cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Extubation Criteria in Children With Upper Respiratory Infection (URI)

The investigators are currently completing a data collection to try to optimize pediatric patients' preoperative screening, in the setting of an upper respiratory infection.

The objectives of this study are to evaluate various extubation criteria and their predictive value for successful extubation in non-cardiac surgical procedures. To evaluate the predictive value of room air oxygen and an original preoperative URI questionnaire in pediatric patients with URI or URI symptoms.

Eligibility Criteria:
Inclusion Criteria:

* All study participants must be undergoing general anesthesia and surgery with an endotracheal tube
* The URI group will be participants with a score of at least 3 on our pre-operative URI survey, with planned airway instrumentation with an endotracheal tube (ETT) for their surgical procedure who are to be discharged same day or on postoperative day 1.
* The non URI group will be participants undergoing elective procedures with no URI symptom or recent URI. Defined as no URI or "allergy" symptom within the past 6 weeks and a score of 1 or less on the URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1.

Exclusion Criteria:

* History of home oxygen use or ventilator dependence,
* Patients undergoing emergent procedures.
* Patients with cyanotic congenital heart disease.
* Patients receiving a surgical procedure where the duration of post procedure
* admission is anticipated to be greater or equal to 2 postoperative days.
* Patients undergoing anesthesia for imaging procedures alone.
* Patients who are extubated deep intentionally.
* Patients intended to be managed with supraglottic airway.
* Patients undergoing total IV anaesthesia (TIVA).
Routine Calcium for Preventing Hypocalcemia

The present study investigated the effect of routine calcium and vitamin D supplementation and tried to find the predictors for postoperative hypocalcemia in patients with thyroid cancer.

The present study investigated the effect of routine calcium and vitamin D supplementation and tried to find the predictors for postoperative hypocalcemia in patients with thyroid cancer. Demographic data, including age, sex, pathologic features, and postoperative laboratory test results were analyzed, as was the development of symptomatic hypocalcemia, defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms. Hypocalcemia was considered permanent in patients who required calcium supplementation for longer than 6 months after thyroidectomy.

Serum concentrations of PTH and ionized calcium were measured 1 and 14 days postoperatively. Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium and 1,000 IU/day cholecalciferol for 2 weeks, beginning on the first postoperative day (POD) to the 14th POD, whereas patients in the control group received no supplementation. If symptomatic hypocalcemia developed, patients in both groups received 2.0 g of intravenous calcium, followed by oral supplementation with 3,000-4,000 mg/day elemental calcium and 1,000-2,000 IU/day cholecalciferol up to the 14th POD. If hypocalcemic symptoms were persistent or worsening 2 hours after calcium administration, patients were administered another intravenous calcium supplementation.

Eligibility Criteria:
Inclusion Criteria:

* patients with thyroid cancer
* euthyroid state
* underwent total thyroidectomy

Exclusion Criteria:

* previous history of neck surgery or irradiation
* calcium supplement before enrollment
* hyperthyroidism or hypothyroidism
* pregnancy
Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy

In pregnancy Restless Legs Syndrome(RLS) is more common than in the general population. During pregnancy iron tablets are the only available safe medication but their efficacy is rather poor. It is the aim of this study to examine the efficacy, practicability and safety of the drug Ferinject® containing the active agent Ferric carboxymaltose for the therapy of Restless Legs Syndrome(RLS) during pregnancy in the case of iron deficiency or anaemia.

20 women with RLS and iron deficiency and/ or anaemia in the third trimester of pregnancy will receive intravenous Ferric carboxymaltose in one or two single doses. Repeated blood tests, pre-and post-therapy actigraphy as well as repeated answering of questionnaires concerning Restless Legs Syndrome(RLS)-symptoms and sleep quality will show the effect of iv-Iron supplementation on Restless Legs Syndrome(RLS)-symptoms during pregnancy.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

1. Pregnant women, singleton pregnancy, in the 3rd trimester
2. Iron Deficiency (Anaemia) defined as Serum Ferritin \< 35ug/l with or without Hb \< 11g/dl.
3. Fulfilling the 4 criteria of the International Restless Legs Study Group (IRLSS)

