cyrilzakka/clinical-trials huggingface dataset:
Triage of Children at the Emergency Department: Manchester Triage System or Pediatric Early Warning Score?

Currently, the Manchester Triage System (MTS) is used to triage all children presenting at the emergency department(ED) in this hospital. This system has been proven safe, but many patients are classified as too urgent. In this hospital adults are prioritised at the ED by a score based on vital signs, the early warning score. A similar score is developed suitable for children. This score, the Pediatric Early Warning Score (PEWS), is already used to determine clinical deterioration.

The investigators hypothesize that children can be triaged safely with the PEWS.

If it is safe, there will be one triage system again at the ED. Another advantage will be more continuity in assessing the condition of patients who are admitted to the hospital.

Background: Triage systems are used at EDs to prioritize patients to make sure that those who need it, receive immediate care.

The MTS is used for children at EDs by many hospitals worldwide, also at the ED of the Isala, the Netherlands. This triage system has been proven safe, but many patients are classified as too urgent. This is a disadvantage because accurate triage is needed to provide access for immediate ill patients and for sufficient flow at the ED.

Currently, adult patients at the ED of the Isala are classified by the early warning score. This is a score based on vital signs and it is easily calculated. It originally has been developed to determine clinical deterioration. For children normal values are different for each age. Therefore there has been developed the PEWS, which is now only used to evaluate clinical patients. Ideally for the continuity in this hospital, there would be one system which can be used for triage as well as for clinical patients. The investigators hypothesize that the PEWS is a safe alternative for the triage of children at the ED.

Design: A form will be attached on the file of all children presenting at the ED, for recording data. These forms will be collected afterwards. The emergency department nurses will record the vital signs, which the investigators need to calculate the PEWS as well as the urgency determined by the MTS for each patient. The expert opinion will also be recorded. This is de urgency according to the doctor who has seen the patient, maximal acceptable door-to-doctor time: very urgent (immediate), urgent (\<15minutes) or normal (\<1hour). At the end of the consultation at the ED, the reference standard will be determined for each patient independent of MTS urgency or PEWS, with data available from the patient file. (1) For secondary outcome measures may or may not hospital admission or intensive care admission will be recorded.

No interventions are made and this study is of no influence on the treatment of the patients.

Eligibility Criteria:
Inclusion Criteria:

* All children presenting at the Emergency Department of the Isala.

Exclusion Criteria:

* Children seen in room 17, the plaster and little trauma room (because of practical reasons).
Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial

Critical care patients experience systemic aggression, which may be the result of trauma, infection or other systemic inflammatory mechanisms. The initial phase of their illness is characterized by metabolic instability and increased catabolism. Nutrition goals in these patients are therefore, on the one hand, to provide sufficient caloric intake to cover energy expenditure while limiting the risks of inappropriate under-feeding, overfeeding- or re-feeding syndrome, and on the other hand, to meet the protein requirements linked to hypercatabolism. In the absence of contraindication, current recommandations state that an intensive care patient who cannot be fed orally, shoul receive continuous enteral nutrition over 24 hours by gastric tube within 48 hours of admission.

However, this 24-hour continuous nutrition method does not correspond to the physiological habit of the human species which includes a physiological nighttime fasting period.This fasting period induces a metabolic switch that regulates several pathways, including glycemic control, oxidative stressresistance and deoxyribonucleic acid (DNA) repair. Furthermore, it takes part un the synchronization of cellular circadian rhythms.

Investigator hypothetises that diurnal cyclic enteral nutrition may improve the prognosis of severe intensive care patients compared to continuous enteral nutrition.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years and over admitted to intensive care
* On invasive mechanical ventilation for less than 24 hours
* With an indication for exclusive enteral feeding by naso- or oro-gastric tube
* With an expected remaining duration of mechanical ventilation \> 72 hours

Exclusion Criteria:

