Kornimate/medical-research-clean huggingface dataset:
darbepoetin trial to improve red cell mass and neuroprotection in preterm infants

Conditions: Neurocognitive; Neuroprotective; Neonatal; Neurodevelopmental Impairment

Summary: study hypothesis: preterm infants administered weekly darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo

advances in neonatal care have led to significant improvements in the survival of the nearly 60,000 very low birth weight (vlbw) infants born each year in the u.s. improving neurodevelopmental outcomes for these preterm infants continues to be a major goal for neonatal care providers. a subset of these infants sustain a grade 3 or 4 intraventricular hemorrhage (ivh) resulting in an increase in the incidence of developmental delay. moreover, almost one third of preterm infants with normal head ultrasounds also develop cognitive delay. although a variety of neuroprotective treatment strategies have been evaluated, no specific treatment has been identified to reduce or prevent brain injury in these most vulnerable preterm infants. a potential neuroprotective therapy involves administering erythropoiesis stimulating agents (esas) such as erythropoietin (epo) and darbepoetin (darbe, a longer acting esa). in addition to stimulating erythropoiesis, esas have been shown to be protective in the developing brain in animal models, making it possibly beneficial for very premature infants who are at risk for intraventricular hemorrhage, hypoxic-ischemic injury, and developmental delay. the neuroprotective mechanisms of esas include increased neurogenesis, decreased neuronal susceptibility to glutamate toxicity, decreased neuronal apoptosis, decreased inflammation, decreased nitric oxide-mediated injury, increased antioxidant response, decreased axonal degeneration, and increased protective effects on glia. this is a randomized, masked, placebo controlled clinical study in which enrolled infants will receive weekly darbe or placebo (sham) dosing. extended follow-up: subjects will be seen for follow-up at 4-5 years (i.e., 4 years - 4 years 11 months) corrected age and 6-7 years (i.e., 6 years - 6 years 11 months) corrected age to characterize the functional, behavioral and neurological outcomes of the extremely low birth weight (elbw) population at school age based on treatment with darbepoetin versus placebo in the neonatal period.

Eligibility criteria:
inclusion criteria: * inborn and outborn preterm infants * 23 0/7-28 6/7 weeks gestational age * ≤24 hours postnatal age exclusion criteria: * hematocrit \> 60% * infants with known congenital or chromosomal anomalies, including congenital heart disease and known brain anomalies * hemorrhagic or hemolytic disease * eeg- confirmed seizures * congenital thrombotic disease * systolic blood pressures \>100 mm hg while not on pressor support * receiving epo or darbe clinically, or planning to receive epo or darbe during hospitalization * infants in whom no aggressive therapy is planned * family will not be available for follow-up at 22-26 months
thickenup® gel express for patients with dysphagia

Conditions: Dysphagia, Esophageal

Summary: evaluation of swallowing function and hydration following consumption of thickenup® gel express in patients with dysphagia.

thickenup® gel express for patients with dysphagia ("hydra-01 study"): effect on swallowing function as assessed by a videofluoroscopy (vfs) one day study with bolus of various viscosities (study part 1) and followed, in a subset of patients, by a united kingdom advisory committee on borderline substances (uk acbs) acceptability 14 days study combined with an exploratory hydration assessment study at a prescribed viscosity (study part 2).

Eligibility criteria:
key inclusion criteria (for study part 1 and part 2): 1. aged ≥ 18 years; 2. diagnosed with oropharyngeal dysphagia and with a documented impaired safety of swallow by v-vst and pas \>1 during vfs; 3. history and/or current of swallowing difficulties; 4. willing to adhere to the restrictions specified in the protocol; 5. must be competent to understand the nature of the study and capable of giving written informed consent. in case patients are not capable of providing written informed consent (i.e. affected by dementia) a family/legal representative could provide the consent for the study. 6. willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use. key exclusion criteria (for study part 1 and part 2): 1. patients suffering from idiosyncratic phenomena or who are allergic to iodinated contrast media; 2. major respiratory disease requiring oxygen or undergoing any type of surgery in the three months prior to the study; 3. current diarrhea, vomiting or abdominal pain; 4. alcohol or drug dependence (based on anamnesis only); 5. covid-19 positive patients (with or without symptoms) at the time of enrolment; 6. patients who, in the judgment of the investigator, are likely to be noncompliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development; 7. having participated in a clinical study in the last 4 weeks and received compensation beyond a certain approved and predefined limit; 8. having a clinical condition that is contraindicated with the study product; 9. positive urine pregnancy test at screening for women of childbearing potential; 10. allergy towards milk, mustard, egg, or celery. additional inclusion criteria for study part 2 only: 1. patient willing to participate in study part 2; 2. patient/caregiver able to record daily gi symptoms, compliance and fluid intake; 3. patient able to respond to acceptability questionnaire (organoleptic properties, texture, appearance). 4. patient willing to only use study product as the sole thickening agent during the part 2. additional exclusion criteria for study part 2 only: 1. undergone a major gastrointestinal surgery less than 3 months prior to enrolment in this study; 2. obstruction of the gastrointestinal tract.
prognostic score to predict major complications after pancreaticoduodenectomy

