Kornimate/medical-research-clean huggingface dataset:
endosonographic shear wave elastography to assess liver and splenic fibrosis

Conditions: Liver Fibrosis; Cirrhosis

Summary: the study is being done to collect information on the effectiveness of endosonographic elastography (a technique which uses sound waves) to measure the stiffness of the liver and spleen. investigators are trying to determine if shear wave elastography is a good way to measure fibrosis instead of biopsy.

study design this is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy of endoscopic ultrasound guided shear wave elastography (eus-swe) with liver biopsy for liver fibrosis. patients who will undergo a standard-of-care eus guided liver biopsy (or have clinically obvious liver cirrhosis) will be prospectively enrolled after obtaining informed consent. all enrolled patients will undergo eus guided liver biopsy, unless they have an obvious diagnosis of cirrhosis. eus-swe of the liver and spleen. in selected patients who have been referred for eus ppg measurement in addition to eus liver biopsy, portal pressures will be measured as well and correlated with elastography of the spleen. the patients will be initially assessed for need for liver biopsy by the gastroenterology/hepatology team as per the current standard of care. only patients with a clear clinical indication for liver biopsy will be enrolled for the study. per current standard of practice at providence sacred heart medical center, patients who need liver biopsy are referred to the interventional gi service for the procedure. these patients will be offered participation in the trial prior the endoscopic procedure. this detailed discussion will include participation in the study, background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up.

Eligibility criteria:
inclusion criteria: * age \> 18 years (irrespective of sex) * patients determined clinically to have liver cirrhosis needing eus for other reasons * patients determined clinically to be candidates for eus guided liver biopsy * elevated liver enzymes without obvious etiology * clinical concern for cirrhosis requiring histological confirmation * patients with known cirrhosis without diagnostic dilemma * ability to provide informed consent and willing to participate exclusion criteria: * surgically altered foregut anatomy which precludes safe endoscopic liver biopsy * coagulopathy with inr greater than 1.6 in patients on anticoagulant therapy * thrombocytopenia with platelet count less than 50,000/ml * pregnancy (positive urine pregnancy test in females of childbearing age)

Keywords: liver fibrosis elastography liver biopsy shear wave elastography endosonographic shear wave elastography
cancer of the uterus and treatment of stress urinary incontinence

Conditions: Endometrial Cancer; Stress Urinary Incontinence

Summary: concurrent treatment of endometrial cancer and sui may improve qol, emotional and physical health and decrease costs for both patients and the health care system. at the time of endometrial cancer diagnosis, not only are women evaluated by a gynecologist and/or a gynecologic oncologist, but the majority will undergo surgery within weeks of their diagnosis. thus, urinary incontinence could easily be identified, a referral made, and concurrent surgery performed. this would spare the patient two surgeries, decrease the emotional distress associated with sui symptoms, decrease the costs associated with sui for the patient and possibly improve overall quality of life. the proposed study will compare the quality of life and clinical outcomes among women with endometrial cancer and sui that have concurrent surgery to women that do not have concurrent surgery. the findings of our proposed research will provide valuable information necessary for woman and clinicians to make decisions regarding the treatment of sui, including evidence regarding the risks and benefits of performing concurrent endometrial cancer and sui surgery.


Eligibility criteria:
inclusion criteria: * women will be eligible if they have: 1. clinical stage 1 or 2 (disease confined to the uterus) endometrial carcinoma or complex atypical hyperplasia 2. answer yes to one screening question: "do you ever leak urine when you cough, sneeze, jump or laugh?" we will include women with complex atypical hyperplasia (cah) because 40% of these women will have an endometrial cancer identified at the time of surgery and the risk factors are the same for cah as they are for clinical stage 1 and 2 endometrial cancers exclusion criteria: * women will be excluded if they have 1. clinical stage 3 and 4 endometrial cancer 2. prior pelvic radiation therapy 3. vesicovaginal fistula 4. urethrovaginal fistula. * we are excluding women with vesicovaginal fistula or urethrovaginal fistula due to the risk of infection when placing a midurethral sling.

