cyrilzakka/clinical-trials huggingface dataset:
Granulocyte-Colony Stimulating Factor (G-CSF) as Optimizing Therapy for Pediatric Liver Transplantation

This study compares the effect of human recombinant Granulocyte-Colony Stimulating Factor (G-CSF) in pediatric patients with liver cirrhosis with a control group. The study aims to observe improvement of (Pediatric End-stage Liver Disease) PELD score and nutritional status prior to liver transplantation procedure. In addition to the intervention, standard treatments for liver cirrhosis are also given for both groups. G-CSF is administered for 12 times.

Condition of disease:

Pediatric patient aged 3 months to 12 years old Liver cirrhosis Undernourished / Severe malnutrition PELD score 10-25

Intervention:

Drug: Recombinant Human G-CSF

Phase:

Phase 3

This open-label randomized control trial conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, aimed to determine the effect of G-CSF to improve PELD score and nutritional status of pediatric patients with liver cirrhosis prior to liver transplantation. A total of 52 pediatric patients with liver cirrhosis, malnutrition and PELD score between 10-25 will be collected and divided into intervention group and control group. The intervention group will be given a subcutaneous injection of G-CSF 5μg/kg/day for 5 days consecutively, followed by a single dose every 3 days up to 12 times throughout the trial. Additionally, both the intervention and control group receive standard liver cirrhosis treatment. Randomization is done using block randomization.

The patients will be clinically monitored and evaluated for anthropometric changes (body weight, mid-arm circumference, mid-arm muscle circumference, and triceps skinfold thickness), complete blood count, absolute neutrophil count, liver function tests, cytokines (IL-10, TNF-α), Procalcitonin, hepatocyte growth factor (HGF), CD34+ cell count and PELD score (albumin, bilirubin, prothrombin and international normalized ratio values).

Data analysis will be performed using IBM SPSS Statistics version 20.0.0.

Eligibility Criteria:
Inclusion Criteria:

* Age between 3 months to 12 years old
* Conscious state
* Without the presence of fever (temperature: \<37,5°C)
* Decompensated liver cirrhosis
* Liver cirrhosis due to various etiology
* Undernourished or severe malnutrition
* PELD score between 10-25

Exclusion Criteria:

* Malignancy (liver origin or other types)
* History of undergoing any organ transplantation procedure
* Acute liver failure
* Failure of any organ other than the liver
* Encephalopathy
* Severe infection such as bacterial peritonitis and pneumonia
Electromyography and Acceleromyography in Ventilated ICU Patients

In intensive care unit (ICU) patients who are mechanically ventilated for a longer period of time, there might be a difference in accuracy and performance of neuromuscular transmission monitoring \[as measured by the train-of-four (TOF)%\] due to a pre-existing TOF fade, correlated to some form of acquired muscle weakness. The investigators therefore propose to search for and compare the optimal monitoring techniques (acceleromyography vs. electromyography) and the optimal muscle monitoring site (peripheral-adductor pollicis vs. central-corrugator supercilii) in ICU patients who require prolonged mechanical ventilation.

The following neuromuscular transmission monitors will be used in the study: an electromyography-based monitor (TetraGraph, Senzime AB, Uppsala, Sweden) and two devices that are the newer generation of quantitative monitoring using three-dimensional acceleromyographic technology: Stimpod (Xavant Technology, Pretoria, South Africa) and TofScan (IDmed, Marseilles, France), both of which require minimal setup for use.

The stimulation pattern of both ulnar and facial nerves will be train-of-four (TOF) delivered every 1 minute, and the mean of three consecutive measurements will be calculated as the TOF% for that patient. Patients will be tested every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* 18 yr. old or older
* expected to require mechanical ventilation for more than 72 hrs

Exclusion Criteria:

* degenerative neurological disease
* receive drugs interfering with NMT (e.g., aminoglycosides or magnesium)
MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.

The purpose of this study is to evaluate the percutaneous transportation and pharmacokinetics of melatonincream 12,5% when used on 80% of the body area. A test battery consisting of blood, saliva, urine samples at 1,2,3,4,5,6,7,8,12,24 and 36 hours after cream application. Cognitive parameters are investigated using KSS, FTT and CRT tests at above mentioned time points.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes
* Age 18-65 years
* No shiftwork
* No intake of caffeine or alcohol one day before investigation, and under the experiment.
* Pittsburgh sleep quality index \<5
* Height 165-190 cm
* Weight 53-85 kg

Exclusion Criteria:

* Pregnancy
* Active skin-disease
* Use of hypnotic or sedative drugs.
* Known sleeping disorder
* Known allergy to contents of the cream.
Turkish Health Enhancement Lifestyle Profile-Screener Questionnaire

The aim of this study was to evaluate the validity, reliability, and cultural adaptation of the Turkish version of the Health Enhancement Lifestyle Profile Screener (T-HELP-Screener).

