Kornimate/medical-research-clean huggingface dataset:
evaluating the efficacy of symri in clinical pediatric populations

Conditions: Brain Injuries; Brain Development Abnormality; Brain Pathology

Summary: synthetic mr technologies has created a quantified imaging solution - symri - to enable radiologists to acquire quantified images and always obtain the best contrast images. this study represents an attempt to assess the clinical utility of this software.

typical magnetic resonance imaging (mri) involves taking many images called 'contrasts' to look at the body in different ways. standard scan settings are usually good enough for a radiologist to review. the best settings often change with the age of the patient and their health, and are time consuming to determine. quantified imaging is an alternative to contrast-based imaging which explicitly measures tissue properties and can be used to create almost any contrast. this method of imaging has been held back by a lack of the right software. synthetic mr technologies has created a quantified imaging solution - symri - to enable radiologists to acquire quantified images and always obtain the best contrast images. the objective of this study is to evaluate symri in a pediatric population to determine if sickkids would be interested in purchasing this product / support health canada approval. specifically, the investigators are interested in determining if symri is clinically useful: * is synthetic imaging quality comparable / better than conventional imaging? * qualitative - are radiologists more confident using synthetic mr vs conventional * quantitative - signal-to-noise (snr) and contrast-to-noise (cnr) * to what extent can total exam times be reduced? * is the software user friendly and would investigators use it?

Eligibility criteria:
inclusion criteria: * any stable patient undergoing clinical mri of the brain is eligible for this study. * research patients undergoing research mri of the brain for another study will be eligible. exclusion criteria: * only those patients where an additional 10 minutes of mr imaging would not be advisable (ie. unstable, implants) or possible (due to scheduling constraints) will be excluded.
rosiglitazone on microalbuminuria in type 2 diabetics

Conditions: Diabetes Mellitus, Type 2

Summary: following a 4-week single-blind placebo run-in period, eligible subjects were randomized in a 1:1 ratio to receive 32 weeks of double-blind study medication: rosiglitazone (starting dose 4mg od) or glyburide (starting dose 5mg od), both in combination with open-label metformin \> or = (1g/day). subjects were stratified for use of acei, nondihydropyridine calcium channel blockers (ndp ccb), or angiotensin ii receptor blockers (arb) to provide equal representation of these subjects in each treatment group.


Eligibility criteria:
inclusion criteria: * male or female subjects, aged 40-80 with t2dm and microalbuminuria previously treated by diet and exercise alone, a single oral antidiabetic agent, or combination oral antidiabetic therapy. exclusion criteria: * pregnancy or lactation, use of any tzd (pioglitazone or rosiglitazone) or insulin, renal disease or renal dysfunction , any degree of congestive heart failure, clinically significant hepatic disease or anemia, presence of unstable or severe angina or coronary insufficiency, high blood pressure

Keywords: microalbuminuria, type 2 diabetes rosiglitazone,
a study of fostamatinib in subjects with impaired hepatic (liver) function

Conditions: Hepatic Impairment; Healthy Volunteers; Pharmacokinetics; Amount of R406 in Blood

Summary: a study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function. the study will also evaluate safety and tolerability in subjects with hepatic impairment.


Eligibility criteria:
inclusion criteria: * males and females (non child-bearing potential) aged 18 years or more, with a weight of at least 50 kg and body mass index (bmi) between 18 and 40 kg/m2 inclusive * healthy subjects only: good health as determined by a medical history, physical examination , ecg and clinical laboratory evaluations * healthy subjects only: negative results for serum hepatitis b and c exclusion criteria: * subjects who have received any medications known to alter drug absorption or elimination within 30 days of first dose. * subjects who smoke more than 10 cigarettes or equivalent per day * absolute neutrophil count \<2500/mm3 * abnormal vital signs, additional systemic disease (eg, cardiac, or renal disease) or abnormal laboratory findings that are judged to be clinically significant by the investigator * healthy volunteers only: use of prescribed medications within 2 weeks of first dose or use of non-prescribed medications within 1 week of first dose * hepatic subjects only: fluctuating or rapidly deteriorating hepatic function