Keywords: sui
ef5 to detect tumor hypoxia in patients with stage iib, stage iiib, or stage iva cervical cancer

Conditions: Cervical Cancer

Summary: rationale: knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. ef5 may be effective in measuring oxygen in tumor tissue and helping to predict the effectiveness of anticancer therapy. purpose: diagnostic trial to study the effectiveness of ef5 in detecting tumor hypoxia in patients who have stage iib, stage iiib, or stage iva cervical cancer.

objectives: * determine the relationship between the level of ef5 binding and pretreatment hemoglobin level, tumor size, and stage of disease in patients with stage iib, iiib, or iva cervical cancer. * determine whether pretreatment tumor hypoxia (measured by ef5 binding) is associated with overall survival, progression-free interval, and local control in these patients. * determine the relationship between ef5 binding and cd-31 labeling (tumor vasculature) and ki-67 labeling (cellular proliferation) in these patients. outline: this is a multicenter study. patients receive ef5 iv over 1-2.5 hours on day 1. tumor hypoxia is measured using immunohistochemical techniques. biopsies are collected 1-2 days later. blood is collected before ef5 is administered and again at the time of surgery. patients are followed approximately 1 month after surgery. projected accrual: a total of 150 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix * stage iib, iiib, or iva * primary disease * no prior treatment * must be enrolled on gog-0191 protocol patient characteristics: age * 18 and over performance status * gog 0-3 life expectancy * not specified hematopoietic * see disease characteristics * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * bilirubin no greater than 1.5 times normal * sgot no greater than 3 times normal * alkaline phosphatase no greater than 3 times normal * hemoglobin less than 13 g/dl renal * creatinine no greater than 2 mg/dl cardiovascular * no cardiac disease that would preclude safe administration of necessary fluid volumes pulmonary * no chronic pulmonary disease that would preclude safe administration of necessary fluid volumes other * no history of grade 3 or 4 peripheral neuropathy * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * must weigh no more than 180 kg prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma stage iib cervical cancer stage iii cervical cancer stage iva cervical cancer
anti-hyperglycemic effect of short-term arginyl-fructose supplementation in subjects with pre-diabetes and newly diagnosed type 2 diabetes: randomized, double-blinded, placebo-controlled trial.

Conditions: Pre-diabetes

Summary: in this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes were randomly assigned to the placebo control group or the test (arginyl-fructose: af) group. we determined fasting serum levels of glucose, hemoglobin a1c (hba1c), insulin, and free fatty acids (ffas), were measured by 2-h oral glucose tolerance tests (ogtts) at baseline and after the 6-week intervention.


Eligibility criteria:
inclusion criteria: - all subjects are with prediabetes (ifg or igt) or newly diagnosed type 2 dm (t2dm) no taking medicine. ifg was defined as fasting glucose between 100 and 125 mg/dl and igt was defined as 2-h ogtts glucose levels 140-199 mg/dl. newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dl or 2-h ogtts level ≥ 200 mg/dl. exclusion criteria: - exclusion criteria included 1) glucose lowering medications or insulin injections; 2) abnormal liver or renal function; 3) chronic stomach and intestines disease; 4) chronic alcoholism; 5) pregnancy or intending to become pregnant during time of study. 6) complications; 7) an occupation that could be dangerous if hypoglycemia should occur.

Keywords: anti-hyperglycemic effect
epidemiological screening of il10ra mutation rate in china

Conditions: Digestive System Disease

Summary: the presentation of ibd in early childhood is uncommon and the monogenetic defects, especially il-10 signaling pathway play a key role in very early onset inflammatory bowel disease (veo-ibd). il-10 or il-10r deficiency associated veo-ibd is considered a rare disorder. to date, there were about 60 cases were reported all over the word. but in our chinese veo-ibd collaboration group, 42 patients with biallelic mutations affecting il10r genes were identified from 93 veo-ibd patients, and the mutation sites are highly concentrated, including 83.9% (26/31) with p.r101w and 55% p.t179t (17/31) mutation, and the proportion of patients from henan( a province of china) is higher. so we speculate that il-10ra mutation may not be very rare, and the frequency of heterozygote subjects might be higher than suspected.

