carbamazepine and newer antiepileptics like levetiracetam. are used for epilepsy. AEDs induce potentially toxic effects over a period of time which remains undetermined over very long time. Earlier studies in this regard, states uneven results about hematological (Hb%, blood cell count etc.) toxicity of AEDs.

Primary Outcome Measures: Study of Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy, All 45 patients will be included within certain inclusion criteria after informed consent will be subjected to full history, general examination,systemic examination including cardiac, chest and abdominal examination will be done to detect associated or excluded conditions and Laboratory tests include complete blood count assay.

The primary outcome measures to be assessed in this study is the effect of Levetiracetam(at least 6 months duration of treatment)on complete blood count including

1. Haemoglobin level.
2. Red cell count.
3. Hematocrit value.
4. M.C.V
5. M.C.H
6. M.C.H.C
7. Platelets count including MPV and PCT.
8. Total leucocytic count including neutrophils(band and segmented), lymphocytes, monocytes, basophils and eosinophils., one years
Modelling of Correlation Between Emergency Department Admissions and Location-specific Air Quality and Weather in the Florence Urban Area
NCT Number: NCT06491290
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Emergency Service, Hospital|Air Pollution|Weather
Interventions: OTHER: No intervention administered
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 480000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2027-12-31
Locations: SOD Medicina e Chirurgia d'Urgenza ed Accettazione, Azienda Ospedaliera-Universitaria Careggi, Florence, 50134, Italy

Summary:
The goal of this observational study is to evaluate the impact of primary air pollutants and weather parameters on emergency department (ED) visits in the metropolitan area of Florence.

Primary Outcome Measures: number of daily emergency department visits, Total number of emergency department visits on a given day, through study completion, 1 year
Other Outcome Measures: number of patients with Levels of Urgency (I-V) of emergency department visits, Levels of urgency of emergency department visits defined according to the Canadian triage system. With I emergency and V non-urgent visit, through study completion, 1 year|Number of patients with the most frequent primary complaints of emergency department visits, through study completion, 1 year|Number of patients hospitalised, Admission to a hospital ward, through study completion, 1 year|In-hospital mortality, Death occurring either in the emergency department or following admission to ward, through study completion, 1 year
Multiparameter Optimized tES for Memory in Aging
NCT Number: NCT06491264
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Aging
Interventions: DEVICE: Transcranial electrical stimulation
Sponsor: Medical University of South Carolina
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-15
Completion Date: 2026-12-31

Summary:
With an aging population worldwide, it is critical to develop effective interventions promoting healthy cognitive aging. Transcranial electrical stimulation (tES) is a promising but not fully realized noninvasive brain stimulation approach that could improve memory. This study investigates the behavioral and electrocortical effects of personalized tES in aging to determine whether whether optimal dosing, electrode placements, and waveforms elicit stronger responses.

Primary Outcome Measures: Electrocortical EEG changes pre- to post-tES, Observe effects of each tES condition within each of the 5 sessions, as measured by TMS-EEG, 1 year|N-back working memory changes pre- to post-tES, Observe effects of each tES condition within each of the 5 sessions on the N-back memory task, 1 year
Secondary Outcome Measures: Rate of side effects from tES, Questionnaire regarding headache, scalp sensation, and other common side effects of tES on a scale of 0-10., 1 year
Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility
NCT Number: NCT06491251
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Unexplained Infertility
Interventions: PROCEDURE: Bilateral Subinguinal microscopic varicocelectomy
Sponsor: Kafrelsheikh University
Sex: MALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-13
Completion Date: 2024-08-01
Locations: Kafrelsheikh University, Kafr Ash Shaykh, 33516, Egypt

Summary:
This study was conducted to assess the efficacy of varicocelectomy in unexplained male infertility with clinical varicocele The primary objective was to assess the pregnancy outcomes in these group. The secondary objective was to analyses improvement in Sperm DNA fragmentation , hormonal profile and semen parameter after varicocelectomy in Unexplained infertility .

