cyrilzakka/clinical-trials huggingface dataset:
Descriptive Study of the Evolution in Proportion of Regulatory B Lymphocytes in Patients Hospitalized in Intensive Care for Severe Sepsis

Severe sepsis and septic shock are the most severe forms of sepsis (which associates a systemic inflammatory response with infection). These are serious pathologies with a lethality estimated at almost 40% at 28 days (after the onset of sepsis).

After a first pro-inflammatory phase, a second compensatory phase called Compensatory Anti-Inflammatory Response Syndrome (CARS) takes place quickly. Patients then show signs of immunosuppression and profound alterations in immune functions. It is during this phase that the vast majority of deaths occur, far from the onset of the shock, which is related to the inability of the immune system to eliminate the initial infectious agent and / or a greater susceptibility Important to develop secondary infections (nosocomial infection, latent virus reactivation ...).

The CARS phase has been the subject of studies focusing on measuring the plasma concentration of anti-inflammatory cytokines (such as Interleukin (IL) -10), the percentage of regulatory T lymphocytes (Treg), Or the percentage of monocytic expression of HLA-DR in septic patients.

The investigator proposes to carry out the first study on a newly described regulatory lymphocytic subpopulation: regulatory B lymphocytes (Breg) from a quantitative and functional point of view in severe septic states.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with severe sepsis or septic shock diagnosed less than 24 hours (defined as D0) and hospitalized in the medical resuscitation department of the Amiens-Picardie University Hospital.
* The definitions of severe sepsis and septic shock are the result of the consensus of the Société de Réanimation de Langue Française dating from 2005:

  * Sepsis refers to a systemic inflammatory response syndrome (SIRS) in the presence of suspected or identified infection. Sepsis is said to be severe when lactate\> 4 mmol / L or arterial hypotension prior to filling or organ dysfunction is present (one is sufficient): hypoxemia with a PaO2 / FIO2 \<300 ratio, renal failure with Hepatic insufficiency with INR\> 4 or bilirubin\> 78 μmol / l, thrombocytopenia (platelets \<100 000 / mm3) and hepatic insufficiency\> 176 μmol / l, coagulation disorders with INR\> 1.5 Disorders of higher functions with a Glasgow Coma Score \<13.
  * Finally, septic shock is defined as a severe sepsis condition with persistent hypotension despite a well-conducted vascular filling (20-40 ml / kg isotonic saline).

Exclusion Criteria:

* Patient with active neoplasia, immune deficiency, autoimmune disease or autoimmune disease.
* Patient under tutorship or curatorship
* Taking an immunomodulatory or immunosuppressive treatment at the time of the study or the year prior to hospitalization for sepsis.
* Antecedent or haematopoietic graft in progress.
* Pregnancy in progress.
* Known history of infection with human immunodeficiency virus (HIV) type 1 or 2 or with hepatitis B or C virus
* Patient with agranulocytosis (defined as neutrophils \<0.5 G / L).
A Study for Participants With Major Depression

This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in treating adults with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for major depressive disorder (MDD) without psychotic features.
* Have education level and a degree of understanding such that the participant can communicate with the site study personnel.
* Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations required by the protocol.

Exclusion Criteria:

* Have had any additional, ongoing psychiatric condition other than major depression or dysthymia that was considered the primary diagnosis within 6 months of the first study visit.
* Have a lifetime history of Bipolar I or II Disorder, psychotic disorder, or a factitious disorder.
* Are judged to be at high risk for imminently harming themselves or others.
* Have a serious medical illness, including any cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic disease, or clinically significant laboratory or electrocardiogram (ECG) abnormality. Clinically significant lab abnormalities are those which, in the judgment of the investigator, indicate a serious medical problem or require intervention.
* Have any diagnosed medical condition which could be exacerbated by treatment with LY2216684, including hypertension, increased heart rate, arrhythmias, heart disease, narrow angle glaucoma, or urinary hesitancy.
Building of Prognosis Model for Patients With Cirrhosis Based on Sarcopenia Assessed by Deep Learning

The goal of this observational study is to develop and validate a fully automated imaging deep learning platform for the evaluation of sarcopenia in liver cirrhosis. Based on this model, a new prognostic model for liver cirrhosis incorporating imaging biomarkers such as sarcopenia will be constructed, and its predictive performance will be validated.

