cyrilzakka/clinical-trials huggingface dataset:
Regional Anesthesia for Cardiothoracic Enhanced Recovery

The erector spinae plane block (ESPB) is a novel regional analgesic technique that provides pain relief with a peripheral nerve block catheter. The goal of this study is to see if bilateral ESPB catheters can improve clinical outcomes in patients undergoing cardiac surgery via sternotomy, such as decreasing the duration of postoperative mechanical ventilation, need for intravenous opioid medications, length of stay in the intensive care unit (ICU), and improving pain scores.


Eligibility Criteria:
Inclusion Criteria:

* Give consent to participate in study
* planned sternotomy
* specific procedures: CABG (coronary artery bypass grafting) or AVR (aortic valve repair or replacement) or MVR (mitral valve repair or replacement) or combination of any of 2 of these
* Primary or first redo sternotomy

Exclusion Criteria:

* Participants who cannot give consent
* Patients who are clinically unstable or require urgent/emergent intervention
* more than1 prior sternotomy
* planned aortic arch procedures
* preoperative coagulopathy (INR \>1.5, PTT \>35) or ongoing anticoagulation (heparin infusion, therapeutic low molecular weight heparin, warfarin, dual antiplatelet therapy)
* Severe ventricular dysfunction (left or right ventricle)
* Symptomatic heart failure (systolic or diastolic)
Can a Patient in Intensive Care be Visited by His or Her Pet?

Nearly half of all intensive care patients describe symptoms of anxiety and depression after a stay in the ICU, and one in five has genuine post-traumatic stress disorder.

As a result, improving patient experience has become a priority in the ICU, and particular attention is being paid to the need to recreate a familiar environment.

Animal-mediated interventions have been developed for a number of patients over many years. These strategies are widely used with elderly patients, and patients with cognitive or psychiatric disorders, for whom the literature shows benefits on anxiety, mood or objective signs of stress.

In the vast majority of experiments carried out to date, the animals (mainly dogs) were prepared and educated for contact with patients, and their handlers trained in this activity, rather like guide dogs. Visiting a care facility with a patient's own pet is rarely described. It may run up against obstacles related to the animal's behavior or infectious risks, but it is nevertheless authorized in many establishments.


Eligibility Criteria:
Inclusion Criteria:

* Conscious adult patients with a pet (dog/cat).
* Patients with no or no longer hemodynamic or respiratory failure, or undergoing rehabilitation, after resolution of the acute phase or at the end of life.
* Patients affiliated to or entitled under a social security scheme.
* Patient who has given written informed consent to participate in the study.

Exclusion Criteria:

* Non-stabilized acute situation (as assessed by the resuscitator).
* Mechanical or amine ventilation or extrarenal purification.
* Tracheostomy.
* Immunosuppression.
* Carriage of multi-resistant bacteria.
* Behavioral or consciousness disorders.
* Pregnancy.
* Skin wounds, extensive burns exceeding 15% of body surface area, external fixator.
* Guardianship or trusteeship.
* Workload incompatible with the visit
* Patient unable to speak French.
Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Patients With Epilepsy

The primary objective of this study is to assess the retention rate of perampanel when given as secondary monotherapy in routine clinical care.

This study is a retrospective study of participants who received perampanel as primary or secondary monotherapy at approximately 40 centers in Europe, Asia, and Australia. Primary monotherapy is defined as the administration of perampanel in the absence of any concomitant antiepileptic drugs (AEDs). Secondary (conversion) monotherapy is defined as the conversion of perampanel from adjunctive therapy to monotherapy by withdrawing concomitant AEDs.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy
* Received perampanel as primary or secondary monotherapy at any time between 1 Jan 2013 and 15 Oct 2015
* Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records per local requirements

Exclusion Criteria:

* Not applicable
Using Short Message Service as a Means of Clinical Engagement in Early Psychosis

Engagement with clinical services for youth with early psychosis represents a significant challenge, with up to 40% of patients dropping out of treatment in the first year. This has been linked to worse illness outcomes and represents a significant barrier to recovery for these patients. This study aims to evaluate the efficacy of short message service (SMS) as a means of improving clinical engagement in early-episode psychosis populations by bridging contact between appointments with weekly check-ins/reminders. These weekly check-ins during the first year of treatment will serve as an additional opportunity to reach out to patients and give them a chance to do the same with their care teams, with patient responses triggering clinician follow-up if necessary.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 16-29
* a diagnosis of an affective or non-affective psychotic disorder (i.e., Bipolar or Major Depressive Disorders with Psychotic Features, Schizophrenia Spectrum Disorders, Other Specified Psychotic Disorders, Substance Induced Psychosis and Attenuated Psychotic Syndrome)
* eligible for follow-up within the Slaight Family Centre for Youth in Transition early intervention service
* within the first 6 months of treatment

Exclusion Criteria:

* involved in another intervention study
* do not have a personal cell phone number
Impact of Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy

Clinical and experimental data suggest that neutrophil activation and extravasation are deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable outcome and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil recruitment in AIS patients were negative. Recently, an experimental study has shown that neutrophil activation and transmigration begin immediately after the occlusion. Inhibition of neutrophil recruitment several hours after the start of ischemia appears therefore too late to have a clinical relevance.

