cyrilzakka/clinical-trials huggingface dataset:
Effect of Dobutamine on Hepatic Blood Flow During Goal-directed Hemodynamic Therapy

Maintaining adequate perfusion pressure and oxygen supply is essential for organ survival. Splanchnic hypoperfusion during the perioperative period in abdominal surgery may result in mucosal ischemia with increased permeability of the gut barrier. Additionally, the liver is also sensitive for hypoxemia and hypoperfusion, especially during liver surgery.

Anesthetics (such as propofol or sevoflurane) have a cardiovascular depressant effect, resulting in a reduction of cardiac output (CO). Dobutamine is used to counteract myocardial depressant effect of anesthetics. Additionally, dobutamine is frequently used during abdominal surgery to maintain splanchnic perfusion.

Dobutamine could increase hepatic blood flow (HBF) indirectly by increasing cardiac output or directly by stimulating adrenergic receptors in the splanchnic circulation. The hepatic circulation has a large number of alpha and beta adrenergic receptors and could be sensitive for adrenergic stimulation such as dobutamine. Hence, dobutamine could have a direct effect on the hepatic vasculature.

The aim of the study is to evaluate the effect of dobutamine on hepatic blood flow during goal directed hemodynamic therapy and to distinguish between potential direct and indirect effects.

All patients receive standardized anesthesia care for pancreaticoduodenectomy according to the existing departmental protocol for these interventions.

All patients receive individualized goal-directed hemodynamic therapy based on the transpulmonary thermodilution technique.

At designated times, hemodynamic variables will be recorded. These include :

* Heart rate (bpm)
* Central venous pressure (mmHg)
* Systolic arterial pressure (mmHg)
* Diastolic arterial pressure (mmHg)
* Mean arterial pressure (mmHg)
* Cardiac index (L/min/m2)
* Pulse pressure variation (PPV)
* Stroke volume variation (SVV)

Measurements of hepatic flow and pressure will be performed by the surgeon :

* Hepatic flow : in the hepatic artery (arterial HBF) and portal vein (portal HBF).
* Pressure measurements : in portal vein (PPorta) and caval vein (PCava)

Measurements will be done :

* without inotropic support
* with infusion of dobutamine 2mcg/kg/min
* with infusion of dobutamine 5mcg/kg/min

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years ≤ 80 years (female or male).
* ASA I - II - III.
* Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
* Patient is scheduled for pancreaticoduodenectomy (Whipple's procedure).

Exclusion Criteria:

* Allergy to the medication dobutamine.
* Renal insufficiency (SCr \> 2 mg/dL).
* Severe heart failure (EF \< 25%).
* Hemodynamic unstable patients.
* Atrial fibrillation.
* Sinus tachycardia \> 100 bpm on pre-operative electrocardiogram.
* Sepsis.
* BMI \> 40.
* Severe coagulopathy (INR \> 2).
* Thrombocytopenia (\< 80 x 103 /mcL).
* End stage liver disease and/or portal hypertension.
* Pregnancy and breastfeeding women.
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy Volunteers

Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg Ferriprox®.

Post-marketing study to evaluate the effect of impaired hepatic function on the pharmacokinetics (PK) of deferiprone and its 3-O-glucuronide metabolite and on the safety of Ferriprox® in subjects with mild and moderate hepatic impairment as compared to healthy volunteers.

Eligibility Criteria:
Main Inclusion Criteria:

All subjects:

1. Adult males or females, 18 - 75 years of age (inclusive);
2. Body weight ≥ 50 kg;
3. Body mass index (BMI) between 19 and 32 kg/mE2 (inclusive);
4. Absolute neutrophil count (ANC) of \>1.5x10E9/L ;

Healthy volunteers:

1. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination);
2. Matched to hepatically impaired subjects in the study by age (+/- 10 years), sex and weight (+/- 15% BMI).

Hepatically impaired subjects:

1. Considered clinically stable in the opinion of the Investigator;
2. Subjects with different degrees of impaired hepatic function as assessed by a Child-Pugh classification score: mild (Class A: 5-6 points) and moderate (Class B: 7-9 points) impaired hepatic function.

Main Exclusion Criteria:

1. For subjects with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).
2. Evidence of liver impairment in healthy volunteers: hepatitis B and C; or aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, clotting factors, serum protein that is considered clinically significant by the Investigator;
3. History or presence of significant clinically unstable respiratory, cardiovascular, pulmonary, hepatic (except for subjects assigned to one of the hepatically impaired groups), renal, hematologic, gastrointestinal, endocrine (except for subjects with hepatic impairment with clinically stable and treated diabetes, hypertension and thyroid disorders), immunologic, dermatologic, neurologic, or psychiatric disease;
4. Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the PK of the investigational medicinal product (e.g. resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, clinically unstable endocrine disease, severe infections, acute inflammations, etc.);
5. Received a pharmacological agent in another clinical trial within 28 days prior to the first dose of the study;
The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

The hypothesis of the study is that laryngeal US can accurately and reliably diagnose laryngomalacia in infants with congenital stridor.

