Kornimate/medical-research-clean huggingface dataset:
long-term follow-up after laparoscopic inguinal hernia repair using tisseel for mesh fixation

Conditions: Hernia, Inguinal; Recurrence; Chronic Pain

Summary: in hernia repair a mesh is used to close the defect in the abdominal wall. this mesh is either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue (tisseel/tissucol) or left unfixated. the investigators believe, and previous studies indicate, that the use of fibrin glue greatly reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in men or recurrence of the hernia)when compared with the use of tacks or staples. the aim of this study is to compare the recurrence rates and amount of postoperative complications in patients who have had inguinal hernia repair with fibrin glue and in patients who have had inguinal hernia repair with tacks, staples or sutures.

the study will use prospectively collected data from the danish hernia database to find the patients. the patients will be contacted using a questionnaire.

Eligibility criteria:
inclusion criteria: inguinal hernia repair from january 2009-september 2012 exclusion criteria: patients lost to follow-up

Keywords: hernia, inguinal hernia repair fibrin tissue adhesive tisseel tissucol recurrence chronic pain dysejaculation
composite variability index versus bispectral index (bis)

Conditions: Sedation During

Summary: the aim of this study is to compare the accuracy of the changes in cvi in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of bis as guided by propofol effect compartment controlled tci (closed-loop).

patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol. for remifentanil, concentrations will be targeted at 0, 2, 4 and 6 ng/ml. after an equilibration period, anesthesia will be induced in all patients using propofol in order to reach and maintain a bis value of 70, 50 or 30. after an equilibration period(from start of propofol infusion), oaa/s will be measured in all patient. all patients will receive a standard pain stimulus (30 seconds, 50 ma) in order to observe the influence of the effect-site concentration of propofol and remifentanil on the cvi. a time window of 5 minutes after the stimulus will be respected to observe the changes in both bis and cvi. after this period, the study will be terminated and classical maintenance of anesthesia will be provided.

Eligibility criteria:
inclusion criteria: * asa class i and ii patients requiring general anesthesia for elective surgical procedures exclusion criteria: * patient refusal * weight less than 70% or more than 130% of ideal body weight, * neurological disorder * recent use of psycho-active medication, including alcohol.

Keywords: composite variability index bispectral index pain
patterns of breast cancer management and prognosis of breast cancer in china

Conditions: Breast Cancer

Summary: this is a multicenter, prospective, e, real-world cohort survey initiated by researchers to focus on the patterns of breast cancer management and prognosis of breast cancer in china, and to establish the multicenter, prospective breast cancer data platform. a total of 18 sites in guangdong and henan have cooperated to build a cooperative network unit. the sites will conduct prospective and standardized records concerning the clinical pathological features, treatment and prognosis of the early breast cancer patients who are treated in their own site each year, registering in the redcap system.this real-world cohort study aims to provide a representative and reliable survey data of epidemiological characteristics, clinical treatment and prognosis of patients with early breast cancer in china and explore the establishment of a national multi-center breast cancer data platform model.


Eligibility criteria:
inclusion criteria: * patients who are hospitalized and treated in a collaborative network unit * agree to enroll in the study and sign the informed consent form * histological diagnosis of ductal carcinoma in situ or invasive breast cancer * accept the surgery-based surgical treatment * willing to cooperate with follow-up work exclusion criteria: * previously excisional biopsy (including minimally invasive resection) of the patient's breast * previously received neoadjuvant chemotherapy * imaging or histological evidence of distant metastasis
recording and evaluating preoperative malnutrition in electively scheduled adult surgical patients with the glim criteria (glim-study)

Conditions: Malnutrition

Summary: data about the prevalence of preoperative malnutrition according to all the five glim criteria among the broad range of surgical patients are lacking. the current study will investigate the prevalence of malnutrition according to all of the five glim criteria in electively planned surgical patients in a large academic hospital, the amsterdam university medical centres, location amc, where over 11.000 patients are operated on yearly.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective surgery at the operating theatres of the aumc, location amc * patients ≥ 18 years * dutch speaking * willing and able to sign consent for re-use of care data * the study can be combined with other studies exclusion criteria: * patients \< 18 years * not speaking dutch * patients who do not sign consent for re-use of care data
tapse/pasp general anesthesia

