Kornimate/medical-research-clean huggingface dataset:
post-market registry of the gore® viabahn® vbx balloon expandable endoprosthesis implanted in peripheral vessels

Conditions: Peripheral Vascular Diseases

Summary: the primary objective of the vbx 17-04 registry is to collect post-market safety and performance data of the gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent graft) in peripheral vessels in patients who require interventional treatment


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * signed informed consent form * endovascular indication for treatment based on treating physician's best medical judgment. * intend for no other stents to be placed in the same peripheral vessel(s) targeted for vbx stent graft placement. * willingness of the patient to adhere to standard of care follow-up requirements. exclusion criteria: * known hypersensitivity to heparin or a previous incident of heparin-induced thrombocytopenia (hit) type ii. * participation in concurrent research study or registry which may confound registry results, unless approved by gore. * pregnant or breast-feeding female at time of informed consent signature. * life expectancy \< 12 months due to comorbidities. * use of the vbx stent graft is for the treatment of de novo iliac occlusive disease. * use of the vbx stent graft is for the treatment of aortic coarctations. * use of the vbx stent graft in the coronary, pulmonary, carotid, vertebral, isolated infrarenal aortic, or vena cava vessels.

Keywords: lesion-exclusion visceral perfusion luminal reconstruction occlusive disease
observational study of patients with subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: this prospective, observational study aim to identify : * prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit * the impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, ...)


Eligibility criteria:
inclusion criteria: * subarachnoid hemorrhage exclusion criteria: * none

Keywords: subarachnoid hemorrhage neurointensive care observational registry
4 x epirubicin, cyclophosphamide, followed by 4 x docetaxel versus 6 x cmf / 6 x cef

Conditions: Breast Cancer

Summary: taxane-based adjuvant chemotherapy is standard in node-positive (n+) early breast cancer (bc). the magnitude of benefit in intermediate-risk n+ early bc is still unclear. west german study group and "arbeitsgemeinschaft gynäkologische onkologie" (wsg-ago) ec-doc is a large trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3 involved lymph nodes (ln).


Eligibility criteria:
inclusion criteria: * female patients * age 18-65 years * eastern cooperative oncology group (ecog) status \< 2 * surgery: r0-resection and \>= 10 removed axillary lymph nodes * m0 by chest x-ray, bone scintigraphy and liver sonography exclusion criteria: * polyneuropathy * creatinin (serum) \> 1,4 mg/dl; bilirubin (serum) \> 2,0 mg/dl * cardia dysfunction, ejection fraction \< lower normal value of each institution * hematopoeitic insufficiency: leucocytes \< 3,5 g/l, thrombocytes \< 100 g/l * second malignant neoplasia, except curatively treated basalioma of the skin * surgery before more the six weeks (42 days) * concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment * breast feeding woman * sequential breast cancer * reasons indicating risk of poor compliance * patients not able to consent
the effect of a low sodium-high potassium salt on blood pressure in vietnamese adults

Conditions: Hypertension

Summary: the purpose of this study was to investigate the effects of low-sodium, high-potassium condiments and salt on blood pressure in untreated (pre)hypertensive vietnamese adults.


Eligibility criteria:
inclusion criteria: untreated prehypertension or mild hypertension (systolic bp between 130 and 160 mmhg and/or diastolic bp between 85 and 100 mmhg) based on the mean of two measurements with a 1-week interval exclusion criteria: diagnosed or self-reported cardiovascular disease diagnosed or self-reported kidney disease

Keywords: blood pressure sodium salt low sodium high potassium salt potassium vietnam randomized controlled trial
monitoring analgesia by ani (analgesia the nociception index)

Conditions: Nociceptive Pain; Surgical Procedure, Unspecified

Summary: the objective of this research is to study the variations of the ani(analgesia the nociception index) according to 2 periods: the "nostim" period before surgical incision under general anesthesia and the period of hemodynamic reactivity "reacthemo" peroperative. this period is defined by a 20% increase in fc and / or pas (the only gold standard today).


