Kornimate/medical-research-clean huggingface dataset:
balanced solution versus saline in intensive care study

Conditions: Critical Illness; Acute Kidney Injury

Summary: a 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically ill patients

pragmatic, multicenter, 2x2 factorial randomized study. severe patients admitted to the icu at moderate to high risk for death or acute kidney injury will be randomly allocated to receive a balanced crystalloid solution (plasma-lyte®) or 0.9% saline and to receive crystalloids by rapid bolus infusion (999 ml/h) or slow infusion (333 ml/h) whenever plasma expansion is needed.

Eligibility criteria:
inclusion criteria (all three): 1. need for plasma expansion, and the clinician considers that plasma-lyte® or 0.9% saline are equally appropriate for patients, with no specific indications or contraindications for any of the fluids or for rapid or slow infusion. 2. patients not expected to be discharged on the day after their admission. 3. at least one of the following risk factors for acute renal injury: 1. age ≥ 65 years 2. hypotension (mean arterial pressure \[map\] \< 65 mmhg or systolic blood pressure \[sbp\] \< 90 mmhg) or use of vasopressors 3. sepsis 4. use of invasive mechanical ventilation or of continuous noninvasive mechanical ventilation (including high-flow nasal cannula) \> 12 hours 5. oliguria (\< 0.5 ml/kg/hour for ≥ 3 hours) 6. serum creatinine ≥ 1.2 mg/dl for women or ≥ 1.4 mg/dl for men 7. liver cirrhosis or acute liver failure exclusion criteria (any of the below): 1. age \< 18 years 2. acute renal failure treated with renal replacement therapy (rrt) or expected to require rrt within the next 6 hours 3. severe hyponatremia (serum sodium ≤ 120 mmol/l) 4. severe hypernatremia (serum sodium ≥ 160 mmol/l) 5. death considered imminent and inevitable within 24 hours 6. patients with suspected or confirmed brain death 7. patients under exclusive palliative care 8. patients previously enrolled in the basics study
endometrial volume as a predictor of endometrial pathology in perimenopausal uterine bleeding endometrial volume as a predictor of endometrial pathology in perimenopausal uterine bleeding

Conditions: Endometrial Disorder

Summary: endometrial thickness has been used as an indicator of risk for endometrial hyperplasia and carcinoma in asymptomatic perimenopausal women. however, there is no cutoff value in perimenopausal women and the same thickness does not express the same endometrial volume in different endometrium because uterine lengths may be different and endometrial irregularities may exist. many studies assessed endometrial volume measured by three-dimensional (3d) tvs as a predictor of malignancy in women with postmenopausal bleeding. to our knowledge there is no study assess endometrial volume measured by two dimension tvs in prediction of endometrial pathology, however it is cheap and available than 3d tvs.


Eligibility criteria:
inclusion criteria: \*perimenopausal women with abnormal bleeding e.g. menorrhagia, metrorrhagia and polymenorrhea. exclusion criteria: \*general or local causes of bleeding, drug intake or recent hormonal contraception
focus of a running schedule and risk of running injuries

Conditions: Running Related Injuries

Summary: running is a natural part of human locomotion and humans have been running for million of years. in modern society, running has become a popular way of exercise and is undertaken by many people worldwide, possibly because it provides a cheap and easily accessible form of exercise, and the positive effects of running on health and fitness are well known. unfortunately, running is also associated with a high risk of injury. the purpose of this project is to investigate how a running schedule which focuses either on running distance or running speed influence the overall risk of injury and the types of injury sustained in recreational runners.

trails directed at investigating differences in injury risk in relation to the focus of the running schedule have been conducted without any firm conclusions. people engaged in recreational running or choosing running as a new and active lifestyle needs guidance on which running schedules minimize the injury risk, aiding their chance of an active lifestyle and possibly reversing the increase in people developing a lifestyle disease. to develop running schedules minimizing the risk of injury, an understanding of the mechanisms that the different training variables impose on the human body is necessary. the existing literature on running intensity and the development of injuries show conflicting result. more studies are necessary to ascertain if there is a relationship between the intensity of running. in such studies, it is important to include other training variables in the analysis and to quantify running exposure using an objective method of measuring the relative intensity and absolute volume.

Eligibility criteria:
inclusion criteria: * on average 1-3 weekly running sessions the past 6 months * owns a pair of running shoes * internet access and mail address * owns a garmin gps watch (pulse rate watch) or an iphone/android phone exclusion criteria: * previous injury in lower extremity within the past 6 months * unable to follow the running regime in 6 consecutive months * do not want to use gps (global positioning system) watch or android/smart phone to register training * unable to read or understand danish * deprecated by personal gp (general practitioner) to run due to former surgery or physical disease * mental condition that does not allow participation (e.g. externalizing behaviors, dementia) * pregnancy * participants with blood pressure above normal according to who guidelines will need to consult own gp (general practitioner) for approval

Keywords: overuse injury running related injury running pattern
post-stroke pathway: analysis and link with one year sequelae in a french cohort of stroke patients

Conditions: Stroke; Stroke Sequelae

Summary: the link between post-stroke pathways and patient sequelae have not yet been clearly defined. the main purpose is to identify the post-stroke life pathways components associated with sequalae at 3 months and 1 year after the acute stroke episode.

stroke is a serious health event, involving the entire health care system and generating considerable socioeconomic weight for society. knowledge of the components, the diversity and the scalability of post-stroke life pathways is currently not sufficient. moreover the link between post-stroke pathways and patient sequelae have not yet been clearly defined. the main purpose is to identify the post-stroke life pathways components associated with sequalae at 3 months and 1 year after the acute stroke episode. the secondary objectives are: 1) to define a typology of the life pathways of stroke patients, , 2) to analyze the social and geographical inequalities in the management of stroke, 4) to estimate the cost of the pathway elements of stroke management; 5) measure the sequelae of stroke patients at three months and one year after the acute episode. the design is a prospective multicenter cohort study with a follow up to 1 year after the acute episode, managed in several hospitals in the aquitaine region (france).

Eligibility criteria:
inclusion criteria: * patient being over 18 years of age living in metropolitan france; * patient with recent stroke (not before 2019) whose diagnosis confirmed by a neuro-vascular physician; * patient managed for stroke in one of the 13 participating hospitals of the aquitaine region; * patient giving consent to participate to papasépa; * patient to be alive at the end of the acute management hospital stay exclusion criteria: * patient refuse to participate to papasépa * patient died during the initial stay

Keywords: stroke pathways sequelae health services research
study to evaluate the pharmacokinetics and the safety of m518101 in plaque psoriasis patients

Conditions: Psoriasis

Summary: this study is to evaluate the pharmacokinetics and safety of m518101 in male and female plaque psoriasis patients.


Eligibility criteria:
inclusion criteria: * who are able and willing to give signed informed consent * who are male or females aged 18 years or older with plaque psoriasis confirmed by the investigator. * who have ≥20% of body surface area (bsa) afflicted with plaques * who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study. exclusion criteria: * who have a history of allergy to vitamin d3 derivative preparations or a history of relevant drug hypersensitivity. * bmi \> 32.0 kg/m2 * who are pregnant or lactating. * who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease. * who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests. * who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study. * whose serum calcium levels exceed the upper limit of reference range * who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization. * who have taken any durg with known effects on calcium metabolism within 30days of randomization * who have been treated with any drug with a known risk of qt prolongation within 30days of randomization.
telomeres parameters in cirrhosis

Conditions: Cirrhosis

Summary: there are several factors that influence telomere length in patients with cirrhosis, such as metabolic derangements and infectious etiologies, the aim of the study is to compare telomere length and other parameters related to genetic instability in telomere/ telomerase system, in peripheral blood lymphocytes in cirrhosis from different etiologies.


Eligibility criteria:
inclusion criteria: * cirrhotic patients from different etiologies exclusion criteria: * decompensated cirrhosis (child c) * age under 18 years * any known malignancy, including hepatocellular carcinoma * patient that are unable to sign for informed consent

Keywords: telomere telomerase cirrhosis
multicenter study on the correction of prolapse via laparoscopy

Conditions: Pelvic Floor Disorders

Summary: in the laparoscopic lateral suspension (lls) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

in the laparoscopic lateral suspension (lls) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

Eligibility criteria:
inclusion criteria: * patients with stage ii- iv primary or recurrent prolapse affecting the anterior or middle vaginal compartment with or without minimal posterior defect (stage i) according to the pop-q. exclusion criteria: * history of abdominal prolapse reconstructive surgery. * history of prolapse reconstructive surgery with vaginal meshes. * stage i according to the pop-q classification or asymptomatic prolapse. * medical contraindication for general anaesthesia. * patient preference for vaginal surgical treatment. * patient does not wish to participate in the study.
intravitreal bevacizumab for the treatment of central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: central serous chorioretinopathy (csc) has been known since it was first described by von graefe and termed "idiopathic detachment of the macula" in 1866, is a well-characterized disorder leading to serous neurosensory elevation of the central macula. the acute form of the disease is associated with focal leakage at the level of the retinal pigment epithelium (rpe) demonstrated with fluorescein angiography (fa). the disorder is self-limited in the majority of patients, who also regain excellent vision. occasionally, the neurosensory detachment persists and leads to pigment epithelial and photoreceptor damage with visual impairment. the purpose of this clinical study is report the use of intravitreal bevacizumab is a new option in the treatment of the chronic or recurrent csc.


