Kornimate/medical-research-clean huggingface dataset:
encochleated oral amphotericin for cryptococcal meningitis trial (enact)

Conditions: Cryptococcal Meningitis

Summary: this study is designed as two sequential trials. the first is a phase i open label trial to evaluate the safety and tolerability of mat2203. the maximal tolerated and non-toxic daily dose,will then be moved forward into a multi-day safety trial. the phase ii trial will investigate toxicity and early fungicidal activity (efa) of mat2203 with flucytosine.

cryptococcal meningitis has emerged as one of the most frequent and deadly opportunistic infections in hiv patients. historically, amphotericin b (amb) has been considered the "gold standard" in antifungal treatments due to its broad spectrum of activity and lack of emergence of resistance. however, the use of amb is limited by side effects, including nephrotoxicity, anemia, and infusion-related reactions. mat2203 or encochleated oral amphotericin b (camb) is a lipid nano-crystal formulation designed for targeted oral delivery of the antifungal drug amb for treatment of fungal and parasitic infections.

Eligibility criteria:
inclusion criteria: * phase 1: * age \>18 years * calculated creatinine clearance \>70 ml/min/1.73 m2 (measured within 3 months) * written informed consent phase 2: * cryptococcal meningitis diagnosed by csf cryptococcal antigen (crag) * ability and willingness to provide informed consent * willing to receive protocol-specified lumbar punctures exclusion criteria: * phase 1: * symptomatic current illness * known significant, untreated health problem * inability to take enteral medicine * pregnant or breast feeding * receiving amphotericin b therapy in past 90 days * phase 2: * presenting glasgow coma scale (gcs) \< 15 * received 3 or more doses of iv amphotericin therapy within last 30 days * inability to take enteral (oral or nasogastric) medicine * cannot or unlikely to attend regular clinic visits * pregnancy or breastfeeding * receiving chemotherapy or corticosteroids * suspected paradoxical immune reconstitution inflammatory syndrome (iris) * recent initiation of hiv therapy or art class switch (within 2 weeks)
primary intensivists and primary nurses to decrease pediatric icu length of stay

Conditions: ICU Length of Stay

Summary: this is a randomized control trial of picu patients admitted for 7 days and expected to remain for at least another 3 days and who have a complex chronic condition. patients will be randomized to usual care or usual care plus a primary intensivist and group of primary nurses (to facilitate passing of important patient information and informed, expedited decision-making). the primary research question is whether having a primary intensivist and nurses decreases picu length of stay.

long-stay intensive care unit (icu) patients, or children who require prolonged hospitalization in the pediatric icu (picu), represent a minority of picu patients but have a disproportionate impact on hospital resources and unfavorable outcomes, including morbidity, mortality, and repeated critical illness. these patients and their families have multifaceted needs (eg, tailored communication) that pose unique challenges to picu providers and the parent-provider relationship. these experiences and needs are compounded and complicated by the transitory care that is typically provided by picu. this transitory care may contribute to 1) patient/family dissatisfaction; 2) ineffective passing of important information day to day and week to week; and 3) delayed decision-making. these latter two potential consequences may, in turn, contribute to prolonged length of stay (los). for these reasons, the investigators propose a randomized control trial to test whether primary intensivists and primary nurses can decrease picu los for long-stay patients. a primary intensivist is one that remains a consistent physician-presence for the patient/family and picu team throughout the child's picu stay, despite changes in the intensivist(s) who orchestrates day-to-day management. primary nurses are a team of picu nurses who provide the all/most of the bedside care to the child. the investigators hypothesize that the long-stay picu patients who are randomized to receive primary intensivists and nurses will have a statistically lower los than those patients who do not.

