Kornimate/medical-research-clean huggingface dataset:
an observational study of a nutritional supplement in an older malnourished or at risk of malnutrition, hip fracture population

Conditions: Malnutrition

Summary: this non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. subjects will be enrolled and observed for a period of 12 weeks.


Eligibility criteria:
inclusion criteria: * subject has voluntarily signed and dated an informed consent form, approved by an independent ethics committee, prior to any participation in the study. * subject is considered malnourished, or is at risk for malnutrition * subject conforms to the requirements set forth on the study product label. * subject has an estimated, or measured, glomerular filtration rate \>30ml/min/1.73m2 (mdrd equation). * subject has been elected for hip fracture surgery and is within three days since surgery. * the study physician determines the subject is fit to participate. * subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition, and has recently been prescribed study oral nutritional supplement by their health care professional. * after surgery, the subject is free living, resides in a nursing home, or remains in hospital and has an expected length of hospital stay \< 15 days. exclusion criteria: * subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption and does not have a caregiver who can assist them with adherence to the study protocol. * subject has active cancer and the study physician determines the subject is not suitable for the study. * subject has uncontrolled diabetes. * subject is known to be allergic or intolerant to any ingredient found in the study product. * participation in another study that has not been approved as a concomitant study.
evaluation of apelin-13 and apelin-36 in women with recurrent pregnancy loss

Conditions: Recurrent Pregnancy Loss

Summary: lower apelin levels are associated with hypertensive disorders with pregnancy, yet no studies investigated its levels in recurrent pregnancy loss


Eligibility criteria:
inclusion criteria: * pregnant women in first trimester * negative antiphospholipid markers * normal karyotype exclusion criteria: * multiple pregnancy * fetal malformations * maternal diseases * smoking or alcohol use * history of or risk factors for preterm labor
wearability, saefty and usability assessment for the upper limb exoskeleton bridge/empatia

Conditions: Muscular Dystrophies

Summary: the study is a feasibility study or pilot study, that is a clinical investigation to acquire the preliminary information on a motorized exoskeleton (bridge / empatia exoskeleton) for the movement of the upper limb in order to develop it, including design changes. the primary objective of the clinical trial is to assess the fit, safety and usability of the device in supporting the execution of daily activities for patients suffering from muscular dystrophy. the risk analysis for the bridge / empatia device does not present particular criticalities that preclude the use of the device in the target population. in any case, during the trial eventual adverse events are recorded for the verification of safety..


Eligibility criteria:
inclusion criteria: 1. availability of the patient and/or caregiver at the signing of the informed consent for participation in a clinical trial study protocol 2. defined diagnosis of muscular dystrophy (duchenne, becker, cingoli type 2 and facio-scapulo-humeral). biopsy will not be performed except in cases where a diagnostic need arises. 3. wheelchair bounded 4. significant weakness in the muscular districts of the shoulder girdle and the proximal upper limb portion detected by the mrc scale (between 0 and 2) 5. cognitive skills that allow the understanding and management of the device 6. arm length measured from the shoulder to the elbow between 26.5 cm and 28.7 cm; forearm length, measured between elbow and wrist, maximum 22.4 cm exclusion criteria: 1. presence of important comorbidities (epilepsy, dependence 24/24 hours from non-invasive and invasive ventilation) 2. behavioral and psychiatric disorders (e.g., emotional problems, depression) 3. inability to maintain a sitting position in a wheelchair

Keywords: exoskeleton upper limb assistive device
the effect of preoperative sgb on poaf after vats

Conditions: Atrial Fibrillation

Summary: the aim of this study is to test if stellate ganglion block can decrease the incidence of atrial fibrillation after video-assisted thoracoscopic surgery and the way it works.

postoperative atrial fibrillation (poaf) is a common complication after video-assisted thoracoscopic surgeries. it leads to early postoperative complications, prolonged icu stay and hospital stay, increased hospital expense and medical system burden. poaf is hard to predict and difficult to treat. the potential mechanism of poaf is not fully understood. since early 2020, covid-19 overwhelmed globally. chest x-rays and ct scans prescribed enormously due to screening for covid-19 infection. lung nodules are frequently discovered and the number of video-assisted thoracoscopic procedures is surged. prevention and new targets of treatment of poaf need to be investigated urgently. this is a double blinded, randomized controlled trial, investigating the effect of autonomic nervous system modulation on poaf. in current study, patients with one or more poaf risks, who undergo video-assisted thoracoscopic lobectomy will be enrolled and randomized into two groups. participants in the sgb group receive stellate ganglion blocks (sgb) preoperatively, while those in the control group receive sham blocks. all the patients receive standardized anesthesia and video-assisted thoracoscopic procedures. all of participants will be monitored with portable ecg monitoring for 48 hours to detect any poaf occurrence. cytokines including il-2, il-6 and inflammatory bio-markers including c-reactive protein and white blood cell count are measured before surgery, 24h and 48h after surgery. the primary outcome is the occurrence of poaf and its duration. the sample size is calculated as 191 patients per group. the presumed result will be that sgb will lower the poaf incidence and shorten the duration after video-assisted thoracoscopic surgeries.

