Kornimate/medical-research-clean huggingface dataset:
a study to investigate efficacy and safety of tour006 in participants 18 to 80 years of age with thyroid eye disease

Conditions: Thyroid Eye Disease

Summary: phase 2b trial of tour006 in thyroid eye disease (ted) to evaluate 20mg and 50mg doses against placebo given by a subcutaneous injection every eight weeks to ted patients who are in the active inflammatory phase of disease.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of graves' disease associated with moderate to severe active ted * onset of active ted symptoms within approximately 15 months * proptosis (exophthalmos) ≥3 mm above the normal range per investigator judgment (based upon race and gender) for the study eye * cas ≥4 (on the 7-item scale) for the study eye * presence of tsi \>130% of the normal reference standard or \>0.55 iu/l (depending on assay method) and laboratory reference ranges additional inclusion criteria are defined in the study protocol. exclusion criteria: * anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision * any previous treatment with teprotumumab or other agent that inhibits the igf-1 receptor * history of systemic (eg, oral or iv) steroid use with a cumulative dose equivalent to \>1 g of methylprednisolone for the treatment of ted. previous oral steroid use with a cumulative dose of ≤1 g methylprednisolone (or equivalent dosage for other systemic corticosteroid) for the treatment of ted, however, is allowed if the corticosteroid was discontinued at least 6 weeks before baseline (day 1) and completely tapered by baseline (if applicable). * systemic (oral or iv) corticosteroid use for conditions other than ted within 6 weeks of baseline (day 1) or not completely tapered by baseline (if applicable). * any major illness/condition or evidence of an unstable clinical condition that, in the investigator's judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study * any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant's participation in the study * pregnant or lactating additional exclusion criteria are defined in the study protocol.

Keywords: ted graves' disease thyroid eye disease exophthalmos eye diseases thyroid diseases graves' ophthalmopathy hyperthyroidism
losartan in treating patients with idiopathic pulmonary fibrosis

Conditions: Precancerous Condition

Summary: rationale: losartan may be effective in treating patients with idiopathic pulmonary fibrosis. purpose: this clinical trial is studying the side effects of losartan and to see how well it works in treating patients with idiopathic pulmonary fibrosis.

objectives: * evaluate the effects of losartan potassium on disease progression in patients with idiopathic pulmonary fibrosis. * determine the safety of this drug in these patients. outline: this is a multicenter study. patients receive oral losartan potassium daily for 1 year in the absence of disease progression or unacceptable toxicity. patients undergo pulmonary function tests with gas diffusion lung volumes, carbon monoxide diffusing capacity (dlco) tests, and 6-minute walk tests at baseline and then at 3, 6, 9, and 12 months. patients also complete baseline/transition dyspnea index questionnaires at baseline and then at 1, 3, 6, 9, and 12 months.

Eligibility criteria:
inclusion criteria: * age \> 21 years * diagnosis of idiopathic pulmonary fibrosis * patients taking coumadin and/or n-acetylcysteine may participate in the study * baseline forced vital capacity (fvc) must be greater than or equal to 50% * baseline 6 minute walk test distance walked must be greater than or equal to 200 meters not requiring greater than 6 lpm of oxygen exclusion criteria: * pregnant, intending to become pregnant or breastfeeding * current or previous smoker of cigarettes or marijuana that recently quit within the last 6 months prior to enrollment * allergy or allergic reaction to losartan or any other angiotensin ii receptor blocker * taking losartan or any other angiotensin ii receptor blocker * baseline systolic blood pressure \< 100 mmhg * currently taking or has taken immunosuppressant agents within the last month such as azathioprine, cyclophosphamide, colchicine and/or prednisone * history of lung transplant * history of kidney failure or liver disease * inability to attend clinic visits

Keywords: precancerous condition
radiographic influences of bisphosphonate treatment on femur

