cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcomes Of Modified Del Nido Cardioplegia In Adult And Pediatric Cardiac Surgery

"Introduction: Modern cardiac surgery prioritizes myocardial protection, incorporating various strategies including cardioplegia to preserve heart function during surgery. The Del Nido (DN) cardioplegia solution, initially for pediatric use, shows promise in adult surgeries due to its longer protection duration and reduced re-dosing needs. However, its efficacy in adults remains under-researched.

This study aims to evaluate the clinical outcomes of modified Del Nido cardioplegia in adult and pediatric cardiac surgeries, comparing intraoperative and postoperative metrics to provide evidence on its efficacy and safety.

To assess the clinical outcomes of modified Del Nido cardioplegia in cardiac surgeries across different age groups, focusing on myocardial protection, hemodynamic stability, surgical outcomes, recovery, and complications.

Eligibility Criteria:
Inclusion Criteria:

* All Pediatric patients with congenital heart diseases.
* Individuals who are capable of giving their informed permission;
* Stable patients undergoing surgical procedures that involve cardiopulmonary bypass and cardiac arrest;
* isolated CABG surgery, or simultaneous CABG;
* isolated single-valve surgery or multiple value procedures.

Exclusion Criteria:

* Previous cardiac surgery
* Patients with preoperative inotropic pharmacologic support
* Patients receiving preoperative mechanical circulatory support,
* Patients with an implanted pacemaker or implantable cardioverter-defibrillator,
* Patients undergoing cardiac surgical procedures
* Patients who underwent off-pump or beating heart CABGs
* Ventilation for the night was scheduled because of severe pulmonary arterial hypertension.
* mediastinal drain causing a delay in extubation, or the need to reopen for bleeding or tamponade.
Propofol and Sevoflurane Anesthesia in Colorectal Cancer Surgery: Incidence of Acute Kidney Injury

The goal of this observational study is to compare anesthetic modalities (intravenous propofol anesthesia with sevoflurane gas anesthesia) in patients who underwent colorectal cancer resection surgery regarding the outcome of acute kidney injury.

The main questions it aims to answer are:

* is there a difference in acute kidney injury incidence in the two anesthetic modalities?
* is there a difference in plasma creatinine between the two anesthetic modalities?
* are there any patient characteristics or intraoperative factors that effect the incidence of acute kidney injury in either anesthetic modality?

The study will analyze data from the CAN clinical trial database. (Cancer and Anesthesia: Survival After Radical Surgery - a Comparison Between Propofol or Sevoflurane Anesthesia, NCT01975064)


Eligibility Criteria:
Inclusion Criteria:

* colorectal surgery and participant in the CAN trial

Exclusion Criteria:

* missing blood samples
National Exhaustive Cohort of Hereditary Stomatocytoses and Other Channelopathies Affecting the Red Blood Cell

Hereditary stomatocytosis is a heterogeneous group of rare constitutional diseases of dominant transmission in the vast majority of cases. The data concerning their clinical and biological presentation, and their evolution are few, and come from about thirty clinical cases. The constitution of an exhaustive French cohort of hereditary stomatocytosis will improve the establishment of the diagnosis and the management of patients

The patient is prospectively included. The referring hematologist will inform the patient about participation in the cohort, give him the information note and obtain his non-objection agreement to the use of his data for research purposes.

The data will be collected from the medical file of each patient as part of his usual annual follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with a diagnosis of stomatocytosis without age limit
* Patient affiliated or beneficiary of french Social Security
* No objection from the patient or legal representative

Exclusion Criteria:

* Diagnosis of stomatocytosis excluded by ektacytometry and / or genetics
* Patient under guardianship, with curators or legal protection
Treatment of Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells

The purpose of this study is to explore the efficacy and safety of autologous adipose-derived mesenchymal stem cells (AMSCs) plus autologous platelet rich plasma (PRP) in the treatment of severe knee osteoarthritis.

This is a single centered, randomized, single blind phase II clinical study. Patients will be divided into two groups of case and control. Patients of case group will receive intra-articular injection of autologous AMSCs suspended in 3 ml autologous PRP for 3 times, patients of control group will receive intra-articular injection of 3 ml of autologous PRP for 3 times. The investigators designed this clinical study to evaluate therapeutic effects of AMSCs in patients with severe knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has Kellgren and Lawrence grade II-IV primary osteoarthritis as determined by X-ray.
2. Subject's pain score is 8-13 points (Lequesne's index).
3. Ages between 40-70 years.
4. Signed informed consent from the subject.