Conditions: Pancreatic Neoplasm

Summary: pancreaticoduodenectomy (pd) still carries a high rate of severe postoperative complications. no score is currently available to help identify the patient's surgical risk. the purpose of this study was to develop and validate a prognostic score to predict major postoperative complications after pd.

the investigators prospectively collected in an electronic database preoperative, intraoperative and outcome data of 700 patients undergoing pd in our institution from 2002 to 2010. the investigators used a multivariate logistic regression analysis to create a new score to predict severe complications defined as clavien-dindo classification iii, iv and v. the score was developed using a random two-thirds of the population (469 patients), and was then validated and calibrated in the remaining third of the patients (231).

Eligibility criteria:
inclusion criteria: - patients undergoing pancreaticoduodenectomy in our institution exclusion criteria: * metastatic disease * patient not suitable for surgery

Keywords: pancreas, pancreaticoduodenectomy, major complications
efficacy of the "атопик soothing cream" in children with mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: a double-blind randomized placebo-controlled trial to evaluate the efficacy of the "атопик soothing cream" in children with mild to moderate atopic dermatitis

"атопик soothing cream" is a lipid complex composed of barley grain, butyrospermum parkii and argania spinosa kernel oil, in a mixture with panthenol and bisabolol. investigators concure that combination of these substances in "атопик soothing cream" will be efficacious non-steroidal treatment of atopic dermatiti ( ad).

Eligibility criteria:
inclusion criteria: * must have clinical diagnosis of mild to moderate atopic dermatitis (ad) at both screening and baseline visits, defined as iga score of 2 or 3 ( rothe 1996) or easi score between 2 and 21 (leshem 2015) * must have ad affecting \>5% total body surface area (tbsa) at baseline * history of ad for at least 3 months prior to baseline * informed consent/assent in accordance with the international conference on harmonization (ich) good clinical practice (gcp) guideline and applicable regulations, before completing any study-related procedures exclusion criteria: * use of topical corticosteroids within 7 days prior to baseline * use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (puva, uvb) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to baseline * subjects that require systemic therapy for the treatment of ad * use of systemic anti-infective or antibiotic treatment within 14 days prior to baseline * subjects who present with clinical conditions other than ad that may interfere with the evaluation (eg, generalized erythroderma, acne, netherton's syndrome, psoriasis) * any clinically significant skin disease other than ad * secondary infection of ad (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at baseline * history of severe anxiety and/or depression; any history of suicide attempt * subjects with a history of human immunodeficiency virus (hiv) as determined by medical history * subjects who, in the opinion of the investigator(s), would be non-compliant with the visit schedule or study procedures * participation in any other investigational trial within 6 weeks of baseline, or during study conduct * chronic condition(s) which are either unstable or not adequately controlled * drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures * any medical condition that may, in the opinion of the investigator(s), preclude the safe administration of test article or safe participation in the study

Keywords: atopic dermatitis topical therapy
effect of intermittent oral tube on dysphagia in parkinson's disease patients

