cyrilzakka/clinical-trials huggingface dataset:
A Randomised Clinical Trial on the Effect of Group Education on Patients With Occupational Hand Eczema

Occupational hand eczema (OHE) is a frequent disease which often takes a chronic course. The burden of the disease is high in a personal as well as in a socio-economic context. There is a need for evaluating new strategies to improve the prognosis for OHE patients. The objectives of the study is to evaluate the effect of group education on sick lave, health-related quality of life and disease severity among individuals with newly notified OHE.

The trial population consist of individuals from the Capital Region of Denmark and Region Zealand with a suspected skin-related industrial injury notified to the Danish National Board of Industrial Injuries (DNBII). Recruitment is started Juli 2012, and will continue until the designed number of participants have been included.

All participants will be assessed in a questionnaire at time T=0 with regard to: self evaluated disease severity, health-related quality of life, skin protective behaviour, knowledge of skin protection, self-efficacy, work-role function and if active in workforce. The participants will then be randomised. The intervention group will be invited to participate in the educative course, and work place visits will be offered. In the intervention group a telephone hot line will be available for further questions concerning these topics. The control group will not have access to any of these interventions. Both intervention group and control group will be contacted every eighth week about number of days of sick leave/absence from workforce. Both groups are re-assessed using a questionnaire at T=12 months. There will be a total of 742 included participants.

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The hypotheses of the PREVEX trial are:

* Early information build on evidence-based skin-protection programmes and work-place visits with counselling in skin care, followed by telephone hotline, will give the participants increased level of knowledge concerning the treatment and prevention of OHE.
* Increased level of knowledge concerning prevention and focus on skin care will have a positive impact on skin-protective behaviour and will lower the severity of HE and prevent the development of chronic eczema.
* The decrease in severity of HE will decrease sick leave and keep the participants in job, or prevent job loss, or facilitate the re-entry into the workforce.
* In total, the intervention will have a positive effect on health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported HE, i.e., individuals answering 'yes' in the questionnaire to the question 'Have you or have you had hand eczema?'
* The questionnaire is sufficiently filled in with respect to 'severity of HE' and 'profession'.
* Written informed consent.

Exclusion Criteria:

* Age below 18 years or above 65 years.
* Permanently excluded from the workforce.
* Inability to understand the Danish language sufficiently to benefit from the course.
* Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results.
* Lack of written informed consent.
Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease

This study will validate the efficacy and safety of the VESTO® Vascular Stent for treating patients with iliac peripheral arterial obstructive disease in a post-market clinical trial

Multicenter study aimed at collecting post-market clinical data on the VESTO® vascular stent for the treatment of patients with iliac peripheral arterial occlusive disease requiring endovascular intervention. The objective of the study is to evaluate the short-term (12-month) safety and clinical performance of the Vesto® vascular stent in patients with iliac peripheral arterial occlusive disease.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older;
2. TASC-II aortoiliac lesion classification of modified class A, B, C, or D;
3. Rutherford classification score of 2 to 5;
4. Access site compatibility with the device delivery system;
5. Compliance with the device's instructions for use (IFU);
6. Patient availability for appropriate follow-up times for the duration of the study;
7. Patient informed about the nature of the study, agreeing to its provisions, and signing the informed consent form.

Exclusion Criteria:

1. Known hypersensitivity to heparin, contrast media, or stent components;
2. Patient with blood dyscrasia;
3. Pregnant or breastfeeding women;
4. Patient currently participating in an investigational drug or device study;
5. Patient undergoing chemotherapy or radiation therapy;
6. Patient with a stent or graft located in the target limb;
7. Patient who underwent angioplasty or bypass surgery within 30 days prior to inclusion in this study;
8. Patient with a life expectancy of less than 12 months;
9. Inability to undergo dual antiplatelet therapy (DAPT)
Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated at week 11 after randomisation. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* histologically confirmed adenocarcinoma of the pancreas
* no evidence of distant metastasis based on computed tomography of the thorax and abdomen
* non resectable pancreatic cancer
* no evidence of peritoneal carcinosis
* ECOG-performance status ≤ 2
* signed study-specific consent form prior to therapy

Exclusion Criteria:

