cyrilzakka/clinical-trials huggingface dataset:
Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis

Several studies have pointed out changes in the epidemiology of the causative bacteria in SBP and bacterascites and in their susceptibility to antibiotics. In particular, the development of beta-lactamase enzymes, which confer resistance to clavulanate, or extended spectrum beta-lactamases in Escherichia coli. The potential emergence of enterococci, methicillin-resistant S. aureus, or fluoroquinolone-resistant bacteria, following norfloxacin prophylaxis, is also a cause of concern since they may be associated with a higher risk of therapeutic failure.

The microbial etiology of SBP remains relatively constant; however, the antibiotic resistance rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime), ciprofloxacin, and ofloxacin increased dramatically

Spontaneous bacterial peritonitis (SBP), defined as an infection of ascites in the absence of a contiguous source of infection.

Spontaneous bacterial peritonitis (SBP) is a common and potentially fatal bacterial infection in patients with cirrhosis and ascites, occurring in 10 to 30% of patients, with in-hospital mortality rates ranging from 20 to 30% .

It is secondary to impaired humoral and cellular immune responses that result in indirect intestinal bacterial translocation into the ascitic fluid.

SBP is also associated with a poor long-term prognosis for patients, as mortality rates can reach 50 to 70% at 1 year.

Early diagnosis and early optimal treatment of these infections with appropriate antibiotics and the prevention of hepatorenal syndrome with albumin are required .

Current European and most other international guidelines recommend the use of a third-generation cephalosporin as the first choice, or amoxicillin-clavulanate acid or fluoroquinolones as an alternative choice.

These recommendations are based mainly on clinical trials that were very often conducted a decade or more ago, and on the assumption that E. coli would be involved in nearly half of the cases.

Several studies have pointed out changes in the epidemiology of the causative bacteria in SBP and bacterascites and in their susceptibility to antibiotics. In particular, the development of beta-lactamase enzymes, which confer resistance to clavulanate, or extended spectrum beta-lactamases in Escherichia coli.The potential emergence of enterococci, methicillin-resistant S. aureus, or fluoroquinolone-resistant bacteria, following norfloxacin prophylaxis, is also a cause of concern since they may be associated with a higher risk of therapeutic failure.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis with ascites and suspected to have SBP.
* ascitic fluid PMNL ≥ 250 cells/mm3

Exclusion Criteria:

* ascitic fluid with polymicrobial infections
* patients started empirical antibiotics without prior culture.
Bioboosti Device for Insomnia Treatment

The purpose of this study is to determine the effects of the Bioboosti device on sleep for patients who have been diagnosed with insomnia.

Insomnia is a common health complaint that is associated with discomfort, loss of productivity, poor health and higher use of healthcare. The use of non-pharmacologic treatments for insomnia has gained much attention in recent years. The investigators are conducting this research because a safe, non-pharmacologic treatment would benefit patients with insomnia, and to see if the Bioboosti device is an effective treatment for insomnia.

Subjects will include patients from the clinics who have the diagnosis of insomnia. Study staff will notify the treating physician of a potential subject. If the subject gives permission and would like to obtain more information, study staff will approach them and provide them with the consent form to review. Study staff may also contact them by phone to explain the study and recruit.

Subjects will be asked to make 5 visits:

Visit 1-- consent form, physical exam, vitals, pregnancy test, sleep log

Visit 2-- sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG

Visit 3-- remove EEG, beginning of treatment with Bioboosti device, sleep log Treatment phase-- subjects use the Bioboosti at home for two weeks

Visit 4-- return of Bioboosti, sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG

Visit 5-- remove EEG, collect sleep logs

Eligibility Criteria:
Inclusion Criteria:

* Patients with insomnia

Exclusion Criteria:

* Untreated moderate or severe sleep apnea
* Major circadian rhythm disorder
* Pregnant women
* Breastfeeding
* Cardiac pacemaker
* Cancer
* Severe conditions related to heart, brain, kidney and hematopoietic system
* Severe/unstable angina pectoris
* Arteria coronaria/ peripheral arterial bypass graft
* Acute congestive heart failure
* Renal insufficiency
* Mechanical intestinal obstruction
* Any electrical devices
Deep Learning-based Classification and Prediction of Radiation Dermatitis in Head and Neck Patients

to develop a deep learning-based model to grade the severity of radiation dermatitis (RD) and predict the severity of radiation dermatitis in patients with head and neck cancer undergoing radiotherapy, so as to provide support for doctors' diagnosis and prediction.

