Kornimate/medical-research-clean huggingface dataset:
the immunomodulatory effect of sugammadex after total hip replacement surgery under neuraxial anaesthesia: a pilot study

Conditions: Innate Inflammatory Response; Osteoarthritis, Hip

Summary: monocenter randomized controlled proof of principle study to investigate the effect of sugammadex at the end of total hip replacement surgery on the postoperative innate immune function

rationale: with infections being the number one complication after surgery, more research is aimed at therapeutic strategies that positively influence the postoperative immune dysregulation. in the search for reducing surgical stress by a deep neuromuscular block (nmb), our group recently found evidence that sugammadex, used to antagonize a deep nmb, may have an immunomodulatory effect. ex vivo analysis showed that sugammadex counteracted the immunosuppressive effect of rocuronium, but even in absence of rocuronium it had a positive effect on cytokine production capacity. therefore, we now propose a clinical pilot study in patients planned for total hip surgery under neuraxial anaesthesia to further investigate whether sugammadex has beneficial immunomodulatory effects. primary objective: to investigate the effect of sugammadex on the postoperative innate immune function. study design: a blinded, randomized controlled pilot study study population: 20 adults scheduled for primary hip replacement surgery under neuraxial anaesthesia. intervention: patients will be randomized between a group receiving sugammadex at the end of surgery and a group receiving placebo. primary endpoint: postoperative innate immune function as reflected by ex vivo mononuclear cell cytokine production capacity upon whole blood lipopolysaccharide (lps) stimulation. secondary endpoint: postoperative innate immune function as reflected by damp release and circulating inflammatory cytokines, quality of recovery score (qor-40) postoperative day 1, postoperative pain and analgesia consumption, 30-day postoperative (infectious) complications

Eligibility criteria:
inclusion criteria: * age of 18 years or older * scheduled for total hip replacement surgery under neuraxial anesthesia * scheduled for primary hip replacement surgery * informed consent obtained exclusion criteria: * insufficient control of the dutch language to read the patient information and to fill out the questionnaires * mentally incapacitated patients * known or suspected hypersensitivity to sugammadex * deficiency of vitamin k dependent clotting factors or coagulopathy * severe renal disease (creatinine clearance \<30 ml/min), including patients on dialysis) * severe liver disease (child-pugh classification c) * women who are or may be pregnant or currently breastfeeding * women of childbearing potential who don't use adequate method of contraception * severe vertebral column disorder * chronic use of psychotropic drugs * known hypertrophic obstructive cardiomyopathy, severe aortic valve stenosis or severe mitral valve stenosis * chronic use of nsaid's, steroids or immunosuppressive drugs
outpatient cardiac rehabilitation in austria

Conditions: Heart Disease

Summary: the aim of this prospective trial is the manifestation of guidelines developed for outpatient cardiac rehabilitation in austria. the evaluation of prospective and retrospective data is supposed to give evidence on morbidity and/or mortality advantages compared to patients not participating in cardiac rehabilitation programs. the database created in this context is supposed to pave the way as instrument to document and comprehend quality and cost effectiveness of outpatient cardiac rehabilitation in austria as a key for quality management.


Eligibility criteria:
inclusion criteria: * heart disease exclusion criteria: * participation in another study within the previous 6 months * medical conditions which prevent patients from complying with the exercise program * acute infections * hypertrophic cardiomyopathy * pulmonary artery embolism or phlebothrombosis within the previous 6 months * unstable angina pectoris * heart failure (nyha iv) * hemodynamically unstable arrhythmia
tla in children with moderate to severe atopic eczema (tla4ae)

Conditions: Atopic Dermatitis Eczema

Summary: this is a single centre randomised, placebo-controlled phase 2 study in which 96 children age 4 to 16 years with moderate to severe, longstanding allergic eczema will be enrolled.

following a 4 to 6 week period on standardised treatment (run-in period, to ensure everyone starts with the same treatment approach), participants will be randomised to an active or dummy temperature-controlled laminar airflow (tla) device, which has been shown to markedly reduce exposure to particles which can cause allergic reactions when being inhaled (inhaled allergens) and other particles which are in the air the investigators breathe in. this has been shown to be an effective treatment of atopic asthma. the participants will undergo a 12-week treatment period. the device will then be removed and a final follow-up visit occurs at 16 weeks. the total study duration, including the run-in period is up to 22 weeks.

