Kornimate/medical-research-clean huggingface dataset:
health and aging brain study: health disparities tau positron emission tomography (pet) scan study

Conditions: Alzheimer Disease

Summary: the purpose of this project is to study the aging brain among participants enrolled in the health and aging brain study: health disparities project . there are a number of things that can influence how people think as they age, including diabetes, depression, as well as our biology. in this study, the investigators seek to study the aging brain by using brain pet scans that create detailed pictures of the brain.

there are a number of things that can influence how we think as people age, including diabetes, depression, as well as our biology. in this study, the investigators are using pet scans with a tracer to create detailed pictures of the brain. this information will be used to help the investigators understand how the brain ages and in the future could be used to develop better diagnostics and treatments for alzheimer's disease and memory loss in mexican americans, african americans, and non-hispanic whites. the goal of this study is to address this disparity by enrolling ethnically diverse participants in this study.

Eligibility criteria:
inclusion criteria: 1. enrolled in the health and aging brain study hd: health disparities project 2. provided consent to re-contact 3. willing and capable of undergoing pet scan of the head exclusion criteria: 1. inability to provide informed consent by self or by proxy. 2. pregnant or breast feeding women\* 3. history of alcoholism or drug dependency/abuse within the last 2 years before screening 4. hypersensitivity to the active substance or to any of the following excipients is contraindicated: sodium dihydrogen phosphate, phosphoric acid, sodium ascorbate, ethanol (anhydrous), water for injection 5. participants may not be in this study if they do not meet the safety criteria to undergo imaging procedures.

Keywords: alzheimer's disease tau pet scan health disparities brain aging
measuring exhaled nitric oxide (eno) using the apieron insight system and the aerocrine niox system

Conditions: Asthma

Summary: collection of quantitative data to demonstrate the accuracy (bias) and precision (repeatability) of the apieron insight(tm) eno breath system as compared to the fda cleared niox eno breath system when testing is performed by asthma patients.

a non-randomized, prospective study of up to 150 subjects with asthma. patients will perform eno testing with the apieron insight(tm) eno system and the niox eno system at the physician's office/clinic after a short demonstration and training by a healthcare professional trained in the use of the devices. exhaled no testing involves inhaling to lung capacity, and then performing a controlled exhalation into a mouthpiece connected to each of the apieron insight(tm) and niox systems. patients will perform an eno measurement with the apieron insight(tm) system and with the fda cleared niox system for the accuracy portion of the study. patients will perform 2 sequential eno measurements on each system for the precision part of the study. subjects that measure eno values over 100 ppb will be asked to repeat 2 sequential eno measurements on each system.

Eligibility criteria:
inclusion criteria: * age 5 or older * pre-existing diagnosis of asthma * non-smoker exclusion criteria: * chronic inflammatory lung disease other than asthma * medical conditions that preclude hand-eye coordination

Keywords: asthma nitric oxide eno feno apieron insight aerocrine niox
propofol versus midazolam in sedation for upper and lower gastrointestinal endoscopy.

Conditions: Gastrointestinal Diseases

Summary: there has been rapid growth in the number and complexity of gastrointestinal (gi) endoscopic procedures performed during the last decade. to ensure safe and effective upper gi endoscopy, the choice of an appropriate sedative agent is crucial. sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. the upper gastrointestinal \[gi\] endoscopy usually performed under moderate sedation sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. the upper gastrointestinal \[gi\] endoscopy usually performed under moderate sedation. benzodiazepines still the most common sedative agents used for conscious sedation, either solely or in combination with opioids for upper gi endoscopy. propofol is a hypnotic drug used for induction of anesthesia with short half-life that permits rapid patient recovery and discharge. thus, its use is for upper gi endoscopy was adopted in many endoscopy centers. so we are going to evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.also we are going to evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.