Eligibility criteria:
inclusion criteria: * picu patients of any age who * have a complex chronic condition * have been admitted to the picu for one week and are predicted by the picu attending to continue to be admitted for at least another 3 days. exclusion criteria: -

Keywords: child critical illness length of stay satisfaction
early management of fracture nose in pediatric patients

Conditions: Fracture Nose

Summary: introduction: nasal fractures are common components of the facial skeleton injuries. nasal bone fractures are the most common type of facial fracture (1), and the third most common fracture of the human skeleton (2). nasal fractures are frequently associated with cartilaginous and soft tissue injuries. the incidence of post- traumatic nasal deformity, if left untreated, varies from 14% to 50% (3).the management of nasal injuries since maliniac's description of the management of nasal fractures in 1947 has seen several variations (3) . the functional and cosmetic problems arising may sometimes necessitate intricate surgical procedures to restore the anatomy. due to constraints of resources and the range of services provided, these injuries are typically managed . most commonly, nasal bone fractures are sustained in fights (34%), accidents (28%), and sports (23%). a 2009 study of 236 patients with facial fractures incurred while playing sports determined that fractures of the nasal bone were most common (4) . in children, nasal fractures are most commonly due to falls. in a study of 100 children with traumatic nasal deformity, liu et al determined that such injuries were most often the result of sports-related trauma (28%), with accidental trauma (21%), interpersonal violence (10%), motor vehicle collisions (6%), and alcohol- related trauma (2%) being the next most common reasons for injury (5) . the possibility of child abuse should be considered in every child presenting with a nasal fracture the prognosis of nasal bone fracture is depend on: if nbfs are treated within correct time parameters, patients should anticipate a successful healing and proper nasal alignment. communication between the surgeon, ent physician, and primary care physician or emergency physician is crucial to the treatment plan (6). the greatest complications from reduction are malunion and cosmetic concerns. incidence of complications is highest in bilateral fractures, comminuted fractures, and fractures with severe nasal septum deviation (7).


Eligibility criteria:
inclusion criteria: * age ranged from since birth to 12 years old * isolated nasal fracture * presented from time of trauma up to 5 days exclusion criteria: * multiple facial fractures * age more than 12 years old * systemic diseases * any hematological disorders
investigation of filaggrin gene mutations among latinx patients with atopic dermatitis

Conditions: Atopic Dermatitis; Eczema

Summary: the study, investigation of filaggrin gene mutations among latinx patients with atopic dermatitis, will examine the association between pathogenic flg lof variants and ad in a new population of latinx patients for which clinical and disease characteristics will be well-described.

filaggrin deficiency is considered a major target for therapy in atopic dermatitis (ad).43 the current status quo with regards to flg lof mutations as the strongest known genetic risk factor in ad stems from incomplete data as the majority of studies that have previously examined this association have been carried out in only a limited group of populations (i.e., european ancestry).30 such partial data impedes our full understanding of genetic risk in ad and consequently has implications for disease prognosis and management. the proposed research represents an attempt to examine long-held paradigms in ad as they relate to genetic risk factors and disease. the development of an independent cohort of latinx subjects with physician-confirmed diagnosis of ad that is also well phenotyped and grouped by ancestry, while also capturing measures of disease severity, will provide the opportunity to examine a population that has been largely absent from prior studies and further advance our understanding of the pathogenomic role flg lof variants in ad.

Eligibility criteria:
inclusion criteria: * established diagnosis of ad based on physician report of at least one-year duration * self-identification as latino/latinx or hispanic exclusion criteria: -
safety study of desirudin, an anticoagulant for the prophylaxis of thrombosis

Conditions: Thrombosis

Summary: the objective of this trial is to demonstrate the clinical utility of fixed-dose sc desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.

hospitalized patients who require dvt prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.

