Kornimate/medical-research-clean huggingface dataset:
artiaid® for knee osteoarthritis: a post-market study

Conditions: Hyaluronic Acid

Summary: the goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of artiaid® intra-articular injection in patients with knee osteoarthritis(oa). the main questions it aims to answer are: * the safety profile of artiaid®; * the clinical performance of artiaid®, such as pain relief and satisfaction of treatment. participants will receive weekly injections of artiaid® for 5 weeks and be follow-up for 26 weeks.

an open-label study will be performed in single center to monitor about 60 patients with knee osteoarthritis(oa), each treated with 5 injections of artiaid® 1.0% (maxigen biotech inc., taiwan). follow-up visits will be at 4 weeks, 12 weeks(a telephone contact by the investigator) and 26 weeks after the injections. the primary endpoint of this study is to monitor the adverse events after injecting artiaid®. the secondary endpoints of this study are demonstrating the clinical performance of artiaid®, such as resting knee pain and satisfaction of treatment by using the visual analog scale (vas). analysis of variance (anova) will be applied to the clinical data and t-test will be used to test for the differences between baseline and each visit. the paired student t-test was used to analyze variations in each group over a period of time. statistical significance was established at p \< 0.05.

Eligibility criteria:
inclusion criteria: * subjects aged older than 40 years old. * able to sign informed consent prior to the study. * subjects have kellgren-lawrence (kl) grade 2 to 3 knee osteoarthritis. * subjects have failed to respond adequately to conservative non-pharmacological therapy. * plasma pregnancy test at screening visit must be negative for fertile female subjects. * subjects in stable progress of disease as judged by the investigator. exclusion criteria: * subjects with known hypersensitivity to hyaluronate preparations. * subjects with infections or skin diseases in the area of the injection site. * pregnancy or breast-feeding woman. * significant drug, alcohol abuse. * joining any clinical trial within 3 months prior to dosing. * subjects have traveled abroad within 3 months prior to the screening visit.

Keywords: viscosupplements osteoarthritis, knee injections, intra-articular
piloting a dietary vitamin e intervention during pregnancy

Conditions: Asthma

Summary: in the last forty years the prevalence of asthma has increased in westernised countries. we have hypothesised that this increase may be a consequence of changing diet. several birth cohort studies have now reported an association between reduced maternal vitamin e intake during pregnancy and childhood asthma. however, it remains to be seen whether increasing maternal vitamin e intake during pregnancy reduces the risk of childhood asthma. we are planning a large placebo controlled trial in pregnant women, to investigate whether optimisation of dietary vitamin e intake to the recommended 15mg/day reduces the likelihood of childhood asthma. we believe that a dietary intervention using vitamin e in its natural form of food is more likely to be successful and acceptable than a vitamin e supplement. we have previously demonstrated than pregnant women can optimise their vitamin e intake using a personalised dietary plan with the help of a dietitian however this intervention was complex and could not be translated into everyday use. with commercial support we have developed a range of soups containing foods naturally rich in vitamin e designed to optimise maternal vitamin e intake to 15mg/day. a range of similar tasting and looking placebo soups has also been developed. in this study we will pilot a randomised controlled trial of the active and placebo soups to ascertain whether pregnant women are willing and able to optimise their vitamin e intake during pregnancy using the soups in order to reduce the risk of their child developing asthma. optimising maternal vitamin e intake during pregnancy.


Eligibility criteria:
inclusion criteria: * 10-12 weeks pregnant. * routine low risk antenatal care. * a personal or partner history of asthma at anytime. * able and willing to give informed consent to participate * able and willing to participate in the study procedures exclusion criteria: * use of vitamin e supplements. * a history of diabetes, coagulopathies or use of anticoagulants, use of clopidogrel, cholestyramine, cyclosporin a, gemfibrozil, isoniazid, orlistat, anticonvulsants. * any other significant disease or disorder which, in the opinion of the investigator, either puts the woman at risk because of participating in the study or may influence the results of the study, or the woman's ability to participate in the study. * participating in another clinical study * previous allocation of randomisation code in the study.

Keywords: asthma pregnancy diet vitamin e
study of the administration of a food supplement in patients with lithiasis treated with extracorporeal shock wave lithotripsy.

Conditions: Lithiasis; Nephrolithiasis

Summary: the extracorporeal shock wave lithotripsy (eswl) is the treatment of choice for most stones in any of their locations. it is about breaking the stone without surgically intervening on the patient and getting him to expel the fragments himself. it is thought that additional treatments to the eswl could improve the success rate of eswl for less favorable stones. the components of our authorized food supplement have shown an inhibitory effect in vitro on the growth of calcium oxalate monohydrate crystals, even in hightly supersaturared solutions. also these components show an inhibitory effect on the growth of calcium phosphate crystals. to sum up, it reduces the formation, inhibits the growth and promotes the dissolution of calcium oxalate and calcium phosphate kidney stones. this is the reason why this experimental study aims to modify the size limit of the stones in the eswl with adjuvant food supplement.

the study treatment will be administered for 10 weeks. first, one dose will be administered every 12 hours for each patient during the 4 weeks prior to eswl. after eswl, and for 6 weeks, one dose will be administered every 24 hours.

