cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Emergency Department (ED) Staff Stress Level During COVID-19 Pandemic

In the context of the COVID-19 pandemic, Emergency Department (ED) are in front line for the reception of patients presenting COVID-19 symptoms and have to face a new situation given the expected number of patients. Staff participate in suspect patients triage, in the diagnosis and the management of Covid-19 patients, having to follow the instructions and recommendations that evolve in real time, depending on the stage, resources and means available. This situation requires that the staff immediately adaptation within this reorganization and redeployment of the activity. Then; they are subject to many stress and anxiety factors such as:

* Increased activity: massive influx of patients, overload of work, lack of material and human resources
* Modification of practices: training in procedures, measures isolation and prevention of contamination of other patients, replacement by professionals reassigned from other departments
* Ethical dilemma: decisions to be made in an emergency, patient prioritization
* Numerous, evolving information, from various sources and sometimes contradictory (national, governance, service, media)
* Individual: fear of personal contamination and of those close to you, personal organization in a situation of confinement of the population, loss of usual social support
* Anxiety and stress management of patients and relatives, their entourage and colleagues In this study, it is proposed to study the psychic impact of the COVID-19 pandemic on emergency department staff.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* medical and paramedical staff working the the emergency room permanently or specifically during the COVID19 pandemic
* not opposed to participate to this study

Exclusion Criteria:

* Staff under legal protection
* refusing to participate
Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias

The purpose of this study is to:

1. compare the long term results of mesh versus suture repair in treatment of abdominal wall defects;
2. find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery.

To determine difference of operation time, applied materials of hernia operations; clinical complications, postoperative pain, hernia recurrence, recovery and normal activity time after surgery.

Eligibility Criteria:
Inclusion Criteria:

* During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements.
* All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study.
* For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed.

Exclusion Criteria:

* Ages fewer than 18 or above 70 years
* Hernia orifice under 5 cm2.
* Planned or accidental intraoperative opening of any bowel.
* Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease.
* Severe renal or hepatic failure
* Advanced stage of tumours or currently treated malignancies.
* Inflamed or muddy content of hernia sac.
* If the patient did not signed the consent form.
The Value of 68Ga-FAPI PET/CT in Detecting Recurrent and Metastatic Lesions in Patients with Thyroid Cancer After Surgery

This study aims to investigate the value of 68Ga-FAPI PET/CT in detecting recurrent and metastatic lesions in patients with thyroid cancer after surgery.

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-FAPI PET/CT when recurrence or metastasis is suspected. The imaging response measurements will be compared with follow-up results or histopathological findings as the gold standard.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with thyroid cancer who have undergone surgery and are suspected of recurrence or metastasis during clinical evaluation.
2. Signed and dated informed consent form.
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process.
4. Aged 18-80 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction.
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person.
A Study of High-intensity Strength Training and Thoracic Aorta Dilatation

The purpose of this study is to describe the prevalence of thoracic aorta dilatation among a group of older (age \> 35 years), experienced weightlifters (\>5 years of weightlifting experience). The secondary aim of this study is to report the prevalence of thoracic aorta dilatation among 3 different groups of weightlifters (body builders, cross-fit athletes, and power lifters).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 35
* ≥5 years of weightlifting experience

Exclusion Criteria:

* Age \< 35
* \< 5 years of weightlifting experience
* personal history of thoracic aorta dilatation/aneurysm/dissection
EMBA Peripheral Embolization Device ("EPED") Study

This is an open label, acute, non-randomized, prospective, "first in man" (FIM) single-center study of the EMBA Medical Peripheral Embolization Device (PED).

This study is a FIM, open label, prospective, single center, non-randomized, evaluation of the EMBA Medical Peripheral Embolization Device (PED) used for arterial or venous embolization in the peripheral vasculature.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is \>18 years of age.
2. Patient is considered a candidate for arterial or venous embolization in the peripheral vasculature.
3. Patient has a target vessel diameter of 3-8mm and a target PED landing zone of greater than 25mm wherein the vessel diameter is between 3 and 8 mm.
4. The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
5. The patient has suitable vessel anatomy that would allow proper placement of the PED.

Exclusion Criteria:

1. The patient has one of the following conditions:

   1.1 Arterio-venous fistula 1.2 Hypercoagulability 1.3 Systemic coagulopathy 1.4 Connective tissue disorder such as Ehlers-Danlos Syndrome 1.5 Congenital arteritis such as Takayasu's Disease 1.6 Other circulatory disorders at the discretion of the implanting physician
2. The patient has an uncontrolled infectious disease.
3. The patient has a life expectancy of less than 6 months.
4. The patient is pregnant.
5. The patient has a condition that inhibits radiographic visualization of the PED.
6. The patient has a known allergy or intolerance to Nitinol.
7. The patient has a known hypersensitivity to contrast that cannot be pre-treated.
8. The patient's access vessels preclude safe insertion of the delivery system.
9. The patient is currently participating in another device or drug study.
Biological Bank for Atrial Fibrillation and Stroke

Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice. This arrhythmia is responsible for 15% of strokes and more than 30% of strokes on people over 65 years.