Eligibility criteria:
inclusion criteria * any visual acuity. * central serous chorioretinopathy
evaluation of the protein intake of the pregnant woman according to the weight status and in pregnant women operated on bariatric surgery

Conditions: Pregnant Women From 20 Amenorrhea Weeks

Summary: adequate equipment for lifelong health is essential to ensure healthy health for fetal development. in france, pregnant women with normal weight have increased protein intake to 0.78-0.95g / kg / day (anc 2001). and more recently, afssa from 2007 proposed a recommended nutritional intake of 0.82-1g / kg / d. an increased requirements in the second and third trimester of 0.25 g / kg / day and 0.46 g / kg / day, respectively, compared with non-pregnancy values. however, the prevalence of the incompatibility remains unknown. in addition, maternal protein intake is inadequate or excessively associated with both intra-uterine growth retardation and small gestational age weights. neonatal hypotrophy is also associated with a risk of chronic diseases in adulthood, including cardiovascular disease, type 2 diabetes, insulin resistance, high blood pressure and coronary heart disease. in obese women or patients undergoing surgery for bariatric surgery, there is currently no recommendation on the recommended protein intake. or, maternal obesity plays a role in the metabolic development of children and bariatric surgery is associated with a major risk of maternal micronutrient deficiencies and intra-uterine growth retardation. prevalence of obesity in france is currently estimated at 17%. moreover, bariatric surgery is also fast-growing in france with a number of interventions having tripled since 2006. thus, a better understanding of maternal food needs and applications throughout pregnancy is needed to improve dietary guidelines and promote fetal, neonatal and long-term health.

the main objective is to evaluate the protein intake of the pregnant woman in the 3rd trimester of pregnancy in 3 populations: * women with bmi ≥ 18.5 and \<30 kg / m² (group 1) * obese women (bmi ≥ 30 kg / m²) (group 2) * women operated on a bariatric surgery (group 3)

Eligibility criteria:
inclusion criteria: * - pregnant women from 20 amenorrhea weeks. * women aged at least 18 years old. * women with bmi ≥ 18.5 and \<30 kg / m² = group 1 * obese women (bmi ≥ 30 kg / m²) = group 2 * women operated on a bariatric surgery (by-pass, sleeve-gastrectomy, gastric band) = group 3 exclusion criteria: * - women with bmi \<18.5 kg / m² * troubles of eating behavior * women with gestational diabetes * medical history of type 1 or type 2 diabetes * multiple pregnancy

Keywords: obesity protein pregnancy bariatric surgery
clinical and histological outcomes of allogenic amnion chorion membrane in the healing of free gingival graft donor site

Conditions: Palatal Wound

Summary: the purpose of this study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival graft (fgg).


Eligibility criteria:
inclusion criteria: * patients attending the clinic for graduate periodontics at the university of texas health science center at houston school of dentistry who are in need of a free gingival graft procedure to augment keratinized gingiva, augment ridge, or cover recession defects. * systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing. exclusion criteria: * size of the fgg that the patient needs bigger than the size of fggs that have to be harvested in this study (two 8mm (width) x 10mm (length) x ≈1.5mm (thickness) fgg). * current heavy smokers(\>10 cigarettes/day) (patients who stop smoking more than one year are eligible) * have diabetes or other systemic diseases that may comprise healing * take antibiotics and/or analgesics within one week before the procedure and have loss of sensation on the palate
sequential hypo- and normo-thermic perfusion to preserve extended criteria donor livers for transplantation

Conditions: Liver Transplantation

Summary: hypothermic machine perfusion (hmp) has been shown to be beneficial to preserve extended criteria donor (ecd) livers for transplantation. normothermic machine perfusion (nmp) had the same benefits and also the convenience on liver quality assessment. the investigators proposed to do sequential hmp (1-4 hours) and nmp (1-14 hours) on 18 ecd transplanted human livers by using an institutional-developed perfusion device for liver transplantation.

