Kornimate/medical-research-clean huggingface dataset:
hypothermia and hemostasis after cardiac arrest

Conditions: Hypothermia; Heart Arrest; Hemostasis; Coagulants

Summary: this is a sub-study to the time-differentiated therapeutic hypothermia (tth48, clinicaltrials.gov identifier: nct01689077). tth48 compares 24 with 48 hours of therapeutic hypothermia at a target temperature of 32-34°c in survivors of out-of-hospital cardiac arrest. the overall aim of this sub-study is to examine the hemostasis in patients resuscitated after cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia our specific aims are: * to investigate the whole blood coagulation using the rotational thromboelastometry. * to investigate the function of platelets


Eligibility criteria:
inclusion criteria: * out of hospital cardiac arrest of presumed cardiac cause * return of spontaneous circulation (rosc) * glasgow coma score \< 8 * age \> 18 years and \< 80 years exclusion criteria: * \> 60 minutes from the circulatory collapse to rosc * time interval \> 4 hours from cardiac arrest to initiation of therapeutic hypothermia * terminal illness * coagulation disorder * unwitnessed asystolia * cerebral performance category 3-4 before the cardiac arrest * severe persistent cardiogenic shock * pregnancy * persistent cardiogenic shock (systolic blood pressure \< 80 despite inotropic treatment) * new apoplexy or intracerebral hemorrhage * lack of consent from the relatives * lack of consent from the gp * lack of consent from the patient if he/she wakes up and is relevant

Keywords: thromboelastometry haemostasis hypothermia heart arrest
characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in spain

Conditions: Asthma

Summary: observational retrospective study to characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in spain

t-ross-ii has been designed to conduct a new observational study to generate additional evidence on the use of tezepelumab in severe asthma patients in routine clinical practice in spain after its launch. this is an observational, multi-centre, retrospective, single-arm study in patients 12 years and older with severe asthma. approximately 400 patients meeting the study eligibility criteria will be included in the t-ross-ii.

Eligibility criteria:
inclusion criteria: patients who received at least 1 tezepelumab dose after commercialization in spain diagnosed with severe asthma who are inadequately controlled with high-dose inhaled corticosteroids and a long-acting β2-agonist ± additional medications for asthma control. * patients aged ≥12 years at the index date. * patients with continuous enrolment in the data source for at least 12-months before the index date. * patients with at least three months of continuous enrolment in the data source after the index date. exclusion criteria: patients who received tezepelumab or any biologic drug for the treatment of asthma in a clinical trial at any time during the 12-months prior to the index date\*. • patients who had initiated 3 or more non-tezepelumab biologic treatment (omalizumab, mepolizumab, reslizumab, benralizumab and dupilumab) for severe asthma at any time prior to the index date).
a study to evaluate the efficacy and safety of ivermectin in covid-19 prevention

Conditions: COVID-19

Summary: a multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for covid-19 prophylaxis

this trial comprises a total observation period of up to 56 days (an on-treatment period of up to 28 days and a safety follow-up of up to 28 days).

Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years, inclusive. 2. body weight \>45 kg. 3. body mass index \>18.5. 4. close contact with a person who has a pcr-confirmed sars-cov-2 infection within 5 days before screening. 5. only one member in the same household will be enrolled. 6. participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments. 7. sars-cov-2 positive index case must be able to give consent to enable collection of the documented positive pcr test. 8. female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial. exclusion criteria: 1. pregnant or breast-feeding. 2. participants who have been administered covid-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study. 3. a positive covid-19 result (pcr or antigen test) within 8 days of screening. 4. presence of typical covid-19 symptoms (fever \>38°c, spo2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening. 5. hypersensitivity to any component of ivermectin. 6. participants who have been administered ivermectin within 30 days prior to screening. 7. participation in another interventional trial within the last 30 days or 5 half-lives of the imp of the other trial, whichever comes first. 8. participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.). 9. history of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors. 10. current use of monoclonal antibodies for the treatment of covid-19.

Keywords: prophylaxis rt-pcr test
effect of l-citrulline supplementation on nafld in adolescents with obesity

Conditions: Non-Alcoholic Fatty Liver Disease; Obesity

Summary: one of the comorbidities of obesity is nonalcoholic fatty liver disease (nafld). l-citrulline is a non-protein amino acid that has shown positive effects on the degree of fat retention and metabolic profile in nafld. the objective is to assess the effect of oral l-citrulline supplementation on liver function and nonalcoholic fatty liver in adolescents with obesity. a clinical study will be carried out in 40 adolescents (15-19 years) with obesity, they will be divided into a control group that will receive a placebo and an experimental group that will receive 6 g of l-citrulline per day for eight weeks.

it is hypothesized that l-citrulline supplementation decreases liver enzymes and the degree of hepatic steatosis in adolescents with obesity. the aim of the study is to assess the effect of oral l-citrulline supplementation on liver function and nonalcoholic fatty liver in adolescents with obesity. a prospective randomized, double-blind clinical study will be carried out in 40 adolescents (15-19 years) with obesity, they will be divided into a control group that will receive a placebo (carboxymethyl cellulose) and an experimental group that will receive 6 g of pure l-citrulline per day per eight weeks. at the beginning and end of the intervention, anthropometric, biochemical and metabolic data will be evaluated, as well as tests of function and degree of hepatic steatosis.

