cyrilzakka/clinical-trials huggingface dataset:
ST-T Segment Changes in Emergency Physicians While on Duty

Preclinical emergency management is frequently associated with a combination of physical and psychological stress.

This stress is known to lead to a broad variety of changes in the physiology even extending in the cardiovascular system. Both physical and psychological stress induces ECG changes. These changes include not only arrhythmias but also deviations in ST-T segment representing the phase of repolarization.

Information about changes in ST-T segment are missing until now. The investigators hypothesise that ST-T deviations occur in emergency physicians during shift at an emergency response car.

In order to show changes in ST-T segment a prospective observational trial will be conducted. By using a 12 lead ECG Holter the investigators will obtain ECGs during shifts of emergency physicians at an emergency response vehicle.

During 12-hour shifts emergency physicians will be attached to the 12 lead Holter ECG. ECGs will be analysed after blinding of names and reason of call (code) to the investigators. The primary outcome will be ST-T segment changes greater than 0.1mV in two corresponding leads for more than 30 seconds per 100 calls.

As secondary outcomes, other ECG changes such as ST-T segment changes \<0.1mV, T wave inversion or HRV will be analysed. Furthermore, surrogate parameter of stress will be measured using NASA-Task Load Index and cognitive appraisal and correlated to ST-T segment changes. Correlations between different phases of calls, different indications of calls and ECG changes will be assessed. Furthermore, correlation between alarm codes apriori defined as stressfull using a delphi process and ST-T segment changes as well es surrogate parameters of stress will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy emergency physicians doing shifts at the Medical University of Vienna's emergency response car

Exclusion Criteria:

* Known pregnancy
* Pre-existing cardiac diseases (valvular heart disease \> I°, any form of cardiomyopathy, history of coronary artery disease, history of myocarditis, any channelopathy, known high degree (\>1% of all beats within 24h) premature atrial or ventricular beats or atrial fibrillation or conduction disturbance.
* Any antiarrhythmic therapy
* Any implanted cardiac device
* Manifest Hyperthyroidism
* Termination of exercise testing due to the commonly used criteria26 or not reaching 85% of maximal predicted load.
Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis

The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on pediatric patients undergoing hemodialysis via the measurement of the following before and after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 8 and 18 years old
* Patients treated with HD for at least 6 months

Exclusion Criteria:

* Patients with malignancy and active inflammatory disease.
* Patients who received vitamin E or any antioxidant treatment during the past 3 months.
Laryngeal Mask Use in Knee-chest Position in Lumbar Surgery in Neurosurgical Patients

Spine surgery is the most common procedure in neurosurgical setting. Some centers have chosen the patient self-position to avoid complications such as accidental extubation or loss of the iv line. The aim of our retrospective study is to describe our experience in the laryngeal mask use for airway management in patient submitted to spine surgery in neurosurgery

Retrospective analysis of our experience in the last 8 years with the airway management in spine surgery in prone position. A total of 358 cases were reviewed from 2008 to 2013.

Airway management (need for LM repositioning, orotracheal intubation because of failed LM insertion), anticipated difficult airway, and airway complications were registered. Statistics were compared between groups with the t test or the χ test, as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* elective spinal surgery

Exclusion Criteria:

* emergency cases
* complex spine surgery
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers

The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male and female subjects between 18 and 45 years old (inclusive);
* BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
* Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator.

Key Exclusion Criteria:

* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
* Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) \< 96% and respiratory rate \< 12 breaths per min;
* History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;
* CRP, ESR, or fibrinogen that are above normal reference ranges at Screening or Day 1.
Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis

At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with cystic fibrosis, suffering from acute pulmonary exacerbations (APE).

It is an outpatient treatment. To assess the efficacy and quality of the treatment, a blood test every 3rd day is taken to determine the concentration of Piperacillin in blood-plasma.

