cyrilzakka/clinical-trials huggingface dataset:
Antiretroviral Switch From Didanosine to Tenofovir in HIV/HCV Co-infected Patients

The primary purpose of this study is to evaluate the impact of changing didanosine in an effective anti-HIV regimen to tenofovir on virologic suppression. We hypothesize that, in patients with maximal virologic suppression on a double class regimen (including two NRTIs and an NNRTI or a PI, boosted with RTV or not), a single drug substitution of didanosine for tenofovir will represent a viable strategy without any negative impact on the virologic efficacy of the regimen.

Primary objective - to determine the impact of changing part of an effective HAART regimen to tenofovir on maintenance of virologic suppression in HCV co-infected patients.

Secondary objective - to assess the safety and tolerability over 12 weeks in patients switched to tenofovir.

Research Method - This will be a single arm observational study to include 30 subjects. Patients requiring HCV treatment will be assessed and patients receiving didanosine will be clinically evaluated to determine an appropriate NRTI drug switch. Patients who are to switch the didanosine component of their regimen to tenofovir will be eligible to participate in the study and will be followed for a period of observation of up to 4 weeks. All patients will be receiving tenofovir as one capsule, once daily. The primary endpoint will be maintenance of virologic suppression between the Baseline visit and week 12 in the overall study group. Measures of adherence to HAART, safety, tolerability and CD4 cell counts will also be obtained at each study visit, and will constitute secondary study endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. Be age 19 or older;
2. Have a confirmed diagnosis of HIV infection;
3. Have a confirmed positive HCV RNA PCR;
4. Have two consecutive HIV RNA levels \<50 copies/mL with the most recent within the past 3 months;
5. Must not exhibit evidence of an acute illness, including an acute opportunistic infection;
6. Must not have any evidence of grade 3-4 laboratory abnormalities;
7. Must be able and willing to provide informed consent.

Exclusion Criteria:

1. Be receiving investigational drug within 30 days prior to beginning this study;
2. If female, be pregnant or breast-feeding;
3. In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for participation for any reason.
Photodynamic Therapy for COVID-19 Prevention

This is a single-center open-label study to evaluate antimicrobial photodynamic therapy (aPDT) for upper airway decolonization in patients presenting with SARS-CoV-2 positive antigen test with mild or no symptoms of COVID-19.

There is a wide variety of people who test positive for SARS-CoV-2. This is directly dependent upon their exposure to the virus, their age and any medical comorbidities that they may have. At this time, it is not possible to predict who will have an adequate immune response to avoid getting COVID-19. Since this remains unpredictable a universal approach to treating SARS-CoV-2 positive patients may be the optimal approach.

The rational for this study design is that in a real world setting numerous patients across a wide variety of conditions will receive testing for SARS-CoV-2 for a variety of reasons. For those who test positive and are asymptomatic or have only mild symptoms, the current standard of care is observation and quarantine. The incubation period can range from 2-14 days with a mean of 5-6 days. Depending upon an individual's original inoculum of virus, comorbidities and other factors they may progress to COVID-19. Preemptive treatment during this time frame may avoid or mitigate COVID-19 disease severity. In certain high-risk individuals attenuating the disease may avoid hospitalization or death, ICU admission and shorten hospital stays.

The nasal disinfection process rapidly and lethally disrupts the microbial cell wall, leaving human tissue unharmed. The topically applied photosensitizer formulation selectively stains bacteria by binding with microbial cell wall components. The red light is absorbed by the photosensitizer molecules, causing electronic state transitions within the photosensitizer. The excited photosensitizer immediately transfers energy to surrounding molecular oxygen, thereby producing reactive oxygen species (ROS) that are responsible for the lethal cell wall disruption.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female ≥ 18 years of age
4. Patient showing a positive test for SARS-CoV-2 with \< 26 Ct of an FDA-approved PCR test who is symptomatic or flu-like illness or pneumonia
5. Ability to tolerate an 12-minute non-painful nasal light illumination

Exclusion Criteria:

1. Inability to tolerate insertion of the light illuminator due to oronasal size, shape, or anatomical variants
2. Known allergic reactions to components of the nasal decolonization treatment including methylene blue or chlorhexidine gluconate.
3. COVID-19 illness that is moderate or severe in nature.
Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI

The investigators intend to evaluate Oxidative Stress biomarkers through a. Catalase Activity Assay; b. Lipid Peroxidation Assay; c. SOD Assay; d. Total Antioxidant Capacity Assay; e. Glutathione Peroxidase at patients with acute myocardial infarction STEMI referred for primary PCI; The investigators also aim to evaluate cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST in these patients with acute myocardial infarction referred for primary PCI; Also, the investigators intend to evaluate body composition through bioimpedance spectroscopy (BCM - Fresenius Care) at the moment of admission.

