cyrilzakka/clinical-trials huggingface dataset:
Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty Liver Disease

Non- alcoholic fatty liver disease (NAFLD) is one of metabolic syndrome manifestation, and has become the leading cause for cirrhosis and the need for liver transplantation.

The Mediterranean diet showed in many trials its benefit in the treatment of the metabolic syndrome and NAFLD. The Paleolithic Diet includes meat, fish, fruits, vegetables, nuts and seeds and avoidance of processed food and most of carbohydrates. In some studies this diet seemed to decrease triglycerides levels and improve insulin resistance.

The aim of this study is to evaluate the influance of the paleolithic diat for the treatment of NAFLD, as shown in the Mediterranean Diet.

Recruitment of 60 patients with the diagnosis NAFLD from clinics in Rabin Medical center, aged 18-65.

Two study groups- Mediterranean Diet and Paleolithic Diet The dietitian will assign randomly for the study groups, and will assess diet adherence within 6 weeks of the trial and in its end- after 3 months.

blood test for liver enzymes, lipids, crp, mda and HbA1C, will be taken at recruitment and after 3 months.

Ultrasound and elastography will be tested at recruitment and after 3 months, to evaluate the degree of the fatty liver, by a the same doctor who is blind to the study groups.

Eligibility Criteria:
Inclusion Criteria:

* NAFLD

Exclusion Criteria:

* pregnancy
* Chronic kidney disease
* post transplant
The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease

The purpose of this study is to investigate the mechanisms underlying bariatric surgery-induced resolution of non-alcoholic fatty liver disease.

Bariatric surgery is one of the few currently available treatment options for non-alcoholic fatty liver disease (NAFLD). In most cases, NAFLD is entirely ameliorated after the surgery but in some individuals, the disease may persist or even progress. The mechanisms underlying the bariatric surgery-mediated resolution of NAFLD and the heterogeneity in the response remain poorly understood. In this study, the investigators will examine the metabolic effects of bariatric surgery-induced resolution of NAFLD. To this end, study subjects who have previously undergone bariatric surgery and metabolic studies will be invited for a follow-up visit for physical examination, evaluation of body composition with bioelectrical impedance and quantification of liver stiffness using non-invasive transient elastography and magnetic resonance elastography (MRE). Body fat composition will be evaluated by magnetic resonance imaging (MRI) and hepatic lipid content will be measured with magnetic resonance spectroscopy (MRS). In addition, 1H nuclear magnetic resonance (NMR) metabolomic analyses will be carried out from plasma samples collected both before and after bariatric surgery. Insulin resistance will be assessed using the HOMA-IR index and the genotypes in disease-modifying genes including PNPLA3, TM6SF2, MBOAT7, MARC1 and HSD17B13 will be assessed. Liver biopsies were obtained at the time of bariatric surgery and, in individuals with a clinical indication, a follow-up liver biopsy will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have undergone bariatric surgery and previously participated in a metabolic study in our research group.
* Participants must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
* Age range from 18-75 years.

Exclusion Criteria:

* No claustrophobia or metal implants to allow magnetic resonance spectroscopy.
* No pregnancy or lactation in women.
Biochip for HCMV Detection in Breast Milk

Human cytomegalovirus (HCMV) is the leading cause of neonatal viral infection and can have a significant impact on the neurosensory development of newborns and especially preterm infants. HCMV infection may result from maternal-fetal transmission during pregnancy or postnatal transmission. While congenital HCMV infection affects about 2-5% of very preterm infants, the risk of postnatal infection, particularly through breast milk, is much higher in this population (prevalence of about 20%). Many learned societies wonder about the interest to inactivate HCMV (by freezing or pasteurization) in breast milk in order to reduce or eliminate contamination of these children. However, freezing is relatively inefficient to reduce contamination and pasteurization drastically alters the nutritional quality of the milk. Therefore, a systematic preventive treatment of breast milk for very preterm infants is not currently recommended. An alternative approach could consist in detecting HCMV in breast milk to target at-risk situations. This detection can be performed by PCR but its cost and the time required to obtain the result prohibits its use for a mass detection. Currently, viral status of breast milk is not explored in practice and, depending on the health centers, breastfeeding is continued as such or milk is systematically inactivated.The main objective of VIRUMILK is to study the feasibility of the CMV detection in breast milk from lactating mothers with a biochip.The ultimate goal is to prevent postnatal HCMV infection of preterm newborns less than 33 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Lactating women (\> 18 years)
* Mothers with infants less than 33 weeks hospitalized in intensive care infant / neonatal the University Hospital of Besancon.
* No opposition mothers.
* Join a French social security or receiving such a scheme.
* Subjects who received medical care during pregnancy.