1. the mutation rates of p.r101w and p.t179t il10ra in henan newborn. 2. is there any clinical symptoms in children with il-10ra-deficient? and the onset of the symptoms. 3. whether the intestinal permeability is normal in heterozygote subjects.

Eligibility criteria:
inclusion criteria: * in the study period, all newborns in the selected hospita exclusion criteria: * children whose guardian refused to participate in the study

Keywords: interleukin-10 inflammatory bowel disease
domperidone as a treatment for dopamine agonist-induced peripheral edema in patients with parkinson's disease

Conditions: Parkinson's Disease; Peripheral Edema

Summary: the dopamine agonists, pramipexole (mirapex) and ropinirole (requip), are drugs that are used to treat symptoms of parkinson's disease. however, these drugs can induce bothersome leg swelling or edema in about 20 percent of patients. the cause of this edema is unknown but may be secondary to stimulation of peripheral dopamine receptors in the kidney or blood vessels. we hypothesise that a peripherally acting dopamine receptor antagonist, will reduce edema in pd patients. this study will assess the effect of the peripheral acting dopamine d2 receptor antagonist, domperidone as a potential treatment for dopamine agonist-induced leg swelling.

the study is a phase ii, randomised double-blind, placebo-controlled, cross-over trial. there are four periods: recruitment and randomisation; treatment period one (4 weeks); washout (1 week); and finally treatment period two (4 weeks). patients will be randomly assigned domperidone 20 mg tid in treatment period one followed by placebo tid in treatment period two, or placebo tid in treatment period one followed by domperidone 20 mg tid in treatment period two.

Eligibility criteria:
inclusion criteria: * idiopathic pd * on a stable medication regimen for at least one month with leg edema occurring after the start of pramipexole or ropinirole and the absence of other possible reasons for discontinuation of pramipexole or ropinirole treatment (e.g. other adverse effects). exclusion criteria: * pregnancy * breastfeeding * women of child bearing age not using a reliable method of contraception * coronary disease, abnormal qt interval on electrocardiogram (ekg) * diabetes mellitus * hepatic disease * alcohol abuse * renal disease * edema of one leg only * presence of other conditions possibly causing leg edema

Keywords: parkinson's disease domperidone peripheral edema pramipexole ropinirole
lycopene following aneurysmal subarachnoid haemorrhage

Conditions: Subarachnoid Hemorrhage; Aneurysm

Summary: in this study the investigators wish to explore the potential neuroprotective effects of acute oral supplementation of lycopene, a natural anti-oxidant derived from tomatoes, on cerebral vasospasm and autoregulation, and examine whether any improvements translate into a reduction of biochemical markers of vascular injury and inflammation a decrease in the prevalence of secondary strokes following subarachnoid haemorrhage.


Eligibility criteria:
inclusion criteria: * age: \> 18 years old, * confirmed aneurysmal subarachnoid hemorrhage (asah), * time from ictus \< 96 hours exclusion criteria: * age: \< 18 years old, * non-aneurysmal sah, * time from ictus \> 96 hours, * severe carotid atherosclerotic disease (≥70%) * high-dose statin therapy (\>80 mg/day fluvastatin; \>40 mg/day simvastatin; \>40 mg/day pravastatin; \>10 mg/day atorvastatin; \>10 mg/day rosuvastatin 28), * allergy or hypersensitivity to tomatoes and tomato products and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin)

