cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander

Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken. This information will be used to determine if liposomal bupivacaine provides better and longer pain control vs. bupivacaine HCl.

Fifty consecutive (25 per arm) patients undergoing unilateral or bilateral breast reconstruction with tissue expanders will be administered intraoperatively in a standardized manner with either bupivicaine HCl (control group) or liposomal bupivacaine/Exparel (experimental group). Pain will be assessed qualitatively through the use of: 1) numeric rating scale during rest (NRS-R) and activity (NRS-A), 2) brief pain inventory (BPI) questionnaire, and 3) postoperative analgesia patient satisfaction scale. Furthermore, investigators will record the use of rescue analgesics for each patient. This part of the study will provide quantitative data that investigators can then use in comparison to the qualitative measurements (NSR, BPI, patient satisfaction scale rate). In turn, this will allow us to objectify patient's pain, thereby increasing the validity of our results. More importantly, this aspect of the investigation will enable us to study the impact that liposomal bupivacaine has in reducing the postoperative usage of opioid medications in this patient population. As this is a pilot study, a sample size of 50 total patients (25 per treatment group) is planned. This sample size should provide estimates of potential effect sizes and variability in the present setting to allow for future study planning. This study should provide adequate evidence of whether pain decreases of 15% or more are unlikely in this setting.

Investigators aim to evaluate the effectiveness of DepoFoam Bupivicaine (Exparel®) to reduce postoperative pain in breast reconstruction patients compared to the current standard treatment (bupivacaine HCl). Investigators hypothesize that patients undergoing breast reconstruction with tissue expander will achieve greater control of post-operative pain and longer lasting analgesia with the use of liposomal bupivacaine.

Eligibility Criteria:
Inclusion Criteria:

* undergoing breast reconstruction with tissue expander

Exclusion Criteria:

* history of adverse reaction to local anesthesia
* chronic liver disease
* history of chronic preoperative consumption of narcotics or opioids
* history of alcohol and/or illicit drug dependence
* undergoing combined procedures
* diagnosed with neuromuscular/neurosensory disorder
* positive pregnancy test
* previous breast conservation therapy (lumpectomy with radiation treatment
* previous surgeries or trauma in the breast or chest region (denervation may bias pain perception)
* axillary node dissection
* psychosis.
Women's Treatment for Trauma and Substance Use Disorders - 1

The purpose of this study is to compare the effectiveness of adding Seeking Safety to standard substance abuse treatment to adding a control condition: Women's Health Education to standard substance abuse treatment.


Eligibility Criteria:
Inclusion Criteria - Women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD.

Exclusion Criteria:

- Women will be excluded from the study who have current psychotic disorders, or a history of active psychosis (past two months); women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD; and women who have current psychotic disorders, or a history of active psychosis (past two months).
NeuroGlove PTSD Study

This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.

This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.

There will be a single cohort in the study consisting of the subjects with PTSD who will receive treatment with NeuroGlove.

The trial is intended to evaluate the impact of the device use on active PTSD symptoms and subject sense of well-being.

Eligibility Criteria:
Inclusion Criteria:

* Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
* Men and women ≥18 and \<85 years of age.
* Carry an active diagnosis of PTSD.
* Suffer from PTSD symptoms that impact subject's daily activities and quality of life.

Exclusion Criteria:

* Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
* Subject lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
* Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)
Outcomes of a Pre-operative Exercise Programme for Live Donor and Recipient Kidney Transplant Patients

The goal of this clinical trial is to learn if a pre-operative outpatient exercise programme, monitored by a smart wearable device is acceptable to live kidney donor and recipient transplant patients. It will also look at the impact of prehabilitation on post operative outcomes. The main questions it aims to answer are:

Is it feasible for renal transplant patients and live kidney donors to participate in a prehabilitation programme in combination with a piece of wearable technology?

Are transplant outcomes improved by prehabilitation regimens delivered by video instruction?

Are there discernible perioperative digital signatures provided by the wearable that link to surgical outcomes?

Is the quality of perioperative sleep linked to surgical outcomes?