Conditions: Parkinson Disease

Summary: the goal of this or clinical trial is to explore intermittent oro-esophageal tube feeding vs. nasogastric tube feeding on nutritional status, dysphagia, and activities of daily living in patients with parkinson's disease. the main question it aims to answer are: • can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with parkinson's disease, better than nasogastric tube feeding. participants will be divided into the control group and observation group evenly. all the patients were provided with routine therapy and given nutritional support by intermittent oro-esophageal tube feeding and nasogastric tube feeding respectively. the nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

nasogastric tube feeding has been widely used in patients with parkinson's disease but has a significant risk of complications. intermittent oro-esophageal tube feeding is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. the goal of this or clinical trial is to explore intermittent oro-esophageal tube feeding vs. nasogastric tube feeding on nutritional status, dysphagia, and activities of daily living in patients with parkinson's disease. the main question it aims to answer are: • can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with parkinson's disease, better than nasogastric tube feeding. participants will be divided into the control group and observation group evenly. all the patients were provided with routine therapy and given nutritional support by intermittent oro-esophageal tube feeding and nasogastric tube feeding respectively. the nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility criteria:
inclusion criteria: * age \>18 years. * meeting the diagnostic criteria for parkinson's disease developed by the neurology branch of the chinese medical association in 2006. * diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study. * water swallow test\> level 3. * stable vital signs, conscious, able to cooperate with assessment and treatment. exclusion criteria: * dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases. * complicated with cognitive impairment or consciousness dysfunction. * simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. * complicated with severe liver and kidney failure, tumors, or hematological disorders.
amisulpride augmentation therapy for clozapine-resistant schizophrenic patients

Conditions: Treatment-resistant Schizophrenia

Summary: this study includes two main components: the first screening phase and the second clinical intervention phase. during the screening phase, subjects with poor response to clozapine are carefully evaluated by chart-review and clinical assessment. via chart-review, clinical data of diagnosis, disease course and previous treatment outcome, and concomitant psychotropic agents are obtained. clinical phenomenology, including psychopathology, psychotic and mood symptoms severity and side effect of psychotropic medication are assessed by clinical interview and observation, which are conducted by experienced clinicians. blood sample will be also obtained from the subjects for measuring the baseline clozapine drug level and extracting dna for further analysis. subjects fulfilling the criteria of treatment-resistant schizophrenia with poor response to adequate dose and duration of clozapine treatment are eligible for the clinical trial phase of 14-week randomized, placebo-controlled amisulpride add-on study. in this phase, subjects are randomly allocated to amisulpride augmentation treatment group and placebo treatment group. subjects in the former group will receive clozapine and amisulpride combination treatment, while in the latter group will receive clozapine and placebo. outcomes of clinical efficacy and safety are carefully evaluated by experienced and well-trained research stuffs in the 14 weeks of clinical study period. all of the above studies will be conducted in four hospitals, including doh bali psychiatric hospital, doh tao-yan psychiatric hospital, and the ju-shang psychiatric hospital. subjects will be recruited from the chronic in-patient settings from these three hospitals.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosed schizophrenic patients; * age between 18 and 60; * before treatment with clozapine, documented treatment failure of two antipsychotics for an adequate duration of 6 weeks and in a sufficient dose of 600 mg/day of chlorpromazine equivalents; * documented failure to show a satisfactory clinical response to an adequate clozapine treatment, defined as at least clozapine 300 mg/day for 3 months or a plasma drug level of 350ng/ml; * at least moderately ill, defined as with a clinical global impression (cgi) greater than 4 or panss total score greater than 75; * persistent positive psychotic symptoms, with rating scores of moderate or worse on at least two of four positive symptom items (delusion, conceptual disorganization, hallucinatory behavior, and suspiciousness/persecution) on positive and negative syndrome scale (panss); exclusion criteria: * patients with concomitant treatment with lithium, anti-convulsants, antidepressants and other antipsychotic medication ; * patients with underlying severe medical illness, such as cardiovascular disease, cerebrovascular disease, bone marrow suppression or epilepsy; * patients with comorbid diagnosis of substance dependence;

Keywords: treatment-resistant schizophrenia clozapine amisulpride
exercise in women with fibromyalgia

Conditions: Fibromyalgia

Summary: background the al-andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes) in women with fibromyalgia. methods one hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited from local associations of fibromyalgia patients in andalucía (southern spain). patients will be randomly assigned to a usual care (control) group (n=60), a water-based exercise intervention group (n=60) or a land-based exercise intervention group (n=60). participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 minutes each) per week during 24 weeks. both exercise interventions will consist of aerobic, muscular strength and flexibility exercises. discussion the investigators study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. if the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. results from the al-andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia.


