cyrilzakka/clinical-trials huggingface dataset:
Vaginal Cuff Dehiscence and Thermal Injury During TLH

Purpose of this randomized control study is to determine if the mode of electrothermal colpotomy incision affects (1) the degree of thermal injury at the time of laparoscopic hysterectomy or (2) the incidence of clinical surrogates of compromised vaginal cuff healing. Women already scheduled for TLH will be randomized to colpotomy incision with the V mode or standard cut/coag form of electrothermal energy.

Prevalence of vaginal cuff injury will be calculated, and cross tabulation tables will be used to examine the association fo dehiscence with proposed risk factors in the retrospective part of the study. In the randomized controlled trial, depth of thermal injury will be compared between the two groups, and a chi-square test will be used to test for a difference in clinical outcomes between the two groups. There is little risk associated with this study above the normal surgical risks; however, the V mode has not been previously been studied for its use in making a colpotomy incision. Loss of confidentiality is a risk of the study, but all samples will be de-identified and given a unique study number, and only individuals directly involved in the study will be given access to the study information.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Patient scheduled for total laparoscopic hysterectomy (TLH)
3. Signed informed consent

Exclusion Criteria:

1. Known pelvic infection within 30 days prior to hysterectomy
The Effect of Central Sensitization on Assessment Capacity of Patients

the aim of this study is to evaluate the effect of dental hyperalgesia and mechanical allodynia on the assessment capacity of individuals in a local Turkish population. The hypothesis of this study is that excessive amounts of pain and a major functional shift in the somatosensory system due to central sensitization might cause unwitting intent.

It included patients between the ages of 18 and 70 who had a symptomatic tooth in need of non-surgical root canal treatment. All enrolled subjects volunteered and signed a written informed consent. Patients diagnosed with systemic diseases and those who had used an analgesic within 12 hours prior to the appointment were excluded from the study. A total of 30 patients were included in the study. A data sheet including patients' demographic data, diagnostic data, and data of explicit declaration of intent was completed. All pain scores were recorded according to the Visual Analog Scale (VAS). After the demographic data, diagnostic data. Patients were explicitly informed that the answers they were going to provide to the questions related to their explicit declaration of intent would not affect their diagnosis or the treatment they would undergo.

Eligibility Criteria:
Inclusion Criteria:

* patients between the ages of 18 and 70 who had a symptomatic tooth in need of non-surgical root canal treatment. All enrolled subjects volunteered and signed a written informed consent

Exclusion Criteria:

* Patients diagnosed with systemic diseases and those who had used an analgesic within 12 hours prior to the appointment were excluded from the study.
Oral and Anal Swab Sampling in Patients With HPV Positivity

Patients whose pathology results are reported as cervical intraepithelial neoplasia (CIN) 1, CIN 2, and CIN 3, are recruited. We aimed to evaluate HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3, by collecting oropharyngeal and anal swab samples. A total of 30 women of reproductive age, who consented to participate, were included in the study.

Human papillomavirus (HPV) positivity is associated with cervical, oropharyngeal, and anal cancers. There is insufficient data in the current literature regarding the effectiveness of obtaining oropharyngeal and anal swabs from patients with HPV positivity is an effective method for detecting potential pathologies. HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3, will be evaluated by collecting oropharyngeal and anal swab samples.

Eligibility Criteria:
Inclusion Criteria:

* HPV-positive women presenting to the Obstetrics and Gynecology clinic, whose cervical pathology results were reported as CIN 1, CIN 2, and CIN 3

Exclusion Criteria:

* HPV-negative women
Automated Anesthesia Guided by the Conox Monitor for Surgery

This study compares automated administration of propofol and remifentanil versus manual administration during general anesthesia for a surgery. The closed-loop coadministration of propofol and remifentanil is guided by qCon and qNox indexes from the Conox monitor.

