Kornimate/medical-research-clean huggingface dataset:
a comparison of two different doses of maternal b12 supplementation in improving infant b12 deficiency and neurodevelopment

Conditions: Vitamin B 12 Deficiency

Summary: supplementation with iron and folate have been part of a worldwide strategy targeting anaemia and neural tube defects for many years. however, vitamin b12 deficiency has received much less attention. high prevalence of deficiency in mothers in the antenatal period and in their infants, has been documented. multiple case series document the neurological consequences of severe deficiency and their reversal with b-12. trials on the subject are limited and those available have either used an ineffective dose or for a short duration. therefore, we propose this randomised controlled trial to compare the efficacy of two different doses (pharmacological and preventive) of maternal vitamin b-12 supplementation in improving infant b12 deficiency and neurodevelopment. we propose to undertake a multi-centric trial in india and nepal given the high prevalence of deficiency reported from these countries and to allow a wider socio-demographic spectrum (pay-for-service hospital catering to middle income populace from india and a free-care public hospital catering to lower income groups from nepal). we will recruit 720 vegetarian, pregnant women from the antenatal clinics of the indian and nepalese centres at their first antenatal visit. elderly primi mothers, taking b12 supplementation, multiple gestations, chronic medical conditions, anticipating moving out of the city, treated for infertility or with known psychological illnesses will be excluded. in stage 1, recruited mothers will be randomized into 2 equal groups (360 each). group 1-daily 250 μg vitamin b12 supplementation. group 2-daily 50 μg vitamin b12 supplementation. b-12 will be started in 1st trimester and continue up to 6 months post-partum. in stage 2, the birth and post-delivery course of the new-born will be monitored and documented for any morbidity. at 9 months, the neurodevelopmental, complementary feeding and home environment will be assessed and infant b12 status will be determined. the two groups will be compared for the primary (neurodevelopment) and secondary outcomes (biochemical parameters in mother and infant). the results of this study will be used to generate scientific evidence on whether b-12 should be supplemented in vegetarian pregnant women with a view to preventing b-12 deficiency and its neurodevelopmental consequences in the infant.


Eligibility criteria:
inclusion criteria: * \<12 weeks gestation vegetarian mothers exclusion criteria: 1. mothers already on b12 supplementation 2. women with multiple gestation, those diagnosed with chronic medical conditions (diabetes mellitus, hypertension, heart disease, neurological disease or thyroid disease), and those who tested positive for hepatitis b, hiv or syphilis (associated with prematurity, iugr and other neonatal morbidities which could influence neurodevelopment) 3. women who anticipate moving out of the city before/ after delivery 4. women treated for infertility 5. women with known psychological illnesses including depression
a postmarketing study of lecanemab in south korean participants with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the primary purpose of this study is to evaluate safety of lecanemab in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (aria)-edema (aria-e), aria-hemosiderin deposition (aria-h), symptomatic aria-e, symptomatic aria-h, and intracerebral hemorrhage (ich) greater-than 1 centimeter (cm) in participants treated with lecanemab.


Eligibility criteria:
inclusion criteria: * 18 years or older at consent * prior to joy-alz enrollment, the treating physician confirms that the participant is suitable for lecanemab treatment, as per the approved indications in south korea * has an identified study partner who provides separate written informed consent * provides written informed consent for the use of medical information to be shared with eisai korea inc. exclusion criteria: * currently participating in an interventional clinical study * has contraindications for lecanemab according to the approved prescribing information in south korea

Keywords: alzheimer's disease lecanemab aria
adjuvant anal imiquimod therapy in anal hpv-lesions: adam-trial

Conditions: Anogenital Human Papillomavirus Infection; Condyloma Anal

Summary: adam is a prospective, randomized, controlled, double-blinded, monocentric trial in patients receiving surgical therapy due to anal hpv infection. aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical imiquimod-therapy). it is planned to include 200 patients. 100 patients receive surgical therapy+ topical imiquimod therapy, 100 patients receive surgical therapy + topical placebo therapy


