Kornimate/medical-research-clean huggingface dataset:
influence of persistent food allergy on nutritional status of children with food allergy

Conditions: Food Allergy

Summary: the goal of this single center retrospective cohort study with observational longitudinal follow up is to compare food - allergic children (egg, milk and peanut allergy) with children in control group (children without any food allergy). the main question\[s\] it aims to answer are: * if children with food allergy groups will have lower food intake od micronutrients? * if growth in children with food allergy is worse as in control group? * if they are more malnourished and in the food allergies group is more stunting than in the control group? * if children with milk allergy have lower intake of calcium in their diet and lower mineral bone density? participants will be asked to do 3 day food diary and to have blood analysed (hemograme, complete blood count, serum iron status, serum protein). if there is a comparison group: researchers will compare milk, egg and peanut allergy group to the control group (peers without food allergy) to see if the food allergy affects growth, macronutrient, micronutrient intake.

study design a single center retrospective cohort study with observational longitudinal follow up will be performed. the study will include three intervention groups (milk, egg and peanut allergy) and a control group (children with no food allergy). patients will be 2 to 12 years old. the patients will be recruited at our university medical center ljubljana, pediatric hospital ljubljana, outpatient care of our department for allergology, rheumatology and clinical immunology. this study will be conducted according to the guidelines in declaration of helsinki and approved by ethics committee of slovenia. written informed consent will be obtained from all the subject's caregivers. the investigators will follow patients from confirmation of food allergy on and will collect data about their weight (kg) and height (cm) from our information system or patients' doctor (or caregiver). the investigators will collect data prospectively for 3 months from outpatient registry of our clinic. at the day of appointment patients will bring 3-day nutrition diary which was later analyzed by dietitian. the parents will attend an appointment by the dietitian where they will be informed about food diary analysis result and given the advice to enhance nutrition if necessary.

Eligibility criteria:
inclusion criteria: * ige-mediated food allergy (skin prick test and/or speciﬁc ige combined with an allergy focused history) exclusion criteria: * other chronic diseases (except atopic dermatitis, asthma, anaphylactic reaction, angioedema), * vegetarian or vegan nutrition.
a 6-months infliximab or placebo study in ua at high risk of ra:clinical,radiological and synovial benefit

Conditions: Undifferentiated Arthritis

Summary: patient with undifferentiated arthritis and the presence of anti-citruline (anti-ccp) antibodies are at high risk to develop ra. the presence of anti-ccp is associated with a higher rate of erosion and a higher risk of progressive and severe ra. the investigators have demonstrated in the ciera study that mtx/ifx combination therapy is superior to mtx alone to reduce mri signs of synovitis and bone edema and is clinically more effective. the immunopathogenesis of undifferentiated arthritis is poorly understood. however, synovial studies from patients with early arthritis suggest that ua and ra may share common immunopathogenic mechanisms. one biopsy study of asymptomatic joints in patients with early arthritis demonstrates synovitis in more than half of the joints samples with prominent t cell and macrophage infiltration, similar to rheumatoid arthritis (ra). thus intensive treatment with anti-tnf antibodies (infliximab) may have an impact on multiple immune mechanisms driving synovitis in undifferentiated arthritis and may influence the clinical outcome. recently, methotrexate has been demonstrated to improve the course of undifferentiated arthritis and prevent the development of ra. short regimen of more intensive therapy with infliximab could alter the radiological, immunopathological and clinical outcome.

not necessary

Eligibility criteria:
inclusion criteria: diagnosis of ua absence of american college of rheumatology (acr) criteria active ua defined by a swollen joint count ≥ 1 and \ 3 months), if needed washout of 4 weeks nsaids stable exclusion criteria: other rheumatic inflammatory diagnosis contraindication to mri (pace-maker, etc.) congestive heart disease active or latent tuberculosis

Keywords: undifferentiated arthritis rheumatoid arthritis infliximab
impact of six patient information leaflets (pil) on doctor patient communication

Conditions: Ankle Sprain; Infectious Colitis; Diverticulitis; Pyelonephritis; Prostatitis; Pneumonitis

Summary: the purpose of this "before-after" prospective multicenter study is to assess the impact of six patient information leaflets (pils) on doctor patient communication scale (dpc) and adherence scale for common acute illnesses in emergency ward.

assessing the impact of six patient information leaflets (pils) on doctor patient communication scale (dpc) and adherence scale for common acute illnesses (infectious colitis, diverticulitis, pneumonitis, prostatitis, pyelonephritis , ankle sprain) in two emergency ward. for "before" study without intervention : usual consultation without pil . for "after study" with intervention : the patient is given a pil related to his disease during the consultation. data collection will take place the same day as the consultation by self-administered questionnaire for dpc scale and also between 7 to 10 days after the consultation by phone survey for dpc scale and adherence scale.

Eligibility criteria:
inclusion criteria: * adult patient. * minor aged over 15 years accompanied by a responsible adult. * the patient must be reachable by telephone within seven to ten days following the consultation. exclusion criteria: * illiterate patient. * patient refusing follow-up call. * patient with visual or hearing impairment. * patient non-francophone. * private patient of liberty by judicial or administrative. * person being a measure of legal protection.

Keywords: ankle sprain infectious colitis diverticulitis pyelonephritis prostatitis pneumonitis patient information leaflet (pil) doctor patient communication adherence satisfaction scale doctor patient communication scale adherence scale satisfaction scale
multi-center clinical trial: evaluation of effectiveness and safety

Conditions: Coronary Disease

Summary: this trial aims to demonstrate the non-inferiority of the ci-cms-005 coronary stent system to the study device as well as to the taxus™ express2™ drug-eluting coronary stent system in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.

this is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in japan. historical data from the 2-arm randomized costar ii trial will be used for comparison.

Eligibility criteria:
inclusion criteria: general inclusion criteria * eligible for percutaneous coronary intervention (pci) * documented stable or unstable angina pectoris (class i, ii, iii or iv), documented ischemia, or documented silent ischemia * documented lvef ≥25% within the last 6 weeks. * eligible for coronary artery bypass graft surgery (cabg) exclusion criteria: general exclusion criteria: - * known sensitivity to paclitaxel or polymeric matrices. * planned treatment with any other pci device in the target vessel(s). * mi within 72 hours prior to the index procedure * patient is in cardiogenic shock * cerebrovascular accident (cva) within the past 6 months * acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150 µmol/l) * contraindication to asa or to ticlopidine * thrombocytopenia * active gi bleeding within past three months * known allergy to cobalt chromium * any prior true anaphylactic reaction to contrast agents

Keywords: percutaneous coronary intervention (pci) drug-eluting stent (des)
evaluation of a novel amino acid based moisturizing cream as part of the daily standard skincare regimen recommended during radiation therapy

Conditions: Erythema; Radiation Therapy, Secondary Skin Reactions

Summary: the goal of this clinical study is to evaluate a novel amino acid based moisturizing cream as part of the daily standard skincare regimen recommended during radiation therapy. the main aim of this study is to assess if the investigational product can improve skin redness associated with radiation therapy. participants will apply a moisturizer daily during the course of their prescribed radiation therapy for breast cancer. researchers will compare against the standard of care.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form. * aged over 18 years old. * has been diagnosed with breast cancer and prescribed radiotherapy as a part of their cancer treatment. * planned radiotherapy, as prescribed by the oncologist, is expected to provide a total radiation dose of up to 60 gray within the first 4 weeks of treatment. * be able to adhere to proposed daily wound/site care as proposed by the protocol in line with the aads recommendations. exclusion criteria: * pre-existing skin conditions which in the opinion of the investigator could impact on the integrity of the study or compromise the safety of the patient (i.e., active eczema, psoriasis, or an open wound over the planned site of radiation). * have a concurrent medical condition or poor functional baseline which in the opinion of the investigator would make them unsuitable or able to fully comply with the study protocol. * are pregnant or actively breast feeding. * known allergic reactions to ingredients of the investigational product or the standard of care.
mobile app to help survivors of childhood cancer navigate long-term follow-up care

Conditions: Childhood Cancer; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial studies the effectiveness of a newly developed survivorship mobile application (app) designed for survivors, or their caregivers, of childhood cancer to help them better navigate long-term follow-up care. the survivorship app provides survivors access to their treatment history and follow-up recommendations, improves knowledge of their diagnosis, treatment, risks, and recommended follow-up care by using a message notification. the ability to quickly connect and establish care planning may enhance adherence to recommended follow-up.

primary objective: i. to determine the difference in survivor/caregiver knowledge and understanding of diagnosis, treatment information, and follow-up needs using the survivorship app. secondary objective: i. to validate the usability and effectiveness of the survivorship mobile application. outline: participants are seen in the survivorship clinic and receive education about potential late effects and the survivorship application on study. participants then use the survivorship app for 4 months on study.

Eligibility criteria:
inclusion criteria: * survivors of childhood cancer attending survivorship clinic at university of california, san francisco (ucsf) or caregivers of a childhood cancer survivor attending survivorship clinic at ucsf. * must have a mobile device (smartphone or smart-tablet) with service plan. * must have ability to read, write, and understand english language. exclusion criteria: * an individual who does not meet any of the criteria mentioned above will be excluded from participation in this study.
assessment of serum and tissue tryptase levels in acne vulgaris patients

Conditions: Acne Vulgaris

Summary: acne vulgaris is an inflammatory disorder of pilosebaceous glands. acne is a highly prevalent inflammatory disease affecting approximately 9.4% of the world's population , and estimated up to 90% among adolescents. by natural course acne starts at 7-12 ages and mostly resolves by the third decade of individuals life . mast cells may play important role in maintenance of physiological functions of our body; they also have a role in pathological and inflammatory mechanisms of many diseases. tryptase is suggested to be important for survival as no tryptase-deficient human subject has yet been reported. tryptase is mainly synthesized by mast cells but a very low amount may originate in basophil with no interference with total levels of the enzyme. tryptase is currently considered as a metabolic signaling and effector mediator for acute mast cell degranulation and late phase of allergy and inflammation .


Eligibility criteria:
inclusion criteria: * patients with acne vulgaris ≥ 18 years old, both male and female patients will be included. exclusion criteria: * patients with the following criteria will be excluded from our study: 1- pregnancy and breast feeding women. 2- women on hormonal contraceptions. 3- patients on topical/systemic treatment for av during the last 6 months prior to the study. 4- patients with other dermatological diseases e.g. psoriasis, vitiligo, dle, etc. 5- patients suffering from chronic medical illness such as; diabetes mellitus, thyroid disease, and cancer.
tolerance of infants with cow's milk protein allergy to extensively hydrolyzed rice protein or casein infant formulas

Conditions: Cow Milk Protein Sensitivity; Tolerance; Growth Failure

Summary: the objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.


Eligibility criteria:
inclusion criteria: * full term healthy newborns (37-42 weeks gestation) * weight at birth ≥ 2500 g * aged between birth to 9 months * symptoms of allergy (skin or digetive) * suspicion of cow milk protein allergy * infants whose parents/caregivers/legal guardians have the ability to understand and comply with the requirements of the study * infants whose parents/caregivers/legal guardians gave their written informed consent to the infant's participation in the study exclusion criteria: * children who have returned to breastfeeding * presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study * in the past 15 days, treatment or medication likely to : * induce confusion in the allergy tets (ex. : skin prick test) and / or * mask the symptoms of an allergic reaction (anti-allergy medications ; anti-histaminic, anti-leucotrienes, corticosteroids, ...) * newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results * children who show signs of malnutrition, or prolonged diarrhea * children whose parents show no willingness to comply with study requirements * consumption of soya protein based, hydrolyzed protein or elemental (amino acid) formula for more than 21 days before inclusion, unless the skin prick test to cow's milk protein is positive, and the ige level indicates the existence of ige mediated allergy to cow's milk protein.

Keywords: allergy cow's milk protein tolerance efficacy infants' growth
transcutaneous mechanical nerve stimulation (tmns) by vibration in the preservation and restoration of urinary continence and erectile function and in the treatment of erectile dysfunction and urinary incontinence in conjunction with nerve sparing radical prostatectomy

Conditions: Erectile Dysfunction; Urinary Incontinence

Summary: after radical prostatectomy nerve damage in the pelvic floor usually occurs. this causes side effects in the form of incontinence and erectile dysfunction. it has previously been shown that one can stimulate the nerves of the pelvic floor by means of transcutaneous mechanical nerve stimulation (tmns) done through vibration. this study will examine the effect of tmns in the preservation and restoration of urinary continence and erectile function and in the treatment of urinary incontinence and erectile dysfunction in conjunction with radical prostatectomy. the theory is that by means of tmns one can stimulate the nerves of the pelvic floor and the penis which may improve their function and there by prevent or minimize the occurrence of incontinence and erectile dysfunction following pelvic surgery. vibration may also help to eliminate these symptoms once they have occurred. it is possible that tmns will also directly increase the blood flow in the cavernosal tissue thus aiding in the preservation of this tissue. in case the improved nerve function is not great enough to secure satisfactory erectile function in itself it may still improve the effect of pde-5-inhibitors. in pilot studies tmns has already shown an effect in the treatment of urinary continence. in this study the patients will be randomized to either tmns treatment or no tmns treatment. in both groups the patients will participate in a pelvic floor muscle training program. in the group receiving active treatment this will be supplemented by tmns treatment. the two groups will be evaluated and compared with regard to erectile function time to continence after surgery.


Eligibility criteria:
inclusion criteria: * scheduled to undergo nerve sparing radical prostatectomy * continent before surgery * a minimum score on the iief-questionnaire of 18 * sexually active exclusion criteria: * treatment with nitrates * treatment with α-blockers * serious cardiovascular disease * severely reduced liver function, * retinitis pigmentosa, * non-arteritic ischemic optic neuropathy (naion) * previous vascular infarction of the eye

Keywords: nerve stimulation tmns prostatectomy prevention restoration treatment vibration non-invasive
assessment of efficacy and safety of uk-390,957 in men with premature ejaculation

Conditions: Ejaculation

Summary: assessment of efficacy and safety uk-390,957.


Eligibility criteria:
inclusion criteria: * premature ejaculation as defined by dsm-iv exclusion criteria: * history of erectile dysfunction
effects of training in a virtual environment in chronic stroke patients

Conditions: Stroke

Summary: the objective of this work will be compare the effects of two balance training programs, one nintendo wii fit-based and the other traditionally-based without the use of a gaming system, on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke patients. it is a prospective, single blinded, randomized clinical trial performed at center of research of the courses of speech therapy, physical therapy and occupational therapy of são paulo university. forty patients will be randomly assigned in control and experimental group, 20 each one.

the objective of this work is to compare the effects of two balance training programs, one nintendo wii fit-based and the other traditionally-based without the use of a gaming system, motor function, balance and quality of life in chronic stroke patients. it is a prospective, single-blinded, randomized clinical trial performed at center of research of the courses of speech therapy, physical therapy and occupational therapy of são paulo university. forty chronic stroke patients are randomly in control and experimental group, 20 each one. both groups conduct 14 training sessions, twice a week, for seven weeks. each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. after this, both groups will performed more 30 minutes of balance training: the control group will performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group will performed the balance training with 8 wii fit games which stimulate motor and cognitive functions. the main outcome measures will be: (1) the lower limb subscale of the fugl-meyer assessment (fma-le); (2); balance evaluation systems test (bestest);(3) the stroke-specific quality of life (ss-qol); (4) 6- minute walk test (6mwt) and (5) the limits of stability (los).

Eligibility criteria:
inclusion criteria: * hemiparetic status resulting from a single stroke at least 6 months earlier; * the ability to walk 10 m independently with or without an assistive device; * the absence of a musculoskeletal condition that could potentially affect the ability to walk safely; * the absence of serious visual impairment or a hearing disorder; * power of at least grade 3 in the hemiplegic lower extremity; * able to understand and follow simple instructions. exclusion criteria: * a montreal cognitive assessment (moca) score of \< 20; * severe dementia or aphasia; * hemispatial neglect, ataxia or any other cerebellar symptom; * inability to stand without minimal assist; * impaired vision * uncontrollable medical complications * participation in other studies or rehabilitation programs

Keywords: postural balance virtual reality exposure therapy gait stroke
the exploration of optimal treatment scheme in patients with type 2 diabetes inadequately controlled with glargine

Conditions: Type2 Diabetes

Summary: glargine is commonly used in insulin supplemental therapy in patients with type 2 diabetes(t2d) at present. however, many patients who treated with glargine still have poor blood glucose control because of insufficient insulin dose or improper oral medication. this study aims to investigate the optimal treatment scheme in order to improve the blood control in these patients. continuous glucose monitoring system (cgms) will be used to assess the blood glucose control at baseline and the moment when the patients achieved standard. oral medications will be standardized first, and insulin doses will be adjusted according to blood glucose values obtained by self-monitoring. glycemic control will be considered as reaching target of glucose if the fasting capillary blood glucose is less than 6.1 mmol/l. the maximum period of blood glucose adjustment will be 1 months. oral medication, the type and dosage of insulin, exercise status, insulin injection skill evaluation, islet function, duration of diabetes, complications and insulin antibodies will be recorded in detail at baseline, reaching target of glucose standard and 3 months after reaching target of glucose.


Eligibility criteria:
inclusion criteria: 1. patients with t2dm, which was defined bypublished criteria of world health organization in 1999; 2. patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study; 3. patients had relatively constant diet and exercise in 2 month before the study. 4. fasting blood glucose was between 6.1 and 16mmoll, and postprandial (or random) blood glucose \<22.2mmol/l exclusion criteria: 1. patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure; 2. patients with severe infectious diseases; 3. patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis; 4. patients with history of psychiatric disorders and were unsuitable to use cgms; 5. any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.