cyrilzakka/clinical-trials huggingface dataset:
Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis

Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial hepatic system

After inclusion, patients will be dialysed with low-flux artificial kidneys. 1 week of dialysis exists of 3 days of dialysis. In week 4, day 2, patients will be treated once with the Prometheus artificial hepatic system or with high-flux dialysis. The other days low-flux kidneys will be used. Week 5 and 6 are a wash-out period. Week 7 is identical to week 4 but the other system than in week 4 is used. Blood samples are taken at regular moments in week 3, week 4 (day 2) and week 7 (day 2).

Eligibility Criteria:
Inclusion Criteria:

* Stable patients
* At least 3 months on dialysis
* Arterio-venous fistula

Exclusion Criteria:

* Diabetic patients
* Malignancies
* Acute illnesses
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder

This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.


Eligibility Criteria:
Key Inclusion Criteria:

* History of jet lag symptoms during the past 5 years.
* The subject is in good health, as determined by a medical and psychiatric history, medical examination, clinical laboratory test results, and electrocardiography (ECG) and physical examination findings.
* Women of childbearing potential must be abstinent or use a medically accepted method of contraception, and must continue use of this method for the duration of the study (and for 30 days after participation in the study).
* The subject is willing to comply with study restrictions and remain at the study center overnight, as required.
* The subject must agree to refrain from alcohol use during the study.
* The subject has a valid U.S. passport

Key Exclusion Criteria:

* The subject has a history (past 12 months) or diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), shift work sleep disorder (SWSD), or any other sleep disorder associated with excessive daytime sleepiness; or the subject has a history or current diagnosis of hypersomnia, insomnia, or sleep disorder.
* The subject has any serious acute or chronic cardiovascular, pulmonary, gastrointestinal, neurological, endocrine or renal illness (including diabetes mellitus), hepatitis, asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant significant medical condition.
* The subject has a history of any cutaneous drug reaction or drug hypersensitivity, or any clinically significant hypersensitivity reaction, or multiple allergies.
* The subject has a history of deep vein thrombosis (DVT).
* The subject has known human immunodeficiency virus (HIV).
* The subject is pregnant or lactating.
* The subject has used nicotine within the last 3 months.
* The subject has a history of seizures, except for a single febrile seizure.
* The subject has a psychiatric disorder that would affect participation in the study or full compliance with study procedures.
* The subject has a clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings.
* The subject used any prescription or over the counter drugs disallowed by the protocol within 7 days of screening visit 2 (i.e., stimulants, hypnotics).
* The subject has used an investigational drug within 1 month before the screening visit.
* The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
* The subject has a known hypersensitivity to armodafinil or modafinil, or any other component of the study drug tablets.
Results of Ocular Compression and Suture Release in Trabeculectomy and Combined Surgery

The use of ocular compression and suture release have helped to improve the safety and decrease the risks of glaucoma filtering surgery. This study looks at the decrease in intraocular pressure and glaucoma medications required following glaucoma filtering surgery.

A retrospective review of surgical results in eyes with at least six months followup was performed for trabeculectomy and combined phacoemulsification-trabeculectomy surgery. A total of 141 eyes were studied.

Eligibility Criteria:
Inclusion Criteria:

* Primary Open Angle Glaucoma
* Six Months Followup
* No previous surgery

Exclusion Criteria:

* Less Than Six Months Followup
* Previous glaucoma surgery
Analysing the French COVID-19 Epidemic Using a National SARS-CoV-2 RT-PCR Database

Analysing ths spread of COVID-19 epidemics in a timely manner is key to implementing public health control strategies. The investigators propose to analyse a large set of laboratory SARS-CoV-2 RT-PCR data to explore potential links between Ct values and epidemic parameters.


Eligibility Criteria:
Inclusion criteria:

- A SARS-Cov2 RT-PCR result with a known sampling date

Exclusion criteria:

- Patient refusing to participate in research
Lung Cancer Screening Implementation Among Employees at Lyon Hospital

Several randomized studies have demonstrated the efficiency of lung cancer screening (LCS) on mortality rates. However, screening efficiency is related to the targeted population and the participation rate.

In France, the participation rate for breast and colon cancer screening programs is respectively 50% and 32%, which is low. Then, it appears very important to determine which factors are influencing the willingness to participate to these programs. Indeed, it will allow a better communication and we will be able to perform screening campaigns adapted to the eligible population.

