cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients

This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve)
3. Chronic hepatitis C (G2 or G3) virus infection diagnosed

Exclusion criteria:

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
3. Hepatitis B Surface Antigen (HBsAg) positive
4. Human immunodeficiency virus (HIV) positive.

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Effectiveness of of Therapeutic Currents in Clinical Dimension and Penetration Depth Dimension in Lower Back

Electrical stimulation therapy for pain reduction was performed already 2000 years ago. In recent years many studies had proved the effectiveness of electrical stimulation in pain management, tissue healing and muscle strengthening. Today there are devices with many types of currents. Each current comes with different statements for its effectiveness and its penetration depth yet there is no consensus on the most effective current in the dimension of penetration depth.

The study shall be recruited patients who underwent implantation of electrodes in the spine (Spinal Cord Stimulation- SCS). The electrode will serve as a voltage reader deep in the tissue. The voltage is generated from electrodes applied on the skin and delivers therapeutic currents to the patients back. The study will be tested 4 different types of currents and number of electrode placement.

Eligibility Criteria:
Inclusion Criteria:

* Normal cognitive status.
* language comprehension (understanding and speaking)a way that allows voluntary cooperation in research and compliance with the testing.

Exclusion Criteria:

* Pregnant women.
* neurological pathologies (such as -head injury) or other systemic diseases that affect the sensation (such as diabetes).
* Each participant which at any stage in research expresses his wish to resign.
Predictors of Postoperative Delirium in Elder Patients After Spine Surgery: Regional Cerebral Oxygen Saturation

Postoperative delirium is an important problem in patients undergoing major surgery. The incidence of delirium was 12.5% in the patients over 70 years old undergoing spine surgery. A study shows that a low preoperative regional cerebral oxygen saturation (rSO2) is associated with postoperative delirium after on-pump cardiac surgery. This same perturbation likely also increases the risk for postoperative delirium after spine surgery, although there are little data that have evaluated this hypothesis. Therefore, this observational study was designed to explore the relationship between perioperative rSO2 and the delirium in elderly patients undergoing spine surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients in the study will be 60 or older undergoing elective major spine surgery (expected operative time is more than 2 hrs).
2. Patients who can do the mini-mental state examination (MMSE), Confusion Assessment Method for the ICU (CAM-ICU) and Intensive Care Delirium Screening Checklist (ICDSC).
3. Patients who understand the nature of the study and are willing to sign the consent form

Exclusion Criteria:

1. Emergency surgery
2. Patients diagnosed with neurocognitive disorders or psychiatric diseases, thus, cannot check MMSE or communicate with other people (e.g. Alzheimer's dementia, alcohol abuse)
3. Patients diagnosed with cerebrovascular disorders (e.g. stroke, atherosclerotic stenosis of carotid artery, TIA)
4. Patients who cannot be followed up until 2 days after surgery
EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice

The main objective of the study is to evaluate the size of the common bile duct (CBD) in a large cohort of patients with jaundice secondary to pancreatic head or distal bile duct malignancy undergoing diagnostic EUS for tissue acquisition or evaluation of resectability and to establish factors associated with a dilation of the CBD greater than 15mm.

Rationale: The size of the common bile duct (CBD) may influence the type of stent used and the type of the procedure performed in cases of EUS-guided biliary drainage. However, no data of the size of the CBD in patients with jaundice presenting with a pancreatic head mass or with a distal cholangiocarcinoma/ carcinoma of the ampulla of Vater are available.

Objectives: To evaluate the size of the CBD in a large cohort of patients with jaundice secondary to pancreatic head or distal bile duct malignancy undergoing diagnostic EUS for tissue acquisition or evaluation of resectability and to establish factors associated with a dilation of the CBD greater than 15mm.

Study design: International prospective observational multicenter trial. Study population: Patients ≥18 years old, referred for EUS-guided tissue sampling or evaluation of resectability of a pancreatic, a distal bile duct lesion or a carcinoma of the ampulla of Vater determining obstructive jaundice.

