Kornimate/medical-research-clean huggingface dataset:
bladder wall thickness in symptomatic urinary stress incontinence and its correlation with urodynamics results

Conditions: Urinary Incontinence , Stress; Incontinence

Summary: this clinical study aims to assess the utility of ultrasonographic bladder wall thickness (bwt) measurement in patients suffering from symptomatic stress urinary incontinence (sui). sui is a condition characterized by involuntary leakage of urine during activities that increase intra-abdominal pressure and represents a very frequent disorder impacting women's quality of life. to diagnose sui more accurately and especially before surgical treatment, patients undergo invasive urodynamic examination. this examination allows us to objectify the presence of any bladder dysfunction and, in particular, to evaluate the presence of detrusor overactivity. detrusor overactivity is defined as any occurrence of detrusor contraction(s) during filing cystometry. these contractions, which may be spontaneous or provoked, produce a waveform on the cystogram, of variable duration and amplitude and may cause or not urgency symptoms. in absence of any urodynamic detrusor overactivity, the patient may be diagnosed with pure sui. this is essential to assess before surgical treatment to avoid worsening of symptoms and to decide whether to treat the patient with concomitant pharmacological treatment. on the contrary, ultrasonography offers a non-invasive and accessible approach to evaluate bladder function. this study will involve a cohort of patients with sui, who will undergo ultrasonographic assessment of bwt and preoperative urodynamic assessment. the objective is to determine whether bwt correlates with the urodynamics results and whether it can predict the presence or absence of detrusor overactivity and confirm the pure stress urinary incontinence


Eligibility criteria:
inclusion criteria: 1. participant is willing and able to give informed consent for participation in the study. 2. women aged \> 18 y.o. 3. women symptomatic for pure or predominant stress incontinence attending the urogynecology outpatient clinic at our institution. 4. patients undergoing urogynecological standard evaluation for their symptoms, including outpatient gynecological visit and a transvaginal ultrasound. 5. patients undergoing invasive urodynamic examination for objective assessment of their symptoms or in preparation for possible anti-incontinence surgery. exclusion criteria: 1. patients with pure or predominant oab symptomatology 2. current use of antimuscarinic agents or beta3-agonists (for example mirabegron) 3. presence of urological or gynecological cancer. 4. patients with previous anti-incontinence surgery. 5. patients with pelvic organ prolapse \> ii stage. 6. patients with chronic bladder retention. 7. patients with neurological diseases that may affect bladder function and urodynamic results. 8. participants unwilling or unable to give informed consent for participation in the study.
transcranial direct current stimulation (tdcs) in chronic neuropathy

Conditions: Neuropathic Pain; Neuralgia

Summary: this study evaluates the effect of additional transcranial direct stimulation (tdcs) on pain in patients with chronic neuropathic pain undergoing treatment with regional anaesthesiological techniques.

about 3.8 million persons in germany suffer from chronic pain with a relevant physical and social impairment representing approximately 7% of the population. chronic pain conditions include patients with neuropathic pain such as trigeminal neuralgia, post-zoster pain or pain after amputations. there is a significant number of patients with pain without response to optimised drug therapy. especially in these chronic pain patients there is data demonstrating maladaptive plasticity as pathophysiological evidence of structural changes in brain connectivity. patients are treated with multimodal pain therapy concepts including interventional procedures with nerve infiltration techniques. one innovative therapeutic option for pain patients is transcranial direct current stimulation (tdcs): in recent clinical trials, patients reported on reduced overall pain intensity following tdcs stimulation series shown e.g. from bolognini et al., antal et al. and most recently from volz and colleagues. however, there is no current data available evaluating a role of tdcs for patients with chronic neuropathic pain treated with regional anaesthesiological techniques. objective: to evaluate effect of additional tdcs series on pain in patients with chronic neuropathic pain primary study endpoint: relative reduction in pain (initial vas measured versus vas after completion of the therapy series) as a numeric value between 0 and 10.

Eligibility criteria:
inclusion criteria: * patients with neuropathic pain with indication of regional anaesthesiological interventions exclusion criteria: * \<18 years of age * pregnancy * police custody * epilepsy * participation in another prospective clinical intervention study within the last 30 days

Keywords: neuropathic pain neuralgia tdcs transcranial direct current stimulation
effects of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic risk factors

Conditions: Metabolic Syndrome

Summary: clinical trial about beneficial effects of natural ingredient containing chlorogenic acid and luteolin on liver health and conditions related to liver (such as metabolic syndrome) for general body health.

this is one randomized, double-blind, placebo-controlled study. the purpose of the present study is to evaluate and/or elucidate the role of the natural supplement, containing chlorogenic acid (10-12%) and luteinyl-7-glucoside (2-4%), on cardio-metabolic risk factors. the research hypothesis is to evaluate whether natural supplement containing chlorogenic acid and luteolin (puraltilix, bionap srl, catania, italy) may improve several cardio-metabolic parameters in subjects with the metabolic syndrome. all subjects will be evaluated at baseline and after 6 months of treatment (with natural supplement or placebo).

