Kornimate/medical-research-clean huggingface dataset:
bioequivalence trial of alprazolam 0.25 mg tablets

Conditions: Anxiety Disorders

Summary: the objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. test product was zamoprax® 0.25 mg (glaxosmithkline) and reference product tafil® 0.25 mg (pharmacia \& upjohn). one tablet was the single dosage. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. the population was composed of 28 healthy volunteers, both genders, adults between 18-50 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: * free will participation according to mexican regulation, helsinki declaration, and good clinical practice. * healthy, between 18 and 50 years. * body mass index between 18 and 27.5 * in good health by complete medical history and laboratory tests. * blood pressure 130-90/ 90-60 mm hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute. * laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, hepatitis b and c antigens, hiv, urinalysis, anti-doping, pregnancy, electrocardiogram exclusion criteria: * alteration of vital signs * not complying with inclusion criteria * history of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. those suffering from muscular trauma 21 days before the beginning of the study. * requirement of any kind of medication during the course of the study, except study medication. * history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. * exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning. * administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study. * hospitalization for any cause in the seven months before the beginning of the study. * administration of investigational drugs in the 60 days before the study. * allergy to any medication, food, or substance. * alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study. * blood donation or loss =\> 450 ml in the 60 days before the beginning of the study. * history of drug or alcohol abuse. * special diet requirement, for instance vegetarian diet. * inability to understand nature, aims, and possible consequences of the study. * non-cooperative attitude during the study. * positive anti-doping or pregnancy test. * breast-feeding. * females on hormonal treatment.

Keywords: mexico bioequivalence alprazolam pharmacokinetics
impact of increased protein density diet to muscle mass and strength among mid-aged and older adults

Conditions: Muscle Loss; Muscle Weakness; Fragility

Summary: the subjects of this intervention program are mainly based on community-dwelling mid-aged and older adults. the investigator's program will provide meals containing different proportionated protein.as this project is a double blind test, only the investigators will know which subject corresponding to specific group of diets. besides, the investigators use the valued-based healthcare standard set as well as the center for epidemiological studies-depression, charlson's comorbidity index montreal cognitive assesment ,and mini nutritional assessment as outcome measures and to use the randomized controlled trial design to validate if increased protein density diet could improve the vitality and health of mid-aged and old adults .

with aging, functions of every organs become to decline. muscle mass, is one of the decline. according to previous research, adults would lose 40% among from aged 20 to 70. if muscle mass decline combining with the decline of muscle strength is so called sarcopenia.when muscle mass decline, infectious risk gets higher, and resilience after illness gets lower. in addition, activity and life quality are also responsible for falling, cognitive difficulty, disability and mortality among seniors. we hope to find out the etiologies of sarcopenia through this program and develop prevention strategy and model to mollify the the negative effect of rapid aging society.

Eligibility criteria:
inclusion criteria: * people who aged 40-75 years * patients with following characteristics: * feeling loss in activity * detecting decline in self's walking speed. * feeling tired of doing everything. * having fell in last year. * people can accept undergoing mri * people willing to follow the program and cooperate with us for following tracking. * people who are neither vegan nor vegetarian * people agree and be able to sign the informed consent. exclusion criteria: * people cannot intake provided meals (e.g.: vegans or vegetarians) or any other who is allergic to our diets. * people with any disease affecting their limbs, including: * having fracture on limbs in the past 6 months * having severe arthritis in the past 6 months * any other whom pi recognized as weak control of their nervous system( e.g.: parkinson's disease and stroke). * people with intermittent limp caused by peripheral artery diseases * people with weak control of mental disorder * people with weak control of cardiopulmonary disease * people with weak control of malignant tumor * people with weak control of kidney diseases (egfr \<60ml/min/1.73) * people with visual impairment and hearing disorder which cannot help to complete the program. * people who are unable to undertake mri * people who have underwent hormone treatment and planned to undergo hormone treatment during program session. * any other condition that pi recognized as not suitable
fascial closure techniques post-operative pain laparoscopy

Conditions: Post-operative Pain; Fascial Closure

Summary: this study compares post-operative incisional pain on post-operative days 1 and 7 who will undergo gynecologic laparoscopic operations. half of participants will undergo conventional fascial closure, while the other will undergo fascial closure by berci fascial closure (karl storz, belgium).

studies have demonstrated that laparoscopic surgery has numerous advantages over laparotomy. the patients who undergo laparoscopic surgery acquired fewer doses of analgesics than who undergo laparotomy. this point is also one of the advantages of the laparoscopic surgery. the fascia closure in fascial defects larger than 10 mm diameters in laparoscopic surgery is an important issue. incisional hernias may occur after laparoscopic surgery. the surgeons prefer the techniques in fascial closure which is more safe and cause less pain. in current study, investigators aim to compare the post-operative incisional pain in two different techniques in gynecologic laparoscopic surgery; conventional versus by 'berci fascial closure'.