Eligibility criteria:
inclusion criteria: * age 4 to 16 years at time of consent * persistent moderate to severe eczema despite treatment with topical corticosteroids (tcs) class ii or more and/or topical calcineurin inhibitors (tci, licenced use only) for at least 3 months. * eczema area and severity index (easi) score ≥12 at screening and randomisation visit and \>10% body surface involved * sensitisation to house dust mite species, confirmed by specific immunoglobulin e (immunocap ≥2) and/or skin prick test (spt ≥5mm) * child able to sleep in their own bed and able to use the device for at least 5 out of 7 nights per week * written, informed consent of parent/legal guardian and patient assent exclusion criteria: * very severe atopic dermatitis * use of systemic immunosuppression (such as cyclosporine, methotrexate, azathioprine, oral steroids) or uv therapy or extracorporal photopheresis within four weeks prior to the screening visit * received therapeutic monoclonal antibodies (such as omalizumab or dupilumab) within six months prior to the screening visit * ongoing or planned desensitisation / immunotherapy during the study * infections requiring systemic antimicrobial treatment within four weeks prior to the screening visit * introduction of special dietary restriction (for eczema treatment) within three months prior to screening visit * severe asthma ≥ step 4 and/or ≥1 course of systemic oral steroids for asthma in the three months prior to screening visit * significant underlying chronic medical condition (chronic other skin disease, inflammatory bowel disease, immunodeficiencies, other uncontrolled systemic disease, cancer) * planned time away from home (=unable to use tla) exceeding 2 days/week; unable to use the device at least 5/7 days in the 2-3 weeks prior to end of intervention period. * prior research participation is not an exclusion criterion, except if it involved eczema disease modifying agents. * participating in current research

Keywords: atopic dermatitis eczema
comparative trial of antidepressant treatment models in hiv care in uganda

Conditions: Depression

Summary: this study compares two models for implementing antidepressant treatment in 10 hiv clinics in uganda. using a cluster randomization, 5 clinics implement a task-shifting, protocolized model, and 5 others rely on clinical acumen. the protocolized model includes (1) routine depression screening at each clinic visit for all adult patients by trained expert patients at triage, (2) training nurses to diagnose depression and prescribe and monitor antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and monitoring by hired study psychiatrists. the clinical acumen model also includes routine depression screening and ongoing supervision, but it relies on the clinical acumen of trained primary care providers to further evaluate and treat patients who show signs of depression at screening, as opposed to a structured protocol. the primary aim is to test the hypothesis that the nurse-driven protocolized model will result in greater uptake of antidepressant treatment and better quality of depression care outcomes. the study will also test the hypotheses that treatment of depression results in improved hiv treatment adherence, work functioning and consistent condom use.

the study evaluates a task-shifting approach to depression treatment that uses an algorithm-based, nurse-driven model for managing antidepressant treatment in 10 ugandan hiv clinics. the model will include (1) case identification facilitated by routine depression screening at each clinic visit for all patients, (2) training nurses to assist primary care providers in implementing antidepressant treatment by performing the initial evaluation, monitoring symptoms and side effects, and making algorithm-based dose recommendations, and (3) layers of supervision and monitoring by psychiatric specialists to ensure safety and quality of care. this model will be implemented at 5 randomly selected clinics (protocolized arm), while 5 other clinics will be selected to also use routine depression screening but will rely on primary care providers to decide whether to further evaluate and treat depression (clinical acumen arm). at each site, random samples of 150 patients (total n=1500) who have screened positive for possible depression will be followed for 12 months. we will compare the two arms on depression evaluation, uptake of antidepressant treatment, and change in depression (treatment response). we will also examine the relationship between change in depression and key economic and public health outcomes (e.g. work status, condom use, hiv treatment adherence).