   * Uncomfortable and unpleasant sensations in the legs
   * An urge to move the legs due to this discomfort and worsening of the symptoms when resting
   * The unpleasant sensations are being relieved by movement such as walking or stretching
   * Worsening of the symptoms in the evening or night
4. RLS score \> 20 (defined as modest to severe RLS symptoms) or RLS symptoms = 3 times per week
5. Patients = 18 years
6. Signed informed consent provided

Exclusion criteria: Criteria

1. Age \< 18 years
2. Multiple pregnancy
3. Depression, psychiatric disease
4. Severe internal underlying disease, that causes fatigue and sleepiness and thus may confound the outcome measures
5. Abuse of alcohol, coffee or drugs
6. Medication (antipsychotics, antihistaminics, tricyclic or SSRI/SNRI antidepressants, L-Dopa, antidopaminergic medication, medium to strong opioids, antiepileptic medication).
7. RLS not due to iron deficiency: RLS secondary to other central nervous system disease or injury. Such disorders included peripheral neuropathy, neurodegenerative disorders and multiple sclerosis
8. RLS secondary to chronic kidney disease
9. Relevant chronic pain syndrome of the extremities other than RLS
10. Known proneness to allergic reactions
11. Known hypersensitivity to Ferric carboxymaltose
12. Relevant disorders of iron metabolism of other aetiology than iron deficiency (e.g. hemochromatosis, hemosiderosis)
Association of Tumour Grade and Sex Steroid Receptor as a Prognostic Index in Breast Cancer

Null hypothesis: Histological grade of tumour bears no relation with the status of sex hormone receptors.

Alternate hypothesis: Both the histological grade of tumour and expression of sex steroid receptors are directly related to each other The investigators aim to;

1. see the relationship of sex steroid receptors with the histological grade of breast cancer.
2. evaluate the efficacy of steroid receptors as a prognostic factor

Breast cancer accounts for the largest number of deaths amongst the female population worldwide. It is now considered as a systemic disease even if diagnosed at an initial stage, as the clinical behaviour cannot be accurately predicted. Due to this reason, it is subjected to new dimensions of research every day. The aggressiveness of the cancer is directly proportional to the histopathological grade at the time of diagnosis. This is true with reference to the clinical stage at the time of presentation, the probability to metastasize and potential to recur. The idea of steroids receptor expression by the tumour is not new, and to evaluate their status prior to the induction of hormone therapy is a must.

The sex steroids, which are produced intratumorally, include estrogen, progesterone, and androgens. They act on their specific receptors present on the cell surface, within the cytoplasm and at the nuclear membrane. It is a measurement of these receptors that decide the potential of an individual to respond to different types of hormones like estrogen receptor blockers and aromatase inhibitors. Do the histological grade of tumour bears some relation with the status of these receptors and can investigators predict and rely just on the cellular behaviour of tumour for the purpose of prognosis is still under investigation. This study is designed to see the relationship between the histopathological grade of the tumour with the expression of sex steroid receptors. It will also try to evaluate whether these receptors bear some prognostic value or not.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with breast cancer irrespective of age, gender and clinical stage

Exclusion Criteria:

* Any patient who lost to follow up
Device-Based Scribe Service (iScribes) on Patient Satisfaction

This project involves the implementation of a device-based scribe service (iScribes) for patient encounters. The objective of the proposed study is to track and compare the allocation of physician time and associated quality metrics with and without the use of iScribes. We anticipate that the use of iScribes will reduce the amount of physician time spent away from the patient (e.g., charting, dictating).

This project involves the implementation of a device-based scribe service (iScribes) for patient encounters. Device based scribing services record the patient-physician encounter and securely transmit data to an off-site facility where trained professionals transcribe the dictations. The information is then sent back to the physician and stored in the providing institutions electronic medical records. The objective of the proposed study is to track and compare the allocation of physician time and associated quality metrics with and without the use of iScribes. We anticipate that the use of iScribes will reduce the amount of physician time spent away from the patient (e.g., charting, dictating).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Written informed consent is obtained
* New patient visit

Exclusion Criteria:

* Patient refuses
* Patient is lacking decisional capability
Growth Parameters & Body Mass Index in Children With Chronic Diseases

Deviations from the normal pattern of growth may be the first clues to pathology as in many chronic diseases evaluated clinically by anthropometric measurements \& body mass index. Growth impairment in children with chronic diseases is associated with disruption of the growth hormone (GH) and predominantly results from undernutrition, chronic inflammation and prolonged corticosteroid treatment.

