cyrilzakka/clinical-trials huggingface dataset:
Role of Low Dose Epinephrine Boluses In Acute Hypotension

The Study evaluates the role of low dose epinephrine boluses in management of acute hypo-tension VS The Traditional management of acute hypo-tension.

Half of the participants suffering from acute hypo-tension will receive low dose epinephrine boluses (≤ 5 µg/kg/dose) and the other half will receive traditional management of shock

Epinephrine, due to its alpha-1 and beta-adrenergic effects, is considered an important part of the management of children with hypo-tension. Epinephrine is typically used as a continuous infusion (0.02-0.5 μg/kg/min) for severe sustained hypo-tension and as a bolus (0.01 mg/kg, maximum dose = 1 mg) for bradycardia, asystole, or pulse-less arrest. There are, however, clinical conditions that may benefit from smaller doses of bolus epinephrine. For example, brief periods of hypo-tension during medical procedures, intermittent hemodynamic instability, and augmentation of low blood pressure in a pre-arrest condition. While a resuscitation (or code) dose of epinephrine would be inappropriate (as it would cause an unacceptable large increase in blood pressure and heart rate \[HR\]), a smaller dose may be particularly useful.

Low-dose bolus vasopressors have been used for decades by anaesthesiologists to prevent post-re-perfusion injury after solid organ transplant, control cerebral oxygenation during anaesthesia and manage acute hypo-tension during spinal surgery. Recently, use of bolus dose phenyl-ephrine has been described in the emergency department setting to augment blood pressure during periods of hypo-tension surrounding intubation. Finally, free open access medical publications have provided some insight into using bolus dose pressors for acute hypotensive episodes in adults. However, there is few published data describing the use of low-dose vasopressor boluses in children.

Eligibility Criteria:
Inclusion Criteria:

* Patients experiencing acute hypotensive episodes whether brief or during or after medical or surgical procedures

Exclusion Criteria:

* Patients experiencing acute hypotensive episodes in arrest or pre-arrest situations
Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)


Eligibility Criteria:
Inclusion Criteria:

* Patients will be outpatients who are aged 6 to 18 years old at the initial screening visit.
* Patients must have ADHD, based on the accepted criteria for that disease
* Patients must not have taken any medication used to treat ADHD for at least two weeks prior to beginning study treatment; and at least one week prior to the study screening visit during which initial ADHD assessments were made
* Patients must be able to swallow capsules
* Patients and parents (or legal guardians) must be judged by the study investigator to be reliable to keep appointments for clinic visits and all tests, including blood tests and any other required examinations

Exclusion Criteria:

* Patients must not have received any treatment within the last 30 days with a drug that has not been approved by their country's appropriate government agency
* Patients will not be included in the study if they have previously experienced any unwanted effects or serious medical events during atomoxetine treatment
* Patients will not be included in the study if they are judged by the study investigator to be at serious suicidal risk
* Patients will not be included in the study if they have cardiovascular disease or other conditions that could be worsened by an increased heart rate or increased blood pressure
Coronavirus Disease (COvid-)19 REgistry on THROMBOSIS Complications

This online-based, observational retrospective registry aims to (i) study the rate of cardiovascular events, encompassing venous thromboembolic and arterial events, in consecutive hospitalized patients with coronavirus (Covid19), (ii) investigate the prevalent use of thromboprophylaxis, (iii) describe the use of imaging tests for the detection of cardiovascular events in patients with Covid19. This will also facilitate and constitute the basis for the conduction of interventional thromboprophylaxis studies in patients with Covid19.


Eligibility Criteria:
Inclusion Criteria:

Hospitalized patients aged ≥ 18 years with a positive test for severe acute respiratory syndrome corona virus 2 (SARS-CoV2)

Exclusion Criteria:

None
Venous Thromboembolism in Advanced Lung Cancer

This is a prospective observatory clinical study, aiming to establish and validate venous thromboembolism risk model in Chinese advanced non-small cell lung cancer.

