cyrilzakka/clinical-trials huggingface dataset:
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock

In this prospective clinical study, the investigators compare the outcome and clinical course of consecutive septic participants treated with intravenous vitamin C, hydrocortisone, and thiamine (treatment group) with a control group treated in the investigators' ICU. The primary outcome is hospital survival. A propensity score is generated to adjust the primary outcome.There is 70 participants in each group.

A prospective randomized controlled trial is conducted.One hundred and forty severe sepsis or septic shock participants admit to the Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University from September 2017.The participants are divided into control group ( n = 70 ) and treatment group ( n = 70 ).The participants in both groups are treated according to "2016 international guidelines for management of sepsis and septic shock",and the participants in treatment group receive intravenous vitamin C, hydrocortisone, and thiamine. The participants in control group receive normal saline.The patients' clinical and demographic data, including age, sex, admitting diagnosis, comorbidities, requirement for mechanical ventilation, use of vasopressors, daily urine output, fluid balance after 24 and 72 h, length of ICU stay (LOS),and laboratory data (serum creatinine, White Blood Cell (WBC), platelet count, total bilirubin, procalcitonin(PCT), and lactate levels), are recorded.The primary outcome is hospital survival. Secondary outcomes include duration of vasopressor therapy,requirement for renal replacement therapy in patients with Acute kidney injury (AKI), ICU LOS, and the change in serum procalcitonin and Sepsis-Related Organ Failure Assessment (SOFA score) over the first 72 h. Summary statistics are used to describe the clinical data and are presented as means±SD, medians and interquartile range, or percentages as appropriate.Statistical analysis is performed with NCSS 11 (NCSS Statistical Software) and SPSS Statistics version 24 (IBM).

Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of sepsis or septic shock (the diagnoses of sepsis and septic shock are based on the 2016 the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)) and a procalcitonin (PCT) level≥2ng/mL.

Sepsis: Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.

Septic shock: Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.

Exclusion Criteria:

* Patients \< 18 years of age, pregnant patients, and patients with limitations of care.
Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand

The researchers planned this study to compare the effects of breast pumps, which are frequently used today, and manual milking after manual massage on the change in milk content when breast and breastfeeding problems develop.

Comparison of the methods used to solve the milk secretion and breastfeeding problems of the participants in the postpartum period; effective and uncomplicated methods should be put forward. Today, breast milk is expressed by hand using massage or pumps. Both milking techniques used have positive and negative aspects. While there are studies showing that breast milk content is affected by the milking techniques used, there are also studies showing that it does not. This study by the researchers was planned to compare the effects of post-massage pumps and manual milking on the change in milk content. For this reason, it is thought that the researchers will contribute to the literature scientifically and, since it is a doctoral thesis, it can be a guide for future studies on the subject.

Eligibility Criteria:
Inclusion Criteria:

Between the ages of 20-35

* Postpartum 1-5. between the day
* Those who gave birth after the 37th week of pregnancy
* The baby does not have any condition that prevents sucking
* Those whose baby is not hospitalized in the neonatal intensive care unit
* Those who do not have literacy problems, mental disabilities and communication problems
* Mothers who agreed to participate in the study voluntarily

Exclusion Criteria:

Those who want to quit working voluntarily

* Inaccessible, cut off communication during operation
* Mothers whose babies were hospitalized during the study
* Hospitalized during the study
* Not completing study post-tests
* Who does not do any milking for a day
* Mothers who express only once a day for two consecutive days
Knowledge and Awareness of Radiation Hazard in Health-care Personnel

Knowledge and awareness of radiation hazard in health-care personnel; A Quaternary-care academic center study Aim: To determine knowledge and concerning about radiation hazard in anesthetic personnel and surgeon

study decide: questionnaire based study to ask concerning and knowledge about radiation hazard


Eligibility Criteria:
Inclusion Criteria:

* Anesthetic personnel
* Surgeon: urology, orthopedic, cardiothoracic, neurosurgeon, general

Exclusion Criteria:

* none
The Effect of Laughter Yoga on Perceived Stress, Work Motivation, and Mental Well-Being

The aim of this randomized controlled experimental study is to examine the effect of laughter yoga applied to intensive care nurses on perceived stress, work motivation, and mental well-being.

The study was conducted with nurses working at Manisa Celal Bayar University Hospital's Surgical Intensive Care and Anesthesia Intensive Care units between December 2022 and March 2023. The Nurse Introduction Form, Nurse Work Motivation Scale, Perceived Stress Scale, and Warwick-Edinburgh Mental Well-being Scale were used to collect data.

