Kornimate/medical-research-clean huggingface dataset:
safety and performance of the polaris® 24 adjustable valve system in hydrocephalus patients' treatment

Conditions: Hydrocephalus

Summary: the sapphyre study is an ambispective (retrospective and prospective) pmcf study with the objective to evaluate the safety and performance of the polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.

the sapphyre study is an ambispective (retrospective and prospective), non-interventional, multicenter, post-market clinical follow-up study. the study objective is to evaluate the safety and performance of sophysa's ce marked polaris® 24 adjustable valve system in the treatment of hydrocephalus by shunting the cerebrospinal fluid. it is expected to recruit 126 patients in two-year. patients will be followed-up up to 5 years post-procedure.

Eligibility criteria:
inclusion criteria: * patient implanted with the polaris® 24 adjustable valve system for the following reasons: * primo implant of a valve shunt-based derivation system, or as a * replacement of another valve -based shunt system, or * endoscopic ventriculostomy (evt) failure * patient having given his/her informed consent prior to inclusion in this study, as per local regulations exclusion criteria: * confirmed or suspected infections along the length of the shunt (meningitis, ventriculitis, peritonitis, septicemia or bacteremia) or any infection present in any part of the body * patient on anticoagulant therapy, or presenting with bleeding diathesis, or with haemorrhagic csf, as the presence of blood in the system could lead to an obstruction in the system * ventriculo-atrial shunts in patient suffering from congenital cardiopathies or other malformations of the cardio-pulmonary system

Keywords: hydrocephalus adjustable valve polaris 24 cerebrospinal fluid
biomarker differences in samples from patients with undifferentiated sarcomas

Conditions: Soft Tissue Sarcoma

Summary: this clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer

study subtype: ancillary/correlative observational study model: cohort time perspective: prospective biospecimen retention: samples with dna biospecimen description: tissue study population description: patients from arst0332 study sampling method: non-probability sample primary objectives: i. to determine what proportion of unclassifiable sarcomas are unclassifiable because the initial evaluation was not sufficiently comprehensive versus what proportion can be regarded as "true" undifferentiated sarcoma when a comprehensive assessment has been performed. ii. to develop formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma. iii. to determine whether undifferentiated sarcoma can be subdivided into separate and distinct pathologic entities that are distinguishable by light microscopy, immunohistochemistry, single nucleotide polymorphism (snp) array profiling, or clinical features. iv. to determine whether undifferentiated sarcomas with specific "actionable mutations" can be identified based on their histologic appearance, immunohistochemical staining characteristics, or snp array profiling features. outline: tissue samples are analyzed for loss of heterozygosity (loh) and snp array profiling using microarray and immunohistochemistry.

Eligibility criteria:
inclusion criteria: * 49 cases of undifferentiated sarcomas from arst0332 (additional cases may be ascertained as eligible for this current project that also fall under arst0332 to be requested later if necessary)
subclinical hypothyroidism and normogonadotropic anovulation

Conditions: Polycystic Ovary Syndrome; Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)

Summary: thyroid hormones (th) can modify the functioning of the hypothalamic-pituitary-ovarian axis, affecting the functions of granulosa cells and the development and apoptosis of preantral follicles. th receptors are present within the oocytes, and th and anti-thyroid antibodies (ata) are present in the follicular fluid. improper thyroid function can cause ovulation disorders, luteal phase failure, impaired endometrial receptivity and result in implantation failures and recurrent miscarriages. while overt hypothyroidism is treated to improve fertility, the effect of subclinical hypothyroidism (sch) and the presence of circulating atas on fertility and obstetric outcomes is uncertain and data on ovarian reserve rates are conflicting. among the causes of ovulation disorders (group ii according to the who classification), polycystic ovary syndrome (pcos) dominates, found in 3-15% of women of reproductive age, and the remaining group of causes is the so-called hypothalamic-pituitary-ovarian axis dysfunction (hpod). the exact etiology of both entities is unknown.

purpose of the study evaluation of ovarian reserve indices in women with normogonadotropic anovulation with sch and without thyroid disease. detailed objectives i) assessment of amh, fsh, lh, estradiol, astral follicle count (afc)/ovarian volume in the subpopulation of women with pcos and sch compared to women with pcos without thyroid disease ii) assessment of amh, fsh, lh, estradiol, afc/ovarian volume in the subpopulation of women with hpod (other than pcos) with sch compared to women with hpod without thyroid disease iii) comparison of amh, fsh, lh, estradiol, afc/ovarian volume in women with pcos and hpod with and without thyroid disease and evaluation of correlation with us ovarian morphology iv) calculation of the cut-off point of amh concentration correlating with a high probability of pcos diagnosis and tsh correlating with unfavorable parameters of ovarian function/hpo axis.

