cyrilzakka/clinical-trials huggingface dataset:
The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)

Post hepatectomy liver failure (PHLF) is a serious medical problem could lead to patient death, however, definite treatment strategy has not been established. The liver is a regenerating organ and the possibility of PHLF could be reduced when the appropriate liver regeneration is guaranteed.

Portal flow has known to be important during liver regeneration. Low portal flow cannot induce proper regeneration, contrary, excessive flow increase shear stress in the hepatic sinusoid resulting liver failure.

Various medications has been used in malignant liver cirrhosis to reduce portal pressure. Among them, somatostatin has been used modulating portal flow reducing portal and sinusoidal pressure.

In this study, the investigators administrate somatostatin at a rate of 3.5ug/kg/hour to PHLF patients (prothrombin time \< 50% and serum total bilirubin \> 2.9mg/dl after liver resection) until recovery from liver failure. For assessment of the recovery of liver failure, the investigators evaluate aspartate transaminase (AST), alanine transaminase (ALT), serum total bilirubin and prothrombin time periodically after administration of medication.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with PHLF without regard primary disease.
2. Ability to provide written informed consent

Exclusion Criteria:

1. Concomitant surgery for another intraabdominal organs.
2. Severe renal disease requiring dialysis.
3. Patients with coagulation disorders or taking warfarin.
4. Immunosuppressed patients or the patients with autoimmune disorders.
5. Women with pregnant, breast-feeding.
6. Hypersensitivity to somatostatin.
7. Patients treated with other investigational product within 30 days at the consents are obtained.
8. Patients with a significantly reduced cognitive abilities.
9. Not eligible to participate for study at the discretion of investigator.
Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy

Baska mask is a new novel supraglottic airway device with many salient features. The investigators aim to determine the benefit of BASKA mask as an effective airway device for laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order to smoothen the surgery and anaesthesia process as well as reduce perioperative complications.

Patient's satisfaction and smooth process is crucial for perioperative care.Conduct of Anaesthesia including choice of airway devices play an important role. Endotracheal intubation has long been regarded as the technique of choice for airway management in laparoscopic surgery. However, there is currently an emerging interest in laryngeal mask as the substitute for endotracheal tube in laparoscopic surgery.

The increased abdominal pressure secondary to gas insufflation in Laparoscopic surgery demands a good supraglottic airway device with features of good seal, aspiration prevention and effective ventilation.

Few studies have evaluated the performance Baska® Mask for various type of surgery and had obtained high "first-attempt" success rate, easy insertion and a good oropharyngeal leak pressure above 30cmH2O with low complications such as sorethroat, dysphonia and dysphagia.

However, study regarding comparison of Baska® mask with endotracheal tube has not been carried out before. Therefore, the investigators would like to evaluate this novel device in comparison with endotracheal tube for laparoscopic surgery in our centre.

This will be a prospective randomized controlled study in University Malaya Medical Centre to compare Baska® mask with the conventional laryngoscope-guided endotracheal intubation for laparoscopic surgeries.

The investigators would like to study the efficacy of this device in term of : time to effective airway insertion, efficacy of airway seal, post-operation device of complications.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years old
* American Society of Anesthesiologists (ASA) physical status I and II BMI ≤ 35
* Laparoscopic cholecystectomy only

Exclusion Criteria:

* Known gastroesophageal reflux
* History of difficult intubation or difficult anaesthesia
* Features of facial, laryngeal and pharyngeal anatomy problem
Automated Hovering for Joint Replacement Surgery

This will evaluate the effectiveness of automated hovering to encourage patients to be discharged to home after hip or knee replacement surgery. Automated hovering includes monitoring of physical activity with an activity monitor, tracking of pain scores, daily feedback and motivational messages, social influence, and connection to clinicians as needed.

