cyrilzakka/clinical-trials huggingface dataset:
Remote Ischaemic Preconditioning in Children Undergoing Cardiac Surgery

Surgical correction of congenital heart defects in children requires the utilization of cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions during surgery. During this process the patient´s circulation is controlled by a bypass machine which provides several functions:

1. Controls the patient's blood flow by pumping of blood in the patient's body.
2. Controls the correct oxygen levels in the patient's blood.
3. Regulates the temperature and fluid level of the blood. This process triggers negative responses in the heart and throughout the whole body, potentially resulting in injury to the heart and other organs such as brain, kidneys and lungs.

Remote ischaemic preconditioning (RIPC) describes a procedure that could potentially reduce the injury to heart muscle during cardiac surgery. The procedure consists of the inflation of a blood pressure cuff on the child's leg for three 5 minute cycles. This process acts by briefly reducing blood flow to the leg muscle, which will then activate the body´s own protective mechanisms and thereby reduce heart injury.

Several animal studies have been used to help the understanding of the mechanisms behind this process, and trials in human adults have showed optimistic results; however evidence regarding the paediatric population is limited and necessary since children present different basal profiles, risks and requirements.

The investigators propose a randomized clinical trial assessing the efficacy of RIPC to provide protection against injury to the heart and other organs in children going through cardiac surgery using CPB at the Royal Hospital for Sick Children. The research project will have a translational approach, integrating basic molecular mechanisms to clinical outcome. The investigators hope it will allow the understanding and utilisation of the patient´s own protective mechanisms, reducing CPB-related injury and ultimately improving patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* Children undergoing cardiac surgery for correction of congenital heart defects utilizing cardiopulmonary bypass and cold blood cardioplegia strategy of myocardial protection.
* Children whose parents understand the child's condition, the purpose of the study and are willing to participate.

Exclusion Criteria:

* Children whose parents either are unwilling or do not have sufficient understanding of the study.
* Emergency operations, where there is insufficient time to establish the study protocol.
* Premature children presenting a corrected gestational age under 35 weeks.
* Presence of extracardiac abnormalities, apart from cases of Down and DiGeorge syndromes which will be included.
* Patients with known viral blood infections (e.g. HIV, Hepatitis B) or severe congenital infection.
* Patients with severe preoperative brain injury.
Contemplative Well-being Apps for the Workplace

The study will examine the use and impact of a meditation app delivered to adult workforce populations facing extreme time demands. Enrollees will be randomized to either app or a wait-list group, and will be assessed in terms of job and daily functioning, well-being, and biomarkers of immune function and stress physiology, and neural structure and function prior to randomization and again at multiple time points after participants commence app engagement. In order to assess efficacy, we will examine the longitudinal changes in all measures in both the mindfulness group, compared to wait-list control group.

Over the last 25 years, research on contemplative practices, a family of practices including mindfulness meditation and yoga, has advanced in domains both clinical and basic, motivated by burgeoning evidence of their efficacy for remediating psychopathology and augmenting well-being and resilience. However, much of this research has examined the effects of scheduled group interventions, delivered in-person by instructors over the course of several weeks. Far less research has looked at the delivery method that is most common and arguably most sustainable for busy adults, namely, smart phone delivered Contemplative Applications (apps) for Well-being (CWAs). The proposed study will examine the use and impact of an app delivered to populations facing extreme time demands.

Eligibility Criteria:
Inclusion Criteria:

* Emory Healthcare and University employees, Cox Enterprises employees, and Emory students

Exclusion Criteria:

* For students and employees in the biomarker sub-study, participants will be studied only if they pass the Society of Magnetic Resonance Imaging standardized MRI screening protocol (exclusions for ferrous metal in any part of body, such as pacemakers, cochlear implants, surgical clips or metal fragments, serious medical conditions, claustrophobia)
Ultrasound and Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response

This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy of chemotherapy in breast cancer precise.

This real-time noninvasive and feasible imaging technique allows us, the investigators at University Hospital Tours, to evaluate early vascular changes of breast tumors during treatment. These vascular changes may precede long-term tumoral regression. Imaging of primary breast lesions may be of value in the prediction of late treatment response.

An ultrasound will be performed before the initiation, and after the second and the last dose of chemotherapy.

To investigate the changes occurring in the vascularization of tumors, we will use an intravascular ultrasound contrast agent SonoVue (sulphur hexafluoride microbubbles).

This agent is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis.

