cyrilzakka/clinical-trials huggingface dataset:
Postoperative Analgesic Effectiveness of Bupivacaine With and Without Dexmedetomidine in Patients With Abdominal Surgery

Abdominal surgeries are major surgical procedures that are performed at any teaching hospital. Pain control is major concern in the intra-operative as well as post-operative period in these patients. Optimal pain control in post-operative period is directly related to patient's recovery, shortens the patients' hospital stay and overall burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality. Different modalities for pain control are used in post-operative period. Opioids are mainstay of treatment in post-operative period but historically are associated with significant side effect profile like dependence, nausea, vomiting, respiratory depression, constipation and many others. Dexmedetomidine is centrally acting α-2 adrenoceptor agonist.

This randomized controlled trial was conducted at Department of Anesthesia, Sahiwal Teaching Hospital, Sahiwal. After institutional review board (IRB) approval, computer-generated random number table was used to randomize the patients to two groups, one group received Bupivacaine plus placebo and the other group received Bupivacaine plus dexmedetomidine. A total of 64 patients met the inclusion criteria and were enrolled in the study in a 1:1. Informed written consent was obtained from all the patients before enrolling them in the study. All patients underwent a pre-operative assessment on the day before surgery. Both groups received wound infiltration with studied drugs at the end of surgery. After surgery patients were shifted to post-surgical ward and assessed for pain using visual analogue scale (VAS) and data was collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variables were presented with mean ±SD. Comparison of quantitative variable between groups was done using independent sample t-test. Comparison of qualitative variable like (Opioid sparing effect, Bradycardia, Hypotension, Nausea, Vomiting) was presented with frequency and percentages. Data was stratified on the basis of gender and age. Post-stratification chi-square test was used to compare both groups for opioid sparing effect in each stratum with p-value ≤0.05 as significant.

Eligibility Criteria:
Inclusion Criteria:

1. Age limit: 18-60 years
2. Gender of patient i.e., male or female
3. Patients listed for abdominal surgeries
4. American Society of Anesthesiologists (ASA) status of I or II

Exclusion Criteria:

1. Patients with history of drug allergy
2. Patients who undergone any analgesia in past 24 hr
3. Patients with liver disease, kidney disease, cardiac disease, sickle cell anemia, severe preeclampsia or CNS disorder on history, clinical and laboratory assessment
4. American Society of Anesthesiologists (ASA) status III or IV
5. Patients with morbid obesity 6, Raynaud's disease Patients on adrenoceptor agonists, antagonists or narcotics before the operation.
A Prospective Multicentre Study Evaluating the Outcomes of the Abdominal Wall Dehiscence Repair Using Posterior Component Separation With Transversus Abdominis Muscle Release Reinforced by a Retro-muscular Mesh - Filling a Step

Purpose: This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR) reinforced by retro-muscular mesh technique.

Methods: Between June 2014 and April 2018, 202 patients with grade IA BA (Björck's first classification) were treated in a prospective multiple-center cohort study.

This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR) reinforced by retro-muscular mesh technique.

Methods: Between June 2014 and April 2018, 202 patients with grade IA BA (Björck's first classification) were treated in a prospective multiple-center cohort study.

Eligibility Criteria:
Inclusion Criteria:

* BA Grade IA according to Björck's initial classification following midline laparotomy from various departments,
* ≥ 18 years
* both sex
* emergency or elective surgery

Exclusion Criteria:

* BA grade 1B,2,3, and 4 according to Björck's initial classification,
* \< 18 years,
* primary laparotomy performed through a non-midline incision, open abdomen,
* if another laparotomy had been performed between the surgery for BA and the end of the follow-up period,
* concomitant intra-abdominal surgery, abdominal complications during BA surgery,
* adherent bowel to the defect edge that cannot be separated,
* patients lost during follow up,
* presence of intra-abdominal contamination that cannot be controlled radiologically,
* history of previous BA repair,
* stoma exteriorized from the midline primary wound,
* temporarily wound closure techniques,
* prior abdominal surgeries other than operation resulted in BA,
* prior abdominal wall hernia repair with or without mesh,
* history of collagen diseases
The Effect of Education Given to Parents of Children With Ventriculoperitoneal Shunt on Their Anxiety and Self-efficacy

This study aims to evaluate the effect of tele-education given to parents of children with ventriculoperitoneal shunt on their anxiety and self-efficacy.

