pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women Compared to Men
NCT Number: NCT06498531
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Sleep-Disordered Breathing
Interventions: DRUG: Acetazolamide|DRUG: Placebo
Sponsor: University of Zurich
Collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov|University Hospital Heidelberg|Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Sex: ALL
Age: ADULT
Enrollment: 270
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2025-12-31
Locations: National Center for Cardiology and Internal Medicine, Bishkek, 720040, Kyrgyzstan

Summary:
Randomized clinical trial evaluating the effect of acetazolamide on sleep disordered breathing in women compared to men travelling to 3600 m.

Primary Outcome Measures: Nocturnal oxygen desaturation index (ODI), Sex-related difference in the altitude-induced change in the ODI (number of ∆SpO2 \>3% per hour time in bed measured by pulse oximetry) between acetazolamide and placebo group., Night 1 at 760 m and Night 1 at 3600 m
Secondary Outcome Measures: Nocturnal oxygen saturation (SpO2), Sex-related difference in the altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group., Night 1 at 760 m and Night 1 at 3600 m|Nocturnal oxygen saturation (SpO2), Sex-related difference in the altitude-induced change in the mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group., Night 1 at 760 m and Night 2 at 3600 m|Apnea/hypopnea index (AHI), Sex-related difference in the altitude-induced change in the mean number of apneas/hypopneas per hour between the acetazolamide and placebo group., Night 1 at 760 m and Night 1 at 3600 m|Apnea/hypopnea index (AHI), Sex-related difference in the altitude-induced change in the mean number of apneas/hypopneas per hour between the acetazolamide and placebo group., Night 1 at 760 m and Night 2 at 3600 m|Subjective sleep quality, Sex-related difference in the altitude-induced change in subjective sleep quality assessed by a 100-mm visual analog scale between the acetazolamide and placebo group., Night 1 at 760 m and Night 1 at 3600 m|Subjective sleep quality, Sex-related difference in the altitude-induced change in subjective sleep quality assessed by a 100-mm visual analog scale between the acetazolamide and placebo group., Night 1 at 760 m and Night 2 at 3600 m|Nocturnal oxygen desaturation index (ODI), Sex-related difference in the altitude-induced change in the ODI (number of ∆SpO2 \>3% per hour time in bed measured by pulse oximetry) between acetazolamide and placebo group., Night 1 at 760 m and Night 2 at 3600 m
A Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer
NCT Number: NCT06498518
Acronym: PRIMUS006
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neoplasms Pancreatic
Interventions: DRUG: IMM-101, Pembrolizumab, Gemcitabine
Sponsor: Karen Carty
Collaborators: NHS Greater Glasgow and Clyde|University of Glasgow
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-17
Completion Date: 2027-12
Locations: University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom|University Hospitals Coventry & Warwickshire, Coventry, CV2 2DX, United Kingdom|Beatson West of Scotland Cancer Centre, Glasgow, G12 0YN, United Kingdom|Royal Free London Hospital, London, United Kingdom|Royal Marsden Hospital, London, United Kingdom|The Christie Hospital, Manchester, United Kingdom

Summary:
Trial to investigate if the addition of two novel immunotherapy agents in combination with a chemotherapy agent can reduce the size of the cancer and how long they can delay the growth of the cancer in patients with metastatic pancreatic cancer.

Primary Outcome Measures: Objective Response Rate, The proportion of patients achieving an objective response, defined by RECIST 1.1, measured using CT scans for radiological assessment of disease until disease progression, Measured every 6 weeks by CT scan(most patients will receive 3-4 CT scans over 24 weeks)
Secondary Outcome Measures: Progression Free Survival, Progression Free survival as measured from date of registration to progression or death (from any cause), At time of progression (estimated to be between 3 and 6 months)|Safety and Tolerability of Gemcitabine in combination with IMM-101 and Pembrolizumab, Occurrence and Frequency of grade 1-5 adverse events measured using NCI CTCAE Version 5, Measured during combination treatment and for up to at least 30 days after the last dose of study therapies. In addition, immune mediated adverse events that occur up to 90 days after the last dose of pembrolizumab|Overall Survival, Survival will be measured from the date of registration and include all causes of death, From date of registration until date of death from any cause ( estimated to be between 6-12 months)
HighCycle: Effect of Acetazolamide on Pulmonary Artery Pressure in Women Compared to Men
NCT Number: NCT06498505
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: High Altitude
Interventions: DRUG: Acetazolamide|DRUG: Placebo
Sponsor: University of Zurich
Collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov|University Hospital Heidelberg|Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Sex: ALL
Age: ADULT
Enrollment: 270
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2025-12-31
Locations: National Center for Cardiology and Internal Medicine, Bishkek, 720040, Kyrgyzstan

Summary:
Randomized clinical trial evaluating the effect of acetazolamide on pulmonary artery pressure in women compared to men travelling to 3600 m.