Conditions: Femur Fracture

Summary: although there is strong evidence that bisphosphonates prevent certain types of osteoporotic fractures, there are concerns that these medications may be associated with rare atypical femoral fractures (aff). but the relationship between long-term bisphosphonate treatment and aff is unclear. in this study, the investigators would like to analyze the long term effects on femur by bisphosphonate treatment.the participants are treated in the investigators hospital more than four years.

bisphosphonates have been widely used in the treatment of osteoporosis. recently, long-term use of bisphosphonates increases the risk for affs in older women, according to the results of a population-based, nested case-control study. unique radiographic pattern of aff is reported, such as simple transverse or short oblique fracture with breaking of medial cortex and cortical thickness. but radiographic evaluation were performed for fracture patients in previous reports and the femoral condition of long-term bisphosphonate treatment patients before fracture is not known. the main objective of this study is to reveal the effects of long-term bisphosphonate treatment on femur.

Eligibility criteria:
inclusion criteria: * patients using bisphosphonate more than four years exclusion criteria: * patients who could not use bisphosphonate

Keywords: osteoporosis bisphosphonate atypical femoral fracture side effect
exploring the needs of hiu patients within the emergency department

Conditions: High Intensity Users; Frequent Attenders

Summary: the aim of this qualitative interview study is to explore the unmet needs of patients who frequently attend the emergency department and the challenges of the staff who support them. the study will interview 10 patients who frequently attend the emergency department and 10 staff members working within the emergency department.


Eligibility criteria:
inclusion criteria: patients who have attended the emergency department at blackburn royal teaching hospital over 5 times in the last 12 months all mdt staff within the emergency department at blackburn royal teaching hospital exclusion criteria: patients under 18 patients who have not attended the emergency department 5 times or more staff who do not work in the emergency department.
genetic susceptibility and influence of the microbiomae in bullous pemphigoid

Conditions: Bullous Pemphigoid

Summary: autoimmune bullous dermatoses include pemphigus, bullous pemphigoid, pemphigoid gestationis, linear iga dermatosis, mucous membrane pemphigoid, lichen planus pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita and dermatitis herpetiformis. autoimmune bullous dermatoses are rare and have an incidence of 20-60 new cases per 1 million person- year in europe. the incidence of the individual entities is slight significantly different within europe, but strongly also in comparison to other countries such as kuwait, singapore, usa and south america. the most common of these disorders is the bullous pemphigoid. a considerable progress has been made in the last years to elucidate the pathogenic role of autoantibodies in these diseases. to this end, various in vitro and animal experiments have been used to understand some basic pathophysiological mechanisms in these diseases. further studies are currently being carried out to explain a precise elucidation of the disease process and to be able to treat the patients targeted later. at present, however, no data are available to explain why certain individuals develop the autoimmune disease and others do not. epidemiological studies showed some triggers to the development of autoimmune dysregulation, e.g. drugs. furthermore, it has been shown that genetic factors play a role in the pathogenesis of the disease. a clear association with certain hla regions have been shown in patients with pemphigus, e.g. about 95% of pemphigus patients from the group of ashkenazi jews have the hla-drb1\*0402 haplotype. recently, the first non-hla gene associated with pemphigus was described. for other conditions such as bullous pemphigoid, pemphigoid gestationis or linear iga dermatosis the association with hla antigens is less pronounced. another indication of the importance of the genetic background in these diseases can be elucidated from the observation of autoantibodies at a low concentration in healthy relatives of pemphigus patients.

study genetic and microbiologic predisposition of patients developing a bullous pemphigoid from peripheral blood and skin flora.

Eligibility criteria:
inclusion criteria: * patients with bullous pemphigoid in active phase * patients with basal cell carcinoma or squamous cell carcinoma and without inflammatory skin disease * patient consenting to participate to the study * patient enrolled in the national healthcare insurance program * patient older than 18 years exclusion criteria: - patients with pemphigoid gestationis
effect of clamshell exercise on lumbopelvic stability and low back pain in post partum women

Conditions: Lumbosacral Instability; Low Back Pain Post Partum

Summary: this study will be conducted on 44 females with postpartum lbp \& pelvic instability, selected from dar of women hospital in port said to investigate effect of clamshell exercise on lumbo-pelvic stability and low back pain in postpartum women.


