Kornimate/medical-research-clean huggingface dataset:
plant stanol esters and preventing asthma symptoms

Conditions: Asthma, Allergic; Cardiovascular Diseases

Summary: plant stanols are known to lower low-density lipoprotein cholesterol. however, studies have suggested that these compounds also influence the immune system. asthmatic responses are predominantly t helper (th)2 cell dependent, while plant stanols were previously found to activate th1 cells and shift the immune response away from the th2 cell dominant asthmatic response. the question now is whether this also translates into a reduction of clinical symptoms in asthma patients.the primary objective of this study is to demonstrate clinical benefits of prolonged consumption of plant stanols (delivered via plant stanol esters) in asthma patients. the secondary objectives are to evaluate the mechanisms via which plant stanols modulate the immune system and to evaluate the effects of plant stanol ester consumption on cardiovascular (cvd) risk parameters.


Eligibility criteria:
inclusion criteria: * diagnosed with allergic asthma (gina step 1-4) which is in a stable phase at the moment of inclusion (defined as no changes in asthma control and lung function in (at least) the past three months) * have been treated with prescribed asthma medication for at least one year * aged 18-70 years old * bmi between 20 and 35 kg/m2 * willing to abstain from products containing plant sterols or stanols one month prior to the study (products with a cholesterol lowering claim of becel proactiv, benecol, danacol, store brands) * willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of becel proactiv, benecol, danacol, store brands) * willing to keep the intake of fish oil supplements constant exclusion criteria: * currently smoking or quitted smoking in the past year, with a maximum of 10 packyears as smoking history (packyears = packs per day \* years of smoking) * allergy to an ingredient of the soft chews * suffering from inflammatory diseases (for cvd, illness must be minimally 3 years ago and currently under control in order to participate in the study) * fasting plasma glucose \> 7.0 mmol/l * fasting serum tc \> 8.0 mmol/l * having donated blood within one month prior to the start of the study, or planning to donate blood during the study * pregnant women * breastfeeding women

Keywords: plant stanols asthma immune system metabolic health
diary for severe trauma

Conditions: Post-traumatic Stress Disorder

Summary: treatment of severe trauma patients includes intensive cares. both trauma and intensive care may lead to a post-traumatic stress disorder‬ and then to a decreased quality of life. diaries may improve the frequency and the intensity of ptsd. aim of investigator is to assess if diaries may improve quality of life after a severe trauma.

trauma is the third cause of death in france and the first cause of death of people under 40 years (48 000 deaths a year). severe trauma defined by an injury severity score ( iss) \> 15 implies intensive care. intensive care unit admission induces considerable psychological distress and memory troubles, both promoting posttraumatic stress disorder (ptsd) and symptoms of anxiety and depression. a diary written prospectively during the icu stay by the staff and relatives has been suggested as a means of help¬ing patients to build a more detailed and factual narrative of their icu stay than would be possible based only on their fragmented memories. garrouste et al. have shown that the intensive care unit diary significantly affected posttraumatic stress disorders in surviving patients 12 months after intensive care unit discharge. besides, severe trauma by itself may decrease the quality of life (qol). it is recommended to assess qol on one year after the trauma. in trauma patients, the change in qol is associated with the presence of a ptsd. consequently, severe trauma patients who undergo a double stress, that of the accident and that of the intensive care unit stay: they may so even more have a decrease of their qol by developing a pstd. the investigator formulate the hypothesis that a diary, written by the staff and relatives from the very acute phase of the icu stay (first 48 hours) to the discharge of icu would improve the qol and would decrease the frequency and the intensity of ptsd of the severe trauma patients one year after the trauma.

Eligibility criteria:
inclusion criteria: * all patients over 18 * with severe trauma (injury severity score (iss) \> 15) * admitted in our trauma centered and hospitalized in intensive care unit for more than 48 h exclusion criteria: * non-french language fluent patients * patients with dementia * hospitalization in intensive care unit less than * opposition to data utilization

Keywords: quality of life post-traumatic stress disorder trauma
apob48 metabolism in plasma and interstitial fluid

Conditions: Diabetes Mellitus, Type 2

Summary: postprandial increases in the levels of atherogenic chylomicron remnant lipoprotein particles have long been considered a presumable risk factor for the development of atherosclerosis with time, also in normolipidemic subjects. apob-48 (chylomicron) in blood is a specific marker for intestinal derived lipoproteins. specific aim: to determine if apob-48 containing lipoproteins may appear in ic in the postprandial state after a standard meal and investigate the effect fasting and feeding have on levels of lipids, apolipoproteins and the cholesterol component of lipoproteins in if and plasma. methodology: intercellular fluid will be collected using the cup technique. if will be collected in intervals corresponding to different periods after food intake. the if from these different occasions will then be analysed and compared using fplc and elisa.


