cyrilzakka/clinical-trials huggingface dataset:
Protein-energy Enriched Milk for Infants With Bronchiolitis

The aim of this study is to investigate if a standardized nutritional intervention with a protein and energy enriched milk could help overcome the catabolic state in children hospitalized with a bronchiolitis and thus creating a better nutritional state during hospitalization and at outpatient follow-up.

The investigators also want to assess the clinical repercussion on the number of hospitalization days, the duration of oxygen support and the quality of life at ouptatient follow-up.

In this study, the investigators aim to assess the effect protein-energy enriched milk to reverse the catabolic state (weight loss, change in mid-upper arm circumference and tricpes skin fold) on the short term and failure to thrive (degree of weight recovery, change in arm circumference) one week after discharge in infants with moderate to severe bronchiolitis. The secondary short term aims are to investigate the effect on the length of hospital stay, days of oxygen support and the rate of antibiotic use. Secondary long term outcomes are the re-admission rate, the persistence of wheezing and the number of work days missed by the parents.

The investigators hypothesize that in those children who received a protein-energy enriched milk during hospitalization the catabolic state will be reversed more quickly by the intervention and will need less hospitalisation days, less oxygen support, less antibiotic use, less re-admission rate, less persistent wheezing and less work days missed by the parents. The investigators also hypothesize that the effects of the nutritional intervention on the proposed outcome parameters will be greater in children screened at high nutritional risk.

Eligibility Criteria:
Inclusion Criteria:

* All children hospitalized at the paediatric wards of UZ Brussel with the diagnosis of moderate to severe bronchiolitis
* Not meeting their normal oral intake are eligible for inclusion between the beginning of December and the end of February 2014
* Bronchiolitis will be defined as a constellation of clinical symptoms and signs that typically begin with rhinitis and cough, and may progress to tachypnea, wheezing, rales, use of accessory muscles and/or nasal flaring

Exclusion Criteria:

* Children admitted to the paediatric intensive care unit
* Children in whom it is unsafe to place a nasogastric tube (e.g. severe mucositis, platelet count \<50.000/µl)
* Children unwilling or unable to participate
* Children that are breast fed
* Children over the age of 12 months
* Children with an underlying malabsorption disease
Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer

Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 30 Gy in 5 fractions, once weekly to the pelvis in post operative patients with endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically confirmed endometrial adenocarcinoma
* Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions: High grade histology OR Outer-half myometrial invasion with any risk factors OR FIGO stage II - IIIC1.
* Age ≥18 years.
* Patients who are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments.

Exclusion Criteria:

* Patient has had prior pelvic radiotherapy.
* Patient has Type II endometrial cancer histology (ie. Serous, clear cell or carcinosarcoma).
* Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
* Patient has a contraindication to CT contrast.
* Patient has a hip prosthesis.
Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery.

Postoperative delirium (POD) is a common complication in elderly patients and is associated with negative clinical outcomes, such as prolonged hospitalizations, cognitive impairment, and higher mortality rate. While the pathophysiology of delirium remains unknown, the cerebral hypoperfusion and neuroinflammatory response are considered to play an important role in the process of POD. The aim of the study is to determine the association between POD and biomarkers in elderly patients undergoing noncardiac and non-neurological surgery.


Eligibility Criteria:
Inclusion Criteria:

* With American Society of Anesthesiologists (ASA) physical status Ⅱ-Ⅳ
* Undergo elective non-cardiac and non-neurological surgery receiving general anesthesia
* Operation time is expected to be longer than 2 hours

Exclusion Criteria:

* Clinical diagnosis of dementia
* Clinical diagnosis of cerebrovascular disorders
* Clinical diagnosis of heart failure
* Clinical diagnosis of liver failure
* Clinical diagnosis of renal failure
* Clinical diagnosis of traumatic brain injury
* Alcohol abuse
* Can not complete the cognitive assessments
* Refuse to sign informed consent
The Evaluation of Cellular and Humoral Immunity to COVID-19 in Moscow Residents

The aim of the research is to estimate the levels of cellular and humoral immunity to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among Moscow residents over 18 years old. During the study, participants will be divided into four groups: healthy volunteers; individuals recovered from coronavirus disease 2019 (COVID-19) with different severity; individuals vaccinated against SARS-CoV-2; individuals who have had COVID-19 concomitantly with comorbidities that characterized by the impact on the immune system (tuberculosis, chronic obstructive pulmonary disease, HIV infection, hematological neoplasia). For all participants included into the study peripheral blood will be collected and the titers of SARS-CoV-2 specific immunoglobulins M (IgM) and immunoglobulins G (IgG), frequencies of the T cells specific to nucleocapsid (N), membrane (M), and spike (S) proteins of SARS-CoV-2 in peripheral blood, as well as the fractions of virus specific T helpers and cytotoxic T cells will be estimated. For smaller cohorts of the participants in all groups the antibody titers and T cell response levels will be examined in dynamics. All participants will be monitored for the incidence of primary or repeated COVID-19 for 1-2 years after inclusion in the study.

