cyrilzakka/clinical-trials huggingface dataset:
Evaluating Erythropoietin as an Indicator for Possible Kidney Injury After Cardiac Surgery

The purpose of the study is to evaluate kidney biomarkers and determine if there is a correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac surgery. An early biomarker for kidney injury may be helpful in identifying, monitoring and managing patients at risk for kidney failure after cardiac surgery. To evaluate Erythropoietin's role as a predictor of poor renal function in the immediate post-bypass period we plan to compare EPO levels to Neutrophil gelatinase-associated lipocalin (NGAL).

Acute kidney injury (AKI) is a serious complication after cardiac surgery and cardio-pulmonary bypass. AKI is associated with high mortality.

Erythropoietin, a hormone produced by the kidneys, will be evaluated as a potential biomarker of kidney injury. Neutrophil gelatinase-associated lipocalin (NGAL) has been studied as a biomarker of kidney injury. Early kidney injury detection has been long sought and NGAL has been shown to be a promising biomarker. A troponinlike biomarker of AKI that is easily measured and capable of both early detection and risk stratification would represent an advancement in our ability to differentiate acute kidney injury from failure.

Investigating EPO as a biomarker may prove to have increased predictive value in the clinical care of cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery with cardiopulmonary bypass with DHCA
* Normal renal function or renal insufficiency-serum creatinine less than 2.5 mg/dL
* Adult male and female patients 18 years and older

Exclusion Criteria:

* VADS
* Emergent cases
* Prolonged hypoxemia before, during or after bypass
* End stage renal disease
* Patients receive erythropoietin receptor agonists
Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study

In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner. Investigation of a wide range of users in various conditions may strengthen the reliability of the FFRAngio measurements.


Eligibility Criteria:
Inclusion Criteria:

* Male and female above 18 years old age which undergo FFR as part of their standard care
* TIMI Grade Flow is equal to 3
* LVEF larger than 45%.
* Subjects with multi-vessel coronary artery disease, with NSTEMI are allowed.

Exclusion Criteria:

* Contraindicated for FFR examination or adenosine administration
* STEMI
* CTO
* TIMI Grade Flow below 3
* Arteries supplying akinetic or severe hypokinetic territories
* Prior CABG on the study vessel
* Left Main stenosis, In-stent restenosis and Collaterals
* Diffused atherosclerosis diseases and tandem lesions
* Aorto-ostial lesion
Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia

The purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (DRGA). In this randomized controlled trial, three analgesic regimens following DRGA in Franciscan Children's Hospital will be compared using both self-report and behavioral measures.

The analgesic therapies to be investigated are ibuprofen monotherapy, alternating ibuprofen and acetaminophen dual-therapy, and combined ibuprofen and acetaminophen dual-therapy. For the purposes of this study, combined therapy is defined as the simultaneous administration of acetaminophen and ibuprofen at regular intervals, whereas alternating therapy is defined as one analgesic (acetaminophen or ibuprofen) administered within a 3 hour interval of the other.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II
* Requiring Oral Rehabilitation under General Anesthesia
* Possess legal guardians proficient in English
* Not have a history of any adverse/allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen

Exclusion Criteria:

* ASA III or IV
* Asthma diagnosis
* Contraindication to acetaminophen or ibuprofen
Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study

This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms related to receiving chemotherapy.

Chemotherapy drugs used to treat cancer can cause many symptoms. Some of the most common symptoms of receiving chemotherapy are nausea, vomiting, and anxiety. These symptoms can affect the quality of life of cancer patients. Medications can help ease these, but many patients continue to experience symptoms despite these treatments.

Acupuncture has been studied in clinical trials in cancer patients and has been shown to be helpful for management of pain, nerve damage from chemotherapy, and nausea.

Ear acupuncture is a type of acupuncture that involves the stimulation of points on the external ear. A few studies have suggested that ear acupuncture may help to reduce symptoms of nausea and anxiety during chemotherapy.