Eligibility criteria:
inclusion criteria: * age 18-45 * irregular periods * infertility due to ovulation disorders * euthyreosis exclusion criteria: * diagnosed and treated thyroid dysfunction, * history of thyroidectomy

Keywords: polycystic ovary syndrome hypothalamic-pituitary-ovarian axis dysfunction ovarian reserve anovulation any-mullerian hormone
adenosine cardioplegia; improved cardioprotection?

Conditions: Angina Pectoris

Summary: 60 elective patients for cabg will be included to receive either standard hyperkalemic cardioplegia (st.thomas hospital solution no i) or cardioplegia where supranormal potassium is replaced with 1.2 mm adenosine. hypothesis as follows: 1. adenosine instead of supranormal potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. adenosine instead of supranormal potassium in the cardioplegic solution gives equal cardioprotection. the patients will be followed with picco-catheter to monitor cardiac function and repetitive blood samples to measure release of cardiac enzymes.


Eligibility criteria:
inclusion criteria: * elective patients * ejection fraction \> 40% * age 40-75 * no release og tnt or ckmb within last week before cabg * pure cabg exclusion criteria: * age \>75 or \< 40 * ef \< 40% * emergency operations * unstable angina * release of tnt or ckmb within the week before operation
pro-resolving and pro-inflammatory responses to acute exhaustive exercise in healthy individuals

Conditions: Exercise

Summary: this is a study of the effects of acute, exhaustive exercise on pro-resolving and pro-inflammatory responses in healthy, trained and untrained adults.

the study requires one visit (a second, optional visit may occur). at the visit, participants will have blood drawn at several time points and also perform an exhaustive bout of treadmill exercise. differences in specialized pro-resolving lipid mediators (spms) and other measures of inflammation and resolution over time will be characterized.

Eligibility criteria:
inclusion criteria: * willingness and ability to provide informed consent and participate in prespire * able to read and speak english adequately to provide informed consent and understand verbal and written instructions. (the diet and sleep questionnaires are not validated in languages other than english) * bmi \< 27kg/m2 * untrained: self-reporting no more than 1 day per week of regular exercise (inclusive of walking \>5,000 steps daily and commuting via bicycle). * trained: self-reporting at least 4 hours of aerobic exercise / moderate or greater intensity physical activity weekly for the past year. exclusion criteria: * anti-platelet medication use * chronic inflammatory or connective tissue disease * history of bleeding or clotting disorder * immunological deficiency * diabetes mellitus * stage 2 or greater hypertension on screening * cardiovascular disease * chronic obstructive lung disease * anemia (hemoglobin \<13g/dl in males or \< 12 g/dl in females) * active smoking * \>5% body weight change over the past 6 months or plan to gain/lose weight during the study * platelet count \<100,000 * use of omega-3 fatty acid supplementation within 3 weeks of study participation * use of drugs or supplements known to inhibit cox-1/cox-2/lipoxygenases * corticosteroid use * use of beta-blocker medications * use of alpha-blocker medications * use of nsaids or aspirin within 2 weeks of study participation * vaccination within 2 weeks of study participation * pregnancy (a state of relative immunological deficiency) * any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric or other conditions that, in the opinion of the local clinician, would preclude participation and successful completion of the protocol. * any other illnesses that, in the opinion of the local clinician, would negatively impact or mitigate participation in and completion of the protocol
a study comparing oral picoplatin with intravenous picoplatin in subjects with solid tumors

Conditions: Bladder Cancer; Breast Cancer; Colorectal Cancer; Gastrointestinal Neoplasm; Head and Neck Cancer; Lung Cancer; Ovarian Cancer; Pancreatic Cancer; Prostate Cancer

Summary: picoplatin is a new platinum-based chemotherapy drug that has been studied in a variety of cancers. phase 1 and 2 studies have demonstrated that picoplatin may be effective in patients whose cancer returns or does not improve after treatment with chemotherapy. in these studies, picoplatin was administered intravenously. a capsule containing picoplatin has been formulated. this study will investigate the activity of the oral capsule in humans. participants with advanced solid tumors will be enrolled.

the primary study design is a randomized, two-period crossover, open label study in which a single dose (cycle 1) of picoplatin will be given either iv or by oral capsule, followed 4 weeks later by a single dose (cycle 2) of picoplatin given either iv or by oral capsule (whichever route was not used in cycle 1). participants may continue to receive cycles of iv picoplatin every 3 weeks, beginning with cycle 3, as part of a continuation study. this study will determine the relative safety, bioavailability, pharmacokinetics, pharmacodynamics, and urinary excretion of picoplatin administered orally with reference to picoplatin administered intravenously.

