cyrilzakka/clinical-trials huggingface dataset:
Burn Out Among Medical Family Doctors

The main objective of this study is to assess the burnout prevalence among French general practitioners in private practice.

As secondary outcomes, this study aim to measure the impact of sociodemographic variables, organizational practice models and workload. the investigators also intend to characterize the prevalence of depression, anxiety, fatigue and stress, drugs and alcohol consumption, use of psychotropic medication, and preferred strategies to cope with their symptoms.

The BOUM protocol is designed to provide a better understanding of the current burnout prevalence among French general practitioners, as well as its risk and protective factors.

In order to fulfil those objectives, the methodologist estimated a 1536 individuals sample size, using an expected prevalence of severe burnout ranged between 10% and 20% (from the the EGPRN study - Soler, J.K., et al., Burnout in European family doctors: the EGPRN study. Family Practice, 2008. 25(4): p. 245-265), thus allowing the investigators to retrieve results with a 95% confidence level and a 2% error margin.

All analyses will be performed in a bilateral formulation for a 5% alpha error under the Stata® software (version 13, StataCorp, College Station, US). A difference will be considered statistically significant for p\<0.05. The population will be described as frequency and percentage for the categorical variables, and as mean ± standard deviation or median \[interquartile range\] for the quantitative variables, according to their statistical distribution (normality studied by the Shapiro-Wilk test). Confidence intervals for population prevalence will be characterised with a binomial test. Comparisons between groups of burnout will be performed using Chi2 or Fisher's exact test for the categorical variables (followed by a Marascuillo post-hoc tests if needed), and by an ANOVA or Kruskal-Wallis test if normality and homoscedasticity not respected (Bartlett test) for the quantitative variables (followed by Tukey-Kramer or Dunn tests when necessary). Finally, considering the variables clinically relevant and those with a pertinent univariate analysis results, a multivariate analyse of ordinal polynomial regression type will be proposed; its results will be expressed as relative risk with 95% confidence intervals and presented as a Forest-plot.

Eligibility Criteria:
Inclusion Criteria:

* General practitioners working in France

Exclusion Criteria:

* None
Accommodative Relief for Uncomfortable Non-Presbyopes

This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).

The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Visual acuity of 20/25 or better in both eyes with habitual contact lenses
* -0.75 D or more myopic in both eyes
* -0.75 D or less astigmatism in both eyes
* Current single vision contact lens wearer who does not require a reading aid
* CLDEQ-8 score of 12 or more points with habitual contact lenses
* No history of ocular surgery or medication
* Reports digital device use of at least 3 hours per day
* No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes)
* No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)
Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects

The purpose of this study is; to determine the pharmacodynamic (PD) effects of ICA-105665 using the intradermal (ID) capsaicin model in healthy male subjects, and to investigate the effect of ICA-105665 on inflammatory hyperalgesia using the ultraviolet B (UV-B) model in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged 18 to 55 years (inclusive).
* Body mass index (BMI) of 18 to 30 kg/m2.
* Non-smokers and smokers of up to 5 cigarettes or equivalent per day.
* Must be able to abstain from smoking during residential periods.
* Demonstration of positive hyperalgesia as defined by an area of hyperalgesia = 15 cm2 15 minutes after ID administration of 100 µg capsaicin.
* Demonstration of negative hyperalgesia as defined by an area of hyperalgesia \< 5 cm2 15 minutes after ID administration of capsaicin vehicle.
* Subject with a skin type compatible with the measures, and without significant skin allergies, pigmentary disorders, or any active dermatological conditions that might interfere with the conduct of the study.

Exclusion Criteria:

* Subject has had a clinically significant illness in the 4 weeks before screening.
* Use of prescribed medications and herbal supplements in the 7 days prior to dosing or over the counter preparations, including multivitamins and paracetamol, in the 48 h before dosing.
* Subject has a significant history of drug/solvent abuse (within 2 years prior to Day 1), or a positive drugs of abuse test at screening.
* Subject with a history of alcohol abuse or currently drinks in excess of 28 units per week (males), or has a positive breath alcohol test at the Screening visit or on Day 1.
* Subject has a Heat pain tolerance threshold (HPTT) of = 50°C at screening.
* Subjects who do not develop erythema at the highest intensity of UV-B light used to establish Minimum erythema dose (MED).
* Known allergy or intolerance to capsaicin or hot peppers.
* Subjects who have any skin trauma, scars or other skin disorder or tattoos on their forearms or on the front of their thighs.
* Subject with active chronic pain conditions or a history of chronic pain conditions.
* Any condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs.
* Previous ingestion of ICA-105665.
* Considering or scheduled to undergo any surgical procedure during the duration of the study.
* Prolonged QT/QTc interval (repeatedly = 450 msec). Received any agent known to alter hepatic or renal clearance (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, clarithromycin, troleandomycin, ketoconazole, miconazole, fluconazole, itraconazole, etc.) for a period of 30 days prior to Day 1.
* History of risk factors for Torsades de Pointes (family history of long QT syndrome, heart failure, hypokalemia).
* Subject is unable to tolerate being blindfolded.
* Subject has participated in a clinical study involving capsaicin within 1 year of the Screening visit.
* Subject has a history of skin cancer.
* Subject has a clinically significant history of anemia.
Impact of Dyspnea, Regional Lung Ventilation, and Diaphragmatic Function During de Novo Acute Respiratory Failure