Eligibility criteria:
inclusion criteria: * over 18 years. * for the t2d study group: diagnosed with type 2 diabetes. exclusion criteria: for subjects with type 2 diabetes: * systemic inflammatory disease that requires active treatment * thyroid disease that requires active treatment * skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated * treatment with oral glucocorticoids * levels of sr, tsh, t4 or hemoglobin in the blood pronouncedly outside the reference range * pregnancy for healthy controls: * registered disease in the health declaration that requires continuous systemic treatment. exception to the above: well controlled hypertension in which case the subject should not have treatment with more than one antihypertensive drug, the drug must not be an alpha-blocker or beta-blocker or thiazide diuretic * skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated * blood pressure pronouncedly above 140/90 * blood test results pronouncedly outside the reference range * pregnancy
european study in bone sarcoma patients over 40 years

Conditions: Spindle Cell Sarcoma of Bone; Osteosarcoma

Summary: the study is a first step of a process to establish the standard chemotherapy treatment with the aim to improve outcome for patients with these rare tumours. for this reason the study will be non-controlled clinical trial. in this regard, the study aims to determine the feasibility of intensive chemotherapy in this age group, and/or separate efficacy analyses according to the different histologic categories and whether the number of patients recruited by the co-operating groups permits future randomised studies.

wide surgical removal of the tumor with the addition of a systemic treatment based on the antineoplastic drugs active against osteosarcoma (adriamycin, cisplatin, ifosfamide, methotrexate). the use of radiation therapy will be given to patients with unresectable tumors. it is recommended in patients who underwent inadequate surgical removal of the tumor. the addition of radiation therapy can not compensate for an adequate surgical treatment. all the patients eligible for the study will receive the planned systemic treatment. depending on clinical features, and feasibility of adequate surgical removal of the tumor, patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment or only an adjuvant chemotherapy. in case of immediate surgery, patients will receive an adjuvant treatment with the 3-drug regimen (cisplatin-adriamycin-ifosfamide).

Eligibility criteria:
inclusion criteria: 1. histologically proven diagnosis of high-grade sarcoma of bone of any site. 2. histologic types: osteosarcoma (high-grade surface, central primary and secondary), fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated chondrosarcoma, angiosarcoma. 3. age: 41 - 65 4. normal bone marrow, hepatic, cardiac and renal function 5. absence of contraindications to the use of cisplatin, adriamycin, and ifosfamide 6. written informed consent exclusion criteria: 1. planned chemotherapy and/or follow-up not feasible 2. previous chemotherapy treatment, which contraindicates the use of one or more drugs, included in the present protocol 3. previous chemotherapy treatment for the current tumor 4. white blood count \< 3.0 x 109/l, and platelets \< 100 x 109/l 5. creatinine clearance \< 70 ml/min 6. left ventricular ejection fraction \< 55% or fractional shortening rate of the left ventricle \<28% 7. serum transaminases and bilirubin \> 2 times the normal values 8. ecog performance status \> 2 9. chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma and ewing's family tumors.
low glycemic index diet in patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to investigate if a low glycemic index diet in comparison with a medium/high glycemic index diet improves the metabolic control in patients with type 1 diabetes.

the glycemic index (gi) was introduced by jenkins and co-workers in the early 1980s, and is a concept for ranking of carbohydrate foods based on their effect on postprandial glycaemia. a meta-analysis of randomised controlled trials of the effect of low gi diets in the management of diabetes showed a beneficial effect (i.e., a reduction in hba1c) of low gi versus high gi foods. however, several critical points concerning the gi concept remain, for instance, how to apply it in practical every day life, how to calculate gi in mixed meals, how to find relevant low gi foods, how to ensure compliance to a low gi diet. the most important issue, however, is the fact that studies on the long-term effects of a low gi diet in type 1 diabetes are lacking. in this study, the critical issue of finding palatable low gi foods will be solved in close collaboration with the food industry. this may lead to the development of new commercial products with low gi, which is necessary if low gi diets are to be advocated for diabetics in the future. comparison(s): a low glycemic index diet, compared to a medium/normal glycemic index diet.