Eligibility criteria:
inclusion criteria: * age: 35-65 years. * meeting the american college of rheumatology criteria: widespread pain for more than 3 months, and pain with 4 kg/cm of pressure reported for 11 or more of 18 tender points. * not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (answer "no" to all questions on the physical activity readiness questionnaire-par-q ). * not to be engaged in regular physical activity \>20 minutes on \>3 days/week. * planning to stay in the same association during the study. * able to ambulate, with or without assistance. * able to communicate. * informed consent: must be capable and willing to provide consent. exclusion criteria: * acute or terminal illness. * myocardial infarction in the past 3 months. * not capable to ambulate. * unstable cardiovascular disease or other medical condition. * upper or lower extremity fracture in the past 3 months. * severe dementia (mmse\<10). * unwillingness to either complete the study requirements or to be randomised into control or training group. * presence of neuromuscular disease or drugs affecting neuromuscular function.

Keywords: fibromyalgia exercise physical activity pain
neurophysiological intraoperative monitoring during aortic surgery

Conditions: Aortic Aneurysm, Thoracic

Summary: the primary objective of this study is to evaluate if the motor-evoked potentials/motor action potential amplitude ratio and motor action potential amplitude measurement are useful in detecting spinal cord ischemia during thoracoabdominal aortic aneurysms surgery. the secondary objective is to evaluate the presence of a correlation between neurophysiological changes and other factors (such as surgical maneuvers, anesthetic and physiologic changes) in order to find which factor is the most important in determining spinal cord ischemia. this study is an observational, single-center, prospective study on patients with thoracoabdominal aortic aneurysms undergoing surgical repair with intraoperative motor-evoked potentials and somatosensory evoked potentials monitoring.


Eligibility criteria:
inclusion criteria: * satisfied criteria for intraoperative neurophysiological monitoring; * sign a written informed consent to participate in the study. exclusion criteria: * no exclusion criteria
study of recovery of intestinal cd4+ and th17 t cells in hiv-infected individuals on short-term antiretroviral therapy

Conditions: HIV Infection

Summary: hiv infection is associated with a state of chronic, generalized immune activation that has been shown in many studies to be a key predictor of progression to aids. the molecular, cellular, and pathophysiological mechanisms underlying the hiv-associated immune activation are complex and still poorly studied. there is, however, growing consensus that both viral and host factors contribute to this phenotype, with emphasis on the role played by the mucosal immune dysfunction (and consequent microbial translocation). moreover if it is known that in hiv-infected individuals, a severe depletion of intestinal cluster of differentiation 4 (cd4+) t-cells, is associated with loss of epithelium integrity, microbial translocation and systemic immune activation, the kinetics of intestinal cd4+ t-cell reconstitution under combined antiretroviral therapy (cart) remains poorly understood. this study sought to evaluate the reconstitution of intestinal cd4+ t-cells, including th1 and th17, in blood and colon samples collected from hiv-infected individuals before and after a short term cart.


Eligibility criteria:
inclusion criteria: * naïve for antiretroviral treatment * met the criteria to start cart according to international guidelines * written informed consent signed exclusion criteria: * treatment with glucocorticosteroids and any immune modulating medication for more than seven days in the previous month * any past or current systemic malignancy, history of inflammatory diseases of the small or large intestine * pregnancy * anemia, use of anticoagulants, and any contraindications to phlebotomy or colonoscopy.

Keywords: hiv infection gut microbial translocation chronic inflammation antiretroviral therapy cart haart th17 th1 cd4+
anxiety, stress and sleep problems in people with early onset dementia

Conditions: Early Onset Dementia; Young Onset Dementia; Stress; Distress, Emotional; Anxiety; Sleep Problem; Sleep; Insomnia

Summary: the aim of this study is to * detect and assess needs of people with early onset dementia regarding anxiety, stress and sleep * implement a 6 week intervention pilot study in wich weekly (hourly) sessions are implemented in day care settings in order to decrease anxiety, stress and sleep problems in people with early onset dementia

1. needs detection by means of survey and interviews 2. implementation of a 6 week program in day care facilities

Eligibility criteria:
inclusion criteria: * diagnosed with early onset dementia before age of 65y exclusion criteria: * severe dementia