Primary Outcome Measures: Pulmonary artery Pressure (PAP), Sex-related difference in the altitude-induced change in RV/RA in mmHg assessed by echocardiography between acetazolamide and placebo group., Day 2 at 760 m and Day 2 at 3600 m
Secondary Outcome Measures: Lung comets, Sex-related difference in the altitude-induced change in ultrasound lung comets assessed by echocardiography between acetazolamide and placebo group., Day 2 at 760 m and Day 2 at 3600 m|Parameters of right heart function, Sex-related difference in the altitude-induced change in parameters of right heart function assessed by echocardiography between acetazolamide and placebo group., Day 2 at 760 m and Day 2 at 3600 m
Early Versus Delayed Laparoscopic Cholecystectomy For Acute Mild Biliary Pancreatitis: A Prospective Comparative Study
NCT Number: NCT06498492
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Biliary Acute Pancreatitis
Interventions: PROCEDURE: Laparoscopic Cholecystectomy
Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-09-01
Completion Date: 2021-08-15
Locations: Ishwor Thapaliya, Kathmandu, 44600, Nepal

Summary:
The goal of this observational study is to evaluate the outcomes of early versus delayed cholecystectomy following mild biliary pancreatitis in Nepalese patients.

Primary Outcome Measures: Total duration of hospital stay among early cholecystectomy group vs delayed cholecystectomy group, In the early group, the time interval between admission to the day of discharge following laparoscopic cholecystectomy was taken into account. In the delayed group, total duration of hospital stay in conservative management period as well as for laparoscopic cholecystectomy was taken into account., 4 weeks
ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
NCT Number: NCT06498479
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Small Cell Lung Cancer
Interventions: DRUG: HS-20093|DRUG: Topotecan
Sponsor: Hansoh BioMedical R&D Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 460
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2027-05-31

Summary:
The main objective of this study is to compare the efficacy of HS-20093 with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed small cell lung cancer (SCLC).

Primary Outcome Measures: Overall survival, Overall survival is defined as the time interval from randomization to death due to any cause., From the date of randomization to the date of death due to any cause; Up to approximately 4.5 years
Secondary Outcome Measures: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigators, Confirmed ORR is defined as the sum of the complete response (CR) rate and partial response (PR) rate as per BICR and investigator per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1., From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.|Disease Control Rate (DCR) Assessed by Blinded Independent Central Review and Investigator, Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) per BICR and investigator assessment per RECIST v1.1., From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.|Duration of Response Assessed by Blinded Independent Central Review and Investigator, Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death., From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first; Up to approximately 4.5 years.|Progression-free Survival Assessed by Blinded Independent Central Review and Investigator, PFS is defined as the time interval from the randomization to disease progression as per BICR and investigator assessment or death due to any cause., From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.|Incidence and Grade of Participants With Treatment-emergent Adverse Events, TEAEs are assessed based on NCI CTCAE v5.0., From the date of first dose to the end of safety follow-up; Up to approximately 4.5 years.
EFFECT OF MYOFASCIAL RELEASE THERAPY IN PATIENTS WITH CERVICAL MYOFASCIAL PAIN SYNDROME
NCT Number: NCT06498466
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Myofacial Pain Syndromes
Interventions: OTHER: myofascial release
Sponsor: Ufuk University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2022-07-01
Locations: Ufuk University, Ankara, Çankaya, 06520, Turkey

Summary:
Objectives: To investigate the effects of myofascial release therapy (MRT) on pain, number of trigger points (TP), pressure pain threshold (PPT), cervical range of motion (ROM), neck disability, and quality of life in the neck pain due to cervical myofascial pain syndrome (MPS).

In this prospective study, patients in Group I (n=30) underwent a standard physical therapy program. Patients in Group II (n=30) additionally underwent MRT 3 days a week. Before and on the 15th day after treatment, patients' pain was measured by visual analog scale (VAS), TP numbers by palpation, PPTs by pressure algometer, cervical ROM by goniometer, disability by Neck Disability Index (NDI) and quality of life by Nottingham Health Profile (NHP) was evaluated.