This study aims to evaluate the effect of tele-education given to parents of children with ventriculoperitoneal shunt on their anxiety and self-efficacy. The type of research was planned as a prospective, randomized controlled experimental study with a pretest-posttest control group. The research will be conducted online with the parents of children with ventriküloperitoneal shunts at Pamukkale University Hospital. The data of the research will be collected between March 2024 and February 2025. In data collection, a personal information form will be used to determine the socio-demographic characteristics of the participants, a parent knowledge test will be used to evaluate their knowledge levels, and the General Self-Efficacy Scale and State and Trait Anxiety Scale will be used to evaluate the dependent variables. It was determined that 60 parents should participate in the study, 30 for the experimental group and 30 for the control group. As the randomization method, "simple randomization" will be used to ensure an equal number of samples in the experimental and control groups. Randomization will be done using the www.randomizer.org application. The data will be analyzed with the SPSS (23.0) package program. Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Significance Test of Difference Between Two Means in comparing independent group differences when parametric test assumptions are met; When parametric test assumptions are not met, Mann-Whitney U test will be used to compare independent group differences.

Eligibility Criteria:
Inclusion Criteria:

* 1. Having a child aged 0-6 with a ventriculoperitoneal shunt 2. Volunteering to participate in the research

Exclusion Criteria:

* 1. Having difficulty accessing the Internet 2. Not joining the online group 3. Not answering survey questions 4. Having a child over 6 years of age with ventriculoperitoneal shunt
Epidemiology of Barrett's Esophagus: A Population Based Study

To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's esophagus (BE) in the community.

To develop a population based clinical risk factor prediction model for the diagnosis of BE and identify novel risk factors for BE which would make population based screening more efficient. This will be an important first step in identifying the target population for BE screening, another crucial component of making screening feasible and efficient


Eligibility Criteria:
Inclusion Criteria:

1. Case: Olmsted county residents \> 18 years old from the barrett's esophagus (BE) incidence cohort who are still alive at the time of study.
2. Control # 1 : Olmsted county residents \> 18 years old that responded to a recent community based survey and reported gastroesophageal reflux (GER) symptoms at least once a week and without a known diagnosis of BE.
3. Control # 2 : Olmsted county residents \> 18 years old that responded to a recent community based survey that did not report any GER symptoms and without a known diagnosis of BE.

Exclusion Criteria:

1. Cases: BE subjects who

   1. Have died prior to the start of this study;
   2. Refuse to participate;
2. Controls: respondents to the "constipation survey" who

   1. Are known to have BE;
   2. Have died prior to the start of this study;
   3. Refuse to participate; -
DexmedetOmidine Complement Treats Chronic insOmnia and Improves Circadian Rhythm (DOCTOR)

It has been reported that dexmedetomidine, alpha-2 adrenoceptor agonist, can activate endogenous neural sleep pathways in the central nervous system. This randomised, double-blinded and controlled trial was designed to investigate whether dexmedetomidine can improve/treat chronic insomnia patients. Its effects on sleep quality and improvement, EEG and circadian rhythm, brain connectivity, cognition and biomarker changes are determined.

Insomnia is a common sleep disorder characterized by difficulty in starting or maintaining sleep, or poor sleep quality and shortened sleep time. The prevalence of insomnia is about 10-20% of population worldwide; Of which about approximately 50% are chronic. Insomnia is a risk factor for cognitive impairment and mental disorder development, and other diseases. Non-pharmacological interventions, e.g. physio-therapy, are often ineffective. Benzodiazepines and their derivatives are commonly prescribed for those patients but their side effects and long-time residual sleepy actions are very risky.

Dexmedetomidine is a highly selective α2 adrenergic receptor agonist with sedative, analgesic and anti-anxiety effects together with remarkable cytoprotective effects. It is widely used as a sedative. Dexmedetomidine was reported promote sleep. It can also modulate "clock" protein expression and hence afford a regulatory effects on the circadian rhythm. This randomised, double-blinded and controlled trial was designed to investigate whether dexmedetomidine can treat chronic insomnia patients. Its effects on sleep quality and improvement, EEG and circadian rhythm, brain connectivity, cognition and biomarker changes are determined. All participants are randomly assigned to receive either dexmedetomidine (a 0.5μg/kg bolus injection for 10 minutes followed by 0.1µg/kg/hr) or placebo (normal saline infusion with an identical protocol as Dex) for 8 hrs from 10pm to 6 am.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18- 65 years old
* Body mass index (BMI) between 18 and 35 kg/m\^2；
* Clinical diagnosis of chronic insomnia；
* Must be able to communicate with site personnel

Exclusion Criteria:

* Clinical diagnosis of mental disorders;
* Pregnancy;
* Current use of psychotropic drug ;
* Clinical diagnosis of neurological diseases
Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation

Atrial fibrillation is the most common arrhythmia. The posterior surface of the left atrium is covered by an extensive network belonging to the autonomic nervous system that can be damaged during the ablation. The involvement of the autonomous nervous system in the genesis and maintenance of atrial fibrillation remains poorly understood. Baroreflex sensitivity is a non-invasive method assessing autonomous nervous system activity.