* Enteral feeding via tube already started
* Parenteral nutrition in progress or deemed necessary by the practitioner
* Active digestive haemorrhage as evidenced by fibroscopy or with need for transfusion
* Digestive surgery less than one month old
* History of mesenteric ischaemia
* History of gastrectomy, oesophagectomy, duodenopancreatectomy, bariatric surgery, short bowel syndrome
* Pregnant, lactating or parturient woman
* Body mass index \< 18 kg/m2
* Person deprived of liberty by judicial or administrative decision, person under forced psychiatric care, person under legal protection (guardianship or curatorship)
* Lack of social security coverage
* Lack of consent or emergency procedure form
* Patient participating in another randomised clinical research study on feeding of resuscitation patients
Vitamin D Supplement for Patients With Tibial Fracture

The purpose is to study:

1. the frequency of vitamin D deficiency at patients with tibial fracture treated with an external ring fixator
2. if vitamin D supplement facilitates fracture healing
3. a possible relation between vitamin D deficiency and the risk of complications and the time of fracture healing

External ring fixator is a widespread and well-known method to treate complex tibial fractures. The effect of treating proximal and distal intra-articulatio tibial fractures has been positive until now.

Complications such as malunions, nonunions, re-fractures and extended time of ring fixation will occur in 5-10% of all tibial fractures in patients treated with ring fixator. Factors like trauma of soft tissue, smoking and compromised afflux of blood are associated with a higher frequency of nonunion.

It has been documented that elderly people with hypovitaminosis D have a higher risk of being affected by osteoporosis and fractures. Furthermore, there is a possible association between the severity of fracture and hypovitaminosis. The time of fracture healing is also extended compared to fractures in patients who are not affected by osteoporosis.

Until now research has not shown whether the fracture healing process is influenzed by vitamin D.

Eligibility Criteria:
Inclusion Criteria:

* Patients with tibial fracture
* A written signed statement of consent
* All potential patients primary with osteosynthesis Iliazov

Exclusion Criteria:

* Tumours in bone
* Metastases to bone marrow
* Chronic renal disease
* Drug abuse
* Abuse of alcohol (\>21 drinks a week for men and \> 14 drinks a week for women)
* Morbus Cushing disease
* Glandulae thyroid disease
* Pregnancy
* Chronic steroid therapy
* Hepatic insufficiency
* Sarcoidosis, tuberculosis or silocosis
* Patients under 18 years
* Inability to take medicine
* Adverse effects of vitamin D or allergic to vitamin D
Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome

The goal of this randomized, double blind, placebo-controlled clinical trial is to learn about, the effect of low dose vitamin D supplementation compares with placebo-controlled group on testosterone level in women with polycystic ovary syndrome. Half of Participants will receive vitamin D and metformin while other half placebo and metformin.

PCOS poses a significant challenge to women's health and quality of life. PCOS is a common heterogenous endocrine disorder in reproductive-aged women. PCOS is characterized by the presence of polycystic ovaries, menstrual dysfunction, infertility and biochemical (elevated androgens) and clinical (hirsutism and/or acne) hyperandrogenism. Hyperandrogenism and insulin resistance exacerbate one another in the development of PCOS, Research has suggested a potential link between Vitamin D deficiency and the prevalence and severity of PCOS. There is also evidence that Vitamin D has a direct effect on the ovaries and adrenal glands, which are the primary sites of androgen production in women. Vitamin D has been found to inhibit the synthesis of androgens in these glands, suggesting that it could potentially be used to manage hyperandrogenism in women with PCOS. Furthermore, studies have shown that Vitamin D supplementation can reduce insulin resistance in women with PCOS, which can subsequently lead to a decrease in the overproduction of androgens. may improves menstrual irregularities.

In human ovarian tissue, vitamin D stimulation of oestrogen and progesterone production and lack of effect on testosterone production may be explained by the expression of the aromatase gene and augmentation of aromatase activity by vitamin D.