Eligibility criteria:
inclusion criteria: age18 to 80 american society of anesthesiologists (asa) class i-ii informed consent. patients scheduled for upper and lower endoscopy. exclusion criteria: chronic use of drugs as benzodiazpines, neuroleptics and anticonvulsants for more than 30 days. hypersensitivity reactions to drugs used in the study. psychiatric patients. pregnancy. being submitted to endoscopy as an emergency procedure.
sofosbuvir/velpatasvir fixed dose combination for 12 weeks in adults with chronic hepatitis c virus (hcv) infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (sof/vel) fixed-dose combination (fdc) for 12 weeks in adults with chronic hepatitis c virus (hcv) infection.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * hcv rna detected at screening * chronic hcv infection (≥ 6 months) documented by medical history or liver biopsy * classification as treatment naïve or treatment experienced. approximately 20% may be treatment-experienced. * cirrhosis determination (approximately 20% may have cirrhosis) * females of childbearing potential must have a negative urine pregnancy test at screening and on day 1 prior to enrollment. * male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol * lactating females must agree to discontinue nursing before the study drug is administered * adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments key exclusion criteria: * current or prior history of any of the following: * clinically-significant illness (other than hcv) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol * clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) * liver transplantation * hepatocellular carcinoma (hcc) (as determined by appropriate imaging at screening for those with cirrhosis) or current malignancy for which the patient is receiving treatment or which may interfere with individual's treatment, assessment or compliance with the protocol. * screening laboratory parameters outside of defined threshold * prior exposure to hcv ns5a inhibitor * pregnant or nursing female * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * use of any prohibited concomitant medications as described in study protocol * known hypersensitivity to vel, sof, or formulation excipients note: other protocol defined inclusion/exclusion criteria may apply.
postoperative analgesia with a catheter under the erector spinae muscle for videothoracoscopic lung surgery

Conditions: Neoplasm of Lung; Thoracic Surgery, Video-Assisted

Summary: the purpose of the research is to prove the analgesic efficacy of a novel technique in regional anaesthesia, i.e. the catheter under the erector spinae muscle (esc). investigators will evaluate the use of the esc for analgesia after video-assisted thoracoscopic lung surgeries in comparison to the standard method of post-operative analgesia, which is the multiple level intercostal block given at the end of surgery by the surgeon. investigators will compare the amount of opioid analgesics required by the patient using the patient controlled pump, the pain status in 48-hours after surgery and compare the differences between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.


Eligibility criteria:
inclusion criteria: * signed written informed consent * asa (american society of anesthesiologists status) i-iii * elective video-assisted thoracic surgery - lobectomy with 3 ports technique * no contraindications for regional anesthesia exclusion criteria: * allergy to local anesthetic * pregnancy, breastfeeding * bmi\>35 * inflammation in the area of es catheter insertion * inability to use the pca pump * inability to execute the main inspiratory and expiratory pressure measurements

Keywords: anesthesia, conduction regional anesthesia post-operative analgesia
intensive versus standard treatment for spinal anesthesia-induced hypotension in preeclamptic patients

Conditions: Adverse Effect

Summary: the objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes in preeclamptic patients following cesarean section.

post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. the 2016 asa guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. the 2018 international consensus in the united kingdom and northern ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. the objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes in preeclamptic patients following cesarean section.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥32 weeks * american society of anesthesiologists physical status classification i to iii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * baseline blood pressure ≥160 mmhg * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly
laparoscopic transvaginal hybrid anterior resection: a prospective data collection

Conditions: Sigmoid Diverticulitis (Hinchey I and II); Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis

Summary: transvaginal hybrid procedures are of interest as an available notes-procedure for the clinical routine. few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. in 2008 lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. the aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine. therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.


Eligibility criteria:
inclusion criteria: * given informed consent * sigmoid diverticulosis (two or more attacks) * sigmoid diverticulitis (hinchey i and ii) exclusion criteria: * asa iv * emergency surgery * liver-malfunction or coagulation disorders * acute diverticulitis (hinchey iii and iv) * malignancy * acute vaginal infection * refusal of mandatory preoperative gynecological examination * pregnancy * endometriosis * previous surgery of colon and rectum * strongly retroflexed uterus * acute pelvic disorders, infection
determine the incidence of long qt amongst a large cohort of subjects diagnosed with unilateral or bilateral sensorineural hearing loss.

