cyrilzakka/clinical-trials huggingface dataset:
Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry

The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients.

This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings.

The AquaPass system is non-invasive and functions independently of the renal system, targeting the direct removal of fluids directly from the interstitial compartment through the skin, by activating the eccrine sweat glands.

The patient wears a component that is connected to a control unit, which induces warm air to create a controlled environment around the skin, stimulating sweat production. The sweat evaporates instantly, ensuring that the patient remains dry and comfortable.

In this study, the investigators would like to further investigate the efficacy of the system, when used in hospital settings in patients hospitalized for decompensated heart failure and fluid overload, and to continue the treatment in their homes, immediately after the hospitalization, for another 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Subject that was hospitalized with fluid overload and a history of chronic heart failure and CKD stages 1-4
* Subject has composite congestion score ≥3.
* Baseline systolic blood pressure at rest of ≥100mmHg.
* Subject is capable of meeting the following study requirements:
* For patients with BMI \<30 kg/m2: baseline NT-pro BNP\>1,600 pg/ml
* For patients with BMI \>30 kg/m2: baseline NT-pro BNP \>800 pg/ml
* For patients with rate-controlled persistent or permanent AF: NT-pro BNP \>2,400 pg/ml.
* Subject successfully completes 2-4 hours of run-in acclimation session
* Minimal sweat rate in the last hour of run-in acclimatization of 130gr/hours

Exclusion Criteria:

* Subject is enrolled to another clinical investigation that might interfere with this study.
* Baseline systolic blood pressure \<100 mm Hg
* Subject considered to be in the acute worsening of the heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrythmia, infection or other medical condition unrelated to fluid overload.
* Subject has any known lower body skin problems (open wounds, ulcers)
* Subject with severe peripheral arterial disease
* Subject is pregnant or planning to become pregnant within the study period, or lactating mothers.
* End-stage renal disease (eGFR\<15 ml/min/1.73 m2) or requiring dialysis.
* Inability or unwillingness to comply with the study requirements.
* History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD).
* Implanted left ventricular assist device or implant anticipated \<3 months.
* Malignancy or other noncardiac condition limiting life expectancy to \<12 months.
Dendritic Cell Vaccine to Prevent COVID-19

This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.

Subjects eligible for treatment will be those who at baseline, are not actively infected with SARS-CoV-2, have no evidence of prior infection with SARSCoV- 2 based on serologic testing, and give informed consent for a vaccination with AV-COVID-19. The patient population will include the elderly and others at higher risk for poor outcomes after COVID-19 infection. For this reason, individuals will not be excluded solely on the basis of age, body mass index, history of hypertension, diabetes, cancer, or autoimmune disease.

After enrolling for screening, subjects will undergo a nasal swab test to exclude active COVID-19 infection and a rapid test for anti-coronavirus antibodies to exclude pre-existing anti-SARS-CoV-2 antibodies. 50 mL of blood will be collected, from which peripheral blood monocytes will be isolated and differentiated into DC before incubation with SARS-CoV-2 S-protein, during which time the protein is digested into 9 to 25 amino acid peptide sequences presented on the dendrites of DC in conjunction with histocompatibility class I and class II molecules. Safety and quality testing will be performed on a small quantity of the batch, and the remaining AV-COVID-19 will be cryopreserved for shipping to the treatment site.

Once the Study Drug is ready, if eligible, the subject will be seen at Study Week-0 for treatment. Prior to injection of the Study Drug, a nasal swab test will be collected to confirm that they are still negative for COVID-19, and blood will be drawn to determine baseline levels of anti-SARS-CoV-2 antibodies. At the treatment site, the product will be thawed and admixed with saline or (saline with GM-CSF), and within 5 hours of thawing, will be injected SC via a 25- gauge needle

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older,
2. in relatively good health with adequate physical and mental function
3. including factors associated with in increased risk for medical complications associated with COVID-19 infection or increased risk for exposure to SARS-CoV-2

Exclusion Criteria:

1. Active COVID-19 infection by PCR testing
2. Pre-existing IgG or IgM SARS-CoV-2 antibodies
3. Pregnant, Known hypersensitivity to GM-CSF
4. Known active immune deficiency disease or active HIV
5. HBV, HCV, On active treatment with corticosteroids or other immunosuppressive agent
6. Participated in previous COVID-19 vaccine study
STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation

Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).

