cyrilzakka/clinical-trials huggingface dataset:
Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment

The aim of interferon therapy in HBeAg positive chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as occurred HBeAg seroconversion and HBsAg loss with sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after withdraw of treatment. In this trail, Nucleoside(acid) analogues(NA) will add on patients with HBV DNA load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies of the combine therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.

HBeAg positive patients with HBV DNA load ≥1000copies/ml after 6 months of peginterferon alpha 2a treatment will be enrolled randomized into two groups, in intervention group, patients will receive entecavir combine with peginterferon alpha 2a(PEG-IFN a-2a) treatment for 48 weeks and follow 24 weeks. Patients in control group will be continue treated with PEG-IFN a-2a for 48 weeks and followed 24 weeks. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of the combined therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.

Eligibility Criteria:
Inclusion Criteria:

* HBeAg positive patients with HBV DNA load ≥1000copies/ml after 6 months of peginterferon a-2a treatment

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
Changes in Muscle Strength, Inflammatory Markers, and Body Composition in Response to Alternate Day Fasting Combined With Krill Oil Supplementation in Adults With Overweight and Obesity

The goal of this double-blind, randomised, controlled trial is to determine the effects of LC n-3 PUFAs supplementation on changes in body composition and muscle strength during body weight loss and body weight maintenance among healthy adults living with overweight and obesity. The main research questions:

* Is supplementation with LC n-3 PUFAs during dietary weight loss intervention (alternative-day fasting) attenuate the reduction in fat-free mass and muscle strength?
* Is supplementation with LC n-3 PUFAs during dietary weight loss intervention (alternative-day fasting) provide additional impact on appetite related hormones (Acylated ghrelin, GLP-1, and PYY) and cardiometabolic risk factors (Post prandial inflammatory markers and Triglycerides)? Participants will be randomly assigned to a PLACEBO (Mix-vegetables oil) or LC n-3 PUFAs group (krill oil) (1:1 basis). Both groups will follow a dietary weight loss intervention (Alternate-day fasting).

The study will last for 20 weeks that divided into 3 phases: four weeks of the preparation phase, eight weeks of body weight loss phase (Alternate Day Fasting), followed by eight weeks of body weight maintenance phase (regular diet).

During the preparation phase, participants will be asked to take 4g/d krill oil capsules or placebo oil (mixed vegetable oil) with their healthy diet (their usual diet) for a period of 4 weeks. After the completion of the four weeks of the preparation phase, the weight loss intervention (Alternate Day Fasting) will start, and it last for eight weeks. Then, after the weight loss intervention, the weight maintenance phase will start, and it takes a period of 8 weeks until the end of the trial (20 weeks - study completion).

Eligibility Criteria:
Inclusion Criteria:

* Healthy (male/female)
* body mass index (BMI) of 25 - 39.9 kg/m2
* Aged between 25 and 65 years
* stable body weight for at least three months

Exclusion Criteria:

* Smokers
* Food allergy
* On any dietary supplements or dietary regimes at the time of the study
* Participants with systolic/diastolic \<90/60 mmHg and \>140/90 mmHg
Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

This is a single-center, open-label, first-in-human dose-escalation study of SHJ002 Ophthalmic Solution in children. (Part 1) Three (3) subjects will receive each concentration of SHJ002 for 3 days in an escalation design in one eye. (Part 2) A Group of 9 additional children will receive the highest tolerated concentration for 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Non-cycloplegic sphere from +1.50 to -4.75 Diopters in one or both eyes.
* A minor able to complete all study assessments and comply with the protocol and has a parent or caregiver willing and able to follow study instructions, comply with the protocol and attend study visits with the subject as required, in the opinion of the Investigator.
* Literate and able to orally communicate.

Exclusion Criteria:

* Non-cycloplegic sphere worse than -4.75 Diopters
* Axial length \> 26 mm
* Hyperopia worse than +1.50 Diopters
* Anisometropia (difference of myopic power \>2.00 D).
* Astigmatism \> 1.5 D.
* Intraocular pressure \> 21 mm Hg or \< 6 mm Hg.
Antibiotic Dosing in Patients on Intermittent Hemodialysis

The adequacy of the currently used dosing regimen of glycopeptides (vancomycin and teicoplanin) and beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) in patients with end-stage kidney disease receiving intermittent hemodialysis is studied by evaluating pharmacokinetics-pharmacodynamics (PK-PD) target attainment. A population pharmacokinetic study is performed to assist the selection of the optimal individualized dose for patients undergoing intermittent dialysis, taking into consideration as many relevant variables as possible.


