cyrilzakka/clinical-trials huggingface dataset:
Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury

This study is an exploratory clinical study to observe the improvement of lung function before and after the treatment by human umbilical cord-derived mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells on non-cardiac surgery-induced lung injury in patients with ischemic heart disease. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, lung function improvement, and adverse events.

This study is an exploratory clinical study to observe the improvement of lung function before and after the treatment by human umbilical cord-derived mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells on non-cardiac surgery-induced lung injury in patients with ischemic heart disease.

The study is a randomized parallel controlled study. The research process is as follows: 1. Sixteen eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into placebo control group (n=8) or hUC-MSCs treatment group (n=8); 2. Knee replacement was performed under general anesthesia in both groups. In the cell therapy group, 1×10\^6/kg human umbilical cord-derived mesenchymal stem cells were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery. Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection, all patients receive a review of which main content includes symptom improvement, lung function improvement, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* The electrocardiogram showed T wave change and ST segment depression
* New York Heart Association (NYHA) Classification of cardiac function Ⅰ-Ⅱ level
* The patient who first time to receive knee replacement
* General anesthesia lasted about 2h
* Signed informed consent

Exclusion Criteria:

* Does not meet the above selection criteria
* Unable to sign the informed consent
* Patients with a malignant tumor, other serious systemic diseases, or psychosis
* Pregnancy, lactation, and those who are not pregnant but do not take effective contraceptives measures
* The patient with a history of an allergic reaction to biological products or drug
* The patient has any infectious diseases (including bacterial and viral infections)
* The patient with cardiac pacemaker implantation within 3 months prior to enrollment
* The patient who had a stroke within 6 months prior to enrollment
* Unable to comply with the agreed timetable of this study
* Patients who are participating in other clinical trials
* Others who are clinically considered unsuitable for this treatment.
Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

This is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be sampled as a measure of the extent of possible metabolic MNTX demethylation.


Eligibility Criteria:
Inclusion Criteria:

1. Males between 18-45
2. Subject weight between 70 and 90 kg
3. In good physical health, with no evidence at screening of acute or chronic disease likely to affect the investigation

Exclusion Criteria:

1. History or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, renal, or other significant chronic condition.
2. Consumption of barbiturates or other inducers or inhibitors of CYP450 isoforms
3. History of or predisposition to erratic or abnormal bowel function.
Body Composition, Bone Mineral Density, Insulin Sensitivity and Echocardiographic Measurements in Klinefelter Syndrome

Klinefelter syndrome (KS) is the most common sex-chromosome disorder with a prevalence of one in 660 men and is a frequent cause of hypogonadism and infertility. It is caused by the presence of extra X-chromosomes, the most common karyotype being 47,XXY. The phenotype is variable, but the most constant finding is small hyalinized testes, hypergonadotrophic hypogonadism, infertility, eunuchoid body proportion, increased height and learning disabilities. Klinefelter syndrome has been associated with increased prevalence of diabetes, osteoporosis and cardiovascular diseases but the pathogenesis is unknown. Accordingly the aim of the study was to investigate measures of body composition, insulin sensitivity, bone mineral density, echocardiography, as well as biochemical markers of endocrine, metabolic and bone function in KS and an age-matched control group.


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* verified KS karyotype (KS patients)

Exclusion Criteria:

* untreated hypothyroidism or hyperthyroidism
* present or past malignant diseases
* clinical liver disease
* treatment with drugs knowing to interfere with glucose homeostasis, fat metabolism or bone modulation (e.g. glucocorticoids)
COVID-19 Patient Cohort: Retinal Damage in Non-invasive Retinal Imaging (OCTA)

The objective of this research is to build a collection of non-invasive retinal imaging (OCT and OCTA) in order to investigate the incidence and impact of retinal damage in patients who have or have had COVID-19.