* fertile patients who refuse effective contraception during study treatment
* synchron second malignant neoplasm except basal cell carcinoma of the skin and carcinoma in situ of the cervix after curative therapy
* the Inclusion of patients with prior or concurrent malignancy (≤ 5 years prior to enrolment in study) must be discussed
* chronic inflammatory disease of the intestine
* known allergic reactions on study medication
* on-treatment participation on other trials
* insufficient liver function: Bilirubin \> 2,0 mg/dl; SGOT, SGPT, alkaline phosphatase, gGT more than 3 times upper limit of normal (after Stent implantation in case of obstructive jaundice); cirrhosis of the liver Child B and C
* insufficient bone marrow function: WBC \< 3,0 x 10\^9/l, Platelets \> 100 x 10\^9/l
* serum creatinine \> 1,5 mg/dl, creatinin clearance \< 60ml/min (or comparable test)
* preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy, myocardial infarction within the past 6 months, unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) class III or IV heart disease
* neurological and/or psychiatric diseases: stroke, dementia, epilepsy, psychosis
* active intractable or uncontrollable infection, HIV-infection
* prior radiotherapy or chemotherapy
Brain and Voice Signatures in Teachers

Primary muscle tension dysphonia voice disorder with symptoms of vocal strain and vocal fatigue is common and can have a significant negative impact on quality of Life. Yet, primary muscle tension dysphonia's causes are unknown precluding precise diagnostic classification. Stress and personality are thought to play a role and thus, the project aims to determine the practical and clinical effect of stress on the control of voice and speech in the brain. Participants are female early career teachers and student teachers with symptoms of vocal fatigue, as well as control participants without vocal fatigue, who perform speech tasks on two different occasions. Neural (imaging of brain), psychobiological (saliva, personality), and voice and speech (muscle activity of voice muscles on the neck with surface sensors, audio recordings) data will compare reactivity patterns of teachers who are stressresponders with those who are nonresponders as well as control participants. The central hypothesis is that voice box stress responders have heightened emotion-motor activations involving the emotional voice production pathway, which correlate with changes in voice muscle activity in the anterior neck. The results will provide fundamentally missing data in our understanding of the role of stress in vocal complaints and will yield new insights about the neural underpinnings of primary muscle tension dysphonia. The study findings will have a significant impact on how clinicians identify so-called laryngoresponders to help them prevent voice disorders.


Eligibility Criteria:
Inclusion Criteria:

Teachers (max. 10 years full-time) or student teachers in good health between 21 and 39 years with symptoms of vocal fatigue.

Control participants in good health between 21 and 39 years without symptoms of vocal fatigue.

Exclusion Criteria:

* Lefthandedness
* Smoking (past 5 years)
* Known changes of the vocal folds (e.g., vocal fold nodules), vocal fold paralysis, surgeries on the larynx or thryoid or current organic or neurological changes of the vocal folds or vocal function per videoendoscopy and -stroboscopy of the larynx
* History of voice therapy
* Hoarseness
* Respiratory illness, allergies (respiratory, silver), reflux or asthma at time of participation
* Hearing disorder or hearing aids
* Psychological, neurological or endocrinological disorders
* Psychotropic or steorid medications
* Body mass index \> 30
* Indications against MRI such as metail parts in or on the body (e.g., permanent dental prostheses or braces, screws, prostheses, piercings or large tattoos
* Nearsightedness \> -5 diopters, if only glasses are worn
* Claustrophobia
* Pregnancy
Microvascular Injury and Distal Thrombosis in COVID-19

Investigators aimed to better understand the pathophysiology of SARS-CoV-2 pneumonia in non-critically ill hospitalized patients secondarily presenting with clinical deterioration and increase in oxygen requirement

Investigators plan to consecutively enrol 25 patients without clinical or biological evidence for superinfection, without left ventricular dysfunction and for whom a pulmonary embolism was discarded by computed tomography pulmonary angiography. Investigators will investigate lung ventilation and perfusion (LVP) by LVP scintigraphy, and, 24 hours later, left and right ventricular function by 99mTc-labelled albumin gated-blood-pool scintigraphy with late (60 mn) tomographic albumin images on the lungs to evaluate lung albumin retention that could indicate microvascular injuries with secondary edema

Eligibility Criteria:
Inclusion Criteria:

* Non-critically ill patients hospitalized in the COVID-19 Unit of the Centre Hospitalier Princesse Grace of Monaco
* Presenting with a sudden clinical deterioration defined by a respiratory rate impairment and/or a rise of oxygen flow to reach a peripheral capillary oxygen saturation (SpO2) of more than 95% during at least 48 hours
* a diagnosis of pulmonary embolism was discarded by CT pulmonary angiography
* no clinical or biological (procalcitonin levels) evidence of lung superinfection
* without clinical evidence for LV dysfunction

Exclusion Criteria:

* Non confirmed COVID-19 pneumonia according to the WHO guidance by a positive result of RT-PCR assay of nasal and pharyngeal swabs,
* Patients without peripheral pulmonary ground-glass opacities or air-space consolidation on their chest CT scan at admission and common laboratory findings including lymphocytopenia, eosinopenia, significantly elevated markers of organ inflammation such as fibrinogen and C-reactive protein.
* Patients could not be included if their medical condition was unstable or precluded a safe transfer to the nuclear medicine department, if they were under mechanical ventilation (either non-invasive or invasive), if they required critical care unit, or in case of a pregnancy.
Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis

This study intends to measure the effects of valsartan/sacubitril compared to baseline standard medical heart failure therapy on reverse remodeling using echocardiographic endocardial surface analysis techniques to assess changes in ventricular volume, function, and shape.

