cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics and Metabolism of Midazolam in CML Patients With Additional Extension Phase to Evaluate the Safety of Nilotinib

This study will evaluate the effects of multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam (as a sensitive CYP3A probe) in CML patients. The following extension study does evaluate the safety of nilotinib.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a cytopathologically confirmed diagnosis of Ph+ CML or Philadelphia chromosome- negative (Ph-) CML patients in accelerated or chronic phase who are resistant and/or intolerant against at least one prior therapy with a BCR-ABL tyrosine kinase inhibitor
2. Female or male ≥ 18 years of age
3. Patients who are nilotinib naïve at study entry, e.g. did not receive any nilotinib treatment prior to study
4. WHO Performance Status of ≤ 2

Exclusion Criteria:

1. Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
2. Impaired cardiac function
3. History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
4. Patients actively receiving therapy with the prohibited co-medications (CYP3A4 inhibitors or inducers, or CYP2C inducers)
5. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval
6. Treatment with immunotherapy or chemotherapy within 3 days (6 weeks for nitrosurea or mitomycin-C) prior to Day 1 or who have not recovered from side effects of such therapy.
7. Treatment with imatinib within 1 week prior to Day 1 or who have not recovered from side effects of such therapy.
8. Patients who have hypersensitivity to midazolam or related compounds

Other protocol-defined inclusion/exclusion criteria may apply
Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population

This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). The virus can cause both acute and chronic disease, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Globally, around 50 million people per year are living with HCV, resulting in 244,000 deaths. The WHO estimates that only 36% of individuals chronically infected with HCV are diagnosed, and the WHO HCV targets include increasing the diagnoses to 90% by 2030. WHO guidelines, published in 2021, strongly recommend offering self-testing for HCV as an additional approach to HCV testing services.

The Panbio™ HCV Self Test, is a lateral flow test, designed for the qualitative detection of antibodies specific to HCV in finger-stick whole blood. The test is designed to be used by lay users and uses a sample volume of 10 µL. The professional use version test (Bioline™ HCV Test) is commercially available and has previously been clinically validated by the manufacturer, demonstrating a sensitivity of 99.3-100% and a specificity of 98.1-100%.

Evaluation of the test performance when used by professional users has been conducted, and evaluation of lay user sensitivity and specificity based on lay user populations outside the EU is being conducted. This study will demonstrate the test performance and usability of the test when used in a European lay user population. The study will be conducted at one recruiting hospital in Spain.

Eligibility Criteria:
Inclusion Criteria:

* Participant is aged 18 or over
* Participant agrees to all aspects of the study and is able and willing to provide informed consent / assent with parental consent.

Exclusion Criteria:

* Participant has already participated in this study on a previous occasion.
* Participant is deemed unfit for the study by the Investigator.
* Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.
* Participant is a practising health-care professional or laboratory scientist / technician or has prior medical or laboratory training or experience
* Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.
* Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.
* Participant is unwilling or unable to provide informed consent.
Study Evaluating InductOs in Diaphyseal Tibia Fractures

Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with acute open tibial shaft fractures (Gustilo Type I, II, IIIA, or IIIB) who require surgical management with reamed, statically locked intramedullary nail fixation and who are at low risk for amputation.
* Subjects should be at least 18 years of age, be skeletally mature, and be able to provide written informed consent.
* Initial fracture stabilization and wound debridement should occur within 1 day after injury and DFC should occur within 14 days after injury.

Exclusion Criteria:

* Planned treatment for the fracture should not include further procedures to promote fracture healing. After 16 weeks have elapsed since DFC, unanticipated procedures to promote fracture healing are permitted as clinically indicated.
* Presence of fracture distraction \> 2 mm following definitive fracture fixation.
* Presence of purulent drainage from the fracture site or evidence of active osteomyelitis.
Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia. Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.

OBJECTIVES:

I. Provide a classification guide that will organize the clinical and laboratory data necessary for assigning each patient with newly diagnosed acute lymphoblastic leukemia (ALL) to a specific treatment clinical trial.

II. Provide an administrative base to capture classification data for correlative studies accompanying current Children's Oncology Group (COG) ALL treatment clinical trials.

III. Provide a central reference guide for all required and research only ALL studies that will be conducted at local and reference laboratories.

