cyrilzakka/clinical-trials huggingface dataset:
Myeloid-Derived Supressor Cells in Cardiac Surgery Patients

Pro- and anti-inflammatory response during the formation of the critical state develops at the same time. Because of its balanced or unbalanced systemic inflammation can be either aborted or able to lead to multiple organ failure. With regard to sepsis, systemic inflammatory response characteristics are well understood, is not achieved in respect of the "sterile" inflammation.

Extracorporeal circulation is a clinical model of systemic inflammatory response due to non-physiological activation of tissue factor in the extracorporeal perfusion, the use of non-pulsatile circulation mode, intentional / unintentional hypothermia, bacterial translocation from the gastrointestinal tract and perfusion deficit.

We have proved that the monocytes demonstrate suppressor function, which can be a predictor of complications from cardiac surgery patients.

The most important component of the formation of multiple organ failure (MOF) in critically ill patients is immunosuppression.

During the study of experimental and clinical tumor growth process scientists has provided a new population of immature myeloid cells (myeloid suppressor cells or suppressor cells of myeloid origin, MDSC). Most of the works have been devoted to the role of MDSC in the development of tumors, where it has been clearly shown that this cell population has an undoubted effect of immune suppression. However, recent studies show that the role of MDSC is not limited to cancer process, but extends to chronic or acute inflammation.

The aim of this study is to determine the role of MDSC in the development of immune suppression and complications after heart surgery carried out under cardiopulmonary bypass.

The use of MEC systems can be useful to prevent the MDSC activation after cardiac surgery.

The procedures to modulate the cytokines concentration can be useful to prevent the MDSC activation after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. the patients with ischemia heart disease and/or valvular heart disease,
2. signed inform consent,
3. CABG and/or valve replacement/plastic procedures.

Exclusion Criteria:

1) congenital heart disease.
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease

This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily.

The maximum study duration is anticipated to be up to 16 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Blood bicarbonate level of 12 to 20 mEq/L.
* Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.
* Stable kidney function defined as \<=20% variability in eGFR during screening period.

Key Exclusion Criteria:

* Any level of low blood bicarbonate during the screening period that in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
* Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within 3 months prior to screening.
* Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that required hospitalization during the preceding 6 months.
* Heart or kidney transplant.
* Chronic obstructive pulmonary disease (COPD) that is treated with chronic oral steroids, that requires the subject to be on oxygen, or that required hospitalization within the previous 6 months.
* Change in doses to alkali therapy in the 4 weeks prior to screening.
* History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent diarrhea or active gastric/duodenal ulcers.
* Serum calcium \<= 8.0 mg/dL at screening.
* Planned initiation of renal replacement therapy within 12 weeks following randomization.
* Use of polymeric binder drugs within 14 days prior to screening.
Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

The management of moderate hemophilia is less codified than those of severe patients; because these patients are theoretically less likely to bleed and therefore less likely to develop arthropathies. Nowaways, the question arises as to the appropriateness of this "symptomatic" management for the prevention of the occurrence of hemophilic arthropathies. Indeed, a significant number of moderate hemophiliacs seems to develop severe arthropathies that cause significant disability. However, because of the very small proportion of these patients in the total number of hemophiliacs, data are lacking on the impact of arthropathies on this population. The investigators therefore propose to include moderate hemophiliac patients in the study to carry out an evaluation of gait, using a gait analysis to determine the consequences of arthropathies, even sub-clinical ones, according to the duration of the disease's progression. In an associated way, the analysis of different clinical (joint assessment; quality of life score;...), radiological (radiographic; ultrasound (synovial thickness)), biological (level of associated factors ; other associated marker), in order to provide a complete picture of the articular situation in these patients with moderate haemophilia.


Eligibility Criteria:
Inclusion Criteria:

* Have moderate Hemophilia A or B.
* Have understood the protocol and signed its consent to participate.
* Patient able to perform a walking test.
* Patient affiliated to a social security system

Exclusion Criteria:

* Pregnant women
* Minor
* Majors under guardianship or curatorship
* Refusal to participate;
* Amputee of a lower limb
* Need for technical walking assistance (walking sticks, walker,...).
* Extensive dermatitis of the lower limbs (need for sensor installation for gait analysis);
* Known NYHA (New York Heart Association) grade III or IV heart failure (resting dyspnea);
* Unstable angina or myocardial infarction within three months of inclusion
* Known severe respiratory disease;
* Parkinson's disease, hemiplegia or paraplegia
* Patient unable to understand the objectives or instructions of the study
* Intercurrent pathology likely to modify walking abilities
Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation

The purpose of this study is to determine whether intravenous fluid management using lower chloride solutions (Hartmann's solutions and Plasmalyte®) will result in better outcome when compared to management using high chloride solutions (0.9% saline and Gelofusine®).

This is a prospective, controlled, before-and-after study. The baseline pre-intervention period will include collection of data while doctors and nurses are unaware that such collection is taking place. During this time, high chloride fluids (saline, Gelofusine, 4% albumin) will continue to be used according to standard practice with an estimated 30,000 liters of saline as well as 2,000 bottles of Gelofusine® being consumed.