The main objective of the study is to evaluate the early vascular changes of the tumor during neoadjuvant chemotherapy compared to the clinical or MRI or histological response.

Eligibility Criteria:
Inclusion Criteria:

* Breast tumor (size equal to or greater than 3 cm.). Patients with diagnosis of benign breast tumor based on biopsy will be excluded from the study after the first ultrasound examination.
* Neoadjuvant chemotherapy is programmed when an epithelial carcinoma is diagnosed by histology.
* Performance status = 0, 1 or 2
* No previous surgery or local radiotherapy

Exclusion Criteria:

* Psychiatric disorders
* Vital threat due to other disease
* Vital prognosis \< 3 months
* Biopsy of the lesion performed within 1 month before the ultrasonography
* Patient known to have a coronary syndrome
* Unstable angina and myocardial infarction
* Acute cardiac failure, Class III/IV cardiac failure
* Several arrhythmias
* Acute endocarditis
* Prosthetic valves
Coaches Activating Reaching and Engaging Patients

The purpose of the Team Based Advance Care Planning CAREPLAN program is to understand if a trained lay navigator who engages with patients with advanced stages of cancer can help patients in advance care planning, improve patient activation, satisfaction, quality of life, and the quality of end of life cancer care while also ensuring goal concordant cancer care at the end of life.

Stanford Cancer Institute plans to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their patients. The CAREPLAN (Coaches Activating, Reaching, and Engaging Patients in Their End of Life Care Plan) intervention is an innovative program aimed to strengthen provider-patient relationships and facilitate whole person care about matters important to patients diagnosed with advanced stages of cancer and important to patients' support network and family. The project is intended to help establish patients' Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for patients with cancer that is intended to improve clinical outcomes and their experiences with their cancer care. The intervention provides patients with lay navigators who assist them and their families in formulating and discussing their goals of care with their health care teams in hopes to engage in shared-decision making for goal concordant care. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation, quality of life, and quality of care and communication and that the program helps to improve goal concordant care receipt at the end of life.

Eligibility Criteria:
Inclusion Criteria:

* All patients who receive care at Stanford Cancer Institute and have genitourinary cancers and have received greater than 2 prior courses of chemotherapy treatment

Exclusion Criteria:

* Patients without capacity to consent
Impact of Persistent Microvascular Obstruction by Cardiac Magnetic Resonance on Prognosis for ST-segment Elevation Myocardial Infarction

The aims of the study were to evaluate the predictive value of persistent microvascular obstruction (MVO) by cardiac magnetic resonance for main adverse cardiac events in ST-segment elevation myocardial infarction patients.

MVO in the acute phase of myocardial infarction has been considered to be strong predictor of a poor prognosis. We plan to explore the relationship between persistent MVO and the long-term prognosis of patients with STEMI. We made hypothesis that patients with persistent MVO have a poor prognosis.


Eligibility Criteria:
Inclusion Criteria:

* ST-segment elevation myocardial infarction undewent primary percutaneous coronary intervention

Exclusion Criteria:

* contraindications for cardiac magnetic resonance
* severe heart failure
* previous myocardial infarction.
Effects of Different Add Powers on the Comfort and Productivity of Computer Users With Fixed or Free Head Movement

The aim of this study is to examine the relationship between optical blur from poor refractive corrections (glasses) of older workers using computers and their productivity and comfort in the workplace. The investigators believe that improving the visual status of subjects who use computers will have a beneficial effect on productivity and visual comfort.

The aim of this study is to examine the relationship between optical blur from poor refractive corrections (glasses) of older workers using computers and their productivity and comfort in the workplace. We believe that improving the visual status of subjects who use computers will have a beneficial effect on productivity and visual comfort. All subjects will be required to complete a vision screening at no charge to decide if they qualify for the study. This is a double-blind study, which means that neither the subject nor the doctors will know which pair of lenses you will be wearing during the parts of the study. Subjects will complete a total of 4 hours of testing. The total amount of testing will be divided into ten 15-minute periods. During each period, the investigator will place different lenses in a trial frame. The trial frame that the subject will wear during the experiment will have their prescription for near plus an unknown pair of lenses. During the testing, the subject will complete a task involving finding and deleting apostrophes from a manuscript on a standard computer. Either the investigator or co-investigator will explain how to do this simple task. Subjects will answer a short survey before and after these tasks to check on symptoms resulting from using the computer. The following periodic measurements will be made during the study: productivity and accuracy to search for apostrophes (') in a document on one of the states of the U.S. These tasks will require a total of 4 hours testing with a total of ten pairs of trial lenses during a single visit.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or greater
* 20/40 visual acuity or better in each eye
* Use a computer at least 1 hour per work day
A Home-based Blood Pressure Monitoring Program to Promote Better Management of Hypertension

In this study the investigators aim to evaluate the effect of home-based blood pressure measurement with an electronic device on medication adherence and blood pressure control.

