cyrilzakka/clinical-trials huggingface dataset:
Fibrinogen to Albumin Ratio (FAR) as a Predictive Biomarker for Lupus Nephritis (LN)

Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN)

Systemic lupus erythematosus is a chronic autoimmune disease often coexists with other diseases and damages multiple organs such as kidney liver nervous system and so on.

Lupus nephritis is clinically evident in 50-60% of patients with systemic lupus erythematosus and it is histologically evident in most SLE patients even those without clinical manifestations of kidney disease .

The current standardized classification system for lupus nephritis is derived from the World Health Organization and the International Society of Nephrology/Renal Pathology Society's recommendations. The classification system is based on glomerular morphologic changes seen on microscopy immune deposits seen on immunofluorescence and also electronic microscopy.

Class 1 - Minimal Mesangial Lupus Nephritis. Class 2 - Mesangial Proliferative Lupus Nephritis. Class 3 - Focal Lupus Nephritis. Class 4 - Diffuse Lupus Nephritis. Class 5 - Membranous Lupus Nephritis. Class 6 - Advanced Sclerosis Lupus Nephritis. Fibrinogen (FIB) is an acute time response protein rises rapidly in inflammation infection myocardial infarction and tumor. The formation and deposition of immune complexes are important mechanism of lupus nephritis the infiltrate of inflammatory cells and the release of inflammatory factors cause renal injury resulting in the decreasing concentration of albumin. The fibrinogen-to-albumin ratio as a new inflammatory marker has been proved to have good predictive value in the diagnosis and prognosis of diabetic nephropathy acute renal injury SLE disease and so on.

Eligibility Criteria:
Inclusion Criteria:

1. 90 Pts with SLE that have LN in different classes.
2. Age between 18-60 yrs.

Exclusion Criteria:

1. Pts with ESRD, manifested cardiac valvular disease, acute infection, history of hepatitis, pts with DM and Cancer.
2. Age below 18 yrs\& above 60 yrs
3. Pt who refused to contribute in this study
Pharmacokinetics of Preoperative Vancomycin

A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.

Background: Vancomycin is used for antibiotic prophylaxis in pediatric surgical patients without a complete understanding of plasma and soft tissue pharmacokinetics. Guidelines recommend incision within 60 minutes after administration; however, tissue concentrations of vancomycin at that early time may not be therapeutic. The Investigators conducted a study of plasma and tissue concentrations in pediatric neurosurgical and orthopedic patients to characterize intraoperative vancomycin pharmacokinetics.

Patients, ages (0.1-18.8 years), undergoing posterior spinal fusion (n=30) or ventriculoperitoneal shunt placement (n=30), received intravenous vancomycin 15 mg/kg over one hour. Skin biopsies were taken at incision and skin closure. Blood samples were also collected at incision and closure; additional samples were drawn at 2- and 4-hours if patient was still in surgery. Population pharmacokinetic (PK) analysis was performed to characterize PK parameter estimates and to develop a model of intraoperative plasma and tissue vancomycin concentrations vs. time.

Eligibility Criteria:
Inclusion Criteria:

1. Neurosurgery patients between the ages of 31 days up to 18 years
2. Receiving a single dose of vancomycin administered prior to surgery for cerebrospinal fluid (CSF) shunt placement or revision.
3. Orthopedic surgical patients between the ages of 31 days up to 18 years
4. Receiving a single dose of vancomycin administered prior to surgery for definitive spinal fusion.

Exclusion Criteria:

1. Patients already receiving vancomycin for treatment of an active infection,
2. Patients who have a Creatinine ≥1.2,
3. Patients who's creatinine clearance less than 50,
4. Known chronic renal failure and are on dialysis,
5. Patients with a known allergy to vancomycin, not including Red Man Syndrome.
A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).


Eligibility Criteria:
Inclusion Criteria AD:

* Male or female \>=50 years of age
* Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24

Inclusion Criteria MCI:

* Male or female \>=50 years of age
* Have a Clinical Dementia Rating (CDR) of 0.5
* MMSE \>24

Normal subjects:

* Male or female \>=50 years of age
* MMSE \>=29
* Normal on psychometric test battery at screening
* Provide informed consent

Exclusion Criteria:

* Have a history or current diagnosis of other neurologic disease
* Have had or currently have a diagnosis of other neurodegenerative disease
* Have participated in experimental therapy targeted to amyloid plaque
Treatment of Low Back Pain in Pregnant Women : Uses of Drugs and Other Therapies

Low back pain is a frequent clinical condition in pregnancy. Drugs treatments are limited. Other therapies are often used, associated or not with drugs (acupuncture, manipulative medicine, physical therapies, homeopathy). Clinical studies suggest a reduction of low back pain with these therapies.

