cyrilzakka/clinical-trials huggingface dataset:
Sensitivity to Acute Cerebral Ischemia in Migrainers

Sensitivity to Acute Middle cerebral or intracranial Carotid artery Occlusion in MIGrainers (SMCO-MIG) is a prospective multi-center study to determine if migraine induces a faster infarct growth as assessed by initial multimodal imaging.

Ischemic stroke results from the occlusion of a brain artery by a clot. Early revascularization by thrombolysis and thrombectomy promotes neurological recovery by saving the area of ischemic penumbra. Progression of ischemic stroke is evaluated on multimodal imaging by the "mismatch ratio" between necrotized core and salvageable hypoperfused volumes.

Migraine affects 12% of the population. Although considered as a benign condition, migraine, particularly with aura, is a risk factor for ischemic stroke. Based on pathophysiological hypothesis and the result of one study, which had several limitations, it's suggest that migraine might increase the sensitivity to cerebral ischemia and induce a faster infarct growth.

The main objective of the study is to determine if the mismatch ratio between irreversibly injured and hypoperfused volumes, measured on initial imaging (MRI or CT) during acute ischemia due to occlusion of the middle cerebral artery or the intracranial internal carotid artery, varies according to the migraine status.

A multicentric prospective cohort will be conduct, outcome study. The initial multimodal imaging (MRI or CT) will be acquired routinely using a harmonized protocol in any patient suspected of an acute stroke. All consecutive patients eligible to the study will be included within 7 days of their initial admission, and evaluated with a short questionnaire classifying them as "migrainers" whose status will undergo a detailed validation at 3 months by a migraine expert, and "non-migrainers" whose status will be validated by repeating the short questionnaire at the follow-up visit at 3 months. All radiological data will be analyzed centrally after the end of the recruitment, by investigators blinded to the migraine status.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 to 75 years old
* Admitted to a stroke unit for an acute ischemic stroke (\<12 h)
* Angiography showing M1/M2 or intracranial internal carotid artery occlusion
* MRI or CT acquired \<24h from IS onset, using a harmonized protocol enabling calculation of the mismatch

Exclusion Criteria:

* Individual enrolled into another study protocol with a period of exclusion still running at potential inclusion
* Coma, dementia, linguistic problem or aphasia preventing responding to the migraine questionnaire
* Refusal of participation
* Persons under legal protection, guardianship or curatorship
Comparison of Two Pain-treatment Techniques After Cesarean Section

Comparison of two types of analgesia after cesarean section.

All patients will anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Written consent will be obtained before the cesarean section. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.25 % bupivacaine) on each side.

Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of operation.

Paracetamol, metamizol, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).

1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Eligibility Criteria:
Inclusion Criteria:

* obtained consent
* singleton pregnancy
* subarachnoid anaesthesia

Exclusion Criteria:

* coagulopathy
* allergy to to local anesthetics
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs
Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM)

To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed T2DM and inadequately controlled with diet and exercise or T2DM diagnosed \<6 months and who had not taken oral antidiabetic medication or insulin for \>3months.
* HbA1C more than 7.5 and less than 11.

Exclusion Criteria:

* Fasting plasma glucose of \>13.5mmol/L
* Type 1 Diabetes Mellitus (T1DM)
* Patient with acute illness hospitalized in last 2 months
* Patient with active liver disease, impaired renal or hepatic functions
* Known hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any other excipients of AMARYL
* Pregnant and lactating women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Immunologic Control of Drug Resistant HIV

Drug resistant HIV strains often develop in patients who have taken anti-HIV drugs for an extended time. However, these drug resistant HIV strains do not always cause an increase in the level of HIV in the blood. This study will explore why some patients with drug resistant virus continue to have low viral loads.

