Kornimate/medical-research-clean huggingface dataset:
optic nerve sheath diameter for prediction of outcome after cardiac arrest

Conditions: Cardiac Arrest

Summary: early prognostication in resuscitated cardiac arrest (ca) patients, within the first day after admission in the intensive care unit (icu), remains difficult. optic nerve sheath diameter (onsd) measurement could predict increased intracranial pressure. preliminary works showed that onsd measurement could be used to predict outcome in post-ca patients. the aim of this study was to assess the ability of bedside onsd ultrasonographic measurement to predict survival and cerebral performance category (cpc) score at hospital discharge in post-cardiac arrest patients treated with therapeutic hypothermia (th).

prospective observational study including all consecutive successfully resuscitated and th-treated ca patients without traumatic or neurological etiology of ca in two french icus. onsd measurements were performed on day 1, 2, and 3 after return of spontaneous circulation (onsd1,2,3 respectively). the primary outcome is survival at hospital discharge (with an average follow-up of 3 month until icu admission).

Eligibility criteria:
inclusion criteria: * unconscious (glasgow coma scale ≤6) * ≥18 years old * admitted in icu after successful resuscitation from ca * treated with th targeted to 33°c exclusion criteria: * unavailable onsd measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability) * traumatic or neurological origin of ca * previous cerebrovascular disease * facial trauma affecting the orbits and/or eyeballs * previous history of ocular pathology such as exophthalmia, glaucoma or cataract.

Keywords: cardiac arrest neuroprognostication optic nerve sheath diameter outcome ultrasonography
phase i pilot study to evaluate the anti-glioblastoma effect of s-gboxin in standard treatment of glioblastoma/diffuse midline glioma and response to treatment (regardless of mutation status)

Conditions: Glioblastoma Multiforme; Diffuse Midline Glioma, H3 K27M-Mutant; Gliosarcoma; Giant Cell Glioblastoma; GBM

Summary: the objective of this pilot study is to evaluate the efficacy of adding s-gboxin to standard rt/tmz treatment protocols in patients with glioblastoma multiforme (gbm) or midline glioma (dmg), regardless of their mutation status

this is a pilot study to evaluate the efficacy of adding the mitochondrial oxidative phosphorylation inhibitor s-gboxin (oxphos) to standard treatment for glioblastoma multiforme or glioma. subjects will start oral s-gboxin orally twice daily and will evaluate the patients and vital status if they tolerate this dose at 3, 7and 15 days after initiation. patients will undergo mri scans before treatment and then at multiple time points during their participation in this clinical trial to monitor early tumor response to treatment ( mri dates will be scheduled by the clinical trial coordinator) peripheral blood samples will be collected at baseline, days 1-7-15-28-36-72 to compare biological indicators of treatment response. in some cases, circulating tumor cells (ctcs) will be monitored by real-time qrt-pcr to correlate with clinical data. patients will also be assessed for the side effects they experience. disease-free and overall survival outcomes will be recorded. patients will also have their depressive symptoms, quality of life, and neurocognitive function assessed at multiple time points during and after treatment. after completion of the study, patients will be followed up at 3 months.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of glioblastoma according to rano criteria by contrast-enhanced mri or pet-ct (including diffuse midline glioma, gliosarcoma or giant cell glioblastoma), relapse or disease progression * patient is able to understand and give consent to participate in the study * karnofsky performance score ≥ 60 * women of childbearing potential must have a negative pregnancy test result no later than 7 days before registration exclusion criteria: * pregnant * known allergies * active treatment on annotner clinical trial * inability to complete with protocol or studio procedures.
safety and efficacy of venlafaxine xr in elderly patients with major depression

Conditions: Depression

Summary: this research study is to evaluate the safety and usefulness of venlafaxine-xr in the treatment of major depression in the elderly.

the primary objective of this pilot study is to evaluate the safety of venlafaxine extended release formulation (xr) in the treatment of geriatric non-psychotic depression. this pilot study's specific aims are to assess the safety of venlafaxine xr in the geriatric population, to estimate the response rate of older depressed subjects treated under open conditions and to evaluate pharmacokinetic characteristics that may impact on safety and outcome.

Eligibility criteria:
inclusion criteria: * men and women of all races who are 60 years old or older; * a dsm-iv diagnosis of major depressive episode without psychotic features; * 17-item ham-d score of \>15 for potential subjects who have not received any antidepressant treatment during this illness episode or ham-d \> 11 for potential subjects who have received treatment with an antidepressant (other than venlafaxine-xr) during this illness episode; * a mmse score of \>15. exclusion criteria: * history of meeting dsm-iv criteria for mania, schizophrenia or other psychotic disorder; * history of substance abuse or dependence, including alcohol, within the last three months; * current hyponatremia (as defined as a serum sodium level \< 130 meq/l); * untreated or uncontrolled hypertension; * a history of being unable to tolerate venlafaxine-xr or venlafaxine immediate release formulation; * history of receiving venlafaxine-xr or venlafaxine immediate release formulation of 6 or more weeks at 300mg/d during index depressive episode; (7) ekg revealing qtc \> 480 msec; * myocardial infarction, unstable angina, palpitation or cardiogenic syncope within 3 months prior to entering this study; * the presence of active suicidal ideation with intent.