This monocentric study is aimed at 3 types of patients:

* Those who have been hospitalized for Covid-19 during the epidemic
* Newly infected and diagnosed patients Covid-19
* Those with paucisymptomatic Covid-19 who did not require hospitalisation

At the patient's inclusion, an ophthalmologic assessment will be performed including :

* visual acuity,
* SD-OCT + multicolor,
* OCT-A,
* color retinography,

Fundus examination, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) in all COVID-19 patients may detect retinal lesions. In addition, if a correlation is demonstrated between clinical and paraclinical parameters and between disease severity and retinal vascular damage in non-invasive imaging (OCT and OCTA), this would allow a better understanding of the pathophysiology of the disease, as well as factors that may influence disease severity and the mechanisms potentially responsible for the observed disorders.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Diagnosis of COVID-19 proven on RT-PCR, antigenic test or chest CT scan
* Affiliation to the general social security system
* A consent signed by the patient

Exclusion Criteria:

- Refusal of patient participation
A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification

This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification.

This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).


Eligibility Criteria:
Inclusion Criteria:

* Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin
* HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of NN9068-3952 trial

Exclusion Criteria:

* Clinically significant diseases of the major organ systems
* Screening calcitonin above or equal to 50 ng/L
Clinical Research in ALS Study

CRiALS is an umbrella protocol through which people are recruited to participate in a range of research studies being conducted by the ALS Research Collaboration (ARC).

Research goals include elucidation of the complex relationship between ALS and related neurodegenerative disorders, development of both wet and dry biomarkers of disease, and delineation of the full course of the natural history of disease from the early pre-symptomatic stages through established and even late-stage disease. These goals are accomplished through the recruitment and evaluation of patients with ALS and related diseases, family members (including people at genetic risk for ALS, but who are not yet affected), and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Member of at least one of the following categories:

   1. Individuals affected with ALS or a related neurodegenerative disease (sporadic or familial)
   2. Unaffected individuals from fALS pedigrees, including pre-symptomatic individuals at genetic risk for ALS or individuals from pedigrees of ALS related diseases.
   3. Healthy controls
3. Able and willing to comply with relevant procedures.

Exclusion Criteria:

1. Subject has a condition or is in a situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol -- including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits.


Eligibility Criteria:
Inclusion Criteria:

* Participants from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
* Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
* Female participants must agree to contraception requirements.

Exclusion Criteria:

* Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
* Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
* Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
* Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.
* Participants must not have adenomatous polyps that have not been removed.
* Participants must not be pregnant or breastfeeding.
Daily Physical Activity in Myelomeningocele

Obesity is getting more common and challenging to treat in children and adolescents with myelomeningocele. Therefore, it is becoming more important to determine daily physical activity in these patients. Daily walking performance and average steps per day in patients with low lumbar and sacral level myelomeningocele are shown to not differ from healthy controls. Step counts can not reflect all torsional accelerations associated with daily living activities. Omnidirectional accelerometers provide all types of body movement outputs and give detailed parameters of physical activity level and energy expenditure. There is no data about energy expenditure and physical activity level of the patients with myelomeningocele in daily routine. This study aims to quantify energy expenditure and physical activity of children and adolescents with low lumbar and sacral level myelomeningocele.

Children and adolescents with low lumbar and sacral level myelomeningocele, and age-, sex-, and BMI-matched controls were included. Omnidirectional accelerometer monitor (Actical®) was used to assess activity energy expenditure and daily durations spent in sedentary, light activity and moderate to vigorous physical activity (MVPA).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed myelomeningocele with the neurological level between L5 and S3
* Patients aged between 6 and 16 years
* Independent ambulatory patients without an assistive device or braces

Exclusion Criteria:

* Presence of disorders other than myelomeningocele that affect physical activity or exercise (e.g. rheumatic disease, cardiovascular disease)
* Unable to wear omnidirectional accelerometer monitor (Actical®, Philips Respironics) for five consecutive days
Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis

To evaluate the safety and clinical efficacy of left atrial appendage in the prevention of thrombus in patients with valvular heart disease, to improve the product according to clinical conditions, to achieve clinically accurate treatment, and to establish the heart valve, the usefulness and universality of Warfarin's anticoagulant model were verified by the specimen library