Primary Outcome Measures: Visual analog scale (VAS), The patients were asked to mark the severity of their neck pain at rest and with movement on a 10-centimeter (cm) line on the 1st and 15th days (0: minimum 10: maximum). The higher the measured value, the greater the pain intensity., 2 weeks|Trigger Point Numbers, In order to detect the trigger points, the neck and back regions of the patients were evaluated by palpation by the physician., 2 weeks|Pressure Pain Threshold, Pressure pain threshold (PPT) was measured with a pressure algometer (Commander\[JTECH medical\]). The disc head of the pressure algometer was placed on the trigger point at a 90° angle. Before the application, the patient was asked to describe the pain when he/she first felt it., 2 weeks.|Cervical Joint Range of Motion (ROM), Cervical ROM measurements were evaluated actively and passively with a goniometer., 2 weeks|Neck Disability Index, Disability was evaluated with the Neck Disability Index. This questionnaire, which evaluates subjective symptoms and daily living activities, consists of a total of 10 sections (pain intensity, personal care, lifting, reading, headache, concentration, work life, driving, sleep, and leisure activities)., 2 weeks|Nottingham Health Profile, Quality of life was assessed with the Nottingham Health Profile. The scale consists of two parts. The first part consists of a total of 38 items, where each item is answered yes or no. This section has a total of 6 sub-dimensions: pain, emotional reactions, sleep, social isolation, physical activity, and energy. The second part consists of 7 items that question whether there are problems in business life, housework, social life, interpersonal relationships, sexual life, hobbies, and holidays, which are the areas of daily life that are most likely to be affected due to the person's health condition, and each item is answered yes or no., 2 weeks
Effectiveness of Telerehabilitation With Trak in Knee and Shoulder Pathology: A Randomized Clinical Trial
NCT Number: NCT06498453
Acronym: TRAK-TEST
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Injury|Knee Injury
Interventions: DEVICE: Trak-Physio knee condition|DEVICE: Trak-Physio in shoulder condition|OTHER: Knee conventional rehabilitation program|OTHER: Shoulder conventional rehabilitation program
Sponsor: Trak Health Solutions S.L.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-03-01
Completion Date: 2023-06-06
Locations: Asunción Klinika, Tolosa, Gipuzkoa, 20400, Spain

Summary:
The main objective of this clinical trial is to compare the effectiveness of digital physiotherapy treatment using the Trak telerehabilitation platform and the application of conventional means on two different health conditions (mild or moderate knee osteoarthritis and shoulder tendinopathy)

Participants will undergo telerehabilitation treatment through the TRAK platform for six weeks (treatment group) or follow the instructions and guidelines collected by health personnel for the same time in face-to-face rehabilitation sessions (control group).

Primary Outcome Measures: Escala DASH, It is used to measure the self-rated upper-extremity disability and symptoms., Baseline and six months|Escala KOOS-PS, It evaluates the patient's opinion about their knee and associated problems., Baseline and six months
Secondary Outcome Measures: Daniels scale, It is used to measure the patients strength on a specific movement and muscle from 0 to 5, being 0 a total paralysis and a 5 the full joint movement with a resistance., Baseline and six months|EVA scale, It is used to measure the level of pain the patient feels., Baseline and six months|Trak designed a satisfaction questionnaire, The trak satisfaction questionnaire was provided to patients in Spanish and consists of 12 questions about usability, usefulness and satisfaction as well as a suggestions section at the end., Baseline and six months|Limb mobility, It will be measured with a goniometer., Baseline and six months
Predicting Breast Cancer With the BRAVE System
NCT Number: NCT06498388
Acronym: BRAVE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Mass|Breast Cancer
Interventions: OTHER: Stiffness measurement by visco-elastography
Sponsor: Université de Sherbrooke
Collaborators: Cancer Research Society
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-12-31
Locations: CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, J1H5N4, Canada

Summary:
Breast cancer predominates among cancer diagnoses in Canadian women. It accounts for around 25% of new cases and contributes to 13% of all cancer-related deaths. In 2020, almost 27,400 Canadian women were diagnosed with breast cancer and 5,000 of them died from it.

Mammography is still the preferred method for screening for breast cancer. Although progress has been made over the years, mammography does have its drawbacks. These include physical discomfort for patients, exposure to X-rays and reduced effectiveness in dense breasts. The study team is therefore interested in developing a new breast cancer detection method, the BRAVE method.

The BRAVE method, short for "BRA-based Visco-Elastography", uses the high contrast of elastic stiffness in malignant breast tumors to detect possible cancer cases without the need for X-rays or breast compression.

The first phase, carried out on a small scale pilot study, aimed to assess the method's ability to distinguish a breast with no abnormalities from one with confirmed cancer. The second phase (current phase), carried out on a larger scale, aims to confirm the sensitivity and specificity of the method in detecting malignant lesions, i.e. to determine whether the method is capable of distinguishing between several types of breast masses.