Eligibility criteria:
inclusion criteria: * men and women aged \>18 years with the metabolic syndrome (as defined by the international criteria: alberti kg, et al. circulation. 2009; 120: 1640-5); * bmi\> 25 kg/m\^2; * subjects able to swallow whole tablets; * informed consent obtained prior to any study-related activities. exclusion criteria: * pregnancy or willingness to become pregnant; * severe liver dysfunction (alt \>2.5 times upper limit of normal); * severe renal failure (egfr\<60 ml/min/1.73 m2 using the mdrd formula); * severe infections at the discretion of the investigator (such as hiv, hbv and hcv); * history or presence of malignant neoplasms within the last 5 years.

Keywords: metabolic parameters cardio-metabolic parameters
phase 2 study of glycomacropeptide versus amino acid diet for management of phenylketonuria

Conditions: Phenylketonuria

Summary: for individuals with phenylketonuria (pku), the investigators hypothesize that glycomacropeptide will provide an acceptable form of low-phenylalanine dietary protein that will improve dietary compliance, blood phenylalanine levels, cognitive function, and ultimately quality of life compared with the usual amino acid based diet. the study is funded by the food and drug administration (fda) office of orphan products development grants program, r01 fd003711.

individuals with phenylketonuria (pku) lack the enzyme phenylalanine hydroxylase that is needed to metabolize the essential amino acid phenylalanine (phe). when eating a normal diet they show an elevated level of phe in blood that is toxic to the brain. in order to prevent brain damage and cognitive impairment, individuals with pku must follow a lifelong, low-phe diet that is restricted in natural foods and requires ingestion of a phe-free amino acid (aa) formula. most adolescents and adults with pku find the aa formula unpalatable and go off the diet resulting in elevated blood phe levels and neuropsychological deterioration. glycomacropeptide (gmp), an intact protein produced during cheese making, is uniquely suited to a low-phe diet because it is the only known dietary protein that contains minimal phe. foods and beverages made with gmp are a palatable alternative to aa formula. the long term goal is to assess the safety, efficacy and acceptability of gmp for the nutritional management of pku. the specific aim is to conduct a randomized, two-stage, 11-wk, crossover trial comparing the gmp diet with the aa diet in 30 subjects with pku ≥12 years of age treated since birth with a low-phe aa diet. the sites are: university of wisconsin-madison, waisman center (primary) and harvard university, children's hospital boston. subjects will be recruited and randomized to begin the first 3-wk of the study with either a low-phe diet in which the majority of dietary protein is provided by gmp or aa medical foods and then, after a 3-wk washout with intake of their usual diet, begin the second diet for 3-wk. dietary education will be provided in a 1-wk base period preceding initiation of each diet.

Eligibility criteria:
inclusion criteria: * identified pku by newborn screening; started diet treatment before 1 mo age * diagnosis of classical or variant pku with documented phenylalanine level of greater than 600 umol/l at 7-10d of age * follows or willing to follow pku diet and consume amino acid medical formula providing more than 50% of protein needs * acceptance of glycomacropeptide foods determined prior to enrollment exclusion criteria: * females who are pregnant or planning pregnancy * individuals with mental deficits due to untreated or poorly controlled pku * individuals with any health condition deemed to interfere with participation

Keywords: diet therapy low phenylalanine diet attention executive function
intravitreal aflibercept for treatment of polypoidal choroidal vasculopathy (pcv)

Conditions: Symtomatic Macular Polypoidal Choroidal Vasculopathy

Summary: objective: to evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular pcv.


Eligibility criteria:
inclusion criteria: * male or female \>/= 18 years * confirmed diagnosis of symptomatic macular pcv in the study eye defined by: - active macular polypoidal lesions shown by icga and - presence of serosanguinous maculopathy * bcva letter score between 78-24 using etdrs visual acuity chart measured at 4 meters exclusion criteria: * previous treatment with systemic anti-vegf drugs within 6 months prior to baseline (e.g., sorafenib \[nexavar®\], sunitinib \[sutent®\], bevacizumab \[avastin®\]) study eye: * active ocular inflammation or infection (ocular or periocular) * uncontrolled intraocular hypertension or glaucoma (iop\> 30 mmpig) despite treatment with anti-glaucoma medication * predominantly-scarred pcv lesions * ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise va or require medical or surgical intervention during the study period * prior treatment with verteporfin pdt, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy * prior treatment with any anti-vegf compound or any investigational treatment * treatment with intravitreal or subtenon corticosteroid injection or device implantation within 90 days
cup revisions through anterior or posterolateral approach: an rct