Based on the results of the study, the relationship between the formation of humoral and cellular immunity against COVID-19, the duration of these types of immunity, as well as their individual contribution to protection against primary or secondary SARS-CoV-2 infection will be analyzed. Additionally, data concerning patients recovered from COVID-19 and having concomitant diseases will provide a valuable information that may help to understand in more details the mechanisms of the development of the SARS-CoV-2 specific immune response.


Eligibility Criteria:
Inclusion Criteria:

* residents of the Moscow city (registered in Moscow);
* 18 years old or above;
* signed informed consent.

Exclusion Criteria:

* citizenship of a foreign state;
* refusal to sign the informed consent.
Effect of C21 on Forearm Blood Flow

The purpose of this study is to assess the effect of C21 on forearm blood flow by use of strain-gauge venous occlusion plethysmography.

Subject will be screened for eligibility. Eligible subjects will receive ascending doses of C21 (3, 10, 30, 100, and 200 µg/min through local intra-arterial infusions for 5 min/dose. Forearm blood flow measurements will be performed in both arms during the last 2 minutes of each dose.

Infusions of sodium nitroprusside will be performed as a positive control using the same methodology.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study and to comply with study requirements.
2. Healthy male subject aged 18-45 years
3. Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
4. Wlling to use condom or be vasectomised or practice sexual abstinence
5. Clinically normal medical history, physical findings, vital signs, ECG and laboratory values

Exclusion Criteria:

1. History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
2. History of thrombotic disease, vascular disorder, or severe bleeding disease.
3. Poor brachial artery access.
4. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of baseline
5. Malignancy within the past 5 years with the exception of basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
6. Any planned major surgery within the duration of the study.
7. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).
8. Abnormal vital signs
9. Prolonged QT interval, cardiac arrhythmias or any clinically significant abnormalities in the resting ECG
10. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to the IMPs, including any of the excipients of the IMPs.
11. Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins, and minerals
12. Regular use of non-steroidal anti-inflammatory drugs or acetylsalicylic acid
13. Vaccination within 1 week prior to dosing or plans to receive any vaccine during the study conduct.
14. Planned treatment or treatment with another investigational drug within 3 months
15. Current regular smokers or users of nicotine products.
16. History of alcohol abuse
17. Presence or history of drug abuse
18. Positive screen for drugs of abuse or alcohol at screening
19. History of, or current use of, anabolic steroids.
20. Inability to refrain from consuming caffeine-containing beverages during Day 1
21. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the 3 months prior to screening.
22. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Intravenous-Morphine and Glucagon-Usage Enhanced MR Cholangiography

Morphine can induce constriction of sphincter of oddi and glucagon can facilitate bile secretion and dilatation of bile duct. We conduct this randomized double blinded study to evaluate the effect of enhancement in MRCP using intravenous morphine and glucagon.

Morphine can induce constriction of sphincter of oddi and glucagon can facilitate bile secretion and dilatation of bile duct. We conduct this randomized double blinded study to evaluate the effect of enhancement in MRCP using intravenous morphine and glucagon.

Eligibility Criteria:
Inclusion Criteria:

* normal volunteer
* living liver donor

Exclusion Criteria:

* COPD
* chronic liver disease
* hypersensitive to glucagon
* DM
* insulinoma
* glucagonoma
* pregnancy
Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion

This study aimed To investigate the effects of estrogen in combination with aspirin and intrauterine balloon on the uterine endometrial repair and reproductive prognosis in patients after surgery for severe intrauterine adhesion .

This cohort study was conducted to investigate whether aspirin could promote the endometrial growth and repair, reduce the recurrence of intrauterine adhesion and improve the menstruation and reproductive prognosis after surgery for severe intrauterine adhesion. Menstruation was evaluated for the first time with a method similar to visual analogue scale (VAS) in which the menstruation was assessed by the patients themselves with 0 as amenorrhea and 100 as normal menstruation. This evaluation avoids the vague terms (such as large or small menstrual blood volume) in previous evaluations and considers the individual difference in menstrual blood volume and different understanding about the menstrual blood volume. Thus, this evaluation is easy to master, quantify and analyze.

