cyrilzakka/clinical-trials huggingface dataset:
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

Prospective, multi-center, randomized, feasibility clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the CytoSorb® device.


Eligibility Criteria:
Inclusion Criteria:

* Elective, cardiac surgery requiring cardiopulmonary bypass with anticipated duration of \>180 minutes

Exclusion Criteria:

* Platelet count \< 20,000/ uL
* Body mass index \<18
* Pregnant women
* Life expectancy of \<14 days
* End stage organ disease
* Active infection
* Undergoing cardiac transplant or ventricular assist device explant, isolated primary coronary artery bypass grafting (CABG) or single valve procedure
* Contraindication to anticoagulation with heparin
* Declined informed consent
Analysis of T Cell Metabolism in Relapsed AML Patients With DLIs and Bicanorm Treatment

In this study, the outcomes of relapsed AML patients receiving DLIs and Bicanorm (Sodium bicarbonate) were analyzed including T cell metabolism and immune phenotype.

Acute myeloid leukemia (AML) patients suffering from relapse after allogeneic hematopoietic cell transplantation (allo-HCT) have a poor survival outcome. Donor lymphocyte infusions (DLIs) to induce graft-versus-leukemia (GvL) effects have a limited survival benefit.

Extensive preclinical studies have shown a beneficial effect of sodium bicarbonate on metabolic fitness of leukemia-reactive T cells in GvL AML models. Therefore, the investigators aimed to investigate a potential benefit of Bicanorm (Sodium bicarbonate) treatment accompanying DLIs in relapsed AML patients. The investigators determined the metabolic and immune phenotype of T cells isolated from patients receiving DLIs before and after Bicanorm (Sodium bicarbonate) treatment.

Eligibility Criteria:
Inclusion Criteria:

* confirmed AML relapse after allo-HCT
* patients receiving DLIs
* age ≥ 18 years
* written informed consent
* ability to understand the nature of the study and the study related procedures and to comply with them

Exclusion Criteria:

* age \< 18 years
* lack of informed consent
Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT

Holmium laser enucleation of the prostate (HoLEP) is routinely performed with 24F, 26F, and 28F laser scopes. Proponents of larger caliber scopes suggest that the larger scope size allows for improved visualization, hemostasis, and operative efficiencies. Proponents of a smaller scope diameter suggest that by eliminating the need for pre-HoLEP urethral dilation to accommodate a larger scope. It has also been proposed that a smaller caliber scope is less traumatic to the urethra resulting in lower rates of bladder neck contracture and urethral stricture disease. Currently, to our knowledge, there are no level one evaluation examining scope size 22F versus 26F sheath in laser enucleation outcomes. The aim of our study is to determine if a smaller diameter scope is associated with improved laser enucleation time, post-operative recovery, rates of same-day discharge, or increasing intra-operative or postoperative complication rates


Eligibility Criteria:
Inclusion Criteria:

1. Males over 50 years of age at the time of enrollment
2. Referred to urology for refractory LUTS secondary to BPH
3. Failed medical (non-surgical) treatment
4. Prostate size on preoperative TRUS of \> 80 ml
5. IPSS \>15, QOL score ≥3 and Qmax \<15 ml/sec
6. Written informed consent to participate in the study
7. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

1. Previous surgical treatment for BPH
2. History of prostate cancer
3. Prostate size \< 80 mL
4. History of urethral stenosis or its management
5. Known or suspected neurogenic bladder
6. Participants with active urinary tract infection until appropriately treated
7. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
Effects of Nature Exposure Intervention on Soccer Performance Among Mentally Fatigued University Players

The current study is going to investigate the nature exposure intervention on the ability of self-regulation and decision-making skills among mentally fatigued soccer players. The subjects will be instructed to view some nature photos, which can facilitate the recovering process for directed attention and the ability of self-regulation. Thus, to see the improvement in decision-making skills.

The intervention of this study is nature exposure, specifically, instruct subjects to view and immerse in some nature photos due to the humanity of biophilia.

The condition of mental fatigue will be induced by the Stroop task.

Before the intervention or process of viewing photos, the baseline will be recorded to compare the post-test value of self-regulation and the score of decision-making skills.

Moreover, the different durations of viewing photos will be implemented to identify the optimal selection.

Eligibility Criteria:
Inclusion Criteria:

* The selection of the participants will be every position without the goalkeeper. The age of them will be at 18-24 years. Only male players will be selected. Players should have at least played from the senior school and have 3 years' training experience.