The goal of this study is to test the approach of automated hovering to encourage patients to be discharged to home safely after lower extremity joint replacement surgery (LEJR). The investigators will target those patients undergoing hip or knee replacement surgery at a large urban hospital system at two different sites. The investigators aim is to increase the number of patients that are discharged to home, by providing patients with a physical activity pedometer, daily pain score tracking through bi-directional text messaging, milestone and nudge messaging for recovery, social influence, and connection to clinicians as needed for 6 weeks after surgery. Eligible participants are age 18-85, with a Risk Assessment and Prediction Tool (RAPT) score of 6-8 and are scheduled to undergo lower-extremity joint replacement surgery. Participants will be randomized 1:1 to usual care (Arm 1) and intervention (Arms 2a and 2b). After enrollment with the monitoring device, participants in the intervention group will be randomized 1:1 to Arm 2a (remote monitoring) or Arm 2b (remote monitoring + goal-setting and social support). Both intervention arms will receive the intervention for 6 weeks post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility Criteria: University of Pennsylvania Health System (UPHS) patients between the ages of 18-85 with a Risk Assessment and Prediction Tool (RAPT) of 6-8 and scheduled to undergo primary lower-extremity joint replacement surgery.

Exclusion Criteria:

* Patients will be excluded if they do not meet all of the inclusion criteria, or if they have bilateral or revision surgery, dementia, end stage renal disease, cirrhosis, metastatic cancer, non- English speaker, or other physical impairment (ex. amputation)
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection

The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection and chronic severe renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C virus (HCV) infection
* Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection.
* Subject must be HCV treatment-naïve or have failed previous HCV treatment.
* Subjects with underlying chronic renal impairment (estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as estimated by the MDRD method at screening, including those requiring dialysis).
* Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with cirrhosis must have documented compensated cirrhosis.

Exclusion Criteria:

* History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
* Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
* HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype; HCV GT3 infected, treatment-experienced subjects were excluded.
* Patients who failed a previous regimen containing protease inhibitor (PIs) and/or nonstructural protein 5A (NS5A) inhibitors.
Appetite Regulation in Children With Failure to Thrive

Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and thus, a sign of undernutrition. This study will include children with FTT, and compare with existing data from children with normal and excessive growth.

The overall aim of this study is to explore whether 1) children who develop FTT with no organic explanation differ from healthy normal weight and overweight children in their basal level of appetite-regulating hormones and 2) if inadequate, normal and excessive growth in children can be partly predicted by variation in their gut microbiome and metabolome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with failure to thrive
* Weight for height \> 1.9 SD below the median by use of the WHO Child Growth Standards
* Age between 12-36 months

Exclusion Criteria:

* Cancer
* Inflammatory bowel disease
* Celiac disease
* Immunodeficiency
* Other somatic disease that can explain the growth failure
Improvement in COPD Elderly Patients Health: Study Protocol

Guidelines development, their implementation and the physicians' adherence may have an impact on the occurrence of Chronic Obstructive Pulmonary Disease (COPD) exacerbations and patient's quality of life. We have developed an educational program based on a checklist to assist general practitioners in managing COPD patients. The results of this trial based on electronic health records from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist, will be directly applicable to primary care in Poland and add new data to the growing body of evidence on interventions to improve chronic illness care and patient's quality of life.

This study is the three-arm cluster controlled randomized trial (CRT) with the patients nested within practices. The effectiveness of Checklist in reduction of COPD exacerbations health outcomes in COPD patients after 2 interventions will be evaluated and compared to that of usual care. The results of this trial will be directly applicable to primary care in Poland and add new data to the growing body of evidence on interventions to improve chronic illness care.

Eligibility Criteria:
Inclusion Criteria:

1. Patients: aged 65 years and older with diagnosis of COPD registered as J-44 (ICD-10).
2. Centres: Primary Health Care Centers (PHCC) with at least 46 COPD patients listed.

Exclusion Criteria:

None
Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults

The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.


Eligibility Criteria:
Inclusion Criteria (Selected)

* Male and female healthy adult subjects

Exclusion Criteria (Selected)

* Subject has protocol specified significant medical history.
* Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
* Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.
Comparison Study Between PET/CT and Whole-Body Diffusion Weighted MRI in the Detection of Distant Malignancies

The purpose of the study is to compare the efficacy of 18F-FDG PET/CT and DWI WB-MRI in detection of distant metastasis of various cancers.

Metastasis is the leading cause of morbidity and mortality in patients with cancer, accounting for \~90% of cancer-associated deaths.

Distant metastasis (DM) is a crucial point in the management of malignant tumors. DM is always associated with poor survival. Conclusive diagnosis of DM is crucial for improving the prognosis, reduction of the recurrence rate and hence, elevation of the 5-year survival rate.

Positron emission tomography/computed tomography (PET/CT) allows the analysis of active tumor tissue in the whole body. So, it obtains improved sensitivity and specificity when compared to conventional imaging modalities.