Eligibility Criteria:
Inclusion Criteria:

* patients with end-stage kidney disease, requiring intermittent hemodialysis
* patient receiving antibiotic treatment for documented or presumed infection (vancomycin, teicoplanin, amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim)

Exclusion Criteria:

* pregnant woman
* absence of written informed consent from the patient
* known hypersensitivity or contra-indication to glycopeptides or beta-lactam antibiotics
Lenvatinib Plus PD-1 Antibody Versus Lenvtinib Alone for Advanced HCC

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with lenvtinib Alone in patients with advanced hepatocellular carcinoma (HCC)

Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and PD-1 antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared the efficacy and safety of lenvatinib plus PD-1 antibody and lenvatinib alone. Thus, the investigators carried out this prospective randomized control study to find out it.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* with no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:
* Platelet count ≥ 75,000/μL
* Hemoglobin ≥ 8.5 g/dL
* Total bilirubin ≤ 30mmol/L
* Serum albumin ≥ 30 g/L
* ASL and AST ≤ 5 x upper limit of normal
* Serum creatinine ≤ 1.5 x upper limit of normal
* INR ≤ 1.5 or PT/APTT within normal limits
* Absolute neutrophil count (ANC) \>1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
Comparison of the Dual Task, Cognitive Skills and Physical Activity With Problematic Game Players and Control Subjects

This study was conducted to compare the cognitive skills, dual-task and physical activity status of individuals who play problem video games and healthy individuals, and to determine how much these skills are affected. The cognitive skills of individuals with video game playing problems and the control group were evaluated with the Montreal Cognitive Assessment Test, the Trail Making Test A \& B sections, and the Stroop test. I evaluated dual tasks with 10-meter walking test (single-double task) and Time Up and Go Test (single-double task). Physical activity levels were evaluated by International Physical Active Questionnaire. The average cognitive skills, dual tasks, and physical activity levels of the individuals in both groups were compared.


Eligibility Criteria:
Inclusion Criteria:

* DSM V (Diagnostic and Statistical Manual of Mental Disorders, revision 5) Internet Gaming Disorder (IOOB) Diagnostic criteria: Providing 5 out of 9 items
* No communication barrier
* To volunteer to participate in research
* Be playing games at least 2 hours a day in the last year

Exclusion Criteria:

* 3 days a week to be doing any sports
* Having a chronic illness
* Psychological disease diagnosis
A Study of Prevalence and Clinical Characteristics of Tic Disorders in Children at Sohag University Hospital

Tics are brief, sudden, repetitive movements and/or sounds that increase with stress, anxiety, transitions, or excitement.

Tics occur most commonly in children and adolescents, with boys more frequently affected than girls The American Academy of Child and Adolescent Psychiatry states that tics affect up to 10 percent of children during their early school years. .

The exact pathophysiologic mechanisms are unknown, but the disorders are likely to be due to disturbances of the cortico striatal- thalamo -circuitry. Risk factors for tic disorders include. Genetics: Tics tend to run in families, so there may be a genetic basis to these disorders. Sex: Men are more likely to be affected by tic disorders than women.

They are divided into motor tics (e.g., blinking, shrugging shoulders, grimacing, or jerking) and vocal tics (e.g., throat clearing, sniffing, grunting) .

Patients describe an inner urge or a local premonitory sensation, which is then relieved by performing the tic. The tic can be voluntarily suppressed for short periods of time. Tics increase with stress, anxiety, transitions, and excitement, and decrease with distraction.

The American Academy of Child and Adolescent Psychiatry states that tics affect up to 10 percent of children during their early school years .The most notable tic disorder is Tourette syndrome, in which both physical and verbal tics occur in the same individual, often at the same time. Transient tic disorder also involves both types of tics, but they often occur individually .

Tic disorders are classified into 3 categories : Transient tic disorders involve motor or vocal tics that last for more than 4 weeks but less than a year. Chronic tic disorders involve either motor tics or vocal tics (but not both) that last for more than a year. Tourette Syndrome, in which both physical and verbal tics occur in the same individual Conditions associated with tic disorders, especially in children with TS, include: anxiety, ADHD, depression ,autism ,spectrum disorder learning difficulties ,OCD speech and language difficulties, sleep difficulties other complications associated with tic disorders are related to the effect of the tics on self-esteem and self-image . Some research! has found that children with TS or any chronic tic disorder experience a lower quality of life and lower self-esteem than those without one of these conditions


Eligibility Criteria:
Inclusion Criteria:

* -Age between 3 and 18 years
* All patients suffering from Tics and fulfill diagnostic criteria according to DSM V

Exclusion Criteria:

* - Patients with age below 3 years and after 18 years old
Designing a Bayesian Model of the Plasma Clearance of Calcium Edetate de Sodium for the Calculation of GFR and Validity Compared to the Renal Clearance of Inulin

Diagnosis of patients with renal insufficiency and recommendations for medical treatment of patients who suffer from chronic renal failure are based on the different stages of Glomerular Filtration Rate (GFR). Many formulas exist to assess GFR. However these formulas are unreliable in many clinical situations (old people, obese patients...). Methods for measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference tracers. Renal clearance of Inulin is the gold standard. However, using these methods is restricted to specialized services because it is long and expensive.