Conditions: Sensorineural Hearing Loss; Long QT Syndrome

Summary: the purpose of this study is to determine the true incidence of long qt (lqt) amongst a large cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing loss.

the purpose of this study is to determine the true incidence of long qt (lqt) amongst a large cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing loss. the goal of this study is to answer the following questions: 1. what is the incidence of an abnormal ecg (qtc \> 450 msec) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss? 2. what percentage of neonates greater than one week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ecg have an identifiable genetic mutation? 3. what is the incidence of an abnormal genetic mutation consistent with long qt regardless of the ecg in neonates with bilateral sensorineural hearing loss?

Eligibility criteria:
inclusion criteria: * all newborns who demonstrate a refer in one or both ears on a routine newborn hearing screen * documentation of informed consent * inborn * ability to perform an abr (auditory brainstem response screen technology) screening test * no major anomalies * subjects' parents willing to provide follow-up data on their child exclusion criteria: * newborns with a syndromic cause of hearing loss * parents unwilling to provide follow-up data * major congenital anomalies * major medical problem or conditions. (i.e., hypoxic ischemic encephalopathy (hie), persistent pulmonary hypertension neonate (pphn), meconium aspiration, etc.) * congenital cytomegalovirus (cmv)

Keywords: sensorineural hearing loss long qt syndrome
a trial to assess the efficacy and safety of biochaperone combo and humalog mix 25 in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: biochaperone combo is a liquid formulation containing both insulin glargine and insulin lispro. the aim of this trial is to assess the efficacy and safety of biochaperone® combo in subjects with type 1 diabetes under a dose of 0.8 u/kg. this trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. each subject will be randomly allocated to one single dose of 0.8 u/kg of biochaperone® combo and to one single dose of 0.8 u/kg of humalog® mix 25 on two separate dosing visits.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for at least (or equal to ) 12 months, * treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months, * body mass index (bmi): 18.0-28.0kg/m2 (both inclusive) exclusion criteria: * type 2 diabetes mellitus, * the receipt of any investigational product within 3 month prior to first dosing, * clinically significant abnormalities, as judged by the investigator, * any systemic treatment with drugs known to interfere with glucose metabolism, * history of alcoholism or drug/chemical abuse and any tobacco product within 5 years prior to screening * blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
diagnostic agreement of ifr and qfr.

Conditions: Fractional Flow Reserve, Myocardial; Coronary Artery Disease

Summary: a prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between qfr and the pressure wire-based ifr in a real world setting.

during coronary angiography, intermediate stenoses can not be adequately assessed by visual assessment alone. it is necessary to evaluate the functional significance to guide their treatment. fractional flow reserve (ffr) is the current gold standard for determining this functional significance but its adoption in clinical practice remains low. the instantaneous wave-free ratio (ifr) is an alternative way to determine the flow-limiting characteristics of a coronary stenosis with a pressure wire but without the need to induce hyperemia. large randomised trials have confirmed the non-inferiority of ifr in respect to ffr in terms of outcome. quantitative flow ratio (qfr) is another new method for evaluating the functional significance of coronary stenosis it is a software-based analysis of conventional angiographic images to estimate the pressure drop caused by a coronary stenosis. the diagnostic agreement with ffr seemed promising in the favor pilot study and a larger trial is enrolling for confirmation. a stepwise approach of qfr and ifr could make the functional assessment of intermediate stenoses more practical and cost-effective. however before being used as a combination in daily practice, qfr has to be validated in respect to ifr. the primary objective of the trial is to investigate the diagnostic agreement between qfr and the pressure wire-based ifr in a real world setting

Eligibility criteria:
inclusion criteria: * age \> 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing) * patients witch semi recent (\>3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction. * willing to participate and able to understand, read and sign the informed consent document before the planned procedure * eligible for coronary angiography and/or percutaneous coronary intervention * coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram. exclusion criteria: * contraindication to adenosine administration * previous coronary artery bypass surgery with patent grafts to the interrogated vessel

Keywords: instantaneous flow ratio quantitative flow ratio fractional flow reserve
volumetric imaging follow up of patients with liver metastases of small intestinal neuroendocrine tumors (nets).

