Kornimate/medical-research-clean huggingface dataset:
efficacy of erythropoietin to improve survival and neurological outcome in hypoxic ischemic encephalopathy

Conditions: Hypoxic Ischemic Encephalopathy

Summary: the purpose of this study is to determine the efficacy of high dose erythropoietin to improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.

hypoxic-ischemic encephalopathy remains the main cause of death or long term neurologic impairments in neonates. yet, therapies for birth asphyxia are currently limited. hypothermia when applied within 6 hours after birth demonstrate partial improvement in outcome of newborns specially those with moderate form. erythropoietin and its receptors are upregulated after brain injury in ischemic conditions. systemically administered erythropoietin is neuroprotective in animal models of birth asphyxia. to date, one study demonstrate improvement neurologic outcome in asphyxiated term newborn under erythropoietin treatment but no reports evaluating beneficial of erythropoietin associated with cooling. this is a large randomised controlled trial to evaluate the efficacy of high dose erythropoietin on outcome at two years of asphyxiated term newborns undergoing cooling.

Eligibility criteria:
inclusion criteria: * term or near-term newborn (\> = 36 weeks gestational age) * moderate to severe encephalopathy * undergoing moderate controlled hypothermia started within 6 hours after delivery : rectal or esophageal temperature maintained at 33.5 ° c + / - 0.5 ° c before h6 * beneficiary of social security plan * informed consent parental authority exclusion criteria: * impossibility of getting controlled hypothermia before h6 * infant older than 12 hours of age * chromosomal or significant congenital abnormality * predictable surgery in the first 3 days of life * uncontrolled collapse * haemorrhagic syndrome unchecked * head trauma with or without skull fracture

Keywords: hypoxic ischemic encephalopathy term neonate neuroprotection erythropoietin
ultrasound-guided erector spinae plane block: a comparative study to assess its analgesic efficacy in pediatric patients undergoing aortic coarctation repair

Conditions: Anesthesia

Summary: the study will include 40 patients who fulfil all the points in the inclusion and exclusion criteria will be randomized into two equal groups, each consisting of 20 patients, namely group (b) and group (c). * group (b): will receive erector spinae plane block. * group (c): will not receive any block. postoperative pain score will be assessed using the flacc scale or face, legs, activity, cry, consolability scale immediately after extubation and at 1, 2, 4, 6, 8, 12, 18, and 24 hours. routine postoperative analgesia in the form of intravenous paracetamol 7.5 mg/kg/6 hours will be given to all patients (the first dose is given after skin closure). rescue analgesia in the form of 1 ug/kg fentanyl intravenously for patients if flacc scale \> 4, and the time for the first rescue analgesic administration will be recorded.


Eligibility criteria:
inclusion criteria: * all pediatric patients presented for aortic coarctation repair via left thoracotomy. exclusion criteria: hypersensitivity to local anesthetic. * mental or neurologic disorders. * preoperative critically ill patients. * parents or legal guardian refusal. * infection at the site of injection. * any liver disease. * any coagulopathy.
genetics of neural tube defects

Conditions: Neural Tube Defects

Summary: the genetics of neural tube defects study at the university of miami: the university of miami john p. hussman institute for human genomics is looking for families to participate in research to identify the genetic and environmental factors that contribute to neural tube defects (ntd). our research goal is to better understand the genetic and environmental causes of both open ntd, like spina bifida and anencephaly, and closed ntd, like lipomeningocele and tethered cord. this will eventually lead to more accurate genetic counseling and risk assessment, improved treatments, and better prevention methods. any individual with a diagnosis of ntd and his/her selected family members can participate, if willing. participation is free. travel is not required. participation involves reading and signing a consent form, providing a blood sample, a family and medical history interview, and granting the research staff permission to review the medical records of the individual(s) with ntd. we maintain the highest standards of confidentiality for all families. if interested, please contact maria ciliberti, the study coordinator, at 1-877-686-6444 (toll free) or directly at 305-243-4360, or by email mciliberti@med.miami.edu . please visit our web site at www.hihg.org for more information.


Eligibility criteria:
inclusion criteria: any individual with a diagnosis of ntd and his/her selected family members can participate, if willing - exclusion criteria: pregnant children will not be enrolled -

Keywords: ntd open ntd spina bifida anencephaly closed ntd lipomeningocele tethered cord.
infection related to short-term central venous catheters

Conditions: Catheter-Related Infections

Summary: this study aims to evaluate the incidence of infection of short-term central venous catheters by comparing different cannulation techniques (by anatomical references and under ultrasound control) and according to the experience of the operator in patients undergoing elective surgery. a prospective observational study will be carried out in which all scheduled surgery patients who have a central venous line inserted for 12 months will be included. those under 18 years of age, patients with catheters lasting more than 14 days and those who do not sign the informed consent will be excluded from this study. a chest x-ray will be performed on all patients in order to diagnose possible complications associated with the technique and, only in case of suspected infection, culture of the catheter tip and blood cultures of blood obtained from the catheter and peripheral blood will be requested.

