cyrilzakka/clinical-trials huggingface dataset:
Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries

This study aims at comparing the analgesic efficacy and safety of bilevel erector spinae versus single level versus general anesthesia for breast cancer surgeries


Eligibility Criteria:
Inclusion Criteria:

* Female
* Diagnosed with breast cancer

Exclusion Criteria:

* Patient refusal
* coagulation defects
* bone metastases
* abnormal kidney and/or liver function tests
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial

The ISCHEMIA-HF trial will randomize participants with multivessel coronary artery disease (CAD) with ejection fraction (EF) ≤40% in a 1:2:2 fashion to guideline-directed medical therapy (GDMT):coronary artery bypass grafting (CABG):percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Left ventricular ejection fraction (LVEF) ≤ 40% within prior 6 months (any local measurement, made within the past 6 months using echocardiography, multigated acquisition (MUGA), computed tomography (CT) scanning, magnetic resonance imaging (MRI), or ventricular angiography is acceptable, provided no subsequent measurement above 40%)
* Participants with multivessel CAD (defined as severe 3 vessel disease or 2 vessel disease including left anterior descending (LAD) artery disease) on coronary CT angiography (CCTA) or invasive coronary angiography
* CAD amenable to either PCI or CABG as determined by the local heart team
* Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
* Participant is able and willing to give written informed consent

Exclusion Criteria:

* Decompensated heart failure or cardiogenic shock in the past 48 hours prior to randomization
* Concomitant significant valvular heart disease requiring surgery
* Prior cardiac surgery
* Dementia with loss of capacity to consent (clinically evident or previously diagnosed)
* Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
* History of noncompliance with medical therapy
* Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
* Pregnancy (known to be pregnant; to be confirmed before randomization, if applicable)
Effects of Planned Training and Music Listened to Before a Cesarean Section on Surgical Fear, Anxiety and Depression

This research was conducted to determine the effect of training and listening to music before a cesarean section on the surgical fear, anxiety and depression

The sample of the experimental study consisted of 120 pregnant women (music: 40, training: 40, control: 40). The data were collected using the Personal Information Form, Surgical Fear Questionnaire, and the Hospital Anxiety and Depression Scale. After the training and listening to music applications, statistically significant differences were found between the music, training, and the control groups in terms of the short-term, long-term sub-scale scores and the overall score of the Surgical Fear Questionnaire, and the anxiety sub-scale scores of the Hospital Anxiety and Depression Scale (p \< .05). Listening to music before the cesarean section was effective in reducing women's short-term and general surgical fears, and the training was also effective in reducing their short-term, long-term, and general surgical fears and anxiety levels.

Eligibility Criteria:
Inclusion Criteria:

* Women who were hospitalized for planned cesarean section,
* Having the first pregnancy,
* Between the ages 19 and 35,
* Who had no diagnosis of a physical or mental disease,
* Who had no physical illness in her baby

Exclusion Criteria:

-
Chronobiology and Childhood Obesity in a Mediterranean Spanish Population

The main objective is to investigate chronobiological aspects of childhood obesity studying the potential relationship between meal patterns and circadian rhythmicity in a cross-sectional sample of obese, overweight and normal weight children/adolescent.

Childhood obesity has more than doubled in children and tripled in adolescents in the past 30 y. As consequence, increasingly children and adolescents suffer from elevated blood pressure, impaired glucose tolerance, hyperinsulinemia, dyslipidemia. Obesity has a multifactorial etiology since there are potentially numerous contributors to its development and progression. Chronobiology, the science that studies periodic (cyclic) changes in living organisms, has been recently proposed as a new and promising topic to investigate. Alterations of circadian (24 h oscillations) system may contribute to obesity and its complications development such as high blood pressure, insulin resistance, altered fasting lipid profile. Conversely, in a vicious manner, obesity has been regarded as a fault in the circadian system explainable by the association with imbalances and fluctuations of hormones/genes expressions rhythms under the influence of body weight changes.