Primary Outcome Measures: varicocelectomy improved spontaneous pregnancy rates, Sub inguinal microscopic varicocelectomy increase spontaneous pregnancy rates in groups with high sperm DNA fragmentation index in comparison to control group or varicocelectomy group with intermediate or normal sperm DNA fragmentation index, follow up 1 year post varicocelectomy|Effect of Infertility duration on sperm parameter and pregnancy rate after varicocelectomy, The infertility duration is sub grouped into three according to months of primary infertility and measures changes in sperm concentration , motility ,morphology and changes in spontaneous pregnancy rate in different groups, follow up 1 year post varicocelectomy
Secondary Outcome Measures: Improvement in Sperm DNA fragmentation index, decrease of sperm DNA fragmentation index after varicocelectomy in group with high sperm DNA fragmentation index \> 25 %, follow up 1 year post varicocelectomy|Changes in sperm concentration , Motility and morphology after varicocelectomy, increasing in sperm concentration , Motility and morphology after varicocelectomy in group with High sperm DNA fragmentation index \> 25% in comparison to group with normal sperm DNA fragmentation index, follow up 1 year post varicocelectomy
Autologous Tumor-Infiltrating Lymphocyte (GTE-001 Injection ) for Treatment of Patients With Advanced Lung Adenocarcinoma
NCT Number: NCT06491225
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Lung Adenocarcinoma；Adult
Interventions: BIOLOGICAL: GTE001 injection
Sponsor: Grit Biotechnology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2027-07-18
Locations: Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200127, China

Summary:
This study is a Multiple centers, open design aimed at evaluating the safety,efficacy and Production feasibility of Autologous Tumor-Infiltrating Lymphocyte (GTE-001 injection ) for treatment of patients with Advanced lung adenocarcinoma,And evaluate potential biomarkers related to GTE-001 activity.

Primary Outcome Measures: Objective response rate, To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator, 3 years
Pulse Checks Using Femoral Artery B-Mode Ultrasound With Compressibility Assessment
NCT Number: NCT06491186
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Arrest, Out-Of-Hospital
Interventions: OTHER: Point of Care Ultrasound
Sponsor: Medical University of Vienna
Collaborators: Ludwig Boltzmann Institute Digital Health and Patient Safety|Emergency Medical Service of Vienna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 69
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-02
Completion Date: 2024-12-31
Locations: Emergency Medical Service of Vienna, Vienna, 1030, Austria

Summary:
The goal of this prospective observational study is to investigate B-mode point-of care ultrasound with arterial compressibility assessment on the femoral artery as a method to determine the presence of a pulse and to compare it with concurrently conducted manual pulse checks.

Primary Outcome Measures: Results of POCUS pulse check, If the femoral artery is both non-compressible and pulsatile, the POCUS pulse check will be considered positive, During cardiac arrest, up to 45 minutes|Results of the concurrently conducted manual pulse check, Parallel to our study team the treating team will conduct standard care, consisting of determining the presence or absence of a pulse by palpation. The results of these manual pulse checks will be recorded by our study team., During cardiac arrest, up to 45 minutes
Secondary Outcome Measures: Arterial compressibility during chest compressions, Before each pulse check, during the last 30 seconds of cardiac compressions, the research team will apply pressure with the ultrasound probe until complete collapse of the femoral vein and visually assess if the neighbouring femoral is compressible as well., During cardiac arrest, up to 45 minutes|Arterial compressibility during rhythm checks, The compressibility of the femoral artery during rhythm checks (part of the "POCUS pulse check" primary outcome) will be recorded and analysed, independently of pulsatility, During cardiac arrest, up to 45 minutes|Arterial pulsatility during rhythm checks, The pulsatility of the femoral artery during rhythm checks (part of the "POCUS pulse check" primary outcome) will be recorded and analysed, independently of compressibility, During cardiac arrest, up to 45 minutes|Time needed for POCUS pulse checks, The POCUS pulse checks will be recorded and the time until presence or absence of a pulse could be determined will be recorded in seconds, During cardiac arrest, up to 45 minutes
Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500™ in Uganda
NCT Number: NCT06491173
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head Trauma|Crushing Skull Injury|Head Injury|Head Injuries, Multiple|Head Injuries, Closed|Head Trauma,Closed|Head Injury Major|Head Injury, Minor|Head Injury, Open|Injury, Craniocerebral|Injury, Head|Multiple Head Injury|Trauma, Head|Head Trauma Injury|Head Trauma, Penetrating|Craniocerebral Injury
Interventions: DEVICE: InfraScanner 2500™
Sponsor: Duke University
Collaborators: Mbarara Regional Referral Hospital|Mayanja Memorial Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-30
Completion Date: 2025-06-30
Locations: Mayanja Memorial Hospital, Mbarara, Uganda|Mbarara Regional Referral Hospital, Mbarara, Uganda

Summary:
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the portable near-infrared-based device (portable NIR-based device), the InfraScanner 2500™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral Hospital (MRRH) or Mayanja Memorial Hospital (MMH) who have sustained or who are suspected to have sustained head trauma.

