Kornimate/medical-research-clean huggingface dataset:
assessment of factors influencing parents' attendance time during feeding time of premature infants born before 35 weeks of amenorrhea in besançon university hospital

Conditions: Premature Birth

Summary: the precise description of parental presence and the associated factors will make it possible to construct an intervention in order to correct potentially low parental participation. the demonstration of the effectiveness of such an intervention will be the subject of a larger study (phrip type). ultimately, the investigators want to personalize the daily support for parents to offer optimal support for parenting.

considering the importance of the bond of attachment, and in particular the emotional tuning between the adult and the premature baby and the particularly important interactions during feeding, it seemed essential to us to make an evaluation of the parental presence during the meals. , which sheds light on the factors influencing this presence. the presence time seems to vary depending on: the child's background, the profile of the parents, the profile of the child and environmental factors. knowing the factors influencing this presence is essential in order to understand the obstacles to the arrival of parents, to think as a team and to offer personalized support in order to allow them to be more present with their baby.

Eligibility criteria:
inclusion criteria: * premature newborn under 35 weeks of amenorrhea (as), hospitalized at besançon university hospital, * newborn baby whose parents: expressed their non-opposition to participate in the study, are affiliated to a social security scheme, are of age, express themselves easily in french. exclusion criteria: * newborn baby whose parents object to participating in the study, * newborns presenting severe malformative anomalies, or malformations of the oral sphere, * newborn baby whose transfer is scheduled before the end of hospitalization (excluding birthing pool at the chu de besançon).
efficacy and safety of alprostadil prevent contrast induced nephropathy

Conditions: Kidney Diseases; Diabetes Mellitus; Acute Kidney Injury; Kidney Failure, Chronic; Renal Insufficiency

Summary: the aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous alprostadil on the incidence of cin in a high-risk population of patients with both type 2 diabetes mellitus (t2dm) and ckd undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

the number of cardiac angiography and percutaneous coronary interventions (pci) has increased steadily in recent years. this has resulted in the increasing incidence of contrast-induced nephropathy (cin). major risk factors for cin include older age, diabetes mellitus (dm), chronic kidney disease (ckd). the aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous alprostadil on the incidence of cin in a high-risk population of patients with both type 2 diabetes mellitus (t2dm) and ckd undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Eligibility criteria:
inclusion criteria: * patient that underwent coronary angiography * t2dm * ckd stages 2 and 3, egfr 30 to 89ml/min per 1.73m2 * alprostadil naive, or not on alprostadil treatment for at least 14 days * withdrawal metformin or aminophylline for 48h before angiography exclusion criteria: * serum cr. more than 3 mg/dl * electrolyte and acid-base imbalance * pulmonary edema * allergy to alprostadil

Keywords: contrast induced nephropathy
effect of auto-bolus interval on analgesic quality during labor analgesia with dural puncture epidural

Conditions: Analgesia

Summary: it is aimed in this study to compare the effect of changing the interval time for programmed auto boluses of local anaesthetics on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.

this study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at atatürk university medical faculty hospital and after obtaining written consent from the participating patients. the study will include pregnant women aged 20 to 45 with american society of anesthesiologists (asa) ii classification, full-term, nulliparous and singleton pregnancies. using a randomisation procedure, the participants will be allocated into two equal groups: group i and group ii.

Eligibility criteria:
inclusion criteria: 1. healthy nulliparous women 2. american society of anaesthesiology score of ii 3. during active labor 4. at weeks 37-42. 5. singlet vertex presentation 6. cervical dilation \<5 cm at the request of labor analgesia 7. vas score \>40 exclusion criteria: 1. age \ 45, 2. morbid obesity 3. presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia) 4. history of drug abuse 5. contrindication for neuraxial blocks 6. conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries) 7. diagnosed fetal abnormalities 8. cases where dura gets punctured unintendedly with the epiduralneedle 9. cases where flow of cerebrospinal fluid (csf) is not observed after dural puncture 10. cases where a cesarean section is performed at any stage of labor 11. cases where labor is completed in 1 hour from the start of analgesia procedure. exclusion criteria: -
the effect of lixisenatide on the effect of pituitary hormones