Undernutrition leads to major adaptations in the endocrine system towards conserving energy, diverting substrates away from growth and reproduction, and providing alternative sources of energy for critical body homeostasis. chronic inflammatory processes exacerbate undernutrition through proinflammatory cytokines such as interleukin-1\&6 and tumor necrosis factor. These growth-regulating mechanisms are disturbed further by corticosteroids used in some chronic conditions for their anti-inflammatory and immunosuppressive properties.

Growth impairment occurs with many chronic conditions e g: Congenital heart dieases (CHD), chronic pulmonary diseases such as bronchial asthma, Gastrointestinal diseases sch as inflammatory bowel disease ,Chronic liver diseases , Chronic renal diseases, Chronic hemolytic anemia and chronic Central nervous system diseases.


Eligibility Criteria:
Inclusion Criteria:

* Age: under 12 years old.
* Both sex .
* Patients with chronic medical diseases.

Exclusion Criteria:

* Age: over 12years old.
* Patients with acute diseases.
* Pediatric with malignancy.
* chronic patients with surgical sequelae.
European Registry of Dialysis Treatment of Pediatric Acute Kidney Injury (AKI)

Acute kidney injury (AKI) is a frequent clinical condition in hospitalized, in particular, in critically ill children. Moreover, AKI is an independent predictor of mortality. An incidence of AKI in pediatric intensive care units (PICU) between 10 and 62% has been reported in recent clinical trials adopting pRIFLE or AKIN criteria, with the highest risk present in cardiac surgery patients. Despite significant developments in the management of AKI, the overall mortality rate of patients with AKI has not improved significantly. Currently, there is no consensus concerning the optimum dialysis modalities to adopt in pediatric AKI. No studies have prospectively compared the efficacy of different types of RRT for pediatric AKI. While PD remains the most commonly used modality in children worldwide, over the last decade CRRT has become the preferred treatment modality for critically ill children with AKI in North America.

The investigators have recently conducted a survey among 34 European Pediatric Nephrology Centers in the ESCAPE Network to obtain current information on dialysis management practices in children. Approximately 900 children with AKI requiring dialysis are managed at these 34 centers per year. This number supports the creation of a prospective European AKI registry.

The main scope of the Registry is to report the epidemiology and outcome of children with AKI treated with dialysis in over 30 Pediatric Nephrology Centers in Europe. Secondary aims are to verify the association of a specific dialysis modality with the outcome and the association of primary disease, co-morbidities, nephrotoxic agents, fluid overload, anuria, basic hemodynamic parameters (BP, HR), basic nutritional intakes (protein and calorie supply) with the outcome.

Data capture will be exclusively web-based via electronic case report forms. Every participating site will be provided with a unique code and password that identify the corresponding site.

Eligibility Criteria:
Inclusion Criteria:

* Children with AKI at Hospital admission or who developed AKI during hospitalization treated with dialysis (PD, HD, CRRT)
* Age: 0-18 yrs

Exclusion Criteria:

* Children with known preexisting CKD (i.e.: AKI on CKD)
The International Imaging Registry in Liver Cirrhosis (BAVENO-VI SPSS GROUP).

The purpose of this study is to perform a multicentre registry of cirrhotic patients who had been submitted to an imagining technique in recent years (angio-CT scan or abdominal MRI), in order to collect anatomical and clinical information. The main objective will be focused on the study of portosystemic shunts and their relation with portal hypertension.

Patient with liver cirrhosis submitted to an abdominal angio-CT scan or a MRI from year 2010 to 2014 will be included in the study. The chosen imaging technique will be angio-CT preferably, but MRI data will also be available. Patients will be identified in every hospital by means of the registry of coded diagnoses and the lists of complementary tests performed. Clinical and radiological data of every patient will be collected. The clinical variables will be obtained from reviewing the patient clinical history. The radiological parameters will be gathered by means of the systematic review of the angio-CT or MRI.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* An evaluable imaging test (angio-CT or MRI) performed by any reason in the study period (from January 2010 to December 2014)

Exclusion Criteria:

* Presence of previous surgical shunts
* Prior liver transplant
* Neurological or psychiatric disorder that do not permit to establish the diagnosis of hepatic encephalopathy
* Presence of hepatocellular carcinoma beyond Milan criteria
* Terminal disease
Validation of the Arabic Version of the Postoperative Quality of Recovery Score 15 (Qor-15Ar)

Anesthesia practice is not only centered on the patient's safety and well-being through the perioperative period but also on enhancing his overall recovery experience. This study aims to provide an adapted questionnaire for the Arabic-speaking population as a measuring tool of the quality of recovery after surgery.