The investigators aim to fully characterise these patients through oxidative millieu, hFABP and make correlations with LVEF dysfunction.

Gathered data:

* Descriptive general demographic data;
* Previous pathologies (ischemic heart disease, peripheral arterial disease, stroke, heart failure, previous percutaneous coronary interventions, coronary artery bypass grafting - CABG, known renal disease);
* Cardiovascular risk factors (age, weight, height, abdominal perimeter, body mass index, smoking, sedentariness, diabetes, hypertension, dyslipidaemia);
* Oxidative Stress biomarkers: Catalase Activity Assay; Lipid Peroxidation Assay; SOD Assay; Total Antioxidant Capacity Assay; Glutathione ;
* Cardiac necrosis markers: Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and OGT;
* Routine biological data;
* Metabolic data (obtained from two body composition monitoring evaluations - before and 12 hours after coronary intervention) - body water, body fat tissue;
* Information regarding primary PCI (less than 12 hours of ischemic symptoms);
* Coronarographic details, type of used stent, periprocedural specific complications, final TIMI - thrombolysis in myocardial infarction - flow);
* Echocardiography at admission (LVEF);
* Measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial);
* Calculating of cardiovascular risk scores: Syntax Score, Framingham score, ASSIGN score, QRISK2 score, PROCAM score, CRUSADE score, GRACE score, CHADS VASc score, MESA score, ASCVD score, Hamilton Depression Rating Scale (HAM-D), Hamilton Rating Scale for Anxiety;
* In-hospital and one month follow-up MACE.

Eligibility Criteria:
Inclusion Criteria:

* Adults with ST elevation Myocardial Infarction (\<12h) diagnostic confirmed;
* Included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);

Exclusion Criteria:

* Patients who do not sign informed consent for primary PCI
Nutritional Support for Patients Operated for Malignant Tumors in HPD Zone

A comprehensive comparative analysis of the effectiveness of isolated enteral, isolated parenteral and mixed type of nutritional support in the early postoperative period in patients after operations performed on the malignant neoplasms of hepatico-pancreatico-duodenal zone.

A prospective, longitudinal, parallel study and retrospective analysis of the results of treatment of 91 patients with malignant tumors of the hepatico-pancreato-duodenal zone who underwent the following operations:

1. resection of various segments of the liver;
2. hemihepatectomy;
3. transhepatic drainage of the right and left hepatic duct;
4. bypass gastroenteroanastomosis or cholecystenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
5. gastro-pancreato-duodenal resection;
6. corpore-caudal resection of the pancreas with splenectomy.

The first group (n=31) included patients who received enteral nutrition (EN) after surgery. The second group (n=30) included patients who received parenteral nutrition (PN) and the third group (n=30) who received mixed nutrition (MN), as a variation of the partial parenteral nutrition technique, in the early postoperative period.

Some nutritional status indicators available for determination at the Oncology Clinic were assessed - body mass index (weight measurements were carried out before surgery, on the 5th, 10th and 15th days), basal metabolic rate (calculated using the Harris-Benedict equation, based on anthropometric data of the patient (gender, age, weight and height).), laboratory parameters: blood hemoglobin, lymphocytes, total protein, serum albumin, serum transferrin, total bilirubin and direct, alanine aminotransferase (ALT), aspartate aminotransferase (AST), which are related to the traditional method for assessing nutritional status

Eligibility Criteria:
Inclusion Criteria:

female and male patients in age of 20-75 with malignant tumors of the hepato-pancreato-duodenal zone who have undergone any of the following operations:

1. resection of various segments of the liver;
2. hemihepatectomy;
3. transhepatic drainage of the right and left hepatic duct;
4. bypass gastroenteroanastomosis or cholecystoenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
5. gastro-pancreatoduodenal resection;
6. corporecaudal resection of the pancreas with splenectomy.

Exclusion Criteria:

* patients in age of up to 20 and older than 75
* pregnant and breastfeeding women
Anesthesia Geriatric Evaluation and Quality of Life After Cardiac Surgery

A prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in cardiac surgery patients.

