Kornimate/medical-research-clean huggingface dataset:
janus feasibility study

Conditions: Sleep Apnea Syndromes

Summary: the purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® system or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years old * subject with moderate to severe central sleep apnea is undergoing a de novo commercial remedē® system implant procedure or other de novo transvenous cardiac implantable device procedure including a pacemaker or an implantable cardiac defibrillator * subject is willing and able to give informed consent exclusion criteria: * subject is unable or unwilling to participate with study procedures or in the investigator's opinion is medically unstable for the procedure (medically unstable is defined as when a patient is expected to have worsening health status if additional procedure time is needed) * subject is pregnant or planning to become pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to the implant) * subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator * subject has body mass index (bmi) \> 40 kg/m2 at the time of implant * subject has had prior neck surgery * previous or currently implanted upper airway stimulation device * subject has had prior oral cavity surgery that may interfere with breathing * subject has significant upper airway-related anatomic anomaly * subject is enrolled in concurrent study that may confound the results of this study * subject is taking muscle relaxant medication unless approved by the site implanter and zoll respicardia clinical staff * subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue
safety study of cenderitide in stable chronic heart failure

Conditions: Heart Failure

Summary: planned enrollment is approximately twelve subjects with stable chronic heart failure. enrolled subjects will receive up to eight sequential days of continuous, stepwise, dose increasing, subcutaneous (sq) infusions of open-label cenderitide via the insulet drug delivery system. planned infusion rates of cenderitide will be administered to subjects continuously during four, 48-hour infusion periods.


Eligibility criteria:
key inclusion criteria: * male or female, ≥ 18 years of age * body mass index (bmi) of 18-40 kg/m2, inclusive * current or historical new york heart association (nyha) functional class ≥ ii * at least one of the following: documented systolic heart failure with an ejection fraction (ef) ≤ 40% and/or a historical measurement of plasma bnp ≥ 150 pg/ml (or nt-probnp ≥ 600 pg/ml) * systolic blood pressure 100-160 mmhg * stable and compliant treatment with oral heart failure medications for at least 4 weeks prior to screening key exclusion criteria: * known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds * current clinical diagnosis of acute decompensated heart failure (adhf) * clinical diagnosis of acute coronary syndrome (acs) within 30 days prior to screening. * symptomatic postural hypotension * evidence of uncorrected volume or sodium ≤ 130 mmol/l or other condition that would predispose the patient to adverse events * clinically significant aortic or mitral valve stenosis * acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns) * severe renal failure defined as creatinine clearance \< 45 ml/min as estimated by either the cockcroft-gault or the mdrd equations * significant pulmonary disease (e.g., history of oral daily steroid dependency, history of carbon dioxide (co2) retention or need for intubation for acute exacerbation, or currently receiving iv steroids) * known hepatic impairment as indicated by any of the following: a) total bilirubin \> 3 mg/dl; b) albumin \< 2.8 mg/dl, with other signs or symptoms of hepatic dysfunction; c) increased ammonia levels, if performed, with other signs or symptoms of hepatic dysfunction

Keywords: chronic heart failure natriuretic peptides cenderitide
early screening of autism spectrum disorder in general and pediatric practices

Conditions: Autism Spectrum Disorder

Summary: early screening for autism spectrum disorder has been validated using different screening tools, in particular m-chat-r and itc in different countries. unfortunaltely, in france, they are not often used. thus, medium age for diagnosis in france is late. yet, early interventions has shown efficiency (grade b of has 2010 recommendations, has 2018) . the american have described an efficient method using partnership between pediatricians and autism specialists (miller et al). autism spectrum disorders concern 1% of population. the third autism plan in france then has 2018 recommandations and the 2018 national strategy for autism have propose to implement three levels for early diagnostic : the frontline is constituted by professionals who can detect the firsts signs ( in nurseries, general practice, pediatric practice, early childhood centers), the second line is constituted by the proximity network of professionals who can diagnose " simple " autism ( cmp, camsp, neurologic pediatricians), the third line is constituted by expert teem in specialized hospital centers for neurodevelopmental disorders diagnostic. this organization is, for now, not efficient. first lines professionals are not always formed to autism detection. when the screening is efficient, professionals have difficulties to address children to proximity teem trained to autism diagnostic because of delays or lack of professionals. the second line professionals are note always trained to use diagnostic tools and tend to address all the children to the third line, even when the diagnostic is not complex. the third lign is saturated by all these requests.

the investigator propose to improve autism screening in our region of rhône-alpes basing on the detection in nursery, and by first line doctors in order to diagnose autism before 3 year of age. after screening, a specialized teem will realize a follow-up by phone to guide practitioners to a diagnostic teem in proximity. early screening realized near family house is compulsory to facilitate accessibility and collaboration between professionals. diagnostic should be realized in a three month delay, conform to the recommendations. our project proposes to screen the general population of children who hasn't been screened yet for autism.

