cyrilzakka/clinical-trials huggingface dataset:
Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

In recent years, the importance of the gut microbiota to human health has been demonstrated. In adulthood, the microbial profile is relatively stable, yet can be transiently altered by factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut microbiota has been shown to differ in normal versus disease states including inflammatory bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship, there is intense interest in designing interventions that positively influence the gut microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that alter the colonic environment in favour of health-promoting bacterial species, such as bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to beneficially alter the microbial profile, there is a need to identify the dosing requirements to positively modulate the gut microbiota. This study will test the effect of two doses of prebiotic on gut microbiota taxonomy and diversity.

The primary objective is to determine the effect of 4 week intake of a moderate dose (7 g/d) or low dose (2.5-3 g/d) of prebiotic on gut microbiota profiles in healthy adults compared to a non-prebiotic containing control.

The primary outcome is change in microbial composition (measured via 16S rRNA sequencing).

The secondary outcomes are change in gastrointestinal (GI) tolerance (measured via questionnaire); change in fecal short chain fatty acids; and change in quality of life.

This study will consist of two separate trials of 12 week duration. Each trial will be performed in a double-blind, randomized, placebo-controlled crossover manner with a 4 week intervention period followed by a 4 week wash-out period and final 4 week cross over.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects who are regular snack consumers
* Not obese (BMI ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2)
* 18 and 65 years of age
* Stable bodyweight for at least 3-months prior to the study.

Exclusion Criteria:

* Chronic disease including but not limited to type 1 or 2 diabetes, cardiovascular disease, liver or pancreas disease.
* Major gastrointestinal surgery
* Pregnant or lactating
* Antibiotic use in the preceding 3 months
* Currently consume probiotic or prebiotics supplements
* Currently consume more than 15 g/d of fiber in women and 18 g/d in men
* Are following a diet or exercise regime designed for weight loss
* Have a BMI greater than 29.9 kg/m2.
* Subjects who are required to start an antibiotic regime during the study will be withdrawn.
Thrombo Embolic Events in Critical Care Patients With Covid-19 Serious Acute Pneumopathy

The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of pro-inflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation-induced thrombosis.

Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. Very few data are available regarding the biological disorders of coagulation in these patients. Th purpose of this project is to analyze hemostasis and coagulation of patients with infection of COVID-19 and severe pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in medical ICU with pneumonia due to COVID-19 infection

Exclusion Criteria:

* patients\< 18 years
Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers

Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of 6.3%. Treatment of diabetic foot ulcer (DFU) is challenging with disappointing outcome. Wound debridement, infection control, pressure relief and revascularization are main pillars of DFU management. Various substances and modalities are being investigated for their potential effects in treating DFU, one of which is LL-37.

In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled. Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream (treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound care. The primary outcomes are the healing rate measured by wound area and granulation index and changes in patterns of aerobic bacteria colonization during the 4-week study duration and changes in concentrations of IL-α and TNF-α from fluid collected from DFU on the end of the second and third week of study compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* Patients with DFU
* Ankle brachial index (ABI) 0.9 - 1.3
* Wound area 5 - 20 cm\^2
* Wound depth until subcutaneous tissue
* Without systemic infection, osteomyelitis, septic arthritis, or fasciitis
* Subjects are willing to participate by signing consent

Exclusion Criteria:

* Gangrene
* On treatment with systemic corticosteroids within 7 days before the start of study
* On treatment with systemic antibiotics within 2 days before the start of study
* Patients with end stage renal disease
Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients

A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for the defense against infections. Hence their decrease (called "neutropenia") leads to a predisposition to infections.

Since infections during neutropenia can be very dangerous, the patients are treated with antibiotics from the very first signs of such an infection (usually fever). If the antibiotics (drugs against bacteria) do not lead to a normalization of the body temperature within four days, a drug against fungi is added.

In the IDEA study, one half of the patients receive the antifungal drug voriconazole (as usual) only in case the antibiotics alone do not lead to a normalization of the body temperature (current standard of care). The other half of the patients receive voriconazole immediately after onset of fever (concomitantly with the antibiotics).

The research question is, whether in the "early-treatment" group fewer manifest fungal infections will be observed than in the "late-treatment" group.


