cyrilzakka/clinical-trials huggingface dataset:
The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants

Despite the fact that oral sucrose is the most frequently studied non-pharmacological intervention for procedural pain relief in infants, there is a paucity of data on the minimal effective dose. The aim of this study is to find the minimal effective dose of sucrose to reduce pain during a single venous blood sampling procedure.


Eligibility Criteria:
Inclusion Criteria:

* born preterm
* more than 1000 gram

Exclusion Criteria:

* severe intraventricular hemorrhage
* cerebral malformations
* other malformations requiring surgery
* medication that may impair pain expression (opioids, paracetamol, sedatives)
Effects of Erector Spinae Plane Block Method Used in Pain Management in Heart Surgery on Vascular Diameters

Off-pump coronary artery bypass grafting (OPCABG) is a bypass method performed on the working heart. Pain is a frequently seen side effect experienced following this surgery. Erector spinae plane block is our analgesia method that the investigators routinely perform prior to the surgery to overcome this problem. In this method, analgesic medication is given via a needle in between the two superficial muscle groups (erector spinae muscles) located in participants back. The investigators believe this method not only provides pain relief, but also is beneficial (dilating) on the vessels that will be used for bypassing the clogged vessels during the surgery. The investigators aimed to measure some parameters in this routine procedure before and after performing the analgesic method with an ultrasound (imaging with sound waves).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are aged between 18-75,
* ASA III
* Patients who are undergoing off pump coronary artery bypass grafting surgery

Exclusion Criteria:

* Patients who are allergic to planned-medications,
* those with previous cardiac surgery,
* patients undergoing emergency surgery,
* uncontrolled diabetes mellitus,
* chronic opioid or opioid receptor agonist users,
* those with pre-operative neuropathies, psychiatric diseases,
* non-communicable patients and
* those who refuse to participate
Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES4)

This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Anterior circulation large vessel occlusion who received endovascular treatment within 24 hours of stroke onset;
* National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
* Successful recanalization (mTICI 2b-3) after endovascular treatment;
* Cerebral circulation time based on DSA of the stroke side was slower than that of the healthy side after successful recanalization;
* ASPECTS ≥ 6 on CT or DWI;
* Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
* Modified Rankin Scale score before stroke onset ≤ 1;
* Signed informed consent by patient or their legally authorized representative.

Exclusion Criteria:

* Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
* Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
* After recanalization, severe and sustained (i.e., \> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
* More than four retrieval attempts in the same vessel;
* Cardiac insufficiency (NYHA Class ≥II);
* Pregnancy, plan to get pregnant or during lactation;
* The estimated life expectancy is less than 6 months due to other serious diseases;
* Other conditions unsuitable for this clinical study assessed by researcher.
Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal

This study aims to assess whether in patients with acute kidney injury (AKI) requiring mechanical ventilation, a strategy that combines renal replacement therapy (RRT) and extracorporeal carbon dioxide removal (ECCO2R) allows reduction of tidal volume and plateau pressure. Systemic Inflammatory Response and Safety Variables will also be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute kidney injury (AKI) requiring renal-replacement therapy and mechanical ventilation of duration ≥ 48 hours

Exclusion Criteria:

* little chance of survival at 24 h (according to clinical judgment), pregnancy, mechanical ventilation with expected duration lower than 48h, age under 18 and over 90
Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies.


Eligibility Criteria:
Inclusion Criteria:

* All patients are selected from the Cardiology Department of Beijing Luhe Hospital and have undergone direct PCI treatment for STEMI.
* STEMI patients must meet the following criteria:

  1. Chest pain duration ≥ 30 minutes, with ST-segment elevation ≥ 0.1 mV in adjacent two leads on the electrocardiogram.
  2. Onset within 24 hours.
  3. Aged between 18 and 80 years.
  4. Signed informed consent form.

Exclusion Criteria:

* Hemodynamically unstable or Killip grade ≥ 2.
* Severe renal insufficiency: Glomerular filtration rate \< 30 ml/min/1.73m\^2.
* Active liver disease or liver dysfunction: AST or ALT levels \> 3 times the upper limit of normal.
* Known allergy to any drug used in the study.
* Previous or planned use of PCSK9 inhibitors.
* Suspected stress cardiomyopathy or acute pericarditis.
* Malignant tumors requiring treatment or other severe systemic diseases.
* Pregnancy or breastfeeding
Idiopathic Pulmonary Fibrosis--Pathogenesis and Staging - SCOR in Occupational and Immunological Lung Diseases

To conduct cross-sectional and longitudinal studies of patients with idiopathic pulmonary fibrosis (IPF) and patients with progressive systemic sclerosis (PSS), with and without associated lung disease.

