cyrilzakka/clinical-trials huggingface dataset:
Simulation-based Education for Managing Stress in ICU Nurses

I. Main outcome Decrease of the stress evaluated 6 months after training. Stress is defined as the presence of job strain as defined by Karasek.

II. Main secondary outcomes

* ICU nurses stress at one year
* Burnout
* Intent-to-leave the ICU
* Quality of life

III. Design

Prospective, randomized, open study comparing 2 groups of ICU nurses:

Simulation group and Control group

Nurses from 9 different adult ICUs will be included. Stratification by ICU will be done (to take into account differences between the ICUs regarding organization, activity, patients...).

This study is observational because nurses can participate to this training when they want. The fact that nurses are in control group delays their participation to this training but does not forbid them to particpate. The nurses from control group will participate to training at the end of study.

IV. Specific measures Control group: none

Simulation group: 5-day specific training with dedicated scenario done by an ICU expert simulation team

V. Study duration 48 months

VI. Ethical aspects - Reglementary concerns

* Study accepted by the Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé (CCTIRS) and by the Commission Nationale de l'Informatique et des Libertés (CNIL)
* Information to the participants prior inclusion

VII. Study population Job strain evaluated in a French study was 59% . The same rate was observed in a survey done in our institution (Assistance Publique Hôpitaux de Marseille). We therefore hypothesized that the intervention (simulation) should be able to reduce the job strain from 59% to 45% of the participants. With a power of 80% and a risk a of 5%, this study needs to include 185 patients per arm. To take into account few participants who will not complete the study, we aimed to include a total of 400 ICU nurses.

VIII Results An interim analysis will be performed after 200 inclusions


Eligibility Criteria:
Inclusion Criteria:

* ICU nurses from adult ICUs with a professional experience in the actual ICU of at least 6 months and no decision to leave the ICU at the time of enrollment

Non inclusion Criteria:

* Less than 6 months of professional activity in the actual ICU at the time of enrollment
* Intent-to-leave in the next 6-month period
* Previous experience of this simulation program
* Pregnant women

Exclusion Criteria :

* ICU nurses who leave their city during the study period
* Pregnant women who miss their job during at least 4 weeks during the study period
Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

Previous studies have demonstrated that altered microvascular blood flow is an important marker of severe sepsis. Usually, these patients need invasive ventilatory support, frequent use of sedatives and it is unknown if these agents interfere or not on microvascular blood flow. The goal of this study was to compare effects of propofol and midazolam infusions on sublingual microcirculation of septic shock patients.


Eligibility Criteria:
Inclusion Criteria:

* Septic shock patients needing mechanical ventilation in pressure or volume-controlled mode.

Exclusion Criteria:

* age less than 18 years,
* pregnancy,
* non-sinus rhythm, and
* contraindication of daily interruption of sedative drug,
* mainly with the use of neuromuscular blocking drugs, or
* patients with intracranial hypertension or epileptical status.
Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction

This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).


Eligibility Criteria:
Inclusion Criteria:

* Women 20-40 years old
* Parity ≥ 1 child
* Requesting long-term contraception
* Written informed consent.

Exclusion Criteria:

* in accordance with the current leaflet
Pressure Wave Guided Atrial Fibrillation Cryoablation

Prospective multicenter observational study evaluating the performance of pressure wave-guided atrial fibrillation cryoablation used in accordance with clinical practice guidelines.

The POLAR-WAVE registry is a prospective, multi-center, single-arm study evaluating the efficacy and safety of pressure-guided atrial fibrillation cryoablation, where the occlusion of pulmonary veins will be assessed by pressure waveforms (instead of contrast), over a follow-up period of 12 months.

This is a non-commercial, investigator-driven clinical study, coordinated by the main investigator from University Hospital "12th of October", Madrid, Spain. Several responsibilities are delegated to the Clinical Research Unit (University Hospital "12th of October", Madrid, Spain).

The study was planned according to the Good Clinical Practices. POLAR-WAVE Study has been approved by the Ethics Committee and Spanish Health Authorities. All participating patients must give written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years.
* Paroxysmal, persistent, or long-lasting persistent atrial fibrillation.
* Indication of pulmonary vein ablation according to clinical practice guidelines.

