Kornimate/medical-research-clean huggingface dataset:
clinical management of childhood intestinal lymphoid nodular hyperplasia

Conditions: Intestinal LNH

Summary: aim of this prospective, parallel multi-arm, randomized, clinical trial, was to compare the clinical outcome of patients methods.we recruited children who undergone diagnostic colonoscopy in umberto i pediatric department (rome, italy) from 2008 to 2010. eligibility criteria were: 1) only demonstration of lnh; 2) no concomitant disease; 3) no treatment assumed since the clinical onset. patients were allocated 1:1:1 to dietetic (group a) vs mesalamine (group b) vs no treatment (group c) for a 8-weeks period. skin prick tests and patch test for common foods, and symptoms scoring at baseline and follow up have been performed by blinded clinicians. chi-square test for trend was used to compare the frequency of symptoms score improvement (\>1 point) among groups. the association of baseline features of patients with the clinical response was estimated by frequency analysis.

lymphoid nodular hyperplasia (lnh) of the lower gastrointestinal tract is a common finding in pediatric colonoscopies, whose clinical significance is not yet been clearly established. although initially considered to be a normal, age-related variant, some authors recently suggested to regard lnh as a marker of food allergy (fa).

Eligibility criteria:
inclusion criteria: 1. isolated finding of lnh\[18\], defined as the demonstration of a significant cluster of lymphoid nodules (\>10/visible field) by endoscopy and lymphoid follicle hyperplasia by hystology; 2. negative results of preliminary evaluation exclusion criteria: 1. diagnosis of concomitant inflammatory, rheumatic or infectious disease, and 2. the assumption of any dietetic or therapy since the clinical onset.

Keywords: lymphoid nodular hyperplasia food allergy
a study of epoetin beta (neorecormon) in participants with solid tumors or hematologic malignancies

Conditions: Anemia

Summary: this study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (sc) epoetin beta (neorecormon) in participants with hematologic malignancies or solid tumors. the anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.


Eligibility criteria:
inclusion criteria: * adults at least 18 years of age * multiple myeloma (mm), low-grade non-hodgkin's lymphoma (nhl), chronic lymphocytic leukemia (cll), breast cancer, lung cancer, or ovarian cancer * anemia with low erythropoeitin (epo) levels exclusion criteria: * poorly controlled hypertension * relevant acute or chronic bleeding requiring therapy within 3 months before study drug * treatment with epo within the last 6 weeks * pregnant or breastfeeding females
change in airway responsiveness after allergen exposure

Conditions: Allergic Asthma

Summary: exposure to allergens changes the way the airway responds to some stimuli (methacholine). the investigators will look at whether or not exposure to allergens changes the way the airway responds to a different stimuli (mannitol) and compare that with the known stimuli (methacholine).


Eligibility criteria:
inclusion criteria: * mild, allergic asthma * fev1 greater than 70% predicted * methacholine pc20 less than or equal to 16mg/ml exclusion criteria: * known sensitivity to mannitol or other excipient * diagnosis of any other respiratory or non respiratory disease/disorder that would preclude the individual from participating * recent thoracic, abdominal or eye surgery * recent allergen exposure (4 weeks), respiratory infection (6 weeks) * current immunotherapy * pregnancy * history of anaphylaxis * use of asthma therapies other than short acting beta agonist

Keywords: asthma allergies mannitol methacholine
observational study of long acting injectable medications (lais) in schizophrenia (oasis)

Conditions: Schizophrenia

Summary: the objectives of this study are to describe characteristics, treatment patterns, and outcomes of patients with schizophrenia newly initiated on 1 of 4 fda-approved atypical long acting injectable (lai) antipsychotics (abilify maintena®, aristada®, invega sustenna® or risperdal consta®)

this is a non-interventional, prospective, multi-center observational cohort study. patients at behavioral health clinics will be enrolled and evaluated by health care professionals (e.g., psychiatrists) according to the standard of care. all patients will be followed for approximately 12 months from their enrollment visit.