Several monitors are currently proposed to evaluate the depth of hypnosis. The Conox monitor differentiates itself from the other brain monitor by calculating two EEG indexes, the qCon and the qNox. The qCon corresponds to the depth of the sedation and the qNox relates to the probability that a nociceptive stimulation triggers a movement of the patient. A controller allowing the automated titration of propofol guided by the qCon and remifentanil guided by the qNox has been developed. In preparation for a large multi-center control trial, this prospective randomized study evaluates the effectiveness of such a closed-loop anesthesia system. Two groups of patients are compared: one arm in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion (TCI) systems, and the second arm in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain qCon between 40 and 60, the recommended range during anesthesia by the manufacturer. It is expected the combined closed-loop anesthesia system group to do similar or better control to maintain the qCon in the desired range.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled surgery for at least one hour
* Consent for participation
* Affiliation to the social security system

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients for which Conox monitor should not be used
* Allergies to propofol or remifentanil
Hemodialysis Without Anticoagulation in Intensive Care Unit

The purpose of this study is to determine the safety and operative efficacy of intermittent hemodialysis without anticoagulation with saline flushes or Nephral 400ST in patients at high risk of bleeding

Hemodialysis in patients who are at high risk of bleeding complications represents a challenge of balancing the needs for establishment of an adequately functioning extracorporeal circuit for dialytic therapy with the requirement of not exacerbating existing bleeding or precipitating bleeding in predisposed subjects.

Several methods of nonheparin dialysis have been used. The method most commonly used to effect such treatment is "saline flushing": saline boluses are delivred at frequent intervals. This method is far from optimal for several reasons, including failure to maintain a patent circuit in significant proportion of patients, an added logistic burden on dialysis nurses. An alternative method of avoiding systemic heparinization is priming the dialysis membrane with heparin before hemodialysis. The method is based on fact that AN69ST (Nephral 400ST , Hospal, France) dialysis membrane have a high affinity for binding heparin, and that the bound heparin exerts a localized antithrombotic effect without systemic spillover.

Comparison: heparin free hemodialysis with saline flushes compared heparin free hemodialysis with Nephral 400ST.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* patient with high risk bleeding
* patient requiring dialytic therapy in intensive care unit

Exclusion Criteria:

* Pregnancy
* History of heparin-induced thrombocytopenia or serious heparin allergy
* History of serious membrane dialysis allergy
* Treatment by any of following medications 24H within the inclusion:

prophylactic or therapeutic anticoagulation with unfractioned heparin or low molecular weight heparin nonsteroidal anti-inflammatory agents direct thrombin inhibitors, antithrombin concentrate, activated protein C, anti-factor Xa pentasaccharide

* Treatement by acetylsalicylic acid or other antiplatelet agent excluding platelet glycoprotein IIb/IIIa antagonists 7 days within the inclusion.
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip™ Device (bRIGHT)

The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).

The TriClip™ bRIGHT EU post-approval study (PAS) study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting. The bRIGHT PAS study is a prospective, single arm, open-label, multi-center, post market registry, conducted to satisfy condition of CE Marking for the TriClip™.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects (\>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
2. Subjects eligible to receive the TriClip™ per the current approved Indications for Use.
3. Subject must provide written informed consent prior to study procedure.

Exclusion Criteria:

1. Subjects participating in another clinical study that may impact the follow-up or results of this study.
Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

This study is to collect blood and urine samples to help identify and validate protein biomarkers of recovery from moderate or severe acute kidney injury (AKI).


Eligibility Criteria:
Inclusion Criteria:a.

* Males and females 21 years of age or older
* Receiving care in an intensive care unit
* Expected to remain in the ICU for at least 48 hours after enrollment
* Use of indwelling urinary catheter as standard care at the time of enrollment
* Subject must have acute kidney injury (KDIGO stage 2 or stage 3) at the time of the first sample collection
* First sample must be collected within 36 hours of meeting KDIGO stage 2 criteria
* Written informed consent provided by patient or legally authorized representative (LAR)

Exclusion Criteria:

* Prior kidney transplantation
* Comfort-measures-only status
* Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
* History of human immunodeficiency virus (HIV) or hepatitis virus (based upon available medical records) infections (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
* Special populations, pregnant women, prisoners or institutionalized individuals
* Patient meets any of the following:

  * Active bleeding with an anticipated need for \> 4 units PRBC in a day
  * Hemoglobin \< 7 g/dL
  * Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes
Effects of Recruitment Maneuver on Functional Residual Capacity

Recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia and ventilation perfusion mismatch. Especially pneumoperitoneum in laparoscopic surgeries affects the functional residual capacity (FRC) negatively. Recently, FRC can be measured at bedside in intensive care units.