Eligibility criteria:
inclusion criteria: 1. provide written informed consent before initiation of any study related procedures. 2. be at least 18 years of age. 3. patients requiring anticoagulation for the prophylaxis of thrombosis. 4. in the opinion of the investigator, an alternative to heparin-based anticoagulant therapies is desirable. exclusion criteria: 1. confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test). 2. intracranial neoplasm, arteriovenous malformation or aneurysm. 3. severe renal insufficiency (chronic or acute) with a gfr of \< or equal to 30 ml/min as determined by measured or estimated creatinine clearance using cockroft-gault method or by estimated gfr using the mdrd formula. 4. known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product 5. participation in other clinical research studies involving the evaluation of other investigational or fda-approved drugs or devices within 30 days of enrollment (participation in observational studies of fda-approved products is acceptable). 6. refusal to undergo blood transfusion should it become necessary 7. active bleeding or irreversible coagulation abnormality. 8. uncontrolled hypertension defined as a blood pressure \> or equal to 180/110 mmhg. 9. patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ecmo. 10. any other disease or condition which, in the judgment of the investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.

Keywords: anticoagulation prophylaxis desirudin direct thrombin inhibitor heparin-induced thrombocytopenia
early predictors for the short term native liver survival in patients with biliary atresia after kasai procedure

Conditions: Biliary Atresia

Summary: many factors have been proven that may affect nls in ba patients after kp;however,the early predictors for nls were not be finally detected.this study was designed to evaluate and identify the preoperative and early postoperative factors associated with nls for early prediction in ba patients after kp.

biliary atresia (ba) is the most common cause of neonatal cholestasis, occurring in approximately 1: 8000 to 1:15000 in asian populations compared with those in europe and the usa, with a ratio of 1: 1.56 in males and females.until now, kasai procedure(kp) remains the preferred treatment for biliary ba;however,nearly 60-70% patients after kp need liver transplants to achieve long-term survival.therefore, it is meaningful to seek and analyze the factors affecting the native liver survival(nls) in ba patients with kp for prediction. luckily， a lot of studies have designed to seek the risk factors for death or liver transplants in ba patients after kp,and many factors have been proven that may affect nls,including old age at kp,low gamma-glutamyl transpeptidase(ggt) level,cytomegalovirus(cmv) infection,early jaundice clearance(jc) and postoperative cholangitis(pc),etal.however,the predictors for nls were not be finally detected.otherwise,the safety of liver transplants has been improved in the past few years and performing liver transplant in young infants has been proven to be feasible.then,it is important to seek early nls predictors for counseling the necessity and timing of liver transplant.unfortunately,early predictors of nls focus on preoperative and early postoperative period after kp were insufficient. this study is primarily designed to evaluate and identify the preoperative and early postoperative factors associated with nls for early prediction in ba patients after kp.

Eligibility criteria:
inclusion criteria: biliary atresia(ba) patients performed with kasai procedure patients completed the follow-up\>6 months exclusion criteria: ba patients without kp patients lost of follow-up ba patients with other severe complications lead to death

Keywords: biliary atresia kasai procedure early predictor native liver survival
improving ultrasound images in brain tumor surgery with the use of brain mimicking fluid

Conditions: Brain Neoplasms; Glioma

Summary: prognosis in patients with glioblastomas (the most aggressive high-grade glioma) remains unfavourable. tools for improving brain tumor surgery, in particular for gliomas, are increasing. there seems to be an agreement that achieving extensive resections, when done safely without jeopardizing neurological function, improves survival. ultrasound is currently used as a tool for providing 2d or 3d images for the purpose of tumor localization and resection control. for the use in resection control the resection cavity is filled with saline to provide acoustic coupling between the ultrasound transducer and tissue. however, attenuation of acoustic waves is very low in saline compared to the brain and this difference in attenuation is the cause of artifacts that may severely degrade the ultrasound images. such artifacts are seen as high-intensity signal at the resection cavity wall and beyond, potentially masking small tumor remnants and generally making the interpretation of images more difficult. this research group has developed an acoustic fluid intended for use in the resection cavity instead of saline. tests in laboratory measurements have shown that the fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery. the investigators expect that the acoustic fluid will make it easier to detect small tumor remnants near the end of an operation, thus increasing success of glioma surgery. the purpose of this study is to test the fluid during surgery for histopathologically proven glioblastoma to assess safety and efficacy.