18F-FDG PET/CT is a diagnostic imaging modality with good quantitative properties. It has proven its interest in diagnosing, staging, and evaluating tumor response.

Whole-body MRI (WB-MRI) has been proposed as another effective whole-body approach for assessing both local invasiveness and distant metastases in patients with newly diagnosed cancers providing several advantages.

WB-MRI primarily provides structural information (revealing a detailed image of the pathology or lesion) on tumor spread; however, the absence of functional datasets has been resolved by incorporating Whole-body Diffusion Weighted Imaging (WB-DWI) into medical practice. WB-DWI shortens examination interpretation times by directing the radiologist's attention to abnormalities, which may then be investigated on anatomic sequences. It enables early detection of skeletal metastases as well as spread to other sites (liver and brain).

DW-MRI measures the Brownian motion of water molecules within intra- and extracellular spaces. This occurs in highly cellular lesions or in environments in which tissue architecture is disrupted and can be quantified by calculating the apparent diffusion coefficient (ADC).

Eligibility Criteria:
Inclusion Criteria:

* Only patients with malignancies proven by histology and patients with metastatic lesions proven by histopathology or cytology were included.

Exclusion Criteria:

* • As regard the PET/CT study, patients who have the general CT contraindications such as pregnancy, breast feeding, history of allergic reaction to the contrast medium, renal disease, etc.

  * As regard the MRI study, general contraindications including claustrophobia, MR-incompatible pacemakers and MR-incompatible heart valves.
  * Patients whose MRI sequences were incomplete, low-quality and/or had no histopathological evidence of metastatic lesions were eliminated from the study.
  * Low-quality or incomplete MRI included MRI exams with incomplete sequence(s), which is particularly common in elderly patients who are unable to tolerate the scan, or uncooperative patients who do not obey breathing instructions and motion artifacts that may impair images and lead to lower accuracy.
  * Declined consent.
Minimum Effective Volume for Selective Trunk Block

The objective of this study is to identify the minimum effective dosage of a mixture of two local anaesthetic drugs called 'levobupivacaine' and 'lignocaine with epinephrine" used to produce an effective ultrasound guided selective trunk block for surgical anaesthesia of the upper limb.

Ultrasound is widely used for brachial plexus block (BPB) and current evidence indicates that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks. Since majority of the innervation to the upper extremity, including the shoulder, arises from the three trunks (superior, middle and inferior) of the brachial plexus, so targeted injections of the individual trunks of the brachial plexus under ultrasound guidance will produce surgical anaesthesia of the entire upper extremity (C5-T1). Principal Investigator refers to this novel technique "selective trunk block" (SeTB) and the preliminary experience with SeTB for surgical anaesthesia of the entire upper extremity has been very encouraging. Currently there are no data describing an optimal dose or volume of local anaesthetic for SeTB. The aim of this study is to identify the minimum dosage of 1:1 mixture of 'levobupivacaine' and "lignocaine with epinephrine" required to produce effective surgical anaesthesia in at least 90% of patients presented for upper limb surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective upper extremity surgery involving the proximal humerus to distal hand or surgery involving any combination of these regions.

Exclusion Criteria:

* Patient refusal
* pregnancy
* skin infection at the site of block placement
* history of allergy to local anaesthetic drugs
* history of bleeding tendency or with evidence of coagulopathy
* pre-existing neurological deficit
* pre-existing neuromuscular disease.
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

It is a normal process in the human body for red blood cells to die, which makes bilirubin.

Bilirubin is cleared away through the liver.

Some babies are born with livers that don't work well enough yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice).

This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high.

Phototherapy is what they call the lights they shine on newborn babies to help the liver get rid of bilirubin.

This study tests an experimental drug to see if it can reduce how much bilirubin is being made in the first place.

The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and effective in the treatment of hyperbilirubinemia in hemolyzing neonates.

Eligibility Criteria:
Inclusion Criteria:

Babies may only participate if they meet all the following criteria:

* Is a term or late preterm baby
* Is at risk for protocol-defined hemolytic disease
* Weighs at least 2500 g (5.5 lbs)
* Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age
* Has parents/guardians who are willing to follow light precautions and sign informed consent

Exclusion Criteria:

The following criteria will make a baby not eligible to participate:

* Needs medications that may prolong the QT interval
* Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias
* Has an Apgar score of 6 or below at age 5 minutes
* Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results
Changes of the Infusion Rate in Insulin Pump Treatment

A pharmacokinetic study of insulin pump treatment using Insulin Aspart. The study consist of three different periods A, B and C where a constant the insulin infusion rate is given during the periods. In period B and C will the infusion start with a bolus.