The goal of this observational study is to collect clinical and abdominal imaging data of patients with liver cirrhosis. The collected imaging data will be used as a model development set to develop, test, and internally validate a fully automated imaging deep learning platform for the evaluation of sarcopenia in liver cirrhosis. Subsequently, relevant data from patients with liver cirrhosis at other centers will be collected and used as an external validation dataset. The model will be externally validated by abdominal radiology experts. Furthermore, we will include sociodemographic information, clinical data, imaging data, and clinical outcomes of the aforementioned liver cirrhosis patients to predict the prognosis of these patients using the established model. This model will be used to construct a new prognostic model for liver cirrhosis incorporating imaging biomarkers such as sarcopenia, and its predictive performance will be validated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of liver cirrhosis, meeting at least one of the following criteria:
* Clinical diagnosis: ICD-10-CM codes K74.100 and K74.607 from our hospital's electronic medical record system
* Liver biopsy pathology or a combination of clinical, laboratory, and imaging examinations confirming liver cirrhosis: Pathological biopsy criteria: fibrosis bridging between lobules leading to lobular structural disarray, nodular regeneration of hepatocytes, formation of pseudo-lobules
* Laboratory tests: the presence of at least 2 of the following 4 abnormal indicators suggesting liver cirrhosis:
* a) Platelet count \< 100×10\^9/L, with no other explainable cause;
* b) Serum albumin \< 35g/L, excluding malnutrition or kidney disease as other causes;
* c) International normalized ratio (INR) \> 1.3 or prolonged prothrombin time (PT) (after discontinuation of thrombolytic or anticoagulant drugs for more than 7 days);
* d)Aspartate aminotransferase to platelet ratio index (APRI) \> 2.
* Availability of high-quality L3-level CT images

Exclusion Criteria:

* Incomplete sociodemographic, laboratory, or imaging data
* Diagnosed or highly suspected malignancy
* Severe chronic kidney disease, respiratory insufficiency, cardiovascular diseases, etc.
* Neurological diseases and muscular degenerative diseases
* Hyperthyroidism, hypothyroidism, tuberculosis, or any other diseases that may affect basal metabolism
* Diseases or conditions causing malabsorption of intestinal nutrients, such as inflammatory bowel disease or gastrointestinal surgery
* Treatment with glucocorticoids or immunosuppressants
* Pregnancy or lactation
Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma

The purpose of this study is to prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.

Radiotherapy alone is commonly used in NK/T-cell lymphoma without adverse risk including lymph node involvement, local invasion, B symptoms and high LDH level. Recently, methotrexate was prove to be a radiosensitizer in NK/T-cell lymphoma cells. Therefore, the investigators aim to verify the superiority and safety of weekly methotrexate in combination with radiotherapy in a randomized phase II study.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-75 years old
* Histological confirmed, previously untreated stage IE nasal NK/T cell lymphoma without following risk factors including local invasion, B symptoms and high LDH level
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Adequate bone marrow and organ functions

Exclusion Criteria:

* non-nasal NK/T-cell lymphoma
* Prior exposure of methotrexate
* With third space effusion
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Randomized Trial of Web-Delivered Acceptance Therapy for Smoking Cessation (WebQuit)

The goal of this study is to determine whether the ACT website provides higher quit rates than a current standard smoking cessation website.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* smokes at least five cigarettes daily for at least past 12 months
* wants to quit in next 30 days
* willing to be randomly assigned to either group
* resides in US
* has at least weekly access to a high speed Internet connection and email
* willing and able to read in English
* not participating in other smoking cessation interventions (including our other intervention studies
* has never used the Smokefree.gov website
* willing to complete all three follow-up surveys
* provide email, phone, and mailing address
* provide contact information for two collaterals (e.g., relatives).
* does not have family, friends, or other household members participating

Exclusion Criteria:

* The exclusion criteria are the opposite of the inclusion criteria above.
Uniportal VATS Versus Chest Tube for Early Empyema

This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (\>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed to have empyema and indicated for surgery.
* Age above 18 years old

Exclusion Criteria:

* Inability to tolerate single lung ventilation.
* Contraindication for general anesthesia/ medically unfit
Ketamine and Stress in OCD

The main goal of this trial is to demonstrate therapeutic efficacy of low dose ketamine in patients with OCD. We expect that ketamine will alleviate symptoms in the hours following application, but also - if effective - that the anti-OCD effects might last for several days after a single infusion.