Most current guidelines recommend to focus on continuing antiplatelet therapy (mostly with aspirin) during noncardiac surgery if possible. Although previous study showed efficacy of continuous antiplatelet therapy in reducing perioperative ischemic cardiovascular events, its effectiveness is still not clear between perioperative bleeding and ischemic risk. Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).

Eligibility Criteria:
Inclusion Criteria:

* Age 19-85 years
* Planning of elective noncardiac surgery or invasive procedure
* At least 1 year interval between the surgery or procedure and last PCI with next generation DES
* Currently on antiplatelet therapy

Exclusion Criteria:

* PCI with BMS(bare metal stent), 1st generation DES or bioresorbable vascular scaffold
* Total length of inserted DES in the 3 vessels \>60 mm
* History of stent thrombosis
* History of coronary artery bypass grafting surgery
* Planned surgery or procedure with high bleeding risk including followings: intracranial neurosurgery, spinal canal surgery, and eye posterior chamber surgery, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), ampullary resection, endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy plus large-balloon papillary dilation, endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) of cystic lesions
* Left ventricular ejection fraction \<40%
* Myocardial infarction within 6 months
* Any overt thromboembolism requiring medical surveillance and/or treatment
* Any clinically overt sign of hemorrhage within 3 months
* Anticoagulant therapy for any reason
* Need of continuation or discontinuation of antiplatelet therapy during surgery or procedure at the discretion of cardiologist or operator
* Any contraindication, adverse drug reaction or hypersensitivity to aspirin
* Pregnant women or women with potential childbearing
* Inability to understand or read the informed content
Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation

Liver is an organ that is well-known for its immune tolerant capacity. However, there were still controversial issues about the impact of immunologic challenge after liver transplantation on the graft function. Different results of graft function affected by immunologic factors such as pre-transplant panel reactive antibody (PRA) status, pre-transplant positive lymphocyte cross match (LCM), or post-transplant circulating donor specific antibody (DSA) has been reported according to individual institutes. There was no trial for presenting anti-donor lymphocyte antibody change after liver transplantation.

The investigators designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode. Also, the investigators will find aspects of anti-donor lymphocyte antibody change after liver transplantation.

Study Design: Target study population is forty patients who will undergo liver transplantation for 1 year in YUHS. Pediatric and early mortality cases will be excluded. Blood sample will be collected at pre-transplant period, post-transplant 7, 14, 21 day, 3 month and 6 month.

Eligibility Criteria:
Inclusion Criteria:

* Liver recipients who undergo liver transplantation between Mar, 2011 and Feb, 2012
* Patients who can be followed for more than 3 months after transplantation

Exclusion Criteria:

* Age under 20 years
* Multi-organ transplantation
* Not agree with informed consent
* Patient who had plant to be transferred to other country or center
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images

AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital fundus images using Artificial Intelligence (AI)-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥22
* Male or female
* Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO).
* Understand the study and volunteer to sign the informed consent

Exclusion Criteria:

* Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
* Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
* History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
* Currently participating in another investigational eye study and actively receiving investigational product for Diabetic Retinopathy (DR) or Diabetic Macular Edema (DME).
* Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
* Participant is contraindicated for imaging by fundus imaging systems used in the study:

  1. Participant is hypersensitive to light
  2. Participant recently underwent photodynamic therapy (PDT)
  3. Participant is taking medication that causes photosensitivity
  4. Participant has a history of angle-closure glaucoma or narrow anterior chamber angles
Malnutrition Assessment Tools in Surgery

The purpose of this study is to evaluate the main malnutrition risk assessment tools in patients undergoing operations of general surgery.