Exclusion Criteria:

* Previous ablation of atrial fibrillation.
* Thrombus in the left atrium.
* Rheumatic heart disease.
* Hypertrophic cardiomyopathy.
* Absolute contraindication to anticoagulation.
* Women in a state of pregnancy, lactation or childbearing age without contraception.
* Life expectancy \< 1 year.
Efficacy of Zinc L-Carnosine Mouth Rinse

A clinical trial to assess the effect of a Zinc-L-Carnosine-based mouth rinse on periodontal tissues and pain after scaling and root planing

A randomized, double blind, 3 group parallel study with random allocation of 75 patients to any of three groups; Zinc-L-Carnosine-based mouth rinse, Chlorhexidine mouth rinse and placebo (water) control. Three days after professional oral hygiene, which aimed at the normalization of the periodontal index, the primary (HI, VAS) and secondary (mSBI; FMPS; VMI; SI) outcomes of the study are measured to obtain baseline information, and then scaling and root planing are carried out.

The participants will be advised to follow their regular oral hygiene procedures (tooth brushing) in addition to the allocated mouth rinse. They will be examined again for primary and secondary outcomes at 7 and 21 days.

Clinical evaluation:

Clinical examination of each participant will be done by a single examiner using the previously described VAS scale and a UNC periodontal probe (No. 5 explorer Hu-Friedy, Chicago, Ill). In addition to these indices, each subject will be asked to report any adverse events they have encountered during the experiment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a PSR score greater than 2 that undergo a session of scaling and root planing

Exclusion Criteria:

* Use of mouth rinses or local or general medication in the preceding three weeks
* Any condition related with allergy or sensitivity with the mouth rinses ingredients
* Systemic and chronic diseases in progress
A Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Trastuzumab, Pertuzumab in Combination With Trastuzumab, or Ado-Trastuzumab Emtansine

The MotHER Pregnancy Registry is a United States (U.S.)-based, prospective, observational cohort study in women with breast cancer who have been or are being treated with a trastuzumab (herceptin)-containing regimen with or without pertuzumab (perjeta) or ado-trastuzumab emtansine (kadcyla) during pregnancy or within 7 months prior to conception (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab emtansine exposure).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant; women identified at any trimester of pregnancy may enroll in this study as long as enrollment occurs prior to experiencing pregnancy outcome (that is \[i.e.\], live birth, stillbirth, or abortion)
* Exposure to at least one dose of trastuzumab (as adjuvant or metastatic treatment), pertuzumab plus trastuzumab combination treatment, or ado-trastuzumab emtansine during pregnancy or within 7 months prior to conception
* United States resident

Exclusion Criteria:

* Prior knowledge of pregnancy outcome (i.e., live birth, stillbirth, or abortion) at time of enrollment
VISIODOL: Validation of the VISIODOL® Scale

The aim of this study is to validate the VISIODOL® scale for screening of pain in people with visual impairment.

The VISIODOL® monocentric study conducted at Clermont-Ferrand University Hospital is a cross-disciplinary diagnostic tool validation performed in patients with acquired or congenital visual impairment and healthy sighted volunteers. Different evaluations by thermal (Pathway Médoc®) and mechanical (electronic Von Frey®) tests will allow to compare the new VISIODOL® scale with the numerical scale, which is a commonly used tool. The ergonomic quality, the satisfaction of use and the quality of life, stress, anxiety and catastrophism of the patients will also be studied.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Subjects aged over 18 / under 60
* Male or female
* Subjects fasting from coffee, tea, Coca-Cola and others stimulants
* Sufficient understanding and cooperation to comply with the study requirements
* Agreed to provide written consent
* Affiliated to the social security
* Subjects with visual impairment (congenital or acquired)
* Subjects with no visual impairment (healthy group)

Exclusion Criteria:

* Subjects under 18 years old
* Administrative and legal criteria (tutorship, curatorship, without social security, in exclusion period of another study)
MenB Vaccine: Implementation Via Information, Empowerment and Accessibility

As part of an effort to increase MenB vaccine uptake among adolescents and young adults, study teams will conduct qualitative research to maximize the effectiveness of nationally recommended MenB educational materials. In this study, Study Teams will assess local barriers to MenB vaccination by conducting focus groups with parents, students, and health care professionals.