Primary Outcome Measures: Stiffness of the breasts, Main marker that will be assessed for its capacity to identify malignant lesions. It will be measured by the viscoelastic property values determined by the BRAVE system., Once, at recruitment, up to 6 months after mammography|Risk and malignancies lesions (RnMLs), Defined by mammography, additional imaging and biopsy results and scored as BI-RADS 5 to 6., At the time of mammogram, which will be no more than 6 months prior to recruitment
Secondary Outcome Measures: Breast density, The breast density can be scored as A: low-density, B: few areas of dense tissue, C: evenly dense, D: extremely dense, and is determined by standard of care imaging. Participants will be gathered in either NMBD group (A or B; normal density) or EMBD group (C or D, elevated density)., Once, at mammogram (up to 6 months prior to recruitement)
Fluid Status and Body Composition Analysis by Bioelectrical Impedance in Patients After Cardiac Surgery (FLUBIACS)
NCT Number: NCT06498375
Acronym: FLUBIACS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiopulmonary Disease|Fluid Overload
Interventions: DIAGNOSTIC_TEST: Bioelectrical impedance
Sponsor: University Medical Centre Ljubljana
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2026-07
Locations: Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana, Ljubljana, Slovenia

Summary:
Evaluation of fluid status in cardiac surgery patients using bioelectrical impedance and its impact on postoperative morbidity and mortality

Primary Outcome Measures: Fluid distribution during the early postoperative period (≤ 5 days), Phase angle (in degrees), Perioperative period (preoperatively, on the first, third, and fifth postoperative day)|Fluid distribution during the early postoperative period (≤ 5 days), Impedance ratio, Perioperative period (preoperatively, on the first, third, and fifth postoperative day)|Fluid distribution during the early postoperative period (≤ 5 days), Total body water (TBW), extracellular water (ECW), intracellular water (ICW) (in litres), Perioperative period (preoperatively, on the first, third, and fifth postoperative day)|Fluid distribution during the early postoperative period (≤ 5 days), Oedema index (ECW/TBW ratio), Perioperative period (preoperatively, on the first, third, and fifth postoperative day)|Fluid distribution during the early postoperative period (≤ 5 days), Body cell mass (in kilograms), Perioperative period (preoperatively, on the first, third, and fifth postoperative day)|Fluid distribution during the early postoperative period (≤ 5 days), Skeletal muscle mass (in kilograms), Perioperative period (preoperatively, on the first, third, and fifth postoperative day)|Fluid distribution during the early postoperative period (≤ 5 days), Bioelectrical impedance vector analysis, Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Secondary Outcome Measures: Impact of fluid distribution/fluid overload on duration of postoperative mechanical ventilation, Duration of stay in ICU (estimated to up to 5 days)|Impact of fluid distribution/fluid overload on postoperative complications (myocardial infarction, cardiogenic shock, vasoplegia, atrial fibrillation, heart failure, bleeding, infections, delirium), Up to 1 year after the operation|Impact of fluid distribution/fluid overload on length of stay in the intensive care unit, Duration of stay in ICU (estimated to up to 5 days)|Impact of fluid distribution/fluid overload on length of hospitalisation, Duration of hospital stay (up to 1 month)|Impact of fluid distribution/fluid overload on 30-day postoperative mortality, On day 30|Impact of fluid distribution/fluid overload on 1-year postoperative mortality, At 1 year postoperatively
The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children
NCT Number: NCT06498362
Acronym: LEVET
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Epilepsy in Children
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: CHILD
Enrollment: 151
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-16
Completion Date: 2025-05-16
Locations: Service pédiatrie 1 - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
Status epilepticus is the leading neurological emergency in children, with mortality 2-7% and significant morbidity (10-20%). It is defined as the occurrence of a crisis lasting more than 5 minutes and requiring the implementation of treatment to stop it and thus limit the immediate and long-term consequences.

The research hypothesis is that LEVETIRACETAM is non-inferior to PHENYTOIN in terms of cessation and absence of recurrence of status epilepticus, with better clinical tolerance in children from 3 months to 17 years old, with or without epileptic disease, with or without a history of status epilepticus

Primary Outcome Measures: Highlight non-inferiority of LEVETIRACETAM compared to PHENYTOIN, The non-inferiority of LEVETIRCETAM in comparison with PHENYTOIN is based on a composite primary endpoint consisting of the total duration of the seizure, the need for another antiepileptic treatment to resolve the seizure or recurrence within 24 hours. following the start of treatment for a new status epilepticus and the total duration of hospitalization.