Eligibility criteria:
inclusion criteria: * adolescents between 15 and 19 years old, residents of the city of león, guanajuato, with obesity due to bmi ≥30 kg / m2 equivalent to the categorization of adults. that they are in stage 5 of tanner scale with diagnosis of mild, moderate or severe nafld and / or alterations in liver enzyme levels. not be under nutritional treatment, not be smokers, not taking multivitamins, if so, a wash time of 30 days will be given. not be allergic to l-citrulline or watermelon. alcohol consumption less than 21 standard drink units for men and 14 standard drink units for women per week (standard drink: any drink with more than 14 g of pure alcohol). exclusion criteria: * present intolerance to l-citrulline or allergy to watermelon. * have an adherence of less than 80 percent of the treatments. * present other causes of liver disease.

Keywords: nafld obesity adolescents l-citrulline supplementation
comparison of 2 novofine® needles on the reflux of insulin

Conditions: Diabetes; Diabetes Mellitus, Type 1; Delivery Systems

Summary: this trial is conducted in europe. this trial aims to ensure that there is no substantial clinically relevant difference between the two novo nordisk needles novofine® 6 x 0.30 mm and novofine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.


Eligibility criteria:
inclusion criteria: * children/adolescents with type 1 diabetes mellitus * usage of novopen® 1.5 for at least 3 months * duration of insulin treatment more than 1 year * normal weight according to tanner scales * the means of the last 2 hba1c measurements taken within the last 6 months must be less than 10.5% exclusion criteria: * pregnancy or desire to become pregnant * clinical relevant peripheral neuropathy as judged by the investigators * pronounced lipodystrophy in accordance with investigator's evaluation * use of drugs that can influence the trial * coagulation disorders (use of anti-coagulants) * serious, chronic diseases, making it highly unlikely that the subject can complete the trial
screening methods in finding lung cancer early in current or former smokers

Conditions: Lung Cancer; Tobacco Use Disorder

Summary: rationale: screening may help doctors find lung cancer sooner, when it may be easier to treat. purpose: this clinical trial is studying screening methods to see how well they find lung cancer early in current or former smokers.

objectives: * to develop a new multi-modal screening strategy and integrated methods to detect lung cancer early in current and former smokers. * to evaluate the impact of the screening modalities on the quality of life of these participants. * to develop a decision analytic framework for determining the cost and effectiveness of a novel lung cancer screening strategy in canada. outline: this is a multicenter study. participants undergo spirometry at baseline. participants also undergo spiral ct scan at baseline and then at 1 and 2 years. participants with semi-solid or solid nodules of 5-10 mm or ground glass opacity (ggo) 8-10 mm or those with growth of an existing nodule, development of a solid component in ggo, or a new nodule undergo an additional ct scan at 3 months. some participants also undergo autofluorescence and white light bronchoscopy and bronchial biopsies. blood samples are collected at baseline and then annually for 2 years for biomarker studies. participants diagnosed with lung cancer undergo additional blood sample collection for biomarker studies. participants complete questionnaires on sociodemographic factors, smoking, occupational exposure, family history, medical data, quality of life, and anxiety at baseline and then every 6 months for up to 2 years.

Eligibility criteria:
disease characteristics: * current or former smoker * a former smoker is defined as one who has stopped smoking ≥ 1 year but \< 15 years ago * estimated 1-year lung cancer risk ≥ 1% patient characteristics: * ecog performance status 0-1 * not pregnant * willing to undergo a spiral chest ct scan * no severe heart disease (e.g., unstable angina or chronic congestive heart failure) * no acute or chronic respiratory failure * no bleeding disorder * no other medical condition that, in the opinion of the investigator, would preclude the participant's safety during study participation or that would unlikely benefit the participant from screening due to shortened life expectancy from the co-morbidity * no diagnosis of cancer, except for any of the following that were previously treated ≥ 5 years ago: * non-melanomatous skin cancer * localized prostate cancer * carcinoma in situ of the cervix * superficial bladder cancer * no known reaction to xylocaine, salbutamol, midazolam, or alfentanil prior concurrent therapy: * more than 2 years since prior chest ct scan * no concurrent anti-coagulant treatment (e.g., warfarin or heparin)