IV. Provide a mechanism for optional banking of leukemia and germline specimens for current and future research.

OUTLINE:

Patients undergo blood collection and bone marrow biopsies at baseline and at the end of induction therapy for immunophenotyping for marker identification; molecular testing for translocations; trisomy analysis by fluorescence in situ hybridization (FISH); and DNA ploidy. Immunophenotype results obtained on this study are used to determine the patient's assignment to specific treatment clinical trials (consistent with acute lymphoblastic leukemia).

After completion of induction therapy, patients are followed once or twice annually.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed acute lymphoblastic leukemia, defined by any of the following:

  * At least 25% blasts in the bone marrow
  * Absolute blast count at least 10,000/mm\^3, if bone marrow aspiration is not performed
* No prior registration on this study
Effect of Extubation Under Deep Anesthesia on Emergence Agitation of Nasal Surgery

This study analyzed the relationship between extubation timing and Emergence agitation in 18-60 years old adults undergoing nasal surgery, such as nasal septum correction, endoscopic sinus surgery, and nasal bone fracture reduction. The number of agitation, sedation score, pain score, operation method, analgesic drugs and other data were recorded to analyze the effect of deep anesthesia extubation on agitation in patients with nasal surgery. It also provides a clinical basis for the prevention and treatment of agitation during the recovery period of such operations in adults.

Nasal surgery is an operation with a high proportion of pain and agitation found in the clinical medical treatment of our hospital. Although the operation time is short, the operation trauma is small, and it does not involve important organs and blood vessels, the clinical observation shows that the incidence of agitation in such patients after operation is high, and the degree of pain varies greatly. Many studies have analyzed the related risk factors of agitation in the wake-up period of adult nasal surgery, and believe that the existence of postoperative endotracheal tube is the main risk factor. However, there is a lack of prospective randomized controlled study on the timing of postoperative extubation in patients with nasal surgery. Therefore, this study analyzes the impact of extubation timing on postoperative agitation, so as to clarify the correlation between postoperative agitation and extubation timing and possible protective factors, which is helpful to early prediction, prevention and treatment, and reduce the incidence of postoperative EA in patients with nasal surgery.

Eligibility Criteria:
Inclusion Criteria:

ASA grade I-II Age 18-60 Patients undergoing selective general anesthesia for the correction of septum, endoscopic sinus surgery, bone fracture reconstruction, resection of sinus tumor, augmentation of nose and other nasal surgery Subjects voluntarily participate in the study and sign informed consent

Exclusion Criteria:

History of mental and neurological diseases; History of chronic pain or long-term use of opioids and other analgesics; History of respiratory diseases, severe pulmonary dysfunction and airway hyperresponsiveness; History of severe hypertension and cardiovascular disease; Pregnant women; Patients with severe primary diseases such as liver, kidney and hematopoietic system; patients with abnormal liver function (ALT, AST and TBIL exceeding 1.5 times the upper limit of normal value) or renal dysfunction (creatinine and urea nitrogen exceeding 1.5 times the upper limit of normal value) History of alcohol or drug abuse; History of epilepsy or a recent epilepsy; Obese patients, BMI ≥ 30kg / m2, or with sleep apnea; In addition to the above, the researchers judged that they were not suitable to participate in this clinical trial.
The Usefulness of CaIMR in Patients With STEMI

The coronary artery system is composed of three different types of blood vessels, namely epicardial arteries, arterioles and capillaries. Compared with epicardial arteries, arterioles and capillaries are lower than the resolution of current angiography systems, so angiography cannot be used for visualization. Existing studies have shown that coronary microcirculation plays an extremely important role in maintaining full myocardial perfusion. Coronary microvascular disorders can lead to myocardial hypoperfusion and ischemia, and are related to the poor prognosis of patients with coronary heart disease. At present, there is no technology that can directly detect the state of the coronary microcirculation in the human body, but the coronary microcirculation function can be indirectly assessed through two invasive and non-invasive methods. Among them, the index of microcirculation resistance (IMR) is widely used to evaluate coronary microcirculation function \[3\]. However, in the case of epicardial stenosis, accurate determination of IMR requires knowledge of coronary artery contraction pressure (Pw). However, measuring IMR is an invasive examination technique, and measuring IMR requires high technical requirements for the operator. Therefore, the CaIMR value obtained by AI technology can well overcome this limitation, and the existing data show that the CaIMR value has a good correlation with the IMR value. However, CaIMR has a clinical prognosis for patients with acute ST-segment elevation myocardial infarction. The predictive value of CaIMR has not yet been explored. This project aims to evaluate the application value of CaIMR in predicting the occurrence of adverse cardiovascular events in patients with acute ST-segment elevation myocardial infarction after percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are clinically diagnosed with acute ST-segment elevation myocardial infarction and are planned to undergo PCI;
* Volunteer to participate and sign the informed consent

