cyrilzakka/clinical-trials huggingface dataset:
The Epidemiology and Approach to Differentiating Etiologies of Shock in the Emergency Department

The Shock Tool study is designed to improve the clinical evaluation for differentiating shock in the emergency department. The goal of this study is to evaluate and improve the accuracy of physicians differentiating causes of shock.

Specific Aim #1: To study the epidemiology of shock in the emergency department Hypothesis 1: We will better understand shock states if we determine shock etiology among patients presenting to the emergency department in a carefully conducted observational prospective study.

Specific Aim #2: To determine the accuracy of physician diagnosis for the underlying etiology of shock.

Hypothesis 2: Physician assessment of the underlying cause of shock is challenging and often inaccurate in the early stages of care in the emergency department.

Specific Aim #3: To optimize the evidence-based approach to assist in the diagnosis of shock etiology from elements readily available when a patient demonstrates shock physiology in the Emergency Department.

Hypothesis 3: An evidenced-based, standardized approach to clinical decision making integrating elements of the history, physical exam, and early testing will improve a physician's ability to accurately differentiate etiologies of shock.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or great
* For pre-shock cohort: HR \> 130, RR\>24, Shock index \> 1, lactate \> 4.0mmol/L, SBP \< 90mm/hg)
* For shock cohort: persistent blood pressure \<90mm/hg after resuscitation

Exclusion Criteria:

* seizure
* isolated atrial fibrillation with discharge after rate control achieved
* discharged from the emergency department
* intoxication or withdrawal
BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM

Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be followed for 2 years for data collection. Major adverse cardiac events (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with the BioMatrix AlphaTM stent per clinical indication and physician's choice;
* Patients who agree to comply with the follow up requirements;
* Patients with a life expectancy of \> 1 year at time of consent;
* Patients eligible to receive dual anti platelet therapy (DAPT) according to guidelines;
* Hemodynamically stable patients.

Exclusion Criteria:

* Inability to provide informed consent;
* Currently participating in another trial before reaching primary endpoint;
* Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the perisurgical period;
* Patient has received an additional stent different from a BioMatrix AlphaTM stent during the index procedure.
Non-invasive Contrast Enhanced Ultrasound Sonography in Intestinal Acute Graft-vs-Host Disease

Intestinal acute graft-vs-host disease (GVHD) is a life-threatening complication after allogeneic hematopoietic cell transplantation. Non-invasive diagnostic procedures are still lacking and diagnosis is difficult. We hypothesized that contrast-enhanced ultrasound sonography (CEUS) could detect microcirculation changes of the bowel walls during intestinal GVHD and help to detect and monitor treatment response. We employed CEUS to prospectively evaluate intestinal GVHD in 83 consecutive transplant patients between 2008 and 2011. Fourteen /83 patients with biopsy-proven intestinal GVHD were selected as study group. Fourteen patients with biopsy-proven stomach GVHD without intestinal symptoms (N=16), normal volunteers (N=6) and patients with neutropenic enterocolitis (N=4), were chosen as control group. All patients were evaluated with both standard transabdominal ultrasonography (US) and CEUS at the onset of intestinal symptoms, during clinical follow up and at flare of symptoms. Standard US revealed non-specific bowel wall thickening, and simultaneous involvement of multiple intestinal segments in 9/14 patients. CEUS showed three distinct patterns of microcirculation changes that correlated with GVHD activity. These findings were not observed in the control group. Moreover, CEUS findings correlated with treatment response and predicted flare of intestinal symptoms. CEUS is a non-invasive, easily reproducible bed-side tool to detect and monitor intestinal GVHD.


Eligibility Criteria:
Inclusion Criteria:

* Bone Marrow Transplant
* intestinal acute graft versus host disease
* stomach GVHD
* neutropenic enterocolitis

Exclusion Criteria:

no biopsy proven intestinal or stomach GVHD no neutropenic enterocolitis
The Frequency of Thyroid Diseases in Women With Breast Cancer

Breast cancer and thyroid disorders are important health challenges commonly encountered in women. The relationship between both conditions still remains unknown. In this study, the frequency of thyroid diseases was investigated in breast cancer patients


Eligibility Criteria:
Inclusion Criteria:

* women, the age between 18-65 years who were diagnosed with breast cancer, but not underwent surgery, radiotherapy or chemothreapy were included into the study

Exclusion Criteria:

* Those with pregnancy, known liver and renal failure, the history of any malignancy other than breast cancer, undergoing a surgical operation due to breast cancer, also those receiving chemotherapy/radiotherapy for the same reason or undergoing partial or complete thyroid surgery or a surgical operation within the past 6 months, and also the patients taking oral anti-diabetic medication, insulin, steroids, thiazide, anti-psychotics and immuno-suppressive medicines affecting the levels of blood glucose, insulin and IR, smokers and those consuming alcohol were excluded
Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan

Fasting during the Ramadan is one of the five pillars of Islam and is a mandatory duty for all healthy adult Muslims. Fasting is considered safe in young healthy subjects but it can induce harmful effects and complications in patients with diabetes. Several studies have demonstrated that patients with type 2 diabetes are prone to hypo and hyper glycemia during fasting. When treating diabetic patients with a treatment guideline the rate of these complications can be reduced. Little data is available on patients with type 2 diabetes treated with insulin. The investigators therefore propose to assess the effect of a protocol containing detemir (levemir) and a premix of insulin aspart (NovoMix70) on glucose control in patients with type 2 diabetes during the Ramadan and to compare this regimen to the standard care patients receive during this period. The investigators assume that patients receiving the intervention will have better glucose control during the Ramadan compared to patients receiving the standard care. As approximately 45 million Muslims suffer from type 2 diabetes and most of them fast during the Ramadan the results of this intervention may be significant and may improve the care of these patients allowing Muslims to respect their religious obligations without compromising their health.


Eligibility Criteria:
Inclusion Criteria:

All of these criteria should be present.

1. Patients with a diagnosis of type 2 diabetes treated with insulin (premix preparations or basal and rapid acting insulin) with or without metformin and/or a sulfonylurea drug for at least three months
2. HbA1c in the past three months ≤ 10%
3. Being capable, and willing, to perform self blood glucose monitoring and use a patient diary as required
4. Age \> 18 years

Exclusion Criteria:

Any of the following:

1. Patients with a diagnosis of type 1 diabetes
2. Hypoglycemia unawareness
3. Hypersensitivity to levemir
4. Hypersensitivity to NovoMix70
5. Creatinine \> 2.5 mg/l
6. AST and or ALT \> 1.5 times the upper limit
7. Pregnancy
8. Mental incapacity, unwillingness or language barrier precluding adequate understanding of the study protocol or cooperation
The Effect of Alveolar Recruitment Maneuver in Laparoscopic Surgery

Investigating the effect of alveolar recruitment on the incidence of postoperative pulmonary complication in patients who undergo laparoscopic surgery

Comparing ventilation with PEEP (positive end expiratory pressure) to ventilation with PEEP and alveolar recruitment, we expect that alveolar recruitment will reduce the incidence of pulmonary complication in patients undergo laparoscopic surgery. Ventilation with only PEEP is generally not enough to reduce postoperative pulmonary complication effectively.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ASA I-II, scheduled to elective laparoscopic surgery

Exclusion Criteria:

* Chronic lung disease
* Cardiovascular disease
* ASA class ≥ III
* Receiving ventilation therapy or received within 6 months
* Refusal of participation in study or failure in informed consent
Palliative Outcome Evaluation Muenster I

For patients with an advanced disease and their families an excellent and compassionate care is essential. However, in hospitals optimal end-of-life care is not yet fully realized and patient's needs are often not met. Palliative care is able to increase patients' quality of life and to carefully meet their and their families' needs.

To improve the awareness of unmet needs patient-reported outcome measurement has been the pivot of latest palliative care research. Besides the improvement of care outcome measurement allows the evaluation of the quality of palliative care and comparisons on a national and international level.

The aim of the present study is to evaluate the quality of palliative care in different settings (palliative care unit, inpatient and outpatient consultation teams) using the Integrated Palliative Care Outcome Scale (IPOS). The IPOS has been lately developed as improved follow-up version of the Palliative Care Outcome Scale (POS) integrating most important questions and simultaneously being brief and comprehensive. The study is planned as a multi-centric observational study. Primary endpoint is the reduction of symptom burden of patients.

The clinical study hypothesis bases on the assumption that palliative care can change the symptom burden, measured by a change in the IPOS overall profile score, and that there might be a difference in the size of the effect depending on the caring setting.

After the enrolment and consent of participation the patient receive a questionnaire consisting of three independent assessments: To assess the symptom burden and specific palliative care needs the Integrated Palliative Outcome Scale (IPOS) is used. To measure the generic health-related quality of life the patient has to answer the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). To get an opinion of the general condition the patient is to complete the NCCN Distress Thermometer which includes a visual analogue scale (with values from 0 to 10).

Meanwhile, a professional palliative caregiver completes a questionnaire about the main demographic aspects of the patients and assess the palliative care needs and the symptom burden using the IPOS.

After one week both, patient and professional palliative caregiver, will receive the same questionnaires again to assess the change from baseline.

Eligibility Criteria:
Inclusion Criteria:

* Indication for palliative care due to any advanced life-limiting and progressive disease
* 18 years and older

Exclusion Criteria:

* Age under 18 years
* pregnant or breastfeeding women
* Inability to understand information for participation
* Refusal of participation
Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770

The objectives of this study are to evaluate the effects of VX-770 on Midazolam and Rosiglitazone, and the effect of Fluconazole on VX-770.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be male or female and between 18 and 55 years of age.
* Subjects must be judged to be in good health.
* Subjects must have a body mass index (BMI) from 18 to 30 kg/m2.