Conditions: Hypotension

Summary: tapse, one of the methods for evaluating right ventricular systolic function; it is a bar parameter that can easily measure apex-basal shortening and provides specific information about global rv function. tapse/pasp can be calculated as load-independent parameters to evaluate rv function. because rv function is sensitive to change in afterload, known as the rv-pulmonary circulation (pc) connection. this study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

tapse, one of the methods for evaluating right ventricular systolic function; it is a bar parameter that can easily measure apex-basal shortening and provides specific information about global rv function. tapse/pasp can be calculated as load-independent parameters to evaluate rv function. because rv function is sensitive to change in afterload, known as the rv-pulmonary circulation (pc) connection. this study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population. patients will be measured by transthoracic echocardiography in the preoperative period, 15-30 minutes before induction. basal hemodynamic parameters and non-invasive and/or hemodynamic values will be recorded every two minutes after induction until surgical incision.patients with a 30% decrease in sbp from the baseline and a decrease in map below 65 mmhg in the first 10 minutes after anesthesia induction will be considered to have hypotension. patients will be divided into 2 groups: 'with' and 'without' hypotension.

Eligibility criteria:
inclusion criteria: 1. written informed consent; 2. 18-75 years old 3. asa physical status 1-3; 4. patients planned for surgery exclusion criteria: 1. the patient is pregnant 2. after cardiac surgery 3. severe pulmonary hypertension 4. severe valve disease 5. hypertrophic or dilated cardiomyopathy 6. presence of acute myocardial infarction 7. patients with severe visual or hearing impairment/disability 8. asa physical status iv or v 9. ischemic heart disease, conduction disorder.

Keywords: tapse pasp general anesthesi̇a
electronic register on advanced heart failure and transplantation di cuore

Conditions: Heart Failure; Heart Transplantation

Summary: the goal of this observational study is to create an electronic registry of patients diagnosed with advanced heart failure or heart transplant, starting from 01/01/1985 and to assess the incidence of advanced heart failure and heart transplant, and characterize patients affected by the first or undergoing the second procedure, starting from 01/01/1985. the primary outcomes are: * hospitalization for cardiovascular cause * death

heart failure is a pathological condition characterized by high morbidity and mortality, and it leads to a significant worsening of the quality of life for patients. the treatment of heart failure involves various options; the goal is to slow down the progression of the disease, reduce hospitalizations, increase survival, and reduce symptoms in order to improve the quality of life. treatments range from pharmacological therapy to lifestyle changes, from device implantation to heart transplant surgery. early diagnosis and treatment often help reduce symptoms, and many patients with heart failure can return to an active life. patients with heart failure must undergo regular check-ups to assess their general physical condition and the status of the disease. it is therefore essential to evaluate and systematize the different therapies. this study is both retrospective and prospective

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * ability to provide informed consent * diagnosis of advanced heart failure or heart transplant exclusion criteria: * none
a pilot feasibility study in recovered heart failure

Conditions: Heart Failure

Summary: one third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. these patients have an excellent long-term prognosis. whether they need to remain on long-term medical therapy is not clear. the investigators will investigate the safety of therapy withdrawal in patients with a previous diagnosis of heart failure and recovered cardiac function, in a randomised controlled trial.

patients with a previous diagnosis of heart failure, who have recovered cardiac function, without symptoms, normal serum biomarker concentrations and who are currently still taking heart failure medications, will be recruited. participants will be randomised to withdrawal of therapy and control arms and will undergo imaging investigations and cardiopulmonary exercise tests at baseline along with serum biomarker tests. those participants randomised to withdrawal of therapy will have a gradual, supervised reduction of medications. if, at anytime, there are signs of recurring heart failure, medications will be restarted. participants in the control arm will continue their medical therapy as usual. participants will be followed up with further biomarker testing, cardiopulmonary exercise testing and imaging investigations at 6 months. the primary end-point will be a relapse in heart failure, defined by adverse remodelling, increase in left ventricular size, rise in serum biomarkers or clinical evidence of heart failure as judged by the clinical team.