1. Image acquisition The images of the neck area were collected from the enrolled patients one week before and every week during radiotherapy. The photographs were taken from three angles (front, left and right oblique) of the neck area.
2. Grading evaluation Each image was individually graded by three experienced radiotherapy experts according to the RD criteria of RTOG
3. Data analysis Construct a dermatitis grading model basing on deep learning. Evaluate the performance of model using accuracy, precision, recall, F1-measure, dice value.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Histologically or cytologically confirmed head and neck carcinoma confirmed by pathology.
* Receive radical radiotherapy including neck area
* Informed consent.

Exclusion Criteria:

* unable to cooperate with image acquisition
(LARS) Score Validation of Turkish Language

Long-term bowel dysfunction after resection for rectal cancer, known as low anterior resection syndrome (LARS), is observed in many patients. The LARS score was developed to measure this syndrome and its impact on quality of life in Danish patients. Recently, English and many other language versions have been validated. The aim of this study was to validate the Turkish translation of the LARS score in Turkish patients who have undergone treatment for rectal cancer.

A total of 326 patients were reviewed and contacted for the study, and 222 (68%) were eligible for the analyses. The association between the LARS score and quality of life and the test-retest reliability were studied. The intraclass correlation coefficient (ICC) was calculated to understand the degree of reliability.

Eligibility Criteria:
Inclusion Criteria:The inclusion criteria were

* rectal adenocarcinoma within 15 cm from the anal verge
* LAR with either PME or TME.
* Bowel continuity restored for at least 18 months when invited for the study.

Exclusion Criteria:Exclusion criteria included

* failed R0 surgery,
* recurrence or dissemination,
* having intestinal stoma,
* previous cancer (except minor skin cancers)
* dementia and inability to speak Turkish (i.e., the need for a translator during treatment).
Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study

Study to evaluate the safety and procedural performance of the KODEX - EPD System when used in the treatment of cardiac arrhythmias. An additional objective is to develop patient specific optimized therapy (PSOT PMCF) via machine learning to improve future treatment of cardiac arrhythmias (PSOT).

PSOT PMCF is a prospective, multi-center, non-randomized, open label, single arm observational/ registry clinical study. Consented subjects who are scheduled to undergo an ablation procedure due to an arrhythmia will be enrolled in the clinical study. The clinical study consists of a standard-of-care index ablation procedure and following up subjects for 12 months to evaluate product safety. The index ablation procedure will be performed using the KODEX - EPD System in conjunction with compatible therapeutic and diagnostic catheters. Electrophysiologists should follow current, local, and expert consensus guidelines when treating subjects.

The PSOT Sub-Study Secondary System is a sub-study of the PSOT PMCF study. The objective of the sub-study is to collect data for the evaluation of the performance of new software features via a secondary system in subjects undergoing standard of care catheter-based endocardial mapping for cardiac arrhythmia's using a commercial KODEX EPD Mapping System.

The KODEX-EPD system in this clinical investigation will have a Primary/Secondary configuration. Data collection and processing will be done on the Primary system in the interventional lab with market released software and the Primary system will be used to guide therapy. Data from the Primary system will be transferred to a second (Secondary) workstation in the control/observation room via unidirectional communication and data on the Secondary system will be processed with non-released software.

Results from this sub-study will be used to support the development and refinement of new software features. It is not the purpose of this sub-study to obtain CE mark.

The primary endpoint of the sub-study is data collection of the KODEX-EPD non-released features from a secondary system.

Eligibility Criteria:
Inclusion Criteria:

1. . Subjects who are eligible for an ablation procedure based on local guidelines,
2. . Subjects must be 18 years of age or above and at a legal age to give informed consent specific to state and national laws
3. . Subjects must be able and willing to comply with all follow-up requirements

Exclusion Criteria

1. . Women who are pregnant (as evidenced by pregnancy test if pre-menopausal; method of assessment upon the discretion of the investigator),
2. . Life expectancy less than 12 months,
3. . Participation in a concurrent clinical study without prior approval from EPD Solutions.
4. . Any contra-indication to use KODEX-EPD System per User Manual.
5. . Unrecovered/unresolved adverse events from any previous invasive procedure
Bacterial Metallophores in the Diagnosis of Acute Pyelonephritis

The project aims to investigate bacterial metallophores as potential diagnostic markers of acute pyelonephritis and complicated urinary tract infections. These secondary metabolites are excreted by pathogenic microorganims in the course of infection for the uptake of iron and other metallic ions from the host. They are species-specific and can be detected in body fluids (including urine) by mass spectrometry. The potential contribution of this project is a culture-independent method for the diagnosis of the causative microbiological agent.

Acute pyelonephritis (AP) is a clinical syndrome characterized by fever, chills, nausea vomiting and costovertebral angle tenderness, bacteriuria and pyuria. The underlying pathophysiology is based on the presence of microbes in the renal parenchyma which may progress to sepsis. Complicated urinary tract infection (cUTI) is one accompanied by abnormalities of the urinary tract or host factors which make the eradication of the infection difficult.

