cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery

This study is designed to investigate the efficacy and safety of a single daily dose of 400 mg lumiracoxib given pre-emptively versus post-operatively in terms of efficacy in reducing pain associated with ambulatory arthroscopic knee surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients who need scheduled minor ambulatory arthroscopic knee surgery.

Exclusion Criteria:

* Patients with any surgical or medical conditions which could place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.

Other protocol-defined inclusion/exclusion criteria may apply.
Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention

This study on children with fetal alcohol spectrum disorder (FASD) aims to (i) characterize their self-regulation deficits, a process important for controlling emotions and behavior, (ii) describe brain structure and function underlying self-regulation, and (iii) determine whether training to improve self-regulation abilities changes brain and behavior. Individuals with FASD have a high risk of cognitive and social deficits, which reflect their difficulties in self-regulation and may lead to mental health concerns in adulthood. Importantly, early intervention improves long-term outcome. However the full extent of self-regulation problems in FASDs is unknown and the underlying neuroanatomy has not been fully described. Furthermore, information on how to best treat children with FASDs is lacking. Thus, the investigators propose three studies with a sample of 8-12 year old children, 40 with FASDs and 20 typically developing controls. In Study 1, the participants will be evaluated on cognitive and social self-regulation abilities using clinical and experimental tests. In Study 2, the participants will undergo a 1-hour MRI scanning session to obtain measures of their brain structure and function. In Study 3, FASDs will be randomly assigned to an immediate or delayed treatment group. The immediate group will undergo 12-weeks of therapy with the Alert Program for Self Regulation®. On conclusion of training, all will repeat Studies 1 and 2 and following this retest, the delayed treatment group will undergo training. The investigators will evaluate change in cognitive and social behavior and in brain structure and function by comparing performance and neuroimaging findings before and after the intervention. The investigators expect Alert training to significantly improve behavior and alter brain regions important for self-regulation. The findings will yield important information for improving self-regulation in FASDs and mitigating the development of mental health challenges.


Eligibility Criteria:
Inclusion Criteria:

* FASD: diagnosis of FAS/pFAS or ARND OR
* healthy child

Exclusion Criteria:

* head injury or other neurological abnormality
* debilitating or chronic medical condition affecting the nervous system
* MRI contraindication, such as braces
* inability to read
* non-English speaking
* IQ below 80 (typically developing controls only)
Obstetric Placement Study Using EST

Combined spinal-epidural (CSE) is an established technique for providing labour analgesia to obstetric patients which provides rapid onset but unsustained analgesia. The epidural catheter can be used to extend and provide continuous pain relief, however during single-segment needle-through-needle CSE, the catheter is untested. This study aims to confirm placement of epidural catheters of anesthesia through the epidural stimulation test (EST) which was first described by the PI of the study for confirming placement of epidural catheters approximately 20 years ago.


Eligibility Criteria:
Inclusion Criteria:

* Females, 18 years and older
* American Society of Anesthesiologists physical status I or II
* Full-term pregnancy with request for epidural early in labour (i.e. Regular labor or C-Section)

Exclusion Criteria:

* Contraindication to regional anesthesia
* Allergy or hypersensitivity to lidocaine, bupivacaine, or fentanyl
* Use of sedatives or opioids
* Abnormal vertebrae anatomy
* Neurological disorder with lumbar involvement
* Implanted electronic devices
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)

The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)


Eligibility Criteria:
Main Inclusion Criteria:

* Adult male and female patients w or w/o dialysis treatment
* Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve.
* Adequate iron substitution

Main Exclusion Criteria:

* History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies
* Contraindications for ESA therapy
* Serum albumin \< 3.0 g/dL
* Immunocompromized patients (immunosuppressive treatment, chemotherapy)
* Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection
* Systemic lupus erythematosus
* Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months
* History of malignancy of any organ system within the last 5 years
* History of use of any non-EU approved ESA
Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.

To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing coronary artery bypass with or without aortic valve replacement.