Eligibility Criteria:
Inclusion Criteria: Between 18-65 age

* Those who have worked as intensive care nurses for at least 6 months
* Those who agree to participate in the research

Exclusion Criteria:

* Those with chronic cough
* Those who have previously received laughter yoga training and practiced
* Those who had surgery within the last 3 months
* Those with diagnosed mental illness and those using medication (antidepressants, antipsychotics,anxiolytic, etc...)
* Those who have neurological diseases such as epilepsy and multiple sclerosis
* Those who have recently experienced a loss (within at least 6 months)
* Those with neurological disorders
* Those who have urinary incontinence problems
* Those who did not agree to participate in the research
A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease

A cross-sectional, non-interventional study to assess walking performance, vascular function, and lower limb calcification in subjects with peripheral artery disease and end-stage kidney disease (PAD-ESKD) receiving hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* ≥55 years of age or ≥45 years of age with diabetes
* Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
* Resting ABI \<0.90 in either leg OR Resting TBI \<0.70 in either leg
* Symptomatic as characterized by a limitation in exercise performance

Exclusion Criteria:

* Above-ankle amputation
* Chronic limb-threatening ischemia (Rutherford 4-6)
* Non-ambulatory status
* A condition other than PAD that limits ability to walk
* Open or endovascular revascularization within 3 months prior to baseline.
* Illnesses, conditions, or planned surgeries within the study period that will interfere with the interpretation of the study results
Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging

Prospective, low intervention, open, single-center, non-commercial clinical trial to improve diagnostics in patients with histiocytosis by assessing the molecular profile of the tumor tissues, monitoring its presence in free-circulating DNA, and determining the efficacy of fluorodeoxyglucose (18F-FDG) in PET-CT imaging.

HISTIOGEN clinical study is part of the POLHISTIO project. The POLHISTIO project is a non-commercial clinical trial aimed at optimizing the diagnosis and treatment of juvenile patients with histiocytosis. The project objectives are defined as follows: 1) to estimate the nature and frequency of mutations in patients with histiocytosis in both tumor tissues and free-circulating DNA; 2) to compare molecular test results with clinical data; 3) to evaluate the diagnostic usefulness of the status of molecular analysis (MRD) as a prognostic factor compared with other recognized factors. As part of the HISTIOGEN protocol, an immortalized cell line will be derived to study the pathogenesis of the disease, drug sensitivity, and drug resistance mechanisms. The project is intended to include patients from all over Poland

Eligibility Criteria:
Inclusion Criteria:

1. Patient under 18 years of age at the time of inclusion.
2. Histopathologically confirmed or suspected histiocytosis (based on prior test results).
3. Signing of informed consent for trial participation according with current legal regulations.

Exclusion Criteria:

1. Lack of inclusion criteria.
2. Pregnancy.
3. Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.
TReatment Of Pulmonary HYpertension 1-US Study

The objective of this study is to assess the safety, performance and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation through subjective and objective change in clinical parameters and haemodynamic evaluation. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 4 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific medications.


Eligibility Criteria:
Inclusion Criteria:

* Patient with known pulmonary arterial hypertension (PAH), diagnosed as idiopathic PAH, connective tissue disease PAH, Anorexogen induced or Heritable PAH
* PAH diagnosis confirmed by hemodynamic evaluation performed prior to screening and showing all of the following: Mean pulmonary artery pressure (mPAP) ≥25 mmHg at rest; Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg; Pulmonary vascular resistance (PVR) at rest \>3 Wood units; Not meeting the criteria for a positive vasodilator response (fall in mPAP ≥ 10 mmHg to ≤ 40 mmHg).
* Patient with a current diagnosis of WHO functional class III
* Patient taking two pulmonary arterial hypertension specific medications other than parenteral prostanoids
* Patient is adhering to a stable drug regimen (i.e., with no changes of dose or medication for a minimum of 3 months prior to enrollment)
* Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150µmol/l

Exclusion Criteria:

* Patients who are treated with parenteral prostanoids
* Pregnant women or women planning a pregnancy within 12 months of study enrolment
* Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry
* Patient with life expectancy of less than a year
* Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
* Patient with pulmonary artery anatomy that precludes treatment
* Patient with moderate to severe pulmonary artery stenosis
* Patient with any pulmonary artery aneurysm
* Patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
* Patient who has implantable cardiac pacemakers, ICDs, neurostimulators, or drug infusion devices
* Patients who are unable to undergo an MRI scan
Improving Mental Health and School Performance in Urban Eighth Graders

This study assesses: (1) the impact of the Relax, Be Aware, Do a Personal Rating (RAP) Club, a school-based prevention program for urban eighth graders, on students' emotional functioning and education outcomes; (2) potential moderators and mediators of RAP Club's effects; and (3) factors related to the implementation of RAP Club, including cost of delivery and perceptions of key stakeholders.