liver transplantation is a successful therapy on the patients with end-stage liver disease, however is limited by the shortage of donor organs. donor criteria were expanded in the past decades, however the extended criteria donor (ecd) livers may induce a higher risk of complications. static cold storage (scs) is the standard procedure for ex vivo liver preservation for about 4 decades, but has the limitation on preserving ecd livers and especially the inconvenience to evaluate liver quality prior to transplantation. hypothermic (4-8 celsius degree) machine perfusion (hmp) and normothermic (35-37 celsius degree) machine perfusion (nmp) have been shown to be beneficial to preserve extended criteria donor (ecd) livers respectively. nmp also had the convenience on liver quality assessment. the investigators had an institutional-developed device for liver nmp used on 25 patients with the fda's ide approval. in the present study the investigators are proposing to expand the use of the device on sequential hmp (1-4 hours) and nmp (1-14 hours) on 18 ecd transplanted human livers. this will be a single center prospective pilot study. the liver metabolism and hydrodynamics during perfusion will be recorded. the transplant procedure and post-transplant care will follow the clinical standard of care. the follow-up period is 12 months after transplantation. the primary end point will be the rate of patient survival and primary non function (pnf) within 30 days after transplantation, while the secondary end points will be: early allograft dysfunction (ead), 6 months patient and graft survival, peak liver function tests in the first 7 days after transplantation, surgical outcomes (operative time, transfusion requirement etc.), rate of post-transplant kidney failure, assessment of histological ischemia reperfusion (liver and bile duct), rate of vascular complications, rate of biliary complications, hospital and icu length of stay, rejection rate, infection rate, the ability to predict function based on "on-pump" viability markers, and the incidence of adverse effect (ae).

Eligibility criteria:
inclusion criteria: * patients undergoing liver transplantation * age 18 or older at the time of transplantation * willingness and ability to comply with the study procedures * signed informed consent form exclusion criteria: * recipient of partial grafts (split and living donors) * mentally or legally incapacitated subjects * inability to understand the procedures due to language barriers * multiorgan transplant
ono-2017 study japanese patients with primary generalized tonic clonic seizures.

Conditions: Epilepsy, Generalized

Summary: to investigate the efficacy and safety of ono-2017 in combination with antiepileptics in japanese epileptic patients with generalized tonic-clonic seizures.


Eligibility criteria:
inclusion criteria: 1. gender and age: japanese patients, regardless of gender, aged 12 years or older at the time of informed consent. 2. subject has a clinical diagnosis of primary generalized tonic-clonic (pgtc) seizures in the setting of idiopathic generalized epilepsy. 3. subject experiences at least 5 primary generalized tonic-clonic (pgtc) seizures in 12 weeks. 4. subject is currently receiving 1 to a maximum of 3 concomitant antiepileptic drugs(aeds) with fixed dosing regimens exclusion criteria: 1. subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment. 2. subject has seizure clusters where individual seizures cannot be counted orclassified. 3. history of non-epileptic or psychogenic seizures. 4. subject has a concomitant diagnosis of partial onset seizure(pos). 5. subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to stevens johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms(dress), drug-induced hypersensitivity syndrome(dihs)) or any drug-related rash requiring hospitalization.
home-based fluid status monitoring in heart failure patients

Conditions: Heart Failure

Summary: this is a prospective, multi-center, single-arm study enrolling adult patients who have been hospitalized for heart failure and subsequently discharged. for the duration of study participation, patients will obtain daily at-home bioimpedance measurements. heart failure symptoms, medications, and re-hospitalizations will be tracked. additionally, quality of life questionnaires will be administered at the beginning and end of study participation.


Eligibility criteria:
inclusion criteria: 1. age 21 years or older 2. nyha class ii or iii at the time of study enrollment 3. undergoing discharge following hospitalization for acute heart failure 4. planned continued treatment for heart failure 5. patient is able to stand or sit upright for bioimpedance spectroscopy measurements 6. patient reports access to reliable wi-fi connection at home 7. patient reports adequate space for the sozo device at home 8. patient provides written informed consent and authorization to use and disclose health information, including willingness to comply with study procedures exclusion criteria: 1. patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator) 2. patient has a confirmed diagnosis of acute coronary syndrome during current admission 3. patient is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion 4. patient has a clinical condition that would not allow them to complete the study 5. patient has had surgical revascularization using saphenous vein grafting that may affect venous return 6. patient is pregnant or lactating 7. patient has nephrotic syndrome or nephrosis 8. patient has end-stage renal disease requiring chronic dialysis 9. patient has been diagnosed with lymphedema 10. patient has chronic liver failure or cirrhosis 11. patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days 12. patient has an amputation of a limb \[exception: amputation of digits may not affect bioimpedance spectroscopy measurements and will be permitted at the discretion of the study sponsor\] 13. patient has any other medical condition that, in the opinion of the investigator, will impair the subject's ability to complete study procedures or participate in the protocol