cyrilzakka/clinical-trials huggingface dataset:
Performance of Clinical and Biological Diagnostic Tests in Reference to the Recommended Tests for the Management of Fungal Peritonitis in Intensive Care

Fungal peritonitis accounts for nearly 70% of invasive candidiasis in surgical resuscitation. Their mortality is high, around 38% and their morbidity also with an increase in length of stay in intensive care, invasive ventilation times and an increase in the number of surgical revisions.

Currently, diagnostic and therapeutic management is based on clinical prognostic scores, of which the "Peritonitis score" (PS) is still used as a reference. These scores are intended to best target a population eligible for probabilistic antifungal treatment pending the confirmation or not of the fungal characteristic of peritonitis by the fungal culture (Gold Standard). In case of severe peritonitis, if the PS is\> or = to 3, the clinician must start a broad-spectrum antifungal treatment which will be continued if the culture of the peritoneal fluid is positive to yeast. If it is \<3, it is not recommended to introduce an anti-fungal outside of very particular cases. In this situation, an anti-fungal treatment is only started if the direct examination of the peritoneal liquid made within 24 hours is positive to yeast or, failing this, to the reception of a positive culture several days later.

However, recent reviews of the "Peritonitis score" have emerged from the analysis of the "fungal peritonitis" subgroup of the AmarCand II study (underestimation in particular) , highlighting the difficulty of identifying this target population. In addition, none of these clinical scores have demonstrated superiority in guiding probabilistic antifungal therapy. Direct examination of peritoneal fluid also suffers from low sensitivity.

New diagnostic approaches using, among other things, blood markers (panfungal PCR, 1,3-Beta-D-glucan, etc.) have developed in recent years. In particular, 1,3-Beta-D-glucan has demonstrated superiority to the candida score in the early diagnosis of intra-abdominal candidiasis. \[8\]. His main interest lies in his strong Negative predictive value. The association of these markers is another way of working to improve their diagnostic performance. The use of these blood markers is encouraged by European and international consensus, however, their dosage in the peritoneal fluid is still under study.

One of the consequences of these diagnostic difficulties is the occurrence of inadequate prescriptions of antifungals in more than 40% of cases of fungal peritonitis in intensive care, or even more than 70% of cases in the case of any type of candidiasis. invasive.

The investigators therefore seek to study the diagnostic performance of fungal markers (BDG and PCR) increasingly realized in CHRU de Nancy in reference to the recommended tests (clinical (PS) and microbiological (ED and culture))


Eligibility Criteria:
Inclusion Criteria:

* Any patient\> 18 years old who has been treated for peritonitis in intensive care unit in CHRU de Nancy during year 2016

Exclusion Criteria:

* None
Comparison of Comprehensive Rehab Program and Pelvic Floor Training in Women With Stress Urinary Incontinence

The goal of this clinical trial is to compare a comprehensive rehabilitation program and a conventional pelvic floor training program in women with stress urinary incontinence,to compare the effects of comprehensive rehabilitation program and conventional pelvic floor training on the severity of SUI, on the strength of pelvic floor muscle and on quality of life in women with SUI. Following the randomization into either the conventional pelvic floor training or comprehensive rehabilitation program group, participants will receive their assigned interventions of three weekly sessions for eight weeks.

The proposed study comparing the effects of conventional pelvic floor training versus a comprehensive rehabilitation program on stress urinary incontinence (SUI) among perimenopausal women holds significant rationale and importance. Given the prevalence and impact of SUI on the quality of life of perimenopausal women, investigating the comparative efficacy of these interventions is crucial for informing evidence-based clinical practice. The study aims to provide insights into the most effective management strategies for SUI in this population, potentially leading to improved treatment outcomes, enhanced quality of life, and reduced healthcare burden associated with this common condition. By addressing this research gap, the study has the potential to significantly benefit both individual patients and the broader healthcare system.