Eligibility criteria:
inclusion criteria: 1. aged 18-65 years 2. ability to understand the inform consent 3. no conversion from laparoscopy to laparotomy exclusion criteria: 1. no-ability to understand the inform consent 2. conversion to laparotomy from laparoscopy

Keywords: fascial closure device laparoscopic surgery postoperative pain
baby-cino: caffeine treatment optimisation in premature infants

Conditions: Infant,Premature; Caffeine

Summary: this study investigates how brain activity and breathing changes in premature babies when their dose of caffeine treatment is changed or stopped. the study will assess premature babies receiving caffeine treatment as part of their clinical care. brain activity will be recorded just before caffeine dose is changed and again two days afterwards. breathing and other 'vital signs' (breathing rate, heart rate, oxygen saturation) will be recorded from the baby's monitor between the recordings of brain activity and for up to two weeks afterwards.


Eligibility criteria:
inclusion criteria: * born to a mother aged 16 or over * admitted to the newborn care unit, john radcliffe hospital * born prematurely (before 37 weeks' gestation) * parent given informed written consent * receiving caffeine citrate exclusion criteria: * known chromosomal abnormality or life-threatening congenital abnormality * severe hypoxic insult at birth * intraventricular haemorrhage grade iii or iv or other severe neurological pathology
a phase ii study of t-dxd plus srt in her2-positive breast cancer brain metastases

Conditions: Breast Cancer; Brain Metastases; Radiotherapy

Summary: this research study will evaluate the efficacy and safety of stereotactic radiotherapy (srt) combined with trastuzumab-deruxtecan (t-dxd; ds-8201a) in her2-positive breast cancer patients with newly diagnosed or progressing brain metastases.


Eligibility criteria:
inclusion criteria: * pathologically confirmed her2 positive advanced breast cancer * age\>18 years. * brain metastases confirmed by enhanced brain mri. metastases number less than 15. * kps≥70 or kps ≥60 with neurologic symptoms caused by bm * life expectancy of more than 6 months * prior therapy of oral dexamethasone not exceeding 16mg/d * time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1. * screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration): 1. absolute neutrophil count (anc) ≥ 1.5 x 109/l, platelets≥ 90 x 109/l, hemoglobin ≥ 90 g/l 2. aspartate aminotransferase/alanine aminotransferase (ast/alt) ≤2.5 x uln without liver metastasis,≤ 5 x uln with liver metastases 3. serum bun and creatinine ≤ 1.5 x upper limit of normal (uln) 4. lvef ≥ 50% 5. qtcf \< 480 ms 6. inr≤1.5×uln，aptt≤1.5×uln * signed the informed consent form prior to patient entry exclusion criteria: * leptomeningeal or hemorrhagic metastases * uncontrolled epilepsy * severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including hiv positive, active hbv/hcv or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc. * history of allergy to treatment regimens * pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures. * inability to complete enhanced mri * not suitable for inclusion for specific reasons judged by sponsor
cdss of traditional chinese medicine intervention for dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: this project is based on artificial intelligence (ai) algorithms to screen the effective methods of traditional chinese medicine intervention for dry eye and its applicable conditions, and optimize the traditional chinese medicine intervention plan for dry eye through the evaluation of evidence-based medicine and expert consensus, and construct the clinical decision support system of traditional chinese medicine intervention for dry eye, secondly, a real-world prospective cohort study design is adopted, the cdss system is used in the ophthalmology clinic, and its practical application effect on patients with dry eye is evaluated.