The primary objective of this study is to determinate how many pregnant women use these alternative therapeutics.

In a second time, we want evaluate efficiency of these therapeutics, especially in pain modification and on quality of life.

Our study is a declarative study on pregnant women in Lorraine.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* medical history of : bifida spina, discal hernia, osteoporosis, vertebral compaction, spondylolisthesis, scoliosis ( over 30°)
A Study to Learn More About How Radium-223 is Being Used With Other Treatments in European Patients Who Have Not Received Radium-223 Before

In this study data from people with metastatic castration-resistant prostate cancer (mCRPC) with bone metastasis are studied. mCRPC is a prostate cancer which has spread to other parts of the body even when the amount of testosterone in the body was reduced. Bone metastasis is when the cancer has spread to the bones.

The study drug, radium-223, is currently available as a treatment for mCRPC with bone metastasis. But, its combination with certain other cancer treatments may lead to medical problems. Therefore the instructions about how doctors should use radium-223 with other cancer treatments were changed.

In this study, the researchers want to learn more about how doctors are now using radium-223 to treat patients with mCRPC and bone metastasis.

The participants in this study will include men in Denmark, Germany, or the Netherlands. They will not have received radium-223 before. They will have at least 6 months of medical records before starting treatment with radium-223. The researchers will collect the participants' medical records up to December 2020.

The researchers will review information from the participants' medical records and medical claims from hospitals where the participants received radium-223. They will look at the medical records of participants who first started receiving radium-223 before there were new instructions about using it with other cancer treatments. They will also look at the medical records of participants who first started receiving radium-223 after there were new instructions.

They will then count how many participants received other specific cancer treatments with radium-223. They will compare the results of the participants' who received radium-223 before the new instructions and those who received it after the new instructions.

There are no required visits or tests in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who receive a first dispensing/administration of radium-223 during the before or after study period
* Patients who have at least 6 months of continuous enrolment in the study databases before the first dispensing/administration of radium-223 (to allow for evaluation of recent medical history and medication use)

Exclusion Criteria:

* Patients who used radium-223 ever before the start of the before study period
Investigation of Hemoglobin Oxygenation With Third Harmonic Generation Microscopy

The specific aims of the project are performing a pre-clinical study on a human model and evaluating the oxygenation and other status of human erythrocytes by spectrally-resolved third harmonic generation (srTHG) microscopy . By analyzing the partitioned third harmonic generation (THG) spectra of oxygenated and deoxygenated erythrocytes ex vivo, the investigators aim to provide a reference standard for quantifying oxygenation and molecular status in this project.

Recently, oximeter, detecting the spectral response at wavelengths of 660nm and 940nm, is widely used to measured oxygenation status. Its low spatial resolution and limited penetration depth in human skin, however, restrict the oximeter in clinical application especially for early detection of cancer. In early-stage cancer development, angiogenesis and oxygen depletion around tumor are two important indicators of tumor growth. If an angiogenesis and low oxygenation status can be identified simultaneously, the investigators can point out the early-stage tumor from normal tissue easily.

The investigators have been working towards the development of third harmonic generation microscopy systems and reported the success of revealing morphology in human skin specimen. Since THG process is based on virtual transition without energy deposition, THG microscopy enables imaging ex vivo specimens without extra label and invasive procedure. To further investigate biological process of biomaterials, the investigators develop a srTHGM where THG spectrum is partitioned to analyze during imaging process. In this project, the investigators aim to elucidate oxygenation concentration and other specific biological molecular of red blood cells through the srTHG microscopy system.

The abilities to reveal structure morphology and its corresponding biological information in situ would provide assistance to diagnose early-stage of tumor and other diseases as well as a potential support in clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

* older than 20 years old

Exclusion Criteria:

* Vulnerable groups, such as pregnant women, prisoners, students, mentally handicapped, aborigines, etc.
Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) Dose-Ranging Study

This study is an open-labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses.

