Kornimate/medical-research-clean huggingface dataset:
spirometric detection of esophageal intubation

Conditions: Hypoxia; Hypoventilation

Summary: in endotracheal intubation, it is essential that the trachea is intubated and not the esophagus. in suboptimal situations (outside an operating theatre), malpositioning of the endotracheal tube occurs frequently and is often fatal. the diagnostic tools that are available in the operating theatre are not appropriate for out-of-hospital situations because of several reasons. moreover, these methods mostly take some time to provide the desired information and don't have optimal specificity and sensitivity. in order to allow fast diagnosis of this potentially fatal complication, we have developed a fully-automatic detection device to diagnose endotracheal tube malpositioning within 2 seconds. a high sensitivity/specificity of the algorithm for waveform-analysis was demonstrated in healthy patients and patients with pulmonary diseases (decreased pulmonary compliance). a new stand-alone device with integrated sensors and microprocessor was developed that gives immediate diagnosis, and stores data for subsequent research purpose. this device will be evaluated in perioperative situations to demonstrate the high sensitivity and specificity in patients in a clinical setting.

the fundamental algorithm for waveform analysis is unchanged, but an additional detection algorithm is incorporated for improved detection of ventilation efforts. in addition, sensors are integrated, automatic feedback electronics are improved, and the device is made more user friendly to be appropriate for out-of-hospital situations in demanding environments. in addition, waveforms will be recorded for later analysis and evaluation of the diagnostic value of a thoracic push ( a gentle push on the sternum) to detect tube position.

Eligibility criteria:
inclusion criteria: * general anesthesia with endotracheal intubation required for the procedure * age: 18 years and older * total intravenous anesthesia with propofol (in order ro guarantee adequate hypnosis during the procedure) exclusion criteria: * oesophageal pathology * patients at risk for desaturation (spo2 \< 95%) if 20 seconds of apnoea is induced after adequate preoxygenation

Keywords: endotracheal intubation esophageal intubation
pharmacokinetic study of synera™ in neonates and infants

Conditions: Pain

Summary: this study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of synera.


Eligibility criteria:
inclusion criteria: * subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg. * subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit. * subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. the indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study. * the additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject. exclusion criteria: * subject has known allergies or sensitivities to any component of synera. * subject has clinically significant laboratory abnormalities. * subject has known multiple allergies that could indicate hypersensitive skin. * subject has known active atopic dermatitis at or near the patch application site.
all-trans retinoic acid (atra) in the treatment of recurrent/metastatic adenoid cystic carcinoma of the head and neck

Conditions: Adenoid Cystic Carcinoma of the Head and Neck

Summary: this is a prospective, open-label, randomized controlled clinical intervention study to evaluate the efficacy and safety of all-trans retinoic acid (atra) in treating patients with recurrent metastatic adenoid cystic carcinoma of the head and neck.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, male or female; 2. ecog ps (performance status) score: 0-1; 3. pathologically or histologically confirmed advanced, recurrent/metastatic acc, with measurable disease (≥10 mm by spiral ct scan, meeting recist 1.1 criteria); 4. patients with therapeutic indications; 5. main organ functions normal, i.e., meeting the criteria below: 1. criteria for routine blood test: (no blood transfusion within 14 days) 1. hb ≥ 90 g/l; 2. wbc ≥ 3.5 × 109/l and \< 10 × 109/l; 3. anc ≥ 1.5 × 109/l; 4. plt ≥ 80 × 109/l 2. criteria for biochemical tests: 1. bil \< 1.25 × upper limit of normal (uln) 2. alt and ast \< 2.5 × uln; in the presence of metastases to liver, alt and ast \< 5 × uln; 3. serum cr ≤ 1 × uln, endogenous creatinine clearance \> 50 ml/min (cockcroft-gault equation); 5. subjects who volunteer to participate in this study, sign the informed consent, have good compliance and cooperate in follow-up; 6. patients who, in the doctor's opinion, can benefit from the treatment. exclusion criteria: 1. previous or existing concomitant malignancies except cured skin basal cell carcinoma or cervical carcinoma in situ; 2. coagulation abnormal (inr\>1.5, aptt\>1.5×uln), history of gastrointestinal hemorrhage in the past 6 months or bleeding tendency \[e.g., presence of active ulcer focus in the stomach, stool occult blood (++), melena and/or hematemesis, hemoptysis in the past 3 months\]; 3. confirmed hypersensitivity to atra; 4. grade i and above coronary artery diseases, arrhythmias \[including qtc prolongation (males: \> 450 ms, females: \> 470 ms)\] and cardiac dysfunction; 5. presence of multiple factors affecting oral administration (e.g. dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 6. pregnant or lactating women; 7. history of psychotropic abuse with abstinence failure, or existing mental disorder; 8. participation in other drug clinical trials within 4 weeks; 9. other concomitant diseases which seriously jeopardize the patient's safety or prevent the patient from completing the study, as judged by the investigator.
does timing of completion radical cholecystectomy determine the survival in incidental carcinoma gallbladder