Exclusion Criteria:

* The study will exclude color blindness, for the Stroop task will involve color. Self-reports should be free of any known disease or sleep disorder and not currently taking any medication.
Doll Therapy on Patients With Moderate and Severe Dementia

Doll therapy is one of the non-pharmacological methods that can be practiced in managing the symptoms of dementia patients. Nurses can practice doll therapy independently, and literature reports that it has positive effects on the behaviors, moods, emotions, cognitive states and social life of patients with moderate and severe dementia. Our country had no study that investigated the effect of doll therapy in managing the cognitive and behavioral symptoms of dementia patients. This project is a randomized controlled trial that aims to investigate the effect of Doll therapy on the cognitive states and agitation levels of patients with moderate and severe dementia.

Dementia is a progressive neurodegenerative disease increasing in prevalence due to the aging population that grows in parallel with the increased life expectancy at birth in recent years. It is characterized with a progressive deterioration in cognitive abilities and memory. Due to the increasing losses in cognitive and physical functions, people with dementia become in need of nursing over time. Agitation is the most common behavioral symptom.

Agitation is defined as improper verbal, vocal and motor activity that are not purposeful and are not caused by confusion. Verbal and physical aggression, restlessness, aimless wandering, profanity, self-harm, continuous and repetitive questioning behavior emerges.Agitation should be managed with reliable and tolerable, effective methods in order to affect the quality of life of both the patient and the caregiver negatively.

Doll therapy is one of the non-pharmacological methods that can be practiced in managing the symptoms of dementia patients. Nurses can practice doll therapy independently, and literature reports that it has positive effects on the behaviors, moods, emotions, cognitive states and social life of patients with moderate and severe dementia.Our country had no study that investigated the effect of doll therapy in managing the cognitive and behavioral symptoms of dementia patients. This study is a randomized controlled trial that aims to investigate the effect of Doll therapy on the cognitive states and agitation levels of patients with moderate and severe dementia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with moderate to severe dementia (those with a SMMT score of 17 or less)
* Having dexterity to hold or caress a baby
* No problem with communication obstruction
* Dementia patients who agree to participate in the study

Exclusion Criteria:

* Mild stage dementia,
* Diagnosed with neurological or psychiatric diseases other than dementia, not accepting the baby despite two attempts,
* Rarely agitated dementia patients with baby dolls
Pause and Breathe: Online Self-Help Mindfulness-Based Intervention: Investigation of Its Efficacy and Mechanism of Change

The current study aims to evaluate the effectiveness of a 4-week self-help online mindfulness-based intervention on mental and physical well-being in comparison to the waitlist control group. This study can provide support to the utility of self-help online mindfulness-based intervention, which may advance our understanding of the causal pathways between mindfulness-based intervention and well-being and guide future research. It is hypothesized that participants in the experimental condition will show better mental well-being, physical well-being, and better improvement in mindfulness and related attributes compared with participants in the control condition.

Upon completing the screening and pre-evaluation questionnaire, participants will be randomly assigned to either mindfulness group or waitlist control group. They will complete three sets of questionnaires in total which will be administered before the intervention (pre-test assessment), right after the 4-week intervention (post-test assessment), and four weeks after the intervention (follow-up assessment), respectively. In the experimental group, participants in the mindfulness group will engage in a 4-week online mindfulness course. The self-help online mindfulness course includes education about mindfulness, guided meditations (e.g., mindful breathing, mindful eating, mindful walking, body scan, acceptance, choiceless awareness and disengaging from thoughts exercise), and guidance on using informal mindfulness skills in day-to-day life. Readings, audio and videos are included to explain the concept of mindfulness and overcome common difficulties associated with mindfulness practice. In the waitlist control group, participants are to refrain from access the online course until they finished the follow-up questionnaire. All participants will be able to access the materials in an online platform after they have completed the research.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be over age 18
* Have access to computer and mobile phone (since this is an internet-based study)
* Have ability to read and comprehend Cantonese

Exclusion Criteria:

* Completion of mindfulness-related program/research in the past 3 months
* Have regular mindfulness practice
Clinical Screening for Firearm Violence Risk

The purpose of the proposed work is to harness cutting-edge machine learning methods to optimize prediction of future firearm violence in youth ages 18-24 so that prevention resources can be allocated efficiently.

Firearm violence is a public health crisis in the United States, and new epidemiological data suggest we may have reached a new endemic level of firearm mortality in recent years. Youth are disproportionately affected by firearm violence, with those age 18-24 being demonstrably the highest risk group. This study will recruit 1,500 youth age 18-24 from urban emergency departments (EDs) in three broadly different locales-Flint, Philadelphia, and Seattle-and administer a baseline survey covering several domains of potential risk factors for future violence, and follow up with those youth at 6- and 12-months to ascertain the primary outcome-firearm violence involvement (as victim or perpetrator, including threats and sub-clinical injuries)-as well as the secondary outcomes: high-risk firearm behaviors, non-firearm violence, and violent injury. This work will generate new insights into the prediction of firearm violence, and will lay the ground for future research involving the development and testing of interventions for interpersonal firearm violence both by identifying potential high-leverage modifiable predictive factors, and by focusing on youth most in need of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Flint, Philadelphia, or Seattle Youth between the ages of 18-24 seeking care for any reason at Hurley Medical Center, the Hospital of University of Pennsylvania, Penn Presbyterian Medical Center, or Harborview Medical Center Emergency Department
* Can provide consent for the study

Exclusion Criteria:

* Do not understand English (\<1% in prior work)
* Unable to provide consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability.
* ED visit requiring intensive psychosocial services (e.g., sexual assault, psychosis, active suicidal ideation, or child abuse)
* In active police custody/prisoners (as they cannot provide consent)
Early Detection of COVID-19 Using Breath Analysis - Feasibility Study

Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.

