cyrilzakka/clinical-trials huggingface dataset:
The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting

This study is to assess the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting.

Desﬂurane, one of the third-generation inhaled anesthetics, is introduced in clinical practice in 1990s. Decades of clinical use has provided evidence for desﬂurane's safe and efﬁcacious use as a general anesthetic. Compared with other volatile anesthestics, it has several characteristics: lower blood and lipid solubility, more stable in vitro and the lowest in vivo metabolism. Its particular low fat solubility properties promote rapid equilibration and rapid elimination at the end of anesthesia which reduces slow compartment accumulation and promotes predictable emergence, early extubation, and the ability to rapidly transfer patients from the operating room to the recovery unit. In addition, several investigations found that patients with desflurane anesthesia recovered their protective airway reﬂexes and awakened to a degree sufﬁcient to minimize the stay in the high dependency recovery area.

A burgeoning body of investigations has shown that desflurane can directly act on myocardial and vascular functions. Desflurane has coronary vasodilative effects in in situ canine hearts which is comparable to sevoflurane does. Although it is controversial regarding to the effect of desflurane on myocardial excitation-contraction coupling and electrophysiologic behavior, a elaborated study found desflurane induced a positive inotropic effect in rat myocardium in vitro compared with isoflurane. A recent study suggested that desflurane decreased right ventricular contractility much less and maintained the right over left pressures ratio at more favorable values compared with sevoflurane. Furthermore, substantial investigations found that clinically relevant concentration desflurane preconditioning or postconditioning could protect myocardium from ischemia-reperfusion in mammalian animal models or isolated human cardiac tissues. However, it is unclear whether desflurane can provide protection for patients with coronary artery disease. Therefore, this study is designed to investigate the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with CAD 2. ASAⅡ～Ⅲ

-

Exclusion Criteria:

1. Left ventricular ejection fraction \<40%
2. Left ventricular aneurysm
3. Acute myocardial infarction in latest two weeks, atrial fibrillation
4. Associated vascular diseases, severe systemic diseases involving the renal and hepatic systems
5. Respiratory disease( forced vital capacity less than 50% of predicted values )
6. Preoperative left bundle branch block -
Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery

This study evaluates whether noninvasive ventilation with continuous positive airway pressure affects tissue perfusion in patients after cardiac surgery.

Patients submitted to open chest cardiac surgery will be enrolled after ICU admission. These patients will be submitted to noninvasive mechanical ventilation with continuous positive airway pressure right after extubation and tissue perfusion markers (central venous oxygen saturation (SVcO2) and lactate) will be obtained via central venous catheter.

Noninvasive mechanical ventilation is a common resource in the ICU to reduce extubation failures and to improve clinical outcomes, whether it can influence tissue perfusion remains unclear.

This study evaluates whether noninvasive ventilation affects tissue perfusion and whether tissue perfusion markers in the ICU are correlated with better clinical results for patients after heart surgery.

Eligibility Criteria:
Inclusion Criteria:

* Presence of central venous catheter
* Invasive arterial pressure catheter
* Invasive mechanical ventilation

Exclusion Criteria:

* Chronic obstructive pulmonary disease
* Morbid obesity
* Hemodynamic instability
* Spontaneous breathing
* Need of invasive mechanical ventilation for more than 24 hours
* Intolerance to noninvasive mechanical ventilation
* Extubation failure
A Clinical Study of CHT102 in MSLN-Positive Advanced Pancreatic Cancer

Evaluate the safety and efficacy of mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer

3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and sign a written informed consent documen；
2. At the date of signing ICF, 18 \~70 years old, male or female；
3. Histopathological confirmed advanced or metastatic pancreatic cancer patients who have failed to standard treatment or intolerance with standard treatment；
4. Positive mesothelin expression;
5. At least one measurable lesion at baseline per RECIST version 1.1；
6. The expected survival time is more than 12 weeks;
7. ECOG 0-1 points;
8. Adequate organ functions.
9 Months Extension Study of SOMVC001 Study (GALA) Vascular Conduit Preservation Solution

This is a 9-months extension to the following study, protocol number: 003-03: "A study to evaluate the use of SOMVC001 (GALA) vascular conduit preservation solution in patients undergoing coronary artery bypass grafting (GABG)". Participation is allowed exclusively to participants enrolled in the main protocol SOMVC001 (GALA).

Patients enrolled in this 9-months extension study of SOMVC001 (GALA) will be contacted by phone twice: 6 months and 9 months after a coronary artery bypass graft (CABG) surgery. During these phone call visits and at twelve months post CABG surgery, adverse events and/or concomitant medication changes will be collected from the participant. Twelve months after the CABG surgery procedure, imaging will be performed using 64-slice or better MDCT-scan angiography. The study participation ends at this MDCT-scan visit.