This is a multi centre prospective observational study including patients undergoing major/major+ operation of general surgery. Patients will be interviewed by surgical trainees and their malnutrition risk will be assessed with the use of SGA, MUST, NRS, MNA-SF etc. Clinical variables and demographics will also be recorded in order to enable meaningful comparisons of malnutrition risk assessment tools in terms of serious postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients undergoing elective or emergency surgery. Urgency of emergent operations is classified as follows, according to the clinical judgment of the surgeon, regarding the maximum time a patient could wait for surgery:

  * 3.Expedited (\>18 hours)
  * 2B. Urgent (6-18 hours)
  * 2A. Urgent (2-6 hours)
  * 1. Immediate (\<2 hours)
* Operations involving the gastrointestinal tract
* Magnitude of operation graded by POSSUM \[17,18\]:

  * Major+ (examples include colonic resection abdominoperineal resection of the rectum, radical total gastrectomy, intestinal bypass, whipple resection)
  * Major (examples include adhesiolysis, stoma formation, small bowel resection, anterior resection, cholecystectomy and exploration of the bile duct)

Exclusion Criteria:

* Age \<18 years
* Magnitude of operation graded by POSSUM:

  * Minor
  * Intermediate
* Inability to perform nutritional assessment
* Inability to provide informed consent
Cognitive Function Analysis and qEEG Study in Long COVID-19 Syndrome Patients

Over than 30% individuals with COVID-19, including the asymptomatic ones, and around 80% of patients hospitalized with COVID-19 may experience post-COVID sequelae, which is commonly referred to as Long COVID Syndrome. This condition has ties to decreased cognitive function and may lead to neuropsychiatric disorders but still need to be studied further. Using a cross-sectional design, this study will analyze the relationship between cognitive function and neuropsychiatric disorders with brain wave activity in Long COVID patients.

The investigators conducted assessments utilizing the quantitative electroencephalogram (qEEG) measurement method and interviews using instruments such as the MOCA questionnaire and Self Rating Questionnaire (SRQ). With this qEEG examination, the investigators hoped that there will be an imbalance/abnormality of brain wave activity that arises related to impaired cognitive function.

This study is aimed to analyze the cognitive function and neuropsychiatry disorders with brain wave activity using qEEG that occurs after COVID/Long Covid Syndrome.

The whole procedure will run for approximately 12 weeks based on the long COVID range.

The determinants of long COVID patients include: never been vaccinated, old age, comorbid, female population, and hospitalized patients.

The total number of subjects with the post-COVID syndrome in the proportion test is 30 subjects.

The measuring instruments used to measure the decline in cognitive function are the MOCA questionnaire and Self Rating Questionnaire (SRQ).

The target population is post-COVID-19 patients with Long COVID Syndrome.

The accessible population is post-COVID-19 patients who have been treated at RSCM Kiara and have regular checkups at the RSCM polyclinic with Long COVID Syndrome for 12 weeks or more.

The control population is post-COVID-19 patients who managed to recover without symptoms.

The Long COVID Syndrome patients who meet the inclusion criteria and have signed the consent.

Eligibility Criteria:
Inclusion Criteria:

1. Post-COVID-19 patients with Long COVID-19 Syndrome
2. Over 18 years old
3. Willing to participate in the research
4. Completed the Montreal Cognitive Assessment (MoCA) and Self Rating Questionnaire (SRQ)

Exclusion Criteria:

1. Patients with neuropsychiatric disorders before being infected with COVID-19
Prognostic Factors of Patients With COVID-19

The outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in China has been declared a public health emergency of international concern. Despite lower mortality rate, SARS-CoV-2 has killed more people than SARS and MERS and the number keeps growing. Epidemic studies have been well described clinical features of patients with COVID-19, with the disease severity being an independent predictor of poor outcome. However, there is still no research investigating the prognostic factors of patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Adult aged \>=18years old;
* Diagnosed with CONVID19. Diagnostic criteria including: Laboratory (RT-PCR) confirmed SARS-Cov-2 infection; CT of the lung conformed to the manifestation of viral pneumonia.
* Criteria for severe or critical ill conditions: Respiratory rate \>=30/min; or Rest SPO2\<=93%; or PaO2/FiO2\<=300mmHg.

Exclusion Criteria:

* Near-death state (expected survival time less than 24 hours);
* Malignant tumor;
* Pregnancy or puerperium women;
* Patients who refused to participant.
Enhancing Slow Wave Sleep With Sodium Oxybate

The purpose of this study is to determine if there the impact of sleep deprivation upon sleepiness, attention, memory, and mood is reduced by pharmacologically enhancing slow wave sleep (SWS) with sodium oxybate.