The objective is to study the time dependent impact of neutrophils in AIS and the predominant mediators in each time point to identify the appropriate therapeutic target and time window.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years old
* acute ischemic stroke secondary to a large vessel occlusion.
* Patients hospitalized for endovascular therapy.

Exclusion Criteria:

* Pregnant or breast feeding patient
* patient under legal protection
* Patient opposition to participate in this study
Closure vs Non Closure of Rectus Muscle at Cesarean Section 5 Year Study

approximation of both recti during lower segment cesarean section may be an important step to lower incidence of intraabdominal adhesions . peritoneal adhesions are of major medical importance and are associated with clinical problems such as chronic pain and infertility.

all patients included in the study should be had the operative history of the previous cesarean section and were done in the cairo university and divid them into 2 groups. 1st group were both recti approximated while the second group were closed without approximating both recti. all patients will be subjected to lower segment cesarean segment to assess the intraperitoneal adhesions, mean operative time, mean hospital stay, postoperative distension, bowel sounds, postoperative infections and morbidity

Eligibility Criteria:
Inclusion Criteria:

* all patients of first lower segment cs at kasr al ainy with previous recorded data including operative data, postoperative data including complications. all patients included in the study are elective cesarean section at 38 weeks of gestation

Exclusion Criteria:

* no history of infection or medical disease
* no history of previous laparotomies
* no history of pregnancy complications
* patients noted to have intraperitoneal adhesions in first cesarean section
Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants

Eupolio is inactivated poliovirus vaccine (IPV). Major purpose of this study is to evaluate safety of Eupolio in 2,000 infants. In addition to the safety, long-term protection after completion of the three primary vaccinations and extent of protective level after a single boosting dose of Eupolio will be evaluated.

As IPV plus bOPV vaccination schedule (3 doses of bOPV plus 2 doses of IPV in infant-toddle vaccination schedule) has been implemented in some countries, this study will also evaluate Eupolio's safety and protective effect in that schedule.


Eligibility Criteria:
Inclusion Criteria:

* Infants in stable health
* Male or female 6 to 8 weeks of age
* Signed informed consent by the infant's parent(s) or legally acceptable representative(s)

Exclusion Criteria:

* Known or suspected poliomyelitis
* Known or suspected febrile(symptom of a fever), or chronic illnesses
* Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration or intake of drug preventing fever
* Known or suspected immune disorders (abnormal activity in protective system in human body) or received immunosuppressive therapy (treatment for weaken protective system in human body)
* Previous use of blood or blood-derived products
* Previous use of polio vaccines
* Seizures (temporary abnormalities in muscle tone or movements due to abnormal activity in the brain)
* Bleeding disorders
* Household contact or intimate exposure with a confirmed case of polio
* Any history of allergy (hypersensitivity) to the components of the polio vaccine
* Participation in another interventional clinical trial simultaneously or within 30 days
Delivery of Inhibitors of Lysyl Oxidase (LysoLox) on Serial Angioplasty and Time to Restenosis

The narrowing of Dialysis Fistulae or Grafts is a near universal problem in patients with end-stage renal disease (ESRD) and requires patients to undergo repeated angioplasty or mechanical opening of the fistula.

The failure of dialysis accesses remains a leading cause of morbidity and medical costs among ESRD subjects. The underlying etiology for dialysis access failure is uniformly due to progressive narrowing of the vessel lumen leading to stasis and thrombosis of the access. The luminal narrowing of arteriovenous fistulae (AVFs) is due to progressive hyperplasia of vessel intima and subsequent infiltration of smooth muscle cells into the vessel media. Areas of stenosis within AVFs are characterized by dense neointimal hyperplasia, infiltration of vascular smooth muscle cells and expansion of extracellular matrix material. Additionally, varying types of vascular injury increase the rate of collagen and elastin deposition within the medial and serosal areas of the vessel.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and \< 90 years old
* Receiving stable out-subject hemodialysis for a minimum of 3 months
* Have a lower arm or upper arm AVF that has been cleared for use by the vascular surgeon or interventional nephrologist
* Have agreed to participate voluntarily and signed and dated an IRB approved, subject informed consent form
* Dysfunctional Dialysis Fistula: Any subject with