Thus, the study will examine changes in circadian rhythmicity over a week period. The primary end point will be to evaluate differences between obese/overweight and non-obese children in chronotypes and the responses of these parameters to meal patterns. In particular, non-invasive measures that are well-established determinants of chronotypes will form the core endpoints for the study. Well designed and age-appropriate questionnaires will provide further information in order to study correlations with eating, sleeping and sedentary/active behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Age: 8-12 years of age
* Children from schools in the region of Murcia (Spain) who enter voluntarily

Exclusion Criteria:

* Children who take melatonin or sleep drugs
Pharmacodynamic Effects of Anti-Vascular Endothelial Growth Factor Therapy in Patients With Advanced Malignancies

1. To determine the effect of anti-vascular endothelial growth factor (VEGF) on endothelial function and on retinal microvasculature
2. To determine endothelial dysfunction as a marker of early response and as an indicator for the development of hypertension and proteinuria in patients treated with anti-VEGF agents
3. To characterize the effect of anti-VEGF therapy on the pulmonary function of patients with malignancy (primary or secondary) involving the lung

The well-established role of vascular endothelial growth factor (VEGF) in carcinogenesis and tumor angiogenesis has led to the development of agents that target this pathway. Anti-VEGF agents the VEGF monoclonal antibody bevacizumab, and the small molecule VEGF receptor tyrosine kinase inhibitors. Angiogenic factors play a key role in the maintenance of lung integrity and normal endothelial function. Endothelial dysfunction has been implicated in hypertension, proteinuria and retinopathy. One of the major issues of anti-VEGF agents is its long-term toxicity especially taking into account the lack of adequate knowledge in this area and the possibility of prolonged periods of therapy in non-progressing patients. Hypertension and proteinuria are commonly seen in patients treated with anti-VEGF agents. In addition, we have also observed in a relatively high frequency of pulmonary air-filled lesions in patients with malignancy in the lung treated with an anti-VEGF agent. Objectives of this exploratory study are to 1) determine the effect of anti-vascular endothelial growth factor (VEGF) on endothelial function 2) determine endothelial dysfunction as a marker of early response and as an indicator for the development of hypertension and proteinuria 3) characterize the effect of anti-VEGF therapy on the pulmonary function of patients with malignancy (primary or secondary) involving the lung in patients treated with anti-VEGF agents. Pharmacodynamic endpoints to be assessed are: blood pressure, brachial artery reactivity, retinal microvessels, microalbuminuria and proteinuria, pulmonary function, assess the effects of anti-VEGF therapy by assessing brachial artery reactivity, retinal vasculature and pulmonary function in a subset of patients receiving anti-VEGF therapy. The development of markers of endothelial dysfunction may result in the early identification of patients who are non-responders or develop toxicity from anti-VEGF treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are receiving single agent anti-VEGF therapy
* Signed written informed consent.
* Patients with measurable pulmonary malignancy (primary or metastatic) as determined by RECIST will undergo assessment of pulmonary function.
* Patients with a known allergy to intravenous contrast used in fluorescein and indocyanine green angiography will be exempt from these investigations but will undergo other study assessments

Exclusion Criteria:

* none
Virtual Reality and 3D Reconstruction in Body Image and Bariatrics

With obesity on the rise, the number of metabolic procedures performed annually is also increasing. Bariatric surgery has a significant impact on metabolic disease but also results in significant weight loss. Approximately, 30-40% of excess weight is lost within the first year following surgery. One of the motivating factors for surgery for patients is body image dissatisfaction and the stigmatisation of living with obesity, which is linked to low esteem, anxiety and depression. However, studies have indicated that following bariatric surgery, patients continue to experience dissatisfaction with their new body and identity due to unmet expectations.

The investigators aim is to start addressing body image issues prior to surgery and provide realistic expectations to patients. This study will be focusing on the feasibility and acceptability of 3D image reconstruction and virtual reality as a method of helping bariatric patients manage their expectations and improve body image satisfaction after surgery. Thereby, leading to better quality of life, improved psychological outcomes and prevention of disordered eating, anxiety and depression.