a prospective observational study will be carried out. the maximum time between the intervention and the final evaluation will be 21 days, since the study evaluates the infection related to short-term catheters and its probable improvement after the removal of the device. all patients undergoing elective surgery who have a central venous line inserted for 12 months will be included in the study. those under 18 years of age, patients with catheters lasting more than 14 days and those who do not sign the informed consent will be excluded. a follow-up of the central venous catheters that are inserted in those patients scheduled for surgery who have an indication for it will be carried out. the criteria for choosing the access route will be carried out according to the usual clinical practice of the responsible anesthesiologist. the asepsis measures that will be carried out both in the insertion and in the maintenance of the catheter will be those used on a regular basis, which follow the recommendations of the guidelines for the prevention of infections related to intravascular catheters of the american center for control and prevention. of diseases.

Eligibility criteria:
inclusion criteria: * patients undergoing elective surgery who have a central venous line inserted during the three months in which the study runs exclusion criteria: * patients under 18 years of age * patients who need to wear the central venous catheter for more than 14 days * patients who do not sign the informed consent.
a randomized double blinded placebo controlled study on the effects of dietary supplementation with a probiotic on stroke patients

Conditions: Stroke, Ischemic; Dysbiosis

Summary: the aim of this study is to determine the effects of an intervention using a commercially available probiotic in a cohort of acute stroke patients. in order to determine this, a double blinded, randomised and placebo-controlled study design was chosen.

patients are recruited from the stroke unit of the ludwig maximilians university munich within seven days of stroke onset. recruited patients are then randomly assigned to either the control or treatment group and subsequently take the commercially available probiotic, or the placebo, twice a day for 3 months. at this point, study participants present themselves for routine clinical examination at the outpatient clinic of the institute for stroke and dementia research (isd). during these examinations, blood and stool samples are collected for metabolomic and metagenomic analysis. additionally, questionnaires concerning cognitive function (moca), depression (bdi) and general gastrointestinal status (gsrs-ibs) are completed. clinical data from both acute admission and three month follow-up are also collected for the purposes of this study. furthermore, members of the same household as the study participants are asked to donate a stool sample. these samples will be used to create a reference cohort for a paired matching approach with the treatment and control groups.

Eligibility criteria:
inclusion criteria: * diagnosis of ischemic stroke with onset in past 7 days * treatment received in the stroke unit of the lmu university hospital, location großhadern exclusion criteria: * chronic immunological disease * severe gastrointestinal disease * colectomy * artificial intestinal outlet (ostomy) * liver cirrhosis, pancreatitis, gastritis, cholecystitis (or other acute gastrointestinal diseases) * chronic alcohol abuse * terminal prognosis

Keywords: gut-brain axis probiotics food supplements microbiome
recruitment maneuvers in ards: effects on respiratory function and inflammatory markers.

Conditions: Acute Lung Injury

Summary: acute respiratory distress syndrom is associated to lung and systemic inflammation, which could be worsened by mechanical ventilation.this included a proteasis - antiproteasis imbalance which could participate to a fibrosis process. low tidal-volume ventilation (6 ml/kg) with low plateau pressure (\< 30 cm h2o) has been proved to decrease mortality when compared with more conventionnal high-volume (12 ml/kg) ventilation.moreover, this lung-protective approach decrease lung annd systemic inflammation. using recruitment maneuvers (i.e. the application during a short time of high pressures with the intention to re-open the lung, followed by an increase of peep-level to keep the lung open, in an attempt to decrease the alveolar shear-stress) has been proposed to improve oxygen and to reduce bio-trauma. however, the effect of such maneuvers on the inflammatory response and on the evolution of ards remains unknown. therefore we have planned a randomized, monocentric, controlled trial consisting of the comparison of two approaches of mechanical ventilation in acute lung injury. this trial will include 30 hemodynamically stable patients fulfilling the ali or ards criteria defined by the us and european consensus conference. they will be randomized in two groups: standard low-volume ventilation vs. recruitment maneuvers. the main objective of our study is to compare both ventilatory strategies in termes of lung and systemic inflammation. the primary outcome measures will be the proteasis activity as measured in broncho alveolar fluid (bal) and pro- and antiinflammatory cytokines activity as measured in the bal and in the blood. two samples (bal and blood) will be obtained at a 48-72 hours interval. in the recruitment maneuver group, the first bal will be obtained two hours before the maneuver. secondary outcome measures will be gaz exchange, respiratory mechanics, systemic hemodynamics and visceral dysfunction scores.