The Lyon Hospital is the second university hospital in France. It is composed of 14 buildings and employed 23 000 persons. More than 160 occupations are represented. So, hospital employees look relevant to be studied for LCS program.

ILYAD was divided in 2 parts. The first one was completed in 2020 and goal to evaluate the number of eligible individuals among the hospital employees. About 800 persons would be eligible for LCS.

This second part of the study will evaluate the participation rate and the feasibility of the LCS program. The study will target the 800 individuals that were identified previously.


Eligibility Criteria:
* Inclusion Criteria :

  * Participant have to meet the criteria below:

Lyon hospital employee at the day of inclusion:

* valid hospital employee number,
* Or retired employee for less than a year before the inclusion

AND meeting eligibility criteria as follow :

* Aged from 50 to 75 yo,
* AND smoke or have smoked ≥ 10 cigarettes/day during ≥ 30 years OR ≥ 15 cigarettes/day for at least 25 years;
* AND active smoker or smoking cessation for ≤ 15 years ;

  * Volunteer to start a program of smoking cessation if active smoker;
  * Consent form signed ;
  * Cover by health insurance.

    * Exclusion Criteria :

Participant have to NOT meet the criteria below :

* Individual not working at Lyon hospital;
* Individual not payed by the Lyon Hospital but working at it;
* Individuals not willing to participate;
* Individual working at René Sabran Hospital;
* Individual meeting one of this non eligibility for LCS criteria defined by the French recommendation:

  * Not able to climb 2 floors of stairs ;
  * Weight ≥ 140Kg
  * Underwent a chest CT scan less than 1 year ago (except screening scanner);
  * History of lung cancer of less than 5 years or under treatment ; history of any cancer under monitoring by chest scanner ;
  * Comorbidity contraindicating therapeutic options or any kind of invasive interventions ;
  * Ongoing or recent respiratory symptoms that might lead to lung cancer diagnosis (hemoptysia, weight loss, recurrent respiratory infection).
* Individual who is pregnant or breast feeding;
* Individual whose mental health is not good enough to participate;
* Individual in jail or under justice evaluation.
Effect of Positive End Expiratory Pressure on Diaphragmatic Fraction Assessed Through Ultrasound in Intubated Patient Undergoing Assisted Ventilation

The investigators aim to assess the effects of positive end-expiratory pressure (PEEP) on diaphragmatic activity evaluated through ultrasound in patients admitted to intensive care unit (ICU) for acute respiratory failure (ARF) assisted via invasive mechanical ventilation in assisted mode.

All adult critically ill patients admitted to intensive care unit (ICU) and undergoing invasive mechanical ventilation (IMV) for more than 24 hours with diagnosis of acute respiratory failure (ARF) will be screened.

The exclusion criteria will be : pregnancy, neuromuscular diseases, wounds or incision at the probe placement site, contraindications to diaphragmatic and abdominal wall unltrasound, contraindications to the placement of a specific nasogastric feeding tube (Electrical activity of the diaphragm catheter).

In all enrolled patients ventilated in assisted mode, diaphragmatic activity will be evaluated through ultrasound and electrical activity of the diaphragm (primary end point) at stepwise decreasing of PEEP level. Also, the activity of remaining respiratory muscles will be assessed through sonography at the same levels of PEEP (secondary end point) Across all study phases, patients will be sedated to assure a Richmond sedation Agitation Scale (RASS) score between 0 and -1.

The following data will be recorded for each positive end-expiratory pressure explored: dosage of sedative drugs, peripheral oxygen saturation (SpO2), inspired oxygen fraction (FiO2), inpiratory and expiratory tidal volume, respiratory rate, electrical activity of the diaphragm (Eadi) (optional data), lung aeration through ultrasound or electrical impedance tomography (optional), thickness of diaphragmatic, parasternal intercostal, external oblique, internal oblique and transversus abdominis, combined with the lung ultrasound score. Thickness is measured at both end-expiration and end-inspiration for each respiratory muscles, as indirect estimation of respiratory muscles effort, and calculated according to standard formula as follows: Thickening fraction (%) = (inspiratory thickness - expiratory thickness) / expiratory thickness \* 100. All ultrasonographic measurements will be performed bedside with patients in semi-recument position, only on the right side , using a portable ultrasound machine equipped with a linear (7.5 - 12.0 MHz) or convex (2.0 - 4.0 MHz) probe. The same protocol will be carried out in case of non invasive ventilation application after extubation, reducing PEEP and inspiratory support