Exclusion Criteria:

1. Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV
2. Subject not suitable for liposuction surgery.
3. Subject with hypersensitivity/allergy to anesthetic.
4. Subject's creatinine values higher than 1.6mg/dl.
5. Subject with body mass index, BMI over 30.
6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
7. Subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
8. Subject enrolled in any other cell therapy studies within the past 30 days.
9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.
Utilizing Augmented Artificial Intelligence for Aminoacidopathies

The objective of the study was to interpret metabolic profiles of plasma amino acid (PAA) and compare reference intervals (RI) of PAA data from Pakistan with data from other countries using Clinical Laboratory Integrated Reports (CLIR). One-year data (reference and cases data) of twenty-two PAA, analyzed by ion exchange high performance chromatography at Biochemical Genetics Laboratory (BGL) of Aga Khan University Pakistan, was compiled in a comma-separated values (.csv) file and uploaded on CLIR Software using AAQP (Amino Acid in Plasma) application for statistical analysis. Among total of 2081 PAA profiles, 92% (n=1913) were completely normal with all PAA values falling within the age-specific reference range. A concordance of 98.8% was noted between the reporting done by the BGL at AKU and then after applying CLIR tools.


Eligibility Criteria:
Inclusion Criteria:

All plasma samples during 1 year received at Biogenetic Lab

Exclusion Criteria:

Subjects with age greater than 16 years
Technical Development of up to 7T Magnetic Field Strength

The objective of this study is to determine whether these new image acquisition strategies and techniques using of up to 7T can produce meaningful structural and physiological information that can serve to improve our understanding of various disease processes in the clinical setting. 200 Control volunteers will be scanned for approximately one hour, without contrast, on up to 7T MRI scanner. 200 Study Participants will be scanned using newly developed imaging software or hardware that conforms to applicable FDA standards and recommendations. The data (images) for the Control and Experimental Group will be de-identified by the scan technologist and downloaded to a workstation within the Radiology Department for offline processing. These images will be reviewed by a trained Radiologist after the subject has departed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy control volunteers, male and female, ages 18 and older (no history of chronic illness, concussion, malignancies, etc.)

Exclusion Criteria:

* Contraindications with MRI (e.g. pacemakers or ferromagnetic material near vital structures, etc.)
Efficacy of Lyophilized Dried Cornus Mas L. on Anthropometric and Biochemical Parameters in Insulin Resistance

The aim of this study is to determine the effect of 3 months supplementation of lyophilize dried cornelian cherry (Cornus mas L.) on women diagnosed with insulin resistance. The baseline and end biochemical parameters and anthropometric measurements will be compared with control subjects.

The main purpose of this study is to determine the efficacy of the lyophilizer-dried powder form of cornelian cherry (Cornus mas L.) grown in our country on inflammation in women with insulin resistance by biochemical parameters.

Sub-objectives of the study;

* Determining the presence of inflammation in women with insulin resistance.
* Determination of the effect of cornelian cherry on both fasting blood glucose, insulin and blood lipid profile.
* Determination of both anti-inflammatory, antidiabetic and antioxidant effects of cornelian cherry.
* Determination of the effect of cornelian cherry on anthropometric measurements.

The aim of this study is to compare the anthropometric measurements and biomarkers of women with insulin resistance as a result of the consumption of powdered cornelian cherry (Cornus mas L.) that has been freeze-dried at -55 degrees with a Lyophilizer device for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 45 years with insulin resistance.
* Those who have not experienced menopause
* Those who applied to the obesity clinic
* Volunteers
* Those who signed the consent form

Exclusion Criteria:

* Those who use medicine for diabetes and thyroid diseases,
* Those taking hormone therapy
* Pregnant and lactating women
* Those with a history of cancer
* Patients with communication problems.
Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold

The aim of this study is to characterize the time profile of the decongestant properties of xylometazoline and to investigate its effect on sleep, general well-being and smell/taste.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Have had moderate common cold symptoms for less than 36 hours.

Exclusion Criteria:

* Congested/runny nose for more than two continuous weeks in the previous 12 months
* Deviated septum or nasal polyps
* Recent use of antibiotics
* Recent sinusitis

Other protocol-defined inclusion/exclusion criteria may apply.
Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies

The primary objectives of the Phase I study 15404 are to evaluate the safety, tolerability and pharmacokinetics of BAY94-9343 given once every 3 weeks in Japanese subjects with advanced, refractory solid tumors.

The secondary objectives are to investigate the efficacy, biomarkers and immunogenicity.


