Kornimate/medical-research-clean huggingface dataset:
postoperative pain and functional patient outcomes after functional endoscopic sinus surgery

Conditions: Pain, Postoperative

Summary: the aim of the study is to quantify postoperative pain after functional endoscopic sinus surgery (fess) and investigate whether preemptive analgesia may positively impact intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and improve patient functional outcomes.

the sphenopalatine ganglion block (spgb) with local anesthetic is used to treat facial pain and headache of various etiologies and has been widely used during functional endoscopic sinus surgery (fess). the purpose of this study was to investigate whether preemptive spgb may positively impact postoperative pain and functional outcomes after fess. a prospective, double-blind randomized placebo-controlled study was performed. 60 patients (18 to 70 yrs), undergoing general anesthesia for bilateral fess, were randomly assigned to receive spgb with either 2 ml 0.25% bupivacaine with epinephrine 1:100,000 (bp, treatment group) or normal saline (ns, control group). spgb was performed preemptively 10 min before the start of surgery. pre- and post operative (day#0, day#7, day#30) visual analogue pain scale, snot-20, ct \& endoscopic scores were compared between the two groups.

Eligibility criteria:
inclusion criteria: 1. the study subjects will be 18-70 year old. 2. the subjects will be american society of anesthesiology physical status i and ii patients. 3. patients with chronic rhinosinusitis, presenting for bilateral functional endoscopic sinus surgery. 4. the subjects should understand informed consent and study instructions, and 5. the subjects should not participate in any other research protocols. exclusion criteria: 1. patients with pre-existing chronic facial pain not related to chronic rhinosinusitis. 2. patients with pre-existing chronic pain of different etiology. 3. patients taking prescription pain medications. 4. patients taking antidepressant medications. 5. patients taking over-the-counter pain medications within 48 hours of scheduled surgery. 6. patients in whom oral opioid-containing analgesics would be contraindicated postoperatively. 7. patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to desflurane or other halogenated agents. 8. patients with the history of arrhythmias or significant coronary artery disease. 9. patients with psychological disorders. 10. patients who are unable to understand the questionnaires or the visual analogue scale (vas) pain scores. 11. patients with the history of substance or alcohol abuse. 12. patients with compromised renal and liver function. 13. patients with abnormal coagulation status or platelet count less than 100,000. 14. pregnant patients. 15. patients with an allergy to bupivacaine, lidocaine or epinephrine. 16. other patients that may be excluded by the investigator, based on medical history and physical examination
the effect of biomarkers of inflammation on graft function in kidney transplantation

Conditions: Renal Transplant Failure and Rejection; Inflammation

Summary: the aim of the study was to investigate the relationship of inflammation markers with postoperative graft function and mortality in patients undergoing kidney transplantation.


Eligibility criteria:
inclusion criteria: * patients underwent renal transplantation exclusion criteria: * patient refusal
noninvasive screening for affected pregnancies: assay development & optimization in affected pregnancies

Conditions: Down Syndrome; Aneuploidy

Summary: to collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (nipd) test. the nipd test employs circulating cell free (ccff) dna extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. the nipd result will be compared to the standard test results obtained from other test methods such as karyotype, fish, qf-pcr, and/or any commercially available nipd test.


Eligibility criteria:
inclusion criteria: * subject is female * subject is 18 years or older * subject is no less than 8 and no more than 36 weeks gestation * subject provides a signed and dated informed consent * subject agrees to provide one or more 30-50ml blood sample(s) in accordance with the protocol * subject has a current pregnancy in which the fetus is known to have chromosomal aneuploidy (e.g. t13, t18, t21) exclusion criteria: * non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy

Keywords: down syndrome, aneuploidy, amniocentesis, chorionic villus sampling, trisomy
multicenter observational study of advanced non-small cell lung cancer with malignant pleural effusion

Conditions: Non-Small Cell Lung Cancer

Summary: multicenter observational study for correlation between tumor mutation burden and immunotherapy efficacy of advanced non-small cell lung cancer with malignant pleural effusion