The most common etiological agents include gram-negative enteric rods, i.e. E. coli, Klebsiella pneumoniae; and Enterococcus spp. Empirical antibiotic treatment should be targeted once culture and sensitivity results become available. This usually takes 24-48 hours, occasionally even 72 hours. Inadequate antibiotic treatment leads to higher mortality if the etiological agent is of a multi-drug resistant phenotype.

Metallophores are a major virulence factor of bacterial pathogens. These are chelating molecules secreted by the microbe for the uptake of iron, copper, and other metals from the host. E.g., siderophores aim at Fe3+ ions removal from the host protein molecules; the complex then adheres to specific extracellular receptors on the microbial cell and is internalized. Yersiniabactin is another metallophore which binds copper.

Proteomic analysis using mass spectrometry has been used in the detection of biomarkers for several pathological conditions: renal failure, post-transplant nephropathy, various malignancies etc. Metallophores can be detected by mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* in-patient with clinical signs and symptoms of AP/cUTI or out-patient with clinical signs and symptoms of acute uncomplicated pyelonephritis or in-patient with no clinical signs of UTI and a negative standard urine culture result

Exclusion Criteria:

* inability to consent
Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection

The goal of this clinical trial is to evaluate the efficacy of colistin compared with colistin plus fosfomycin against carbapenem-resistant Acinetobacter baumanii infection in Thailand. The main questions it aims to answer the following main questions:

1. Which group has better clinical response at end of treatment
2. Which group has better clinical response at 72 hours and micrological cure at 72 hours and at end of treatment

Participants will be randomized in a 1:1 ratio to receive a combination of intravenous colistin plus intravenous fosfomycin (combination group) or colistin alone (monotherapy group) to determine if monotherapy or combination therapy has a better outcome.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 20 years old patients who have CRAB infections (pneumonia, urinary tract infection, skin and soft tissue infection, bloodstream infection)
* Able to provide informed consent or having a legal proxy who can provide informed consent in case the subject is unable to provide consent on his own

Exclusion Criteria:

* Minimum inhibitory concentration (MIC) of colistin \> 2 mg/L
* Complicated infection with inadequate source controlled
* Intracranial infection
* Infective endocarditis
* Intraabdominal infection
* Bone and joint infection
* Allergic to or have contraindication(s) to any treatment regimen in the study
* Polymicrobial infection with Carbapenem-resistant Psuedomonas aeruginosa, Carbapenem-resistant Enterobacterales (CRE), Vancomycin-resistant Enterococcus (VRE)
* Pregnancy
* Previous treatment with colistin or fosfomycin more than 96 hours
* Life expectancy of 24 hour or less
* Refusal to participate in the study
* Hospice treatment
Percutaneous Closure of Atrial Septal Defects in Children: Integration of 3D Echocardiography and Fluoroscopy Imaging.

The interventional catheterization allows the percutaneous treatment of congenital heart diseases as the atrial septal defect (ASD). The examination is guided by the X-rays with stochastic side effects worrying at the child's. The software "Echonavigator" allows to merge the ultrasound image and fluoroscopic. This innovative software facilitates the procedures and reduce the irradiation time in some adult procedures.

The aim of this study was to validate the image fusion in children.

The software "Echonavigator" will be used after the introduction of the percutaneous closure of ASD prosthesis. The image fusion on fluoroscopy will then be applied and the bias between the generated ultrasound image and the X-ray view of the prosthesis will be measured. The center marker visible prosthesis ultrasound and fluoroscopy used as a reference marker.

Eligibility Criteria:
Inclusion Criteria:

* Weight higher than or equal to 20 kg
* Presence of an ostium secundum atrial septal defect diagnosed by transthoracic echocardiography and associated with a shunt from left to right evidenced by the significant dilation of the right cavities liable to a closure
* The ASD should have an anatomy allowing percutaneous closure according to international recommendations

Exclusion Criteria:

* Children with contraindication to transesophageal ultrasound according to international recommendations
* ADS with minor shunt without indication of closure
* Refusal to participate in the study expressed by parental authority
Fat Burning After a Meal

The purpose of the study is to determine how adding a carbohydrate beverage to a meal with different protein levels affects the rate at which one's body burns fats, sugars, and proteins.


Eligibility Criteria:
Inclusion Criteria:

* BMI less than 25 kg/m2
* ability to sign the consent form
* availability of transportation

Exclusion Criteria:

* percent body fat greater than or equal to 25% for males and 35% for females
* allergies to any study foods
* more than a 10% change in body weight within the past 2 months
* current or planned pregnancy
* lactation
* metabolic illness/disease(s)
* active cancer or in short-term remission (less than 3 years)
* infectious diseases
* alcohol or drug abuse
* tobacco use
* presence of acute illness
* taking medications known to affect energy expenditure and appetite
Nonrandomized Evaluation of a Multidimensional Behavioral Intervention

This intervention is designed to promote enhanced use of compensation strategies including calendar and task list use, and organization systems, as well as increased engagement with brain health activities including physical exercise, cognitive activities, and stress reduction.