Youth in low-income urban communities are often exposed to chronic stress and trauma, which poses risk for emotional, behavioral, and academic problems. This study will evaluate the impact of RAP Club, a trauma-informed school-based prevention program intended to promote positive emotional and academic development for eighth graders. Participants will be randomly assigned within schools to receive RAP Club or Healthy Topics, a health education active control condition.

The study will achieve the following specific aims:

1. Test whether students randomized to RAP Club have improved academic, social-emotional, and behavioral outcomes as compared to those randomized to Healthy Topics (e.g., student-reported mood and stress; teacher-rated academic performance; academic record data).
2. Explore potential moderators (e.g., baseline trauma exposure, emotional regulation) and mediators (e.g., changes in self-regulation and emotional symptoms) of RAP Club's effects.
3. Evaluate factors related to program implementation, including cost of delivering RAP Club versus Healthy Topics and perceptions of key stakeholders (teachers, group facilitators, students) regarding intervention acceptability and sustainability.

Eligibility Criteria:
Inclusion Criteria:

* Subject is attending eighth grade at a participating Baltimore City Public School
* Subject is not in a self-contained special education classroom
* Subject provides written parent permission and written assent

Exclusion Criteria:

* Non English-speaking
NIR Fluorescence Imaging With ICG for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours

This is an open-label pilot study including 10 GIST patients scheduled for an elective open or laparoscopic resection at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC), Rotterdam. Patients will receive a single dose injection of 10mg ICG at a given moment during the 24 hours prior to surgery or during surgery. The timing of administration will be determined according to a step-up, step-down procedure. Standard of care surgery will be performed and a NIR fluorescence imaging system will be used to record the GIST under fluorescence.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with GIST by histology or cytology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection.
* 18 years

Exclusion Criteria:

* History of an allergy or hypersensitivity to sodium iodide, iodine or ICG
* Patients with hyperthyroidism and patients with an autonomous thyroid adenoma
* Patients pregnant or breastfeeding
* Patients with severe renal insufficiency (eGFR \<30)
Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk.

Current national guidelines recommend the use of OLGIM score to evaluate the risk of gastric cancer in patients, and close gastroscopic monitoring should be performed after OLGIM grade III/IV. However, it would not be clinically feasible to require at least four biopsies. Confocal laser endomicroscopy is able to magnify the tissue by 1000X, which can be seen at the cellular level. Observing goblet cells under Confocal laser endomicroscopy is simpler and diagnostic accuracy is comparable to pathology. Confocal laser endomicroscopy enables better assessment of intestinal metaplasia in gastric mucosa, thus quantifying the risk of gastric cancer and avoiding multiple biopsies.

Globally, gastric cancer is the fifth most prevalent malignancy and the third leading cause of cancer mortality. Current national guidelines recommend the use of OLGIM score to evaluate the risk of gastric cancer in patients, and close gastroscopic monitoring should be performed after OLGIM grade III/IV. However, it would not be clinically feasible to require at least four biopsies. Confocal laser endomicroscopy is able to magnify the tissue by 1000X, which can be seen at the cellular level. Observing goblet cells under Confocal laser endomicroscopy is simpler and diagnostic accuracy is comparable to pathology. Confocal laser endomicroscopy enables better assessment of intestinal metaplasia in gastric mucosa, thus quantifying the risk of gastric cancer and avoiding multiple biopsies. The investigators aim to design the CGGIM scores to evaluate gastric cancer risk.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-80 years undergoing the confocal laser endomicroscopy examination

Exclusion Criteria:

* Patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
* Patients with previous surgical procedures on the stomach
* Patients with contraindications to biopsy
* Patients who refuse to sign the informed consent form
Relationship Between Level of GPCR Autoantibodies and Cardiac Structure & Funtions Based on UCG and CMR

This study is a prospective cohort study，we want to observe the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI;and combined with different cardiovascular antibody levels and various indicators, evaluate the impact of ischemia-reperfusion injury and prognosis in STEMI patients after emergency PCI.