The need for another antiepileptic drug or recurrence is a binary variable with presence (= yes = 1) or absence (= no = 0).

The total duration of the crisis is expressed in minutes, and corresponds to the interval between the identification of the event and the objectification of its cessation.

The total duration of hospitalization is expressed in days, and corresponds to the duration between the first day of hospitalization (regardless of the location) and the day of discharge (regardless of the department)., Up to 2 years
miRNA in Septic Acute Kidney Injury
NCT Number: NCT06498336
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sepsis|Acute Kidney Injury|Acute Kidney Injury Due to Sepsis
Interventions: DIAGNOSTIC_TEST: Laboratory examination to determine the presence of sepsis|DIAGNOSTIC_TEST: Laboratory examination to determine the presence of sepsis and acute kidney injury|DIAGNOSTIC_TEST: Laboratory examination to determine miRNA and biochemical parameters
Sponsor: University Hospital Ostrava
Collaborators: University Hospital Olomouc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-02
Completion Date: 2027-12-31
Locations: University Hospital Ostrava, Ostrava, Moravian-Silesian Region, 708 52, Czechia|University Hospital Olomouc, Olomouc, Olomouc Region, 779 00, Czechia

Summary:
Acute kidney injury is a common and serious complication of sepsis and septic shock, which may be associated with a worse outcome of the patient's condition. The exact pathophysiological mechanism of septic acute kidney injury remains a challenge. One of the possible causes appears to be endothelial dysfunction and mitochondrial damage of renal tubular cells. The aim of this study is to identify specific microRNAs associated with these pathophysiological events in sepsis and septic acute kidney injury. And to establish a new potential diagnostic or therapeutic target for the prevention or treatment of septic acute kidney injury.

Primary Outcome Measures: Determination of serum expression of pentraxin 3 (PTX3) and uromodulin, To determine the concentration of serum PTX3 and serum uromodulin in critically ill septic patients and their comparison to serum concentrations of creatinine and the acute kidney injury (AKI) stage as well as to the concentrations of procalcitonin (PCT) and interleukin-6 (IL-6) as inflammation markers on day 1 and 4 of study. The serum concentrations of PTX3 and uromodulin in ng/mL will be determined also in healthy volunteers to establish the laboratory reference ranges (values)., 4 days|Determination of expression and 4 days course investigation of miRNAs, To determine the expression and 4-day time course investigation of 7 specific circulating miRNAs associated with sepsis and septic acute kidney injury from 352 miRNA targets using a two-tailed Quantitative reverse transcription polymerase chain reaction (RT-qPCR). All selected miRNAs will be determined also in healthy volunteers to establish the laboratory reference ranges (values)., 4 days|Target genes of miRNAs and their association with endothelial dysfunction and mitochondrial injury in sepsis, To match the target genes (from miRNA database) of these specifically expressed miRNAs with biochemical pathways associated with serum PTX3 and uromodulin involved in endothelial dysfunction of renal microvasculature, the influence of mitochondrial injury/dysfunction with reactive oxygen species production and activation of cell apoptosis in septic acute kidney injury., 4 days
Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT
NCT Number: NCT06498323
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Intravenous|Thrombosis|Acute Ischemic Stroke
Interventions: DRUG: tenecteplase
Sponsor: Mahidol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-08-03
Completion Date: 2025-08-31
Locations: Siriraj Stroke Center,Siriraj Hospital, Bangkok, 10700, Thailand

Summary:
Acute ischemic stroke is one of the devastating diseases that increase hospitalization, disabilities, and deaths worldwide. Current treatment with intravenous thrombolytic agent can help reduce disabilities and improve quality of life. Intravenous Alteplase is proven benefit and now used as the first-line drug for acute ischemic stroke with symptom onset less than 4.5 hours and without contraindications.

Tenecteplase, a genetically engineered tissue-type plasminogen activator, has been questioned to treat acute ischemic stroke instead of intravenous alteplase. Tenecteplase has more advantages over alteplase including higher fibrin specificity, longer half-life and easier to administer as a single intravenous bolus. The efficacy and safety of intravenous tenecteplase has been studied recently. In 2017, A phase 3 randomized open-label, blinded trial (NOR-TEST) 6 showed that there were no significant differences in efficacy and safety between tenecteplase and alteplase in mild stroke patients. A study in 2020, in the setting of acute large artery occlusion, Tenecteplase resulted in a better 90-day neurological outcome and provided more benefits in reperfusion before endovascular thrombectomy10. Regarding safety concerns, tenecteplase showed no significant higher incidence of intracerebral hemorrhage. Administration, tenecteplase might be better in the setting of the case on mobile stroke units. Assuming, earlier reperfusion by thrombolytic drug may have improved patient's neurologic outcomes. We aim to compare the efficacy and safety between intravenous tenecteplase and alteplase in acute ischemic stroke patients given on mobile stroke units within 4.5 hours after symptom onset.