Keywords: small cell lung cancer non-small cell lung cancer tobacco use disorder
birch-spire safety and efficacy study

Conditions: Rhinitis

Summary: the purpose of this study is to evaluate the safety and tolerability of multiple administrations of birch-spire. to make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 to 65 years; * minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen * birch ige ≥ 0.35 ku/l * positive skin prick test to whole birch allergen exclusion criteria: * any past history of asthma * fev1 \< 80% of predicted * history of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food * acute phase skin response to whole birch allergen with a mean wheal diameter \> 50mm * administration of adrenaline (epinephrine) is contraindicated * history of severe drug allergy or anaphylactic reaction to food. * history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Keywords: allergy birch rhinitis rhinoconjuntivitis spire toleromune
the change of cem and the prognosis of coronary artery disease in real clinical practice

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to investigate the change of total cholesterol content of erythrocyte membranes (cem) in patients with coronary artery disease treated with secondary prevention drugs, and the correlation with the prognosis.

in this clinical trial, plasma samples, the red cells and associated clinical data of patients with coronary artery disease were collected from department of cardiology of lu'an shili hospital and the first affiliated hospital of jinan university. blood samples collected from all the participants at baseline (prior to the follow-up) and the time points of follow-up were placed into ordinary test tubes and stored at 4°c for less than 4 hours. after centrifuged, plasma and erythrocyte membranes was separated and stored at -80°c. the change of total cholesterol content of erythrocyte membranes (cem) was measured. a follow-up form was designed according to the research purpose and discussed among the team members. the follow-up was performed through telephone by the trained investigators with good communication skills and knowledge on the diagnosis and treatment of coronary artery disease. patients were followed up every six months from the day of discharge. the results of the follow-up were entered into the database, a process that was carried out by a designated person and double-checked by an independent person. the primary clinical endpoints were composite atherosclerotic cardiovascular disease outcomes, defined as nonfatal myocardial infarction, nonfatal stroke, or cardiovascular mortality. secondary clinical endpoints were revascularization, including percutaneous coronary intervention and coronary artery bypass grafting, and class iv heart failure requiring hospitalization.

Eligibility criteria:
inclusion criteria: * signed informed consent; * first diagnosis of cad through cag; * aged 45-70. exclusion criteria: * patients with severe liver or kidney damage; * taking statins within the last 3 months; * patients who had been diagnosed with cad and treated with oral medication; * chronic diseases of the blood system; * familial hyperlipidemia patients; * patients combining autoimmune disease; * patients combining acute infectious disease; * patients who undertaken surgery or injury; * patients who combining cancer; * patients who taking glucocorticoid replacement therapy; * abnormal red blood cell (rbc) count (m: \ 5.5 × 1012/l; f: \ 5.0 × 1012/l) or abnormal hemoglobin (m: \ 160 g/l; f: \ 150 g/l).

Keywords: prognosis all-cause mortality myocardial infarction stroke
dexmedetomidine and dexamethasone as an adjuvant to ropivacaine in thoracic surgery

Conditions: Pain, Postoperative; Oxidative Stress

Summary: the aim of the study is to investigate the effect of preoperative epidural dexmedetomidine compared to dexamethasone on postoperative pain control, analgesic consumption and oxydative stress response in patients undergoing thoracic surgery

the aim of the study is to investigate the effect of preoperative epidural dexmedetomidine compared to dexamethasone on postoperative pain control, analgesic consumption and oxydative stress response in patients undergoing thoracic surgery. investigation will include patients between 30-70 years undergoing thoracic surgery due to malignant process of lung or oesophagus. patients are divided in two groups: epidural administration of 0.375% ropivacaine with 1 mcg/kg dexmedetomidine (group 1) and epidural administration of 0.375% ropivacaine with 8 mg dexamethasone.

Eligibility criteria:
inclusion criteria: * patients undergoing thoracic surgery due to malignant process of lung or oesophagus asa (american society of anesthesiologists) status i-iii exclusion criteria: * neurological or psychiatric disease * corticosteroid therapy * anamnesis of myocardial infarct within last 6 months * severe aortic stenosis * kidney insufficiency * liver insufficiency * allergy * coagulation disorders
validation of ocular pain questionnaire: single-center, prospective observational study