1. Haemodynamic effects, evaluated by invasive haemodynamic data (arterial line and PAC) of opioid given as single drug and in combination with Propofol (first 30 patients only).
2. Cognitive dysfunction evaluated by standard test preoperative and postoperative day 1, 4 and 30
3. Recovery quality and time parameters using objective ICU score criteria
4. Cardioprotection effect evaluated by myocardial biochemical markers obtained preoperative and postoperative 4, 9 and 18 hours

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for coronary artery bypass grafting (CABG) +/- aortic valve replacement (AVR)

Exclusion Criteria:

* Ejection Fraction \< 30%
* Previous Myocardial Infarction within 4 weeks
* Severe pulmonary hypertension (mean pulmonary artery pressure (mPAP) \> 33% of mean arterial pressure (MAP)
* Arterial hypertension (Sap \> 180, Dap \> 110)
* Diabetes, Non- and Insulin dependent
* Non usable echocardiography windows
Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass

Cardiac surgery patients have many risk factors for endothelial dysfunction (hypertension, atherosclerosis, dyslipidemia, chronic renal failure ...).

It is likely that a significant number of patients suffering from a preexisting endothelial dysfunction. This endothelial dysfunction can be assessed by a molecular approach (determination of NO, ICAM1, VCAM1, IL8, endothelial microparticles ...). Extracorporeal circulation with ischemia-reperfusion causes a breach of particularly important glycocalyx as ischemia-reperfusion injury is. No studies have evaluated the time course of the infringement, and its association with the immediate post-operative complications (SIRS, coagulopathy, vasoplegic syndrome, renal failure). Only one study has regained an association between endothelial dysfunction during cardiac bypass surgery and postoperative cardiac surgery vasoplegic syndrome. A study in noncardiac surgery has regained an association between endothelial dysfunction (assessed by a vasoplegia test) and postoperative acute renal failure. Thus there is some data in the literature to suggest that the occurrence of postoperative complications (SIRS, coagulopathy, capillary leak syndrome, acute circulatory failure vasoplegic and acute renal failure) may result from the interaction between a pre-existing endothelial dysfunction and "operative" aggression (extracorporeal circulation). The onset of complications result from an interaction that depends on the importance of endothelial dysfunction at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years.
* Patient operated on for cardiac surgical myocardial revascularization (CABG) or surgical correction of aortic valve.
* Consent signed.

Exclusion Criteria:

* Standing arrhythmia.
* Pregnant woman.
* curative anticoagulation (warfarin, NANCO, heparin).
* Patient under guardianship.
* Patient Refused to participate.
* Cardiac surgery without CPB.
* bicuspid aortic valve.
* Participation in another study.
* preoperative sepsis.
* Minor or major, under guardianship or trusteeship (art L1121-5, L1121-8 and L1122 1-2)
To Evaluate if Multiple Doses of Ketoconazole Change the Blood Concentration of YM150 (Darexaban)

The primary objective of this study is to determine the effect of ketoconazole on the blood concentrations of darexaban and its metabolites (drug degradation products). The secondary objective of the study is to evaluate the safety and tolerability of a single dose of darexaban alone and when administered together with ketoconazole.

This is an open-label, 2-period crossover study in young healthy male subjects to evaluate the effect of multiple once daily doses of ketoconazole on the pharmacokinetics (PK) of darexaban and metabolites after a single dose of darexaban. In addition, safety and tolerability of darexaban administered alone and in combination with ketoconazole, is evaluated. Eligible subjects are admitted to the clinical unit in the morning of Day -1. The subjects are randomized to receive either first darexaban plus ketaconazole and then darexaban alone, or first darexaban alone followed by darexaban plus ketoconazole.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5-30.0 kg/m2
* Male subjects must be non-fertile, i.e. surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies

Exclusion Criteria:

* Known or suspected hypersensitivity to darexaban or ketoconazole or any components of the formulation used
* Any of the liver function tests (i.e. ALT, AST and bilirubin) above the upper limit of normal at repeated measures
* Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
* Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
* Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)
* Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the 3 months prior to admission to the Clinical Unit
* Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
* Any use of drugs of abuse, or smoking of more than 10 cigarettes (or equivalent) or more than 21 units (210 g) of alcohol per week within the 3 months prior to study
* Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life
Effect of Hysteroscopic Metroplasty on Reproductive Outcome in Patients with RIF

In recent years with the continuous improvement of ART technology, it has brought new hope to infertile couples, however more than half of the patients still experience multiple transfer failures. Abnormalities in the structure of the uterine cavity are one of the main factors that lead to the failure of embryo implantation. Hysteroscopic metroplasty with cold scissors is an innovative technique of our team, in which micro-scissors are used in the procedure instead of the previous electric knife. Our previous study found that this technique has the effect of improving fertility outcomes in patients with T-shaped uterus.