Participants (parents of 16-23 year old teens and young adults, high school and college students 16-23 years old, and health care professionals for 16-23 year olds) will be asked to share their thoughts on the completeness of nationally recommended and publicly available MenB vaccine educational materials in addressing hesitations to receipt of the MenB vaccine. There is no risk in discussing reactions to educational materials. The biggest risk is disclosure of information provided in the study which will be reactions to health-promotion material.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide informed consent or assent

Exclusion Criteria:

* Inability to provide informed consent or assent
Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response

The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).


Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for bipolar depression, in the opinion of the investigator, according to the Diagnostic and Statistical Manual of Mental Disorders \[Text Revision\] (DSM-IV-TR) disease diagnostic criteria.
* Patients must have experienced, in the opinion of the investigator, at least one previous hypomanic, manic or mixed episode as defined in DSM-IV-TR.
* Subjects must have an initial score at Visit 1 of at least 20 on the MADRS.

Exclusion Criteria:

* Any patient currently meeting DSM-IV-TR criteria rapid-cycling course.
* A CGI-Severity - Mania score of at least 3.
Epidemiology Research on Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) in Adult ICU in Shanghai

To survey the prevalence and the mortality of the Acute Lung Injury/ Acute Respiratory Distress Syndrome (ALI/ARDS) in 12 university hospital ICUs in Shanghai.

Acute lung injury is a critical illness syndrome consisted of acute hypoxemic respiratory failure with bilateral pulmonary infiltrates that are not attributed to left atrial hypertension. The severity of the hypoxemia differentiates these two entities, with a ratio of partial pressure of oxygen in arterial blood (PaO2) to inspired fraction of oxygen (FIO2) of less than 200 mm Hg for ARDS and of less than 300 mm Hg for ALI.\[1\] Although ARDS initially was reported in 1967 by Ashbaugh and colleagues\[2\], it was not until 1992 that the American-European Consensus Conference (AECC) on ARDS developed a standardized definition for ARDS and ALI. There are many epidemiologic researches about the incidence and mortality of the ALI/ARDS.\[3-6\] Gorden D \[3\] reported that a total of 1113 King County residents undergoing mechanical ventilation met the criteria for acute lung injury and were 15 years of age or older. On the basis of this figure, the crude incidence of acute lung injury was 78.9 per 100,000 person-years and the age-adjusted incidence was 86.2 per 100,000 person-years. The in-hospital mortality rate was 38.5 percent. In our country, Yueming Lu \[7\] reported in-hospital and 90-day mortalities of ARDS patients were 68.5 and 70.4% in Shanghai ICU in 2004.

In recent years, significant progress has been made in the diagnosis and treatment of the ALI/ARDS, such as the application of the lung protective ventilation strategy and the CRRT, which may prove the symptoms and the prognosis of the ALI/ARDS. However, controversies still remained. Ventilation drive pressure, early application of neuromuscular blockade, strategy of PEEP level are frequently met questions in routine practice. In our country, a guideline for the treatment and diagnosis of ALI/ARDS was developed in 2006 \[8\]. So the incidence and the mortality of this disease are unknown in our country now. Therefore, the investigators will perform a prospective, multi-center study to survey the incidence, risk factors and outcome of ALI/ARDS in 13 adult ICU in Shanghai.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with ALI/ARDS who are admitted to the study ICUs between 1st Aug. 2010 at 00:00 hours (midnight) and the finish date of 31st Jan. 2011 at 23:59 hours (11.59 pm). Patients who are already in the ICUs prior to 1st Aug. 2010 at 00:00 hours will not be included in the study.

Exclusion Criteria:

* Patients less than 15 years old.
* Patients with the organ transplantation, end-stage of the malignant tumors and brain death.
* The GCS of the patient is less than 8.
* Patients with severe sepsis who were directly transferred to the study ICUs from another hospital or another ICU.
* For all patients who are discharged from the ICU and readmitted to the ICU again during the study period, only the first admission during the study period will be included.
Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)

The purpose of the study is to determine if topically applied nitric oxide gas is effective in reducing the quantity of bacteria (including MRSA)in a wound.


Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent
* Must be ≥ 18 years of age and not of child bearing potential
* Must have an ulcer in which the presence of MRSA has been identified, but which is not clinically infected
* Must have an ulcer size not to extend beyond the inner borders of the dressing

Exclusion Criteria:

* Is a female of child bearing years or who could become pregnant
* Is \< 18 years of age
* Has an clinically infected skin ulcer
* Has a ulcer that is being treated with a topical antimicrobial agent or has been treated with a topical antimicrobial agent during 3 days prior to enrolment
* Has been using systemic antibiotics during 7 days prior to enrolment into this study
* Has an ulcer which is identified as malignant in origin (e.g. Marjolin's ulcer)
* Has an ulcer size beyond the inner borders of the dressing
* Is septic or has other signs of an invasive infection
* Has used any investigational drug within 30 days preceding study participation.
* Suffers from a condition, which, in the opinion of the Investigator, would compromise his or her safety.
* Suffers from a condition which, in the opinion of the Investigator, would compromise the quality of the data.
* Has a known allergy to any of the products that are part of this protocol
* Suffers from a condition which, in the opinion of the Investigator, would seriously interfere negatively with the normal parameters of immune response to an infection.
* Is using any of the prohibited concomitant medications or treatments
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder

The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.

The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term

Exclusion Criteria:

* Previous cardiac problems of the patient or the parents or current cardiac findings of the patient; Relevant medical condition other than ADHD; ADHD medication within a specified timeperiod prior to study start; Pregnancy or nursing; Positive drug screen

Other protocol-defined inclusion/exclusion criteria may apply
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).

To compare safety and efficacy of SakuraBead with corticosteroid injection for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on a total of approximately 89 patients who will be followed up for a period of 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is able and willing to provide written informed consent, and
2. Clinical diagnosis of knee OA, and
3. Moderate to severe knee pain (WOMAC Pain ≥ 10), and
4. Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
6. Age ≥ 40 years and \< 80 years, and
7. Able to comply with all treatments and follow-up visits.

Exclusion Criteria:

1. Severe knee OA (Kellgren-Lawrence grade 4), or
2. Current infection of target joint, or
3. Life expectancy less than 36 months, or
4. Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
6. Prior knee replacement surgery in the target knee, or
7. Pain score of \>3 NRS on the non-target knee, or
8. An acute internal derangement of the target knee, or
9. History of uncorrectable coagulopathy, or
10. Prior iodinated contrast reaction resulting in anaphylaxis, or
11. Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
12. Has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or
13. Contraindication to MRI, or
14. At the discretion of the Principal Investigator
Fibre suppLements fOR Pre-diAbetes - An Assessment Oral Fibre Supplements on Pre-diabetes Outcome Measures

This trial will investigate whether a powdered fibre mix helps maintain healthy blood glucose levels in participants with pre-diabetes, where high blood sugar is a risk of diabetes.

Pre-diabetes is characterised by high blood glucose levels, high plasma cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL). Dietary fibre consumption has been hypothesised to improve these metabolic parameters through the viscous properties, and the production of short-chain fatty acids (SCFA) in the intestine.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide informed consent
* Have a Body Mass Index (BMI) of at least 25 kg/m2
* Men or post menopausal\* women aged 18-70
* Identified as pre-diabetic (HbA1c 6.0% (42 mmol/mol) to 6.4% (47 mmol/ mol)) within the previous 12 months
* Baseline HbA1c result within the range 5.8% (40 mmol/mol) - 6.5% (48 mmol/mol)
* Willing to complete in clinic blood tests and a participant trial survey
* Have access to a smartphone or a computer

Exclusion Criteria:

* Receiving medication to treat Type 1 or Type 2 diabetes in the previous 6 months
* Have a Body Mass Index (BMI) \<25 kg/m2 and \>45 kg/m2
* Loss of more than 5% body weight in last 3 months
* Current participation in weight loss program or planned in the next 16 weeks
* Steroid use (except for over the counter NSAID's, topical steroids and inhalers)
* Severe hepatic diseases (including chronic persistent hepatitis, liver cirrhosis or the co-occurrence of positive hepatitis B virus surface antigen and abnormal hepatic transaminase (serum concentrations of alanine transaminase or aspartate transaminase \>2.5× the upper normal limit))
* Continuous antibiotic use for \>3 days within 4 weeks prior to enrolment
* Continuous use of weight-loss drug for within 3 months of study entry
Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.

For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).


Eligibility Criteria:
Inclusion Criteria:

* Benign Prostatic Hyperplasia, based on medical history
* Voiding symptoms

Exclusion Criteria:

* Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder
* Major organ dysfunction
* Eczema (atopic dermatitis) treated during the last 6 months
* Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior randomization or with α blockers or saw palmetto within the last 6 weeks prior to randomization
* Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy
* History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months