Conditions: Ocular Pain; OSDI; OPAS

Summary: this study will be a single-center, observational, prospective validation study with survey and sample characteristics comparable to similar validation studies in the literature. pain represents a physiological response to the presence of tissue damage and is associated with numerous pathological conditions of the ocular surface. furthermore, in the presence of dysfunction of the nociceptive system, ocular pain can occur chronically with neuropathic features. pain quantification systems used to guide symptomatic therapy include the ocular surface disease index (osdi); the ocular pain assessment survey (opas); and the standardized patient evaluation of eye dryness (speed). the osdi assesses the presence of ocular symptoms, their impact on activities of daily living, and the presence of any aggravating factors. although it is used in clinical practice and research activities in a translated version, it has never been validated in italian. the opas studies in more detail the characteristics of pain and associated symptoms and their impact on the patient's overall quality of life. this instrument has neither been translated nor validated in an italian version. the failure to validate the osdi and opas questionnaires in the italian version marks the starting point for this validative study. the speed questionnaire, already translated and validated in italian, will be used as the gold standard and will allow comparison of the other instruments. finally, six questions regarding imaginary scenarios of pain experiences will be proposed to assess the individual threshold of nociceptive sensitivity taken from the pain sensitivity questionnaire (two for mild pain assessment, two for intermediate intensity stimuli, and two for intense pain situations). therefore, the primary objective of the study is to validate the italian version of the osdi and opas questionnaires while the secondary objective is to analyze the responses to the questionnaires by subgroups of general sensitivity to nociceptive stimuli.


Eligibility criteria:
inclusion criteria: * na exclusion criteria: * na

Keywords: ocular pain osdi opas questionnaire
rectal water-contrast transvaginal ultrasonography versus sonovaginography for the diagnosis of posterior deep pelvic endometriosis

Conditions: Endometriosis, Rectum; Endometriosis of Vagina; Endometriosis Rectovaginal Septum; Endometriosis Pelvic; Endometriosis of Colon; Endometriosis

Summary: as the surgical treatment of posterior deep endometriosis may be challenging for surgeons and carry significant risks for patients, preoperative assessment of the location, characteristics and presence of nodules of posterior deep endometriosis is important in order to inform the patient about the various treatment possibilities and to allow adequate counseling regarding treatment strategy. the aim of this study is to investigate the accuracy of rectal water-contrast transvaginal ultrasonography (rwc-tvs), and sonovaginography (svg) in patients with clinical suspicion of posterior deep endometriosis (die).


Eligibility criteria:
inclusion criteria: * clinical presentation suggestive of the presence of posterior deep infiltrating endometriosis exclusion criteria: * previous diagnosis of posterior deep infiltrating endometriosis by radiologic imaging (i.e. magnetic resonance, computed tomography) * previous surgical diagnosis of posterior deep infiltrating endometriosis

Keywords: rectosigmoid endometriosis; posterior pelvic deep endometriosis; vaginal endometriosis; rectovaginal endometriosis
evaluation of the efficacy of a homeopathic protocol in patients with non-metastatic breast cancer

Conditions: Breast Cancer Female; Joint Pain

Summary: interventional, randomised, prospective, monocentric study

interventional, randomised, prospective, monocentric study primary objective : demonstrate the interest of the homeopathic protocol to reduce the onset or aggravation of joint pain as a result of the taking of ai compared to conventional care secondary objective : compare between the two treatment groups: * evolution of joint pain * evolution of joint stiffness-rate of onset of pain and joint stiffness-delay in onset or aggravation of pain-evolution of the number of painful locations-evolution of the impact of pain on the quality of the sleep-consumption of permitted concomitant treatments (analgesics) * evolution of symptoms of hormonal deprivation-adherence to ai treatment * tolerance to ai * change seen by patients * stop rate and switch of ai-rate of recurrence of breast cancer describe in patients receiving homeopathic treatment: * adherence to homeopathic treatment * tolerance to homeopathic treatment * group a: group of patients receiving conventional treatment (drug analgesic class 1) for joint pain + homeopathic treatment * group b: group of patients receiving conventional treatment (drug analgesic class 1) for joint pain schedule : * inclusions start at: 01/09/2018 * end date of inclusions: 01/09/2021 * end date of follow-up: 23/03/2022 * study report: 23/03/2023

Eligibility criteria:
inclusion criteria: * menopausal patient * achieved histologically confirmed non-metastatic breast cancer with positive hormonal receptors * starting an adjuvant anti-hormonal treatment with an ai * patient benefiting from a social protection scheme * patient mastering the french language -signature of free and informed consent - exclusion criteria: * patient whose treatment with chemotherapy or radiotherapy is ongoing or anticipated during the theoretical period of the study or patient who has completed her chemotherapy treatment within a period of less than 4 weeks prior to the inclusion visit * patient with proven inflammatory rheumatism already diagnosed with rheumatoid arthritis, lupus, psoriatic rheumatism, ankylosing spondylitis -concomitant treatment with other complementary medicines (excepted vitamin d), unless the treatment has been stable for at least 1 month. * current treatment with narcotic drugs or corticosteroids * patient with overexpressing breast cancer her2