The lack of studies evaluating FRC measurements peroperatively and how recruitment maneuvers affect it, attract attention.

An ICU-ventilator capable to measure the FRC will be used for the mechanical ventilation in patients undergıoing laparoscopic surgery, where anaesthesia maintenance will be achieved with TIVA.

FRC will be measured in different steps of the operation. In the study group, a recruitment manover will be applied to evaluate its effects on FRC.

Eligibility Criteria:
Inclusion Criteria:

1-18-65 years age 2-no lung disease 3-laparoscopic cholecystectomies surgery

Exclusion Criteria:

1. \<18 years old
2. \>65 years old
3. denial of patient
4. patients having one of: lung disease, cardiac failure, severe cardiac valvular disease
Effects of High-Intensity Interval Training (HIT) While in a Hyperoxic-Hyperbaric Environment on Exercise Performance

Hyperbaric oxygen has previously been tested as a possible means for pre-conditioning to enhance exercise performance. This study is designed to examine the effects of exercising in a hyperbaric chamber for improving fitness when combined with high-intensity training.

The purpose of this research study is to determine the incremental benefit of high intensity interval training (HIT) in a hyperbaric-hyperoxic environment with HIT alone in healthy subjects and to compare the effect of HIT at an intermediate altitude (SLC, UT; altitude 1420 m) with that performed at sea-level (Durham, NC) in healthy subjects. While VO2 max is determined by the functional interdependence of the respiratory, cardiovascular and muscular systems, ultimately VO2 max is determined by mitochondrial oxidative capacity. Exercise training increases mitochondrial capacity. There is evidence that high intensity interval training (HIT) programs are effective at increasing exercise capacity. Furthermore, there is evidence that training while in a hyperbaric-hyperoxic environment may potentiate the HIT training effect through its effects on mitochondrial oxidative capacity, but this has not been scientifically tested. Our hypothesis is that high intensity interval training (HIT) in a hyperoxichyperbaric environment performed six-times over a two-week period will increase exercise performance compared with HIT performed in ambient conditions in healthy subjects. The primary outcome studied will be the effect of high-volume interval training in a hyperbaric-hyperoxic on VO2max.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals, ages 18-40 years that are sedentary or recreationally active but not involved in any structured endurance training will be eligible for the study. This level of activity will be defined as performing mild-moderate aerobic exercise 0-3 times per week.
* VO2 max within normal limits (defined as 84-120% predicted using Wasserman reference equations48).
* Spirometry within predicted limits.

Exclusion Criteria:

* Subjects unable to complete a satisfactory VO2 max test
* Individuals with chronic cardiovascular disease such as hypertension, valve disease, coronary artery disease, cardiac conduction abnormalities, etc.
* History of pneumothorax or chronic lung disease such as asthma, COPD, bronchiectasis
* Active Smokers
* Pregnant women
* Persons unable to read or understand English, not in full mental capacity or suffer from blindness.
Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints

Through recent studies residual curarization (RC) remains frequent but serious event, that could be easily avoided in the presence of a paraclinical monitoring and by antagonization of curares. However, conventional monitors focus only on peripheral muscles, whereas ultrasonography allows direct visualization of laryngeal muscles, particularly the vocal cords, which are directly influenced by neuromuscular blocking agents. The aim of the study was to evaluate the ultrasound mobility of the vocal cords after awakening and extubation of general anesthesia compared to their preoperative mobility and its correlation with clinical and paraclinical diagnostic criteria (DG) for RC.