Serum 25OH-D level has been shown to be negatively correlated with serum androgen levels DHEAS, testosterone and hirsutism. Assumption that vitamin D supplementation may also have a positive impact on serum testosterone levels. Metformin is prescribed for reducing IR in PCOS women. This is a double-blind, randomized placebo-controlled trial in PCOS women who are receiving Metformin therapy. The intervention group will receive Vitamin D Cholecalciferol (D3) 1000 I.U daily for 8 weeks, with the Metformin as prescribed by the physician whereas control group will receive placebo with Metformin during the study period. We will compare change of Total Testosterone, Vitamin D level, Fasting blood glucose, Hirsutism, Menstrual regularities and BMI, at the time of recruitment with after 8 weeks intervention in both the intervention and placebo controlled groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed case of PCOS

Age 18 years to 45 years

Exclusion Criteria:

* Pregnancy, lactating women

Diagnosed case of diabetes mellitus, liver disease, heart disease, kidney stones and disease, Tuberculosis, hyperparathyroidism

Patients receiving vitamin D, calcium supplementation within the last two months

Known hypersensitivity to Vitamin D

Patients unwilling to participate or unwilling to give written consent
Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer

To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-small-cell carcinoma of the lung
* Patients with locally advanced disease or metastatic disease, candidates to surgery after evaluation by oncologist and thoracic surgeon
* Tumour with possibility of curative surgery
* At least one uni-dimensionally measurable lesion
* Adequate pulmonary function to perform the planned surgical resection

Exclusion Criteria:

* Active infection (at the investigator's discretion)
* Pregnancy or breast-feeding
* Serious concomitant illness at the investigator's discretion
* Previous diagnosis of malignant disease
* They have received treatment during the last 30 days with a drug, other than the study drug, that has not received regulatory approval for any indication at the time of their entry in the study
A Study of How CagriSema Works on Appetite in People With Excess Body Weight

Part A: The study will look at participants appetite and energy intake and also look at the mechanisms of brain associated with appetite and food intake. Participants will not get any medicine and will be in a group that will be compared to another group receiving a weight-loss medicine. The study will last for about 6 months.

Part B: The study will look at how CagriSema works on participants appetite and energy intake and will be compared with a ''dummy'' medicine. The study will also look at how participants brain works when participants take the medicine. Participants will either get CagriSema or ''dummy'' medicine.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-65 years (both inclusive) at the time of signing informed consent
* Right-handed as evaluated by the Edinburgh Handedness Inventory
* Body weight less than or equal to 180 kilogram at screening

For Part A:

* A score of 7 or less on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
* Body mass index between 18.5 and 24.9 kilogram per meter square (both inclusive) at screening

For Part B:

* A score of 8 or more on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
* Body mass index equal to or above 27.0 kilogram per meter square. Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion Criteria:

* Contraindication for magnetic resonance scanning

For Part B:

* Glycated haemoglobin greater than or equal to 6.5 % (48 millimoles per mole) at screening
* History of type 1 or type 2 diabetes mellitus
Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices ( CGI-EPM-IX )

This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX)

This is a minimal risk study where patients at UroPartners Urology Group will consent to SARS-CoV-2 nasopharyngeal swab testing using both, a standard of care test with standard Viral Transport Medium and a second test using Convergent Genomics' proprietary Enhanced Preservation Media (EPM-IX). Subjects will self-swab each nostril during their medical appointment at UroPartners. UroPartners designated staff with then send the collection kits out for testing. Clinical information will be collected that includes age, gender, race, ethnicity and history of cancer. All of these data points will be anonymized.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥18 years of age
* Subject is a current patient at UroPartners and is willing to be tested for Covid- 19 during a routine visit
* Subject must be able to understand and willingly provide informed consent

Exclusion Criteria:

* Cannot provide informed consent
Mobile Subthreshold Exercise Program for Concussion

Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat youth with prolonged symptoms of concussion.

6-week pilot study of a novel intervention for concussion, administering a sub-threshold exercise program in a mobile fashion using video conferencing and providing feedback using wrist-worn accelerometry and heart rate monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Concussion diagnosed by a healthcare provider that occurred 2 weeks-6 months ago
* Continued symptoms with at least 3 symptoms on the HBI and a score of 20+
* No other issues that would preclude physical activity
* Parents and youth are English-speaking

Exclusion Criteria:

- Already participating in \>30 minutes of MVPA/day
A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC

This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria;
2. ECOG performance status score of 0 or 1 point;
3. No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
4. Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment;
5. At least 1 measurable lesion according to RECIST V1.1);
6. Child-Pugh:≤6
7. Adequate organ and bone marrow function.