With the increasing number of anesthesia procedures performed every year, the concept of rapid rehabilitation after surgery has become a primary goal of the perioperative management of patients. This postoperative recovery concerns not only the physical aspect but also encompasses the general concept of well-being and enhancement of the patient's experience. There are many tools to assess postoperative recovery. However, none has been validated within the Moroccan surgical population.

The Qor-15 (Quality of Recovery) score is a scale for measuring postoperative recovery. It was developed in 2013 by Myles et al and has been validated in a widely variable population \[1\]. It includes 15 items, each rated from 0 to 10. Our objective is to validate the Arabic version of the QOR-15Ar within a Moroccan surgical population.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted for an emergency or elective surgical procedure.

Exclusion Criteria:

* patients under 18 years old
* a weak understanding of the Arabic language
* intracranial Surgery
* underlying psychiatric pathology compromising the completion of the questionnaire
* the presence of life-threatening postoperative complications (e.g. hemorrhagic shock, etc.)
Study of Clofarabine in Combination With Low Dose Cytarabine to Treat Myelodysplastic Syndromes

This is an interventional, multicenter, open label, phase II study designed to evaluate the safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated patients with poor risk of Myelodisplastic Syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 55 to 80 years
* Written informed consent to participate in the clinical trial
* Morphologically confirmed diagnosis of MDS according to WHO classification, and IPSS INT-2 or high risk according to IPSS index
* ECOG performance status 0-2
* No previous chemotherapy
* Serum bilirubin ≤1.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
* AST and ALT ≤2.5 times ULN
* Alkaline phosphatase ≤2.5 times ULN
* Serum creatinine ≤ 1 mg/dl: if serum creatinine \> 1.0 mg/dl, then the estimated glomerular filtration rate (GFR) must be \>60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine) -1.154 x age in years -0-023 x 0.742 (if patient is female) x 1.212 (if patient is black)
* HIV negative

Exclusion Criteria:

* Have had any other chemotherapy or any investigational therapy as a treatment for MDS. Patients who received chemotherapy for other cancers than MDS/AML can be enrolled, provided that at least 6 months elapsed from accomplishment of the last course of chemo.
* Have had a prior hematopoietic stem cell transplant for MDS
* Have an uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
* Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
* Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart
* Have had any prior treatment with Clofarabine
* Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy with the following exceptions: a.)Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease -free duration, are eligible for this study if definitive treatment for the condition has been completed. b.)Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
* Have prior positive test for the Human Immunodeficiency Virus (HIV), HCV, HBV.
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects

The purpose of this study is to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects.


Eligibility Criteria:
Inclusion Criteria:

Additional screening criteria check may apply for qualification:

* Able to provide written informed consent to participate in this study after reading the participant information sheet and Informed Consent Form (ICF), and after having the opportunity to discuss the study with the Investigator or designee.
* Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory and other tests at Screening and Day -1.
* A body weight of ≥60 kg for males and ≥50 kg for females and a body mass index (BMI) (Quetelet index) ranging from 18 to 30.0 kg/m2 inclusive at Screening and Day -1.
* In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the Protocol restrictions and requirements.

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

* Subjects with clinically significant (in the opinion of the Investigator) endocrine, thyroid, hepatic, respiratory, gastrointestinal, neurological, renal, cardiovascular disease, or history (within the last 5 years) of any significant psychiatric/psychotic illness disorder (including anxiety, depression and reactive depression).
* Female subjects who are pregnant (positive pregnancy test at Screening or Day -1) or lactating.
* Having previously received MT-6345 as part of this study.
* Clinically relevant abnormal medical history, physical findings or laboratory values at Screening or Day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator.
* Subjects who test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at Screening.