Following a wash out period of education and preparation, there will be a complete shift to a working environment where use of saline, Gelofusine and any other fluids with a high chloride level (\>110 mmol/L)will be restricted and substituted with fluids of lower chloride concentration similar to blood; either Hartmann's solution or Plasmalyte® or 20% albumin.

The study will compare a 6 month control period (before) and a six month intervention period (after).

Eligibility Criteria:
Inclusion Criteria:

* All Intensive Care Unit (ICU) admissions at Austin Hospital
* All Emergency Department (ED) admissions at Austin Hospital
* All operations at Operating Theatre (OT) with hospital stay of more than 48 hours

Exclusion Criteria: Nil
A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy

This Phase I Clinical Study assessed the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have fully understood this study and voluntarily signed the informed consent form;
2. Male or female subjects, aged between 18 and 75 years;
3. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
4. Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;
5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
6. Subjects who are able to follow the study protocol as judged by the investigator.

Exclusion Criteria:

1. Subjects with secondary membranous nephropathy;
2. Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
3. Subjects with decreases in urine protein ≥ 50% within 6 months before screening;
4. Subjects who have received or are receiving renal replacement therapy;
5. Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
6. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
7. Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;
8. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies；
9. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;
11. Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;
12. Subjects with a history of alcoholism or drug abuse within 12 months;
13. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;
14. Subjects with CD4+ T lymphocyte count \< 300 cells/μL;
15. Other conditions unsuitable for participation in this study determined by the Investigator.
The Effectiveness of a Coach-Focused Intervention on Preventing Knee Injuries in Amateur Football Players

The goal of this clinical trial is to find out if a coach-focused intervention can help prevent sudden-onset, severe knee injuries in youth and senior amateur football players. The main question it aims to answer is:

Does a coach-focused intervention reduce the number of sudden-onset, severe knee injuries? Researchers will compare a coach-focused intervention, designed to help coaches to use effective injury prevention training, to usual football practice to see if the intervention can prevent sudden-onset, severe knee injuries in football players.

Participants will:

Either receive weekly information and motivation on effective injury prevention training or continue their usual football practice for 14 weeks.

All will receive a weekly text message with a survey link to report any sudden-onset knee injuries among their players for 18 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Coach or manager at Danish amateur football teams at levels from under 14 (U14) years to senior teams.
2. Minimum 18 years of age.
3. Access to a mobile phone and computer.

Exclusion Criteria:

1. Limited Danish language skills, which prevents full understanding of the provided material and questionnaires.
2. Affiliation to teams playing under a license ranking by the Danish Football Association where training by a physical trainer is required according to the license criteria of the Danish Football Association).
3. Affiliation solely with old boys'/girls' teams (where the players have to be aged 32 and 29 , respectively, in the current season ).
Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer

The purpose of this study is to determine the difference of skin carotenoid levels between subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell carcinomas (BCC) and a control group.

There has been experimental and clinical research evaluating association of different carotenoids and incidence of malignancies, including Non- Melanoma Skin Cancer (NMSC). An easy and inexpensive way to determine which subjects would benefit from supplementation with carotenoids or retinoids could be the measurement of skin carotenoid levels.The least invasive way to perform it is through Raman spectroscopy which is a technique that uses a laser light that can be used to quantify carotenoids on the skin. We will compare the skin carotenoid levels of subjects with previous history of SCC or BCC and subjects without history of previous NMSC.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 50 and 75 years old without history of previous SCC or BCC.
* Fitzpatrick skin types I-IV.
* Willing and able to understand and sign informed consent.
* Able to complete study and comply with study procedures

Exclusion Criteria:

* Regular ingestion of supplements containing carotenoids or vitamin A in the past 4 weeks.
* Use of topical retinoids in the past 4 weeks.
* Treatment with systemic retinoids in the past 6 months.
* Dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, palmar psoriasis, hand dermatitis or palmo-plantar keratoderma.
* Previous history of psoriasis.
* Clinically significant abnormal findings or conditions, which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
* Subjects who are known to be pregnant or planning a pregnancy.
The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries

Effective postoperative pain control results in decreased cardiac and pulmonary complications, patient satisfaction and early mobilization. A prospective, randomized comparative study was done of analgesic efficacy, opioid requirement and side effects in patients undergoing lower abdominal cancer surgeries. In Study Group Ultrasound guided Transversus Abdominis Plane (TAP) block was given and control Group no TAP block was given. Patient controlled analgesia (PCA) with intravenous morphine was given to both group patients, and total good PCA demands in both the groups was studied.