Eligibility Criteria:
Inclusion Criteria:

* Acute leukemia, aggressive lymphoma, bone marrow or stem cell transplantation;
* Neutropenia (\<500 neutrophils/µL) of at least 10 days;
* Newly diagnosed fever;
* Positive panfungal polymerase chain reaction assay

Exclusion Criteria:

* Documented bacterial infection during screening or at randomization
* Fungemia or other documented invasive fungal infection during screening or at randomization.
Ovarian Function and Gynecological Profile of Patients Carrying a Pathogenic Variant of the HNF1B Gene (GYN-HNF1)

The main objective of this study is to study the ovarian function of patients with hepatocyte nuclear factor-1beta (HNF1B) abnormality, followed in the reference centers of Toulouse and Paris University Hospitals. The secondary objectives are to know the gynecological profile of these patients.

A dosage of anti-mullerian hormone (AMH) will be added to the usual balance, whatever the phase of the cycle and a pelvic ultrasound will be performed by the same operator by center. Patients will be received in a dedicated consultation to complete a questionnaire on gynecological and obstetric history, as well as their personal and family history. There will be no gynecological examination during this consultation.

HNF1B mutations can be responsible for genital malformations associated with renal development abnormalities. HNF1b is also a candidate gene involved in the development of the renal tract and the Mullerian system but there is no data in the literature regarding the ovarian function and clinical gynecological profile of these patients.

The main objective of this study is to study the ovarian function of patients with HNF1B abnormality, followed in the reference centers of Toulouse and Paris University Hospitals. The secondary objectives are to know the gynecological profile of these patients.

A dosage of AMH will be added to the usual balance, whatever the phase of the cycle and a pelvic ultrasound will be performed. Patients will be received in a dedicated consultation to complete a questionnaire on gynecological and obstetric history, as well as their personal and family history. There will be no gynecological examination during this consultation.

Eligibility Criteria:
Inclusion Criteria:

* Girls from 12 years of age carrying a pathogenic variant of the HNF1 B gene and monitored in the reference center for rare renal diseases
* Person affiliated or beneficiary of a social security scheme.
* Free, informed and written consent signed by the participant or her legal representative if a minor patient and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Woman unable to answer
* Pregnant or breastfeeding woman
* Refusal of participation by the patient or her legal representative
* Person under a protection system for adults (such as safeguard of justice, guardianship or curatorship)
* History of chemotherapy, radiotherapy, brachytherapy
* History of ovarian endometrium
CHWs' Challenges and Job Satisfaction

1. Determine the role of CHWs in health system.
2. Identify the barriers \& obstacles they face in their work.
3. Determine factors related to motivation and satisfaction of CHWs job.
4. Identify the role of CHWs in family planning services.

WHO consider "Community health workers should be members of the communities where they work, should be selected by the communities, should be answerable to the communities' needs and priorities, should be supported by the health system but not necessarily a part of the government and have shorter training than professional health workforce".

CHWs aims to provide appropriate, accessible care and bring care closer to mothers and babies, bridging the service delivery gap in underserved communities.

CHWs can effectively provide key primary, maternal, and newborn health care services including immunizations, tuberculosis treatment and contraceptive counseling.

CHWs face several challenges in reaching their full potential. Many of the obstacle's stem from a lack of understanding about their role within primary health system.

CHWs are faced by community and familial expectations of selflessness, equitably applied care, maintaining domestic responsibilities at home and implied understanding that extra work did not amount to extra pay.

In addition, motivation and satisfaction are key not only for retention but also for performance. Better workforce performance is positively associated with higher job satisfaction, and low levels of job satisfaction adversely affect employee commitment and sequentially affect achievement of organizational objectives and performance. Factors strongly associated with CHW satisfaction include relationships with health workers and communities, the availability of job aides and the capacity to provide services and with the training. On the other hand, CHWs were highly dissatisfied with the unavailability of transportation for carrying out their tasks and the lack of allowances or financial incentives. Also, Non-financial incentives include community recognition and respect, acquisition of valued skills, personal growth and development, accomplishment, peer support and community factors like relations with communities and leaders. Other supportive CHW programmed factors.

include frequent supervision and continuous training. therefore, CHW interventions must be implemented with an understanding of the complex challenges faced by CHWs and community members. This would in turn empower CHWs in navigating complex relationships within the community and the health system.

Eligibility Criteria:
Inclusion Criteria:

* Community health workers working in Assiut governorate.

Exclusion Criteria:

* Other healthcare providers.
* People with mental illness.
Current Treatment Modalities for Wide Necked Intracranial Aneurysms

* Give an effective treatment for intracranial wide necked aneurysm and can detect the best method could be used.
* Improve the outcome of these patients and decease rate of recurrence and complications.