Patients with cystic fibrosis (CF) are often colonized with multidrug-resistant microorganisms, which increases the risk of suboptimal dosing of antibiotics as the time above the minimum inhibitory concentration (T\>MIC) is suboptimal. Continuous infusion of beta-lactam antibiotics is more likely to optimize T\>MIC than intermittent infusion. At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with CF, suffering from acute pulmonary exacerbations (APE). It is an outpatient treatment, and the patients are given 16 g of piperacillin per 24 hours. To assess the efficacy and quality of the treatment, a blood test every 3rd day will be required to monitor the blood-plasma concentration of piperacillin, as well as C-reactive protein (CRP) and white blood cell count (WBC).

Eligibility Criteria:
Inclusion Criteria:

* Patients with Cystic Fibrosis, suffering from acute pulmonary exacerbations, treated with continuous infusion of Piperacillin/Tazobactam for a period of two weeks.

Exclusion Criteria:

* Age under 18
Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer

This is a biomedical and prospective study of interventional type. The trial will include 29 patients over a period of 15 months + 24 months of follow up maximum.

The study will be conduct in womens with metastatic invasive breast cancer or locally advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line hormone therapy for metastatic breast cancer) is indicated.

The main objective of this pilot study is to evaluate the feasibility to detect in the circulating blood of patients, before treatment (T0), the presence of the fifteen tissular microRNAs described in preclinical studies as possibly involved in hormone resistance/sensitivity.

In parallel of the detection of these specific miRNAs, we will conduct a larger scale analysis of circulating miRNAs in these patients before (T = 0) and after one month of treatment (T28).


Eligibility Criteria:
Inclusion Criteria:

1. Women of more than 18 years old (menopausal or not)
2. Women with metastatic invasive breast cancer or locally advanced (without surgical project), for which treatment with tamoxifen or anti aromatase

   +/- LH-RH agonist, is indicated (anti-aromatase prescribed for menopausal womens; tamoxifen prescribed for both menopausal, pre menopausal or not menopausal womens).
3. Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (\>= 10% of tumor cells by IHC technique).

   Cancer HER2 negative.
4. Evaluable disease (measurable according RECIST criteria or not)
5. Any previous adjuvant hormone therapy should be discontinued for at least 21 days.
6. One or two prior metastatic lines of chemotherapy are allowed
7. General status WHO 0-2
8. The women of childbearing age must use an effective contraception for the duration of the study
9. Informed consent obtained and signed before any specific study procedure
10. Patient member in a national insurance scheme

Exclusion Criteria:

1. Patient already treated with hormone therapy or not having stopped the previous adjuvant hormone therapy for at least 21 days.
2. Prescription of chemotherapy and / or other targeted therapy (other than hormone therapy) for the treatment of the breast cancer
3. Any previous hormone therapy for metastatic or locally advanced (without surgical project) breast cancer
4. Known hypercalcaemia before miRNA dosage at T=0 requiring immediate biphosphonate therapy
5. Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the the inclusion of the patient in the study inappropriate in the opinion of the investigator.
6. Patient unable to follow procedures, visits, examinations described in the study.
7. Pregnant women or nursing mothers will not participate in the study.
8. Patients under legal guardianship
Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

OBJECTIVES:

I. Evaluate an educational program that has been pretested for cultural appropriateness and literacy requirements in patients with systemic lupus erythematosus (SLE).

II. Assess the impact of this educational program on patients with SLE, with an emphasis on recognizing cardinal symptoms, coping with fatigue, regulating medications, and communicating with the physician.

PROTOCOL OUTLINE:

Patients are randomly assigned to 1 of 2 groups.

One group participates in an educational program administered and coordinated by a health educator. The program includes 1 or 2 educational sessions emphasizing practical advice, each lasting approximately 1.5 hours; social support from a patient-identified management partner; and behavioral reinforcement from health center staff, the patient partner, and written and audio materials.

The control group receives patient educational materials consistent with usual care (pamphlets).

