Kornimate/medical-research-clean huggingface dataset:
study to evaluate sc route of administration of ofatumumab in ra patients

Conditions: Arthritis, Rheumatoid

Summary: this study will examine the safety and tolerability, pk and pd of subcutaneously administered gsk1841157 in patients with ra on stable dose methotrexate. the study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on pd markers with an acceptable safety profile.


Eligibility criteria:
key inclusion criteria: * male or female aged ≥ 18 years * a diagnosis of rheumatoid arthritis according to the american college of rheumatology (acr1987 classification) of at least six months prior to screening * subjects must be treated with mtx, 7.5-25 mg/week, for at least 12 weeks prior to visit 2, with the last 4 weeks prior to day 2 at a stable dosage * patient must be willing to receive folic acid ≥5mg/wk 4 weeks prior to baseline administered according to locally accepted practice * body mass index (bmi) \< 35kg/m2 (inclusive) * capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form key exclusion criteria: * subjects with a history of a rheumatic autoimmune disease other than ra (except secondary sjögren's syndrome), or with significant systemic involvement secondary to ra (vasculitis, pulmonary fibrosis or felty's syndrome) * previous exposure to biologic cell depleting anti-rheumatic therapies, including investigational compounds (e.g. anti-cd11a, anti-cd19, anti-cd20, anti-cd22, anti-blys/baff, anti-cd3, anti-cd4, anti-cd5, anti-cd52) * exposure to etanercept \< 4 weeks, infliximab or adalimumab \< 8 weeks, or abatacept or anakinra \< 12 weeks prior to visit 2 * received any of the following treatments within 4 weeks prior to visit 2: * anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies) * glucocorticoid unless given in doses equivalent to ≤ 10 mg of prednisolone /day * intra-articular, i.m. or iv corticosteroids * live/attenuated vaccinations * cyclosporine * azathioprine * penicillamine * sulfasalazine * bucillamine * hydroxychloroquine * chloroquine * exposure to leflunomide within 12 weeks prior to visit 2 unless the subject has completed peroral cholestyramine treatment * exposure to gold therapy ≤ 12 weeks prior to visit 2 * exposure to iv immunogammaglobulins ≤ 24 weeks prior to visit 2 * past or current malignant melanoma * chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, renal infection, chest infection with bronchiectasis, tuberculosis and active hepatitis b and c * history of significant cerebrovascular disease * positive plasma / white cell jc virus (jcv) pcr (either compartment)

Keywords: gsk1841157; rheumatoid arthritis, b-cell depletion anti-cd20 monoclonal antibody,
study of human regular u-500 insulin in adult participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to compare the effectiveness of human regular u-500 insulin three times a day versus twice a day.


Eligibility criteria:
major inclusion criteria: * have type 2 diabetes mellitus (world health organization \[who\] classification of diabetes) * have a body mass index (bmi) ≥25 kilogram per square meter (kg/m\^2) * have glycated hemoglobin a1c (hba1c) ≥7.5% and ≤12.0%, as measured by the central laboratory at entry * current u-100 insulin/analogue users on \>200 and ≤600 units per day for ≥3 months at study entry and reconfirmed at randomization * have a history of stable body weight for at least 3 months prior to study entry * concomitant medications may include metformin (met), dipeptidyl peptidase-4 (dpp-4) inhibitors approved for use with insulin at time of study entry (for example, sitagliptin, saxagliptin, and linagliptin), pioglitazone, and/or sulfonylureas (sus)/glinides (repaglinide or nateglinide). participant's oral antihyperglycemic drug (oad) dose(s) must have been stable for ≥3 months major exclusion criteria: * have type 1 diabetes mellitus or other types of diabetes mellitus apart from type 2 diabetes mellitus * have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range * have chronic kidney disease stage 4 and higher or history of renal transplantation * have history of more than 1 episode of severe hypoglycemia within the 6 months prior to study entry * have received insulin by continuous subcutaneous insulin infusion in the 3 months prior to study entry * have received u-500r in the 3 months prior to study entry * have had a blood transfusion or severe blood loss within 3 months prior to study entry or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia * are taking chronic systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study entry * have an irregular sleep/wake cycle * have used rosiglitazone, once- or twice-daily glucagon-like peptide-1 (glp-1) receptor agents, pramlintide, or other injectable or oral antihyperglycemic therapy not listed in the inclusion criteria in the 3 months prior to study entry. participants may not have used once-weekly glp-1 receptor agents in the 4 months prior to study entry * have used any weight loss drugs in the 3 months prior to study entry * have a history of bariatric surgery * have a history of malignancy other than basal cell or squamous cell skin cancer * have new york heart association (nyha) class iii or iv per nyha cardiac disease functional classification * are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable
a study to evaluate the efficacy and safety of asp4901 in patients with benign prostate hyperplasia