Eligibility criteria:
inclusion criteria: * ability to understand and willingness to sign and date a written consent document * male and female patients \>= 18 years of age * negative urine/serum pregnancy test * indication for surgical therapy of anal hpv lesions exclusion criteria: * participation in another clinical study with experimental therapy * diagnosis and therapy of hpv associated lesions in the last 12 months * known intolerance of hypersensitivity to imiquimod * women who are pregnant of lactating

Keywords: condylomata acuminata, fulguration, imiquimod
impact of fluid status on liver elastography and t1-mapping results in patients undergoing cmr.

Conditions: NAFLD/MAFLD; Liver Fibrosis; CMR

Summary: correlation between cmr t1-times, liver t1-times, fibroscan and fluid status to identify the correlation and pathogenesis of liver disease in patients with heart disease.


Eligibility criteria:
inclusion criteria: * referred for cardiovascular magnetic resonance imaging exclusion criteria: * non-compatible devices

Keywords: nafld cmr
efficacy of urokinase containing locking solutions for thrombotic dysfunction of tunneled hemodialysis catheters

Conditions: Kidney Failure, Chronic; Vascular Access Devices

Summary: thrombotic dysfunction is a common complication of tunneled cuffed catheters (tcc) leading to inadequate dialysis dose, need to catheter replacement with as consequence progressive exclusion of vascular sites. thrombolytic agent can be used as therapeutic locking solution to dissolve the clotting formed in of around the catheter lumen. there are few studies on the optimal approach of tcc-related thrombosis with thrombolytic containing locking solution (dose, number of administrations, timing of administration - intra or interdialytic use). the primary objective of this retrospective study was to compare the efficacy of inter versus intradialytic urokinase containing locking solution on restoration of the tcc blood flow. the investigators also assess the question of multiple administrations of urokinase are more efficient than one single administration


Eligibility criteria:
inclusion criteria: * hemodialysis patients over 18 years old, receiving hemodialysis between 1st may 2010 and 31st october 2014 via a tunneled cuffed catheter at the hemodialysis unit of universitair ziekenhuis brussel hospital. exclusion criteria: * patients younger than 18 years old * patients with a temporary dialysis catheter * patients who never received a tunneled hemodialysis catheter in this period * patients who didn't have a medical file at the universitair ziekenhuis brussel hospital
liver and spleen stiffness to predict the presence of esaphageal varices in cirrhotic with advanced hcc

Conditions: Hepatocellular Carcinoma; Liver Cirrhosis; Portal Hypertension

Summary: elasto-hcc is a prospective, uncontrolled, multicenter observational study involving several hepatology centers in italy. patients with liver cirrhosis and advanced hepatocellular carcinoma (hcc) who will need to undergo systemic therapy will be enrolled. patients in the first phase will undergo measurement of liver and spleen stiffness and upper endoscopic evaluation and will subsequently be followed for 12 months

hepatocellular carcinoma (hcc) and clinically significant portal hypertension (csph) frequently coexist, affecting cirrhotic individuals' prognosis. recently it has been confirmed that in cirrhotic patients with favorable baveno vi consensus (platelets\>150000/mm3 and liver stiffness measurement (lsm\<20 kpa) or combined model based on spleen stiffness, endoscopic screening for varices could be avoided. the portal hypertension (ph)-related complications in all patients should be avoided and well managed, especially if they have advanced hcc (ahcc) at diagnosis. however, unlike patients without hcc, endoscopy is recommended for those who undergo systemic therapy, even if compatible with favorable baveno vi consensus . the reasons for this indication derive from the consideration that the presence of hcc could influence the measurement of lsm and platelet count. to date, in cirrhotic patients without hcc, according to baveno vii consensus and the last easl guidelines for non-invasive tests (nits), besides lsm, spleen stiffness measurement (ssm) is now considered the most accurate nits for assessing portal hypertension and predicting the presence of esophageal varices (evs) and varices needing treatment (vnt). to date, no studies have evaluated the accuracy of nits (lsm/ssm) on patients with advanced hcc (ahcc) who should undergo systemic therapy. the study aims to assess the performance of ssm to rule out vnt in patients with ahcc who undergo systemic therapy. each center will prospectively collect data according to an electronic e-cfr on redcap (research electronic data capture) system, a web application designed to support data capture for research studies in a secure manner.