This will be a randomized controlled trial. Non probability sampling technique will be used.The data collection procedure begins with the recruitment phase, potential participants meeting the study's criteria will be identified and provided with detailed information about the research aims and procedures. Once recruited, participants will undergo a screening process to confirm their eligibility, including assessments such as medical history reviews and diagnostic tests. After obtaining informed consent, baseline assessments will be conducted to establish the participants' initial status regarding urinary symptoms and quality of life. Following randomization into either the conventional pelvic floor training or comprehensive rehabilitation program group, participants will receive their assigned interventions of three weekly sessions for eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* Perimenopausal and post-menopausal women
* Age 40-60 years
* Medically diagnosed patients of stress urinary incontinence

Exclusion Criteria:

* History of pelvic surgery within the past six months.
* Current urinary tract infections or other active urinary tract disorders.
* Neurological conditions affecting bladder control.
* Inability to participate in the prescribed intervention due to physical or cognitive limitations.
* Participation in other pelvic floor rehabilitation programs concurrently or previously within the last 6 months.
Evaluation of Professional Practices in the Treatment of Refractory Idiopathic Overactive Bladder at the Dose of 50 Units (TOX50IUU)

Considering that the 2013 Hermieu's guidelines differs from the product marketing authorization delivered in November 2014, the primary endpoints is to evaluate life quality by questionnaires at the baseline time, and after two, six and twelve weeks of treatment in patients suffer from urinary incontinence by refractory idiopathic overactive bladder and treated by Botox® at the dose of 50UI (international units)

Currently, Botox injection is one of the second-line treatments for urinary incontinence by idiopathic overactive bladder. Multiple studies have shown that Botox at the dose of 50UI is effective but not for a long time. Maximum efficiency is about two weeks and until about twelve weeks compared to the dose between 100UI and 300UI that shown an efficiency until twenty-four at thirty-six weeks. But it's not without consequence since the side effects are more numerous increasing the dose. The most frequent are urinary retention with necessary to perform clean intermittent catheterization and urinary infection.

This dose at 50UI is therefore more a test to assess the patient's tolerance to the product, as recommended by the product marketing authorization.

So, through this evaluation of professional practices, investigators would like to evaluate the patient satisfaction treated in hospital, with a first dose at 50UI.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥ 18 yo
* Refractory idiopathic overactive bladder
* Eligibility to an injection treatment
* Capacity to perform clean intermittent catheterization

Exclusion Criteria:

* Protected adults (under trusteeship, guardianship or judicial protection)
* Patients under anticholinergics for an other desease (psychiatric, neurologic for example)
* Known hypersensitivity or at risk of hypersensitivity to botulinum toxin type A like myasthenic syndrom
* Patients who suffer from an overactive bladder with a known cause (neurological, urological condition)
* urinary infection under treatment \< 48 hours before Botox® injections
* Suspicious looking bladder requiring biopsies during the cystoscopy
* Pregnant or breastfeeding women
* Language barriers
Topotecan Pharmacokinetic Characterization Study

A multi-center, open label, single dose Phase I pharmacokinetic (PK) characterization of weekly IV (intravenous) topotecan given at 4mg/m2. 15 patients will be evaluated.


Eligibility Criteria:
Inclusion criteria:

* Written informed consent
* Performance status of 0, 1, or 2 on the Eastern Co-operative Oncology Group (ECOG) Scale
* Predicted life expectancy of at least 3 months
* Subjects with histologically or cytologically confirmed advanced solid tumors who have failed conventional therapy for their tumor type or have a tumor type for which no standard effective therapy exists; OR Patients for whom single-agent topotecan therapy is suitable
* At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery
* Must be free of post-treatment side effects (with the exception of alopecia)
* No concurrent chemotherapy, biologic therapy or radiotherapy is allowed
* Hemoglobin = 9.0 g/dL
* WBC = 3,500/mm3 \[= 3.5 x 109/L\]
* Neutrophils = 1,500/mm3 \[= 1.5 x 109/L\]
* Platelets = 100,000/mm3 \[= 100.0 x 109/L\]
* Calculated creatinine clearance=60 mL/min using the Cockcroft-Gault formula
* Serum bilirubin \< 2.0 mg/dL (34 µmol/L) AST, SGPT/ALT and alkaline phosphatase \< 2 times the upper limit of normal if liver metastases cannot be visualized by abdominal computed tomography (CT) or magnetic resonance imaging (MRI scan)
* If liver metastases are present, subjects with \< 5 times the upper limit of normal are eligible to participate