This study is being done to evaluate the potential benefits of using ear acupuncture to reduce symptoms like nausea and anxiety for women receiving chemotherapy for breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* History of histologically or cytologically proven Stage I-III breast cancer receiving intravenous chemotherapy on an every 14 days or every 21 days schedule
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Signed informed consent

Exclusion Criteria:

* Receiving weekly chemotherapy
* Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
* Uncontrolled seizure disorder
* Pregnancy or potential pregnancy
* Active clinically significant uncontrolled infection
* Prior use of acupuncture within 3 months prior to the study entry
* Uncontrolled major psychiatric disorders, such as major depression or psychosis
* Metastatic breast or other cancer
Management of TA in VaS-Patients and HT

Stroke is an independent risk factor for venous thrombosis (VTE), which leads to a significant increase in the mortality and disability rate after stroke. For patients with high risk factors for VTE such as advanced age, paralysis, infection, dehydration, etc., the incidence of death and disability is higher. Studies have shown that the incidence of deep vein thrombosis in bedridden ischemic stroke patients is about 20%, and the incidence of pulmonary embolism is about 2%, and causes 10% of post-stroke deaths. In order to prevent the occurrence of VTE, the American Heart Association, the American Stroke Association, the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association, etc. pointed out in the guidelines that heparin or low molecular weight heparin should be used for stroke patients with "restricted mobility" or "incapable mobility" to prevent VTE. For patients with evidence of thrombosis or symptoms of DVT, antithrombotic therapy should be initiated immediately. Paradoxically, ischemic stroke significantly increases the risk of cerebral hemorrhage. Besides There is an increased risk of primary intracerebral hemorrhage (ICH) associated with aspirin or antiplatelet agent monotherapy and it is difficult to achieve a balance between preventing blood clots and reducing the risk of bleeding complications. In addition, stroke patients are elderly and have speech and intellectual impairment, and the non-specific symptoms and signs of intracranial hemorrhage caused by improper antithrombotic therapy make the rate of misdiagnosis and missed diagnosis extremely high. Therefore, clarifying the clinical characteristics of stroke patients with VTE and launching targeted interventions to effectively balance the risk of anti-thrombosis and bleeding have become the key to improving the prognosis of patients.

This study is based on real-world data to study the bleeding risk and antithrombotic treatment options in VaS (1) the risk factors associated with hemorrhage in patients with VTE after stroke; and (2) the characteristics and pharmacotherapeutics regimen of high-risk populations with VTE after stroke; and(3) the Optimal antithrombotic treatment regimen for patients with VTE after stroke, including the timing of starting and stopping the antithrombotic treatment, selection of varieties, dosage, and course of treatment, etc.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with VTE after stroke
* Use at least one antithrombotic drug

Exclusion Criteria:

* Case information is incomplete
* Non-spontaneous cerebral hemorrhage
* Suffer from serious blood system disease
* Do not accept follow-up
Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)

Different trials have shown that fractional flow reserve (FFR) could successfully guide revascularization in patients undergoing percutaneous coronary intervention (PCI).

It is conceivable that a similar revascularization guidance could be useful also for surgical revascularization i.e. coronary by-pass graft (CABG). Experience learns that grafts placed on vessels with hemodynamically non-significant stenosis often occlude due to competitive antegrade flow.

Resting full-cycle Flow Ratio (RFR) is a measurement performed to evaluate the hemodynamic severity of coronary stenosis. Differently from FFR which is a measurement performed in maximal hyperemia, the RFR is a measurement that is performed in rest and therefore may predict better than FFR the baseline equilibriums that could lead to graft failure, while it has similar capacity to identify hemodynamically significant stenosis as FFR. It is unknown whether RFR guided CABG revascularization is superior as compared to angiography alone.


Eligibility Criteria:
Inclusion Criteria:

* All patients between 18 or older undergoing CABG
* Patients willing and capable to provide written informed consent

Exclusion Criteria:

* Previous CABG
* Concomitant severe valvular disease intervention
* Remaining (expected) coronary stenosis of \> 50% diameter stenosis distally to graft anastomosis
* Left ventricular ejection fraction \<30%
* Known transmural myocardial infarction
* Documented microvascular disease
* RFR/FFR measurement judged impossible
* Life expectancy \<2 years
* Participation in other investigational clinical trials
The Effects of Optimizing Post-operative Pain Management With Multi Modal Analgesia on Immune Suppression and Oncologic Outcome in Patients Undergoing Laparoscopic Colorectal Surgery

Traditionally, pain control methods based on narcotic analgesics have been used to control severe pain after surgery, but this has resulted in side effects such as vomiting, constipation, dizziness, mental confusion due to drugs, and respiratory depression. This slowed the recovery of the patient after surgery and increased the duration of hospitalization, which had a negative impact on the patient 's prognosis. In addition, research has been conducted on the use of various painkillers in a variety of ways over the past decade to reduce the dose of narcotic analgesics and to increase the effectiveness of pain control, since studies of anesthetics and narcotic analgesics have shown immunosuppressive effects.