Adherence to treatment is disappointingly low among patients with chronic health disorders especially after 6 month of initiating drug therapy. In hypertensive patients , as reported by WHO, 50% of non-adherence could be expected. Poor adherence to anti hypertensive medications results in increased morbidity, mortality and costs. One of the reasons that could implicate medications adherence can be attributed to seeing no physical sign of better controlling blood pressure. Self monitoring of blood pressure at home has been reported to improve patients adherence to their medications.

This study is a 2-arm randomized controlled trial. The investigators aim to evaluate the effect of home-based blood pressure measurement with an electronic device on medication adherence and blood pressure status.

One hundred ninety six hypertensive patients aged at least 18 years old are recruited in an ambulatory care setting and are evenly allocated to the study arms with balanced-block telephone randomization.

Appropriate medication is prescribed as preferred by the cardiologist (single daily dose medicines are recommended). Patients in both arms are followed for 24 weeks, each will be visited by the cardiologist four times during the study period. In each visit, patients' blood pressure will be measured twice by a nurse in the office.

In the intervention arm, electronic blood pressure device is provided for each patient and he/she will be trained to measure blood pressure at home once daily (same time each day). A logbook is also provided to document the daily blood pressure level.

Primary outcome of the study is the blood pressure measured at each office visit overtime. Medication adherence is measured by pill count method as the secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients older than 18
* Patients newly diagnosed as hypertension stage 1
* Patients previously on antihypertensive treatment but uncontrolled hypertension
* Patients not possessing electronic self blood pressure measurement device
* Patients with functional ability to use the device

Exclusion Criteria:

* Patients requiring two or more antihypertensive drugs at the start of the study
* Patients with secondary hypertension
* Patients cardiovascular comorbidities and other interfering medical conditions
* Patients with drug contraindication or documented drug allergy
* Patients with serum creatinine \> 150 microliters

Withdrawal criteria:

* Inadequate therapeutic effect requiring an increase of more than 20% in pre-established number of visits
* Emergence of adverse drug reactions requiring cessation of medication
Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"

The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure".

The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure", renal disfunction, cerebral disfunction ,and inflamtory response

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years old
* Hepatic cirrhosis diagnosed by biopsy or clinical, analytic and ultra sound data.
* acute on chronic liver failure: defined by an acute deterioration in hepatic function produced in 2-4 weeks with jaundice (total serum bilirubin ≥ 5 mg/dl ) and hepatic encephalopathy (≥ grade 2) and/or renal insufficiency (serum creatinine ≥ 2 mg/dl)

Exclusion Criteria:

* Neoplasm disease including hepatocarcinoma which exceed Milan criteria (1 tumour \> 5cm, up to 3 tumours \<3 cm)
* Active bacterial or fungal infection with hemodynamic instability which require the utilization of vasoactive drugs at moderate dose (\>0,5 μg/Kg/min of noradrenaline)
* Structural moderate to severe cardiopathy (Cardiac Index \<2l/min/m2)
* Chronic renal insufficiency in treatment with haemodialysis
* Chronic moderate o severe pulmonary disease (maximum expiratory volume in a second \<50%)
* Active transplant
* human immunodeficiency virus infection
* Pregnancy or lactation
* Acute respiratory distress syndrome (P02/Fi02\< 200mm Hg) or acute lung injury (P02/Fi02\< 300mm Hg)
* Hemodynamic instability (\>0,5 μg/Kg/min of noradrenaline)
* Bleeding in the digestive tract in the previous 72h to the treatment
* Severe coagulopathy: INR ≥ 3.0 (Quick ≤ 20%) and/or platelets \< 30000//mm3
* Extrahepatic cholestasis
* Hepatobiliary surgery in the last 6 months (except laparoscopic Cholecystectomy)
* Concentrations bilirubin ≥ 5mg/dl during the period above 4 weeks previous to inclusion
* Concomitant participation in an other clinical trial
* Drug addiction
* Mental status which does not allow the patient to understand the trial, with the exception of hepatic encephalopathy.
Decoding the Cognitive Trajectory of Hong Kong SuperAgers: a Longitudinal Follow-up Study

This is a prospective follow-up study conducted at the Department of Psychiatry, The Chinese University of Hong Kong. The participants, including high-performing elderly (SuperAgers), normal ageing elderly and neurocognitive disorder (NCD) patients will be re-invited from our previous cohort (2013-2014) (N=488).