Keywords: phase 1 healthy volunteers volunteers with hepatic impairment pharmacokinetics fostamatinib
apixaban in the prevention of stroke and systemic embolism in patients with atrial fibrillation in real-life setting in france

Conditions: Anticoagulation

Summary: the present study will be conducted to assess the following research questions in real-life conditions in france: what are the patient and disease characteristics, comorbidities and treatment history in nvaf patients initiating a new anticoagulant (ac) treatment, according to treatment currently available and prescribed (apixaban, other noacs, vkas), and are the ac-naive patient profiles different from one treatment pattern to another when initiating a new ac treatment? what are the hcp's reasons for discontinuing the previous ac strategy for initiating and choosing the newly initiated ac treatment in nvaf patients? what are the conditions of newly-initiated apixaban prescriptions in nvaf patients: prescriber, proportion of naïve/experienced patients, daily dosage and number of daily doses?


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years * diagnosed with non valvular atrial fibrillation (nvaf) * prescribed with a newly initiated ac treatment (apixaban, other noacs or vkas). newly initiated ac treatment is defined as any ac treatment initiated within the past 3 months, including day of enrolment exclusion criteria: * patients with atrial fibrillation (af) due to reversible causes * patients with a diagnosis of vaf. the term vaf is used to imply that af is related to rheumatic valvular disease (predominantly mitral stenosis) or prosthetic heart valves * patients participating in an ongoing clinical trial in af
outcomes study of glycosylated hemoglobin control in cox-maze iv during cardiac surgery

Conditions: Cardiac Surgery

Summary: in recent years, a growing body of research has shown that diabetes plays an important role in the development and recurrence of atrial fibrillation. how to achieve the treatment and prevention of recurrence of atrial fibrillation through appropriate blood glucose control is the current focus of clinical research. glycosylated hemoglobin (hba1c) is the product of a non-enzymatic reaction in which hemoglobin in red blood cells is combined with sugars in the serum (mainly glucose). the purpose of this multicenter, randomized controlled study is to compare the effects of different glycosylated hemoglobin control strategies on the effectiveness of cox-maze iv procedure for atrial fibrillation during cardiac surgery.


Eligibility criteria:
inclusion criteria: * age ≥18 years * elective cardiac surgery * a clear diagnosis of diabetes mellitus, and hba1c ≥ 7.5% at the time of initial diagnosis and treatment * preoperative combination of persistent or long-term persistent atrial fibrillation exclusion criteria: * emergency surgery or limited-term surgery * previous cardiac surgery * left atrial diameter \> 65 mm * serum creatine \> 1.8 mg/dl * previous severe liver disease * pregnant or planning to become pregnant * have a malignant tumor

Keywords: cardiac surgery atrial fibrillation glycosylated hemoglobin cox-maze iv
the international registry for leigh syndrome

Conditions: Leigh Syndrome; Leigh Disease; Leigh's Necrotizing Encephalopathy; Subacute Necrotizing Encephalomyopathy; Subacute Necrotizing Encephalomyelopathy

Summary: the purpose of this study is to develop a database containing clinical and laboratory information for patients with leigh syndrome. the goal is to provide a greater understanding of leigh syndrome allowing further characterization of this disease.

leigh syndrome, also known as juvenile sub-acute necrotizing encephalopathy, is a progressive neurodegenerative disorder associated with dysfunction of mitochondrial oxidative phosphorylation (oxphos). first described in 1951 by british neuropsychiatrist archibald denis leigh, the condition has evolved from a post mortem diagnosis to a clinical entity with characteristic radiologic and laboratory findings. leigh syndrome is a rare and heterogeneous disease, finding a substantial number of patients to study is difficult. the lack of natural history data in leigh syndrome and the small number of patients included in clinical reports thus far has limited the ability to fully comprehend the progression of this disease and assess prognostic factors. a leigh syndrome database will help improve our understanding of this rare disease leading to an improved ability to predict outcomes and/or improve treatment paradigms. collecting natural history data on leigh syndrome and integrating this information into a database will be useful in understanding the course of the disease and identifying trends.