Eligibility criteria:
inclusion criteria: * a glioblastoma is suspected when there is a solitary brain tumour with ring-like contrast enhancement and oedema with no recent history (last 3 years) of primary tumour elsewhere * in cases where histopathology is not known from previous biopsy or resection (i.e. diagnosis is suspected based on mri findings and not from previous surgery) a tissue sample for frozen section is necessary. the fluid will only be used in cases where glioblastoma is suggested from this preliminary histopathological assessment. exclusion criteria: * intended biopsy only (meaning: cases not suitable for resection) * other entities than glioblastoma is suspected * allergy to diary products and marine products * hypersensitvity to egg protein * hypersensitivity to soya or peanut protein * hypersensitvity to glycerol

Keywords: ultrasonography ultrasonics brain surgery
safety study of inhaling carbon monoxide in healthy volunteers

Conditions: Healthy

Summary: post operative ileus (poi), a temporary paralysis of the intestines, is a serious health care problem. it normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. the objective of this study is to determine if inhaling very low doses of carbon monoxide (co) before and after colon surgery will shorten the duration of normal poi and/or prevent the development of poi complications in patients undergoing colon surgery. this preliminary study will be conducted in ten healthy volunteers to monitor for blood levels and adverse effects that occur at different durations of exposure of inhaled co to establish a safe dose for patients in the main trial. for the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either co or oxygen by face mask before and after their operation. we hypothesize that healthy volunteers will be able to tolerate 1 hour doses of 250 ppm of co with minimal side effects. it is also anticipated that for each dose of co administered, the blood levels of co will remain well under poisonous levels. finally, we anticipate blood levels of co will return to baseline level within 24 hours following the last dose of co.


Eligibility criteria:
inclusion criteria: * men and women, age \> 18 years. * women must be using acceptable contraceptives, post-menopausal or surgically sterile. * no prior smoking history. * bmi between 16 and 30 inclusive. * in good health as per medical history, physical exam, vital signs \& ecg. exclusion criteria: * exposure to carbon monoxide during the 48 hours prior to the study day. * occupational exposure to co. * significant disease that may put the volunteer at risk because of participation in the study or may influence the results of the study or the volunteer's ability to participate in the study. * baseline blood level of cohb \>2%. * patients with underlying lung disease such as asthma or copd. * baseline oxygen saturation \<92% on room air. * planned pregnancy, already pregnant or breastfeeding. * participation in another clinical trial within 2 months prior to study.

Keywords: healthy volunteer
the genetics behind vitamin d status (vitdgen)

Conditions: Vitamin D Deficiency

Summary: the overall purpose of the study is to investigate whether there is a relationship between 26 different single nucleotide polymorphisms (snps) in the vitamin d pathway, ultraviolet b (uv-b) irradiation of the skin and vitamin d status. the hypothesis is that vitamin d status are influated by different genetic genotypes in the vitamin d pathway.

in this study approximately 80 participants (over 18 years) are included. all the participants has previously participated in the vitmad intervention study (nct01184716) . participants will in total receive 4 times uv-b irradiation (3 sed) with two day apart each time, to stimulate vitamin d production in the skin. the participants skintype will be measured. the study starts in january 2013 and runs to the end of marts 2013. during this winter period, it is in denmark not possible to produce vitamin d in the skin through sunlight exposure.

Eligibility criteria:
inclusion criteria: * health participants over 18 years, that previously participated in vitmad intervention study exclusion criteria: * skindiseases * intake of medicin that causes photosensitive skin * pregnant or nursing * sun vacation 3 month before the intervention * intake of vitamin d supplement 3 month before the intervention

Keywords: snps vitamin d vitamin d status uvb irradiation genetics
the multiple dose of pk/pd study of shr2285 tablets in healthy subjects

Conditions: Thrombus

Summary: the study is a randomized, single-blind, placebo-controlled, multiple-dose escalation phase i trials. 2 dose groups were designed, 12 subjects in each dose group.the drug was administered single dose and multiple doses.


