Kornimate/medical-research-clean huggingface dataset:
transcranial direct stimulation for persistent fatigue treatment post-covid-19

Conditions: COVID-19

Summary: fatigue is common and disabling in patients with post-covid syndrome. there is no treatment available at this moment, and fatigue has important consequences. the main aim of this study is to evaluate the changes in the severity of fatigue using non-invasive neuromodulation in patients with post-covid condition. this is a randomized, parallel, double-blind, placebo-controlled clinical trial using transcranial direct current stimulation. secondary aims include changes in cognition, depression, and quality of life.


Eligibility criteria:
inclusion criteria: * diagnosis of covid-19 with pcr-confirmation. * fatigue linked to covid-19 * no diagnosis of neurological, psychiatric or medical disorder with potential impact on fatigue. exclusion criteria: * stroke before covid-19 * history of traumatic brain lesion or central nervous system infection previous to covid-19 * radiotherapy or chemotherapy for cancer * severe sensorial deficits * drugs or uncontrolled medical disorder with potential impact on fatigue. * history of abuse of alcohol or other toxics. * any contraindication for tdcs (metallic implants, brain devices, pacemakers, head injuries).

Keywords: post-covid-19 syndrome post-covid-19 condition persistent covid-19 long-haul covid-19 fatigue
efficacy of whole-body electromyostimulation (wb-ems) training in participants with pre-diabetes

Conditions: Pre-diabetes

Summary: the goal of this pilot study is to assess the efficacy of the intervention (wb-ems training) in a sedentary group of adults with pre-diabetes and to estimate the potential effect sizes. the main goals and questions it aims to answer are: * efficacy wb-ems training in sedentary adults with pre-diabetes, * has wb-ems training positive effects on hba1c and other biomarkers? researchers will compare the intervention group with two control groups to see if wb-ems training has effects on pre-diabetes.

the study is planned as a randomized controlled pilot study. the intervention phase duration is set to 16 weeks. prior to the study start, all subjects will be screened for their eligibility according to defined inclusion and exclusion criteria. sixty eligible sedentary individuals with pre-diabetes between the ages of 40 and 65 years will be randomised to one intervention group (n=20) and two control groups (n=20 each). the main exercise intervention will be conducted via wb-ems using a medical device approved system (miha bodytec®, type ii, gersthofen, germany). participants in the intervention and one control group will receive an activity tracker (vivosmart 5, garmin) to measure daily steps during the 16-week intervention phase. all study groups will further receive an evidence-based lifestyle education programme (6 x 20 minutes for 3 months), which provides education, information, and advice to prevent disease progression and improve quality of life and mobility. during the baseline visit and after 16 weeks endpoint measurements incl. blood biomarkers, cardiometabolic and body composition parameters will be assessed. the intervention group will additionally attend a follow-up visit after 32 weeks and the parameters will be assessed again.

Eligibility criteria:
inclusion criteria: * community-dwelling sedentary (\<20 min physical activity on \<3 days/week) men and women aged 40-65 years without diabetes type 2 * elevated hba1c levels (5.7%-6.4%), * not functionally impaired (short physical performance battery (sppb) ≥10) * signed informed consent * consent to use the wb-ems and activity tracker exclusion criteria: * high-grade arrhythmia/vhf/sm carriers, heart failure \>nyha2, nephropathy (gfr\<60), * cognitive impairment * diabetes type 2
strategic management to optimize response to cardiac resynchronization therapy

Conditions: Heart Failure

Summary: the primary objective is to evaluate the benefit of the smartdelay™ algorithm in patients with a prolonged rv-lv interval.

the primary hypothesis of smart crt is that among cardiac resynchronization therapy defibrillator (crt-d) patients with prolonged inrerventricular delay between the rv and lv leads, crt with atrioventricular optimization (avo) will result in greater reverse lv remodeling compared with crt programmed at nominal settings (120 ms).

