cyrilzakka/clinical-trials huggingface dataset:
E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms

The purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.


Eligibility Criteria:
Inclusion Criteria:

* Patients must comply with the indications for use
* Patient must have an infrarenal aortic aneurysm with diameter \>5cm or an infrarenal aortic aneurysm with 4 to 5cm that has increased in size by 0.5cm in the last 6 months
* Patient must be available for the appropriate follow-up times for the duration of the study
* Patient has signed the informed consent before intervention

Exclusion Criteria:

* Patients with one of the contraindications as indicated in the instructions for use
* Patients with infectious aneurysm
* Patients with inflammatory aneurysm
* Patients with pseudoaneurysm
* Patients with ruptured or traumatic aneurysm
* Patients with suprarenal, juxtarenal, or pararenal aneurysm
* Patients with aortic dissection
* Patients with a reversed conical neck that is defined as a \>3mm distal increase over a 15mm length
* Patients who have a congenital degenerative Collagen disease or connective tissue disorder
* Patients with thrombocytopenia
* Patients with creatinine \>2.4 mg/dl immediately before the Intervention
* Patients with hyperthyreosis
* Patients with malignancy needing chemotherapy or Radiation
* Patients who are enrolled in another clinical study
* Patients with life expectancy of less than 24 months
Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients

The purpose of this study is to investigate differences in glycemia

* during the whole hemodialysis day and the whole freeday
* during hemodialysis, during the evening and the night after hemodialysis and at the same time intervals during the freeday in an unselected type 2 diabetic patient group using both glucose-containing and glucose-free dialysate.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic patient
* undergoing stable intermittent thrice weekly hemodialysis for at least one month

Exclusion Criteria:

* None
A Pilot Study Efficiency of Techniques of 'Snail ' and 'Go-back' Application of an Alcoholic Antiseptic on Healthy Skin Before the Placement of a Intra-vascular Device,

Given the lack of scientific data on the effect of the antiseptic application technique on reducing the number of microorganisms present during application, this pilot study will provide data on the initial level of microorganisms in this population of healthy volunteers and on the difference before and after antiseptic application according to both techniques. These data will be useful to then calculate the study size suitable for a formal comparative study.

During their care, many patients benefit from invasive procedures. These treatments involve a break-in of the healthy skin which, without the application of preventive measures, can be at the origin of an infection starting from the micro-organisms present on the skin.

Cutaneous antisepsis, which objective is to reduce or even eliminate commensal and transient flora microorganisms, is an essential preventive measure during an invasive act on healthy skin. The choice of antiseptic most suitable in this context has been the subject of numerous publications and recommendations (including: French Society of Hospital Hygiene - SF2H- 2016). But there is no consensus on application technique.

In France, there is two application techniques : the "snail" and the "back and forth" techniques. These two techniques have never been compared in clinical trials. This study will bring preliminary evidence on empirical practices, in order to complement the recommendations of good antiseptic practices and ultimately reduce infections.

This brings us to the following question: what are the effects of the application of an alcoholic antiseptic by "back and forth" and "snail" techniques on healthy skin? We'll conduced a monocentric non-comparative, randomized, matched pilot study, to provide data on the initial level of microorganisms in this population of healthy volunteers and on the difference before and after antiseptic application according to both techniques. These data will be useful to then calculate the study size suitable for a formal comparative study between application techniques.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Nursing student (NS)
* Signed consent
* Major (18 years old and over)

Exclusion Criteria:

* Allergy to the antiseptic used in the study
* Contamination visible at the bend of the elbow
* Impossibility to carry out the procedure on one of the arms
Non-invasive Modulation of Autonomic Cardiac Nervous System

To demonstrate the effect of non invasive vagus nerve (VNS) stimulation on heart rate variability and MSNA signal.

First part: Assessment of the muscle sympathetic nerve activity (MSNA) at baseline using microneurography performed on the superficial peroneal nerve.

Second part: Acquisition of the MSNA signal during non-invasive VNS and apnea. Non-invasive VNS is performed using several frequencies of stimulation. Maximal and voluntaries apnea are performed at the end of the expiration.