Keywords: aneurysmal subarachnoid hemorrhage (asah) cerebral vasospasm impaired cerebral autoregulation transient hyperaemic response test delayed ischaemic neurological deficits
metatarsophalangeal joint sprain kinesiotaping

Conditions: Turf Toe; Metatarsophalangeal (Joint) Sprain

Summary: kinesio taping would reduce pain, improve gait performance, and enhance the functional capacity of turf toe patients undergoing physical therapy

health practitioners have recently become interested in using kinesiology taping in clinical practice as an alternative to traditional taping and bracing procedures for treating a variety of diseases, including sprain of metatarsophalangeal joint of the big toe. patients with turf toe can benefit from kinesiology tape because it offers therapeutic support and stability while preserving a normal range of motion.

Eligibility criteria:
inclusion criteria: * comprised athletes with 2nd grade turf toe. * medically stable. * had foot pain for more than a month prior to enrollment. * didn't have persistent, incapacitating pain. * had a doctor's note approving their decision to stop taking painkillers during the research. exclusion criteria: * if they had any surgical intervention before. * range of motion limitation in the ankle joint. * inability to exercise. * systemic disease. * any other orthopedic problem at ankle joints.

Keywords: turf toe metatarsophalangeal sprain functional ability gait parameters kinesiology taping
effect of live combined bifidobacterium and lactobacillus on glycemic control and other outcomes in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus; Probiotics

Summary: aim evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. however, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. this study investigated the effect of live combined bifidobacterium and lactobacillus preparation on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.

design a randomized, single-blind, parallel-group, controlled clinical trial. setting diabetes clinic of a teaching hospital in shenzhen china participants a total of 30 participants with type 1 diabetes, aged 18-60 years, will be recruited and randomly assigned to receive either probiotics (n = 15) or placebo (n = 15) for 12 weeks. outcomes primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity c-reactive protein. the gut microbiota profile will be analyzed before and after intervention and between groups.

Eligibility criteria:
inclusion criteria: type 1 diabetes patients ,age 18-60years old,18 kg/m2≤bmi≤30kg/m2, 7.0mmol/l\<fasting blood glucose \<13.0mmol/l；hba1c≤10%，ketonuria (-)； exclusion criteria: pregnancy, lactation, having other severe chronic illnesses.taking other anti-diabetic drugs
three months treatment with sb683699 in patients with relapsing multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the study will evaluate the effectiveness and safety of the investigational drug sb683699 in treating patients with relapsing multiple sclerosis (ms), using data from magnetic resonance imaging (mri) scans as the main measure.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis (ms). * expanded disability status score 0 - 6.5. * one or more relapse of ms in previous 12 months. * currently not taking any medications for ms (apart from those used to treat symptoms). exclusion criteria: * patients with significantly abnormal laboratory tests or electrocardiogram (ecg) results. * subjects who cannot have mri scans. * women who are pregnant, breast feeding or planning to become pregnant during the study.

Keywords: multiple sclerosis relapsing remitting relapsing-remitting ms (rrms)
infusion of donor lymphocytes depleted of cd25+ regulatory t-cells in patients with relapsed hematologic malignancies

Conditions: Hematologic Malignancies

Summary: the purpose of this research study is to evaluate the safety and efficacy of cell depletion in a donor lymphocyte infusion (dli) product with the use of the clinimacs machine. previously, patients with hematologic malignancies who have relapsed after transplant have been given infusions of donor white blood cells calsed donor lymphocyte infusion (dli) as a way to boost their immune function and fight cancer. information from other research studies suggests that lowering the number of a certain type of white blood cell called cd25+ tregs in the dli may allow for a greater effect. in this research study, we are looking for the appropriate dose of dli depleted of the cd25+ treg white blood cells that can be given safely.