This study will apply a randomized, double blind, comparator-controlled cross-over design and will be conducted at the Department of Psychiatry and Psychotherapy of the Medical University of Vienna. We will include 30 participants with a primary diagnosis of OCD. Participants will undergo ketamine and comparator infusions in either inpatient- or outpatient settings to assess the therapeutic capabilities of ketamine in OCD. Furthermore, participants' neurocognitive function and stress responses will be tested with four neurocognitive tasks and a cold pressor test paradigm. Study subjects will be given an option to participate in an open-label follow up with up to 8 infusions over a period of a month.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of obsessive-compulsive disorder
* A score of 16 or higher on the Yale-Brown Obsessive Compulsive Scale and ability to provide written informed consent
* At least one previous treatment for OCD

Exclusion Criteria:

* Any history of current or past psychotic disorder
* A manic episode within the preceding three years
* Current or unstable remitted substance abuse or dependence except nicotine
* Pregnancy or elevated risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception
* Any current severe personality disorder except comorbid anankastic personality disorder
* Morbus Raynaud
* Inability to follow the study protocol or adhere to operational requirements
* Current and unstable suicidality
* Unstable hypertension
* Untreated hyperthyroidism
* Any unstable cardiovascular disease
* Untreated disorders severely affecting the HPA-axis (M.Addison, M.Cushing)
* Current pharmacological therapy severely affecting the HPA-axis like corticosteroids or ACTH
Effects of Cox-II Inhibitor on Biochemical Markers in Cardiovascular-related Adverse Effects

The selective cyclooxygenase-2 (COX-2) inhibitors have been associated with increased cardiovascular risk. The goal of the present study is to investigate the impacts of COX-2 inhibitors on biochemical indices in cardiovascular disease. As the reviewer suggested, the investigators propose to study the effects of Cox-II inhibitor using experimentally induced hyperlipidemic rats. Plasma total cholesterol, LDL and triglyceride concentrations will be determined before and after animals treated with cyclooxygenase-2 (COX-2) inhibitors. Biochemical markers related to cardiovascular events including prostaglandin I2, thromboxaneA2 and others will also be investigated. The investigators will also investigate these biochemical markers in patients taking Celecoxib and NSAIDs. The investigators hope these studies will reveal clinically useful biochemical markers for cardiovascular events in patients taking Cox-II inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Male/female age \>18
* Clinical diagnosed of arthritis

Exclusion Criteria:

* Must not be pregnant/breastfeeding
* Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.
Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis

This randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the Internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in persons with MS. The investigators hypothesize that individuals who receive the 6-month behavioral intervention will demonstrate an increase in physical activity behavior that will last throughout a 6-month follow up compared with participants in the control condition. The investigators further hypothesize that individuals in the behavioral intervention will demonstrate better walking mobility and cognitive function, reduced fatigue, depression, anxiety, and pain, and improved quality of life compared to the control condition. The investigators hypothesize that the behavioral intervention will increase physical activity through positive changes in self-efficacy, outcome expectations, goal setting, and impediments as social-cognitive determinants.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS
* Relapse free in the past 30 days
* Internet and email access
* Willingness to complete the questionnaires, wear the accelerometer, and undergo randomization
* Being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months
* Ability to ambulate with or without assistance (i.e. walking with or without a can or walker, but not a wheelchair)
* Age between 18 and 64

Exclusion Criteria:

* Moderate or high risk for undertaking strenuous or maximal exercise per participants response to the PAR-Q. Those who report no more than one YES or affirmative on the 7 item PAR-Q will be considered at low risk and included for participation. All others will be considered at moderate or high risk and excluded from participation.
Ultrasound in Deep Brain Stimulation

It is the purpose of this proposal to apply tFUS to the ventral posterior lateral (VPL) nucleus of the thalamus in humans.

Current non-invasive neuromodulatory approaches like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have proven efficacious for inducing transient plastic changes in the human cortex. However, these technologies have poor spatial resolution, suffer from a depth focality tradeoff and experience significant attenuation at depth. Thus, they cannot effectively target neural tissue below the surface of the cortex. Transcranial focused ultrasound (tFUS) is a new and very promising non-surgical low-energy technique for inducing transient plasticity with high spatial resolution, adjustable focus and low tissue attenuation. tFUS has been used safely and effectively for neural stimulation in mouse, rabbit and monkey and my research has shown tFUS to also be a safe and effective method of transient cortical stimulation in humans. Having demonstrated its efficacy in humans for cortical stimulation, the next step is to take advantage of tFUS' high spatial resolution and deep focal lengths to stimulate sub-cortical neural structures. Currently, the only way to stimulate sub-cortical structures involves expensive and risky surgery. It is the purpose of this proposal to test tFUS for sub-cortical stimulation. The ability to individually stimulate small neural structures deep to the cortex without invasive surgery would have broad application in basic neuroscience for the investigation of brain structure and function as well as for the potential diagnosis and therapy of many neurological and psychiatric diseases.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* Provide written informed consent