Introduction:

The current population is ageing in a rapid pace. Currently elderly represent 17.8% of the Dutch population. Most recent estimates show this will increase to 25.6% 20 years' time. This rise in elderly will also reflect on the population of patients being referred for cardiac surgery. Especially elderly patients are at risk for postoperative complications, mortality or functional decline. In frail elderly this effect might be more pronounced. Frailty is an umbrella term that encompasses patient related factors such as weight loss, muscle wasting, inactivity, comorbidities and polypharmacy. Current scoring systems that are used to predict postoperative mortality and complications following cardiac surgery perform poorly in the elderly population and do not take into account frailty. Moreover they are designed to predict mortality and complications and are not validated to predict patient reported outcome measures such as quality of life or functional status. The aim of the AGE study is assess the value of frailty factors in predicting an improvement in quality of life one year after cardiac surgery.

Methods:

The AGE study is a prospective observational cohort study. All patients aged 70 years or older, scheduled for cardiac surgery, mentally competent and have signed informed consent are eligible for the study. During routine preoperative screening patients will be screened for frailty using different questionnaires and physical tests. The battery of tests exist of Short Form 36 (SF36), Multi Nutritional Assessment (MNA), Mini Mental State Examination (MMSE) and Nagi's scale for disability, Three physical tests: five meter walking speed, timed get up and go test and hand grip strength. A non-invasive measurement of Advanced Glycation Endproducts (AGEs) and a medication review. A blood sample will be taken to determine vitamin status, iron deficiency, pre-operative inflammatory parameters, CMV status, pneumococcal carriage and cardiac biomarkers. After surgery electronic patients charts will be studied to score postoperative complications or mortality. Three months and one year after cardiac surgery patients will receive SF-36 and World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaires to determine quality of life and functional status.

Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years or older
* Mentally competent
* Planned cardiac surgery (coronary, valvular, rhythm, aortic or combination of those)
* Signed informed consent
Precision Medicine in the Management of Heart Transplant Recipients

The goal of this clinical trial is to demonstrate that a multiparametric approach, based on the integration of biomolecular, histological, imaging, and clinical information, along with the use of machine learning methods, can identify among heart transplant patients those at higher risk of rejection, infectious events, and chronic graft dysfunction.

Patients have been and will be treated according to clinical practice, in accordance with the physician's judgment and the information provided in the Technical Data Sheet of each individual product used in concomitant therapies, if administered according to clinical practice. The diagnostic-therapeutic pathway of the patients will not be in any way influenced by the results of tissue tests performed for the purposes of the study

The main focus of the study, and the primary outcome measure, is the diagnosis of rejection based on the histopathological examination of myocardial biopsies. At the time of each biopsy procedure, or within the 5 days immediately preceding, enrolled patients will undergo specific non-invasive investigations, along with baseline clinical and laboratory evaluations.

Additional analyses will be performed on myocardial tissue samples obtained during biopsies conducted for clinical practice, including the analysis of the intramyocardial gene expression profile (nanostring and microarray), to identify molecular profiles specific to cellular or antibody-mediated rejection.

The results of these investigations will be correlated with the findings from histopathological and molecular analyses of the biopsies using artificial intelligence methods, in order to develop a non-invasive investigation algorithm that can predict the risk of rejection.

Similarly, these diagnostic investigations will be longitudinally related to the incidence of infection events, as defined above, and to the development of myocardial fibrosis diagnosed by cardiac magnetic resonance imaging.

In a subsequent phase, biopsies will be reclassified through the examination of histopathological morphology using machine learning techniques. The result of the re-evaluation of the histological samples will be correlated with the diagnosis based on the intramyocardial gene expression and the predictiveness of the previously developed algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Have received an orthotopic heart transplant
* Clinical indication for performing a myocardial biopsy (either as part of standard monitoring or for suspected rejection)
* Obtaining informed consent

Exclusion Criteria:

* Severe complications in the post-operative phase that may limit the patient's short-term survival.
Comparison Between Percutaneous Femoral Nerve Neuromodulation Associated With Femoral Nerve Block and Standard Clinical Practice in Patients Undergoing Knee Arthroplasty.

The goal of this clinical trial is to compare the maximum isometric contraction force differential of the quadriceps in the postoperative period after the use of a peripheral nerve neuromodulation program in patients undergoing knee arthroplasty. The main questions it aims to answer are if the combination of a peripheral neuromodulation program in the perioperative period improves analgesic quality and short-term functional recovery in patients undergoing knee arthroplasty,

Participants will be asked to reach a maximum knee extension prior to neurostimulation Patients will have the electrodes inserted under direct ultrasound vision and placed near the femoral nerve.

Researchers will compare whether there is a difference in both quadriceps contraction force and analgesia between the stimulated group and the control group.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Those who sign the informed consent
* Not pregnant
* Cognitive capacity that allows subjective postoperative evaluations.

