Kornimate/medical-research-clean huggingface dataset:
cerebral blood flow in neonates during major cardiac surgery.

Conditions: Hypoperfusion in Newborn With Congenital Heart Disease

Summary: rationale: during cardiac surgery, neonates are at high risk of cerebral damage: 36-78% will have new cerebral lesions after surgery. adequate cerebral perfusion (cbf) is mandatory to prevent postoperative brain damage and neurobehavioral outcomes. for cbf, the systemic blood pressure should be managed above the brain's critical closing pressure (crcp), and preferably above the lower limit of autoregulation (lla), if intact. objective: the investigators aim to study the patient specific threshold for arterial blood pressure to maintain adequate cerebral perfusion (cbfv) in the perioperative setting and the association between perioperative abnormalities with postoperative brain damage and neurobehavioral outcomes. study design: in a prospective observational cohort study bilateral cerebral blood flow velocity (cbfv) measurements are performed with transcranial doppler (tcd), together with invasive arterial blood pressure (iabp) measurements in the perioperative period. study population: neonates (semi-) electively scheduled for major cardiac- and non cardiac surgery. main study parameters/endpoints: main study endpoint is the critical closing pressure (crcp) within and between subjects. furthermore, we evaluate the association with new white matter injury (wmi) on the postoperative mri. nature and extent of the burden and risks associated with participation, benefit and group relatedness: anticipated risks caused by tcd monitoring in neonates are considered negligible when monitoring is executed according to the bmus guidelines and alara principle. each time energy is converted from one form to another, part of it is inevitably converted to heat. theoretically, if at all, the maximum temperature rise will happen at the skin- temporal bone side, where the monitoring probes are placed. a maximal thermal index (ti) of 0.7 is allowed, this corresponds with 0.7 o c temperature rise. patients might not benefit from participation in this study as the tcd measurements are only visible and available to the tcd operator, and we do not yet know how the results could possibly influence the procedure. however, in the unlikely situation where cerebral perfusion is severely compromised for a longer period of time or in case of occurrence of large air emboli, improper cannulation or cross clamping the cardiac team will be notified. therefore, a neonate might benefit from participation.


Eligibility criteria:
inclusion criteria: * term infant aged \ 32 weeks and with a corrected age \< 42 days * (semi-) elective cardiac of major non-cardiac surgery * routine placement of an arterial cannula for invasive blood pressure monitoring. exclusion criteria: * grade iii-iv intracranial hemorrhage. * emergency surgery or semi-elective surgery performed out of hours. * informed consent from the parents is not obtained.

Keywords: tcd hypoperfusion critical closing pressure
appraisal of mdco-157 and plavix® pharmacokinetics and pharmacodynamics in healthy volunteers with an evaluation

Conditions: Pharmacokinetics and Pharmacodynamics in Healthy Volunteers

Summary: following a first, dose ascending study that enrolled 144 normal healthy volunteers (nhvs), this study, to be conducted in approximately 36 nhvs, will provide pertinent information in determining the dose-response of mdco-157 for platelet aggregation inhibition and p2y12 receptor inhibition effects and in selection of doses that match the antiplatelet effects of 300 mg plavix® ®. the study will also provide additional data for pharmacokinetics (pk), safety and tolerability of single doses of mdco-157.


Eligibility criteria:
inclusion criteria * healthy males or females 18 to 45 years of age, inclusive. * provide written informed consent for genetic testing and written informed consent for the study before initiation of any study related procedures * affiliated to the french social security system * screening and baseline fridericia's correction (qtcf) interval \< 450 msec and baseline heart rate between 50 and 100 bpm (inclusive) exclusion criteria: * known or suspected hypersensitivity or allergy to clopidogrel, captisol, plavix® , or its excipients * body mass index \ 30 kg/m² * inability to communicate with the investigator or comply with study related procedures, or high likelihood of being lost to follow up * known or suspected pregnancy or lactating female * medical history, physical examination including 12-lead ecg or laboratory evaluation conducted at the screening visit with results indicative of any disease or condition which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk * tobacco product use within the last 6 months prior to dosing * platelet count \< 150,000/µl * a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations * active pathological bleeding such as peptic ulcer or intracranial hemorrhage * positive screen for hepatitis b (hepatitis b surface antigen hbsag), hepatitis c (hepatitis c antibody), or hiv (anti-hiv 1/2) * received an investigational drug within a period of 30 days or 5 half-lives, whichever is longer, prior to enrollment in the study * use of aspirin, other non-steroidal anti-inflammatory drugs, cyp3a4 inhibitors (ketoconazole), cyp2c19 inhibitors (eg, omeprazole) or other drugs known to affect platelet function or coagulation within 14 days prior to receiving study drug (mdco-157 or oral clopidogrel) * grapefruit within 10 days prior to receiving study drug (mdco-157 or plavix®) * use of any over-the-counter medication, including herbal products, within 7 days prior to administration of study drug (mdco-157 or plavix®), except for up to 2 grams of acetaminophen per day for up to 3 days for pain control
a phase ii study vepemb in patients with hodgkin's lymphoma aged ≥ 60 years