Conditions: Benign Prostate Hyperplasia

Summary: the purpose of this study is to compare the efficacy of asp4901 with placebo in patients with benign prostatic hyperplasia. the safety and tolerability of asp4901 will also be evaluated.

this is a multicenter, randomized, parallel-group, placebo-controlled, active-referenced, double-blind study. after obtaining the written consent, patients meeting the eligibility criteria at the preliminary enrollment will receive oral administration of placebo in a single-blinded manner (single-blind placebo run-in period). then, patients meeting the eligibility criteria at the main enrollment will receive drug or placebo (double-blind treatment period) for 4 weeks. furthermore, patients will be followed up for 1 week to confirm the safety of the study drugs after the treatment period (safety follow-up period).

Eligibility criteria:
inclusion criteria: * dysuria associated with bph for at least 12 weeks before providing consent * a total ipss core of 13 or higher * a qol score of 3 or higher * a maximum urinary flow rate (qmax) of ≥4 ml/sec and \<15 ml/sec. * a prostate volume of ≥20 ml. exclusion criteria: * a postvoid residual volume (pvr) of \>350 ml * a previous or concurrent symptomatic urinary tract infection within 4 weeks of the study * a cataract operation scheduled to be performed during the study period * previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study * hypersensitivity to asp4901 or tamsulosin hydrochloride * presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant

Keywords: asp4901 bph
study for the knowledge of risk factors associated with breast cancer in women

Conditions: Breast Neoplasm Female; Nutrition Related Cancer; Habits, Diet; Cancer, Breast

Summary: breast cancer is the most frequent tumor in western women. in spain about 26,000 new breast cancers are diagnosed each year. this type of tumor is increasing worldwide with an increase in aggressive neoplasms in young women. there are some risk factors responsible for this global increase: lifestyle, diet and body weight especially in postmenopausal women. some cell mutations, especially in the brca1, brca2 and p53 genes, are associated with a very high risk of this type of cancer. some authors have calculated the contribution of various modifiable risk factors to the global burden of breast cancer, and they concluded that 21% of all breast cancer deaths are attributable to alcohol consumption, overweight and obesity, and lack of physical activity. nowadays, there aren't specific studies in the community of madrid designed to know the risk factors related to breast cancer. for this reason, it is proposed to carry out an observational study that collects detailed information about dietary habits, genetic factors and life quality of a group of women with recent diagnosis in pre or post-surgical phase.

1. storage of biological sample at the hospital. 2. patient's breast pathology characteristics. 3. study of concomitant pathologies. 4. dietary study: "frequency of food consumption" questionnaire referring to the last year eating habits before having been breast cancer diagnosed. 5. physical activity study in the year prior to the diagnosis of breast cancer. 6. anthropometric study: weight, size, waist circumference and body composition (% fat mass,% lean mass,% body water). 7. study of other risk factors of breast cancer: age, family history, reproductive history, medications consumed... 8. biochemical study: biochemical variables of the last blood analysis performed on the volunteer in the hospital center. 9. saliva collection to proceed with the genetic analysis. 10. collection of stool sample to carry out the microbiota study.

Eligibility criteria:
inclusion criteria: * older women than 18 years old * newly diagnosed patients with a breast tumor (phase i, ii or iii). being in one of the following cases: 1. patient who has not yet received any treatment and the committee has decided that as a first treatment will receive chemo or radiotherapy. 2. patient who has just undergone surgery and is waiting to start adjuvant treatment with chemo or radiotherapy. * sign the informed consent. exclusion criteria: * patients with stage iv disease. * associated eating disorders. * patients with dementia, mental illness or decreased cognitive function. * pregnant or lactating women.

Keywords: breast neoplasm cancer risk factor nutrition
esomeprazole treatment co-diagnosed non erosive reflux disease (nerd) and chronic gastritis patients

Conditions: Non Erosive Reflux Disease; Chronic Gastritis

Summary: to compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and 2 weeks esomeprazole treatment regimen group in co-diagnosed nerd and chronic gastritis patients, as evaluated by gerdq after 24 weeks maintenance treatment/follow up.

a multicenter, randomized, open-label phase iv study exploring symptom control rate in co-diagnosed nerd and chronic gastritis patients treated with 8 weeks esomeprazole treatment regimen and 2 weeks esomeprazole treatment regimen.