Objectives: This study aims to investigate the cognitive changes in older adults with different cognitive statuses.

Eligibility Criteria:
Inclusion Criteria:

* SuperAgers are determined by the scores of global cognitive function. This ensured that the participants are divided by a measure relevant to the current study without directly biasing the results toward the domain of interest;
* Normal aging: the cases with the scores of cognitive performance within 1.5 standard deviation (SD) of age and education matched normative values derived from our cohort study, of which presented with HK MoCA score greater than 26 and CDR score equal to 0;
* NCD patients are deﬁned as: evidence of modest decline in one or more cognitive domains, which is set as ≥ 1.5 SD below the age- and education-adjusted normative scores; no interference with independence in everyday activities; and no comorbid major psychiatric disorders.

Exclusion Criteria:

* History of bipolar disorders or psychosis;
* History of major neurological deﬁcits including stroke, transient ischemic attack or traumatic brain injury;
* Comorbidities with depressive symptoms.
The Supporting Healthy Marriage Evaluation

The Supporting Healthy Marriage (SHM) evaluation was launched in 2003 to test the effectiveness of a skills-based relationship education program designed to help low- and modest-income married couples strengthen their relationships and to support more stable and more nurturing home environments and more positive outcomes for parents and their children. The evaluation was led by MDRC with Abt Associates and other partners, and it was sponsored by the Administration for Children and Families, in the U.S. Department of Health and Human Services.

SHM was a voluntary, year long, marriage education program for lower-income, married couples who had children or were expecting a child. The program provided group workshops based on structured curricula; supplemental activities to build on workshop themes; and family support services to address participation barriers, connect families with other services, and reinforce curricular themes. The study's random assignment design compared outcomes for families who were offered SHM's services with outcomes for a similar group of families who were not but could access other services in the community.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible for the study, couples were supposed to be low income, married, at least 18 years old, and either expecting a child or parents of a child under age 18 who was living in their home -- though couples were not required to provide any documentation verifying that they met these eligibility criteria.
* They also had to understand one of the languages in which SHM services were offered (English or, in some locations, Spanish).

Exclusion Criteria:

* Indication of domestic violence in the relationship
Conscious Sedation for Cataract Operations Under Topical Anaesthesia

Topical anaesthesia of the eye for ophthalmologic procedures avoids pain and discomfort of local anaesthetic injection in the peribulbar or retrobulbar block so that patient comfortability is achieved. Sedation during topical anaesthesia of the eye is mostly required to achieve anxiolysis, amnesia and keeping the patient calm all through the procedure. In the present study, the investigators will investigate the effect of nalbuphine/dexmedetomidine versus nalbuphine/propofol on the sedation as a primary outcome, intra-operative, postoperative analgesia, vital signs, patient and surgeon satisfaction and side effects as secondary outcomes

In both groups, the patients will receive i.v. nalbuphine 50 μg/kg. Patients in group D, will receive an i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h. Patients in group P, will receive a bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion started at 0.025 mg/kg/min .If sedation score was \<3, rescue sedation with boluses of midazolam 0.01 mg/kg will be given. If the patient complained of pain (Numerical verbal pain rating scale ≥3) during the surgery, i.v. fentanyl 50 μg will be given as an intra-operative rescue analgesic and the surgeon will be instructed to use additional topical local anaesthetic eye drops if appropriate. After the completion of surgery, all infusions will be stopped, and the patients will be shifted to the postanaesthetic care unit (PACU) to be monitored for 2 hours before discharge.

Eligibility Criteria:
Inclusion Criteria:

* Both genders,
* 20 and 65 years,
* American Society of Anesthesiologists (ASA) physical status I and II,
* Scheduled for cataract extraction surgery under topical anaesthesia.

Exclusion Criteria:

* Known allergy to local anaesthetics,
* Allergy to study drugs,
* Second or third-degree heart block,
* Alcohol or drug abuse
* Morbid obesity, pregnant and lactating females,
* Patients with severe cardiac, renal and hepatic disorders.