Intervention: EUS examination Main study parameters/endpoints: measurement of the CBD in patients with an obstructive distal biliary mass. Determine the factors associated with a CBD greater than 15mm Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Measurement of the CBD during EUS examination does not add additional risks to the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with jaundice and a pancreatic head mass lesion referred for EUS-guided tissue acquisition or staging
* Patients with jaundice and a distal CBD lesion suggestive of cholangiocarcinoma or a carcinoma of the ampulla of Vater referred for EUS-guided tissue acquisition or staging
* Serum bilirubin level ≥3 mg/dL
* Age ≥18 years
* Written informed consent

Exclusion Criteria:

* Presence of altered anatomy from previous gastric surgery (Billroth II or Roux-en-Y anastomosis)
* Previously performed sphincterotomy, biliary plastic stent or metal stent placement
* Previous percutaneous drainage of the bile duct
* Pregnancy
* Inability to sign the informed consent
Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging

The purpose of this study is to determine whether fusion technique of preradiofrequency ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

RFA is one of commonly used local therapies for primary or secondary liver tumors. And percutaneous liver biopsy is very important technique to confirm the diagnosis of focal hepatic lesion whether benign or malignancy.

For successful and safe procedure, safe access route and lesion visibility are essential , and the conditions are usually evaluated on pre-procedure planning ultrasonography (USG). However, these procedure is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine US and CT/MR fusion technique would be able to improve RFA or liver biopsy feasibility in patients with liver tumors in comparison with conventional US alone technique.

In addition, to assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

Eligibility Criteria:
Inclusion Criteria:

* all conditions should be satisfied for inclusion.

  * referred to Radiology in our institution for liver tumor RFA or percutaneous liver biopsy
  * available pre-procedure liver CT or liver MR imaging within 6 weeks

Exclusion Criteria:

* any contraindication of liver RFA or percutaneous liver biopsy • any patients who received treatment between pre-RFA imaging and planned RFA.
The Classification of Difficult Weaning and the Predictive Value of Relative Factors for Difficult Weaning

To evaluate the distribution of different types of difficult weaning and the predictive value of weaning relative factors.

108 patients who passed the spontaneous breathing test (SBT) were included in this study,every patient were performed 30-60 minutes SBT after enrollment.Patients were divided into succeed weaning and difficult weaning group according the results of SBT, the difficult weaning group were futher divided into A(Airway and Lung dysfunction),B（Brain dysfunction）,C（Cardic dysfunction）,D（Diaphragm dysfunction）,E（Endocrine and metabolic dysfunction）five different groups according to the causes of difficult weaning. The respiratory mechanical parameters,the diameter of inferior vena cava and the diaphgram excursion were recorded before SBT and 30 minutes after SBT.

Eligibility Criteria:
Inclusion Criteria:

* mechanical ventilation patients
* prepared to weaning
* sign on the acknowledged

Exclusion Criteria:

* endotracheotomy
* single lung
* pregnant
* heart,liver,renal failure
Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology

The purpose of this study is to explore manifestations of Heart Failure Using Infrared Thermal Imaging Technology.

Temperature is a vital and useful indicator for various diseases.Infrared thermal imaging (IRTI) allows the temperature representation of the body surface by thermal distribution, where it depends on the complex relationships defining the heat exchange processes between skin tissue, inner tissue, local vasculature, and metabolic activity.

The decrease in cardiac output in heart failure activate a series of compensatory adaption that are intended to maintain cardiovascular homeostasis. One of most important adaptation is activation of sympathetic nervous system, which could cause peripheral cutaneous vasoconstriction and decrease the skim temperature. Hence, the skim temperature of heart failure would be lower than health people,but which could not discovery by eye. The investigators hypothesize that IRTI could evaluate heart failure by the imaging of temperature distribution in the face on early stages.The aim of this study is to determine the effectiveness of infrared thermal imaging in evaluating heart failure.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to participate in the trial and sign the informed consent form
2. Aged: 18-85 years
3. Was diagnosed as heart failure
4. There is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (face)
5. There is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases

Exclusion Criteria:

1. Fever causes by any reasons, temperature higher than 37.4℃
2. Infection
3. Renal failure
4. Cerebrovascular diseases
5. Moderate anemia or more
6. Not willing to participate in clinical trials
Evaluation of Nephrectomy Specimen for Intracranial Aneurysm Development in ADPKD

ADPKD is the most common form of hereditary kidney disease and is known to occur in 1 of 400 to 1000 population in the U.S. ADPKD consists of 2.8% of patients receiving kidney transplantation in the investigator's center. It is known that ADPKD is associated with vascular anomalies, including abdominal aneurysms, valvular anomalies and especially intracranial aneurysms. Intracranial aneurysms occur in 9\~12% of the ADPKD population which is higher than 2\~3% in the general population and is known to be associated with PKD1 or PKD2 heritage.

Until now, most of the studies regarding intracranial aneurysms in ADPKD are conducted in animal models, and there are only few cellular studies conducted from human samples. Total 154 patients received kidney transplantation for ADPKD from 1994 to December 2018 at Asan Medical Center, Seoul, Korea. While performing kidney transplantation to ESRD ADPKD patients, nephrectomy has been routinely performed for polycystic kidney and the nephrectomy specimens can be obtained. The objective of this study is to investigate the mechanism of intracranial aneurysm in ADPKD patients by analyzing gene characteristics from nephrectomy specimens.