BACKGROUND:

Idiopathic pulmonary fibrosis (IPF) is a disease of unknown etiology characterized pathologically by a chronic inflammatory process (alveolitis) that precedes and likely controls the alterations in connective tissue matrix that eventually destroys the normal lung architecture. The mechanisms involved in this process are not known. A complex cell-cell interactive sequence, involving principally neutrophils, lymphocytes, macrophages, fibroblast, and epithelial cells is believed to be responsible.

The SCOR in Occupational and Immunological Lung Diseases was first awarded in December, 1981. The subproject on idiopathic pulmonary fibrosis was first awarded in December, 1986.

DESIGN NARRATIVE:

The cross-sectional comparison examined bronchoalveolar lavage, high resolution, thin-section computer tomography (HRCT), neutrophil or monocyte labeled scintigraphy). The serial, longitudinal evaluation monitored the progression of disease. The study of PSS patients, without disease or with subclinical disease, was particularly useful because it allowed examination of the early events in the pathogenesis of IPF. The long-term goal of the project was to determine what alterations in cellular composition, function and trafficking occurred in the lung parenchyma of patients with IPF and to relate these alterations to the disease stage, prognosis, and therapeutic responsiveness.

The major objectives of the study were: (1) to continue the prospective, longitudinal study of carefully defined cases of IPF; (2) to initiate a study of patients with PSS, a disease that provided a useful paradigm for studying the early events of the disease; (3) to determine the role of the lymphocyte in IPF, by defining the subset of T lymphocytes responsible for modulating macrophage function; (4) to establish the role of non-invasive techniques (bronchoalveolar lavage (BAL), HRCT scanning and scintigraphy -- neutrophil and monocyte labelled cells) in assessing the activity of inflammation in carefully evaluated patients; (5) to determine the relationship of these results to the -- carefully defined and serially obtained -- clinical, radiographical, and physiological findings and to the histopathologic abnormalities (in patients that underwent lung biopsy, predominantly IPF cases). (6) to perform studies utilizing blood, BAL fluid and lung tissue in an effort to understand the pathogenic mechanisms that underlied the inflammatory/immune cellular injury and fibrosis that characterize this disease.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility Criteria:
No eligibility criteria
A Random Selection of Patients From the SENTRY Study Who Have a Bioconverted Sentry IVC Filter in Situ With a Minimum Dwell Time of 24 Months From a Single Center Follow up

IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up

IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Signed the informed consent document
* Participants from the SENTRY clinical trial willing to undergo one time IVUS evaluation ( outpatient )

Exclusion Criteria:

* Any filter that remained non converted.
HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.

Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients.

Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in the treatment of patients with low or selected intermediate risk, organ confined prostate cancer.

There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with several fractionation schedule treating the same group of patients. One phase II trial showed its effectiveness given in one fraction of 19 Gy.

In the trial investigators randomly select patients to treat with either LDR prostate brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy.

Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate risk group.

Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time treatment planning. Dose constraints are defined for both methods.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) status \<=1
* 40-75 years old
* expected life expectancy\>10 years
* low risk prostate cancer (Prostate specific antigen (PSA)\<=10ng/ml, gleason score \<7, T status\<=2a), less than 50 % positive biopsy cores
* selected intermediate prostate cancer (PSA)=10-\<15ng/ml or gleason score =3+4(but not 4+3), or T2b-c, less than 50 % positive biopsy cores)
* International prostate symptom score (IPSS) \<=15
* Prostate volume\<=50cm3
* no pubic interference
* no prior prostate operation, except biopsy
* no prior radiation to pelvis
* patient signed the informed consent

Exclusion Criteria:

* \<40 years or \>75 years old
* PSA\>15 ng/ml gleason score 4+3 , score 8-10
* ECOG\>=2
* T3-4
* percent core positivity \>50 %
* TUR operation within six months prior to the brachytherapy prostate volume\<10 cm3 or \>50 cm3 IPSS \>15
Comparison of a TauroLock™ Based Regimen to 4% Citrate as Lock Solution in Tunneled Haemodialysis Catheters for the Prevention of Bacteraemia and Dysfunction

Catheter infections and dysfunctions are a major cause of morbidity and mortality in haemodialysis patients. According to the US Renal Data System, infection is the second leading cause of death in dialysis patients and the leading cause of catheter removal and morbidity in patients with end-stage renal disease.

