cyrilzakka/clinical-trials huggingface dataset:
rtPA in in the Prevention of CVAD-Associated Thrombosis and Infection in Pediatric Patients With Short Bowel Syndrome

The primary research question is, in patients with short bowel syndrome requiring central venous access device (CVAD) for long-term total parenteral nutrition, is once weekly recombinant tissue plasminogen activator (rtPA) lock therapy more effective than routine care using heparin flushes in reducing the incidence of line-associated thrombosis and infection.

Central venous access devices (CVAD) are used routinely in chronically ill pediatric patients for administration of medications, parenteral nutrition and laboratory testing. Several complications resulting from the use of long-term CVADs, namely venous sepsis and thrombosis, can significantly increase associated morbidity and mortality. CVAD-associated thrombosis occurs in up to 50% of children with long-term CVAD use and this is especially common in patients requiring life-sustaining long-term total parenteral nutrition (1). Catheter thrombosis may arise from fibrin sheath formation around the catheter tip, intraluminal blood clot within the catheter, or venous thrombosis obstructing the vein and occluding the catheter tip. Within 24 hours and typically within 2 weeks of placement of a CVAD, a fibrin sheath forms around its tip (2-5). Development of intraluminal thrombosis or venous thrombosis is less predictable.

There is a growing body of evidence linking the development of CVAD-associated thrombosis and line-related infection. It is known that proteins within the thrombus including fibronectin and fibrinogen attract bacteria, specifically staphylococcal species. The bacteria bind to ligands associated with the thrombus thus allowing for bacterial proliferation (6-8). The clinical relevance of line thrombus in development of line infection is underscored in a study of pediatric patients with Hickman catheters, of whom 18% with catheter thrombosis developed a line-associated bloodstream infection, while none developed a catheter infection that did not also have a catheter clot (7). Thus, we hypothesize that prevention of catheter-related clot formation with use of a local thrombolytic agent will also prevent infection in the catheter.

The primary research question we pose is, in patients with short bowel syndrome requiring central venous access device (CVAD) for long-term total parenteral nutrition, is once weekly recombinant tissue plasminogen activator (rtPA) lock therapy more effective than routine care using heparin flushes in reducing the incidence of line-associated thrombosis and infection.

Eligibility Criteria:
Inclusion Criteria:

1. subjects with short bowel syndrome
2. requirement for central venous access device (CVAD) for long-term TPN administration
3. age \>/= 6 months to \< 16 years
4. ability to initiate rtPA during hospitalization for newly inserted CVAD
5. ability to be enrolled within 48 hours of CVAD placement.

Exclusion Criteria:

1. platelet count \<50,000
2. active bleeding
3. age =/\> 16 years at time of consent.
Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning

Numerous studies Have shown that limb ischemic preconditioning can protect vital organs (including the heart) from ischemia-reperfusion injury,which has a broad application prospect.But its mechanism is still unclear. Evidence showed that humoral mechanisms may play an important role. This study was carried out on the limb ischemic preconditioning in healthy volunteers, collected their serum at different time points before and after treatment,classified and identified the serum proteins during different periods of limb ischemic preconditioning,by using methods including high abundant protein removal,Two-dimensional electrophoresis chromatography and mass spectrometry,then analysed activation and synthesis of the proteins in order to search for the proteins or peptides whose synthesis was activated by ischemic preconditioning. This study will be the first systemic explore of the changes in serum proteins of limb ischemic preconditioning in human body,and lay theoretical basis for the clinical application of limb ischemic preconditioning and for further explore of its humoral mechanism,thus provide clues for searching for protein or peptide having protective effects for organs.