The investigators conducted an analytical prospective observational and comparative study between March 2022 and May 2022. The investigators included all patients proposed for elective surgery under general anesthesia with Tracheal intubation other than ENT surgery, ages 18 to 70 years, consenting, classified ASA class I, II, or III, with no history of difficult intubation and/or ventilation, divided into two groups that differ by neostigmine use: group A: systematic decurarization, group B: extubation through clinical criteria. Ultrasound assessments of the vocal cords were performed at 3 different time points: before induction (T0), after extubation (T1), in SSPI 30 minutes after extubation (T2). The investigators have defined H0, H1 and H2, the maximum amplitudes of the vocal cords measured respectively at T0, T1 and T2. The primary endpoint was the ultrasound judged vocal cord range of motion with a ratio of pre- to post curarization amplitude defining the HA score, calculated using the following formulas: H0-H1, H0-H2, HAt1=H1/H0, HAt2=H2/H0. The investigators conducted a single then multi-variate analysis.

Eligibility Criteria:
Inclusion Criteria:

* patients proposed for elective surgery under general anesthesia with Tracheal intubation other than ENT surgery

Exclusion Criteria:

* Patients whose airway management was ensured by supraglottic device
* Patients who have experienced an intraoperative incident requiring them to be kept intubated after surgery
* ENT surgery
* non consenting patients
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. ≥40 to ≤80 years old
2. COPD diagnosis ≥1 year,
3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy ≥3 consecutive months prior to V1
5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids
6. EOS ≥ 150 cells/μL during screening
7. CAT ≥15 at screening
8. Former or current smokers ≥10 pack-years

Exclusion Criteria:

1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
2. Asthma, incl. pediatric, or ACOS
3. Any unstable disorder that can impact participants safety or study outcomes
4. Tuberculosis requiring treatment within 12 months prior V2
5. Malignancies current or past

   Concomitant therapies:
   * Macrolides (less than 6 months)
   * Systemic immuno-suppressive, -modulating medications
6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT
The Effect of 40 Hz Transcranial Stimulation on the Incidence of Delirium After Total Hip Replacement or Total Knee Replacement Arthroplasty in Elderly Patients.

Delirium is an acute confusional state, it is a sign of acute encephalopathy, also known as acute brain failure, acute brain dysfunction or mental state changes.Postoperative delirium can cause post-traumatic stress disorder, affects patients' quality of life, extend the length of hospital stay, increased hospitalization cost, and is closely relative to short-term and long-term mortality after surgery. Exogenous 40 Hz stimulation can improve cognitive functioning. Therefore, the aim of this study was to investigate the effect of exogenous 40Hz stimulation on the incidence of postoperative delirium in elderly patients undergoing hip and knee replacement.


Eligibility Criteria:
Inclusion Criteria:

1.65-85 years old, gender not limited 2.General anesthesia unilateral total hip replacement surgery or unilateral total knee replacement 3.ASA classification I-III 4.No drugs for mental and central nervous system diseases were used before surgery 5.Preoperative MMSE score illiterate \> 17 points, primary \> 20 points, junior high school and above \> 24 points 6.Obtaining informed consent

Exclusion Criteria:

1. Severe liver and kidney dysfunction
2. here were mental and nervous system diseases before operation
3. Have a history of alcoholism, long-term use of sedative or analgesic
4. A history of a delirium and other reasons are reluctant to cooperate
5. Massive blood loss and blood transfusion during operation, prolonged operation time
A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium

The purpose of this study is to evaluate the effect of a pre-ICU admission virtual reality ICU simulation on post-operative delirium in the elective cardiothoracic surgical population while in the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Baseline normal neurological function pre-operatively.
* Planned use of mechanical ventilator with endotracheal tube post-operatively after planned cardiothoracic surgical procedure.

Exclusion Criteria:

* Chronic dementia, Alzheimer's disease, or other chronic neurological disease (i.e., Bi-Polar).
* Chronic use of neurological altering medications such as benzodiazepines, psychotropic, anti-depressants, anxiolytics.
* Patient undergoing emergent surgery.
* Use of post-operative cardiopulmonary support devices such as ECMO (extracorporeal membrane oxygenation), intra-aortic balloon pump, total artificial heart, or other similar device.