Exclusion Criteria:

* History of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
* Subjects who have human immunodeficiency virus (HIV), hepatitis C, or active hepatitis B.
* Female subjects and female partner(s) of male subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug.
* History of cardiovascular disease, hypoglycemia, or edema.
Virtual Sedation During Elective Procedures in the Cathlab

This study aims to investigate the effectiveness of virtual reality (VR) as a non-pharmacological tool against anxiety and pain during elective procedures in the catheterization laboratory (cathlab).

To assess the effectiveness of VR in the clinical setting of daily practice within the cathlab, a comparative effectiveness trial will be conducted. A sample of patients scheduled for a planned procedure in the cathlab of UZ Brussel will be selected using convenience sampling.

Participants eligible for this study will be assigned to either the control group or the intervention group after signing the informed consent form. The control group in this study will receive standard care according to current practice for the planned procedure, while the intervention group will receive standard care along with the virtual reality headset intervention.

The primary outcome of anxiety will be measured using the Visual Analog Scale (VAS) for anxiety and the State-Trait Anxiety Inventory (STAI) questionnaire. The secondary outcome of pain will be measured using the VAS scale for pain.

Other outcomes such as satisfaction and potential nausea during the procedure will be assessed through a questionnaire that participants will fill out after the procedure. The physician who performed the procedure in the intervention group, as well as the involved nurses during the procedure, will complete a similar questionnaire to evaluate the use of the VR headset from the operators' perspective.

The outcomes of the two groups will be statistically compared using the SPSS software package.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective procedure in line with the following criteria in the cathlab of the UZB: limited feedback requirements from the patient to the physician, per-formed under local anaesthesia, risk estimated as normal i.e. haemodynamically stable patients (Stable vital signs such as heart rate and blood pressure) and no expected complications, electively planned and duration expected to be between 30 minutes and two hours.
* Agreeing to participate via signed informed consent.
* Being at least 18 years of age.
* Being fluent in either English, French or Dutch language.

Exclusion Criteria:

* Ailments which would make wearing of the headset uncomfortable or impossible.
* cognitive impairment such as dementia or delirium.
* Severe hearing impairment, as this will limit the immersion.
* Severe visual impairment not compensated by glasses, such as blindness.
Measurement of Sweat Sodium Concentration in Patients With Chronic Kidney Disease

It has been shown that excretion of sodium and water through the skin in the form of sweat represents a regulatory mechanism of electrolyte- and fluid balance. Since patients with chronic kidney disease (CKD) exhibit increased skin sodium content, we investigated the feasibility of sweat testing as a novel experimental tool to a more complete assessment of fluid- and sodium homeostasis.

In this cross-sectional feasibility study, we applied pilocarpine iontophoresis to induce sweat testing in 58 patients across various stages of CKD including patients after kidney transplantation as well as a healthy control cohort (n=6) to investigate possible effects of CKD and transplantation status on sweat rate and sodium concentration. Due to non-linear relationships, we modeled our data using polynomial regression.

Decline of kidney function showed a significant association with lower sweat rates: adj R²= 0.2278, F(2, 61) = 10.29, p = 0.000141. Sweat sodium concentrations were increased in moderate CKD, however this effect was lost in end stage renal disease: adj R² = 0.3701, F(4, 59) = 10.26, p = 2.261e-06. We observed higher sweat weight in males compared to females.

Diagnostic sweat analysis represents an innovative and promising noninvasive option for more thorough investigation of sodium- and fluid homeostasis in CKD patients. Lower sweat rates and higher sweat sodium concentrations represent a unique feature of CKD patients with potential therapeutic implications.


Eligibility Criteria:
Inclusion Criteria:

Completed 18th year of life and the ability and willingness to provide informed consent

Exclusion Criteria:

General exclusion criteria were signs of acute infection, clinical signs of kidney graft rejection or pregnancy. Exclusion criteria for the healthy controls were pregnancy or the presence of chronic metabolic, renal, cardiovascular, or rheumatologic conditions, hypertension, chronic or recent intake (8 weeks prior to testing) of psychiatric or antihypertensive medication.
Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign and malignant pancreatic and periampullary diseases. Despite improved surgical technique and postoperative care, the mortality rate after PD is high reaching up to 30%, due to high incidence of postoperative complications . Pancreatic fistula (PF) is the one of the most frequent complications of PD and the major contributor to postoperative morbidity The aim of this study to evaluate the effect of the perioperative octreotide use after PD for prevention of the postoperative pancreatic fistula. The secondary outcomes are overall postoperative complications, mortality and the cost benefit relationship of the use of the perioperative octreotide.

