cyrilzakka/clinical-trials huggingface dataset:
Reducing Length of Stay in the Emergency Department

Emergency department (ED) crowding has become an international challenge in the recent decades.

Length of stay (LOS) is a useful marker to monitor ED crowding. Searching for the possible causes and reducing barriers may have the greatest impact on EDLOS.

Therefore, the investigators assembled a multidisciplinary team for improvement of the ED process, to undergo assessments of ED patient flow with the spirit of lean-sigma methodologies. The objectives of this study were to evaluate a Lean-sigma-based initiative to lessen EDLOS.

Lean aims to smooth out the workflow and to eliminate wastes. In the ED settings, lean principles can display the process of the ED patient flow. Six sigma, a complementary strategy, has the merit to compensate the potential weakness of Lean through a data-driven process. Currently, a combination of Lean and Six sigma methodologies develops to solve the problems of workflow.

It became clear that concurrent multifaceted interventions were needed to reduce EDLOS. Therefore, the investigators assembled a multidisciplinary quality improvement team for improvement of the ED process, to undergo assessments of ED patient flow with the spirit of lean-sigma methodologies. The objectives of this study were to evaluate a Lean-sigma-based initiative to lessen EDLOS.

Eligibility Criteria:
Inclusion Criteria:

* the patients were registered in the ED from Jan, 2015 to Dec, 2015.

Exclusion Criteria:

* the patients were excluded because of left without seeing a physician.
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* For Dose Escalation:

  * Subjects with any previously treated advanced (metastatic or refractory) solid tumor
* For Cohort Expansion:

  * Subjects must have a previously treated advanced solid tumor to be eligible
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
* Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men

Exclusion Criteria:

* Known central nervous system metastases or central nervous system as the only source of disease
* Other concomitant malignancies (with some exceptions per protocol)
* Active, known or suspected autoimmune disease
* Uncontrolled or significant cardiovascular disease
* History of active or chronic hepatitis (e.g. Hep B or C)
* Impaired liver or bone marrow function
* Major surgery less than 1 month before start of the study
Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis

Axial spondyloarthropathy (SpA) is the most common inflammatory rheumatism (1% of the general population) with important medico-economic consequences.

Fatigue is a major feature of SA. It can be defined as a feeling of reduced muscle capacity, lack of energy and exhaustion. The fatigue reaches an abnormally high level (fatigue severity score (FSS) ≥4, called severe fatigue in this protocol) in more than two thirds of patients with SA.

Skeletal muscle repercussions are present during SA. It is characterized by a decrease in exercise capacity independently of pain and ankylosis but is associated with a decrease in strength and muscle mass, the importance of which varies from one study to another.

The link between fatigue (subjective sensation) and the skeletal muscular impact (objective) of SA has never been studied.

This work will:

1. Study for the first time the implication of the objective skeletal muscular impact in fatigue during SA.
2. Better characterize the skeletal muscle impact of SA;
3. Characterize the evolution of the fatigue and the muscular impact under targeted therapy

Eligibility Criteria:
Inclusion criteria:

* Axial SA according to the ASAS criteria;
* Targeted therapy naïve patients
* Indication to start a targeted therapy;
* Initiation of targeted therapy ≤ 15 days before inclusion
* ≥ 18 years old, no upper age limit;
* Subject affiliated to a social health insurance reimbursement;
* Subject able to understand the aims and risks of the research and having signed a dated and informed consent
* Subject informed of the results of the preliminary medical examination
* Woman in childbearing age: negative beta-HCG test and effective contraception;
* Sufficient understanding of French to follow the protocol.