Primary Outcome Measures: Number of Participants With Detection of Intracranial hemorrhage (ICH) by the InfraScanner 2500™ Stratified by CT Positive and CT Negative Status, Precision of the InfraScanner 2500™ relative to CT scans in an African, LMIC (lower middle income country) population., Within 30 minutes following CT scan
Secondary Outcome Measures: Number of Participants With Detection of Intracranial hemorrhage (ICH) by the InfraScanner 2500™, Accuracy of the InfraScanner 2500™ in darker-skinned populations within LMICs., Within 30 minutes following CT scan
Increase Residents' Confidence in Emergency Front of Neck Access (eFONA).
NCT Number: NCT06491147
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Unexpected Difficult Airway
Interventions: OTHER: Emergency front of neck access
Sponsor: Kocaeli City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-30
Completion Date: 2024-12-31

Summary:
Emergency front of neck access (eFONA) in a non-ventilated, non-oxygenated (CVCO) patient scenario is a life-saving and important competency for anesthesiologists to learn and even repeat intermittently. The Difficult Airway Society (DAS) guideline does not elaborate on how to conduct eFONA training, while the Canadian guideline states that successful performance of such rarely used skills requires regular practice in a simulation environment that focuses on technique and provides expert feedback. In this guideline, it was also mentioned that during training, procedures can be repeatedly performed in a simulate environment and interrupted for immediate feedback. In line with these recommendations, the investigators will create an easy, inexpensive, feasible and repeatable simulation-based learning environment in the operating room of the hospital. In this model study, it is aimed to teach the cricothyrotomy technique to anesthesiologists who have no experience in eFONA with an easy set up and to increase the confidence of the participants in this subject.

Primary Outcome Measures: Emergency front of neck access training practice on a model, In this model study, it was aimed to teach the cricothyrotomy technique to anesthesiologists who had no experience in Emergency front of neck access (eFONA) and to increase the confidence of the participants in this subject. The participants who participated in the research will be asked the question "If you need to create an emergency FONA procedure, how long would you open it?", the answers will be recorded and compared with the values after the research. Thus, it is aimed to increase the self-confidence of residents in eFONA., 6 months
Liposomal Irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
NCT Number: NCT06491134
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Esophageal Squamous Cell Carcinoma
Interventions: DRUG: Liposomal Irinotecan Hydrochloride
Sponsor: Hebei Medical University Fourth Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2028-02-28

Summary:
Observation of maximum tolerable dose (MTD), dose limiting toxicity (DLT), and phase II clinical recommended dose (RP2D) of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal squamous cell carcinoma. Evaluate the efficacy and safety of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma.

Primary Outcome Measures: maximum tolerable dose (MTD), The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing dose-limiting, through study completion, an average of 1 year
Secondary Outcome Measures: Objective response rate (ORR), The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, Within 28 days of the end of treatment|Progress-free survival(PFS), Progression-free survival will be measured from the start of treatment until the first documentation of confirmed disease progression or death due to any cause, whichever occurs first., 2-years
Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
NCT Number: NCT06491108
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Enlarged Prostate With Lower Urinary Tract Symptoms
Interventions: DRUG: Vardenafil 5 Mg Oral Tablet
Sponsor: Tanta University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-07-01
Locations: Faculity of medicine - Tanta university, Tanta, Gharbia, 31528, Egypt

Summary:
The main objective of this prospective randomized controlled study is to compare safety and efficacy of Vardenafil versus Tadalafil versus Tamsulosin in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS.

Primary Outcome Measures: International prostate symptom score (IPSS total score), Change in pre and post treatment condition (IPSS : international prostate symptom score - decresing in the score equals improving the symptoms ), 3 months|The maximum urinary flow rate (Q-max), Change in pre and post treatment condition (increasing at Q-max equals improving the symptoms ), 3 months
Secondary Outcome Measures: Sexual Health Inventory for Men (SHIM), Change in pre and post treatment condition (SHIM: Sexual Health Inventory for Men - increasing in the score equals improving the symptoms ), 3 months
Effect of Flax in Yogurt on Blood Cyanide Levels
NCT Number: NCT06491095
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: 0 g Flax|DIETARY_SUPPLEMENT: 40 g whole ground flaxseed|DIETARY_SUPPLEMENT: 40 g roasted then ground whole flaxseed|DIETARY_SUPPLEMENT: 40 g of whole intact flaxseeds|DIETARY_SUPPLEMENT: 28 g flax hulls
Sponsor: St. Boniface Hospital
Collaborators: Agriculture and Agri-Food Canada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-16
Completion Date: 2026-03-28
Locations: I. H. Asper Clinical Research Institute, Winnipeg, Manitoba, R2H 2A6, Canada