Exclusion Criteria:

* Coronary angiography suggests that it is not suitable for PCI;
* Have performed CABG surgery in the past;
* Lesion of left or right coronary ostium;
* The target vessel is an infarct-related artery (old or acute myocardial infarction recovery period);
* The immediate effect of target vessel PCI is not ideal (such as: final TIMI blood flow \<grade 3, dissection with restricted blood flow, side branch occlusion with diameter\> 1.5 mm, distal embolism or thrombus shown by angiography);
* Severe systemic infection;
* Patients with malignant wasting disease whose estimated survival time is less than 1 year.
PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates

There is increasing evidence linking a fetal and early neonatal systemic inflammatory response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white matter injury (WMI) in very preterm infants. Babies with evidence of adrenal insufficiency early in life may not be able to control the inflammatory response and are thereby more likely to develop BPD than babies who do not show such evidence of inflammation. We designed a randomized controlled trial to test the hypothesis whether very preterm babies at high-risk of BPD, treated with low doses of HC during the first 10 days of life, are more likely to survive without BPD at 36 weeks of post-menstrual age (PMA), compared to babies treated with placebo.

Individual patients and study procedures. Entry criteria: gestational age between 24 weeks and 27 weeks + 6 days, babies born to mother with either clinical chorioamnionitis, preterm and prelabor rupture of the membranes (PPROM), or preterm labor, written informed consent obtained before inclusion and randomization. Exclusion criteria: babies born with birth weight below the 3th percentile, PPROM before 22 weeks, major fetal anomaly or congenital malformation, mother refusal or inability to provide consent. Stratification: stratum A: 24-25 weeks and stratum B: 26-27 weeks. Centrally controlled randomization takes place between 12 and 48 hours of age and patients assigned to the HC group are treated with 0,5 mg/kg HC intravenously twice a day for seven days and once a day for the next three days. Ibuprofen is only given to babies with persistent ductus arteriosis (PDA) echocardiographically confirmed at 24 hours of age or older.

Outcome variables. The primary outcome is a dichotomous variable: survival without BPD at 36 weeks PMA. A consistent physiologic definition of BPD will be used by all participating centres (Walsh MC, Pediatrics 2004;114:1305-11). Secondary outcome variables include features of WMI on MRI performed at 40 weeks PMA and neurodevelopmental outcome at 2-year of corrected age. Other outcome variables include death before discharge, BPD at 28 days and 36 weeks, duration of mechanical ventilation and O2 supplementation, need for vasopressors, use of open-labeled postnatal steroids (HC or dexamethasone), confirmed or suspected early and late onset sepsis, PDA, gastrointestinal perforation, NEC, ROP, IVH, biological markers of the neonatal inflammatory response syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 24 weeks and 27 weeks + 6 days
* Babies born to mother with either clinical chorioamnionitis, preterm and prelabor rupture of the membranes (PPROM), or preterm labor
* Written informed consent obtained before inclusion and randomization.

Exclusion Criteria:

* Babies born to mothers with birth weight below the 3th percentile
* PPROM before 22 weeks
* Major fetal anomaly or congenital malformation
* Mother refusal or inability to provide consent.
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section

Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care

This is a randomized double blinded study which compare between single dose cefepime versus cefuroxime plus metronidazole during emergency intrapartum cesarean section.

Outcomes will include fever, wound infection, and urinary tract infection.

Eligibility Criteria:
Inclusion Criteria:

* intrapartum caesarean section

Exclusion Criteria:

* evidence of infection
Fertility Preservation in Case of Endometriosis

Fertility Preservation is now considered as crucial for the well-being of women battling cancer. However, others indications have more recently emerged. Women with endometriosis may represent a suitable group since they are at risk for compromise ovarian reserve. Data on FP in endometriosis patients are rare: only small retrospective study, case-reports and opinion publications .Nowadays, there is no available data concerning real indications for PF on endometriosis patients (endometriomas, risk of surgery, deep endometriosis?), criteria for eligibility (ovarian reserve parameters, age), quality of oocytes and number of oocytes necessary to give at least one live birth.