Conditions: Loosening, Prosthesis

Summary: with increasing numbers of total hip arthroplasties performed each year, the incidence of problems related to loosening and wear of total hip arthroplasties is expected to also increase. while the anterior approach for primary total hip arthroplasty has demonstrated to result in a faster short-term recovery than the traditional lateral and posterior approach, this effect has not yet been investigated in revision surgery. accelerating functional outcome may increase patient satisfaction and reduce healthcare costs. the primary objective is to assess whether isolated cup revision surgery through the anterior approach results in increased functional status and higher patient satisfaction than through the posterolateral approach. this is a prospective randomized controlled trial (rct) in which 68 patients will be included (34 per group). patients will be evaluated preoperatively and 6 weeks, 3 months and 1 year postoperatively. the main endpoints are functional recovery as measured with the 30-sec chair stand test (30s-cst), 40m fast paced walking test (40m fpwt) and the stair climb test (sct). secondary endpoints are modified borg scale outcomes after the functional tests, numeric rating scale (nrs) for pain (rest/movement), oxford hip score (ohs), hoos-ps, eq-5d-5l, satisfaction, cup inclination and complications at 30 days and 90 days postoperatively.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * on waiting list or scheduled for isolated cup revision surgery through anterior or posterolateral approach * a good command of the dutch language exclusion criteria: * revision for confirmed or suspected infection * not suitable for both approaches under study, as judged by orthopaedic surgeon * unable to fully understand study information and to accurately/reliably complete the questionnaires, as judged by researcher and/or orthopaedic surgeon * unable to accurately follow instructions for study procedures / measurements, as judged by researcher and/or orthopaedic surgeon * unwilling to sign informed consent form

Keywords: isolated cup revision hip revision surgery anterior approach posterolateral approach cup revision surgery
effects of remote ischemic pre-conditioning in moyamoya disease patients

Conditions: Moyamoya Disease; Remote Ischemic Preconditioning

Summary: in the present study, investigators evaluated whether ripc reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (edas).

background: brain ischemia and injury contributed to perioperative morbidity and mortality in revascularization surgery. remote ischemic preconditioning (ripc), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. previous study found combined remote ischemic pre- and post-conditioning can be effective in reducing neurologic complications and the duration of hospitalization in moyamoya patients undergoing direct revascularization.in order to investigate whether ripc before edas can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study. designing: about 328 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1 ratio to ripc group and sham ripc group (control). remote limb ischemic preconditioning (ripc) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmhg for 5-min followed by deflating the cuff for 5-min, patients in the ripc group will do it twice a day for at least five days before edas. patients in the sham ripc group receive sham ripc treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmhg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least five days before edas. cerebral injury is assessed by plasma human soluble protein-100b (s-100b) and neuron specific enolase (nse). clinical outcomes are determined by cerebrovascular events (including ischemic stroke, transient ischemic attack (tia), cerebral hemorrhage and transient neurological deficit) and death or dependent.

Eligibility criteria:
inclusion criteria: 1. patients who diagnosed with moyamoya disease 2. adults 18 to 65 years of age 3. the onset symptoms manifested as ischemic symptoms (tia or stroke) or atypical symptoms (headache, epilepsy or asymptomatic) 4. able to receive the necessary imaging examination 5. patients who pre-agreed to the study exclusion criteria: 1. prior cerebral hemorrhage history 2. other brain or cerebrovascular disease 3. previous history of revascularization surgery 4. dependent (mrs \> 2) 5. receive other type of revascularization surgery 6. peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion). 7. patients who do not agree with the study

Keywords: moyamoya disease cerebrovascular disorders arterial occlusive diseases ischemia
iodine supplementation on breast cancer

Conditions: Breast Cancer

Summary: the trial investigates the effect of oral supplement of molecular iodine (i2) alone and in combination with 4 to 6 cycles of fec/te (5-fluorouracil, epirubicin, cyclophosphamide/taxotere, epirubicin) treatment in woman diagnosticated with early (stage ii) and advance (stage iii) breast cancer, respectively. the study analyzes the clinical response \[tumor size, thyroid status, side effects (common toxicity criteria v4.0)\] and molecular mechanisms in the tumor samples (transcriptomic, proteins and immune responses).

