cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients

Therapeutic plasma exchange (TPE) has been proposed as a rescue therapy in critically ill COVID-19 patients. The aim of this study is to determine whether combining TPE with convalescent plasma (CVP) transfusion early during the intensive care unit (ICU) stay, improves survival among this heterogeneous population.

This single centre prospective, non-randomised controlled trial will be conducted in an 8 bed COVID-19 ICU and will include patients with severe COVID-19 pneumonia requiring ICU monitoring and therapy. 19 patients will be treated performing TPE followed by CVP transfusion while for 19 patients will receive standard treatment according to hospital protocols. TPE will be initiated during the first 24 hours after ICU admission, followed immediately by transfusion of CVP. The primary endpoint is survival at 30 days. Secondary endpoints include assessing the evolution of biomarkers, such as the partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio), C reactive protein (CRP), lactate dehydrogenase (LDH) and ferritin at the 7-day follow-up.

Eligibility Criteria:
Inclusion Criteria:

* positive reverse transcriptase PCR test for COVID 19
* COVID-19 pneumonia
* All patients included were adults (\>18 years)
* Acute respiratory failure

Exclusion Criteria:

* pregnant women
* patients with suspected or confirmed pulmonary embolism
* patients with terminal disease
Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS)

The specific aim of this study is to validate our hypothesis that the magnetic ureteral stents have the same amount of adverse effects as the more commonly used non-magnetic ureteral stents. If this hypothesis would be confirmed then the usage of magnetic ureteral stents would be justified for both reducing patient discomfort by way of fewer cystoscopies and possibly also decreasing the overall expenditures of treatment.

Many urological procedures involving the kidney and the ureters require a stent replacement to avoid un-wanted adverse invents caused by the procedure itself. The stenting, however, predisposes the patient to adverse effects of its own and the application and removal of the stent is a notable monetary expense. The use of magnetic ureteral stents that can be removed via catheter instead of requiring an additional cystoscopy for removal would reduce the discomfort to patients and also possibly decrease the expenditures of the overall treatment. However, the comparability of standard ureteral stents and the magnetic ureteral stents is largely unknown due to there being no published research on the subject as of this time. The specific aim of this study is to validate our hypothesis that the magnetic ureteral stents have the same amount of adverse effects as the more commonly used non-magnetic ureteral stents.

The design is as prospective randomized, single-blinded, multi-institutional, non-inferiority study conducted in Hospital Districts of Southwest Finland, Päijät-Häme, Pohjois-Savo, Satakunta and Keski-Suomi. Using age and gender stratification, patients are randomised 1:1 fashion into having a magnetic (n=85) or standard ureter stent (n=85). The primary objectives are the mean differences between the two groups in pain and urinary symptoms scores determined by the Ureteral Stent Symptom Questionnaire (USSQ) 4 weeks after stent placement.

The patients will be recruited starting from the 4rd quarter of 2018 and ending during the 3rd quarter of 2020. Preliminary analysis of all results will be available in September 2020 and reports are expected to be written during December 2020.

Eligibility Criteria:
Inclusion Criteria:

* Language spoken: Finnish
* Clinically evaluated need for short term ureter stenting in course of extracorporeal shockwave lithotripsy-treatment or after pyeloscopy
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Current use of alpha blockers
* Patients undergoing emergency ureteroscopy and stenting
* Patients with a long term ureter stents
* Any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist
The Relationship Between Total Sialic Acid and Superoxide Dismutase and the Diagnosis and Prognosis of Lipoid Pneumonia

The goal of this observational study is to explore the correlation between total sialic acid combined with superoxide dismutase and the diagnosis and prognosis of lipid pneumonia in the patient with lipid pneumonia, cough, bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema. The main question it aims to answer is:

Whether superoxide dismutase (SOD) and total sialic acid (TSA) could be used as diagnostic markers to distinguish lipid pneumonia from patient with cough, and bacterial and fungal pneumonia, cryptogenic organizing pneumonia, pulmonary alveolar proteinosis, lung mucinous adenocarcinoma and pulmonary edema, whether SOD and TSA be associated with the prognosis of patients with lipid pneumonia?