Modern management of acute respiratory failure aims to relieve dyspnea and anxiety by providing a non-invasive respiratory support. This approach tries to avoid endotracheal intubation, patient self inflicted lung injuries (PSILI) and diaphragmatic dysfunction. The present study aims to evaluate dyspnea, pulmonary regional ventilation and diaphragmatic function in patients with hypoxemic acute respiratory failure by different observations, and to bring risk factor for intubation out.

Patients aged of 18 years or more, presenting with an acute respiratory failure without hypercapnia will be included in the study. Clinical and biological variables, dyspnea assessment, regional lung ventilation (electrical impedance tomography) and diaphragm function (ultrasound) will be evaluated at inclusion and at 2 hours, 4 hours and 48 hours after inclusion. In case of intubation, diaphragmatic function will be also evaluated with phrenic nerve stimulation technique.

Primary endpoint is intubation at day 7. Secondary endpoints are measurement of dyspnea, pulmonary ventilation and diaphragmatic function, also ventilator free days, ICU length of stay and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Acute respiratory insufficiency defined by the three following items :

  1. PaO2/ FiO2 \<300
  2. Respiratory rate \> 25/min
  3. Oxygen support \> 10L/min or High Flow nasal oxygen (HFNO)
* Non opposition by the patient to be included
* Social insurance

Exclusion Criteria:

* Respiratory acidosis (pH \< 7,35 PaCO2 \> 45mmHg or 6kPa)
* Chronic respiratory disease ( COPD, bronchiectasis...)
* Cardiogenic Acute lung oedema
* Non intubation decision at randomisation
* Contraindication for Electro-impedance tomography-belt placement (chest trauma with rib fractures, thoracic wound, chest tube).
* Uncommunicative patient (Glasgow coma scale \<12)
* Guardianship or curators for vulnerable patients.
Effects of Sufentanil on the Intraoperative Hemodynamics

This study is a randomized, controlled trial. A total of 92 patients will be randomized to receive sufentanil or remifentanil during extracranial-intracranial bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo elective extracranial-intracranial bypass surgery
* American Society of Anesthesiologists grade 1,2,3
* Age \> 18 years old

Exclusion Criteria:

* Refuse to participate to the study
* American Society of Anesthesiologists grade 4
* Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
* Allergic history of opioid
* pregnant
* MAO Inhibitor user
* Severe respiratory insufficiency
SP16 SERPIN-like Peptide Administration in Healthy Individuals

This study is a randomized, double-blind, placebo-controlled Phase 1 Clinical Trial of 24 healthy individuals to test the safety, tolerability and pharmacokinetics of a single subcutaneous administration of Serpin Peptide 16 (SP16), a Serine Protease Inhibitor (Serpin)-like, small peptide agonist of the Low Density Lipoprotein Receptor-like Protein 1 (LRPP1) hypothesized to have anti-inflammatory activity.

One of the major determinants for outcome in patients with acute myocardial infarction (AMI) is the degree of inflammatory response. SP16 is a synthetic anti-inflammatory peptide developed to reproduce the anti-inflammatory activities of naturally occurring Serpins and has been tested as a treatment for AMI in mice. This Phase I trial will be the first to test the hypothesis that a single subcutaneous administration of SP16 is safe and well tolerated in healthy individuals, while also assessing the pharmacokinetic parameters of three different dosages. Participants will undergo direct clinical monitoring for up to 12 hours after drug administration. Additionally, participants will follow up with the same assessments at 24 hours, 48-72 hours and 7 days post drug administration.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18 to 59 years
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Ability to take oral medication and be willing to adhere to the medication regimen
* For females of reproductive potential: Use of highly effective contraception
* For males of reproductive potential: Use of condoms