dry eye is a common disease that affects tears and ocular surface. it can cause ocular surface discomfort, visual impairment and even blindness, affect the quality of life of patients and cause social and psychological harm. interventions related to traditional chinese medicine can effectively alleviate the clinical symptoms and signs of patients with dry eye, and are an indispensable part of the treatment of dry eye. however, at present, patients with dry eye are mainly diagnosed at the western medicine ophthalmology clinic. due to the lack of knowledge of chinese medicine by western medicine ophthalmologists, they are unable to provide patients with good guidance on chinese medicine intervention measures, which may cause patients to miss chinese medicine-related treatments. this project provides doctors of western medicine with a clinical decision support system (cdss) of chinese medicine interventions for dry eye syndrome, so as to improve doctors' guidance and decision-making of chinese medicine for patients. this project is based on artificial intelligence (ai) algorithms to screen the effective methods of traditional chinese medicine intervention for dry eye and its applicable conditions, and optimize the traditional chinese medicine intervention plan for dry eye through the evaluation of evidence-based medicine and expert consensus, and construct the clinical decision support system of traditional chinese medicine intervention for dry eye, secondly, a real-world prospective cohort study design is adopted, the cdss system is used in the ophthalmology clinic, and its practical application effect on patients with dry eye is evaluated.

Eligibility criteria:
inclusion criteria: 1. ages 18 to 80 year-old. 2. meet the diagnostic criteria for dry eye, including ocular surface symptoms and signs. exclusion criteria: 1. there are contradictions in diagnostic information, and the real condition of the disease is doubtful; 2. the absence of necessary observation indicators; 3. lack of necessary prognostic information; 4. the informed consent is not approved.
molecular mechanism identification in inherited arrhythmias and valvulopathies from induced pluripotent stem cells

Conditions: Inherited Arrhythmias and Valvulopathies

Summary: the recent developments of research on ips (induced pluripotent stem) cells lead to the establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with genetic and cellular characteristics of the donors. these cells represent a biological material more readily available to identify the pathophysiological mechanisms involved in the diseases of brs or ers patients, which will lead to the identification of genetic markers.


Eligibility criteria:
inclusion criteria: * patient with a family history of inherited arrhythmia or valvulopathy * age : 22-60 yo. * patient no confine to bed * male or female * written consent * patient affiliated to the french social security exclusion criteria: * pregnant woman * patient under 22 yo or adults under guardianship * indication against local anesthesia * anticoagulant treatment * absence or positivity of hiv, hbv, hcv serology

Keywords: ips fibroblast arrhythmias valvulopathies electrophysiology genetics
effect of korean red ginseng on women with cold hypersensitivity of hands and feet

Conditions: Cold Hypersensitivity

Summary: 1. objectives 1. to verify effect of korean red ginseng on cold hypersensitivity of hands and feet in women 2. to establish scientific evidence for the use of korean red ginseng by investigating changes of infrared thermography 2. hypothesis the hypothesis is that korean red ginseng will reduce cold hypersensitivity of hands and feet more effectively than placebo after 8 weeks administration of interventions- korean red ginseng or the placebo.

design * this trial is a randomized, double blind, placebo controlled trial with 80 patients. * the trial will be implemented at kyung hee university hospital at gangdong in seoul, korea. * participants will take korean red ginseng or placebo for 8 weeks and will be followed up during 4 weeks. * during the administration period, 6 capsules 2 times a day (1h after breakfast and dinner) of korean red ginseng or its placebo will be provided.

Eligibility criteria:
inclusion criteria: 1. female aged 16 to 60 years 2. women complaining cold hypersensitivity on hands and feet 3. thermal deviation between the palm and the upper arm is higher than 0.3℃ exclusion criteria: 1. skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography 2. alcohol abuse and alcoholic 3. history of cancer within 5 years 4. severe depression 5. hypertension and diabetes 6. pregnancy or breastfeeding 7. abnormal finding from blood test at screening visit 8. allergic to korean red ginseng 9. took herbal medicine or health functional food within a week participated another clinical trials within 3 months

Keywords: cold hypersensitivity korean red ginseng infrared thermography cold stress test distal-dorsal difference
brain fmrt in takotsubo cardiomyopathy

Conditions: Takotsubo Cardiomyopathy

Summary: certain cardiac and neurologic diseases influence each other via a still poorly understood "brain-heart axis". subarachnoidal bleedings are well known to cause ecg alterations resembling those of myocardial infarction, along with a reduction of systolic myocardial function ("neurogenic stunned myocardium"). alterations of the right insula region by a stroke or intracranial hemorrhage go along with a sympathetic activation (increased circulating catecholamine levels, tachycardia, arterial hypertension). in contrast, alterations of the left insula region often cause vagal reactions such as bradycardia, arterial hypotension. takotsubo cardiomyopathy (ttc) is a just recently recognised subform of heart attacks, often caused by psychological or physical stress (death of a beloved one, divorce, job loss, infection, preoperative state). in more than 90% of cases, ttc affects postmenopausal women. functional mrt enables imaging of activated brain regions, either without ("resting state") or with specific stimuli. the investigators speculate that there is a specific involvement of the insula region during ttc.


