cyrilzakka/clinical-trials huggingface dataset:
Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony (FOCUS-Right)

The goal of this prospective single center clinical trial is to evaluate the safety and feasibility of performing simultaneous exercise stress cardiac magnetic resonance (CPET-CMR) and cardiopulmonary exercise testing in patients with pre-existing left bundle branch area pacemakers (LBBAP) programmed to an atrial sensing mode. Measurements of right ventricular, left ventricular function, and exercise capacity will be obtained at various LBBAP programming parameters at rest and during low intensity exercise. The main aims of the study are:

* Demonstrate the safety and feasibility of performing CPET-CMR in patients with pre-existing LBBAP programmed to P-synchronous ventricular pacing mode.
* Generate preliminary data evaluating differences in RV function, LV function, and exercise capacity during various pacemaker programming settings.

Conduction system pacing, namely left bundle branch area pacing (LBBAP) represents an important pacing modality introduced to avoid the deleterious effects of non-physiologic ventricular activation during chronic right ventricular pacing and /or left bundle branch block (LBBBP). Previous studies have demonstrated that LBBAP exhibits similar or superior left ventricular resynchronization compared to conventional treatment modalities, the impact of this novel pacing strategy on the right ventricle has not yet been addressed. This study aims to demonstrate the safety and feasibility of assessing LBBAP performance with a focus on right ventricular function in a novel way utilizing Cardiopulmonary Exercise Testing and Exercise Stress Cardiac Magnetic Resonance.

The investigators plan a 1-day prospective non-randomized controlled pilot study in which up to 20 subjects with left bundle branch area pacemakers with evidence of output dependent anodal capture will undergo low intensity exercise CPET-CMR at three different LBBAP settings (underlying rhythm, non-selective left bundle pacing, non-selective left bundle pacing with anodal stimulation).

Eligibility Criteria:
Inclusion Criteria:

* presence of dual chamber LBBAP implantation
* presence of anodal capture with bipolar pacing configuration as determined at pacing implant.

Exclusion Criteria:

* Known history of chronotropic incompetence
* high degree or complete heart block
* inability to tolerate NVP during initial device interrogation
* pregnancy
* inability to undergo MRI or exercise utilizing supine bicycle at target work-load
* presence of MRI unsafe pacemaker components.
A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.

HF is an advanced or terminal stage of various heart diseases, with high rehospitalization and mortality rates. In HF patients, undernutrition is not uncommon and represents one of the most significant determinants of poor clinical outcomes. Therefore, nutritional management is of paramount importance for patients with HF.The basic method of nutritional management is to effectively identify the nutritional status of patients with heart failure, especially in elderly patients with heart failure who are not easy to find in the early stage. Limited data are available regarding the association between CONUT score and prognosis in elder patients with HFpEF, despite its easy availability in routine blood chemistry. Therefore, we aimed to evaluate the prognostic significance of CONUT score and to compare it with other well-established nutritional indices in HFpEF, a common HF phenotype in the elderly population with coronary artery disease.

This was a single-center retrospective cohort study which were approved by the Clinical Research Ethics Committee of our hospital (TRECKY2021-185). Written informed consent was obtained from all patients.

Participants were accorded with diagnostic criteria of CAD and HFpEF excluding rheumatic heart disease, congenital heart disease, acute myocardial infarction, hemodialysis or hemofiltration, tumour activity, urgent surgery, death during hospitalization, HF of unknown reasons, New York Heart Association(NYHA) class1and data deficiency. Demographic characteristics and medical parameters were collected from the electronic medical record system . All enrolled patients were followed-up in an outpatients setting. The primary endpoint of this study was readmission due to heart failure and all-cause mortality in the first year after hospitalization. To explore the prognostic significance of controlling nutritional status score in elderly with ejection fraction preserved heart failure and compare controlling nutritional status score with other objective nutritional indices.All analyses were performed using Statistical Product Service Solutions(SPSS) version 19.0 .


Eligibility Criteria:
Inclusion Criteria:

1. Elderly patients (≧65years old) were accorded with diagnostic criteria of coronary artery disease, HFpEF and NYHA Ⅱ-Ⅳ
2. Coronary artery disease was defined
3. The diagnosis of HF was made according to the recommendations of the European Society of Cardiology .
4. HFpEF was defined
5. Severity of functional class was based on NYHA scale.

Exclusion Criteria:

1. Rheumatic heart disease
2. congenital heart disease
3. acute myocardial infarction
4. hemodialysis or hemofiltration
5. tumour activity, urgent surgery
6. death during hospitalization
7. HF of unknown reasons
8. NYHA classⅠ
9. data deficiency
10. loss of follow-up
Composition of the Exhaust Gas of Pneumoperitoneum During Laparoscopic Surgery

This research aims to study the composition of the peritoneal exhaust gas during laparoscopic surgery to detect and possibly quantify the presence of air and / or N2O. This purely descriptive work is part of other experimental work that the investigators have already published.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient who will benefit from a laparoscopic surgery at Strasbourg University Hospitals
* Patient who has consented to the use of her medical data for research purposes.