Keywords: elderly
transversalis fascia plane block in pediatric patients

Conditions: Pain, Postoperative; Regional Anesthesia; Parental Satisfaction

Summary: to investigate the effects of transversalis fascia plan block after induction of anesthesia on perioperative opioid consumption, hemodynamic changes, postoperative flacc pediatric pain score, non-opioid analgesic use and parental satisfaction in pediatric patients undergoing unilateral inguinal hernia or undescended testicular repair under general anesthesia.


Eligibility criteria:
inclusion criteria: * 1-9 years old * asa i-ii risk group * patients whose consent was obtained from their parents with an informed consent form * patients who will undergo inguinal hernia or undescended testi exclusion criteria: * asa \>2 * history of allergy to local anesthetics * known coagulation disorders * infection near the entry site * body mass index \>30 * those whose parents refused to participate in the study * those contraindicated for regional anesthesia * those with neurological or neuromuscular disease * patients with psychiatric problems * patients with a history of opioid use * chronic analgesic use * operation duration exceeding 2 hours

Keywords: postoperative pain pain scores
mri fusion biopsy vs. micro-ultrasound guided biopsy

Conditions: Prostate Cancer

Summary: the purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (exactvu) and by multiparametric magnetic-resonance imaging (mpmri).

this is a pilot clinical trial with 30 patients with either: 1) suspected prostate cancer (based on elevated psa or abnormal digital rectal exam (dre), or 2) known low-risk prostate cancer being managed with active surveillance. enrolled patients will undergo mri fusion biopsy and standard-template 12 core trus biopsy as the standard-of-care. patients will also undergo micro-ultrasound evaluation and targeted biopsy if lesions are identified. detection rates of clinically significant lesions by exactvu and by mri will be compared.

Eligibility criteria:
inclusion criteria: 1. patients scheduled to undergo biopsy and with one of the following: * men with suspicion of prostate cancer * men on active surveillance 2. age ≥18 \[30\] 3. have available multiparametric prostate mri 4. able to provide written, informed consent 5. no significant medical illness which in the opinion of the investigator would preclude entry to study procedures 6. be willing and able to comply with scheduled visits exclusion criteria: 1. previously confirmed prostate cancer diagnosis with grade group \>= 2 2. unable to undergo prostate biopsy 3. prostate mri unable to be evaluated using the pi-rads v2 criteria 4. men with contraindication for mri or a prostate biopsy 5. prostate biopsy within 8 weeks prior to mpmri. 6. any history of prostate treatment
abt-450/ritonavir/ abt-267 (abt-450/r/abt-267) and abt-333 co-administered with ribavirin (rbv) in treatment naïve and treatment experienced asian adults with genotype 1b chronic hepatitis c virus (hcv) infection and compensated cirrhosis

Conditions: Chronic Hepatitis C Virus (HCV)

Summary: this is a phase 3, open-label, multicenter study evaluating the efficacy and safety of abt-450/r/ abt-267 and abt-333 coadministered with rbv for 12 weeks in hcv genotype 1b, treatment naïve and interferon (ifn) (alpha, beta or pegifn) plus rbv treatment-experienced asian adults with compensated cirrhosis.


Eligibility criteria:
inclusion criteria: 1. chinese, south korean, and taiwanese descent with full chinese, south korean, and taiwanese parentage. 2. chronic hcv-infection prior to study enrollment. 3. screening laboratory result indicating hcv genotype 1b-infection. 4. compensated cirrhosis defined as a child-pugh score of less than or equal to 6 at screening. 5. per local standard practice, documentation of cirrhosis by one of the following methods: * diagnosis on previous liver biopsy or liver biopsy conducted during screening e.g., metavir score of \> 3 (including 3/4 or 3 - 4), ishak score of \> 4 or, * fibroscan score ≥ 14.6 kilopascals (kpa) within 6 months of screening or during the screening period. exclusion criteria: 1. hcv genotype performed during screening indicating unable to genotype or infection with any other hcv genotype. 2. positive test result at screening for hepatitis b surface antigen (hbsag), or hepatitis b virus (hbv) dna \> lower limit of quantification (lloq) if hbsag negative, or anti-human immunodeficiency virus antibody (hiv ab). 3. use of known strong inducers of cytochrome p450 3a (cyp3a) or strong inhibitors of cyp2c8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration. 4. any current or past clinical evidence of child-pugh b or c classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy. 5. serum alpha-fetoprotein (safp) \> 100 ng/ml at screening. 6. confirmed presence of hepatocellular carcinoma (hcc) indicated on imaging techniques such as computed tomography (ct) scan or magnetic resonance imaging (mri) within 3 months prior to screening or on an ultrasound performed at screening (a positive ultrasound result should be confirmed with ct scan or mri.) 7. any primary cause of liver disease other than chronic hcv-infection, including but not limited to the following: * hemochromatosis * alpha-1 antitrypsin deficiency * wilson's disease * autoimmune hepatitis * alcoholic liver disease * drug-related liver disease steatosis and steatohepatitis on a liver biopsy coincident with hcv-related changes would not be considered exclusionary unless the steatohepatitis is considered to be the primary cause of the liver disease. 8. screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.