Participants will:

Wear a wrist or ring worn wearable device for a total of 14 weeks (2 week baseline, 6 week pre op and 6 week post op) Engage in a 6 week pre operative exercise programme at home/gym Keep a diary and answer surveys on their experience of the exercise regimen and wearable device


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and over
* Live kidney donor or transplant recipient

Exclusion Criteria:

* Deceased donor transplant recipient
* Patient unable to wear or tolerate wearable device
* Unstable angina, recent myocardial infarction, recent cerebrovascular accident or new arrythmia
* Patient declines or is unable to participate in the exercise programme
* Lacks capacity to give informed consent to participate in trial
* Non-English speaking
* No access to a smart device to download application
A Study on the Prevalence of Obstructive Sleep Apnea in Patients With Type II Diabetes Mellitus

OSA is prevalent among patients with type II DM

Obstructive sleep apnea (OSA) has been reported to be common (prevalence ranged from 23-86%) in previous studies involving Caucasian diabetic patients. The investigators aim at finding out the prevalence of OSA in Chinese diabetic patients and identify the clinical predictors associated with OSA.

Recruited subjects will undergo overnight polysomnography, anthropometric measurements, blood tests including glycosylated hemoglobin, renal function, glucose level, blood pressure measurement both during the clinic visit and after admission for in-laboratory sleep study.

Eligibility Criteria:
Inclusion Criteria:

* Patients, age 18 - 75, with type 2 diabetes mellitus, including those on diet, on oral-hypoglycaemic agents or on insulin
* Patients who are able to give written consent to undergo polysomnography

Exclusion Criteria:

* Patients who are unable or unwilling to give written consent to participate in the study
* Patients with unstable medical illness or poor functional performance
* Patients with recent myocardial infarction or hospital admission for congestive heart failure or cardiac arrhythmia in the past three months
* Patients on renal replacement therapy for diabetic nephropathy or chronic renal failure, or plan to start renal replacement therapy in the coming six months
* Patients suffered from recent stroke in the past six months or previous history of stroke with significant focal neurological deficit
* Patients with type I diabetes
* Pregnant lady or lactating women
Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and bladder blood flow.

To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and blood flow.

Eligibility Criteria:
Inclusion Criteria:

* Overactive bladder syndrome

Exclusion Criteria:

* Allergy to mirabegron or solifenacin.
* Patients with severe hypertension who are difficult to control, known urethral diverticulum, known bladder malignant tumors, urinary retention patients, gastric retention patients, uncontrolled angular glaucoma patients, dialysis patients, severe renal dysfunction , moderate liver dysfunction, use strong inhibitors of CYP3A4 such as ketoconazole.
Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

According to the literature, presepsin was recommended not only as an effective indicator in the diagnosis of sepsis in intensive care units, but also as a reliable prognostic marker of postoperative inflammatory processes in cardiac surgery. Previous study carried out in Petrovsky NRCS related to biomarkers in cardiac surgery and presepsin in particular showed good sensitivity in infection complications prognosis.

Various biomarkers are being used to improve the quality of prediction models aiming to improve clinical outcomes and reduce mortality in the cardiac surgery patient population. In particular, presepsin and procalcitonin have comparable prognostic value for adverse renal, cardiovascular and respiratory outcomes in cardiac surgery patients. In addition, presepsin has in-hospital, 30-day, and 6-month prognostic mortality rate value and is also highly effective for the early diagnosis of sepsis in patients in the intensive care unit. In the previous study the absence of an increase in the level of presepsin in the first 6 hours after surgery was associated with an increased risk of developing a complicated course of the postoperative period (OR 4.15, 95% CI: 1.83-9.41). The combination of two risk factors - a presepsin level at the end of surgery \>519.5 pg/ml and the absence of an increase in the presepsin level in the first 6 hours after surgery was associated with an increased risk of developing a complicated course of the postoperative period (OR 5.80, 95% CI: 2. 19-15.35). The hypothesis of this study suggests that in case of insufficient prevention of infectious complications, based on the dynamics of presepsin, it is permissible to administer the broad-spectrum drug ampicillin/sulbactam 3 g. every 6 hours for at least 72 hours from the date of surgery. It is expected that changes in the tactics of antibacterial therapy will reduce the number of inflammatory complications in patients undergoing surgery on thoracic aorta.

