cyrilzakka/clinical-trials huggingface dataset:
Metformin and Lactoferrin in Sepsis in Icu

Sepsis is a life-threatening organ dysfunction triggered by an unregulated response of a host to infection. Sepsis is a reason for substantial mortality and morbidity among intensive care unit (ICU) patients. 1 Therefore, the aim of our study is to compare the safety and efficacy of metformin and lactoferrin in ICU patients with sepsis.

Sepsis is a life-threatening organ dysfunction triggered by an unregulated response of a host to infection. Sepsis is a reason for substantial mortality and morbidity among intensive care unit (ICU) patients. 1 The pathophysiology of sepsis has changed spectacularly over the last several decades. Significant comprehension into the components of the inflammatory response has been achieved. Inflammation contributes to endothelial injury and initiates coagulation pathways.2 The inflammatory reaction is mediated by the release of cytokines (tumor necrosis factor-alpha, interleukins, and prostaglandins) from neutrophils and macrophages. The cytokines trigger the extrinsic coagulation cascade and inhibit fibrinolysis. These overlapping processes end with organ dysfunction.3 The Sequential Organ Failure Assessment or SOFA score was developed to assess the acute morbidity of critical illness at a population level and has been extensively validated as a tool for this purpose across a range of healthcare settings and environments.4 Metformin is oral anti-diabetic agent that has positive effects such as antioxidant and anti-inflammatory properties which are considered potentially beneficial properties for management of septic patients. Previous studies showed that preadmission metformin use may reduce mortality in adult patients with sepsis and diabetes mellitus. Therefore, our study aims to test the potential efficacy of metformin in all subsets of patient with sepsis.5,6 Lactoferrin is a cationic glycoprotein and associated with many activities including the relevant anti-inflammatory one, especially associated to the downregulation of pro-inflammatory cytokines besides its anti-microbial and immunomodulatory effect.7 A previous study suggested that lactoferrin supplementation to enteral feeds with or without probiotics decreases late-onset sepsis in preterm infants without adverse effects and this encourage us to test its role in adult patients with sepsis.8 Therefore, the aim of our study is to compare the safety and efficacy of metformin and lactoferrin in ICU patients with sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

  1. Age more than 18 years old.
  2. A diagnosis of sepsis according to the latest Sepsis definition.11
  3. Estimated GFR \&gt;45 ml/minute.

Exclusion Criteria:

Exclusion Criteria:

1. Pregnancy and breast feeding.
2. End stage hepatic disease.
3. End stage renal disease -
Screens, Virtual Reality and Digital Addiction (EVADD)

This is an observational study questionnaire-based. This study will be carried out to evaluate the methods of consumption (work/outside work), the characteristics of the tools used, the addictive risk, the consequences on mental and physical health and the impact on quality of life of people exposed to screens and smartphones.

A sample of 800 000 people will be used to learn about the entire French population. Participants will be asked to respond to an anonymous digital survey.

The ultimate goal of this work is to have quality information to help facilitate therapeutic efforts in support of those who may need it.

Inappropriate use of the smartphone is defined as excessive use of the technological tool interfering with social and/or professional activities causing negative consequences such as the alteration of certain cognitive functions such as attention. In addition, the excessive use of smartphones has generated a new form of digital symptoms such as NOMO or nomophobia (addiction to mobile phones by compulsive checking of new messages or social networks) and FOMO (fear of being excluded enriching social experiences, Fear of Missing Out).

From the perspective of social media addiction, research has shown that there is a fine line between habitual, frequent, unproblematic use and problematic and possibly addictive use of social media. Users who express symptoms and consequences traditionally associated with substance addiction (salience, mood changes, tolerance phenomenon, craving, withdrawal, relapse) could be addicted to social media.

Nowadays, abstinence from digital media and consumption cannot realistically be achieved in the context of SR addiction, as the internet and social media have become essential parts of our lives. Rather than shutting down social media altogether, therapy should focus on establishing controlled social media use and digital media awareness.

This study will be carried out to evaluate the methods of consumption (work/outside work), the characteristics of the tools used, the addictive risk, the consequences on mental and physical health and the impact on quality of life of people exposed to screens and smartphones.

A sample of 800 000 people will be used to learn about the entire French population. Participants will be asked to respond to an anonymous digital survey.