Conditions: Gall Bladder Carcinoma; Survival

Summary: various factors determine the long term survival in this non-uniform cohort of incidental gallbladder cancer. timing of re-intervention is suggested to play an important role in the outcome. few centers are proponents of early surgery in order to prevent dissemination, while others have suggested an intentional delay of 3 months to filter out cases with aggressive pathology. in the present study, investigators intend to evaluate the factors affecting survival in incidental gallbladder cancer (igbc) with special reference to timing of re-intervention.

surgical gastroenterology department at our institute is a tertiary referral center for hepatobiliary malignancies; covering a large part of north and north-east india. the details and progress reports of patients of gallbladder cancer (gbc) being referred to and treated at the institute is maintained in a prospective manner on hospital data base. this includes demographic data, presenting complains, details of relevant investigations done outside and in the hospital, previous surgery, pre-hospital course, operative findings, post operative course and final histopathology. being a retrospective analysis of data not affecting clinical outcomes, ethical approval was not taken. during the study period (jan 2009 to dec 2018), 1049 participants with diagnosis of gbc (including 91 igbc participants) were admitted; 239/958 participants with diagnosis of gbc and 48/91 with diagnosis of gbc could undergo resection with curative intent. information regarding adjuvant therapy, recurrence, and survival were retrieved through data maintained on follow up out-patient cards till december 2019. few participants who stopped visiting the hospital were contacted telephonically or through letters. all available histopathology blocks and slides following the index cholecystectomy were re-reviewed by the pathologists in the institute. tumor type, differentiation and primary t stage were documented for majority of cases. interval between index cholecystectomy and date of re-operation was calculated for all the participants and divided into 3 groups: early (\ 12 weeks). primary objective was to assess the effect of tumor characteristics and the time gap (between index surgery and re-resection) on overall survival following curative (r0/r1) resection.

Eligibility criteria:
inclusion criteria: all incidental carcinoma gallbladder patients who could undergo curative resection during the study period (jan 2009 to dec 2018) exclusion criteria: metastasis on preoperative investigation or on staging laparoscopy

Keywords: incidental gallbladder cancer re-resection survival
study of the vaginal microbiota and the potential of a vaginal probiotic cream in vaginal candidosis

Conditions: Candidiasis, Vulvovaginal

Summary: this study evaluated the effect of a vaginal gel containing three live probiotic bacteria on vaginal candida albicans infection in flemish patients (n=20). the therapeutic effects of the gel will be clinically evaluated (vaginal ph, microscopic and clinical scores). the effect on the vaginal microbiome will be evaluated through 16s ribosomal rna amplicon sequencing via miseq illumina and polymerase chain reaction (pcr) for candida albicans.


Eligibility criteria:
inclusion criteria: * informed consent * willing to adhere to protocol * premenopausal * positive candida microscopy and/or culture * at least two of the following vaginal symptoms: burning, itching, redness, fissure, discharge, vulvar edema, postcoital itching, lesions with partner exclusion criteria: * vaginal use of any products 1 week or less before randomization * use of oral or local antimycotic treatment 1 week or less before randomization * unprotected sexual contact 24 hours preceding randomization * vaginal douching 24 hours preceding randomization * patient does not agree to participate in the study

Keywords: vaginal, yeast infection, candida, candidosis
post-conditioning to reduce infarct size

Conditions: Myocardial Infarction

Summary: when angioplasty (ptca) and stenting of the blood vessels of the heart is the treatment for a heart attack, there is damage to the heart muscle that is caused by the sudden opening of the blood vessels. this is called "reperfusion injury". the cell death is due to inflammation and the generation of free radicals. the primary objective of this study is to determine if post-conditioning(four brief (30 second) ptca balloon inflations) reduces damage to the heart muscle. this will be measured by heart enzyme tests-ck measurements- and by cardiac mri.


Eligibility criteria:
inclusion criteria: * age ≥ 18 \< 80 * able to give informed consent * 100% occlusion of a major epicardial vessel with timi 0 flow exclusion criteria: * significant collateral blood flow to the distal vasculature of the occluded vessel. * previous cabg * previous q-wave myocardial infarction in the same territory

Keywords: reperfusion injury post-conditioning infarct size
calcium-phosphate complications induced by iv iron supplementation in patients with rendu-osler disease

Conditions: Rendu Osler Disease

Summary: hypophosphatemia induced by treatments with injectable iron is a frequent side effect already reported during marketing. situations of osteomalacia secondary to these hypophosphatemias are rarer and reported in the form of case reports in the literature. hypophosphatemia in this context is attributed to an excess of fgf-23 (defect of degradation linked to carbohydrates in martial preparations) with renal leakage of phosphate. rendu-osler disease (rom) is an autosomal dominant genetic disease, favoring the formation of vascular malformations, including nasal and digestive telangiectasias causing repeated bleeding, even hemorrhages. iron deficiency is frequent and profound there, and oral martial treatments are often insufficient to compensate for these losses. regular iron infusions, to avoid transfusions, are often necessary.