According to studies, 30 to 40% of isolated atrial fibrillations could be familial. Atrial fibrillation has significant genetic heterogeneity. About 40 genes have been identified as potentially involved. Studies have identified genes common to the risk of atrial fibrillation and stroke. Despite the pathophysiology of atrial fibrillation has been intensively and extensively studied for almost a century, there are still many questions. The pathophysiology is not sufficiently understood to allow finding more effective therapies. It is necessary to identify genetic determinants and thus potentially new pharmacological targets more adapted.

The establishment of a biological database will test hypotheses concerning the genetic origin and thromboembolic process of atrial fibrillation and associated stroke.


Eligibility Criteria:
Group 1a

* Inclusion Criteria :

  - AF history
* Exclusion Criteria :

  * No AF history
  * patient who didn't signed consent

Group 1b

* Inclusion Criteria :

  * AF history
  * Scheduled electrophysiological exploration or AF ablation
* Exclusion Criteria :

  * No AF history
  * pregnant women
  * patient who didn't signed consent

Group 1c

* Inclusion Criteria :

  * AF/AT history
  * Stroke history
* Exclusion Criteria :

  * No Stroke history
  * patient who didn't signed consent

Group 2

* Inclusion Criteria :

  * patient over 80
  * ECG: sinusal rhythm
  * TTE : no left atrial dilatation
* Exclusion Criteria :

  * atrial fibrillation history
  * TTE : Left atria \>25cm², \> 34m/m2), FEVG \< 50%
  * ECG : QRS \> 90 ms
  * cardiac pathologies (excepted hypertension and valvulopathies)
  * History of stroke and transient ischemic attack
  * patient who didn't signed consent

Group 3

* Inclusion Criteria :

  * cryptogenic stroke or transient ischemic attack history before 50 yo
  * No AF history
* Exclusion Criteria :

  * AF history
  * stroke or transient ischemic attack over 50 yo
  * patient who didn't signed consent
TAP Block Versus Conventional Systemic Analgesia

The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.

Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.

Laparoscopic cholecystectomy constitutes a routinely performed procedure world-wide. Analgesia accounts for one of the major keys for success especially in enhanced recovery after surgery pathway and ambulatory surgery. Hence, controlling opioid consumption used in conventional systemic analgesia is mandatory while reliving pain. The TAP block is integrated within a multimodal analgesia. It corresponds to a locoregional analgesia.

The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.

Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.

Eligibility Criteria:
Inclusion Criteria:

All patients scheduled for elective laparoscopic cholecystectomy at the department of surgery, Mahmoud El Matri Hospital, Ariana

Exclusion Criteria:

* Severe renal insufficiency (GFR \< 30 ml/min)
* Severe hepatic insufficiency (TT ≤ 50%)
* Severe COPD (FEV1 \> 30%)
* Metastatic malignancy
* Hematologic disease or a congenital clotting disorder
* Preoperative opioid use
* Age under 18 years
* Pregnancy or breast-feeding
* Hyper-reactivity toward ropivacaine
* Estimated risk for conversion to open surgery \> 50%
[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.

The purpose of this study is to assess the long-term safety and tolerability of \[S,S\]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy
* Patients at screening must have a score \>/=40 mm on the pain visual analogue scale

Exclusion Criteria:

* Patients with significant hepatic impairment
* Patients with other severe pain, that may impair the self-assessment of the pain due to DPN
Real and Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS)Effect on Knee Proprioception

Delayed onset muscle soreness (DOMS) can have an impact on the proprioception of knee joint . The study aim is to assess the effect of manual massage, diathermy and sham diathermy the proprioception of the knee joint in patients affected by DOMS.

Delayed onset muscle soreness (DOMS) can have an impact on the proprioception of knee joint. The study aim is to assess the effect of manual massage, diathermy and sham diathermy on the proprioception of the knee joint in patients affected by DOMS.

Proprioception will be measured with "Technique" an App available on appstore , on the basis of the work on knee proprioception by S M Mir 2008 , and data about pain with numbering pain rating scale (NPRS) and pre-post treatment and global impression of change (PGIC) will be acquired.

Eligibility Criteria:
Inclusion Criteria:

* Patients with DOMS after a skimountaineering race

Exclusion Criteria:

* Comorbidities, trauma
The Virtual BETTER Study

The focus of this project is to examine how delivering virtual care impacts health behaviour change for patients with chronic illnesses compared to in-person visits using a chronic disease prevention and screening (CDPS) program called BETTER (Building on Existing Tools To ImprovE Chronic Disease PRevention and Screening in Primary Care).