This is an observational study questionnaire-based. The ultimate goal of this work is not to overpathologize daily behaviours, but to have quality information to help facilitate therapeutic efforts in support of those who may need it.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older (adult)
* members of the PRO-BTP insurance (email list)
* understanding French language

Exclusion Criteria:

* less than 18 years old
Troponin Excretion in Urine in Patients With and Without Chronic Kidney Disease

In this study, in order to better understand the mechanism of troponin clearance and the reason for elevated troponin levels in patients with CKD, we aim to evaluate quantitatively the excretion of troponin in the urine in patients with and without CKD, and with and without myocardial injury. We will compare urinary troponin levels with blood troponin levels in these patients. In addition, we will compare the levels of hs-cTnT and hs-cTnI in the patients' sera and urine.

The study population will be screened at the internal wards, the nephrology ward and clinic, and the intensive cardiac care unit (ICCU) of Soroka Medical Center. It will include patients who suffer from AMI, patients with CKD with and without any cardiac disease and patients with no known renal or cardiac disease.

The following information and measurements will be collected:

Demographics - age, sex, weight, height. Past medical history - specifically regarding renal and cardiac diseases and procedures.

Measured variables in blood serum - troponin T, troponin I, creatinine, total protein, albumin, myoglobin Measured variables in urine - troponin T, troponin I, creatinine, total protein, albumin, microalbumin, β2-microglobulin Calculations - GFR (according to MDRD equation), troponin correction to creatinine (gr troponin per gr creatinine), troponin excretion ( ), urine albumin/creatinine ratio, urine protein/creatinine ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are able to give informed consent.
2. Age ≥ 18

Exclusion Criteria:

1. Pregnant women
2. Patients after kidney transplantation.
3. Patients after heart transplantation.
4. Anuric patients.
Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis

Based on the fact that the fundamental pathogenic mechanism of the Multiple Sclerosis (MS) disease is neuroinflammation, related in turn to cellular oxidation and mitochondrial alterations, this project aims to assess the impact of a nutritional intervention on the evolution of MS patients in their different slopes. To this end, the administration of medium-chain triglycerides, whose metabolism produces the increase of ketone bodies in the blood, will be carried out; and another of the antioxidant polyphenol epigallocatechin gallate. This procedure will be applied over 6 months, based on a isocaloric Mediterranean diet, with a population for the study of 80 patients with different variants of the disease. The assessment of the intervention will be carried out every two months, at motor-functional, anthropometric, cognitive and emotional, inflammatory, and oxidation levels.


Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis patients older than 19 years ans under 65 who sign informed consent of the study

Exclusion Criteria:

* Patients with coconut oil intolerance or other chronic metabolic pathologies
First Observatory of Precocious Puberty.

The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.

Due to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.

The establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.

The investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data.


Eligibility Criteria:
Inclusion Criteria:

Precocious puberty group (PP) :

* Suspected precocious puberty (girl aged \< 8 years or boy aged \< 9 years when the first signs of development\* appear)
* Suspected precocious puberty (girl aged \< 8 years or boy aged \< 9 years when the first signs of development\* appear)

Advanced puberty group (AP) :

* Suspected advanced puberty (girl aged ≥ 8 and \< 10 years or boy aged ≥ 9 and \< 11 years when the first signs of development\* appear)
* First consultation with the investigator (pediatric endocrinologist).

Control group :

* Boy or girl without signs of pubertal development (Tanner 1);
* Matched to the PP group on sex and age (+/- 1 year);
* Consultation with the same investigator over the same period (same quarter) as a patient in the PP group

Exclusion Criteria:

All groups

* Consultation with the same investigator over the same period (same quarter) as a patient in the PP group
* Family not speaking French, language barrier.
Maternal TDF and FTC to Reduce NNRTI Resistance Mutations After Intrapartum NVP

The purpose of this study is to determine whether the addition of tenofovir (TDF) and emtricitabine (FTC)to a standard PMTCT regimen containing single-dose nevirapine (NVP) can reduce the development of post-ingestion HIV resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Single-dose intrapartum and neonatal nevirapine (NVP), either alone or in combination with short course zidovudine (ZDV) is in widespread use to prevent mother-to-child HIV transmission throughout the developing world. Though the public health benefits cannot be overstated, widespread use of NVP in this fashion may come at a cost. Non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations are induced in at least 20% and probably a larger proportion of women exposed to NVP in this fashion. Addition of short-course ZDV does not appear to mitigate this effect substantially. The full implications of these NVP resistance mutations are yet unknown, though there is concern that they may result in reduced efficacy of the NVP or other NNRTIs in long-term, therapeutic regimens.

We are conducting a clinical trial of tenofovir (TDF) and emtricitabine (FTC), marketed as a fixed dose combination, Truvada ™, to reduce NNRTI-resistance post-delivery in the setting of NVP with or without ZDV for PMTCT. TDF and FTC are both Category B drugs and are approved for use in pregnancy. They have several characteristics that make them ideal candidate drugs for use in conjunction with NVP, including long intracellular half-lives and established safety profile among adults for HIV treatment.

Women will be enrolled between 28 and 38 weeks of gestation. As part of normal PMTCT services, they may choose NVP-boosted ZDV or single dose NVP for PMTCT; We anticipate that most (\~80%) will choose the former. At arrival for delivery, they will be randomized to receive either the two study drugs (intervention) or no drug (control). A total of 400 women will be randomized, and followed, along with their infants, for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Serologically confirmed HIV infection;
* Gestational age of 28 to 38 weeks;
* Previous selection of a NVP-based PMTCT regimen (with or without ZDV)
* Willingness to participate in a randomized trial;
* Willingness to follow up in a postpartum visit schedule;
* Willingness to allow her infant to participate in this trial;

Exclusion Criteria:

* Use of antiretroviral medications before this pregnancy, even in a single dose.
* Current use of antiretroviral medications for treatment of advanced HIV disease and/or AIDS
* Illness or complication of pregnancy likely to warrant transfer to the University Teaching Hospital (UTH), known at time of randomization;
* Known or suspected allergy to NVP or other benzodiazepine medications;
* History of known liver disease.
* Hemoglobin level of 7.9 g/dL or less
Do Patients With Fish or Shellfish Allergy Tolerate the Consumption of Fish Oil Supplements? A Clinical Study

The purpose of this clinical study is to test whether patients with fish or shellfish allergy can ingest different types of fish oil supplements without having an allergic reaction.

To achieve this, the recruited participants will be asked to:

* provide a blood sample (used for Basophil Histamine Release Assay)
* undergo a skin-prick-test
* partake in multiple oral provocations

These three tests will indicate the likelihood that the participants can consume fish oil supplements without adverse allergic reactions (See the detailed description for an explanation of the tests).

The investigators will test the participants tolerance for three different types fish oil supplements: Fish oil, Cod liver oil, and krill oil.

The Basophil Histamine Release Assay is a test that indicates whether or not the immune cells of the participant reacts when it comes into contact with the fish oils.

The skin-prick-test involves the participants having their skin exposed to the fish oils. This is done by first exposing a tiny needle to the given fish oil, and then pricking the needle into the skin on the forearm of the participant. In this way, the immune cells of the skin is exposed to the fish oils. If an allergic reaction occurs, the pricked skin will swell and turn reddish.

During the oral provocation, the participant is asked to ingest small, but increasing, doses of the fish oils over a period of 2 hours. The provocation will end when either an allergic reaction occurs or the participant has ingested a total dose of 5 mL fish oil.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years old)
* Legally competent
* Understands Danish

Exclusion Criteria:

* Current use of antihistamine, immunosuppressants, and/or anti-IgE-treatment that cannot be safely terminated during the study period
* The presence of severe diseases such as: Cardiovascular disease, asthma, cancer, liver disease, kidney disease, hematological diseases, neurological diseases, dementia, immunological diseases, and endocrine diseases
* Chronic urticaria
* Severe atopic eczema
* Pregnancy and/or breastfeeding
* Participation in another clinical study the previous three months
* Known excessive use of alcohol and/or substance abuse
Effect of Two Preventive Exercise Programs for Swimmer's Shoulder on the Torque of Shoulder Rotator Muscles in Competitive Swimmers

The purpose of this study was to verify the effectiveness of two 12-week preventive exercise programs for swimmer's shoulder with monitoring and progression over time, on the peak torque and respective conventional concentric ratio and functional ratio. One of these programs was performed with weights and the other with an elastic band. This study hypothesized that the two preventive exercise programs minimize shoulder rotators imbalanced during the swimming season. The study design is a care provider and participants blinded, parallel, randomized controlled trial


Eligibility Criteria:
Inclusion Criteria:

* Competitve swimmer in the current season.
* Aged between 16-35 years old.
* Have a minimum of 5 years of experience in national competitions.
* Performed a minimum of 8 hours of weekly swimming training.

Exclusion Criteria:

* Subjects who had performed at least 6 weeks of treatment such as physical therapy, injections, and medication.
* Clinical situations such as a history of significant shoulder pain in the last 6 months, a history of traumatic shoulder injuries such as fractures, subluxations, cervical or thoracic conditions, previous shoulder surgeries, shoulder range of motion deficits, or neurological injuries.
Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents

The rationale for this study is to further explore if development of antibodies against TNF-α blocking agents is associated with reduced clinical effect/worsened clinical outcome. An important aspect of the study is to carry out an exploratory analysis of the immunogenicity of the 4 recommended TNF-α blockers in the treatment of RA in Denmark, using the same cell-based assay.

no sampling

Eligibility Criteria:
Inclusion Criteria:

* Subject fulfils criteria for Rheumatoid Arthritis (RA) according to ACR or EULAR criteria.
* Subjects who are planned to start treatment with ADA, ETA, CER or IFX
* Subjects taking a minimum weekly dose of 7.5 mg of methotrexate

Exclusion Criteria:

* Patients with compliance problems
* Patients who have difficulties in reading and understanding local language
* Patients with Juvenile Idiopathic Arthritis (JIA)
* Azathioprine or cyclophosphamide treatment within 6 months before entering into the study
An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD

The objective of this study is to determine if inpatient COPD education would result in improved patient knowledge of COPD.

A prospective cohort study utilizing a pre-test/post-test design will be used to test a COPD education intervention on a convenience sample of 30 patients with a diagnosis of COPD. Study participants will complete the Chronic Obstructive Pulmonary Disease questionnaire (COPD-Q) to assess their COPD knowledge. Next, a respiratory therapist will provide the first scripted COPD education session. The patient will complete the COPD-Q 24 hours and 30 days post-discharge. Demographic data, smoking status, pack-years, COPD spirometry grade, COPD symptom and exacerbation grade, previous hospital admissions, support system for managing COPD, attendance at previous formal education for COPD, current and home medications, pulmonary function test (PFT) results, vaccinations, and level of education data will be collected. Data related to patient recruitment will also be collected. Means and standard deviation will be reported for interval data. Total frequency and percentages will be reported for nominal data, and median and 25th and 75th percentile will be reported for COPD severity. Repeated measures ANOVA (p\< 0.05) will be used to evaluate if an inpatient COPD self-management intervention can increase the patient's knowledge of COPD after 24 hours and again at 30 days after the initial education session.

This study is expected to show that an inpatient education of COPD can increase the patient's COPD knowledge prior to discharge and that it will be retained for at least one month post-discharge.

Eligibility Criteria:
Inclusion Criteria:

* History of COPD
* Spirometry confirmation of COPD either from chart or bedside spirometry i. FEV1(forced expiatory volume in 1 second)/FVC (forced vital capacity) \<70% ii. FEV1 \< 80% predicted
* Willingness to participate
* English-speaking
* Working phone

Exclusion Criteria:

* Cognitively impaired (including sedation)
* Intubated
* Non-English-speaking
* Receiving palliative or hospice service
* Enrolled in any other educational research s
Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?

Neonatal hyperbilirubinemia elongates hospital stay and may require treatment. The investigators noticed that bilirubin levels were higher among infants of primipara mothers than among multipara mothers. As this data is dichotomic and easy to produce, and may influence the maintenance, the investigators decided to find out if primiparity is a risk factor for neonatal hyperbilirubinemia. The investigators intend to collect data from patient files during one year, and compare the bilirubin levels and length of stay between newborns to primipara mothers and multipara mothers.

Neonatal hyperbilirubinemia elongates hospital stay and may require treatment. The investigators noticed that bilirubin levels were higher among infants of primipara mothers than among multipara mothers. As this data is dichotomic and easy to produce, and may influence the maintenance, the investigators decided to find out if primiparity is a risk factor for neonatal hyperbilirubinemia. The investigators intend to collect data from patient files during one year, and compare the bilirubin levels and length of stay between newborns to primipara mothers and multipara mothers.

Eligibility Criteria:
Inclusion Criteria:

* All infants that were born during one year in a single medical center and were transferred to well baby nursery, and were discharged from the well baby nursery.

Exclusion Criteria:

* Infants who were transferred to neonatal intensive care unit due to any reason.
* Infants whose mother could not take care of them (due to admission to intensive care unit, or due to adoption)