Eligibility criteria:
inclusion criteria: * must be able to speak, read and understand english * diagnosis of schizophrenia as defined by the treating clinician * newly initiating treatment with 1 of 4 atypical long acting injectables (lais): abilify maintena, aristada, invega sustenna, or risperdal consta) * additional criteria may apply exclusion criteria: * currently participating or planning to participate in an interventional clinical study, or has completed participation in an interventional clinical study within 30 days before enrollment * in the opinion of the investigator, is currently an imminent danger to himself/herself. \[note: a prior history of suicidal ideation or suicidal attempt is not exclusionary.\] * additional criteria may apply

Keywords: alkermes schizophrenia aristada abilify maintena invega sustenna risperdal consta cohort study observational phase 4
japan early diabetes intervention study

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to compare the suppressive effect of two kinds of interventions on the worsening/progression to definite diabetes: standard lifestyle guidance and standard lifestyle guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide).

in newly-diagnosed early diabetes patients, a randomized comparative study will be conducted to compare the suppressive effect of the following two kinds of interventions on the worsening/progression to definite diabetes which has a harmful hyperglycemia i.e. an increased risk of microangiopathy: standard education for the improvement of lifestyle in accordance with the "guidelines for the treatment of diabetes mellitus in japan" of the japan diabetes society (jds) and standard lifestyle guidance combined with pharmacological intervention using the lowest possible dose of commercially available oral hypoglycemic agents (one of acarbose, metformin, or gliclazide) in japan.

Eligibility criteria:
inclusion criteria: * results of 75-g oral glucose tolerance test (75 g ogtt)will be used to confirm fpg \ = 200 mg/dl and hba1c \<= 6.9% exclusion criteria: * type 1 diabetes mellitus * undergoing treatment with steroids * secondary diabetes mellitus * diabetes mellitus due to suspected gene abnormalities * bmi \>= 35 kg/m2 or bmi \< 18.5 kg/m2 * undergone a surgery * severe hyperuricemia (gout) associated with organ dysfunction * severe vascular diseases with organ dysfunction * cancer or other malignant neoplasms * liver cirrhosis or chronic hepatic, chronic renal failure * gastrointestinal disorders * always performing rigorous muscular exercise * severe infection or serious trauma * women who are pregnant * alcohol dependence or drug dependence * drug allergy * anemic * abnormal hemoglobinuria * severe mental disease

Keywords: japan early diabetes intervention study
metastatic spinal cord compression (mscc): treatment timing and survival rate

Conditions: Neoplasm Metastasis; Spinal Cord Compression

Summary: patients with metastatic spinal cord compression (mscc) are treated with different options according to the life expectancy. survival and surgical outcome can be influenced by surgical timing in mscc patients treated with palliative decompression.

mscc patients who underwent palliative decompression after january 2012 in national taiwan university hospital (ntuh) were divided into the preoperative motor function intact group (group a) and motor deficit group (group b). the motor deficit group was subdivided into operation within 48 hours (group b1), and after 48 hours (group b2). all patients underwent palliative decompression and posterior stabilization. investigators did wide laminectomy for tumor invading the vertebral body, and debulking surgery for tumor destructing the posterior column of the spine. investigators retrospectively reviewed all patient records, including patient demographics, prognostic factors for survival (kaplan-meier survival analysis), neurological outcome (frankel grade), primary tumor, complications, and relevance of tomita and tokuhashi scores.