In detail, will be recorded incidence of composite safety outcomes consisting of Major Adverse Cardiac Events (MACE) (death, myocardial infarction \[MI\], and repeat revascularization), angina, arrhythmias, shortness of breath \[SOB\], decreased lumen change, graft occlusion and significant stenosis based on Fitzgibbon's scale B and O, following CABG surgery.

Patients in this study are their own control; they receive two SVG; one exposed to GALA and the other exposed to heparinized dose saline. The effect of treatment (GALA vs. Saline) will be evaluated on paired grafts within-person. Therefore, treatment effect will be presented by graft and not by patient. Only adverse clinical events will be presented by patient including their potential relationship to the study product.

Eligibility Criteria:
Inclusion Criteria:

* patients from protocol #003-03 who agree to be followed for an additional 9 months by signing informed consent.

Exclusion Criteria:

* patients who have a contraindication to undergo MDCT angiography ant 12 months post CABG surgery.
OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer

Patients enrolled in the study will be randomized before surgery: in one study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard), while in the other arm it will be conducted using the OSNA method.

This is a non-inferiority randomized trial with the incidence of patients with metastatic SLN as primary endpoint. Based on recent literature, incidence of patients with metastatic SLN detected by ultrastaging has an average value of 11%. Assuming a -4% as the maximum allowable difference in detection rate to declare non-inferiority, a power of 80% and a significance level of 2.5% (one-side) a sample size of 1922 (961 per arm) is needed. Two interim analyses are planned, one after the first 640 and the second after 1280 patients. At the first interim analysis null hypothesis (inferiority of OSNA with respect to ultrastaging) will be rejected at a significance level \<0.00010 otherwise the study will go on and at the second analysis the null hypothesis will be rejected at a significance level of 0.0059. The final analysis will use 0.0189 as significance threshold. The O'Brien Fleming alpha spending function was used to define these values.

The primary endpoint is defined as the proportion of patients with positive SLN over the total of randomized patients. This proportion will be reported together with the 95% confidence interval to better identify the range of inferential values. Incidence of isolated tumor cells, micro- and macro-metastasis will be calculated.

Number of copies of CK19 mRNA to define volume of metastases will be adapted from previous reports.

To describe the sample, quantitative variables will be summarized using median and interquartile range while categorical items will be reported as absolute counts and percentages. Patients will be described according the arm they were randomized to. A first analysis will be performed on an Intent-To-Treat basis, considering all randomized patients. A secondary analysis will be performed on the Per-Protocol population.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed endometrial cancer
* Apparent (pre-operative) FIGO stage I-II
* Radical surgery
* Attempt of SLN mapping

Exclusion Criteria:

* Uterine sarcoma (including endometrial stromal sarcoma)
* Fertility sparing surgery
* Dedifferentiated histology
* Undifferentiated histology
* Neoadjuvant therapy
* Previous surgery to pelvic lymph nodes
* Lymph nodes with short axis \>15 mm at pre-operative imaging
Impact of Postprandial 'Exercise Snacks' on Protein and Glucose Metabolism Following a Period of Step Reduction in Older Adults

The purpose of this study is to assess the impact of 3-days reduced physical activity (\<1500 steps/day) with/without 'exercise snacks' (15 chair stands with calf raises every 30 min) on skeletal muscle metabolic health.

Many adults gradually lose muscle size, strength, and function after the age of 50. These losses are believed to occur faster with periods of reduced activity (e.g., lower step counts or physical movement when sick or injured) and can be difficult to regain by merely returning to a previously normal activity status. Such periods of reduced activity can also impair the body's ability to use the nutrients in the food consumed (e.g., proteins and carbohydrates), which increases the risk of frailty, type 2 diabetes, and ultimately a reduced quality of life. It is important to identify strategies to prevent these losses in muscle size, strength, and function especially during periods of reduced activity.

Recently, our laboratory has found that performing repeated bodyweight chair squats (repeated sit-to-stands with a calf raise) during a single day of reduced activity improves the muscle's ability to use carbohydrates and proteins, which may be a viable strategy to offset the negative effects of step reduction on muscle health.

In this study, the investigators will assess whether completing bodyweight chair squats at regular intervals (i.e., 'exercise snacks') reduces the negative effects of step reduction on carbohydrate and protein metabolism following a meal. The investigators will determine the impact of 'exercise snacks' (15 chair stands with calf raises every 30 min) compared to seated rest on protein and carbohydrate metabolism following three days of step reduction. The investigators will also assess how these responses compare to those seen following three days of normal (i.e., habitual) activity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy older (age: 60-80 y) adults
* BMI between normal to overweight (18.5-29.9 kg/m2)

Exclusion Criteria:

* Regular use of nonsteroidal anti-inflammatory drugs (with the exception of daily low-dose aspirin)
* Alcohol consumption during the study period
* Use of anticoagulants
* Use of a walker, cane, or assistive walking device
* Current or recently remised cancer
* Infectious or gastrointestinal disease
* Inability to comply with study protocol (e.g., \>1,500 steps/day during Step-Reduction Phase)
* Regular tobacco use
* Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.)
* Diagnosed chronic illness (e.g. type 2 diabetes, heart disease, thyroid disease)
* Hormonal Replacement Therapy
Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1

The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy.


Eligibility Criteria:
Male and non-pregnant female subjects seeking outpatient treatment for opioid dependence with physiological features without serious medical or psychiatric disorders.
A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.

The study is a randomized, controlled, multi-site clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old (including 18 and 75 years);
2. clinically diagnosed grade 2 or 3 radiation-induced lung injury;
3. the course of radiation-induced lung injury is less than 2 months;
4. ECOG 0-2;
5. the expected survival time is more than 6 months;
6. the functional level of major organs meets the following standards: ANC≥3.0×109/L，PLT≥100×109/L，Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN， ALT、AST≤2.0×ULN
7. capable of eating solid food upon enrollment;
8. subjects will voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

1. have a history of chronic bronchial acute attack or severe pulmonary heart disease;
2. pneumonectomy;
3. tumor progression;
4. severe pulmonary infection;
5. creatinine clearance rate \< 30ml/min, severe renal disease or need dialysis;
6. concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study;
7. patients with active peptic ulcer;
8. pregnant women and patients with mental illness;
9. participating in clinical trials of other drugs within 3 months;
10. the investigator determined that subject was not suitable.
Study to Evaluate the Efficacy and Safety of Tacrolimus in Kidney Transplant Recipients (BLOSSOM)

The purpose of this study is to evaluate the efficacy and Safety after conversion to TacroBell SR cap. or TacroBell cap. in patients who in renal transplant patients undergoing maintenance therapy with Reference Tacrolimus.

This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to TacroBell SR cap. or TacroBell cap. administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Reference Tacrolimus.

Eligibility Criteria:
Inclusion Criteria:

* Over 20 years old(male or female)
* Patients with eGFR (By CKD-EPI) ≥30mL/min/1.73m\^2 and spot urine P/C ratio≤0.5 at screening test
* Patients who are taking Tacrolimus twice a day for maintenance therapy and have Trough level of 3\~10ng/ml
* Agreement with written informed consent

Exclusion Criteria:

* Patients who have transplanted organs other than kidney
* Patients with acute rejection who have been clinically treated within the last month
* Patients who have changed their administration of adjuvant immunosuppressants and corticosteroids within the last month (dose change, discontinuation, etc.)
* Patients who have been diagnosed with cancer within the last 5 years (except skin cancer or thyroid cancer determined by the investigator that treatment has been completed)
* Patients deemed inappropriate for screening due to severe digestive disorders at screening
* Patients with severe systemic infections requiring treatment (transplantation may be possible after the infection is completely lost or controlled)
* Patients with genetic problems of galactose-intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
* If the following cases occur during screening
* Treatment of active liver disease or increased one or more of the liver function tests (T-bilirubin, AST, ALT) levels more than three times the upper limit of normal range
* Patients with WBC \<2,500/mm\^3, PLT \<75,000/mm\^3, ANC \<1,300/μL
* Patients who have experienced hypersensitivity reactions or serious abnormalities with medicines used in this clinical trial or with similar chemical structures (Tacrolimus, etc.)
* Pregnant or lactating women
* Patients of childbearing potential who do not agree to the proper use of contraception during the trial
* Patients who received other investigational drugs within 4 weeks prior to consent of the document
* Patients unable to participate in the clinical trial due to the judgment of other investigators
Importance of Neurogenic Inflammation in the Angiogenic Response of the Dental Pulp as a Defensive Response

This study measures SP, CGRP and VEGF expression in human dental pulp under occlusal trauma induced by occlusal interferences under moderate orthodontic forces or under a combination of occlusal trauma and moderate orthodontic forces because in clinical reality, patients under orthodontic treatment experience a combination of these stimuli on their pulp tissue.

