cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants

The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed by monitoring of inflammatory parameters.


Eligibility Criteria:
Inclusion Criteria:

* prematurity (birth weight 500 - 1500 g)
* postnatal age \<= 72 h
* need for cumulative parenteral energy supply of at least 70% during study duration
* signed informed consent form

Exclusion Criteria:

* simultaneous participation in another clinical study
* platelet count below 50000 /ml
* cumulative enteral energy supply of \> 30 % during study duration
* serious congenital infections and/or diseases
* serious metabolic disturbances
* severe cranial bleeding (Papile III, IV)
* need for administration of blood products
* contra-indication for iv lipid administration
* withdrawal of consent
Effect of Precariousness in RUral Areas During preGNANCY

The link between precarious situations and health conditions are more described in previous study. Precarious situations are more frequent and complex especially in rural areas. There are recognized like a risk factor of complications during pregnancy and delivery. It's necessary to describe antenatal cares for rural women in precarious situations to prevent those situations, to understand their difficulties in order to reduce inequalities and health spending.

The aim of the PRUGNANCY study is to understand the difficulties of rural parturient women and the strategies developed to overcome them. Recognized earlier precarious situations and valorized General Practitioners and restore them to the follow-up or parturient women.

It's a multicenter prospective observational study with a quali-quantitative method. This study involved three maternities in Auvergne region (Issoire, Thiers, Saint-Flour). Precarious women living in rural areas are included. They will be followed during a period of two months after childbirth. The main assessment criterion is the adequation rate between antenatal care for those women and the HAS recommendation's.

The amount necessary to highlight a significant difference is 190 patients (IC 95% \[0.429 - 0.571\] ; risk = 5 % ; Adequation rate = 50 % ; lost to follow-up rate = 10 % ; deprivation rate = 27 %).

The secondary criteria of judgment are the reasons for not realized antenatal and postnatal cares, the difficulties of realized antenatal and postnatal cares, the strategies developed to overcome them, the term and health status of the child birth (Apgar score, birth weight), the health status of the child birth and his mother during the two post-partum months (HAS recommendation's).

Eligibility Criteria:
Inclusion Criteria:

* Women old enough to procreate. Precariousness: EPICES scale \> 30, 17. Live in rural areas (INSEE definition).

Exclusion Criteria:

* To be unable to answer the questionnaire: intellectual disability or no French speaker or illiterates.

EPICES scale not completed. Women who gave birth to a stillborn child. Medical interruption of pregnancy.
ASSIST Registry Studying Various Operator Techniques

The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO).

ASSIST is a prospective, global, consecutive enrollment Registry of anterior circulation acute ischemic stroke patients with an LVO who undergo treatment with one of the interventional techniques using Stryker Neurovascular devices for the first pass. The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO) in the anterior circulation. Data will be collected on the use of Stryker market-released neurovascular mechanical access and mechanical thrombectomy devices that are commercially available or that may be approved for commercial use during the conduct of the Registry. This Registry will also collect data, including time-to-treatment and quality of life measures, to allow for subset analyses.

Eligibility Criteria:
Inclusion Criteria:

* Subjects experiencing acute ischemic stroke (AIS) who are eligible for restoration of blood flow using Stryker Neurovascular market-released products in the neurovasculature to remove thrombus
* Occlusion of intracranial anterior circulation vessel
* Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 48 hours post-procedure
* Subject is willing to comply with the protocol follow-up requirements
* Subject is treated using at least one of the defined techniques for the first pass in the neurovasculature to remove thrombus.

Exclusion Criteria:

* The subject is participating in another device trial or any other clinical trial where the study procedure or treatment might confound this study's endpoint.
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis

Effects of Wheat-based diet vs. ATI-free diet on NASH

40 patients with the diagnosis of a non-alcoholic- steatohepatitis (NASH) will be recruited at the University Hospitals of Mainz and Frankfurt. Patients are assessed with regards to their diet using standardized questionnaire and nutritionists.

Patients will be randomized into two parallel groups. The first group will continue a wheat-based Nutrition, while the second Group will receive dietary counselling to achieve an ATI-free nutrition, trying to reduce the daily ATI consumption.