Primary Outcome Measures: mRS Score, mRS Score, at 3 months
Secondary Outcome Measures: NIHSS Score at 24 hrs, NIHSS Score at 24 hrs after intravenous tenecteplase, at 24 hours
Retrospective Study of Invasive Fungal Infections With Filamentous Fungi in Heart Transplant Patients
NCT Number: NCT06498310
Acronym: IMI-CART
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Invasive Fungal Infections
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-08
Completion Date: 2025-11-08
Locations: Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are common and serious in immunocompromised subjects and particularly organ transplant patients. There is little recent data in heart transplantation, particularly on the incidence and risk factors of fungal infections. . It is therefore important to have recent data on incidence, risk and prognostic factors in order to improve the management of this severe complication.

Primary Outcome Measures: To identify the incidence, risk factors and prognostic factors associated with invasive fungal infections caused by filamentous fungi in heart transplant patients., 1. Incidence: number of cases of invasive fungal infection compared to the number of heart transplant patients per year in the study centers
2. Risk factors: Case-control study. Clinical, microbiological or radiological factors statistically associated with cases of invasive fungal infection compared to controls.
3. Prognostic factors: Clinical, microbiological or radiological factors of invasive fungal infections associated with mortality at the 12th week., Up to 2 years
Analysis of the Impact of a Temporo-spatial Reorientation Tool on the Speed of Improvement of Confusional Syndrome
NCT Number: NCT06498297
Acronym: Rob'Gazette
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Attention Disorder
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-24
Completion Date: 2025-04-24
Locations: Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
Confusion syndrome is defined by attentional disorders and disorganization of cognitive functions that are acute and reversible. There are patient-specific predisposing factors and precipitating factors. Elderly people, due to their comorbidities, are more at risk. Confusion syndrome affects approximately 23% of elderly patients in the medical department, 33% in the rehabilitation department and its occurrence is preventable in 30 to 40% of cases. The health expenditure generated by its occurrence was estimated at 182 billion dollars per year by combining the expenditure of 18 European countries in 2011. The occurrence of a delirium increases the duration of hospitalization, increases the risk of falls, loss of autonomy, can lead to an impairment of quality of life at 6 months and is linked to excess mortality.

The gold standard for making the diagnosis of delirium is the use of the DSM-5 criteria, but their use is time-consuming and requires that staff be trained in their use. The 4 "A" test (tool to help identify confusional syndrome) can be used to monitor confusional syndromes; it has the advantage of being able to be taken in less than 3 minutes.

Concerning the management of a confusional syndrome, a non-pharmacological multi-component approach is recommended as first line for its prevention but there is no treatment to date. A tool to help with temporo-spatial reorientation (La Rob'Gazette) has been set up in the Medical Care and Geriatric Rehabilitation (SMRG) departments of the HUS

Primary Outcome Measures: Speed of improvement of the 4AT of the entire population, The analysis will be undertaken on patients for whom at least two 4AT measurements are available (in order to be able to calculate a change). It will be based on a mixed linear model including the variable to be tested, time and their interaction. Variables deemed clinically relevant or statistically significant at the threshold of p \< 0.10 will be included in a multivariate model. Then the non-significant and irrelevant variables will be removed from the model. The significance threshold will be 0.05 for this final model., Up to 2 years
Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus
NCT Number: NCT06498284
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes Mellitus, Type II
Interventions: DRUG: HM-002-1005
Sponsor: Hua Medicine Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-25
Completion Date: 2024-07-23
Locations: Clinical Pharmacology of Miami, Hialeah, Florida, 33014, United States

Summary:
The purposes of this study are to:

* Evaluate the safety and tolerability of the study drug.
* Measure how much of the study drug (HM-002-1005) and its breakdown product get into the bloodstream, and how long it takes the body to get rid of them.
* Measure the amount of glucose (blood sugar) and a substance called C-peptide in the bloodstream after receiving the study drug.

Researchers will compare the study drug to a placebo (a look-alike substance that contains no drug).

