Kornimate/medical-research-clean huggingface dataset:
cardiovascular rehabilitation and reeducation (cvrr) in patients with cardiac pathologies and the 6-minute stepper test

Conditions: Cardiac Disease

Summary: the objective is to study the validity of the 6-minute stepper test (st6) in order to determine tolerance to effort in cardiovascular patients

the 6-minute stepper test (st6) is an test used and validated in patients with respiratory disorders (chronic obstructive pulmonary disease) in order to evaluate their tolerance to exercise. it is well tolerated and reproducible in these patients, with the advantage that it can be performed without spatial constraints. however, this test is not yet used in cardiology. this study proposes to validate the st6, to evaluate the exercise tolerance of patients suffering from cardiovascular pathologies.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, * patient with a cardiac pathology (coronary bypass, valve replacement, heart transplant, coronary angioplasty), * registered in cardiovascular rehabilitation at the mitterie clinic, * number of rehabilitation sessions at least equal to 30, * ejection fraction ≥ 45%, * signed written consent of the patient, * affiliation to a social security scheme. exclusion criteria: * cardiac decompensation, * severe functional limitation, * unstable acute coronary syndrome, * decompensated heart failure, * severe ventricular rhythm disorders, * presence of an intracardiac thrombus with high embolic risk, * presence of a medium to large pericardial effusion (effusion of more than 10mm circumferential or 14mm localized on ultrasound), * recent history (months prior to inclusion) of thrombophlebitis with or without pulmonary embolism, * severe and/or symptomatic left ventricular ejection obstruction, * any progressive inflammatory and/or infectious disease, * severe pulmonary arterial hypertension, * oxygen therapy, * musculoskeletal or balance problems that would limit the ability to do any of the following the fiscal year. * pregnant or breastfeeding women, * incapacity to consent (including persons under guardianship or curatorship)

Keywords: cardiovascular rehabilitation stepper test 6-minute
cerebellar superficial siderosis in cerebral amyloid angiopathy

Conditions: Cerebral Amyloid Angiopathy; Siderosis

Summary: cerebellar superficial siderosis (ss) has been recently reported to be present in about 10% of both hereditary (n=50) and sporadic (n=46) cerebral amyloid angiopathy (caa) patients on 3t mri using susceptibility-weighted imaging (swi) in the majority of patients. in that study, cerebellar ss was associated with a higher number of supratentorial lobar and superficial cerebellar macrobleeds (although cerebellar ss was not directly located adjacent to these cerebellar macrobleeds). it is unclear if cerebellar ss is caused by in situ leakage of cerebellar leptomeningeal vessels or rather represents hemorrhagic diffusion from cerebellar parenchymal micro/macrobleeds or from supratentorial bleeding sources via the tentorium cerebelli (tc).


Eligibility criteria:
inclusion criteria: * caa patients (according to the modified boston criteria) * with acute symptoms related to acute ich, acute subarachnoid haemorrhage, or cortical ss exclusion criteria: * patients with recent trauma, * patients with anticoagulation treatment, * patients with pathological blood coagulation tests (activated partial thromboplastin time \[aptt\] ratio=patient's aptt/normal control aptt\] \>1.2; or partial thromboplastin time \[ptt\] \<75%) or platelet count (\<100 x 109/l) * patients with inflammatory caa
cold-induced brown fat activation and hepatic steatosis

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: in the recent years, research on brown adipose tissue (bat) revealed that larger amounts as well as higher activity thereof are associated with a favourable metabolic phenotype. longitudinal studies which applied recurrent cooling sessions demonstrated a high plasticity of bat which significantly increased in size and activity during these studies. these changes were accompanied by improvements in body fat mass as well as insulin sensitivity. non-alcoholic fatty liver disease (nafld) is estimated to advance to the primary cause of liver cirrhosis and hepatocellular carcinoma in the following years. besides predisposing genetic and possibly nutritional factors, the insulin resistance syndrome and obesity are the main factors contributing to this excessive hepatic lipid accumulation. the aim of this study is to investigate whether bat recruitment via cold-acclimation results in decreased hepatic lipid content in overweight/obese patients with nafld.