Participants will answer online survey questions about their symptoms, changes in oxygen status, and changes in the most recent CT image of the lung for up to 10 years after treatment. We will count participants' baseline data including: gender, age, smoking history, comorbidities, lung function, imaging findings, hormone use or not, ICU treatment, death or not, the type of cause of lipid pneumonia, how it is diagnosed, and their baseline SOD and TSA.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥ 18 years old;
2. The diagnosis of lipoid pneumonia must be supported by lung biopsy pathological support or positive oil red O or Sudan staining in bronchoalveolar lavage fluid;
3. Patients with bacterial and fungal pneumonia must be supported by etiological evidence;
4. Patients with cryptogenic organizing pneumonia and pulmonary alveolar proteinosis must be supported by lung biopsy pathology;
5. Patients with lung mucinous adenocarcinoma must be supported by lung tissue biopsy;
6. Lung imaging of patients with pulmonary edema must show paving stone signs;

Exclusion Criteria:

1. Age\&lt; 18 years old;
2. The patient only has a history of lipid inhalation and no pathology or positive lipoid staining;
3. Co-infection with the corona virus disease 2019 at the onset of illness;
4. Pregnant
Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic

Retrospective observational cohort study including patients with Crohn's Disease undergoing minimally invasive ileocolic resection.

All consecutive patients with Crohn's disease (CD) who underwent minimally invasive ileocolic resection from 2014 at Mayo Clinic were retrospectively identified using a prospectively maintained institutional database.

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease
* Ileocolic resection

Exclusion Criteria:

- N/A
A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease

In this prospective, phase 2b, multicenter, randomized, double-masked, vehicle-controlled, parallel-arm study, approximately 880 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or vehicle as topical ophthalmic eye drops administered bilaterally BID.

The study will comprise two phases: a two-week screening phase/run-in and a six-week double-masked treatment phase.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of dry eye disease for at least 6 months
* An unanesthetized Schirmer's test score (STS) of ≤ 10mm and ≥ 1mm in the study eye
* Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study

Exclusion Criteria:

* Any clinically significant slit lamp finding
* Any ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammation
* Best-corrected visual acuity ≥0.7 logarithm of the minimum angle of resolution
* Any keratorefractive surgery within the last 12 months
* Any intraocular or extraocular surgery within 3 months
* Any blepharoplasty or corneal transplant in either eye
* Any form of punctual, or intracanalicular occlusion in either eye
* History or presence of any ocular disorder that may interfere with study results
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in subjects with bipolar disorder experiencing an acute episode of mania or mania with mixed features.

The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Eligibility Criteria:
Inclusion Criteria

* Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
* Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
* Participants must require hospitalization for the acute exacerbation or relapse of mania.
* Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
* Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
* Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.

Exclusion Criteria:

* Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
* Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
* Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.
* Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
* Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
* Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow

Forty-six consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled. After the left IMA was harvested, free flow was measured under controlled hemodynamic conditions before any intervention (flow 1) and at a mean of 12.5 minutes after the topical application of one of three agents (milrinone, nitroglycerin or normal saline) on the IMA (flow 2).

Fifty consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled in this study. Patients were randomly assigned to receive the topical application of one of three agents: milrinone (Baxter Pharmaceuticals, Ahmedabad, India) 10 mg in 20 ml of dextrose 5%, nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline, or normal saline (0.9% sodium chloride solution) as control.

All surgical procedures and measurements were carried out by a single surgeon who was blinded to the topical agent which was applied. Each patient enrolled in the study gave a written informed consent, and the study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the local human research committee.