Eligibility criteria:
inclusion criteria: * age 18 years or above * screens positive for depression (scores \> 2 on phq-2) * medically stable * client at the hiv clinic (and hence, hiv positive) exclusion criteria: * active acute opportunistic infection * about to start hiv antiretroviral therapy or started antiretroviral therapy within past 4 weeks

Keywords: depression, uganda, hiv, task-shifting, condom use, adherence
probiotic yoghurt effect on experimental gingivitis

Conditions: Gingivitis

Summary: the aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation. fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. the test group subjects (n=26) consumed probiotic yoghurt containing bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. gingival crevicular fluid (gcf) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. interleukin-1β levels were determined in gcf by elisa.

probiotics are viable bacteria with scientifically confirmed health benefits for gastrointestinal system. however, there is paucity of information on its impact in periodontal disease. the aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation. fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. the test group subjects (n=26) consumed probiotic yoghurt containing bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. gingival crevicular fluid (gcf) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. interleukin-1β levels were determined in gcf by elisa.

Eligibility criteria:
inclusion criteria: * no or minimal clinical signs of gingival inflammation * gingival index ≤ 1 * no probing depth (probing depth \> 3 mm) * no approximal attachment loss \> 2 mm * non smokers exclusion criteria: * systemic diseases * antibiotics and anti-inflammatory drugs within 3 months before the study * untreated caries lesions or local retention factors * mouth-breathing * allergies * previous probiotic supplements in diet

Keywords: bifidobacterium gingivitis gingival crevicular fluid interleukin-1beta probiotics
study on the biomarkers of anti-vegf treatment for choroidal neovascularization

Conditions: Choroidal Neovascularization

Summary: choroidal neovascularization (cnv), also known as subretinal neovascularization, is a proliferative change from choroidal capillaries that has become one of the most important causes of blindness worldwide. cnv can occur in a variety of fundus diseases, including pathologic myopia, polypoidal choroidal vasculopathy. at present, intravitreal injection of anti-vascular endothelial growth factor (vegf) drugs is the first-line effective treatment for cnv. although a number of clinical studies have shown that the treatment of cnv with anti-vegf drugs has achieved good visual and anatomical effects, there are still some patients whose cnv has not decreased significantly or even progressed continuously after treatment. rapid advances in imaging technology have made it possible to explore the quantitative and qualitative characteristics of choroid and cnv, especially swept source optical coherence tomography angiography (ss-octa). the objectives are to improve the octa typing of cnv and analyze the vascular morphological characteristics of each type; to identify the changes in vascular characteristics of cnv after anti-vegf treatment in vitreous cavity; and to elucidate the predictive effects of neovascularization and choroidal vascular characteristics on visual acuity and anatomic effects of vitreous anti-vegf drug treatment for cnv.


Eligibility criteria:
inclusion criteria: * age \>18 years old * active choroidal neovascularization (activity criteria: blood vessel leakage confirmed by ffa, or subretinal fluid accumulation or bleeding seen by oct) * history of anti-vegf drug therapy * at least 3 months of follow-up data. exclusion criteria: * unable to complete the examination due to severe cataract or vitreous hemorrhage * any retinal diseases except choroidal neovascularization, such as multifocal choroiditis, diabetic retinopathy * history of intraocular surgery
a study of imaging, blood, and tissue samples to guide treatment of colon cancer and related liver tumors

Conditions: Colon Cancer; Liver Tumors

Summary: the purpose of this study is to explore novel ways of diagnosing colon cancer and predicting its propensity to spread to other organs such as the liver.