Eligibility criteria:
inclusion criteria: * all participants with a diagnosis of leigh syndrome will be invited to participate exclusion criteria: * people without leigh syndrome

Keywords: leigh syndrome leigh disease leigh's necrotizing encephalopathy subacute necrotizing encephalomyelopathy subacute necrotizing encephalomyopathy
mother-to-child hepatitis d transmission

Conditions: Hepatitis D; Transmission

Summary: hbv can be transmitted from mother-to-child, with a risk increasing according to maternal hbv dna during pregnancy. hdv is a defective virus using hbs ag for its own replication. nucleosides analogues have only a minor impact on quantitative hbs ag level. data about vertical hdv transmission are old, justifying a new study.

hepatitis b virus (hbv) can be transmitted from mother-to-child, with a risk increasing according to maternal hbv dna viral load during the last trimester of pregnancy. nucleosides analogues, lamivudine, telbivudine, or nucleotides analogues, tenofovir df decrease hbv mother-to-child transmission risk, and are recommended in guidelines (easl 2012) for pregnant women with hbv dna above 1,000 000 i.u/ml. hdv is a defective virus using hbs ag for its own replication. hdv-hbv co-infection is a re-emerging infectious disease in western countries, due to immigration of people coming from endemic areas. nucleosides analogues have only a minor impact on quantitative hbs ag level (boyd a et al. aids research and human retroviruses 2013). data about vertical hdv transmission are old (rizzetto, et al. j med virol 1982), before a large use of nucleosides/nucleotides analogues in hbv infected pregnant women, justifying a new study.

Eligibility criteria:
inclusion criteria: * children born in the maternity department, lariboisiere hospital, * from hbv-hdv co-infected women * with a positive hdv rna during pregnancy in the pregnant woman exclusion criteria: * negative hdv rna during pregnancy in the pregnant woman
mesenchymal stem cell transplantation in the treatment of chronic antibody mediated kidney graft rejection (abmr)

Conditions: Interventional

Summary: transplant rejection is one of the biggest limitations in renal transplant procedures, where the kidney can undergo an acute, late acute, or chronic transplant rejection. with the advancement in transplantation protocols, acute survival of renal transplants has improved, but long-term survival is still unsatisfactory, as most of the renal transplants develop chronic graft rejection. unfortunately, there is little the investigators know when it comes to improving long-term survival of renal transplants. mesenchymal stem cells (msc) have been shown to have immunosuppressive and repairing properties. the purpose of this study is to find out whether msc in combination with standard therapy of antibody mediated rejection (abmr) are more effective in preventing organ deterioration and maintaining kidney function.

participants will be assigned to receive the full immunosuppressive therapy indicated to treat chronic abmr (including plasmapheresis (pf) 7x, intravenous immune globulins 100 mg/kg 7x, corticosteroid) and msc infusions (2x106cells/kg bw after pf) (group 1) and be compared to historic controls according to "propensity score matching" (treated with immunosuppressive therapy alone (group 2)). patients will undergo msc infusions at the start of the study after each pf. one year post- infusions, patients will be evaluated and undergo kidney biopsies. blood collection will occur at regular intervals, serum creatinine and the estimated creatinine clearance will be monthly recorded. the transplanted kidney function and morphology (us doppler) will be evaluated.

Eligibility criteria:
inclusion criteria: * recipients of a renal allograft, male and female patients age \>18 * the egf\>20 ml/min/1.73 m2, * renal biopsy criteria: chronic active abmr. * written informed consent, compliant with local regulations. exclusion criteria: * recipients of multiple organs. * pregnant women. * malignant disease in last 5 years * active autoimmune disease * active infection including hepatitis b, hepatitis c, hiv, or tuberculosis * evidence of congestive cardiac failure and/or acute coronary syndrome in past 6 months. * evidence of liver disease * inadequate compliance to treatment.
dacarbazine and ipilimumab vs. dacarbazine with placebo in untreated unresectable stage iii or iv melanoma

Conditions: Melanoma

Summary: the purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. one treatment is an investigational compound (a drug that is not currently approved by the united states food and drug administration \[fda\]), know as ipilimumab (also known as mdx-010 or bms-734016) together with an approved chemotherapy drug called dacarbazine

for the extension phase: allocation: single arm study; masking: open label; intervention model: single group

Eligibility criteria:
inclusion criteria: * informed consent * measurable disease * eastern cooperative oncology group (ecog) 0 or 1 * lab / imaging requirements * neg for human immunodeficiency virus (hiv), hepatitis b (hepb), c * men and women \> 18 years (16 were allowable) * prior therapy restriction (adjuvant only) exclusion: * pregnant / nursing * inadequate contraception * brain metastasis * primary ocular or mucosal melanoma

Keywords: stage iiic n3 (unresectable) stage iv melanoma
cmv-mva triplex vac.enhance adap. nk cell recon. after auto hsct in pt lymphoid malig

Conditions: Lymphoma; Multiple Myeloma

Summary: this is a prospective, interventional study administering 2 doses of the experimental vaccine (cmv-mva triplex) to 20 evaluable patients (10 cmv-seropositive and 10 seronegative) undergoing autologous hematopoietic cell transplantation (hct) for lymphoma or myeloma on days 28 and 56 post-hct. the absolute number of adaptive nk cells (cd56dimcd57+nkg2c+) at various days will be compared.


Eligibility criteria:
inclusion criteria: * age \> 18 years * lymphoma or multiple myeloma * planned co-enrollment on current (at the time of this study version) or future (opening subsequent to this study) standard of care autologous stem cell transplant protocol. \* must meet all eligibility requirements of the co-enrolled parent study * sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control until at least day 100 post-hct * voluntary written consent signed before performance of any study-related procedure not part of normal medical care exclusion criteria: * cmv immunoglobulin, valganciclovir, ganciclovir, foscarnet, or other anti-cmv therapy within 3 months before the first vaccine is planned. acyclovir and valacyclovir are allowed. * pregnant or breast feeding. the fda has not classified this agent into a specified pregnancy category. females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy * planned immunotherapy post-hct. proteasome inhibitors and/or immunomodulators, such as but not limited to lenalidomide or pomalidomide, used for myeloma maintenance are allowed.
study of fviia variant bay86-6150 (b0189) in subjects with moderate or severe hemophilia types a or b with or without inhibitors

Conditions: Hemophilia A; Hemophilia B

Summary: this is the first in humans study of bay86-6150 (b0189) in non-bleeding subjects with moderate or severe congenital hemophilia a or b with or without inhibitors. this is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study. it is designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic and pharmacodynamic profile of bay86-6150 (b0189) and to determine a dose or range of doses to be examined in subsequent studies.


Eligibility criteria:
inclusion criteria: * history of moderate or severe congenital hemophilia a or b with or without inhibitors to factor viii (fviii) or factor ix (fix) * male subjects 18-65 years of age inclusive * able to dismiss factor replacement therapy during the course of the study unless required for the treatment of an acute bleeding episode * written informed consent * willing and able to comply with the requirements of the protocol * have adequate venous access * willing to use an effective method of contraception until day 30 of their study participation exclusion criteria: * received factor replacement therapy or treatment with any other procoagulant therapeutics, or any antifibrinolytic agents, including blood products, at anytime within 5 days prior to administration of investigational medicinal product (imp) * planned administration of factor replacement therapy or treatment with any other procoagulant therapeutics or any antifibrinolytic agents, including blood products, at anytime during the study period * acute bleeding episode or any ongoing bleeding episode at any time within 7 days prior to administration imp * clinically relevant coagulation disorder other than congenital hemophilia a or b * history of angina or receiving treatment for angina * history of coronary atherosclerotic disease, disseminated intravascular coagulopathy, or stage 2 hypertension defined as systolic blood pressure (sbp) \>/= 160 mmhg or diastolic blood pressure (dbp) \>/= 90 mmhg * history of transient ischemic attack, stroke, myocardial infarction, coronary artery disease, congestive heart failure, or thromboembolic event * active infection on day of imp administration or septicemia at any time within 30 days prior to administration of imp
multimodal study of the human brain epilepsy tissue