Eligibility criteria:
inclusion criteria: * age over 18 * hospitalization in the icu * under mechanical ventilation * acute lung injury (ali)criteria * first week of ali * hemodynamic stability (map \> 75 mmhg since one hour) * informed consent signed (patient or relatives) exclusion criteria: * pregnancy * obesity (bmi \> 40 kg/m2) * high probability of d-28 death * severe burn injury * severe hepatic cirrhosis (child-pugh c) * aplasia * hiv or chv infection * use of more than 0.5 mg/kg of steroïds * immunosuppressor agents * hemopathy * contra indications for bal * contra indications for recruitment maneuvers * baro-traumatism * left cardiac failure * chronic respiratory failure * inclusion in another study during the past month
effects of monopolar electrocautery use during surgery on implanted cardiac defibrillators

Conditions: Heart Failure; Tachycardia, Ventricular

Summary: this observational protocol will evaluate the effects of monopolar electrocautery (me) on implantable cardioverter defibrillators (icds) in patients undergoing surgery. me can cause electromagnetic interference (emi) leading to icd damage or inadvertent icd discharge (shocks). recommended practice calls for the preoperative reprogramming of icds when me will be used to prevent patients from receiving inadvertent shocks. this requires the presence of someone trained in icd programming, but a trained person is not always readily available. in this study the investigators will reprogram icds prior to surgery according to current practice, but will also record what would have happened had the icd reprogramming not occurred ("detection on" but "therapy off"). in addition, the investigators will evaluate the effect of the location of the electrosurgery unit (esu) return pad on the incidence of emi. the investigators hypothesize that directing the current return path away from the icd will result in lower emi rates than previously described.


Eligibility criteria:
inclusion criteria: * adult individuals of both genders, 18 years of age and older * for patients undergoing surgery about the waist, previous implantation of a functioning boston scientific or medtronic icd * for patients undergoing surgery below the waist, previous implantation of a functioning boston scientific, medtronic, st. jude medical, or biotronik icd * signed informed consent exclusion criteria: * surgery involving the icd pocket (generator change out procedure) * surgery or procedures exclusively involving bipolar electrocautery (such as ophthalmic surgery) * patients undergoing surgery above the waist with icds not manufactured by medtronic or boston scientific (other icds do not allow reprogramming to allow emi detection without the potential for inadvertent icd discharge)

Keywords: electrosurgery cardiac surgical procedures surgical procedures, operative defibrillators
an integrated program to promote anti-cannabis messages

Conditions: Cannabis

Summary: the number of youngsters abusing cannabis is surging, the public health consequences caused by cannabis can be unpredictable. educating the public especially the young population about cannabis need to be highlighted. to successfully promote anti-cannabis messages to youngsters and prevent them from taking cannabis, the involvement of their parents and modern technology such as robots can be helpful. this project aims to educate the young population and their parents about cannabis, particularly its legal consequences and clarifying their misconceptions.

a pre-post study design will be used. a total of 50 nursing students and 150 parent-child-dyads will be recruited by sending mass emails or sending invitation letters. the nursing students are in their year 2 or above bachelor program in the hong kong polytechnic university. the inclusion criteria for parent-child-dyads include: (1) children who are aged 13 - 20, (2) children who have a parent who are willing to join with the child, and (3) parent-child dyads who are able to speak in cantonese and write in chinese. the outcome measures will cover demographic data, the knowledge about cannabis-related harm, the permissive attitude towards smoking cannabis and drugs trafficking.

Eligibility criteria:
inclusion criteria * children who are aged 13 - 20 * children who have a parent who are willing to join with the child exclusion criteria: -parents and children who are not able to speak cantonese and write in chinese

Keywords: nursing students child parents
effectiveness of smartphone application for weight loss

Conditions: Weight Loss

Summary: the aim of this study is to determine the effectiveness of smartphone application for weight loss in healthy female adults. to determine the association between fitness application usage and physical activity behavior of the healthy female adults.

obesity has turned into a significant, rising well-being epidemic around the world. doing almost no physical work has been connected with chronic weakness results and diminished personal satisfaction in adulthood. it has been perceived that innovation can uphold wellbeing upgrades around the world. the applications that target wellbeing advancement have turned into a focal piece of individuals' lives and have exhibited enormous expansions being used. proper evidence behind usage of smart phone application for weight loss is sparse and is based on different clinical experiences and a smaller number of studies with limited methodological design. this study will contribute to describing the effectiveness of smartphone application for weight loss in female adults as well as to determine the association between fitness application usage and physical activity behavior.