Conditions: Healthy; Type 1 Diabetes

Summary: the current study has two aims: 1. to test the hypothesis that a single dose of lixisenatide can be used as a growth hormone stimulation test; 2. to test if the growth hormone-stimulating effect is mediated by changes in blood glucose. the secondary objective of the study is to monitor the effect of lixisenatide on other pituitary hormones and physiological parameters (blood glucose, blood pressure, heart rate, nausea).

the randomized, blinded, placebo-controlled clinical trial is conducted on 5 healthy volunteers and 5 patients with type 1 diabetes. all study subjects receive once a placebo and once 10 micrograms of lixisenatide. the order of administration of study medication is decided on randomization. the placebo and lixisenatide are administered at least 2 days apart. blood samples are taken 30 minutes and immediately before study medication administration and 30, 60, 90, 120, and 150 minutes after study medication administration,. the primary endpoint is the peak value of growth hormone measured during the 2,5 hours after study medication administration.

Eligibility criteria:
inclusion criteria: 1. healthy volunteers: * male sex * age 18-60 years * body weight \> 65 kg 2. patients with type 1 diabetes: * type 1 diabetes * male sex * age 18-60 years * body weight \> 65 kg * c-peptide in fasting blood sample \<0,1 nmol/l * hba1c \< 8,5% exclusion criteria: 1. healthy volunteers: * use of aldosterone antagonist * use of glucocorticosteroid * use of other medication that potentially significantly affects pituitary function. 2. patients with type 1 diabetes: * use of aldosterone antagonist * use of glucocorticosteroid * use of other medication that potentially significantly affects pituitary function. * the patient is excluded from the study if a significant change in blood glucose occurs in the study center.
efficacy and safety of odanacatib (mk-0822) in participants with involutional osteoporosis (mk-0822-022)

Conditions: Osteoporosis Postmenopausal

Summary: the purpose of this study is to assess the dose-response on the percent change from baseline in lumbar spine bone mineral density (bmd) at lumbar vertebrae 1 to 4 (l1- l4) when odanacatib (mk-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52 weeks to japanese involutional osteoporosis participants. the study will also assess safety and tolerability of odanacatib (10, 25, and 50 mg) in these participants. the study will enroll approximately 280 participants and randomly assign them to 3 different doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin d3 and calcium carbonate. the primary efficacy hypothesis is that a dose-response relationship on the percent change from baseline in lumbar spine bmd (l1- l4) is seen when odanacatib 10, 25, 50 mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis participants. the primary safety hypothesis is that odanacatib will be safe and well tolerated over 52 weeks to involutional osteoporosis participants.


Eligibility criteria:
inclusion criteria: * postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85 * participant who has low bone mineral density * participant has anatomy suitable for dual-energy x-ray absorptiometry (dxa) of the lumber spine and hip * participant is ambulatory (can walk) exclusion criteria: * participant has secondary osteoporosis or has a metabolic bone disorder other than osteoporosis or osteopenia * participant has received osteoporosis medications or other medications that affect bone * participant is already participating in another drug study
effects of resistant starch in a baked snack bar on a post-prandial glycemic and insulinemic response

Conditions: Hyperglycemia, Diabetes, and Obesity

Summary: * about two-thirds of adults in the united states are overweight or obese which can cause adverse health consequences for those individuals. post-prandial hyperglycemia is one of these possible consequences and is associated with a higher risk for type 2 diabetes. controlling hyperglycemia is important in the prevention of the onset of diabetes and obesity. resistant starch is a dietary carbohydrate which is not completely digested in the gut and produces energy for the body to use. the investigators are interested in assessing the effects of resistant starch on postprandial blood glucose and insulin concentrations. * aim: to assess the effects of a resistant starch on post-prandial blood glucose and insulin concentrations. * hypothesis: a baked snack bar with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to a baked snack bar with maltodextrin (an easily digested carbohydrate).