We aim to assess whether limb ischemic preconditioning protects remote tissue or organs through a humoral mechanism.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers aging 20-30 years old
* no cardiac，hepatic or renal，peripheral vascular diseases
* be willing to enter our study and sign an written informed consent

Exclusion Criteria:

* younger than 20 years old or older than 30 years old
* having cardiac，hepatic or renal，peripheral vascular diseases
* refuse to enter our study or sign an written informed consent
A Study to Assess the Effect of Ritonavir on the Single-Dose Pharmacokinetics of JNJ-61393215 in Healthy Participants

The primary purpose of this study is to assess the effect of ritonavir, on the single-dose pharmacokinetics (PK) of JNJ-61393215 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants or female participants of non-childbearing potential between 18 and 55 years of age, inclusive
* Before enrollment, female participants must be of non-childbearing potential; postmenopausal state is defined as no menses for 12 months without an alternative medical cause, as documented by medical records or physician's notes and Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy
* Participants must have a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m\^2), inclusive (BMI = weight/height\^2) and body weight not less than 50 kg
* Participant must be healthy based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic

Exclusion Criteria:

* Participant has any clinically significant abnormal findings in physical examination, vital signs or 12-lead ECG \[including QT corrected according to Fridericia's formula (QTcF) greater than (\>) 450 milliseconds (msec) and less than or equal to (=\<) 470 (milliseconds) msec for females, Left Bundle Branch Block, atrioventricular (AV) Block second degree or higher, permanent pacemaker or implantable cardioverter defibrillator (ICD)\] at screening or admission (up to Day 1 predose), which in the opinion of the investigator are not appropriate and reasonable for the population under study
* Participant has a history of or current liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable
* Participant has any liver function test (including alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (ALP) and bilirubin at screening \>1.5 \* ULN (upper limit of normal)
* Participant has estimated glomerular filtration rate (eGFR) less than (\<) 60 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2) at screening (provided by the local laboratory)
* Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
Motor and Cognitive Functions in Acquired and Developmental Brain Damaged Patients

Neurological pathologies cause important and permanent disabilities in every day life. These pathologies can follow stoke, affecting two people per one thousand each year or cerebral palsy, affecting two births per one thousand each year. To date, the diagnosis and the rehabilitation of motor and cognitive problems has been carried out separately by different domains. For example, physiotherapists have focused on motor problems and neuropsychologists have focused on cognitive functions. However, a number of studies have demonstrated a link between motor and cognitive abilities in adults and children. The present study has three main aims: (1) to better evaluate motor and cognitive problems in brain damaged patients (all ages), (2) to understand the link between motor and cognitive abilities in patients and healthy participants and, (3) to propose new types of therapies based on the link between motor and cognitive functions.


Eligibility Criteria:
Inclusion Criteria:

* Congenital cerebral palsy and acquired brain injury children and adult patients
* Presenting upper limb paresis and/or hemineglect
* Between the age of 3 to 90.
* Able to understand and carry out simple verbal instruction

Exclusion Criteria:

* IQ \< 70
* Severe aphasia, attentional disorder or psychiatric disorders
* Neurodegenerative disorders
A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

The objective of this study is to examine and quantify the efficacy and safety of a new treatment protocol using platelet-rich plasma for penile length enhancement.


Eligibility Criteria:
Inclusion Criteria:

1. Stretched penile length between 3.5 - 8.0 in
2. Age 20-55 years of age
3. Desire penile length elongation
4. Willing to complete all aspects of combined treatment plan
5. Able to measure erect penile length and mid-shaft girth at 1-month intervals
6. Judged to be in good health based on medical history, physical exam, and laboratory profile
7. Is willing and able to cooperate with the requirement of the study (e.g. completion of all planned study visits)

Exclusion Criteria:

1. No prior surgical Peyronie's disease treatment
2. No chordee with or without hypospadias
3. No infiltration by benign or malignant mass
4. No active STD
5. No infiltration by an infectious agent such as lymphogranuloma venereum
6. No uncontrolled psychiatric conditions
7. No uncontrolled neurologic conditions
8. No other uncontrolled medical conditions such as HTN or DM
9. No history of spontaneous priapism
10. Is unable to safely use the study devices as determined by the principal investigator
11. No thrombosis of the dorsal penile artery or vein
12. No known history of coagulation disorder
13. No known history of stroke, bleeding, or another significant medical conditional which the investigator deems makes the subject unsuitable for enrollment in the study
14. Testosterone level lower than 500
Sympatholytic Effect of Thoracic ESP

The primary endpoint of this study was to identify if erector spinae plane bloock (ESPB) demonstrates any sympatholytic effect.

The secondary endpoint of this study was to compare the changes of PI value between responders and non-responders.

The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively.