The clinical trial will run over 16 weeks including 4 visits at the study center. Study visits include physical examinations, blood-based parameters, cytokines and urine samples, as well for the analysis of the intestinal microbiome by using stool samples. In addition the patients have to complete dietary and health-related quality of life (HRQL) questionnaires. Visits are planned at baseline, W4, W8 and W16.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven NASH in the past 36 months with increased ALT: males: \>60, females: \>42 U/ml
* no body weight modification about \>10% in the past 24 weeks
* no new drugs treating parts of the metabolic syndrome in the past 12 weeks
* for patients with Diabetes: HbA1c value \<8,6%
* the ability to understand the aim and the possible individual consequences of this Trial
* signed and dated consent before the Trial starts

Exclusion Criteria:

* unstable coronary heart disease, stroke in the past 6 months
* different liver diseases
* proceeded fibrosis (Fibroscan \>9,6 kPA) or histological cirrhosis
* hepatocellular carcinoma or not curative treated carcinomas
* alcohol consumption \>10g/day (females), \>20g/day (males)
* gravidity
* drugs causing secondary NASH (e.g. Tamoxifen, corticosteroids)
* immunological or inflammatory diseases (e.g. systemic Lupus erythematodes)
* warfarin therapy
* implementation of another Special diet
Covid-19 Epidemic Lockdown Impact on Psychomotor Performance

PURPOSE:

To detect the Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children.

BACKGROUND:

The corona virus disease (COVID-19) affected virtually all countries including Egypt as records showed 156,397 subjects including all age groups, Adolescents and children represent sector in the records, lockdown can contribute to widespread psychological distress and an increased risk of physical inactivity consequences shortly. Psychomotor disorders are expected during and aftermath of the pandemic. Validated Questionnaires are tools to assess the psychomotor condition during and after pandemic lockdown as safe and valid assessment tool.

HYPOTHESES:

Covid-19 Epidemic Lockdown has an impact on Psychomotor performance in Egyptian Children.

RESEARCH QUESTION:

Does Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children?


Eligibility Criteria:
Inclusion Criteria:

100 participants will be chosen according to the following criteria : subject in both sexes and their age will ranged between

1. 6-9 years.
2. 10-13 years.
3. 14-18 years All subjects should be clinically and medically stable

Exclusion Criteria:

Subjects with psychological or Motor impairment will be excluded from the study.
Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection

This study aims to investigate the epidemiology of SARS-CoV-2 infection among: i) HCW who triage patients with suspected SARS-CoV-2 infection and provide care to COVID-19 patients; and ii) laboratory personnel who test clinical samples for SARS-CoV-2 infection. After the second wave of the pandemic enrolment will be widen to any person working at the study hospitals.


Eligibility Criteria:
Inclusion Criteria:

* HCWs of any staff category at the study hospitals.

Exclusion Criteria:

* None
A Hospital Based Survey on Lung Cancer Related-pain in Northern China

This cross-sectional study, utilizing two sets of questionaire designed for patients and physicians respectively, aims at the epidemiology, the clinical features, and the current status of evaluation and management of lung cancer related pain in 20 participating hospitals in Northern China.

Lung malignancies have become the most common cause of mortality among patients with cancer in China. A significant proportion of lung cancer patients suffer from cancer related pain, however few studies have reported the prevalence and clinical features of such pain, especially in China.

This study is a cross-sectional survey in 20 hospitals in Northern China. We designed two separate series of questions to be answered by patients and cancer management professionals. In the patient questionaire, we collect information on the prevalence, location, intensity, impact on life of lung cancer related pain. Questions on how doctors evaluate and manage the pain are included in both the patients' and physicians' surveys. In the doctors' questionaire, we also assess current situation of cancer pain educational programs attended in medical schools and post graduation through related questions.

Eligibility Criteria:
Inclusion Criteria:

1. The patient questionaire

   * All patients (outpatient and inpatient) diagnosed with lung cancer visiting the participating hospitals on the designated day of investigation
   * Informed consent must be obtained from the participating patients
2. The physician questionaire

   * All physicians who receive lung cancer patients (outpatient and inpatient) in the participating hospitals on the designated day of investigation
Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype

This is the first study with a real diagnostic and prognostic focus in prenatal. In addition to this innovative aspect, the identification of cryptic imbalances in fetuses with malformative syndrome would be an invaluable resource for the identification of new genes involved in development, as is already the case for postnatal studies.