Exclusion Criteria:

* Under 18 years old
* IC rejection or withdrawal
* Pregnancy
* Cognitive impairment
* Contraindication for Regional Anesthesia
The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia

The goal of our protocol is to re-establish patency in ALLI, by combining both balloon maceration of a thrombus and angiojet PMT thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk .

Acute lower extremity arterial ischemia (ALLI) is a common emergency in vascular surgery that has a high risk of limb amputation and mortality .It is caused by the blockage of an arterial flow to an extremity, which can be either thrombotic or embolic . Timely diagnosis and proper treatment for ALI are critical as to save limb viability .

Treatment options include surgical embolectomy, catheter-directed thrombolysis (CDT) , as well as pharmacochemical thrombectomy , Each of those approaches has its own disadvantages.

Fogarty manoeuvre embolectomy although flexible technique that can be used in a variety of situation, it is an open surgical procedure, carries the risk of complications such as bleeding and wound healing disorders. Additionally, it may impose a risk of arterial wall injury in the presence of underlying arterial lesions.

While CDT avoids common surgical complication its advantages include high risk of thrombo-lytic bleeding, residual thrombosis and long operation time and hospital stay.

As to address those limitations previous research has shown that using PMT as a first-line treatment for ALI provides rapid reperfusion to the extremity, reduces procedure time, and has an low risk profile .

The AngioJet Thrombectomy System (Boston Scientific Corporation, Marlborough, MA, USA) is a rheolytic PMT device that utilizes pressurized saline jets to generate a localized low-pressure zone (Bernoulli principle that results in fragmentation of the thrombus at the distal tip of the catheter.

The saline jets also provide the driving force through which the macerated thrombus particles are removed from the lesion site through the catheter. Several studies have demonstrated the effectiveness of the AngioJet system .

The goal of our protocol is to re-establish patency in ALLI, by combining both balloon maceration of a thrombus and angiojet PMT thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk .

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Symptom onset within 14 days for acute limb ischemia or within 30 days for subacute limb ischemia due to embolic or thrombotic occlusion of a native arteries, bypass graft, or arterial stent.

Rutherford category I, IIa or IIb

Exclusion Criteria:

* ALLI secondary to dissections, vasculitis, and/or target vessel trauma
* Pregnancy or positive pregnancy test
* Rutherford category III Irreversible (neglected) limb ischemia
* patients allergic to contrast agent,
* serum creatine\>300 mmol/L
OUT OF THE ICU SHIFTING

Numerous studies dealt with the hospital doctors' work but little is known about the work of ICU doctors, especially concerning the medical time spent outside the Intensive Care Unit (ICU) which is a significant workload that has never been evaluated to date. The main objective of our study was to evaluate the time spent by ICU doctors outside the unit, for the management of their patients during the IHT and for the care of patients in other departments. Secondary objectives were to describe the organization and distribution of medical time outside the intensive care unit.

In this observational study, which took place during 5 years, from January 2012 to December 2016 in the medical ICU of the "Nouvel Hôpital Civil" at the University Hospitals of Strasbourg, every day after the morning medical staff, the anonymized information were collected in a register.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Physician anesthetist of Intensive Care Unit of new civil hospital in Strasbourg
* Physician anesthetist who has agreed to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
Rapid Assessment of Donor Liver Quality

Aims：

1. Conduct multi-center, prospective and open research on liver quality assessment and establish LSCM liver quality assessment system
2. Classification of liver quality grades by LSCM for different pathological conditions (steatosis, fibrosis, hepatocyte necrosis, etc.)
3. Compare the specificity and sensitivity of LSCM evaluation results with the results of liver donor quality evaluation and intraoperative pathological biopsy results.
4. LSCM classifies the quality of donor liver and compares the recovery of liver function on the first day after liver transplantation.
5. LSCM grades the quality of donor liver and compares the long-term prognosis


Eligibility Criteria:
Inclusion Criteria:

* All donor livers to be used for liver transplantations

Exclusion Criteria:

* Exclusion of multiple organ transplantation
* Exclusion of detached transplantation and partial liver transplantation, etc.
* Removal of blood type incompatible patients for transplantation
* Exclusion of poor donor liver quality due to surgical technique (such as hepatic artery embolization) , portal vein thrombosis, etc.)
* Any form of substance abuse, mental illness or any disease that the investigator believes may interfere with the patient's understanding of the research requirements.
* Can not complete routine research follow-up, and other circumstances that the investigator believes are not suitable for the experiment.