Eligibility criteria:
inclusion criteria: * 1.patients undergoing elective thoracoscopic lobectomy; * 2.patients with one or more risk factors of poaf. according to literature, risks factors of poaf including male, aged over 65, obesity (bmi\>30kg/m2), cardiac co-morbidity ( hypertension, myocardial infarction, heart failure, arrhythmia, history of valve procedure), diabetes, chronic renal insufficiency (increased creatinine level), obstructive sleep apnea syndrome (diagnosed or stop-bang scores ≥3). exclusion criteria: * 1. patients with permanent atrial fibrillation, left ventricular or right ventricular pacemaker implantation or removal; * 2. patients use antiarrhythmic drugs (except beta-blockers); * 3.patients use immunosuppressive drugs preoperatively; * 4.patients with active infection or sepsis; * 5. patients with neurologic disorder; * 6.patients with immune deficiency syndrome.

Keywords: postoperative atrial fibrillation stellate ganglion block
multimodal imaging in vitreo-retinal surgery and macular dystrophies

Conditions: Macular Holes; Epiretinal Membrane; Retinal Detachment; Macular Dystrophies

Summary: the aim of the study is to identify morphological and functional biomarkers of post-operative recovery after vitreoretinal surgery, using decisional support systems (dss), based on multimodal big-data analysis by means of machine learning techniques in daily clinical practice

the aim of the study is to identify morphological and functional biomarkers of post-operative recovery after vitreoretinal surgery. identifying the biomarkers and assessing the predictivity of recovery will make it possible to highlight the categories of patients who can benefit most from surgical treatment, and to target the patient more precisely for personalised medicine and surgery. the introduction of new decisional support systems (dss), based on multimodal big-data analysis through machine learning techniques in daily clinical practice, is providing new useful information in patient assessment for personalised surgery.

Eligibility criteria:
inclusion criteria: * all patients to undergo vitreo-retinal surgery for: 1. macular hole 2. epiretinal membranes 3. retinal detachment 4. macular dystrophies (retinal pre-prosthesis) exclusion criteria: * patients under 18 years of age will be excluded; patients in whom morphological examinations cannot be performed due to poor cooperation or opacity of the dioptric media (e.g. corneal pathology). quality of morphological images inadequate for post acquisition processing (\<6/10).

Keywords: vitreoretinal surgery machine learning decisional support systems
yoga training in allergic rhinitis patients

Conditions: Allergic Rhinitis

Summary: the purpose of this study was to investigate effects of yoga training on rhinitis symptoms and cytokines in allergic rhinitis patients. twenty-seven allergic rhinitis patients, aged 18-45 year old, were randomized into 2 groups: control group (con; n=14) and yoga group (yog; n=13). the control group had normal life and the yoga group was required to complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week. physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-test and post-test. the dependent variables between pre-test and post-test were analyzed by a paired t-test. the dependent variables between groups were analyzed by independent t-test. one way repeated measures anova was used to compare the variables among pre-test, after 4 weeks, and after 8 weeks. differences were considered to be significant at p \< 0.05.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of allergic rhinitis diseases * clinical symptoms of persistent rhinitis (nasal congestion, sneeze, nasal itching, and running nose) for more than 4 days per week. * positive skin prick test (wheal diameter\>3 mm.) to house dust mite (d. pteronyssinus) and using normal saline as the negative control. * stopped taking all medicine before the study such as antihistamine for at least 3 days, oral steroid and nasal steroid for at least 2 weeks and luekotriene receptor antagonist for at least a week prior to the study, but the patients could take pseudo ephedrine. * subjects were not to have participated in a regular exercise program for at least 6 months prior to the start of the study, and to avoid taking any form of dietary supplement during the course of the study. exclusion criteria: * asthma * chronic rhino-sinusitis * hypertension * cardiovascular diseases * a smoking habit

Keywords: allergic rhinitis yoga cytokines rhinitis symptoms
navigation laser versus traditional laser photocoagulation for mild diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the aim of this study is to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser.

navigation laser is a novel fundus imaging and laser treatment method that allows imaging (infrared, colour, fluorescein angiography) and integrated laser treatment of the retina. besides documentation, precision,safety and patient comfort,the main theoretical advantages lie in retina navigation.this randomized, parallel controlled, clinical-trial aims to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser. the primary outcome measures is the best-corrected visual acuity (bcva) of the participants at 1 year after treatment. besides, the slit-lamp examination, tonometry, funduscopy, and oct, ffa, icga examinations will also be compared between different groups to find the advantage of navigation laser .