Eligibility criteria:
inclusion criteria: 1. post-partum females complaining of lbp and lumber instability 2. their age will be ranged from 25-35 years. 3. their bmi will be ranged from 25-30 kg/m2 exclusion criteria: 1. spinal deformity. 2. lower limb deformity. 3. osteosarcoma 4. mental disorders. 5-25\>bmi\>30 6-performing any physical exercise at the time of the study. 7-bad general health

Keywords: clamshell exercise lumbopelvic instability low back pain post partum
the effects of dexmedetomidine on postoperative renal function in valvular heart surgery

Conditions: Acute Kidney Injury

Summary: the purpose of study is to compare the incidence of acute kidney injury in patients receiving perioperative dexmedetomidine or placebo undergoing valvular heart surgery.


Eligibility criteria:
inclusion criteria: * adult patients over the age of 20 scheduled for valvular heart surgery exclusion criteria: * left ventricular-ejection fraction \< 30% * preexisting congestive heart failure * severe coronary artery disease * hemodynamically unstable arrhythmia * cardiogenic shock during perioperative period * ventricular assist device * severe renal dysfunction (egfr \< 15ml/min per 1.73m2)
resting postural tremor in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: early diagnosis is a key factor for effective treatment of multiple sclerosis. accelerometer and gyroscope measurement of tremor could screen potential motor control dysfunction and predict a risk for development of multiple sclerosis.

the aim of this study is to test whether specially developed accelerometer and gyroscope can differentiate pattern of resting postural tremor in healthy and people with multiple sclerosis. spectral analysis and the correlation of the average signal spectra will be computed. moreover, categorization based on the tremor component according to the maximum likelihood estimation will be done.

Eligibility criteria:
inclusion criteria: group 1: * definite diagnosis of ms * prevailed motor deficit of upper extremities, but without visible tremor * stable clinical status in the preceding 3 months * expanded disability status scale score (edss) ≥ 2 ≤ 7.5, and * no corticosteroid therapy in the preceding month group 2: * healthy volunteers in the age of 20-70 years will be employed * there will be defined as persons without any neurological disease diagnose at the time of the measurement. exclusion criteria (both groups): patients with factors disturbing mobility (e.g. stroke, pregnancy, fractures) were excluded from the study.

Keywords: tremor accelerometer
an investigational drug (cal) versus zoledronic acid (zometa®) in patients with breast cancer

Conditions: Breast Neoplasms; Breast Cancer; Metastasis

Summary: this study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (cal) to the parathyroid hormone-related protein (pthrp) when compared to zoledronic acid in patients with breast cancer metastatic to bone. the study will also evaluate the possible effects of both study drugs on performance status, markers of bone metabolism, and skeletal events related to bone metastasis including elevated blood calcium levels, bone pain, metastatic lesions, complications and interventions. the levels of cal in the blood will also be evaluated.


Eligibility criteria:
major inclusion criteria - others stipulated within the protocol the study physician must assure you have/are: * must be a female at least 18 years of age and be using an effective form of birth control. * a documented history of breast cancer and at least one bone metastasis that has not been previously treated by radiation or surgery, and is not anticipated to be treated within the next 24 weeks. * a total body bone scan and other radiographic scan(s) performed on you within 4 weeks prior to or during the screening period sufficient to image all sites of bone metastases. * you must be willing to perform a daily telephone diary and be willing to keep a paper diary and provide voluntary consent to participate in this study. major exclusion criteria - others stipulated within the protocol the study physician must assure you do not have/are not: * a change in analgesic (pain relief) type medication during the screening period (example, non-narcotic to narcotic). * received radiation therapy to any bone metastasis or started a new course of chemotherapy within 3 weeks prior to the screening visit or during the screening period. * used any bisphosphonate type drug during the 30 days prior to the anticipated first dose of study drug * vertebral spine or weight-bearing bone metastasis that would place you at imminent risk for fracture or surgical intervention. * evidence of active infection or immune deficiency, renal failure, abnormal liver function, or a serum calcium level \> 10.1 mg/dl. * use of any investigational drug within 30 days prior to screening.