Eligibility Criteria:
Inclusion Criteria:

* Japanese subjects ≥ 20 years of age
* ECOG Performance Status of 0 to 1
* Life expectancy of at least 12 weeks
* Subjects with advanced, histologically or cytologically confirmed solid tumors, not amenable to any standard therapy, have no standard therapy available
* Subjects whose fresh or archival tumor tissues are available
* Measurable disease with at least one lesion that can be accurately measured in at least one dimension according to RECIST criteria (Version 1.1 or modified version)
* Adequate bone marrow, liver, and renal function

Exclusion Criteria:

* Anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks of start of the first dose
* Impaired cardiac function or clinically significant cardiac disease (i.e., congestive heart failure (CHF) NYHA Class III or IV)
* Myocardial infarction or onset of unstable angina \< 3 months prior to general screening
* Cardiac arrhythmias in the electrocardiogram that would interfere with QT/QTc interval measurement (LBBB (left bundle branch block), AV block, atrial fibrillation)
* QTc \>470 ms, derived as the average of the 3 values measured by the ECG recorder's algorithm on the ECG triplicate
* LVEF (left ventricular ejection fraction) \<50 %
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 90 mmHg, despite optimal medical management
* Known human immunodeficiency virus (HIV) infection
* Subjects with an active hepatitis B or C infection requiring treatment
* Personal or family history of Long QT Syndrome (LQTS)
* Subject with clinically significant eye disorders
Alterations in CD8αβ and CD8αα T Cell Levels in Patients With Rheumatoid Arthritis

To evaluate the changes in the frequencies of circulating CD4+ and CD4- T cells expressing CD8αα and CD8αβ in peripheral blood of RA patients in comparison with healthy controls. Also, to correlate circulating and synovial fluid levels of these cells with disease activity score (DAS28) and other indices of disease severity.

Rheumatoid arthritis (RA) is a chronic, inflammatory, systemic autoimmune disease of the joints . CD4+ T cells are predominant in the synovial tissue with increased number of CD8 effector and memory T cells in synovial fluid and tissue of RA patients . CD8 functions as a dimer; including homodimer CD8αα and heterodimer CD8αβ . CD8αβ is a superior T-cell co-receptor that enhances functional avidity, CD8αα functions as a TCR corepressor to negatively regulate T cell activation . CD8αα T cells are found in human intestine and peripheral blood . CD8αα T cells increased markedly in the lesions of psoriasis where they played a pro-inflammatory role . The lower percentage of CD8αα+ mucosa associated-invariant T (MAIT) cells was found to be associated with MAIT cell dysfunction in gut immunity in necrotizing enterocolitis patients . T cells express the CD8β chain either at a high (CD8βhigh) or low density (CD8βlow ). There was a relative increase in CD8βlow cells in patients with SLE which were associated with an increased disease activity . Double positive (DP) T lymphocytes, include CD4CD8αβhigh and CD4CD8αα T cell subsets in the human blood . DP8α cells decreased in the blood and colonic mucosa of patients with inflammatory bowel disease compared with healthy individuals . CD4CD8αβhigh T cells are present at higher frequencies in some auto-immune diseases . Whether CD8αα or CD8αβ T cells contribute to the pathogenesis of RA, has not been clarified so far. investigators hypothesize that, an alteration in the frequency and distribution of these T cell subsets in RA patients might be associated with disease activity

Eligibility Criteria:
Inclusion Criteria:

* Patients with RA who fulfilled the 2010 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) revised criteria for RA (12).

Patients having knee effusion .

Exclusion Criteria:

* Patients with autoimmune diseases other than RA. Patients or controls with tumors, infections, or other severe organ damage.
Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery

An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment


Eligibility Criteria:
Inclusion criteria:

Patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study

Exclusion criteria:

All patients who should not be treated with Pradaxa 150 mg according to the European Summary of Product Characteristics (SPC):

severe renal impairment (creatinine clearance \< 30 ml/min); elevated liver enzymes \> 2 upper limit of normal (ULN); Hepatic impairment or liver disease expected to have any impact on survival, anaesthesia with post-operative indwelling epidural catheters, hypersensitivity to dabigatran etexilate or to any of the excipients, active clinically significant bleeding, organic lesion at risk of bleeding, spontaneous or pharmacological impairment of haemostasis, concomitant treatment with quinidine, protehetic heart valve requiring anticoagulant treatment
Target-controlled Infusion Anesthesia and Post-induction Hypotension

Hemodynamic changes during induction of anesthesia may have adverse outcomes and should therefore be avoided. The decrease in blood pressure during induction of anesthesia with propofol is due to a decrease in systemic vascular resistance or cardiac output and may be increased by the concomitant use of other drugs such as remifentanil. Target controlled infusion (TCI) system aims to reach the theoretically targeted blood or brain concentration of anesthetic agents based on the patient's age, weight, and height, with computer-assisted algorithms. In manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight, which may cause hypotension in patients with low cardiovascular performance. As target-controlled infusion (TCI) obviates the need to calculate the infusion rate manually, the use of TCI may provide a better hemodynamic profile during anesthesia induction This study was designed to test the hypothesis that propofol by TCI anesthesia induction is associated with a lower hypotension rate when compared with manual anesthesia induction