Eligibility criteria:
inclusion criteria: 1. males or females, aged 18-45. 2. subjects with no cardiovascular disease, sitting blood pressure: 90mmhg ≤sbp\<140mmhg; 50mmhg ≤dbp\<90mmhg and 50 ≤ hr \<110 beats / min. 3. body mass index (bmi) between 18 to 28. 4. participant in general good health. no clinically significant findings in vital signs, physical examination, 12-lead ecg ,x-ray and laboratory parameters. exclusion criteria: 1. males or females, aged 18-45. 2. subjects with no cardiovascular disease, sitting blood pressure: 90mmhg ≤sbp\<140mmhg; 50mmhg ≤dbp\<90mmhg and 50 ≤ hr \<110 beats / min. 3. body mass index (bmi) between 18 to 28. 4. participant in general good health. no clinically significant findings in vital signs, physical examination, 12-lead ecg ,x-ray and laboratory parameters. exclusion criteria: 1. alanine aminotransferase (alt) or aspartate aminotransferase (ast) or total bilirubin/direct bilirubin \> 1x uln during screening/baseline. 2. serum creatinine\> 1x uln during screening/baseline. 3. abnormal coagulation function. 4. a clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs. 5. subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening. 6. blood donation or blood loss within 1 month≥200 mlor≥400 ml within 3 months before administration. 7. human immunodeficiency virus antibody (hiv-ab), syphilis serological examination, hepatitis b virus surface antigen (hbsag), hepatitis c virus antibody (hcv-ab) were positive. 8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening. 9.female subjects who did not receive contraception at least 30 days before administration.
epidemiology of risk factors for hospital-acquired pneumonia (hap) in intensive care unit (icu) patients

Conditions: Ventilator-Associated Pneumonia

Summary: a retrospective, observational study compiled data from all consecutively admitted patients older than 18 years at icu university hospital in olomouc in the period from 1 january 2011 to 31 december 2015 who fulfilled the criteria of hap. the aim was to determine the severity of the specific risk factors of early and late hap. risk factors were divided into factors from the patient and from the hospitalization. furthermore, an assessment of their relationship to mortality.

the primary outcome was to evaluate the relationship between risk factors and the development of early/late onset hap. another outcome was assessed to evaluate the relation of risk factors early/late onset hap and mortality. the crucial time for evaluating the presence of risk factors was their presence from hospital admission to the moment of fulfilling the criteria for pneumonia. risk factors were divided into two groups, on factors of the patient (uncontrollable) and by the hospitalization (controllable). factors of the patient were: gender (male/female), age at enrollment (years), acute physiology and chronic health evaluation ii (apache ii) score, multi-organ failure presence (mof), hypertension, ischemic heart disease (ihd) chronic renal insufficiency (cri), continual use of renal replacement therapy (crrt), acute renal insufficiency (ari), diabetes mellitus (dm), chronical obstructive pulmonary disease (copd), immunosuppression or leukopenia \<1.5x109/l, impaired consciousness with glasgow coma scale (gcs) \<8 tracheotomy, head trauma/neurosurgery, abdominal surgery-thoracotomy. side factors hospitalization were: aspiration into the lungs, urgent intubation, reintubated, sedation, bronchoscopy, nasogastric intubation, enteral feeding continuously/intermittently intolerance of enteral nutrition, physiotherapy, repeated transport of the patient from the icu, length of hospital stay, length of mechanical ventilation, 30-day mortality.

Eligibility criteria:
inclusion criteria: * hospital-acquired pneumonia * intensive care patient * x-ray signs of pneumonia exclusion criteria: * age less than 18 years * negative culture findings in the airways * low quantity of culture findings

Keywords: hospital-acquired pneumonia epidemiology risk factors