ESPB can achieve analgesic effect by blocking the ventral and doramal ramus and possibly by diffusion into paravertebral space. In constrast to lumar region, thoracic paravertebral space is very close to the sympathetic chain. Therefore, sympatholytic effect might be achieved by thoracic ESPB. No previous study has demonstrated the sympatholytic effect of ESPB.

Eligibility Criteria:
Inclusion Criteria:

* Complex regional pain syndrome
* Post-thoracotomy pain syndrome
* Cervical foraminal stenosis
* Cervical disc herniation
* Herpes zoster

Exclusion Criteria:

* Pregnacy
* Coagulation abormality
* Previous spine surgery
* Allergy to local anesthetics
A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2

Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy of a single IV dose of suvratoxumab in mechanically ventilated subjects in the ICU who are at high risk for S. aureus infections and who are currently free of active S. aureus-related disease but are colonized with S. aureus in the LRT.

Eligibility Criteria:
Inclusion Criteria:

1. Colonized with Staphylococcus aureus;
2. Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.

Exclusion Criteria:

1. Staphylococcal disease at randomisation;
2. Lung injury score consistent with pneumonia;
3. Chronic tracheostomy patients;
4. The study subject is moribund
5. Receipt of anti- S. aureus systemic antibiotics
6. Active pulmonary disease
Automatic Evaluation of the Severity of Gastric Intestinal Metaplasia With Pathology Artificial Intelligence Diagnosis System

The OLGIM staging system is highly recommended for a comprehensive assessment of GIM severity to evaluate patients' gastric cancer risk. However, its need to take at least 4 biopsies is not clinically feasible due to a serious shortage of pathologists compared with the large number of gastric cancer screening population.

We plan to develop a Digital Pathology artificial intelligence diagnosis system (DPAIDS), to automatically identify tumor areas in whole slide images(WSI) and quickly and accurately quantify the severity of intestinal metaplasia according to the proportion of intestinal metaplasia areas.

Gastric cancer is the fifth most prevalent malignancy and the third most deadly worldwide, and intestinal metaplasia (IM) is a common precancerous state that is closely associated with gastric carcinogenesis .The OLGIM staging system is highly recommended for a comprehensive assessment of GIM severity to evaluate patients' gastric cancer risk. However, its need to take at least four biopsies is not clinically feasible due to a serious shortage of pathologists compared with the large number of gastric cancer screening population. Developing automated screening methods can reduce the heavy diagnostic workload. With advances in digital pathology scanning devices and deep learning technologies, whole-slide images (WSI) have been used to develop automated cancer diagnostic systems.

We plan to develop a Digital Pathology artificial intelligence diagnosis system (DPAIDS), to automatically identify tumor areas in whole slide images(WSI) and quickly and accurately quantify the severity of intestinal metaplasia according to the proportion of intestinal metaplasia areas. Then biopsies will be prospectively collected and prepared as WSI for model validation.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 40-75 years who undergo the gastroscopy examination and biopsy

Exclusion Criteria:

* patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
* patients with previous surgical procedures on the stomach
* patients with contraindications to biopsy
* patients who refuse to sign the informed consent form
Comparison of Healthy Diets on Breast Cancer Markers

Women post breast mass biopsy with ER+or ER- cancer will be randomized to two diets--goal of 45 of them to a ketogenic insulin inhibiting diet, 20 to a low fat diet with whole grains and fruits and vegetables. The initial biopsy will be evaluated along with the surgical specimen pathology to compare changes in biomarkers, particularly of proliferation (Ki-67) and apoptosis (TUNEL).

A healthy diet has been defined in various ways. The investigators wish to compare the effects of two diets on ER positive breast cancer tissues. The diets will be administered between the time of diagnosis and the time of surgical removal. Both diets have been proposed as healthy, but differ in their composition. One constitutes a low fat diet with extra fiber, fruits and vegetable servings, while the other comprises a diet low in carbohydrate content, aiming to lower insulin secretion. Patients will be randomized to each group, with 20 assigned to the low fat arm and 45 to the low carbohydrate arm.

Eligibility Criteria:
Inclusion Criteria:

Women with biopsy proven breast cancer.