Exclusion criteria:

* Targeted therapy in progress for \> 15 days prior to inclusion
* Contraindication to the use of targeted therapy
* Systemic corticosteroids in the 15 days preceding the V0 visit
* Associated extramuscular inflammatory disease (s) (excluding ocular and cutaneous involvement) eg chronic inflammatory bowel disease
* Associated fibromyalgia (Questionnaire score FiRST ≥5) achieved during the V0 visit
* History of coronary artery disease: exercise angina, acute coronary syndrome and / or coronary angioplasty,
* History of lower extremity arterial disease: vascular claudication and / or lower extremity angioplasty
* COPD
* Neuromuscular pathology
* Insufficiency of organ (renal, hepatic pulmonary heart)
* Sleep apnea
* Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject, etc.)
* Subject under the protection of justice
* Subject under guardianship or curatorship
* Breastfeeding
* Pregnancy
* Subject in exclusion period defined by another clinical study or participating in a study likely to impact the results of the research
Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.

A prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates will be asked to participate who have an area of extremity or truncal scar measuring approximately 6cmX6cm total, in one contiguous region. The study sites, will consist of four equally sized treatment areas (3cm x 3cm), will be randomized to be treated with PDL, CO2, a combination of CO2+PDL, and an untreated control for 6 treatments. The areas will be photographed prior to each treatment and at the final visit 4-6 months after the last treatment. Color, pliability and thickness will be measured using a colorimeter, cutometer and high frequency ultrasound respectively at each appointment. Additionally, the Patient Observer Scar Assessment Scale (POSAS) will be used to score the quality of the scar, using two trained, blinded observers. The patients will also be asked on a voluntary basis for a pre-trial and post-trial 3mm punch biopsy to evaluate for the presence of histological changes.


Eligibility Criteria:
Inclusion Criteria:

1. Must have at least four areas of burn scar located on the trunk or extremities measuring 3cm x 3cm and not previously treated with laser.
2. Timing: There has been a minimum of 1 month after burn closure
3. The subject is at least 18 years of age and not older than 65.
4. Able and willing to provide verbal and written consent.

Exclusion Criteria:

1. Active infection in experimental area
2. Use of isotretinoin (Accutane) in last six months
3. Life or limb-threatening injury/disease
4. Prior history of non-compliance with medical regimes
5. Active drug use/abuse
6. Active psychiatric illness except depression (unless being treated for suicidal intentions)
7. Pregnancy
8. Active cancer, or new diagnosis of cancer within the past 5 years, with the exception of basal cell carcinoma, melanoma and squamous cell carcinoma, as long as the subject is disease free at the time of enrollment.
9. Prior PDL or other laser treatment of the study area.
10. Patient unable to tolerate laser procedure.
Iterative Redesign of a Behavioral Skills Training Program for Use in Educational Settings

This study proposes to redesign the RUBI Parent Training program, a low-intensity intervention for youth with autism spectrum disorder and disruptive behavior, for use by school personnel in the classroom. Using a mixed-methods approach, 40 school staff members from 20 elementary schools will be recruited to inform current classroom behavior management practices and RUBI redesign needs.

Approximately 50% of children with autism spectrum disorder (ASD) exhibit disruptive behaviors such as tantrums, aggression, and noncompliance that significantly impact social, adaptive, and academic functioning. The RUBI program is an evidence-based parent-mediated intervention that improves disruptive behavior in children with ASD. Considering schools serve as the primary intervention setting for children with ASD, and teachers and school staff often struggle to address challenging behavior, there is an opportunity to meaningfully improve care by adapting RUBI for delivery in schools. To address these needs, the Discover, Design/Build, Test (DDBT) framework,which leverages user-centered design and implementation science, will be used to engage 40 end users from 20 elementary schools to inform current classroom behavior management practices and redesign needs for the RUBI curriculum to ensure that the modified curriculum (RUBI in Educational Settings; RUBIES) is useful and useable for school personnel who work with children with ASD. Specific aims include:

Aim 1: Identify the contextual constraints and end users (teachers, school psychologists, behavior technicians, classroom aides) relevant to the management of disruptive behavior in the classroom. Through in-class behavioral observations and interviews, Aim 1 will allow us to understand the values and priorities of the school context and end users directly involved with children with ASD (e.g. resources, work flow, policies).