VTE has high incidence in lung cancer and increases the mortality. Appropriate preventive measures contribute to 50% increase of incidence. The investigators are to investigate the VTE in advanced non-small cell lung cancer and delineate the risk factors to establish a VTE risk model system helping clinicians to differentiate VTE high risk population and apply early prevention in order to reduce the incidence of VTE.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the time of screening.
* Eastern Cooperative Oncology Group performance status of ≤ 2.
* Written informed consent obtained from the patient.
* Histologically and cytologically documented Stage 3B-4 lung cancer (according to Version 8 of the International Association for the Study of Lung Cancer Staging system).
* Patients with stage 1 to 3, who undergo radical therapy with disease free survival (DFS) \>12 months.
* Willingness and ability to comply with scheduled visits and other study procedures.

Exclusion Criteria:

* History of another primary malignancy except for malignancy treated with curative intent with known active disease ≥ 5 years before date of the informed consent.
* Without signed informed consent.
* Unwillingness or inability to comply with scheduled visits or other study procedures.
* Previously diagnosed with VTE before signing informed consent.
Acupuncture Versus Titrated Morphine in Patients With Renal Colic

The aim of this study is to compare the clinical efficacy and safety profiles of a 30 minutes acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score \>/= 70) taking for example acute renal colic.

acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score \>/= 70) taking for example acute renal colic.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* Presenting with acute non complicated renal colic
* Baseline VAS score \>/= 70

Exclusion Criteria:

* complicated renal colic
* VAS score \< 70
* Pain of traumatic origin
* Coagulation abnormalities
* Skin affections impairing the use of pre-specified insertion points
* Enable to use the VAS
* Patients who received analgesics less than 6 hours prior to enrollment
* Patients refusing or enable to give written informed consent
* Pregnant women
Investigation of Myocardial Protection Level With Specific Cardioplegia Methods in Cardiac Surgery

Investigating the myocardial effects of cold blood cardioplegia and del nido cardioplegia solution, which are routinely used in clinical practice, will contribute to the studies in the literature on the safety and efficacy of these two methods.

For this purpose, patients with coronary artery disease that going to be Coronary Artery Bypass Graft (CABG) surgery will be classified within the scope of the SYNTAX score, the level of exposure to cardioplegia change in proportion to their score will be examined. Also, left ventricular muscle mass will be calculated in patients who will undergo Aortic Valve replacement (AVR) due to Aortic Stenosis, and myocardial protection level proportional to muscle mass will be examined, and cardioplegia efficiency will be compared.

Endocan, E-Selectin, TNF(Tumor Necrosis Factor)-alpha, Total Oxidant and Antioxidant status will be studied on sequential blood samples taken from patients who will undergo Elective Coronary Artery Bypass Grafting operation and aortic valve replacement, via retrograde cardioplegia cannula before induction, at the beginning of cardiopulmonary bypass and after removing the cross-clamp. With routinely used parameters like hemogram, lactate, liver and kidney function tests morbidity-mortality rates for specific cardioplegia technique will be compared

Eligibility Criteria:
Inclusion Criteria:

* Subjects planned to have elective coronary artery bypass grafting for coronary artery disease
* Subjects planned to have elective aortic valve surgery due to aortic valve stenosis
* Patients aged 18-75 years
* BMI of 18.5-30
* Diabetic and non-diabetic patients
* Smokers and non-smokers

Exclusion Criteria:

* Subjects under 18 years old
* Subjects older than 75 years
* Patients requiring valve surgery with coronary artery bypass
* Patients requiring aortic valve surgery with pathologies other than aortic valve stenosis
* Patients requiring mitral or tricuspid valve surgery
* Patients undergoing emergency coronary bypass
* BMI \> 30 obese patients
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was used for the evidence of the dose adjustment for the patients with renal impairment, and observed plasma gabapentin concentration.

Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.