Eligibility criteria:
inclusion criteria: * body mass index 28 - 40 kg/m\^2 * hepatic lipid content \> 10 % exclusion criteria: * endocrine disease, except treated hypo-/hyperthyroidism and hypertriglyceridemia (\<500 mg/dl) and untreated type ii diabetes mellitus (fasting glucose \< 140 mg/dl) * use of beta-blockers, alpha-blockers and rilmenidine * chronic kidney disease * inflammatory bowel disease * active malignant disease * autoimmune disease * chronic alcohol abuse or alcohol consumption greater than 30g/d for men or 20 g/d for women * transferrin saturation \> 40% * serum alpha-1 antitrypsin \< 90 mg/dl * serum ceruloplasmin \< 20 mg/dl * positive serology for autoimmune hepatitis * positive hepatitis serology * liver cirrhosis * portal hypertension * pregnancy * contraindications for magnetic resonance imaging
tocolytic therapy for preterm labor in multiple gestation

Conditions: Labor Preterm Multiple

Summary: to compare the tocolytic efficacy oxytocin receptor antagonist (atosiban) with that of calcium channel blockers (nifedipine) among women with multiple gestation who present with threatened preterm labor.

preterm birth remains the principal cause of early neonatal death. infants born preterm (before 37 weeks' gestation) often suffer significant immediate morbidity and need lengthy stays in neonatal intensive care units. moreover, there is a significant risk of long-term neurological morbidity in a proportion of the survivors. patients with a multiple gestation are at significant risk for preterm labor and delivery as approximately 60% of all those pregnancies will be delivered preterm. a number of oxytocin receptor antagonists have been developed, and of these, three, atosiban, barusiban and retosiban have been investigated in humans as tocolytic agents. to date, only atosiban is in use outside of clinical trials. atosiban is an oxytocin receptor antagonist which was specifically developed for the treatment of preterm labor. early reports of the use of atosiban for tocolysis showed promise both in vitro and in animal studies, and preliminary studies in pregnant and non-pregnant humans suggested a very low incidence of maternal side effects .

Eligibility criteria:
inclusion criteria: 1. twin pregnancy 2. gestational age between 24+0 and 32+6 weeks 3. intact amniotic membranes 4. threatened preterm labor 5. age 18-50. exclusion criteria: 1. rupture of membranes 2. vaginal bleeding resulting from placenta previa or placental abruption 3. fever above 38°c 4. severe preeclampsia 5. maternal cardiovascular or liver diseases 6. systolic blood pressure less than 90 mm hg 7. known uterine malformation 8. intrauterine growth restriction below the fifth percentile 9. non-reassuring fetal status 10. antepartum diagnosis of major fetal malformations 11. fetal death 12. previous tocolytic therapy or betamethasone treatment
activation of autophagy and suppression of apoptosis by dapagliflozin attenuates inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: the inflammatory bowel diseases (ibd) are described as complex, recurrent inflammatory conditions which are manifested as crohn's disease (cd) and ulcerative colitis (uc). the common symptoms of ibd include debilitating/severe diarrhea, abdominal pain, weight loss, and chronic fatigue; events that may culminate in life-threatening complications. the pathogenesis of ibd has been characterized as complex/multi-factorial that includes disruption of intestinal epithelial barrier with consequent translocation of commensal microbial products as the prime event that instigates severe immune responses and intestinal inflammation.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * both male and female will be * mild and moderate uc patients diagnosed and confirmed by endoscope exclusion criteria: * breast feeding * significant liver and kidney function abnormalities * colorectal cancer patients * patients with severe uc * patients taking rectal or systemic steroids * patients taking immunosuppressives or biological therapies * addiction to alcohol and / or drugs * known allergy to the dapagliflozin
pentoxifylline in the treatment of nec in premature neonates

Conditions: Necrotizing Enterocolitis

Summary: pentoxifylline improves microcirculation and decreases tnf alpha levels associated with sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature neonates.

preterm neonates with a clinical suspicion of necrotizing enterocolitis (nec) will potentially be candidates for study. after obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1. treatment group: to receive iv pentoxifylline (5 mg/kg/hour to run over 6 hour x 6 days) and 2. placebo group: to receive an equal volume of ½ normal saline to run over 6 hours x 6 days.