Eligibility criteria:
inclusion criteria: * postmenopausal females aged below 90 years * informed written consent * ttc or nstemi / stemi undergoing coronary angiography within 24 hours of symptom onset exclusion criteria: * delayed coronary angiography (\> 24 hours after symptom onset) * inability to perform rsfmrt within the first 72 hours after coronary angiography * inability to communicate in german language * contraindications for a mrt examination (including pacemaker, implantable cardioverter-defibrillator, mechanical heart valves, claustrophobia, severe adipositas) * drug addiction, under guardianship * inability to stick to the follow up examination
effects of nurse-counselling in the improvement of the type1 diabetes control in adolescents

Conditions: Type 1 Diabetes

Summary: the incidence of type 1 diabetes is increasing in france. a recent cross sectional study has shown that in france, only 15% of children and 26% of adults had hba1c\<7%. adolescents seem to need particularly a better metabolic control. working hypothesis: we hypothesized that a stricter control of glycaemia by nurse-counselling could probably improve metabolic control in adolescents with type 1 diabetes. objectives: to show that nurse-counselling may improve levels of patient satisfaction. methodology: the main criterion is the patient acceptance of diabetes measured by an analogical visual scale rated from 0 (i cope very well with my diabetes, i cope very badly with my diabetes) to 10 cm. the scale will be measured every quarter within 12 months follow-up. we wish to improve patient's appreciation by 10 mm, near to "i cope very well with my diabetes". this is a randomised parallel group study with 36 subjects in each group. during the follow-up, the "routine follow-up" group will continue its routine care. the "complementary follow-up" group will be called by nurses every 15 days and consult monthly. hba1c is the secondary criterion and will be measured every 3 months. the total study duration is 18 months including 6 months for the recruitment and 12 months for the patients follow-up


Eligibility criteria:
inclusion criteria: * patients aged 13 to 18 years with a type1 diabetes diagnosed at least one year earlier, * hba1c rate \> 8 %. exclusion criteria: * hba1c \< 8 %; * patients participating in another study

Keywords: type1 diabetes; nurse-counselling; adolescent
task-dependent operation of a mechanism intracortical inhibition in dystonia

Conditions: Dystonia, Primary

Summary: cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (lici) can be studied by paired pulses transcranial magnetic stimulation (tms). some recent evidences suggest that lici may be one of the mechanisms by which the motor comment is adapted to the ongoing motor task with lici strength being dependent on task complexity. in writer cramp and musician cramp, two forms of dystonia, the cortical excitability is not correctly modulated in some complex gestures. the hypothesis is that this task dependent perturbation of excitability in writer cramp could be due to a lack of lici efficiency.


Eligibility criteria:
inclusion criteria: * patient with hand dystonia : writers cramp * subject affiliated to social security regimen. for healthy volunteers : * healthy volunteer without neurological disorders based on sensorimotor examination. * subject affiliated to social security regimen. exclusion criteria : * subject unable to receive informed consent (dementia). * contraindication to transcranial magnetic stimulation(tms) (epilepsia, intracranial metalic foreign object, hearing device, cochlear implant). * patient using a psychotrope treatment. * patient under guardianship or curatorship. * pregnant or nursing women. * patient with a cardiac stimulator. for healthy volunteers only : • abnormal neurological evaluation based on sensorimotor examination or neurological history ( epilepsy, stroke ; brain or spinal cord surgery ; history of neurological disease affective sensitive and motor control)
end-tidal carbon dioxide as a measure of carboxyhemoglobin in carbon monoxide poisoning

Conditions: Carbon Monoxide Exposure

Summary: the purpose of this study is to determine whether a relationship exists between etco2 and carboxyhemoglobin levels in carbon monoxide exposure. our hypothesis is that a liner relationship exists between etco2 and carboxyhemoglobin in carbon monoxide poisoning.


Eligibility criteria:
inclusion criteria: * carbon monoxide exposure exclusion criteria: * less than 18 years old * suicide attempt * unable to provide informed consent * pregnant

Keywords: carbon monoxide carboxyhemoglobin end-tidal carbon dioxide capnography