Eligibility Criteria:
Inclusion Criteria:

Thoracic aorta aneurysm/dissection

Exclusion Criteria:

Blood sample hemolysis
Ageing and Acute Care Physicians' Performance

The proportion of older acute care physicians (ACPs) has been increasing. Ageing is associated with physiological changes and research investigating how such age-related physiological changes affect clinical performance is lacking. Specifically, Crisis Resource Management (CRM) consists of essential clinical skills in acute care specialties which when absent, can significantly impact patient safety. As such, the goals of this study are to investigate whether ageing has a correlation with baseline CRM skills of ACPs and whether ageing influences learning from high fidelity simulation.

The proportion of older acute care physicians (ACP), emergency, critical care \& anesthesia, has been steadily increasing. Ageing is associated with physiological changes, which in turn can influence a physician's clinical abilities and decision-making. The litigation and physician disciplinary data suggests that incidents involving all physicians are likely to occur later in practice, with degree of injury identified in the claims being of greater severity. However research, investigating how age-related physiological changes affect clinical performance and patient safety, is lacking.

CRM skills are essential skills within acute care specialties, and are vital for patient safety. CRM encompasses technical skills, as well as a rapid and organized approach to non-technical, cognitive skills such as decision-making, task management, situational awareness and team management. High-fidelity full body mannequin simulation-based education is effective for learning CRM, including transfer of skills from the simulated setting to the clinical setting and improving patient outcome. However, there is a gap in the literature on whether physicians' age influences baseline CRM performance and also learning from simulation-based education.

Although the effectiveness of high-fidelity simulation-based education has been studied extensively in junior learner populations (students, residents, fellows), there are a limited number of studies investigating its effectiveness in teaching CRM in the ageing physician population. In fact, a recent systematic review looking at the role of simulation in continuing medical education (CME) in ACPs supported that there is limited evidence supporting improved learning. Despite not knowing whether simulation is the correct tool in an ageing population, it is being recommended as a training, regulation and assessment tool for practicing physicians.

Objectives:

The goals of this study are to:

1. Investigate whether ageing has a correlation with baseline CRM skills of ACPs using simulated crisis scenarios and
2. Assess whether ageing influences learning from high fidelity simulation.

Eligibility Criteria:
Inclusion Criteria:

* Emergency physicians
* Critical care physicians
* Anesthesiologists
* minimum 5 years of practice post-residency

Exclusion Criteria:

* Post-call day of participation
Multiomics After Headache Provocation of People Who Are Unable to Have Headache

Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache.

The aim of the study is to identify factors that protect against headache by studying multiomics in people who never have had a headache (headache resistant) versus non-resistant controls.

The investigators will measure multiomic changes (transcriptomics and metabolomics) after headache provocation with isosorbide mononitrate. 3 blood samples, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate.

The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.


Eligibility Criteria:
Inclusion Criteria:

* Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
* Weight: 45 kg to 95 kg

Exclusion Criteria:

* Daily consumption of any medication.
* Consumption of any medication less than 12 hours prior to the study day.
* Headache on the study day or 48 hours prior to the study day.
* Amnestic or clinical signs of hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg).
* Any severe cardiovascular disease, including cerebrovascular illness.
* Amnestic or clinical signs of current mental illness.
* Amnestic or clinical signs of current substance or drug abuse.
* Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.
Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity

Obesity is common (\>30% of US adults), contributes to substantial morbidity and mortality, but is difficult to treat. Partly this is due to the transient, arduous and modest nature of lifestyle interventions. Partly it is due to the limited efficacy and safety problems of existing pharmacotherapy. Only one drug, orlistat, is approved for long-term use in obesity; but its effects on weight are relatively small. There are drugs that have been approved for other diseases but which also reduce weight. One promising approach to treating obesity is combination therapy with orlistat and one or more of these other agents. The investigators propose an innovative approach to developing new therapies for obesity coupling the use of combination therapy with rigorous assessment of cardiovascular safety. Vascular function is a quantitative surrogate clinical endpoint that has been strongly and independently linked to future cardiovascular events.