Eligibility criteria:
inclusion criteria: * patient with ibd * scheduled surgery: laparotomy or laparoscopic resection with high risk of laparo-conversion exclusion criteria: * patient included in another current study or the previous month * urgent surgery * toxicomania or receiving opioids preoperatively * pregnant woman * psychosis * betablocker treatment * diabetic dysautonomia * non-sinus heart rate * pacemaker heart transplant
non-comparative study to assess the visual performances and safety of a progressive multifocal intraocular lens

Conditions: Cataract; Presbyopia

Summary: this is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.

to evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the iol mini well ready, can be confirmed in the practical surgical routine with a population belonging to different eu countries

Eligibility criteria:
inclusion criteria: * any gender and age above 18 years. * refractive lens exchange (rle) or cataract surgery. * healthy corneas, not treated surgically. * patients willing to have surgery in both eyes in a short period of time (within 2 weeks). * patients request to receive the iol mini well ready implant exclusion criteria: * previous corneal surgery (i.e. pterygium, refractive surgery). * eye diseases determining a probable postoperative visual acuity \< 20/40. * pseudoexfoliation. * abnormal pupil size and position. * use of contact lens 30 days before the preoperative visit. * corneal warpage. * predicted postoperative corneal astigmatism higher than 1 d.

Keywords: refractive lens exchange (rle) or cataract surgery
paclitaxel in treating patients with unresectable locally advanced or metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.

objectives: * determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (genexol\^®-pm). * determine the best overall response rate and duration of response in patients treated with this drug. * determine the overall survival of patients treated with this drug. * determine the clinical benefit and safety of this drug in these patients. outline: patients receive paclitaxel loaded polymeric micelle (genexol\^®-pm) iv over 3 hours on day 1. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 43 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed epithelial carcinoma of the pancreas * unresectable\* locally advanced or metastatic disease note: \*documented by high-quality contrast-enhanced ct scan * no known or clinical evidence of cns metastasis patient characteristics: age * 18 and over performance status * ecog 0-1 life expectancy * not specified hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 hepatic * sgot or sgpt ≤ 2.5 times upper limit of normal (uln) * bilirubin ≤ 1.5 times uln renal * creatinine ≤ 1.5 times uln other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ * no unstable or serious medical condition * no psychiatric disorder that would preclude giving informed consent prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy for pancreatic cancer * prior fluorouracil as a radiosensitizer allowed endocrine therapy * not specified radiotherapy * more than 6 weeks since prior radiotherapy for pancreatic cancer * disease must have progressed after completion of radiotherapy surgery * more than 14 days since prior major surgery and recovered other * more than 30 days since prior investigational agents

Keywords: stage iii pancreatic cancer recurrent pancreatic cancer stage iv pancreatic cancer
patient-centered breast cancer teleprehabilitation

Conditions: Breast Cancer; Breast Neoplasms; Surgery

Summary: surgery, the cornerstone of most cancer treatments, is associated with considerable postoperative complications. adjusting patients' health behavior before surgery may have beneficial effects on postoperative outcomes. women (n=50) who will undergo breast surgery because of stage i-iii breast cancer are eligible. all participants will receive multimodal patient-centered teleprehabilitation comprising of motivational interviewing, education, exercise therapy, and stress management.

feasibility, participation rate, patient satisfaction, intervention safety, and treatment adherence will be monitored as primary outcomes. fatigue, pain, quality of life (qol), physical activity levels, perceived injustice, self-efficacy, and healthcare use are secondary outcomes and will be assessed by self-reported questionnaires at baseline, 0-, 2-, and 6 months post-intervention. proof of concept for using telecommunication and exercise therapy in prehabilitation prior to breast cancer surgery is available. we expect the proposed intervention to be feasible and effective at reducing fatigue, pain, perceived injustice, and healthcare use, and at improving treatment adherence, qol, physical activity levels, and self-efficacy. effective prehabilitation interventions can reduce the long-term symptoms that arise/persist beyond treatment completion, improving patients' qol. by using telecommunication technologies, socio-economic barriers can be reduced, making care accessible to all.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * scheduled for primary breast surgery because of stage i-iii breast cancer * able to speak and read dutch fluently exclusion criteria: * stage iv breast cancer * a medical contra-indication for physical activity * not being able to access a computer or mobile device at home

Keywords: prehabilitation teleprehabilitation breast cancer surgery
validation of an intracycle ct motion correction algorithm for diagnostic accuracy

Conditions: Coronary Artery Disease; Coronary Arteriosclerosis

Summary: to demonstrate the incremental utility of ssf for individuals undergoing ccta, with expected improvements in image quality and diagnostic accuracy.