Eligibility criteria:
inclusion criteria: * patients with metastatic spinal cord compression (mscc) who underwent palliative decompression in national taiwan university hospital after january 1st, 2012. exclusion criteria: * patients with metastatic spinal cord compression (mscc) who underwent palliative decompression before december 31st, 2011, or those who were not treated in national taiwan university hospital.
safety and efficacy of a novel glucagon formulation in type 1 diabetic patients following insulin-induced hypoglycemia

Conditions: Hypoglycemia

Summary: in this study, participants with type 1 diabetes received insulin through an infusion into a vein to reduce their blood glucose, and then received nasal glucagon (ng) or glucagon for injection under the skin, and their blood glucose was measured for 3 hours. the main objective of this study was to evaluate the safety and efficacy of intranasal and subcutaneous glucagon (sc) in reversing insulin-induced hypoglycemia in participants with type 1 diabetes.

in the study, up to four (4) treatments were administered as a single dose either intranasally or subcutaneously to eighteen (18) male or female participants under fasting conditions and following the use of insulin to lower blood glucose. the participants were assigned at random to a group that received one treatment for each of the 3 study periods. the glucagon administrations were separated by approximately 7 calendar days. for 2 participants, a single dose of 3 mg ng was administered at the 4th period that was separated by at least 21 calendar days from the 3rd period.

Eligibility criteria:
inclusion criteria: * history of type 1 diabetes between 2 and 30 years * receiving daily insulin injections or insulin pump therapy for at least 2 years * if patient is taking lantus, levemir or equivalent once-daily in the evening as basal insulin, must be willing to transition to once-daily in the morning at least 48 hours prior to 1st dosing, and to follow this dosing regimen for the entire duration of the study * body mass index (bmi) greater than or equal to 20.00 and below or equal to 33.00 kg/m2 * female patients must not be pregnant, and must be using effective contraception. * light-, non- or ex-smokers. a light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. an ex smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study exclusion criteria: * history of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the previous 6 months before day 1 of this study * score ≥4 on the clarke hypoglycemia awareness survey at screening * presence or history of pheochromocytoma (i.e. adrenal gland tumor) * presence or history of significant upper respiratory or allergic (i.e., seasonal rhinitis) disease * presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy * known presence of hereditary problems of galactose and /or lactose intolerance * history of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs

Keywords: hypoglycemia diabetes mellitus
safety of formalin-free fixatives for in-vivo fixation of skin lesions.

Conditions: Skin Abnormality

Summary: existing methods of diagnosing and treating skin lesions are either surgical, which enables an histological diagnosis or destructive (electrodesiccation, liquid nitrogen, laser, caustics) with no possibility of obtaining histology. the ingredients of current formulations for in-vivo skin fixation (mohs, solcoderm) are unstable, inconvenient for application and painful - therefore their use was abandoned. the investigators will examine the safety of stable formalin-free formulations for in-vivo fixation of human skin lesions .these formulations were safe and had a rapid onset of fixation effect in in-vivo animal studies.

the formulations are comprised of standard non-toxic laboratory chemicals that are used in various dermatological preparations. transition metal salts - zinc chloride, zinc bromide, zinc iodide,zinc nitrate, zinc sulphate. copper chloride ,copper bromide, copper iodide, copper nitrate, copper sulphate. keratolytics - salicylic acid , lactic acid, nitric acid, pyruvic acid,oxalic acid, trichloro acetic acid, phenol, resorcinol,urea . the solvents and penetration enhancers of the ingredients - water, ethanol, dimethyl sulfoxide, propylene glycol, glycerol. patients with skin lesions that after clinical diagnosis are usually treated by dermatologists with destructive modalities without an histological evaluation will be included in the study. the clinical diagnoses include viral warts, seborrheic warts, skin tags, solar keratoses, fibromata and hemangiomata. the treated lesions will be located on the trunk and limbs. lesions on the face will not be included in the study. the formulations will be infiltrated intra-dermally into the lesions in a maximal volume not exceeding 0.05 ml. after the achievement of the desired local fixation effect, the lesions will be examined by a pathologist. the patients will be closely followed-up during the procedure and the degree of possible associated pain will be evaluated. possible local infection and the degree of scarring will be evaluated until complete healing of the treated area will occur. the histological result will be informed to the patients.