Eligibility criteria:
inclusion criteria: * histological diagnosis of non-hematological malignancy. * patients for whom no standard therapy exists and for whom, in the opinion of the investigator, treatments with single agent picoplatin is appropriate. * 18 years of age or older. * ecog performance status 0-2. * life expectancy of at least 12 weeks. (additional inclusion criteria apply.) exclusion criteria: * symptomatic or uncontrolled brain metastases. * prior radiation involving ≥ 30% of the total bone marrow space. * any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study. * gastrointestinal surgery that might interfere with absorption of orally administered drug. * active inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding. * clinical evidence of pancreatic injury or active pancreatitis. * female subjects who are pregnant or breastfeeding. (additional exclusion criteria apply.)

Keywords: picoplatin tumor cancer sarcoma neoplasm advanced platinum chemotherapy solid tumor
pharmaco-metabolomic effects of statins: metastatine

Conditions: Cardiovascular Diseases

Summary: statins are effective in cardio-vascular prevention by lowering ldl-cholesterol levels but also through other mechanisms poorly understood. our hypothesis is that some of these effects are mediated by microbiota alteration, leading to diminution of expression of microbiota derived pro-atherogenic metabolites.

the aim of this prospective double blind placebo-controlled study is to evaluate the acute effects of statins on microbiota and its derived metabolites at 2 and 6 weeks.

Eligibility criteria:
inclusion criteria: * patient with cardiovascular risk requiring statins in primary prevention * contraception for women of childbearing age exclusion criteria: * previous antibiotics, proton pomp inhibitors, statins or other hypolipidemic drugs intake in the previous three months * renal insufficiency with creatinine clearance \<40ml/min * contra-indication to statins * previously known conditions affecting muscles, or digestive system * requirement of statins in secondary prevention

Keywords: statins cardiovascular risk primary prevention microbiota metabolomics
comparison of external physical vibration lithecbole(epvl) in different time after retrograde intrarenal surgery(rirs)

Conditions: Calculi

Summary: the treatment of renal calculus by retrograde intrarenal surgery(rirs) isn't able to eliminate stone completely

to evaluate the efficacy and safety of external physical vibration lithecbole for the treatment of residual stone in different time (3 days ,7 days and 14 days) after the operation of rirs

Eligibility criteria:
inclusion criteria: 1.age of 18-75 years; exclusion criteria: 1.urinary tract anomalies, stricture or obstruction;

Keywords: stones external physical vibration lithecbole
effect of insulin detemir on use of energy in type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the purpose of this trial is to investigate if there is any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in patients with type 1 diabetes, whilst taking two different, commercially available insulins for the treatment of their diabetes.

the study had been temporarily halted due to an unplanned interim analysis. the sponsor is now aware that a further interim analysis has been performed by the site and therefore a decision has been made not to recommence the study

Eligibility criteria:
inclusion criteria: * type 1 diabetes for more than 12 months * current treatment: basal-bolus insulin regimen for more than three months (i.e. at least one daily injection of long-acting insulin (including insulin glargine) and fast-acting insulin with each main meal) * hba1c (glycosylated haemoglobin a1c) between 7.0 and 11.0% * able and willing to maintain consistent physical activity level throughout the entire study period * able and willing to maintain consistent eating habits throughout the entire study period exclusion criteria: * proliferative retinopathy that has required acute treatment within the last six months * recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator * liver, kidney or heart problems as judged by the investigator * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures * known or suspected allergy to trial products or related products * receipt of any investigational drug within one month prior to this trial
transplantation of bone marrow derived mesenchymal stem cells in affected knee osteoarthritis by rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: osteoarthritis of the knee is one of the most common causes of disability among elderly. arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as knee osteoarthritis. as the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in t2-weighted mri as increase in signal density. patients are treated initially by pain management. in patients who don't response to first line treatment invasive treatment like total knee replacement is done. the investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (bm-mscs) in 60 patients with knee osteoarthritis.

in this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group a (control group) received only routine medical therapies and placebo injected into there knees.. group b received mesenchymal stem cells in addition of routine medical therapy. patients were categorized according to the following stimulation protocols: to assess the outcomes, after mesenchymal stem cells transplantation at months 1,3,6 and 12 we will examine the patients by: womac questioners, das28 scoring , radiographies assessments and biochemical analysis with laboratory tests.

Eligibility criteria:
inclusion criteria: 1. age 18 to 65 years 2. body mass index (bmi) ≤30 kg/m2 3. the presence of osteoarthritis based on mri and american rheumatism association criteria since 6 months before invitation exclusion criteria: 1. response to routine treatment at last one year.

Keywords: mesenchymal stem cells osteoarthritis arthritis rheumatoid
microvascular monitoring in circulatory shock and sepsis (mimicss)

Conditions: Sepsis; Shock; Critical Illness

Summary: investigation of the feasibility of using near-infrared spectroscopy (nirs) to monitor microvascular function in critically ill patients.

this is a prospective observational study using non-invasive nirs for microvascular monitoring in the icu. the study involves no interventions above standard of care other than the application of the nirs monitors. nirs will be applied to skeletal muscle and the brain longitudinally throughout icu admission. vital signs are extracted continuously from the icu monitor and clinical data are recorded from patient records. the broad goals of the study are: 1. determine the feasibility of longitudinal nirs monitoring in icu patients 2. determine the ability to derive patient-specific microvascular metrics using nirs 3. explore the relationship between microvascular metrics and icu mortality

Eligibility criteria:
inclusion criteria: * admitted to icu * receiving invasive mechanical ventilation exclusion criteria: * body mass index \>40 * more than 24 hours has elapsed since icu admission * death is deemed to be imminent and inevitable during the next 24 hours * known allergy to the textile components of the device * significant clinical jaundice, ecchymosis * covid positive microbiological result * the treating clinician believes that participation in the domain would not be in the best interests of the patient * consent declined from patient or authorized third party

Keywords: near-infrared spectroscopy
atac - endometrial sub-protocol

Conditions: Breast Cancer

Summary: to compare the difference between the arimidex group and the tamoxifen group in the incidence of abnormal endometrial histological findings arising after treatment has commenced.


Eligibility criteria:
inclusion criteria: * patients eligible for entry into the main atac trial (1033il/0029) * not received any previous tamoxifen, for whatever reason * not undergone a hysterectomy and do not have a hysterectomy planned within the next 6 years * no previous endometrial ablation exclusion criteria: * excluded from entry into the main atac trial (1033il/0029). as detailed in section 4.4 of the main atac trial (1033il/0029)

Keywords: endometrial endometrial histological findings
electronic strategies to enhance venous thromboemboli (vte) prophylaxis in hospitalized medical patients

Conditions: Venous Thromboembolism

Summary: venous thromboemboli (vte) are abnormal blood clots that commonly form in the blood vessels of the legs or lungs. they can block normal blood flow, damage organs, and even cause death. the risk of vte is increased in people who are sick or immobile. vte is the most common preventable cause of death in hospitalized patients, and its vte prevention should be a top patient safety priority. though there is good evidence that injectable blood thinners and/or compression stockings can prevent vte, over 30% of hospitalized medical patients in hamilton, ontario receive inappropriate prevention. hamilton health sciences corporation is in the process of introducing "electronic order sets" - computer programs that help doctors order medications and other healthcare interventions for their patients. the investigators would like to study if these electronic order sets can help improve the rate of appropriate vte prevention in hospitalized medical patients. the investigators will examine the rate before and after the introduction of electronic order sets at the juravinski hospital and the hamilton general hospital. doctors at the hamilton general hospital will also get to use an additional computer program, called a computerized decision support system (cdss), that helps them decide on the best strategy to prevent vte in individual patients. the rates of vte prevention at each hospital will be compared to each other, and to the rates at st. joseph's healthcare hamilton, which will receive neither the order sets nor the cdss.


Eligibility criteria:
inclusion criteria: * adult patients at least 18 years of age * hospitalization on a general internal medicine ward exclusion criteria: * receiving therapeutic anticoagulation at time of hospitalization

Keywords: venous thromboembolism thromboprophylaxis anticoagulants hospitalized medical patients electronic order sets decision support knowledge translation patient safety
sleep, physical activity and multiple sclerosis symptoms in pediatric multiple sclerosis

Conditions: Pediatric Multiple Sclerosis

Summary: most youth with ms experience symptoms such as depression and fatigue. in addition, cognitive issues, especially with attention and memory occur frequently. however, little is known about interventions that might work to improve these symptoms. in other work, the investigators have shown that higher levels of physical activity are associated with lower levels of depression and fatigue. importantly, sleep problems are frequently encountered in youth with ms, and were seen in 60% of surveyed youth with ms in the investigators preliminary work. modifiable lifestyle factors such as sleep and physical activity (pa) may play a key role in ameliorating common symptoms in pediatric ms. however, sleep has not been objectively described in pediatric ms, and the relationship between pa and sleep is poorly understood. this study aims to address these gaps.


Eligibility criteria:
inclusion criteria: 1. children ages 10 to 17 years, 11 months; 2. ms diagnosis following standard definitions (ipmssg); 3. healthy controls will include any child without a history of disease or disability exclusion criteria: 1. inability to communicate or understand english; 2. those within 30 days of a relapse; 3. children who exhibit severe respiratory problems at baseline (e.g. use of tracheotomy)