method of research: 1. ⅲb-ⅳ nsclc patients, tumor mutation burden (tmb) was tested by the 448 gene panel with pleural effusion and tissue sample, to observed mutation characteristics;tissue and pleural effusion cell precipitation:tmb (next generation sequencing, 448 gene panel;average sequencing depth: above 5000×) 2. the date of blood routine examination(neutrophils to lymphocytes ratio (nlr)) and serological tumor maker of nsclc were collected before treatment;the the results of programmed death ligand 1 (pdl1) expression level were collected also; 3. collected imaging(ct)and pathological data before treatment; 4. immunotherapy was applied for 8 weeks to evaluate the efficacy; 5. the tumor mutation burden of pleural effusion was tested again for the patients of hyper-progression after immunotherapy, the mutation characteristics and changes were observed, the molecular mutation change before and after treatment were evaluated, and the correlation with immunotherapy was analyzed.hyper-progression (hpd) were defined as tumor growth rate excess of 50% compared to baseline ct scans prior to treatment initiation.the patient underwent imaging examination (chest ct or pet-ct) at 2 months (8 weeks) after 3 full doses of immunotherapy drugs. 6. the date of blood routine examination(neutrophils to lymphocytes ratio (nlr)) and serological tumor maker of nsclc were collected after treatment; 7. imaging, ct and pathological data of patients after treatment were collected

Eligibility criteria:
inclusion criteria: 1. male or female,18 years ≤ age ≤80 years; 2. pathologically confirmed stage ⅲb-ⅳ nsclc, which is not suitable for surgical resection; 3. no systematic anti-tumor treatment; 4. pleural effusion ≥50ml,tissue samples can be obtained; 5. the driver gene was negative, and immunotherapy was proposed; 6. according to recist 1.1, at least one tumor lesion that can be measured or evaluated; 7. signed and dated informed consent exclusion criteria: 1. no pathological diagnosis or the diagnosis is not clear; 2. severe pneumonia or tuberculosis; 3. tumor tissues cannot be obtained; 4. combine with other tumor type or other subtypes of lung cancer; 5. poor compliance, unable to complete follow-up; 6. the investigator judges the situation that may affect the clinical search process and results

Keywords: multicenter observational study tumor mutation burden (tmb) immunotherapy pleural effusion
safety study to evaluate the occurrence of efad in pediatric patients with pnac who require more than eight weeks of omegaven treatment

Conditions: Parenteral Nutrition Associated Liver Disease (PNALD); Essential Fatty Acid Deficiency; Malnutrition; Pediatric ALL

Summary: this study will demonstrate safety in pediatric patients with parenteral nutrition-associated cholestasis treated with omegaven®, which is indicated as a source of calories and fatty acids in this patient population


Eligibility criteria:
inclusion criteria: 1. patient's parent(s) or legal guardian(s) has provided a signed and dated informed consent form (icf). 2. pediatric patient (\<18 years) has been diagnosed with pnac, defined as direct or conjugated bilirubin (dbil) ≥ 2.0 mg/dl with no other known cause of liver dysfunction at the time of enrollment and is expected to require omegaven treatment for at least eight weeks. 3. patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring pn. exclusion criteria: 1. patient has received omegaven within four weeks before inclusion in the study 2. patient has any other known cause of chronic liver disease such as hepatitis c, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepatic congestion due to heart failure, etc. 3. patient has known cirrhosis (liver biopsy is not required under this protocol). 4. patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis. 5. patient has previously received a liver-only or liver-inclusive transplant. 6. patient has hemodynamic instability due to any major cardiac anomaly. 7. patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer). 8. patient has multi-organ failure, septic shock, hypotension requiring pressor therapy, persistent pulmonary hypertension requiring inhaled nitric oxides, or requires extracorporeal membrane oxygenation (ecmo) or similar intervention. 9. patient has renal failure and requires renal replacement therapy. 10. patient has a severe hemorrhagic disorder. 11. patient has severe hyperlipidemia or a severe disorder of lipid metabolism characterized by hypertriglyceridemia (i.e., serum triglyceride level \> 1,000 mg/dl). 12. patient has a record of efad before inclusion in the study 13. patient has been diagnosed with or is suspected to have an inborn error of metabolism. 14. patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of omegaven. 15. patient is subject to treatment limitation. 16. patient is enrolled in any other study with an investigational medicinal product during the course of the current study.
effect of hyperbaric oxygen on functional connectivity in patients with cerebral small vessel disease

Conditions: Cerebral Small Vessel Diseases

Summary: patients will have a functional mri before and after 10 hyperbaric oxygen treatments.

functional mri studies will be done before and 4-6 weeks after hyperbaric oxygen treatment to assess changes in connectivity of resting state neural networks. 10 hyperbaric treatments at 2 atmospheres absolute for 1 hour at pressure will be administered. a review of symptoms and and thorough clinical neurological examination by an experienced neurologist familiar with these studies will be done before and 4-6 weeks after the hyperbaric treatments.