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. combining more than one chemotherapy drug may kill more cancer cells. purpose: this phase ii trial is studying how well combination chemotherapy works in treating older patients with previously untreated hodgkin's lymphoma.

objectives: primary * determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with hodgkin's lymphoma. * determine whether the application of the hasenclever prognostic index is valid in these patients at diagnosis. outline: this is an open-label, multicenter study. * chemotherapy: patients receive vinblastine iv and cyclophosphamide iv on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone iv and bleomycin iv on day 15. treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage ia or iia) disease or 6 courses in patients with advanced (stage ib or iib-iv) disease. * radiotherapy: patients with early stage disease receive involved-field radiotherapy. patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. radiotherapy begins 4 weeks after the completion of chemotherapy. patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 150 patients will be accrued for this study within 36 months.

Eligibility criteria:
inclusion criteria: histologically confirmed classical hodgkin lymphoma (hl). no previous treatment for hl. age ≥ 60. "non fragile" patient (see appendix 1) i.e. patient's mental and physical status must be sufficient to withstand the treatment described. no concomitant neoplasia requiring treatment or known hiv infection. written informed consent. exclusion criteria: nodular lymphocyte predominance hodgkin lymphoma (nlphl) age \<60. patient previously treated for hl. known hiv infection or concomitant neoplasia. "fragile patient" (see appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy. unable to give informed consent.

Keywords: stage i adult hodgkin lymphoma stage ii adult hodgkin lymphoma stage iii adult hodgkin lymphoma stage iv adult hodgkin lymphoma
efficacy and safety study of nv1fgf in patients with severe peripheral artery occlusive disease.

Conditions: Severe Peripheral Artery Occlusive Disease

Summary: peripheral arterial occlusive disease (paod) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. chronic paod can be regarded as a marker of generalized atherosclerosis. paod threatens the survival of an extremity and often causes lifelong disablement from a painful leg. the clinical consequences of paod include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.a variety of medical therapies have been investigated for patients with paod. there is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers. also, the use of intramuscular angiogenic vegf-a gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe paod


Eligibility criteria:
inclusion criteria: 1. informed consent was to be signed before proceeding with any study procedure. 2. patients with severe pad. 3. trophic lesions with no signs of healing (no reduction in ulcer size or depth) for at least 2 weeks prior to first study treatment administration (day 1). 4. patients with objective evidence of peripheral vascular disease in the diseased limb on 2 consecutive examinations performed at least 1 week apart. 5. demonstration or documentation of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries as assessed by angiography or magnetic resonance angiography (mra) 6. transcutaneous oxygen pressure (tcpo2): mean resting supine tcpo2 of the foot of ≤40 mmhg based on 2 separate measures performed at least 1 week apart 7. poor/not candidates for revascularization exclusion criteria 1. previous or current history of malignant disease. 2. positive cancer screening (liver, prostate, colon, cervix, breast, lung) 3. successful lower extremity surgery (bypass/angioplasty of the leg to be treated) within 3 months prior to the first administration of study treatment \[day 1\]). 4. patients planned to undergo amputation of target limb within 1 month following the first administration of study treatment. 5. patients with a history of severe renal failure. 6. creatinine \>2.0 mg/dl (176 µmol/l) or estimated creatinine clearance \<30 ml. 7. serious concomitant medical conditions not adequately controlled (other than severe pad), 8. buerger's disease. 9. patients in dialysis. 10. active proliferative retinopathy 11. patients who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment. 12. previous treatment with any angiogenic growth factor. 13. positive serology for hiv 1 or 2. 14. participation in clinical trials of non-approved experimental agents within 4 weeks before study entry.