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* invasive mechanical ventilation \> 48 hours

Exclusion Criteria:

* pregnancy
* neuromuscular disease
* wounds or incision at the probe placement site.
A Study Of PF-05175157 In Healthy Volunteers

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 years (inclusive).
* Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* In addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination.
* Body Mass Index (BMI) of 17.5 to 29.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
* Evidence or history of any chronic ongoing or current pulmonary disease.
* History of smoking in the past 5 years or history or evidence of habitual use of other (non-smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0.
* Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye symptoms or retinal/optic nerve disease.
* Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular lubricants, or use of contact lenses.
Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure

Heart failure (HF) is a major healthcare problem. In patients with Heart Failure with Reduced Ejection Fraction (HFrEF), aldosterone antagonists reduce mortality and hospitalization rate. Gender-related differences have been described in the regulation of renin angiotensin aldosterone system (RAAS), which is at the core of the pathophysiology of HF. Regarding gender-related differences in the use of MRAs, less is known about the effects of androgens on RAAS.

In this single-center prospective cohort, a total of 100 adult (≥ 18 years) ambulatory patients of both sexes with the diagnosis of HF with HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy started an aldosterone antagonist are enrolled and followed-up for 6 months. Patients are categorized according to their apparent sexual gender into two groups: the male group and the female group.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of heart failure with reduced ejection fraction HFrEF (LVEF≤ 40%) and New York Heart Association (NYHA) class II-IV under optimized medical therapy who are presented to the outpatient clinic and started an aldosterone antagonist at the time of enrollment.

Exclusion Criteria:

* Pregnancy or breast-feeding.
* Serum creatinine \> 2.5 mg/dL (221 μmol/L) in males and \> 2 mg/dL (177 μmol/L) in women (or estimated glomerular filtration rate eGFR ≤ 30 mL/minute/1.73 m2).
* Hyperkalemia (serum potassium level \> 5 mEq/L).
* Renal transplant.
* Concomitant administration of strong CYP3A inhibitors.
* Concomitant administration of potassium supplements or potassium-sparing diuretics.
* Disorders of adrenal glands (Addison disease).
* Patients who used mineralocorticoid receptor antagonists in the last 2 weeks before enrollment.
* Patients with a history of mineralocorticoid receptor antagonists allergy or intolerance.
Endoscopy Screening for Esophageal Cancer

Patients with head and neck cancer frequently develop synchronous or metachronous esophageal malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for esophageal cancer in head and neck cancer patients. The Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions. However, whether the application of NBI improves the detection results have not been critically evaluated.

This study aims to investigate the diagnostic value of the NBI system in the endoscopic screening for esophageal neoplastic lesions in patients with head and neck cancer.

This is a prospective blinded controlled tandem endoscopy trial conducted in a regional medical center (Lotung Poh-Ai Hospital, Taiwan). Patients with tissue diagnosis of head and neck cancer are enrolled. Endoscopy screening for esophageal lesions is first performed by using the conventional white light system. Suspicious lesions are recorded. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy. After the endoscopic inspection completed, all suspicious lesions are biopsied. Before each procedure, which one of the two participating endoscopists applies the conventional or NBI system is randomized. The diagnostic rate of esophageal neoplasm by the conventional white light system and that of the NBI system are compared.

The endpoint is the neoplastic lesion detected on endoscopic biopsy. We considered invasive cancer, carcinoma in-situ, and high-grade dysplasia (which usually cannot be distinguished from carcinoma in situ) as the primary points. Any dysplastic lesions were considered as secondary points.

Eligibility Criteria:
Inclusion Criteria:

* patients with tissue diagnosis of head and neck cancer
* histopathology of head and neck cancer is carcinoma (including squamous cell carcinoma, adenocarcinoma or undifferentiated)
* aged more than 18 years old
* agree to under go upper gastrointestinal endoscopy

Exclusion Criteria:

* lack of written informed consent
* the origin of head and neck cancer is metastatic
* histopathology of head and neck cancer is not carcinoma (e.g., sarcoma, lymphoma, etc)
* incomplete upper gastrointestinal endoscopy
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010

An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information

An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information

Eligibility Criteria:
Inclusion criteria

* Subjects administered with rosiglitazone/metformin as an adjunct to diet and exercise for the treatment of type2 diabetes mellitus
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
* Subjects administered with rosiglitazone/metformin following the locally approved prescribing information

