cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient

The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.

This trial was a parallel, open-label, single dose study. The subject was divided into one of three groups according to the degree of renal Insufficiency,including normal, mild and moderate. All subjects were given SHR3824 20mg, the blood and urine samples were collected before and after dosing.

Eligibility Criteria:
Inclusion Criteria:

* with a body mass index(BMI) between 19 and 33 Kg/m2;
* The estimated glomerular filtration rate (eGFR)of subjects in groups must meet the corresponding standards:mild renal insufficiency:60 to 89 ml/min/1.73m2;Moderate renal insufficiency: 30 to 59 ml/min/1.73m2.
* Had signed the informed consent himself or herself voluntarily.

Exclusion Criteria:

* Urinary tract infections, or vulvovaginal mycotic infections
* Suspected or diagnosed as kidney cancer or other malignancies in patients
* Autoimmune kidney disease, history of renal transplantation, dialysis patients being treated
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SHR3824,SGLT2 inhibitor analogs, or any other structural analogs
* Alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;Tobacco is defined as five or more per day.
* Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
* Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
Innate Immunity in Allergic Asthma

The purpose of this study is to determine whether a potential type 2 signature, obtained through stimulation of cell lines with various allergens in vitro, correlates with an allergic or asthmatic disease state ex vivo. This type 2 signature will be multi-hierarchical in nature and will be comprised cell surface receptor expression, pathway activation, and gene upregulation.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years of age
* no history of allergic disease (healthy controls), have clinically diagnosed allergies, or have clinically diagnosed asthma.

Exclusion Criteria:

* Pregnant women and prisoners will be excluded from the study.
* Individuals currently suffering from any acute infections and those known to suffer from light-headedness will be excluded.
The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency

This trial is an observational cohort study. Patients aged 8-15 years with symptomatic convergence insufficiency and 150 patients with symptomatic convergence insufficiency who had not received visual training were selected from the Tianjin Eye Hospital Optometry Center and received 1 course of visual training treatment. Self-assessment and other assessments were combined, and the patient and guardian questionnaires were collected. The EQ-5D-Y and CHU9D scales were used to evaluate Chinese patients' health-related quality of life with symptomatic convergence insufficiency. The feasibility of the EQ-5D-Y and CHU9D scales in assessing the health-related quality of life of Chinese patients with symptomatic convergence insufficiency was analyzed. To assess the effectiveness of visual training on visual symptoms and improvement of quality of life in patients with symptomatic convergence insufficiency


Eligibility Criteria:
Inclusion Criteria:

* 8\~15 years old
* Monocular best corrected visual acuity at distance and near was more than 0.8
* Near exophoria 4Δ greater than distance exophoria
* NPC ≥ 6cm
* PFV ≤15△BO
* Stereogram ≤500 ''
* Score of CISS questionnaire ≥16 or COVD questionnaire≥20

Exclusion Criteria:

* present constant strabismus, nystagmus or vertical phoria at distance or near.
* developmental delay or ocular surgery
* Myopia≤ -6.00D, Hyperopia ≥ +5.00D, Astigmatism ≥ 4.00D
* Monocular Amplitude of accommodation\<5D
* Other diseases except myopia
Fontan Fitness Trial

The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention. The main questions it aims to answer are:

* Does a home-based, digital intervention increase physical activity (PA) in youth with the FC compared to enhanced usual care?
* Does a home-based, digital intervention increase physical fitness in youth with the FC compared to enhanced usual care?
* Do multi-level factors (medical, neurodevelopmental, sociodemographic, neighborhood) impact the effectiveness of the digital intervention?

Researchers will compare participants in the enhanced usual care arm to those in the exercise intervention arm to see if the digital intervention is effective.

All participants will wear a PA tracker for 12 months and complete testing at baseline, 6 months, and 12 months.

In addition, participants in the exercise intervention arm will complete a 6-month exercise intervention with the following components:

* aerobic exercise
* resistance exercise
* engagement strategies

The Fontan Circulation is associated with poor exercise performance and reduced quality of life. Current standard of care encourages physical activity (PA) in this population, but few structured interventions exist. Participants will be randomly assigned to either enhanced usual care (PA tracker and standard encouragement) or an interactive digital intervention that includes personalized aerobic and resistance exercises with behavioral engagement strategies. This study will evaluate a home-based, digital intervention delivered through a mobile health platform to promote PA and improve fitness among youth with FC.

