Kornimate/medical-research-clean huggingface dataset:
research on the effects of combined neurostimulation protocols on stress

Conditions: Stress Reaction; Stress Related Disorder; Major Depressive Disorder

Summary: the study examines the effects of the combined use of two different non-invasive brain stimulation (nibs) techniques targeting the dlpfc on stress reactivity and recovery.

transcranial direct current stimulation (tdcs) will be combined with intermittent theta burst stimulation (itbs) in order to maximize the effects coming from each of the techniques on their own. a group of 74 healthy participants wil be submitted to two different stimulation protocols (sham tdcs + active itbs and active tdcs + active itbs) with one-week in between and results on stress reactivity will be examined. in order to improve therapeutic protocols, this study with healthy participants is a crucial first step in order to further conduct clinical studies with psychiatric samples.

Eligibility criteria:
inclusion criteria: - aged between 18-45 years old exclusion criteria: * the presence of psychiatric disorders * usage of psychotropic medication * any or cardiovascular neurological condition * personal or family history of epilepsy or other neurological disorders * unstable medical condition, as well as chronic pain conditions, (such as fibromyalgia) or increased blood pressure * eye disease(s) * current substance abuse * inner ear prosthesis * any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker) * any implanted metal device in the head region * metal objects or magnetic objects in the brain or around the head (only removable earrings \& piercing are allowed) * recent neurosurgical interventions * pregnancy * skin problems in the head region * recent fractures or wounds on the hand

Keywords: non-invasive brain stimulation intermittent theta burst stimulation (itbs) transcranial direct current stimulation (tdcs) dorsolateral prefrontal cortex stress reactivity stress-related disorders major depressive disorder
a prospective, randomized trialcomparing oral n-acetylcysteine and intravenous sodium bicarbonate

Conditions: Nephropathy

Summary: the purpose of this study is to compare the efficacy of oral n-acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy (cin) after cardiac catheterization.

it is thought that n-acetylcysteine may reduce the ability of generated oxygen free radicals to damage cells by scavenging them. n-acetylcysteine may also increase the biologic effects of nitric oxide by combining with nitric oxide to form s-nitrosothiol, a more stable form and potent vasodilator. it also increases the expression of nitric oxide synthesis and may improve blood flow. oxidants activate a signal-transduction cascade and molecular response that may initiate the cell-death pathway. these pathways seem to be sensitive to the redox state of the cell and are inhibited by n-acetylcysteine, which promotes pathways that lead to repair and survival whenever cells are under oxidant stress.

Eligibility criteria:
inclusion criteria: 19 years of age * baseline serum creatinine or * calculated creatinine * stable renal function * left ventricular ejection fraction * non-pregnant, non-lactating females (all women of childbearing potential must have a negative serum pregnancy test. no contraception will be required * able to sign informed consent exclusion criteria: * acute renal failure * history of kidney transplant * currently receiving n-acetylcysteine _ contraindication of hypersensitivity to n-acetylcysteine or sodium bicarbonate * left ventricular ejection fraction * pregnant, lactating females * allergy to contrast dye

Keywords: contrast induced nephropathy
pet-ct imaging using fdg-labeled human erythrocytes in breast cancer patient

Conditions: Breast Cancer; Breast Cancer, Female; Breast Cancer, Male; Breast Neoplasms

Summary: this is a single arm, phase 0 study to evaluate the safety and efficacy of pet-ct scans with fdg-labeled rbc in patients with breast cancer. cardiac ejection fraction can be calculated and monitored in breast cancer patients during chemotherapy using a fdg-rbc pet-ct scan. the purpose of this study is to determine if calculated cardiac ejection fraction shows high concordance with results from echocardiography.


Eligibility criteria:
inclusion criteria: * participants must have histologically confirmed breast cancer and be scheduled for neoadjuvant trastuzumab- or anthracycline-based chemotherapy. * age \>18 years. * eastern cooperative oncology group (ecog) performance status 0-1 (karnofsky \>60%). * must be able to complete an informed consent process. * must have normal organ and marrow function: leukocytes \>3,000/μl; absolute neutrophil count \>1,500/μl; platelets \>100,000/μl; total bilirubin within normal institutional limits; aspartate aminotransferase (ast)\[sgot\] / alanine aminotransferase (alt)\[sgpt\]: less than 2.5 x institutional upper limit of normal; creatinine within normal institutional limits - or - creatinine clearance\>60 ml/min/1.73 m\^2 for patients with creatinine level above institutional normal. * echocardiogram results should be of sufficiently suitable quality (adequate acoustic window access) to provide a reliable ejection fraction range calculation. the cardiac ejection fraction on the pre-treatment echocardiogram should be 50% or higher. * participants should be naïve to trastuzumab or anthracycline chemotherapy prior to enrollment. exclusion criteria: * prior history of invasive breast cancer and treatment with anthracycline chemotherapy. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to fdg. * known symptomatic coagulopathies, bleeding diathesis, hemoglobinopathies, or hemolytic anemia. * participants should have no clinically significant heart disease such as congestive heart failure. participants should not have other significant structural heart disease by echocardiogram, or cardiac dysrhythmia on standard of care electrocardiogram that may adversely affect the cardiac imaging results obtained with fdg-rbc pet-ct imaging. * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * women who are pregnant. * found to have a cardiac ejection fraction less than 50% on the pre-treatment echocardiogram.