Exclusion Criteria:

1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
2. Have a history of hepatic encephalopathy or have a history of liver transplantation.
3. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
4. Central nervous system (CNS) metastasis.
5. Uncontrolled high blood pressure, systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg after optimal medical treatment.
6. Local treatment for liver lesions within 4 weeks.
Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding

A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.

A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients.

In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, two consensus statements and two meta-analysis. In our previous experience, we used omeprazole 160 mg /day infusion instead of 8 mg/h in these patients and obtained a good result .

The objectives of this study are to assess the outcomes of two different regimens of high dose of intravenous pantoprazole after endoscopic therapy in patients with peptic ulcer bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding, a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was observed within 24 hours of hospital admission.

Exclusion Criteria:

* If patients were pregnant
* Did not obtain initial hemostasis with endoscopic injection of epinephrine
* Did not give written informed consent
* Had bleeding tendency (platelet count \< 50×109/L, serum prothrombin \< 30% of normal, or were taking anticoagulants), uremia.
The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery

The investigators applied upper airway ultrasonographic examination focusing the measurement of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate the change of upper airway anatomy before and after the surgery. The investigators also tried to find any findings of ultrasonographic examination that could reliably predict the dyspnea or airway compression after extubation. The investigators tried to compare the ultrasonographic findings with those of chest radiograph to validate the measurements of the ultrasonographic examination. A cuff leak test was preformed to evaluate its ability to predict the upper airway obstruction in shoulder arthroscopic surgery.

During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the shoulder and trachea, compressing the upper airway. Although the extravasation is generally reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or life-threatening complications.

An endotracheal tube is the most reliable method of securing the airway from airway obstruction during a shoulder arthroscopy surgery. However, since the airway may become obstructed after extubation, airway patency should be verified before extubation. Direct visualization of the larynx or trachea using laryngoscopy or bronchoscopy is difficult due to the presence of the tracheal tube. A cuff leak around the tracheal tube in a cuff-deflated condition is suggested to be a predictor of successful extubation. However, its reliability has been questioned in adult patients. A cuff leak could be affected by paratracheal pressure, which is thought to be elevated during shoulder arthroscopy. In a recent study, it was shown that laryngeal ultrasound can be a reliable, non-invasive method for the evaluation of laryngeal morphology or predicting post-extubation stridor.

The investigators applied upper airway ultrasonographic examination focusing the measurement of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate the change of upper airway anatomy before and after the surgery. The investigators also tried to find any findings of ultrasonographic examination that could reliably predict the dyspnea or airway compression after extubation. The investigators tried to compare the ultrasonographic findings with those of chest radiograph to validate the measurements of the ultrasonographic examination. A cuff leak test was preformed to evaluate its ability to predict the upper airway obstruction in shoulder arthroscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)

Exclusion Criteria:

* patients with airway anomaly
* patients with anticipated difficult airway
* patients with hemodynamic unstability
* patients with severe cardiopulmonary disease
Analysis of the Pulmonary Microbiome

The purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia.

The purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia with severe acute respiratory failure, requiring admission to the Intensive Care Unit, and to compare it with that of patients diagnosed with pneumonia but who do not develop severe acute respiratory failure and subsequent admission to the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute respiratory failure
* Patients with suspect of pneumonia

Exclusion Criteria:

* pregnancy
* age \< 18 years
Validity and Reliability of CTQ-SSS in Carpal Tunnel Syndrome.

To determine the validity and reliability of the shorter version of the CTQ-SSS in patients with carpal tunnel syndrome (CTS) undergoing nonsurgical management.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with carpal tunnel syndrome based on clinical presentation and/or nerve conduction studies.
* Patients aged 18 years to 60 years old.
* Patients who are undergoing nonsurgical management for carpal tunnel syndrome.

Exclusion Criteria:

* Patients with a history of hand or wrist surgery within the past 6 months.
* Patients with severe hand or wrist pain that would prevent completion of the outcome measures or interfere with their ability to participate in the study.
* Patients with severe cognitive impairment or language barrier that would prevent understanding of the study instructions or interfere with their ability to participate in the study.
* Patients with any other medical condition that could affect hand function or interfere with test completion.