ADPKD is associated with PKD1 gene on chromosome 16 and PKD2 gene on chromosome 4 and these gene respectively code polycystin 1 and polycystin 2. Currently the hypotheses for increased intracranial aneurysm rate in ADPKD patients is that mutation of polycystin is not only confined to nephron tissues but also in endothelial cells and vascular smooth muscle cells and results in mutation of vascular phenotype. Also recent studies show polycystin complex causes cystic changes through mutation in primary cilia in renal epithelium. Wild type endothelial cells respond to fluid shear stress by regulating levels of intracellular calcium and nitric oxide, however, PKD1 or PKD2 mutation in fetal aortic endothelial cells revealed loss of these responses.

During kidney transplantation, bilateral nephrectomies are routinely performed to ADPKD patients. In this study, the investigators plan to perform PKD gene tests and gene sequencing from polycystic kidney nephrectomy specimens of154 ADPKD patients who received kidney transplantation at Asan Medical Center between 1994 and 2018. The aim of this study to analyze the gene mutation of ADPKD patients and investigate mechanisms associated with intracranial aneurysm occurence in ADPKD patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients between age 18 and 80,
* Patients who received kidney transplantation for ADPKD at Asan Medical Center between 1994 and 2018,
* Patients who received nephrectomy for polycystic kidney

Exclusion Criteria:

* those who refuse or are unable to provide consent form,
* pregnancy
Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)

To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year
* Acute ischemic stroke confirmed by non-contrast computed tomography and use of CTA for assessment of LVO as determined by local investigators;
* The time from last known well to treatment: 4.5 - 6 hours;
* NIHSS ≥ 4 at randomization;
* First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
* Uncertainty over the benefits and risks of thrombolysis by researcher;
* Signed informed consent.

Exclusion Criteria:

* Pre-stroke disability (mRS≥2);
* Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion;
* Any contraindication to intravenous thrombolysis: Obvious head injury or stroke within 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Intracranial tumor, arteriovenous malformation or aneurysm; Intracranial or spinal cord surgery within 3 months; Myocardial infarction within 3 months; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Arterial puncture at a noncompressible site within the previous seven days; Active internal hemorrhage; Coagulation abnormalities: platelet count of \<100000/mm3; Aortic arch dissection; Heparin therapy within 24 hours; Infective endocarditis; Oral warfarin is being taken and INR\>1.6 or APTT abnormal; Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg; Blood glucose \< 50 mg/dl (2.7mmol/L); Neurological deficit after epileptic seizures;
* Pregnancy;
* Allergy to test drugs;
* Comorbidity with other serious diseases;
* Participating in other clinical trials within 3 months;
* Patients not suitable for the study considered by researcher.
Safety and Efficacy of Intravenous (IV) Dexmedetomidine During Flexible Bronchoscopy and Endobronchial Ultrasound

To achieve safe,consistent, continuous sedation using Dexmedetomidine in advaced bronchoscopy procedures that may reduce the need for rapid pain sedative infusion.

Dexmedetomidine hydrochloride as a single agent produces sedation, pain relief, anxiety redution, stable respiratory rates, and predictable cardiovascular responses. Dexmedetomidine facilitates patient comfort, compliance and comprehension by offering sedation with the ability to awaken patients. This study is being done to determine sedation efficacy and dosing; measure reduction or eliminate the need for rapid sedative infusion during bronchoscopy; improvement of patient comfort and safety during complex bronchoscopy; establish a new paradigm for moderate sedation during flexible bronchoscopy

Eligibility Criteria:
Inclusion Criteria:

* Adults between the age of 18 and 85
* Adults scheduled for flexible brochoscopy using EUBS (Endobronchial Ultrasound)

Exclusion Criteria:

* Sever bradycardia (rate \< 50) and / or related bradydysrhymias (e.g. advanced heart block)
* Impaired ventricular functions (EF \<30%)
* Hypovolemia or hypotension (SBP \<90 or MAP \<a55)
* Have GFR less than 15ml/min 1.73m2 or undergoing hemodialysis
* Endstage liver disease.
Multimodal Assessment of the Neurological Prognosis of Patients With Brain Lesions on ExtraCorporeal Life Support

It seems of the greatest importance to evaluate the neurological prognosis of patients with brain lesions after cardiorespiratory arrest or circulatory failure requiring circulatory assistance.

