Kornimate/medical-research-clean huggingface dataset:
prothrombin time predicts steroid response in severe alcoholic hepatitis.

Conditions: Alcoholic Hepatitis

Summary: alcoholic hepatitis (ah) is the most severe form of acute alcohol-related liver disease. maddrey's discriminant function (mdf) \>32 defines the severe form of ah, which is associated with a high mortality. corticosteroid therapy (cs) represents the main medical treatment that may reduce short-term mortality. lille score at day 7 assesses the therapeutic response to steroid therapy. at present, no parameters able to predict the response to steroid therapy have been highlighted. the mdf depends mainly on prothrombin time (pt). aim of the present study was to evaluate if the pt value could predict the response to cs in severe ah (sah).


Eligibility criteria:
inclusion criteria: - clinical diagnosis of first episode of severe alcoholic hepatitis with maddrey's function score of 32 or higher, and the absence of contraindication to cs therapy (non-controlled infections/sepsis, hepatic encephalopathy, recent acute gastrointestinal bleeding, severe kidney dysfunction). the diagnosis of ah was based on the criteria of the national institute on alcohol abuse and alcoholism (niaaa)-funded alcoholic hepatitis consortia (crabb dw, 2016). in particular, were enrolled in the study patients with: heavy alcohol use for \>6 months, with an average consumption of more than 3 drinks (∼40 g) per day for women and 4 drinks (∼50-60 g) per day for men and with \ 1.5 with an ast level \> 45 iu/l (1.5 times upper limit of normal) and \ 3 mg/dl. exclusion criteria: * acute or chronic viral hepatitis, * nonalcoholic steatohepatitis, * cocaine use, * drug-induced liver injury, * fulminant wilsons disease, * hepatocellular carcinoma, * portal vein thrombosis, * biliary obstruction, * severe autoimmune liver disease, * neoplasms, * severe comorbidities.

Keywords: early liver transplantation alcohol cirrhosis corticosteroid therapy maddrey's discriminant function lille score prothrombin time alcohol use disorder steroid response
study of allogeneic bone marrow transplantation following cyclophosphamide and radiotherapy in patients with fanconi's anemia

Conditions: Fanconi's Anemia

Summary: objectives: i. determine the effectiveness of moderate dose cyclophosphamide and total lymphoid radiotherapy in terms of improving the survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with fanconi's aplastic anemia.

protocol outline: patients receive cyclophosphamide iv over 2 hours on day -6 through -3 and total lymphoid radiotherapy on day -1. patients undergo allogeneic bone marrow transplantation on day 0. patients are followed for at least 100 days.

Eligibility criteria:
* diagnosis of severe aplastic anemia with the typical phenotype of fanconi's anemia: short stature hypoplastic radii skin pigmentation renal anomalies chromosomal fragility * family history of fanconi's anemia * histocompatible related donor no evidence of excessive in vitro chromosome fragility typical of fanconi's anemia normal cbc and bone marrow

Keywords: fanconi's anemia aplastic anemia hematologic disorders rare disease
comparison of er:yag laser, co2 laser and scalpel excision of fibrous hyperplasia on the buccal mucosa

Conditions: Fibrous Hyperplasia on Oral Mucosa

Summary: the aim of the rct is to analyse clinical and histopathological particularities for excisional biopsies of fibrous hyperplasia in the buccal mucosa performed with er:yag laser, co2 laser and scalpel. the primary outcome parameter is to evaluate the thermal damage zone on the excised specimens. secondary parameters are time of surgery, intraoperative bleeding, the need for additional electrocoagulation or sutures and patient's postsurgical perception of pain, other postsurgical effects and use of analgesics.


Eligibility criteria:
inclusion criteria: * clinical tentative diagnosis of fibrous hyperplasia in the buccal mucosa * fibrous hyperplasia dimensions 0.5 to 2 cm * patient understands and reads the german language * written informed consent exclusion criteria: * untreated diabetes typ ii * severe infectious disease (hiv, hepatitis) * severe psychiatric disease * immunosuppressive therapy * anticoagulation * pregnancy; a pregnancy test (clearblue®) is performed in women of childbearing age

Keywords: co2 laser thermal damage zone er:yag laser
single ascending dose study of cti-1601 versus placebo in subjects with friedreich's ataxia

Conditions: Friedreich Ataxia

Summary: to evaluate the safety and tolerability of single ascending doses of cti-1601 in participants with friedreich's ataxia

single ascending dose (sad), double-blind, placebo controlled study. to evaluate the safety and tolerability of single ascending doses of cti-1601 in subjects with friedreich's ataxia. secondary objectives: 1. to evaluate the pharmacokinetics (pk) of cti-1601 following increasing single doses of subcutaneously (sc) administered cti-1601. 2. to evaluate the pharmacodynamics (pd) of cti-1601 following increasing single doses of sc administered cti-1601. cti-1601 or placebo - dose/mode of administration: single dose/subcutaneous

Eligibility criteria:
inclusion criteria: 1. subject has genetically confirmed friedreich's ataxia diagnosis, homozygous gaa repeat expansions, with repeat sizing (if available) included on diagnostic report. 2. subject is male or female, 18 years of age or older at screening. 3. subject must have a mfars_neuro score ≥ 20 and be able to traverse a distance of 25 feet with or without some assistive device (cane, walker, crutches, self-propelled wheelchair) and (a) be able to sit upright with thighs together and arms crossed without requiring support on more than two sides; (b) be able to transfer from bed to chair independently or with minimal assistance if, in the opinion of the investigator, the degree of physical disability does not result in undue risk to the subject while participating in the study; and (c) perform basic daily care, such as feeding themselves and personal hygiene, with minimal assistance. 4. subjects must weigh \> 40 kilograms (kg). exclusion criteria: 1. subjects who are confirmed as compound heterozygous (gaa repeat expansion on only one allele) for friedreich's ataxia. 2. subject requires use of amiodarone. 3. subject used erythropoietin, etravirine, or gamma interferon within 3 months prior to screening. 4. subject use of investigational drug (other than cti-1601) or device within 90 days prior to screening. 5. subject use of daily biotin supplementation that exceeds 30 mcg/day, either as part of a multivitamin or as a standalone supplement, within 7 days prior to study drug administration and/or throughout the entire study. 6. subject has clinically significant arrhythmia on electrocardiogram (ecg), or evidence of predisposition to significant ventricular arrhythmia on ecg, or evidence of active and unstable coronary artery disease. 7. male subject who has an ecg qtcf \> 450 milliseconds or female subject who has an ecg qtcf \> 470 milliseconds. 8. subject has a screening echocardiogram ejection fraction \<45 percent. 9. subject has a history of aspiration, aspiration pneumonia, or recurrent episodes of pneumonia (greater than or equal to 2 episodes of pneumonia) within the last 12 months. 10. subjects with known or suspected chronic use of cannabinoid products.
factors affecting perioperative outcomes

Conditions: Pelvic Organ Prolapse

Summary: the specific aim of this study is to determine if pre-existing depression and anxiety affect perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse. * hypothesis 1: patients with depression will have increased analgesic use and longer hospital stays postoperatively * hypothesis 2: patients with anxiety will have increased analgesic use and longer hospital stays postoperatively. a secondary aim is to characterize the incidence and severity of depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse.

objectives: the purpose of this study is to assess preoperative depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse and to determine if pre-existing depression and anxiety will affect perioperative outcomes in this patient population. methodology: patients from the university of oklahoma urogynecology clinics who have been scheduled to undergo surgery for pelvic organ prolapse will be invited to participate in this study. informed consent will be obtained prior to study enrollment. data obtained from a preoperative visit with each participant will include demographic information, medical and surgical histories, and a complete physical examination. after enrollment into the study, each participant will be started on a standardized dose of analgesics. the visual analog scale will be used to assess the level of pain at the surgical site and pain medications will be adjusted as necessary. information regarding their postoperative course will be tracked, including any complications, use of pain medications, and length of hospital stay.

Eligibility criteria:
inclusion criteria: * age at least 21 * scheduled to undergo surgery for the treatment of pelvic organ prolapse at the university of oklahoma health sciences center exclusion criteria: * age \< 21 * inability to complete the written questionnaires * undergoing concurrent procedures for condition other than pelvic organ prolapse

Keywords: depression anxiety pelvic organ prolapse pop
effect of touch methods in preterm infants during endotracheal aspiration

Conditions: Endotracheal Aspiration

Summary: the purpose of this study was to determine the effect of gentle human touch (ght) and yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.

background: preterm infants in the neonatal intensive care unit are exposed to various painful procedures, so different non-pharmacological pain control techniques are used to alleviate pain. aims: to determine the effect of gentle human touch (ght) and yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants. design: a randomized controlled crossover trial. setting: this study was conducted in the neonatal intensive care unit between july 2022 and june 2023. methods: thirty neonates were enrolled in this study based on inclusion criteria. the samples were randomly received a sequence of suctioning with yakson and ght and routine care. neonatal pain agitation and sedation scale and comfort neo were used to collect the data.