Aim 2: Identify targets for RUBI redesign. Using in-depth intervention demonstration of RUBI paired with behavioral rehearsal, prospective think-aloud, and structured assessment methods, Aim 2 will allow us to determine which RUBI components should be retained, eliminated, or modified to address the needs of the context and end-users identified in Aim 1.

Aim 3: Iteratively adapt RUBI content and procedures based on identified targets for redesign and continual user testing to improve the hypothesized mechanisms of redesign (usability) and perceptual implementation outcomes (feasibility, acceptability, and appropriateness). Aim 3 will allow us to determine the extent to which redesigned RUBI, or RUBIES, improves usability and implementation outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Elementary school (kindergarten through 5th grade) personnel (i.e. general and special education teachers, school psychologist, paraprofessionals)
* Works with at least one student with ASD for part of the day

Exclusion Criteria:

-School personnel who do not have contact with youth with ASD during the work day
A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.

By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination.
* Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes.
* Age of 1-14 years.
* Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion Criteria:

* Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
* With history of allergies on traditional Chinese medicine.
* Patients or their guardians suffering from Psychiatric diseases.
* Attending other clinical studies on HFMD after diagnosed.
SPHERE Per-AF Post-Approval Study

SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.

The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9™ Catheter and Affera™ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months)
2. Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)
3. Patient is ≥ 18 years of age
4. Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System
5. Patient is willing and able to comply with study requirements and give informed consent

Exclusion Criteria:

1. Long-standing persistent AF (continuous AF sustained \>12 months)
2. Prior left atrial catheter or surgical ablation
3. Life expectancy \<36 months
4. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
5. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
Direct Mechanical Thrombectomy Versus Bridging Therapy

This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt.

This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt. In the first arm, 17 patients were recruited and underwent direct mechanical thrombectomy without receiving recombinant tissue plasminogen activator. In the bridging therapy arm, 34 patients received first tissue plasminogen activator then underwent direct mechanical thrombectomy. The efficacy was evaluated by the NIHSS improvement 24 hours following stroke onset and the modified Rankin scale 3 months following stroke. Safety was assessed by the procedural complications rate especially the hemorhagic transformation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with anterior ischemic stroke due to large vessel occlusion.
* A previous autonomous modified Rankin Scale (mRS) of less than 2.
* A National Institutes of Health Stroke Scale (NIHSS)≥4
* A groin puncture within 4.5 hours of the neurological deficit onset.

Exclusion Criteria:

* Imaging documentation of intracranial haemorrhage
* A premorbid mRS score of 2 or more
* Absence of diffusion perfusion mismatch in CT perfusion.
Study About Simvastatin in Portal Hypertension in Compensated Cirrhosis

The purpose of this study is to determine whether simvastatin is effective in the prevention of progression of porta hypertension in compensated cirrhosis patients.

Decompensation of cirrhosis is associated with a dramatic reduction of survival. Progression of portal hypertension (PHT) is the main determinant of decompensation that appears when portal pressure gradient (PPG) is ≥10mmHg (clinically significant HTP). 40% of compensated cirrhotic patients have mild PHT. However, with progression of disease 41% develop clinically significant PHT. In cirrhosis, PHT results from increased resistance to blood flow, with a dynamic component due to decreased nitric oxide (NO) bioavailability. In advanced disease increased portal venous inflow also contributes to PHT. Beta-blockers have not been useful in compensated cirrhosis with mild PHT. In early cirrhosis, vasodilators may be more adequate. Statins, drugs that inhibit the activity of HMG-CoA reductase, induce selective hepatic vasodilation due to an enhanced bioavailability of NO. Acutely, they decreases hepatic resistance, while with long-term use statins decreases PPG without deleterious effects on systemic circulation. This multicenter, randomized, double-blind placebo-controlled study is aimed at assessing whether treatment with simvastatin may prevent progression of mild PHT (with PPG between 6 and 10 mmHg) to clinically significant PHT. Patients with compensated cirrhosis, without previous decompensation, without esophageal varices at risk and with PPG between 6 and 10 mmHg will be included. The calculated sample size is 80 patients and the duration of the study 4 years (2 years including and a follow-up of at least 2 year).