Eligibility criteria:
inclusion criteria: * age \> 18 yrs; * cirrhotic patients of any etiology with ahcc scheduled to receive any line of systemic treatment for hcc; * patients are willing and able to give informed consent. exclusion criteria: * presence of splenic, mesenteric, or portal vein thrombosis. * previous placement of tips at the time of informed consent.

Keywords: hcc liver stiffness spleen stiffness esophageal varices portal hypertension
treatment of hepatocellular carcinoma with radiofrequency ablation (rfa) associated with postoperative tace

Conditions: Cancer of Liver

Summary: a rct was conducted to elucidate whether the treatment outcome of hcc could be improved by rfa associated with postoperative tace.

a randomized study was conducted to elucidate whether the outcome of hepatocellular carcinoma could be improved by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization.

Eligibility criteria:
inclusion criteria: * patients with hepatocellular,confirmed by pathological examination * patients with a live function test showed child a or b * indocyanine green test showed less than 30％ after 15min,and the patients showed a tolerance of rfa and tace * tumor stage is early period(according to milan standard),that is,the diameter of single node should be less than 5cm；the node of tumor should be less than 3 and the diameter less than 3cm. * without metastasis in lymphnode or other organs * written consent inform assigned exclusion criteria: * preoperative examination showed malignant thrombosis in the first class branch of portal vein or hepatic vein or vena cava * metastatic cancer of liver * patients with a poor tolerance of rfa and tace * patients received other therapies.

Keywords: radiofrequency ablation cancer of liver postoperative transhepatic arterial chemoembolization prospective
screening type 2 diabetes mellitus on the 2nd day after delivery in women with gestational diabetes mellitus

Conditions: Diabetes, Gestational

Summary: gestational diabetes mellitus (gdm) is defined as a hyperglycemia with onset or first recognition during pregnancy. gdm complicates 5 to 25% of pregnancies, depending on the diagnostic criteria used and the population being studied. gdm is an important red flag: up to 70% women with gdm will develop type 2 diabetes mellitus (t2dm) during their lifetime. accordingly, professional associations recommend t2dm postpartum screening (t2dm-pp-s), 6-to-24 weeks after delivery. a 75g oral glucose tolerance test (ogtt) should be performed for diagnosis (gold standard). nevertheless, this t2dm-pp-s recommendation has failed worldwide for the same reasons: the presently impractical pattern of the testing. a solution is direly needed. our overall goal is to improve detection of pre-diabetes and diabetes and more specifically, to facilitate the recommended t2dm-pp-s in women diagnosed with gdm. we hypothesize that, in gdm women, results of an ogtt performed after delivery, before hospital discharge (ogtt-1) predict results of the recommended ogtt at 6-to-12 weeks postpartum (ogtt-2). our aims are: 1. to validate in caucasian women the predictive threshold value of the 2hr-glucose of ogtt-1 established by our stage-1 study. 2. to determine, in a multiethnic non-caucasian cohort, the threshold value for the 2hr-glucose of ogtt-1 that is predictive of abnormal glucose tolerance at ogtt-2. 3. to define the ogtt time preference of women (before hospital discharge vs. 6-to-12 weeks postpartum). if our results are in line with our stage-1 data, most redundant 6-to-24 weeks postpartum ogtt will be avoided. medical practice will change.


