Kornimate/medical-research-clean huggingface dataset:
effect of high-dose naloxone infusion on pain and hyperalgesia in patients following groin-hernia repair.

Conditions: Central Nervous System Sensitization; Pain; Hyperalgesia

Summary: recent studies have focused on the role of endogenous opioids on central sensitization. central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache. animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. this suggests latent sensitization. in the present study, investigators hypothesize that a high-dose target-controlled naloxone infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a unilateral primary open groin hernia repair procedure. investigators aim to show that latent sensitization is present in humans and is modulated by endogenous opioids.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 65 years * signed informed consent * patients submitted to unilateral, primary inguinal, open herniotomy 6-8 weeks prior to study start. * open operating procedure a.m. lichtenstein. * urin sample without traces of opioids (morphine, methadon, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphine, dextromethorphan) * asa i-ii * body mass index (bmi): 18 \< bmi \< 30 exclusion criteria: * volunteers , who do not speak or understand danish * patients, who cannot cooperate with the investigation * patients who have had previous surgery in the groin region * patients with pain at rest \> 3 (nrs) * activity-related pain in the surgical field \> 5 * allergic reaction against morphine or other opioids (including naloxone), * abuse of alcohol or drugs - according to investigator's evaluation * use of psychotropic drugs (exception of ssri) * neurologic or psychiatric disease * chronic pain condition * regular use of analgesic drugs * skin lesions and tattoos in the assessment areas * nerve lesions in the assessment sites (for instance, after trauma, disc herniation, etc.) * use of prescription drugs 1 week before the trial * use of over-the-counter drugs 48 hours before the trial

Keywords: central sensitization endogenous opioids humans latent sensitization naloxone open groin hernia repair pain randomized controlled trial secondary hyperalgesia target-controlled infusion
effect of kinesio taping of pain, swelling and trismus after mandibular third molar surgery

Conditions: KINESIOTAPING; Third Molar Extraction Surgery; Pain; Swelling; Trismus

Summary: this study evaluates the effectiveness of kinesio taping in reducing swelling, pain, and trismus complications after wisdom tooth extraction surgery. patients undergoing bilateral symmetrical extraction of mandibular third molars, kinesio tape was applied on the study side and placebo tape on the control side. pain intensity was assessed using the visual analog scale (vas), swelling was measured using predefined facial landmarks, and mouth opening was recorded using interincisal distance measurements. data were collected preoperatively (t0) and on the 1st (t1), 2nd (t2), and 3rd (t3) postoperative days.

introduction: complications following third molar surgery can affect patients' quality of life. kinesio taping is a simple, non-invasive method with a clear mechanism of action in fluid drainage, one of the strategies for symptom reduction in wisdom tooth extraction surgery. this study evaluates the effectiveness of kinesio taping in reducing swelling, pain, and trismus complications after wisdom tooth extraction surgery. methods: a split-mouth, randomized, placebo-controlled clinical trial was conducted on 17 patients indicated bilateral mandibular third molar extraction. each patient had kinesio tape applied to one surgical site and a placebo tape to the contralateral side. pain intensity was assessed using the visual analog scale (vas), swelling was measured using predefined facial landmarks, and mouth opening was recorded using interincisal distance measurements. data were collected preoperatively (t0) and on the 1st (t1), 2nd (t2), and 3rd (t3) postoperative days.

Eligibility criteria:
inclusion criteria: * patients have bilaterally impacted mandibular third molars that are relatively symmetrical and have the same difficulty according to pell and gregory's classification, with an angulation difference between the two teeth not exceeding 15°. the angulation of each third molar is measured on a panoramic x-ray as the angle formed between the long axis of the third molar and the adjacent second molar. * patients do not have preoperative symptoms of swelling or pain. * patients agree to participate in the study after receiving a clear explanation and counseling. exclusion criteria: * patients with systemic conditions contraindicating tooth extraction surgery.
baveno vi criteria in dynamic monitoring of high-risk varices in compensated cirrhotic patients

Conditions: Cirrhosis; Varices; Non-invasive Evaluation

Summary: patients meet baveno vi criteria (with a liver stiffness \ 150,000 are considered to have very low risk of having varices requiring treatment, but whether these patients can be followed up by repetition of this criteria lacks sufficient evidence. this study aimed to assess the value of baveno vi criteria for following up and monitoring of varices needing treatment in patients with compensated cirrhosis.