Eligibility criteria:
inclusion criteria: 1. have an index diagnosis of heart failure confirmed by 2 independent operators based on clinical details. 2. be currently taking at least 1 of the following medications loop diuretic, betablocker, angiotension converting enzyme inhibitor/angiotensin receptor blocker and mineralocorticoid receptor antagonist. 3. have demonstrated evidence of left ventricular reverse remodelling following the initial diagnosis with subsequent improvement in ejection fraction to \>50% and normalisation of left ventricular (lv) volumes. 4. have no symptoms of heart failure (nyha class 1). 5. low plasma ntprobnp. exclusion criteria: 1. uncontrolled hypertension. 2. more than moderate valvular disease. 3. estimated glomerular filtration rate \<30mls/min. 4. atrial/supraventricular/ventricular arrhythmia requiring beta-blockade. 5. pregnancy. 6. unstable angina. 7. age \<16 years

Keywords: recovery
effectiveness of mindfulness based relapse prevention for chronic users of benzodiazepines

Conditions: Benzodiazepine Dependence

Summary: benzodiazepines (bzd) are the most prescribed psychiatric drugs in brazil, especially for women. although it is recommended that the use of bzd is not greater than four weeks, there are many cases of prolonged use due to the lack of treatment options for dealing with complaints of insomnia. given this, the aim of this project is to evaluate the program mindfulness-based relapse prevention (mbrp) for adult women with chronic use of benzodiazepine (bzd) to induce sleep. specifically aims to evaluate if the mbrp program, can reduce the pattern of use and level of dependence of chronic users of bzd under gradual reduction (tapering) or cessation of the use of bzd. this study will be conducted at the drug dependency unit (uded) of the department of psychobiology of federal university of são paulo. the study will count with two groups: intervention group (ig) and control group (cg) (that will stay in the waitlist until the eighth month . the sample will comprise 100 women with chronic use of bzd as hypnotics, 50 will be randomized in the ig condition and 50 in the cg condition. changes will be evaluated on several variables such as cessation and dependence of bzd, quality of life, sleep, anxiety, depression and sexual satisfaction before and after the intervention in both groups. the data will be submitted to descriptive and inferential bivariate and multivariate statistic analyzes. it is hoped that this study create subsidies for the development of complementary interventions for the management of withdrawal symptoms in chronic users of bzd.


Eligibility criteria:
inclusion criteria: * literate adult women * using benzodiazepine (bzd) for inducing sleep for at least 03 months (90 days), for at least four times a week. exclusion criteria: * having practiced regularly meditation, yoga or similar previously, at least once a week, for at least three months, or have carried this practice regularly at least once a week in the last year for at least one month * neurological disorders, anxiety refractory to other treatments or insomnia secondary to other severe clinical conditions, which the bzd withdrawal is considered as a potential risk for worsening * presence of not controlled clinical disease or of greater severity, such as cancer, schizophrenia, epilepsy * presence of psychiatric illness which withdrawal of bzd is considered a potential risk for worsening * dependence or abuse of alcohol or other drugs, except tobacco * in acute treatment for psychological or psychiatric problems * be participating in a tapering bzd protocol, or similar

Keywords: mindfulness benzodiazepines sleep dependence relapse prevention
the efficacy of hypertonic lactate solution in cabg(coronary artery bypass grafting) patients

Conditions: Low Cardiac Output

Summary: previous clinical trials with 11.2% hypertonic ringer's lactate in post-operative cabg subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach circulation volume, as compared to sodium chloride.it also does not cause hyperchloremic acidosis, which is of value in treating shock patients. the primary objectives of this prospective, randomized, open-label trial are to evaluate the clinical efficacy of hypertonic lactate in comparison to ringer's lactate to maintain hemodynamic stability in intra- and post-cabg subjects in relation to hemodynamic status and body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence of adverse events.the secondary objectives are to evaluate comparative clinical efficacy of the two fluids in relation to reduction in concomitant drug utilization, duration of ventilator usage, length of stay in icu as well as total duration of hospitalization and neurocognitive status upto a period of 1 year post-cabg.

details provided in summary.

Eligibility criteria:
inclusion criteria: * male or female * 45 to 80 years * cabg patients with on or off pump procedure * ejection fraction \< 50% * given informed consent exclusion criteria: * combined operations * severe arrhythmia(vt, af rapid response, heart blocks) and severe hemodynamic imbalance * severe bleeding and/or re-operation * hypernatremia \> 155 mmol/l * severe liver failure(sgot, sgpt 2x normal) * severe renal failure(creatinine \> 2 mg. %) * major diseases(eg. cancer)

Keywords: coronary artery bypass grafting iv cardiac output
validation of a new method of limb volumetry