Exclusion Criteria:

* Legal incapacity or limited legal capacity.
* Topics without health insurance.
* Topics being in the disqualification of another study or under the "national register of volunteers."
Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in Preeclampsia

The aim of the present study is to evaluate the implication of adipokines, inflammation, insulin resistance and endothelial dysfunction in the pathogenesis of preeclampsia and in pregnancy related complications.

This observational parallel study will be conducted on pregnant women with normal pregnancy, pregnant women with Preeclampsia, and on healthy non-pregnant women. All participants will be recruited from the Outpatient Clinic of Obstetrics and Gynecology Department at Menoufia University Hospital (Shebin El-Kom, Egypt). The study will be approved by the Research Ethics Committee of Menoufia University and all the involved subjects will give their written informed consent.

This study will involve a total number of 60 women who will be further classified into: 20 non-pregnant women who serve as the control group (group 1), 20 pregnant women with normal pregnancy at their third trimesters (group 2) and 20 pregnant women with Preeclampsia at their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria. The pregnant women will be assessed in their third trimesters and further re-evaluated 4 weeks after delivery. The gestational ages will be determined conventionally and re-affirmed by ultrasonographic measurement.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with normal pregnancy (n=20)
* Pregnant women with Preeclampsia (n=20) at their third trimesters of pregnancy will be included in the study. Preeclampsia will be defined and diagnosed by constant elevation in blood pressure greater than 140/90 mmHg and by the presence of proteinuria above 300 mg /24 hour with the absence of both urinary tract infection and previous history of hypertension.
* Apparently healthy non-pregnant females (n=20) will be included in this study also.

Exclusion Criteria:

* Women with risk factors for oxidative stress such as smokers and
* Those with a medical history of diabetes mellitus (DM) and Tuberculosis (T.B).
* Women with a history of hypertension, familial hyperlipidemia, liver diseases, inflammatory diseases, and renal impairment.
* Non-pregnant women on hormonal therapy or hormonal contraceptives.
Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval

This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer


Eligibility Criteria:
Inclusion Criteria:

* Non Smoker
* Normal resting 12-lead ECG with normal QTc interval (\<450 msec)
* Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening

Exclusion Criteria:

* Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
* Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
* Judgement by the investigator, that the healthy volunteer should not participate in the study
Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial

Fluid management during neurosurgery presents a special clinical agenda. Volume overload can have detrimental effects on intracranial pressure by increasing either cerebral blood volume or hydrostatically driven cerebral edema formation. On the other hand, an overt restrictive fluid strategy may risk hemodynamic instability.

Recently, dynamic fluid responsiveness parameters such as stroke volume variation (SVV) have been shown as a more precise parameters for fluid management including in neurosurgical patients. The threshold of SVV is reported about 10-15%. In this study, the investigators aim to using two SVV threshold to conduct intraoperative fluid therapy for craniotomy. Randomization will be generated by computer sampling. One of the two groups of patients will be managed with fluid bolus to keep intraoperative SVV \<10% presenting the "normovolemia" group. The other group of patients will be kept intraoperative SVV \<18% which is slightly above previously reported SVV threshold upper limit. The second group thus presents the "restrictive" group. Clinical outcomes, laboratory analysis including S100-B for neuronal damage and neutrophil gelatinase-associated lipocalin (NGAL) for acute kidney injury, will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Supratentorial brain tumor receiving elective craniotomy
* BMI between 18.5-27.0 kg.m-2

Exclusion Criteria:

* Cardiac dysfunction, such as coronary artery diseases; atrial fibrillation;

  * NYHA class II
* Renal dysfunction, eGFR\< 60 ml.min-1.1.73m-2
* Pulmonary cormorbidity, such as COPD
Treatment for Partial Lesions of the Fingers Flexor Tendons : Tangential Resection or Direct Suture

Flexors tendon injuries are frequent and serious with a potential of definitive functional aftereffects. In the case of partial injury, the treatment is debated. There are 2 techniques of possible repair, the direct suture and the tangential resection. The investigators have already demonstrated that this last technique was favorable for injuries going to 50 %. In the case of partial section between 50 and 75 %, the investigators think that the technique of tangential resection compared with the direct suture would not increase the risks of secondary breaks, would authorize even an immediate mobilization and would decrease the secondary complications.