Eligibility criteria:
inclusion criteria: * renal lithiasis with high radiological and clinical suspicion of calcium oxalate or calcium phosphate, size of the largest diameter between 1.5x1cm and 2x1cm, which will be treated by eswl, being symptomatic with little probability of spontaneous expulsion. * signed informed consent to participate in the clinical study. exclusion criteria: * lithiasis of more than 20 mm and less than 15 mm for the largest diameter. * taking medications with influence on urinary lithogenesis (citrate, bicarbonate, thiazides, bisphosphonates, magnesium, calcium, vitamin b6, vitamin d, vitamin a, xanthine-oxidase inhibitors, uricosurics, probiotics, urease inhibitors, cystine binders, topiramate , antiretrovirals). * taking medications that influence urine ph (citrate, bicarbonate, carbonic anhydrase inhibitors, l-methionine, vitamin c, ammonium chloride). * taking selective serotonin reuptake inhibitor antidepressant medications. * taking anticoagulants and antiaggregants. * eswl contraindications: urine infection, active or recurrent; hemorrhagic diathesis; pregnant or lactating patients; others (extreme obesity, arterial aneurysm near the location of the stone, etc.).
motivational interview intervention to help patients formulate their goals for medical care in the emergency department

Conditions: Emergency Service, Hospital; Motivational Interviewing; Advance Care Planning

Summary: test the acceptability and feasibility of a brief motivational interview intervention to facilitate advance care planning (acp) conversations for older adults with serious co-morbid illness being discharged from the emergency department (ed). the investigators will interview the participants to understand their perception of the intervention and collect patient-reported outcomes data after leaving the ed.

this study is designed to engage seriously ill older adults in conversations about their goals of care. our intervention is intended to help these patients understand the significance of ed visits in the course of their illnesses.

Eligibility criteria:
inclusion criteria: * ≥65 years of age * english-speaking * capacity to consent * and ≥1 serious illness (new york heart association stage 3 or 4 heart failure, oxygen-dependent chronic obstructive lung disease, chronic kidney disease on dialysis, and metastatic cancer.) or determined by the emergency department provider that the patient has a high likelihood of death in the next 12 months ("i would not be surprised if this patient died in the next 12 months."). exclusion criteria: * acute physical or emotional distress * determined by emergency department provider not to be appropriate * clearly documented goals for medical care already exists (e.g. medical order for life sustaining treatment - molst). * already enrolled in this study
study to determine the efficacy of real-time cgm in preventing hypoglycemia among insulin-treated patients with dm2 on hemodialysis, compared to standard of care (poc bg)

Conditions: End-Stage Renal Disease; Type 2 Diabetes

Summary: the study is conducted to assess the efficacy of real-time cgm data in preventing hypoglycemia in patients with type 2 diabetes and end-stage kidney disease (eskd), treated with insulin therapy and receiving hemodialysis.

the study is conducted to assess the efficacy of real-time cgm data in preventing hypoglycemia among patients with type 2 diabetes (dm2), treated with insulin and receiving hemodialysis. the study will provide novel insights into the glycemic exposure patterns among dialysis patients and will provide preliminary data for future outcomes-based studies determining the best glycemic targets for this group.

Eligibility criteria:
inclusion criteria: * adult subjects with type 2 diabetes * receiving hemodialysis (for at least 90 days) * treated with insulin therapy \[basal insulin alone (glargine u100, glargine u300, detemir, degludec, nph)\], or in combination with bolus insulin (at least one or more injections of aspart, lispro, glulisine, regular insulin) or in combination with incretin therapy (dppiv or glp1) * willingness to wear the cgm * currently performing self-monitored blood glucose (at least 2 times daily). exclusion criteria: * use of sulfonylureas or thiazolidinediones alone or in combination with insulin * use of personal/real-time cgm 3 months prior to study entry (blinded cgm is allowed) * prior use of insulin pumps or hybrid close loop systems (for at least the prior 28 days) * current or anticipated use of stress steroids doses (prednisone ≤5mg or its equivalent is allowed) * subjects who are sensitive or allergic to adhesive * extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites * any condition that, in the opinion of the investigator, would interfere with their participation in the trial (e.g., marked visual or hearing impairment, active alcohol or drug abuse, mental illness) or pose excessive risk to study staff handling venous blood samples * situations that will limit the subject's ability to comply with the protocol (per investigator discretion) * active malignancy * unable to give informed consent * at least 10% of time spent in clinical relevant hypoglycemia (\<54 mg/dl) during blinded cgm period * significant hypoglycemia (\< 40 mg/dl) * severe hyperglycemia (bg\> 400 mg/dl) * extensive skin abnormalities at insertion sites * pregnancy or breastfeeding * severe anemia (hemoglobin \< 5 mg/dl) * polycythemia (hemoglobin \>17 mg/dl) * subjects taking acetaminophen (more than 1 gr every six hours) * hydroxyurea (may cause interference with the sensor membrane).