We propose a monocentric observational cohort study, evaluating the efficacy of oocytes cryopreservation as fertility preservation procedure, in young adult female subjects with endometriosis, to finally define the criteria of eligibility for PF procedures in case of endometriosis.

Monocentric observational cohort study, enrolling young patients with endometriosis, without birth project for the moment, and asking for fertility preservation, in order to preserve mature oocytes.

Protocol of this study :

* information and signatures of consent file ;
* ovarian stimulation, oocytes retrieval and mature oocytes cryopreservation (one or more procedures)
* questionnaires every year, describing quality of life in this context of endometriosis and evolution (treatment, surgery, ART, pregnancies)
* data about number and rate of thawed oocytes after preservation, pregnancy rate and live birth rate with these oocytes.

Eligibility Criteria:
Inclusion Criteria:

* women from 18 to 36 years old
* endometriosis disease proved by sonography, MRI and/or surgery
* Consenting to participate to the study

Exclusion Criteria:

* Any contraindication for ovarian stimulation.
* Any contraindication for pregnancy .- Impossible Follow-up.
Glycemic Responses of an Innovative Oat Porridge

The aim of this study is to investigate whether enzymatic modification of starch in a food product using amylomaltase induces a lower glycemic response in healthy subjects compared to its unmodified counterpart.

A single-blind, randomized, cross-over study design will be applied. During each of the two study visits, healthy participants will consume an oatmeal porridge. One porridge will be treated will amylomaltase to modify the molecular structure of starch while the other porridge will serve as a control (unmodified counterpart). Blood glucose measurements will be taken postprandially at regular time points.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) range 18.5 - 25.0 kg/m2 at screening visit
* Fasting whole blood glucose values \< 6.3 mmol/L
* Regular diet with 3 meals a day (at least 5 times a week)
* Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigators on the basis of medical history
* Willingness to maintain habitual diet, physical activity pattern, and body weight throughout the trial and refrain from smoking for 12 h prior to each visit
* Willingness to abstain from alcohol consumption and to avoid vigorous physical activity for 24 h prior to study visits.
* Adequate level of understanding spoken and written English
* Willingness to provide informed consent to participate in the study

Exclusion Criteria:

* Failure to meet any one of the inclusion criteria
* Recent participation in any clinical trial (\< 90 days)
* Pregnant or lactating in the period of the study
* Known history of AIDS, hepatitis, diabetes mellitus (Type I and II), cardiovascular disease, any pathology (or recent surgical event) of the gastrointestinal system or any current metabolic or endocrine disease
* Alcohol consumption of \> 14 standard drinks for women and \> 21 standard drinks for men per week
* Celiac disease or gluten intolerance
* Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids the last 4 weeks before the screening visit
* Use of antibiotics during the last three months
* Reported slimming or medically prescribed diet
* Unwillingness or inability to comply with the experimental procedures and to follow the safety guidelines
Study on Patient Blood Management in Haematological Patients

The investigators noticed a variable prescription of blood components to haematological patients in the hospital. This study will analyze the prescription and administration of blood components to Haematological patients (pre measurement). Based on these results guidelines on transfusion triggers will be updated and educated to the physicians and new ICT (information and communications technology) implementations will be added to the electronic order for blood components. The investigators hope to see afterwards (post measurement) a more stable prescription and administration of blood components and a more economic use of blood components.

This study is set up as a first step of implementing patient blood management (PBM) in this hospital. PBM is an evidence-based, multidisciplinary approach to optimizing the care of patients who might need transfusion. Not only in pre/per/postoperative setting but also in haematology PBM guidelines can be implemented. Examples are: use of a restrictive haemoglobin trigger for red blood cells (RBC) transfusion, single use policy for the administration of RBC and platelets, administration only for correct indications (including the introduction of an electronic clinical decision support system for ordering blood components), ...

Eligibility Criteria:
Inclusion Criteria:

* all adult patients hospitalised at the haematology wards of the University Hospitals of Leuven (UZ Leuven) between 01/08/2017 and 31/07/2018 (pre measurement) and between between 01/08/2019 and 31/07/2020 (post measurement)

Exclusion Criteria:

* ambulatory patients
* patients without blood transfusion administered in their hospitalised period
* patients with no haematological illness that were hospitalised at the haematological wards