An interventional diagnostic prospective study study with risks and minimal constraints.

Eligibility Criteria:
Inclusion Criteria:

Hospitalized group:

* Age 18 to 75 years at the time of consent
* Positive results for SARS-CoV-2
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Was not treated with Anti-viral drugs
* Not a pregnant woman

Healthy group:

* Healthy volunteers
* Age 18 to 75 years at the time of consent
* No history of COVID-19
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Was not treated with Anti-viral drugs
* Not a pregnant woman

Sexes Eligible for Study: All

Exclusion Criteria:

Hospitalized group:

* Age under 18 years old
* (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure or claustrophobia when wearing the sampling mask
* Persons under guardianship or deprived of liberty
* Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease

Healthy group:

* Age under 18 years old
* History of COVID-19
* Persons under guardianship or deprived of liberty
* Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
Network Medicine Approaches to Classify Heart Failure With PReserved Ejection Fraction by Signatures of DNA Methylation and Point-of-carE Risk calculaTors (PRESMET)

Heart failure (HF) is a syndrome, resulting from structural or functional impairment of ventricular filling or ejection of blood. Effective HF management depends on accurate and rapid diagnosis requiring assessment of symptoms and physical signs in combination with advanced and expensive imaging tools. However, several challenges arise from the traditional symptom-based diagnosis because co-morbidities of HF have similar presentations. This implies the need for a deeper knowledge of mechanistic links among genetic and epigenetic events governing the pathophysiology of HF leading to a novel molecular-based system to differentiate HF phenotypes. Now, it is emerging that the pathophysiology of HFpEF and HFrEF is different, it provides an opportunity to identify biomarker candidates that could aid in HF diagnosis and stratification between these two forms of the disease. The aim of PRESMET project is to perform liquid biopsy strategies to identify novel putative non-invasive epigenetic-sensitive biomarkers that could be used either alone or in combination with established diagnostic tests, such as natriuretic peptide, to help differentiate HFpEF from HFrEF. The Investigators will perform DNA methylation analysis on CD4+ T cells isolated from patients versus controls. Remarkably, big data generated from NGS tools will be analyzed by advanced network-oriented algorithms. Our results may provide a useful clinical roadmap in order to improve precision medicine and personalized therapy of HF.

The Investigators will perform the first Network Medicine approach to integrate the DNA methylome of circulating CD4+T cells and clinical parameters in patients with HFpEF and HFrEF.

Liquid biopsy strategies will be performed to isolate PBMCs and purificate CD4+ T cells. Successivelly, genomic DNA will be extracted on columns and will be send out for RRBS.

Network-oriented algorithms will be used to analyze DNA methylation signatures and to identify specific epigenetic changes in relation to left ventricle ejection fraction.

Network-oriented DNA methylation signatures will be integrated to the H2FPEF point-of-care calculator and, then, will be validated by the use of q-RT-PCR, WB, and ELISA.

Eligibility Criteria:
Inclusion Criteria:

* HFrEF (LVEF \< 40%)
* HFpEF (LVEF \> 50%)

Exclusion Criteria:

* Patients with HF with a history of a reduced LVEF ≤ 40% (HFrEF) who recover LV function (LVEF ≥ 50%)
* Chronic inflammatory diseases
* Cancer
A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections

Intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic bacteria. Antibiotics used in intra-abdominal infections should aim to cover organisms such as Enterobacteriaceae and Bacteroides fragilis, which are the commonest organisms known to cause such infections. Combinations of a third-generation cephalosporin, an aminoglycoside and metronidazole are often used to treat such infections in surgical settings. An alternative to such combinations is the use of a beta lactam - beta lactamase inhibitor combination. Magnex (cefoperazone- sulbactam) is one such combination, which has been shown to be as effective as a standard multidrug regimen such as gentamicin and clindamycin in the management of intra-abdominal infections. The combination of ceftazidime, amikacin and metronidazole has been chosen as a comparator regimen because of its broad coverage of Gram-negative and anaerobic organisms found in such conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged greater or equal to 12 years
* Intra-abdominal infection documented by laparotomy or laparoscopy or percutaneous aspiration within 24 hours prior to screening
* Presence of at least three of the following five indicators consistent with intra-abdominal infections (Fever, leucocytosis, abdominal symptoms, abdominal signs, radiological evaluation)
* Written informed consent obtained