Eligibility criteria:
inclusion criteria: * type i diabetes, durability \>5 years * age 20-65 years * normal weight (bmi 19-26 kg/m2) * diabetic treatment with mealtime and bedtime insulin. * hba1c ≤10 % * informed consent to participate in the study. exclusion criteria: * diabetic complications; neuropathy, foot ulcers and/or gastroparesis. * a known food intolerance of gluten, leguminous plants, nuts or almonds. * pregnancy or breast-feeding. * concurrent participation in another research study with metabolic effects. * previously regular follow-up with a dietician at sdc during the last year. * adjustment during the study of medical treatment other than insulin and/or nutritional supplement with metabolic effects. * non acceptance of the study diet or food products that are recommended in the study. * disability to read and understand the danish language. * unable to receive and/or store the test products. * place of residence \>1 hr drive from sdc.

Keywords: diabetes mellitus, type 1 glycemic index diet hba1c lipids
a drug use investigation of enbrel for post-marketing surveillance (pms) for ra and psa

Conditions: Rheumatoid Arthritis

Summary: the objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of enbrel during the post-marketing period as required by korea food and drug administration (kfda)'s regulation. 1. unknown adverse reactions, especially serious adverse reactions 2. incidences of adverse reactions under routine drug uses 3. factors that may affect the safety of the drug 4. factors that may affect the efficacy of the drug this investigation spanned 3 different studies, 0881a-101575 (alias b1801105) nct00195403, 0881a-102018 (alias b1801112) nct00195416 and 0881a-102212 (alias b1801113). all studies have been combined into this record.


Eligibility criteria:
inclusion criteria rheumatoid arthritis * adults: treatment of active rheumatoid arthritis (ra) in adults when the response to disease-modifying antirhematic drugs (dmards), including mtx, has been inadequate * children: treatment of active polyarticular-course chronic active rheumatoid arthritis in children aged 4 to 17 years who have had an inadequate response to, or whom have proved intolerant of, mtx psoriatic arthritis - active and progressive psoriatic arthritis (psa) in adults who do not respond adequately to previous dmards exclusion criteria * patients to whom enbrel is contraindicated as per the local labeling * patients with known hypersensitivity to enbrel or any component of the product * patients with sepsis or risk of sepsis * patients with active infections including chronic or localized infections such as tuberculosis. (treatment of enbrel should not be initiated.)

Keywords: rheumatoid arthritis
leflunomide associated with topical corticosteroids for bullous pemphigoid

Conditions: Bullous Pemphigoid

Summary: bullous pemphigoid (bp) is the most common blistering auto-immune disease of skin with an incidence estimated to 400 new cases per year. topical corticosteroid therapy is considered the standard treatment for bullous pemphigoïd in 2002. topical corticosteroid requires an initial large hospitalization during the acute phase and rehospitalization during relapse. the usefulness of immunosuppressive drugs have suggested by uncontrolled study. in this way, leflunomide could be an alternative therapy, and to reduce relapse and/or resistance risks. this study could prove the efficacity of leflunomide, associated with short time topical corticosteroids.

pre-inclusion stage: case history, clinical examination, laboratory study, inclusion criteria checking. inclusion stage: inclusion and exclusion criteria checking, clinical examination, disease follow-up, written inform consent. ambulatory hospitalisation, laboratory study. treatment and follow-up of the patients. clobetasol propionate cream application and leflunomide introduction. after inclusion, the treatment will begin with 40 g topical corticosteroid per day and 20 mg leflunomide per day. topical corticosteroids will be progressively decreased during 5 months and stopped. follow-up: monthly during one year in the department of dermatology, university hospital (clinical examination, laboratory study).

Eligibility criteria:
inclusion criteria: * adult ≥ 65 years old * bullous pemphigoid : * newly diagnosed bullous pemphigoid : no treatment or topical corticosteroids therapy for less than one month * bp diagnosed : resistance of the bp to the treatment or recurrence 6 months at least after diagnosis * follow up monthly during one year accepted * written inform consent exclusion criteria: * none

Keywords: bullous pemphigoid leflunomide corticosteroid treatment reduction patients are screened by: the physicians in different departments of the hospital, the liberal dermatologists and the general practicioners. phase i: patients will be referred to the investigators of dupuytren hospital dermatology department. phase ii: patients will be referred to the investigators of purpan (toulouse), haut leveque (pessac) and dupuytren (limoges) hospitals.
walking interventions, cognitive remediation and mild cognitive impairment

Conditions: Cognitive Impairment

Summary: the purpose of this study is to determine the effects of a coordinated intervention of cognitive remediation training (crt) and walking intervention on cognition and gait in the elderly.

this is a single blind randomized study designed to understand the effects of different interventions, walking interventions and cognitive remediation in particular, towards cognition and gait in the elderly. the study uses a 4 arm approach consisting of 4 intervention groups, with each intervention lasting for 12 weeks. the investigators will investigate the effect of each intervention towards cognitive function and gait. all interventions will be conducted on site at the pennington biomedical research center, and will be focused on determining the effects of different combinations of walking, cognitive remediation, healthy living courses, and reading. cognitive measures will include objective clinical measures related to dementia, and the gait analysis will include in clinic and "free living" measures related to falls.