The main objective is to highlight that the tangential resection is not lower than the classic technique on the clinical plan The secondary objectives are to highlight the non-inferiority of the tangential technique in clinical terms (pains, dexterity, complications), radiologics (MRI, ultrasound) and functional (function, go back to leisures and professional activities)


Eligibility Criteria:
Inclusion Criteria:

* wound dating less than 48 hours
* partial section from 50 % to 75 % of the flexor tendons (deep and/or superficial flexors, long flexor of the thumb) in zones 1, 2, 3, T1 and T2
* tendinous injuries on a single finger

Exclusion Criteria:

-
Walking and Thinking - Brain Activity During Complex Walking in Aging and Parkinson's Disease

Every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. However, the process of aging or the sequelae of neurological diseases such as Parkinson's disease (PD) compromises motor-cognitive interaction necessary for an independent lifestyle. While motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions.

The challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecological valid state. The investigators aim therefore to explore brain function during complex walking in healthy and PD by investigating the effects of age and neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fNIRS) and advanced gait analysis in real time in young, older healthy adults and people with PD.


Eligibility Criteria:
Healthy young:

Inclusion criteria:

-18 to 50 years

Exclusion criteria:

* Disease or condition that affects cognition, gait or balance.
* Severe hearing or visual impairments that affects participation in the assessments

Healthy elderly:

Inclusion criteria:

* ≥60 years of age,
* 23 or more on the Montreal Cognitive Assessment (MoCA)

Exclusion criteria:

* Disease or condition that affects gait or balance.
* Severe hearing or visual impairments that affects participation in the assessments

Parkinson cohort:

Inclusion criteria:

* ≥60 years of age
* a clinical diagnosis of PD≤6 months prior to enrollment
* with the ability to walk without a mobility device for ≤5 minutes continuously.

Exclusion criteria:

* People with speech difficulties (e.g. aphasia)
* cognitive difficulties affecting the ability to understand and/or follow verbal/written - instructions
* severe freezing of gait
* Severe hearing or visual impairments that affects participation in the assessments
* Other neurological diseases
* Other disease that can affect gait or balance.
Different Ways of Airway Management in Elective Minor Surgeries in Geriatric Patients

different ways of airway management in elective minor surgeries of geriatric patients

The investigators will used two different ways of pro-seal laryngeal mask insertion technique (laryngoscopy- guided technique or the standard technique) in elective minor surgeries of geriatric toothless patients.

The investigators will record the respiratory dynamics, heartbeat, systolic, diastolic, mean arterial pressures every 5 minutes during surgery. The investigators will record the laryngeal mask insertion time and oropharyngeal leakage pressure. The investigators will evaluate the placement of a laryngeal mask according to young criteria. The development and severity of coughing, retching, laryngospasm, extremity, and head movement during laryngeal mask placement will be recorded. Bloodstains, sore throat, hoarseness will be recorded on the mask that may develop due to laryngeal mask placement. The investigators will use the Briacombe scoring and Campbell category system to assess the position of laryngeal mask airway devices.

Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status I or II or III
2. Who were scheduled to minor elective ambulatory surgery (e.g. urology operations)
3. Patients undergoing general anesthesia
4. Those who are planned to wear a laryngeal mask for surgical procedure

Exclusion Criteria:

1. patients with full stomach
2. A history of gastric reflux
3. A history of convulsions, cardiovascular or neuromuscular disease
4. Allergies to the study drugs
5. obese (Body mass index (BMI) ≥ 40 kg / m2)
6. suspected difficult airway and hyper-reactive airway disease
Comparison of Efficiency and Effectiveness of Two Types of Bonded Orthodontic Retainers: an RCT.

Comparson of efficiency and effectiveness of twisted/coaxial and linked retainers, placed under relative versus absolute isolation.

The domain of orthodontic retention is controversial. Orthodontic retention is the final step in an orthodontic procedure, and is performed after removal of the orthodontic appliance. Its goal is to prevent the relapse in occlusion or positioning of the teeth. Every patient will need some form of retention to maintain the ideal result. The bonded retainer is frequently used in the lower incisor region. It is capable to prevent relapse of orthodontic treatment but prevents tertiary crowding as well. Advantages of fixed retainers are in general no need for compliance and optimal aesthetics. The retention wire can stay in place for many years. Currently, there is a tendency towards lifelong retention. Disadvantages are more plaque and calculus accumulation, and possibly a poorer periodontal index.