The study will take place at St Mary's Hospital (London) and the West London NHS Trust Bariatric Clinic from March 2022 to September 2022 (7 months). The study aims to recruit 10 participants from the Tier 3 Bariatric Preoperative Group. Once the participant has provided written consent, a photograph of them will be taken using a handheld 3D scanner on a secure password protected device. The images will be processed to produce two reconstructed images, one with 15% less body weight and the second with 25% less body weight. The participants will be divided into groups of 5 and shown their reconstructed images using individual virtual reality headsets. The participants will only have access to their own images. This will be followed up with group peer discussion meetings and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* In the tier 3 preoperative bariatric group
* 18 to 75 years old
* Male and Female

Exclusion Criteria:

* Anyone who cannot provide informed consent.
* Anyone with significant mental health instability
Correlation Between Carbon Dioxide Measured in End of Exhalation and Arterial Blood

The purpose of this study is to study the correlation between carbon dioxide measured by capnography at the enf of exhalation and arterial blood in COPD patients with nasal cannula in critical care unit.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* COPD patients

Exclusion Criteria:

* Under-aged
* Pregnant
* Major burns
Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery

The investigators plan to evaluate the analgesic effect of systemic Lidocaine in addition to general anesthesia during bariatric surgery. Patients will be subdivided into a "Lidocaine group" and a "Control group".

The primary outcome will be the proportion of patients suffering from higher pain intensity within the first four hours after bariatric surgery.

Secondary outcomes include the average maximal pain intensity during first four hours and during 48 hours, total opiate consumption, occurence of postoperative nausea and vomiting, time to first defecation and total time spent in hospital.

Postoperative pain is a common problem in today's surgery, although pain management techniques have improved in the last years. Systemic application of lidocaine has gained interest since several studies have shown its analgesic, anti-inflammatory and antihyperalgesic properties. In this clinical trial the analgesic effect of intravenously administrated lidocaine is compared with placebo. Despite longstanding use as an antiarrhythmic agent and its use in many clinical trial as analgesic, lidocaine is not licensed for this indication and application. Current studies, setting the focus on abdominal surgery, indicated that the systemic application of lidocaine was associated with fewer intensity of pain at rest and during mobilization and resulted in a decrease of patients'opiate consumption.

The intervention to be studied will either be the additional application of systemic lidocaine 1% to general anesthesia in bariatric surgery or the application of placebo. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. The population to be studied will include 140 patients listed for bariatric surgery at the Kantonsspital St. Gallen. Patients, medical practitioner, nurses and investigators will be blinded. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.

Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic bariatric surgery
* ASA classification I - III
* age 18 - 80
* given informed consent

Exclusion Criteria:

* no written consent
* allergy to the investigational product
* cardiac arrhythmia (pacemaker)
* liver dysfunction (Child-Pugh classification A, B or C)
* pregnancy
* central nervous disease
* chronic pain and pre-existing opiate prescription
* expected non-compliance
* drug/alcohol abuse
Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery

The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.

Pediatric patients undergoing cardiac surgery are at risk for adverse clinical outcomes due a inadequate tissue perfusion. Recent studies have been demonstraded which the monitorization of continuos central venous saturation could be benneficial. There is evidence that monitoring continues venous oxygen saturation (ScvO2) can be beneficial in patient outcomes, guided by ScvO2 therapy has been associated with improved outcomes in resuscitation of critically ill patients with sepsis and after congenital heart surgery complexa. The early detection and treatment of tissue hypoxia can prevent morbidity and mortality. tissue hypoxia may be a result of the imbalance between supply (DO2) and oxygen consumption (VO2). If the fault supply, oxygen consumption is maintained by increased oxygen extraction resulting in decreased central venous oxygen saturation

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery with cardiopulmonary bypass
* Written informed consent

Exclusion Criteria:

* Cardiac arrhythmia
* Emergency operation
* Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min)
* Neoplasia
* Heart transplant
* Participation in another study
Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis

A pilot study to assess the safety, feasibility, and potential (uncontrolled) efficacy of continuous glucose monitoring (CGMS) in conjunction with an insulin pump to improve glycemic control for treatment of type 1 and type 2 diabetic patients with gastroparesis

This multicenter, uncontrolled, open label treatment study is to assess the safety of CGMS in guiding insulin pump therapy for 24 weeks by measuring mild, moderate, and severe hypoglycemic episodes in patients with type 1 and type 2 diabetes and gastroparesis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 70 years old at registration
* Type 1 or Type 2 diabetes mellitus for at least 2 years
* Symptoms of gastroparesis (nausea, vomiting, early satiety, bloating, fullness, discomfort) for at least 1 year prior to registration
* Gastroparesis Cardinal Symptom Index (GCSI) score of 18
* Delayed gastric emptying on gastric scintigraphy within 1 year of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours
* Hemoglobin A1c of at least 8.0% at registration regardless of current therapy. Individuals already receiving diabetes therapy via an insulin pump will be eligible for study participation if, in the opinion of the investigators, he/she may acquire additional benefit from continuous glucose monitoring that might improve glycemic control
* Normal upper endoscopy within 1 year of registration
* No clinical or imaging evidence of obstruction
* Successful mastering of use of CGMS during the run-in period

Exclusion Criteria:

* Prior gastric surgery including fundoplication
* Other systemic disease potentially causative of gastrointestinal symptoms
* Acute or chronic renal insufficiency with creatinine \>1.5 mg/dL
* Psychiatric disease or eating disorder
* Pregnancy
* Any other condition which, in the opinion of the investigators, would impede compliance or hinder completion of the study
Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Pre- and Post-Desvenlafaxine Treatment

Anhedonia (the lack of pleasure in normally pleasurable things) is a common symptom of major depressive disorder (MDD), and it may impact how patients with depression experience reward. Understanding how anhedonia is related to the experience of reward may help improve how depression is treated. Computer tasks can be used to measure how reward is experienced, and these measures might be able to predict things like who is likely to become depressed, or who will respond to antidepressant medication. Studying the relationship between anhedonia and reward in patients with depression might also tell us something about how to improve diagnosis and treatment of other psychiatric disorders.This is an open label controlled treatment study lasting 8 weeks. The brain scans will be used to find changes in brain areas that may be related to how people perform on the tasks. The investigators goal is to use this information to help us find a reliable predictor that can be used to guide MDD treatment.


Eligibility Criteria:
Inclusion/exclusion criteria for MDD patients (n=40) are as follows:

Inclusion Criteria

1. DSM-5 criteria for Major Depressive Episode (MDE) within a MDD, confirmed through MINI diagnosis
2. Age between 18 and 60 years
3. Hamilton Depression Rating Scale - 17 item (HRSD-17)58 \> 17 (moderate to severe symptoms)
4. Free of psychotropic medications for at least 5 half-lives before baseline visit
5. Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)

Exclusion Criteria

1. Pregnancy/lactation
2. Medical condition requiring immediate investigation or treatment
3. Recent (\< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
4. Lifetime history of psychosis, other Axis I comorbidities are allowable
5. Significant Axis II diagnosis
6. Previous intolerance or failure to respond to an adequate trial of desvenlafaxine
7. Failure of \> 2 antidepressant treatments of adequate dose and duration for current MDE

Inclusion/exclusion criteria for Healthy Controls (n=20) are as follows:

Inclusion Criteria

1. Age between 18 and 60 years
2. Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)

Exclusion Criteria

1. Pregnancy/lactation
2. Medical condition requiring immediate investigation or treatment
3. Lifetime history of any psychiatric disorder
4. Lifetime history of receiving an antidepressant
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)

The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.

A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.

Eligibility Criteria:
Inclusion Criteria:

* Planned cataract removal in both eyes.
* Willing and able to complete all required postoperative visits.
* Able to understand, read and write English and willing to sign an approved statement of informed consent.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.
* Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.
* Ocular trauma or ocular surface disease that would affect study measurements.
* Patients who desire monovision correction.
* Other protocol-specified exclusion criteria may apply.