cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial

Opioid-free anesthesia (OFA) is a general anesthesia based on the use of hypnotics and non-opioid analgesics (lidocaine, ketamine, dexamethasone, esmolol). This technique has been used for the past 10 years, during which randomized and non-randomized studies have demonstrated a number of positive effects on cardiac function:

* better analgesia and decreased postoperative morphine consumption,
* better respiratory function,
* better hemodynamic stability,
* better postoperative cognitive function.

The hypothesis of the present study is that the use of OFA during cardiac surgery is associated with:

* Improved intraoperative hemodynamic stability
* A decrease in the incidence of postoperative complications
* A reduction in intensive care and hospital length of stay


Eligibility Criteria:
Inclusion Criteria:

* Patient who has provided written and informed consent
* Adult patient
* Patient undergoing cardiac surgery which is:

  1. Scheduled
  2. With bypass surgery
  3. Of the following types: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass surgery, aortic surgery, combined surgery

Exclusion Criteria:

* Person not affiliated to national health insurance
* Person under legal protection (curatorship, guardianship)
* Person under court order
* Pregnant or breastfeeding woman
* Adult unable to express consent
* Patient already included once in the study
* Patient requiring emergency surgery within 24 hours
* Patients with hypersensitivity to local anesthetics or opiates or to any of the excipients in the products used
* Patients on antidepressants, neuroleptics such as non-selective MAOIs (iproniazid), selective A MAOI (moclobemide), selective B MAOI (selegiline) gabapentin (Neurontin®)
* Patients with an unprotected atrioventricular conduction disorder
* Patients with a prolonged QTc (\> 450 ms) on preoperative ECG
* Patient with severe liver failure (PT\< 30%)
* Patient suffering from respiratory failure (Long-term oxygen therapy patient except OSA)
* Patient with uncontrolled epilepsy
* Patient with preoperative cognitive dysfunction (MMS \<24)
* Patient with intracranial hypertension
* Patient with chronic kidney failure (dialysis, creatinine \> 200 μmol L-1)
* Patient with porphyria
* Patients treated with linezolid (Zyvoxid®)
* Patients with severe arterial hypotension (systolic BP\<90 mmHg)
Establishment of Abbreviated Pancreatobiliary MRI Protocol

This study aims to establish abbreviated PB MRI protocol for patients on regular imaging follow-up for pancreas cystic neoplasm.


Eligibility Criteria:
Inclusion Criteria:

* on follow-up for pancreas intraductal mucinous neoplasm
* OR incidentally detected pancreas cyst (equal to or larger than 1cm)
* AND scheduled for CECT or has CECT within a months
* AND sign informed consent

Exclusion Criteria:

* Any absolute or relative contra-indication for contrast-enhanced MRI
* No pancreas cystic neoplasm
* History of pancreatectomy
* History of any procedure for pancreatic cyst (ablation, aspiration...) in a year
* Hemosiderosis
* Suspicion of acute pancreatitis
Effects of Ciprofol Anesthesia on Learning and Memory Function and Antidepressant Effects of ECT in Depressive Patients

In this clinical study, propofol was used as the positive control, and a randomized controlled trial design was used to observe the effects of ciprofol anesthesia on learning and memory function and antidepressant efficacy in patients with ECT. A total of 390 depressed patients who were to undergo electroconvulsive therapy were selected and randomly divided into two groups, namely the propofol group (n=195 cases) and the ciprofol group (n=195 cases). The patients in the propofol group were given propofol 1.5mg/kg + succinylcholine 1mg/kg, and the patients in the ciprofol group were given ciprofol 0.4mg/kg and succinylcholine 1mg/kg, and the patients were given electroshock after anesthesia treat.

Ciprofol injection, whose active component (HSK3486) is propofol analogue, is a novel treatment for anesthesia induction and maintenance. It has been authorized for commercialization in China on December 14, 2020.

The purpose of this experiment is to know the effect of ciprofol on the antidepressant effect and cognitive function of depressive patients after electroconvulsive therapy. Ciprofol is very similar in structure to propofol, so propofol was used as the control group in this experiment.