Operative Technique After sternal incision, the skeletonized left IMA was harvested from the subclavian artery to its bifurcation with low-powered electrocautery, and major collaterals were ligated with hemoclips. Following systemic heparinization (300 units/kg to achieve an activated clotting time target of 480 seconds), the IMA was divided proximal to its bifurcation. The first IMA flow (flow 1) was measured by reading the volume of blood ejected from the tip of the freely bleeding IMA through a one-minute period. Heart rate, mean arterial pressure and central venous pressure were documented at the same time. The tip of the artery was occluded with a bulldog clamp, and a swab which was soaked with the selected vasodilator at room temperature (18.0 to 20.0 degrees C) was wrapped around the IMA, and was left undisturbed until the second set of measurements.

Cannulation for cardiopulmonary bypass was carried out, and the pump was used to transfuse or drain blood from the patient in order to restore the mean arterial and central venous pressures as nearly as possible to the previous values. Systemic vasopressors or vasodilators were not used. The IMA was then unwrapped and the second IMA flow (flow 2) was measured in the same way. Time, heart rate, and mean arterial and central venous pressures were also recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective primary coronary artery bypass grafting

Exclusion Criteria:

* patients who developed ischemic events during surgery
Hand Dermatitis in the Care and Hospital Staff

Study of the prevalence and risk factors of occupational dermatitis in the hands of caregivers and hospital staff of the Brest CHRU.

Monocentric cross-sectional descriptive study by anonymous self-questionnaire designed to evaluate among caregivers and agents hospitals of the CHRU de Brest:

* the prevalence of occupational hands dermatitis
* the risk factors for hands dermatitis
* the clinical description of the hands dermatitis
* the rates of dermatitis according to hand hygiene practices (soap, hydro-alcoholic solution, associations of the two, wearing gloves ...)
* the changes in the hygiene practices of caregivers and hospital staff of the University Hospital caused by hand dermatitis.
* the professional and socio-economic impact of these hands dermatitis
* the evaluation of the use of care for these hands dermatitis.
* the assessment of the association of hand dermatitis with a personal or family atopic history.

Eligibility Criteria:
Inclusion Criteria:

* Any caregiver, hospital staff or staff involved incare or stretchering of CHU patients returning tosocioprofessional categories cited in the questionnaire.
* Major person
* Participation Agreement

Exclusion Criteria:

* Minor person.
* Administrative Services Staff, Restaurant Staff,technical staff
* Refusal to participate
Comparison Between Remimazolam Tosilate and Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy

Midazolam is a commonly used drug in gastrointestinal endoscopy due to the good cardiovascular stability and mild respiratory depression for elderly patients. However, there is the concern about the the longer and less predictable recovery or the potential for repeat sedation when the active metabolite becomes bioavailable. Remimazolam Tosilate is an innovative benzodiazepine with better sedation effect and less recovery or resedation issues than midazolam, which possibly make the drug more suitable in elderly patients. We aim to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.

Before starting the endoscopy procedures, patients were randomized to receive remimazolam tosilate or midazolam to maintain sufficient sedation, then remifentanil was slowly injected for patients' sufficient analgesia during the examination. We aim to use patients' recovery time, cognition function and other measurement scales to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to undergo a routine diagnostic or therapeutic gastrointestinal endoscopy ;
2. Age 60 to 75 ;
3. ASA physical status score of I, II or III;
4. A body mass index (BMI) of 19 to 28 kg/m2;
5. Systolic blood pressure of 90-140mmHg, diastolic blood pressure of 50-90mmHg, resting heart rate of 50-100bpm and blood pulse oxygen saturation ≥95%

Exclusion Criteria:

1. Those who are refused to be included;
2. Those who are allergic to the drugs used in this study;
3. Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);
4. Severe cardiac dysfunction: NYHA cardiac functions grade 3-4, a history of recent myocardial infarction or cerebral infarction, severe conduction block or malignant arrhythmia;
5. Renal failure or liver cirrhosis;
6. Severe lung infection or upper respiratory tract infection;
7. Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status;
8. Advanced cancer accompanied by extensive intra-abdominal metastasis, acute and chronic obstruction of the gastrointestinal tract, bleeding and severe abdominal effusion;
Anesthesia-handover Checklist and Perioperative Outcomes in Elderly

