Kornimate/medical-research-clean huggingface dataset:
gm-csf to decrease icu acquired infections

Conditions: Septic Shock; Severe Sepsis

Summary: the concept of acquired immunodeficiency after a first severe infection in the icu is widely described in the literature. there is a dual risk: increased mortality and increased secondary infections. several approaches of immunostimulatory treatments have been proposed in the literature. the treatment proposed by this study consists of the administration of granulocyte-macrophage colony-stimulating factor (gm-csf), colony stimulating factor widely used particularly in the usa where it is marketed. a phase 2 clinical trial was conducted in germany in 2009. the main objective is to measure the incidence of icu-acquired infections in 2 groups of patients treated by gm-csf or placebo. icu patients at risk are defined as surviving at d3 from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. the detection of immunosuppressed patients will be achieved by measuring the hla-dr (human leucocyte antigen dr)with a threshold of less to 8000 sites. our hypothesis is that the number of secondary infections (primary endpoint) will be significantly reduced in the treated group.


Eligibility criteria:
inclusion criteria: icu patients presenting a severe sepsis or a septic shock associated with a sepsis-induced immunosuppression. 1. - severe sepsis or septic shock defined by the association of: at least 2 criteria of systemic inflammation response syndrome (sirs) a clinically or microbiologically defined infection and respectively at least one organ failure (level ≥ 2 in one organ failure of the sofa score) or the need of a vasopressor treatment (epinephrine or norepinephrine ≥ 0,25mg/kg/min for at least 6 hrs to maintain a systolic pressure ≥ 90 mmhg or a mean arterial pressure ≥ 65 mmhg). 2. - and sepsis-induced immunosuppression: reduced mhla-dr levels (\< 8,000 monoclonal antibodies (mab) per cell at d3). exclusion criteria: 1. - therapeutic limitation 2. evolutive hemopathy, neutropenia \< 500/mm3, stemcell transplant 3. solid tumor with on-going chemotherapy or radiotherapy 4. human immunodeficiency virus (hiv) infection with cd 4 count \< 200 cell/mm3 5. immunosuppressive treatment (including corticosteroid at immunosuppressive dose : \> 10 mg equivalent prednisolone and cumulative dose \> 700 mg) 6. primary immunodeficiency . 7. extra corporeal circulation within one month 8. recent cardio-pulmonary resuscitation (within the current clinical episode) 9. patients admitted in icu for extensive burns 10. contraindications to sargramostim 11. pregnant or lactating women 12. participation to another interventional study.

Keywords: septic shock severe sepsis gm-csf immunosuppression hospital-acquired infections icu-acquired infections hla-dr monocytes
telemedicine notifications with machine learning for postoperative care

Conditions: Surgery--Complications; Perioperative/Postoperative Complications; Acute Kidney Injury; Hospital Mortality

Summary: the odin-report study will be a randomized controlled trial of the effect of providing machine learning risk forecasts to providers caring for patients immediately after surgery on serious complications. the complications studied will be icu admission or death on wards, acute kidney injury, and hospital length of stay.

this will be a single center, randomized, controlled, pragmatic clinical trial. the investigators will screen surgical patients enrolled in tectonics (nct03923699) and randomized to intraoperative contact. near the end of the operation, the investigators will calculate the same machine learning risk forecasts of major complications as tectonics, and enroll patients if all of the following are true: (1) no icu admission is intended (2) ml mortality risk forecast is in top 15% of historical pacu patients. patients will be randomized 1:1:1 to no contact, brief contact, and full contact. the postoperative provider (pacu physician, anesthesiologist, ward clinician) will be notified before arrival of the risk forecast in the contact groups, and in the full contact group an additional set of explanatory ml outputs will be provided. the intention-to-treat principle will be followed for all analyses.

Eligibility criteria:
inclusion criteria: * enrolled in tectonics study (id 201903026, nct03923699), in or randomized to contact * workweek hours * preoperative assessment completed * estimated risk of mortality in top 15% of historical pacu patients exclusion criteria: * not enrolled in tectonics study * operating room randomized to non-contact in tectonics * planned icu admission

Keywords: telemedicine anesthesia control tower machine learning forecasting algorithms randomized controlled trial pacu
protein supplementation to promote muscle protein anabolism in frail elderly people

Conditions: Sarcopenia

Summary: the present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.