Eligibility Criteria:
Inclusion Criteria:

1. Depressed patients who plan to receive MECT.
2. Meet the diagnostic criteria of DSM-IV depression
3. 16≤age≤45 years old, gender is not limited
4. ASA score is I or II
5. The depressive episode lasted for at least 2 weeks
6. Clearly understand and voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

1. Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc.
2. Foreign bodies in the body: such as pacemakers, intracranial electrodes, etc.
3. Those who have a history of epilepsy
4. Those who are taking reserpine
5. Those with acute and systemic infectious diseases, with moderate or higher fever
6. Those with a history of manic episodes
7. Those with anesthetics, Allergic to muscle relaxants
8. Pregnant women
9. Glaucoma
10. Bipolar disorder, or combined with other mental illnesses, mental retardation
11. Those who are judged not suitable for MECT treatment by the competent physician
12. History of drug abuse
Study of Two Surgical Approaches for Total Hip Arthroplasty

A prospective, comparative, randomized single surgeon study comparing minimally invasive total hip arthroplasty (MIS) via anterior approach to conventional total hip arthroplasty via anterolateral transgluteal approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with osteoarthritis of the hip and have decided to undergo total hip arthroplasty
* Patients willing to sign the consent form

Exclusion Criteria:

* Patient is unwilling to sign the consent form
* Patient is involved in another study
Diagnoses Associated With Persistent Elevation of Creatine Kinase

Serum creatinine kinase (CK) level varies with age, gender, race and physical activity. For these reasons there is no normal serum CK level. Many pathological situations cause hyperCKemia, such as neuromuscular disorders (muscular dystrophy, inflammatory myositis, mitochondrial myopathy) and multiple systemic causes. The diagnostic approach to pauci or asymtomatic hyperCKemia can therefore be difficult and lead to multiple, and sometimes invasive tests, such as muscle biopsy. This study aims to describe the diagnoses associated with persistent elevation of serum creatine kinase and to precise the role of the muscule biopsy.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalised in a ward of internal medicin
* having a persistent elevation of serum creatine kinase \>3 times the upper normal laboratory value, repeated for 2 times

Exclusion Criteria:

* known neuro-muscular disease causing elevation of creatine kinase
* evident post-traumatic cause responsible for the elevation of creatine kinase
* incomplete medical records
A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag

The purpose of the study is to evaluate the change from baseline to 12 months after study enrollment in the number of the following non-invasive risk criteria: World Health Organization Functional Class (WHO/FC), 6-minute walk distance (6MWD), Brain Natriuretic Peptide (BNP) or N-terminal pro-brain Natriuretic Peptide (NT-proBNP).


Eligibility Criteria:
Inclusion Criteria:

* Participants in the clinical classification of pulmonary hypertension Group 1 (PAH)
* Participants with idiopathic, heritable and associated forms of PAH (connective tissue disease, congenital heart disease corrected at least 1-year ago, human immunodeficiency virus infection, drug use or toxin, and porto-pulmonary)
* Confirmed diagnosis of PAH with hemodynamic study right heart catheterization (RHC) at enrolment or at latest follow-up (not later than twelve months from enrolment date)
* Participants with a low or intermediate mortality risk profile, as per clinical judgement based on a multiparametric approach including clinical, functional exercise, right ventricular function and hemodynamic parameters
* Participants currently in treatment with selexipag and/or macitentan (in monotherapy or in combination therapy)

Exclusion Criteria:

* Participants in Group 1 that are responders to the vasoreactivity test
* Participants with pulmonary veno-occlusive disease (PVOD), defined on the basis of the following chest findings at high-resolution computed tomography (HRCT): centrilobular ground-glass opacities, smooth thickening of interlobular septa, mediastinal lymph node enlargement
* Participants already in treatment with subcutaneous/intravenous prostanoids. Iloprost interventional (IV) (treatment of digital ulcers in systemic sclerosis \[SSc\] participants according to european league against rheumatism \[EULAR\] guidelines) is allowed
* Participants currently enrolled in an interventional study
Biopsy Collection and Repository Database

Use samples procured from patients to improve understanding of molecular, cellular, and tissue-level processes produced by a variety of cardiac diseases and therapeutic interventions.

This is a prospective study enrolling patients referred for or undergoing cardiovascular procedures or treatment at the University of Kentucky. The study aims to facilitate the discovery of novel diagnostic biomarkers and therapeutic targets and improve the pathophysiological understanding of cardiac conditions.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing evaluation of a cardiac condition or receiving a right heart catheterization with biopsy clinically indicated who are at least 18 years of age.

Exclusion Criteria:

* Patients without a cardiovascular or amyloidosis diagnosis, under 18 years of age.
Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers

Patients with Idiopathic Pulmonary Fibrosis (IPF) and their caregivers will be randomized to receive this intervention or usual care. The intervention will include information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, digital (tablet) delivered by an interventionist. The usual care group will be provided with routine printed patient education.