Eligibility criteria:
inclusion criteria: * infants in the 26-36/6 gestational week and at appropriate gestational age (aga) * infants undergoing ventilator support with an endotracheal tube exclusion criteria: * infants taking opiates and sedatives within four hours, having undergone a painful procedure at least one hour before * infants congenital anomalies, sepsis or haemorrhagic disease that might prevent yakson and ght * infants who underwent surgery and had a chest tube * infants with intracranial hemorrhage

Keywords: therapeutic touch pain preterm infant
physical exercise influence among overweight and obese pregnant women

Conditions: Obesity; Overweight

Summary: objective: to evaluate the association between physical exercise for obese or overweight women and the maternal, perinatal outcomes and perception of these women about their quality of life. methods: a randomized controlled clinical trial with 78 pregnant women. overweight or obese (bmi ≥ 26 kg / m²), gestational age between 14 and 24 weeks and from age 18 years were included. they will be divided into two random groups: one which will an exercise program under supervision and guidance received from home exercises (study group) and another that followed the standard routine prenatal care service (control group). both groups will receive standardized nutritional counseling by the department of nutrition and dietetics and a questionnaire measuring quality of life whoqol-short at 14 - 24 weeks and at 36 weeks of pregnancy. the intervention results will be analyzed by intention to treat. a p value less than 0.05 will be used to determine statistical significance.

objective: to evaluate the association between physical exercise for obese or overweight women and the maternal, perinatal outcomes and perception of these women about their quality of life. methods: a randomized controlled clinical trial with 78 pregnant women. overweight or obese (bmi ≥ 26 kg / m²), gestational age between 14 and 24 weeks and from age 18 years were included. they will be divided into two random groups: one which will an exercise program under supervision and guidance received from home exercises (study group) and another that followed the standard routine prenatal care service (control group). both groups will receive standardized nutritional counseling by the department of nutrition and dietetics and a questionnaire measuring quality of life whoqol-short at 14 - 24 weeks and at 36 weeks of pregnancy. the intervention results will be analyzed by intention to treat. a p value less than 0.05 will be used to determine statistical significance.

Eligibility criteria:
* overweight or obese (bmi ≥ 26 kg / m²), * gestational age between 14 and 24 weeks and from age 18 years * no contraindication for physical exercise on pregnancy

Keywords: pregnancy obesity physical exercise quality of life
drug use investigation for flolan (epoprostenol) injection 0.5mg・1.5mg

Conditions: Cardiovascular Disease

Summary: the objective of this study is to evaluate the incidence of adverse events in japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items; 1. unknown adverse reactions (especially, significant adverse reactions) 2. adverse reaction onset status under practical drug use conditions 3. factors possibly influential on safety 4. factors possibly influential on efficacy 5. patient's prognosis, efficacy and safety in long-term use


Eligibility criteria:
inclusion criteria: * subjects with cardiovascular disease exclusion criteria: * subjects with hypersensitivity to epoprostenol * subjects with right cardiac failure during an acute exacerbation * subjects with severe left ventricular systolic dysfunction * subjects with serious left ventricular dysfunction * subjects whose pulmonary edema getting worse during dose initiation
the safety and tolerability of gw805858 in healthy volunteers and mild asthmatics

Conditions: Asthma

Summary: this study will be the first time in human study (ftih) aiming to assess the safety and tolerability of gw805858 for both single and repeat dose. the study also aims to assess safety and tolerability in mild asthmatic subjects as well as healthy volunteers.


Eligibility criteria:
inclusion criteria: * men or women of non-child bearing potential, aged between 18 and 60 years of age inclusive. * body weight = 50 kg (110 lbs) for men and = 45 kg for women and body mass index (bmi) within the range 19.0-30.0 kg/m2 inclusive. * the subject is a current non-smoker who has not used any tobacco products in the last year. * a signed and dated written informed consent is obtained for the subject. * the subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions. * if asthmatic, the subject must be a clinically stable asthmatic. exclusion criteria: * the subject has a history of allergy to ingredients within the inhaler. * the subject has received an investigational drug or participated in any other research trial within 30 days, prior to the first dose of current study medication. * the subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including st john's wort) within 14 days prior to the first dose of study medication. * the subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female. * the subject has any history of breathing problems (e.g. history of asthmatic symptoms). * the subject is infected with the hepatitis b, hepatitis c, or hiv virus. * the subject has had a respiratory tract infection or worsening of asthma within 4 weeks of the start of the study. * the subject has a past or present disease, which as judged by the investigator, may affect the outcome of this study. * the subject has a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxia seizures. * the subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study. * the subject is unable to abstain from other drugs that may interfere with the conduct of the study. * the subject has ongoing rhinitis that requires treatment.

Keywords: gw805858 mdi asthma surfactant
a study of eloralintide (ly3841136) in chinese participants with obesity or overweight

Conditions: Obesity; Overweight

Summary: the purpose of this study is to evaluate how well eloralintide (ly3841136) is tolerated and what side effects may occur in overweight and obese chinese participants. the study drug will be administered subcutaneously (sc) (under the skin). blood tests will be performed to check how much eloralintide gets into the bloodstream and how long it takes the body to eliminate it. the study will last approximately 10 weeks excluding a screening period.