However, to date, there is no clinical or paraclinical diagnostic test to reliably assess the future of these patients.

The objective of this study is to highlight the clinical and imaging factors for establishing a neurological prognosis in patients at risk of brain lesions under ExtraCorporeal Life Support (ECLS).


Eligibility Criteria:
Inclusion Criteria:

* Patients with brain lesions on veno-arterial circulatory support after cardiac arrest or cardiogenic shock who require at least 24 hours of sedation

Exclusion Criteria:

* Extubation expected within the first 24 hours of management
* Minor patient
* Pregnant women
Risk Factors And Outcomes Of Hospital Acquired AKI

The aim of the study is to assess the common risk factors for development of hospital acquired acute kidney injury among hospitalized patients in Alexandria Main University hospital and their outcomes.

Hospital-acquired AKI (HAAKI) is defined as acute renal insult occurring 48 hours or more after admission to a health care facility and It is estimated to occur in 13-18% of hospitalized patients. The early diagnosis of HAAKI reflects on improvement in morbidity and mortality rates especially in developing countries which goes parallel with the goal The International Society of Nephrology (ISN) to eliminate preventable or treatable deaths from AKI by 2025, the "0 by 25" initiative.

Data concerning the spectrum of acute kidney injury (AKI) in Egypt are generally scarce.

Eligibility Criteria:
Inclusion Criteria:

1. Fulfilment of definition of acute kidney injury according to KDIGO reference.
2. Age more than 18 years.

Exclusion Criteria:

1. Mentally or physically unfit patients.
2. Patients who developed acute kidney injury within 48 hours of admission to hospital.
Canine-Assisted ANxiety Reduction IN Emergency Care IV

Prior literature demonstrates that human stress can be reduced with exposure to animals. This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient and provider stress. The objectives of this study are to determine if interaction with a certified therapy dog and handler can;

* decrease reported anxiety levels in emergency department (ED) patients,
* decrease salivary cortisol in ED patients,
* decrease total morphine equivalent dosing in the emergency department or at discharge and/or,
* decrease reported stress levels in emergency department providers caring for participating patients

when compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Age 18-89 years
* Chronic pain, defined as pain on most days for \>6 weeks
* Triage pain score \>6 out of 10

OR

* Age 18-89 years
* Currently experience crisis, including suicidality, or
* Meet the standard of a provider assessment of "severe stress" defined by their identification that the patient meets a score of greater than six on the FACES stress scale

Providers

• Faculty, residents, advanced practitioners, and nurses who work in the ED and identify themselves as being the nurse or physician of record for the enrolled patients.

Therapy Dog Handlers

• Handler of a certified therapy dog and volunteer of Eskenazi's Therapy Dog Program

Exclusion Criteria:

Patients

* Violent behavior
* Overt intoxication
* Non-English speaking
* Any reported prior fear or adverse reaction to dogs

Providers

• Any reported prior fear or adverse reaction to dogs

Therapy Dog Handlers

• None
GGO-dominant PPLs Diagnosis Using CLE and ssRAB-guided Cryobiopsy

The purpose of the study is to evaluate the diagnostic performance and safety of cryobiopsy for ground-glass opacity (GGO)-dominant peripheral pulmonary lesions (PPLs) under the guidance of shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with confocal laser endomicroscopy (CLE). Additionally, the study aims to establish CLE interpretation criteria for GGO-dominant PPLs based on histopathological characteristics and validate the proposed criteria.

This is a single-arm, single-center, and prospective study. Approximately 119 patients with GGO-dominant PPLs will be enrolled to undergo CLE and ssRAB-guided cryobiopsy for the diagnosis of lesions. During the procedure, CLE will be used to examine the lesion. The primary endpoint is the diagnostic yield of the procedure. The secondary endpoints include the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the procedure, CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions, and the complication rate.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years;
2. Thin-slice chest CT showing GGO-dominant peripheral pulmonary lesions (diameter≥8mm, GGO component≥50%);
3. Suspected pulmonary malignant tumor which requires transbronchial lung biopsy for diagnosis;
4. Patients who have good compliance and sign informed consent.

Exclusion Criteria:

1. Diffuse GGO, suspected of benign or infectious lesions;
2. Preoperative imaging showing the target biopsy lesion adjacent to medium or large blood vessels;
3. Patients with contraindications of bronchoscopy;
4. Presence of concomitant endobronchial lesion during the bronchoscopy procedure;
5. Pregnant or lactating women;
6. Patients with known allergy for fluorescein;
7. The investigators believe that patient has other conditions that are not suitable for the study.