The study will recruit up to 200 participants aged 10-17 years with FC. After initial testing and a two-week run-in period, 120 participants with peak VO2 between 45% and 80% of predicted norms will be randomized. The intervention will last 6 months, followed by a 5.5-month monitoring phase. Outcomes will include changes in PA (measured via accelerometry), peak VO2, muscle strength, body composition, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Fontan Circulation present
* Girls ≥11 years of age or menstruating must have negative urine pregnancy test
* Neurodevelopmental capacity to complete all study procedures
* Physical capacity to complete all study procedures
* English speaking with at least one English speaking parent/guardian
* To enroll in the randomized control trial, percent predicted peak VO2 \<80% of age-sex matched normal controls on the baseline exercise stress test (EST)

Exclusion Criteria:

* Inability to complete an EST at any time (i.e. limited physical or executive function)
* Uncontrolled lymphatic disorders
* Exercise induced or uncontrolled arrhythmias
* Pacemaker or internal cardiac defibrillator (ICD)
* Peak VO2 \<45% age-sex predicted
* Having had or under consideration for a heart transplant
* Pregnant or lactating females
* Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children

Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. Melatonin has a low bio-availability of approximately 15 %. The safety of exogenous melatonin for pediatric patients has been studied with no apparent serious adverse effects, even at repeated short-term use of high doses of intravenous melatonin. The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postopreative agitation and emergence delirium in children after an elective surgical procedure. The study is designed as a randomised, double-blind, placebo-controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 1-6 years
* Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia maintained with sevoflurane

Exclusion Criteria:

* Any known allergy or contraindication to study treatment or excipåients
* Current daily medication with melatonin
Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy

This is a controlled clinical trial with the aim to study the effects of electroacupuncture on neuropathic pain reduction, quality of life and changes in sensory and motor nerve conduction velocity in patients with type 2 diabetes mellitus, beneficiaries of the familiar medical centers 20, 40 and 41 of the Instituto Mexicano del Seguro Social, at north of Mexico City, in colaboration with the human acupuncture specialty of the Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Mexico.

Controlled clinical trial to evaluate the effect of electroacupuncture on the reduction of neuropathic pain, quality of life; electrophysiological, inflammatory response, oxidative stress, and genetic expression, in patients with type 2 diabetes mellitus, beneficiaries from the family medical centers 20 , 40 and 41 of the Instituto Mexicano del Seguro Social, at north of Mexico City.

Once the acceptance letter has been signed, a series of questionnaires (MNSI, MDNS, DN-4, NRS, and SF-36), and a physical examination will be carried out to meet the necessary criteria to continue participating.

Only candidates with clinical diagnosis of diabetic polyneuropathy will have an electrophysiological examination by nerve conduction velocity study, if so, patients will be randomized to the electroacupunture or sham acupuncture groups.

Before intervention, laboratory studies will be taken after fasting for 8 to 10 hours, to determine biochemichal profile (glucose, urea, creatinine, uric acid , triglycerides, total cholesterol, HDL and LDL), oxidative stress (Malondialdehyde), inflammatory response (IL-6, IL1β, TNF-α, IL-10 and IL-18 cytokines), and gene expression (5-HT1AR, Neurokinin 1, α-adrenoreceptors, NGF, CX3CR1, GAP-43, and NT3).

Intervention will be applied in a total of 32 acupuncture sessions, divided into two intervention cycles, that is, 16 sessions over two months, with a rest period of one month in between.

At the end of both cycles of interventions, the questionnaires, the nerve conduction velocity study the biochemical and molecular studies will be re-assessed. Finally, this will be re-evaluated after three months post-intervention in order to evaluate the effect of intervention over time.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes.
* Patients with clinical diabetic peripheral polyneuropathy.
* Patients with electrophysiological diagnosis of diabetic peripheral polyneuropathy in its different types of classification.