Eligibility criteria:
inclusion criteria: * subject must be indicated to receive a de novo quadripolar boston scientific cardiac resynchronization therapy defibrillator (crt-d) in conjunction with an acuity x4 lv lead. this includes subjects who are indicated to receive an upgrade to a bsc x4 crt-d from a previously implanted device. * in order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet bsc us indications for use defined as those subjects who receive stable optimal pharmacologic therapy (opt) for heart failure and who meet any one of the following classifications: * moderate to severe heart failure (nyha class iii-iv) with ef ≤ 35% and qrs duration ≥ 120 ms * left bundle branch block (lbbb) with qrs duration ≥ 130 ms, ef ≤ 30%, and mild (nyha class ii) ischemic or nonischemic heart failure or asymptomatic (nyha class i) ischemic heart failure * subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws * subject is willing and capable of providing informed consent * subject is willing and capable of complying with visits and procedures as defined by this protocol exclusion criteria: * subjects with documented permanent complete av block * subjects with permanent or chronic atrial fibrillation (af) or in af at the time of enrollment * subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle * subjects on the active heart transplant list or who has or is to receive ventricular assist device (vad) * life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc...) * subject with a known or suspected sensitivity to dexamethasone acetate (dxa) * subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from boston scientific * women of childbearing potential who are or plan to become pregnant during the course of the trial * subjects currently requiring dialysis
a 16-week study to evaluate the efficacy, safety, and tolerability of gly-200 in participants with obesity

Conditions: Obesity

Summary: this study will evaluate the efficacy, safety, and tolerability of gly-200 in participants with obesity.

this study is a phase 2, randomized, double-blind, placebo-controlled, multi-center study in adult participants with obesity. approximately 70 participants will be randomized in a 1:1 ratio to gly-200 (2.0 g, twice daily) or placebo (twice daily). there will be a ≤ 28-day screening period. dosing will occur for 16 weeks. clinic visits will occur at screening, week 0 (day 1), and weeks 1, 2, 4, 6, 8, 12, 16, and 17 \[end of study (eos)\] or early termination (et). phone visits will occur at week 3, 10, and 14.

Eligibility criteria:
inclusion criteria: * male or female, ≥ 18 and ≤ 70 years old at the time of screening * bmi ≥ 32 and ≤ 40 kg/m² at screening exclusion criteria: * known history of any form of diabetes mellitus, or hba1c ≥6.5% (48 mmol/mol) * participants who have had an increase or decrease in body weight more than 5% within the last 3 months * treated with any prescription medication or procedure that promotes weight loss or weight gain in the last 6 months * use of any drug treatment that affects gastric ph * use of any drug treatment that affects gastrointestinal motility * diagnosis or treatment of any symptomatic or structural abnormality of the gi tract or active disease within 12 months * clinically significant symptoms (as determined by the investigator) of nausea, vomiting, bloating, diarrhea, flatulence, constipation, or abdominal pain in the last 30 days

Keywords: obesity glyscend, inc. gly-200
a prospective, multicenter, randomized, open-label study of 12 week duration to evaluate the effect of vildagliptin added to insulin on glycaemic control in haemodialyzed patients with type 2 diabetes: probe analysis of cgm

Conditions: Haemodialyzed, Type 2 Diabetes

Summary: diabetes is a major concern for dialysis units, as it is now the most common cause of end-stage renal disease in france. in 2010 at initiation of dialysis treatment, more than one patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % type 2 diabetes) and especially in east part of france. diabetic patients on dialysis have a high burden of morbidity and mortality, particularly from cardiovascular disease. tight glycaemic and blood pressure control in diabetic patients has an important impact in reducing risk of progression nephropathy. data are scarce on how diabetes should best be treated in dialysis patients. the evidence for improving glycaemic control in patients on dialysis having an impact on mortality or morbidity is sparse. indeed, many factors make improving glycaemic control in patients on dialysis very challenging, including therapeutic difficulties with hypoglycaemic agents, monitoring difficulties, dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia. standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are contraindicated in patients on dialysis. thus insulin has been the mainstay of treatment. newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues have become available, but until recently, renal failure has precluded their use. newer gliptins, however, are now licensed for use in 'severe renal failure', although they have yet to be trialed in dialysis patients. the investigators study, using continuous glucose monitoring as a new tool for monitoring of therapy should provide information on vildagliptin in add on therapy to insulin in this population.


Eligibility criteria:
inclusion criteria: * patients treated by haemodialysis for more than 3 months with 1g/l glucose in dialysate fluid * patients treated by stable doses of insulin (any regimen) for type 2 diabetes without any oral antidiabetic agent * age \> 18 years * tgo, tpo and lipase \< 3x uln * effective means of contraception non-inclusion criteria: * blood transfusion in the 2 previous months * life expectancy less than 1 year * chronic inflammatory disease * steroid treatment \> 5mg/day * cancer (evolutive or requiring chemotherapy or radiotherapy) with the exception of breast intraductal carcinoma operated * patient waiting for programmed surgery * history of cardiovascular disease (stroke, coronary heart disease, hospitalization for heart failure) in the 4 previous months * patients suffering from stage 3 and 4 cardiac insufficiency * non-compliant patients * history of pancreatitis * history of angioedema * hypersensitivity to the active substance or to any of the excipients of galvus® * pregnancy or breastfeeding
evaluation of the effect of chicory inulin-type fructans in constipated adults

Conditions: Constipation - Functional

Summary: constipation is common in the general population, especially in women and in the elderly, which can significantly affect quality of life of the individual. there is a general consumer trend to seek natural food options, also when addressing health issues such as constipation. consumers seek tasty options and there is a paucity of tasty functional foods to address constipation. adding natural fiber to food, like inulin-type fructans from chicory root fiber, can increase fiber intake and potentially prevent or resolve constipation issues. this study aimed to increase the body of scientific data on inulin-type fructans by way of a randomized, placebo-controlled, cross-over study. maltodextrin was used as the placebo in this study.


Eligibility criteria:
inclusion criteria: * able to give written informed consent * between 18 and 75 years of age * have functional constipation according to the rome iii diagnostic criteria * subjects were to continue on their normal diet and agreed to not take probiotic or prebiotic products/supplements and supplemental dietary fibres for the duration of the study * the subject agrees to complete the patient diary for two weeks prior to study entry and for the duration of the study * subject is in general good health as determined by the investigator. exclusion criteria: * subjects less than 18 and greater than 75 years of age * females who are pregnant, lactating or wish to become pregnant during the study. * subjects who are hypersensitive to any of the components of the test product, * subjects who have an obstructive or metabolic aetiology for constipation, * subjects who have a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative), * subjects currently taking supplemental dietary fibres or have taken them within two weeks of the screening visit, * subjects who are taking a probiotic or prebiotic product/supplement or had taken them within two weeks of the screening visit

Keywords: adults functional constipation inulin-type fructans
sentine lymph node in early ovarian cancer (selly)

Conditions: Sentinel Lymph Node; Ovarian Cancer Stage I

Summary: the present study aims at investigating the feasibility, the detection rate and the negative predictive value of sentinel node in predicting the presence or absence of lymph node metastasis in ovarian cancer patients

patients with early stage ovarian cancer have a good prognosis. however, nearly 15% of the initially diagnosed as early stage ovarian cancers, will be upstaged after an appropriate surgical staging due to lymphatic metastasis, despite of preoperative radiological data. therefore, complete pelvic and para-aortic lymphadenectomy in these patients represents a crucial procedure. on the other hand, nodal dissection may be associated with threatening intra- and post-operative complications. if feasible and accurate, the sentinel lymph node procedure could be a modality to avoid unnecessary radical lymphadenectomy without missing important information on nodal status. with the present study we aim at exploring the role of sentinel node dissection in early ovarian cancer patients. patients with ovarian cancer macroscopically limited to the ovary (early ovarian cancer) will receive injection of a tracer (patent blue or indocyanine green) which have already been proven safe and extremely effective in several other gynecologic and non-gynecologic malignancies. then the retroperitoneal spaces will be opened as for a standard lymphadenectomy procedure and the lymph node marked with the tracer will be identified. after dissection of the sentinel node, lymphadenectomy will be completed according to current guidelines. operative data, pathological findings and accuracy of sentinel node in predicting nodal status will be registered.

Eligibility criteria:
inclusion criteria: * epithelial ovarian cancer * early stage disease limited to the ovary exclusion criteria: * evidence of extraovarian disease * allergy to the materials used

Keywords: ovarian cancer laparoscopy sentinel node lymphadenectomy
pancreatic cancer evolution upon treatment