Keywords: chemotherapy induced cardiotoxicity tumor blood perfusion
global fkrp registry

Conditions: LGMD2I; LGMDR9; Limb Girdle Muscular Dystrophy; Congenital Muscular Dystrophy; Muscle-Eye-Brain Disease; Walker-Warburg Syndrome; FKRP Gene Mutation

Summary: mutations in the fukutin related protein (fkrp) gene cause the condition limb girdle muscular dystrophy type r9 (lgmdr9) also known as lgmd2i, and the rarer conditions congenital muscular dystrophy (mdc1c), muscle eye brain disease (meb) and walker-warburg syndrome (wws). lgmdr9 is the most common fkrp-related condition, and is especially prevalent in northern europe. the aim is to facilitate a questionnaire based research study in order to better characterise and understand the disease globally. by maintaining a global registry this will help identify potential participants eligible for clinical trials in the future.

the global fkrp registry (https://www.fkrp-registry.org/) is an international registry for patients with an fkrp-related condition; no experimental intervention is involved. patients will receive information on the most up to date standards of care relating to their disease and may be invited to participate in relevant clinical trials. their data will be updated annually and stored indefinitely, or until they request their data to be removed. the data will be collected via an online form and will be stored on a secure server based in the united kingdom and looked after by the registry staff at newcastle university. data collected from patients will include demographic information, diagnosis, current condition, age of onset, medication, contractures, family history and results of genetic testing, if available. other optional questionnaires will focus on patients' pain and quality of life. further information collected from patients' doctors will include, heart and lung function, muscle strength, muscle and brain mri findings and genetics. the fkrp registry is funded by lgmd2i research fund and curelgmd2i. the primary objectives of the global fkrp registry are to: * accelerate and facilitate clinical trials by locating potential research subjects quickly and efficiently * facilitate in the planning of clinical trials * assist the neuromuscular community with the development of recommendations and standards of care * characterise and describe the fkrp population as a whole, enhancing the understanding of the prevalence throughout the world.

Eligibility criteria:
inclusion criteria: * all patients with a confirmed diagnosis of an fkrp-related condition are eligible for inclusion. diagnosis will be confirmed via genetic testing results. exclusion criteria: * there is no exclusion criteria for registration with this patient registry.

Keywords: lgmd2i lgmdr9 limb girdle muscular dystrophy congenital muscular dystrophy muscle-eye-brain disease walker-warburg syndrome fkrp gene mutation
oral alkali production and caries prevention in children (longitudinal)

Conditions: Dental Caries

Summary: the fact that dental caries remains a major public health problem mandates that oral-health researchers explore new strategies for assessment of caries risk, as well as for caries prevention and management. dental caries occurs when acids produced by bacterial glycolysis of dietary carbohydrates causes demineralization of the tooth enamel. a major focus of caries research has been on identifying and characterizing acid-generating bacteria and the mechanisms of acid resistance. the purpose of this study is to investigate over time the relationship between alkali production and caries.

this study will require a total of 6 study visits over a 2 to 3 year period. the first study visit will last about one hour. at this study visit, parent-administered questionnaires will be used to collect information on the following: (a) the participant's demographic background (age, gender, and race), (b) socio-economic status (parents' income and housing condition), (c) participant's oral health practice (feeding histories, diet habits, oral hygiene measures, and dental attendance), and (d) systemic diseases. during the study visit, the participant's complete medical and dental history will be obtained and reviewed, and a dental exam will be performed in order to determine participants' caries status, and intraoral pictures may be taken of participants' teeth. at this visit and remaining visits participants will not be allowed to brush or clean teeth using any type of oral hygiene procedures for 8 hours prior to the visit. saliva and plaque (the solf white-yellowish material on the tooth surface) will be collected at each visit. the investigator will use a small probe to measure the ph of the dental plaque that builds up on the teeth. the participant will be asked to dip one finger into a glass containing a buffer solution and the probe will be placed on the teeth from which plaque will be taken. plaque samples will be collected by gently scrapping the tooth using a sterile instrument. if the participant does not have enough plaque samples, they will be asked to return on the following day.