There is evidence that catheter lock solutions containing taurolidine reduce the risk of catheter related infections and improve catheter patency. Lock solutions have a local, but no systemic effect. In this study a taurolidine based lock regimen (TauroLock™-Hep500, Tauropharm, Waldbüttelbrunn, Germany, 2x/week and TauroLock™-U25.000, Tauropharm, Waldbüttelbrunn, Germany, 1x/ week) will be compared to 4% citrate (CitraFlow™ 4%, MedXL, Montreal, Canada, 3x/week) as standard lock solution.

The objective of this study is to evaluate if a TauroLock™ based regimen to lock tunneled haemodialysis catheters has reducing effects on catheter related blood stream infections and catheter dysfunctions.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged greater than 18 years.
* Written informed consent.
* Requirement for haemodialysis using a tunneled dialysis catheter.

Exclusion Criteria:

* Children aged less than 18 years.
* Positive blood culture in previous seven days before catheter insertion.
* Heparin induced thrombocytopenia and any contraindication for anticoagulation (recent or planned surgery, thrombocytopenia \< 70G/l, bleeding disorder).
Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions

Prospective, monocentric study for the evaluation of latent pulmonary arterial hypertension in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.

Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) usually develops secondary to chronic volume overload of the pulmonary circulation following left to right shunt. This overload leads to elevated pulmonary artery pressure (PAP) and later to increased pulmonary vascular resistance (PVR). This causes pressure overload in the right heart, and thereby right ventricular (RV) and right atrial (RA) dysfunction, which may implicate considerable morbidity and even mortality. Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated, the disease already evolved to an advanced (partially irreversible) stage and treatment is often initiated too late.

Dismissal from follow-up after a surgical correction of simple CHD was customized in the seventies and eighties. There is no literature available that learns us whether these patients really need follow-up or not. A substantial number must have insidiously developed PAH or mild pulmonary vascular disease (PVD) and still are prone to develop PAH later in life. It is relevant to recall these patients dismissed from follow-up in the past, because they might carry a lot of useful information on the natural history of PAH development. Focus will lie mainly on patients with simple shunt lesions, as atrial septal defect (ASD) and ventricular septal defect (VSD).

Eligibility Criteria:
Inclusion Criteria:

* Previous repair for secundum ASD, VSD

Exclusion Criteria:

* Other congenital heart disease
* Chronic lung disease or total lung capacity \< 80% of predicted value
* History of pulmonary embolism
Effect of Rate-responsive Compared to VDD Pacing in Cardiac Resynchronization Therapy Recipients

This study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure.

Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population.

Despite neutral results on hard clinical outcomes of the atrial support in CRT patients, it is not clear if a rate-responsive pacing may add incremental benefits on exercise capability.

The aim of this study is to assess the impact of RR pacing compare to VVD pacing in patients implanted with CRT devices in term of functional capacity, measured by the six-minute walking test (6MWT). This simple test has shown to be an independent predictors of mortality in this cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate in the study and signing the approved Patient Informed Consent (PIC) Form;
* Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA).
* Sinus rhythm at the time of CRT device implantation with heart rate at rest above 50 bpm.

Exclusion Criteria:

* Permanent Atrial Fibrillation;
* Inability to perform 6MWT;
* Suboptimal HF drug therapy;
* Heart rate at rest above 50 bpm.
5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression

In December 2015, Health Canada issued a warning about a potential relationship between suicide and finasteride use and called for further research. No population based studies have assessed the risk of suicide with finasteride use, and this risk is not currently part of the product monograph. Furthermore, the link between depression and finasteride has not been well studied in the older population who are the primary users of this medication.


Eligibility Criteria:
Inclusion Criteria:

* All men \>66 years of age in Ontario between 2003-2013

Exclusion Criteria:

* Non Ontario residents
* No prescriptions filled in prior 180 days
* Prior exposure to finasteride/dutasteride in the 2 years prior to study enrollment.
* Prescription initiated during hospital admission or ER visit.
BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections

A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. Serological test results will have no impact on the therapeutic approach.