the leading causes of failure of breast cancer treatment are the rapid development of metastases and tumor resistance to antineoplastic drugs. anthracyclines (doxorubicin (dox), epirubicin, etc.) are the golden standard in neoadjuvant therapy and are commonly used in the fec/te (5-fluorouracil, epirubicin, cyclophosphamide/taxotere, epirubicin) combination therapy during advanced breast cancer. however, even when treated with this potent chemotherapeutic combination, 30% of patients develop chemoresistance and cardiomyopathic side effects. previous studies support that the oral supplement of molecular iodine (i2) exerts synergistic antineoplastic and cardioprotective impact when used in combination with the dox in rodent and canine mammary cancer model. the present study performed two randomized clinical groups including women with early (stage ii) and advanced (stage iii) breast cancer. in the early group, women were treated with i2 (5 mg/day) or placebo (colored water) for 7 to 35 days. in the advanced group, patients received treatment (i2 or placebo) along with 4 to 6 cycles of fec/te treatment. the study analyzes the clinical response \[tumor size, thyroid status, side effects (common toxicity criteria v4.0)\] and molecular mechanisms in the tumor samples (transcriptomic, proteins and immune responses).

Eligibility criteria:
inclusion criteria: * histologically confirmed, stage ii or iii breast cancer * scheduled to surgical of the primary tumor (stage ii) * will receive neoadjuvant fec/te chemotherapy (stage iii). * age \> 18 and \< 81 years * non-pregnant * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * known sensitivity to iodine or fec/te * concurrent severe and/or uncontrolled disease * myocardial infarction within the last six months before the study * unstable or uncontrolled hypertension * thyroid dysfunction
whey protein effects on gycemic control and vascular function

Conditions: Blood Sugar (Glucose) Control; Blood Vessel (Vascular) Dysfunction

Summary: risk for heart and blood vessel diseases is increased when blood sugar rises. blood vessel dysfunction is common to such diseases. elevated blood sugar after eating promotes blood vessel dysfunction. dietary factors other than carbohydrates influence rises and falls in blood sugar. dietary protein is associated with improved blood sugar control. whey protein effectively blunts the rise in blood sugar after consuming a carbohydrate rich drink/meal in normal weight and obese adults. this study will investigate the efficacy of drinking a whey protein beverage prior to eating for improved daily blood sugar control in normal weight and obese adults in the "real world." also, the study will test this dietary approach to reduce blood vessel dysfunction associated with eating a meal that causes blood sugar to rise. 24 normal weight and 24 obese men and premenopausal women (18-50y) will participate. subjects will wear a sensor to monitor daily blood sugar changes in response to their typically consumed diets for 2 days. subjects will report to the ucla ctrc the morning after the monitoring period for measurement of blood vessel function after eating a breakfast cereal meal. blood samples will be obtained before and after the meal to measure relevant health markers. subjects will repeat the 2-day diet and breakfast cereal meal challenge after a week or more, and will consume either a chocolate flavored 1) whey protein or 2) gelatin protein (control) shake prior to each meal. neither subjects nor researchers will know which protein ("double blind"). subjects will receive the alternate protein intervention after another week or more ("crossover"). we think drinking the protein shake prior to meals will reduce daily blood sugar rises and falls after eating and blunt the blood vessel dysfunction that results from eating the breakfast cereal.


Eligibility criteria:
inclusion criteria: * age 18-50 years * bmi between 18.5 and 25 or ≥ 30 * willingness to provide written informed consent exclusion criteria: * pregnant or breastfeeding currently or in prior 6 months * menopause in women * regular consumption of \> 1 serving per day of milk/yogurt * known heart arrhythmia * use of tobacco products * any disease/pathological condition known to influence outcomes * use of medications/dietary supplements known to influence outcomes * recent or planned changes in diet/exercise
preoperative irinotecan drug-eluting beads for patients with unresectable colorectal liver metastasis

Conditions: Colorectal Cancer; Liver Metastases

Summary: trans arterial chemoembolization using irinotecan drug-eluting beads before liver surgery for patients with primarily unresectable colorectal liver metastasis


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * histologically proven colorectal liver metastasis； * with liver-dominant disease； * primarily evaluated as potentially resectable and conversed successfully * adequate hematologic function: absolute neutrophil count (anc)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (inr) ≤1.3 (within 1 week prior to randomization) * adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl (within 1 week prior to randomization); * written informed consent for participation in the trial. exclusion criteria: * primarily evaluated as resectable * failed to converse * patients with known hypersensitivity reactions to any of the components of the study treatments. * pregnancy (absence confirmed by serum/urine β-hcg) or breast-feeding * other previous malignancy within 5 years * known drug abuse/ alcohol abuse * legal incapacity or limited legal capacity