Eligibility criteria:
inclusion criteria: * heartburn and/or regurgitation symptoms last for at least 3 months * endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis) within 2 weeks prior to randomization gerdq score =8 exclusion criteria: * endoscopic visible reflux esophagitis, esophageal varices, barrett's esophagus, malignancy or peptic ulcer patients with hp positive result and are eager to take hp eradication therapy will be excluded * if hp positive, patients could take hp eradication therapy after the study completion previous ppi or h2ra therapy in the last 2 weeks before enrollment

Keywords: gi nexium phase iv co-diagnosed nerd
monteggia fractures: analysis of patient reported outcome measurements in correlation to ulnar fracture localization

Conditions: Monteggia's Fracture

Summary: patients who had suffered a monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (prom) after treatment with osteosynthesis.

a retrospective, monocentric study will be performed. patients who underwent surgical treatment after suffering a monteggia injury or a monteggia like lesion between 2012 and 2018 will be included. fractures will classified after bado and jupiter, according to the fracture location of the proximal ulna, as well as regarding the potential accompanying ligamentary injury. in a follow-up examination validated patient-reported outcome measures (disabilities of arm, shoulder and hand score \[dash\], meps \[mayo elbow performance score\], oxford elbow score \[oes\], pain, subjective elbow score) and functionality (range of motion \[rom\], posterolateral instability, strength, valgus-/varus-stress) will be evaluated. in addition, treatment strategy and complications will be analysed.

Eligibility criteria:
inclusion criteria: * patients with monteggia fractures treated with osteosynthesis between 2012 and 2018 * understanding of german language (written and oral) * informed consent exclusion criteria: * patients not meeting the above criteria

Keywords: elbow fracture patient reported outcome
a study to evaluate the effect of wellbutrin xl on intraocular pressure

Conditions: Depressive Disorder

Summary: this study will be conducted in healthy volunteers to investigate the effect on intraocular pressure of 2 weeks of treatment with 300mg wellbutrin xl/day.


Eligibility criteria:
inclusion criteria: * healthy males or females. * non-smokers * agree to remain in the clinic for the time defined in the protocol. * normal ecg. exclusion criteria: * any serious medical disorder or condition. * any history of an endocrine disorder. * any clinically significant laboratory abnormality. * history of psychiatric illness. * any history of suicidal attempts or behavior. * risk factors for precipitation of angle closure glaucoma or elevated iop. * inability to refrain from use of contact lenses during the study days, if correction is required. * self-administered beck depression inventory ii scale total score greater than 9, and a suicide question score of greater than zero. * current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - women having a positive serum hcg pregnancy test at screening, a positive urine pregnancy test before admission to the unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.

Keywords: wellbutrin xl, intraocular pressure, healthy volunteers
impact of cataract surgery on the incidence and progression of dry eye disease

Conditions: Dry Eye

Summary: relation between dry eye and cataract

study the impact of cataract surgery on the incidence and progression of dry eye disease

Eligibility criteria:
inclusion criteria: * patients aged above 40-years old undergoing cataract surgery * patients without dry eye disease * patients with mild to moderate degree of dry eye disease both gender, male and female exclusion criteria: * patients aged less 40-year old undergoing cataract surgery * patients with severe degrees of dry eye disease * patients with autoimmune disease * patients with chronic blepharitis

Keywords: dry eye cataract surgery
application of raw corn starch on patients with insulinoma

Conditions: Hyperinsulinemic Hypoglycemia; Insulinoma; Raw Corn Starch

Summary: this will be a prospective single-arm before-and-after clinical trial in which raw corn starch (rcs) will be first applied on patients with unoperated insulinoma. nutritional intervention with supplementation of rcs will be initiated in 20 patients with suspected insulinoma to improve their hypoglycemia before the surgery. duration of nutritional intervention, fasting blood glucose, lipid profile, weight change, bmi and other metabolic indices will be recorded and compared before and after the intervention.

insulinoma is a rare disease which can cause recurrent hyperinsulinemic hypoglycemia, subsequent hyperphagia as well as weight gain. as only 50% \~ 60% of pharmacological therapy (diazoxide, somatostatin, etc) is effective to elevate blood glucose, the nutritional interventions play a role as an important supportive treatment to maintain glycemic stablization and control weight gain before the curative surgery. as the essential management for patients with glycogen storage disease (gsd), the extended release cornstarch has been proved superior to prevent hypoglycemia since 1980s. its application has elevated gsd patients' quality of life and prolonged their survival. in view of its charicteristic of chronic release in gastrointestinal tract, we will for the first time try to utilize the raw corn starch (rcs) on patients with suspected insulinoma and evaluate its efficacy of improving hypoglycemia in such patients. this will be a prospective single-arm before-and-after clinical trial. nutritional intervention with supplementation of rcs will be initiated in 20 patients with suspected insulinoma to improve their hypoglycemia before the surgery. duration of nutritional intervention, fasting blood glucose, lipid profile, weight change, bmi and other metabolic indices will be recorded and compared before and after the intervention.