hypothesis: coronary ct angiography (ccta) employing a novel intracycle motion compensation algorithm (snapshot freeze \[ssf\]) will be superior to ccta without an intracycle motion compensation algorithm ("conventional" ccta) for diagnostic accuracy and image quality. scientific basis: preliminary study (leipsic, min, journal of cardiovascular computed tomography \[in press\]) of coronary ct angiograms in individuals undergoing pre-procedural assessment for transcatheter aortic valve replacement (n=36) demonstrate improved image quality of ccta using ssf compared to ccta not using ssf. importantly, individuals in this study did not receive heart rate slowing agents (e.g., beta blockers), and diagnostic image quality was substantially improved. while not statistically powered on a per-patient basis, per-segment diagnostic accuracy of ccta using ssf was superior to conventional ccta. these results are complementary to those derived from internal testing at ge healthcare wherein phantom work has demonstrated improved diagnostic performance using ssf compared to conventional image acquisitions. long-term goal/purpose: to demonstrate the incremental utility of ssf for individuals undergoing ccta, with expected improvements in image quality and diagnostic accuracy. if the aims of this study are achieved, the use of ssf for effective temporal resolution improvement may obviate (or reduce) the need for ct hardware for improved temporal resolution.

Eligibility criteria:
inclusion criteria: 1. consenting adult patients ≥18 years of age; 2. suspected but without known prior history of cad 3. not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., av nodal blockers such as beta blockers, calcium channel blockers or digoxin) 4. glomerular filtration rate \>60 ml/min 5. ccta and ica within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization) exclusion criteria: 1. incomplete ica or ccta; 2. known cad (prior myocardial infarction, pci, cabg) 3. atrial fibrillation 4. abnormal renal function (gfr \<60 ml/min) 5. unwilling or unable to give consent 6. non-cardiac illness with life expectancy \<1 year 7. concomitant participation in another clinical trial in which subject is subject to investigational drug or device 8. pregnant women 9. allergy to iodinated contrast agent 10. contraindications to nitroglycerin 11. systolic blood pressure ≤90 mm hg 12. contraindications to β blockers or nitroglycerin

Keywords: heart disease coronary artery disease coronary arteriosclerosis
a diagnostic imaging study of 64cu-sartate using pet on patients with known or suspected neuroendocrine tumors (disco)

Conditions: Neuroendocrine Tumors

Summary: the purpose of this study is to assess the performance of imaging agent 64cu-sartate in participants with known or suspected gastroenteropancreatic (gep) neuroendocrine tumors (nets) as a potential new way to help diagnose nets.

up to 63 participants will be recruited in this study and who are confirmed or suspected to have nets based on biochemical evidence or that of conventional anatomical or molecular imaging.

Eligibility criteria:
inclusion criteria: 1. signed informed consent; 2. age at enrolment ≥ 18 years; 3. life expectancy ≥ 12 weeks; 4. known diagnosis of gep net or suspicion of gep net based on axial imaging (e.g. on ct and/or mri and/or fdg) and/or biochemical evidence of net; 5. adequate recovery from acute toxic effects of any prior therapy; 6. adequate renal function (egfr \>30 ml/min); 7. pre-study 68ga-dotatate pet/ct scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64cu-sartate; exclusion criteria: 1. female participant who are pregnant or lactating; 2. male or female participant of childbearing potential not willing to practice an effective method of birth control while participating on the study to avoid possible damage to the foetus. abstinence is considered acceptable; 3. participant has received any treatment (including experimental treatment) for their net in the interval between 68ga-dotatate pet/ct and 64cu sartate pet/ct scan; 4. any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study; 5. history of other active malignancy within the last 2 years the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, in-situ carcinoma of the uterine cervix, or prostate cancer that is controlled by hormone therapy (patients may continue hormone therapy while on study). 6. active oncologic therapy within 8 weeks prior to the 68gadotatate pet/ct scan (long-acting somatostatin analogues are permitted and not considered active oncological treatment); 7. participants with diffuse or infiltrative hepatic involvement based on the pre-study 68ga-dotatate pet/ct scan; 8. participants with extensive marrow/skeletal involvement (\>20 lesions) based on the pre-study 68ga-dotatate pet/ct scan.
influence of stroke on the composition of intestinal microbiota

Conditions: Stroke; Transient Ischemic Attack (TIA)

Summary: the aim of the study is to verify the hypothesis that the microbial colonisation of the gut is changed in patients after stroke and that the gut microbiome of severely affected stroke patients differs from that of patients with only a short disruption of blood circulation in the brain (transient ischemic attack, tia). for this, the composition of gut microbiota in stool samples will be analyzed by 454 pyrosequencing. further, the correlation of stroke-associated changes in the microbiome with immunological parameters will be analyzed.