Eligibility criteria:
inclusion criteria: * patients must be undergoing one of the following procedures as part of their routine care in order to meet the inclusion criteria: * operation for presumed stage i-iv colon cancer including colectomy, hepatectomy, or abdominal surgery (e.g. insertion of haip) * colectomy for presumed benign or pre-malignant colon tumors (e.g. large nonneoplastic polyps or adenomas) * open, laparoscopic, or robotic resections * ≥18 years old exclusion criteria: * extrahepatic crc metastasis * no preoperative portal venous phase ct scan performed up to two months prior to day of surgery pathology demonstrating a malignant tumor other than colorectal adenocarcinoma. * stage iv colon cancer with resectable hepatic disease undergoing hepatectomy with active primary colon tumor still in place (despite chemo-radiation therapy) and no plans for colectomy. * receipt of experimental therapies for colon cancer (e.g. checkpoint inhibitors or novel targeted agents). of note, approved targeted agents (such as anti-angiogenic agents, egfr inhibitors etc) are not an exclusion criterion. * history of non-colonic malignancy w/in 5 years (except non-melanomatous skin cancer) * colon cancer with microsatellite instability (msi-high) if known preoperatively * known hereditary colon cancer syndrome such as familial adenomatous polyposis (fap) or hereditary nonpolyposis colorectal cancer (hnpcc) * known liver disease (e.g. non-alcoholic steatohepatitis, cirrhosis, viral or other form of hepatitis, etc) * inr \>2 or known clotting factor deficiency * anticipated need for full anticoagulation during hospitalization * receipt of medications that increase significantly the risk of bleeding after liver biopsy (at the surgeon"s discretion) * intraoperative discovery of pathology that precludes the planned surgical resection or liver biopsy, or makes resection futile (such as peritoneal carcinomatosis or other extrahepatic metastatic disease) * operating surgeon deems research interventions to be more than a minimal risk for the patient

Keywords: tissue samples 17-594
efficacy of blis k12 as preventive measure for rheumatic children

Conditions: Rheumatic Fever

Summary: the purpose of this study is to determine whether daily treatment with streptococcus salivarius blis k-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever.

children diagnosed with rheumatic fever are currently given preventive streptococcal treatment with either monthly im (intramuscular injection) penicillin or daily oral penicillin. this preventive treatment is recommended for years until the child is 20 y old or even later. the compliance rate for this treatment declines significantly with time (the injections are painful) and even with good adherence the prevention is not complete. in the last few years a new product licensed as "blis k-12" has been developed and approved by fda as gras (generally recognized as safe) status from 2011. this probiotic treatment prevents the pathogenic strep a from adhering to the throat of the child thus preventing the infection. this kind of prevention is better for the long run for the patient and for the surrounding, it is better tolerated, is effective even if a dose is skipped or missed is not painful and is tasty to the children. so the investigators assumption is that giving this product to children instead of penicillin either orally or intramuscularlly will be better tolerated thus give a better protection profile with much less side effects. the investigators will be giving blis k-12 to those children on the trial on a daily basis for 6 autumn-winter months instead of penicillin and will monitor the children by monthly throat swabs. the investigators will also obtain anti streptolysin blood test at the end of the period from all participants to evaluate possible strep encounters.

Eligibility criteria:
inclusion criteria: * rheumatic heart disease with recommended strep prophylaxis exclusion criteria: * less than one year from first diagnosis * refusal to take the tablets

Keywords: blis k12 streptococcus
cognitive, morphological and neurobiological progressive aspects in bipolar disorders in the elderly: toward to a neurodegenerescence detection?

Conditions: Senile Plaques; Tau Proteins; Alzheimer Disease; Bipolar Disorders; Mild Cognitive Impairment

Summary: the purpose of this study is to identify association between cerebrospinal fluid alzheimer's disease's neurodegenerescence biomarkers (tau, ptau, aß40 and aß1-42) and occurrence of cognitive deficits in older patients with bipolar disorders.


Eligibility criteria:
inclusion criteria: * male or female subject aged between 60 and 80 years old * in patient or out-patient at one of the centers participating in the study * mini-mental state examination (mmse) score \> 20 at baseline * patient with diagnostic of amnestic-mild cognitive impairment * patients suffering of bipolar disorders type i or ii * in remitted (euthymic) state at baseline exclusion criteria: * pre-existing history of dementia * history of neurologic disorder * lifetime history of a severe psychiatric disorder other than bipolar disorders * current medical problems * patients treated with electroconvulsive therapy within the past six months * patients with substance abuse or dependence within the past 12 months * patients hospitalized without consent

Keywords: alzheimer disease bipolar disorders mild cognitive impairement
study to determine the effect of synbiotics in patients with pre-diabetes

Conditions: PreDiabetes

Summary: the aim of this study is to examine the effect of metabolic rheostat™ and butyrate ultra on blood glucose levels after a liquid meal challenge in patients with prediabetes. in addition, the study also aims to look at the effect of metabolic rheostat™ and butyrate ultra on weight, hgba1c, fasting glucose, cholesterol, triglycerides, inflammation markers, and hormones.

this is a double blinded, pilot placebo-controlled trial of two interventions compared to placebo to determine the effects individually of metabolic rheostat™ and butyrate ultra daily consumption for 8 weeks on glucose homeostasis in subjects with prediabetes. the entire study will last 10 weeks including screen. the study will include 20 subjects with prediabetes treated with metabolic rheostat™; 20 subjects with prediabetes treated with butyrate ultra and 20 subjects with prediabetes treated with placebo. participants will take 6 capsules daily, two capsules three times per day 30 minutes prior to each meal for 56 days.

Eligibility criteria:
inclusion criteria: 1. male and female subjects with pre-diabetes. 2. age\> 18 years 3. ability to understand and the willingness to sign a written informed consent. 4. willing and able to comply with trial protocol and follow-up. exclusion criteria: 1. current use of any other investigational agent. 2. current use of any agent for treatment of diabetes. 3. history of adverse effects, intolerance, or allergic reactions attributed to any medications. 4. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 5. abnormal blood analysis for complete blood count (cbc), hepatic and renal injury tests.

Keywords: glucose control microbiome prediabetes
transplantation of autologous cardiac stem cells in ischemic heart failure

Conditions: Heart Failure

Summary: this study is a prospective, randomized, double blind , controlled trial to assess the efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients with ischemic heart failure.

heart failure is a common, costly, disabling, and potentially deadly condition. heart transplantation is the ultimate approach to treating heart failure, but this is costly and excludes patients who are poor candidates for transplantation given their co morbidities, or for whom a donor organ is unavailable. currently, there is no effective intervention to regenerate dead heart muscle after a heart attack. our hypothesis is that cscs regenerates myocardium. in this study all eligible patients are randomly allocated into two study groups by a permuted block randomization method: group a (case group) received 5-10 millions autologous cardiac stem cells, group b (control group) just received placebo. they follow up for 18 months.

Eligibility criteria:
inclusion criteria: * 1- ef≤40 (by echocardiography) 2- not responding to standard therapies for heart failure \>1m 3- nyha class ≥ iii 4- myocardial infarction due to coronary artery atherosclerotic disease 5-an area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or mri) 6-no hiv/viral hepatitis 7-normal liver function (sgpt \< 3 times the upper reference range) 8-no or controlled diabetes (hemoglobin a1c \< 8.5%) 9- ability to provide informed consent and follow-up with protocol procedures exclusion criteria: * 1 prior icd placement(\<2w)/sustained ventricular arrhythmias 2-cardiogenic shock 3- pregnancy and child-bearing 4- congenital / valvular heart disease

Keywords: cardiac stem ce heart failure cardiac function intracoronary transplantation