Eligibility criteria:
inclusion criteria: * age 2 to 7 years exclusion criteria: * treated with antibiotics within the past 3 months * taking any medication at the time of the study * uses orthodontic appliance, and * has performed oral hygiene procedures in the past 8 hour prior to the collection appointment.

Keywords: plaque saliva caries
clinical trial on pharmacokinetic and tolerability of ap701

Conditions: Pharmacokinetic; Tolerability; Safety

Summary: this study aims to investigate the uptake of ap701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

pharmacokinetic parameters and tolerability of ap701 is studied over 30 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.

Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent form 2. male in the age of 35 - 60 year at study start 3. body mass index of 18 to 30 kg/m2 4. non-smoker, no use of any tabaco products 5. good general health status (karnofsky score = 100) 6. current ecg without abnormal findings (i.a. qtcf \< 450 ms) 7. physical examination, medical history without exclusionary findings 8. pulse rate between 50 and 90 bpm 9. blood pressure between systolic 90 - 140 mmhg, diastolic 50 - 90 mmhg 10. lab values for liver function (alt, ast, ap, bilirubin total) within normal ranges 11. lab values for renal function (s-creatinine, egfr) within normal range 12. negative test result on hiv i, hiv ii, hepatitis b cell surface antigen, hepatitis c antibody 13. negative test result of urine screening for cannabis, alcohol, and substance abuse exclusion criteria: 1. medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure 2. use of cannabis products within the last 8 weeks 3. use of opioids 4. former or present dependency (e.g. to alcohol, medicinal products, drugs) 5. participation in another clinical trial within the last four weeks prior to study inclusion 6. present, former, or family history of mental illnesses such as severe de pression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder 7. acute severe somatic disease (e.g. gastrointestinal diseases, influenza) 8. body temperature ≥ 38 °c 9. present cardiovascular, respiratory, diabetic, or cancer disease 10. hepatitis or other liver and renal disease 11. other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial 12. indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation) 13. taking any pharmaceutical products (including any medication interacting with metabolism of thc, e.g. st. john's wort)

Keywords: cannabis cannabis based medicine thc tetrahydrocannbinol
investigation of the effect of cognitive behavioral approach-based psychoeducation

Conditions: Substance Use Disorders; Self Efficacy; Addiction

Summary: this study, which was planned to examine the effects of cognitive behavioral approach-based psychoeducation on addiction profiles, self-efficacy levels and addiction courses in patients with substance use disorders, was carried out as a randomized controlled experimental study.

it can be said that alcohol/substance nurses, by applying cognitive behavioral approach-based psychoeducation to patients with substance use disorders, can have a positive effect on reducing the severity of addiction, increasing their self-efficacy levels, and providing the care, education and counseling support that patients need. the aim of this study is to examine the effects of cognitive behavioral approach-based psychoeducation applied to patients with substance use disorder on addiction profiles, self-efficacy levels and addiction courses.

Eligibility criteria:
inclusion criteria: 1. to be diagnosed with "substance use disorder" according to the diagnostic and statistical manual of mental disorders-v, 2. to be over 18 years old, 3. volunteering to participate in the research. exclusion criteria: 1. other than substance use disorder, chronic, requiring ongoing help and care the presence of a medical illness, 2. being illiterate (the types of scales to be used must be self-report forms) because of).

Keywords: substance use disorder psychosocial intervention self efficacy psychiatric nursing
audit on anemia variation after major gynacological surgery

Conditions: Anemia

Summary: the study aims to increase our understanding of variability in adherence to anaemia management guidelines and to assess the impact of anaemia management in clinical care following major gynaecological surgery

anemia affects nearly a quarter of the world and is common in surgical patients with a third of patients presenting with preoperative anemia and three quarters of patients discharged from hospital with anemia. the world health organization defines anemia as an insufficient circulating red cell mass, with haemoglobin (hb) concentration of \< 130 g.l-1 for men and \< 120 g.l-1 for women . perioperative anemia is associated with increased postoperative complications and delayed patient recovery leading to increased post-operative morbidity and mortality. anaemia also leads to an increased use of allogeneic blood transfusions, which is an independent risk for poorer patient outcomes. postoperative anemia can be due to blood loss at operation or secondary to the inflammatory process associated with surgery, which causes an increase in hepcidin production resulting in functional iron deficiency and reduced red cell production. in recent years, there has been a significant increase in the use of intravenous iron therapy for preoperative anemia in line with major international guidelines