At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life care planning. The proposed study will measure feasibility, acceptability, and impact of a Supportive Care intervention.

Idiopathic Pulmonary Fibrosis (IPF) is a disease of aging associated with intense medical and financial burden and expected to grow in incidence within the US population. Median survival from diagnosis is 3.8 years, although some patients succumb to a rapid death within 6 months. New therapies have recently become available. While these medications slow the rate of pulmonary deterioration, they have no impact on ultimate survival or quality of life. Although transplantation is an effective surgical therapy, less than 20% of patients ever receive a lung transplant. The remaining 80% have few treatment options and a likely rapidly progressive downhill course. Despite the fatal prognosis, we have found that patients and caregivers often fail to understand the poor prognosis as the disease relentlessly progresses. At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life care planning.

The proposed study will measure feasibility, acceptability, and impact of a Supportive Care intervention. Patients with IPF and their caregivers will be randomized to receive this intervention or usual care. The intervention will include information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, digital (tablet) delivered by an interventionist. The usual care group will be provided with routine printed patient education.

Eligibility Criteria:
Inclusion Criteria:

* 45 years or older
* Primary Diagnosis of with Idiopathic Pulmonary Fibrosis (IPF)
* Has a caregiver, 18 years or older (spouse/partner/child/family member/friend), willing to participate.
* Sees a Simmons Center Physician for usual IPF care.

Exclusion Criteria:

* less than 45 years
* Not diagnosed with IPF
* Has an unwilling caregiver, or a caregiver under 18.
* Does not see a Simmons Center Physician for usual IPF care.
Neurofeedback in Adolescents With Emotion Dysregulation

A treatment to improve emotion regulation is tested in young patients with trauma-related mental disorder. The Electrical FingerPrint (EFP) from the amygdala is used for presenting patients with feedback (i.e. neurofeedback) from the amygdala, a brain region which plays a critical role in emotion and mental disorder. Via feedback, patients learn to self-regulate the neural circuit of emotion.

The study tests a neurofeedback treatment for emotion regulation training in adolescent patients suffering from emotional disturbances, indicated by diagnosis with borderline personality disorder (BPD) and/or post-traumatic stress disorder (PTSD), using innovative Electric Finger-Print (EFP) technology. With neurofeedback, patients can learn to regulate brain activation from emotion brain circuit. The technique allows neurofeedback training of sub-cortical brain activation outside the brain scanner, using an electroencephalography (EEG) surrogate of amygdala activation. The novel approach combines the advantages of functional magnetic resonance imaging (fMRI, i.e. high spatial resolution) and EEG (high scalability). EFP allows the probing of deep brain signals with scalp-electrodes, thus bridging a technological gap in neurofeedback training. The developers used EEG feature extraction and machine learning to receive model coefficients (i.e. the EFP) predicting amygdala BOLD activation based on EEG-channel activity (see Citations in this registration).

Participation in this trial is offered to patients who receive residential treatment at the adolescence center of the Central Institute of Mental Health (Mannheim, Germany) to obtain proof-of-concept in this special population, and to show potential value of adjuvant neurofeedback treatment. Patients in the treatment group receive 10 neurofeedback sessions within 5 weeks. Transfer is assessed with neural and questionnaire measures afterwards. A treatment-as-usual (TAU) control group does not receive the neurofeedback. We expect to replicate correlation of EFP with the blood oxygenation level dependent (BOLD) signal from the amygdala, which is tested via simultaneous fMRI-EEG data acquisition post-treatment. Additionally, we assume improved amygdala-BOLD regulation in an fMRI neurofeedback test.

This study aims to extend proof-of-concept of EFP neurofeedback to an adolescent population suffering from severe emotional disturbances.

Eligibility Criteria:
Inclusion Criteria:

* Female patients will be included with four or more BPD and/or PTSD criteria (DSM-5)
* Willingness to participate in the study
* On residential treatment at adolescence center (Central Institute of Mental Health) throughout the study, including assessment of transfer.