The rate of atrial fibrillation recurrence after ablation is currently high and a better understanding of the mechanisms associated with recurrence is essential to improve selection of the patients who will benefit the most from this procedure.

The aim of this study is to evaluate the association between the baroreflex sensitivity and atrial fibrillation recurrences and to analyze the prognostic contribution of the baroreflex measurement compared to other published criteria.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* Patients with paroxysmal atrial fibrillation, hospitalized for atrial fibrillation ablation,
* Assessable baroreflex sensitivity before ablation,
* Free subject, without guardianship or curatorship or subordination,
* Patients benefiting from a Social Security assurance,
* Informed consent signed by the patient after clear and fair information about the study.

Exclusion Criteria:

* Age \< 18,
* History of atrial fibrillation ablation,
* Inability to calculate the baroreflex sensitivity
* Contraindication to the performance of a cardiac CT scan (allergy to iodine, severe renal insufficiency with clearance \<30 ml/mn/m2),
* Inability to have continuous ECG recording by subcutaneous Holter,
Vitamin D and Cocaine Administration

This study is designed to explore the effects of acute pre-treatment with 1,25-dihydroxyvitamin D3 (calcitriol), as compared to placebo on the behavioral (e.g., attempts to self-administer and ultimate number of infusions/boluses of cocaine self-administered), neurocognitive (e.g., performance on computerized tests of reward related learning such as the probabilistic selection task or PST and probabilistic reward task or PRT), and subjective effects (e.g, computerized visual analog scale \[VAS\] ratings of euphoria/, craving, etc.) of cocaine in experienced, non-treatment seeking users of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-55 years
* Voluntary, written, informed consent
* Physically healthy by medical history, physical, neurological, ECG and laboratory examinations
* DSM-5 criteria for at least moderate Cocaine Use Disorder
* Recent street cocaine use in excess of quantities used in the current study
* Intravenous and/or smoked (crack/ freebase) use
* Positive urine toxicology screen for cocaine
* Laboratory evidence of vitamin D sufficiency (i.e., 25(OH)-vitamin D3 level ≥ 20/mg)
* For females, a negative serum pregnancy (HCG) test at screening and admission, and a negative urine pregnancy test (HCG) on cocaine administration days.

Exclusion Criteria:

* A history of other substance dependence (except for nicotine). Positive urine toxicology for cannabis is accepted for the study unless there is evidence for dependence per Structured Clinical Interview for DSM-5 (SCID) interview. Positive urine toxicology for other drugs at screening will be repeated. If positive again and/or positive at admission, subjects will be excluded
* \< 1 year of cocaine abuse/dependence
* A primary DSM-5 Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) unrelated to cocaine as determined by the SCID-5
* Medical comorbidities including serum calcium ( \> 10.5 mg/dl, serum phosphorus \> 4.2 mg/dl), hyperparathyroidism, kidney disease (e.g., Serum creatinine \> 1.3 mg/dl)
* A history of significant and uncontrolled medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular, seizures, traumatic brain injury) illness
* A history of seizures
* Current use of psychotropic/potentially psychoactive medications or medications that can have drug drug interactions with calcitriol, including over the counter Vitamin D products, thiazide diuretics, and calcium supplements, etc, as referenced in the package insert for calcitriol
* Seeking treatment for drug abuse/dependence
* Hypersensitivity to calcitriol
* For females, physical or laboratory (HCG) evidence of pregnancy.
Quality of Incoming Call Handling in an Emergency Dispatch Center

The aim of Emergency Medical Dispatch (EMD) is to ensure prompt access to medical care for all at all times, initiate appropriate responses quickly, arrange suitable hospital facilities, and coordinate patient transport and hospitalization.

In France, care begins with an incoming call managed by the EM Dispatchers, who collect the patient's details and assess the seriousness of the situation. This severity assessment is essential for triggering the appropriate resources: direct dispatch of first-aiders in extreme emergencies, or transfer of the call to an emergency or general practitioner.

Under- or over-assessment will necessitate redirection, resulting in a loss of time and opportunity for the patient, or emergency channel congestion. Errors at this stage can impact the entire care pathway.