Adult patients of both sexes undergoing major lower abdominal cancer surgeries were enrolled in the study. After obtaining written informed consent from all the patients, they were randomly allotted to either Study (TAP) Group or Control group. Standard general anesthesia with endotracheal intubation was performed in all the patients. Preoperatively all patients received information about Visual Analogue Scale (VAS) for Pain Score from 1 to 10 depending on intensity of pain and about the use of Patient Controlled Analgesia (PCA) Pump. After the end of surgery and before extubation bilateral Ultrasound guided Transversus Abdominis Plane (TAP) block was performed with 16 G Tuohy needle and 18 G Braun Perifix epidural catheter was placed about 6-8 cms in situ. Bupivacaine 0.25 % 20 ml was given bilaterally and repeated 8 hourly in the Postoperative Anaesthesia Care Unit (PACU) for first 24 hours. The PCA Pump was set to deliver bolus Intravenous Morphine 1 milligram ( mg ) with lock out interval 10 minutes. In the PACU heart rate, Non invasive blood pressure, Visual Analogue Score at rest and on knee flexion, Sedation score, nausea and vomiting, any side effects as itching was noted by care provider at 0, 2, 4, 6, 12, 18 and 24 hours. Total and good PCA demands upto 24 hours was recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients belonging to American Society of Anesthesiologist (ASA) Physical Status I to III, for Open lower abdominal major onco surgeries more than 2 hours duration.

Exclusion Criteria:

* Patient refusal to participate in the study, allergy to local anesthetics, coagulopathy, local skin infection at the site of TAP Block.
Donepezil and Brain Activity Patterns in Those at Risk For Alzheimer's Disease

The purpose of the study is to examine patterns of brain activity in people who are at risk for memory problems (e.g., Alzheimer's disease or dementia)before and after the medication donepezil. Although genetic testing will be done, the results will not be shared with study participants.

Once the genetic testing is completed subjects may continue to the second phase of the study. During this time they will be asked to take the medication donepezil (which is approved by the FDA for the treatment of Alzheimer's disease).

Donepezil is not FDA approved for healthy volunteers and is therefore considered investigational in this study.

HYPOTHESIS

1. Cognitively intact individuals with normal brain morphology at genetic risk for developing Alzheimer's' Disease (AD) show alterations in brain activation patterns during tasks that require memory compared to similar individuals with lower risk for developing AD.
2. Donepezil, a cholinesterase inhibitor, can normalize such brain activation patterns in subjects at risk for AD.

SPECIFIC AIMS

1. To replicate a recent study1, and compare brain activation in subjects genetically at risk for AD (carriers of the є4 allele of the apolipoprotein E gene (APOE)) with subjects at lower risk for AD (lacking the є4 allele) during tasks that require memory, via functional magnetic resonance imaging (fMRI).
2. To determine if administration of a drug currently indicated in the treatment of AD, donepezil, can reverse fMRI brain activation patterns of at risk subjects to patterns similar to those of subjects at lower genetic risk for AD.

Eligibility Criteria:
Inclusion Criteria:

* Subjects may report experiencing subjective memory dysfunction, however they must be found by clinical evaluation to have no memory dysfunction
* Neuropsychological test battery in the normal range
* Ages 40-85

Exclusion Criteria:

* Dementia (Mini-Mental State Exam less than 25/30)
* Left-handedness
* Current medication that could influence cognition
* Medical, psychiatric, and neurologic conditions, including cerebrovascular disease or uncontrolled hypertension
* Claustrophobia
* Surgical clips or implants
* Pacemakers or other implanted electronic devices
* History of sheet metal work
Orthobiologic Treatment for Knee Osteoarthritis

The goal of this randomized clinical trial is to compare treatment for osteoarthritis in the knee using platelet rich plasma (PRP) or adipose stem cells (ADS). The main questions it aims to answer are:

* Will the patients clinically benefit from the treatment, and if so, which treatment is better?
* Will there be radiological findings to support this? Participants will be randomized into one of four groups: PRP, ADS, PRP + ADS or placebo treatment (saline) and will be examined and get an X-ray and MRI of the knee taken at inclusion and after 1 and 2 years.

Patients will be randomized into one of four treatment groups and then be followed up at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after intervention. They will fill out scores and be clinically evaluated, as well as radiologically examined at inclusion and at the final check up (x-ray and MRI).

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis in the knee grade I-III using the Kellgren-Lawrance Grading Scale
* Age 40-70 years
* Minimum VAS 3
* No use of NSAIDs or steroids the last 14 days
* No injections of hyaluronic acid the last three months
* Varus/valgus deformity \&lt;5 degrees as evaluated on x-ray imaging

Exclusion Criteria:

* Pregnant or breastfeeding women
* Cancer
* Other etiologies of knee pain (refered pain, pain from the back, dislocated meniscus on MRI, osteoarthritis grade IV using the Kellgren-Lawrance Grading Scale)
* Previous knee surgery on the affected knee
* Secondary osteoarthritis in the knee
* Previous infection in the knee
* Other diseases (rheumatoid arthritis, diabetes, systemic diseases or corticosteroid-demaning disease)
* Patients with a high risk of deep vein thrombosis
* Patients who cannot cooperate/are low compliance (psychiatric disease) or has contraindications for MRI
Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis

The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.


Eligibility Criteria:
Inclusion Criteria:

* Chronic renal failure requiring hemodialysis.
* No medical history of central vena catheterization.
* Maintenance hemodialysis after central vena catheterization.
* Signed informed consent.

Exclusion Criteria:

* Had been performed central venous puncture or catheterization before.
* Can not use heparin.
* Refused to sign the informed consent.
* Advanced cancer patients.
* With or will take arteriovenous fistula surgery in right arm.
* Other inappropriate situation