Eligibility criteria:
inclusion criteria: * aged ≥18 years * diagnosed as diabetic retinopathy with mild macular edema * bcva≥0.5 * no macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months exclusion criteria: * blood glucose was not controlled steadily(hba1cd≥10%) * accompanied with severe hypertension（bp≥180/110mmhg） * taking part in other clinical trial within 3 months * planning panretinal photocoagulation(prp) within 3 months * performed cataract surgery in the last 3 months * accompanied with other retinal vascular disease that can lead to macular edema, for example branch retinal vein occlusion(brvo),central retinal vein occlusion(crvo) * accompanied with severe opacity of refractive media that maybe impact therapy and observation * accompanied with nystagmus * accompanied with some history that maybe interfere with result or increase the risk of patients

Keywords: diabetic macular edema navigation laser laser photocoagulation
being a parent: evaluation of a parenting intervention for childhood behavioral problems

Conditions: Childhood Behavior Problems; Positive Parenting Skills; Parental Concerns; Parents' Sense of Competence

Summary: this randomized controlled trial aims to test the efficacy of an early parenting intervention for childhood behavior problems in the portuguese community. more specifically, this research intends to: 1) examine the effects of the parenting intervention in childhood behavior problems, positive parenting skills and parental concerns; 2) test participants' adherence, acceptability and dropout rates of the parenting intervention; and 3) qualitatively analyze the experience of parents' who received the intervention. researchers will compare an intervention group with a waitlist control group to see if there are any significant differences between these groups regarding childhood behavior problems and the aforementioned parenting dimensions. participants in both groups will be able to participate in the parenting intervention that has a duration of 9 weeks. furthermore, they will be asked to fill in pre and post data.


Eligibility criteria:
inclusion criteria: * primary caregivers who identify difficulties managing the behavior of a child between the ages of 2 and 11 years old. exclusion criteria: * primary caregivers of children with serious neurodevelopmental or cognitive disorders diagnosed; * primary caregivers of children institucionalized; * primary caregivers who do not comprehend, read or write in portuguese; * primary caregivers inability to commit to weekly sessions.

Keywords: parenting interventions childhood behavior problems positve parenting
predictive objective parameters for outcome of the treatment of stress urinary incontinence

Conditions: Urinary Incontinence

Summary: to investigate the role of preoperative maximum urethral closure pressure and valsalva leak point pressure in predicting outcome in patients who underwent trans-obturator tape for the treatment of female stress urinary incontinence.

a prospective observational descriptive study conducted from may 2002 to november 2005 at a single tertiary urban teaching university uro-gynecological department. 65 patients affected by stress or mixed urinary incontinence (stress component clinically predominant), defined according to international continence society guidelines, associated or not with urethral hypermobility underwent surgery which consisted of a fusion-welded, non-woven, non-knitted polypropylene tape (obtape® mentor-porges). preoperative mucp and vlpp, stratified as ≤ or \> 40 cmh20 and ≤ or \> 60 cmh2o respectively, were separately or in combination correlated with primary (continence status: dry or wet) and secondary outcome variables (qol questionnaires).

Eligibility criteria:
inclusion criteria: * mixed urinary incontinence (stress component clinically predominant) exclusion criteria: * \> grade ii uro-genital prolapse in any vaginal compartment * previous incontinence surgery * urine retention, neurogenic bladder, benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma) * active pelvic inflammatory disease * known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid) * pregnancy or lactation; and * any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Keywords: stress urinary incontinence mixed urinary incontinence surgery trans obturator tape maximum urethral closure pressure valsalva leak point pressure outcome
a trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (somapacitan) compared to daily dosing of norditropin® simplexx® in children with growth hormone deficiency

Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children

Summary: this trial is conducted in europe and asia. the aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (nnc0195-0092, somapacitan) compared to daily dosing of norditropin® simplexx® (somatropin) in children with growth hormone deficiency.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ghd (growth hormone deficiency) as defined by two different gh (growth hormone) stimulation tests, peak gh level below or equal to 7.0 ng/ml. for children with three or more pituitary hormone deficiencies only one gh stimulation test will be needed. if in accordance with country specific practice, growth hormone deficiency can be defined by only one gh stimulation test, peak gh level below or equal to 7.0 ng/ml. * pre-pubertal children at screening. boys: tanner stage 1 and age above or equal to 6 years and below 13 years. girls: tanner stage 1 and age above or equal to 6 years and below 12 years * body weight above or equal to 16.0 kg and below or equal to 50.0 kg * stable gh replacement treatment for at least 3 months exclusion criteria: * history or presence of malignancy * overt diabetes mellitus (fasting blood glucose above or equal to 7.0 mmol/l)
probiotic visbiome for inflammation and translocation in hiv ι

Conditions: HIV-1 Infection

Summary: modern antiretroviral therapy (art) has transformed the clinical care and lived experience of hiv infection. however, increased rates of adverse health conditions that are related to immune activation, such as cardiovascular disease (cvd) and neurodegenerative disease in art-treated individuals persist. an important cause of this inflammation is the gut cd4 t cell loss and the "leaking" or translocation of luminal gut bacteria and other microbes across the bowel wall and into the bloodstream. the use of complementary and alternative therapies is common among people living with hiv, however their efficacy has generally not been well demonstrated. probiotics are live microbes that may provide a health benefit to the host and the investigators believe that the simultaneous use of probiotics along with antiretroviral therapy (art) will improve gut cd4 t cell restoration and function and therefore reduce microbial translocation and immune activation. probiotic visbiome consists of a high potency blend of eight different probiotics. the precise mechanism of action of visbiome is unknown, but preclinical studies have shown that visbiome may modulate the immune response towards a phenotype that is associated with reduce inflammation, and visbiome was also protective in a non-human primate model of siv infection. therefore, we believe that the "beneficial" bacteria from visbiome will accelerate the normalization of gut immune cells and function in hiv-infected individuals as they start art. early resolution of gut immune cells may normalize microbial translocation and immune activation and will reduce the rates of hiv-associated comorbidities.


Eligibility criteria:
inclusion criteria: * documented hiv-1 infection * male adult (age \>18 years) * antiretroviral therapy-naïve * ability to provide informed consent * hiv-1 viral load ≥1,000 copies/ml exclusion criteria: * current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance * taking pharmaceutical grade probiotics * any of the following abnormal laboratory results in screening: * hemoglobin \<85 g/l * neutrophil count \<750 cells/μl * platelet count \<50,000 cells/μl * ast or alt \>5x the upper limit of normal * malignancy * colitis * liver fibrosis (decompensated cirrhosis), portal hypertension or clinical hepatitis * other significant underlying disease (non-hiv-1) that might impinge upon disease progression or death
study to evaluate effect of everolimus in progression of graft vascular illness on patients with heart transplant

Conditions: Cardiac Transplant

Summary: the purpose of this study is to evaluate if there is a significantly less incidence of major clinical events due to graft vascular illness in recipients of a cardiac transplant on treatment with an immunosuppressive combination, which includes everolimus, compared to those that continue the previously used immunosuppressive treatment.

this is a prospective, randomized, multicentre, open and controlled study, to evaluate the efficacy and safety of everolimus combined with cyclosporin for microemulsion and steroids according to medical judgement, opposite to the usual therapy which the patient already has received (typically: ciclosporin + azathioprine or mycophenolate mofetil + steroids according to the judgement of the doctor) for patients receiving a cardiac orthotopic transplant since at least 12 months. the patients will be randomized in a 2:1 proportion (everolimus:control), in order to make it possible for the majority of patients to receive the potentially active treatment in a lethal illness for which there is not efficient known treatment up to date. the study duration will be 2 years of follow-up for each patient. at the end of this period, the patients will be offered the possibility to maintain the immunosuppressive treatment to which they have been assigned, and periodic revisions will be made each 3-6 months. the two treatment groups are: group i - everolimus twice a day v.o. + cyclosporin for microemulsion in reduced doses +/- steroids. group ii - cyclosporin for microemulsion + azathioprine or mycophenolate mofetil +/- steroids (the same administration schedule and medication which the patient received earlier).

Eligibility criteria:
inclusion criteria: * patients suffering a heart transplantation at least 12 months before the inclusion. * patients with significant graft vascular cardiac illness. exclusion criteria: * patients who received more than one solid organ. * hypersensibility to everolimus. * patients with expected surviving less than 6 months. * analytic abnormality significant (platelets \ 2,5 mg/dl) * neoplasm and/or severe systemic illness. * mental significant illness. * patients who have received sirolimus or everolimus in any moment after transplant. * pregnant or lactating woman.

Keywords: effect of everolimus in graft vascular cardiac illness