Keywords: hcv infection compensated cirrhosis
short versus long protocol for ivf and ivf+icsi

Conditions: Infertility; Ovarian Hyperstimulation Syndrome; Quality of Life; Live Birth

Summary: purpose: comparing a gnrh agonist and an antagonist protocol for ivf/icsi with regard to 1. frequency of ovarian hyperstimulation syndrome (ohss) (1. outcome measure) 2. quality of life (2. outcome measure) 3. live birth rate (2. outcome measure) 4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol and vascular endothelial growth factor in follicular fluid(not only compared between gnrh agonist and antagonist protocol, but also between patients with ohss and no ohss and patients becoming pregnant and not becoming pregnant (2. outcome measure), and 5. number of oocytes removed per treatment, number of embryo transfers per treatment and number of spontaneous abortions per treatment (these three parameters are tertiary outcome measures). in addition to the above mentioned efficacy outcome measures the safety outcome measure "frequency of known side-effects" will be compared between the two protocols.

patients: 1100 patients are randomized prospectively to either treatment. stratification: =\ 36 y, ivf/icsi, and treatment centre. methods: ohss is quantified by consecutive measurements of weight, abdominal diameter, ultrasound measurements of ascites and ovarian volume, paraclinical parameters, and by a systematic patient questionnaire. furthermore it is registered if the patients have been hospitalized and/or have had ascites drainage performed due to ohss. data from the first 100 patients are used together with golans ohss-classification, to make a more precise definition of ohss. this definition is applied prospectively on data from the remaining patients. quality of life is gauged by a questionnaire. child birth rate is ascertained by a pregnancy response questionnaire and by obtaining data from the danish national birth registry. statistics: the study is designed to be able to show a 50% reduction of ohss comparing short to long protocol.

Eligibility criteria:
inclusion criteria: * all patients referred for infertility receiving their first ivf or ivf+icsi treatment exclusion criteria: * previous ivf or ivf+icsi-treatment * uterine anomalies * it is necessary to perform direct sperm aspiration from husband's/partner's testicles * allergy to one of the intervention products * patient is 40 years or above

Keywords: ohss quality of life ivf icsi gnrh-agonist gnrh-antagonist
norwegian intensive care unit dalteparin effect study

Conditions: Acute Kidney Injury; Deep Venous Thrombosis

Summary: the main purpose of the norides study is to investigate the effect of pharmacological thromboprophylaxis with low molecular weight heparins (lmwhs) in critically ill patients, and how it is affected by presence of acute kidney injury (aki) and treatment with hemodialysis. the main objective is to compare the prophylactic effect of dalteparin in intensive care unit (icu) patients with aki and citrate-calcium dialysis (cica-dialysis) with a control group of icu patients with normal kidney function. our main hypothesis is that cica-dialysis reduces dalteparin effect, and that patients undergoing cica-dialysis do not achieve adequate prophylaxis against venous thromboembolism (vte). the primary endpoint is development of dvt during icu stay, the secondary endpoint inadequate heparin effect measured in blood samples.

description of deep venous thrombosis (dvt) diagnosis: screening for dvt using doppler ultrasound (dus) of both upper- and lower extremities will be performed within 48 hours after icu admission and thereafter twice a week until discharge from icu or icu stay equal to 30 days. an additional dus will be performed 3 months after icu discharge. description of heparin effect measured in blood samples: blood samples will be drawn from intravasal catheters (preferably arterial, alternatively central venous) to examine heparin effect (anti-xa activity, thrombin generation assay (tga) and thrombelastography (teg) and other haematological analyses including antithrombin concentrations. whole blood will be drawn on two separate days (from minimum day 2 to maximum day 30 dependent on the dialysis therapy) of icu stay immediately before and 4 hours after dalteparin administration in order to measure tough and peak effect of heparin. dalteparin effect in icu patients undergoing dialysis therapy will be measured one day with and one day without ongoing dialysis therapy in order to distinguish the effect of aki from the effect of continuous renal replacement therapy (crrt).