Patients are followed at 6, 12, 24, and 36 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria

Recruitment from the Medical College of Virginia SLE registry
Preload Dependency by Impedance Cardiography After Cardiac Surgery

The primary purpose of this study is to investigate wether the measure of stroke volume (SV) variations by impedance cardiography during passive leg raising (PLR) can reliably predict preload dependency after cardiac surgery, in comparison to a reference parameter : velocity time integral (VTI) variation measured by transthoracical echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Men or women over 18 years
* Affiliated to a social protection
* Signed written consent
* Informed about the results of the medical visit
* All type of cardiac surgery with extracorporeal circulation performed at University Hospital of Strasbourg
* Sedated and under mechanical ventilation

Exclusion Criteria:

* Cardiac arrhythmia
* Contraindication to PLR maneuver
* Exclusion period due to inclusion in a previous or ongoing study
* Impossibility to provide enlightened information
* Patient deprived of liberty, under judicial protection, trusteeship or guardianship
* Pregnancy, lactation
Methylphenidate to Improve Balance and Walking in MS

Methylphenidate is an amphetamine-like psychomotor stimulant drug currently approved for the treatment of attention-deficit hyperactivity disorder (ADHD), postural orthostasis tachycardia syndrome and narcolepsy. It is also often prescribed off label to people with MS to improve fatigue. It is proposed that methylphenidate may also improve imbalance and walking deficits in MS by improving concentration and central integration, one of the primary mechanisms thought to underlie imbalance and walking deficits in MS.

The proposed pilot study will examine the effects of methylphenidate on imbalance and walking in 24 subjects with MS and imbalance. The subjects will be randomly assigned to receive either an escalating does of methylphenidate, 20mg, 40mg or 60mg, divided into two doses each day, or matched placebo for 2 weeks at each dose. If a subject does not tolerate dose escalation they will be instructed to discontinue use of the drug. The maximum safely tolerated dose for each subject will be noted. Changes from baseline in subject's walking speed, balance, vestibular function, cognitive function, and fatigue will be assessed at each dose.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-65
* Able to walk at least 100m without an aide or with unilateral assistance
* Poor static balance, specifically prolonged APR latencies (≥ 1 standard deviation (SD) \> mean for healthy people in this age range), OR
* Reduced balance-related activity (ABC scores ≤ 85%)
* Walking difficulties, specifically T25FW \> 6 seconds, OR reduced self perceived walking (MSWS-12 scores ≥ 50/60)

Exclusion Criteria:

* Currently taking methylphenidate, modafinil, or armodafinil.(any within the last 2 weeks)
* Cause(s) of imbalance other than MS
* Systolic pressure consistently greater than 150 mm Hg or diastolic pressure consistently greater than 90 mm Hg
* Contraindications to methylphenidate (Anxiety, tension, agitation, thyrotoxicosis, tachyarrhythmias, severe angina pectoris or glaucoma, hypersensitivity to methylphenidate, motor tics or a family history or diagnosis of Tourette's syndrome, seizures, severe or poorly controlled hypertension, treatment with monoamine oxidase inhibitors currently or within the last 14 days, current use of guanethidine, pressors, coumarin anticoagulants, anticonvulsants, phenylbutazone, or tricyclic antidepressants, history of drug abuse or alcoholism)
* Pregnancy or breastfeeding
Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* LGG including the brainstem and supratentorial only , (WHO grade I-II), confirmed by biopsy unless in Neurofibromatosis type 1 (NF1) participants with classic appearance
* Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor)
* Scheduled to receive systemic therapy
* Performance Score: Karnofsky ≥ 50 for participants \&gt; 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
* Age between ≥ 1 years but ≤21 years at time of study registration

Exclusion Criteria:

1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
2. Pregnant participants
3. Patient who would require sedation or anesthesia for imaging beyond SOC.
4. Participants who weigh less than 8 kg.
5. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.
6. Participants with a history of abnormal kidney function or creatinine \&gt;= CTCAE v5.0 grade 2 at time of study registration.
7. Participants with primary tumors of the spinal cord.
Study of the Outcome of Patients With Acute Myeloblastic Leukemia and Myelodysplastic Syndrome Receiving Iron Chelation Therapy After Allogeneic Hematopoietic Stem Cell Transplantation

Iron chelation, mostly associated with multiple red blood cell transfusion, is relatively common in patients with hematological malignancies receiving allo-HSCT.