Many types of bonded retainers with different properties could be bonded, each with different effects on periodontal health, potentially a different ability to maintain alignment, and different amounts of failure.

Different types of failure of fixed bonded retainers are possible. When the retainer does not stay in place and is debonded, this is is described as failure. It is also possible the retainer maintains bonded but shows unwanted tooth movement in the bonded teeth. This can also be described as a failure.

Bonding of the retention wire is a technique sensitive process. Correct and passive bonding could prevent debonding of the retainers. To eliminate moisture in the bonding process, it is possible to place a rubberdam before bonding the retainer.

One aim of this study is to compare two types of bonded retainer: the standard coaxial or twisted retainer. The other aim is to compare two bonding protocols with and without rubberdam isolation

Two general PICO questions can be formulated:

In an orthodontic patient (P), will fixed retention with a Ortho-flextech tm (Reliance orthodontic products, Itasca III, USA) (I) as compared to a 0.0195 in dead-soft coaxial wire (Respond; Ormco, Orange, Calif). (C) result in a more effective or efficient retention treatment (O)?

In an orthodontic patient (P), will placement of the retainer with rubber dam (I) result in less debonding (O) as compared to relative isolation with cotton rolls (C)?

Efficiency: is the procedure faster or cheaper than the alternative? Effectiveness: is the procedure better in maintaining the end result of treatment than the alternative? Are there less biomechanical or biological side effects?

Eligibility Criteria:
Inclusion Criteria:

* Fixed orthodontic appliances upper and lower jaw
* Patient stays for 2 years in Belgium
* Parents consent
* Proper oral hygiene

Exclusion Criteria:

* Orthognathic surgery
* Craniofacial disorders
* Cleft lip palate patients
* Orthodontic treatment without fixed appliances
* Extra retention other than bonded wire in the lower jaw
Prevalence of Cardiac Amyloidosis in Patients Undergoing Surgery for Lumbar Spinal Stenosis.

Patients undergoing surgery for lumbar spinal stenosis will have biopsies of the ligamentum flavum sent to the department of pathology for histologic screening.

If the ligament biopsy contains amyloid, patients will receive an echocardiogram, an ecg, biomarker testing, and a bone tracer scintigraphy diagnostic of cardiac amyloidosis.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for surgery for lumbar spinal stenosis
* Age \> 65 years
* Informed written consent

Exclusion Criteria:

* Known amyloidosis
* Myelomatosis
* Monoclonal gammopathy of unknown significance, MGUS
* Morbus Waldenstrøm
Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste

Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica', the famous 'Toothbrush Tree' used for centuries. The astringent and anti-bacterial properties of Meswak helps reduce tooth decay , fight plaque and prevent gum diseases. Miswak Herb is a rare, potent, priceless, wonder herb that delivers incredible Dental Care benefits.

This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate antibacterial effect miswak toothpaste compared to fluoride toothpaste in high caries risk patients.

Eligibility Criteria:
Inclusion Criteria:

* High caries risk patients.
* At least one carious tooth according to CAT caries risk assessment model.
* Patient compliance

Exclusion Criteria:

* Participant in another trial.
* Using another antimicrobial agents since one month of sampling.
* Systemic diseases or concomitant medication affecting salivary flow.
* Parafunctional habits.
* Pregnancy.
Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism

Observational, multicenter, national, cross-sectional study aiming to describe the epidemiological clinical, biological and therapeutic profile of patients suffering from defect in secretion (hypoparathyroidism) or action (pseudo-hypoparathyroidism) of parathyroid hormone.

Endocrinologists from both sectors (public and private) are participating in the study. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.

Eligibility Criteria:
Inclusion Criteria:

* Hypoparathyroidism defined by low serum calcium \< 2.2 mmol/l (\< 88 mg/l) associated with inadequate PTH (low or normal) and normal creatinine

Exclusion Criteria:

* Cervical surgery \< 6 months.
* Transient (neonatal, etc.) or functional (dysmagnesemia, etc.) hypoparathyroidism.
* Other causes of hypocalcemia: vitamin D deficiency, chronic renal failure, etc.
* Familial hypocalcemia hypercalciuria.
* Pseudo-pseudo-hypoparathyroidism.