Exclusion criteria:

* Women who are pregnant or lactating
* Women subjects of childbearing potential who refuse to abstain from sexual intercourse or practice adequate contraception. Childbearing potential is defined as women who are not surgically sterilized (i.e. have not had a hysterectomy, bilateral oophorectomy \[ovariectomy\], or bilateral tubal ligation) or post-menopausal (i.e., documented absence of menses for one year prior to entry into the study).
* Men unwilling to abstain from sex or use effective contraception during the study and for 3 months following completion of topotecan treatment
* Subjects with uncontrolled emesis, regardless of etiology
* Active infection
* Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
* Treatment with another investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer)
* History of allergic reactions to compounds chemically related to topotecan.
Ketohexokinase Isoforms in Endometrial Cancer.

Our preliminary analysis with clinical database suggested that, in patients with type I endometrial cancer, high ketohexokinase-expressing group have lower survival probabilities than low ketohexokinase-expressing group. To understand the importance of ketohexokinase expression and isoform switch during the development of type I endometrial cancer, we propose a series of in vitro experiments and clinical examinations in this project.


Eligibility Criteria:
Inclusion Criteria:

* \>20 years
* Women with endometrial cancer who are about to be admitted to hospital for gynecological staging.
* Women who have undergone gynecological staging surgery for endometrial cancer in the past.

Exclusion Criteria:

* Women with endometrial cancer who receive preoperative chemotherapy or radiation therapy.
DNA Methylation Biomarkers to Predict Survival After Surgery for Lung Adenocarcinoma

This study is designed to assess DNA 5-methylcytosine (5mC) methylation modifications in lung adenocarcinoma (LUAD) samples and develop a prognosis-predictive model for LUAD based on cancer tissue DNA 5mC levels. The research will link post-surgical recurrence and survival outcomes to the DNA 5mC profiles of patients. By collaborating with two hospitals in China, this multicentral study will utilize over three years of prognostic data from LUAD patients to validate the model's accuracy. Additionally, the research aims to explore the potential of the model in guiding adjuvant treatment strategies by comparing the differences in outcomes between high-risk patients who receive further treatment and those who do not. This study aspires to enhance future treatment planning for LUAD patients, providing personalized and effective therapeutic options based on precise prognostic predictions.

* Model Development

  * The methylation data will be analyzed to identify specific 5mC methylation patterns associated with post-surgical recurrence and survival outcomes.
  * A prognostic model will be developed based on these methylation profiles to predict LUAD prognosis.
* Model Validation

  * Clinical data from LUAD patients at two hospitals in China, including over three years of follow-up information, will be used to validate the accuracy and reliability of the prognostic model.
  * Statistical methods will be applied to assess the model's predictive power and its ability to accurately stratify patients into different risk categories.
* Exploration of Follow-up and Adjuvant Therapy Guidance

  * The study will compare outcomes between high-risk patients who receive additional adjuvant treatment and those who do not, based on the risk categories identified by the prognostic model.
  * This comparison aims to explore the model's potential in guiding adjuvant therapy decisions, ultimately enhancing personalized treatment strategies and improving survival rates for LUAD patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed early-stage lung adenocarcinoma, or clinically diagnosed early-stage lung adenocarcinoma.
* Underwent surgical treatment
* Cancer tissues well paraffin-embedded or cryopreserved

Exclusion Criteria:

* Diagnosed with other serious illnesses
* Received other treatments before surgery
* Surgery to remove multiple cancerous tissues
BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)

This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed.

The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment.

Patients enrolled into the trial will be treated and followed until death or lost to follow-up.