Eligibility criteria:
inclusion criteria: * patients with skin lesions that are not treated with histology exclusion criteria: * seriously ill patients

Keywords: patients with skin lesions that are treated by dermatologists with destructive modalities without histological evaluation.
study of the functional effects of nusinersen in 5q-spinal muscular amyotrophy adults (sma type 2 or 3 forms)

Conditions: Spinal Muscular Atrophy

Summary: spinal muscular atrophy (sma) is an autosomal recessive disease caused by a mutation of exon 7, in 95% of cases, encoding the gene for the motor neuron survival protein called smn1 (survival motor neuron) located on chromosome 5q. patients with an sma-5q mutation suffer from progressive muscle deficiency and subsequent atrophy induced by degeneration of motor neurons in the spinal cord. gene therapy is now available for the management of spinal muscular atrophy and nusinersen is the first approved treatment. nusinersen has been granted marketing authorization in france since may 30, 2017. nusinersen has a high level of medical service rendered (msr) for types i, ii, and iii, but the improvement in medical service rendered (imsr) is assessed as moderate for types i and ii. for type iii, imsr is not known.

the aim of the study will be to evaluate the impact on functional motor abilities of intrathecally-injected nusinersen in adult 5q-sma type 2 and type 3 persons. if the efficacy of nusinersen protocol will demonstrate the positive impact for patient's, the results of this study would promote an improvement in the medical service rendered in this population in terms of disease stabilization, maintenance of functional capacities and social participation.

Eligibility criteria:
inclusion criteria : * adults (over 18 years of age) * 5q-sma type 2 or 3 * with indication for nusinersen treatment by the physician of the center of reference and competence for neuromuscular diseases * accepting treatment by nusinersen * agreeing to participate in the study (signature of the informed consent form). * living within a radius of 40 km of the investigation center (for logistical reasons related to the conduct of assessments in the patient's home). * affiliated to a social security system. exclusion criteria : * minors (less than 18 years of age) * with a contra-indication to the nusinersen: pregnancy, breast feeding, hypersensitivity to the nusinersen * with a contraindication to lumbar puncture: hemostasis disorder, intracerebral mass * benefiting from another gene therapy drug to treat spinal muscular atrophy.

Keywords: oligonucleotides survival of motor 2 protein muscular atrophy quality of life genetic therapy single-case studies as topic humans adult
role of mr spectroscopy in brain tumors

Conditions: Brain Neoplasms

Summary: in order to come as close as possible to the correct diagnosis of cns tumors, mri is the long-standing accepted method of choice that can in some cases be supported by the use of ct to demonstrate calcification or bone destruction. in individual cases mri spectroscopy can be helpful for the differentiation between neoplasms and inflammatory lesions or surveillance of tumor therapy, just as perfusion

proton magnetic resonance spectroscopy (h-mrs) may be helpful in suggesting tumor histology and tumor grade and may better define tumor extension and the ideal site for biopsy compared with conventional magnetic resonance (mr) imaging. a multifunctional approach with diffusion-weighted imaging, perfusion-weighted imaging, and permeability maps, along with h-mrs, may enhance the accuracy of the diagnosis and characterization of brain tumors and estimation of therapeutic response. integration of advanced imaging techniques with conventional mr imaging and the clinical history help to improve the accuracy, sensitivity, and specificity in differentiating tumors and nonneoplastic lesions.

Eligibility criteria:
inclusion criteria: * all patients with space-occupying lesions exclusion criteria: * post operative cases * non-neoplastic nature
altered mastication contribute to tmj pain

Conditions: Temporomandibular Joint Disorders; Mastication Disorder

Summary: the cause of temporomandibular joint disorders remains unknown. it is considered multifactorial and includes physical (peripheral) and psychosocial (central) factors. it has been showed an association: a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the symptomatic side. this finding argues the possibility of causation of some of these characteristics. this double blind longitudinal study aims to assess if the presence of one habitual chewing side could contribute to temporomandibular joint disorders over time. method. young adults with no signs or symptoms of tmd will be assessed. participants with one chewing side (observed and interview); with steeper condylar path and lower lateral guidance angles will be considered consistent one side chewers, and this side will be considered more susceptible to suffer tmd. mouth opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. four years later, both tmjs of each participant presenting signs and/or symptoms will be evaluated according to dc/tmd.