Continuous recording of the following parameters:

* non-invasive arterial blood pressure
* R-R interval
* electrocardiogram
* MSNA activity
* respiratory curve signal
* respiratory rate, oxygen saturation

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* \>18 years old

Exclusion Criteria:

* pregnancy and breastfeeding
* smoke
* alcool/energy drinks/coffee consumption, exertion 24h before the participation
Intervention to Decrease Anxiety in Parents of Infants in the Neonatal Intensive Care Unit (NICU)

Infants born premature face numerous medical problems, causing significant anxiety for their parents. Parents experience a range of negative emotions including concern for the health and well being of their fragile infant, guilt, and disappointment. Research has indicated that having an infant in the Neonatal Intensive Care Unit (NICU) is highly stressful for parents and multiple studies have demonstrated that parents can develop significant psychological reactions to this experience. Specifically, many parents develop clinically significant anxiety disorders such as acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). This not only impacts the mental well-being of the parents, but also can lead to problems with the parent-infant relationship, and, in turn, negatively impact the infant and the family as a whole. Despite the reported negative effects parents experience due to the stress of having an infant on the NICU, surprisingly little research has examined how to reduce parents' symptoms of anxiety. Because parents play an essential role in the care of their infant after discharge from the NICU, treating the parent's emotional distress is highly important. The purpose of this study is to examine the efficacy of a cognitive-behaviorally based intervention in reducing parents' symptoms of anxiety associated with having an infant on the NICU. This treatment is modeled after treatments that have proven effective with parents of children with other types of medical problems, for example, parents of children with cancer. It is the hope of the investigators that this intervention will effectively reduce symptoms of anxiety of NICU parents as well as the likelihood of developing subsequent psychological disorders.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older;
2. Participants speak either English or Spanish;
3. The participant's infant is expected to live;
4. The participant's infant was born at Lucile Packard Children's Hospital or transferred to the hospital within 72 hours;
5. Participant's infant is over 1000 grams

Exclusion Criteria:

1. Individuals under 18 years of age;
2. Individuals who do not speak either English or Spanish;
3. Individuals whose infant was not born at or transferred to (within 72 hours of The infant's birth) Lucile Packard Children's Hospital;
4. Individuals whose infant has a life threatening condition and is not expected to survive;
5. Current drug abuse/dependence
Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence

This study will assess the bioequivalence (BE) of Lesinurad/Allopurinol Fixed-Dose Combination (FDC) Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects

The study will assess the BE between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fed state.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a body mass index ranging between 18 kg/m2 and 30 kg/m2.
* Screening serum urate level is ≤ 7.0 mg/dL.

Exclusion Criteria:

* Asian subject who has a positive test for the HLA-B\*5801 allele.
* History or suspicion of kidney stones.
* Estimated creatinine clearance, as determined at Screening, of \< 90 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
* Undergone major surgery within 3 months prior to Screening.
* Donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1or has given a plasma donation within 4 weeks prior to Day 1.
* Inadequate venous access or unsuitable veins for repeated venipuncture.
* Received any strong or moderate enzyme-inducing drug or product within 2 months prior to Screening
A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia

At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of three antiviral drugs in the treatment of 2019-nCoV pneumonia by studying the efficacy of abidol hydrochloride, oseltamivir and lopinavir/ritonavir in the treatment of 2019-nCoV viral pneumonia, and to explore effective antiviral drugs for new coronavirus. To provide reliable evidence-based medicine basis for the treatment of viral pneumonia caused by new coronavirus infection.


Eligibility Criteria:
Inclusion Criteria:

1. 2019-nCoV nucleic acid test was positive.
2. CT of the lung conformed to the manifestation of viral pneumonia.

Exclusion Criteria:

1. Patients who meet any of the contraindications in the experimental drug labeling
2. Patients who do not want to participate in this clinical study
Evaluation of Antral Ultrasonography for Full Stomach Diagnosis Before Pediatric Surgical Emergencies

This study evaluates antral ultrasonography for the diagnosis of full stomach before surgical emergencies in pediatric population. Preoperative ultrasonographic antral evaluation is compared to peroperative gastric aspirate with nasogastric tube.