Participants will:

* Stay 5 days and 4 nights or 6 days and 5 nights at the research site, and have a follow-up phone call 7 days after leaving the research site.
* Take one (1) dose of the study drug or placebo
* Have blood taken to measure the amount of study drug and its breakdown product and the levels of glucose and C-peptide
* Have safety tests such as vital sign, ECGs, and glucose measurements

Primary Outcome Measures: Incidence of adverse events, incidence and severity of adverse events from Day1 to Day 11, 11 Days|Area under the plasma concentration versus time curve (AUC), area under the concentration-time curve from time 0 to 72 hours postdose of HM-002-1005 in plasma, 72 hour|maximum observed concentration (Cmax), Cmax of HM-002-1005 in plasma, 72 hours|time of the maximum observed concentration (Tmax), Tmax of HM-002-1005 in plasma, 72 hours|apparent terminal elimination half life (t1/2), t1/2 of HM-002-1005 in plasma, 72 hours
Secondary Outcome Measures: glucose concentration following single oral dose of HM-002-1005, serum glucose concentration over 24 hours after dosing, 24 hours
Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain
NCT Number: NCT06498271
Acronym: BACK-4P
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Low Back Pain
Interventions: DEVICE: Personalized and automated digital coaching using a mobile application
Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: Arthritis Foundation|Societe Francaise de Rhumatologie|Association Malakoff Médéric Innovation Santé
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 330
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-03
Locations: Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - hôpital Cochin, Paris, 75014, France

Summary:
The investigators hypothesize that a personalized and automated digital coaching could reduce activity limitations in people with chronic low back pain as compared to usual care

Primary Outcome Measures: Mean change in activity limitations, French version of the self-administered Roland Morris Disability Questionnaires (RMDQ). Higher scores indicate worse function, 4 months
Secondary Outcome Measures: Mean change in activity limitations at 12 months after consent, French version of the self-administered Roland Morris Disability Questionnaires (RMDQ). Higher scores indicate worse function, 12 months|Mean change in the intensity of low back pain at 4 months after consent, Self-administered numerical scale with 11 classes incremented by 10 points (0, no pain and 100, maximum pain), 4 months|Mean change in the intensity of low back pain at 12 months after consent, Self-administered numerical scale with 11 classes incremented by 10 points (0, no pain and 100, maximum pain), 12 months|Work absenteeism at 4 months after consent, Number of self-reported days off work, 4 months|Work absenteeism at 12 months after consent, Number of self-reported days off work, 12 months
Early Abdominal Wall Prosthesis Infections: Epidemiology, Risk Factors and Factors Linked to Recovery
NCT Number: NCT06498245
Acronym: AWPI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Abdominal Wall Prosthesis Infections
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-16
Completion Date: 2024-12-31
Locations: Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
Abdominal wall prosthesis infections are among the complications most feared by digestive surgeons. Indeed, this complication is associated with high morbidity and is difficult to manage (antibiotic therapy? surgical revision?). Much data is missing in the literature because there are many types of prosthesis, implemented in patients with very varied conditions and the treatment is not strictly speaking codified.

The investigators wish to carry out a retrospective study on approximately 500 patients and research the main characteristics of the different infections (which microorganism? which site? what time of appearance), the factors linked to the appearance of these infections and above all how to optimize their management. charge.

Primary Outcome Measures: Recovery of wall prosthesis infection after 3 months from the start of the infection, 3 months from the start of the infection of the prothesis
Optimization of the Skin Test Procedure With Iodinated Contrast Products for Certain Patients Suspected of Immediate Hypersensitivity
NCT Number: NCT06498219
Acronym: OPT-TC-PCI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Contrast Sensitivity
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-21
Completion Date: 2024-12-31
Locations: Service de Pneumologie - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
Hypersensitivity to iodinated contrast products (ICP) affects 1 to 3% of injected patients. These reactions require an allergological assessment with skin tests in order to distinguish allergic immunological mechanisms from other non-specific mechanisms. Current recommendations recommend carrying out prick tests followed by intradermal reactions up to a 10th dilution. However, undiluted IDRs are carried out by several teams under certain conditions, without this having been validated. Experience tends to show that these IDRs are relevant in certain patients to make the diagnosis without risk.

Primary Outcome Measures: Retrospective study of the relevance of performing pure intradermal reactions to iodinated contrast products (ICP) after obtaining a pure negative prick test., This retrospective study concerns patients treated at the Strasbourg University Hospital in the period from June 1, 2020 to July 3, 2023 for suspected allergic hypersensitivity to (ICP) and having had at least one undiluted intradermal reaction to one or more (ICP) ., Files analyzed retrospectively cover the period from June 1, 2020 to July 3, 2023.
AR Training Versus Patching in Unilateral Amblyopia
NCT Number: NCT06498206
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amblyopia Unilateral
Interventions: OTHER: AR training|OTHER: Patching
Sponsor: Eye & ENT Hospital of Fudan University
Collaborators: First Affiliated Hospital of Fujian Medical University|Shanghai Tongren Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12
Locations: Eye & ENT Hospital of Fudan University, Shanghai, China

Summary:
This is a multi-center, randomized controlled trial to compare the effectiveness of AR training with patching for the treatment of unilateral amblyopia.