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis diagnosed by previous biopsy or by clinical, laboratory, ultrasound
* Portal hypertension gradient between6 mmHg and10 mmHg
* Absence of esophageal and gastric varices or small esophageal varices without red signs
* Absence previous episodes of gastrointestinal hemorrhage, ascites, encephalopathy or jaundice
* Written informed consent

Exclusion Criteria:

* Age \<18 and\> 80 years,
* Presence or history of ascites, clinical or ultrasound,
* Previous decompensation of liver cirrhosis, ascites or SBP, bleeding varices, large varices, hepatic encephalopathy, jaundice,
* Thrombosis splenoportal,
* Hepatocellular carcinoma;
* Child-Pugh \>7 point
* Any comorbidity that leads to a restriction therapy and / or a life expectancy \<12 months
* Absolute contraindication to treatment with statins or allergy Simvastatin;
* Concomitant potent CYP3A4 inhibitors (eg., itraconazole, ketoconazole, protease inhibitors, HIV, erythromycin, clarithromycin, telithromycin and nefazodone),
* Pretreatment (\<1 month) with simvastatin or other lipid-lowering,
* Previous episodes of rhabdomyolysis,
* Active alcoholic hepatitis,
* Refusal to participate in the study or the informed consent claim;
* Pre-treatment with beta blockers or nitrates, or endoscopic treatment for varicose veins or portosystemic derivations;
* Pregnancy and lactation.
Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants

An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
* Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.

Exclusion Criteria:

* History of chronic illness
* Chronic headaches
* Recurrent dizziness
* Personal or family history of heart disease
* Personal history of bleeding diathesis

Other protocol defined inclusion/exclusion criteria could apply
Estimation of Plasma Folate Apparent Volume of Distribution in Adults

The aim of this study is to calculate the plasma apparent volume of distribution of natural folate to give a more accurate value for use in a mathematical model of apparent folate absorption.

Bioavailability is a major determinant of nutritional status. In order to determine a safe level of folate fortification, its bioavailability must be assessed, so that risk-benefit analysis can be carried out. Recently, a mathematical model of folate true absorption which takes into account the liver first pass was devised (ref 1). In this model, the volume of distribution is a convenient method for describing how well a nutrient is removed from plasma and distributed into tissues.

In this study, volume of distribution will be more accurately estimated using an intravenous dose of labelled (13C5) dose of natural folate (5-methyltetrahydrofolic acid) in healthy adults aged 18-65, over a wide body mass index (BMI) range.

Healthy adults will be given an IV dose of a small amount of 13C5 5-methyltetrahydrofolic acid, and blood samples will be taken at regular time points via a cannula over a 2hr time period.

The primary objective is to estimate the sampled plasma pool volume of distribution in order to quantify the fraction of any folate test dose, or folate metabolites, appearing in systemic plasma circulation in future studies of bioavailability.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Aged 18-65
* Body mass index above 19.5 and below 40
* Smokers and non-smokers
* Participation in the FolGene study

Exclusion Criteria:

* Pregnancy or been pregnant in last 12 months
* History of fits, seizures or blackouts
* Parallel participation in other research projects which invole dietary intervention and/or sampling of biological fluids/material which study nurses advice would affect either wellbeing of volunteer or the study data, apart from participation in the FolGene study
* Any person related to or living with a member of the study team
* Participation in another research project which involves blood sampling within the last 4 months unless total amount blood combined from both studies is less than 470ml
* Had donated blood within 16 weeks of starting the study
* Prescribed medication for epilepsy/seizures
* Diabetics
* History of any gastrointestinal disorder requiring medical treatment
* Any long term medical condition requiring active treatment which may affect volunteers wellbeing or the study data