While the current pandemic has launched a likely irreversible transition towards increased utilization of virtual methods for delivery of healthcare, we have only a very superficial understanding of how this shift will affect health outcomes and equity of access to health services. Several randomized trials comparing virtual to in-person delivery of health services have been completed, but none have examined the effect of interventions to address health behaviours, arguably one of the most challenging issues in healthcare and one that is most sensitive to the therapeutic relationship and modifiers to that relationship such as the mode of communication. The focus of this project is to examine how delivering virtual care impacts health behaviour change for patients with chronic illnesses compared to in-person visits using a chronic disease prevention and screening (CDPS) program called BETTER (Building on Existing Tools To ImprovE Chronic Disease PRevention and Screening in Primary Care).

Eligibility Criteria:
Inclusion Criteria:

* Persons aged 40-70
* Persons who are already booking a BETTER prevention visit.

Exclusion Criteria:

* Persons with the presence of a terminal illness
* Persons in active treatment (i.e., systemic and/or radiation therapy) for cancer.
* Persons who are unable to provide informed consent.
Interdisciplinary E-health Based Follow-up of Preterm Born Children

The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children.

* At first, there will be focus groups with experts and affected families to finalize and optimize the study procedure. After that, 90 children will be recruited (ages 2, 5 and 10)
* T0: App-questions for the children at the ages of 5 and 10 and the parents of all children to mental, somatic and sleep problems of the children and well-being of the parents, sleep tracking and recording of a sleep sequence of the children; differentiated examinations and questionnaires to mental and somatic problems of the children by interdisciplinary study team
* Interdisciplinary study team meeting to generate recommendations for the families
* Interdisciplinary study team recommendations for the families
* T1: Comparable to T0 but only measurements that were assessed with questionnaires/at home plus post-experimental questionnaire
* Focus groups with participating families and the study team experts for evaluation of the study procedure and intervention

Eligibility Criteria:
Inclusion Criteria:

* female and male preterm born children (\<32 week of pregnancy) that are treated at the clinic in Tübingen and their parents
* Existence of systematical neonatal data and consent of the care person to use this data
* Existence of the data of the 2 year regular follow-up (for the 5 and 10 year olds)

Exclusion Criteria:

* lack of access to a mobile phone/tablet including internet access
* insufficient knowledge of the German language of both parents
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China

The human gut microbiome has been associated with many health factors but variability between studies limits the exploration of effects between them. This study aims to systematically characterize the gut microbiota of various critical chronic diseases, compare the similarities and differences of the microbiome signatures linked to different regions and diseases, and further investigate their impacts on microbiota-based diagnostic models.

Many studies demonstrate that microbial dysbiosis has been linked to many human pathologies. However, the current understanding of the identification of the disease-associated microbiome signatures remains limited, largely owing to the heterogeneity of microbial community structures which are shaped by the host. Undoubtedly, profiles of microbial biomarkers require validation in large, independent, population-based cohorts from different districts. Based on these, the investigator plan to organize a multicentric cross-sectional cohort, not only to systematically characterize the gut microbiota of various critical chronic diseases, such as liver cancer, gastric cancer, pancreatic cancer, lung cancer, nasopharyngeal cancer, hypertension, acute coronary syndrome, primary aldosteronism, epilepsy, chronic kidney disease, and subclinical hypothyroidism but also to compare the similarities and differences of the microbiome signatures linked to different regions and different diseases and to further investigate their impacts on microbiota-based diagnostic models. In this study, for each kind of disease, the investigators expect to recruit 500 patients with a confirmed diagnosis and 500 sex- and age-matched controls, to record their information related to demography, body measurement, lifestyle, diet, medication, diseases, and biochemistry, and to collect their feces, saliva, urine and blood samples.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-75 years;
2. living in the province where the hospital is located in the last three years;
3. with a medical diagnosis of one of the target diseases;
4. willing to provide written informed consent.

Exclusion Criteria:

1. female in pregnancy or lactation(unless the subject is pregnant women);
2. with medical diagnoses of other serious illnesses;
3. with a history of bariatric surgery or intestinal resection, except for appendectomy；
4. individual who was treated with drugs in the preceding 1 month, including antibiotics, metformin, statins, acid inhibitor, probiotics, and probiotics; individuals having consumed yogurt more than 3 times in the preceding 1 month; heavy drinkers who have consumed more than 4 taels of liquor or 1000ml of beer; frequent alcohol consumers who have drunk per week in the last month.
Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine

The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.

Exclusion Criteria:

* Pregnancy or lactation.
* Positivity for anti hepatitis antibodies.
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL.
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Administration of any other vaccine(s) or any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial