Kornimate/medical-research-clean huggingface dataset:
extensively hydrolyzed formula: hypoallergenicity

Conditions: Food Hypersensitivity

Summary: the primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.


Eligibility criteria:
inclusion criteria: 1. born at term (\>36 weeks gestation) 2. two (2) months to ≤ 12 years of age at enrollment 3. documented cow's milk allergy (cma) within the 6 months prior to enrollment by: 1. reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and \[detectable serum milk-specific ige (\>0.7 kiu/l) or positive skin prick test (wheal greater than 5 mm\]), or 2. physician-supervised oral food challenge that elicited immediate allergic symptoms, or 3. results of laboratory tests highly predictive of clinical reactivity to milk * serum milk ige ≥15 \[kiu/l\]or ≥ 5 \[kiu/l if younger than 1 year or, * skin prick tests mean wheal \>10 mm 4. otherwise healthy 5. if subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled 6. expected daily intake of at least 8 oz (240 ml) of the study formula during the open challenge phase 7. having obtained his/her legal representative's informed consent. exclusion criteria: 1. children consuming mother's milk at the time of inclusion and during the trial 2. any chromosomal or major congenital anomalies 3. any major gastrointestinal disease or abnormalities other than cma 4. chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable) 5. immunodeficiency 6. receiving free amino acid formula 7. anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable) 8. oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay) 9. unstable asthma 10. severe uncontrolled eczema 11. recent ( within the last 3 months) severe anaphylactic reaction to milk 12. subject who in the investigator's assessment cannot be expected to adhere to the study protocol 13. currently participating in another clinical trial

Keywords: cow's milk allergy cma
hypnosis in the management of atopic dermatitis in children and teenagers

Conditions: Dermatitis

Summary: atopic dermatitis (ad) is a chronic inflammatory dermatosis, common in children. it causes pruritus and skin lesions that can have a significant impact on patients' quality of life. ad can be difficult to treat because of its chronicity, demanding local care, corticophobia and the financial cost of non-reimbursed products. patients are often looking for therapeutic alternatives. medical hypnosis is a therapeutic alternative via hypnoanalgesia induced by direct suggestions of comfort and skin soothing and via anxiolysis, by working on stress management and self-esteem reinforcement. four studies are interested in its action in ad and seem to show a reduction in pruritus, skin pain, an improvement in the intensity of atopic dermatitis, sleep, mood and for some a cure of ad. these results are encouraging but limited by the absence of a control group or by the small population included. therefore, we propose in a first step to evaluate the feasibility of an hypnosis program through a pilot study, designed in the miniature format of a future, larger scale, randomized controlled trial.


Eligibility criteria:
inclusion criteria: * children aged 8 to 17 years * understanding french * with moderate to severe ad clinically diagnosed by a physician (scoring atopic dermatitis (scorad) ≥ 25) * referred by their referring physician in the reunionese therapeutic education program for ad provided within the atopy school of the reunion university hospital. - oral consent of the child and of one of the legal representatives collected. exclusion criteria: * children refusing to participate in the hypnosis session * not having the possibility to listen to an audio file, * already practicing self-hypnosis for their ad before inclusion, * having a contraindication to hypnosis (psychiatric disorders, psychosis) * treated by a systemic treatment for their ad.
does inclusion of diaphragmatic breathing exercises in complete decongestive therapy provide further benefits in patients with breast cancer related lymphedema

Conditions: Lymphedema, Breast Cancer; Lymphedema of Upper Limb

Summary: complete decongestive therapy is proven to be effective in reducing lymphedema related symptoms such as swelling and pain. breathing exercises, on the other hand, may also help managing lymphedema symptoms. deep breathing creates a pressure change in the abdomen, which creates a vacuum effect in the thoracic cavity and helps to empty the lymphatic vessels. thus, we aimed to investigate whether addition of diaphragmatic breathing exercises to physical exercise component of complete decongestive therapy provides further benefits on lymphedema volume, pain and quality of life in patients with breast cancer related lymphedema.