Eligibility criteria:
inclusion criteria: * frail elderly individuals * able to understand and perform the study procedures exclusion criteria: * type i or type ii diabetes (fasted blood glucose level ≥7,0 mmol) * no recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire) * use of anti-coagulation medication (except of acetyl salicyl acid) * renal insufficiency (egfr \<60 ml/min/1.73 m2) * allergic or sensitive for milk proteins

Keywords: sarcopenia frail elderly protein drink skeletal muscle mass muscle mass in elderly
confirmation of accuracy of the tool-in-lesion technology (tilt) of the galaxy system with integrated tomo technology

Conditions: Lung Cancer; Nodes, Lung

Summary: this study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

successful biopsy of peripheral pulmonary lesions continues to be a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. in this study, investigators will evaluate the feasibility of the galaxy system, which uses a built-in real-time navigation system called tilt technology, to both access and biopsy peripheral pulmonary lesions.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information, determined by the treating physicians based on the site's standard of care 3. peripheral pulmonary subsolid and solid nodules (ppns) sized 1-3 cm measured as the largest dimension where all or the majority of the lesion is located in the periphery of the lung 4. pre-procedural ct is conducted within 90 days of the bronchoscopy procedure 5. ppns that are accessible bronchoscopically on planning ct reconstruction 6. informed consent properly obtained per local regulations exclusion criteria: 1. known pregnancy or breastfeeding 2. patients with pure ground-glass nodules on pre-procedural chest ct 3. uncontrolled coagulopathy or bleeding disorders 4. ongoing systemic infection 5. history of lobectomy or pneumonectomy 6. patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days. 7. moderate-to-severe hypoxia, hypoxemia, or hypercarbia per pi's discretion 8. patients with pacemakers or defibrillators 9. unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist

Keywords: lung cancer, robotic assisted bronchoscopy
artemis synovial markers in arthritis childhood

Conditions: Septic Arthritis; Juvenile Idiopathic Arthritis

Summary: the aim of this study is to find markers that could differentiate infectious and inflammatory arthritis. the investigators want to find markers by differential analysis by compare synovial fluids of septic and inflammatory arthritis. the investigators will use for this analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. the investigators will use one marker or a score with biological and clinical data to discriminate arthritis of infectious and inflammatory etiology.


Eligibility criteria:
inclusion criteria: * septic arthritis with bacteriological identification * juvenile idiopathic arthritis beyond the ilar definition * having acute arthritis requiring an articular draining * child benefiting from a national insurance scheme * collection of the consent of the parents or the legal representative exclusion criteria: * contraindication in an articular draining: platelet 50 000 / mm3, rate of prothrombins lower than 70 %, activated partial thromboplastin times (aptt)\> 1,5 * treatment by biotherapy, corticoids or other immuno suppressor in the month preceding the articular draining. * treatment by antibiotic begun more than 24 hours before the draining.

Keywords: arthritis septic juvenile idiopathic arthritis diagnosis proteomic cytokine monocytes
vascular risk progression in normal and diabetic control subjects.

Conditions: Diabetes; Inflammation

Summary: the purpose of this study is to look at the progression of cardiovascular disease (cvd) in normal control individuals and in patients with controlled diabetes.

cardiovascular disease remains the greatest cause of mortality in people with diabetes mellitus. this observation study will evaluate non-traditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over 1 year. this study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intimal medical thickness.

Eligibility criteria:
inclusion criteria: * 19 years old or more and willing to return for annual testing for 2 years. * those with diabetes need to have the condition for at least 5 years. * normal controls need to have no diabetes, kidney disease, or chronic disease. exclusion criteria: * estimated gfr \<60 (ml/min/1.73m2) * any condition that would change weight dramatically in the near future such as malabsorption, pregnancy, malignancy * for normal: bmi\>30, bp \> 140/90 , ldl \> 130. * for diabetes: bp\> 135/85, a1c\> 8%. ldl \> 100.

Keywords: diabetes vascular risk inflammation
comparative efficacy of a toothpaste that reduces plaque and gingivitis

Conditions: Gingivitis

Summary: the objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.


Eligibility criteria:
inclusion criteria: * availability for the six-month duration of the study. * good general health. * minimum of 20 uncrowned permanent natural teeth (excluding third molars). * initial gingivitis index of at least 1.0 as determined by the use of the loe and silness gingival index. * initial plaque index of at least 1.5 as determined by the use of the quigley and hein plaque index (turesky modification). * signed informed consent form. exclusion criteria: * presence of orthodontic bands. * presence of partial removable dentures. * tumor(s) of the soft or hard tissues of the oral cavity. * advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of * periodontal attachment or alveolar bone). * five or more carious lesions requiring immediate restorative treatment. * use of antibiotics any time during the one month prior to entry into the study. * participation in any other clinical study or test panel within the one month prior to entry * into the study. * pregnant women or women who are breast feeding. * receive a dental prophylaxis in the past two weeks prior to baseline examinations. * history of allergic to personal care/consumer products or their ingredients. * taking any prescription medicines. that might interfere with the study outcome. * individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.