Summary:
A randomized, controlled, cross-over post-prandial trial in healthy human volunteers will be conducted at the IH Asper Institute to determine the effect whole ground flaxseed, roasted then ground whole flaxseed, whole intact flaxseed and flaxseed hulls mixed into yogurt on blood cyanide levels.

Primary Outcome Measures: Peak blood level of cyanide, highest concentration of cyanide during 180 min postprandial period, 180 minutes|iAUC blood cyanide, incremental area under the curve for cyanide from 0-180 min, 180 min
Secondary Outcome Measures: Cyanogenic glycoside and thiocyanate concentrations in plasma and urine, 180 minutes
Other Outcome Measures: Concentration of metabolites in blood and urine, Identification and concentration of metabolites in plasma and urine determined by LC-QTOF-MS, 180 minutes
Risk Factors of Depression, Anxiety and Eating Disorder After Bariatric Surgery
NCT Number: NCT06491069
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Depression|Anxiety|Eating Disorders|Bariatric Surgery
Sponsor: Sohag University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-07-15

Summary:
the goal of this observational study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery.

participants will undergo psychometric tests.

Primary Outcome Measures: risk factors of depression , anxiety and rating disorder after bariatric surgery, identification of risk factors that lead to occurrence of depression and anxiety and eating disorders in patients who had bariatric surgeris, baseline
Post-Operative Thoracolumosacral Orthosis for PJK
NCT Number: NCT06491030
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Proximal Junctional Kyphosis|Adult Spinal Deformity Surgery|Thoracolumbosacral Orthosis
Interventions: DEVICE: Align PJK™ TLSO brace|OTHER: Standard of Care
Sponsor: Hospital for Special Surgery, New York
Collaborators: Aspen Medical Products
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2026-12
Locations: Indiana Spine Group, Carmel, Indiana, 46032, United States|University of Kansas, Overland Park, Kansas, 66211, United States|Hospital for Special Surgery, New York, New York, 10021, United States|University of Texas Health, Houston, Bellaire, Texas, 77401, United States|Texas Back Institute, Dallas, Texas, 75243, United States|Virgina Mason Franciscan Health, Seattle, Washington, 98101, United States

Summary:
Proximal junctional kyphosis (PJK) is a common post-operative radiographic finding after surgery for adult spinal deformity (ASD) patients. Although the clinical relevance of isolated PJK is unclear, PJK can progress to symptomatic proximal junctional failures which requires a large revision surgery. Currently, post-operative bracing with a thoracolumbosacral orthosis (TLSO) is common practice after spinal deformity surgery, however the efficacy of this in preventing PJK is unknown. This multi-center randomized control trial identified 84 patients undergoing thoracolumbosacral fusion for ASD and plans to study the efficacy of a novel post-operative TLSO in preventing the development of PJK as defined by the proximal junctional angle on 6-month post-operative X-rays.

Primary Outcome Measures: The incidence of proximal junctional kyphosis development, As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values., This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.
Secondary Outcome Measures: Change in patient reported outcome measures, VAS leg pain, and VAS back pain (scale of 0-10). 0= no pain; 10=worst possible pain, 6 week and 6-month time points|Change in patient reported outcome measures, Oswestry Disability Index (0-20% minimal disability; 21-40% moderate disability; 41-60% severe disability; 61-80 cripple, pain impinges on all aspects of life; 81-100% patients are bed bound), 6 week and 6-month time points
Evaluation of DiaSorin LIAISON® PTX3 (Long Pentraxin 3) Assay in Patients With Pneumonia
NCT Number: NCT06491004
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pneumonia
Interventions: DIAGNOSTIC_TEST: PTX3 assay
Sponsor: Diasorin Italia S.p.A.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 281
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-09-20
Completion Date: 2024-03-29
Locations: Istituto Clinico Humanitas, Rozzano, Milan, 20089, Italy|Cliniche Humanitas Gavazzeni, Bergamo, 24125, Italy

Summary:
LIAISON® PTX3 is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of Long Pentraxin 3 (PTX3) in human plasma samples.