Eligibility Criteria:
Inclusion Criteria:

* Pre-operative adhesion score was ≥9
* The prior menstrual cycle was regular, and the sex hormone was normal
* Patients had fertility requirement
* Male semen examination showed normal; (5) There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery

Exclusion Criteria:

* Pre-operative adhesion score was \<9
* Prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction and infertility
* Patients had no fertility requirement
* Patients had male factor infertility
* Patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic analgesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, gastric or duodenal ulcer and asthma.
Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children

Acute viral respiratory infections are among the most common causes of hospitalization in the pediatric population. The usual presentation of viral respiratory tract infections (VRTI) includes fever, malaise, wheezing and or coughing, rhinorrhea and loss of appetite. Up to 50% of children will have at least one viral-induced wheezing illness by school age. Currently treatment of VRTI is essentially supportive and no specific and efficient treatments are known. Given the lack of effective medications, current treatment for severe viral lower respiratory tract infection (LRTI) in infants relies on supportive measures only. These measures include supplementation of oxygen, monitoring of apnea, nasal/gastric tube feeding or intravenous fluids, and, if required, respiratory support with nasal bi-level positive-airway pressure. VTRI therefore represent an important unmet need for improved treatment strategies. Acupuncture's effect on has also been studied. Acupuncture has been shown to be a safe and effective in various respiratory tract inflammations. A review published in 2011 have found that acupuncture is safe for pediatric patients. Acupuncture's effect on acute viral induced wheezing and cough in hospitalized children has yet to be studied. Since the current standard of care is supportive care only, using acupuncture as an additional treatment may provide benefit in reducing wheezing, respiratory distress, and shorten hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* The presence of acute viral respiratory disease

Exclusion Criteria:

* Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability
The Unstable Thoracic Cage Injury

* Analysis of patient data and computed tomography scan of polytraumatized patients thoracic spine fractures
* A concomitant sternal fracture was identified an indicator for an unstable thoracic spine fracture

Previous studies stated, that sternal fractures can be regarded as an indicator for thoracic spine fractures and described the combined injury pattern of thoracic spine fracture and sternal fracture as "upper thoracic cage injury". But literature research is lacking data that in patients with a thoracic cage injury a highly unstable thoracic spine fracture can be expected.

In a large cohort of 130 patients with a thoracic spine fracture and concomitant sternal fracture the investigators analyzed the injury pattern and evaluated associated injuries, trauma mechanism, and clinical outcome.

The investigators could prove that in patients with a thoracic cage injury the concomitant sternal fracture may be regarded as an indicator for an unstable thoracic spine fracture, which requires surgical stabilization. Furthermore the analysis revealed that even a highly rotationally unstable type C fracture has to be expected, if sternal and thoracic spine fractures are located in the same segment.

Eligibility Criteria:
Inclusion Criteria:

* Sternal fracture and concomitant thoracic spine fracture
* Injury Severity Scale ≥ 16
* Age under 50 years
* Presence of a whole body computed-tomography (CT-scan) performed at admission of the patient to the hospital

Exclusion Criteria:

* Missing consent
* Incomplete patient data
A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification

The study aims at detecting the minimum effective daily dose and duration of difluprednate that can be used to treat postoperative inflammation after phacoemulsification without increasing the intraocular pressure, and whether it can be safely given within the first 24 hours after the operation.

Conventional phacoemulsification will be performed by the same surgeon for all the cases using the stop and chop technique. Anterior chamber examination for flare and cells using slit-lamp biomicroscopy according to the SUN recommendations and intraocular pressure measurement using Goldmann applanation tonometer will be done for all the cases before surgery and on the 1st, 3rd, 7th, 14th days as well as one month after the procedure.