Conditions: Neuroendocrine Tumors; Liver Metastases

Summary: more than 50% of intestinal nets are metastatic at the time of diagnosis, the liver being the main affected organ in 50-90% of cases. initial liver tumor burden and slope of the tumor growth rate are two major prognostic factors in patients with intestinal nets, followed by tumor grade at pathology. they are used in routine practice by oncologists to adapt patient treatment. unlike other tumors, most nets metastases are slow-growing tumors. previous studies have shown that approximately half of the patients diagnosed with liver metastases showed no progression over a period of 3 to 6 months. the aim of this non randomised retrospective cohort study is to investigate whether the volumetric monitoring of the total tumor burden compared to the recist 1.1 criteria (used in routine practice by radiologists) at baseline and early follow-up (3 to 6 months) is more suitable for nets, making possible to predict the prognosis at the onset of the disease, and also allowing a better adaptation of the treatment. the secondary objectives are to evaluate if the initial volume of the liver tumor is a prognostic factor of time to progression, to correlate the initial liver tumor volume and the number of liver lesions to the blood concentration of chromogranin a (cga), the presence of extra-abdominal disease and to correlate the tumor growth rate (tgr) and ki 67 (%) at base-line.


Eligibility criteria:
inclusion criteria: * well differentiated intestinal neuroendocrine tumor with at least one liver metastasis * the liver metastasis must be visible and measurable on ct scans or mri * patients monitored without invasive liver treatment : surgery, rf ablation / trans-arterial chemoembolization * patients monitored without systemic treatment such as: chemotherapy, everolimus, sunitinib (somatostatin analogues allowed) * surgery of the primary tumor allowed exclusion criteria: * other type of nets * absence of liver metastases * liver metastases not visible on ct scans/mri, poorly limited lesions and small target lesions ( less than 10mm) that are difficult to measure * lesions visible only on diffusion-weighted imaging -mri acquisitions, thus presenting poorly limited contours * invasive liver treatment : surgery, radio frequency / trans-arterial chemoembolization * systemic treatments: chemotherapy / everolimus / sunitinib * insufficient follow-up data
genetic and blood biomarkers in neurological and neuromuscular diseases

Conditions: Neurological Disorders; Neuromuscular Disorders

Summary: the purpose of this study is to identify genetic or other factors in the subjects blood that may predispose them to getting a particular disease or tell researchers how the disease will behave, for example how fast it will progress or what areas of the body might be affected. a second goal is to relate such factors to how such a condition affects the subjects clinically as well as how it affects the electrical functions of nerves and muscles.

the etiology of many neurological and neuromuscular disorders is largely unknown. contributions likely come from both inherited and environmental factors. amyotrophic lateral sclerosis ("als") is a prototypical example. in 5-10% of cases, genetic mutations exert a strong enough influence on disease development that the syndrome is transmitted in a clearly mendelian fashion. investigations in these "familial" als cases have identified more than 20 causative disease genes. intensive study of these genes has helped identify several key cellular pathways as important for disease, not only in cases with obvious gene mutations, but even in the 90% of als cases that appear to be "sporadic." further insights have come from investigating blood biomarkers in als such as gene and protein expression and lymphocyte profiling. it is hoped that further genetic and biomarker analysis will identify additional genetic risk factors or biomarkers to better understand the disease and improve therapeutic development. these advances can be applied not just to als but to the broad range of neurological and neuromuscular diseases, including charcot marie tooth neuropathy, the muscular dystrophies, epilepsies, parkinson's disease, and alzheimer's disease.

Eligibility criteria:
inclusion criteria: * subjects will be individuals with neurologic or neuromuscular disease who are deemed well-enough for sample collection. exclusion criteria: * subjects who are not willing to undergo sample collection, genetic analysis, or unwilling to share clinical information or their samples. * pregnant women will also be excluded.