To assist EM dispatchers, aids have been developed. Firstly, In France, a diploma course was created in 2019. Various training methods exist. Their contribution to the quality of incoming calls handling remains unevaluated. Secondly, EM centers use regulation protocols designed to guide dispatchers in call handling and identifying the seriousness of the situation.

The regulation protocol used at Besançon University Hospital is ProQA (Priority Dispatch Corporation, Salt Lake City, UT, US). It uses standardized questions and records EM Dispatchers' decisions and the responses they obtain from callers. These responses are considered by ProQA, which then assigns a "severity" code to the call.

The assistance provided by regulation protocols, however useful, remains insufficient. Contextual factors can complicate compliance with regulation protocols, making matching resources to needs challenging.

AQUA is a software package dedicated to quality control, enabling EM Dispatcher's supervisors to rate the quality of all stages of the call-taking process. This ensures that all key questions have been asked and that they have been asked correctly. In addition, the 'severity' code obtained by the EM Dispatcher can be compared with the 'severity' code obtained by the supervisor, using a qualifying analysis method and data entry software. The calls are replayed under optimal conditions, in a calm environment and allowing supervisors to listen multiple times to ensure no information is missed. the supervisors' code is therefore the reference code.

CRRAQPA study's aim is to assess the quality of incoming call handling and to identify the factors that influence this quality.


Eligibility Criteria:
Inclusion Criteria:

* Calls handled by a professional EM Dispatcher during the study period.

Exclusion Criteria:

* Calls handled by a medical student functioning as an EM Dispatcher.
* Calls for which the "severity" code is unfounded.
Effect of Body-mass Index (BMI) on Median Effective Dose of Intrathecal Hyperbaric Bupivacaine

The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine between two different BMI groups.

The effect of BMI on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose (ED50)of intrathecal bupivacaine between two different BMI groups. The investigators determined the ED50 and ED 95 of intrathecal hyperbaric bupivacaine of subjects with BMI below 27.5 kg/m2, and subjects with BMI over 27.5 kg/m2, respectively. By comparing the difference of ED50 and ED95 between the groups, the investigators tried to quantify the effect of BMI on the bupivacaine dose requirement.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective total knee replacement arthroplasty

Exclusion Criteria:

* Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.
* The patients with height less than 140 cm or more than 160 cm, body-mass index (BMI) less than 20 or greater than 35 were also excluded.
Effect of Perioperative Intravenous Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery

Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the patient. The investigators seek to determine if the addition of systemic lidocaine can improve the quality of recovery after spine surgery and reduce the requirement for opiate therapy.

Consented patients will be randomized to either saline group or lidocaine group. General anesthesia will be induced as it would normally be done in any patient undergoing spine surgery. Once the patient is positioned for the surgery bolus followed by the infusion of either the study drug or the placebo will be administered. The infusion will be stopped at the end of surgery and the patient will be transferred to the post anesthesia care unit. Post operative pain score will be evaluated for the first 24 hrs and also the amount of pain medications used will be recorded. At the end of 24 hours quality of recovery will be assessed using a qor-40 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 18-80 yrs;
2. American Society of Anesthesiology Physical Status I, II or III; and
3. Patients undergoing thoracic or lumbosacral spine surgeries with or without instrumentation via the posterior approach with planned admission to the post anesthesia care unit after surgery-

Exclusion Criteria:

1. Allergy to any of the study medications or anesthetic agents used in the study;
2. American Society of Anesthesiology physical status IV;
3. Spine surgery with the expected duration of surgery being more than 4 hours as determined by the attending surgeon;
4. History of severe hepatic dysfunction with liver enzymes elevated to more than 3 times the normal or International normalized ratio of more than 2 and renal dysfunction with GFR less than 60 ml/min
5. History of previous spinal fusion or instrumentation;
6. Diagnosis of cancer of the spine;
7. History of surgery for abscess or osteomyelitis;
8. History of cardiac dysrhythmia or heart block;
9. History of chronic heroin or methadone use;
10. Preoperative use of any systemic corticosteroid;
11. History of seizure disorder; and
12. Patient inability to properly describe postoperative pain to investigators (dementia, delirium, psychiatric disorder).
Use of Lidocaine in Endoscopic Submucosal Dissection

The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection.

The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Endoscopic submucosal dissection for the treatments of early gastric neoplasm

Exclusion Criteria:

1. Allergy to lidocaine
2. Chronic pain
3. Chronic abuse of opioid or NSAID
4. Atrioventricular conductance block
5. Liver dysfunction
6. Renal dysfunction