This research aims to:

1. to test the feasibility of this protocol, ie the practical application of this new technology in the context of prenatal diagnosis,
2. demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities in fetuses with a thick neck associated with other malformations and recruited on the strict criteria mentioned above,
3. assist in the diagnosis of these fetuses and genetic information for their families,
4. identify new regions of the genome potentially involved in the occurrence of congenital malformations.


Eligibility Criteria:
Inclusion Criteria:

* a karyotype performed from a trophoblast biopsy or an amniotic fluid puncture is normal or apparently balanced.
* The fetuses included in the study should have one of the following two criteria:
* 1) Thick bone (greater than 99th percentile, between week 11 and week 13 of amenorrhoea plus 6 days, correlated to a cranio-caudal length measured between 45 and 84 mm) detected in the first trimester of pregnancy associated with One or more echographic sign (s).
* 2) At least two ultrasound call signs involving the following organs (heart, kidney, brain, limbs, digestive tract, face) or intrauterine growth retardation (less than 3rd percentile) associated with one of these Signs of appeal.

Exclusion Criteria:

* The parturientes in emergency situation,
* Benefiting from a legal protection (guardianship / curatorship)
Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)

This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.

This treatment has been approved for sale to the public.

Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health based on medical history
* Subject has no history of measles, mumps, rubella, chickenpox, or shingles

Exclusion Criteria:

* Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination
* Subject has history of immune disorders
* Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start
* Subject has received an inactivated vaccine within 14 days of first dose of study vaccine
* Subject has received a live vaccine within 30 days of first dose of study vaccine
* Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine
* Subject has had a fever within 72 hours of study start
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor

The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.

Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the womb (uterus), before oxytocin can be started. Prostaglandins have been shown to ripen, or soften, the cervix; at present, the only prostaglandin approved for marketing by FDA for this purpose is dinoprostone. Dinoprostone can be delivered in several ways; one method is to use a polymer vaginal insert that slowly releases the dinoprostone directly to the cervical tissues. This product is called Cervidil (R) and has been marketed for more than 10 years in the United States. Misoprostol is another form of prostaglandin that is approved for protecting the stomach and intestinal lining for patients taking NSAIDs. Misoprostol has also been used by many obstetricians for cervical ripening and inducing contractions, but, it is not approved by FDA for this purpose.

The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol. This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil. Two different doses of misoprostol will be tested (50 micrograms and 100 micrograms); each vaginal insert will gradually release a small, controlled amount of misoprostol over up to 24 hours.

Comparator: The Cervidil (R) vaginal insert containing dinoprostone will be the comparator in this study.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor

Exclusion Criteria:

* No uterine scar (no previous delivery by cesarean section)
* No multiple gestation
* No condition that disallows use of prostaglandins for induction of labor
* No more than 3 previous vaginal births beyond 24 weeks gestation
Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis

The current study sought to prolong the observational interval after initiating medication with fingolimod and to measure the long-term effects of fingolimod on HR and HRV as an indicator of autonomic nervous system function in patients with RR-MS.

Fingolimod (Gilenya®; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA) is a novel oral disease-modifying therapy that acts as a sphingosine-1-phosphate (S1P) receptor agonist and reduces the recirculation of lymphocytes to blood and peripheral tissues, including inflammatory lesions.

A critical part of fingolimod therapy still remains in the screening and initiation phases because of the risk of cardiac events. It is well known that the first dose of fingolimod is associated with a decrease in heart rate (HR) and slowing of atrioventricular (AV) conduction. Patients were continuously observed for a minimum of 6 hours after taking fingolimod. Because resurgence of heart rate began at 6 hours, the actual recommendation for observation is only 6 hours. Data about the effect of fingolimod after this time period is lacking.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation
* Individuals over the age of 18 years
* Patients with relapsing-remitting forms of multiple sclerosis who were considered eligible for fingolimod treatment on a clinical basis.