Exclusion criteria

* Subjects with previous history of hypersensitivity to rosiglitazone and/or metformin or any other ingredient
* Subjects with previous history of lactic acidosis, renal disease or renal dysfunction, hepatic dysfunction, cardiogenic shock, heart failure, myocardial infarction, pulmonary infarction and any other status with stomach upset
* Subjects with type 1 diabetes mellitus
* Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
* Subjects with severe infection, pre/post surgery, severe trauma
* Subjects with malnutrition, inanition, emaciation, pituitary insufficiency, adrenal insufficiency
* Subjects undergoing radiologic studies involving intravascular administration of iodinated contrast materials
Effect of Early Gait Training on Knee Cartilage Degeneration After Anterior Cruciate Ligament Reconstruction

A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for middle-aged people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation.

In this randomized controlled clinical study, patients with primary unilateral ACL rupture were included. In addition to standardized rehabilitation training content, gait training intervention under weight loss was added to the subjects in the early postoperative period. The control group only received standardized rehabilitation training. Based on motion testing and dynamic analysis, the influence of early postoperative gait training on postoperative gait biomechanical characteristics was explored. And the influence of early cartilage health status; Based on functional MRI, the effects of early postoperative gait training on biochemical parameters of knee tibiofemoral and patellofemoral cartilage were investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with ACL rupture were diagnosed by MRI;
2. Unilateral ACL rupture for the first time should be performed in our hospital (Department of Sports Medicine, Peking University Third Hospital)The art of reconstruction;
3. Normal BMI range: 18.5-23.9 kg/m2;
4. Within 6 months from the trauma;
5. The affected knee joint has passed the acute stage, no obvious redness, pain,inflammation, and limited joint motion,basically restore joint motion.

Exclusion Criteria:

1. BMI\<18.5 kg/m2 or BMI≥24 kg/m2);
2. There is a history of contralateral lower limb musculoskeletal system injury and surgery;
3. ACL injury time \> 6 months;
4. Outerbridge damage rating Ⅲ and Ⅳ;
5. Patients with meniscal tears who are expected to undergo meniscal suture surgery at the time of ACLR surgery;
6. Serious injury to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament;
7. There is metabolic syndrome (obesity, dyslipidemia, diabetes, etc.), which will involve articular cartilage Epidemic diseases, serious cardiovascular and cerebrovascular diseases, etc.;
8. Those who do not want to accept this treatment
Disseminating Public Health Evidence to Support State Health Department Prevention of Cancer and Other Chronic Diseases

The purpose of this study is to identify and evaluate dissemination strategies to promote the uptake of evidence-based cancer and other chronic disease prevention among state-level public health practitioners. Dissemination strategies such as multi-day in-person training workshops and electronic information exchange modalities are hypothesized to associate with improved access and use of public health evidence and organizational supports for program and policy decision making based on evidence-based public health.

Evidence-based public health approaches to prevent cancer and other chronic diseases have been identified in recent decades and have the potential for high impact. Yet barriers to implement prevention approaches persist as a result of multiple factors including lack of organizational support, limited resources, competing priorities, and limited skill among the public health workforce. The purpose of this study was to learn how best to promote the adoption of evidence based public health practice related to chronic disease prevention. This cluster randomized trial aimed to evaluate the dissemination of public health knowledge about evidence-based prevention of cancer and other chronic diseases and test receptivity and usefulness of dissemination strategies directed toward state health department chronic disease practitioners to enhance capacity and organizational support for evidence-based chronic disease prevention. Twelve state health department chronic disease units were randomly selected and assigned to intervention or control. State health department staff and the university-based study team jointly identified, refined, and selected dissemination strategies. Intervention strategies included multi-day in-person training workshops, remote telephone follow-up and technical assistance, supplemental brief remote trainings, and health department work unit procedural changes to support and strengthen evidence-based decision making. Evaluation methods included pre-post surveys and structured qualitative phone interviews.

Eligibility Criteria:
Inclusion Criteria:

* State Health Department chronic disease units (cluster) in the United States and corresponding public health workforce (individuals within cluster)

Exclusion Criteria:

* State health department has received extensive technical assistance and training comparable to our intervention (dissemination activities)
* Origin state has no logical matching pair matched state based on state population size
* Origin state has the lowest excess burden of cancer and other chronic risk and disease
* Origin state health department has lowest or highest capacity for EBDM as determined from previous research