Atrial fibrillation (AF) is a common arrhythmia. The risk of ischemic stroke in AF patients is 4-5 times higher than that in non-af patients, and leads to nearly 20% mortality and nearly 60% disability. Atrial fibrillation is associated with valvular disease and atrial fibrillation in about 30-70% of patients with valvular heart disease. Left atrial thrombus occurs in 15-25% of patients with atrial fibrillation. More than 90% of patients with atrial thrombus is located in the left atrial appendage. In patients with valvular atrial fibrillation, the left atrial appendage is clamped at the same time of valvular surgery to avoid recurrence of atrial thrombus-related stroke. In this clinical trial, the left atrial appendage was used to clamp the prethrombotic site of the heart to prevent stroke and improve the prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with valvular heart disease aged between 18 and 75
2. Valvular heart disease \[Cardiovascular Surgery Volume, Clinical Diagnosis and Treatment Guidelines, Chinese Medical Association (2011 edition)\]
3. Preoperative cardiac function grade II-III (NYHA), no operation-related contraindications
4. Understand the nature of this study, agree to participate in all terms of this study, sign informed consent, agree to accept postoperative treatment plan and follow-up requirements, and cooperate to complete follow-up

Exclusion Criteria:

1. Patients whose left atrial appendage has been resected or occluded
2. She had a history of open heart surgery with extensive adhesion of the pericardium
3. Patients cannot be returned due to other reasons
4. Failed to reach the end point in clinical trials of other drugs or devices
5. X-ray is contraindicated or not suitable for TEE examination
6. Those who are considered unsuitable for the clinical trial by the investigator
Exposure to Chemical Substances Within Household Waste Incineration Plants

Employees of household waste incineration plants (UIOM) are exposed to multiple chemical substances that can pose a risk to their health.

The studies carried out find increases in certain toxic chemicals (heavy metals, dioxins), in the biological fluids of employees (blood, urine), in particular before the 2000s Another study conducted by Tait finds potential organic alterations.The investigators wish to complete the dissertation work with, in particular, an analysis of the quantitative elements of the exposure assessment (metrologies and biometrologies)

The aim of the study is to evaluate the recorded chemical exposures of certain employees of a household waste incineration plant (UIOM) in order to deduce the risk to their health.

Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Subject currently working, or having worked in the Strasbourg waste incineration plant between 01/01/2013 and 01/09/2022 within the maintenance or operating team
* Subject not objecting, after being informed, to the reuse of their data for the purposes of this research
* Subject in whom one or more biometrologies (blood lead level measurement, urinary cadmium level measurement, urinary 1-hydroxypyrene level measurement) were performed

Exclusion criteria:

-Subject who expressed their opposition to participating in the study
Central Venous Catheters in Pediatric Anesthesia and Intensive Care

Securing the intravenous line is one of the fundamental interventions in paediatric anaesthesia and intensive care. Central venous catheters (CVC) are indicated for long-term stay in intensive care unit (ICU), in case of circulatory instability and the need for vasopressor therapy, for hypertonic solutions administration and parenteral nutrition. The dominant method of CVC insertions is the Seldingers´ method (over the wire) and ultrasound real-time navigation in recommended. Ultrasound-guided (USG) CVC insertion however requires experience personnel and relevant training.This could be the main reason, that CVC the real-time ultrasound navigation is still not adequately implemented into the clinical practice.

After Ethics committee approval, patients indicated for CVC insertions will be included. Based on the observational design of the trial, the method of insertion (Real-time ultrasound navigation versus anatomical-based CVC insertion) will be based on operators´ decision.The indication for CVC insertion, primary planned site of insertion, USG implementation, site of actual CVC cannulation and associated complications will be recorded. The primary aim of the study was to compare the effectivity of Real-time ultrasound navigation versus anatomical-based CVC insertion in paediatric patients and the 1st percutaneous puncture success rate. The secondary aims will be the incidence of associated complications and the time form first percutaneous puncture, to definitely securing the CVC in place. The primary hypothesis is that the Ultrasound-guided CVC insertion is superior, with the higher overall success, higher first attempt success rate and with lower incidence of associated complications.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients within the age limit indicated for CVC insertion

Exclusion Criteria:

* Outside the age limit
Retroclavicular Approach to Infraclavicular Block

In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.