Eligibility criteria:
inclusion criteria: * icu patients receiving prophylactic dalteparin exclusion criteria: * age \< 18 years * intraocular bleeding * intracranial bleeding * acute spinal cord lesion * inherited coagulopathy * ongoing, uncontrolled bleeding * therapeutic anticoagulation * uncorrected coagulopathy * pregnancy or postpartum \< 6 weeks * participation in an interventional study * rifle class e * consent not received * icu length of stay less than 48 hours * dvt detected at first dus examination

Keywords: acute kidney injury deep venous thrombosis dialysis prophylaxis
estimated impact of fungal colonization in cystic fibrosis from secondary exploitation of mucofong database.

Conditions: Cystic Fibrosis Lung

Summary: the main objective of the project "mucofong" (19021906 national french program n which vaincre la mucoviscidose participated: n82006/ 351) was to determine the fungi present the respiratory tract of cf patients responsible for either colonization or authentic infectious diseases. the mucofong data allowed the team to provide for the 1st time national french guidelines for the management of cf sputum mycological analysis (mucomicrobes work group coordinated by prof. plésiat published in 2015 in the remic book). nevertheless, the team has a comprehensive database that it still has to analyze beyond these initial results. the main goal today is to clarify the role of fungi in the lung function degradation of these patients by studying the overall risk and estimated impact of fungal colonization in our cohort.

the material includes data from the followup of the 300 patients (3 visits per patient for which the team collected and verified the biological radiological and clinical data). relations between aspergillus fumigatus or candida albicans and lung function or clinical outcome of patients will be longitudinally analyzed taking as output variable fev1, according to bibliography data available. to assess the attributed fungal risk, the team will focus on the 57 patients de novo colonized by fungi at the second visit. three physician experts will determine the impact of such fungal colonization on the patient clinical and respiratory parameters. the expert conclusion concordance and statistical significance will be evaluated using the kappa score. this project will be realized in collaboration with the groups of prof. r. thiebaut (methodology and epidemiology service bordeaux university hospital, inserm u1219 / inria sistm) and prof. m. fayon (department of pediatrics, pediatric reference centre) university hospital of bordeaux.

Eligibility criteria:
inclusion criteria: all patients included in the database meet the following criteria: * patient whose diagnosis of cystic fibrosis has been validated on the criteria in force, * patient usually followed in one of the 7 centers involved in the phrc, * patient aged at least 6 years without an upper age limit, * patient benefiting from a mycological assessment carried out in the context of the usual microbiological monitoring (good clinical practice), * cystic fibrosis patient benefiting from a mycological assessment carried out in front of a clinical episode of aggravation requiring biological exploration, * patient who has signed informed consent at the time of inclusion,-patient affiliated with a social security scheme. exclusion criteria: patients meeting the following criteria were not included in the database: * pulmonary transplant patient, * patient or their parents (if the patient is a minor) refusing any participation in the study, * major incapable subject, under guardianship or under the protection of justice, * refusal or inability to give informed consent.
telmisartan/amlodipine (80/5) vs. telmisartan/amlodipine (40/5) vs. amlodipine 10 or 5 in resistant hypertension

Conditions: Hypertension

Summary: the primary objectives of this trial are (a) to demonstrate that the fixed-dose combination t40/a5 or the fixed-dose combination t80/a5 is superior in reducing blood pressure at eight weeks compared with a5 (b) to demonstrate that the fixed-dose combination t40/a5 or the fixed-dose combination t80/a5 is not inferior in reducing blood pressure at eight weeks compared with a10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination t40/a5 pooled with the fixed-dose combination t80/a5 is superior (less oedema) to a10 in patients who fail to respond adequately to six weeks treatment with a5.


Eligibility criteria:
inclusion criteria: 1. patients aged at least 18 years at the date of signing the consent form 2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study 3. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy 4. able to stop any current antihypertensive therapy without unacceptable risk to the patient (investigator's decision) 5. willing and able to provide written informed consent (in accordance with good clinical practice and local legislation). exclusion criteria: 1. are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. 2. known or suspected secondary hypertension 3. mean seated systolic blood pressure (sbp) over 200 mmhg and/or mean seated diastolic blood pressure (dbp) over 120 mmhg at visit 1 or 2 or mean seated sbp over 180 mmhg and/or mean seated dbp over 120 mmhg at the end of the run-in period (visit 3) 4. any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency) 5. severe renal impairment (e.g. serum creatinine \>3.0 mg/dl or \>265 mcmol/l, known creatinine clearance \<30ml/min or clinical markers of severe renal impairment) 6. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant 7. clinically relevant hyperkalaemia 8. uncorrected volume or sodium depletion. 9. primary aldosteronism. 10. hereditary fructose or lactose intolerance