Exclusion Criteria:

* Evidence of a current significant medical illness or psychiatric or central or peripheral neurologic disorder
* History of loss of consciousness of more than ten minutes in the past year or loss of consciousness in a lifetime that required rehabilitation services
* Personal or family history of seizure
* Any history of stroke/transient ischemic attack (TIA)
* Taking any medications that may decrease the threshold for seizure
* Affirmative answers to one or more questions of the provided attached safety questionnaires. These are not absolute contraindications to this study but the risk/benefit ratio will be carefully balanced by the PI
* Failure to follow laboratory or study procedures
Validity Assessment of the "LabForGames Warning" Serious Game

The use of simulation in medical education has been associated with positive results in the acquisition of knowledge, skills, behaviors and patient outcome. Serious games are useful educational tools since they allow both theory and practice training for an important number of learners, simultaneously. However, few studies have evaluated the validity and effectiveness of serious games.

Our simulation unit (LabForSIMS- Faculté de Médecine Paris-Sud, France) has developed a serious game named "LabForGames Warning" for nursing students with the following learning objectives: to recognize and to address the degradation of a patient's clinical condition and to work on the issue of inter-professional communication. The aim of the present study is to determine content and construct validities of the "LabForGames Warning" serious game before its use as a healthcare professional training tool.

This observational single-center open study will be conducted in the simulation center of the Paris-Sud medical school (LabForSIMS). After written consent, the study population (nurses and nursing students) will attend a three hours simulation session with the "LabForGames Warning" serious game and will be divided into three groups :

* Nursing students
* New Nurses: Nurses with \< 2 years experience
* Expert Nurses: Intensive nurses, with ≥ 4 years experience post graduate.

During three hours, each learner will play with the three different cases of the "LabForGames Warning" serious game then an auto-evaluation will be recorded.

The primary outcome measure was the evaluation of the construct validity:

The score (/100) and the duration (min) of each case of the serious game will be reported in order to assess whether the difference of the measures is related to the difference of skills between the three groups. An auto-evaluation of clinical reasoning will also be recorded.

The secondary outcome measure was the evaluation of content and face validities. For content validity, the content and parameters will be tested by the nurses ≥ 4 years experienced (Ten-point Likert scale) For face validity, the students' satisfaction and the resemblance between the virtual game and the real life clinical practice will be evaluated in the three groups (Ten-point Likert scale).

Eligibility Criteria:
Inclusion Criteria:

* Nursing students or nurses with \< 2 years experience or intensive nurses (with ≥ 4 years experience post graduate)
* and having agreed to participate

Exclusion Criteria:

* Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (\< 18 years)
* Refusal to participate in to the study Refusal to sign in the confidentiality clause
Electroencephalogram (EEG) and Electroconvulsive Therapy(ECT) Response in Schizophrenia

This study is designed to find quantitative Electroencephalogram(qEEG) biomarkers to predict Electroconvulsive Therapy(ECT) Response in Schizophrenia

The purpose of this proposal is to explore quantitative Electroencephalogram(qEEG) biomarkers that would predict Electroconvulsive Therapy(ECT) Response in Schizophrenia (SZD). The investigators will recruit 30 SZD patients who are preparing for ECT treatment and assesse psychotic symptoms using Positive and Negative symptom scale(PANSS) before and after 8-sessions clinical course of ECT treatment. These patients needed ECT treatment are assessed by clinicians according to American Psychiatric Association(APA) guidelines. Meanwhile resting EEG will be recorded for 10 minutes before the first episode of ECT treatment. Decrease of PANSS scores will be calculated after the last session of ECT treatment to distinguish responder/non-responder.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 criteria for SZD
* patients needed ECT treatment assessed by clinicians using American psychological Association(APA) guidelines.
* symptoms must be of at least moderate severity (PANSS score \>71)
* age between 18 to 60 years old
* medications will be stable for at least four weeks prior to ECT, and there will be no dose changes unless medically necessary

Exclusion Criteria:

* any additional current psychiatric comorbidity
* pregnancy or prepare to have a baby
* current use of any Antiepileptic drugs
* history of taking any kinds of Physicotherapeutics within 6 months
* severe psychotic symptoms that make patients could not accomplish the clinical interview
Expanded Access for ACE-011

This is an expanded access program (EAP) for eligible participants designed to provide access to ACE-011.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-