LIAISON® PTX3, in conjunction with clinical evaluation and other laboratory findings, may serve as an aid in the determination of disease severity and prognosis of patients with community-acquired (CAP) and hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).

Primary Outcome Measures: Pneumonia severity measured by pneumonia specific index (PSI), CURB-65, and Sequential Organ Failure Assessment (SOFA) as a mortality prediction score, Evaluate Long Pentraxin 3 (PTX3) correlation with pneumonia severity and clinical outcome: pneumonia severity is assessed by clinical scores, specifically pneumonia severity index (PSI), CURB-65, Sequential Organ Failure Assessment (SOFA) and Horowitz Index as a mortality prediction score; clinical outcome means hospitalization, intensive care unit (ICU) admission, mortality (at 28 days), discharge.

PSI (pneumonia severity) score: I or II MILD; III MODERATE; IV or V SEVERE. CURB-65 score: 0-1 MILD; 2 MODERATE; 3-4-5 SEVERE SOFA score: 0 to 3 MILD; 4 to 9 MODERATE; 10 to 14 or more SEVERE

Clinical severity:

presence of unilateral pneumonia with less than 50% parenchymal involvement; basal bilateral pneumonia LOW unilateral pneumonia with more than 50% parenchymal involvement; bilateral with involvement of a large area of parenchyma HIGH

Horowitz Index (P/F ratio), mmHg:

\>300 no distress respiratory syndrome; \>200 to 300 MILD; \>100 to 200 MODERATE; \<=100 SEVERE, Day 0 (baseline), day 3, day 7, at discarge, an average of 1 month (if applicable)|PTX3 cutoffs, Identify PTX3 cutoffs (LIAISON® PTX3 assay) to distinguish pneumonia severity: pneumonia severity is assessed by clinical scores (PSI, CURB-65, SOFA and Horowitz Indexas a mortality prediction score).

Details in Primary Outcome Measure 1, Day 0 (baseline), day 3, day 7, at discarge, an average of 1 month (if applicable)
Comparison of HRS-5965 Capsules and Tablets in Healthy Subjects
NCT Number: NCT06490991
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Paroxysmal Nocturnal Hemoglobinuria，IgA Nephropathy
Interventions: DRUG: HRS-5965 tablets；HRS-5965 capsules
Sponsor: Chengdu Suncadia Medicine Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-17
Completion Date: 2024-12
Locations: ZhongShan Hospital FuDan University, ShangHai, Shanghai, 200032, China

Summary:
The study is designed as a single-center, randomized, open-label, cross-over phase I clinical trial with the intention of recruiting 16 healthy subjects.

Primary Outcome Measures: The relative bioavailability (Fr) values between HRS-5965 capsules and HRS-5965 tablets taken on an empty stomach, 0-144hours|Relative bioavailability (Fr) values of HRS-5965 capsules taken on an empty stomach, 0-144hours
Predictors of Early Hematoma Expansion in Patients With Acute Intracerebral Hemorrhage (Clinical and Laboratory Study)
NCT Number: NCT06490978
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: ICH - Intracerebral Hemorrhage
Interventions: RADIATION: CT Brain
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-12-01

Summary:
This study aim to develop inflammatory score based on proper integration of several inflammatory markers and investigate whether it was associated with hematoma expansion and poor outcomes in patients with ICH .

Primary Outcome Measures: primary (main): appropriate predictor of hematoma expansion and poor outcomes with good accuracies., The current study suggests inflammatory score consisting of appropriate integration of NLR, PLR, MLR, SII, LDH, and CRP is independently associated with hematoma expansion and poor outcomes of different terms in ICH patients, including secondary neurological deterioration within 48 hours, 30-day mortality, and 3-month poor mRS. Moreover, inflammatory score greater than or equal to 5 is validated as an appropriate predictor of hematoma expansion and poor outcomes with good accuracies, Baseline
Secondary Outcome Measures: Secondary outcome, Secondary (subsidiary) :

1. inflammatory score based on proper integration of several inflammatory markers
2. investigate whether it was associated with hematoma expansion in patients with ICH Helping . in better outcome and good prognosis
3. prediction of secondary neurological deterioration within 48 hours, 30-day mortality, and 3- month poor mRS

Secondary (subsidiary) :

1. inflammatory score based on proper integration of several inflammatory markers
2. investigate whether it was associated with hematoma expansion in patients with ICH Helping . in better outcome and good prognosis
3. prediction of secondary neurological deterioration within 48 hours, 30-day mortality, and 3- month poor mRS, One year
Study of Health Behavior in Patients After Heart Valve Replacement： Longitudinal Studies
NCT Number: NCT06490952
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Valve Diseases|Health Behavior|Postoperative Period
Sponsor: Fujian Medical University Union Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 219
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-12-01
Locations: Fujian Medical University Union Hospital, Fuzhou, Fujian, 350000, China

Summary:
To investigates the influencing factors and the pathways of health behavior in patients after heart valve replacement.