Eligibility criteria:
inclusion criteria: * women aged between 18 and 45 years; * having a positive diagnosis of gestational diabetes mellitus (gdm) (iadpsg or cda criteria or patient followed for gdm); * treated with diet, insulin or oral hypoglycemic agents; * have given birth to a child at term (gestational age ≥ 37 weeks); * have signed the consent form. exclusion criteria: * history of glucose intolerance or diabetes before the pregnancy; * have presented another obstetrical pathology during the pregnancy; * severe gestational high blood pressure with proteinuria; * delayed intrauterine development syndrome; * pregnancy with more than a foetus; * drug addiction; * had complications during the delivery such as: * moderate to severe postpartum bleeding; * surgery in postpartum (curettage, hysterectomy, etc.).
dexmed/buspirone synergism on shivering

Conditions: Hypothermia

Summary: the purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia. the design of the study includes four study days done in random order. the days are as follows: 1) control (no drug); 2) buspirone 60 mg orally; 3) dexmedetomidine (delivered by a computer-controlled iv infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6 ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic technique in addition to the pic line catheter, a simple peripheral catheter will be inserted into the other arm for drug administration. throughout the study period, mean-skin temperature will be maintained at 31°c by adjusting the temperature of circulating water (cincinnati sub-zero, cincinnati, oh) and forced-air warmers (augustine medical, inc., eden prairie, mn). furthermore, the back, upper-body, and lower-body will individually be maintained at the designated skin temperature. lactated ringer's solution cooled to ≈3°c will be infused via the pic-line at rates sufficient to decrease tympanic membrane temperature ≈1.5°c/h. fluid will be administered as long as oxygen consumption or electromyographic intensity (see below) continues to increase or a total of 5 liters of fluid is given. heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at the ankle. in case heart rate and/or blood pressure changes unexpectedly (by more than 30% of the baseline), the study will stop and the volunteer will be re-warmed immediately.


Eligibility criteria:
inclusion criteria: * 18-40 years * normal weight (bmi \<35) * healthy exclusion criteria: * obese (bmi \>35) * taking any drugs * thyroid disease, dysautonomia, or raynaud's syndrome * severe claustrophobia
mhealth-cardiac rehabilitation for inoca

Conditions: Ischemia

Summary: this is a multi-site phase ii, 2:1 pragmatic randomized trial of 250 participants within the nyu langone health (nyulh) and emory university medical center system to evaluate mobile health cardiac rehabilitation (mhealth-cr) in patients who meet clinical criteria for inoca (ischemia and no obstructive coronary disease on imaging). participants will be randomized to mhealth-cr or usual care. the study intervention takes place for 3 months which is the time period for most traditional cr programs. the overall study goals are threefold: 1) to evaluate whether an mhealth-cr intervention that includes activity tracking, weekly counseling, and exercise documentation, improves health status (i.e., symptoms, function, and quality of life) in patients with inoca at 3 months; 2) to evaluate effects of the mhealth-cr intervention vs. usual care on physical activity and exercise capacity, general health status, and depressive symptoms (secondary endpoints). we will also evaluate effects on primary and secondary outcomes at 6 months and 1 year; and 3) to characterize engagement and elucidate any factors that limit engagement.


Eligibility criteria:
inclusion criteria: * age 18 and over * diagnosis of ischemia with non-obstructive coronary arteries (inoca) based on evidence of ischemia and/or ischemic symptoms, plus non-obstructive coronary artery disease (cad) on computed tomography (ct) or invasive angiography exclusion criteria: * seattle angina questionnaire (saq) = 100 * non-ambulatory * pregnant * moderate or severe cognitive impairment * unable/willing to provide consent * incarcerated * unable to use mhealth * severe osteoarthritis or joint replacement within 3 months * parkinsons disease or other movement disorders * regular use of walker * life expectancy \< 12 months * clinical judgement concerning other safety or non-adherence issues * unable to read and communicate in english since the app content is currently only available in english.