Eligibility Criteria:
Inclusion Criteria:

* Surgical emergency procedure
* ASA I-II

Exclusion Criteria:

* Ultrasound antrum assessment not possible
* No nasogastric tube during surgery
* Vital emergency
* Patient from Critical Care Ward
* Time between ultrasound assessment and gastric content collecting up to 20min
* Child and/or Parents doesn't/don't want to participate in the study
* Personal medical history of gastric or oesophagus desease
DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study

In patients with pancreatic duct cannulation initially by chance, double guide wire technique and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar success rates. The incidence of post-procedure pancreatitis was similar in the two groups, but post-procedure hyperamylasemia was significantly higher in the DGT group.

This was a prospective, randomized study conducted in three tertiary referral hospital in Korea. Three endoscopists performed the ERCP who had ERCP experience more than ten years From October 2010 to August 2012, ERCPs were performed on patients with pancreatobiliary diseases at Soonchunhyang University Seoul Hospital, Hanyang University Guri Hospital and Kosin University Gospel Hospital. Bile duct cannulation was attempted for various reasons (removal of bile duct stones, biliary stenting, cytology of bile, biopsy of the bile duct, etc.).

Patients who satisfied the following inclusion criteria were enrolled in this study: (1) initially pancreatic duct cannulation by chance, (2) successful insertion of the guidewire into the pancreatic duct to at least half of the presumed total length of the pancreatic duct,, and (3) age 20 years or older. Exclusion criteria were: (1) refusal the ERCP, (2) previous endoscopic sphincterotomy or endoscopic papillary balloon dilatation, (3) acute pancreatitis at the time of the procedure, (4) pregnancy and (5) anatomical change due to past surgery; total gastrectomy, Billroth II operation, Whipples's operation etc. Patients who satisfied the inclusion criteria were randomly assigned to either the double-guidewire technique (DGT) group or the transpancreatic precut sphincterotomy (TPS) group; A randomization list for group allocation was generated by using computer-based pseudo-random number generators. We compared both techniques , for a maximum of ten extra attempts which are CBD cannulation by each methods. We obtained the written informed consent from all enrolled patients.

Eligibility Criteria:
Inclusion Criteria:

* ERCP patient, over 20 years old, pancreatic duct cannulation patients by chance

Exclusion Criteria:

* refuse the ERCP, post procedure state(EST, subtotal gastrectomy, Whipples' Op except gastroduodenostomy), use another method, under 20 years old.
Care Transitions in Renal Disease Patients

The goal of this pilot is to reduce the 30-day hospital readmission rate for dialysis patients. It is a quality improvement project that consistent of 4 "tracks." Tracks 1 \& 2: Implement use of checklists of activities for staff to complete when patients are admitted to the hospital, and post-hospitalization with emphasis on fluid assessment, nutrition management, patient coaching, and communication between institutions. Track 3: Work with physicians to develop process to individualize post-hospitalization dialysis orders and improve medication reconciliation. Track 4: Use a renal Care Transitions Case Manager to follow patients in the hospital and 30 days post-hospitalization to facilitate care and patient coaching.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients
* All patients admitted to the hospital during the study period

Exclusion Criteria:

* Patients \<18 years old
Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis

The Polish multicentre observational (non-interventional) study aiming to collect data on the management and clinical outcomes of patients with gMG that received ravulizumab.

The Polish, prospective, multicenter, observational, cohort study designed to collect longitudinal data on the management and clinical outcomes of patients with gMG naive to complement inhibitors who received ravulizumab in the scope of routine clinical practice within the frames of National Drug Program (NDP) for up to 42 months (\~ 6 months baseline and \~36 months follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Adult (aged ≥18 years) patients with gMG, naive to complement inhibitors, receiving ravulizumab treatment in the frames of NDP in Poland.
* Patients willing to participate in the study and signed Informed Consent Form (ICF).
* Vaccination against N. meningitidis

Exclusion Criteria:

* Those who plan to participate in gMG clinical trial on/after the date of first ravulizumab infusion through NDP.
* Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Study to Investigate the Pharmacokinetic Profile

A randomized, open-label, single-dose, parallel-arm, Phase 1 study to investigate the pharmacokinetic profile of a fixed-dose combination tablet of tesofensine and metoprolol (Tesomet) and co-administration of tesofensine plus commercial metoprolol in adult healthy subjects

This is a randomized, open-label, parallel-arm study in 60 healthy male subjects who meet the inclusion and none of the exclusion criteria for the study. Each subject will participate in a screening period, a baseline period (the day preceding drug administration), and a single-dose treatment period with an on-site observation period of at least 48 hours after the dose.