Keywords: gingivitis and plaque
study of the effects of cpap and hhhfnc on diaphragmatic dimensions in preterm infants

Conditions: Respirtory Distress

Summary: this is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (cpap) versus heated humidified high flow nasal cannula (hhhfnc) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm infants.

preterm infants will be recruited consecutively from nicu of mansoura university children's hospital. they will be randomized in two groups; one group will start on nasal cpap (fisher \& paykel healthcare, auckland, new z ealand) (pressure 5 cmh2o) for 60 minutes and then will be switched to hhhfnc (fisher \& paykel healthcare, auckland, new z ealand) (flow of 4 l/m) for another 60 minutes. the other group will start on hhhfnc and then switched to nasal cpap. after the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team. ultrasonographic assessment of diaphragmatic dimensions and excursion will be analyzed in different respiratory cycles and the average of 3 cycles will be calculated at the end of the 60 minutes periods on nasal cpap and hhhfnc.

Eligibility criteria:
inclusion criteria: * preterm infants \< 37 weeks. * stable on nasal continuous positive airway pressure (cpap) for at least 24 hours. * on less than 35% oxygen. exclusion criteria: * congenital and acquired problems of the gastrointestinal tract as necrotizing enterocolitis, esophageal perforation and tracheoesophageal fistula. * phrenic nerve injury and/or diaphragm paralysis * congenital/acquired neurological deficit and/or seizures * hemodynamic instability * congenital heart disease (including symptomatic patent ductus arteriosus) * undergoing treatment for sepsis or pneumonia. * use of muscle relaxants, narcotic analgesics, or gastric motility agents. * congenital anomalies of respiratory tract. * infants requiring more than 35% oxygen. * infants with facial anomalies. * infants with pneumothorax and/or pneumomediatinum. * infants in the immediate postoperative period. * infants with significant gastric residues and vomiting.
dual pet/ct imaging in lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to compare conventional pet/ct scan performed 1 hour after injection of the radioactive tracer fdg (pet/ct\[1\]) with pet/ct performed after 3 hours (pet/ct\[3\]) in a group of patients with biopsy verified lung cancer or high suspicion of lung cancer after initial work-up (chest x-ray and ct of thorax/upper abdomen), who are potentially operable.

the investigators also want to: * to find the sensitivity, specificity and accuracy in pet/ct 1h and 3 h in the staging of lung cancer (n-/m-stage). our gold standard is pathology, when not possible - follow-up (se gold standard 6.1.1) * to compare suvmax with the expression of glut1 and g-6-pase in tumors * to compare the expression of glut1 with the activity of g6pase * to compare suvmax, ri, tumor/liver ratio, glut1 and g-6-pase with the occurrence of relapse within a year after curative surgery

Eligibility criteria:
inclusion criteria: * cytologic/histologic-verified lung cancer or high suspicion of lung cancer after initial work up * candidate to curative intended surgery after initial work up (usually chest x-ray, ct of chest/upper abdomen and if needed spirometry). exclusion criteria: * former lung cancer * contraindications for pet/ct: pregnancy, recent chemoradiotherapy * diabetes mellitus.

Keywords: dual time pet/ct glucose-6-phosphatase
characterizing cftr modulated changes in sweat chloride and their association with clinical outcomes

Conditions: Cystic Fibrosis

Summary: this is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (sc) values from approximately 5000 cystic fibrosis (cf) patients prescribed and currently receiving commercially approved cystic fibrosis transmembrane conductance regulator (cftr) modulator therapies.

eligible subjects who have been prescribed and chronically taking a commercially approved cftr modulator for at least 3 months will be enrolled for a single visit to collect sweat to be analyzed for sc at their local site laboratory. limited clinical data obtained at this visit will be augmented by retrospective and prospective data obtained from the cystic fibrosis foundation patient registry (cffpr). study subjects who have been prescribed and switch to an alternative commercially approved cftr modulator will be approached to re-enroll in the study after being on the alternative modulator for at least 3 months so that a new sc value can be obtained.