Exclusion Criteria:

* General Pharmacological therapy with benzodiazepines
* Substance use
* Pregnancy
* Eplilepsy, traumatic brain injury, brain tumor or otherwise severe neurological or medical history
* BMI \> 16.5
* Non-removable electrical implants
* Non-removable ferrous metal implants Permanent make-up and tattoos
* Claustrophobia
Skin Preparation for Elective Foot and Ankle Surgery

Surgical site infections (SSIs) make about 31% of all nosocomial infections and they are the most common hospital-acquired infection. For foot and ankle elective interventions, SSI rate is reported between 0.4% and 3.6%. This study will investigate the effectiveness of skin cleaning with isopropyl alcohol and scrubbing with chlorhexidine soap before standard skin preparation in reducing microbial load and surgical site infections for elective foot and ankle surgeries. Current standard of care includes skin preparation with iodine or chlorhexidine solution prior to sterile draping and the start of surgery. Standard of care will be applied to all patients. The use of an additional "pre-scrub" with isopropyl alcohol and scrubbing with chlorhexidine soap will be applied to the experimental group. The control group will receive only the standard of care skin preparation with iodine or chlorhexidine solution prior to draping.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective foot and ankle surgeries
* age over 18

Exclusion Criteria:

* trauma as the indication for surgery
* open injuries
* non-elective procedures
* amputations
* prior surgical site infection through the planned incision
* pregnancy. All potential participants of child-bearing potential follow the standard pre-operative protocol to ensure they are not in pregnant status prior to SOC surgical procedure.
Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction

The aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a decision-making algorithm for immediate prosthetic breast reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* unilateral or bilateral mastectomy followed by two stage breast reconstruction with subcutaneous tissue expander and Acellular Dermal Matrix (ADM)
* risk-reducing mastectomies followed by two stage breast reconstruction with subcutaneous tissue expander and ADM

Exclusion Criteria:

* partial or total submuscular tissue expander placement,
* tissue expander placement in conjunction with latissimus dorsi muscle flap or without ADM, -delayed reconstructions
* previous breast surgery
Lateral Rectus Muscle Tendon Elongation

To evaluate a technique using resected medial rectus muscle transplantation for elongation of Lateral rectus tendon as a monocular surgery for large angle sensory exotropia.

A prospective study done in Tanta university in the period between January 2017 and June 2018.It included 16 patients with sensory exotropia ≥50PD. Full history was taken. Visual acuity, cycloplegic refraction and fundus exam of both eyes was performed prior to surgery. Strabismus angles were measured at near and distance by alternate prism cover test. Any limitation of adduction or abduction was scaled from -4 to 0. Patients were followed for 6 months.

SURGICAL PROCEDURE:

The MR muscle was dissected through a limbal incision. Two single arm 6-0 Vicryl sutures were placed at desired distance from the insertion as the routine resection of rectus muscle and another pair of 6-0 Vicryl was placed at the insertion. The muscle was then incised from its insertion, and the posteriorly (distally) placed 6-0 Vicryl sutures were passed through the original insertion. The resected segment is then put in saline. A vicryl 6-0 suture was tied at the LR muscle insertion. The muscle was incised from its insertion. Next, the stump of the resected segment was then sutured to the sclera at the desired position measured by the strabismus caliber according to the surgical dosage sufficient to correct the premeasured distant angle (taking into consideration the length of the added segment, which will be added to the amount of recession), and the distal end of this stump was sutured with the proximal end of LR with the 6-0 Vicryl already placed on the LR. Now the elongated muscle was sutured at desired site from the original insertion of LR as done in routine rectus muscle recession.

The patients were followed at 1day after surgery, 2 weeks, 3 month, and 6 months.

In each visit the distant angle of deviation was measured by prism cover test, any limitation of adduction and abduction was scaled, and patient satisfaction with results at last follow up was obtained, all results were recorded and tabulated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD.

Exclusion Criteria:

* Patients with exotropia other than sensory type (alternating exotropia, intermittent exotropia)
* Angle of deviation less than 50 PD.
* visual acuity more than 0.2 decimal in affected eye .
* A or V pattern exotropia.
* Nystagmus .
* Refusal of surgery by the adult patients or caregiver of children.
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central venous access device.

Further study details as provided by Nuvelo

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent
* Ages 18 or older
* Unable to withdraw at least 3 mL of blood from a central venous access device
* Hemodynamically stable
* Available for follow-up assessments

Exclusion Criteria:

* Inability to infuse at least 2 mL of saline through the catheter
* Catheter placed less than 48 hours prior to detection of occlusion
* Catheter used for hemodialysis or pheresis
* Previous treatment with plasminogen activator for current episode of catheter occlusion
* Less than 18 years of age
* Any evidence of mechanical or nonthrombotic occlusion
* In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
* Increased risk for drug extravasation
* Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g., intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
* Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
* Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
* Any other subject feature that in the opinion of the investigator should preclude study participation