Eligibility criteria:
inclusion criteria: * white matter hyperintensities on mri * 2 or more neurological symptoms or impairments e.g. gait disturbances, disequilibrium, cognitive decline, dysmetria, hyper-rflexia exclusion criteria: * contraindication to hyperbaric oxygen treatment e.g. pulmonary emphysema, seizure disorder * major eustachian tube dysfunction * stroke with previous 6 months * extreme cognitive impairment * major depression * history of migraine, electroshock therapy, brain irradiation, brain tumor, head trauma * other uncontrolled co-morbidities, e.g. diabetes, renal or hepatic dysfunction, hypertension, thyroid disorders, carotid artery stenosis (\>70%)

Keywords: small vessel disease of the brain hyperbaric oxygen functional connectivity mri
effects of physical exercise to prevent osteoporosis in postmenopausal women

Conditions: Osteoporosis, Postmenopausal; Osteoporosis, Osteopenia; Physical Activity

Summary: according to the world health organization criteria, osteoporosis was defined as a bone mineral density that lies 2.5 standard deviations or more below the average value for young healthy women. osteoporosis is a major cause of fractures and can lead to serious complications in postmenopausal women. for this reason, approaches to prevent the appearance and progression of osteoporosis are of primary importance. this randomized clinical trial analyzes the effects of two types of physical exercise oriented to prevent osteoporosis in postmenopausal women with pharmacological supplements of calcium and vitamin-d.


Eligibility criteria:
inclusion criteria: * postmenopausal woman * pharmacological treatment (vitamind+calcium) exclusion criteria: * disease or physical-mental condition which prevents to perform the proposed physical exercise
posterior maxillary ridge augmentation with sinus lift using mineralized plasmatic matrix versus autogenous bone graft

Conditions: Bone Resorption

Summary: using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards in sinus lift procedures for future implant insertion.

to study the effectiveness of mpm in ridge augmentation with implant insertion compared with autogenous bone graft. -pico population(p) : patients with defective posterior maxillary alveolar ridge. intervention (i) :implant placement and ridge augmentation with mpm. comparator (c) : autogenous bone graft. outcome (o) : patient satisfaction - implant stability.

Eligibility criteria:
inclusion criteria: 1. patients systemically free. 2. patients with posterior maxillary defective ridges indicated for sinus lift procedure. 3. cases with 5 mm bone height or less are included in the study. 4. age between 18 and 50 years. 5. both sexes. 6. patients physically able to tolerate surgical and restorative procedures. 7. good oral hygiene. 8. highly motivated patients. exclusion criteria: 1. patients allergic to local anesthetic agent. 2. medium and heavy smokers. 3. pregnant females. 4. presence of any pathosis in the pre-implant site. 5. presence of any mucosal disease. 6. history of oral radiotherapy. 7. history of prolonged steroids use. 8. psychological disorders.
a study of lasmiditan (ly573144) in children aged 6 to 17 with migraine

Conditions: Migraine

Summary: the purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. the study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine. the study will last about 6 weeks, and includes 4 visits.


Eligibility criteria:
inclusion criteria: * participants must have a history of migraine headaches for more than 6 months * participants must have a history of 2 to 15 migraine headaches per month in the past 2 months * participants must weigh between 15 and 55 kilograms (kg) * participants must not have a migraine headache on the day of lasmiditan administration exclusion criteria: * participants must not be pregnant or nursing * participants must not have any acute, serious, or unstable medical condition * participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator * participants must not be on a medicine that acts in the brain and spinal cord
prediction model for lateral lymph node metastasis

Conditions: Rectal Cancer

Summary: mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. radiomics parameters of lateral lymph nodes would be extracted by expert software. then a part of the nodes would be used as the training set to build the prediction model, and the another part nodes would be used as the validation set.

after performing lateral lymph node dissection for the enrolled patients, we would find the targeted lateral node which was matched with the enlarged one in imaging from the specimen. then the nodes would be send for pathological examination. then we would extract the radiomics parameters of the nodes from the pretreatment ct and mri with itk-snap software. according to the pathological status, lymph nodes and corresponding radiomics parameters would be divided into positive and negative groups. then significant parameters would be selected by r software. then the prediction model with nomogram would be developed. 70% nodes would be used for for model development and the other 30% would be used for validation.

Eligibility criteria:
inclusion criteria: * middle to low-lying rectal adenocarcinoma patients with enlarged lateral lymph node ≥5mm for short diameter in ct and/or mri exclusion criteria: * other kind of rectal tumor including neuroendocrine and malignant. * high location rectal cancer. * recurrent rectal cancer

Keywords: rectal cancer lymph node metastasis prediction model
wound eversion versus planar closure for face or neck wounds

Conditions: Operative Wound

Summary: the aim of this study is to determine whether wound edge eversion, achieved by careful placement of dermal sutures, improves the cosmetic outcome of operative wounds closed on the head or neck.

it has been established that as wounds heal, the resultant tissue remodeling results in wound contracture. surgeons are taught that by everting wounds' edges with well-placed dermal sutures, there is less depression of the resultant scar. a prior study conducted by us at this center found that wound eversion was not associated with better cosmetic outcome (1). however, it was noted that most of the procedures were performed off the head and neck, places where the effects of eversion were thought to be most beneficial (2) thus our goal is to now study the effects of eversion exclusively on the face and neck.