Our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular function in obese human subjects. The co-primary endpoints will be weight and vascular function.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 75 years
* Male or postmenopausal female
* BMI ≥ 30 kg/m2
* One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome)

Exclusion Criteria:

* Congestive heart failure
* Renal impairment
* History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion)
* Type I diabetes mellitus
* Weight loss \> 10% in the past 6 months
* Recurrent nephrolithiasis
* Current treatment for seizure disorder
* Hepatic cirrhosis
* Current use of study medications
* Current use of oral estrogen
* History of smoking cessation in the past three months
* Current cholestasis or malabsorption syndrome
* Planned use of any herbal or over-the-counter supplements for weight loss
* History of allergic reactions to metformin, topiramate, orlistat or any of ingredients
* Medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours
* Participation in another clinical drug study within four weeks prior to this investigation.
* Participation in any other weight loss or rigorous exercise program.
* Any disease or condition that in the opinion of the investigator may interfere with completion of the study
Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction

Postoperative cognitive dysfunction (POCD) describes a condition where cognitive functions such as attention, perception, concentration, learning, abstract thinking and problem solving are impaired postoperatively. These changes can be resolved after weeks and months. In some cases, changes are permanent.

The aetiology of POCD is multifactorial. One described risk factor is preoperative existing depressive symptoms in patients undergoing cardiac surgery.

A total of 300 consecutive patients and 80 healthy controls will be enrolled in this study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The co gnitive function will be tested and compared to tests done before surgery. Postoperatively - from the day of operation until the 7th day (except day 6) - grade of sedation, agitation, signs of delirium, pain, cardiac, respiratory, renal and infectious complications will be monitored.

Next to preoperative depressive symptoms we will also evaluate a diagnosed depression, anxiety, pain, health-related quality of life, physical comorbidities, adrenal cortical insufficiency, type of anaesthesia, intraoperative blood loss, organ complications, postoperative delirium, baseline cognitive functioning and the number of operations/anaesthetics in the study period after the initial operation as further potential predictors of POCD.

In addition, laboratory values and certain medications will be documented. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate and cortisone therapy.

Eligibility Criteria:
Inclusion Criteria for patients and healthy controls:

* Age \> 60 years
* Written informed patient's consent

Additional Inclusion Criteria for patients:

* Elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia
* Minimum of duration of operation 120 minutes
* Baseline testing 3-14 days preoperatively

Additional Inclusion Criteria for healthy controls:

* matched for age, gender and education
* no surgery over the study period

Exclusion Criteria for patients and healthy control:

* German not mother tongue
* Illiteracy
* Mental disability
* Vision impairment not correctable
* Hearing impairment not correctable
* Illegal substance abuse (current or past history)
* Alcohol abuse (current or past history)
* Chronic benzodiazepine use
* Psychosis (current or past history)
* Parkinson Disease
* Dementia
* Multiple sclerosis
* Epilepsy (current or past history)
* Cerebral tumor (current or past history)
* Apoplexy or intracranial bleeding (current or past history)
* Severe traumatic brain injury (current or past history)
* Severe liver disease (Child Pugh B, C, liver insufficiency)
* Severe kidney disease with dialysis
* Mini Mental Status Examination \< 24 points
Delayed 18F-FDG PET/CT in Improving Visualization of Brain Tumors in Patients With Glioblastoma

This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) works in improving visualization of brain tumors in patients with glioblastoma. Radiotracers such as 18F-FDG are highly taken up by tumors in the brain and are visualized using PET/CT. Increasing the interval of time between 18F-FDG administration and PET/CT scan may improve the visualization of brain tumors in patients with glioblastoma.

PRIMARY OBJECTIVES:

I. To improve the visualization/delineation of glioblastoma lesions using delayed 18F-FDG PET/CT imaging.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV). Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection.

Note:

Standard Uptake Value (SUV) is defined for state-of-the art PET/CT scanners as Standardized uptake values = count activity per ml within region of interest (MBq/ml)/\[injected dose (MBq)/body weight (kgx1000)\]

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven high grade glioma scheduled for 18F-FDG PET/CT

Exclusion Criteria:

* Severe psychiatric illness
* Inability to give written consent
* Breast feeding/pregnancy