Keywords: esrd continuous glucose monitoring diabetes
at work and coping - effect study of workcoping for patients with anxiety and depression

Conditions: Anxiety; Depression

Summary: mental disorders, mainly various anxiety and depressive disorders, are an increasing reason for sick leave and disability pension. cognitive behaviour therapy (cbt) has been shown to have an effect on anxiety and depression, but the investigators know little about this in relation to employment. close follow-up in ordinary employment increase employment participation for serious mental illness, but this is not yet investigated to the same degree for lighter mental disorders. center for work-coping (no: "senter for jobbmestring" - sjm) combines cognitive behaviour therapy (cbt) and individual placement and support (ips) and facilitation of work for people with anxiety and depression who are in danger of falling out of work. the purpose of this project is to evaluate the effectiveness of the model in sjm. the effect will be evaluated through a randomized controlled trial (rct) in which participants will be randomized to sjm or regular follow-up by the norwegian labour and welfare administration (nav) or by their regular general practitioners (gp) and self-help resources. the main outcome measures are work participation with changes in mental health as a secondary outcome.


Eligibility criteria:
inclusion criteria: * problems coping with work due to psychological illness (anxiety and depression) * reasonable closeness to work (possible to return within a year) exclusion criteria: * other reasons as primary cause of work problems * serous psychiatric disorders * suicide risk * pregnancy * ongoing psychological treatment (therapy) * ongoing substance abuse

Keywords: anxiety depression vocational rehabilitation common mental disorders mental health problems work related therapy
social media for colorectal cancer screening

Conditions: Colorectal Cancer; Cancer Screening

Summary: using social media for health promotion is an innovative and emerging approach but remains relatively unexplored in cancer screening. uptake of colorectal cancer (crc) screening remains low and standard methods of reaching out are expensive with limited impact. the objective of this study is to conduct a cluster randomized controlled trial (rct) to test the effectiveness of social media messages for crc screening on screening intention (primary outcome). the results of this trial will be of interest to ontario health and are likely to be taken up by other screening programs looking for innovative and novel ways to increase screening participation. the study results will be easily translatable identifying the most compelling crc screening messages while the approach can easily be translated to other cancer disease sites with screening programs.

the investigators will conduct a cluster randomized controlled trial (rct) in facebook users (aged 50+) in ontario. randomization will be done at the level of the forward sortation area (fsa) - the first three characters of the postal code. all fsas in ontario will be randomized to one of six study arms - users assigned to each arm will receive one of the social media messages or no message (control). if users click on the message, a webpage with further information on screening will appear and participants will be asked to indicate intention to get screened for crc. the primary outcome will be intention to screen and secondary outcomes will include other engagement metrics such as reach, cost-per-click, click-through rates, number of likes, number of impressions, and post comments. this study will inform the feasibility of using social media for crc screening and identify the most compelling crc screening messages for the screen-eligible population.

Eligibility criteria:
inclusion criteria: * facebook users in ontario who are between 55-64 years of age

Keywords: social media ad campaigns
real time 3-dimensional echocardiography for left ventricular lead site selection to reduce cardiac resynchronization therapy non-responder rates

Conditions: Heart Failure

Summary: the purpose of this study is to demonstrate that cardiac resynchronization therapy (crt) responder rate can be improved by 3-dimensional (3d) echo-guided left ventricular (lv) lead placement compared to traditional lv lead placement.


Eligibility criteria:
inclusion criteria: * patients will be implanted with an fda approved st. jude medical crt-d device (i.e. promote® or newer devices with similar functionality) * patients will have an approved indication per american college of cardiology/american heart association/heart rhythm society guidelines for implantation of a crt-d * patients will receive a new implant or an upgrade from an existing pacemaker or implantable cardiovertor defibrillator with no prior left ventricular lead placement * patients must be in sinus rhythm at the time of enrollment visit and baseline measurements exclusion criteria: * persistent or permanent atrial fibrillation * heart transplantation * recent myocardial infarction (\< 90 days) * contra-indication to contrast agent * are less than 18 years of age * are pregnant * are currently participating in a clinical investigation that includes an active treatment arm * have a life expectancy of less than 6 months
savepace - search av extension and managed ventricular pacing for promoting atrio-ventricular conduction

Conditions: Sick Sinus Syndrome; Heart Failure, Congestive; Atrial Fibrillation; Bradycardia; Ventricular Dysfunction

Summary: save pace is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent af.

conventional dual-chamber pacing maintains atrioventricular synchrony but results in high percentages of ventricular pacing, which causes ventricular desynchronization and has been linked to an increased risk of atrial fibrillation in patients with sinus-node disease. patients with sinus-node disease and intact atrioventricular conduction are randomly assigned to receive conventional dual-chamber pacing or dual-chamber minimal ventricular pacing with the use of new medtronic pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization. the primary end point was time to persistent atrial fibrillation.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * willing and able to give informed consent * willing and able to comply with the study follow-up schedule * class i/classii indications for dual chamber pacing * initial implant of a kappa 700, kappa 900, enpulse, or enrhythm dual chamber ipg * demonstrate 1 to 1 conduction and a qrs interval of \< 120ms at 100 beats per minutes for a period of nine seconds while atrial pacing exclusion criteria: * less than 18 years of age * unwilling or unable to give informed consent * unwilling or unable to commit to follow-up schedule * medical conditions that would preclude the testing required by the protocol or limit study participation * enrolled or intend to participate in another clinical trial during the course of this study * a life expectancy of less than 2 years * history of continuous atrial fibrillation for the 6 months prior to screen visit * two or more cardioversions, chemical or electrical, within the past 6 months prior to screen * history of persistent second or third degree atrioventricular block * a prior implant of pacemaker or defibrillator device * a baseline, pre-paced qrs \>120 ms on surface ecg * failure of the 1 to 1 atrioventricular conduction test * anticipated major cardiac surgery within the course of the study

Keywords: right ventricular pacing persistent atrial fibrillation atrioventricular conduction heart failure hospitalization cardiovascular health care utilization sinus-node disease minimized ventricular pacing
fracture-related outcome study for operatively treated tibia shaft fractures

Conditions: Tibial Fracture; Fracture of the Tibia Type AO/OTA 42

Summary: approximately 1000 patients presenting with tibial shaft fractures (ao type 42) will be enrolled prospectively in this registry. all patients are treated and followed at 6 weeks, 6 months and 1 year postoperative always following the local standard of care (routine) visit schedule up to 36 months if required. data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications) and their corresponding treatment


Eligibility criteria:
inclusion criteria: * age 18 years or older at the time of the injury * diagnosis of a primary tibial shaft fracture (fracture type 42 according to the ao/ota fracture and dislocation classification) that will be treated operatively as part of standard of care exclusion criteria: * pathological fracture caused by malignancy * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Keywords: fracture fixation surgical treatment fracture reduction
impact of a low carbohydrate breakfast on glucose control in type 2 diabetes

Conditions: Type2 Diabetes

Summary: large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to sustained hyperglycaemia across the day. lowering consumption of dietary carbohydrate is known to reduce post-meal glucose excursions but it is unknown whether lowering the carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout the day. the aim of this study is to examine, under free living conditions and using typical dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal glycemia when compared to consuming a low-fat breakfast (per the current diabetes guidelines).


Eligibility criteria:
inclusion criteria: * physician-diagnosed type 2 diabetes (\>6 months) exclusion criteria: * exogenous insulin * a1c \> 9% * cardiovascular, liver, or renal other disease * breakfast and meal skippers
molecular mechanisms of dutasteride and dietary interventions to prevent prostate cancer and reduce its progression

Conditions: Prostatic Neoplasms; Low Grade Prostate Cancer

Summary: the purpose of this study is to determine whether marine omega-3 fatty acids and 5-alpha-reductase inhibitor are effective in the progression of prostate cancer for low-risk prostate cancer patients.

the study has a duration of 1 year for each participant. subjects will be first assigned to a dietary or a dutasteride intervention that they will consume for the first 6 months. after 6 months, all men will have a combined intervention of dutasteride and diet to complete follow-up of 12 months. this will allow us to study interactive effects. dietary intervention consists on a high w-3 long-chain fatty acids diet without supplement and to reduce intake of saturated and trans fatty acids. prostatic biopsies will be taken at time of diagnosis and at 6 and 12 months after the beginning of the study. blood will be drawn before each prostate biopsy session and urine will be collected before each prostate biopsy and after digital rectal examination.

Eligibility criteria:
inclusion criteria: * low-risk prostatic neoplasms * candidate for active surveillance * informed consent exclusion criteria: * current fish oil supplementation * current nsaid use

Keywords: prostatic neoplasms low grade prostate cancer