Keywords: nv1fgf paod cli
ebus-guided tbna for molecular diagnostic of mediastinal lymph nodes (ln)

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle aspiration (ebus-tbna).

nsclc is a common cancer. accurate and early staging has a significant impact on outcome. ebus-tbna of involved mediastinal lymph nodes is critical. molecular markers could improve mediastinal staging.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * samples are collected before surgery or before any therapy * ecog 0 or 1 * clinical stage i-ii, t1-2, n0-1, m0) * surgically respectable * patient with enlarged med. lymphnodes (control group) exclusion criteria: * previous rt/cht * previous or current cancer of other entity
assessment of right ventricular function after acute pulmonary embolism using speckle tracking echocardiography

Conditions: Pulmonary Embolism

Summary: 1. to asses regional rv function in patients presented with acute pulmonary embolism using speckle tracking echocardiography 2. to evaluate its relationship to long term mortality.

pulmonary embolism (pe) is the third most common cardiovascular cause of death after myocardial infarction and stroke . the incidence of pe has been increasing ,with significant associated mortality; a recent registry of pe patients reported a mortality rate \> 10% at 30 days. there are a number of emerging contemporary pe therapies, including thrombolysis, catheter intervention and surgery. early and accurate identification of pe in patients is therefore critical. a transthoracic echocardiogram (tte) may help when there is a clinical suspicion for pe, and its use in confirmed pe is widely recommended . a number of right atrial (ra) and right ventricular (rv) parameters have been shown to be abnormal in patients with pe . in addition, ra and rv enlargement portends a worse prognosis in these patients .

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of acute pulmonary embolism 2. age: 20 - 70 years. exclusion criteria: 1. coronary artery disease 2. patient of atrial fibrillation. 3. patient of impaired rv function due to chest disease (cor-pulmonale) 4. patient with impaired ejection fraction (ef) \<50% 5. moderate to severe valvular heart disease. 6. atrio-ventricular conduction disturbance. 7. poor echogenicity
effectiveness of a digital health application for multiple sclerosis (levidex)

Conditions: Multiple Sclerosis

Summary: the trial aims to evaluate the effectiveness of a novel digital health application (levidex), which was designed to increase quality of life in persons with multiple sclerosis (ms). therefore, 470 people with ms will be recruited and randomized to two groups: (1) an intervention group that will receive access to levidex in addition to treatment as usual (tau) (n = 235) and (2) a control group receiving an overview of relevant brochures from the deutsche multiple sklerose gesellschaft (german multiple sclerosis society) on the topic of lifestyle in ms in addition to tau (n = 235).the primary outcome measure is the total score on the hamburg quality of life questionnaire for multiple sclerosis (halems), collected 6 months post-randomization.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * impaired health-related quality of life (total score of the hamburg quality of life questionnaire for multiple sclerosis \[halems\] ≥ 2) * specialist treatment in the last three months before study inclusion * diagnosis of ms (relevant icd-10-gm diagnoses g35.x), confirmed by a medical document or equivalent certificate * sufficient cognitive and motor skills to use an online program * consent to participate * sufficient knowledge of the german language * access to the internet exclusion criteria: * presence of severe impairment of independence or abilities (degree of care \["pflegegrad", § 15 sgb xi\] ≥ 3)
quality assessment of a multifaceted, perioperative infection control bundle

Conditions: Perioperative Transmission

Summary: surgical site infections increase patient morbidity and healthcare costs. the centers for disease control and prevention emphasizes improved basic preventive measures to reduce bacterial transmission and infections for patients undergoing surgery. we conducted a previous study that showed our treatment bundle is highly effective. our current study planned to examine patterns/rate of s. aureus transmission to improve feedback widespread implementation of the perioperative infection prevention program at iowa. the purpose of this study is to assess the fidelity of the set of interventions in controlling perioperative s. aureus and to provide data feedback via surveillance involving epidemiology of transmission for system optimization.

the operating room schedule will be reviewed each day by the research assistant. at the start of each case, the technician will obtain an or pathtrac kit and will fill out required card indicating the or number, the surgery date, and the type of surgery. the cards will be placed back into the kit. sample collection will be directed via use of the kit. the first sample is the adjustable pressure-limiting valve and agent dial of the machine before patient entry (measures terminal cleaning), then provider (attending and assistant) hands after they enter but before patient interaction, then the provider nose and mouth after induction of anesthesia and patient stabilization, then provider hands, then same environmental sites, then provider sites again, then stopcock. a transmission event will be defined as detection of s. aureus pathogens among 2 distinct, epidemiologically-related reservoirs within a surveillance unit. the software platform will process transmission dynamics in order to continually summarize the epidemiology of s. aureus transmission, with results updated daily as case-pair data is continually entered into the program. this information will be continually displayed to identify the most common reservoir of origin, the most common transmission locations (vectors), and involvement of key portals of entry (stopcocks). these will become improvement targets with feedback provided via automated failure mode analysis reports. the research assistant will use the reports to continually optimize the interventions during the observational period.