Exclusion Criteria:

-
Role of Clinical Pharmacists in Epilepsy Management

Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients' quality of life. This study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a Vietnamese general hospital.

Phenytoin, carbamazepine, and valproic acid, which are among the first-generation AEDs, are prescribed in many countries around the world, including Vietnam. These agents have complicated pharmacokinetics, which may result in alterations in absorption, distribution, and metabolism. This means that, given the same dose, the serum concentration of each drug may vary between patients. The management of epilepsy, as a result, requires inter-professional collaboration to ensure therapeutic optimization. As healthcare professionals, clinical pharmacists play an important role in epilepsy management, which includes establishing a therapeutic drug monitoring (TDM) protocol, adjusting doses, monitoring ADRs, etc.

However, the clinical pharmacy practices in epilepsy management are quite limited in Vietnam. The treatment gap-the proportion of people with epilepsy who are not adequately treated-still remains very high, especially in rural areas (84.7%), which probably results from discontinuing the treatment or refusing to take medications. This shows a need for pharmacist consultations for patients with epilepsy and their family members, as they may be lack information about AEDs or motivation in controlling potential seizures. In addition, the adjustments of antiepileptic drugs by pharmacists are not routine procedures, nor are monitored for effectiveness in many Vietnamese hospitals. This lack of engagement threatens the patients' safety and decreases their quality of life. To address this issue, certain interventions are needed to enable pharmacists to manage patients with epilepsy more systematically. This study was therefore conducted to evaluate the effectiveness of pharmacist interventions in epilepsy treatment at a general hospital in Vietnam.

Eligibility Criteria:
Inclusion Criteria:

* were prescribed a monotherapy or polytherapy of phenytoin, carbamazepine, or valproic acid.
* were treated for more than one month.

Exclusion Criteria:

* were pregnant or breastfeeding women.
* had a history of alcoholism.
* had liver or renal disease.
* were using drugs known to have an influence on cytochrome P450 enzymes.
Mitochondrial Function in Peripheral Arterial Disease

The aim of this study is to investigate the effect of different treatment strategies on mitochondrial function and to correlate in-vitro results to findings from in-vivo measurements of mitochondrial function. The authors hypothesize that interventional revascularization and therefore the restoration of blood and oxygen supply is more relevant to mitochondrial function compared to the effect of exercise training.

Resulting from a chronic narrowing of arteries by atherosclerotic lesions, the leading clinical symptom of peripheral arterial disease (PAD), a walking induced pain, reduces quality of life of patients. Affected muscle regions are altered by a characterized myopathy and mitochondria are known to play a crucial role in this pathophysiological mechanism. There are different methodological approaches to investigate mitochondrial function in-vivo as well as in-vitro. Regarding our own preliminary data, mitochondria are known to recover after successful revascularization. The effect of different treatment strategies on mitochondrial function and the correlation of in-vitro to clinical more applicable in-vivo methods was understudied so far.

The overall aim of this study is to investigate the effect of different treatment strategies on mitochondrial function and to correlate in-vitro results to findings from in-vivo measurements of mitochondrial function. The authors hypothesize that interventional revascularization and therefore the restoration of blood and oxygen supply is more relevant to mitochondrial function compared to the effect of exercise training.

Patients with isolated pathologies of the superficial femoral artery and symptomatic PAD (Fontaine stage IIB) will be included and randomized to different treatment groups (conservative treatment versus interventional revascularization). Near-infrared refracted spectroscopy and the TIVITA ® hyperspectral camera will be used for in-vivo measurement of peripheral oxygen saturation and distal perfusion before and after an exercise. Muscle biopsies will be obtained from affected (gastrocnemius muscle) as well as from unaffected muscle (lateral vastus muscle) shortly before and 12 weeks after initiating treatment. Muscle samples will be investigated by measurement of CSA regarding mitochondrial content and HRR regarding mitochondrial respiration as well as for oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* Isolated flow limiting arteriosclerotic lesion of the superficial femoral artery
* Unilateral grade II b (Fontaine) peripheral arterial disease
* Informed consent

Exclusion Criteria:

* Flow limiting arteriosclerotic lesions of the infrarenal aorta, iliac arteries or common/ deep femoral artery
* Contraindication for exercise therapy