  * Two or more venous pressure readings exceeding 250 mmHg for a minimum of 5 minutes at a blood flow of 500mls/min within a single dialysis run AND a documented reduction in KT/V by \> 0.2; OR
  * Patients with venous pressures \> 250 mm Hg on two or more days within a 30 day period OR
  * Patients who on physical exam are found to have palpable obstructions, post-stenotic dilation of the access or evidence of prolonged post-dialysis bleeding.
* Any patient with one of the above conditions will be to have a dysfunctional AVF. This definition will be applied to the screening of study subjects as well as the determination of recurrent fistula dysfunction at 12 months.

Exclusion Criteria:

* Scheduled for surgical revision of the fistula;
* Have been in another investigational (non-approved) drug or device study within the previous 30 days;

  \*\*have a known allergy to any component of the investigational product (drug or device)
* Subjects with a "Hero Graft" will be excluded from the study
* Subjects having received a stent for correction of a prior stenosis will be excluded from the trial
* Subjects with more than \> 3 hemodynamically significant stenosis at one time (with the exception of a central venous stenosis)
* Subjects who are pregnant will be excluded from the trial (pregnancy test will be performed on subjects of child bearing potential). A urine pregnancy test will be utilized.
Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients

The trial is a pilot study prior to a following phase III trial and is designed to test the feasibility, acceptability and technical usability of supplementary web-based follow-up in lung cancer via a patient-reported outcome application.

This pilot study will test if the use of AmbuFlex (a generic on-line system for self-recorded patient reported outcomes) is feasible for a following randomized trial (PRO-WIDE trial - Patient Reported Outcomes used for Weekly Internet-based DEtection of progressive disease in lung cancer; a randomized controlled trial). The RCT (randomized controlled trial) will test if weekly supplementary internet-based self-monitoring of 12 core symptoms can increase survival in Danish lung cancer patients during follow-up or maintenance treatment. A threshold mechanism will automatically send an alert to the hospital in case of alarming symptoms and the patient will be contacted by the clinicians.

In the pilot study, initial interviews with 7-10 patients will explore possible missing items and conceptual issues in the questionnaire. Based on the results an adjustment of the questionnaire will be considered.

Then the system including the alert trigger mechanism will be tested on 20 patients in medical antineoplastic treatment for three consecutive weeks. Acceptability, usability and relevance will be evaluated by a questionnaire at the end of the study period. Inclusion-rate, number of alerts per completed questionnaire and time usage of alert-management will be registered. For final evaluation, interviews with two nurses and two doctors will be made at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Stage IV lung cancer in palliative treatment with 3 weeks treatment intervals and next planned attendance at the hospital after 3 weeks.
2. Access to internet connection
3. Performance status ≤ 2
4. Patient has given his/her written informed consent

Exclusion Criteria:

1. Persons deprived of liberty or under guardianship or curators
2. Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial.
Clinical Validation of Nerveblox, an Artificial Intelligence Software to Support Ultrasound-Guided Regional Anesthesia Procedures

This single-center, prospective study is being conducted at AABP Integrative Pain Care and Wellness in Brooklyn, New York, USA. The aim of this study is to collect ultrasound images from healthy volunteers and evaluate the performance of the Nerveblox software using this image dataset. Nerveblox is a software as a medical device which is designed to assist anesthesiologist for ultrasound-guided regional anesthesia, prior to needling procedure.

This study aims to validate the performance of AI technology in regional anesthesia through a clinical evaluation conducted on the U.S. population.

Data collection method and Analysis:

A total of 40 healthy subjects were enrolled and scanned by three different expert anesthesiologists. Twelve different peripheral nerve and plane block regions supported by the Nerveblox software were scanned bilaterally. Each participant spent approximately 30 minutes in the ultrasound scanning session, with each ultrasound clip lasting 10 seconds.

Age, gender, weight, and height data were collected and reported for each subject. Subjects were selected to balance the BMI distribution between those with BMI \< 30 kg/m² and those with BMI ≥ 30 kg/m². An FDA-cleared, commercially available ultrasound device was used during the scanning process, and the Nerveblox software was not utilized in the data collection sessions.

Collected ultrasound clips included both ideal and non-ideal block views. The collected ultrasound scans were processed post hoc by the Nerveblox software, and the resulting outputs, alongside the raw ultrasound images, will be assessed by a panel of expert anesthesiologists. These clips were reviewed by two separate groups of reviewers, each consisting of three members.