Exclusion Criteria:

* Insufficient knowledge of the German language (not able to understand and write the German language)
* Physical or psychological incapability to take part in the study
The Impact of Preoperative Aromatherapy Upon Time to First Analgesia Request After Cesarean Section

one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding

. Recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.

Pain is amongst the most common problems after surgery

(1). Pain is an unpleasant sensory and emotional experience, which is associated with the real or probably damage of tissue. Unrelieved postoperative pain in addition to creating fears in the surgical patients, it makes adverse psychological impact on them

* The uncontrolled postoperative pain will make a lot of acute and chronic effects, including systemic mediators, hypercoagulability, postoperative immunosuppression, and delayed wound healing
* So, one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding. Recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 40 years
* Body mass index (BMI) of 18-35 kg/m2
* Patients with the American Society of Anesthesiologists (ASA) physical status I/II,
* Patients scheduled for elective cesarean section.

Exclusion Criteria:

* Patient refusal

  * Allergy to local anaesthetics
  * Anosmia
  * Coagulopathy,
  * Chronic pain syndromes
  * Prolonged opioid medication
  * Patients who received any analgesic 24 h before surgery.
Effect of vitaminD3 or 25(OH)D3 Fortified Dairy on Vitmain D Status and CVD Risk Markers

This study aims to compare the acute effect of consuming milk and butter fortified with either vitamin D3 or 25 (OH) D3 on serum/plasma vitamin D status in humans. In addition, the effect of vitamin D3 or 25 (OH) D3 in milk and butter on certain CVD risk markers and cognitive function will be examined.

There is mounting evidence to show that vitamin D deficiency may increase the risk of many common and serious diseases, including osteoporosis, cardiovascular disease, some cancers and type 1 diabetes (Holick and Chen, 2008). Hypovitaminosis D is now prevalent in the UK general population. Due to diet and lifestyle changes and the use of sun block products most people do not endogenously synthesise sufficient vitamin D from sunlight exposure (Hyppönen and Power, 2007). Therefore, vitamin D intakes from dietary sources have become very important, however this is limited as there are only a few foods naturally rich in vitamin D.

Some countries (e.g. USA, Canada) fortify milk with vitamin D which results in milk being the major contributor to vitamin D intake. Vitamin D3 is the most common form used for the fortification of currently fortified foods. However, there is now some evidence that 25(OH)D3 can increase vitamin D status of humans more effectively than vitamin D3 (Bischoff-Ferrari et al, 2012; Cashman et al, 2012). To our knowledge, very few human intervention studies have compared the efficacy of 25(OH)D3 versus vitamin D3 to increase vitamin D status, and there has been no acute human study to examine the effect of the both forms of vitamin D fortified dairy products on vitamin D status in humans.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 20-35 kg/m2
* Glucose \<7 mmol/l (not diagnosed with diabetes)
* Total cholesterol \<7 mmol/l
* TAG \<4 mmol/l
* Serum 25(OH)D3 ≤50 nmol/L
* Normal liver and kidney function
* Haemoglobin: adult male \>125 g/L

Exclusion Criteria:

* Milk allergy/intolerance or lactose intolerance
* Cardiovascular, renal, gastrointestinal, respiratory, endocrine disease or cancer
* Use of nutritional supplements, particularly those containing vitamin D
* Outdoor workers and use of tanning beds
* Overseas holidays two months before or during study period
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)

The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children \>=6 to \<=10 years old with primary hypercholesterolemia. The study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The safety of ezetimibe in this subject population will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Each subject may be of either sex and of any race/ethnicity, and must be \>=6 and \<=10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months with a LDL-C of \>159mg/dL
* Each subject's parent/guardian must be willing to give written informed consent on his/her behalf.

Exclusion Criteria:

Each subject must not:

* Have known hypersensitivity or any contraindication to ezetimibe.
* Have use of any investigational drugs within 30 days of study entry.
* Be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
* Be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing
* Have known congenital cardiac disorder.
* Have documented or laboratory values consistent with homozygous familial hypercholesterolemia (HoFH).
* Be known to be human immunodeficiency virus (HIV) positive.