The prevalence of intracranial aneurysms in the adult population is estimated to be around 2 %. Most remain asymptomatic, but there is a risk of rupture of 1.2 % per year, and this risk increases in line with the diameter of the aneurysm. If rupture occurs, subarachnoid hemorrhage and its associated acute complications are responsible for high mortality (between 30 and 67 %) and morbidity (between 15 and 30 %).

Coil embolization of intracranial aneurysms has made remarkable technological progress since the International Subarachnoid Aneurysm Trial (ISAT) data were released in 2005. However, wide-necked aneurysms remain a great challenge to be treated via the endovascular means, as they are associated with a significantly greater incidence of adverse events when compared with narrow-necked ones.

Acutely ruptured wide-necked intracranial aneurysms pose technical challenges to the treating physician; thus, multiple endovascular techniques have been described to treat these lesions, including balloon-assisted coil placement, double microcatheter technique, and microcatheter assisted coil placement. However, the use of these techniques can sometimes be limited, owing to the lack of permanent support for the coil mass inside the aneurysm sac, which may lead to coil prolapse or migration after the procedure, especially for wide-necked aneurysms (dome-to-neck ratio is less than 1) or tiny aneurysms (3 mm). Therefore, surgical clipping is preferred for acutely ruptured wide-necked intracranial aneurysms in most institutions. Surgery, however, may also be challenging in some of these lesions, since clips may slip, and surgical access may be limited because of the swelling of the brain in the acute setting of a subarachnoid hemorrhage.

Flow diverters are new implantable medical devices that make possible to embolize wide-necked aneurysms without the use of coils; the efficacy results published to date are encouraging in terms of complete occlusion in the medium-term, thereby confirming the innovative nature of the flow diversion technique that we aim to evaluate without the use of coils.

Eligibility Criteria:
Inclusion Criteria:

• Patients who undergo surgical clipping or any endovascular techniques used in treatment of wide-necked intracranial aneurysms. Wide-necked aneurysms are defined as aneurysms with a fundus-to-neck ratio of less than 2 or a neck diameter of 14 mm.

Exclusion Criteria:

* patients with narrow-necked intracranial aneurysms
* patients who are unfit for any neurosurgical interventions.
* patients who had artery aneurysm and vascular malformation due to some trauma.
Lipid Peroxidation in Workers Exposed to Al,Ga,In,As,and Sb in Optoelectronic Industry

To investigate whether exposure to Al, Ga, In, As, and Sb induces lipid peroxidation in humans. Whole blood and urine levels of 170 workers were analysed by use of ICP-MS. MDA, the product of lipid peroxidation was determined by HPLC

If MDA as an index of lipid peroxidation can be induced by these metals. We will suggest reducing exposure to these metals

Eligibility Criteria:
Inclusion Criteria:

* Optoelectronic workers

Exclusion Criteria:

* Office workers
Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis

OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis.

II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, dose escalation study.

There are 7 experimental cohorts, each treated with a different oral dose of CPX or placebo. Within each cohort, 4 patients receive a single dose of CPX and 1 patient receives placebo. Each patient is monitored 24 hours postdose. Escalation to the next dose level for each subsequent cohort begins only after the safety data obtained from the previous cohort is reviewed and found not to limit dose escalation.

All patients return for a follow up evaluation 1 week after dosing.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

* Mild cystic fibrosis
* Not pregnant or nursing Negative pregnancy test
Lower Limb Mechanical Characteristics: Effect on Running Mechanics and Energetics

Inter-individual variability in energetic cost of running may be partly explained by lower limbs mechanical characteristics. The transposition of muscle mechanical model with two components (contractile and elastic) to the whole lower limb mechanical behavior analysis during running. The main aim of present investigation is to study the effects of lower limb mechanical characteristic (force, velocity, stiffness) on the energetic cost of running using a lower limb mechanical approach including both contractile and elastic components.Twenty healthy men will run on a treadmill at 12km.h-1 in 8 different 5 min-conditions. Through conditions, stride frequency, sole stiffness and subject's body weight will be changed to allow artificial variations in lower limb mechanical characteristics. Energetic and non-invasive mechanical measurements analysis will be performed to obtain energetic cost of running and to compute force, velocity and stiffness of lower limbs for each condition.

Main aim: Identify the effect of mechanical characteristic induced on lower limbs on the energetic cost of running.

Secondary aim : Minimize the energetic cost of running by lower limb mechanical characteristics optimization.

