Kornimate/medical-research-clean huggingface dataset:
tnferade™ plus chemo/radiation/surgery for rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to determine if the addition of tnferade™ to pre-operative chemoradiotherapy increases the number of pathologic complete responses when compared to pre-operative chemoradiotherapy alone as assessed following complete surgical resection of primary rectal cancer.


Eligibility criteria:
inclusion criteria: * all patients who have biopsy proven t3 or t4 rectal cancer which is confined to the primary tumor site with or without regional lymph node involvement * patients must be willing to return for follow-up * patients must be able to give and sign informed consent * patients must be suitable candidates for surgical resection post-chemoradiation, i.e. no history of severe congestive heart failure or severe pulmonary disease * life expectancy \> 6 months exclusion criteria: * patients with evidence of distant metastatic disease * any of the following hematologic abnormalities: hemoglobin (hgb) \ 1.5 (except in patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment cannot be withheld for vector injection or surgery). * a history of hepatic cirrhosis or present hepatic dysfunction with total bilirubin \> 2.0 mg/dl except for patients with gilbert's syndrome who must have a direct bilirubin \ /= 2.5 times upper limit of normal. * renal insufficiency as determined by a serum creatinine \> 2.0 mg/dl * patients may not have received prior therapy with chemotherapy, biologic therapy or radiation therapy for rectal cancer * significant history of a medical problem that would preclude the patient from undergoing an operative procedure such as a history of severe congestive heart failure or active ischemic heart disease * concurrent second malignancy requiring systemic therapy * pregnant or lactating women * chronic systemic corticosteroid use * prior surgery for rectal cancer * patients with history of deep venous thrombosis or pulmonary embolism * patients with doppler evidence of deep venous thrombosis at screening * known history of documented coagulopathy or thrombophilic disorders * hormone replacement therapy within one month prior to day 1 * known history of documented cerebrovascular disease, stroke or transient ischemic attack (tia) * surgery within the last one month, excluding diverting colostomy or ileostomy for obstruction
prognosis factors associated with convulsive status epilepticus in adults

Conditions: Status Epilepticus

Summary: the aim of the study is to evaluate, prospectively, prognosis factors associated with convulsive status epilepticus (cse) in adults hospitalized in intensive care units.

status epilepticus is a neurologic and medical emergency associated with high mortality and morbidity rates. according to the operational definition convulsive status epilepticus (cse) is defined as a single clinical seizure lasting more than 10 min, or two or more repeated seizures over a period of more than 10 minutes without intervening recovery of consciousness. there are a few to date in literature reporting prognosis factors associated with this condition and, at this time, there are no published data considering an operational definition of cse. in a retrospective study considering an operational definition we identified a seizure duration of 15 min associated with poor outcome (not yet published). the principal goal of this study is to evaluate factors associated with outcome in cse, in particular seizure duration of more than 15 minutes. the secondary goals are to evaluate the epidemiology and management at every stage of cse thus redefined.

Eligibility criteria:
inclusion criteria: * more than 18 years old * convulsive status epilepticus according to operational definition as any seizure lasting for 10 minutes or longer, or two or more intermittent seizures lasting for greater than 10 minutes from which the patient did not regain consciousness. * beginning of seizure less than 12 hours before intensive care unit admission * convulsive status epilepticus occurring during intensive care unit stay exclusion criteria: * less than 18 years old * patients that seized up to 9 minutes * beginning of seizure more than 12 hours before intensive care unit admission

Keywords: convulsive status epilepticus outcome prognosis factors seizure duration adult electroencephalogram intensive care unit
cardiac surgery neuroprotection study in elders

Conditions: Post-operative Cognitive Decline; Post-operative Delirium

Summary: the goal of this study is to determine the potential ability of intranasal insulin to prevent post-operative cognitive decline and post-operative delirium in an elderly cardiac surgery population.

nearly half of all intensive care unit (icu) admissions consist of adults \> 65 years old, an age group that is at high risk for developing cognitive decline and delirium in the icu. over 50% and 70% of critically ill cardiac surgery patients develop post-operative delirium (pod) and post-operative cognitive decline (pocd), respectively. these two forms of acute cognitive dysfunction are associated with increased mortality and poor functional recovery. while distinct conditions, pod has been associated with the subsequent development of pocd, suggesting a mechanistic link. no proven pharmacologic treatments targeting the prevention of both pod and pocd in elderly patients exist to date. recent data suggest that insulin administered into the central nervous system via intranasal delivery improves cognitive function in elderly patients with alzheimer's disease and mild cognitive impairment. however, its utility in preventing pod and pocd in elderly critically ill patients has not been investigated. the hypothesis of this study is that intranasal insulin can prevent pod and pocd in elderly critically ill patients admitted to the intensive care unit after undergoing cardiac surgery. to test this hypothesis, this randomized, placebo-controlled, double-blinded phase ii study will enroll 60 patients \>= 65 years old undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass, and will treat them with either 40 iu of aspart insulin or placebo intranasally before surgery and then four times a day for 7 days or until hospital discharge (whichever occurs first).

Eligibility criteria:
inclusion criteria: 1. elderly patients (\>=65 years old) 2. undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass 3. english or spanish-speaking exclusion criteria: 1. severe dementia, neurodegenerative, or psychiatric disease that prevents patient from living independently at baseline 2. emergent surgery 3. inability to perform cognitive testing (i.e. difficulty hearing or inability to speak) 4. contraindications to intranasal administration of medication
is adipose tissue a reservoir for sars-cov2 spread in covid-19 patients?

Conditions: Covid-19 Patients

Summary: resident cells of human adipose tissue express ace2 and dpp4, receptors for sars-cov2. the hypothesis is that the virus may enter and spread in fat depots.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years old * patients testing positive for covid19 * patients affiliated to social security * signing of free and informed consent exclusion criteria: * vulnerable persons (- minors, * adults under guardianship or curatorship, * pregnant women, * persons deprived of their liberty, * persons who do not master the french language)
study to assess the efficacy and safety of incdss in type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes

Summary: this is a multi-center, single-blind, parallel group, randomized controlled trial to access the effect and safety of the artificial intelligence assisted insulin titration system (incdss) in patients with type 2 diabetes mellitus.

as one of the most common treatments for diabetes inpatients, insulin regimens often vary due to different physicians. since 2016, zhongshan hospital has set up the internet-based glucose management system (igms) to monitor plasma glucose of diabetes patients, and further set up an artificial intelligence assisted insulin titration system (incdss) to recommend insulin regime in 2019. previous single-center clinical trial (nct04053959) have indicated the efficacy and safety of incdss in glycemic management in patients with type 2 diabetes. this multi-center study enrolls 142 patients with type 2 diabetes from three sites who are on treatment of diabetes for at least 3 months. they will be randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. patients in the intervention group (incdss group) receive insulin regimen set by incdss and patients in regular treatment regime group receive insulin regimen recommended by endocrinologists. this study will be conducted in the department of endocrinology in shanghai zhongshan hospital, shanghai fifth people's hospital, shanghai xuhui central hospital, and will consist of a 5-day intervention period. patient allocation will be stratified by hba1c and sites. the primary endpoint is the time in target glucose range during the trial period.

Eligibility criteria:
inclusion criteria: * men or women aged 18 and above years old; * subjects who had been diagnosed with type 2 diabetes; * subjects who are on diabetes treatment for at least 3 months; * hba1c: 7.0%-11.0%. exclusion criteria: * subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state; * subjects who change the insulin regimens during hospitalization; * bmi ≥ 45kg/m2; * women who are pregnant or nursing; * subjects with severe cardiac, hepatic, renal or general diseases; * subjects with psychiatric disorders or impaired cognitive function; * subjects with severe edema, infections or peripheral circulation disorders; * patients treated with surgery during hospitalization; * subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.

Keywords: incdss t2d ai
a study to assess the analgesic properties of a sublingual wafer formulation of ketamine following third molar extraction

Conditions: Pain

Summary: this is a phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging, placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post operative pain after undergoing third molar extraction.


Eligibility criteria:
18- 38 years of age scheduled to undergo two ipsilateral third molar extractions
a study to evaluate safety, tolerability, and efficacy of eteplirsen in participants with duchenne muscular dystrophy (dmd) who have completed study 4658-102 (nct03218995)

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this extension study is to evaluate the ongoing safety and tolerability of additional treatment with eteplirsen administered once weekly by intravenous (iv) infusion in male participants with dmd who have successfully completed the 96-week eteplirsen study 4658-102.


Eligibility criteria:
inclusion criteria: * participant successfully completes 96 weeks of treatment in study 4658-102. exclusion criteria: * participant has a prior or ongoing medical condition that, in the investigator's opinion, could adversely affect the safety of the participant, or make it unlikely that the course of treatment or follow-up would be completed, or impair the assessment of study results. other inclusion/exclusion criteria apply.

Keywords: dmd duchenne eteplirsen dystrophy dystrophin exon skipping exon 51 ambulatory pediatric
indexed aortic area in bicuspid aortic valve aortopathy

Conditions: Thoracic Aortic Aneurysm; Bicuspid Cardiac Valve

Summary: this study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve. this will shed light on whether aneurysms with smaller diameters than those recommended for surgical intervention by guidelines are still at risk of aortic complications attending an abnormally high indexed aortic area.