Conditions: Focal Drug-resistant Epilepsy

Summary: the tipi2 study is a blood and tissue collection protocol to create an annotated biorepository to support research in drug-resistant epilepsy. the aim of the study will be to identify new pathophysiological pathways. for this purpose, the investigators will investigate with a multimodal approach blood and brain samples from patients undergoing a surgery for focal drug-resistant epilepsy. the adult patients will be enrolled either during the pre-surgical evaluation or right before the surgery.

this study aims to investigate blood and brain samples from patients with drug-resistant epilepsy in order to identify new pathophysiological biomarkers. the investigators will first conduct multimodal research, including: * electrophysiological analyses * immunohistochemistry and genetic studies * biochemistry analyses samples will be stored at -80°c for future research. patients will undergo a follow-up evaluation within the 36 months following the surgery. new clinical data and biological samples will be collected then.

Eligibility criteria:
inclusion criteria: * 18 yo or above * patients with a focal drug-resistant epilepsy * patients hospitalized for a pre-surgical evaluation or for an epilepsy surgery * consent obtained from the patient, or legally authorized representative * affiliated to a social security system exclusion criteria: * none

Keywords: focal drug-resistant epilepsy surgery biorepository biomarkers
evaluating race specific age accumulation as a behavioral biomarker prostate cancer survivors

Conditions: Prostate Cancer

Summary: the purpose of this study is to show that reduction in advanced glycation end-products (ages) is associated with the beneficial regulation of receptor for age (rage) mediated tumor response which may correlate with improved quality of life in pca survivors. ages are produced by the body and are affected by lifestyle, weight and diet.


Eligibility criteria:
inclusion criteria: 1. patient diagnosed with non-metastatic stage i-iii prostate cancer 2. age 45 years and older 3. within 12 months of first histologic prostate cancer diagnosis. 4. completed planned chemotherapy and/or radiation therapy 4 weeks or more prior to study. 5. bmi \> 25 6. ecog performance status 0 or 1. 7. access to a telephone. 8. able to read and understand written and spoken english. 9. participants must be accessible for treatment and follow-up and must sign informed consent. 10. subjects with known diabetes are permitted. however, they must be under active treatment for this condition. 11. participants must past the cardiac rehabilitation center stress test. exclusion criteria: 1. planned enrollment in other formalized physical activity or diet counseling program during the 12 weeks of study 2. received chemotherapy or radiation therapy within 4 weeks of enrollment 3. had previous weight loss surgery (e.g. gastric bypass, sleeve gastrectomy and biliary pancreatic diversion). 4. previously participated in cardiac-rehab 5. have constrained mobility secondary to problems with balance, bone and/or joint disease 6. have unstable angina or cardiovascular disease that prohibits exercise.
antimony plus pentoxifylline in cutaneous leishmaniasis

Conditions: Cutaneous Leishmaniasis

Summary: the purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis.


Eligibility criteria:
inclusion criteria: * newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (pcr) methods or by intradermal skin testing (montenegro test). * number of lesions: 1 to 3 ulcerative lesions. * lesion´s diameter: 1 to 5 cm. * disease duration: up to three months. exclusion criteria: * safety concerns: * ast, alt \>3 times upper limit of normal range * serum creatinine or bun \>1.5 times upper limit of normal range * evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary) * immunodeficiency or antibody to hiv * any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, hiv, or other major infectious diseases * lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months * lack of suitability for the trial: * negative parasitology (aspirate/biopsy/pcr)or negative montenegro test * any history of prior anti-leishmania therapy * any condition which compromises ability to comply with the study procedures * administrative reasons: * lack of ability or willingness to give informed consent (patient and/or parent / legal representative) * anticipated non-availability for study visits/procedures

Keywords: cutaneous leishmaniasis pentoxifylline meglumine antimoniate l. braziliensis