Eligibility criteria:
inclusion criteria: * preterm infants \<1750 gm. birth weight * abdominal x-ray consistent with nec (dilated loops, bowel wall edema, fixed or persistent dilated loop with (or without pneumatosis) exclusion criteria: * abdominal perforation

Keywords: nec premature infants tnf pentoxifylline
a clinical study of the safety and efficacy of mebo wound ointment in subjects with venous leg ulcers

Conditions: Ulcers

Summary: this is a phase ii, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of mebo in the treatment of 14 subjects with vlus. subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either mebo or soc (7 subjects per treatment arm).

to assess the safety and efficacy of mebo in the treatment of 14 subjects with vlus. subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either mebo or soc (7 subjects per treatment arm).

Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age. 2. able and willing to provide informed consent. 3. able and willing to comply with protocol visits and procedures. 4. a full-thickness vlu that has been open continuously for ≥4 weeks and ≤1 year. exclusion criteria: 1. ulcer of a non-venous hypertensive pathophysiology. 2. known or suspected allergy to any of the components of mebo. 3. malignancy on target ulcer limb. 4. received another investigational device or drug within 30 days of enrollment. 5. non-compliance in the screening or run-in period.

Keywords: venous leg ulcers, vlu
swedish study on stroke after tavr

Conditions: Aortic Valve Disease; Stroke

Summary: this study aims at studying the frequency of late stroke after transcatheter aortic valve replacement/implantation

since the start of transcatheter aortic valve implnatations/replacements (tavr/tavi) implantations in sweden in 2008 all procedures have been added to a national database, which now contains 5000+ procedures. at the same time, all admissions to the hospital is also recorded with diagnosis in a separate database. we intend to make a nation-wide complete follow up of all tavr/tavi patients in swede that has received the diagnosis of stroke after the implantation. in addition data will also be collected from the national stroke database for detailed information of the cases

Eligibility criteria:
inclusion criteria: all patients that has under tavr/tavi in sweden between 2008 and 2018 exclusion criteria: patients unable to follow up due to emigration or missing social security number exclusion criteria: periprocedural stroke

Keywords: tavr stroke
fixed dose comparison of escitalopram to an active comparator in severely depressed patients

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients

escitalopram is the s-enantiomer of citalopram. both escitalopram and citalopram are selective serotonin reuptake inhibitors (ssris) and are used to treat depression in adults. this study is designed to evaluate the safety and efficacy of escitalopram and an active comparator in severely depressed patients.

Eligibility criteria:
inclusion criteria: * patients must meet dsm-iv criteria for major depressive disorder. * patients must have severe depression. * madrs greater than or equal to 30 exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control. * patients who are considered a suicide risk. * patients who currently meet dsm-iv criteria for: a principal diagnosis for axis i disorder other than mdd (comorbid gad is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia. * patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder. * patients with history of any psychotic disorder or any psychotic feature.

Keywords: major depressive disorder
bez235 phase ii trial in patients with advanced pancreatic neuroendocrine tumors (pnet) after failure of mtor inhibitor therapy.

Conditions: Pancreatic Neuroendocrine Tumors (pNET)

Summary: this is a phase ii study in 2 stages, evaluating bez235 plus best supportive care (bsc) versus placebo plus bsc in patients with advanced pancreatic neuroendocrine tumors (pnet) after failure of mtor inhibitor therapy. study design: this was a phase ii, two-stage, multicenter study, where stage 1 was a single arm, open label design and stage 2 was planned to be a randomized, double-blind study. however, at the end of stage 1, the futility was met and hence the stage 2 was not initiated.


Eligibility criteria:
inclusion criteria: * unresectable or metastatic, histologically confirmed low or intermediate grade pancreatic neuroendocrine tumor with radiological evidence of disease progression since last treatment * refractory disease to treatment with mtor inhibitor * measurable disease per recist version 1.1 using computed tomography (ct) or magnetic resonance imaging (mri) * prior or concurrent therapy with ssa is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; ssa is not considered as a systemic treatment. * who ps ≤ 1 * adequate bone marrow function or organ function exclusion criteria: * previous treatment with any pi3k or akt inhibitor * discontinuation prior mtor inhibitor therapy due to toxicity * poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma * radiotherapy, or major surgery within 4 weeks prior to study treatment start * hepatic artery embolization or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of study treatment start. * more than 3 prior systemic treatment regimens (including cytotoxic chemotherapy, targeted therapy, immunotherapy)

Keywords: advanced pancreatic neuroendocrine tumor bez235 pnet
immunogenicity and safety of sabin-ipv replacement vaccination