There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR. Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a tracer comes from its exclusive elimination by glomerular filtration.

Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for every included patient during a hospital day care (First visit V1). For transplanted patients, plasma clearance of Calcium edetate de sodium will be repeated within one week (more or less 48hours) during annual medical check-up of renal transplantation (Second visit V2).


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for V1:
* For transplanted patients : patients from 18 to 80 years, after estimation of their renal function by MDRDs formulas (MDRD = Modification of Diet in Renal Disease) , regardless their nephropathy, regardless the age of the transplantation, with a normal state body hydratation, with a social insurance and who have given their prior consent.
* For other patients : patients from 18 to 80 years, after estimation of their renal function by MDRDs formulas, who need a reliable assess of their renal function, with a normal state body hydratation, with a social insurance and who have given their prior consent.
* Inclusion criteria for V2: Transplanted patients who have participated to V1, with stable clinical conditions, with a stable GFR (less than 30% variation of creatinine clearance by MDRDs formulas) and who have given their prior consent.

Exclusion Criteria:

* Hypersensitivity to Calcium edetate de sodium
* Inulin or excipients
* Lead or other heavy metal intoxication
* Volume expansion or dehydration
* Acute renal disease
* Bladder voiding affections
* Coagulation disorders
* Poor venous capital
* People in guardianship
* Patients already involved in an other research
* Women in child bearing age without any method of contraception
* Pregnant or lactating women.
An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes

The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes for at least 3 months.
* Diabetes managed with diet and exercise alone or with either metformin or sulfonylurea alone as an adjunct to diet and exercise.
* Diabetes therapy must be unchanged for at least 3 months prior to screening.
* Females must be of non-childbearing potential (surgically sterilized or at least 1 year post-menopausal, as defined by cessation of menses). Female patients who are not surgically sterilized and who are less than or equal to 45 years should have their post-menopausal status confirmed by FSH greater that 30ng/mL at screening.

Exclusion Criteria:

* Current use of insulin or any antidiabetic agent other than a sulfonylurea agent or metformin.
* Current use of metformin or a sulfonylurea agent in combination.
* History of liver disease.
* History of unstable angina (as defined by the Braunwald system), myocardial infarction, or a coronary revascularization procedure within the past 6 months.
* Currently suspected carcinoma or history of carcinoma in the last 5 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
Mechanism of Insulin-Resistant in Lean Non-Diabetics

The study is designed to test the following primary hypothesis:

* Aerobic exercise training will improve insulin sensitivity in insulin resistant subjects through changes in the major cellular signaling pathways and and/or their regulators.

Accordingly, the proposed study is designed to accomplish the following specific aims:

* Quantitate how exercise training improves insulin sensitivity and decreases cardiovascular risk factors in a general population of lean, nondiabetic, insulin resistant subjects. Effects on known cardiovascular risk factors including blood pressure and serum lipoproteins will be evaluated. Change in regional adiposity will also be measured
* Determine the effects of a program of regular aerobic exercise on in the insulin receptor signaling pathway. Biopsies of vastus lateralis muscle from insulin resistant subjects will be obtained before and after a hyperinsulinemic glucose clamp. This procedure will take place in the untrained state and after exercise training. The investigators will measure changes in the insulin receptor and the activity of the major components of the intracellular insulin signaling pathway. The investigators will also look intracellular proteins that regulate this signaling pathway.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 20-50
* No regular exercise for past 2 years

Exclusion Criteria:

* Diabetes, Cardiovascular disease, Pregnant or lactating females,BMI \>27
* Medications that may interfere with carbohydrate metabolism - glucocorticoids, adrenergic agonists, ACE inhibitors, alpha blockers, diuretics, beta blockers, oral contraceptives, HMG CoA reductase inhibitors
* History of epilepsy, cancer, hepatitis, active infection, active Graves' disease, cystic fibrosis, sickle cell anemia, peripheral vascular disease, cerebrovascular disease, asthma
* Any medical condition that in the opinion of the investigator will interfere with safe completion of the trial
* Inability to give informed consent
* Prior participation in a clinical trial that could potentially alter insulin sensitivity: e.g., use of new insulin sensitizers
* HIV seropositive
* Anemia (Hgb \< 12 g/dl)
A Self-controlled Study of the Effect of Partial Spectral Absence of Visible Light on the Pupil