Despite the emergence of high level drug resistance in HIV-infected patients on stable antiretroviral therapy, plasma HIV RNA levels generally remain below the pretherapy viral load "set-point". The virologic and immunologic determinants of this lower steady state level of viremia have not been defined. Preliminary data indicate that: 1) drug resistant variants have reduced replicative capacity and pathogenic potential; 2) drug resistant viremia is associated with reduced T cell activation and turnover compared to wild-type viremia; and 3) patients with low level drug resistant viremia often have HIV-specific CD4 cells that are absent in patients with higher levels of viremia. This study will investigate whether the emergence of a poorly fit, drug resistant variant results in the generation of an effective HIV-specific CD4 cell response and if this response contributes to the establishment of a lower steady state level of viremia.

Participants in this study will be followed for 2 years or until antiretroviral therapy is modified or discontinued. Study visits will occur every 2 months, for a total of 14 visits. Study visits will include a patient interview and blood tests to measure the breadth and magnitude of the HIV-specific CD4 and CD8 cell responses as a function of viral load, viral replicative capacity, drug resistance phenotype, T cell turnover, and thymic function.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected for at least 6 months prior to study entry
* Documented pretherapy or off-therapy viral load of more than 10,000 copies/ml on at least 2 occasions or more than 20,000 copies/ml on at least 1 occasion
* At least a 70% reduction in plasma HIV RNA levels from pretherapy baseline
* Stable highly active antiretroviral therapy (HAART) regimen for at least 4 months prior to study entry
* HIV viral load of 200 to 10,000 copies/ml for 3 months prior to study entry
* CD4 count greater than 100 cells/mm3 and a nadir CD4 count less than 500 cells/mm3
* Virologic failure as defined by DHHS guidelines on at least one HAART regimen prior to the study entry HAART regimen
* Documented adherence to antiretroviral therapy
* Two major resistance mutations to at least two antiretroviral drug classes

Exclusion Criteria:

* Significant toxicity on current HAART regimen
Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice

The primary objective is to evaluate the performance parameters of the proposed DLAD (Carebot AI CXR) in comparison to individual radiologists.

In the period between October 18th, 2022, and November 17th, 2022, anonymized chest X-ray images of patients were collected at the Radiodiagnostic Department of the Havířov Hospital, p.o. The collection process involved utilizing the CloudPACS imaging and archiving system provided by OR-CZ spol. s r.o.

The collected X-ray images were subjected to the proposed DLAD (Carebot AI CXR) for analysis. Subsequently, the DLAD's performance was compared with the standard clinical practice, where radiologists assessed the CXR images in the simulated hospital setting with access to standard viewing tools (e.g., pan, zoom, WW/WL) and were given an unlimited amount of time to complete the review. Each radiologist determined the presence or absence of 7 indicated radiological findings, including atelectasis (ATE), consolidation (CON), pleural effusion (EFF), pulmonary lesion (LES), subcutaneous emphysema (SCE), cardiomegaly (CMG), and pneumothorax (PNO).

Eligibility Criteria:
Inclusion Criteria:

* Hospital patients \> 18 years who were referred for chest radiography October 18th, 2022, and November 17th, 2022 at the Radiodiagnostic Department of the Havířov Hospital, p.o.

Exclusion Criteria:

* Patients \< 18 years
* Chest X-ray images in lateral positions
* Duplicated chest X-ray images
Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology

This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Then genes analyzed by Gene Ontology, protein interactions, and signaling pathway enrichment using the expression matrix.


Eligibility Criteria:
Inclusion Criteria:

1.18 to 75 years 2.diagnosed with incisional hernia 3.normal tumour markers 4.elective surgery patients.

Exclusion Criteria:

1. patients with vital organ failure (heart liver, lung, kidney and others)
2. malignant tumors not been completely relieved by active treatment,
3. patients who have psychiatric diseases or comprehension disorders.
4. patients with metabolic disease involving connective tissue collagen.
The Predictive Value of CT-PET in Esophageal Cancer