Eligibility criteria:
inclusion criteria: 1. patients with liver cirrhosis diagnosed according to clinical or pathological criteria; 2. no decompensation events in the past, no ascites shown by ultrasound, no significant abnormality in liver function and coagulation function; 3. willing to carry out routine diagnosis and treatment evaluation and follow-up liver stiffness test and gastroscopy; 4. patients meet baveno vi criteria (with a liver stiffness \ 150,000) at baseline, or patients don't meet baveno vi criteria (with a liver stiffness ≥ 20kpa or with a platelet count ≤150,000) at baseline, but don't have varices requiring treatment (proved by endoscopy). 5. voluntarily signed the informed consent. exclusion criteria: 1. patients with liver carcinoma; 2. patients with portal vein thrombosis; 3. patients with varices requiring treatment confirmed by gastroscopy during the screening period; 4. patients who have received propranolol, ligation, sclerosis, splenectomy, transcatheter splenic arterial embolization, transjugular interhepatic portosystemicstent-shunt and other treatments to decrease portal hypertension in the past.
identification and characterisation of sleep disorders in a population of patients with non-small cell lung cancer

Conditions: Cell Lung Cancer; Sleep Disorders

Summary: this exploratory study will identify and characterise disorders frequently reported by patients as contributing to or altering their quality of life. this will enable a decision tree to be drawn up for diagnosis, referral and treatment of the sleep disorders collected, tailored to patients in this population. this decision tree should help to improve the management of patients with a cancer diagnosis presenting with sleep disorders.


Eligibility criteria:
inclusion criteria: * patient aged 18 and over. * being monitored and treated for non-small cell lung cancer. * with or without ongoing cancer-specific treatment. with no neurocognitive impairment (moca test score ≥26/30). * with a clinically assessed life expectancy of more than 3 months (royal marsden hospital 0-1) and general health (ecog \<2). * able to understand the study documents written in french * able to complete the study questionnaires written in french. * contactable by telephone throughout the study * affiliated to a social security scheme or entitled beneficiary * not opposed to taking part in the study exclusion criteria: * patient refusing to take part in the study * with a mental illness of the psychosis type monitored and treated prior to the study * patient under guardianship or curatorship * patient under court protection
combining performance of call ems and simultaneous chest compressions in a lone rescuer cpr

Conditions: Out-of-Hospital Cardiac Arrest

Summary: investigators designed the novel combining technique that rescuer start the chest compression with one hand during calling for help to the emergency medical system (ems) via a cell phone with another hand when he witnessed the arrest victim. this method may be helpful to reduce the hand-off time and increase the faction time of chest compression until the arrival of ems members. to verify this hypothesis, we conducted a random, controlled simulation study.

this study used a random, controlled design in the simulation setting using a manikin. study participants were recruited from healthy adult (age \> 18 years) laypersons who attended the bls training courses provided by the bls training class. the simulation scenario consists of witness of an out of hospital cardiac arrest and activation of the ems system with the prepared cellular phone. interventional method contained the immediate starting of the chest compression with one hand during the calling for help to the ems via a cell phone with another hand. we compare the quality of cpr between the novel interventional method (start cpr during call to ems) and conventional method (first call to ems and then start cpr).

Eligibility criteria:
inclusion criteria: * all healthy volunteers who attended the basic cpr training class * agreement with the simulation trial exclusion criteria: * volunteers who had some healthy problem which may affect the study results * not agreement with the simulation trial

Keywords: cardiopulmonary resuscitation emergency medical services cell phones simulation training
montelukast as a controller of atopic syndrome

Conditions: Seasonal Allergic Rhinitis; Allergic Conjunctivitis; Atopic Eczema; Asthma

Summary: the purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.


Eligibility criteria:
inclusion criteria: * wheal diameter at least 4 mm in skin-prick test for both birch and timothy * allergic symptoms in both upper airways (allergic rhinitis) and lower airways (asthma-like symptoms or diagnosed asthma) and at least one of the following: * allergic conjunctivitis * atopic eczema * oral symptoms from vegetables or fruits by cross reactivity to birch * urticaria in allergen exposure exclusion criteria: * need for regular treatment with glucocorticoids * current smoking * other major disease or need for regular drug treatment * pregnancy
the cardio-protective effect of cardiomyopeptidin on myocardial injury in icu patients with non-organic heart disease: a prospective, single-blind, randomized controlled pilot study

Conditions: Myocardial Injury; ICU

Summary: the study was a single-center, randomized controlled pilot study. to explore the cardioprotective effect of cardiopeptidin on non-heart disease patients with severe cardiac injury by comparing whether cardiopeptidin was used.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. the high-sensitive troponin t index was higher than the normal value during icu hospitalization 3. obtain the informed consent of the subject or legal agent exclusion criteria: 1. patients who are expected to die within 48 hours of icu admission 2. previous diagnosis of acute coronary syndrome, chronic cardiomyopathy, pulmonary heart disease, acute myocarditis, pericardial tamponade and other diseases that have been confirmed to cause myocardial injury 3. cardiopulmonary resuscitation and/or electrical defibrillation before admission 4. patients with acute ischemic stroke 5. patients with stage 5 chronic kidney disease 6. during pregnancy or breastfeeding
safety and immunogenicity study of 3 vaccinations with ticovac in 2 dosages in healthy children aged between 6 months and 3 years

Conditions: Encephalitis, Tick-borne

Summary: the purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with ticovac 0.25 ml and ticovac 0.5 ml, and b) whether there is a difference in terms of safety between the two products.