Eligibility criteria:
inclusion criteria: * age: adult, 18_60 years * procedure: a major gynecological surgery is defined as an operation with an incision into the abdominal cavity and anticipated duration of more than one hour. procedures performed using any surgical approach, including open and laparoscopic surgery are included. * urgency: patients undergoing planned (elective or expedited) or unplanned (emergency) surgery exclusion criteria: * procedures: surgery classified as minor operations such as; diagnostic laparoscopy (emergency or elective), d\&c. * indication: palliative procedures as determined pre-operatively and explicitly stated in the medical record or consent form. * return to theatre: each patient should only be included in the study once. patients returning to theatre due to complications following earlier surgery
study of amiodarone given before lung surgery to prevent atrial fibrillation after lung resection

Conditions: Atrial Fibrillation; Lung Cancer

Summary: atrial fibrillation is a very common complication of pulmonary resection. patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. we propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. we plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

atrial fibrillation is a very common complication of pulmonary resection. patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. we propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. we plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Eligibility criteria:
inclusion criteria: * resectable lung nodule or mass exclusion criteria: * allergy to amiodarone * currently taking amiodarone * documented atrial fibrillation within past 12 months * known pulmonary fibrosis * known hepatic dysfunction * thyroid disease * 2nd or 3rd degree heart block * severe sa node disease * bradycardia-induced syncope * pregnancy

Keywords: atrial fibrillation lung cancer pulmonary resection post-operative complications
low dose spinal anesthesia in cesarean surgery

Conditions: Maternal Hypotension; Anesthesia

Summary: anesthesia for cesarean section requires special importance because it may affect both mother and the baby. to avoid maternal hypotension related to spinal anesthesia must be the primary objective during anesthesia. even though many factors influence sensory nerve block for surgical anesthesia, local anesthetic dose is the main determinant. another factor that influence the sensory nerve block is the obesity related to pregnancy. due to the enlargement of epidural venous plexus related to pregnancy, the subarachnoid and epidural space reduces, so the local anesthetic requirement also reduces. many investigators recommend lower dose of local anesthetic in obese patients due to reduced requirement there are many studies about dose regimens for cesarean anesthesia, but ideal dose have not been found. investigators have designed this study to see the effects of conventional dose (10 mg bupivacaine) vs. low dose plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and normal weight pregnant for cesarean section. the hypothesis was: the low dose regimen provides surgical anesthesia in obese patients while avoiding maternal hypotension.


Eligibility criteria:
inclusion criteria: * pregnant patients exclusion criteria: * spinal anesthesia contraindications, thrombocytopenia, coagulation defects, cardiomyopathy, placenta previa, twin pregnancy, hypersensitivity to amide local anesthetics or fentanyl, infection at the injection site, neurologic disease.

Keywords: spinal anesthesia cesarean maternal hypotension
copeptin and hfabp in cardiac surgery

Conditions: Coronary Artery Disease; Valvular Heart Disease

Summary: in-hospital mortality after cardiac surgery ranges from 2-6%. many patients suffer from major adverse cardiovascular events (mace) which results in impaired disability-free survival. troponin plays the central role in identifying mace. however, interpretation after cardiac surgery is difficult due to ischemia-reperfusion-injury and direct surgical trauma. while the 4th universal definition of type 5 myocardial infarction uses the 10 x uln as cut-off, \>90% of patients after on-pump procedures exceed this cut-off. clinical consequences are unclear. the dynamic of copeptin and heart-type fatty acid binding protein (h-fabp) concentrations starts very early, i.e. several hours before troponin. the investigators plan a prospective multicenter cohort study to evaluate 1) the independent association between copeptin and h-fabp with disability -free survival and mace after cardiac surgery; 2) the predictive gain of their addition to the euroscore ii; 3) the independent association between h-fabp and acute kidney injury.

the initial patient visit will take place after screening of patients and eligibility assessment and no later than on the day before surgery (day -1). after provision of patient information and written informed consent, baseline data will be extracted from clinical source documents. blood will be sampled prior to induction (troponin), upon arrival in the intensive care unit (troponin, hfabp and copeptin), and on postoperative day 1 and 2 (troponin). sampling will occur as far as possible concurrently to clinically indicated blood samples. blood samples will be analyzed in a certified laboratory. all patients will be contacted after 30 days and 12 months by e-mail, postal mail and/or phone call to obtain for the 12-item whodas 2 and information on potential events.

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years of age) * elective surgery * on-pump cardiac surgery (cabg and/or valvular surgery) exclusion criteria: * heart transplantation (htx) * acs at presentation (\< 14 days) * emergency surgery * preoperative inotropic or mechanical circulatory support * left or right ventricular assist device implantation * unwilling or unable to provide consent * inability to follow the procedures of the study, e.g. due to language barriers, psychiatric disorders, dementia