Maintaining normotension is one of the top priorities for anesthesiologists due to its negative effects. Although there are a lot of studies and knowledge on the topic approximately 20-30% of patients develop post-induction hypotension. Mostly it occurs due to the adverse effects of anesthetics such as a decrease in systemic vascular resistance or cardiac output and the interplay between them. The risk can be minimized in two steps: first by identifying high-risk patients, and second with tight control of hemodynamic parameters. As a second step, tight hemodynamic control during induction may be done using target-controlled infusion (TCI) systems, which systems help to adjust the dosage to the needs of each patient by measuring hypnotic effects through the bispectral index (BIS).

TCI models for propofol have been previously compared with manual infusions, however, it is not clear whether it still contributes to or triggers hemodynamic deterioration. Therefore in this study, the investigators' aim is to determine the effect of two different anesthesia techniques on the development of postinduction hypotension through hemodynamic parameters monitored by the pressure recording analytical method (PRAM). The secondary aim is to identify risk factors that can predict postinduction hypotension

Eligibility Criteria:
Inclusion Criteria:

* Patients with the American Society of Anesthesiology physical status 1-3
* Underwent major elective surgery
* Required intra-arterial blood pressure monitoring before induction.

Exclusion Criteria:

* Under 18 years of age
* Arrhythmia (atrial fibrillation, frequent premature beat)
* Severe valvular heart disease
* Morbid obesity
* Intubation difficulty
* Drug addiction
* Treatment with opiates
* Pregnancy
* Emergency surgery
Risk Analysis for Cardiovascular Autonomic Neuropathy

This is a large-scale, community-based, cross-sectional study to evaluate environmental and genetic risk factors for cardiovascular autonomic neuropathy in general Chinese population.

A large-scale, community-based, cross-sectional study was conducted to explore the extent to which risk factors associated with cardiovascular autonomic neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). Data involved in demographic information, clinical biomarkers such as glucose and lipids profiles, medical and therapy history were collected. Every participants was complete DNA extracted and genotyped. Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of CAN. Univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of CAN. In addition, clinical risk model, simply screening model and non-linear system model such as artificial neural network was created, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Survey Chinese participants with undiagnosed CAN
* Aged 30-90 years, were included in this study.

Exclusion Criteria:

* Some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their CA function. Briefly, the exclusion criteria were as follows:

  1. history or findings of arrhythmia and hyperthyroidism or hypothyroidism
  2. pregnancy or lactation
  3. serious hepatic or renal dysfunctions (GFR \< 30 mL/min/1.73m2).
* Of these subjects, complete baseline data were obtained for 2,092 (69.46%) of the participants.
Effects of a Patient Driven Assessment Process With Complex Pain Patients

The objective of this study is to engage patients with chronic pain and other key stakeholders in an iterative process of pilot-testing a validated patient generated instrument, the Measure Yourself Medical Outcome Profile (MYMOP), to support primary care encounters and provide a direct comparison between a strategy of incorporating patient reported outcomes into the package of care for complex pain patients and usual care. The specific aims of this phase of the project are to: 1) adapt the MYMOP for use in the primary care setting well-integrated into everyday practice flow, and 2) evaluate whether the utilization of the MYMOP data in routine primary care encounters results in improvements in patient symptoms and functioning over time as well as increased satisfaction with the visit for patients and primary care providers. To achieve Aim 2, the investigators will compare the reported outcomes and health care utilization from participating patients in this study for whom the MYMOP-based instrument will be used in routine clinical care to a matched group of chronic pain patients who will not receive the MYMOP-based assessment but will otherwise have similarly collected data. This also allows us to evaluate of the extent to which use of the tool adds patient-centered information to more conventional instruments. In addition to these two aims, for a third aim, the investigators plan to collect qualitative data from patients, their family members, Kaiser Permanente Northwest (KPNW) health care providers, and KPNW administrators to better understand the needs of this subpopulation of patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Kaiser Permanente Northwest health plan members with at least 12 months of continuous eligibility at time of study entry and receive primary care from participating physicians
* Continued opioid use during the previous 6 months, as defined by 2 or more dispenses of long-acting opioids and/or a minimum cumulative supply of 90 days' worth of short-acting opioids based on electronic medical record (EMR) d) EMR recorded diagnosis of nonspecific chronic pain, Fibromyalgia, or diagnosis of ≥ 2 types of pain in the past year

Exclusion Criteria:

* Active cancer
* Substance abuse or dependence
* Hospice care
* Severe mental illness