Eligibility criteria:
inclusion criteria: * adult (at least 18 years old) patient undergoing surgery requiring anesthesia and placement of a peripheral and/or central intravenous catheter. exclusion criteria: * \<18 years old, shellfish, iodine, chlorhexidine allergies, no anesthesia and/or placement of peripheral and/or central intravenous catheter required
comparison of laparoscopic and open total gastrectomy for locally advanced gastric cancer

Conditions: Gastric Cancer

Summary: evidence of implementation of laparoscopic total gastrectomy (ltg) for locally advanced gastric cancer (gc) remains inadequate. this study aimed to compare short- and mid-term outcomes of ltg versus open total gastrectomy (otg) for ct2-4a gc.

gastric cancer (gc) is a significant public health issue worldwide. surgical resection and lymphadenectomy is the first option for curative treatment of this disease. for tumors located in the middle and/or upper third of the stomach, open total gastrectomy (otg) has long been the standard surgery. while the advantage of laparoscopic distal gastrectomy over open distal gastrectomy for not only early gastric cancer (egc) but also locally advanced gastric cancer (agc) had been proven, the use of laparoscopic total gastrectomy (ltg) for gc, particularly for agc, has not been widely accepted due to technical challenges with lymphadenectomy at the distal pancreas and the splenic hilum as well as the complexity of the esophago-jejunal reconstruction. recently, there has been advancement in laparoscopic techniques and improved surgical experience, a standard procedure of ltg has been established, leading to increase utilization of ltg, especially for egc. two large rcts, klass-03 in korea and class-02 in china, provided good evidence for the advantages of ltg for egc. however, for agc, some prior studies have demonstrated the safety of ltg compared to otg but lacked significant data for survival. until now, there have been no completed rcts to determine the short- and long-term outcomes of ltg for agc. in the research center, ltg has been accepted as a standard procedure for egc since 2008 and for agc since 2013. in vietnam and other low-to-middle-income countries, most gc was diagnosed in an advanced stage. it is needed to have evidence of the feasibility, safety, and oncological results of ltg for locally advanced gc. investigators performed this study to compare the technical feasibility, short- and long-term outcomes of ltg versus otg for stage t2-4a gc.

Eligibility criteria:
inclusion criteria: * pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma * age: 18 - 80 year old * tumor required total gastrectomy for radical treatment * preoperative cancer stage (ct scan stage): ct2-4ananym0 * asa score: ≤ 3 * informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available) exclusion criteria: * concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer * bulky lymph node andd/or para-aortic lymph node metastasis * combined esophagectomy due to invading to the esophagus * pregnant patient
trial of dapsone 5.0% gel in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: multi-center, double-blind, randomized, placebo-controlled trial of dapsone 5.0% gel in the treatment of acne vulgaris.

multi-center, double-blind, randomized, placebo-controlled trial of dapsone 5.0% gel in the treatment of acne vulgaris for 84 days in male and female subjects age 12-40.

Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant females aged ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris. * informed consent/assent: for subjects 12 to 17 years of age inclusive must have provided institutional review board (irb) approved written assent that must be accompanied by an irb approved written consent from the subject's legally acceptable representatives (i.e., parent or guardian). in addition, all subjects or their legally acceptable representatives must sign a health insurance portability and accountability act (hipaa) authorization. * on the face, subjects must have ≥ 20 inflammatory lesions (i.e., papules and pustules), and ≥ 25 non-inflammatory lesions (open and closed comedones) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts). for the purposes of study treatment and evaluation, all lesions on the face should be counted, including those on the nose. subjects may have acne lesions on other areas of the body (e.g., back, chest, and arms) which should be excluded from the count, treatment and the iga evaluation. * subjects must have an acne severity grade of 3 or 4 per the iga * subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period other than the study drug. exclusion criteria: * prior or current concomitant therapies that would interfere with assessments in the study. * prior or current concomitant therapies skin conditions that would interfere with assessments in the study. * prior, current or planned procedures that would interfere with assessments in the study. * current or planned activities that would interfere with assessment in the study. * subjects who have a baseline local skin site reaction score of 3 \[severe (marked/intense)\] for any signs and/or symptoms of irritation as scored using the local skin site reaction scores.