Conditions: Edema; Chronic Venous Insufficiency; Lymphedema

Summary: volumetry is essential for the diagnosis and follow-up of patients with limb edema. the objective of this project is the validation of real-time reconstruction and calculation of limb volume using a 3d laser scanner. water - displacement volumetry (water-filled boot) is the reference method with known accuracy and reproducibility, but is not commonly used in clinical practice because it is cumbersome, difficult, and time-consuming. the most commonly used method remains segmental limb perimetry with a tape measure, followed by volume calculation using the truncated cones formula, thus excluding de facts extremities (hands and feet) which can neither be likened to cones nor easily measured. quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. it is mandatory for the evaluation of therapeutic approaches. the present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. it is mandatory for the evaluation of therapeutic approaches. the present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with real-time 3d reconstruction. its advantages are non-contact, accurate and detailed quantification of edema, including extremities, allowing to assess the magnitude and topography of physiological, pathological, or treatment - induced volume changes. this approach will ultimately provide data that will used for designing personalized limb compression ortheses.

in each subject and patient, limb volume will be measured once by water - displacement (wd) and twice by 3d laser scanning (3d), by 2 independent operators, in random order. in a subgroup of patients, measurements will be repeated in the morning and evening, twice a year (during winter and during summer) to estimate the nycthemeral and seasonal effects. measurements will be performed in healthy subjects and in patients with chronic venous insufficiency or lymphedema.

Eligibility criteria:
inclusion criteria: * either healthy adult or - adult and chronic venous insufficiency c1s, c3, or c5 (ceap classification) or - primary lymphedema (between 10-90 years old) exclusion criteria: * no consent form

Keywords: volumetry 3d displacement of water lymphoedema venous chronic insufficiency
new magnetic resonance imaging biomarkers in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a disabling and rapidly progressive neurodegenerative disorder. there is no treatment that significantly slows progression. our project aims to find new biomarkers in mri at three levels: cerebral, medullary and muscular. these markers could allow an earlier diagnosis of the disease by showing more specific lesions of als and to quantify these lesions to measure the progression of the disease. this study will use advanced magnetic resonance imaging (mri) techniques high field (3t) and very high field (7t) mri. results from neurological and electrophysiological tests will be compared to the mri. subjects will be recruited from als center of marseille, france. mri will be done on als patients at baseline, at 3 month and at 6 month intervals.


Eligibility criteria:
inclusion criteria: * patients will be adults with a diagnosis of als. * healthy controls will also be recruited and will be age- and gender-matched to patients. * patients able to undergo a brain mri for approximately an hour. exclusion criteria: * subjects with other psychiatric or cns or pns diseases. * subjects ineligible for mri investigation due to a pacemaker or other metallic foreign body, or significant claustrophobia that could affect the ability to have an mri scan.
implementing peri-operative mobile application for contactless vital signs

Conditions: Blood Pressure, Heart Rate, Breathing Rate and Oxygen Level

Summary: the huge impact of the covid-19 pandemic on global healthcare systems has prompted search for novel tools to stem the tide. new digital health tools can provide possible health solutions in this time of unprecedented medical crisis to mitigate the impact of this pandemic. this proof of concept study will determine the feasibility and effectiveness of implementing a mobile application for contactless measurement of vital signs (mac-vital) such as blood pressure (bp), heart rate (hr), respiratory rate (rr) and oxyhemoglobin saturation (spo2) from surgical patients peri-operatively. contactless measurement of vital signs will bridge the current gap between virtual care and in-person medical assessments. this study aims to determine whether a mobile app can effectively measure vital signs without any person to person contact and how this technology can be implemented in a peri-operative setting during covid-19.

this study is a prospective proof of concept study to be conducted at toronto western hospital,toronto general hospital, hamilton general hospital (hamilton, ontario), juravinski hospital (hamilton, ontario) and trillium health partners, mississauga, ontario. this proof of concept study will determine the feasibility and effectiveness of implementing a contactless mobile application to obtain vital signs from patients in the peri-operative setting. informed consent to participate in the study will be obtained. vital signs measurement will be obtained by the research staff using hospital standard medical devices and the anura research app will also be used to measure vital signs. measurement will take place before surgery and post surgery (1 ±2hrs and 2 ±4hrs after surgery).

Eligibility criteria:
inclusion criteria * patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia * 18 years or older exclusion criteria * refusal to consent for the study * non-english speaking.