Internal consistency of the T-HELP-Screener was measured using Kuder-Richardson. Test-retest reliability was performed with 66 of the 150 participants using intraclass correlation coefficient (ICC). Construct validity of the T-HELP-Screener was analyzed with the Healthy Lifestyle Behavior Scale-II (HLBS-II).

Eligibility Criteria:
Inclusion Criteria:

age over 65 years, no communication problems, and a Mini-Mental State Examination score of 24 or above

Exclusion Criteria:

communication problem
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial

This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure.


Eligibility Criteria:
Inclusion Criteria:

* Heart Failure patients NYHA Class II or III
* Renal Impairment Left Ventricular Ejection Function \<40%
* GFR 30 to 75 mL/min/1.73m2
* Optimal stable medical therapy

Exclusion Criteria:

* Renal artery anatomy must be eligible for treatment as determined by Angiography, and
* History of prior renal artery intervention
* Single functioning kidney.
* Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
* Systolic BP \< 90 mmHG
Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks, the EMPOWER Study

This study evaluates the skin and surrounding soft tissue that is removed during an implant reconstruction after a mastectomy.

PRIMARY OBJECTIVE:

I. Characterize the nanomechanical properties of the skin and adjacent soft tissue removed at the time of postmastectomy implant reconstruction.

OUTLINE: This is an observational study.

Patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* \* Age 18 and older

  * Female sex
  * Patient with history of mastectomy with tissue expander placement
  * Tissue expander in place at time of study enrollment
  * Patient plans to undergo surgery to exchange tissue expander for permanent breast implant within the next 3 months of signing the informed consent
  * Ability to understand and provide written informed consent in accordance with institutional policies
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets

The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male with good health
* 20 to 45 years of age at screening
* Body weight ±20% of ideal body weight
* Willingness and ability to comply with study procedures and communicate with investigators
* Provided written consent voluntarily after informed of all the pertinent aspects of the trial

Exclusion Criteria:

* Clinically significant abnormality on medical interview, physical examination, electrocardiogram or clinical laboratory evaluations
* Clinically significant acute or chronic medical conditions
* Use of prescriptive medicine within 14 days, or over-the-counter drug within 7 days before the first day of drug administration
* Participation in clinical trial within 3 months before the first day of drug administration
* Alcohol abuse
* Habitual smoker
* Habitual user of herbal medicine
* Use of grapefruit-containing food or grapefruit juice during the study period
* Positive drug abuse test and Positive HBs-antigen, HCV-antibody, or HIV-antibody test
Highly Cross-linked Polyethylene in Total Knee Arthroplasty

The aim of this study was to determine clinical and radiographic results after posterior cruciate-substituting total knee arthroplasties with highly cross-linked polyethylene in one knee and compression mold conventional polyethylene in the contralateral knee in the same patients.


Eligibility Criteria:
Inclusion Criteria:

* Younger than 65 years old
* with end stage knee arthritis bad enough for knee replacement

Exclusion Criteria:

* inflammatory arthritis
* combined foot and ankle disorders.
* dementia
* patient older than 65 years old.
Anxiety Sensitivity Treatment for Heroin Users

Anxiety Sensitivity Treatment for Heroin Users is a development project targeting mild and above levels of anxiety sensitivity that will involve the testing of a specialized protocol for improving treatment retention and outcomes for heroin dependent individuals in a residential substance use treatment. ASTH-HR will integrate established treatment modules such as Healthy Relationships, along with interoceptive exposure, affect management, and psycho-education exercises developed for anxiety prevention and treatment programs with standard substance use treatment.


Eligibility Criteria:
Inclusion Criteria:

* exhibit a score of 21 on a self-report measure of anxiety sensitivity
* be in 28 days of residential substance use treatment.
* meet criteria for current opioid dependence as determined by SCID interview administered at intake.

Exclusion Criteria:

* evidence of limited mental competency
* the inability to give informed, voluntary, written consent to participate
* current psychosis
* current bipolar disorder.
Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)

The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant history.


Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic hepatitis C
* At least 18 years old
* Eligibility determined based on the diagnosis and medical judgment only.

Exclusion Criteria:

* None
Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing

This registry will evaluate treatment selection for patients with newly diagnosed, localized prostate cancer following Prolaris testing. It will measure the proportion of men who initially select treatment with active surveillance, the time frame between active surveillance selection and any change in treatment, and clinical outcomes.