* the original marrow/stem cell donor will undergo one or two white blood cell collection procedures called leukopheresis. the cells collected from the first leukopheresis will be sent to the laboratory where the amount of white blood cells collected will be measured. if the number of cells collected at the first leukopheresis is not enough, the donor will have a second leukopheresis procedure. * once enough lymphocytes are collected from the donor, the clinimacs cd25 reagent system device will reduce the number of cd25+ tregs. the cd25+ depleted donor lymphocytes will then be infused to the participant intravenously. participants will be observed for about one hour after the infusion. * one, two, four and eight weeks after the dli, participants will return to the clinic for follow-up visits. at each visit a physical exam, questions about the participants general health, and blood tests will be performed.

Eligibility criteria:
inclusion criteria: * patients with hematologic malignancies that have relapsed after hla-a, -b, -c, and-drbi matched allogeneic hematopoietic stem cell transplantation * at least 2 months following hematopoietic stem cell transplantation * off any systemic immunosuppressive medication for treatment or prevention of gvhd, for a minimum of 2 weeks prior to study entry * recipient with donor chimerism of 20% or greater within 6 weeks prior to dli * patient with less than 50% bone marrow involvement (% cellularity) and less than 5cm lymph nodes, in the 6 weeks prior to dli * 18 years of age or older * ecog performance status score 0-2 * prior stem cell donor is medically fit to undergo leukapheresis procedure exclusion criteria: * relapsed cml in chronic phase * prior donor lymphocyte infusion or other immunotherapy treatment within 8 weeks prior to enrollment * chemotherapy within 4 weeks prior to enrollment * clinically significant and active autoimmune disease in donor or patient. this is defined as autoimmune disease resulting in organ dysfunction and/or requiring systemic therapy * evidence of active acute or chronic gvhd * uncontrolled infection

Keywords: cd25+ tregs dli donor lymphocyte infusion
initial combination with pioglitazone study (0431-064)

Conditions: Type 2 Diabetes Mellitus

Summary: a clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.


Eligibility criteria:
general inclusion criteria: * patients ≥18 years old with type 2 diabetes mellitus (a specific type of diabetes) general exclusion criteria: * patient has a history of type 1 diabetes mellitus or history of ketoacidosis * patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4 months * patient was on \>4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years
a study of peginterferon alfa-2a with or without ribavirin in participants with chronic hepatitis d (chd)

Conditions: Hepatitis D, Chronic

Summary: this single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with chd.


Eligibility criteria:
inclusion criteria: * positive hepatitis b surface antigen (hbsag) for the prior 6 months * positive anti-delta for the prior 3 months * positive hdv rna at screening * elevated alt (1 to 10 times upper limit of normal) prior to first dose * chronic, necroinflammatory hepatitis documented within the prior 18 months (non-cirrhotic) or 30 months (cirrhotic) * negative pregnancy and adequate contraceptive use exclusion criteria: * antiviral therapy for chd within previous 3 months * positive for hepatitis a or c, or human immunodeficiency virus (hiv) * increased risk of metabolic liver disease * decompensated liver disease * elevated bilirubin * poor hematologic or renal function * drug/alcohol abuse within 1 year prior to study * history of significant psychiatric, autoimmune, pulmonary, cardiac, oncologic, or thyroid disease * organ transplantation with existing functional graft * retinopathy or other ophthalmologic complication of diabetes or hypertension * inclusion in another investigational trial within previous 12 weeks
assessment of blood glucose monitoring systems - evaluation of oxygen dependency

Conditions: Diabetes

Summary: systems for blood glucose monitoring with glucose oxidase enzyme reaction on test strips can be affected by the partial pressure of oxygen of the blood sample. in this study, we investigate the influence of different partial pressure of oxygen in blood samples on measurement results. systems with labelled oxygen-dependency as well as systems without labelled oxygen-dependency are evaluated.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * male or female subjects with type 1 or type 2 diabetes or healthy subjects * signed informed consent form exclusion criteria: * pregnancy or lactation period * severe acute illness that, in the opinion of the investigator, might pose additional risk to the subject * severe chronic illness that, in the opinion of the investigator, might pose additional risk to the subject