Exclusion Criteria:

* Acute or chronic illness affecting organ function or requiring medications (including, but not limited to, cardiovascular, hepatic, renal hematologic, neurologic, dermatologic, psychiatric, or rheumatologic disease);
* Febrile illness within the previous 14 days;
* Known allergic reactions to components of the study agent;
* Treatment with another investigational drug or other intervention within 30 days;
* Current tobacco use or tobacco use within 60 days;
* Household contacts who are immunocompromised;
* Chronic infection(s) (of any kind);
* Malignancy (of any kind);
* Substance abuse disorder(s);
* Pregnancy or breastfeeding;
* Any other conditions that would place the subject at increased risk of adverse events or interfere with the conduct or interpretation of the study, in the opinion of the investigators.
Post-amputation Survival Following Rehabilitation Medium and Long-term Follow up Study, a Retrospective Analysis.

This is a retrospective data analysis of patients who underwent lower limb amputation and rehabilitation and follow up.

Investigators analysed their survival outcomes in relation to various comorbidities i. e ischaemic heart disease, renal impairment, vascular interventions.

Inclusion criteria: Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.

Exclusion criteria: Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records.

Eligibility Criteria:
Inclusion Criteria:

Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.

Exclusion criteria:

Exclusion Criteria:

Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records
A Problem Solving Intervention Involving Employees at Risk of Sick Leave Due to Common Mental Disorders

The overall aim of this randomized controlled trial is to evaluate the effectiveness of a problem-solving intervention for the prevention of sick leave among employees with early signs of CMDs. The intervention is delivered by first-line managers and a 30% reduction in sick leave days is expected in the experimental condition compared to treatment-as-usual, during the 12- months follow-up.

The overall aim of this randomized controlled trial is to evaluate the effectiveness of a problem-solving intervention for the prevention of sick leave among employees with early signs of CMDs. The intervention is delivered by first-line managers and a 30% reduction in sick leave days is expected in the experimental condition compared to treatment-as-usual, during the 12- months follow-up.

In an alongside process evaluation on the intervention's core activities, i.e. identification of early signs of CMDs, training of first-line managers in problem-solving and communication, we will:

* evaluate whether and to what extent it was possible for the first-line managers to adhere to the intervention's protocol,
* investigate the association between the intervention's core activities and number of sick leave days,
* identify the facilitators and barriers to the intervention among first-line managers and employees and,
* explore the first-line manager's organizational resources supporting their general managerial work.

The study will be conducted in private sector companies, among first-line managers and blue-collar workers. The outcomes will be evaluated on both cluster- and individual participant level.

Eligibility Criteria:
Inclusion Criteria:

* scoring with a cut-off ≥3 points on the GHQ-12, or a positive answer on the question on risk of SA, namely employee believes that he/she will receive a sickness certification due to stress, anxiety, or depression the following 12 months.
* negative answer on the question on bullying, namely employee has not been exposed to bullying by his or her first line manager.
* understand written and spoken Swedish.

Exclusion Criteria:

* Ongoing sick leave (full- or part-time), leave of absence, pregnancy.
* Sick leave ≥14 calendar days during the last 3 months due to CMD.
* At the time for inclusion planned long-term absence during the coming year (for example parental leave, new job, retirement).
Vitamin D 24'000 IU for Oral Intermittent Supplementation

Vitamin D deficiency (defined as 25(OH)-vitamin D serum level \<50 nmol/l) is cured with oral supplementation. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly (24'000 IU) or weekly (5'600 IU) is possible. Commercially available intermittent pharmaceutical forms in Switzerland are liquid (oily or alcoholic solution). The study aims to compare the rise of vitamin D3 levels after treatment between newly developed soft capsules and monthly solution (primary outcome), and to evaluate the effect of a loading dose (without infringing the cumulative maximal dose of 4'000 IU per day) on the achievement of optimal values \>75 nmol/l (secondary outcome). The investigators will use newly developed soft capsules and alcoholic solution, which are commercially available in Switzerland.

Group Control, Alcoholic Drinking Solution: 5 ml of an alcoholic drinking solution with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).

Group IMP, Capsules: one capsule with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).

Group IMP + loading dose, Loading Dose: one capsule with 24'000 IU vitamin D p.o. once a week during an individually calculated number of weeks.

All 3 groups: Measurement of vitamin D in serum before therapy and one week after the last dose.