Eligibility criteria:
inclusion criteria: * thirty healthy men and women (aged 18-29y) will be recruited from the greater lafayette, in region with the expectation that ≥20 subjects will complete the study. subjects must weigh \>110 pounds, with a bmi between 20.0 and 29.9. exclusion criteria: * weight change \> 3kg in the past 3 months * exercising vigorously over the past 3 months as well as no exercise 3 days prior to testing day * intestinal disorders including lipid mal-absorption or lactose intolerance * abnormal liver or kidney function tests; fasting blood glucose \>100mg/dl * smoking * drinking more than 2 alcoholic drinks per day * taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration. * subjects must not be pregnant or lactating.
clozapine/paliperidone versus clozapine/placebo in resistant schizophrenia

Conditions: Schizophrenia; Schizophrenic Disorders; Psychotic Disorder

Summary: augmentation of clozapine with paliperidone in the treatment of resistant schizophrenia has not been tested until now in randomized controlled trials. this combination is supposed to have therapeutic efficacy in the treatment of resistant schizophrenia.

this is a 12 weeks, blind study (the patient, investigator, and sponsor do not know the study drug and dosage being taken by the patient) of the safety and tolerability of flexible-dose (3 to 12mg per day), extended-release (er) paliperidone in combination with clozapine with a diagnosis of schizophrenia. patients who have completed study or who discontinued from that study because of lack of efficacy but completed a minimum of 21 days of the study may enter this study. this study consists of a 21-day screening and washout phase (to discontinue and "wash out" any medication not allowed in the study), and a double blind treatment phase of 12 weeks, during which all patients will take oral paliperidone er every day and clozapine versus clozapine alone, and a post-treatment phase consisting of a follow-up visit completed 1 week after a patient has received the final dose of paliperidone er. the study, including the screening and posttreatment phase, will last approximately 30 weeks. screening and washout may be conducted while a patient is an outpatient. safety will be assessed by laboratory measurements (chemistry, liver function tests, hematology, hormone, lipid assessments, prolactin \[blinded\], urinalysis, and urine drug screens; body weight, height, and waist circumference measurements; ecgs and the esrs (extrapyramidal syndrome rating scale). these instruments will be used to assess extrapyramidal symptoms (eps) and dyskinesias. adverse events will be monitored including psychiatric adverse events of interest (worsening of psychosis, hyperprolactinemia, weight gain) that may be associated with paliperidone er in this population. the primary aim of this study is to evaluate the long-term (12 weeks) safety and tolerability of clozapine/paliperidone er in resistant schizophrenia. as exploratory secondary aims, the study will assess the effect of clozapine/paliperidone er on the long-term symptoms of schizophrenia as measured by the changes in the positive and negative syndrome scale for schizophrenia (panss) scores, the global improvement in severity of illness as measured by the clinical global impression(cgi) scale. patients begin the study at 6.0 mg/day of oral paliperidone er. if a higher dosage is needed, the dosage will be increased (in increments of 3 mg/day not more frequently than once every 5 days) to 12 mg/day. if the 6.0 mg/day dosage is not well tolerated, the dosage may be decreased (not more frequently than once every 5 days) to 3.0 mg/day. patients will be dosed for up to 6 months.