To evaluate use of the Prolaris score in treatment management decisions in an ethnically and racially diverse population of men who have been newly diagnosed with prostate cancer and who are potential candidates for active surveillance. This registry will evaluate oncologic and co-morbidity outcomes in patients who receive Prolaris testing. Additionally, the registry will measure the prevalence and distribution of pathogenic mutations in hereditary cancer risk-associated genes among men with prostate cancer who meet National Cancer Center Network (NCCN) criteria for hereditary cancer genetic testing.

The primary objective of this registry is to evaluate initial selection of active surveillance (Active Surveillance selection) versus definitive therapy (DT) among men with newly diagnosed prostate cancer who make treatment decisions with Prolaris testing, and among patient subsets defined by race/ethnicity.

The secondary objectives of the registry are to evaluate progression of from Active Surveillance to definitive therapy over time and prostate cancer-associated morbidities that affect quality of life among men with newly diagnosed prostate cancer and who undergo Prolaris testing, and among patient subsets defined by racial/ethnic background and ancestry.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older on date of enrollment.
* Diagnosed within the past six months with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites.
* Received Prolaris testing and a resulting CCR score from the diagnostic biopsy sample as standard of care.
* Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).

Exclusion Criteria:

* Estimated life expectancy \< 10 years.
* Clinical evidence of metastasis or lymph node involvement.
* Received pelvic radiation prior to biopsy.
* Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha- reductase inhibitor (5-ARI) use is permitted.
* Plan to use PrCa-specific prognostic testing other than PSA for treatment decision making during Active Surveillance.
* Currently participating in an interventional clinical trial.
* Unable to provide routine clinical informed consent.
Timely Ordering of Pharmacogenetic Testing

The goal of this trial is to learn if a machine learning (ML) model can help optimize drug therapy in the pediatric population. The main question\[s\] it aims to answer are whether a machine learning model predicting receipt of a targeted medication within the next three months:

* Increases the offering of pharmacogenetic testing prior to receipt of a targeted medication
* Increases the number of patients with pharmacogenetic results prior to receipt of a targeted medication
* Increases the number of patients who have alteration in medication choice or dose based on pharmacogenetic results

This trial only focuses on the prediction and provision of participants with a high-risk of receiving a medication with a pharmacogenetic indication in the next three months.

This study aims to evaluate the effectiveness of a ML model in predicting patients at high risk of requiring a "targeted medication" within the next three months. A machine learning model will predict, the morning following admission to any inpatient service, whether there will be receipt of a targeted medication within the next three months. The research team will be notified regarding eligible patients each morning, and the research team or pharmacogenomics team will approach the patient's primary care team as applicable. By leveraging ML, this study seeks to enhance the identification of patients who would benefit from such medications in a timely and resource-efficient manner.

The study team identified specific medications as indications for pharmacogenetic testing based on prevalence and level of evidence for modifying prescribing practices. These pre-selected medications are referred to as "targeted medications" and are as follows: azathioprine, brivaracetam, clobazam, clopidogrel, flecainide, phenytoin, tacrolimus, voriconazole and warfarin. Only systemically administered (oral, subcutaneous, intramuscular or intravenous) medications or prescriptions (e.g. not topical, intrathecal or intravitreal) are included. Phenytoin was only considered if given orally (to exclude emergency administration without a plan for ongoing treatment).

Pharmacogenetic testing will be offered to participants and conducted as addressed in an associated pharmacogenetic testing protocol (REB# 1000053445 PI: Iris Cohn).

Eligibility Criteria:
Inclusion Criteria:

* Inpatient at The Hospital for Sick Children
* Between 6 months to 18 years old

Exclusion Criteria:

* Prior pharmacogenetic testing and/or prior receipt of a targeted medication
* Current Intensive Care Unit (ICU) admission
* Expected hospital discharge is prior to midnight on the day of admission
Neuroinflammation in Hypertension Study

To demonstrate that in patients with resistant hypertension oral treatment with minocycline via inhibition of central immune cell activation and inflammation results in reduced central sympathetic outflow and concomitant lowering of BP.

This is a randomized, double-blind, placebo controlled, parallel group design study aiming to compare the effects of minocycline 100mg twice daily vs matched placebo for 12 weeks on ambulatory BP and the parameters of sympathetic and immune activation

Eligibility Criteria:
Inclusion Criteria:

* Aged: 45 -65 years
* Signed informed consent
* Clinical diagnosis of Resistant Hypertension
* Daytime systolic ambulatory BP \>135mmHg.

Exclusion Criteria:• eGFR of \<45 mL/min/1.73m2

* History of myocardial infarction (MI) or any cardiovascular event within 3 months of screening period, clinically significant AV conduction disturbances and/or arrhythmias,
* current of past history of heart failure (LVEF ≤40%)
* psychotropic agents, antidepressants and NSAIDS
* alcohol consumption of \>3 standard drinks.
* known hypersensitivity or contraindication to minocycline or other tetracyclines.
Cigarette and E-cigarette Flavors Manipulations in the Experimental Tobacco Marketplace

This is a one-session study that participants complete remotely including consent, Experimental Tobacco Marketplace purchases, and assessments to examine the effects of cigarette and e-cigarette flavors on cigarette demand and substitution in the Experimental Tobacco Marketplace.