Eligibility criteria:
inclusion criteria: * diagnosis of arm lymphedema after being treated for unilateral breast cancer with axillary node dissection * completion of the treatments for the disease including chemotherapy and radiotherapy after breast surgery exclusion criteria: * having recurrent cancer * having cognitive disability * having any concurrent diseases that may interfere with the measurement of lymphedema
effect of liraglutide in combination with sulfonylurea (su) on blood glucose control in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (su) compared to su monotherapy, as assessed by hba1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. liraglutide will be compared to placebo, in combination with su. trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * diet/exercise therapy with sulfonylurea (su) for at least eight weeks * hba1c greater than or equal to 7.0% and less than 10.0% * bmi less than 35 kg/m2 exclusion criteria: * treatment with insulin within the last 12 weeks * treatment with any drug that could interfere with the glucose level * any serious medical condition * females who are pregnant, have intention of becoming pregnant or are breastfeeding
acute response to exercise in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is a chronic inflammatory disease that affects the joints, causing pain, edema, physical disability and poor quality of life. in addition, ra patients are at increased risk of developing cardiovascular disease (cvd) and premature death. the most effective pharmacological treatment is the use of biological agents that inhibit the action of specific substances, such as interleukin 6 (il-6) and tumor necrosis factors (tnf). physical exercise is considered a first-line non-pharmacological treatment in ra, improving inflammatory and metabolic profile, functional capacity, fatigue and preventing the onset of cvd. there is evidence that il-6, when secreted as a result of exercise, brings several benefits. however, there is no study investigating the interaction between biological il-6 blocking agents and exercise on metabolic responses, such as insulin sensitivity and glucose uptake, in patients with ra. to answer this question, adult women diagnosed with ra and healthy controls will be recruited for an acute session of exercise. ra patients will be divided into 2 groups, according to the pharmacological treatment (tocilizumab or anti-tnf). the acute responses of insulin sensitivity after an acute session of exercise will be assessed by the hyperinsulinemic euglycemic clamp, and the molecular pathways will be assessed by muscle biopsy and gene and protein expression analysis. positron emission tomography-magnetic resonance imaging (pet/mri) will be performed to quantify skeletal muscle glucose uptake.


Eligibility criteria:
inclusion criteria: * adult women diagnosed with rheumatoid arthritis under pharmacological treatment, for at least 6 months, with a monoclonal antibody against the interleukin-6 receptor or tnf-alpha inhibitors; * stable dose of monoclonal antibody against the interleukin-6 receptor or tnf-alpha inhibitors in the previous 3 months; exclusion criteria: * any physical limitation or disability that preclude exercise participation; * participation in a structured exercise program in the previous 12 months;
total intravenous anesthesia versus inhalation anesthesia on postoperative liver function

Conditions: Laparoscopic Sleeve Gastrectomy

Summary: the pandemic of obesity has become a serious issue of public health worldwide as the size of the obese population has almost tripled over the last four decades and continues to riseزthe epidemic of obesity has led to a significant increase in the prevalence of non-alcoholic fatty liver disease (nafld). nafld is currently the most common chronic liver disease, with an estimated global prevalence at 25-30%, rising up to 90% in morbidly obese patients

anesthesia and surgery may deteriorate liver function in patients with elevated liver enzyme levels; therefore, in these patients, choosing anaesthetics with less hepatotoxicity may be important. halothane, which is a typical inhalational anesthetic, is known for its liver and kidney toxicity. the latest anesthetic agents, including sevoflurane and desflurane, are associated with less hepatotoxicity, although rare cases of acute liver injury have been reported with these agentsزpropofol (2,6-diisopropylphenol) is an intravenous anesthetic. its pharmacokinetic profile makes it very suitable for total intravenous anesthesia (tiva) and this is a widely used technique in many centers. its use results in a rapid onset and offset with fewer side effects including postoperative nausea and vomiting, making it particularly favorable in the ambulatory setting

Eligibility criteria:
inclusion criteria: * obese patients * had asa i-iii * diagnosed with non-alcoholic steatohepatitis (nash) liver disease * undergoing laparoscopic sleeve gastrectomy exclusion criteria: * cases wherein surgeries were performed using anesthetic methods that were not clearly identified as tiva or inha * heart surgery or cesarean section, and cases of neuromuscular diseases

Keywords: total intravenous anesthesia inhalation anesthesia laparoscopic sleeve gastrectomy
hydroxychloroquine in children's interstitial lung diseases with genetic causes

Conditions: Interstitial Lung Disease; Surfactant Dysfunction

Summary: the aim of this proposed study is to evaluate the efficacy and safety of hydroxychloroquine (hcq) in children's interstitial lung diseases(child) with genetic causes. this study is a randomized controlled clinical trial.

children interstitial lung disease (child) is a heterogeneous group of rare respiratory disorders of known and unknown etiologies that are mostly chronic and associated with high morbidity and mortality. genetic factors are important contributors to child. genetic variations have been mainly described in genes encoding (or interacting with) the surfactant proteins (sp): sp-c (sftpc) and the atp-binding cassette-family a-member 3 (abca3) (abca3), and less frequently in the genes encoding nkx homeobox 2 (nkx2)-1 (nkx2-1), sp-b (sftpb), sp-a (sftpa) and other genes. hydroxychloroquine has been reported to be useful in cases or case series of child including those with genetic causes alone or in combination with systemic steroids. however, the efficacy is highly variable and no randomized controlled study has been reported. the study is a randomized controlled investigation aiming to evaluate the efficacy and safety of hydroxychloroquine in child with genetic causes.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of child with age\<18 years * genetically diagnosed (e.g. sftpc, sftpb, abca3, nkx2-1, csf2ra, csf2rb, iars, mars, copa, slc7a7, lrba) * patients have to be clinically stable with no major changes in their medication in the last 4 weeks * no hcq treatment in the last 12 weeks * signed and dated informed consent of the subject (if subject has the ability) and the representatives (of underaged children) must be available before start of any specific trial procedures exclusion criteria: * acute severe infectious exacerbations * known hypersensitivity to hcq, or other ingredients of the tablets * proven retinopathy or maculopathy * renal insufficiency at screening, defined as glomerular filtration rate (gfr)\< 40 ml/min/1.73 m2 in patients aged 3 to 8 weeks\< 60 ml/min/1.73 m2 in patients ≥ 8 weeks of age * participation in other clinical trials during the present clinical trial
radiotherapy-associated atrial fibrillation

Conditions: Atrial Fibrillation New Onset

Summary: radiotherapy associated atrial fibrillation (radaf) is an observational study to evaluate onset time and frequency of atrial fibrillation in patients with thoracic malignancies and breast cancer. each patient will have 12 lead ecg prior, and daily during radiotherapy.

collected data will be truly anonymised and individuals will no longer identifiable, and than evaluated for occurrence of atrial fibrillation. inclusing criteria: 1. patients with radiotherapy for thoracic malignancy or breast cancer 2. between 18-99 years-old exclusion criteria: 1. patients with history of radiotherapy 2. patients with history of atrial fibrillation 3. patients with pacemaker implantation

Eligibility criteria:
inclusion criteria: * patients with radiotherapy for thoracic malignancy or breast cancer * between 18-99 years-old exclusion criteria: * patients with history of radiotherapy * patients with history of atrial fibrillation * patients with pacemaker implantation

Keywords: atrial fibrillation breast cancer lung cancer thoracic malignancies cardiotoxicity
impact of whey and soy protein ingestion in conjunction with energy restriction in overweight/obese individuals

Conditions: Obesity

Summary: it is known that dieting (restricted energy intake) without resistance training leads to a reduced metabolic rate, and the loss of both fat and muscle mass. when exercise is not included in a period of restricted energy intake, the degree to which muscle mass is lost is highly dependent upon protein consumption. whey protein is a high quality protein isolated from milk and is known to stimulate new protein synthesis for all proteins in your body. previous research has established that the consumption of whey protein has been correlated with retaining muscle mass while stimulating fat loss. however, the mechanisms behind these findings is still unknown. the purpose of this study is to establish a mechanistic underpinning to the efficacy of whey protein versus soy protein and a carbohydrate control (maltodextrin), in promoting fat mass loss and lean mass retention during a period of short-term controlled dietary energy deficit (-750 kcalories/day).


Eligibility criteria:
inclusion criteria: * aged 35 to 55 years old * moderately obese/overweight (body mass index \> 25 and \< 42 kg/m2) * healthy * non-smoker exclusion criteria: * suffer from type 2 diabetes, hyperlipidemia, or thyroid dysfunction * taking medications * having an unstable weight in the past 4-6 months, or dieting at some time during the past 6 months * taking weight loss products or aids (including energy drinks)

Keywords: obesity overweight muscle protein muscle protein synthesis muscle protein breakdown whey soy caloric restriction
development of a validated chart for intermediate vision assessment

Conditions: Myopia; Hyperopia; Presbyopia; Astigmatism

Summary: development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity.

development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity (iva). it is known that no validated method for the evaluation of iva exists. primary objective of the study is to validate a specific computer-based chart (optotype) that will enable: a) comparative studies among different groups of presbyopic patients with refractive errors (ie. myopia, hyperopia, and/or astigmatism), and, b) assessment of the efficacy of surgical refractive procedures (ie. lasik) on presbyopic patients. intermediate visual acuity chart is similar to the prevalent jaeger chart. it consists of short blocks of text in various type sizes.the computer screen is set at a specific reading distance (1 meter) and the patient is asked to read the passage with the smallest type he/she can see. according to the smallest text he/she can read, iva is classified from iva1 (which is considered the equivalent of 20/20 distance visual acuity) to iva5 validation of the computer-based iva chart will be done by correlating the results of the iva chart to the corresponding ones from the validated 20/20 distant and jaeger near visual acuity charts, in a random sample of study participants with different refractive errors and different near and distant visual acuities.

Eligibility criteria:
inclusion criteria: * native greek participants or foreigners with perfect knowledge (verbal and written) of greek language exclusion criteria: * glaucoma or suspicion for glaucoma, * corneal disease or suspicion for corneal disease * fundus disease or suspicion for fundus disease * pregnancy or nursing, * underlying autoimmune disease * mental or neurologic disease
novel lung imaging in adults undergoing radiation therapy to assess for radiation pneumonitis

Conditions: Lung Cancer; Breast Cancer; Mediastinum Lesion; Radiation Pneumonitis

Summary: the purpose of this study is to to compare lung function data generated by applying high fidelity functional lung imaging (hffli) software to 4d ct, cone beam ct, and fluoroscopic images of the lungs breathing to determine whether different modalities of imaging provide similar data on lung movement and function. hffli may detect changes in lung function in patients undergoing external beam radiotherapy for cancer.

this study is designed to test a novel technology to examine early changes in the lung in hopes of identifying patients who may be at risk for radiation pneumonitis. eligible subjects will undergo standard of care treatment with the use of the varian truebeam system for radiation therapy of a cancer lesion in the chest. the imaging data acquired as part of usual standard of care for these patients is a pre-treatment 4d planning ct scan, and a daily cone beam ct at each radiation treatment visit. we will also obtain a series of images consisting of five six-second cinefluorographs (real time fluoroscopic movies, for a total each time of 30 seconds of fluoroscopy) of the lungs while the subject is breathing, each at precisely measured angles to the subject, on 4 different occasions. this study will compare lung function data generated by applying high fidelity functional lung imaging (hffli) software to 4d ct, cone beam ct, and fluoroscopic images of the lungs breathing to determine the degree of correlation between data generated from different imaging modalities. the study is open to adults over the age of 18, at any stage of cancer.