Exclusion Criteria:

- Refusal of the patient to participate in the study
Liver Disease in Adults With Alpha-1 AT Deficiency

This cohort study will evaluate the prevalence of the infra clinical liver injuries among a group of adult patients presenting with Alpha-1 AT deficiency followed up in a large university hospital in Lyon, France.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Presenting an Alpha-1 AT deficiency (Alpha-1 AT level \<0.8g/l at the time of diagnosis)

Exclusion Criteria:

* Patients presenting a liver disease not related to the Alpha-1 AT deficiency
Postoperative Complication After G.A

What are the possible postoperative complications that may occur for children following dental treatment under general anaesthesia and is there a correlation between those complications and type of dental treatment done?

Nowadays, early childhood caries (ECC) remains a significant challenge of public health in Egyptian children. In most cases, children with ECC could accept dental treatment under non-pharmacological behavior management or sedation. However, some very young children or those suffering severe anxiety, mental or physical disabilities, could only be treated under dental general anesthesia (DGA).

Dental general anesthesia (DGA) is a safe and high-quality restorative and preventive treatment option for children with severe early childhood caries (S-ECC), who require extensive dental treatment and exhibit anxiety and emotional or cognitive immaturity or are medically compromised. However, several postoperative complications have been reported in children under DGA in many studies.

For a day-stay, general anesthesia procedure to be an acceptable option, care during and after surgery must be of the highest quality, and postoperative complications must be minimized.

Eligibility Criteria:
Inclusion Criteria:

1. Children with age range from 3 to 6 years old .
2. Children affected by dental caries in more than 4 primary teeth.
3. Uncooperative child indicated for treatment under G.A
4. Classified by American Society of Anaesthesiologists Physical Status as Class 1
5. Parents accepted to participate and willing to sign an informed consent.

Exclusion Criteria:

* 1) The children whose guardians or caregivers have a problem in communicating with the medical staff
Dural Tenting Sutures in Neurosurgery - is it Necessary?

This study evaluates the necessity of dural tenting sutures in craniotomies. The sutures elevate the dura, a layer between the brain and skull. Supposedly, by doing so, they prevent blood collecting between dura mater and the skull. These blood collections, called epidural hematomas, contributed greatly to postoperative mortality in the early days of neurosurgery. There have been several reports questioning the ongoing need for them in neurosurgery, thanks to modern hemostatic techniques. Moreover, it has been published in the literature, and is a common knowledge as well, that some neurosurgeons do not use these sutures at all, and do not have worse outcomes than their colleagues.

In this study, half of the randomly assigned participants will undergo craniotomy without dural tenting sutures and will be considered an intervention group. The other half will undergo craniotomy with these sutures.

In the early days of neurosurgery, epidural hemorrhages (EDH) contributed to a high mortality rate after craniotomies. Almost a century ago Walter Dandy reported dural tenting sutures as an effective way of preventing postoperative EDH. Over time, his technique gained in popularity and significance to finally become a neurosurgical standard.

Yet, there have been several retrospective reports questioning the ongoing need for dural tenting sutures. Dandy's explanation that the hemostasis under hypotensive conditions is deceiving and eventually causes EDH may be obsolete. These days, proper intra- and postoperative care, including maintenance of normovolemia and normotension and the use of modern hemostatic agents, may be enough for effective hemostasis. Evading of this suturing technique by some surgeons supports this argument even further.

Thus, there is a fundamental need to evaluate the necessity of dural tenting sutures in an unbiased, evidence-based manner.

Eligibility Criteria:
Inclusion Criteria:

* male or female over 18 and under 75 years old
* qualified for an elective supratentorial craniotomy with a diameter of at least 3 cm
* Glasgow Coma Scale 15 preoperatively
* Modified Rankin Scale 0, 1 or 2 preoperatively

Exclusion Criteria:

* Coagulation abnormalities before the surgery
* Revision craniotomy
* Skull base surgery
PREemptive Analgesia With preGABAlin in HEART Surgery

BACKGROUND: Postoperative pain after cardiac surgery has high incidence and is associated with worse morbidity. Pregabalin is a new antiepileptic drug used in patients with chronic pain and has been studied even more in postoperative. OBJECTIVE: Evaluate whether preemptive pregabalin use compared with placebo decreases pain perception in patients undergoing cardiac surgery in the first 24 hours and 2 months after hospital discharge; evaluate analgesic consumption in the immediate postoperative period; evaluate differences in blood gas parameters between groups; evaluate anesthetic recovery by QoR-40; assess incidence of serious adverse events (reintubation and mental confusion); incidence of delirium through the CAM-ICU questionnaire; assess adverse drug events (nausea, vomiting, pharmacodermia, allergic reactions). METHOD: Randomized, triple-blind, placebo-controlled clinical trial. EXPECTED RESULTS: Postoperative pain control with a drug that could cause fewer side effects, may lead to faster clinical improvement, fewer medications and fewer procedures, and lower healthcare costs with a decrease in intensive care unit (ICU) stay.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo median sternotomy due to the need for cardiac surgery (valvular or myocardial revascularization);
* Patients between 18 and 70 years old;
* Patients able to swallow tablets and agree to participate in this clinical trial.

