Kornimate/medical-research-clean huggingface dataset:
pre-emptive pregabalin on attenuating maternal anxiety and stress response to intubation during caesarean section

Conditions: Anxiety State; Sedation

Summary: there is exaggerated neuroendocrine stress response to laryngoscopy and endotracheal intubation during the induction to anesthesia-delivery (i-d) period under light anesthesia. mechanical stimulation of laryngeal proprioceptors elicits increased secretion of cortisol and catecholamine with subsequent elevation of blood pressure from 40 to 50 % and heart rate up to 20 % during direct laryngoscopy and endotracheal intubation

the sample size was calculated using open epi program assuming that the mean visual analogue scale anxiety score was 49.3±14.1 among oral pregabalin group and was 58.6± 14.4 among placebo group (8) so at power of study 80% confidence interval 95%, the sample size was calculated to be 74 cases (37in each group

Eligibility criteria:
inclusion criteria: * age: 21-38 years old. * pregnant female with a singleton fetus of at least 36 weeks of gestation. * american society of anesthesiologist physical status: 1\& ii. * body mass index (bmi) (25-30kg/m²). * type of operations: elective caesarean section under general anesthesia. * written informed consent from the parturient. exclusion criteria: * altered mental state. * women with known history of allergy to pregabalin. * women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, hepatic, renal, cardiovascular, respiratory disease and neuropsychiatric disorders. * patients receiving anticonvulsants, antidepressants. * pregnancy induced hypertension, intrauterine growth restriction or fetal compromise
the addition of sufentanil interscalene block in shoulder surgery

Conditions: Postoperative Pain; Shoulder Surgery

Summary: the purpose of this study is to compare the effects and side effects of interscale block performed with naropin 0.1% cum sufentanil or naropin 0.1% in shoulder surgery.

the purpose of this study is to compare the duration of postoperative analgesia and supplemental opioid consumption and side effects of interscale block performed with naropin 0.1% cum sufentanil or naropin 0.1% in shoulder surgery

Eligibility criteria:
inclusion criteria: * asa i-iii * age 18-80 * shoulder surgery performed under interscalene block and general anesthesia exclusion criteria: * contraindication of interscalene block * severe chronic obstructive lung disease * non-cooperative patient * intolerance to opioids * pregnancy * rheumatoid arthritis and diabetes with peripheral polyneuropathy * chronic pain or daily opioid intake
exercise enhances brain function in attention-deficit/hyperactivity disorder (adhd)

Conditions: Exercise; ADHD; Executive Dysfunction

Summary: the aim of the study was to investigate the different effects of exercise types on inhibitory control in children with attention-deficit/ hyperactivity disorder.

study inclusion criteria were as follows: (1) age between 8 and 12 years; (2) diagnosed with adhd by a pediatric psychiatrist; and (3) no history of brain injury or neurological conditions, such as exhibited epileptic seizures, serious head injuries, and periods of unconsciousness.

Eligibility criteria:
inclusion criteria: 1. aged between 7 and 12 years 2. diagnosed by a pediatric psychiatrist 3. no history of brain injury 4. no neurological conditions exclusion criteria: 1. less than 50% accuracy 2. failed to complete the task 3. cannot follow the instruction

Keywords: intensity exercise executive function adhd
glycemic metrics and patterns in people with and without prediabetes

Conditions: Pre Diabetes

Summary: the freestyle libre 3 continuous glucose monitoring (fsl3) system is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.

this is a non-pivotal, non-randomized, multi-center, prospective, non-significant risk to evaluate the glycemic profiles of people with and without a prediabetes diagnosis using continuous glucose monitoring. up to 2000 subjects will be enrolled in up to 20 sites. approximately 50% of evaluable subjects will have a prediabetes diagnosis.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age. * subject must be willing and able to provide written signed and dated informed consent. exclusion criteria: * subject has a diagnosis of type 1 diabetes, type 2 diabetes, or gestational diabetes. * subject is known to be currently practicing a low-carbohydrate or ketogenic diet at the time of enrollment. * subject is known to be pregnant at the time of enrollment. * subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin. * subject is currently on any form of treatment indicated for the treatment of diabetes. * subject is currently on any form of medication indicated for weight loss.
personalised antiplatelet therapy for patients with symptomatic peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: peripheral arterial disease (pad) is a condition where the blood vessels in the legs get blocked. it affects one out of every five adults over the age of 65. as it is the main cause of amputations, the nhs performs over 20,000 operations every year to prevent them. people with pad benefit from tablets to thin their blood as this improves outcomes after surgery and prevents heart attacks and strokes. the main tablets for this purpose are aspirin and clopidogrel. these work in most people, but up to a third of patients do not get any benefit from them, as their bodies cannot process them. we call this resistance to therapy (rt).because blood thinning is particularly important after operations people with rt may be at higher risk of their operation failing leading to amputation and/or problems such as heart attacks and strokes. testing for rt has not traditionally been performed because it requires complex laboratory procedures. recent development in technology now means that bedside tests are available for rt. we will use a simple beside test for rt in patients with severe pad. we will use this test to see how many of these patients have rt and whether this affects their risk of complications after an operation. if we find that rt does affect outcomes for patients with pad, the information obtained will be used to plan future research to determine if changing blood thinning therapy in people with cr improves their outcomes after surgery.