This is an open labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses according to the following chart:

Group / N\* / rFla-MBP

A / 8/ 25 micrograms

B / 8/ 125 micrograms

C / 8/ 625 micrograms

D / 8/ 1000 micrograms

\* minimum of 6 volunteers per group

An interval no less than 60 days following the first dose will separate the first dose of each volunteer group receiving different rFla-MBP doses. All volunteers will receive three immunizations. The first dosing time point is Day 0, the second is Day 14 (+/- 1 day), the third is day 28 (+/- 2 days). Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* 70% accuracy on comprehension test
* Availability for required visits and telephone follow up

Exclusion Criteria:

* Pregnancy or breastfeeding
* Chronic health problems
* Abnormalities found on physical examination
* Use of immunosuppressive drugs, such as corticosteroids or chemotherapy
* Positive blood test for HIV-1, hepatits B surface antigen (HBsAG) or hepatitis C virus (HCV)
* Abnormalities found on basic laboratory screening
* Prior exposure to Campylobacter
* Current smoker
* Chronic sinusitis or seasonal rhinitis
Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)

The increasing use of telemedicine in surgical care has demonstrated significant poten-tial for improving patient outcomes and optimizing healthcare resources. This study investigates the efficacy of the RedScar© app in telematic detection and monitoring of surgical site infections (SSIs), a major cause of healthcare-associated infections (HAIs) with significant economic and health impacts. RedScar© leverages a patient's smartphone to provide automated infection risk assessments without requiring clini-cian input, offering a potential solution for remote postoperative care. In a pilot study, RedScar© demonstrated 100% sensitivity and 83.13% specificity in detecting SSIs, with high patient satisfaction regarding its comfort, cost-effectiveness, and ability to reduce absenteeism. This multicenter prospective study aims to validate these findings, com-paring app-based detection with in-person evaluations. Primary objectives include as-sessing the sensitivity and specificity of RedScar© using receiver operating character-istic (ROC) analysis, while secondary objectives include evaluating patient satisfaction and standardizing telematic follow-up across centers. The study will include 168 pa-tients undergoing abdominal surgery, with follow-up assessments conducted remotely via the app and in-person at specified intervals. Data will be analysed using descrip-tive and statistical methods to assess diagnostic accuracy and patient satisfaction. This research seeks to further develop RedScar© as a reliable, scalable tool for enhancing postoperative care, reducing healthcare costs, and improving patient experiences in surgical recovery.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have signed an informed consent.
* Participants must be over 18 years of age.
* Participants must have undergone either urgent or scheduled surgery performed via laparotomy or laparoscopy.
* Participants need access to a smartphone capable of downloading the app with android OS.
* Either the participant or a close family member must be able to operate the app effectively.
* Participants must be able to attend follow-up consultations at the surgical outpatient clinic after discharge, one week post-surgery, or earlier if the app flags a potential infection.

Exclusion Criteria:

* Patients who lack access to a smartphone or are unable to properly use the app.
* Patients unfamiliar with mobile devices or unable to comprehend the app's functionality or questions.
* Patients who did not provide informed consent.
* Patients who are unable to comply with the follow-up requirements.
Ischemic Stroke and Early Vertical Positioning (SEVEL)

Even if it is a daily questioning for the stroke physician, no concrete recommendation exists regarding the time-point of the mobilization of stroke patients. In this study, we will compare two mobilisation strategies: early versus delayed "verticalisation". 400 ischemic stroke patients will be included in this prospective randomized controlled trial, equally distributed in two groups. In the early mobilisation procedure the patient is allowed to go and sit outside of the bed the day after the stroke onset, whereas in the other arm, this procedure is delayed to the third day after stroke onset. The outcome in both groups will be assessed by the modified Rankin Scale at 3 months, which is commonly used in stroke study to investigate the functional outcome of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Persistent neurological impairment at the participated time, related to an ischemic stroke defined by a sudden neurological deficit. The neurological deficit must not accompany hemorrhage on cerebral tomodensitometry which occurs on the same day or the day previous to the participation
* Patient hospitalized in Neurology department on the day of the participation
* Patient affiliated to the social security

Exclusion Criteria:

* Malignant cerebral infarction, loss of consciousness, comatose with GCS under 13, cerebral herniation, life- threatening infarction.
* Minor neurological deficit defined by isolated facial palsy, dysarthria, hemianopia, sensitive impairment, or every clinical condition that let the physician thinks that the stay in the hospital would be less than 72 hours.
* Known intracranial stenosis above 50% linked to the current infarction
* History of orthostatic neurological degradation
* Vomiting
* Deep venous thrombosis or suspicion of.
* Patients displaying a loss of autonomy with a Rankin score \>3 previous to stroke onset.
* Patient's refusal
* Patient under legal protection
Hydration Intervention in Children

The investigators are conducting this research study to determine learn how daily habits and fluid choices impact children's health, sleep, cognitive function and mood. The investigators look to determine if a hydration intervention using an alternative beverage may impact these variables in children.