Based on the previous study, this study is an open randomized controlled trial to include patients with more than 2 or more ART implantation failures. For the first time, cold knife hysteroscopic hysterectomy was used to treat patients with cryptic uterine stenosis in patients with repeated RIF implantation failures to assess the clinical efficacy of the technique and to investigate the effect of this technique on the pregnancy outcome of reimplantation of embryos in patients with repeated ART implantation failures. Meanwhile, this project is the first to study the diagnostic value of transvaginal 3D ultrasound/MRI for the assessment of uterine cavity status in patients with RIF, with a view to exploring the value of noninvasive imaging as an alternative to invasive hysteroscopy in the clinical management of RIF. The aim of the study is to provide a reference for early diagnosis and treatment of patients with repeated ART implantation failures, and to improve the pregnancy outcome of their reimplanted embryos.


Eligibility Criteria:
Inclusion Criteria:

* At least twice previous implantation failures
* Willing to receive further embryo transfer

Exclusion Criteria:

* Sturctural intrauterine lesions
* Severe adenomyosis
* Premature ovarian failure
* BMI \> 35 kg/m\^2
* Severe systemic disease or maligant tumor
Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus

Although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (DM), women entering pregnancy with type 1 DM continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (HDP). At present, there is a lack of effective preventive interventions for HDP, which are associated with significant maternal and neonatal morbidity and mortality. Clinical and in vitro data have shown promise for metformin in prevention of HDP in non-diabetic women. Metformin has a reassuring fetal safety profile and has been well studied in type 1 DM outside of pregnancy. The hypothesis to be tested in this application is that compared to usual care, daily oral metformin therapy initiated prior to 20 weeks' gestation in women with type 1 DM reduces the frequency of HDP.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18-50 years
* 12 0/7 and 19 6/7 weeks of gestation
* Diagnosed with type 1 DM prior to pregnancy.

Exclusion Criteria:

* Known allergy or adverse reaction to metformin
* Multiple gestation
* Abnormal obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy
* Medical comorbidities that increase risk for metformin use: renal insufficiency (creatinine \> 1.1 mg/dL), proteinuria (P:C \>0.3 or 24-hour urine protein \> 300 mg), active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes 3x above normal), inflammatory bowel disease (Crohn's and Ulcerative colitis), major hematologic disorder (including alloimmune and isoimmune thrombocytopenia).
Determination of the Clinical Impact of Continuous Surveillance Monitoring (SM) and Utility of IPI.

Single site prospective observational nested study of bedside CS20p monitor on the GCF impeded into a retrospective review of the frequency of escalation of care with intermittent vitals signs compared to continuous respiratory monitoring.

Single site observational study of alarms and workflow on the general care floor where continuous surveillance monitoring (SM) with capnography and pulse oximetry is the standard of care before and after the Integrated Pulmonary Index is enabled within the context of a historical review of frequency of escalation of care as a function of the frequency and method of monitoring respiratory status. Observation of alarms will be electronically recorded on a Clinical Observation Tool (COT or iPad) that will have a virtual view of the CS20p measurements and alarm alerts for 24 hours on several patients at the same time. Patients will only be enrolled for 24 hours of observation of alarm status with associated patient activity and clinical interventions. Observation data with IPI disabled prior to implementation of IPI/IPI alarms will be used to evaluate optimal alarm alert settings including an IPI alert when enabled. Observation will continue with IPI enabled and alarms adjusted to study clinical utility of IPI on the GCF.

Eligibility Criteria:
Inclusion Criteria:

1. Spontaneous breathing adults ≥ 18 years of age, both male and female
2. On dual parameter CS20p monitoring with both capnography and pulse oximetry per Vanderbilt standard of care to monitor patients for respiratory compromise.
3. Expected minimum duration of 24 hours of continued capnography and pulse oximetry monitoring.

Exclusion Criteria:

1. Those patients who are expected to be discharged within six hours on the randomly selected observation floor.
2. Those patients not on the randomly selected floor for observation.
3. Those subjects randomly removed from the selected floor for observation pool in order to limit the number of subjects to be observed.
4. Those subjects in rooms with limited Wi-Fi signal quality as per VUMC IT.
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings.

The objective of this study is to compare the effectiveness of single-hormone closed-loop and sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with T1D for 12 days in outpatient settings.