Eligibility Criteria:
Inclusion criteria:

1. Patients with pathologic confirmation of NSCLC Stage III-B (with pleural effusion) or Stage IV adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). One of the chemotherapy regimens must have been platinum-based.
2. Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
3. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2
4. Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as \>20 mm using conventional techniques or \>10 mm with spiral CT scan
5. Male and female patients age \>18 years
6. Life expectancy of at least three (3) months
7. Written informed consent that is consistent with ICH-GCP guidelines

Exclusion criteria:

1. Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of treatment Day 1
2. Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks
3. Active brain metastases
4. Significant or recent acute gastrointestinal disorders with diarrhea
5. Patients who have any other life-threatening illness or organ system dysfunction,
6. Other malignancies diagnosed within the past five (5) years
7. Radiotherapy within the past 2 weeks prior to treatment
8. History of clinically significant or uncontrolled cardiac disease
9. Adequate ANC and platelet count
10. Adequate liver and kidney function
11. Patients with any serious active infection including known HIV, active hepatitis B or active hepatitis C
Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites

This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at

A trained healthcare provide will collect 50μL of capillary whole blood and 11mL of EDTA venous whole blood (VWB) to be tested with the iStatis Syphilis Ab Test on site according to the 'Test Procedure' described in the Instructions for Use (IFU) supplied with the reagents. Same procedure must be followed using the extracted plasma sample to test 30μL of the plasma sample extracted and obtained through processing of the VWB on the iStatis Syphilis Ab Test. An aliquot of the plasma sample will be transferred to the central laboratory to establish the reference test result using an enzyme immunoassay (EIA) (Abbott Architect Syphilis Tp EDA). In case of positive results in the EIA reference test of (Abbott Architect Syphilis Tp EDA), the sample will be sent for BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA) testing.

Eligibility Criteria:
Inclusion Criteria:

* Participants/subjects (males, females, and pregnant women) getting tested for syphilis for one or more of the following reasons:

  o at risk for syphilis ohaving signs and symptoms indicative for syphilis oRoutine testing
* Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.

Exclusion Criteria:

* Participant younger than 18 years old
* Participants unable to provide written informed consent
* Participants currently undergoing treatment
Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial-

Depression in neurocognitive disorders (Alzheimers' disease and related disoders) is a highly prevalent condition, especially in nursing homes. While it is associated with significant distress, the current conventional antidepressants have shown only modest efficacy and exposed to potentially severe side effects.

Recent evidence suggests that nitrous oxide (N2O) in its most commonly used packaging of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) has rapid antidepressant properties and a good safety profile. However, no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes.

The principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks, with a dosage escalation procedure.

Participants will be exposed to 3 sessions of EMONO (or Medical Air), with intervals of 1 week between sessions : a first session of 20 minutes, a second of 40 minutes one week later and a final session of 60 minutes one week later. Efficacy will be assessed 1 week after each session and 4 weeks after the last session.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 60 and over living in nursing home
* Diagnosis of major neurocognitive disorder according to DSM-V for at least 6 month
* MMSE \<= 20/30
* NPI depression \>= 4/12
* Patient, family and legal representive consent where applicable Person affiliated to a social security schem

Exclusion Criteria:

* NPI agitation \> 6/12
* Unstable somatic pathology (in particular unstable neurological or cardiological pathologies at risk of interfering with the diffusion of MEOPA) and any unexplained recent neurological abnormality.
* Contraindications to the use of MEOPA
* Patients who have already been treated with MEOPA in the 6 months prior to inclusion, for example for painful treatment
* Sub-physiological plasma vitamin B12 or B9 concentration (below the lower limit of the laboratory value).
* A person participating in a clinical drug study or in a period of exclusion from any clinical study due to previous participation
* Personne participant à une étude clinique médicamenteuse ou en période d'exclusion de toute étude clinique du fait d'une précédente participation
the EXPOSITION Study

This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage.


Eligibility Criteria:
Inclusion Criteria:

* We will include persons with Multiple Sclerosis (pwMS) attending the Centro Sclerosi Multipla of the IRCCS Fondazione C. Mondino of Pavia, according to the following inclusion criteria:

  * Age ≥ 18 years
  * Diagnosis of MS according to 2017 McDonald criteria
  * Relapsing-remitting course (RR)
  * Routine clinical examinations scheduled in the study period September 15, 2023, to March 15, 2024,
  * Residing in the provinces of Pavia and Milano
  * Informed consent form signed

Exclusion Criteria:

* Exclusion criteria will involve people refusing to participate in the study or people not completely meet the inclusion criteria. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled.