Kornimate/medical-research-clean huggingface dataset:
study of the approximate entropy of adrenocorticotropic hormone and cortisol secretion in patients with head injury

Conditions: Brain Injury; Craniocerebral Trauma

Summary: objectives: i. determine the randomness of adrenocorticotropic hormone (acth) and cortisol secretion using approximate entropy in patients who have sustained a head injury. ii. determine the correlation between randomness of acth and cortisol secretion and stages of sleep in these patients.

protocol outline: patients are stratified according to type of injury (closed head injury due to trauma vs vascular accidents). patients are admitted two times for overnight assessment. admission 1: patients receive cosyntropin iv. blood is drawn at 30 and 60 minutes after iv infusion. patients receive oral metyrapone before sleep. a sham sleep study is conducted through the night and patients' blood is drawn in the morning. admission 2: at least 2 weeks after admission 1, patients return for an overnight admission. starting in the evening, blood is drawn every 15 minutes for 12 hours. a sleep study is conducted through the night.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- patients who have sustained head injury closed head injury from trauma or vascular accidents like strokes and hemorrhages --prior/concurrent therapy-- endocrine therapy: no concurrent cortisol replacement other: no blood donation during and for 1 month after study --patient characteristics-- hematopoietic: hemoglobin normal other: * no hypopituitarism * no body mass index of 28 or greater * not pregnant or nursing * must have normal menstrual cycles * no severe mental impairment * must not require legal guardian

Keywords: brain injury neurologic and psychiatric disorders rare disease
effect of vitamin e fortified whey drink on nutritional, inflammatory and oxidative markers in hemodialysis patients

Conditions: Chronic Kidney Disease

Summary: the purpose of the study is to evaluate the effect of vitamin e fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients

the aim of this interventional study was to evaluate the effect of vitamin e fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients. 92 hemodialysis patients were selected for the study. inclusion criteria included: mean age of 17-65 years old; having mild, moderate or severe malnutrition based on the sga (subjective global assessment) assessment; being dialyzed at least 2 times a week for 3 months. exclusion criteria included: hospitalization in the last month; active infection; using immunosuppressant drugs or multi-vitamins; pregnancy. the ethics committee of shiraz university of medical sciences reviewed and approved the protocol of this study.informed consent were signed by all of them for participating in the study. weight and height of the patients were recorded for bmi (body mass index) calculation. then, all of the patients were assigned into 4 groups: 1. consumption of 220 milliliters of whey drink three times a week, 2. consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin e three times a week, 3. consumption of 400 milligrams of vitamin e three times a week, 4. control group: no intervention. patients were followed for 2 months. at the beginning and the end of the 2-month intervention period, 10 milliliters of blood were taken from all of the patients and nutritional status of the patients were assessed as the primary outcome. serum levels of malondialdehyde, c-reactive protein, albumin, transferrin and lipoproteins were also measured. sga, mis and sf-12 questionnaires were filled for all of the patients at the beginning and the end of the study.

Eligibility criteria:
inclusion criteria: * mean age of 17-65 years old; * having mild, moderate or severe malnutrition based on the sga (subjective global assessment) assessment; * be dialyzed at least 2 times a week for 3 months exclusion criteria: * hospitalization in the last month; * active infection; * using immunosuppressant drugs or multi-vitamins; * pregnancy, consuming whey or soy products

Keywords: whey protein malnutrition oxidative stress hemodialysis
longitudinal study of cortisol and pulmonary function

Conditions: Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease

Summary: to conduct a longitudinal study of the relationship between the rate of decline of pulmonary function and measurements of cortisol concentration and excretion in a sample of middle-aged and older men and their wives. the study tested the hypothesis that persons whose plasma cortisol concentrations were relatively low, albeit within the normal range, were predisposed to excessively rapid deterioration of pulmonary function during aging.

background: it was hoped that the study would provide important insights into the pathogenesis of chronic obstructive pulmonary disease with potential implications for prevention and early therapeutic intervention. design narrative: all subjects participating in the normative aging study were recruited for the study at the time of their next scheduled examination. twenty-four hour urinary excretion of free cortisol, morning serum cortisol concentration, and pre- and post-bronchodilator spirometric indices were measured. for the 700 subjects who were recruited during years one and two of the study, these measurements were repeated when subjects returned for their next triennial examination in years four and five of the study. respiratory illness and smoking questionnaire data, total and differential leukocyte counts, and methacholine inhalation challenge test data were also available at both time points. the specific aims of the study were to examine: (1) the cross-sectional relationship between level of pulmonary function and both morning serum cortisol concentration and 24-hour urinary free cortisol excretion; (2) the relationship between the rate of decline of pulmonary function during the follow-up interval and these measurements of cortisol concentration and excretion; (3) whether these relationships were modified by smoking history, blood total leukocyte count, methacholine airway responsiveness, or other characteristics; and (4) the stability over time of serum cortisol concentration and urinary cortisol excretion in this aging population. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
efficacy and safety of mometasone furoate for persistent asthma previously treated with low-dose inhaled glucocorticosteroids (ics) (study p06115)

Conditions: Asthma

Summary: mometasone furoate (mf) is a synthetic glucocorticosteroid that, when administered to asthma patients with a dry powder inhaler (asmanex® twisthaler®) at dosages of 100 to 400 mcg twice daily, has been shown to improve lung function, reduce symptoms of asthma, and reduce frequency and severity of exacerbations by reducing airway inflammation, with a relatively low potential to cause systemic side effects such as hypothalamic-pituitary-adrenal (hpa) axis suppression. an experimental formulation of mf 100 mcg delivered twice daily via a pressurized metered-dose inhaler (mdi) also has been shown to be effective in improving lung function of asthma patients as measured by forced expiratory volume in 1 second (fev1). this trial is designed to verify the effectiveness of twice daily mf mdi 100 mcg in treating asthma in adults and adolescents previously treated with low dosages of inhaled corticosteroids (ics), as measured by improvement in morning fev1 and time to first asthma exacerbation over 12 weeks of treatment.


Eligibility criteria:
inclusion criteria: * an adult or adolescent subject with a diagnosis of persistent asthma of \>=6 months duration may be selected for this study. * both subject (and/or parent/guardian, if appropriate) and investigator must agree that changing therapy is acceptable and poses no inherent risk. * subject must have been using a low daily maintenance dose of inhaled corticosteroids (ics), with or without added long-acting β2-agonist (laba), for \>=12 weeks prior to screening, and must have been on a stable regimen (daily dose unchanged) for at least the last 2 weeks of that period. * at screening, the subject must have a prebronchodilator fev1 between 60% and 90% of the predicted value when restricted medications have been withheld. * to be randomized, the subjects must be symptomatic with fev1 at baseline must be between 50% and 85% of predicted. exclusion criteria: * a subject must not have been admitted to the hospital for management of airway obstruction within the last 3 months prior to screening, and must not have experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication, as judged by the clinical investigator at any time from screening to baseline/randomization. * in addition, a subject must not have demonstrated a decrease in absolute fev1 of \>20% at any time from screening to baseline, or a decrease in am peak expiratory flow (pef) below the pef stability limit on any 2 consecutive days prior to baseline/randomization.
adjunctive use of fute (flupentixol) in multi-acting receptor-targeted antipsychotics treated schizophrenia patients

Conditions: Schizophrenia; Psychosis; Metabolic Syndrome; Flupentixol; Antipsychotic Agents; Central Nervous System Diseases; Clinical Therapy; Olanzapine; Quetiapine

Summary: fute (flupentixol) combined with martas (multiple-acting receptor targeted antipsychotics) drugs has its clinical efficacy toward positive symptoms and might reduce the metabolic syndrome-related factors in patients. this study is the first clinical trial to explore the treatment of patients with flupentixol combined with martas. however, due to research limitations, the number of patients who participated in the clinical trial is small, and it depends on subsequent larger-scale clinical trials for more in-depth verification.

objectives the effects of adjunctive fute (flupentixol) with martas (multiple-acting receptor targeted antipsychotics) on the metabolic profiles of patients and clinical efficacy of treatment in schizophrenia. methodology it is expected to be admitted to patients with schizophrenia who are over 20 years old and are being treated with martas antipsychotics due to poor treatment efficacy or significant weight gain after use, poor blood sugar control, and other metabolic syndrome-related problems, but patients who do not meet the medication standards for diabetes or hyperlipidemia, and are willing to accept additional use of flupentixol after evaluation by the physician. to compare whether the original martas dose can be effectively reduced after additional use of flupentixol for at least 12 weeks, whether the symptoms of psychosis have improved, and whether the various factors of metabolic syndrome have improved. number of patients it is estimated that 30 subjects will be recruited to participate in this clinical trial. this report is an interim report with the results of 15 subjects. diagnosis and main criteria for inclusion patients suffering from schizophrenia who are over 20 years old and are using martas antipsychotics. test product, dose and mode of administration, batch number fute f.c. tablets (flupentixol), the clinically recommended dosage should be adjusted according to the individual conditions of the patients. generally speaking, a low dose should be administered at the beginning. then the dosage is increased according to the treatment response to achieve the appropriate curative effect as soon as possible. the maintenance dose is usually administered as a single dose in the morning, and the maintenance dose is usually 5-20 mg/day. the initial dose is 3-15 mg/day, divided into 2-3 administrations, and can be increased to 40 mg/day if necessary.