Reviewers were asked to evaluate:

* Highlighting of Safety-Critical Anatomical Structures: For each safety-critical anatomical landmark on each clip, the majority opinion (at least 2 out of 3) was used to determine the overall panel results.
* Image Quality: Experts rated image quality on a scale from 1 to 5. These results were then converted to a binary measure for analysis.
* Effect of color highlighting on the perceived risks of ultrasound-guided regional anesthesia

Data were expressed as frequencies and shown as a percentage of the total clips analyzed. Inter-rater agreement was reported by block region.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* In good general health

Exclusion Criteria:

* Pregnancy
* Inability to lie to flat
* Any complaint or anatomical deformity on the regions to be scanned
Impact of Exercise Training on Cardiac Function in Man

The purpose of this study is to monitor the impact of exercise training on cardiac functions and lipoprotein lipids.

Exercise can increase the mass of left ventricle, which is also called athletic heart. Athletic heart is most frequently encountered as a pathological manifestation of cardiovascular disease, and the early determinants of athelitic remodeling in the general population are largely unknown. We will recruit 45 men aged 18-25 years who will run 5000 meters 2/day for 3 months. caridac function is examined by ECG and echocardiogram, blood pressure, lipoprotein, heart rate, body weight, cardiac troponin will be examined prior to exercise program and 3 months after exercise.

Eligibility Criteria:
Inclusion Criteria:

* men
* age 18-25 years
* body mass index (BMI) 18-25 kg/m2
* no regular exercise
* no tobacco use
* no current use of prescribed medications
* no self-report of acute of chronic diseases

Exclusion Criteria:

* conditions that do not meet the inclusion criteria listed.
Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.

To study the effects of GLP-1 analogues combined with metformin and metformin on gonadal and metabolic profiles in PCOS patients with BMI ≥ 24 in China. 60 cases of overweight PCOS patients were collected from Shengjing hospital. The intervention period was 3 months after intervention with met or met + GLP-1. To evaluate the improvement of met or met + GLP-1 in the treatment of hyperandremia, glucose metabolism, BMI, waist circumference, menstruation, hairiness and acne in PCOS patients with different BMI.


Eligibility Criteria:
Inclusion Criteria:

1. Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria
2. Overweight/obesity (BMI≥24 kg/m2)
3. No pregnant plan in recent 6 months
4. Written consent for participation in the study

Exclusion Criteria:

1. type 1 or type 2 diabetes mellitus
2. Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
3. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
4. Serious systemic disease or malignant tumor
5. History of pancreatitis (chronic, acute or recurrent)
6. Body weight change ≥10% at 3 months before treatment
7. Used oral contraceptives or sex hormone drugs in the past 1 month
8. Used oral glucocorticoids in the past 1 month
9. Substance (alcohol or drug) abuse or dependence within 3 months
10. Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d)
11. Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR\<60ml/min/1.73m2)
12. Increase of transaminases up to \< 2.5 times of upper limit of normal value
13. Have a history of thromboembolic disease or thrombotic tendency
14. Subjects in pregnant or lactating or within 1 year after delivery
15. Subjects have an allergic history to the drugs used in the study
16. Subjects have participated in other clinical researches of medicine within 1 month prior to randomization
17. Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening
Determination of Biomarkers of Exposure and Biomarkers of Potential Harm in Asian Adult Cigarette Smokers

The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in smokers and non smokers.

Since Japanese mortality associated with cardiovascular disease (CVD) is lower than that in the USA although Japan is one of the top four tobacco consuming countries, this study aims to determine biomarkers of both level of exposure and CVD-related biological effects in Japanese smokers compared to non-smokers.

Biomarkers of Exposure (BoExp) include 2-naphthylamine (2-NA), 4-aminobiphenyl (4-ABP), 4-(methylnitrosaminoi)-1-(3-pyridil)-1-butanone (NNK), carbon monoxide (CO), nicotine, pyrene and 0-toluidine (o-TOL). CVD-related biomarkers include white blood cell (WBC) count, high sensitivity C-reactive protein (hs-CRP) and homocysteine in plasma; complemented with urinary 8-epi-prostaglandin F2α (8-epi-PGF2α), plasma malondialdehyde (MDA), urinary 11-DTXB2, plasma fibrinogen, high-density lipoprotein-cholesterol, triglycerides, sICAM-1, sVCAM-1 and von Willebrand Factor.

Eligibility Criteria:
Inclusion Criteria:

* Smokers have smoked commercially available conventional cigarettes (CC)
* With a minimum consumption of 10 CC per day for the last 5 years

Exclusion Criteria:

* Any prior medical condition or chronic disease
* Recent infection
* History of cancer
* Use of concomitant medication
* History of alcohol abuse
* Pregnant women