Eligibility Criteria:
Inclusion Criteria:

1. Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures.
2. Males between 18 to 55 years of age, inclusive, at the Screening Visit.
3. Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (\< 500 ng/mL) at the Screening Visit and admission.
4. BMI between 18.5 and 30.0 kg/m2, inclusive, at the Screening Visit.
5. Healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory evaluations).

Exclusion Criteria:

1. Subject has history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy as judged by the Investigator.
2. Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
3. Subject has history of alcohol and/or illicit drug abuse within 2 years of entry.
4. Subject is unwilling to avoid consumption of coffee and caffeine-containing beverages within 48 hours prior to admission until discharge from the clinical site.
5. Subject is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical site.
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery

This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Has signed the trial-specific informed consent form.
2. Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized, e.g. tubal ligation, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
3. Patients undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
4. Patients undergoing surgery of more than one cardiac valve (valves surgery), or
5. Patients undergoing surgery of the aortic root or ascending part of the aorta, or
6. Patients undergoing surgery of the aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, or
7. Patients with stage III chronic kidney disease (eGFR 30-59 ml/min determined by the Modification of Diet in Renal Disease (MDRD formula)) undergoing CABG or Valve surgery

Exclusion Criteria:

1. Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
2. Cardiac surgery to be performed with hypothermic circulatory arrest.
3. Confirmed or suspected endocarditis.
4. EF ≤ 20%, evaluated within 2 months prior to screening visit.
5. Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
6. Active peptic ulcer disease and gastritis.
7. Receiving dopamine, adrenalin or noradrenalin at any dose at any time 14 days prior to Day of surgery.
8. Known or suspected hypersensitivity to the investigational medicinal product.
9. Current participation in any other interventional clinical trial.
10. Previously dosed with AP214.
11. Use of investigational medicinal products within the previous 6 months.
12. Body weight above 130 kg.
13. History of any organ transplant.
14. Women who are of childbearing potential, pregnant, or breast-feeding.
15. Current abuse of alcohol or substance, according to the investigator's medical judgment.
16. Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
17. Any history of cancer within the last 2 years
18. Any history of dialysis.
19. Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.
Stroke Motor Rehabilitation and Recovery Study

SMaHRT (Stroke Motor reHabiliation and Recovery sTudy) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic and hemorrhagic stroke.

Participants will be enrolled in the SMaHRT study during their acute stroke hospitalization and will have research visits spanning the post-stroke care continuum at approximately 6 weeks, 3 months, 6 months, one year, two years, and three years after stroke. The study will collect demographics and clinical outcome measures, clinical neuroimages, video and robot-kinematic data and neurophysiology data through TMS and EEG in order to quantify the course of motor recovery. The research visits may be accompanied by a comprehensive clinical visit to the Massachusetts General Hospital Neurorecovery Clinic. The goal is to understand the behavioral, neuroanatomic, and neurophysiologic underpinnings of motor recovery toward developing personalized strategies and neurotechnologies to facilitate neurorehabilitation and enable better recovery for people with stroke.

Eligibility Criteria:
Inclusion Criteria

* Age 18 - 90
* Upper extremity motor weakness after ischemic and/or hemorrhagic stroke as defined by a score of \>=1 on NIH Stroke Scale Arm Motor Drift Questions 5A or 5B
* Ability to follow simple commands in English
* Score of zero or 1 on the NIH Stroke Scale Level of Consciousness Questions 1a and 1b and a score of zero on the NIH Stroke Scale Level of Consciousness Question 1c.
* Stable medical status as determined by primary care team
* Inpatient on the MGH stroke neurology service

Exclusion Criteria

* Prior history of developmental, neurologic, or major psychiatric disorder resulting in functional disability
* Prior history of visual or auditory disorders limiting ability to participate in testing
* Evidence of an uncontrolled seizure disorder
* Patients for whom EEG leads are contraindicated