Exclusion Criteria:

* Patients with chronic renal failure with creatinine clearance less than or equal to 30 mL/min;
* Patients with known hypersensitivity to pregabalin;
* Hemodynamically unstable patients using vasoactive drugs the day before surgery;
* Unconscious and/or sedated patients, or without cognitive discernment to use the visual analog scale;
* Patients previously submitted to sternotomy; emergency surgery;
* Patients with neurological diseases; anticonvulsant drug users.
Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Microaspiration is the main route for entry of contaminated secretions into the lower respiratory tract of intubated critically ill patients. Tracheobronchial colonization might progress to ventilator-associated pneumonia (VAP) when the quantity and virulence of bacteria are high and when local and general host defenses are weak.

Recent in vitro and animal studies suggest that tapered-cuff tracheal tubes could be associated with reduced microaspiration of contaminated secretions and might be helpful in preventing VAP.

Eligibility Criteria:
Inclusion Criteria:

* age \> or = 18 years
* tracheal intubation
* predictable duration of mechanical ventilation \> 48h
* enteral nutrition

Exclusion Criteria:

* pregnant women
* refuse to participate to the study
* no informed consent
* contre indication for semirecumbent position
The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have completed the 6 month study duration in the A6301083 study.
* Subjects must have a positive ulcer treatment response, defined as a reduction in the study ulcer area size (ie, ulcer area reduction \>0%) at Visit 8 (EOT Visit) from baseline in the A6301083 study.
* All ulcers must have an ulcer staging of 1C, 2C, 1D or 2D according to the University of Texas wound classification system

Exclusion Criteria:

* Subjects who have the following:
* Intact skin healing (defined as 100% reduction in ulcer surface area with full epithelialisation at or prior to the EOT visit in the A6301083 study).
* A study ulcer area at Visit 8 (EOT visit) which is greater or equal to the baseline ulcer area (ie, ulcer area increase ≥0%) in the A6301083 study.
* Subjects with an ulcer grading of 0 or 3 or staging of A or B according to the University of Texas wound classification system.
* Subjects with a known bleeding disorder or evidence of active bleeding.
* Subjects who are on dialysis.
* Subjects who where found to be major protocol violators in A6301083 study.
* Subjects who did not complete the 6 month study period of the A6301083 study
Atropine for Preventing Ventilator-Associated Pneumonia

A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.

A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia was conducted in Passo Fundo - RS, south Brazil. 40 adult patients were included (exploratory stage 2 trial). Interventions were initiated until 48 hours of patients were submitted to orotracheal intubation: 2 drops of atropine (eye drop) by sublingual way, compared to placebo on the same regimen. Efficacy outcomes were pneumonia and death, but safety was also assessed. No difference was observed between the placebo and atropine groups in terms of efficacy and safety outcomes. The small sample and a significance difference in terms of initiating the interventions (medians: 48h for atropine; 24h for placebo) may be a conservative bias. This can not exclude a possible benefit of atropine that should be better evaluated in a stage 3 trial.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient admitted in intensive care unit with endotracheal intubation and ventilator initiated until 48 hours

Exclusion Criteria:

* Pneumonia, radiotherapy, chemiotherapy, conditions that interfere with saliva production or change normal oral cavity shape
"Loss of Resistance" Versus CompuFlo® for Epidural Placement

The purpose of this study is to compare how well the CompuFlo® computerized syringe pump works as compared to the traditional method of inserting an epidural (a needle placed in one's back to give pain medicine).

It is possible to utilize epidural anesthesia as the sole anesthetic technique for thoracic, abdominal, and lower extremity surgeries, as a method of postoperative pain management after surgery, and for pain relief during labor and delivery. However, despite the various benefits of epidural anesthesia, this procedure is not utilized to its maximum potential in the operating room. One reason for inadequate utilization of this procedure is the difficulty in properly identifying the epidural space. Current techniques for identifying the epidural space rely on the subjective perception of the operator on loss of resistance to air or saline as the needle passes from the ligamentum flavum into the epidural space. CompuFlo®'s pressure-sensing technology provides an objective measurement for proper placement of the epidural.