A major focus of research in oncology is to identify patients who, following induction therapy, have a complete pathologic response, presenting opportunities for novel trials, including extended therapy or non-operative approaches, in addition to identifying cohorts who are resistant to the neoadjuvant therapy. The current gold standard for determining response to CRT is pathological evaluation following surgical resection, in particular the Mandard Tumour Regression Grade (TRG) or some modification thereof. At this time, however, there is no preclinical early response or post-treatment biomarker, nor endoscopic or radiologic assessment that predicts pathologic response prior to surgical resection.The aim of this study is to determine the accuracy of CT-PET for prediction of histopathologic response and/or oncologic outcome for patients with esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced esophageal or junctional neoplasm
* Histologically confirmed adenocarcinoma or squamous cell carcinoma
* Scheduled to undergo nCRT followed by surgery as per multidisciplinary Tumor Board
* CT-PET at diagnosis of malignancy (within 2 weeks from diagnosis), performed at study Center
* CT-PET 4-6 weeks after completion of nCRT, prior to surgical resection

Exclusion Criteria:

* Incomplete data, patient lost to follow-up
* Scans performed at alternate Center
Accuracy of Pulse Oximeters With Profound Hypoxia

To test the accuracy of a non-invasive blood oxygen saturation monitor which is placed on a subject with profound hypoxia.

A radial arterial cannula was placed in either the left or right wrist of each subject for arterial blood sampling and blood pressure monitoring. Blood gas analysis to determine oxyhemoglobin saturation (SaO2)was performed using an ABL-90 multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen, serial 1393-090R0359N0002). This instrument contains factory certified calibration standards and quality control algorithms.

Each subject had two control blood samples taken at the beginning of each experiment, while breathing room air. Hypoxia was then induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable. Two arterial blood samples were then obtained, approximately 30 seconds apart. Each stable plateau therefore was maintained for at least 60 seconds with SpO2 fluctuating by less than 2-3%. The plateaus were nominally at 100%, room air saturation, 93%, 90%, 87%, 85%, 82%, 80%, 77%, 75% and 70%. A total of 270 samples were obtained at the saturation plateaus across this span. Data were provided for analysis. At least 200 data points were collected for each type of oximeter and probe combination studied.

Pulse oximeter data is taken as 5 second averages corresponding to the point of arterial blood analysis. Individual data points may be missed or excluded for dropped signals or failure of the oximeter signal to achieve an appropriate plateau. Data is plotted as Hemoximeter data (SaO2) vs. pulse oximeter bias (SpO2 - SaO2). A different marker is used for each study subject. Linear regression is shown for all subjects combined, and the equation with R2 is shown on the plot. Mean bias is displayed as a solid horizontal line, and the upper and lower limits of agreement (mean bias ± 1.96•SD\*) are shown by dashed horizontal lines. For the "pooled" plots, different markers are used for each pulse oximeter. Tables of mean, standard deviation, standard error, minimum, maximum, 95% confidence interval, count and root mean square are provided for each oximeter's bias, and all oximeters combined in the following ranges of SaO2 (Hemoximeter): 60 - 80%, 80 - 100%, 60 - 100%, 70 - 100%, 50 - 60%, 60 - 70%, 70 - 80%, 80 -90%, and 90 - 100%.

Eligibility Criteria:
Inclusion Criteria:

* Normal hemoglobin levels (Hemoglobin ≤ 10gm•dl-1)
* Healthy
* Non-smoking individuals
* 21-49

Exclusion Criteria:

* Unhealthy
A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course

The purpose of this study is to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol.
2. Women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)\] during the study and up to 30 days after the last dose of the study drug..
3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
4. Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E study.

Exclusion Criteria:

1. Premature discontinuation from the MS-LAQ-301 study, for any reason.
2. Pregnancy \[according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit\] or breastfeeding.
3. Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-301 study, which preclude safe participation and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-301E study.
4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
Risk of Recurrence of de Novo Mutations: Research and Quantification of Paternal Germinal Mosaicism by the Combined Use of Genomic Tools

