Kornimate/medical-research-clean huggingface dataset:
a study to determine the long term safety and efficacy of albiglutide in combination with oral monotherapy antihyperglycemic medications in japanese patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: this study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in japanese subjects with type 2 diabetes mellitus.

this study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in japanese subjects with type 2 diabetes mellitus. subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added.

Eligibility criteria:
inclusion criteria: * subjects with diagnosis of type 2 diabetes mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication * body mass index (bmi) 17 to 40 kg/ m2 inclusive * subjects with an hba1c between 7.0% and 10.0% at screening * creatinine clearance \>30 ml/min (calculated using the cockcroft-gault formula) exclusion criteria: * history of type 1 diabetes mellitus * female subject is pregnant, lactating, or \<6 weeks postpartum * clinically significant cardiovascular and/or cerebrovascular disease * current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator * serum amylase \>=3 ×uln and/or serum lipase \>=2 × uln and/or subject is experiencing any symptoms possibly related to pancreatitis * prior use of a glp-1r agonist or dpp-iv inhibitor within 6 months before screening

Keywords: albiglutide japanese glucagon-like peptide-1 gsk716155
proximal femoral nail antirotation (pfna) versus pfna augmentation

Conditions: Hip Fractures; Closed Fracture of Hip

Summary: the purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a proximal femoral nail antirotation (pfna) and augmentation can better be mobilized than patients without augmentation.

to avoid the pain-causing relative movement between implant and bone, surgical techniques and devices allowing augmentation of the femoral head have recently been developed. biomechanical studies showed that augmentation leads to a better axial stability and pull-out strength. in clinical practice, this might facilitate early mobilization and full weight-bearing with less pain. the purpose of this study is therefore to evaluate whether patients with trochanteric fractures being treated with a pfna and augmentation can better be mobilized than patients without augmentation. in particular, it will be measured whether patients with a pfna augmentation can walk faster than the non-augmented patients, measured with the timed up and go test.

Eligibility criteria:
inclusion criteria: * age 75 years and older * closed unstable trochanteric fracture: ao 31 - a2 and a3 * low energy trauma (e.g.fall from standing height) * definitive fracture fixation within 72 hrs. after admission * indication for pfna fixation (with or without augmentation) * ability to walk independently (walking aids are allowed) prior to injury * signed written informed consent and agreement to attend the planned fus * able to understand and read country national language at an elementary level exclusion criteria: * pathologic fracture * polytrauma * any additional fracture * open fracture * recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment * active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years * asa class v and vi * any implant at the same hip * hemiplegia * patients with legal guardian * patients who have participated in any other device or drug related clinical trial that could influence the results of the present study within the previous month * fractures and injuries opening into the articulation and vascular structure * infection * patients with clotting disorders * patients with severe cardiac and / or pulmonary insufficiency * patients with known hypersensitivity or allergy to any of the components of traumacem v+ cement (polymethyl methacrylate / acrylate, zirconium dioxide, hydroxyapatite,benzoyl peroxide, methyl methacrylate,hydroquinone, n,n-dimethyl-p-toluidine) * perforation of the femoral head into the joint with the guide wire used for the pfna blade * risk of potential leakage into the joint identified by using contrast fluid (pfna augmentation group only) * intraoperative decision to use implants other than pfna
short anovaginal distance is associated with obstetric anal sphincter rupture

Conditions: Perineal Tear; Obstetric Trauma

Summary: anovaginal distance measured by palpation and perineal ultrasound are similar.

background: objective diagnostic methods for obstetric anal sphincter rupture, (oasr) such as endoanalt ultrasound (eaus), show missed ruptures that can lead to anal incontinence. to perform eaus after all deliveries at all hours, although it may lead to diagnostic improvement is not feasible in most delivery wards. another objective method for screening women after delivery to identify oasr would be of value. bidigital palpation of the perineum is often suggested without specifying what results are relevant. aim: the aim of this study was to establish if the palpated anovaginal distance after delivery could be confirmed by perineal ultrasound and correlated to the extent of the perineal tear. materials and methods: a structured educational programme for midwives (palpation) and doctors (perineal ultrasound) was accomplished. midwives were instructed to record the palpated anovaginal distance in primiparae with spontaneous vaginal delivery and no episiotomy. if the avd was found to be shorter than 2 cm, she recorded a primary diagnosis of probable grade 2, suspected grade 3 or probable grade 3 and called the doctor. the avd was then measured by perineal ultrasound by a doctor aware of a laceration but not it´s extent, which was then established by clinical exam and perineal ultrasound.