Very little advancement has been made in improving training to identify the correct location of the epidural space. Epidural anesthesia has a relatively higher failure rate when performed by residents in training. The skills of trainees differ greatly, and there are no standard teaching methods to teach epidural anesthesia. Statistical analysis conducted by Naik et al. concluded that some residents may need as many as 75 attempts at epidural anesthesia to ensure proficiency.

The CompuFlo® is a computerized syringe pump capable of volume and pressure-controlled infusion. It has a pressure sensor and a mathematical algorithm capable of determining the pressure at the needle tip. Pressures are continuously monitored and displayed, which are reflected by acoustic changes in tone. A dramatic pressure decrease and a high tissue compliance (pressure does not increase despite continuous infusion) signifies entrance into the epidural space. Combining a program with a low upper pressure limit and a high infusion rate mimics the technique used by the loss of resistance with saline proponents (constant pressure on the plunger). It combines the "feel" of inserting an epidural needle with the visualization of the pressure level, as well as a sound indicator to indicate proper placement.

Eligibility Criteria:
Inclusion Criteria:

* Any obstetric patient presenting for vaginal delivery desiring epidural anesthesia
* American Society of Anesthesiologists (ASA) Physical Classification I-III
* Aged 18-65 years

Exclusion Criteria:

* Obstetric patients presenting for Cesarean section
* American Society of Anesthesiologists Physical Classification ≥ IV
* Contraindications for epidural anesthesia
* Allergy to local anesthetics
Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients

To investigate the efficacy and safety of perioperative Transauricular vagal nerve stimulation in improving Postoperative Delirium in elderly patients undergoing elective surgery Lay the groundwork for a Phase III study.

This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation(taVNS) to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive taVNS, while the control group will only wear a taVNS stimulator without current stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Age≥65 years
* Expected operation time≥ 2 hours
* Postoperative hospital stay≥ 4 days
* Sign the informed consent form

Exclusion Criteria:

* Neurosurgery or cardiac surgery
* Emergency surgery within 6 hours of admission
* End-stage disease with an expected survival of \< 3 months
* Preoperative severe cognitive dysfunction affected perioperative cognitive function assessment
* Severe sinus bradycardia, AVB of degree II and above, pacemaker placement
A Clinical Investigation to Assess the Performance of Natural Rubber Latex Condoms in Couples

This investigation is designed to evaluate the performance rate of a new natural rubber latex (NRL) male condom.

In this clinical investigation, a new NRL male condom (test condom) will be evaluated against two marketed NRL male condoms of varying thickness (condom A and condom B). This clinical investigation will also evaluate the in-use tolerance of the test and the two reference condoms.

Eligibility Criteria:
Inclusion Criteria:

1. A male and a female subject aged: 18 - 60 years inclusive.
2. All subjects must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
3. All couples must be sexually active, and agree to have penile-vaginal intercourse with a frequency sufficient to meet protocol requirements (a minimum of 5 coital acts over 4 weeks).
4. The female partner should use one other established highly effective form of non-barrier contraception, unless post-menopausal.
5. Couples must agree not to use drugs or non-investigational devices that can affect sexual performance e.g. medication/medical devices used to treat erectile dysfunction.

Exclusion Criteria:

1. Either partner is or becomes aware of an allergy or sensitivity to the ingredients of the test products, including the test or control condoms or any lubrication products provided.
2. Either partner has a pre-existing skin condition (severe eczema/psoriasis) or systemic allergic reactions or as confirmed by the subject and physical examination.
3. Either partner that needs to use condoms for a specific sexually transmitted infection (STI) protection e.g. discordance for Human Immunodeficiency Virus (HIV) or herpes.
4. Subjects that have previous or planned genital surgery, that in the opinion of the Investigator would consider the subject unsuitable to participate in the clinical investigation e.g. laser for abnormal smear.
5. Male partners that have known erectile or ejaculatory dysfunction.
6. Either partner that requires to use/is using medication or preparations that are applied topically to the genitalia area or intravaginally other than that supplied for the investigation.
7. A female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) in the previous 3 months which, in the opinion of the investigator, deems the partner unsuitable for the investigation.
8. Any participant who has clinical symptoms or signs of a sexually transmitted diseases (STD) or HIV/AIDS or has a previous history of high risk behaviour as judged by the investigator.
9. Female partner using medication which in the investigators opinion would affect vaginal mucosal secretion, such as Chlorpheniramine at any time in the 14 days (or 5 half-lives of the drug, whichever is longer) before first condom use.
10. A male partner with abnormal penile anatomy that would, in the opinion of the investigator, affect the ability to keep the condom in place during intercourse.
11. Either partner intends to continue to use antihistamines, anti-inflammatory drugs or pain killers for the duration of the investigation.