Eligibility criteria:
inclusion criteria: * men and women meeting all criteria listed below will be included in the study: * subjects between 65-85 years of age inclusive * subjects with short physical performance battery of 10 or greater * subjects averaging less than 5,000 steps per day * subjects with mini mental state exam 25-28, inclusive * subjects with normal for age physical-neurological exam * subjects able to walk a city block without a walking aid * written informed consent obtained prior to performing any study procedures exclusion criteria: * subjects with difficult walking due to pain or posture * subjects with difficulty in using computer due to significant visual and/or fine motor impairment * subjects with large weight loss (\>15 kilogram) in the last 12 months * subjects with geriatric depression scale \> 9. * subjects with malignancies in the past 5 years, with the exception of skin cancer therapeutically controlled * subjects with abnormal electrocardiogram results. these include: a resting heart rate below 40 bpm or above 100 bpm, previously unknown and/or untreated atrial fibrillation or flutter, evidence of a third degree a-v block, a previously undocumented left bundle branch block, s-t segment depression of greater than 2 mm, evidence of a previous mi, or any other findings that in the clinical judgment of the medical investigator preclude participation in an exercise intervention. * subjects with shortness of breath, exertional angina, uncontrolled high blood pressure or any other chronic medical condition deemed by the physician to preclude participation in an exercise intervention. * subjects with any other medical condition or disease that is life-threatening or that can interfere with, or be aggravated by, exercise. * subjects who currently smoke.
evaluation of prostate cancer margins

Conditions: Prostate Cancer

Summary: pathological assessment of prostate tissue


Eligibility criteria:
inclusion criteria: * diagnosed with prostate cancer * subject must be scheduled for robotic-assisted radical prostatectomy at the clinical site. exclusion criteria: * none
af ablation based on high density voltage mapping and cfae

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the efficacy of additional ablation targeting complex fractionated atrial electrogram area within low voltage zone identified by high resolution mapping in patients with persistent atrial fibrillation.

fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each group. a test group includes those who undergoing ablation targeting low voltage areas which contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a control group includes who undergoing pulmonary vein isolation only.

Eligibility criteria:
inclusion criteria: 1. age over 20 years old and under 80 years old 2. patients with non-valvular atrial fibrillation 3. patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. patients who are available of follow-up at least for more than three months after catheter ablation exclusion criteria: 1. patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm 2. patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease. 3. patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation 4. patients in the subject group vulnerable to clinical study 5. patients who had undergone a prior catheter ablation for atrial fibrillation
safety and effectiveness of infliximab in slovakia when used for rheumatoid arthritis (study p04741)(completed)

Conditions: Rheumatoid Arthritis

Summary: this study will gather information on the safety and efficacy of patients with rheumatoid arthritis (ra) who are starting treatment with infliximab for the first time. patients will be treated in the usual manner according to local guidelines and normal clinical practice.

local patients, diagnosed with ra at the national institute of rheumatic diseases, piestany, slovakia, can participate, if their physicians have decided to treat the patient with infliximab. registration for the trial will be done on a voluntary basis.

Eligibility criteria:
inclusion criteria: * subject must have been given patient leaflet, * subject must not have ever received infliximab at the time of registration, * subject must be a good candidate for infliximab as per summary of product characteristics * subject must sign the approved consent form exclusion criteria: * none
normal lacritin levels in human tears- development of a new clinical assay

Conditions: Tear Protein Lacritin in Human Tears

Summary: purpose: to build a library of normal tear lacritin values by collecting tears from normal adult human subjects and to develop a non-invasive clinical assay for lacritin. such an assay will provide more sensitive indicators of eye disease for clinicians and determine if a particular therapy, such as recombinant lacritin drops, is of benefit.


Eligibility criteria:
inclusion criteria: 1. military health care beneficiary between the ages of 21-55. 2. male or female, of any race, and at least 21 years old and not older than 55 years old at the time of tear collection. 3. appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by principal investigator or sub-investigator. 4. ability and willingness to understand and provide informed consent to participate in this study. exclusion criteria: 1. irritated eye reflected by patient statements or finding of "red" eye. 2. individuals with any infections or inflammatory ocular condition (e.g. have "pink eye" or uveitis). 3. individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotrophic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions. 4. individuals who are on any topical eye medications. 5. anyone who reports previous reaction or the possibility of an allergic reaction to 0.5% proparacaine.

Keywords: lacritin