Eligibility Criteria:
Inclusion Criteria:

* Japanese epilepsy patients with renal impairment

Exclusion Criteria:

* NA
Implementation of Ischemic Heart Disease Clinical Practice Guidelines

The purpose of this study is to design and evaluate targeted implementation strategies to fully integrate the VHA clinical practice guidelines for ischemic heart disease into VHA clinical practice. Effectively implementing the guideline will enhance the quality, appropriateness, timeliness, and cost effectiveness of care delivered to veterans with ischemic heart disease.

Background:

The purpose of this study is to design and evaluate targeted implementation strategies to fully integrate the VHA clinical practice guidelines for ischemic heart disease into VHA clinical practice. Effectively implementing the guideline will enhance the quality, appropriateness, timeliness, and cost effectiveness of care delivered to veterans with ischemic heart disease.

Objectives:

The long-term objective of this study is to identify the best strategies for implementing the IHD guidelines to improve guideline adherence and provider acceptance. The specific objectives of the study are to: 1) describe the temporal aspects of guideline acceptance and adherence over three periods of time: pre-implementation, post-implementation of general strategies, and post- implementation of targeted strategies; 2) assess the relative effectiveness of targeted intervention strategies on guideline adherence; 3) identify the relationships among provider beliefs, attitudes, and their intentions to use guidelines; 4) identify the costs associated with implementation of general and targeted implementation strategies; and 5) describe provider satisfaction with targeted implementation strategies.

Methods:

Qualitative (focus groups, interviews with key informants) and quantitative methods (surveys, chart reviews) are used to address study objectives. A survey will be sent to providers to measure beliefs and attitudes that predict provider acceptance to clinical practice guidelines. Patient level data will be collected from reviews of charts from each facility. Based on provider focus groups we will design targeted strategies to overcome system barriers and address needs identified by providers to support clinical practice guideline implementation. A randomized trial will be conducted to assess the relative effectiveness of the targeted intervention strategies.

Status:

Data collection has ended. We are currently evaluating adherence data at all sites following introduction of case management to determine if the intervention increases adherence to the guidelines.

Eligibility Criteria:
Inclusion Criteria:

None

Exclusion Criteria:
STereotactic sAlvage Radiotherapy for Macroscopic Prostate Bed Recurrence After prostatectomy-a Prospective Observational Study

STereotactic sAlvage Radiotherapy for macroscopic prostate bed Recurrence after prostatectomy (STARR trial) is a prospective observational study aimed to assess outcome after Stereotactic salvage radiotherapy (SSRT) for macroscopic prostate bed recurrence after radical prostatectomy.

This is a prospective observational multicenter study including patients affected by patients with macroscopic recurrence within prostate bed after RP detected with Choline or PSMA CT-PET and confirmed with pelvic MRI (except for cases in which MRI is contraindicated). Patients will be treated with SSRT on macroscopic prostate bed recurrence for a total dose of from 35 in 5 fractions. Planned size of the overall study population is 90 patients. The study will include a screening phase and a treatment phase. The screening phase allows for assessment of subject eligibility, demographics, PSA, comorbidities and current drug therapies up to 45 days prior to randomization.

The treatment phase consists of SSRT administered on prostate bed macroscopic recurrence. Different techniques will be allowed provided that treatment respects doses and fractionation indicated per-protocol (35 Gy in 5 fractions) and that dose constraints to organs at risk (OAR) reported in this document are observed. The total planned duration of the study is 40 months, consisting in 16 months enrollment period, during which patients will perform the screening and and later phase of 24 months in which patients will continue to be submitted to periodic checks every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by biochemical recurrence after radical prostatectomy for prostate cancer (defined as a PSA increase \> 0.2 ng/ml)
* Presence of macroscopic recurrence in prostate bed, determined with either Choline or PSMA PET imaging and confirmed through MRI (except for cases in which MRI is contraindicated)
* Absence of distant and/or regional sites of disease outside prostate bed
* Patients free from Androgen deprivation therapy (ADT) (Adjuvant ADT after radical prostatectomy for pN+ patients is allowed if \> 12 months from biochemical recurrence)

Exclusion Criteria:

* Presence of distant and/or regional sites of disease outside prostate bed
* Patient undergoing ADT or withdrawal of adjuvant ADT within12 months from biochemical recurrence
* Absence of disease detection from one of the two imaging modalities used (Choline or PSMA Pet and MRI must be positive- except for cases in which MRI is contraindicated)
* Any condition for which, in the opinion of the treating physician, SSRT would be contraindicated for the patient (i.e peristence of moderate/severe urinary distress after prostatectomy, post-surgical complications etc)
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)

This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.