Eligibility criteria:
inclusion criteria: * age \>18 years * first-time surgery * bicuspid aortic valve confirmed * thoracic aortic aneurysm involving aortic root or ascending aorta exclusion criteria: * no available pre-operative cross-sectional imaging * re-do surgery
changes in brain activity (functional mri study) before and after behavioral therapy of height phobia

Conditions: Height Phobia; Fear of Heights

Summary: we are interested in investigating the functional brain abnormalities of height phobia. subjects will be have a functional mri scan before and after a course of treatment with behavioral therapy.

the purpose of this study is to investigate the effects of in vivo exposure therapy on the functional brain activity of subjects with height phobia using a fear provocation paradigm. we expect differential activation of the fear circuitry in height phobics compared to non-phobic controls, and that successful behavioral therapy will normalize the heightened fear response in height phobia.

Eligibility criteria:
inclusion criteria: * specific phobia of heights exclusion criteria: * history of medical problems

Keywords: height phobia fear of heights specific phobia
creon 40,000 for treatment of pei (pancreatic exocrine insufficiency) due to chronic pancreatitis

Conditions: Pancreatic Insufficiency

Summary: this study will provide efficacy data for creon 40,000 in cp subjects as well as long-term safety data. during the long-term treatment with creon 40,000 nutritional parameters will be assessed and correlated with cfa.


Eligibility criteria:
inclusion criteria * pancreatic exocrine insufficiency has to be proven (in medical history) by a pancreatic function test * chronic pancreatitis has to be proven (in medical history) by ct, ercp, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology * females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (iud) or use birth control pills or equivalent injectable contraceptive. the subject must have been practicing the selected method of birth control for at least 3 months prior to visit 1 (day -14). * subjects with a pathological stool fat during run in period (\> 10g/24 h) exclusion criteria * ileus or acute abdomen * any type of malignancy involving the digestive tract in the last 5 years * presence of pseudo pancreatic cysts \>= 4 cm * current excessive intake of alcohol or drug abuse * hypersensitivity vs porcine proteins / pancreatin

Keywords: pancreatic exocrine insufficiency due to chronic pancreatitis
non-invasive management of chronic venous insufficiency

Conditions: Venous Insufficiency

Summary: the purpose of this study is: -item one to use two new non-invasive technologies to evaluate scarring and swelling associated with chronic venous insufficiency. the study hypothesis: - item one non-invasive technologies can provide a tool for assessing risk of ulcer development based on the tissue edema and alteration.


Eligibility criteria:
inclusion criteria: * participants with cvi with ceap class 4 or higher * participants with no cvi class 0 exclusion criteria: * open ulcers or lower extremity amputation * diabetics with hba1c greater than 7.0 * arterial occlusive disease * bmi greater than 35 * any connective tissue disorder (lipodermatosclerosis and fibrosis) * participants with metallic prosthesis or implants * participants with renal impairment * pregnancy * inability or refusal to wear compression stockings prescribed by physician (cvi patients only)

Keywords: edema blood supply lower legs venous stasis
pulmonary fibrosis and telomerase mutation study

Conditions: Pulmonary Fibrosis

Summary: this study is an observational and retrospective study of patients with pulmonary fibrosis associated or not with telomerase mutation. the purpose of this study is to describe in detail the cases with telomerase mutation in terms of features on ct scan, respiratory function and evolution, in comparison to control subjects with idiopathic pulmonary fibrosis and no telomerase mutation identified or family history.

two "control" subjects will be enrolled for one subject with telomerase mutation. the data are all the results of investigations conducted for the diagnosis of idiopathic pulmonary fibrosis and during routine follow up of patients. the ct scans will reviewed centrally to homogenize the description.

Eligibility criteria:
inclusion criteria: * diffuse interstitial lung disease on ct scan * telomerase mutation analysis exclusion criteria: * presence of connective tissue disease, or pneumoconiosis or drug induced lung disease

Keywords: pulmonary fibrosis telomerase mutation
male stress urinary incontinence and sexual health

Conditions: Prostate Cancer

Summary: the purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health.