Eligibility criteria:
inclusion criteria: * over 18 years of age * able to give informed consent themselves * patient scheduled for cutaneous surgical procedure with predicted linear closure on the face or neck * willing to return for follow up visits exclusion criteria: * mentally handicapped * unable to understand written and oral english * incarceration * under 18 years of age * pregnant women * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners

Keywords: wound edge eversion dermal sutures
use of radiofrequency ablation for rgb salvage

Conditions: Obesity

Summary: the present study will assess the feasibility of using endoscopic radiofrequency ablation (rfa) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance after a failed roux-en-y gastric bypass.

obesity is a leading cause of preventable death in the united states, with approximately 300,000 related deaths per year. the most commonly performed bariatric surgical interventions are roux-en y gastric bypass (rgb) and laparoscopic adjustable gastric band placement. despite the overall initial success of rgb to induce significant ebwl in the majority of patients, significant weight regain occurs in about 25% of patients at 2+ years following surgery. given the preliminary success of endoscopic, non-surgical salvage interventions for the failed (uncomplicated) rgb patient, the present study will assess the feasibility of using endoscopic radiofrequency ablation (rfa) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance. a reduction of size and compliance may, as others have reported, result in re-establish weight loss and achieve an acceptable ebwl with minimal patient morbidity.

Eligibility criteria:
inclusion criteria: 1. history of rgb surgery at least 1 year prior to enrollment 2. achievement of \> 40% ebwl after rgb 3. weight regain of \> 25% of the lost weight at the time of enrollment. for example, if excess body weight was 50 kg prior to rgb, patient must have lost at least 20 kg after rgb, then regained at least 5 kg to be eligible for the present study 4. age 18-70 inclusive 5. subject is able to tolerate endoscopy and sedation 6. subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (icf) exclusion criteria: 1. history of any bariatric surgery other than rgb, including lap band 2. history or presence of a gastrogastric fistula or gastric pouch / jejunal ulceration 3. gastrojejunostomy \> 4 cm in diameter (size estimated at time of endoscopy) 4. perceived inability of the patient by the investigator to comply with a post-treatment diet or medication regimen 5. history of alcohol, tobacco and/or controlled substance dependency that would impair the patient from complying with protocol requirements 6. pregnancy 7. subject is unable to provide informed consent for this study

Keywords: rgb salvage, rfa
evaluation of cirvo™ mobile compression device for treatment of venous leg ulcers

Conditions: Venous Leg Ulcer

Summary: this study in venous leg ulcer (vlu) patients will evaluate the use of cirvo™ therapy for the treatment of vlu when applied for a minimum of two hours daily for up to 12 weeks.


Eligibility criteria:
inclusion criteria: 1. male or female patients between 18 and 80 years of age 2. patients (ceap 6) who have not previously experienced a period of open ulceration exceeding 26 weeks in the affected leg 3. total venous ulcer area \< 20cm2 4. duration of therapy for active venous ulcer \<26 weeks prior to enrollment 5. venous insufficiency documented by venous reflex ultrasound showing mild, moderate, or severe reflux in the superficial or deep venous system exclusion criteria: 1. acute dvt within the 3 months prior to enrollment 2. ulcer present for \<2 weeks 3. ulcers extending with exposed fascia, tendon, or bone within the wound margins 4. lateral malleolus ulcers 5. ulcers with perforator incompetence deep to the ulceration (within 5 cm of the wound border) 6. active infection (systemic or in the affected limb) 7. lower extremity gangrene 8. diabetes mellitus (type i or ii) requiring medication 9. history of pulmonary vascular disease (pvd) 10. history of pulmonary edema 11. history of decompensated congestive heart failure (chf) 12. open surgery or major trauma to the legs within the last six months 13. history of lower limb malignancy, primary or secondary 14. acute symptomatic lower extremity thrombophlebitis 15. pregnant or breastfeeding 16. calf geometry on which cirvo(tm) device does not appropriately fit 17. known sensitivity to any of the materials used in the cirvo(tm) device 18. currently participating or plans to participate in in any other investigational clinical evaluation during the 12 week study period that may, in the opinion of the investigator, affect blood flow and/or venous leg ulcer

Keywords: mobile compression device