This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency. Total of 540 subjects aged 10-40 years old will be involved in this study. The subject will be divided into 4 groups, 3 groups are the investigational group and 1 group are the active comparator group. Each group consist of 135 subjects.

The objective of the study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization, to assess the safety of In-House Recombinant Hepatitis B vaccine, to evaluate immunogenicity and safety in three consecutive batches of In-House Recombinant Hepatitis B vaccine and also evaluate immunogenicity and safety after primary series of investigational product compare to control.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individu as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator.
* Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/informed assent form.
* Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

* Subject concomitantly enrolled or scheduled to be enrolled in another trial.
* Subjects with known history of Hepatitis B contained vaccination in the last 10 years.
* Evolving severe illness and/or chronic disease and fever (axillary temperature ≥ 37.5°C) within the 48 hours preceding enrollment.
* Known history of allergy to any component of the vaccines (based on anamnesis).
* HBsAg positive.
* Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
* History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
* Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant.
* Pregnancy \& Lactation (Adult).
* Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
Impact of Diet and/or Exercise-induced Weight Loss on Cardiovascular Risk Factors

The purpose of this pilot study is to examine the effect of diet and/or exercise-induced weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin levels and sex steroids in obese postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* obese postmenopausal women
* able to exercise
* non-smokers

Exclusion Criteria:

* cardiovascular disease
* medications that would interfere with outcome measures (e.g., including ACE inhibitors, lipid lowering medications, beta-blockers, etc)
* known diabetes
Assessment of the Safety and Pharmacokinetics of Single and Multiple Oral Doses of AZD4316 in Healthy Subjects

The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD4316 following oral administration of single and multiple doses to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
* Female subjects must not be pregnant, must not be lactating and must be of non-child-bearing potential (i.e. they must be post-menopausal or surgically sterile)
* Male subjects should be willing to use barrier contraception i.e. condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
* Subjects who are healthy as determined by pre study medical history, physical examination, 12-Lead ECG

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG, including changes that may interfere with the interpretation of QTcF interval changes.
* Current smokers, those who have smoked or used nicotine products within the previous three months.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4316.
* Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
Cytokine Removal in Cardiopulmonary Bypass Patients

Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in systemic inflammation and the main producers of pro- and antiinflammatory cytokines. Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6 and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory response induces post surgical monocyte immunosuppression which is indicated by an impaired production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral circulation with increased lactate levels, pronounced fluid accumulation, increased need of vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to decrease the inflammatory process have the potential to improve the perioperative course.

Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels for the first 36 hours after surgery and induces a decreased inflammatory response for up to 3 days post surgery.

Patients, who have an elective cardiac surgical intervention with an expected CBP duration \>120 minutes (e.g.: valve surgery, coronary artery bypass graft (CABG), combined procedures) will be enrolled to the study after given informed consent.

Patients, who decline will be asked to collect their secondary outcome data to create a "real - life" group and increase the number of patients in the control group. In this "real - life" group no additional blood samples will be taken.

Eligibility Criteria:
Inclusion Criteria:

* elective cardiac surgical intervention with an expected CBP duration \>120 minutes

Exclusion Criteria:

* Emergency procedures
* Heart transplantation
* Elective left ventricular assist device (LVAD) implantation
* Pulmonary thromendarterectomy
* Declined informed consent
* Serum creatinine \> 2mg/dl
* Body mass index \< 18
* Age \< 18 years
* Pregnant woman
* Receiving chemotherapy or diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
* Receiving antileukocyte drugs
* Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)
* CRP \> 2mg/dl
* History of Stroke
* Bilirubin \>2mg/dl