All cases will receive Nepafenac 0.1% ( Nevanac 0.1%) 3 times per day on the last preoperative day, one tablet of Acetazolamide 250 mg (Cidamex 250mg) within the first 3 hours after the procedure and Moxifloxacin (Vigamox 0.5%) 0.1 ml intracameral and post-operative drops 3 times per day for 10 days and will be divided into:

In this pilot study:

* Group A : will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation
* Group B : will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation

Eligibility Criteria:
Inclusion Criteria:

* Age 40-80
* Grade 1 to 4 nuclear cataract LOCS II
* Cumulative dissipated energy CDE 1 to 10
* Done by a single surgeon using the chopping technique

Exclusion Criteria:

* History of uveitis
* the use of topical or systemic steroids on the last post-operative day
* Intraoperative or postoperative complications
* Intraoperative iris manipulations or phaco traume
Proenkephalin A and Kidney Replacement Therapy

Acute kidney injury (AKI) is a common problem encountered in the intensive care unit (ICU), estimated to occur in up to 60% of all critically ill patients, depending on the definition. Recent large randomized clinical trials in critical care nephrology have focused on the optimal timing of initiation of acute kidney replacement therapy (KRT). However, less is known about the ideal circumstances in which KRT may be successfully discontinued.

The novel serum-biomarker proenkephalin A 119-159 (penkid) has been found to be strongly negatively correlated with measured GFR. Whether penkid may have a role in initiation and discontinuation of KRT remains unknown.

Acute kidney injury (AKI) is a common problem encountered in the intensive care unit (ICU), estimated to occur in up to 60% of all critically ill patients, depending on the definition. Recent large randomized clinical trials in critical care nephrology have focused on the optimal timing of initiation of acute kidney replacement therapy (KRT). However, less is known about the ideal circumstances in which KRT may be successfully discontinued. KRT is a complex and expensive therapy, with complications including catheter-associated infections, hemorrhage, hemodynamic instability, and potential delayed renal recovery.

The novel serum-biomarker proenkephalin A 119-159 (penkid) is a stable fragment derived from the precursor enkephalins, which are known as small endogenous opioid peptides and are produced throughout the human body, including the kidneys. Plasma concentrations of penkid have been found to be strongly negatively correlated with measured glomerular filtration rate. Whether penkid may have a role in initiation and discontinuation of KRT remains unknown.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age with AKI requiring KRT

Exclusion Criteria:

* Chronic kidney disease with estimated glomerular filtration rate \<30 mL/min/1.73 m2
* Non-end stage renal disease with extracorporeal ultrafiltration due to diuretic- resistant fluid overload
* Decision to limit therapeutic interventions
* History of solid-organ transplants
* Pregnancy
Health-related Quality of Life in Patients on Anticoagulants

The present study has been designed to describe the health-related quality of life in patients with non valvular atrial fibrillation who have been prescribed a specific anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to study initiation. It will be conducted in Departments of Internal Medicine from approximately 50 centers in Spain. It consists of an only visit that will coincide with one of those performed by the patients as part of routine follow-up of their disease. 500 patients seen in internal medicine are planned to be included in the study


Eligibility Criteria:
Inclusion Criteria:

* The patient is willing and provides written informed consent to participate in this study.
* The patient is at least 18 years of age
* The patient has a diagnosis of non-valvular atrial fibrillation
* The patient is on the same anticoagulant therapy (VKA or DOAC) during at least 6 months and maximum 2 years.
* If treated with VKA, availability of % Time in Therapeutic Range (TTR) in past analytical records or enough amount of International Normalized Ratio (INR) measures to calculate it.

Exclusion Criteria:

* Current participation in any clinical trial of a drug or device
* Contraindication to the use of DOAC or VKA as described in the Summary of Product Characteristics (SmPC).
Prevalence of HbA1C in Women With PCOS

Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes Association has suggested screening of women with PCOS for HbA1C.

In view of recent suggestion of American Diabetes Association(ADA)to screen women with PCOS for HbA1C,we intend to study its prevalence in all categories of obesity in women with PCOS.

Women with PCOS by Rotterdam criteria will be screened for insulin resistance by using different techniques or tests.

Further, the sensitivity and specificity of HbA1C will be compared with sensitivity and specificity of other insulin resistance markers such as OGTT, Free androgen index, free testosterone, fasting insulin to glucose ratio, HOMA-IR and HOMA-B-CELL.

Eligibility Criteria:
Inclusion Criteria:

1. BMI of 25-35 Kg/Mt2
2. Atleast three of the Rotterdam criteria for diagnosis of PCOS.
3. Subjects with well stabilized Thyroid,if they had documented evidence of previousthyroid disorder.

Exclusion Criteria:

1. Subjects with documented diagnosis of Metabolic Syndrome.
2. Subjects with laparocopic and histopathologic diagnosis of Endometriosis. 3Subjects with Primary hyperprolectineamia.

4.Subjects with basal FSH \>/=15mIU/ml. 5.Subjects with continuously elevated 17-0h-p.