Eligibility criteria:
inclusion criteria: 1. written informed consent (and assent when applicable) obtained from subject or subject's legal representative 2. enrolled in the cffpr 3. male or female ≥ 4 months of age on day of study visit 4. diagnosis of cf. 5. current treatment with a prescribed commercially approved cftr modulator for at least 90 days prior to enrollment 6. able to perform the testing and procedures required for this study, as judged by the investigator additional inclusion criteria for chec-pkpd sub-study: 1. male or female ≥ 6 years of age on day of study visit. 2. current treatment with elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to enrollment. 3. last dose of elexacaftor/tezacaftor/ivacaftor taken at least 24hours and last dose of ivacaftor taken at least 12 hours prior to trough blood draw on day of visit. exclusion criteria: 1. presence of a condition or abnormality that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data 2. currently enrolled in an investigational trial (including open-label follow-on studies and early access programs (eap) of an agent expected to have an impact on sweat chloride (refer to current list provided on study website)

Keywords: cf cystic fibrosis sweat sweat chloride cftr modulator
oral glucose solution as pain relief in newborns: results of a clinical trial

Conditions: Pain

Summary: this study investigates which concentration of glucose is most effective in reducing pain for venipuncture in the newborn.

this double-blind clinical trial is conducted on a maternity and newborn (n\*) ward. each time, during at least one month, one of the four selected solutions (glucose 10%, 20%, 30% and placebo) will be administered orally, 2 minutes prior to the venipuncture. the pain from the skin puncture will be scored using a validated pain scale (the "leuven" pain scale).

Eligibility criteria:
inclusion criteria * neonates were included if they had to undergo a venipuncture as part of routine medical care. exclusion criteria * unstable neonates with respiratory support as well as neonates with a proven neurological abnormality were excluded. * newborns who had been administered sedatives, analgesics or naloxone during the past 48 hours were excluded along with premature infants younger than 32 weeks post menstrual age.

Keywords: newborn pain glucose solution venipuncture non-pharmacologic pain relief.
of caregiver family members for the disabled in bukhara

Conditions: Caregiver Burden

Summary: the responsibilities of caring for a disabled family member may cause caregivers to develop risky behaviors for caregiver's health. therefore, we aimed to examine the relationship between caregiver burdens and healthy lifestyle behaviors of family members caring for a disabled child.

in the study, family members living in bukhara, uzbekistan, and caring for a disabled person under the age of 24 were evaluated. caregiver burden was evaluated with the caregiver burden scale and healthy lifestyle behaviors were evaluated with the healthy lifestyle behaviors scale ii. the fact that there is no earlier study on caregivers of disabled people in uzbekistan and no research in the literature examining the relationship between caregiving burden and healthy lifestyle behaviors in individuals with disabled children, make this study unique.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * having a disabled child to take care of * being literate exclusion criteria: * the age of the disabled person being cared for is over 24 years old.

Keywords: handicapped caregiver burden healthy lifestyle
inflammatory bowel disease research registry

Conditions: Inflammatory Bowel Disease

Summary: the objective and aims of this study is to develop the university of california irvine medical center inflammatory bowel disease research registry for the purpose of: 1. performance of retrospective studies on inflammatory bowel disease to assess disease outcomes and response to therapy. 2. obtaining permission from the research registry participants to be contacted by members of the university of california irvine medical center inflammatory bowel disease research center to identify patients that may be eligible for participation in future research studies. 3. performance of studies to quantify disease phenotypes and treatment patterns.

purpose: the goal of the university of california irvine medical center inflammatory bowel disease research registry is to study ibd characteristics, response to therapy, and disease outcomes. the information will also serve to identify patients for future research studies. objective and specific aims the objective is to develop the university of california irvine medical center inflammatory bowel disease research registry for the purpose of: 1. performance of retrospective studies on inflammatory bowel disease to assess disease outcomes and response to therapy. 2. obtaining permission from the research registry participants to be contacted by members of the university of california irvine medical center inflammatory bowel disease research center to identify patients that may be eligible for participation in future research studies. 3. performance of studies to quantify disease phenotypes and treatment patterns. study design: participation in the university of california irvine medical center inflammatory bowel disease research registry is limited to placement of a subjects' identifiable medical information related to inflammatory bowel disease in a database and the use of this information for retrospective research studies of inflammatory bowel disease. patients who present or develop inflammatory bowel disease at the university of california irvine medical center will be asked to participate in the research registry. patients must provide written, informed consent to allow past, current and future identifiable medical records related to gastrointestinal hemorrhage to be placed in the study's registry. the medical record information that will be used for the research registry will be directly related to inflammatory bowel disease. however, since concurrent medical conditions and treatments, not directly related to inflammatory bowel disease may impact inflammatory bowel disease it is likely that all of the past, current and future identifiable medical record information will be placed in the research registry.

Eligibility criteria:
inclusion criteria: * patients receiving or seeking care at uci medical center diagnosed with ibd exclusion criteria: * subjects under the age of 18 * prisoner of the state

Keywords: ibd study