Kornimate/medical-research-clean huggingface dataset:
noac9 - circulating tumor dna guided follow-up in anal cancer

Conditions: Anal Cancer

Summary: this study investigates if circulating tumor dna can improve the detection of early treatment failure or recurrence in localized squamous cell carcinoma of the anus (scca) after curative chemoradiotherapy thereby increasing the potential for cure. this will be done by comparing the standard follow-up program with ctdna guided imaging follow-up. secondly, the aim is to establish early interventions against late morbidities.

squamous cell carcinoma of the anus (scca) is a rare disease with less than 200 new cases in denmark and sweden each year and approximately 100 new cases in norway and finland but with increasing incidence. primary treatment is chemo-radiotherapy (crt) comprising high dose imrt based radiation therapy with combination chemotherapy of 5-fu and cisplatin. overall treatment response is good in small tumors, but less pronounced for high-risk tumors. in absence of complete pathological response after crt or local recurrence, patients are evaluated for. salvage surgery. the importance of r0 resection on overall survival has been described in several studies. it is suggested that early detection of treatment failure and recurrences increases the chance of possible curative surgery (r0-resection) and thereby overall survival. a follow-up program has 3 purposes 1. to detect lack of complete response to primary treatment 2. early detection of local or distant recurrences 3. describing and managing late morbidity purpose: the main purpose of this follow-up study is to investigate if circulating tumor tdna can improve detection of early treatment failure or recurrences thereby assisting in increasing the potential for cure. secondly, to provide evidence for use of imaging and third objective is to establish early intervention against late morbidities.

Eligibility criteria:
inclusion criteria: * patients with scca eligible for definitive (chemo)radiotherapy * ≥ 18 of years * written and oral consent exclusion criteria: * conditions that will contraindicate blood samples * conditions that will contraindicate a pet-ct scan. * potential lack of compliance to standard fu program and study participation.

Keywords: anal cancer circulating tumor dna plasma hpv follow-up
prevelance of fragmented qrs complex and prolonged qt interval in cirrhotic patients

Conditions: Liver Cirrhosis

Summary: .cardiac affection in liver cirrhosis is a clinical condition characterized by impaired diastolic relaxation and contractility with electrophysiological abnormalities. .cirrhotic patients with cardiac abnormality have higher mortality rates compared to patients without cardiac affection. the suggested pathophysiologic mechanisms of cardiac affection in cirrhotic patients are; alterations in the beta-adrenergic signaling pathway and, myocardial fibrosis formation, sympathetic nervous system activation and changes in ion channels. .as a component of cardiac involvement in cirrhotic patients fragmented qrs complex and prolongation of the corrected qt interval has been documented in most of the cases with liver cirrhosis (lc) and its prevalence increases with the severity of the disease

.cardiac affection in liver cirrhosis is a clinical condition characterized by impaired diastolic relaxation and contractility with electrophysiological abnormalities. .cirrhotic patients with cardiac abnormality have higher mortality rates compared to patients without cardiac affection. the suggested pathophysiologic mechanisms of cardiac affection in cirrhotic patients are; alterations in the beta-adrenergic signaling pathway and, myocardial fibrosis formation, sympathetic nervous system activation and changes in ion channels. .as a component of cardiac involvement in cirrhotic patients fragmented qrs complex and prolongation of the corrected qt interval has been documented in most of the cases with liver cirrhosis (lc) and its prevalence increases with the severity of the disease. .fragmented qrs (fqrs) is a convenient marker of myocardial scar evaluated by 12-lead electrocardiogram (ecg) recording. fqrs is defined as additional spikes within the qrs complex. in patients with cad, fqrs was associated with myocardial scar detected by single photon emission tomography and was a predictor of cardiac events. fqrs was also a predictor of mortality and arrhythmic events in patients with reduced left ventricular function. the usefulness of fqrs for detecting myocardial scar and for identifying high-risk patients has been expanded to various cardiac diseases, such as cardiac cirrhosis, arrhythmogenic right ventricular cardiomyopathy, acute coronary syndrome. fqrs can be caused by zigzag conduction around the scarred myocardium, resulting in multiple spikes within the qrs complex .

Eligibility criteria:
inclusion criteria: * all cirrhotic patients based on history and clinical diagnosis exclusion criteria: 1. patients known to be rheumatic heart disease 2. patients known to be hypertensive 3. patients with documented significant coronary artery disease 4. patients taking drugs that affect qt interval

Keywords: evaluation
three injections of euflexxa (sodium hyaluronate) for treatment of chronic shoulder pain associated with osteoarthritis (oa)

Conditions: Osteoarthritis

Summary: the hypothesis of this study is that by using 3 injections of euflexxa, there will be an improvement in pain levels and range of motion.

to demonstrate that euflexxa is safe for the treatment of chronic shoulder pain associated with osteoarthritis.

Eligibility criteria:
inclusion criteria: 1. be age 30 to 79 2. give written informed consent for trial participation 3. must have shoulder pain for a minimum of 6 months but less than 5 years 4. must have a pain intensity score of \> 5 5. must be willing to discontinue all pain medications 24 hours prior to each clinic visit 6. must have a stable pain medication regime 1 month prior to treatment 7. agrees to maintain pain medication doses within 30% (increase or decrease) of the baseline dose exclusion criteria: 1. any history of full thickness rotator cuff tear or joint effusion 2. a diagnosis of chronic acromioclavical disease, active epicondylitis, or active carpal tunnel disease 3. has had more than 2 corticosteroid injections in the previous 3 months 4. has an infection or an inflammatory condition of the trial shoulder 5. has acute or inflammatory arthropathy in the trial shoulder, e.g. gouty arthritis, psoriatic arthritis or rheumatoid arthritis. has a history of systemic inflammatory arthropathies, e.g. polyarthritis, rheumatoid arthritis, psoriatic arthritis or gout 6. has severe joint effusion of the trial shoulder 7. has a diagnosis of cancer within the past 5 years (basal cell carcinoma is not excluded) 8. has had any hyaluronate agent or other chondroprotective agents in the trial shoulder 9. has a hypersensitivity to ha products, eggs, birds or feathers 10. has a history of substance abuse, alcohol abuse or psychiatric condition, that in the opinion of the investigator, will potentially interfere with participation 11. has any medical condition that may increase the risk associated with intra-articular injections, to include (but are not limited to): thrombocytopenia, blood disorders treated with warfarin or anticoagulants, anemia or other concomitant diseases that, in the opinion of the investigator, will interfere with the evaluation of the trial treatment, e.g., renal or liver disease, uncontrolled diabetes, significant cardiovascular, immune deficiency, or infectious disease 12. is actively involved in a litigation involving workers' compensation 13. is a female that is pregnant, planning to become pregnant or is lactating 14. has participated in a clinical trial within the past four weeks
rehablines: a further use databank to (re)use routine clinical data for scientific research in rehabilitation of people with physical disabilities and/or chronic diseases

Conditions: Rehabilitation

Summary: within the center of rehabilitation multidisciplinary treatment is provided to people with various physical disabilities and/or chronic diseases. during and in the context of this treatment, a lot of data is routinely collected. rehablines is initiated to re-use this routine clinical data in a database for future scientific research. rehablines aims to: - efficiently conduct high quality scientific research aimed at patient characteristics, underlying disease processes, and treatment effects; - provide insight into (short and long-term) treatment effects and efficiency of these rehabilitation treatments; - personalize treatment by comparing data from the individual patient with data from a large number of patients with similar characteristics from rehablines.


Eligibility criteria:
inclusion criteria: * all participants receiving care at the center for rehabilitation of the university medical center groningen exclusion criteria: * n.a.
time restricted eating (tre) and high-intensity interval training (hiit) to improve health in patients with metabolic syndrome (mets)

Conditions: Metabolic Syndrome; Exercise; Weight Loss; Obesity; Cardiometabolic Syndrome; Time Restricted Eating

Summary: studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and cardiometabolic health markers in the absence of caloric restriction. limited research in subjects with metabolic syndrome (mets) suggests that this feeding paradigm may also apply to human health when combined with an exercise training program, but more research is needed to confirm this hypothesis. this project will determine the independent and combined effects of high-intensity interval training and time-restricted eating on cardiometabolic factors among overweight or obese patients with mets. the intervention period will be sixteen weeks. before and after the intervention, mets components (i.e., mets z score), body composition, and physical fitness will be measured and compared between groups who are doing either high-intensity interval training, time-restricted eating, both high-intensity interval training and time-restricted eating, or who are in a control group. physical activity, diet, sleep quality, and intervention adherence will also be measured.


Eligibility criteria:
inclusion criteria: metabolic syndrome patients diagnosed according to the international diabetes federation consensus of 2009 (alberti, et al., circulation): * waist circumference ≥ 92 cm (men) or ≥ 80 cm (women). * triglycerides ≥ 150 mg/dl (or on drug treatment for elevated triglycerides). * reduced hdl-c \< 40 mg/dl (men), \< 50 mg/dl (women) (or on drug treatment for reduced hdl-c). * elevated blood pressure, systolic blood pressure ≥ 130 mmhg and/or diastolic blood pressure ≥ 85 mmhg (or treatment with an antihypertensive drug with a history of hypertension). * elevated fasting glucose ≥ 100 mg/dl (or drug treatment of elevated blood glucose). * age ≥18 to ≤65 years * previously inactive (\<150 min·wk-1 of the moderate-intensity activity assessed by 7-d ipaq exclusion criteria: * pregnancy, and lactation within 24 weeks of study commencement * untreated cardiovascular or renal disease * type 1 diabetes * any condition associated with exercise intolerance. * habitual eating window \< 12 hours * performing high-intensity training more than once a week * body mass variations \> 4 kg three months prior to study commencement * shift work that includes night shifts

Keywords: metabolic syndrome hiit exercise training time restricted eating
prospective randomized clinical trial for effect of stellate ganglion block in medically refractory ventricular tachycardia

Conditions: Refractory Ventricular Tachycardia

Summary: the investigators will compare the effects of psgb(percutaneous stellate ganglion block) in patients with recurrent sustained vt/vf in spite of appropriate medical therapy and cardio-version/ defibrillation after correction of underlying correctable factors with those without psgb by prospective randomized trail. psgb will be performed every 3 days by anesthesiology specialist after cardiologist's request, until the stabilization of vt/vf. we will compare the frequency and episode number of vt/vf, procedure related complication, acute and long-term mortality.

recurrent ventricular tachycardia(vt)/ fibrillation(vf) increases mortality, especially in patients with structural heart disease. it has been reported that cardiac sympathectomy reduces vt/vf episodes in patients with complex vt, long qt syndrome, catecholaminergic polymorphic vt, or myocarditis. however, cardiac sympathectomy operation is hard to conduct in patients with hemodynamically unstable recurrent vt/vf or electrical storm. therefore, we hypothesized that bed-side percutaneous stellate ganglion block (psgb) reduces vt/vf episodes and mortality in patients with repetitive vt/vf who are properly managed with optimal medical therapies.

Eligibility criteria:
inclusion criteria: * patients agreement of consent * af patient age 20-85 * patient are diagnosed refractory ventricular tachycardia * patients who have generated refractory ventricular tachycardia despite of defibrillation and drug therapy * patients with icd have generated icd shock or anti-tachycardia pacing despite of defibrillation and drug therapy exclusion criteria: * patients who do not agree with study inclusion * patients who do not taken stellate ganglion block due to unstable hemodynamic status * patients have experienced major hemorrhagic complication * patients of the dnr status * patients with malignancy tumor, major neurogenic disease or gastrointestinal disease
tachosil® versus standard haemostatic treatment of haemorrhage in cardiovascular surgery (tc-023-im)

Conditions: Haemorrhage; Haemostasis; Cardiovascular Surgery

Summary: to demonstrate efficacy and safety of tachosil® in cardiovascular surgery


Eligibility criteria:
inclusion criteria: all inclusion criteria must be answered "yes" for a subject to participate in the trial. at screening: 1. has the subject given informed consent according to local requirements before any trial related activities? a trial related activity is any procedure that would not have been performed during the routine management of the subject. in this trial the screening is the first trial related activity. 2. for female subjects of childbearing potential: is the pregnancy test at screening negative? 3. does the female subject of childbearing potential use adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device)? 4. is the subject ≥ 18 years of age? 5. is the following planned: an elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary bypass procedure? intra operative (after primary haemostatic treatment): 6. is bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment present? 7. has the area with the most problematic haemorrhage (target area) been identified? (please note that this must be done before randomisation). 8. is it possible to compress the randomised treatment (tachosil® or control fleece material) for 3 minutes? exclusion criteria: all exclusion criteria must be answered "no" for a subject to participate in the trial. at screening: 1. has the subject participated in any other trial with an investigational drug or device within 30 days before inclusion in this trial? 2. does the subject participate in a clinical trial concomitantly with the present trial? 3. is the subject undergoing an emergency operation? 4. has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin? 5. is the subject suffering from known coagulopathy? 6. is the subject currently participating or has the subject previously participated in the tc-023-im trial? 7. is the female subject pregnant or breast feeding? intra operative (after primary haemostatic treatment): 8. has liquid fibrin sealant/glue or tachosil® been applied? 9. has the following occurred: disseminated intravascular coagulation (dic), i.e. micro vascular bleeding?

Keywords: surgical treatment of haemorrhage
clinical decision-making and virtual reality exercise

Conditions: Degenerative Lumbar Spinal Stenosis; Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Intervertebral Discs

Summary: degenerative lumbar spine disease (dlsd) is common in elderly individuals and can result in pain, muscle weakness, and paresthesia. numerous studies have reported that patients with dlsd usually have postural balance instability, which may affect the patient's gait, functional activities, and quality of life. the investigators propose to achieve the following aims: (1) to develop a clinical balance diagnostic tool to identify patients with dlsd who may require lumbar surgery (2) to investigate the effects of virtual reality skateboard exercise training on gait and balance in patients with dlsd, as well as to compare them with asymptomatic participants.


Eligibility criteria:
inclusion criteria: * 1) able to stand and walk for 5 minutes independently * 2) aged between 50 and 80 years * 3) received a diagnosis of dlsd based on imaging exclusion criteria: * 1) previous lumbar surgery * 2) neurological disorder such as stroke or spinal cord injury * 3) metabolic disease such as diabetes mellitus * 4) vestibular disease such as meniere's disease.

Keywords: virtual reality degenerative lumbar spine disease rehabilitation biomechanic balance
examining the effects of neuromodulation on glucose metabolism in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this is an open-label, proof of concept study with a single active treatment arm designed to assess whether cvs-based stimulation has a beneficial effect on patients with type 2 diabetes. the primary outcome measure is a difference between pre and post-treatment a1c.


Eligibility criteria:
inclusion criteria a subject is eligible for the study if all of the following criteria are met: * provide written informed consent prior to enrollment. * is male or female between 18-70 years old. * has been diagnosed with type ii diabetes for greater than 12 months. * is currently either using lifestyle modification or taking one or two of the following oral antihyperglycemic agents and has been on stable doses for 90 days prior to screening: * metformin * dpp-4 inhibitors (sitagliptin, saxagliptin, alogliptin, linaglyptin) * pioglitazone * has an a l c between 7.5 - 9.0% based upon point of care testing performed at visit 1. * currently performs self-monitoring blood glucose checks at least 3 times per week. * able to adhere to protocol requirements. exclusion criteria a subject will be excluded if any of the following criteria are met: * has type 1 diabetes or gestational diabetes. * is pregnant or planning to become pregnant during the course of the study. * current use or use in the past 6 months of sulfonylureas. * current use or use in the past 6 months of insulin * history of cardiovascular disease or cerebrovascular disease. * any planned surgery during the course of the study. * current continuous renal replacement therapy. * current oral or injectable steroid use or use within the previous 3 months. * previous or current treatment with deep brain stimulation. * any previous known disease, injury, or surgical intervention involving the brain or central nervous system. * moderate or greater hearing loss. * presence of a cochlear implant. * diagnosed vestibular dysfunction. * eye surgery within the previous three months. * any history of previous ear surgery. * active ear infections or a perforated tympanic membrane. * presence of a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Keywords: neuromodulation caloric vestibular stimulation type 2 diabetes
a study to evaluate infliximab in subjects with moderate-to-severe psoriasis not responding to standard or biologic therapy (study p04612)

Conditions: Psoriasis

Summary: subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. subjects will receive infliximab infusions (5 mg/kg of body weight) at weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. the efficacy of infliximab will be evaluated by the psoriasis area and severity index (pasi).


Eligibility criteria:
inclusion criteria: * \>=18 to 75 years of age, of either gender, and of any race. * psoriasis covering at least 10% of total body surface area (bsa) and pasi \>=12 at screening and baseline. * diagnosis of moderate-to-severe psoriasis at least 6 months prior the screening. * eligible to infliximab who have failed at least 1 of the following: corticosteroids, methotrexate (mtx), systemic retinoids, cyclosporine, psoralen-ultraviolet a (puva), ultraviolet b (uvb) phototherapy, and/or biologics (etanercept or efalizumab). * eligible according to tuberculosis (tb) eligibility assessment, screening and early detection of reactivation rules. * chest x-ray within 3 months prior to screening with no evidence of malignancy, infection, or fibrosis. * screening and baseline tests (complete blood count \[cbc\], blood chemistry, and urinalysis) must be within protocol-specified parameters. * free of significant disease that could interfere with study evaluations. * willing to give written informed consent and able to adhere to protocol visits and procedures. * women of childbearing potential and all men must be using adequate birth control and must continue to do so for 6 months after receiving the last dose of study medication. * females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. exclusion criteria: * standard concomitant psoriasis therapies. * active or latent tb. * history of chronic infectious disease, opportunistic infection, or serious infection within 2 months of enrollment. * history of lymphoproliferative disease. * malignancy in past 5 years (except treated basal cell carcinoma \[bcc\]). * treatment with tumor necrosis factor (tnf) antagonists within previous 6 weeks. * current drug-induced psoriasis. * females who are pregnant or nursing and females and males who are planning pregnancy within 6 months from the last infusion of infliximab. * previously treated with infliximab. * concomitant diagnosis of congestive heart failure (chf) including medically-controlled asymptomatic subjects. * history of chronic or recurrent infectious disease. * have or have had a serious infection or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to screening. * have or have had an opportunistic infection within 6 months prior to screening.