Exclusion Criteria:

* Type 1 Diabetes or gestational diabetes.
* Systemic autoimmune diseases.
* Hematological disorders.
* HIV diagnosis.
* Cancer in treatment.
* Pregnancy.
* Other types of neurological disorders or neuropathies.
* Intervention with acupuncture six months previously.
* Patients with pacemarkers.
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with Alzheimer's disease


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Probable AD according to the National Institute on Aging- Alzheimer's Association (NIA-AA) guidelines (McKhann et al 2011).
* MMSE score of 5 to 24 (inclusive) at the Screening Visit.
* Has clinically significant agitation/aggression defined as Neuropsychiatric Inventory (NPI)-agitation/aggression subscore of ≥4.
* No response or suboptimal response to standard nonpharmacological interventions.

Exclusion Criteria:

* The agitation/aggression is attributable to concomitant medications, environmental conditions, or active medical or psychiatric condition.
* Current diagnosis of major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM IV TR).
* Has persistent and distressing psychotic symptoms (delusion and/or hallucinations) that require psychiatric hospitalization.
Post-Operative Cesarean Section Cosmesis

Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.

Cesarean delivery is the most common surgical procedure performed in the United States, with over 1 million procedures performed per year. Based on recent Center for Disease Control (CDC) National Vital Statistics Report (2021) 32.1% of all births in the United States were via cesarean delivery. Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Absorbable staples, made from a combination of polylactic and polyglycolic acid, are a relatively new option for skin closure at the time of surgery. This study is a randomized trial that will investigates two cesarean skin closure techniques-subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples (INSORB)-to determine if one is associated with better scar cosmesis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-44
* Any race
* Any parity
* Scheduled cesarean section
* Neuraxial analgesia

Exclusion Criteria:

* Non-English Speaking
* Incarcerated
* Maternal Connective Tissue Disorder
* Systemic maternal steroid use
* Three prior cesarean deliveries
* Body Mass Index (BMI) \>40
Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion

The goal of this clinical trial is to determine if direct ischemic post-conditioning (IPostC) can alleviate ischemic-reperfusion injury (I/R) in patients who have undergone endovascular thrombectomy (EVT). Additionally, the study aims to explore the underlying mechanisms of direct IPostC.

The primary questions this trial seeks to answer are:

1. Is direct IPostC effective for acute stroke patients with large vessel occlusion?
2. What are the underlying mechanisms of direct IPostC?

Participants will be randomly assigned to one of two groups: an EVT alone group or an EVT plus direct IPostC group. Direct IPostC will be administered immediately after EVT through four cycles of mechanical interruptions of reperfusion. We will evaluate outcomes based on final infarct volume, infarct volume growth, clinical parameters, and I/R-related imaging and laboratory biomarkers. Additionally, an exploratory multi-omics analysis will be conducted to uncover the detailed mechanisms of direct IPostC.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic stroke confirmed by CT or MRI.
2. Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal 3. carotid artery (ICA) and middle cerebral artery (MCA M1/M2).

4. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.

5. The patient or legally authorized representative has signed an informed consent form.

Exclusion Criteria:

1. Inability to perform an MRI or CT scan for any reason.
2. Presence of any condition that would interfere with neurological assessment or any psychiatric disorders.
3. Stroke onset accompanied by seizures, resulting in the inability to obtain an accurate NIHSS baseline.
4. Pregnancy.
5. Presence of other serious, advanced, or terminal illnesses.
Knee Osteoarthritis and Balneotherapy

The goal of this clinical trial is to assess the efficacy of a 18-day balneotherapy program in the rheumatology indication in patients presented with knee osteoarthritis. The main questions of the study aims to answer are how balneotherapy improves functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients' quality of life.

Participants are randomly assigned in control or treatment (spa) groups. All receive standard of care for knee osteoarthritis throughout the study. Balneotherapy program consists of 18-days of spa treatment with Mineral Water of Saint Jean d'Angely. Functional incapacity, disorders and quality of life induced were measured at baseline and then 6 months later.

Variation from baseline were compared in control and treatment groups to assess the efficacy of the balneotherapy program.


Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 evidenced by a knee X-ray examination in the past 3 years);
* 100-normalized score of the WOMAC physical function subscale of 30 or greater;
* Available for balneotherapy program and the 6-month study follow-up;
* Signed inform consent;
* with health insurance affiliation.