Eligibility criteria:
inclusion criteria: * adult females * age between 18-40 years. * individuals with bmi ≥ 25 exclusion criteria: * pathological conditions affecting any system * suffering from recent unhealed msk injury/trauma

Keywords: adult females exercise adherence obesity physical activity vo2 max weight loss
study of dpd for predicting efficacy and safety to s-1 plus oxaliplatin in gastrointestinal cancer

Conditions: Gastrointestinal Cancer

Summary: in this study, the relationship between dpd and the effects of s-1 combined with oxaliplatin chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.

a new oral dpd inhibitory fluoropyrimidine (dif), s-1, is reportedly effective against gastrointestinal carcinoma. in this study, the relationship between activity of dpd in peripheral blood and the effects of chemotherapy were investigated in 200 patients treated with first-line s-1 combined with platinum chemotherapy for gastrointestinal carcinoma.

Eligibility criteria:
inclusion criteria: * age ≧18; * histologically or cytologically confirmed gastrointestinal cancer； * ecog ≦2; * physician's intention to treat with s-1 combined with platinum regimen on disease status and clinical judgment; * life expectancy of at least three months; * written informed consent to participate in the trial; exclusion criteria: * history of severe hypersensitivity reactions to the ingredients of s-1 or oxaliplatin; * inadequate hematopoietic function which is defined as below: * white blood cell (wbc) less than 3,500/mm\^3 * absolute neutrophil count (anc) less than 1,500/mm\^3 * platelets less than 80,000/mm\^3 * inadequate hepatic or renal function which is defined as below: * serum bilirubin greater than 1.5 times the upper limit of normal range * alanine aminotransferase (alt) or aspartate aminotransferase (ast) * greater than 2.5 times the uln if no demonstrable liver metastases or * greater than 5 times the uln in the presence of liver metastases * blood creatinine level greater than 2 times uln * presence of peripheral neuropathy; * receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug; * women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (including male); * psychiatric disorder or symptom that makes participation of the patient difficult; * concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months; * severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes; * known dpd deficiency; * receiving a concomitant treatment with sorivudine or brivudine within two months;

Keywords: s-1 oxaliplatin dihydropyrimidine dehydrogenase
results of endovascular treatment for infrapopliteal arterial occlusive disease.

Conditions: Infrapopliteal Artery Occlusive Disease; Endovascular Treatment

Summary: this study is a prospective, multi-center observational study, which evaluates the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.

this study is a prospective, multi-center observational study. this study will be conducted at 38 centers and is expected to enroll more than 3000 patients. and we will evaluate the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.

Eligibility criteria:
inclusion criteria: patients ≥ 18 years of age; patients with ≥1 infrapopliteal artery disease (p3 popliteal artery, anterior tibial artery, posterior tibial artery, peroneal artery, tibiofibular trunk) need to receive endovascular treatment, regardless of whether there is a combination of supra-knee or submalleolar occlusion; patients voluntary and capable of follow-up; exclusion criteria: patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc., and those who are unable to undergo endovascular therapy for other reasons; pregnant and lactating women; patients with thromboangiitis obliterans；

Keywords: endovascular treatment infrapopliteal artery disease drug-coated balloons angioplasty atherectomy
avelumab combined with cetuximab and irinotecan for treatment refractory metastatic colorectal microsatellite stable cancer

Conditions: Colorectal Neoplasms, Malignant

Summary: cancer immunotherapy with immunostimulatory antibodies targeting the ctla-4 or pd-1/pd-l1 pathways has demonstrated its efficacy in variable proportions of cancer. for metastatic colorectal cancer (mcrc) it appeared that only the small subgroup of patients with msi-h tumors (microsatellite instability-high phenotype) had a clinically meaningful response to the anti-pd-1- l1 antibodies. in the majority group of non-msi-h crc (90-95% of patients), current research expect that additional means would be able to render the tumor "immunogenic" (like msi-h crc) and increase the intratumoral immune infiltrate which is the prerequisite to observe a benefit from pd1-pd-l1 inhibitors. combinations of immune checkpoint inhibitors and procedures that increase intratumoral immune responses, such as targeted therapy, are actively explored.


Eligibility criteria:
inclusion criteria: * age 18 and over, performance status: ecog 0-1 * histologically proven metastatic colorectal adenocarcinoma, refractory to standard chemotherapy (fluoropyrimidine, oxaliplatin, irinotecan) and anti-egfr treatment (only for ras wt tumor) * measurable disease (recist 1.1) * metastasis accessible for sequential biopsies * patient consent for metastasis biopsies in the study protocol * braf v600e wild-type and mss tumors * adequate normal organ and marrow function (see adequate section of the full protocol for definition) * life expectancy of at least 4 months exclusion criteria: * concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy that are not indicated in the study protocol * systemic autoimmune disease, * chronic treatment with corticoids or other immunosuppressive treatment * clinically significant cardiac, lung or general disease despite optimal treatment * non-progressive disease following irinotecan-based treatment. * for ras wt, non-progressive disease following anti-egfr treatment.