Eligibility criteria:
inclusion criteria: * healthies * full dentates * normal occlusion * one habitual chewing side exclusion criteria: * severe malocclusion, dental decay, severe periodontal disease. pains from other origins or orthodontics are not criteria for exclusion

Keywords: occlusion pain
efficacy and pharmacokinetic-pharmacodynamic relationship of intranasally administered sufentanil, ketamine, and ct001

Conditions: Pain

Summary: a randomised, double-blind, parallel-group, study comparing the analgesic effect of intranasal ct001 to intranasal sufentanil, intranasal ketamine or placebo for treatment of acute pain in adults undergoing surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed.


Eligibility criteria:
inclusion criteria: * healthy (the american society of anaesthesiologists' physical classification system (asa) i-ii) male or female participants scheduled for surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed * age: ≥ 18 and \< 56 years * body mass index above (\>)18.5 or below (\<) 30.0 kg/m2 * prior to randomisation: numeric pain rating scale (nrs anchored by 0 = "no pain", 10 = "worst pain imaginable") ≥ 5 at rest within 4 hours after the administration of the last dose of local anaesthetic exclusion criteria: * current or history of any clinically significant disease or disorder, which, in the opinion of the investigator, may put the potential subject at risk when participating in the study, or influence the potential subject's ability to participate in the study or influence the study results. * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product that is likely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedure * history of increased bleeding tendency * clinically significant mental illness * opioid risk tool score of \>3 * pain catastrophizing scale score, total points \>30 * hospital anxiety and depression scale (hads), points ≥ 11 for anxiety or ≥ 11 points for depression * daily intake of analgesics * history of alcohol or drug abuse or use of illicit drugs or positive screen for drugs of abuse at screening or on admission to the clinic prior to the administration of the investigational product. * abnormal nasal cavity/airway
change in peripheral oxygen saturation by using different breathing procedures in high altitude

Conditions: Acute Mountain Sickness

Summary: in this investigation the researchers explore whether different types of breathing procedures can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain sickness or a high altitude pulmonary edema.

acute mountain sickness (ams) is a pathological effect of high altitude on humans caused by acute exposure to low partial pressure of oxygen at high altitude. it commonly occurs above 2500 meters of altitude. ams appears as a collection of nonspecific symptoms acquired at high altitude or in low air pressure resembling a case of "flu, carbon monoxide poisoning, or a hangover". it is caused by a drop in pressure and lowering partial pressure of oxygen during increasing altitude. the direct consequence of those changes is a hypoxic pulmonary vasoconstriction (euler-lijestrand-mechanism). in addition a rise in pulmonary blood pressure (hypertonia) can occur so that there is a higher risk of developing a high altitude pulmonary edema (hape). in this investigation the investigators are exploring whether different types of breathing procedures can improve the peripheral oxygen saturation. we are comparing breathing with no regulation with two different procedures of hyperventilation during trekking in different altitudes. procedure 1 (hyperventilation 1) describes inhalation during one step and exhalation during the next step. procedure 2 (hyperventilation 2) describes inhalation and exhalation during one step. the effect of the different breathing procedures can be quantified measuring the peripheral oxygen saturation. in addition the investigators are comparing the breathing rate and the minute ventilation as well as the expiratory end-tidal co2-partial pressure of the three different breathing procedures. furthermore, the investigators are examining the ability to concentrate in order to quantify the effect of ams on organ functions.

Eligibility criteria:
exclusion criteria: * acute clinically significant inter-current diseases

Keywords: ams hape high altitude oxygen saturation mountain climbing breathing