Stridor is a respiratory noise caused by partial obstruction of the large airways at the level of the pharynx, larynx and/or trachea. The most prevalent congenital cause of stridor is laryngomalacia. Flexible laryngobronchoscopy (FLB) under sedation is regarded as the gold standard. However, FLB under sedation has some drawbacks as it requires venous access, use of sedative agents, may cause discomfort for the patient and is costly.

Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique. It allows for dynamic assessment of moving structures in an awake patient and the results can be easily displayed and recorded.


Eligibility Criteria:
Inclusion Criteria:

Infants referred for FLB and bronchoscopy due to congenital stridor at the Department of Pediatric Pulmonology, Critical Care and Sleep Medicine at the Tel Aviv Sourasky Medical Centre

Exclusion Criteria:

* Prior knowledge of the cause for stridor
* History of foreign body aspiration
Non-invasive Ventilation in Preterm Infants

This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants prospective data collection will be conducted by chart review and by downloading ventilatory data from the ventilator. A registration of respiratory severity score will be done by a caregiver during the weaning period. This consists of a visual assessment of the work of breathing every 2 hours. For participants on NIV-NAVA consenting to the interventional part of the study a titration procedure will be conducted, afterwards serial electrical impedance tomography and lung and diaphragm ultrasound measurements will be done.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants (\< 37 weeks GA) supported with non-invasive respiratory support for at least 24 hours. Non-invasive respiratory support can consist of non-invasive NAVA, nasal continuous positive airway pressure (nCPAP) or high flow nasal canula (flow \> 2 liters/min).The support can be given as primary respiratory support or as respiratory support after weaning from invasive ventilation (= after extubation).
* Infants can only be enrolled after written and signed informed consent by the parents.

Exclusion Criteria:

* Infant born after a gestational age of 37 weeks or more.
* Infants with major congenital malformations or chromosomal abnormalities (eg trisomy 18, congenital diaphragmatic hernia...)
Multiomics Study of Fibrosis Factors After Liver Transplantation and Exploration of Fibrosis Methylation Biomarkers

This is a retrospective observational study in liver transplantation recipients with or without allograft liver fibrosis. Based on the GM-seq and Tcr-Seq data, a novel diagnostic model including DNA-methylation and TCR-Seq biomarkers will be established.

This is a retrospective study on 60 patients who had previously received liver transplantation in our hospital. The patients will be stratified according to age, including 20 children and 20 adults with allograft liver fibrosis after liver transplantation, while 10 children and 10 adults with fibrosis, respectively.

1. The differential analysis of DNA-methylation will be performed between the allograft liver fibrosis cohort and the control cohort based on the GM-seq sequencing data. And the fibrosis-specific DNA-methylation CpG sites or regions in liver and peripheral blood will be explored in the liver transplantation recipients.
2. The abundance and diversity of TCR between the allograft liver fibrosis cohort and the control cohort will be analyzed. And the fibrosis-specific TCR sequence of allograft liver fibrosis will be screened based on TCR-Seq sequencing and tNGS.
3. The characteristics of DNA-methylation and TCR-Seq biomarkers in allograft liver fibrosis population will be defined. And the similarities and differences of the characteristics between children and adults will be explored.
4. Based on the GM-seq and Tcr-Seq data, a novel diagnostic model including DNA-methylation and TCR-Seq biomarkers will be established.

Eligibility Criteria:
Inclusion Criteria:

1. Living donor liver transplantation of left outer lobe or left half liver for biliary atresia in children (≤18 years old), or orthotopic liver transplantation for hepatitis B cirrhosis in adults (\> 18 years old), regardless of gender;
2. Oral tacrolimus immunosuppressive therapy;
3. Received liver transplantation in our hospital for the first time and did not receive liver transplantation again;
4. Patients need to be admitted to hospital for programmed liver biopsy or receive liver biopsy due to abnormal liver function;
5. Complete clinical data and samples (including liver puncture biopsy specimens, plasma, and PBMC of the same period);
6. The subjects or their guardians voluntarily join the study, sign the informed consent, comply well, and cooperate with follow-up.