Eligibility criteria:
inclusion criteria: women who just had their firstborn child through vaginal delivery at the delivery ward at the university hospital in linköping, sweden from october 2014 to january 2016. - exclusion criteria: inability to understand swedish -

Keywords: perineal tear bidigital palpation perineal ultrasound post partum diagnostics
nutrition-dense smoothie diets reduced dysphagia risk in the elderly

Conditions: Dysphagia

Summary: the investigators aimed to compare the effect of consuming high protein (23-34% energy ratio) and low carbohydrate (25-38% energy ratio) smoothie formulas vs. consuming ensure (a conventional well-known commercial formula) on the swallowing capacity by using flexible endoscopic evaluation of swallowing (fees) in the elderly people with dysphagia risk.

the investigators aimed to determine the effect of 3 high protein (23-34% energy ratio) and low carbohydrate (25-38% energy ratio) smoothie formulas ((1) white sesame soy milk smoothie (ws), (2) black sesame soy milk smoothie (low carbohydrate, bslc), and (3) chicken shitake smoothie (cs); 1 kcal/ml) from natural ingredients as compared with ensure. the double blind randomized placebo controlled cross-over design study involved 63 subjects aged above 65 years old. they were also divided into asymptomatic (n=32) or symptomatic swallowing difficulty (n=31) group based on self-reported swallowing difficulty symptoms. all subjects assessed five drinks (ws, bslc, cs vs. ensure) for sensory testing, product acceptance and marketing survey using questionnaires. swallowing capacity was determined by using flexible endoscopic examination of swallowing (fees) only for each of the three drinks (sw, cs vs. ensure) in a blinded random sequence.

Eligibility criteria:
inclusion criteria: * swallowing difficulty group (ssd) who with symptomatic swallowing difficulties or with a history of swallowing difficulties, coughing or choking when eating or drinking or a sign of malnutrition * control group (wsd) who without a history of swallowing difficulties, coughing or choking when eating or drinking or a sign of malnutrition exclusion criteria: 1. people with chronic illnesses and tube feeding 2. people with anterior bone deformity e.g. facial fracture, sino-nasal or anterior skill-based tumor/surgery

Keywords: aging smoothie drink dysphagia swallowing capacity
incurable ill patients attitudes towards euthanasia and assisted suicide

Conditions: Incurable Cancer Diseases; Other Incurable Diseases

Summary: euthanasia and assisted dying are of growing interest for patients with incurable diseases. the possible methods are widely discussed by patient-societies, physicians, lawyers, theologians and philosophers. during the last years several opinion-polls were conducted with healthy people or medical stuff, but no surveys were conducted to get the attitude of incurable ill patients. the hypothesis of the investigators' study is: "palliative care medicine is a better option for incurable ill patients than an assisted suicide."


Eligibility criteria:
inclusion criteria: * age \>= 18 years * incurable illness * mental state thet allows to answer a questionnaire exclusion criteria: * somnolence * low mental state * curable disease * depression with danger of acute suicide

Keywords: euthanasia assisted suicide assisted dying palliative care medicine
protection of autonomic nervous system during lower spine surgical procedures: a safety and feasibility study

Conditions: Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Spinal Curvatures; Spinal Stenosis; Spondylitis; Spondylosis; Osteoarthropathy, Primary Hypertrophic; Spinal Neoplasms

Summary: a safety and feasibility study of free-run and stimulated corporal electromyography (emg) to assess autonomic neural function during spinal and/or pelvic surgery in women and men.

this is a safety and efficacy trial to assess autonomic neural function monitoring during spinal and/or pelvic surgery. during standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated emg will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from individual patients. throughout the duration of the spinal surgery, the neurophysiologist will continuously monitor autonomic function. smooth muscle free-running (continuous) and stimulated emg will be recorded. emg data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. the success rates of 1) credible and safe emg recording and 2) positive emg responses to each stimulation method will be calculated.

Eligibility criteria:
inclusion criteria: 1. patients must be ≥ 18 years of age 2. patients are undergoing lumbar spine surgical and/or pelvic procedure at abbott northwestern hospital 3. patients must be capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed. exclusion criteria: 1. patients ≥ 70 years of age 2. patients with obvious groin infection and/or herniation 3. patients with ongoing psychiatric concerns

Keywords: intraoperative monitoring intraoperative neuromonitoring autonomic nervous system spine surgery pelvic surgery sexual function bowel function bladder function
validation of an ankle foot orthosis with anterior support for foot drop

Conditions: Foot Drop

Summary: the objective of this research is to compare the new ankle foot orthosis (afo) with prior support developed by turbomed, with the afo with posterior support from turbomed as well as two competing afos currently on the market. with this research, we seek to answer the following questions: * is the new afo as biomechanically efficient as the afos currently on the market? * is the new afo more comfortable than the afo currently on the market? * is the new afo easier to put on and attach than the afos currently on the market?