patients with peripheral arterial disease, a condition whereby arteries in the legs become narrow or blocked, are not only at a higher risk of limb loss but also of suffering heart attacks and strokes. to manage this risk and to ensure surgery for the blocked arteries is successful, they are prescribed tablets to make their blood less sticky, called antiplatelet agents. aspirin and clopidogrel are the two tablets most commonly prescribed for this purpose. in some patients, these two tablets are not effective as expected, because of interactions with other medications they are on or because their bodies cannot process them. this is known as resistance to antiplatelet therapy. the main aim of this study is to establish how common resistance to aspirin and clopidogrel is in patients with peripheral arterial disease.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 years. * patients with severely symptomatic aorto-iliac and infra-inguinal peripheral arterial disease. * patients with the ability to provide written informed consent. * patients on antiplatelet therapy exclusion criteria: * patients under the age of 18 years. * patients unable or unwilling to provide written informed consent. * patients with acute limb ischaemia of the lower limb. * patients with aneurysmal disease of the arteries of the lower limb. * patients with severe diabetic foot sepsis. * patients with a known history of clotting disorders * patients with inherited bleeding disorders
core study covid-19

Conditions: Coronavirus Infection (COVID-19)

Summary: this is a brazilian version of the clinical characterization protocol for serious emerging infections (isaric/who ). this is a standardized protocol for the rapid, coordinated clinical investigation of coronavirus disease (covid-19). patients with acute illness suspected to be caused by emerging will be enrolled. this protocol has been designed to enable data to be prospectively collected.

the study will be conducted at multiple sites (to be determined by the spread of disease and availability of resources). it is appreciated that settings will vary in terms of clinical infrastructure, resources and capacity. this study will enrol eligible patients (adults) with confirmed or suspected infection with a pathogen relevant to the study objectives. recruitment of patients with day 1 (enrolment) data and biological samples is the priority. observational analyses will be stratified according to available data. outcome data for primary and secondary objectives will be derived from data from routine clinical and laboratory assessments performed as part of standard inpatient medical management at the treating site, documented using proportionate case report forms (crf; either paper or web-based electronic 'ecrf'). clinical and laboratory data will be collected throughout the acute illness period according to local resources. priority at all times will be given to the collection of clinical information. research data will be integrated as much as possible with information available from hospital and regulatory files.

Eligibility criteria:
inclusion criteria: * suspected or proven coronavirus infection (covid-19) exclusion criteria: * confirmed diagnosis of a pathogen unrelated to the objectives of this study (or other non-infectious diagnosis) and no indication or likelihood of co-infection with a relevant pathogen.

Keywords: coronavirus
reducing pain and promoting neurodevelopment among preterm neonates

Conditions: Neonatal Disease; Neonatal Disorder

Summary: to determine the effects of multisensory stimulation and soft tissue therapy on procedural pain and neurodevelopment among neonates admitted to the nicu is the aim of the study. the study will be two groups randomized clinical trial of five days intervention program. the intervention will be given among two groups. group a will receive both multisensory stimulation and soft tissue therapy, group b will receive only regular hospital care. the pipp and n-pass will be used for assessing pain. the infanib and premie-neuro will be used for assessing neuromotor development among neonates. the outcomes will be taken before and after the fifth day of the intervention. multisensory stimulation and soft tissue therapy might help in reducing pain and promoting neurodevelopment.

this study will utilize two parallel groups, randomised design to analyze the effects of soft tissue therapy and multisensory stimulation on pain and neurodevelopment. 104 neonates admitted in nicu will be recruited through purposive sampling for the trial. procedural pain will be assessed with pipp and n-pass through recorded video. neurodevelopmental outcomes will be assessed with infanib scale and premie-neuro. the measurements will be taken after 24 hours of birth at the baseline and after the fifth day of the intervention. the treatment will be given into two groups i.e. group a (multisensory stimulation and soft tissue therapy group), group b (routine hospital care). mss will consist of auditory stimulation, tacto-kinesthetic stimulation, vestibular stimulation, visual stimulation, oral-stimulation, and olfactive stimulation. soft tissue therapy consisted of stroking, effleurage, skin rolling, and kneading techniques, will be given in 5 phases-forehead and face, back and neck, chest and abdomen, upper-lower limbs. total 30 min. of the treatment plan, per day, will be given to the neonates, after 30 min. of feed, for up to 5 days of nicu stay.