This study mainly observed the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI by measuring autoantibodies; and the changes of autoantibodies in STEMI patients compared with coronary angiography-negative patients. At the same time, combined with different cardiovascular antibody levels and various indicators, the effect of ischemia-reperfusion injury and prognosis after emergency PCI in STEMI patients was evaluated. The correlation between autoantibody changes and imaging indicators in STEMI patients was evaluated by cardiac color Doppler ultrasound and CMR.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patients meet the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2015)"; ②STMEI patients undergoing emergency PCI should undergo emergency PCI within 12 hours of onset at Beijing Friendship Hospital affiliated to Capital Medical University; ③ The selected patients were able to complete the MRI and STE examinations; ④ They agreed to be enrolled in the trial and signed the informed consent.

Exclusion Criteria:

* Past myocardial infarction or revascularization (PCI or CABG); ②Congestive heart failure LVEF\<40%; ③Atrial fibrillation; ④Renal insufficiency (GFR\<30 ml/min); disease; ⑥ rheumatic immune system disease; ⑦ malignant tumor; ⑧ claustrophobia; ⑨ contraindication to CMR;
A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)

This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female patients with epilepsy on stable doses of topiramate.
2. Able to voluntarily provide written informed consent to participate in the study.
3. Use of an effective form of birth control if of child-bearing potential.

Exclusion Criteria:

1. Diagnosis of status epilepticus, non-epileptic seizures, or any progressive CNS disease.
2. Recent or recurrent suicidal thoughts or ideation.
3. Clinically significant medical condition that may affect the safety of the subject.
4. Females who are pregnant or lactating.
the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery

The method of Cotton Padding (mCP) was summarized by combining with many years clinical experience and the traditional ancient books.The mCP could be used in Rectovaginal Fistula (RVF) post operation effectively,in order to improve the wound.The research aim is to observe if the mCP could influence the time of staying in hospital, healing time after RVF surgery.

The method of Cotton Padding (mCP) originating from extensive and profound traditional chinese medicine (TCM) and being one of traditional surgical treatments of chronic wounds,could promote the wound healing after RVF surgery in previous clinical experience.

The research aim is to observe if the mCP could influence the time of staying in hospital, healing time,quality of life,complications after RVF surgery.

Also,investigators will try to explain the mechanism about the mDM improving the wound healing by the chinese architectural theory and the nanomechanical properties.

Eligibility Criteria:
Inclusion Criteria:

* rectovaginal fistula because of parturition,stapler,traumatic injury.

Exclusion Criteria:

* rectovaginal fistula because of IBD,radiation,cancer.
Comparison of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil and a Nitinol Guide Wire

In ERCP practice, most often a combined use of guidewires is necessary to attain a therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a stricture to a nitinol wire for improved stability with the use of therapeutic devices. A new guide-wire (G240) combines these characteristics with a stable shaft and a hydrophilic tip. The investigators test the hypothesis that the use of this new guidewire would decrease number of guidewires used within one ERCP session.

This is a randomized, monocentric study.

Eligibility Criteria:
Inclusion Criteria:

* Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data)

Exclusion Criteria:

* Operatively alternated anatomy of the patient.
* Intervention of the pancreatic duct.
Home Inotropic Therapy in Children

Inotropic therapy is a well-established practice for children with advanced congestive heart failure (CHF). Inotropes are intravenous medications to help the heart pump stronger and prolong life while awaiting heart transplantation. Traditionally children have been maintained on inotropic therapy in the hospital under close, monitored supervision. The United Network for Organ Sharing (UNOS), which governs organ distribution, has now changed listing criteria allowing patients awaiting heart transplantation to be discharged to home, yet maintaining a higher status on the waiting list. In adults, home inotropic therapy has been shown to be a safe and cost-effective bridge to transplantation. To date, there are no data on the use of home inotropic therapy in children.

Hypothesis:

We request to do a retrospective chart review of patients receiving this therapy to determine safety and efficacy of continuous ambulatory home inotropic therapy in children.

Hypothesis:

We request to do a retrospective chart review of patients receiving this therapy to determine safety and efficacy of continuous ambulatory home inotropic therapy in children.

Methods:

Data will be obtained from CHOA and Coram Home Healthcare, Inc over a two year period, January 1, 2004 through December 31, 2005. Data will be collected on approximately 35 children aged 0-18 years receiving therapy. The length of therapy, type of therapy, therapy-related complications, number of readmissions, deaths at home and catheter-related infections data will be collected.

Inclusion Criteria:

Receiving inotropic support at home Choa patients with Coram Healthcare only

Eligibility Criteria:
Inclusion Criteria:

* Receiving inotropic support at home
* Choa patients with Coram Healthcare only
* medical charts between 2.2.2004 and 12.31.2005

Exclusion Criteria:

* those who do not meet inclusion criteria