Exclusion Criteria:

* Presented with balneotherapy contra-indication;
* Having had spa treatment in the past 6 months or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months;
* Presented with chronic pain other than osteoarthritis, with scheduled surgery related to knee osteoarthritis;
* regulatory reason (guardianship or already enrolled in a clinical trial).
Ischemia Time and Graft Survival

Study the effect of ischemia time on patient and graft survival.

Study the effect of cold ischemia and warm ischemia on graft function after one year and patient one year survival.

Eligibility Criteria:
Inclusion Criteria:

* recipients of living donor liver transplantation

Exclusion Criteria:

* early mortality
Armolipid Plus and Metabolic Syndrome

Metabolic syndrome is a highly prevalent condition characterized by visceral obesity, abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events. Such findings appear to be associated with a decrease in insulin sensitivity. Management of metabolic syndrome is currently aimed at treating individual components of the disease without addressing this underlying pathophysiologic mechanism; this translates into multidrug regimens, high costs and patient compliance issues.

Armolipid Plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin K,policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial function; subgroup analyses also suggested a benefit on indices of insulin resistance.

Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity and on the diagnostic parameters of metabolic syndrome.

60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial; active treatment will consist of Armolipid Plus (1 tbl qd).

Primary end point will be the reduction of the insulin/glucose ratio, both after overnight fast (HOMA index) and after an oral glucose tolerance test (OGTT).


Eligibility Criteria:
Inclusion Criteria:

Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference \> 102 cm (M) or \>88 cm(F), and two or more of these criteria:

* fasting blood glucose \>100 mg;
* systolic blood pressure \>135 or diastolic blood pressure \>85 mmHg or patients in treatment with antihypertensive drugs;
* triglyceridemia \>150 mg/dl;
* HDL cholesterolemia \< 40 mg/dl(M), \< 50 mg/dl(F).

Exclusion Criteria:

* pregnancy
* diabetes mellitus in pharmacologic treatment;
* hepatic failure;
* creatininemia \>2 mg/dl;
* triglyceridemia \> 500 mg/dl;
* heart failure.
Differential Regulation of miRNA and Protein in Human Plasma Extracellular Vesicles by Different Types of Exercise.

Aims/hypothesis: Both continuous aerobic training (CAT) and high intensity interval training (HIIT) are recommended to promote health and prevent diseases. Exercise-induced circulating extracellular vesicles (EX-EVs) have been suggested to play essential roles in mediating organ crosstalk, but corresponding molecular mechanisms remain largely unexplored. We aimed to assess and compare the systemic effects of CAT and HIIT via multi-omics integration analysis of EX-EVs.

Methods: Five healthy male volunteers were assigned to HIIT (20 minutes of cycling with periods of 2 minutes at 80-95% HRmax separated by 2 minutes of active recovery) and CAT (20 minutes of cycling at 60-80% of HRmax), with a 7-day interval between sessions. Plasma EVs were collected at rest or immediately after each training section, prior to proteomics and miRNA profile analysis.

Before the formal experiment, the volunteers were undergoing a thorough physical examination and proper training to ensure that they were able to complete the experiment. The participants refrained from exercise 24 hours prior to the test to ensure the integrity and accuracy of the results. All volunteers had a standardized breakfast, and all tests started at 9:00 a.m. The volunteers successively completed both HIIT and CAT under the supervision of a professional coach, and the interval between each type of exercise was 7 days. Each training session was initiated with a brief 2-minute standardized warm-up, followed by 20 minutes of cycling consisting of periods of 2 minutes at 80-95% maximal heart rate (HRmax) separated by 2 minutes of active recovery for the HIIT group or 20 minutes of cycling at 60-80% of HRmax for the CAT group. A real-time heart rate monitoring system was continuously used during each training session. The participants were instructed to continue their regular physical activities and eating habits throughout the intervention period. Blood samples were collected at rest or immediately after each training session for further analysis.

Eligibility Criteria:
Inclusion Criteria:

18-65 years of age Body mass index (BMI) values between 18-28 kg/m2 More than 3 h of physical activity per week Acknowledgment of informed consent.

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Exclusion Criteria:

Smokers Body weight change \&gt;5 kg in 6 months Unsuitable for physical training (heart disease, respiratory disorders or any conditions that could be aggravated by exercise) Currently taking medication or having a history of medication such as steroids, beta-blockers or anticoagulants.