Eligibility criteria:
inclusion criteria: * adults 18 years and older * prospective subjects will have been referred to radiation oncology for treatment requiring the use of the varian truebeam system, for radiation therapy of a cancer lesion in the chest wall, lung, breast, or mediastinum in which the radiation field will include a portion of lung * the subject is able to understand the risks, benefits, and possible alternatives to participation in the study, and is able to give both written and verbal voluntary informed consent exclusion criteria: * for any reason, including pregnancy, subject is considered by the investigator to be an unsuitable candidate or is put at excess risk by the study procedures. * significant existing lung disease, not related to cancer as determined by the pi's review of the patient's pfts.
deployment of american heart association heart failure protocols and content within the intel® health guide system

Conditions: Heart Failure

Summary: this purposed of this study is to ascertain if the implementation of remote patient management systems utilizing american heart association (aha) guideline-based heart failure protocols and educational content can improve the management of patients with congestive heart failure.

this prospective, comparative study uses a pre-post test design to ascertain if the implementation of remote patient management systems utilizing aha guideline-based heart failure protocols and educational content can successfully address the following objectives: * validate the suitability of the intel health guide to deploy aha guideline-based patient care protocols and health content to patients managing congestive heart failure * confirm that the aha protocols as deployed on the hgs are supportive for clinicians following the aha guidelines in a telehealth environment * validate and verify that the data intended to be collected was effectively collected * measure patient and provider satisfaction with use of the system

Eligibility criteria:
inclusion criteria: * patient has a diagnosis of heart failure nyha and is currently in functional class ii- iv status. * patient has been hospitalized for an episode of acute hf decompensation within the last 30 days. * patients with other co-morbidities such as atrial fibrillation, diabetes, coronary artery disease, copd, hypertension, may be included in this evaluation. these conditions shall be documented during enrollment. * have telephone line or broadband internet availability to connect intel® health guide. * are physically and mentally capable to complete the monitoring process or have a caregiver capable of assisting in the use of the intel® health guide. * will be willing and able to sign an informed consent form to participate in this evaluation for a duration of 60 days. * live within a reasonable distance (30 miles or less) from the institution. exclusion criteria: * have a life expectancy of less than six months. * live in a nursing home or other multi-member assisted living facility. * intend to be away from their home for more than 2 weeks (14 days) total during the 60 days. * are unable to read english at a minimum 5th grade level. * do not live within a reasonable distance (30 miles or less) from the institution.

Keywords: heart failure congestive heart failure telemedicine
correcting platelet dysfunction after traumatic brain injury

Conditions: Platelet Dysfunction; Traumatic Brain Injury

Summary: this study evaluates the impact of platelet transfusion on geriatric patients with platelet dysfunction from traumatic brain injury. the authors hypothesize that patients will recover better if their platelet dysfunction is corrected with platelet transfusion.

the geriatric population is subject to traumatic brain injury, often occurring as a result of falls. this patient population is also often receiving anticoagulants and platelet inhibitors increasing their risk of post-injury hemorrhage. following traumatic brain injury, even without platelet inhibitor medications, platelets become dysfunctional and are no longer able to assist with clot formation. therefore risk of hemorrhage is increased, both in the brain, and other hemorrhagic sites. clinical practice at carolinas medical center is to transfuse platelets in patients with platelet dysfunction following brain injury. the current study is investigating the impact of transfusion on correction of platelet dysfunction and patient outcome. furthermore, stored platelet dysfunction can be corrected by supplementation with cytochrome c, which supports mitochondrial function. therefore, the ability of cytochrome c to correct dysfunction in ex vivo platelets from patients with traumatic brain injury will be assessed.

Eligibility criteria:
inclusion criteria: traumatic brain injury with glasgow coma scale score (gcs) \<=13 exclusion criteria: previously know coagulation dysfunction