1. Inclusion of 5 families Inclusions will be made by the clinical genetics department of the Rouen University Hospital (monocentric study) and will correspond to trios of parents + child with unexplained developmental abnormalities. The inclusion of patients will be integrated in routine care and will have as immediate benefit for the included families the extensive analysis of the proband and their parents' genomes by short and long read sequencing techniques, which represent the most comprehensive diagnostic tests for developmental diseases, and which are not currently routinely available. Inclusion in clinical genetics by clinicians accustomed to prescribing genome-wide analyses will allow clear and complete information to families. Collection of consents. The trio's DNA will already be available at the molecular genetics laboratory, and a new blood sample may be proposed if necessary. Collection of sperm from the father.
2. Identification of a large set of de novo mutations. Extraction of blood DNA and sending for sequencing of the complete genome to the National Centre for Research in Human Genomics (CNRGH, Evry), in the framework of a collaboration already initiated. Analysis of the sequencing data thanks to the already existing expertise in Rouen. Identification of about 40-120 de novo mutations per trio. At this stage: interpretation of the variations identified with the secondary objective of identifying the cause of the disease in children. Long read genomes will allow to phase the de novo variants to the paternal or to the maternal haplotype.
3. Search for de novo mutations in paternal sperm samples. Extraction of spermatic DNA. Design of a sequencing panel targeting the genetic variations identified in the different trios. Preparation of the libraries, targeted high throughput sequencing at great depth thanks to the techniques and equipment already operational. Specific search for the de novo variations identified in the probands (in 2.), with for each evaluation of (i) the presence of the variation in the sperm sample, (ii) the quantity of mosaicism, reflecting the proportion of carrier spermatozoa and therefore the risk of recurrence, (iii) the presence of my variation in the blood sample of both parents in deep sequencing.


Eligibility Criteria:
Inclusion Criteria:

* Trio consisting of a child with a developmental disorder and both unaffected parents
* Absence of etiology after clinical expertise and genetic testing
* Indication of a genome-wide sequencing analysis
* Child from spontaneous pregnancy without ovulation stimulation treatment
* Availability of DNA blood samples
* Affiliation to a social insurance
* Patient or patient's legal representative who has read and understood the information letter and has signed the consent form

Exclusion Criteria:

* Lack of indication for a genome-wide analysis in the proband
* Etiology of the developmental disorder already identified
* Proband born after In-Vitro Fertilization
* Impossibility of non-invasive sperm collection from the father
Comparison Between Dexmedetomidine and Propofol for Patients in the Intensive Care Unit After Abdominal Surgery

This is a single-blind randomized clinical trial. Patients undergoing abdominal surgery will be enrolled and randomly divided into two groups: dexmedetomidine group and propofol group. In the dexmedetomidine group, patients will receive continuous intravenous infusion of dexmedetomidine (infusion dosage range: 0.1 \~ 0.7 mcg/kg/h). In the propofol group, patients will receive continuous intravenous infusion of propofol (infusion dosage range: 0.3 \~ 1.6 mg/kg/h). Hemodynamics will be continuously monitored using a non-invasive monitoring with chest bioreactance technique at preset time points (0, 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results and fluid balance will be recorded. The microcirculation will be examined by Cytocam. The following microcirculatory parameters will be investigated: total small vessel density, perfused small vessel density, microvascular flow index, and heterogeneity index. The enzyme-linked immunosorbent assays will be used to measure serum level of endocan, diamine oxidase, and neutrophil gelatinase-associated lipocalin at preset time points. The primary goal of this study is to compare the effect on microcirculation between dexmedetomidine and propofol in intensive care unit patients after abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* non-emergent major abdominal surgery with ICU admission
* the need of sedation during ICU stay

Exclusion Criteria:

* age younger than 20 years and older than 89 years
* refractory bradycardia (HR \< 60 bpm after treatment)
* severe AV block (2nd or 3rd degree)
* refractory shock (MAP \< 60 mm Hg after treatment)
* severe heart failure or NYHA 4
* new onset of myocardial infarction within 4 weeks
* receive CPR within 4 weeks
* APACHE score \> 30 before enrollment
* severe liver cirrhosis or CHILD B or C
* pregnancy
* allergic history to dexmedetomidine or propofol
* be enrolled in other clinical trials related to dexmedetomidine or propofol within 4 weeks
* non-native speakers