Eligibility criteria:
inclusion criteria: resistant schizophrenia failure in therapeutic response to three previous antipsychotic drugs - exclusion criteria: age upper 50 other psychiatric diagnosis head trauma neurological diseases -
computerized cognitive rehabilitation in ms patients

Conditions: Multiple Sclerosis; Cognitive Impairment

Summary: this study examines a home-based computerized cognitive rehabilitation intervention in adults with multiple sclerosis compared to placebo (videogame). patients are assessed through pre-and post neuropsychological testing.

patients will be randomized to enter a 6 week course of computer based cognitive rehabilitation focused on improving attention, learning, and memory. control patients will receive an alternative home-based computer program not designed for cognitive remediation but of the same duration. the primary outcome will be performance on neuropsychological testing in the intervention sample compared to controls. secondary outcomes will be the measures of self-efficacy, work productivity, quality of life, fatigue, depression, anxiety, and healthcare utilization. healthcare utilization variables include annual total cost (current year and prior), number and cost of er/hospital/outpatient visits, number of hospital visits, hospital length of stay, number preventive visits, total number claims, and number of new medications initiated. in addition, acute changes in neuropsychological testing induced by a bout of physical activity (i.e. self-paced walking during the six-minute walk test) will be examined, and that pattern of change will be compared between intervention and control groups at each data collection point. each subject will participate for a total of 6 months.

Eligibility criteria:
inclusion criteria: 1. diagnosis of multiple sclerosis with cognitive complaint exclusion criteria: 1. patients unwilling to participate 2. patients who cannot attend npt sessions 3. patients with severe cognitive impairment 4. non-english speaking patients (testing materials are in english) 5. patients with intact neuropsychological functioning at baseline on testing
physical activity in persons with charcot-marie-tooth: developing a measurement instrument

Conditions: Hereditary Motor and Sensory Neuropathy; Charcot-Marie-Tooth; Polyneuropathies

Summary: the project will develop knowledge about physical activity in persons with charcot-marie-tooth (cmt) in norway. we plan to explore instruments to measure physical activity level for the target-group at the community level. we want to understand which type of activities, activity intensities and how persons with cmt perform habitual physical activity. subsequently, a physical activity measurement instrument adapted to persons with cmt will be developed. this instrument can be used in a future intervention project to promote physical activity in this group.

charcot-marie-tooth (cmt) is a condition that potentially affects daily life function including physical activity. currently, there is no specific treatment. to prevent physical deconditioning, physical activity recommended. furthermore, other studies have found the benefit of being physically active, including people with neuromuscular disorders (nmd). . apart from the physical activity in a rehabilitation center, physical activity also needs to be maintained at the community level in people's everyday life. to measure physical activity level in the community, we need an instrument that is designed for doing so. a questionnaire can be used to collect information about type of activity, activity duration and intensity. the instruments available so far to measure physical activity at the community level are not specifically adapted to persons with cmt. therefore, this study will focus on revising the questionnaire based on the inputs from persons with cmt themselves. furthermore, the revised questionnaire will be compared with the original one in addition to yet another instrument.

Eligibility criteria:
inclusion criteria: * adults with a genetically confirmed cmt diagnosis. * residing in norway * age between 18 to 65 years old. exclusion criteria: * had major surgery within three months prior to the study period. * experiencing serious illness (e.g. bedridden, hospitalized).

Keywords: cmt ipaq nmd charcot-marie-tooth international physical activity questionnaire neuromuscular disorders activity diary hereditary neuropathy
the relationship between risperdal treatment and quality of life in patients with alzheimer's disease and behavioural and psychological symptoms of dementia (bpsd)

Conditions: Dementia; Alzheimer's Disease

Summary: to evaluate the relationship between risperidone treatment, treatment discontinuation rate, and quality of life of patients with alzheimer's disease and bpsd.

this is an interventional, placebo-controlled, double blind, prospective study. the total duration of this study will be 12 weeks. (1). baseline phase: subjects diagnosed as alzheimer's disease and bpsd will be evaluated for entry to the trial. subjects must meet the inclusion/exclusion criteria before entering the treatment phase. after obtaining informed consent, a physical examination, brief neurologic examination, and clinical laboratory tests appropriate are recommended. (2). treatment phase: all patients enrolled will be randomized to treatment with risperdal oral solution or placebo. the dosage of treatment medication will begin with 0.5 ml/ per day (0.5mg) (as the local product information leaflet). investigators can titrate dosage according to patients' clinical situation. the maximum dose will be 2ml/ per day. the standardized assessments include npi, which covers 12 domains of behavioral and neuro-vegetative symptoms, casi for cognitive function test, and sf-36 for quality of life. adverse events will be recorded.