Primary Outcome Measures: Health behavior, A set of behavioral activities undertaken by an individual to promote or maintain health., At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Secondary Outcome Measures: Social support, Support received by an individual from within a social relationship., At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.|Anxiety and depression, Measuring the psychological situation., At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.|Self-efficacy, Measure the level of self-confidence., At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.|Medication Literacy, Measuring medication-taking skills., At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Clinical Trial of Efepoetin Alfa in Healthy Subjects
NCT Number: NCT06490939
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Efepoetin Alfa
Sponsor: Genexine, Inc.
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-08-31
Locations: Hanyang University Medical Center, Seoul, 04763, Korea, Republic of

Summary:
An open-label, parallel-group, single-center, Phase I study to compare the pharmacokinetic/pharmacodynamic characteristics, safety, and tolerability of a single intravenous administration of Efepoetin Alfa in healthy subjects

Primary Outcome Measures: PharmacoKinetic parameters (Cmax), To measure the concentration of Efepoetin alfa in serum for 336 hours after administration of the investigational product for the pharmacokinetic parameters peak blood concentration, up to 4 weeks|PharmacoKinetic parameters (AUClast), To measure the concentration of Efepoetin alfa in serum for 336 hours after administration of the investigational product for the pharmacokinetic parameters area under the blood concentration-time curve, up to 4 weeks
Secondary Outcome Measures: PharmacoKinetic parameters (AUC0-t, AUCinf, AUC%Extrap, CL, tmax, Vd, t1/2), Pharmacokinetic parameters of Efepoetin alfa blood concentration after a single intravenous administration of the investigational product, up to 4 weeks|Pharmacodynamic parameters (Emax, ΔEmax, AUEC, ΔAUEC), Pharmacodynamic parameters of hemoglobin, reticulocyte and reticulocyte hemoglobin content after administration of the investigational product, up to 4 weeks
Other Outcome Measures: Exploratory, Assessment or iron storage function, up to 4 weeks|Incidence, nature and severity of adverse events, Graded according to NCI CTCAE v5.0, up to 4 weeks|Immunogenicity, Incidence of anti-drug antibodies (ADAs) relative to baseline, up to 4 weeks
NMR Based Metabolomic Study of Serum Biomarkers in Patients With Parkinson's Disease and Atypical Parkinsonian Syndrome
NCT Number: NCT06490926
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Progressive Supranuclear Palsy|Multiple System Atrophy|Parkinson's Disease
Sponsor: Fujian Medical University Union Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-01
Completion Date: 2026-02-01
Locations: Fujian Medical University Union Hospital, Fuzhou, Fujian, 350000, China

Summary:
At present, the diagnosis of Parkinsons disease(PD) mainly relies on clinical symptoms and is easily confused with atypical Parkinsonian syndrome(APS) in the early stages. There is an urgent need for reliable biomarkers. This project aims to use metabolomics technology based on proton nuclear magnetic resonance spectroscopy to study the metabolomic characteristics of patients with PD and APS, and preliminarily screen for possible diagnostic biomarkers of PD and APS.

Primary Outcome Measures: metabolite, baseline
Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes
NCT Number: NCT06490913
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Liver Metastases of Colorectal Cancer
Interventions: DRUG: Capecitabine|DRUG: oxaliplatin|DRUG: Cetuximab|DRUG: Oxaliplatin|DRUG: Leucovorin|DRUG: 5-FU
Sponsor: Fujian Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2025-12-31

Summary:
The purpose of this Phase II single-arm study is to prospectively explore the efficacy of chemotherapy plus EGFR inhibitors in patients with liver metastases from total wild-type colorectal cancer with ctDNA superselective negative genes.

Primary Outcome Measures: Objective Response Rate, every 2 weeks
Secondary Outcome Measures: overall survival, Around 2 years