Eligibility criteria:
inclusion criteria: * patients who suffer from schizophrenia are over 20 years old and are using martas antipsychotics. exclusion criteria: * \>65y aged patients. * \>other non-schizophrenia disease.

Keywords: schizophrenia metabolic syndrome flupentixol olanzapine quetiapine central nervous system diseases clinical therapy antipsychotic agents
treatment of cantonese speakers with childhood apraxia of speech

Conditions: Childhood Apraxia of Speech

Summary: the proposed study aims to investigate the efficacy of the dynamic temporal and tactile cueing treatment in cantonese-english bilingual speakers with childhood apraxia of speech.

four ce children with cas will be recruited and receive two versions of the dttc treatment (i.e., dttc in english \[dttc-e\] and dttc in cantonese \[dttc-c\]). after the initial assessment and baseline probe sessions, all the participants will be randomly assigned to receive either dttc-e or dttc-c in the first 6-week treatment phase. then, the between-treatment probe sessions will be conducted during a 2-week washout period. this will be followed by the second 6-week treatment phase, which will be the other version of dttc. post-treatment probe sessions will be conducted one week and one month after completion of the second treatment. participants' speech productions will be transcribed and evaluated based on their accuracy in phonemes, stress, and tone. growth curve analysis (mirman, 2014) will be conducted to examine the group differences in the outcome measures across the treatment sessions.

Eligibility criteria:
inclusion criteria: * (1) 3;0 - 11;11 (years;months) years of age at treatment commencement; * (2) speak both cantonese and english: one caregiver one language for at least one year; speaking different languages at home versus school; and/or speak different languages at different times of day; * (3) no concomitant developmental disorders including autism spectrum disorder; * (4) no structural abnormalities that affect speech, such as cleft lip and/or palate; * (5) no uncorrected vision impairment; and * (6) no hearing loss; * (7) cas diagnosis confirmed by the research team based on the available diagnostic criteria in cantonese speakers, which will be described in the next section exclusion criteria: -
effects of vestibular habituation and ocular reflex exercises on vertigo

Conditions: Vertigo

Summary: the aim of this study is to determine the comparative effects of vestibular habituation and ocular reflex exercises on gait stability, dizziness severity, and fear of fall in elderly population with vertigo

vestibular habituation exercises focus on helping individual adapt to and reduce symptoms related to vestibular disorder such as improving balance , reducing dizziness and enhance overall functional abilities. ocular reflex exercises focus on improving eye movement control and coordination such as improving visual tracking , stability and focus. this randomized clinical trial will be conducted at services hospital and jinnah hospital for a duration of 10 months. the sample size will consist of 50 participants. 25 participants will be assigned to vestibular habituation exercise group and 25 to ocular reflex exercises group. data will be collected using these assessment tools, including the dynamic gait index for gait stability, the fall efficacy scale for fear of fall, and dizziness handicap inventory for dizziness severity. pre-intervention assessments will be conducted for all two groups. the effects of the interventions will be measured at baseline ,in the 3rd week ,post intervention, after 6 weeks, and at a 9th week follow up. data analysis will be performed by using spss 26 software

Eligibility criteria:
inclusion criteria: 1. both male and female patients 2. age 65-75 3. patient with vestibular disorder for at least 6 months 4. patient with unspecific dizziness sensation for at least 3 months 5. dizziness handicap inventory score \> 16 - exclusion criteria: 1. patient with central nervous system diseases, like stroke, multiple sclerosis, parkinson's disease. 2. orthopedic problems that precluded performance of the exercises 3. systemic diseases with no medication control 4. if patient were legally blind or had dementia 5. patient with no history of epilepsy and other neurological diseases -

Keywords: vertigo habituation ocular reflex fear of fall gait stability
safety and efficacy of bc lispram

Conditions: Type1 Diabetes Mellitus

Summary: this pilot study is a 50-hour randomized, open-label, crossover study in an inpatient setting assessing the safety, pharmacodynamics, pharmacokinetics, and closed-loop efficacy of i) bc lispram delivery and ii) rapid insulin delivery.

subjects will be randomized to intervention sequences. the first 6 participants will be randomly allocated to a sequence of three treatments composed of (i) treatment with active comparator insulin lispro, (ii) treatment with bc lispram, and (iii) treatment with bc lispram (dual wave bolus). the following 10 participants will be randomly allocated to a sequence of either two or three treatments. each treatment period will last 50 hours. pk/pd assessment will be performed under an open-loop system and will be followed by a 24 hour of closed-loop assessment.

Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of age. * clinical diagnosis of type 1 diabetes for at least 12 months. the diagnosis of type 1 diabetes is based on the investigator's judgment; c peptide level and antibody determinations are not needed. * insulin pump therapy for at least 3 months, with daily insulin needs ranging between 30 and 80 u. * most recent hba1c ≤ 9.5% (over the last two months). * effective birth control in female participants of childbearing potential. medically acceptable contraception methods include condom, pills, and intrauterine device. exclusion criteria: * current or ≤ 1 month use of other antihyperglycemic agents (sglt2, glp-1, metformin, acarbose, etc....). * current use of glucocorticoid medication. * use of medication that alters gastrointestinal motility. * planned or ongoing pregnancy. * breastfeeding individuals * severe hypoglycemic episode within one month of admission. * severe diabetic ketoacidosis episode within one month of admission. * clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. * recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. * known hypersensitivity to any of the study drugs or their excipients. * allergy to paracetamol (acetaminophen). * other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. * clinically abnormal significant values for haemato, biochemistry, or urinalysis screening test as judged by the principle investigator for underlying disease. * failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Keywords: pramlintide
the effect of a home-based orofacial exercise program on oral aperture of systemic sclerosis patients

Conditions: Microstomia; Systemic Sclerosis

Summary: systemic sclerosis is a systemic disease which may involve multiple organ systems and cause functional disabilities. microstomia is one of the most common complications of the disease which may result in difficulties performing oral self-care, complication in professional dental care and even malnutrition in the advanced cases. since the disease is rare and the studies are limited, there is still not an agreed upon orofacial exercise program to improve the oral aperture of the patients. therefore, we aimed to investigate the effect of a newly diseased home-based exercise program for improving microstomia in those patient population.

the study was designed as a single-blind, prospective, randomized controlled study with a 2-month follow-up period, carried out in rheumatology outpatient clinic, between march 2017 - january 2019. systemic sclerosis patients with an oral aperture of \<40mm were included in the study. patients were randomly divided into two groups. randomization was done as the sealed envelope method. after the informed consent was taken, the opaque envelope that the patient have chosen was opened and patients were offered the allocated treatment regimen. group 1 was given exercise regimen and oral hygiene care advices for the first one month; followed by no exercise but oral hygiene care advices for the next four weeks. group 2, as the control group, received oral hygiene care advices for the first one month, followed by the exercise regimen twice a day along with oral hygiene care advices for the next four weeks. oral care advices were given to every participant by a dentist involved in the study at their first visit. with this protocol, we aimed (a) to investigate whether there is a benefit of the exercise program on microstomia; (b) to observe the carryover effect of exercise therapy on microstomia after discontinuing the treatment over a period of time; (c) to estimate the intervention strategy by comparing the same medical approach with different sequences. the exercise program was demonstrated to patients by a clinician at the first visit and given to all patients printed as a manual to be done every day for one month duration of the exercise program. additionally, a diary was given to patients to mark when they have completed the exercise and to note in the case of pain on daily basis. the exercise regimen was developed on the basis of previous studies and clinical knowledge.

Eligibility criteria:
inclusion criteria: \* systemic sclerosis patients with an interincisal distance of \<40 mm exclusion criteria: * patients with missing teeth * dysfunction of temporo-mandibular joints * oral malignancy * recent dental procedures * multiple active digital ulcers * diagnosed psychiatric conditions

Keywords: exercise microstomia oral aperture rehabilitation systemic sclerosis
evaluation of the clinical efficacy of y-strut® medical device implanted for contralateral percutaneous internal fixation of proximal femur, in patient with a low energy per trochanteric fracture on the first side

Conditions: Fracture of Hip; Osteoporosis

Summary: hip50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with y-strut® device implanted on the contralateral proximal femur as percutaneous internal fixation to prevent contralateral hip fracture in case of osteoporosis. the primary objective of this study is to evaluate the clinical efficacy of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation. a total of 50 patients from france will be enrolled (until december 2020) and followed up to 24 months.


Eligibility criteria:
inclusion criteria: * patient of 60 years and older, according to ce indication; * patient with information form signed to participate in the study; * patients presenting a first low energy hip fracture on one side and having a y-strut® device implanted on the contralateral hip between 0 and 120 days after the treatment of the fracture of the first hip; exclusion criteria: * patient who refuse to participate to this study; * patient implanted with y-strut® for another indication; * patient already enrolled in a clinical study, excluding his participation to hip50.

Keywords: osteosynthesis prophylactic consolidation proximal femur
hiv/std safer sex skills groups for men in drug treatment programs - 1

Conditions: Behavior Therapy

Summary: the purpose of this study is to evaluate a five-session human immunodeficiency virus/acquired immune deficiency disease (hiv/aids) group therapy designed specifically for heterosexual men. this therapy is compared to standard hiv/aids education, which generally consists of a single session of hiv education.


Eligibility criteria:
all adult males age 18 and above in drug abuse treatment at participating community treatment providers will be invited to participate.

Keywords: behavioral intervention