Exclusion Criteria:

1. Combined multi-organ transplantation;
2. Pregnancy or lactation;
3. Severe systemic infection;
4. Contraindications of liver biopsy with multiple organ failure or coagulation dysfunction;
5. Previous history of allergy to narcotic or sedative drugs;
6. In the stage of acute rejection hormone shock therapy;
7. Incomplete clinical data and samples;
8. Situations considered unsuitable for inclusion by other researchers.
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

Patients with chronic liver disease who have a recent biopsy will be offered a breath test. Correlation will be shown between histology and breath test in determining cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 with chronic liver disease

Exclusion Criteria:

* Patients that are taking hepatotoxin drug.
* Patient with severe congestive heart failure
* Patient with severe pulmonary hypertension
* Patient with uncontrolled diabetes mellitus
* Patient with previous surgical bypass surgery for morbid obesity
* Patient with extensive small bowel resection
* Patient currently receiving total parenteral nutrition
* Patient is a recipients of any organ transplant
* Patients that received any anti-viral treatment within the past year
* Women who are pregnant
* Patient allergic to acetaminophen (such as Tylenol or any other related medications)
* Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
* Patients unable to sign informed consent
* Patients that based on the opinion of the investigator should not be enrolled into this study
* Patients that are participating in other clinical trials evaluating experimental treatments or procedures
Oxytocin And Uterotonic Agent Use For Cesarean Delivery

The central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean delivery

The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during elective cesarean delivery will:

1. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone.

Secondary outcomes to be evaluated will be:

1. Reduce the side effects associated with uterotonic drug use
2. Reduce the time to establishment and maintenance of adequate uterine tone

The current guidelines for the administration of oxytocin during cesarean delivery are diverse, empiric, and vague. A stepwise, standardized, checklist driven algorithm for the use of oxytocin and other uterotonic agents during cesarean delivery is needed to guide practitioners in a clear and concise manner. This algorithm should encompass laboring and non-laboring women, as well as prophylactic and therapeutic uses of oxytocin and other uterotonic agents.

More specifically, the investigators believe that the following points should be incorporated into a protocol: 1) oxytocin should be used in initial doses of less than 5 IU; 2) oxytocin should not be administered as a rapid IV bolus; 3) an initial rapid infusion of oxytocin should be followed by a maintenance infusion; 4) higher initial and infusion doses of oxytocin offer no clinical benefit and should be avoided; and 5) if it appears that oxytocin is not producing effective uterine contractions, other uterotonic drugs acting via different pathways should be considered in a standardized way.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I or II health status
* Age between 18 and 50 yrs
* Singleton pregnancies in vertex position
* Elective (without prior labor) cesarean delivery with a planned lower uterine (pfannenstiel) incision

Exclusion Criteria:

* Conditions that predispose to uterine atony and postpartum hemorrhage
Investigation of the Validity, Reliability, and Responsiveness of BETY-BQ in Chronic Kidney Disease, on Dialysis, and Kidney Transplantation

A review of the literature has shown that Chronic Kidney Disease (CKD) is strongly associated with an increasing degree of psychosocial impact, such as depression and anxiety and a decrease in quality of life. Therefore, while determining the psychosocial aspects of the disease gains importance, it is reported that determining and evaluating the biopsychosocial characteristics may facilitate the disease management of individuals. Considering that CKD is associated with various comorbidities, psychosocial features, and symptom burden, it is interpreted that patient-reported outcome measures may support the complex management of these individuals. Routine collection and use of patient-reported outcome measures may provide valuable data for understanding the disease from both individual and community perspectives, with the potential to improve the quality of care and outcomes.

The Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise model based on physical exercise and an example of a biopsychosocial approach developed for patients with rheumatism. The BETY-Biopsychosocial Questionnaire (BETY-BQ) was created by repeated statistics of improvement characteristics reported by individuals who participated in BETY sessions for many years. The BETY-BQ holistically assesses many biopsychosocial characteristics of the person, such as pain, functionality, mood, sociability, sexuality, and sleep. Therefore, there is a need for scales that assess these symptoms holistically in chronic kidney disease. BETY-BQ can be envisaged as an assessment tool for interdisciplinary healthcare team members who want to evaluate the CKD population, including individuals on dialysis and kidney transplant recipients. Since the BETY-BQ can assess biopsychosocial characteristics quickly and its structure was created with the feedback of individuals with chronic diseases, it aimed to examine its validation in this disease group.

In this study, which investigators planned to contribute to this field, investigators aimed to investigate the validity, reliability, and sensitivity of BETY-BQ in individuals diagnosed with chronic kidney disease on dialysis and kidney transplantation.


Eligibility Criteria:
Individuals with chronic kidney disease:

Inclusion Criteria:

* Being diagnosed with chronic kidney disease
* To be over 18 years old
* Consent of the participant

Exclusion Criteria:

* Acute infection
* Being diagnosed with cancer

Individuals on dialysis:

Inclusion Criteria:

* Being a dialysis patient
* To be over 18 years old
* Consent of the participant

Exclusion Criteria:

* Acute infection
* Being diagnosed with cancer

Kidney transplant recipients:

Inclusion Criteria:

* To have had a kidney transplant
* To be over 18 years old
* Consent of the participant

Exclusion Criteria:

* Acute infection
* Being diagnosed with cancer
Angiotensin II Receptor Blockers (ARB) and ACE Inhibitors (ACEI) on Silent Brain Infarction and Cognitive Decline

The purpose of this study is to elucidate whether or not angiotensin II receptor blockers (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on development or progression of silent brain infarction and cognitive decline in Japanese patients with essential hypertension in the elderly.