The investigators hypothesize that dual-hormone closed-loop will increase the percentage of time of glucose levels spent in the target range in adults compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 3 months.
4. HbA1c ≤ 12%.

Exclusion Criteria:

1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
2. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
3. Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
4. Chronic use of acetaminophen. Acetaminophen may interfere with glucose sensor readings
5. Pregnancy (ongoing or current attempt to become pregnant)
6. Breastfeeding
7. No nearby party for assistance if needed
8. Plans to go abroad or travel at more than 2 hours distance from Montreal during the trial period
9. Severe hypoglycemic episode within two weeks of screening or during the run-in period
10. Severe hyperglycemic episode requiring hospitalization in the last 3 months
11. Current use of glucocorticoid medication (except low stable dose and inhaled steroids)
12. Known or suspected allergy to the trial products
13. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator
14. Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)
Aromatherapy for Anxiety and Self-esteem: Clinical Trial

The aim of this study was to determine whether the use of Ylang Ylang essential oil through dermal application or inhalation alters the perception of anxiety and self-esteem and physiological parameters such us blood pressure and temperature.

34 nurses from the University Hospital participated in this study and were randomized into three groups: one that received the Ylang Ylang Essential Oil cutaneous route, the second received the Essential Oil inhalation and the third (placebo) received the essence of Ylang ylang cutaneous route.

Eligibility Criteria:
Inclusion Criteria:

* be an employee of the nursing team and not be on probation
* accept make use gel or freshener containing essential oil or essence ylang ylang
* respond Anxiety Inventory(STAI)and Self-esteem scale and present moderate, high or very high anxiety on the STAI, medium or low self-esteem on the scale Self-esteem
* accept not wear perfume during the survey period
* accept the smell of Ylang Ylang.

Exclusion Criteria:

* Self reported Hypotension
* Medical License or vacation during the period
Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients

This study aim to determine whether a small-dose esketamine infusion can be used for pain control in severe burn patients, and thereby reduce the total intra-operative opioid requirement. Secondary objectives are to determine whether this low-dose esketamine infusion will increase the stability of circulation.


Eligibility Criteria:
Inclusion Criteria:

* All intubated adult burn patients( age\>18 ), presenting to the operating room;
* Burn area\> 30%.

Exclusion Criteria:

* Allergy to Esketamine or benzodiazepines
* Esketamine or ketamine use in the preceding 24 hours
* Increased intracranial pressure
* Increased intraocular pressure
* Porphyria
* Thyroid disorders
* Seizures
* Acute myocardial ischemia
* Children (patients under age 18), prisoners, pregnant or breastfeeding women, patients with psychosis, patients with developmental delay, and any condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the trial endpoints.
Post SARS-Cov-2 Disease Anesthesia Events

Estimating and recording the rate of occurrence of pulmonary and cardiovascular complications during the perioperative period in patients with past covid infection


Eligibility Criteria:
Inclusion Criteria:

* all patients above 18 years with past history of covid-19 during past 6 months undergoing surgery

Exclusion Criteria:

* hemodynamically unstable Patients requiring oxygen therapy
GDF-8 Levels in ICSI Cycles

The aim of this study is to investigate the role of GDF-8 in regulating progesterone levels during controlled ovarian stimulation in patients undergoing ICSI-ET and to evaluate its effects on pregnancy rates.

The main questions are

* Does serum GDF-8 correlate with serum Progesterone levels during ovarian stimulation?
* Does serum GDF-8 serum level at different time-points during ovarian stimulation correlate with pregnancy rate?

participants will undergo ICSI-ET cycle using the long GnRH-agonist protocol and serum levels of GDF-8 and progesterone will be measured at three time-points during the trial: on day of hCG trigger administration, on day of oocyte pickup, and 14 days after embryo transfer


Eligibility Criteria:
Inclusion Criteria:

* The study population included women who underwent their first ICSI-ET cycles due to male and/or tubal factors or unexplained infertility, aged 20-35 years, whose BMI ranged from 19-29.9 kg/m2, with regular menstrual cycles

Exclusion Criteria:

* women with PCOS, couples with azoospermic husbands, women with poor ovarian reserve testing (AMH \< 1.2 ng/dl and/or AFC \< 5), women diagnosed with endometriosis, and women with medical comorbidities such as thyroid disorders, DM, hyperprolactinemia, etc.