Eligibility criteria:
inclusion criteria: * having recurrent symptoms of hypoglycemia (blood glucose less than 2.8 mmol/l) which could be relieved by intake of glucose, which condition accords with typical whipple triad. * being proved to have abnormally increased secretion of endogeneous insulin at onset of hypoglycemia. * diagnosis of insulinoma is highly suspected, in view of clinical presentation, laboratory tests and imaging examinations. exclusion criteria: * severe gastrointestinal dysfunction with intolerance of raw corn starch
cognitive behavioural therapy for obesity

Conditions: Obesity

Summary: the purpose of this study is to evaluate the effectiveness of a cognitive behavioural treatment (cbt) designed to help obese patients lose weight and to maintain their weight losses over time. it is hypothesized that cbt will result in greater sustained weight loss.

the primary aim of the present study is to improve the maintenance of weight loss, and hence the physical, psychological and social well-being, of obese patients who have sought weight loss treatment. to do so, it will implement a cognitive-behavioural treatment (cbt) with motivational enhancement strategies specifically designed to target weight maintenance. it is hypothesized that the maintenance-oriented cbt approach will result in sustained weight loss, as well as improved physical, psychological and social well-being.

Eligibility criteria:
inclusion criteria: * the participants will be recruited from among patients referred to the metabolism and obesity service of royal prince alfred hospital. * the inclusion criteria include: 18-65 years of age and a body mass index (bmi: kg/m2) between 30-45. exclusion criteria: * psychiatric conditions (i.e., current psychosis, severe depression, mental retardation, and drug or alcohol abuse) * or physical conditions (i.e., significant hepatic or renal dysfunction and significant cardiovascular disease such as heart failure, stroke and transient ischaemic attacks) that would preclude full participation in the study; * current treatment for obesity; * current treatments known to affect eating or weight (e.g., medications); * pregnancy.

Keywords: obesity cbt motivational enhancement therapy weight loss maintenance
study of imatinib in children with neurofibromatosis and airway tumors

Conditions: Neurofibroma, Plexiform

Summary: the purpose of this study is to look at a subset of plexiform neurofibromas and determine if the airway tumors are more sensitive to imatinib therapy. funding source - fda oopd


Eligibility criteria:
inclusion criteria: 1. patients aged: \> 6 months and \< 12 years of age. 2. diagnosis of neurofibromatosis type 1 (nf1). 3. presence of symptomatic airway plexiform neurofibromas ; defined by abnormal sleep study or pulmonary function testing. 4. patients must have measurable (\> 1.5 cm in two dimensions or able to assess a minimum of 3 slices) disease by magnetic resonance imaging (mri). 5. patients must have a karnofsky of \> 70% or lansky of \> 50% and a life expectancy of \> 2 months. 6. adequate end organ function, defined as the following: total bilirubin \ 1.5 x 109/l, platelets \> 100 x 109/l. 7. patients must be able to swallow whole pills or crushed pills in a soft food such as pudding or apple sauce; or have other gi access such as a g-tube. 8. written, voluntary informed consent/assent. exclusion criteria: 1. patient has received any other investigational agents within 14 days of first day of study drug dosing. 2. patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. existence of any other malignant disease is not allowed. 3. patient with grade iii/iv cardiac problems as defined by the new york heart association criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) 4. patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection). 5. patient has a known brain metastasis. non-specific cns changes on mri/ct characteristic of nf1 are allowed, but not known cns malignancies requiring therapeutic intervention. 6. patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). 7. patient has a known diagnosis of human immunodeficiency virus (hiv) infection. 8. patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-c) prior to study entry. 9. patient previously received radiotherapy to \> 25 % of the bone marrow 10. patient had a major surgery within 2 weeks prior to study entry. 11. patient/parent with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. 12. patients who have or anticipate receiving permanent (or semi-permanent) metallic structures attached to their body. (e.g., braces on teeth, body piercings), which their physicians believe will interfere with the mri. 13. patient has an unstable airway requiring more urgent intervention or deemed unable to travel due to unstable airway by referring md.