It will be investigated if a steady state of insulin will be obtained faster in period B and C then A.

A pharmacokinetic study of insulin pump treatment using Insulin Aspart. The study consist of three different periods A, B and C where a constant the insulin infusion rate is given during the periods. Each period will last 12 hours and blood will be drawn to measure absorbed Insulin Aspart. During period A will a constant the infusion rate of insulin be given. In period B and C will there at the start of the constant infusion rate be given a bolus. The bolus in period C is calculated on the basis of the results in period B, therefore will all participants experience period C last where as period A and B is randomized cross-over. Period C is written in the protocol as optional and it is evaluated after period A and B if period C will be performed.

The hypothesis is that steady state of insulin will be obtained faster in period B and C than A.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Healthy volunteer
* Men and women between ≥18 and \<50 years
* Women in the child-bearing age should be sufficient protected against pregnancy (use birth control pill or intrauterine device or be sterilized or hysterectomized)
* BMI between 18-30 kg/m\^2 (both included)

Exclusion Criteria:

* Suspected or known allergy against the drug used in the study or similar drugs
* Previous history of endocrinology disease (including Diabetes Mellitus)
* Suspected or known alcohol- or drug abuse
* Any disease influencing the study, evaluated by the investigator
* Pregnancy, breast-feeding or the wish of becoming pregnant during the study period. Furthermore women in the child bearing age not sufficient protected against pregnancy (sufficient is: use of birth control pill or intrauterine device or be sterilized or hysterectomized)
* Participation in other research projects during the last 3 months before this project
ESWL Vs Flexible Uretroscopy in Management of Upper Ureteric Stones a Prospective Randomized Study

This comparison between ESWL and flexible ureteroscopy aims to explore the efficacy, safety, and outcomes of these treatments for upper ureteric stones under 15 mm, focusing on stone-free rates, procedural risks, recovery times, and recurrence rates. A thorough understanding of these techniques is essential for optimizing patient outcomes and personalizing treatment strategies.

study aim to evaluate the effectiveness, safety, and cost of SWL compared to flexible uretroscopy in management patients with upper ureteric stone less than 15 mm in size

The management of upper ureteric stones, particularly those less than 15 mm in size, has seen significant advancements with the development of minimally invasive techniques. Urolithiasis is a common condition, and selecting the most appropriate treatment is crucial for effective stone clearance and minimizing complications. Two widely used approaches in treating upper ureteric stones are Extracorporeal Shock Wave Lithotripsy (ESWL) and Flexible Ureteroscopy (FURS).

ESWL, a non-invasive procedure, uses focused shock waves to fragment the stone into smaller pieces that can be passed naturally through the urinary tract. Its non-invasiveness makes it an attractive option for many patients; however, its success is influenced by factors such as stone composition, location, and patient anatomy. In contrast, Flexible Ureteroscopy (FURS) is a minimally invasive endoscopic technique where a flexible ureteroscope is passed through the urinary tract to directly visualize and fragment the stone using a laser (usually a Holmium: YAG laser). This method allows for a more targeted approach and is often used when ESWL is less effective or contraindicated.

ESWL and FURS have distinct advantages and limitations, and the choice between them depends on factors including stone size, density, location, and patient-specific considerations such as body habitus and anatomical variations.

Eligibility Criteria:
Inclusion Criteria:

* patients age\>18 years old. Stone site: upper ureteric stone. Stone side: unilateral stones Stone size: stones diameter up to 1cm Stone number: single or multiple Radio-opaque stone

Exclusion Criteria:

* patients with solitary kidney or only function kidney renal impairment present of distal obstruction pregnancy, current breast feeding. Bleeding tendency or anticoagulation. ipsilateral ureterolithiasis, Acute or chronic nephritis, or Renal tuberculosis aneurysm of the aorta or renal artery. inability to position the patient on the SWL table (eg, due to severe skeletal deformity or morbid obesity).

radiolucent stones that are not visible on ultrasound. severe metabolic disturbances (eg, cystinuria, primary hyperparathyroidism, or renal tubular acidosis)