Eligibility criteria:
inclusion criteria: * male and female children aged between 6 and 47 months * no history of any previous tbe vaccination * clinically healthy * informed consent provided by the parents exclusion criteria: * history of allergic reactions, in particular allergic reactions to one of the components of the vaccine * suffering from a disease that cannot be effectively treated or stabilised * suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions * suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system * hiv-positivity (no special hiv test required for the purpose of the study) * suffering from a febrile disease * history of vaccination against yellow fever and/or japanese encephalitis * participation in another clinical trial

Keywords: tick-borne encephalitis
physical training program in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: purpose: to assess the efficacy of a physical training program in patients with ankylosing spondylitis (as) in a randomized controlled study

as is a chronic inflammatory rheumatic disorder affecting spine, peripheral joints and entheses. patients undergo pain, stiffness and reduced mobility of spine and joints. patients experience limitations in physical activities and reduced quality of life. some uncontrolled studies reported benefits of physical activity in patients with as. the aim of the present study is to assess the efficacy of a physical training program in patients with as. patients will be randomized in two parallel arms: program of personalized physical training (intervention group \[pepc\]) or program of information about physical activity (control group \[piap\]). patients will be evaluated at 12 and 24 weeks on activity, functional and metrological scores (asas 20, asas 5/6, asdas, basdai, basfi, basmi); biological inflammation (crp); nsaid use and pain vas. primary outcome: percentage of patients reaching an asas 20 response at 12 weeks. secondary outcomes: asas 20 at 24 weeks, asas5/6, asdas, basdai, basfi, basmi, crp, nsaid use and pain vas at 12 and 24 weeks. statistical analysis: comparison of the percentage of patients reaching an asas 20 response at 12 weeks in each arm using a fisher's exact test (main outcome).

Eligibility criteria:
inclusion criteria: * patients with as according to asas criteria, * treated or not with nsaid, * synthetic dmard or anti-tnf agent. exclusion criteria: * contraindications to physical training program (e.g. cardiac failure, pregnancy, painful arthroplasty or lower limbs damaged joint).

Keywords: ankylosing spondylitis physical training program
effects of weight reduction on sleep and alertness in long-distance truck and bus drivers

Conditions: Abdominal Obesity

Summary: the study is a year-long health-behaviour intervention in obese, male truck-drivers to lose weight moderately by 10%, using monthly individual counseling. the investigators hypothesize that lifestyle modification (increased physical activity, changes in eating habits, and improved schedule for sleep) through weight loss improves daytime alertness and quality of sleep, reduces daytime sleepiness, and improves cardiovascular risk factors and health-related fitness.

daytime sleepiness, i.e., being fatigued at work is an important risk factor for traffic accidents involving commercial vehicles. sleep-related disturbances and daytime fatigue may be partly related to obesity, which is common among truck drivers. this study is a randomised 12-month health-behaviour intervention in obese, male truck-drivers. we hypothesize that lifestyle modification (increased physical activity; decreased energy intake; and improved schedule for sleep), aimed to reduce weight moderately by 10%, improves daytime alertness and quality of sleep, reduces daytime sleepiness, and improves cardiometabolic health and health-related fitness. the primary aim is weight loss. we will recruit 140 participants aged 30-62 years and with abdominal obesity. the participants are randomised into an intervention (int) and control (con) group, for 12 months. the int group gets individual lifestyle counseling monthly. after 12 months, the con group receives weight-loss counseling for 3 months. assessments (psychological vigilance test, sleep duration, dietary intake, physical activity, metabolic syndrome, health-related fitness) take place at months 0, 12 and 24. we expect to develop counseling strategies (leading to weight loss through changes in lifestyle) that can be used to improve sleep, alertness and cardiometabolic health in occupational health care.