This study uses a mixed design (within-subject repeated measures and between-group). Participants will be assigned to two different groups according to their preferred cigarette flavor (tobacco/menthol). Every participant will complete behavioral tasks and make hypothetical purchases of tobacco products in an online store under four different scenarios: a) e-cigarette flavor restricted and cigarette flavor restricted, b) e-cigarette flavor unrestricted and cigarette flavor restricted, c) e-cigarette flavor restricted and cigarette flavor unrestricted, d) e-cigarette flavor unrestricted and cigarette flavor unrestricted.

Eligibility Criteria:
Inclusion Criteria:

* currently smoke at least 10 cigarettes per day
* have smoked at least 100 cigarettes (lifetime), and
* are 21 years of age or older.

Exclusion Criteria:

* inaccurate identification of usual brand of cigarette's as menthol or non-menthol
Angiotensin Receptor Blockers in Aortic Stenosis

This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.

Studies support the concept that activation of the renin-angiotensin system may be involved in the progression of valve stenosis and myocardial fibrosis in aortic stenosis. Furthermore recent studies have shown that renin-angiotensin system medication may slow down aortic stenosis progression rate and left ventricle remodeling.

Thus the present study is a randomized control trial to test the efficacy of the angiotensin receptor blocker (ARB) to slow down aortic stenosis progression and left ventricular remodeling/dysfunction in patients with mild-to-moderate aortic stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate aortic stenosis (peak aortic jet velocity ≥2.5 and \<4m/s)
* Normal left ventricular ejection fraction (i.e. ≥50%)
* Systolic blood pressure \>110 mmHg
* Diastolic blood pressure \>70 mmHg

Exclusion Criteria:

* More than mild aortic or mitral regurgitation, or mitral stenosis
* Current use or documented indication for renin-angiotensin system medication or Aliskiren
* Known allergy or intolerance to angiotensin II receptor blockers (ARBs)
* Alzheimer, dementia or known non-compliant patient
* Renal dysfunction (glomerular filtration rate \<30ml/min/1.73m2)
* Chronic hyperkalemia
* Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment
* Newly diagnosed (\<2 months) or poorly controlled diabetes
* Pre-existing obstructive coronary artery disease with CCS III-IV angina or recent myocardial infarction (\<3 months)
* Pregnant or lactating women
* Patients unable to read, understand or sign research consent
Barriers and Facilitators to MMR Vaccination Among Healthcare Workers

Measles is a highly contagious disease which can result in severe complications in some patients. Healthcare workers have a higher risk of getting measles than the general population because of their increased risk of exposure from patients with measles attending hospitals. Having had measles in the past or at least one dose of the measles, mumps and rubella (MMR) vaccine provides protection (immunity) against measles. UK government guidelines therefore recommend that healthcare workers and non-clinical staff with direct patient contact are fully vaccinated or have other evidence of immunity. Yet, evidence from recent measles outbreaks suggests that some healthcare workers are not immune or do not know if they are immune, with implications for containment efforts, cost and transmission. The purpose of this study is to identify barriers and facilitators to uptake of the MMR vaccine among healthcare workers at King's College Hospital NHS Foundation Trust (KCH). KCH healthcare workers will be eligible to take part in the study if they are aged 18 and over and have direct contact with patients. In addition, the research will focus on four subgroups of healthcare workers at KCH: those who are not immune, those who have not completed the full vaccination schedule, those who don't know their immunity status, those received the vaccine only after joining KCH. The latter may provide insights into facilitators to vaccine uptake. Measles immunity forms part of the occupational health screening at KCH. A series of semi structured interviews lasting approximately 1 hour will explore participants' experiences of the occupational health vaccine screening process and measles vaccine campaigns at KCH; why they are unvaccinated/not fully vaccinated/do not know if they are immune/decided to be vaccinated after joining KCH; and what measures or interventions may help healthcare workers when deciding whether to get the MMR vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Are aged 18 and over
* Currently work as a healthcare worker at KCH
* Have direct contact with patients
* Don't know if they have had measles and don't know if they have been vaccinated
* Or: Have not had measles and have not received the MMR vaccine
* Or: Have only received 1 dose of the MMR vaccine
* Or: Received the MMR vaccine after joining KCH

Exclusion Criteria:

* Are aged \<18 years old
* Work in a role at KCH that does not involve direct contact with patients (e.g., administrative or business staff)
* Have had measles in the past or both doses of the MMR vaccine before joining KCH
* Are not able to give informed consent