Keywords: cal parathyroid hormone-related protein (pthrp) breast cancer bone metastasis hypercalcemia
primary urethral realignment versus suprapubic cystostomy after pelvic fracture urethral injury

Conditions: Pelvic Fracture; Urethra Tear; Urethra Injury Male; Trauma; Surgery

Summary: pelvic fracture urethral injuries (pfui) occur in up to 10% of pelvic fractures. it remains controversial whether initial urethral realignment after pfui decreases rates of urethral obstruction and the need for subsequent urethral procedures. the retrospective record review should determine the utility of acute urethral realignment after pfui.

a retrospective chart review to compare outcomes between urethral realignment (group 1) and suprapubic tube (spt) placement (group 2). the comparison will be between two routinely practiced management approaches of urethral injury after pelvic fracture. prior studies demonstrate urethral realignment is associated with a 15% to 50% reduction in urethral obstruction, however, it has also been associated with higher rates of incontinence and erectile dysfunction. our hypothesis is that early realignment of traumatic urethral injuries after pelvic fracture lowers the incidence of complications like urethral strictures and subsequent need for surgeries.

Eligibility criteria:
inclusion criteria: men \> 18 years old blunt force trauma presence of pelvic fracture urethral injury inability to pass a foley catheter retrograde through the injury into the bladder exclusion criteria: straddle type urethral injuries without a pelvic fracture passage of a catheter successfully in a retrograde fashion

Keywords: pelvic fracture urethral injury urethra disruption trauma
comparison of plasma neutrophil gelatinase - associated lipocalin (ngal) levels

Conditions: Prostatectomy

Summary: the purpose of the study is to compare the effect of two surgical techniques (open vs robotic assisted) on plasma levels of ngal (neutrophil gelatinase-associated lipocalin) after radical prostatectomy.

patients undergoing radical prostatectomy are at increased risk of acute kidney injury (aki) because of intraoperative bleeding, obstructive uropathy and older age. in particular robot-assisted laparoscopic radical prostatectomy (ralp) which is in increasing demand as an alternative surgical option for retropubic radical prostatectomy (rrp) is associated with postoperative renal dysfunction because pneumoperitoneum during ralp can decrease cardiac output and renal perfusion. ngal may become important for diagnosis of postoperative aki after urogenital oncosurgery.

Eligibility criteria:
inclusion criteria: * patients who undergo prostatectomy * american society of anesthesiology (asa) i-iii exclusion criteria: * preexisting renal disease * emergency surgery * heart failure * peripheral vascular disease

Keywords: ngal prostatectomy acute kidney injury
cardiac surgery and diaphragm function

Conditions: Cardiac Surgery

Summary: diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical ventilation and cause respiratory distress. the investigators' main objective is to determine the incidence of diaphragm dysfunction ( using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic thickening fraction) in a selected population of cardiac surgery patients during weaning from mechanical ventilation. the second endpoints are to determine the associated risk factors to post-operative diaphragm weakness and the consequence on the patient outcome.


Eligibility criteria:
inclusion criteria: * 18 years old and older * planned surgery * ready for weaning from mechanical ventilation exclusion criteria: * protected patient * patient refusal

Keywords: cardiac surgery diaphragm dysfunction mechanical ventilation weaning respiratory paralysis muscle weakness cardiac bypass valvular surgery respiratory insufficiency
free fatty acids and vascular function in subjects with diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this study will test the hypothesis that reduction in release of free fatty acids from adipocytes will restore insulin-mediated endothelium-dependent vasodilation and skeletal muscle glucose metabolism in subject with type 2 diabetes.