This study intends to measure the effects of valsartan/sacubitril compared to baseline standard medical heart failure therapy on reverse remodeling using echocardiographic endocardial surface analysis techniques to assess changes in ventricular volume, function, and shape. Furthermore, Metaiodobenzylguanidine (MIBG) scintigraphy and the heart to mediastinum ratio will be used to assess Left Ventricle (LV) volume regression and risk reduction. The investigators also intend to measure the effects of valsartan/sacubitril on exercise capacity as assessed by the 6 minute walk test and peak Volume of Oxygen (V02) on cardiopulmonary exercise testing. Additionally, the investigators will examine the impact of valsartan/sacubitril on functional status and quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Qualia Health (a novel iPhone application that incorporates Fitbit technology to provide a "real time" daily 6 minute step count and assesses quality of life using a series of short targeted questions. The investigators will also measure Brain Natriuretic Peptide (BNP), N-terminal of the Prohormone Brain Natriuretic Peptide (NT-proBNP), and Rho-kinase (a biomarker associated with heart failure) levels at multiple time-points throughout the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged ≥18 years
2. Congestive Heart Failure (CHF) New York Heart Association (NYHA) class II-IV with 25%≤ Left Ventricular Ejection Fraction (LVEF) ≤40% (ECHO within last 6 months)

   * NT-proBNP ≥ 600 pg/mL OR
   * NT-proBNP ≥ 400 pg/mL and a hospitalization for heart failure within the last 12 months
3. Stable and optimized on an angiotensin-converting-enzyme inhibitor (ACEI) equivalent to enalapril ≥ 10 twice a day (BID) for at least 4 weeks
4. Stable and optimized on a beta-blocker for at least 4 weeks
5. Optimized dosing of aldosterone antagonist at stable dose for at least 4 weeks

Exclusion Criteria:

1. History of angioedema
2. estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2 at screening
3. Serum potassium \> 5.2 mmol/L at screening
4. Symptomatic hypotension as defined by Investigator, systolic blood pressure (SBP) \< 100 mmHg at screening
5. Current acute decompensated heart failure
6. History of severe pulmonary disease
7. Active malignancy
8. Requirement for treatment with both angiotensin-converting-enzyme inhibitor (ACEI) and angiotensin receptor blockers (ARB)
Montelukast for Patients With Obstructive Sleep Apnea Syndrome

This study compares the effect of Montelukast vs Placebo on Flow Mediated Dilatation of the Brachial Artery (FMD) in patients with obstructive sleep apnea syndrome.

Obstructive Sleep Apnea Syndrome (OSAS) induces low-grade systemic and vascular inflammation, including activation of the leukotriene pathway.

In apneic patients, the urinary excretion of LTE4, a systemic marker of CysLT pathway activation, is increased in relation to the severity of OSAS and it's an independent predictor of cardiovascular risk event occurring at 10 years.

Montelukast is a CysLT1 receptor antagonist. By blocking CysLT1 receptors, montelukast prevents vasoconstriction, proliferation and migration of smooth muscle cells, adhesion molecule expression, and leukocyte recruitment induced by CysLTs.Montelukast may improve endothelial function and reduce vascular remodeling in apneic patients.

A pharmacological blockade of CysLT pathway would be an interesting therapeutic strategy to limit the cardiovascular consequences of OSAS.

Eligibility Criteria:
Inclusion Criteria:

* With mild to moderate obstructive sleep apnea syndrome (apnea / hypopnea index\> 15 and \<30 events per hour)
* Little symptomatic (Epworth sleepiness score \<10)
* Polysomnography within 3 months prior to inclusion
* With a history of myocardial infarction or stroke
* Affiliation to Social Security or beneficiary of such a scheme
* Signed consent

Exclusion Criteria:

* OSAS support by PPC
* Cancer
* Chronic inflammatory disease
* Asthma previously treated with Montelukast
* Chronic infectious disease
* Epworth sleepiness scale ≥10
* Contraindication to Montelukast: Hypersensitivity to the active substance or to the excipients
* Contraindications to trinitrin: hypersensitivity to nitrates, state of shock, severe hypotension, association with sildenafil, obstructive cardiomyopathy, inferior right sided myocardial infarction with right ventricular extension, acute, except in case of signs left ventricular failure, intracranial hypertension, breastfeeding
* Treatment with phenobarbital, phenytoin, rifampicin: risk of montelukast metabolism increase and thus decrease of its effectiveness
* Persons referred in Articles L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mothers, person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection, can not be included in clinical trials)
* Subject in exclusion period of another study
* Subject can not be contacted in case of emergency
Blood Characteristics and Abdominal Emergency Surgery

After surgical tissue damage, cellular blood components are involved in tissue repair processes, yet their preoperative characteristics are not considered in routine clinical practice.