Eligibility criteria:
inclusion criteria: * foot drop following surgery or an accident (functional calf, without contracture and not spastic) * foot drop following a cerebral vascular accident (with or without spasticity, mild to moderate) * ability to stand and walk alone without technical assistance * ability to communicate comfort/discomfort exclusion criteria: * sore to one of the feet
rct study on safety of lpd and opd in the treatment of periampullary tumors

Conditions: Periampullary Tumor; Complication; Death; Survival

Summary: pancreaticoduodenectomy (pd) is considered one of the most complex and dangerous procedures in general surgery. this procedure is the preferred surgical procedure for treating tumors around the ampulla. traditional open pancreaticoduodenectomy (opd) has brought great surgical trauma to patients while treating diseases. in 1994, gagner et al first reported laparoscopic pancreaticoduodenectomy (lpd). with the development of laparoscopic techniques, the updating of devices, and the continuous accumulation of laparoscopic gastrointestinal surgery experience, the results of retrospective studies published show that there is no significant difference in safety between lpd and opd. however, the results of the recently published rct study show that the mortality associated with lpd complications is five times greater than that of opd. at present, the security of lpd has been controversial. therefore we conducted a prospective randomized controlled trial with a primary outcome of perioperative complications, providing evidence-based results for the safe and effective clinical development of lpd.


Eligibility criteria:
preoperative imaging diagnosis of periampullary tumor, or preoperative pathological diagnosis of periampullary tumor, preoperative evaluation can be performed pancreaticoduodenectomy; serum bilirubin was less than 100 μ mol/l before operation; sign a written informed consent form and agree to be randomly divided into groups for surgical treatment.
shaping motor neural functioning of developmental stuttering to improve fluency

Conditions: Stuttering

Summary: developmental stuttering (ds) is a motor/speech disorder, characterized by specific alterations in the functioning of brain circuits. non-invasive brain stimulation may be useful to shape the altered functioning and connectivity of these systems. as a consequence, this project aims to expand the neurophysiological understanding of ds, evaluating effects of transcranial electrical stimulation (tes) on speech fluency and brain functioning of adults with persistent ds. this project will provide high-impact insights into the functioning of ds neural system, also proposing innovative and/or personalized rehabilitation.

investigators will evaluate the effect of different tes protocols targeting motor associative regions (about 10 "consecutive" stimulation sessions, in different days; tes will be compared to sham stimulation), in association with "canonical" speech therapy. about 30 right-handed adults with idiopathic and persistent ds since childhood will be recruited (age 18-59 years; please see below for inlusion/exclusion criteria). participants will be subdivided in three groups (in association to speech therapy): two groups will undergo transcranial random noise stimulation or transcranial direct current stimulation, while the third group will undergo sham (placebo) stimulation . effects will be assessed by measuring stuttering severity (i.e. objective evaluation of stuttering), behavioral/cognitive scales (i.e. subjective evaluation of stuttering), as well as a series of neurophysiological indexes useful to evaluate brain functioning and connectivity (e.g. tms\[transcranial magnetic stimulation\]-induced motor/evoked potentials and eeg brain activity). evaluations will be realized before the start of the tes protocols, as well as at the end of the cycles. follow-up evaluations (starting from about 6 weeks after completion of stimulation sessions) are also foreseen after the end of the treatments.

Eligibility criteria:
(main) inclusion criteria: -right-handed adults with idiopathic, persistent ds since childhood (main) exclusion criteria: * contraindications to non-invasive brain stimulation; * currently assumption of drugs acting on the central nervous system; * presence of overt neurological/psychiatric/medical conditions or overt comorbidities (e.g. obsessive-compulsive disorder).