Eligibility criteria:
inclusion criteria: * male * age 30-62 years * long-distance truck or bus driver (on average continuous driving for at least one hour daily outside the city center) * irregular working hours (on average at least once weekly between 0600-1800 hours) * waist circumference at least 100 cm * sedentary: leisure physical activity no more than 30 minutes twice weekly at moderate intensity, and no medical contraindications to increase physical activity exclusion criteria: * no moderate or severe sleep apnoea with cpap therapy or with previous surgical operations in the neck area (e.g., uppp) * no regular use of sleeping medicines (on average not more often than once weekly) * no severe sleep disorder * greatly elevated resting blood pressure (\> 180/120 mmhg) * no diabetes mellitus with medication

Keywords: abdominal obesity weight reduction diet exercise training lifestyle activity health-related fitness walking actigraphy lifestyle modification sleep sleep hygiene alertness daytime sleepiness metabolic syndrome counselling health education truck drivers bus drivers randomized controlled trial
eversense® non-adjunctive use post approval study

Conditions: Diabetes

Summary: this is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the eversense cgm system non-adjunctively compared to self-monitoring of blood glucose (smbg) using a blood glucose (bg) meter in participants with either type 1 or type 2 diabetes. subjects will serve as their own control, with their baseline based on using smbg to manage their diabetes for the first 6 months followed by using eversense cgm system non-adjunctively for the second 6 months. total follow-up duration is 12 months. the investigation will include both clinic visits and home use of eversense cgm system. the nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. all care decisions specific to diabetes will be based on blood glucose (bg) values in the first phase and the eversense cgm system values in the second phase.


Eligibility criteria:
inclusion criteria: 1. subject has diabetes 2. subject is ≥18 years of age 3. subject has a smartphone that is internet enabled 4. subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion 5. subjects is willing and able to provide written signed and dated informed consent exclusion criteria: 1. subject is critically ill or hospitalized 2. prior use of cgm defined as: * no more than 1 week of continuous cgm use in the last 6 months, and * at least 4 weeks of continuous use of cgm in the last 12 months or 12 weeks total use in the past 3 years. 3. subject has a known contraindication to dexamethasone or dexamethasone acetate 4. subjects requiring intravenous mannitol or mannitol irrigation solutions 5. subject is on dialysis at the time of enrollment 6. female subjects who are pregnant, planning on becoming pregnant or nursing

Keywords: type 1 diabetes type 2 diabetes
exercise program for colorectal older patients

Conditions: Colorectal Neoplasms; Aged

Summary: the exercise for colorectal older patients (ecool program) is randomized controlled trial to assess the effects of an exercise program on physical function and health-related quality of life of patients 75 years and older with colorectal cancer undergoing surgery. ecool is a multicomponent home-based exercise intervention focused on the development of strength, balance, gait ability and inspiratory muscle function of older patients who receive weekly telephone follow-up from cancer diagnosis to 3 months after surgery. the investigators expect that ecool program will improve physical function and health-related quality of life of older patients 3 months after surgery and to maintain these benefits up to 6 months after surgery compared with the control group receiving usual care.

colorectal cancer (crc) is the second most common cancer and the second cause of cancer-related death in europe. thirty-one percent of new cases are older than 74 years. the decrease in reserve capacity (i.e., frailty), comorbidity and the surgical treatment imply that the elderly patient is at greater risk of functional decline (reported between 15% and 18% three months after surgery).up to 50% of those who have experienced functional decline do not recover previous levels of functional independence. the aim of this research is to investigate the effects of a multicomponent physical exercise program on physical function and health-related quality of life (hrqol) of patients 75 years and older with crc undergoing surgery. the exercise program focuses on the development of strength, balance, gait ability and inspiratory muscle function of older patients who receive weekly telephone follow-up from cancer diagnosis to 3 months after surgery. weekly telephone follow-up is provided by an exercise specialist who monitors adherence to the exercise program and insists on its compliance, clarifies any doubt and prescribes exercise progression. moreover, patients complete a supervised exercise session at baseline, during hospitalization and one month after surgery to ensure correct exercise execution and provide feedback. the investigators expect that ecool program will improve physical function and hrqol of older patients 3 months after surgery and to maintain these benefits up to 6 months after surgery compared with the control group receiving usual care.

Eligibility criteria:
inclusion criteria: * patients aged 75 years or older diagnosed with colorectal cancer. * patients included in colorectal surgery waiting list of the hospital general universitario gregorio marañon (madrid, spain) * patients able to communicate, understand and sign the informed consent. exclusion criteria: * patients finally excluded for colorectal surgery. * patients with absolute contraindications to exercise * walk disability (fac \<2) * severe cognitive impairment (mmse \<18) * terminal illness

Keywords: cancer elderly exercise prehabilitation rehabilitation surgery colorectal physical activity