This multicenter prospective observational study is designed to establish the impact of iron chelation on relapse after allo-HSCT in patients with acute myeloid leukemia and myelodysplastic syndrome. The investigators will compare the results obtained in the prospective study to those observed in a historical retrospective cohort of paired patients who did not receive chelation. Given our clinical experience and literature results, the investigators will evaluate the Exjade chelator. Although not demonstrated, the presence of mutations of the HFE gene could play an indirect role on leukemogenesis by promoting overload. It is therefore important to evaluate the status in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* adults older than 18 years old
* Patients with AML or MDS in complete remission receiving CSH transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning.
* Patients with iron overload defined by at least one ferritinemia\> 1000 μg / L in the 6th month after CSH allograft
* Creatinine less than 1.5 x ULN; ALAT and ASAT \<2 x ULN
* Patients giving their informed consent (prior to performing any study procedure)

Exclusion Criteria:

* Hypersensitivity to the Exjade
* Association with another iron chelator
* Proteinuria\> 1g / 24h
* Acute and chronic hepatitis (B and C viruses); HIV
* Extended corrected QT
* History of ocular toxicity related to iron chelation treatment
* Gastrointestinal Abnormal Absorption of Oral Medications
* Pregnancy and lactation
Position Intervention to Reduce Hypoxemia in Sedation Patients

Hypoxemia was defined as an SpO2 of \< 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. In special environments, including outside the operating room where emergency airway management for critically ill and injured patients is needed, or in areas with limited medical resources like remote areas, adopting simple interventions by changing position to maintain patients' respiratory function can be more economical, convenient and safe.

Hypoxemia was defined as an SpO2 of \< 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. In special environments, including outside the operating room where emergency airway management for critically ill and injured patients is needed, or in areas with limited medical resources like remote areas, adopting simple positional interventions to maintain patients' respiratory function can be more economical, convenient and safe. This study aims to conduct a prospective, multicenter, randomized controlled trial to observe the level of patients' oxygen saturation and the occurrence of hypoxemia under different body positions (supine and lateral positions), and its impact on prognosis, providing reliable evidence-based medical evidence for the prevention and treatment of complications in patients requiring airway management.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with 18 years or older
2. Without obvious cardiovascular or pulmonary dysfunction
3. Scheduled to undergo procedure or surgery with sedation
4. Signed the informed consent form

Exclusion Criteria:

1. Preexisting bradycardia (heart rate \<50 beats/min), hypotension (systolic blood pressure \< 80mmHg), or hypoxemia (SpO2 \< 90%);
2. Requiring supplemental chronic or intermittent oxygen therapy because of preexisting diseases
3. Preexisting diseases which unable to tolerate reduced SpO2 or Partial pressure of carbon dioxide in artery (PaCO2) diseases, such as severe cardiovascular and cerebrovascular diseases, intracranial hypertension or severe lung diseases;
4. Coagulation disorders or a tendency of nose bleeding;
5. Patients whose body position cannot be altered;
6. Participated in other intervention clinical studies in the past 3 months;
7. Other conditions deemed unsuitable for inclusion by the researcher;
8. Patients and guardians refused to participate in this trial.
Cleft Palate Technique and Maxillary Growth

comparison of the maxillary growth between cleft palate patients that underwent to repair by 2 flap palatoplasty versus Furlow with buccinator technique


Eligibility Criteria:
Inclusion Criteria:

* 5-6 years old childreen with previous treated complete cleft lip and palate, nonsyndromic.
* lip and palate repair performed by one craniofacial surgeon

Exclusion Criteria:

* Patients with syndromic cleft lip.
* Redu cases
* Bilateral cleft lip
* Patient older 6years or younger 5 years.
* Associated Cardiac anomalies.
* Any systemic condition