This study investigate the effect of multimodal analgesics for postoperative pain control on immune function amd prognosis in patients undergoing laparoscopic colorectal cancer resection.


Eligibility Criteria:
Inclusion Criteria:

1. elective laparoscopic colorectal resection due to colorectal cancer
2. curative, resectable operation
3. ASA classification Ⅰ-Ⅲ

Exclusion Criteria:

1. elective co-operation due to distance metastasis
2. preoperative chemo/radiation therapy
3. drug allergy to opioid, tramadol, local anesthetics
4. MAOi medication (within 14 days of surgery)
5. decreased hepatic/renal function
6. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner
7. pregnant, lactating women
8. palliative surgery
Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury

To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.

Subjects presenting with a wrist injury, tibial fracture, or hip injury that require protocol defined standard imaging will have an X-Ray, CT Scan (or MRI per site preference) and TOMO completed. Images will be assessed to determine if TOMO is appropriate to supplement or replace the need for the other standard images.

Eligibility Criteria:
Inclusion Criteria:

* Physician request to have diagnostic imaging for condition areas

Exclusion Criteria:

* Under 18
* Pregnancy
* Insufficient Anatomical Coverage or Potential Image Problems
Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

This trial is conducted in South America. This aim of this trial is to evaluate the comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Treatment with insulin NPH
* Body Mass Index (BMI) below 30 kg/m2

Exclusion Criteria:

* Total daily insulin dose greater than 1.40 IU/kg
* Treatment with oral antidiabetic drugs (OADs)
Effectiveness of Exercise Cardiac Rehabilitation

The objective of this multidisciplinary study is to employ health-economic evaluation in determining the health benefits achieved with exercise-based cardiac rehabilitation and the costs derived from it compared with conventional post-acute care of cardiac patients in the Finnish health care system.

The cost-effectiveness of exercise-based cardiac rehabilitation has not been systematically studied earlier in Finland, and it is not justifiable to directly apply the results of studies done in other countries to circumstances in Finland due to differences in the health care and social security systems between the countries. The research will utilize top Finnish expertise spanning clinical cardiology, health economics, and physical education. The hypothesis is that a quality-adjusted life year of a cardiac patient (cost/QALY) is 20 % less costly in a rehabilitation group than in a conventional post-acute care group.

The participants in the study will be recruited from Oulu University Hospital patients from the Oulu region (n = 300) who have suffered acute coronary syndrome (angiographically diagnosed coronary artery disease). Of these patients, 130 will be randomized to exercise-based cardiac rehabilitation (Verve) and 170 to a control group. Dropping out of the intervention will be mini-mized by means of careful definition of the inclusion criteria and close follow-up. The rehabilitation will seek to implement the most recent international recommendations for health-enhancing physical activity (% of those who achieved the exercise target). Instructions for a progressive training model will be compiled. The amount of exercise will be monitored objectively with a wrist-worn device based on wellness technology. Subjective loading of both the training and health-enhancing physical activity will be monitored using self-evaluation. The study will last one year for each patient, after which cost-effectiveness will be analyzed (University of Eastern Finland). The results of the research will facilitate decision making and choices in Finnish health care when arranging rehabilitation for cardiac patients and planning the optimal utilization of health care resources.

Eligibility Criteria:
Inclusion Criteria:

* The patients undergo coronary angiography and are diagnosed with coronary artery disease.

Exclusion Criteria:

* New York Heart Association (NYHA) class IV
* heart failure
* unstable chest pain (angina pectoris) at the time of randomization
* severe peripheral atherosclerosis (intermittent claudication)
* severe retinopathy or neuropathy related to diabetes.
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.

This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* recipient of a first orthotopic liver transplant.

Exclusion Criteria:

* history of organ transplants;
* patient receiving a multi-organ transplant;
* calculated creatinine clearance \<=30mL/min before transplant;
* leukocyte count \< 2000/mm3 at randomization;
* history of cancer within past 5 years, except for successfully treated basal cell or squamous cell cancer, or in situ cervical cancer;
* pregnant or breast-feeding females, or females of childbearing age not using effective contraception.
Lumbar ESPB in Hip Replacement Surgery

In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed.