Eligibility criteria:
inclusion criteria: 1. male or female patients whose age 60 years or older diagnosed with alzheimer's disease and bpsd without exposure to any antipsychotics within 1 month prior to study start. 2. subjects and subjects' relatives or legal representatives have signed the informed consent form, in accordance with the regulations of the local ethical committee. 3. subjects must remain in good health, as determined by medical history, complete physical examinations, laboratory tests and ecg. exclusion criteria: 1. neurodegenerative disorders such as parkinson's disease, pick's disease or huntington's chorea, down's syndrome, creutzfeldt-jacob disease. 2. one of the following conditions possibly resulting in cognitive impairment: acute cerebral trauma caused by post traumatic brain injury, subdural hematoma and injuries secondary to chronic trauma; hypoxic cerebral damage;; cerebral neoplasia;; mental retardation or oligophrenia 3. multi-infarct dementia or clinically active cerebrovascular disease 4. subjects with the severe co-existing medical conditions. 5. current clinically significant cardiovascular disease that would be expected to limit the subject's ability to participate in and complete a 3-month trial. 6. history of drug or alcohol abuse within the last year. 7. female subjects of childbearing potential without adequate contraception. 8. history of severe drug allergy or hypersensitivity; including recorded hypersensitivity to risperidone. 9. participation in a clinical trial of any investigational drug within 1 month (30 days) prior to study entry.
safety and efficacy of mecobalamin injection in peripheral neuropathies patients (study jgazsy091109)

Conditions: Peripheral Neuropathy

Summary: this is an open-label, randomized, multi-center clinical trial to evaluate the safety and efficacy in peripheral neuropathies patients treated with mecobalamin injection


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of diabetes induced peripheral neuropathy, other peripheral neuropathies (idiopathic, nutritional and metabolic nature of entrapment neuropathy). 2. significant spontaneous pain and / or numbness and other symptoms of neuropathy. tss (total symptom score) \>=7.5. 3. participation in clinical trials voluntarily and signed informed consent form exclusion criteria: 1. pregnancy, preparation for pregnancy or breast-feeding women 2. peripheral neuropathy caused by drugs, poisoning, cancer or genetic 3. alanine aminotransferase (alt), aspartate aminotransferase (ast): 2.0 times more than the upper limit of normal; creatinine (cr) 1.5 times above the upper limit of normal. 4. serious organ disease or other serious primary disease merger, the mentally ill, poorly controlled hypertension (blood pressure more than 150/100 mmhg after using antihypertensive drugs) 5. diagnosis of patients with diabetic peripheral neuropathy, but has diabetes ketosis, ketoacidosis and severe infection within the past two weeks 6. bleeding or bleeding tendency in 2 months 7. have allergy 8. noncompliance or cannot meet those 9. participation in other clinical trials in the last 3 months 10. participant unsuitable to participate in this test as investigator considering

Keywords: mecobalamin peripheral neuropathy diabetic neuropathy
effectiveness of periodontal treatment for the glycemic conttrol of type ii diabetes mellitus

Conditions: Patient Compliance

Summary: the project is intended to find out the effect of periodontal treatment for the glycemic control of type ii diabetes mellitus patients.


Eligibility criteria:
inclusion criteria: 1. patients having diabetes mellitus and diagnosed with periodontitis for last six months. 2. aged between 30-60 years. 3. patients with hba1c level 7-9.5%, measured within three months prior to present study. exclusion criteria: 1. patients with acute oral infection 2. need for immediate tooth extractions 3. severe hypertension (\>180/110 mm hg) 4. edentulous patients 5. patients with diabetic nephropathy 6. patients with diabetic retinopathy