Eligibility criteria:
inclusion criteria: * adult men age 18-80 who have had an open or laparoscopic radical prostatectomy more than 6 months ago who have bothersome urinary incontinence. exclusion criteria: * any significant cardiac or pulmonary co-morbidities that would preclude the patient from another surgical procedure as they would be too high risk for general anesthesia. * they will also be excluded if based on their anatomy or urodynamics, they will most likely not benefit from a surgical incontinence procedure (e.g. poor bladder contractility, bladder neck contracture, etc).
bsep function rescue during childhood inhereditary cholestatic diseases

Conditions: Hereditary Diseases; Cholestasis, Intrahepatic

Summary: the purpose of the study is to improve the prognosis of inhereditary cholestasis caused by abcb11 gene mutations by using bsep function rescue drugs

bile acids function as detergents to aid digestion and as signaling molecules to regulate gene expression and metabolism. they are synthesized from cholesterol in the liver, secreted into bile and re -turned from chyme to liver in portal- vein blood 6-10 times per day (enterohepatic circulation. enterohepatic circulation of bile acids involves more than 20 transporters among which bile salt export pump (bsep), encoded by abcb11 plays a key role. bsep medi-ates the secretion of bile acids across the canalicular membrane of hepatocytes into bile to provide the osmotic pressure for bile flow. mutations in abcb11 can cause absence or dysfunction of bsep leading to cholestasis. bile acid accumulation in hepatocytes caused by bsep dysfunction is associated with a range of liver dis-eases, ranging from transient neonatal cholestasis to fatal progressive familial intrahepatic cholestasis (pfic), with jaundice, growth retardation, cirrhosis, liver failure and death. our current indicates that more than 70% patents with abcb11 mutations need liver-transplantation or dead during follow-up. in recent years, some targeted drugs including 4-phenylbutyrate(for patients with bsep trafficking abnormal), ivacaftor(for patients with abnormal bsep transport function), and gentamicin (for patients with none sense mutations) have emerged make it possible for individual targeted therapy possible.

Eligibility criteria:
inclusion criteria: * with signed informed consent form from the guardian, and the patient if applicable. * aged from 2 month to 18 years old. * with cholestatic disease caused by abcb11 biallelic mutation. * long-term residence in china. exclusion criteria: * currently receiving or previously received experimental drugs. * the child is already in the stage of liver failure, or in unstable state that are not suitable for drug treatment according to the researcher's judgment: serious complications such as bleeding tendency and skin rash. * accompany with other chronic liver disease (viral hepatitis b and c, autoimmune hepatitis, wilson disease, cystic fibrosis, primary biliary cirrhosis, biliary atresia, sclerosing cholangitis, bile acid synthesis defects, and infections, cholestasis caused by space-occupying and other reasons). * suffered from congenital torches infection, including toxoplasma gondii, rubella virus, cytomegalovirus, herpes simplex virus, eb virus, syphilis, hiv, etc. * with any other major medical conditions that may affect drug absorption, metabolism, or excretion based on the researcher's judgment. * known or suspected hypersensitivity to any experimental drugs or their indigents. * patients with alcohol or drug dependence. * in receiving any investigational drugs or within 60 days before enrollment.

Keywords: bsep abcb11 biliary diversion liver biopsy gene
peer delivered, emotion regulation-focused mental health prevention training for fire fighter trainees

Conditions: PTSD; Alcohol Use Disorder; Depression; Anxiety

Summary: the goal of this clinical trial is to determine if a peer-delivered emotion regulation training (brief-unified protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. the main questions it aims to answer are: * do firefighter recruits who receive peer-delivered brief-unified protocol report lower ptsd symptom severity over time compared to those who receive psychoeducation? * do firefighter recruits who receive peer-delivered brief-unified protocol report lower aud, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation? * do changes in neuroticism or emotion regulation mediate the effect of receiving the brief-unified protocol on the treatment outcomes? participants will: * participate in a brief-unified protocol workshop or psychoeducation workshop during fire academy training. * complete a questionnaire prior to the workshop. * complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy. researchers will compare firefighters who receive a peer-delivered brief-unified protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the brief-unified protocol is effective for preventing posttraumatic stress and other psychological health symptoms.


Eligibility criteria:
inclusion criteria: * 21 years of age or older * english speaking * able to sign an informed consent form * able to complete the self-report assessment * willing to be contacted to complete post and follow-up assessments exclusion criteria: * pregnant * have plans to relocate within two months of protocol initiation * report psychotic symptoms or suicidal behavior within the past 2 weeks * are currently dependent on substances other than tobacco or caffeine
identification of nerves using fluorescein sodium

Conditions: Pleomorphic Adenoma of the Parotid; Warthin Tumor; Head and Neck Disorder; Head and Neck; Thyroid Disease; Thyroidectomy

Summary: the purpose of this study is to see if there is benefit in using an iv contrast (sodium fluorescein) to identify nerves during head and neck surgery.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 2. 18 years or older 3. scheduled for open head and neck surgery exclusion criteria: 1. inability or unwillingness of a subject 2. pregnancy 3. vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students) 4. patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study 5. history of adverse reaction to fluorescein including allergy. 6. history of renal failure or chronic kidney disease