Keywords: inoca anoca ischemia no obstructive coronary artery disease
exercise and nerve function in diabetes

Conditions: Diabetic Neuropathy

Summary: the purpose of this study is to describe the effect of a 10-week exercise program on nerve function and number of nerve fibers in the skin in the lower leg in people with diabetic neuropathy.

the objective for this application is to quantify the benefits of exercise on nerve function including proprioception, and investigate the relationship of these findings with improvements in epidermal and dermal innervation. in this pilot project, we will pursue 2 specific aims: 1) determine the effect of an exercise intervention on nerve function in people with diabetic neuropathy, and 2) assess changes in cutaneous innervation following participation in an exercise program.

Eligibility criteria:
inclusion criteria: * age 40-70 * type 2 diabetes * peripheral neuropathy exclusion criteria: * serious cardiac history or other medical problems that would prevent safe participation in exercise

Keywords: neuropathy diabetes
sleep and activity monitoring after thoracic surgery

Conditions: Thoracic Surgery; Surgery, Thoracic

Summary: show by collecting sleep and activity data, outcomes after thoracic surgery are improved with better sleep and increased activity.

little is known about how sleep deprivation affects recovery after thoracic surgery. there is some evidence that in cardiac surgery, sleep disturbance can lead to delayed recovery and mental status changes in the postoperative period. there are no similar reports of studies after thoracic surgery. we think that increased activity after surgery is beneficial for a rapid recovery and prevents blood clots, pneumonia and deconditioning. without specific data this is difficult to prove.

Eligibility criteria:
inclusion criteria: * undergoing thoracic surgery at mayo clinic rochester * expected to stay in hospital for at least 4 days * signed consent form exclusion criteria: * unable to provide consent

Keywords: sleep exercise activity
role of cyberknife stereotactic radiation therapy (sbrt) followed by gemcitabine for patients with locally advanced pancreatic cancer

Conditions: Pancreatic Cancer; Unresectable Pancreatic Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of stereotactic radiation therapy given in five fractions (30 gray in 5 fractions) followed by gemcitabine in patients with locally advanced pancreatic cancer.

the purpose of this phase i/ii study is to evaluate the efficacy and toxicity of a different stereotactic body radiation therapy regimen combined with gemcitabine. in the present study, 5 daily fractions of 6 gray will be given over two weeks. stereotactic body radiation therapy will be given with the cyberknife system. this treatment technique allows to give a higher dose to the tumor as compared to conventional external beam radiation while lowering the dose to the normal tissues around. this treatment system is also capable of following the motion that the pancreas assumes during respiration as well as during treatment. this enables us to reduce the margin of security and further reduce dose to surrounding normal tissue. the primary objective of this study is to evaluate acute and chronic toxicity of this regimen of stereotactic radiation therapy followed by gemcitabine. quality of life, local control and overall survival will also be evaluated.

Eligibility criteria:
inclusion criteria: * pancreatic adenocarcinoma, histologically and/or cytologically proven * locally advanced pancreatic cancer, surgically non resectable * no distant metastasis * work-up including medical history, physical exam, biochemistry, chest x-ray, ct-scan of abdomen and pelvis * ecog performance status : ≤ 2 * primary tumor visible on ct-scan * maximum tumor diameter of 6 cm (including primary tumor and regional lymph nodes) * white blood cell count \> 3000 /ul, neutrophils \> 1500 /ul, platelets \> 100 000/ul, hemoglobin \> 95 mg/l, total bilirubin \< 1,5 normal limit, ast/alt \< 2,5 normal limit, normal creatinin * ≥ 18 years of age * signed informed consent exclusion criteria: * prior abdominal radiation therapy * connective tissue disease (scleroderma, lupus) * prior treatment for pancreatic cancer such as radiation therapy, chemotherapy or surgery.

Keywords: pancreatic cancer stereotactic body radiotherapy radiation gemcitabine locally advanced