SWS has been hypothesized to be a time of relatively high neural recuperation from wakefulness. That hypothesis has been prompted by a number of observations, including: 1) enhanced SWS following sleep deprivation in proportion to the duration of prior wakefulness, 2) reduced amounts of SWS during nocturnal sleep following afternoon/evening naps, 3) a gradual decline in SWS across a night of sleep, and 4) increased SWS following nights of fragmented sleep. Within the two-process model of sleep regulation, heightened SWS has been viewed as reflecting Process S, the homeostatic component. Many authors have proposed that increased SWS represents ongoing cortical recovery from prior wakefulness activities and is a time of relatively heightened neurophysiologic restoration or recuperation. In a prior study which we conducted (Walsh et al., 1994) there was a suggestion, from post hoc analyses, that SWS may prevent adverse effects of sleep loss. Additionally, we recently published the results of an investigation of pharmacologically-enhanced SWS (with tiagabine) during sleep restriction which demonstrated preserved neurobehavioral performance despite sleep restriction (Walsh et al, 2006). In the proposed research we will examine whether pharmacological enhancement of SWS with sodium oxybate reduces the impact of sleep deprivation upon sleepiness, attention, performance, mood, and autonomic nervous system activity.

Eligibility Criteria:
Inclusion Criteria:

1. males and females, ages 18-50 inclusive
2. use of adequate contraceptive procedures throughout the study for females.

Exclusion Criteria:

1. pregnancy or lactating
2. prior use of or allergy to sodium oxybate
3. participation in a clinical research trial within the past 30 days
4. blood donation within the past 30 days
Follow-Up Extension to the Family Study of Binge Eating Disorder

This study involves a 2.5 and 5 year follow-up interview for individuals who participated in the initial family study of binge eating disorder. The study includes individuals with and without eating disorder as well as their first degree relatives. As part of the study, participants will be interviewed about their current psychiatric and medical symptoms, their blood pressure will be measured, and laboratory specimens will be obtained.

Previously we completed a family interview study of 150 individuals with binge eating disorder, 150 matched controls, and approximately 888 of their first degree relatives. In follow-up to this, we are interviewing these individuals again at 2.5 and 5 years after their initial interview. During the course of the interview, individuals are asked about their psychiatric and medical history and blood pressure and laboratory specimens are obtained to measure, among other things, fasting lipids and glucose.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with or without binge eating disorder and their family members who participated in the initial family study of binge eating disorder and agree to be followed up at 2.5 and 5 years.

Exclusion Criteria:

* Unwilling or unable to participate in the follow-up study.
A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections

The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tract infections (bladder infections).

This is an open-label (all people involved know the identity of the intervention), multi-center (conducted in more than 1 center) study, to evaluate the safety and effectiveness of doripenem in treating Thai participants with nosocomial pneumonia, complicated intra-abdominal and urinary tract infections. The study consists of 4 visits: Visit 1 (Baseline), Visit 2 (End-of-Treatment \[EOT\], up to Day 14), Visit 3 (Phone visit, Test-of-Cure \[TOC\], up to Day 14 after EOT) and Visit 4 (Phone visit, Day 90). Participants will receive 500 milligram (mg) of doripenem as intravenous infusion (directly into the vein) every 8 hours for at least 3 days after clinical response and extended up to 14 days. Efficacy will primarily be evaluated by determination of clinical response. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Eligibility Criteria:

Inclusion Criteria:

* Male or female participants with 18 years old age and above
* Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections
* Must have evidence of a systemic inflammatory response syndrome with at least one of the these: fever (body temperature greater than 38 degree celcius) or hypothermia (body temperature less than 36 degree celcius) or elevated total peripheral white blood cell count greater than or equal to 12,000 cells per cubic millimeter or leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood pressure relative to Baseline of greater than 15 millimeter of mercury systolic or increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater than 20 bpm
* Candidate for treatment with carbapenems, with at least one of these conditions: Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial infection with failure of previous treatment or modified therapy; known pathogens with resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/ batalactamase intibitor and susceptible to carbapenem or known infection caused by gram negative bacteria
* Signed informed consent

Exclusion Criteria:

* Pregnant or lactating female participants
* History of severe allergies to antibiotics such as penicillins, cephalosporins and carbapenems
* Hypersensitivity to doripenem and/or excipients
* Previous use of carbapenems within 7 days of study entry
* Participants in terminal stage of malignancy