Eligibility criteria:
inclusion criteria * preterm between 30- 36 weeks of gestation * birth weight \>1000 g * not receiving analgesics/sedatives * apgar score ranged between 4-6 in 1 min. \& 7 to 9 in 5 min. * undergoing routine healthcare procedures in nicu exclusion criteria * preterm with surgery * preterm having unstable vitals * preterm with congenital malformations * preterm who require mechanical ventilation * having inborn errors of metabolism and also with seizures disorders,

Keywords: neonates pain
transcorneal electrical stimulation - multicenter safety study

Conditions: Retinitis Pigmentosa

Summary: the purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a dtl-like electrode in patients with rp.

this is a single-arm open label interventional safety trial with rp patients, who receive weekly tes for 6 months on 1 eye followed by observation for another 6 months without stimulation. the primary outcome measure is safety, indicated by the frequency and severity of adverse events.

Eligibility criteria:
inclusion criteria: * patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist * adult patients who are capable of giving consent, * visual acuity ≥ 0.02 * because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician) * the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol exclusion criteria: * diabetic retinopathy * neovascularisation of any origin * after arterial or venous occlusion * after retinal detachment * silicone oil tamponade * dry or exudative age-related macular degeneration * macular edema * all forms of glaucoma * any form of corneal degeneration that reduces visual acuity * systemic diseases that are difficult to control or manage, that could endanger the normal study schedule * patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic * forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia * simultaneous participation in another interventional study or history of interventions whose effect may still persist

Keywords: transcorneal electrostimulation
effectiveness of intravenous immunoglobulins (ivig) in toxic shock syndromes in children

Conditions: Staphylococcal Infection; Streptococcal Infection

Summary: ighn2 is an international, multicenter, double blind, randomized controlled trial aimed at assessing the efficacy on organ dysfunctions of intravenous immunoglobulins (ivig) treatment in the acute phase of streptococcal or staphylococcal toxic shock syndrome in children.


Eligibility criteria:
inclusion criteria: * child/adolescent: 1 month \< age \< 17 year-old, * admitted to picu with a strong suspicion of staphylococcal or streptococcal infection; at least one following criterion, with at least one following criteria: 1. toxic shock syndrom as defined by centre for disease control criteria 2. or group a streptococcus necrotizing fasciitis (positive streptest) 3. or varicella with infected lesions and rash or positive streptest 4. or erythrodermic rash in menstrual period 5. or pleuropneumonia with erythrodermic rash or positive streptest in pleural fluid 6. or erythrodermic rash and biological fluid positive to streptococcus a or staphylococcus (articular, pericardial, bronchopulmonary, pharynx) * with shock resistant to fluid resuscitation, defined as existence, despite 40 ml/kg of fluid bolus within 1 hour, of: 1. hypotension (\< 5th percentile) 2. or systolic blood pressure \< 2 sd regarding age 3. or need for vasoactive drugs in order to maintain blood pressure at a normal level (dopamine \> 5µg/kg/min or dobutamine, adrenaline, noradrenaline, milrinone whatever the dose) 4. or 2 signs of hypo perfusion among: 1. metabolic acidosis with base deficit \> 5 2. lactate x 2 normal laboratory value 3. diuresis \< 0,5 ml/kg/h 4. capillary refill time \> 5 sec 5. skin/central temperature difference \> 3°c * with informed consent signed by at least one parent before any procedures or treatments related to the study. exclusion criteria: * first signs of shock appeared more than 24h ago * known hypersensitivity to one of the components (study treatment or placebo , see below) * hypersensitivity to homologous immunoglobulins, specifically in very rare cases of ig a deficit, when the patient has anti-iga antibodies * known hyperprolinemia * immunodeficiency (acquired or not), * immunosuppressive drugs * no health cover
a study to evaluate the efficacy and safety of imsidolimab (anb019) in adults with generalized pustular psoriasis

Conditions: Generalized Pustular Psoriasis

Summary: the main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active gpp.