Eligibility criteria:
inclusion criteria: * age: 18 and older * ischemic cerebral infarction within the last 40 hours, anterior circulation infarct (aca, mca) and/or posterior circulation infarct (pca, ba) of any severity * patient consent or consent by a legal representative * nihss \> or =9 (stroke patients) * nihss \< 1 (for tia patients) exclusion criteria: * intracranial hemorrhage * preexisting dysphagia * signs of infection upon admission (clinical/paraclinical) * existing antibiotic therapy upon admission or within the last 2 weeks before admission * mechanical ventilation upon admission * participation in an interventional therapy study

Keywords: ischemia stroke transient ischemic attack (tia) microbiome microbiota gut
myocardial hemodynamic effects of levosimendan

Conditions: Heart Failure

Summary: this study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan. levosimendan (simdaxtm, abbott laboratories, abbott park, il) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated congestive heart failure (chf). levosimendan is a new calcium sensitizer that binds to troponin c. this agent is approved in europe for treatment of heart failure patients. in the united states, this agent is currently under phase iii investigation for intravenous treatment of patients with acutely decompensated hf who have dyspnea at rest or with minimal activity. levosimendan has been studied in these patients with acute hf and is considered experimental in the united states for this population.


Eligibility criteria:
inclusion criteria: * all patients will have either a sinus or paced atrial rhythm with atrioventricular synchrony on electrocardiography * all patients will have a history of heart failure diagnosed clinically with history of prior symptoms or signs of heart failure with at least one of the following symptoms within the past month: dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, pedal edema * in asymptomatic patients, patients may be enrolled if they have at least one of the following clinical signs of heart failure: left ventricular third and/or fourth heart sound, jugular venous pressure \>7 mmhg, sustained left ventricular impulse, or pulmonary congestion on auscultation * all patients will have echocardiographic evidence of left ventricular dysfunction exclusion criteria: * under age 18
pilot study of sedation with propofol in refractory pains due to care in palliative care unit

Conditions: Refractory Pains; End of Life Patients

Summary: in the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. these situations may necessitate temporary sedation to improve comfort and facilitate treatment. no proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however midazolam is the general recommendation. the investigators believe that propofol could be used in this instance

in the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. these situations may necessitate temporary sedation to improve comfort and facilitate treatment. no proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however midazolam is the general recommendation. the investigators believe that propofol could be used in this instance. the arguments in favour of propofol include its pharmaco-kinetic characteristics and the fact that it is currently used in other circumstances. propofol has an action delay which is more rapid that midazolam therefore its effect is seen 1 minute after a bolus and 5 minutes after for midazolam. the effect after a short administration lasts only a few minutes however the effect of midazolam is more prolonged (sometimes several hours). as with midazolam, a titrated use in weaker doses, should allow sufficient sedation, in the context which interests us, without marked secondary effects. it is not unreasonable to think that the short action duration of propofol could minimise respiratory risks in the hours after the treatment compared to midazolam. with propofol, the patient wakes as soon as the painful medical procedure has finished, with midazolam sedation may be prolonged to several hours leading to a risk respiratory depression or secretion retention. for these reasons; the investigators would like to verify that the use of propofol is feasible in the context of refractory pain associated with medical procedures (dressing changes, movement during personal care tasks e.g. washing) in the palliative care unit. this is a preliminary study prior to completion of a more extensive multi-centre research project on the role propofol could play in this situation.

Eligibility criteria:
inclusion criteria: * patients hospitalized in palliative care unit * dying terminally patients * pains resisting to fentanyl and meopa (melange equimolaire oxygène protocyde d'azote) (emono = equimolar mixture of oxygene and nitrous oxide) exclusion criteria: * contra-indication to soya * contra-indication to egg lecithin * respiratory insufficiency