Exclusion Criteria:

* Rapidly progressive illness or critically ill subjects
* Pregnant or lactating women, or women of childbearing potential not using an effective method of contraception.
* Treatment with a presumably effective systemic antimicrobial agent for \>24 hours within a 72 hour period prior to study entry unless the subject did not sufficiently respond to the treatment (as judged by the investigator)
Postpartum Depression

Postpartum depression (PPD) is one of the most common psychiatric complications of pregnancy and postpartum. It is often defined as an episode of depressive disorder that occurs in the postpartum period. Evidence suggests that PPD has serious consequences on the quality of life of all family members, increases the risk for familial conflicts, leaving great negative effects on maternal-infant interaction. The aim of our study was to investigate and shed the light on the determinants of development of PPD mainly maternal age among women in Jordan. We also aimed at examining additional factors on prevalence of PPD and providing more information on PPD among Jordanian mothers.

This was a retrospective descriptive cross-sectional study and included patients were those diagnosed to have PPD within 6 months of delivery at Jordan University hospital (JUH) in the period 1st of January 2014 to the 1st of March 2021, Amman, Jordan. Data was collected retrospectively from the electronic files, from the departments of obstetrics and gynecology and psychiatry JUH in patients, outpatient clinics, inpatients' files delivery room records. All data are electronic in the period of the study. Inclusion criteria; patients with confirmed diagnosis of PPD with complete clinical data and have no other psychiatric diseases. Exclusion criteria; patients with maternal blues, patients with a diagnosis of any other psychiatric diseases, cases of unconfirmed depression and those with missing data.

Main outcome measure was the number of patients who developed PPD within 6 months of childbirth in relation to age, parity and mode of delivery. We collected data of patients who were confirmed to have a diagnosis of postpartum depression by a consultant psychiatrist in the hospital who followed diagnostic criteria of the American psychiatric association11. Intellectual disability was not specifically assessed in our patients.

The variables and information collected for this study included age, parity, mode of delivery, body mass index (BMI) that was objectively measured routinely in our obstetric population. In addition, medications, chronic diseases, past history of depression, psychiatry, breast feeding, and any social or marital problems were also retrieved. Data related to antenatal complications like antepartum hemorrhage (APH), diabetes mellitus (DM), preeclampsia toxemia (PET), urinary tract infection (UTI)/pyelonephritis necessitated hospital admission, postpartum hemorrhage (PPH) with no need for blood transfusion, PPH with blood transfusion, emergency hysterectomy for bleeding, fetal outcome including nursery (good, term), neonatal intensive care unit (NICU) admission: preterm, hypoxemia/acidosis, birth trauma, congenital anomalies, fetal loss \[Intrauterine Fetal Death (IUFD), stillborn, neonatal\] were also obtained

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed diagnosis of PPD
* with complete clinical data
* have no other psychiatric diseases

Exclusion Criteria:

* patients with maternal blues
* patients with a diagnosis of any other psychiatric diseases
* cases of unconfirmed depression
* those with missing data.
Histopathological Analysis Versus Full-field Optical Coherence Tomography of Minor Salivary Gland Biopsy in Suspect Sjogren Syndrome

Primary Sjögren syndrome (pSS) is a systemic autoimmune disease that mainly affects the exocrine glands leading to severe dryness of mucosal surfaces, principally in the mouth and eyes. The other clinical manifestations are fatigue and musculoskeletal pain. Diagnosis of pSS associates clinical abnormalities with specific antibodies (Ro/SSA and La/SSB antibodies) or histopathological criteria of a minor salivary gland biopsy (the presence and number of lymphocytic focus, as well as chronicity findings like acinar atrophy, ductal dilatation or fibrosis). Apart from its variable sensitivity, one of the weaknesses of minor salivary gland biopsy is the delay in obtaining the result due to the time required to prepare the sample for histological analysis.

Our group recently demonstrated the use of full-field optical coherence tomography (FF-OCT) to visualize structural changes associated with the inflammatory processes in Giant Cell Arteritis (temporal artery biopsy examination). It may suggests a further use of dynamic FF-OCT of minor salivary gland biopsy to visualize structural changes associated with the lymhocytic focus to ensure rapid on-site diagnosis of pSS.

This study does not require additional examination, and will use the data performed from the minor salivary gland biopsy carried out as part of usual care, in comparison with the results of the conventional histopathological examination.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years of age with suspected Sjogren Syndrome received minor gland salivary biopsy

Exclusion Criteria:

* Inability to perform dynamic full-field optical coherence tomography observation at the moment of temporal artery biopsy