Specific Aim 1 (Primary): To compare the improvement of visual acuity in the amblyopic eye between AR training and patching for the treatment of unilateral amblyopia.

Specific Aim 2 (Secondary): To compare the improvement of visual functions between AR training and patching for the treatment of unilateral amblyopia.

Primary Outcome Measures: Change in visual acuity, Best-corrected visual acuity in the amblyopic eye measured with ETDRS chart., 2 weeks, 4 weeks, 9 weeks, 13 weeks
Secondary Outcome Measures: Change in stereopsis, Near and far stereopsis measured with Randot Stereotest pattern., 2 weeks, 4 weeks, 9 weeks, 13 weeks|Change in contrast sensitivity, Contrast sensitivity in each eye measured with contrast sensitivity testing instrument CSV-1000®., 2 weeks, 4 weeks, 9 weeks, 13 weeks|Treatment success rate, The rate of patients with best-corrected visual acuity (measured with ETDRS chart) in the amblyopic eye improved no less than 0.2 logMAR after treatment., 2 weeks, 4 weeks, 9 weeks, 13 weeks
Other Outcome Measures: Normal proportion in the worth-4 dot test, The proportion of patients in each group with normal results in the worth-4 dot test., 2 weeks, 4 weeks, 9 weeks, 13 weeks|Normal proportion in the Bagolini striated glasses test, The proportion of patients in each group with normal results in the Bagolini striated glasses test., 2 weeks, 4 weeks, 9 weeks, 13 weeks
Cancer-related Fatigue Among Patients Receiving Home-based Palliative Care
NCT Number: NCT06498193
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: to Investigate the Level of Fatigue Among Terminal Cancer Patients Receiving Home-based Hospice Care
Sponsor: National Taipei University of Nursing and Health Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-09-30
Locations: National Taipei university of nursing and health science, Taipei, Taiwan

Summary:
Cancer-related fatigue, which significantly impacts the quality of life, is prevalent among patients with terminal cancer. The experiences of fatigue, its associated needs, and the strategies for managing it are closely linked to the individual uniqueness, cultural background, and resource availability of terminal cancer patients.

Primary Outcome Measures: comparing CRF scores at baseline with those after one week,, The BFI survey was utilized to promptly assess CRF severity and its impact on daily functioning., 1 week
Periodontal Initial Treatment Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus
NCT Number: NCT06498180
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oral Lichen Planus|Periodontal Diseases
Interventions: OTHER: Periodontal initial treatment under local anesthesia|DRUG: Glucocorticoid Therapy|BEHAVIORAL: oral hygiene instruction
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-31
Completion Date: 2028-03-31
Locations: Shanghai Ninth People's Hospital, Shanghai, Shanghai, 200011, China

Summary:
The purpose of this clinical trial is to understand whether the combination of periodontal initial treatment under local anesthesia and glucocorticoids can improve the effectiveness of treatment for erosive oral lichen planus. It will also understand the safety of this treatment regimen.

This study is a single-center, parallel-group, randomized self-controlled trial. The researchers will compare the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia with traditional glucocorticoid therapy to see if the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia promotes the healing of erosive oral lichen planus.

Participants will:

One side received periodontal initial treatment combined with glucocorticoid under local anesthesia, while the other side received traditional glucocorticoid therapy Clinical examination at 2, 4, 8, and 12 weeks after treatment Note down the size of their erosion lesion area and periodontal clinical parameters

Primary Outcome Measures: The erosion area of oral lichen planus, The erosion area of oral lichen planus, 3 months
Secondary Outcome Measures: visual analogue scale, Mark a horizontal line of 0-10cm on paper with a ruler, and determine the score in millimeters (mm). The score range is 0-100mm, with higher scores indicating greater pain intensity, 2, 4, 8, and 12 weeks|Clinical score of oral lichen planus, 2, 4, 8, and 12 weeks|probing depth, 4, 8, and 12 weeks|clinical attachment loss, 4, 8, and 12 weeks|plaque index, 4, 8, and 12 weeks|Full mouth bleeding scores, 4, 8, and 12 weeks
Other Outcome Measures: complication, Infection, bleeding, liver and kidney damage, difficulty eating due to pain, 2, 4, 8, and 12 weeks