Eligibility criteria:
inclusion criteria: * diagnosis of active gpp * japanese dermatology association (jda) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on generalized pustular psoriasis physician's global assessment (gpppga) * must be candidates for systemic therapy or phototherapy exclusion criteria: * erythrodermic, guttate psoriasis, drug induced gpp * any other ongoing inflammatory disease that interfere with the investigator's ability to evaluate the subject's response to therapy * history of recurrent or chronic infection * ongoing use of psoriasis prohibited medication other protocol-defined inclusion/exclusion criteria may apply

Keywords: gpp
oral propionate to treat and prevent diabetes

Conditions: Diabetes Mellitus

Summary: the aim of these studies is to firstly determine the pharmacokinetic profile of orally administered enteric coated sodium propionate. subsequently, the most efficacious dose at improving glucose tolerance following an oral glucose challenge will be determined. the investigators will then determine the mechanism of action of propionate, whether it acts by altering beta cell function directly or by augmenting the incretin effect or both

the nhs spends £1m per hour, 10% of its yearly budget, treating diabetes. in the uk cases of diabetes are expected to top 4 million by 2025. there is an urgent need for new therapies. the short chain fatty acid propionate is a natural substance produced by digestion of fermentable carbohydrates. preclinical and early human data demonstrate it improves pancreatic function and glucose control. the investigators aim to conduct proof of principle studies to determine if oral delivery of propionate improves glucose control in patients at risk of developing diabetes.

Eligibility criteria:
inclusion criteria: study 1: healthy men and women aged between 18 and 70 years with bmi between 20-25 kg/m2 and with normal fasting blood glucose (below5.5mmol/l and hba1c less than 5.7% will be eligible to volunteer. study 2: as for study 1. study 3: cohort 1: volunteers aged between 30 to 70 with a bmi between 25-35 kg/m2 who do not have impaired fasting glucose and have hba1c below 5.7%. cohort 2: volunteers aged between 30 to 70 years with a bmi between 25-35 kg/m2 who have impaired fasting glucose (between 5.5-7mmol/l) and hba1c between 5.7% and 6.5%, * exclusion criteria:• type 1 or type 2 diabetes * gained or lost ≥ 3kg weight in the past three months * taken prescription medicines having an impact on metabolism, appetite regulation, glucose homeostasis and hormonal regulation * taken any dietary supplements in the last 6 months * any chronic illness * cardiovascular disease * excess alcohol intake * current smokers * any gastrointestinal disorder e.g. crohn's disease, coeliac disease or irritable bowel syndrome * a history of drug or alcohol abuse in the last 2 years * pregnancy (all women of child bearing age will undergo a pregnancy test). * pancreatitis * use of medications likely to interfere with glucose metabolism, appetite regulation, hormonal balance.

Keywords: diabetes mellitus propionate
lemborexant vs zopiclone vs clonidine for insomnia treatment in chronic pain patients

Conditions: Chronic Insomnia; Chronic Pain

Summary: prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. for insomnia treatment, each patient ingests prescribed doses of lemborexant or zopiclone or clonidine on alternate nights. each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. each patient completes the diary for 3 continuous weeks. pain is measured using the numeric pain rating scale. sleep score is measured using the likert sleep scale. a change in the pain or sleep scores by 2-points is considered significant.

objectives: chronic pain is usually associated with insomnia. the objective of this clinical study is to compare the safety and efficacy of lemborexant or zopiclone or clonidine; for the management of chronic insomnia in patients with chronic pain. methods: prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. for insomnia treatment, each patient ingests prescribed doses of lemborexant or zopiclone or clonidine on alternate nights. each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. each patient completes the diary for 3 continuous weeks. pain is measured using the numeric pain rating scale. sleep score is measured using the likert sleep scale. a change in the pain or sleep scores by 2-points is considered significant. data analyzed with ibm® spss® statistics 25 (ibm corp, armonk, ny); using student's t-test, anova, pearson chi-square test, and regression analysis. p-value \<0.05 is considered significant.

Eligibility criteria:
inclusion criteria: * adult chronic pain patients * good treatment compliance * severe chronic insomnia * failure of non-pharmacologic sleep therapy * regular zopiclone therapy for 3 months or more * regular sleep diary * regular pain diary * informed consent for diary review * consent for clinical record quality assurance review exclusion criteria: * obstructive sleep apnoea * body mass index (bmi) ≥40 * organ insufficiency * cognitive disorder * inability to provide consent * major neuropsychiatric disorder * unreliable diary * cannabis use * regular alcohol intake * stimulant use * substance abuse * poor treatment compliance * high dose opioid * gabapentinoid use * sedative use * mild insomina * irregular zopiclone intake * regular zopiclone therapy for less than 3 months * previous adverse/allergic reactions to clonidine or zopiclone

Keywords: sedative hypnotic