Two rules were used to stop the study. First stopping rule was a fixed-sample-size. The investigators used an up-and-down method to estimate the threshold for an all-or-none response for present study design. Therefore, for sample size calculation, the investigators applied the formula by Dixon and Massey, n=2(SD/SEM)2 (SD: standard deviation and SEM: standard error of mean). Second stopping rule included demonstration of minimum of five consecutive up-and-down sequences. On the basis of previous studies with similar binary outcomes, the investigators estimated that a priori a minimum of five negative-positive up-and down deflections was required to calculate MEV50.

Eligibility Criteria:
Inclusion Criteria:

* patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
* American Society of Anesthesiologists class I, II or III

Exclusion Criteria:

* patients \<18 years old
* \>65 years old
* body mass index (BMI) \<20 or \>35 kg/m2
* inability to provide written informed consent
* refusal of regional anesthesia
* pregnancy
* contraindication for regional anesthesia
Development of Green Mei Products for the Prevention of Metabolic Syndrome

The aim of this study is to investigate the antihypertensive effects of Mei-Gin formula-4 (MGF-4) and Mei-Gin formula-7.

It's a randomized, and single-blind trial and was designed to evaluate the effects of MGFs (MGF-4 and MGF-4) on blood pressure. 50 participants with hypertension (systolic blood pressure between 130-179 mmHg or diastolic blood pressure between 85-109 mmHg) who did not accept any hypertension medication were randomized allocated to either MGF-4 or MGF-7 group. Participants were instructed to take 4 capsules of MGF-4 or MGF-7 daily throughout the duration of the 8 weeks intervention study. After treatment, the change of the blood pressure and relative mechanism were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* The age of the subject is 20 to 70 years old.
* The subject is a patient with hypertension (SBP is between 130-179 mmHg, DBP is between 85-109mmHg, one of the two can be diagnosed), and there are no serious illnesses requiring hospitalization during the study period treatment.
* No hypertension medication.
* The subject can understand the test process described in the consent form and the possible potential risks and benefits, and able to sign the consent form.
* The subjects shall observe diet control during the trial period.

Exclusion Criteria:

* Subjects diagnosed with cancer and still under active treatment.
* Subjects diagnosed with heart disease and still under active treatment.
* Other drugs are used, whose pharmacological effects may affect blood pressure or may aggravate the effects of drugs.
* Subjects who have systemic infection and need systemic antibiotics.
Anecortave Acetate Risk-Reduction Trial (AART)

A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Dry AMD study eye, Wet AMD non-study eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Age
* Other protocol-defined exclusion criteria may apply.
PRP Use in Treatment of Fistula Ano

In treatment of perianal fistula several methods are described. However, since the Hippocrates basics of surgical treatment has not changed very much. the aim of this study is to evaluate the effectiveness of PRP gel in treatment of perianal fistula.

Perianal fistula is a chronic condition that seriously affects the patients' quality of life. There are different treatment modalities used in treatment. Recently sphincter preserving methods are becoming more popular with low complication rates. Most of this methods aiming the closure of fistula tract by different pathways.

Platelet rich plasma (PRP) is used in a wide range of conditions in medicine. The investigator's team showed the effective treatment of pilonidal disease by use of PRP gel. In the recent study, aim to evaluate the effectiveness of PRP gel in treatment of perianal fistula.

Patients with perianal fistula will be evaluated for the study. After taking permission with informed consent; cases will be included in the study. Cases with inflammatory bowel disease, platelet function disorders or connective tissue disorders that may alter wound healing will be excluded from the study.

After, PRP application to the fistula tract patients will be taken to follow up. Perianal fistulas will be followed by magnetic resonance imaging 1 month after the application. Pre-application and post-application scans will be used for the evaluation of the treatment success.

Eligibility Criteria:
Inclusion Criteria:

* patients with perianal fistula
* signing the informed consent form
* above the age of 18

Exclusion Criteria:

* inflammatory bowel disease
* previous radiation therapy
* having connective tissue disorders