Previous studies have shown that the spectrum of light influences myopia. LED lights with a partially absent light spectrum increase the risk of myopia progression compared to LEDs with a full spectrum, potentially mediated by the excitability of the parasympathetic nervous system. This study intends to compare pupil size and area, as well as parameters regulated by the autonomic nervous system (such as skin bioelectrical activity and heart rate), between LEDs with a full visible spectrum and LEDs with a partially absent spectrum around 470nm and 730nm. We aim to elucidate the physiological mechanism underlying the effect of light spectrum on pupil changes and myopia.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 7-45 years 2. Able to wear multi-channel physiological measurement devices and cooperate with experimental procedures.

  3. Binocular? spherical power between -0.50 to -5.00 diopters, and cylinder power no more than -1.50 diopters.

  4. Voluntarily participate in this study with informed consent form signed.

Exclusion Criteria:

* 1. History of diseases affecting autonomic nervous system function, such as depression and anxiety.

  2. History of eye diseases such as strabismus, amblyopia, keratitis, and glaucoma, which are unsuitable for eye movement test.

  3. History of major systemic diseases or surgeries such as cranial surgery, myocardial infarction, or stroke.

  4. Systemic medication history that may affect autonomic nervous system function, including but not limited to antidepressants, antihistamines, anticholinergics, antipsychotics, and sedative-hypnotic drugs like diazepam or lorazepam.

  5. Use of eyedrops such as mydriatics or miotics that will affect pupil size. 6. Having difficulty in understanding and cooperating with the trial, such as those with disabilities, communication barriers, or those unable to undertake examinations.

  7. Other contradictions that the physician may consider inappropriate for enrolment.
Cocoa and Endothelial Function in Adults With Elevated BMI

Cardiovascular disease is the leading cause of death in the United States. Studies have shown that obesity is an important risk factor for development of cardiovascular disease. Endothelial dysfunction, a pathologic feature of obesity, predicts the occurrence of cardiovascular disease. Recent research findings indicate that consumption of cocoa exerts cardioprotective effects, which include increasing HDL levels, reduction in systolic BP, inhibition of platelet aggregation/activity and activation of endothelial nitric oxide synthase.

Proposed is a randomized controlled trial consisting of 4 phases designed to examine the dose-response, and the acute and sustained effects of cocoa consumption on endothelial function as a marker of cardiovascular disease risk in 45 otherwise healthy adults with a BMI 25-35kg/m2.

Endothelial function has been used extensively to evaluate the acute and chronic effects of foods and nutrients on cardiac risk and can provide a direct measurement of the effect of cocoa powder consumption on vascular physiology in healthy adults with BMI between 25-35 kg/m2.

To our knowledge, our study is the first to examine the dose response effects of sugar free, liquid, cocoa and solid, dark chocolate with sugar consumption on FMD, concentrating on individuals with elevated BMI. Given the current epidemic of obesity in the United States; its role as a risk factor in the development of cardiovascular disease; and the fact that cardiovascular disease is the leading cause of mortality in this country, examination of the cardio-protective effects of cocoa or dark chocolate in an at risk population is of considerable potential interest. Demonstrating that ingestion of cocoa may reverse damage caused to the endothelium may lead to new dietary recommendations that may help curb the prevalence of heart disease in the U.S.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 30 -75
* BMI between 25-35 kg/m2
* waist circumference above 88 cms. in women and 102 cms. in men
* non-smoker
* no strenuous exercise at least 8 hours prior to scanning
* to facilitate recruitment individuals with diagnosed hypertension or hyperlipidemia will be included provided that they have been stable on their medications for three months, and can refrain from taking their medication 12 hours prior to BARS testing.

Exclusion Criteria:

* Failure to meet inclusion criteria
* anticipated inability to complete study protocol for any reason
* current eating disorder
* diagnosed coronary artery disease
* diabetes
* sleep apnea
* current or impending pregnancy
* insulin or glucose sensitizing medication use, vasoactive medication or nutriceutical use (glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators)
* regular use of high dose vitamin E or C and unable to discontinue for duration of the study
* regular use of fiber supplements and unable to discontinue for duration of the study
* restricted diets by choice (i.e. vegan, Atkins diet etc)
* allergy to cocoa or chocolate.