Eligibility Criteria:
Inclusion Criteria:

* healthy men being between 20 and 35 years old and doing regularly physical activities
* subjects must be able to run at 12 km/h during 15 minutes in aerobic condition
* not be sedentary and not do running competitions
* be affiliated to a social security system
* Sign a written inform consent

Exclusion Criteria:

* presenting a clinic sign of intolerance to exercise, and particularly to running
* overweight subjects
* having a medical treatment which may interfere with the running quality or with one of the physiological parameters measured
* taking part at the same moment in another medicinal research
MicroRNA Profile and Erenumab Treatment

Erenumab, a monoclonal antibody acting on the calcitonin gene-related peptide (CGRP) receptor, is an effective and safe migraine-specific preventive drug. The use of migraine-specific preventive drugs paves the way for a novel method to study migraine pathogenesis. Migraine is a complex disorder with several genetic and epigenetic influence, including that of microRNA. Several microRNAs, including those of inflammation and of endothelial function, have high expression levels in subjects with migraine; however, the findings of the available studies are insufficient to provide epigenetic biomarkers for migraine. Besides, little evidence is available on the role of migraine preventive treatments in the expression of microRNA. The study aims at evaluating the expression profiles of microRNAs before and after erenumab treatment prescribed according to clinical indication. The study will include women with episodic or chronic migraine treated with erenumab 140 mg monthly according to the Summary of Product Characteristics and local reimbursement criteria. The study will compare the expression profile of microRNAs in women with episodic and chronic migraine; besides, it will investigate differences in migraine-associated microRNA expression according to age, migraine characteristics, pain intensity, response to erenumab, migraine-related impact and disability.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 25 to 50 years
* Chronic or episodic migraine with or without aura diagnosed according to the International Classification of Headache Disorders - 3rd edition
* Receiving a first prescription of erenumab for migraine prevention according to the Summary of Product Characteristics and local reimbursement criteria
* At least 1 year from migraine onset
* Provided informed consent

Exclusion Criteria:

* Headache other than migraine
* Prior exposure to erenumab or other monoclonal antibodies targeting CGRP or its receptor
* Use of any migraine preventive treatment in the last 60 days or 5 half-lives or 4 months if ever treated with botulinum toxin A
* Pregnant or nursing
* Body Mass Index \<18 or \>30 Kg/m2
* Heavy smoking (more than 20 cigarettes per day)
* Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other revascularization procedures within 12 months prior to first visit
* Illicit drug abuse
* Major psychiatric disorders
* Infective or inflammatory diseases
* Any chronic medication prescribed for indications different from migraine within 60 days before study initiation
The Effect of 4 Weeks of L-Citrulline Supplementation on Macro- and Microvascular Function in Type 2 Diabetes

The purpose of this study is to examine the effect of 4 weeks of Citrulline supplementation on macro- and microvascular function during acute hyperglycemia in middle-aged and older adults with type 2 diabetes.

Using a double-blind, randomized, placebo-controlled, and cross-over design, middle-aged and older adults with type 2 diabetes will be randomized to receive either CIT supplementation (6g/day) or placebo (Microcrystalline Cellulose, 6g/day) for 4 weeks.

There will be a total of 5 laboratory visits. Visit 1 (screening visit) will take approximately 1 hour and 30 minutes, visit 2 will take approximately 2 hours and 30 minutes, and visits 3-5 will be approximately 3 hours each.

Visit 1 will measure blood pressure, blood glucose and lipid levels, anthropometry, body composition, and muscle strengths. Visits 2-5 will assess vascular function and glucose control during fasted and acute hyperglycemia conditions induced by 75g of glucose ingestion.

Eligibility Criteria:
Inclusion Criteria:

* Middle-aged and older women and men between 40-75 years old
* A physician diagnosed type 2 diabetes at least 3 months ago
* Treated with an oral hypoglycemic medication
* Body mass index \< 40 kg/m2
* Systolic blood pressure \< 160 mmHg
* Sedentary (defined as \< 120 min/week of exercise)
* Not currently participating in exercise or dietary interventions for at least 2 months prior the present study and willing to abstain from participating in those strategies during the duration of this study.

Exclusion Criteria:

* \< 40 years of age and \> 65 years of age
* Use of medications and/or any supplements that may affect outcome variables (such as arginine- or citrulline-containing supplements, nitrates, and nitroglycerin)
* Body mass index ≥ 40 kg/m2
* Systolic blood pressure ≥ 160 mmHg
* Recent changes in medications within 3 months
* Current smoking any tobacco use
* Type 1 diabetes, severe cardiovascular/renal/pulmonary diseases
* More than 7 alcoholic drinks/week of consumption
* Premenopausal women with an irregular menstrual cycle (oligomenorrhea) or pregnancy