Conditions: Pancreatic Cancer

Summary: this project aims at evaluating the different subtypes of pancreatic cancer on eus-tissue acquisition of pancreatic cancer patients, and their possible modifications throughout time. the study takes advantage of a systematic evaluation of pancreatic cancers through diagnostic eus-guided fine needle biopsy (fnb) sampling of the mass performed during a restaging eus. fnb samples represent a valuable source of cancer cells, both for the histological diagnosis and as the source of tumor macromolecules, including dna and rna. study design this is a prospective study enrolling patients with non-metastatic pancreatic cancer who already underwent diagnostic eus with tissue acquisition and rapid on-site evaluation (rose) by cytologist positive for pancreatic cancer, with a first sample acquired for diagnostic purposes and a second sample stored for rna extraction acquired with the already approved protocol biogastro. as recommended by guidelines, patients will follow the standard pathway of treatment, being sent to chemotherapy and will then undergo restaging of the lesion and re-evaluation of vascular invasion by ct and eus. during this second session of eus a new specimen of the tumor will be sampled for diagnostic purposes, with a second pass undergoing for rna extraction.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * willing to sign informed consent * patient with ct scan or mri or eus defining the lesion as locally advanced * patient who already underwent eus-ta for solid lesion of the pancreas positive for pancreatic ductal adenocarcinoma (pdac) * patient undergoing neoadjuvant chemotherapy * patient primarily followed at san raffaele hospital exclusion criteria: * patients not willing to sign informed consent * pregnancy and breastfeeding * cytology positive for malignancies other than pdac * patient undergoing progression at re-staging ct scan
efficacy comparison of warfarin versus rivaroxaban cvt

Conditions: Cerebral Venous Thrombosis

Summary: with regard to cerebral venous thrombosis (cvt) importance as a life threatening disease, specific care is necessary, known anti-coagulants have limitations.vitamin k antagonists such as warfarin, require laboratory monitoring and exact administration starting and maintenance dose. although rivaroxaban(selective and direct xa factor antagonist ) has no monitoring and no drug interaction. this study aim to focus on efficacy of warfarin versus rivaroxaban.


Eligibility criteria:
iinclusion criteria: * patients of both gender * age 18 years and higher * proven cvt on neuro imaging ( mri-mrv) exclusion criteria: * patients suffering from renal failure(gfr\<30) patients * patients with contraindications for oral anticoagulation * patient who having pregnancy * uncooperative patient for completing the course of treatment
a single-dose, pharmacokinetic/pharmacodynamic (pk/pd), & safety study of biib017 in participants with renal impairment & healthy volunteers

Conditions: Healthy; Renal Insufficiency

Summary: the primary objective of the study is to evaluate the pharmacokinetics (pk) of a single dose of pegylated interferon beta-1a (biib017) administered subcutaneous in participants with renal impairment and in participants with normal renal function (healthy participants). a secondary objective of this study in this study population is to evaluate the safety and tolerability of a single dose of pegylated interferon beta-1a administered subcutaneous.

this study is an open-label, multicenter, non-randomized, serial-group study to estimate the effect of renal impairment on biib017 pk/pd. the study will be conducted at approximately 3 sites in the us and will enroll approximately 35 participants: 6 healthy volunteers (normal renal function), 9 with mild renal impairment, 6 with moderate renal impairment, 8 with severe renal impairment, and 6 participants with end stage renal disease who require hemodialysis 2 to 3 times a week.

Eligibility criteria:
key inclusion criteria: * subjects must have stable renal disease (i.e., no change in disease status within the last month) as determined by the investigator with laboratory and clinical findings that support the diagnosis of renal impairment. * must have body mass index (bmi) between 18 and 35 kg/m2 inclusive. key exclusion criteria: * history of any clinically unstable (in the past 6 months prior to screening) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, and psychiatric, or other major disease as determined by the investigator. * any evidence of clinically significant findings on screening evaluations, which, in the opinion of the investigator would pose a safety risk, or would interfere with appropriate interpretation of safety or pk data, or other unspecified reasons that, in the opinion of the investigator or biogen idec, make the subject unsuitable for enrollment note: other protocol defined inclusion/exclusion criteria may apply
human milk fortifier and cytokine profile

Conditions: Infant, Very Low Birth Weight

Summary: this is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.

in very low birth weight (vlbw) infants and preterm infants human milk fortifier (hmf) is often added to breast milk feedings in order to add extra calories, vitamins, and minerals. it is well known that breast milk feedings are easier to digest and have immune benefits compared to formula feedings. cytokines, marker of immune function, can be found in blood, stool, and breast milk. this study involves collection of blood and stool samples to monitor cytokines. the purpose of this study is to understand whether human milk fortifier alters infants' cytokines.

Eligibility criteria:
inclusion criteria: * infants born weighing less than 1500 grams * exclusive breast milk feedings with intention to fortify with human milk fortifier exclusion criteria: * positive blood culture * history of necrotizing enterocolitis * significant lung disease at the start of the study

Keywords: very low birth weight infants hmf immune system function