Substance P (SP) and calcitonin gene-related peptide (CGRP) are neuropeptides that are assembled in the cell bodies of the trigeminal nerve and are transported through axonal flow to the nerve endings in human dental pulp, mainly in type-C nerve fibers and free nerve endings, where they are released to fulfill important biological functions.

SP plays an important role in pulp tissue reparation because it stimulates angiogenesis using direct mechanisms by modulating the growth of endothelial cells and fibroblasts through the activation of growth factors such as VEGF and IGF-1 and stimulates cell migration and proliferation to form mineralized tissue as a defense mechanism. It also uses indirect mechanisms such as binding to granulocytes or macrophages, which allow cells with angiogenic potential to be attracted.

CGRP has a key role in pulp reparation because of its angiogenic potential, which is linked to endothelial cell stimulation via the cAMP-PKA pathway, promoting cell proliferation. It boosts VEGF expression and stimulates focal adhesion kinase involved in the stabilization and maturation of blood vessels. It can stimulate growth factors that act on fibroblasts, such as HGF, IGF-1, and bFGF, and it can also produce an effect on odontoblast-like cells by increasing BMP-2 expression and allowing cell proliferation after 24 h. This shows that it can contribute to mineralized matrix formation

Angiogenesis is mediated by several growth factors, such as the VEGF. VEGF is released in the pulp tissue as a response to a harmful stimulus to counteract emerging hypoxic areas regulating oxygen and nutrients supply to cell populations by forming new blood vessels. VEGF is present in endothelial cells, mast cells, macrophages, lymphocytes, undifferentiated mesenchymal cells, fibroblasts, and odontoblast-like cells, and it controls neurogenic inflammation and reparation processes in combination with SP due to its angiogenic potential.

SP, CGRP, VEGF expression can be altered by the masticatory function, occlusal trauma, orthodontic movements, or a combination of occlusal trauma and orthodontic movements, which often takes place in patients under orthodontic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Teeth in normal masticatory function
* Complete root development verified clinically and radiographically

Exclusion Criteria:

* Patients under medication
* Smokers
* Pregnant women were excluded
* Teeth with caries
* Teeth with restaurations,
* Teeth with previous orthodontic treatment
* Teeth with periodontal disorders
* Teeth with parafunctional habits.
Cognitive Aging and Training With Video-games

The ageing of the population will inevitably lead to a growing number of older people living alone and in need of care. Given the high cost of geriatric care, a critical research issue is exploring ways to improve or maintain cognitive and functional status in old age. Unfortunately, it has been shown that training those specific cognitive processes most sensitive to ageing (such as speed of processing or working memory), produces only limited beneficial effects. However, research also suggests that factors such as cognitive engagement, physical activity and social context may act as more general modulators of cognitive decline. This project is a longitudinal study with experimental and control groups. It is inspired from the engagement model of cognitive optimization suggesting that a lifestyle marked by social and intellectual engagement may mitigate age-related declines on cognitive functioning. It uses new cutting-edge information computing technology (ICT) solutions to improve or simply maintain cognitive functions in the elderly. This research investigates how the treatment reduces the effects of cognitive age-related decline in executive control processes and episodic (explicit) memory using behavioral and imaging measures. The results will provide significant knowledge on the potential of new ICT technologies to delay, compensate, and even prevent common chronic problems experienced by the elderly population. The hypothesis is that cognitive training with video-games through ICT solutions will promote brain and mental health and independence. Ultimately, the objective is to contribute to the understanding of factors that help avoiding the (personal and economic) consequences of long-term care in geriatric institutions.

The aim of the present project was to investigate whether older adults could benefit from brain training with video games in a series of cognitive tasks. Two groups of healthy older adults participated in the study. The experimental group received 20 1-hr video game training sessions using a commercially available brain-training package (Lumosity) involving problem solving, mental calculation, working memory and attention tasks. The control group did not practice this package and, instead, attended meetings with the other members of the study several times along the course of the study. Both groups were evaluated before and after the training (experimental group) or a similar period of time (control group) using different cognitive tasks in a 2 (Group: Experimental, control) x 2 (Time os assessment: Pre, post) mixed factorial design.

Eligibility Criteria:
Inclusion Criteria:

* Mini-Mental State Examination (MMSE) score 26 or greater
* Global Deterioration Scale (GDS) score less than 5
* Independent living
* Normal or correct to normal vision and hearing

Exclusion Criteria:

* Diagnosis of dementia
* Planned move from study area
* Inability to complete study activities
* Scores lower than inclusion criteria requirements Communication problems.