during the past two decades, there has been a steady increase in the incidence of diabetes mellitus, such that nearly 17 million people are now afflicted. the vast majority of these have type 2 diabetes. over the next 40 years, the type 2 diabetic population in the united states is expected to increase to nearly 30 million. diabetes substantially increases the risk of atherosclerosis, and thereby, cardiovascular morbidity and mortality. indeed, cardiovascular disease causes more than 50% of the mortality in patients with diabetes. people with type 2 diabetes manifest two cardinal signs of dysmetabolism: hyperglycemia and insulin resistance. insulin resistance is a progressive phenomenon that occurs well before the onset of frank diabetes, and results in alterations in insulin signaling. experimental studies suggest that insulin signaling is required for vascular homeostasis, and its impairment is associated with endothelial dysfunction. in the clinical setting, insulin resistance is associated with atherosclerosis and predicts cardiovascular events independent of hyperglycemia. therefore, we will study the importance of insulin signaling in endothelial biology in humans and the effects of free fatty acids on endothelial function in people with type 2 diabetes.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (as defined by the national diabetes data group) * normal cardiovascular exam * non smoker (for 1 year prior to entry) * healthy volunteers * no known medical problems * normal cardiovascular exam * fasting glucose \< 110 mg/dl * non-smoker (for 1 year prior to entry) exclusion criteria: type 2 diabetics * untreated hypertension (\>140/90 mmhg) * untreated hypercholesterolemia (ldl \> 75th percentile for age) * cigarette smoking within 1 year * neuropathy requiring medication * nephropathy (\> 300mg/24 hour urinary albumin, or serum creatinine \> 1.4 mg/dl * abnormal cardiovascular exam * treatment with thiazolidinedione within 1 year * post-menopausal women taking hormone replacement therapy (note: subjects taking angiotensin converting enzyme (ace) inhibitors or angiotensin receptor blockers (arbs) must stop these medications for 2 weeks prior to taking study drug. if blood pressure rises to \>140/90, subjects will be prescribed an alternative medication or be withdrawn from the study. healthy volunteers * abnormal cardiovascular exam * use of prescription medications * fasting glucose \> 110mg/dl * cigarette smoking within 1 year

Keywords: insulin resistance insulin signaling endothelium-dependent vasodilation
safety and immunogenicity study of scb-1019t in children

Conditions: RSV Infection

Summary: this phase 1 study in australia will evaluate the safety, reactogenicity and immunogenicity of the bivalent recombinant respiratory syncytial virus (rsv) vaccine (cho cell) (scb-1019t) in children 2-\<6 years of age.

this phase 1 randomized, placebo-controlled, observer-blind study will evaluate the safety, reactogenicity and immunogenicity of different formulations of scb-1019t vaccine in children 2-\<6 years of age. a placebo is used as a control in the study because there is no licensed rsv comparator vaccine available for young children globally.

Eligibility criteria:
inclusion criteria: • male and female participants 2 to \<6 years of age at visit 1. • parents/guardians of participants willing and able to provide written informed consent and comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. • healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator. for full inclusion criteria, please refer to full protocol. exclusion criteria: * acute disease or fever (≥38°c) at time of vaccination. for participants with minor illness and/or fever at the time of vaccination, visit 1 may be rescheduled. * evidence of chronic diseases including hepatitis, bleeding disorders, metabolic diseases, autoimmune diseases, neurological conditions that impair respiratory functions, genetic disorders that increase the risk of severe respiratory diseases, major congenital malformations, cardiac and lung diseases or reactive airway diseases. for full exclusion criteria, please refer to full protocol

Keywords: rsv vaccine
aripiprazole pharmacokinetics (pk) and tolerability study in children and adolescents

Conditions: Schizophrenia; Mania

Summary: the purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.


Eligibility criteria:
inclusion criteria: * children and adolescents between 10-17 years, in good physical health, preferentially with a primary schizophrenia spectrum diagnosis or bipolar spectrum disorder exclusion criteria: * history of mental retardation * any neurological disorder with the exception of pervasive developmental disorder (pdd), attention deficit hyperactivity disorder (adhd), and tourette's syndrome

Keywords: pharmacokinetics, aripiprazole acute mania in pediatric populations