Maintaining an appropriate level of hydration throughout the day has multiple health benefits. Maintaining a desirable hydration status improves overall health and wellbeing (mood, reaction time, sleep quality, cognitive function, etc.) in adults, but negative health and mental effects of hypohydration are not fully understood in an adolescent population. Maintaining appropriate hydration in adolescents presents unique challenges with respect to schedule (e.g. the availability of fluid during the school day and after school activities) as well as ensuring the most beneficial beverage choice. Adolescents can be very meticulous regarding their preferred beverage (e.g. choosing a sugary drink over water) and parents prefer their children consume the healthiest option for their food and beverages, often times leading to conflict.

Therefore the purpose/goal of the proposed study is to determine if a hydration intervention using an alternative sweetened beverage will improve hydration and other overall health (e.g. cognitive function, sleep quality, mood etc.)

The investigators hypothesize, that by giving children an alternative tasty option, they will consume more fluids which may lead to improving and maintaining their chronic hydration state. Implementing a beverage intervention with a sweet alternative option (i.e. Creative Roots) could improve hydration levels in adolescents. In turn, possibly improving mood, reaction time, sleep quality, and cognitive function. All of which are vital in the overall development of the adolescent.


Eligibility Criteria:
Inclusion Criteria:

* males and females
* aged 7-12 years old
* Guardians must also meet the criteria which is that

  * 1) they shop at Whole Foods, Costco, or Trader Joe's
  * 2) they use organic ingredients \&
  * 3) they check the nutritional content on foods for their children.

Exclusion Criteria:

* prior diagnosis of cognitive or learning disabilities
* history of chronic kidney disease,
* diabetes
* sleep disorders
* use of medications that may alter water balance (e.g. diuretics, laxatives, antacids, anti-histamines, NSAIDs, blood pressure medication)
* mood and anxiety medications (e.g. antidepressants, anxiolytics, beta-blockers, ADHD medications).
* Other medications that can cause urine color changes include isoniazid, sulfasalazine, metronidazole, nitrofurantoin, amitriptyline, cimetidine, indomethacin, zaleplon, methocarbamol, metoclopramide, warfarin, rifampin, and phenazopyridine
* Participants who do not like the Creative Roots beverage
Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

This is a steering group approved substudy to the Target Temperature Management trial (TTM, ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly controlled temperature regimes for survivors of out-of-hospital cardiac arrest.

The primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control patients with myocardial infarction.

Our secondary aims are:

* To investigate the impact of cognitive impairment on our patients' ability to participate in society and their health related quality of life.
* To investigate the relationship between our patients cognitive impairments and their relatives/informants health related quality of life and feelings of burden.
* To test the hypothesis that the simple cognitive screening battery used in the TTM main trial is sensitive enough to detect all patients with significant cognitive disability.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause
* Unconsciousness after sustained return of spontaneous circulation (ROSC)

Exclusion Criteria at time for inclusion in the TTM study:

* Known bleeding diathesis
* Suspected or confirmed acute intracranial bleeding
* Suspected or confirmed stroke
* Unwitnessed asystole
* Known limitations in therapy and Do Not Resuscitate-order
* Known disease making 180 days survival unlikely
* Known prearrest status Cerebral Performance Category (CPC)3 or 4
* Temperature \<30°on admission

  * 4 hours (240 minutes) from ROSC to screening
* Systolic blood pressure \<80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump
* In-hospital cardiac arrest
* OHCA of presumed non-cardiac arrest cause

Additional Exclusion criteria for the sub-study:

* Disability to speak the site language well enough to complete tests without interpreter
* Controls should never have suffered a cardiac arrest
Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens

Research concerning women pathogenic microflora during different conditions

Study of microflora of different groups of women of reproductive age, determination of pathogens and their further study, samples of a newly synthesized compound on isolated pathogens

Eligibility Criteria:
Inclusion Criteria:

* urogenital infections, pregnancy

Exclusion Criteria:

* healthy microflora