Eligibility criteria:
inclusion criteria: * chinese participants. to qualify as chinese, all 4 of the participant's biological grandparents must be of exclusive chinese descent and born in china * have had a stable body weight for 3 months prior to screening. participants with body weight change of less than 5% will be allowed * have not modified diet or adopted any nutritional lifestyle modification for 3 months before randomization * have clinical laboratory test results within a normal range for the population or investigative site at screening and lead-in, or results with acceptable deviations that are judged to be not clinically significant by the investigator * have a body mass index (bmi) within the range 27 to 40 kilogram per square meter (kg/m²) exclusion criteria: * are pregnant, or intend to become pregnant or to breastfeed during the study * have known allergies to related compounds of eloralintide * have any of the following abnormal blood pressure (bp) and/or pulse rate at screening, constituting a risk when taking the investigational product with minor deviations judged to be acceptable by the investigator: * supine bp \> 160/90 millimeter mercury (mmhg) * supine pulse rate \ 100 beats per minute (bpm) * orthostatic hypotension * have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs * regularly use known drugs of abuse and/or show positive findings on drug screening that are not consistent with the medical history or concomitant medication history * have donated blood of more than 450 ml within the previous 3 months of study screening, or intend to donate blood during the course of the study * have a history of chronic medical conditions involving the heart, liver, or kidneys * have a medical history or current evidence of clinically significant cardiac condition
the effect of simulation method on nursing students' burn patient care planning

Conditions: Patient Simulation; Burns

Summary: aim: this research was conducted as a single-blind randomized control group intervention trial to determine the effectiveness of simulation method performed using high-fidelity human patient simulator in nursing students' burn patient care planning.

materials and methods: the research was carried out with randomly-selected 61 students including 31 in intervention and 30 in control groups who took the surgical diseases nursing course in the spring term of the 2017-2018 academic year. the research data were collected using "personal information form", "cognitive level assessment test for burn patient care", "the student satisfaction and self-confidence in learning scale", "simulation design scale", "educational practices questionnaire", and "evaluation form for burn patient care plan". in the application process of the research, knowledge tests were administered as a pretest, second test, and posttest, and first and second applications of burn patient care plans were performed with all students. in the research, the application of burn patient scenario was performed only with the intervention group. descriptive statistics, chi-square, mann-whitney u test, and wilcoxon sign test were used to analyze the data.

Eligibility criteria:
inclusion criteria: * enrolled in the course * had not taken this course and any training on burn patient care before * accepted to participate in the research exclusion criteria: * have any records of absence * taken this course and training on burn patient care before * graduate of health vocational high school

Keywords: simulation nursing education burns nursing process
validation and standardisation of a "neuralix" digital ecological battery

Conditions: Traumatic Brain Injuries

Summary: the management of head trauma patients requires the assessment of cognitive disorders using standardized neuropsychological tests and questionnaires. however, the evaluation tools currently available present well-identified limitations limiting the accuracy of the measurements (in a non-exhaustive manner, let us cite for example the absence of control of the rate of "false positives" or even the impossibility of measuring the improvement or decline in performance over time). in order to overcome these limitations, the neuralix battery was created with particular attention to the assessment of memory and executive functions largely impacted after head trauma. the neuralix battery comes in the form of a digital application accessible online and allowing a global assessment of cognitive functions in adults. in addition, the processing of results includes the operationalization of decision criteria taking into account the limitations cited above in order to improve the sensitivity of the evaluation. the vanolix study proposes the validation of the neuralix cognitive battery with head trauma patients of moderate to severe intensity as well as its standardization with healthy volunteers, these two steps being essential to making the tool available to clinician-researchers.


Eligibility criteria:
inclusion criteria: * french-speaking subject aged 18 to 65 years old * signed consent to participate * history of head trauma of moderate to severe intensity, i.e. having presented the high risk criteria of the study by masters et al. (1987) at the time of the head trauma, and occurred a maximum of 5 years after inclusion in the vanolix study exclusion criteria: * visual or hearing or motor deficit disrupting the taking of cognitive tests * subject with insufficient knowledge of counting (up to 25), the alphabet, reading, or french writing * subject with a severe intellectual disability * subject with past psychiatric or behavioral disorders requiring a stay \>2 days in a specialized environment or requiring current treatment other than a single anxiolytic * current treatment with antidepressant * current treatment with antipsychotic or multiple anxiolytics * single anxiolytic treatment initiated or increased for less than 1 month or current antiepileptic treatment * subject with a neurological condition or a history leading to cerebral dysfunction likely to interfere with the cognitive assessment