Eligibility Criteria:
Inclusion Criteria:

* vitamin D deficiency by serum level \<50 nmol/l

Exclusion Criteria:

* hypercalcaemia
Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution

This is a comparative, open label, parallel group, non interventional study to further demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety shall be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product according to the instructions for use six times daily in both eyes over a period of 28 days. Response to treatment is recorded at day 28.


Eligibility Criteria:
Inclusion Criteria:

* Male or female person aged 18 years
* Demonstrated mild to moderate keratoconjunctivitis sicca ( "dry eye")
* Acute symptoms of dry eye: DEWS 1-3
* tear break-up time TBUT \<10s
* agreement to abide by the routinely provided doctor's appointment for follow-up (reflected in the planned visits of observation plan resist)

Exclusion Criteria:

* inflammation of the anterior segment or trauma
* Contact lens wearers
* Any disease that can, in the opinion of the treating physician to affect the outcome of the study.
* Patients with known intolerance to one of the substances used
* Surgical procedures to the eyes in the last 6 weeks before inclusion in the trial
* patients with addictive disorders or substance abuse fallow in the past 12 months, as well as persons incapable of giving consent
Fetal Cardiac Function

The aim of our study is to evaluate the effect of PE and FGR on fetal cardiac function. Pregnancies with preeclampsia and FGR, and preeclampsia with normal fetal growth are evaluated by echocardiography and compared with uncomplicated pregnancies.

Preeclampsia (PE) represent a major concern in public health, affecting 2-8% of all pregnancies and considered one of the leading causes of perinatal morbidity and mortality. Fetal growth restriction (FGR) ia also a common health problem affecting about 5-10% of all pregnancies and commonly associates with preeclampsia . It is estimated that 20% of cases of PE present with FGR and about 50% of early-onset FGR cases will eventually coexist with PE .

Both syndromes share some pathophysiologic features, with a variable involvement of placental insufficiency and cause fetal cardiovascular remodeling and adaptations . Fetal adaptations as metabolic and cardiovascular programming occur in response to adverse intrauterine conditions as PE and FGR . Offspring from preeclamptic pregnancies showed cardiac structural and functional changes and greater blood pressure in childhood and adolescence .

Most of the studies on FGR included pregnancies complicated by PE and vice versa, which fails to adequately assess the independent effect of each condition on the fetal cardiac functions.

Eligibility Criteria:
Inclusion criteria:

* Pregnant women more than or equals 28 weeks
* Preeclampsia defined as systolic blood pressure 140 mm Hg and/or diastolic blood pressure 90 mm Hg
* Fetus with normal growth or with growth restriction

Exclusion criteria:

* congenital malformations
* intrauterine infection
* multiple pregnancies
* fetuses of mothers treated with a tocolytic agent
* fetuses with abnormal heart rates (tachycardia or bradycardia)
Predicting Treatment and Care Difficulties Among HIV Infected Patients

Much of HIV is related to behaviour: sexual risk taking, late diagnosis, adherence to antiretroviral therapy, follow up, disclosure of one's HIV status. The project aimed to use various psychometric tools to determine if these scores have a predictive value on late testing, treatment succes, quality of follow up, and disclosure of HIV to sex partners. The expected outcomes would be to be able to stratify patients using a behavioural risk score and allocate targeted ressources to improve the quality of care for the most at risk patients.


Eligibility Criteria:
Inclusion Criteria:

* HIV Infected outpatient

Exclusion Criteria:

* Refusal to participate
Clinical Validation Study of Multi-EPI Mix

This study aims to assess the diagnostic validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI.

The study aims to assess the imaging quality with regards to artefacts and lesion conspicuity as well as its diagnostic potential in rendering a probable diagnosis. The primary study aim is to define the AUC for diagnostic performance of minute MRI compared to conventional MRI.

Included patients are those with suspiscion of cerebral pathology.

Study participancts are investigated at 3T.

Eligibility Criteria:
Inclusion Criteria:

- Neuroradiological MRI

Exclusion Criteria:

- Aborted exam
Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial

The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.


Eligibility Criteria:
Inclusion Criteria

* Signed Written Informed Consent
* Subjects must have received at least one dose of Asunaprevir and/or Daclatasvir
* Subjects participating in Daclatasvir and/or Asunaprevir studies (ie, protocol numbers beginning with AI443, AI444 or AI447) may enroll regardless of virologic response
* Completed the required post-treatment follow-up period in previous study
* Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability at the clinical site
* Men and women, ages 18 and older

Exclusion Criteria:

* Subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C (CHC) after completion of the previous study during which Asunaprevir and/or Daclatasvir were administered
* Subject must not be participating in any other trial, excluding non-interventional trials
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness