Kornimate/medical-research-clean huggingface dataset:
human repeat insult patch test of wound dressings

Conditions: Skin Sensitization

Summary: the purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of iv clear™, tegaderm chg™ and silicone vehicle control dressings.

a single center, within-subject randomized study design in healthy adult subjects. qualified subjects will complete three phases of the study (induction, rest and challenge). data for irritation, adhesion and pain upon removal will be collected from the individual patch sites.

Eligibility criteria:
inclusion criteria: * male or female, 18 years or older * in good health, as determined by medical history and concomitant medication * able to comprehend and sign informed consent * unable to bear children or willing to use adequate birth control * willing and able to follow study directions, to participate in the study and to return for all specific visit exclusion criteria: * subject pregnant, planning a pregnancy or lactating * diabetes (any type) * mastectomy involving removal of lymph nodes * clinically significant skin disease, including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer * asthma or other severe respiratory disease requiring medication * self-reported immunological disorders including (but not limited to) hiv positive, aids, rheumatoid arthritis, and systematic lupus erythematosus * treatment of any type of cancer within the last two years or history of skin cancer in the test area * use of any of the following: topically applied products (e.g. medicals, lotions, creams, etc.) at the application site within 3 days of first application of test articles, immunosuppressive drugs within 30 days of first application of test articles, systemic or topical corticosteroids within 30 days of first application of test articles, and systemic or topically applied anti-inflammatory and antihistamine medications within 3 days of first application of test articles * participation in any patch test for irritation or sensitization within the last four weeks * participation in any investigational drug study within the last four weeks * damaged skin in or around the test sites which includes: sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfiguration * known sensitization to adhesives, bandages, or materials used in test articles * medical condition which, in investigator's judgment, makes the subject ineligible or places the subject at undue risk
polyamine-enriched diet in healthy older adults with subjective cognitive decline

Conditions: Subjective Cognitive Decline

Summary: the overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance of individuals with subjective cognitive decline.

memory abilities are known to decline during aging, a process that is accelerated in pathological conditions like subjective, mild cognitive impairment (mci) and alzheimer's disease (ad), all of which are a growing public-health concern with devastating effects. polyamines supplementation and corresponding up-regulation of autophagy (i.e., cellular protein degradation pathways) may be a key target of intervention against age-related memory decline. the study will investigate whether a polyamine-enriched dietary supplementation (through capsule intake) could provide positive effects on the cognitive function of elderly individuals (60-80 years old) with subjective cognitive decline.

Eligibility criteria:
inclusion criteria: * cognitive healthy subjects with subjective memory decline and self-reported concerns * 60-80 years old * no manifest dementia (dsm-iv criteria) * no limitations in activities of daily living * capacity for consent exclusion criteria: * gluten, histamine or wheat seedling intolerance * severe neurological, internal or psychological diseases * advanced heart or respiratory diseases, severe arteriosclerosis, untreated thyroid disease or diabetes * malignant tumors, current or past history * brain tumors, stroke * disorders that impair attention * dementia * coagulation disorder, marcumar or ass therapy * drug abuse or alcohol dependency * current polyamine substitution

Keywords: subjective cognitive decline dementia lifestyle polyamine memory elderly prevention treatment dietary supplement polyamine-enriched diet
handball-based exercise and type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this single-arm pilot study aims to investigate the feasibility of a handball-based intervention to people diagnosed with type 2 diabetes, including monitoring aerobic intensities and movement strategies during the intervention, and monitoring recruitment, adherence, and adverse events. furthermore, the study aims to investigate the feasibility of a test battery including both physiological and patient-reported outcomes, and to investigate preliminary exercise effects.

physical activity and exercise are known to be beneficial for increasing insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes. but many patients who recently have been diagnosed with type-2 diabetes is often living a sedentary lifestyle and have poor adherence to physical interventions. high intensity interval training as well as team-based interventions has proven to be effectful in regulation of physiological parameters related to type 2 diabetes. the aim of this study is to investigate the feasibility of a handball-based intervention to people diagnosed with type 2 diabetes

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * understands and speaks danish exclusion criteria: * if general practitioner do not recommend participation in the intervention

Keywords: diabetes mellitus glucose metabolism disorder metabolic diseases endocrine system disease team handball training team sport
fecal microbiota transplantation for early clostridioides difficile infection

Conditions: Clostridium Difficile Infection; Clostridioides Difficile Infection

Summary: clostridioides difficile (cd) infection (cdi) is a global health threat with an urgent need for new treatment strategies. faecal microbiota transplantation (fmt) is effective for recurrent clostridioides difficile infection (cdi), and is currently recommended for multiple (three or more), recurrent cdi infections. the role of fmt earlier in the treatment hierarchy of cdi remains to be determined. in this randomized, double-blinded, placebo-controlled clinical trial, we compare fmt with placebo following standard antibiotic treatment for first or second clostridioides difficile infection.

this is a parallel arm placebo-controlled clinical trial. we aim to include 84 adult patients with their first or second episode of clostridioides difficile (formerly clostridium difficile) infection. all patients receive vancomycin standard therapy. patients are randomised in a 1:1 ratio to two treatments with capsules that contain either fmt+fmt or placebo+placebo. the primary outcome is absence of c difficile-associated disease 8 weeks after randomisation. patients who have fulminant disease where it is deemed unethical to give placebo are offered open-label fmt. the primary outcome in patients with fulminant c difficile infection is 8 weeks mortality.

Eligibility criteria:
inclusion criteria: * 1. or 2. cdi (within a year) defined as: \> 3 bowel movements of bristol 6-7 per day and positive stool cd-test. * age 18 years or higher. exclusion criteria: * pregnancy * does not speak or understand the danish language * current antibiotic treatment other than vancomycin * current treatment with potential interations with vancomycin * allergy to vancomycin * previous anaphylactic reactions due to food allergies * continuous need for proton pump inhibitor * documented gastroparesis * fulminant cdi

Keywords: fecal microbiota tranplantation, fmt, cdi
blood levels of local anaesthetic in hip arthroplasty

Conditions: Osteoarthritis, Hip

Summary: the primary goal is to evaluate ropivacaine blood concentrations during and after local anaesthetic (ropivacaine) infiltration - the caledonian technique - for total hip replacement surgery. the investigators plan to measure these levels by testing blood samples taken over a timed period. this will allow us to confirm whether the current regimen of local anaesthetic use is within safe limits.

local anaesthetic (la) toxicity may occur when the blood levels of a drug become particularly high. there is a need to confirm that the technique is safe to use. in addition, journal case reports may only describe serious side-effects of toxicity such as abnormal heart rhythms whilst more subtle clinical signs are rarely reported. the investigators would like to study whether or not toxic levels may be approached in some patients or whether more subtle toxicity symptoms and signs are missed. for example, irregular heartbeat, low blood pressure or confusion/agitation. therefore, the investigators intend to study ropivacaine blood levels in patients receiving a total hip replacement in the golden jubilee national hospital. a series of timed samples will be taken during the perioperative period. the anaesthesia and surgery will be performed as routine and no new treatment will be involved. patient demographics, ropivacaine blood levels and clinical observations following la administration will be collected.

Eligibility criteria:
inclusion criteria: * male or female patients greater than 65 years of age exclusion criteria: * patients with a known sensitivity/allergy to ropivacaine or amide-type local anaesthetics * patients who are not suitable for the caledonian technique * patients who refuse or are unable to give consent * patients undergoing bilateral hip replacements * patients with known heart, liver or kidney failure

Keywords: hip arthroplasty
a pharmacodynamic study of a personalized strategy for p2y12 inhibition versus ticagrelor in reducing ischemic and bleeding risk

Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention

Summary: in patients with heart attacks, the treatment of choice is to restore blood flow with percutaneous coronary intervention (pci) (use of stents (metal meshes) to open blockages). after pci, the standard drug treatment includes aspirin and clopidogrel. these medications block full function of the platelet cells, which are responsible for clotting. despite their use, patients after pci are at risk for heart attacks, sudden clotting of stents or death. a major contributor may be resistance to clopidogrel. new more potent drugs, which can overcome the resistance, are now available; however, they come with an increase chance of severe bleeding and costs. an ideal solution would be to identify at-risk patients and selectively treat them with more potent drugs, while lower-risk patients continue with clopidogrel. this type of strategy (personalized strategy) would decrease heart attacks and death (compared to clopidogrel), while also preventing bleeding complications (compared to treating all patients with the new drugs). of resistant patients, many carry genes (inherited units) that prevent proper absorption of clopidogrel. our group has developed and tested a new bedside genetic test, which identifies carriers of at-risk genes. however, this technique alone does not identify all at-risk patients. consequently, we have now devised a novel tool, which combines genetics with patient characteristics to identify high-risk patients. the present study combines this new tool into a strategy for personalized treatment. patients with heart attacks who undergo pci will be randomly assigned to 1 of 3 strategies: a) new personalized strategy, b) clopidogrel strategy (previous standard drug) or c) ticagrelor strategy (stronger approved drug). the function of the platelet cells will be measured at 1 month to determine potential benefits. evaluation of this new personalized strategy is important for improving patient outcomes after pci. the hypothesis is that patients receiving a personalized strategy will have decrease risk for future heart attacks and bleeding.


Eligibility criteria:
inclusion criteria: * patients: age \>18 yrs, \< 75yrs -\> 60 kg ( since march 2015 age \>75 and \< 60 kg eligible - but prasugrel reduced to 5mg daily if randomized to personalized therapy arm) * nstemi undergoing pci will be eligible exclusion criteria: - patients will be excluded if they have: i) a contra-indication for clopidogrel or prasugrel or ticagrelor (as per monograph), ii) have an intolerance to aspirin, iii) have absolute requirement for ticagrelor or prasugrel (e.g. stent thrombosis, allergic reaction to clopidogrel), iv) requirement for anti-coagulation treatment, v) a history of stroke, tia or intracranial hemorrhage , vi) a platelet count \ 52%, ix) severe liver dysfunction, x) renal insufficiency (creatinine clearance \< 30ml/min), xi) adjuvant therapy with a glycoprotein iibiiia inhibitor.
proteomic approach using matrix-assisted laser desorption/ionization tandem time-of-flight (maldi-tof/tof) of tumor response in rectal carcinoma after radiochemotherapy

Conditions: Rectal Adenocarcinoma

Summary: treatment for locally-advanced rectal adenocarcinoma includes preoperative radiochemotherapy before surgery with total mesorectal excision in order to reduce tumor infiltration, facilitate oncologic surgery and improve survival. about fifty percent of these patients are good responders i.e. their tumor infiltration reduces in the rectal wall and regional lymph nodes in order to be graded ypt0 to t2 n0 after pathologic assessment (so called downstaging). at the opposite, bad responders (ypt3-4 and/or n+) are not sensitive to standard preoperative radiochemotherapy, and their survival is poor than good responders. until now, response to preoperative radiochemotherapy cannot be anticipated before pathological assessment of surgical specimen. proteomic analysis of sera from good and bad responders to preoperative radiochemotherapy could allow identification of early biomarkers of tumor response, and subsequently adaptation of treatment to increase preoperative treatment efficiency and survival in most patients.

good or bad responders to preoperative radiochemotherapy for locally-advanced rectal adenocarcinoma cannot be anticipated before pathological assessment of rectal specimen. the purpose of this prospective monocentric study is to look for early seric biomarkers predictive of tumor response (good and bad responders) in patients treated by preoperative radiochemotherapy (45 gy) for rectal adenocarcinoma using a proteomic approach. all patients with locally-advanced rectal adenocarcinoma will be enrolled. sequential samples of sera will be collected before, during preoperative treatment and before surgery, and analysed using a maldi-tof-tof method. proteomic analysis will be correlated to pathological response in order to identify potential early biomarkers of tumor response.

Eligibility criteria:
inclusion criteria: * t3t4 or n+ m0 rectal carcinoma * histologically-proven adenocarcinoma * from 0 to 15 cm from the anal verge * patient is at least 18 years of age * ecog performance status \</= 2 * patient and doctor have signed informed consent exclusion criteria: * metastatic disease * t1-t2 n0 rectal carcinoma * contra indication of radiotherapy or chemotherapy * history of cancer * severe renal insufficiency * symptomatic cardiac or coronary insufficiency * patient included in a trial * previous radiotherapy or chemotherapy for this cancer * no contraceptive treatment

Keywords: tumor response rectal adenocarcinoma preoperative radiochemotherapy proteomic analysis maldi-tof-tof rectal adenocarcinoma, tumor response after preoperative radiochemotherapy
exercise study in patients with lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: in the course of their disease patients with non small cell lung cancer (nsclc) often experience impaired psychological and physical functioning resulting in a reduced quality of life (qol). the aim of the study is to explore the feasibility and the effects of an eight weeks combined muscle strength and endurance training on physical capacity and qol.

in this open, prospective, single center study 40 patients (pts) with nsclc undergoing adjuvant or palliative chemo-/ or radiotherapy are enrolled. physical status is assessed by using the 6 minute walk test (6mwt) for endurance and by using the handheld dynamometer (hhdm) for strength (flexion and extension of elbow, hip and knee). psychological performance is measured by standardized questionnaires (mfi, fact-l, phq - 9). data are collected at baseline (t0) and after the 8 weeks sports intervention (t1). pts are instructed to train at least 5 times/ week in the inpatient setting. after discharge pts are instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. feasibility is defined as an adherence of two trainings per week during at least 6 weeks (out of 8 weeks of the intervention).

Eligibility criteria:
inclusion criteria: * male and female patients * histological confirmed diagnosis of non small cell lung cancer (nsclc) * current treatment: chemo-and/or radiotherapy * age \> 18y * body mass index (bmi) \> 18 * written informed consent exclusion criteria: * acute infection * immobility \> 2 days * severe neurological impairment * severe cardiac impairment * severe pulmonal impairment * severe renal impairment * acute bleedings * alcohol-/drug-abuse

Keywords: nsclc exercise intervention quality of life
esmolol vs. labetalol in endoscopic sinus surgery

Conditions: Chronic Sinusitis

Summary: the purpose of this study is to compare esmolol and labetalol bleeding and intra-operative visibility scores in functional endoscopic sinus surgery.

background: improved intraoperative visibility during functional endoscopic sinus surgery (fess) decreases the risk of serious orbital or skull base injuries. beta blockers are among several methods used to reduce mean arterial pressure (map), heart rate (hr) and mucosal bleeding. labetalol (mixed alpha-1-beta blocker) reduces hr and map; however, its alpha-1 blockade may mitigate topical epinephrine decongestant effects. esmolol (selective beta-1 blocker) does not have direct antagonistic effects on topical epinephrine. this study compares the hemodynamic parameters (rate of blood loss, map control, hr) and intraoperative visibility during fess between esmolol and labetalol.

Eligibility criteria:
inclusion criteria: * history of crs with or without nasal polyps * undergoing fess for crs * american society of anesthesiologists (asa) physical status 1 (healthy) or 2 (patient with mild systemic disease). exclusion criteria: * pregnancy * asthma * copd * bradycardia * heart failure * end stage renal disease * cerebrovascular accident * diabetes mellitus * preoperative use of nsaids, aspirin, or beta-blockers * body mass index (bmi) greater than 40 kg/m2.
detection of familial hypercholesterolaemia in cardiovascular disease registry

Conditions: Familial Hypercholesterolemia; Cardiac Event; Percutaneous Coronary Intervention

Summary: familial hypercholesterolaemia (fh) is an autosomal dominant somatic mutation commonly located on the ldl-receptor, apob, and pcks9 gene. the estimated prevalence of homozygous fh is estimated at 1 in a million, whereas the prevalence of heterozygous fh ranges from 1/500-1/200 (0.2-0.5%) of the general population. the majority of individuals suffering from fh remain undiagnosed and without treatment. using preexisting clinical guidelines, this study scored patients within national cardiovascular disease (cvd) registries for fh with the aim of evaluating prevalence of fh among individuals suffering from premature cardiac events within the uk. following scoring of the registry, this study also examined the relationship between cholesterol and survival after a premature event in order to understand the possible ramifications of untreated fh on patient survival.

familial hypercholesterolaemia (fh) is a genetic disorder caused by a mutation in the low-density lipoprotein receptor (ldl-r) gene. individuals suffering from fh experience elevated cholesterol levels that are outside of the accepted range of healthy cholesterol levels. when left untreated fh may cause complications in cardiovascular health and may cause premature cardiac events. current screening methods for this disease do not successfully diagnose the majority of fh cases. this study applies three clinical diagnostic tools--dutch lipid clinic network criteria (dlcn-criteria), make early diagnosis to prevent early deaths (medped) criteria, and the simon broome register criteria--within national registries in order to define possible, probable, and definite cases of fh. the national registries used for this study are the myocardial ischaemia national audit project (minap) and national audit of percutaneous coronary intervention (bcis) audit. following scoring of patients, a one-year and 30-day survival model were created in order to assess the effect of elevated cholesterol on survival, as suspected fh patients will have elevated cholesterol levels. data within minap ranges from 2003-2013 and data from bcis ranges from 2007-2014. patient information within the audits was collected following admission to english and welsh hospitals following a coronary event or percutaneous coronary intervention (pci). information related to survival and mortality was collected annually within each audit. participants for this study were those experiencing a premature cardiovascular event or coronary intervention (men \<55 and women\<60).

Eligibility criteria:
inclusion criteria: * experienced a cardiac event and is therefore entered in cvd audit * first registered event within audits exclusion criteria: * under age 18 * previous diagnosis of fh