Conditions: Vaccination

Summary: this study replaced the 2nd and 3rd dose of salk-ipv (produced by sanofi) with sabin-ipv (produced by cnbg) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement.

it is required by china food and drug administration (cfda) that considering in the real situation ipv receivers may be immuned by different viral strains of this vaccine, a phase 4 clinical trial aiming to demonstrate the safety and immunogenicity of the immunization schedule should be carried out. to be specific, the subjects were divided into 2 groups. group 1 received salk-ipv+sabin-ipv+sabin-ipv respectively at the age of 2,3,4 months old. group 2 received salk-ipv+salk-ipv+salk-ipv respectively at the age of 2,3,4 months old. blood sample was collected before vaccination and 30 days after the third dose of vaccination. neutralization antibody against type i, type ii and type iii poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. the safety of both immunization schedule will also been monitored.

Eligibility criteria:
inclusion criteria: * subjects aged from 60 days to 89 days old at the date of recruitment; * with informed consent signed by parent(s) or guardians; * parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions; * subjects did not receive any vaccines within 14 days; * axillary temperature ≤37.0℃ exclusion criteria: * allergic to any ingredient of vaccine or with allergy history to any vaccine; * acute febrile disease or infectious disease; * serious chronic diseases; * any other factor that makes the investigator determines the subject is unsuitable for this study;
quality of life in patients with difficult-to-treat basal cell carcinoma: an evaluation of impact and surgical outcomes.

Conditions: Basal Cell Carcinoma

Summary: face-qol is an observational, prospective, multicenter study aimed at evaluating the impact of surgical treatment on quality of life in patients with stage iia and iiib difficult-to-treat basal cell carcinoma of the face, according to the european academy of dermato-oncology classification, using patient-reported outcomes. the main questions the study seeks to answer are: can surgery, as the gold standard treatment, lead to an improvement in the quality of life of patients with difficult-to-treat basal cell carcinoma in functionally and cosmetically challenging sites of the face (i.e., stage iia and iiib)? which clinical and individual variables have the greatest impact on patients' quality of life? participants will complete questionnaires assessing their quality of life and the impact of the disease on their daily lives.


Eligibility criteria:
inclusion criteria: * clinical or histological diagnosis of difficult-to-treat basal cell carcinoma (dtt-bcc) classified as stage iia or iiib according to the eado classification. * tumor location: face. * intervention: surgical treatment of facial stage iia and iiib difficult-to-treat basal cell carcinoma. * sufficient knowledge of spoken and written italian by the patient. exclusion criteria: * known psychiatric or substance abuse disorders that may interfere with cooperation and compliance with trial requirements. * inoperable or metastatic difficult-to-treat basal cell carcinoma. * contraindications to surgery related to the patient's condition. * previous radiation therapy involving the field of the target lesion.
efficacy and safety assessments of a peritoneal dialysis solution containing glucose, xylitol, and l-carnitine in capd

Conditions: End Stage Renal Disease

Summary: prospective, randomized, controlled clinical trial. the aim is to compare the effects of the peritoneal dialysis solution ipx15, containing glucose (0.5%), xylitol (1.5%) and l-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose pd solution), for the nocturnal exchange with the pd solution ipx07, containing glucose (0.5%), xylitol (0.7%) and l-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose pd solution), for the diurnal (short dwell) exchanges. planned total recruitment is 40 patients with stable end-stage renal disease (esrd) treated by continuous ambulatory peritoneal dialysis (capd). treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of esrd treated for at least three months with capd, as stated by the medical staff of the center; * stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration; * hemoglobin level ≥ 9g/dl; * absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection; * to understand and sign an informed consent form. exclusion criteria: * history of alcohol or drug abuse in the last six months before selection for the study; * androgen therapy in the last six months before selection; * active infections; * history of congestive heart failure stage iii and iv new york heart association (nyha); * history of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection; * clinically relevant cardiac arrhythmia; * clinically relevant abnormalities of functional hepatic tests; * therapy with l-carnitine or its derivatives in the last three months before selection; * pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception; * presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year; * participation in another clinical study within the past month; * known allergic reactions to l-carnitine or xylitol.
observational study evaluating the safety of novomix® in type 2 diabetes patients previously treated with a human premix insulin

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the objective of this observational study is to evaluate the number of serious side effects, when initiating novomix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus exclusion criteria: * known or suspected allergy to study product or related products. * pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months.