Keywords: developmental stuttering neuromodulation transcranial electrical stimulation speech fluency motor networks
clinical observation on bone metabolism induced by chronic renal insufficiency

Conditions: Chronic Renal Insufficiency; Renal Osteodystrophy

Summary: patients with chronic renal insufficiency usually develop secondary osteoporosis or bone loss, which is called renal osteodystrophy. most of the previous studies focused on bone metabolism of patients in late stage of chronic renal insufficiency, especially those with chronic dialysis. in this study, bone metabolism of patients in different stages of chronic renal insufficiency will be observed to reveal the mechanism of development of renal osteodystrophy and provide clues for early intervention on renal osteodystrophy.

in this study, patients with chronic renal insufficiency (ckd1-5, defined by glomerular filtration rate，gfr) and healthy people as control will be recruited (50/group, total 300). blood urea nitrogen, creatinine,lumbar and hip bone mineral density, bone turnover biochemical markers including serum total propeptide of type i procollagen（pinp）, bone alkaline phosphatase（balp）, bone gla-protein (bgp) and β-crosslaps（β-ctx）, serum calcium and phosphorus and related regulators including fibroblast growth factor 23 (fgf23), 25-hydroxyl-vitamin d （25-oh-vitd）, parathyroid hormone（pth） will be detected. the relationship between kidney function and bone turnover, and the rules throughout the development process of renal osteodystrophy will be analysed.the micro ribonucleotide（mirna）array will also be performed to screen the biomarkers of renal osteodystrophy in different stage.

Eligibility criteria:
inclusion criteria: 1. 20-50 years old 2. chronic renal insufficiency (control: normal kidney function; case: ckd 1-5) 3. be willing to and be able to join in the study and signed informed consent 4. have not accepted systematical treatment on bone loss or osteoporosis exclusion criteria: 1. allergies 2. secondary osteoporosis caused by other diseases. 3. postmenopausal women 4. mental illness or psychosis 5. patients with bone fracture and need surgery treatment 6. taking any medicine that will affect bone metabolism for a long time and can not stop 7. women during pregnant stage and breast-feed stage 8. with deformity or disability

Keywords: chronic renal insufficient, renal osteodystrophy, bone mineral density, bone turnover, kidney function
68ga-dotatate pet scan in neuroendocrine cancer

Conditions: Neuroendocrine Carcinoma

Summary: neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. the 68ga-dotatate pet scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. the investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.

eligible participants will undergo baseline assessments at enrollment. study participants will receive a one-time administration of 68gadotatate and undergo a pet/ct imaging study. scans will be performed with "negative" oral contrast (e.g. volumen™ or equivalent), as many nets involve the gi tract.

Eligibility criteria:
inclusion criteria: * known diagnosis of neuroendocrine tumor * at least 18 years of age * able to provide informed consent * karnofsky score greater than 50 * females of childbearing potential must have a negative pregnancy test at screening/baseline exclusion criteria: * serum creatinine \>3.0 mg/dl (270 μm/l) * hepatic enzyme levels more than 5 times upper limit of normal. * known severe allergy or hypersensitivity to iv radiographic contrast. * use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments. * patients with a body weight of 400 pounds or more or not able to enter the bore of the pet/ct scanner due to bmi, because of the compromise in image quality with ct, pet/ct and mri that will result. * inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.). * inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * recognized concurrent active infection * any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.

Keywords: neuroendocrine neuroendocrine carcinoma neuroendocrine tumor carcinoid carcinoid tumor islet cell tumor apudoma gallium pet scan
role of rapid on-site evaluation for mutational analysis of ebus-tbna specimens

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of the study is to determine if rapid on-site evaluation of ebus-tbna samples can increase the percentage of patients with advanced non-squamous non-small cell lung cancer in whom both pathologic subtyping and mutational analysis are obtained.


Eligibility criteria:
inclusion criteria: * age \> 18 years * suspected hilar or mediastinal lymph node metastasis from lung cancer exclusion criteria: * pregnancy * uncontrolled coagulopathy * refusal to sign informed consent
clinical evaluation of backstop in patients undergoing intraureteric stone lithotripsy

Conditions: Renal Calculi; Kidney Stones

Summary: the purpose of this clinical study is to evaluate backstop, a polymer-based device that is intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration. it is a water soluble polymer with reverse thermosensitive properties; the polymer exists as a liquid at low temperature (below 17 c) and rapidly transitions to a high viscosity gel at body temperature (i.e. in the ureter). backstop is injected above the stones in the ureter and is intended to prevent retrograde migration of stones during ureteroscopic lithotripsy. upon completion of the lithotripsy procedure, backstop dissolves naturally or by irrigation. the study hypothesis is that a greater proportion of patients will experience no retropulsion of a kidney stone when backstop is used versus no anti-retropulsion device when undergoing intracorporeal lithotripsy.


Eligibility criteria:
inclusion criteria: * patient with a solitary, radio-opaque ureteral stone in the proximal ureter. * clinical indication for treatment by ureteroscopic lithotripsy. * minimum 18 years old (or any institutional age limits for participation in clinical study). * patients must be willing and able to participate in any follow-up visits, as required. * patients must provide informed consent. exclusion criteria: -

Keywords: renal calculi kidney stones