Hypertension plays a major role in the development of cardiovascular diseases. Treating hypertension has been associated with reduction in the risk of stroke and myocardial infarction. Angiotensin converting enzyme inhibitor (ACEI), ramipril, showed a 32 % in relative risk of reduction in the Heart Outcomes Prevention Evaluation (HOPE) trial. Angiotensin II receptor blocker (ARB), losartan, also showed a 25 % in relative risk of reduction in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE).

Elderly people, especially hypertensive patients, with silent brain infarction have an increased risk of stroke and cognitive decline. However, no reports are seen on comparison of the effects of ARBs and ACEIs on progression of silent brain infarction and cognitive decline in patients with essential hypertension in the elderly.

The researchers therefore longitudinally evaluate silent brain infarction using magnetic resonance imaging and cognitive decline by Mini-Mental State Examination twice at an interval of 2 years in patients with essential hypertension in the elderly who are received antihypertensive therapy by ARB or ACEI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with essential hypertension (systolic blood pressure\>=140 mmHg and/or diastolic blood pressure\>=90, or treated with antihypertensive drugs)
* Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging

Exclusion Criteria:

* Secondary hypertension
* Atrial fibrillation
* History or signs of cerebral disorders other than cerebrovascular disease
* Malignant tumor
* Chronic renal failure
* Severe congestive heart failure
* Hyperkalemia
* Stenosis of bilateral renal artery
A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Pilot Study

The purpose of this study is to:

1. Determine whether the Physical Therapy (PT) \& Fitbit® intervention should proceed to a full-scale clinical trial. This decision will be based on three hypotheses: Treatment promise (Hypothesis 1A): People in the PT \& Fitbit® will walk 1250 more steps/day and spend 7 min/day more in moderate to vigorous physical activity (MVPA) than the control at discharge and at 6 months and 12 months, Safety (Hypothesis 1B): \< 5% will have adverse events because of the intervention, A research assistant will collect data on adverse events that occur from the time of randomization until the last follow-up visit 3 months after discharge from PT. An adverse event is any unfavorable or unintended diagnosis, sign, symptom, or disease temporarily associated with the study intervention, which may or may not be related to the intervention. Adverse events include any new events not present during the pre-intervention period or events that were present during the pre-intervention period which have increased in severity. Major adverse events, such as infection, re-hospitalization or development of new comorbidities will also be noted. Recruitment (Hypothesis 1C): 75 recruited, 90% to complete trial, and 85% complete visit at 6 months and 12 months.
2. To evaluate the short- and long-term adherence of the PT \& Fitbit® intervention. Short-term Adherence (Hypothesis 2A): 90% of subjects in the PT\& Fitbit® group will wear the Fitbit® and participate in goal setting and behavioral counseling while in PT. Long-term Adherence (Hypothesis 2B): 75% of PT \& Fitbit® will wear the Fitbit® at 6 months and 12 months.
3. To quantify changes in potential underlying mechanisms for increased physical activity. (Hypothesis 3): Change in self-efficacy for physical activity, walking endurance and participation in daily activities will be associated with improvements in physical activity.
4. To assess intervention fidelity (Hypothesis 4): (4a) using the electronic medical record, the treating PT will check off that they 1) reviewed physical activity recorded by the Fitbit® and 2) discussed step goals for all study subjects randomized to the intervention group. (4b) treating PTs will be asked to audio record five-intervention interactions/week using a digital audio recorder. A research assistant will then assess whether the PT 1) reviewed physical activity and 2) discussed step goals. Lastly, the duration of the intervention will be noted.

The study is a pilot study to determine the feasibility of a full trial.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 45
* Seeking outpatient physical therapy after unilateral TKR

Exclusion Criteria:

* Not interested in increasing physical activity
* Co-morbidities other than unilateral TKR that limit physical activity
* Planning on having another lower extremity surgery in the next 6 months
* Have had another lower extremity surgery in the past 6 months
Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD)

The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure.

Seventy Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with posttraumatic stress disorders (PTSD) will be randomly assigned to one of two 4-week treatments (45 min/day): (1) bright light exposure or (2) a negative ion generator. Clinical assessments ,as well as self-reported measures of PTSD, anxiety, depression, and sleep will be assessed

Eligibility Criteria:
Inclusion Criteria:

* Veteran of Operation Iraqi Freedom or Operation Enduring Freedom with Posttraumatic Stress Disorder
* receiving other treatment or stopped other treatment prior to study

Exclusion Criteria:

* bipolar disorder
* psychosis
* alcohol/drug abuse