The purpose of this study is to test the feasibility and efficacy of a 10-week multi-dimensional intervention for older adults with subjective cognitive concerns (SCC). The goal of this intervention is to enhance compensation skills related to everyday executive and everyday memory functions through training in the systematic use of a calendar system, goal setting and task list system, and organizational strategies within the context of the individual's daily life. This multidimensional intervention program also targets engagement in healthy lifestyle activities (physical exercise, intellectual stimulation, positive emotional functioning) to further promote brain health and functional resilience. Importantly, both treatment components work synergistically as the use of compensation strategies assists in building healthy activities into daily routines (e.g., scheduling exercise into one's calendar and putting it on a task list).

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of subjective cognitive complaints (SCC)
* Age 65+
* English speaking
* Available informant to complete surveys
* Ambulatory

Exclusion Criteria:

* Known neurological condition
* Severe psychiatric illness (e.g., current depression)
Low Dose Dexamethasone for Distal Radius Fractures

The addition of the steroid dexamethasone to a single injection of local anesthetic has been shown to significantly prolong the duration of peripheral nerve blockade compared to local anesthetic alone. This allows for improved post-operative pain scores and reduces opioid use in the early post-operative period. However, the use of a steroid adjuvant in regional nerve blocks is generally not considered standard of care, and there is considerable variation among anesthesiologists regarding preferred formulations and the role of adjuvants in regional anesthesia. A recent study from our institution demonstrated the effectiveness of dexamethasone directly mixed with local anesthetic at multiple doses compared to placebo for upper extremity surgery. With this prospective randomized controlled blinded trial, we hope to definitively establish which method of adjuvant dexamethasone administration is superior in extending the effects of a brachial plexus nerve block.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 undergoing open reduction and internal fixation of a distal radius fracture less than 3 weeks from injury with a volar plate technique
* American Society of Anesthesiologists (ASA) levels 1 through 3 at time of surgery
* Opioid naïve patients

Exclusion Criteria:

* History of Drug/opioid/alcohol abuse
* Polytrauma patients
* History of inflammatory disorder, infection, dementia, psychiatric/neurological disorder, relevant drug/local anesthesia allergy, relevant chronic upper extremity pain (RSD, fibromyalgia, neuralgia, etc)
* Excessive BMI
* Pregnancy
Neurologic and Neurophysiologic Assessment of Clinical Course in Patients With Intraspinal Processes

Patients included in the study are treated at the Klinik für Neurochirurgie USZ. The clinical course is documented at Paraplegikerzentrum Balgrist using validated diagnostic procedures (e.g. SCIM, ASIA, neurophysiology).

Study aims:

Prognostic value of clinical diagnosis and additional diagnostic procedures? Which parameters exhibit optimal prognostic power? Differences between tumor/AVM associated lesions and traumatic lesions? What can we learn for pathophysiology and treatment?

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria:

* Benign intraspinal process (tumor or vascular malformation AVM)
* Primary lesion caudal of the brainstem, affecting C1
* Cognitive ability to give written informed consent

Exclusion criteria:

* Metastases, malign tumors
* Traumatic lesions
* Myelitis, polyneuropathy
* Disc prolaps
Use of Anticoagulant, and Associated Factors of Anticoagulant Refusal Atrial Fibrillation Patients

Atrial fibrillation is a clinically significant cardiac arrhythmia that increases the risk of stroke by 3 to 4 times. Oral anticoagulation has been shown to mitigate stroke risk by two-thirds among patients with AF and is widely recommended in optimizing AF management.Direct oral anticoagulants have also been demonstrated to be superior to warfarin with respect to the risk of fatal bleeding and stroke prevention.

However, the previous study finding highlighted a great gap between current guidelines and the clinical management of AF .Nonetheless, the decision for anticoagulant use is not straightforward.It is worth to investigate the updated prevalence of anticoagulant use, the reasons for not receiving anticoagulant, and the factors independently associated with anticoagulant refusal in patients with non-valvular atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis as atrial fibrillation
* aged ≧18 years
* able to given consent

Exclusion Criteria:

* Unable/unwillingness to sign informed consent to study
* mechanical heart valve
* moderate-to-severe mitral stenosis
* Transient atrial fibrillation from reversible cause (e.g., during respiratory tract infection or bronchospasm)
* pregnancy
* hospitalization within 1 month prior to inclusion in the study.