Eligibility criteria:
inclusion criteria: * major subject (≥ 18 years old) * suffering from rendu-osler disease and receiving iv iron supplementation * subject not objecting, after information, to the reuse of their data for scientific research purposes exclusion criteria: * subject who expressed their opposition to participating in the study * subject under safeguard of justice * subject under guardianship or curatorship

Keywords: rendu-osler disease hypophosphatemia injectable iron osteomalacia carbohydrates iron deficiency
folfirinox followed by ipilimumab with pancreatic tumor vaccine in treatment of metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Adenocarcinoma

Summary: this study will enroll patients who have metastatic pancreatic cancer with stable disease on folfirinox chemotherapy. the main purpose of this study is to compare survival between patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to receive folfirinox. funding source - fda office of orphan product development (oopd)


Eligibility criteria:
inclusion criteria (abbreviated): 1. documented adenocarcinoma of the pancreas 2. stable metastatic pancreatic cancer after 8-12 doses of folfirinox 3. eastern cooperative oncology group (ecog) performance status of 0 or 1 4. life expectancy greater than 3 months 5. adequate organ and marrow function defined by study-specified laboratory tests. 6. must use acceptable form of birth control while on study 7. oxygen saturation on room air \>92% exclusion criteria (abbreviated): 1. surgery within 4 weeks of dosing investigational agent (some exceptions for minor procedures) 2. off folfirinox treatment for more than 70 days prior to treatment on study 3. prior chemotherapy for metastatic pancreatic cancer (other than folfirinox or adjuvant therapy). 4. history of prior treatment with ipilimumab, anti-pd1 antibody, cd137 agonist, or anti-cd40 antibody 5. received any non-oncology live vaccine therapy up to one month prior to or after any dose of ipilimumab/vaccine 6. receiving any other investigational agents 7. any of the following concomitant therapy: il-2, interferon, immunosuppressive agents, or chronic use of systemic corticosteroids 8. history of symptomatic autoimmune disease or immune impairment. thyroid disease is allowed. 9. known brain metastasis 10. radiographic ascites that is apparent on physical exam or requiring intervention in the 2 months prior to enrollment 11. uncontrolled intercurrent illness 12. known or suspected hypersensitivity to gm-csf 13. chronic hiv, hepatitis b or hepatitis c 14. pregnant or breastfeeding women

Keywords: pancreatic cancer vaccine immunotherapy ipilimumab cytotoxic t-lymphocyte-associated protein 4 (ctla-4) antibody folfirinox
gut microbiota analysis in patients undergoing duodencephalopancreasectomy for pancreatic cancer

Conditions: Pancreatic Cancer, Adult

Summary: pancreatic head cancer represents one of the most frequent malignancies with an incidence of about 13500 new cases each year. the primary objective of the study is to test whether there are bacterial species associated with increased risk of complications in patients with peri-ampullary neoplasia undergoing dcp.

pancreatic head cancer represents one of the most frequent malignancies with an incidence of about 13500 new cases each year. the only curative strategy for such neoplasm is still surgical resection by duodenocephalopancreasectomy (dcp) surgery. however, this procedure has a postoperative morbidity of about 70% with a severe complication rate of 20%. the most frequent complications are pancreatic fistula, biliary fistula, and infectious complications in general. these complications often account for a high postoperative mortality rate that even in high-volume centers reaches 5%. although some predictive risk factors are known (comorbidities and the patient's age, the consistency of the pancreatic stump to be anastomized and/or type of pathology treated), there is still no study that has evaluated the influence of the gut microbiota in the determinism of complications. this hypothesis appears suggestive and supported by indirect evidence from the literature. some preliminary studies performed in the field of colo-rectal surgery have shown that the presence of certain bacterial families such as lachnospiraceae or bacteroidaceae are correlated with a significant increase in anastomotic dehiscence. low microbial diversity also appears to be correlated with increased risk of anastomotic dehiscence. in contrast, the presence of other species such as prevotella copri or streptococcus genus seem to correlate with a reduced risk of dehiscence. the primary objective of the study is: to test whether there are bacterial species associated with increased risk of complications in patients with peri-ampullary neoplasia undergoing dcp. other objectives to be verified are: 1. the association between bacterial species and the occurrence of pancreatic fistula in terms of frequency and severity 2. the association between bacterial species and the occurrence of biliary fistula in terms of frequency and severity 3. the association between bacterial species and the occurrence of infectious complications of any kind.

Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of resectable pancreatic adenocarcinoma with indication for "upfront" surgical treatment * asa (american society of anesthesiology) score \< 4 * obtaining informed consent exclusion criteria: - pregnant or lactating women

Keywords: pancreatic cancer
effect of banaba (lagerstroemia speciosa) on metabolic syndrome, insulin secretion and insulin sensitivity

Conditions: Metabolic Syndrome X

Summary: the metabolic syndrome is a high prevalence disease worldwide. about a quarter of the adult population suffers the disease. banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion. the investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

a randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the international diabetes federation (idf). waist circumference, glucose, insulin levels, and lipid profile were evaluated after a 75 g of dextrose load. 12 received banaba, 500 mg, two times per day (1000 mg) before meals during 3 months. the remaining 12 patients received placebo with the same prescription. area under the curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (stumvoll index) and insulin sensitivity (matsuda index). this protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers. results are presented as mean and standard deviation. intra and inter group differences were tested using the wilcoxon signed-rank and mann-whitney u-test respectively; p≤0.05 was considered significant.

Eligibility criteria:
inclusion criteria: * patients both sexes, * age between 30 and 60 years, * metabolic syndrome according to the idf criteria * waist circumference * man ≥90 cm * woman ≥80 cm and two of the following criteria: * high density lipoprotein * man ≤40 mg/dl * woman ≤50 mg/dl * fasting glucose ≥100 mg/dl * triglycerides ≥150 mg/dl * blood pressure ≥130/85 mmhg * informed consent signed exclusion criteria: * women with confirmed or suspected pregnancy * women under lactation and/or puerperium * hypersensibility to resveratrol * physical impossibility for taking pills * known uncontrolled renal, hepatic, heart or thyroid diseased * previous treatment for the metabolic syndrome components * body mass index ≥39.9 kg/m2 * fasting glucose ≥126 mg/dl * triglycerides ≥500 mg/dl * total cholesterol ≥240 mg/dl * low density lipoprotein (c-ldl) ≥190 mg/dl * blood pressure ≥140/90 mmhg

Keywords: metabolic syndrome central obesity banaba insulin secretion insulin sensitivity
iris : use of implantable defibrillator in high-risk patients early after acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. the prognosis appears not improved by medication with antiarrhythmics (class i/iii). a positive effect of beta-blockers (metoprolol cr/zok) on total mortality after myocardial infarction in patients with heart failure is well established. on the other hand, an implantable defibrillator (icd) proved to be superior to medication when used for secondary prevention in patients after cardiac arrest. the question arises whether icd therapy is also effective in primary prevention in high risk patients after acute myocardial infarction. this study determines if patients, who were defined as high risk patients in the early post infarction phase by means of noninvasive methods, benefit from primary prevention by means of an icd. special emphasis is put on an individual optimization of the infarction therapy, including beta-blockers.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction (5-31 days) * fulfill requirement i and/or ii : * i first ecg heart rate \>= 90 bpm (within day 1-2 post mi) and lvef \<= 40 % (within day 5-31 post-mi) * ii \>= 1 episode of non-sustained ventricular tachycardia \>= 150 bpm (on holter, within 5-31 days post-mi) exclusion criteria: * patients with ventricular arrhythmia, requiring clinical therapy, before the index infarction or more than 48 h later * patients with therapy refractory heart failure (nyha iv) * myocardial infarction older than 31 days * first-ecg not available or was recorded more than 48 h after the symptom onset. * patients with indication for cabg operation before inclusion * patients with cerebral organic psycho syndrome * secondary diseases which clearly limit life expectancy * patient with right sided artificial heart valve * patients with poor compliance * patients who are participating in another study * unstable clinical condition * pregnancy * no consent from patient

Keywords: acute myocardial infarction non-sustained ventricular tachycardia left ventricular dysfunction implantable cardioverter defibrillator icd risk-stratification
effect of electroacupuncture on p6 acupoint on hypertensive patients.

Conditions: Hypertension

Summary: this is a randomized controlled clinical trial with three parallel arms. this trial aims to evaluate the effectiveness of electroacupuncture on p6 acupoint for patients with hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.


Eligibility criteria:
inclusion criteria: * patients above 18 years old * have not recently had any changes in anti-hypertensive medications * have not recently been discharged from hospital/are stable * is not having any acute infection. exclusion criteria: * trypanophobia * below 18 years of age * is currently having an acute infection * is unstable or have been discharged recently from hospital * changes made to anti-hypertensive medications

Keywords: acupuncture