This study will be a prospective randomized controlled trial for perioperative use of octreotide in patients after PD for pancreatic and periampullary tumours from May 2014 to April 2017 in Gastroenterology surgical center, Mansoura University, Egypt.

The primary outcome of the study is the effect of perioperative use of octreotide on the rate of development of postoperative pancreatic fistula in patients after PD for pancreatic and periampullary tumours. The secondary outcome is postoperative overall complications, mortality, duration of the hospital length of stay and cost-benefit relationship of perioperative use of octreotide.

Enrolled patients will be randomized to either the octreotide or the placebo group. The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy . Patients in the octreotide group will receive sandostatin 100ug SC every 8 hours daily staring from the day of operation to the postoperative day 7. Patients in the placebo group will receive saline administered in a similar manner.

Eligibility Criteria:
Inclusion Criteria:

1. All patients with pancreatic and periampullary tumours anticipated for PD will be eligible to participate in this trial.
2. patients with non dilated pancreatic duct and soft pancreas

Exclusion Criteria:

Exclusion criteria:

1. Age over 70.
2. Patients who underwent total or distal pancreatic resection.
3. Patients with unresectable disease who will undergo any surgical procedure other than PD for pancreatic and periampullary tumours.
4. Patients underwent neoadjuvant chemotherapy or radiotherapy.
5. PD more than 3mm.
6. firm pancreas.
7. PJ
High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease

High-flow nasal cannula is an oxygenation technique increasingly used for patients admitted for acute respiratory failure. Literature essentially concerns "de novo" acute hypoxemic failure and the interest of high-flow during take care of chronic obstructive pulmonary disease patients is few studied. Physiological studies reported potential benefits of high-flow nasal cannula oxygenation in chronic obstructive pulmonary disease patients including dead space clearance and decrease of respiratory, which lead to decrease work of breathing. As inhaled bronchodilators are part of treatment of chronic obstructive pulmonary disease exacerbation, nebulization could be also provided through high-flow nasal cannula oxygen therapy. The aim of our study is to determine whether a beta-2 agonist nebulization administered through High-flow nasal cannula is efficient to improve spirometry of patients for admitted hronic obstructive pulmonary disease exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* Arterial pH over 7.25,
* Respiratory rate under 35 breaths/mn
* Glasgow Coma Scale equal to 15,
* indication of beta-2 agonist nebulization less than 8 per day (time between two nebulization more than 3 hours),
* NIV sessions spaced more than 6 hours.

Exclusion Criteria:

* Urgent endotracheal intubation;
* Contraindication to beta 2 adrenergic agonist;
* Another organ failure (hemodynamic and neurological instability);
* Cardioselective beta-blocker during treatment of copd exacerbation;
Ventilatory Settings and Monitoring Variables Associated With Weaning Failure in Critically Ill Patients

Mechanical ventilation (MV) is essential in managing acute respiratory failure. Its duration is a crucial aspect since both, unnecessary prolongation and premature withdrawal have deleterious effects on patient outcomes in the ICU. The process of weaning refers to the set of procedures and evaluations carried out to discontinue MV. Regardless of the definition used, within the population undergoing weaning, there is a group of patients who successfully pass the daily screening but fail the spontaneous breathing trial (SBT) or the separate attempt (SA). In Argentina, this figure is 39.5%, and 31.4% in patients with COVID-19. On the other hand, another group of patients successfully passes the SA, is extubated, but fails in post-extubation. This failure rate varies in the literature, ranging from approximately 10 to 20%. In our country, this figure is 16% in the general population and rises to 29.7% in COVID-19 patients. Additionally, this population is divided into those who cannot tolerate ventilation without an artificial airway due to upper airway patency issues (such as laryngeal edema), i.e., "airway failure," and those who experience acute respiratory failure. In 2023, the WEAN SAFE study reported novel findings regarding variables associated with weaning failure. In multivariable analysis, it was found that the MV settings and monitoring variables at the time of the first SBT - respiratory rate, positive end-expiratory pressure (PEEP), dynamic airway pressure difference (peak pressure (Ppeak) minus PEEP) on the day of the SA - were associated with weaning failure. In this context, the investigators will conduct a retrospective cohort study, whose primary objective will be to assess which MV settings and monitoring variables are associated with weaning failure.

\*\*Primary Objective\*\* To determine if there are any MV settings or monitoring variables that are associated with extubation failure.

\*\*Secondary Objective\*\* To determine if there are any MV settings or monitoring variables that are associated with failure in the first SBT.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* MV for at least 48 hours, regardless of the cause of onset
* Undergone at least one extubation, regardless of the outcome
* At least one spontaneous breathing trial (SBT) during their ICU stay, regardless of the outcome

Exclusion Criteria:

* MV records containing incorrect or inconsistent data
* did not have adequate or continuous monitoring during the weaning process