Study objective: To evaluate the diagnostic performance of an antibody detection kit for the serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci, Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the reference method: the bacterial culture of deep intraoperative samples.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients
2. Patients 18 years of age or older
3. Patient with a bone and joint prosthetic device: total hip prosthesis (THP) or total knee prosthesis (TKP) or total shoulder prosthesis (TSP)
4. Patients with a revision of a failed prosthesis, regardless of the cause and whether septic or not
5. Patients who have not expressed their opposition to the use of their personal medical data and blood samples

Exclusion Criteria:

1. Patients already enrolled or clinically reviewed following a relapse
2. Patients with several prostheses requiring at least two revisions during the same surgical procedure
3. Patients for whom the microbiologist and/or doctor responsible for the care refuses that these patients participate in the study
4. HIV+ patients
5. Patients undergoing chemotherapy for a blood disease or solid tumour
6. Patients under guardianship or trusteeship
7. Patients who are expected to be difficult to monitor (life expectancy less than 1 year, or homeless people, foreigner in transit)
Impact of Covid-19 Pandemic on Children With Neuromuscular Disease and Their Parents in Turkey: Parent Perspective

Parents of children with neuromuscular disease have been already at risk of depression, anxiety and burden. Additionally, the daily lives of children with neuromuscular disease and their parents have been significantly affected by the COVID-19 pandemic. Therefore, this study investigated parents' perspective on the effect of the COVID-19 pandemic on children with neuromuscular diseases and themselves.

The 55-item survey created by the researchers was applied online to determine the psychological and physical effects of COVID-19 on neuromuscular patients and their families. This survey also included the Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9).

Eligibility Criteria:
Inclusion Criteria:

* taking care for a child with NMD whose age was between 0-18 years,
* having the ability to read and write Turkish language,
* having access to phone or e-mail,
* being volunteer.

Exclusion Criteria:

* having a child who have an additional diagnosis besides NMD and taking care of any other person in the family.
Nutraceutical Citrulline in Pregnancy

The purpose of this study is to determine if oral of L-citrulline (3 grams/day) for 3 weeks provided in mid-pregnancy to pregnant women with type 2 diabetes will increase the plasma L-arginine/ADMA ratio, lower maternal blood pressure and increase maternal levels of placental growth factor (PlGF).

The pregnancy-specific syndrome preeclampsia is a leading cause of maternal and fetal morbidity and mortality. The underlying cause of preeclampsia is unknown, however several pre-existing maternal conditions are associated with an increased risk of preeclampsia including: diabetes, hypertension, renal dysfunction, obesity and history of preeclampsia. Specifically, the risk of preeclampsia is five times greater in women with diabetes.

Several lines of evidence indicate that endothelial dysfunction is a central feature of the pathophysiology of preeclampsia. Asymmetric dimethylarginine (ADMA) is a methylated metabolite of the amino acid L-arginine and an endogenous inhibitor of nitric oxide synthase (NOS). High concentrations of ADMA contribute to endothelial dysfunction and ADMA inhibits angiogenesis and arteriogenesis, activities important in pregnancy and deficient in preeclampsia. ADMA concentrations are higher early in pregnancy among women who later develop preeclampsia. This protocol describes a randomized placebo-controlled trial of L-citrulline in 40 pregnant women with type 2 diabetes from approximately sixteen to nineteen weeks gestation, to determine whether L-citrulline supplementation increases the plasma L-arginine/ADMA ratio, lowers maternal blood pressure and increases a circulating marker of placental function (placental growth factor PLGF).

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Type 2 diabetes with hemoglobin A1c \<8
* Gestational age at randomization between 14 and 16 weeks based on clinical information
* Maternal age between 14 and 40 years

Exclusion Criteria:

* Chronic hypertension
* Major fetal anomaly
* Fetal demise
* Planned termination of the pregnancy
* Collagen vascular disease (autoimmune disease) on medication
* Renal disease
* Epilepsy or other seizure disorder
* Active or chronic liver disease
* Heart disease, known illicit drug or alcohol abuse during current pregnancy
* Already taking L-citrulline as a supplement (1gram/day or more)