With the increasing number of surgical cases, intraoperative handover of anesthesia care is common and inevitable. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals. However, verbal handover is often an informal, unstructured process during which omissions and errors can occur. It is possible that an improved anesthesia handover may reduce the related adverse events. This study aims to test the hypothesis that use of a well-designed, structured handover-checklist to improve handover quality may decrease the occurrence of postoperative complications in elderly patients undergoing major noncardiac surgery.

It was estimated that more than 9 million patients undergo surgery with a complete anesthesia handover each year worldwide. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals; and there is no unified patient handover guideline at present.

It is well recognized that the transfer-of-care is a point of vulnerability where valuable patient information can be distorted and omitted. A previous study of the investigators showed that handover of anesthesia care was associated with a higher risk of delirium in elderly patients after major noncardiac surgery. The World Health Organization has included communication during patient care handovers among its top 5 patient safety initiatives.

It is possible that an improved anesthesia-handover protocol may reduce the related adverse events. Many efforts have performed to optimize handover processes. However, handover quality between anesthesiologists has rarely been investigated. The investigators hypothesize that a well-designed, structured handover-checklist will improve handover quality and reduce the occurrence of postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

1. Elderly patients (aged 65 years and over);
2. Scheduled to undergo major non-cardiac surgery with an expected duration of at least 2 hours;
3. Requirement of complete handover between anesthesiologists during surgery (initial anesthesiologist no longer returns).

Exclusion Criteria:

1. Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
2. Inability to communicate before surgery (coma, profound dementia or language barrier);
3. Craniocerebral injury or neurosurgery;
4. Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (requiring dialysis), or expected survival of \<24 hours.
Using Glucose Sensors to Prevent Hypoglycemia

Hypoglycemia is the most common complication of Type 1 diabetes particularly in those who strive for good glycemic control. In some patients there is a loss of awareness of hypoglycaemia so that the first manifestation of hypoglycaemia may be confusion or coma. Such a situation may carry risks that the patient may harm him or her self. Medtronic has recently developed a continuous glucose sensor that determines the glucose level every 3 minutes using a subcutaneous sensor and transmits the information to a remote device (Paradigm RT) that may be worn or left close by eg on a bedside table. The device may be programmed to alarm for a rapidly falling glucose or for low glucose levels.

We propose to use this in 16 patients with severe hypoglycemia as evidenced by a high HYPO score and see if we can decrease the number of hypoglycemic reactions and document this improvement with a better HYPO score.

Sixteen patients with Type 1 diabetes (as defined by: onset under the age of 25, lean at time of onset, continuous insulin use, and/or history of ketoacidosis and C-peptide negative), with a HYPO score over the seventy-fifth percentile (\>423), will be approached and offered the study.

The study will be conducted over a three month time-frame. The first month will be a run-in period for participants to collect four weeks of glucose readings and information about their hypoglycemic events. These records will be used to calculate the baseline modified HYPO score. Patients will be screened during the first month for thyroid disease, celiac disease and Addison's disease.

During the second month they will meet with the study nurse for an intensive instruction period on the use of the Paradigm RT sensor. They will spend this month practicing to use the sensor and confirming they can use it adequately.

During the final month they will wear the sensor and collect glucose and hypoglycemia records for calculation of the final modified HYPO score.

The end point will be the change from the baseline modified HYPO score to the final four week HYPO score and this would be used to identify any improvement.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus confirmed by C-peptide \<0.10 nmol/L
* age 18 - 70 yrs.
* HYPO score \>423
* normal TSH, serum cortisol and anti-transglutaminase (ATTG)

Exclusion Criteria:

* current diagnosis of cancer
* planning a pregnancy
* Inability to give informed consent