Surgical injuries initiate the recruitment of cellular blood components for tissue repair. Baseline inflammation levels and cellular response to tissue damage are absent from perioperative management algorithms despite their importance in regeneration. This project seeks to examine patients preoperative parameters before surgery and evaluate if there is a correlation with clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 65 years of age at surgery.
* Patients with acute intra-abdominal pathology requiring emergency surgery.
* A complete blood count was performed in the emergency department of our center within 24 hours before surgery.

Exclusion Criteria:

* Patients who are users of anticoagulation before admission for any reason
* Patients who have had previous hospitalization or surgery in the last 6 months.
Laser Assisted Treatment of Fistula In Ano

Randomised Controlled Trial comparing Laser assisted closure of transsphincteric fistula to the rectal advancement flap.

A prevalent and complex fistula type is the high transsphincteric (TS) fistula. It typically runs through the upper two-thirds of the external anal sphincter (EAS) and is, due to the high risk of fecal incontinence, not suitable for fistulotomy and sphincter sparing treatment is required. To be included in this trial the participants should have a single, continuous TS fistula of cryptoglandular origin, that is treated by loose seton drainage for at least 2 months and is mapped by MRI. Participants with IBD, hidradenitis suppurativa or a malignant fistula will be excluded. Intervention Fistula Laser Closing (FiLaCTM) (Biolitec, Germany) is an endofistular technique, using a radial-emitting laser fiber that emits laser light with a maximum penetration depth of 2 - 3 mm. It destroys both the crypt gland and the additional epithelial layer of the fistula without damaging the sphincter. The fiber is inserted until the internal opening, activated and pulled backwards slowly, allowing the laser to have its effect. The external opening is excised and the internal opening is closed with a single absorbable suture. Rectal advancement flap is currently the gold standard for sphincter sparing treatment of high transsphincteric fistulae. The fistula is cored out and an advancement flap is made of mucosa and submucosa. The opening of the fistula in the flap is excised, the residual internal opening is closed with absorbable suture and the flap is sutured below the fistula to the anoderm. The advancement flap is a difficult technique that requires a relatively large transanal dissection that results in postoperative pain and may lead to disturbances in continence. Preliminary results with the Filac technique show fistula healing rates comparable to the advancement flap. Due to its simplicity, speed and minimal invasiveness the investigators expect a benefit for the participants in terms of postoperative pain, operating time and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with fistula involving more than one-third of the external anal sphincter
* Single, continuous fistula tract at time of inclusion
* Loose seton present in fistula tract for 2 months or more at time of inclusion
* Age ≥ 18
* Able to complete an informed written consent, understand its implications and contents, and participate in follow-up

Exclusion Criteria:

* Fistula tract \< 1 cm
* Complex fistula tract system (branching of fistula tract inside the sphincter complex)
* Pregnancy
* HIV-positive
* Crohn´s disease, Ulcerative colitis
* Fistula due to malignancy
* Tuberculosis
* Hidradenitis Suppurativa
* No internal opening
* Unable to undergo or contraindications to MRI
The Impact of Ashwagandha on Perceived Stress, Sleep and Food Cravings in College Students

The purpose of this study was to compare the impact of 700 mg daily ashwagandha (Withania Somnifera) in healthy college students on sleep, stress and food cravings to healthy college students taking placebo.

College aged students tend to report significant daily stress but there is no research on herbal interventions to ameliorate this condition in this population.

This study is a mixed methods, randomized, double blinded, placebo controlled 30 day trial targeting a college aged population. Participants are randomly allocated to either an intervention group (ashwagandha) or a placebo group. Each participant is given a bottle of capsules (capsules look identical but are filled either with a full spectrum dried extract ashwagandha herb or a placebo filled with glycerin). Directions included consuming 1 capsule in the morning and one capsule in the evening. Questionnaires were collected prior to the study and at the end of the study, including an assessment of daily affect. A subset of each group volunteered to attend an intervention specific focus group at 30 days completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Enrolled at the university

Exclusion Criteria:

* sensitivity to nightshade vegetables;
* peptic ulcer;
* pregnant or expected to become pregnant in the near future;
* breastfeeding;
* had recent or planned surgery;
* hypotensive;
* diagnosed with diabetes;
* and/or taking any of the following classes of medications: benzodiazepines, central nervous system depressants, diabetes medication, thyroid medication, immune suppressors, cardiovascular medication.