This is a prospective trial in patients undergoing elective hip replacement surgery.

Written informed consent will be obtained from each patient, and our study will be conducted following the tenets of the Declaration of Helsinki for medical research involving human subjects.

Before the surgery, preoperative pain severity, chronic pain severity, and ability to sit, stand, and walk will be assessed.

Each participant will be anesthetized with spinal technique and randomly allocated patients according to postoperative analgesia to the continuous epidural (Epidural) group and the continuous lumbar erector spinae plane block (ESPB) group. Both regional techniques will be continued during the first day. Investigators will measure postoperative oxycodone consumption with a patient-controlled analgesia (PCA) pump. At several points, the patients' pain at rest and during activity will be evaluated on the visual analog scale (VAS, 0-10), their quadriceps femoris muscle strength on the Lovett scale (0-5), and their ability to sit, stand upright, and walk on the Timed Up and Go test. Moreover, the patient's recovery will be assessed through the Quality of Recovery 40 (QoR-40) questionnaire on the first postoperative day.

After the patient's discharge, information regarding acute and chronic pain severity and quality of recovery will be collected during the phone interview.

Eligibility Criteria:
Inclusion Criteria:

* primary hip replacement surgery due to coxarthrosis
* anesthetized with spinal technique
* able to use PCA pump
* having access to phone

Exclusion Criteria:

* patients taking painkillers not related to coxarthrosis;
* having active cancer,
* dementia or challenging contact with the patient;
* suffering from depression or other psychiatric disorders that required antidepressant treatment;
* consuming alcohol or recreational drug addiction;
* contraindications to the regional block.
Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome

Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a major source of morbidity and mortality in this population. It can lead to sleep apnea, cor pulmonale, diabetes mellitus, and atherosclerosis. PWS has distinct characteristics that set it apart from other forms of obesity including insatiable appetite and food-seeking behavior which can be disruptive to home and school activities, and can cause severe social and psychological turmoil within families. PWS is also associated with unique hormonal abnormalities, most notably hyperghrelinemia. Ghrelin is a gut hormone produced in the stomach that stimulates food intake during a fast. It is hypothesized that the extremely high ghrelin levels in patients with PWS may cause or contribute to their insatiable appetite. Exenatide, a medication used in the treatment of type 2 diabetes mellitus in adults, appears to suppress ghrelin levels and cause weight loss. It was designed to mimic glucagon-like peptide 1 (GLP-1), an incretin hormone that stimulates insulin secretion and delays gastric emptying, among other effects. In the present study, the investigators will investigate the effects of a 6 month trial of exenatide in overweight adolescents with PWS. The investigators will quantify the changes in weight and body composition, as well as subjective measures of appetite, and concentrations of appetite-associated hormones. The investigators hypothesize that exenatide will improve weight, body composition, appetite, and plasma ghrelin levels during the treatment period.

BACKGROUND:

Prader-Willi syndrome (PWS) is associated with hyperphagia and hyperghrelinemia with major morbidity because of obesity without effective medical treatment targeting hyperphagia. Exenatide (Byetta \[synthetic Exendin-4\]; AstraZeneca, Wilmington DE) is a GLP-1 receptor agonist which reduces appetite and weight and may be an effective treatment in PWS.

OBJECTIVE: The objective of this study is to determine the effect of a 6-month trial of exenatide on appetite, weight and gut hormones in youth with PWS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Prader Willi Syndrome confirmed by genetic testing (DNA methylation or FISH)
* Ages 13-20 years
* body mass index (BMI) \> 85th percentile for age and gender

Exclusion Criteria:

* Is currently using or has previously used a glucagon-like peptide-1 (GLP-1) agonist
* History of pancreatitis, or renal failure
* History of familial pancreatitis
* Amylase, or lipase levels \> 2.5 times the upper limit of normal any time in the previous 2 years
* Creatinine clearance \< 30 mL/min
* Other syndromic diagnoses
* gastrointestinal (GI) or renal illness in the 1 month prior to entering study
* Inability to take study drug
* Pregnancy
* Initiation of growth hormone (GH), estrogen, or testosterone or change \> 25% of dose/kg/day during the 6 months prior to starting study
* Non-English speaking