Eligibility criteria:
inclusion criteria: * patients aged between 16 and 24 months exclusion criteria: * patient with previous autism spectrum disorder (asd) diagnostic

Keywords: autism spectrum disorder screening itc m-chat-r
predictive ability of intra-abdominal pressure for mortality in patients with severe acute pancreatitis

Conditions: Acute Pancreatitis; Intra-Abdominal Hypertension

Summary: severe acute pancreatitis (sap) is an acute inflammatory condition of the pancreas characterized by organ dysfunction and increased mortality. increased intra-abdominal pressure(iap) in sap is a result of inflammation of pancreatic and peripancreatic tissue, aggressive fluid resuscitation and increased capillary permeability, which is associated with organ dysfunction, by limiting the vascular supply to the tissue. abdominal compartment syndrome (acs) is defined as iap greater than 20 mm of hg and is considered an abdominal catastrophe. intra-abdominal hypertension (iah, intra-abdominal pressure \> 12mm of hg), may contribute to early organ dysfunction, acs and eventually hemodynamic collapse if left untreated. this signifies the need for determining the burden of the condition and identifying the high risk patient group who are prone to develop iah /acs and predicting mortality associated with the condition. measurement of iap will be done indirectly by measuring intravesicular pressure using modified kron's method. iap will be measured at the time of admission into intensive care unit (icu) and every day thereafter during the initial five days of icu admission. any reading of iap ≥12 mm of hg shall be considered as iah. sofa and apache ii score will be noted on the day of admission in the icu. any interventions, surgical or non surgical as per clinician's decision will be recorded. the patients will be followed up until discharge or mortality until 30 days. the proposed study aims to assess the predictive ability of iap during the first 5 days of icu admission for predicting mortality in patients with sap. prediction accuracy will also be compared with sofa and apache ii scores.


Eligibility criteria:
inclusion criteria: \>patients with severe acute pancreatitis in the age group of 18-65 years admitted to icu within 72 hours of onset of symptoms exclusion criteria: * previous history of any abdominal or pelvic surgery * known case of bladder tumor or bladder abnormality. * difficulty in urinary catheterization * use of neuromuscular blockade * pregnant patients

Keywords: severe acute pancreatitis intra abdominal pressure mortality intra abdominal hypertension
effects of knee injections on patients with knee osteoarthritis

Conditions: Knee Osteoarthritis; Injection; Effect of Drug

Summary: using a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to hyaluronic acid injection on patients with knee osteoarthritis, under the basis of international classification of functioning, disability and health.

a total of 60 patients will be collected. the participants will be randomized into three groups, including the hyaluronic acid combined corticosteroid group, hyaluronic acid combined dextrose group, and hyaluronic acid combined normal saline group (placebo group). the functional performance and knee-related quality of life (western ontario and mcmaster universities osteoarthritis index、knee injury and osteoarthritis outcome score), pain (pressure threshold by pain pressure ergometer), and physical activity (10 meters normal and fast walk, up and downstairs, 5 repeated chair-rising time, timed up and go test) and image progression by high-resolution ultrasound will be evaluated before treatment, one week after injections, one month after injections, three months after injections, and six months after injections. participants and evaluators will be both blinded to the group's allocation during the whole course of intervention.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of knee osteoarthritis 2. can walk for 15 meters 3. kellgren-lawrence grade 2 or greater 4. can follow up for 6 months exclusion criteria: 1. major diseases will affect balance, such as stroke 2. infectious disease, 3. rheumatoid arthritis, 4. malignancy 5. pregnancy or prepare to pregnant 6. received knee injections in the past 6 months 7. previous knee operation history

Keywords: knee osteoarthritis steroid hyaluronic acid dextrose
bendamustine and rituximab (br) as induction and maintenance in relapsed and refractory chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: cll is an incurable disease with conventional chemotherapy. in the absence of tp53 disruption, a chemoimmunotherapy (cit) regimen is recommended as front-line and second-line treatment in those patients who attained a long progression-free survival (pfs) with the previous regimen. bendamustine and rituximab (br) is one of the most widely adopted cit regimens, including second-line treatment. unfortunately, durations of remission following br combination therapy tend to be short in patients with heavily pre-treated disease or who have already received rituximab. the incorporation of a maintenance following induction chemotherapy to overcome the shorter remission durations in this population is a reasonable option.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cd20-positive cll that meets the iwcll criteria (hallek et al, 2008). * relapsed or refractory status of disease after at least one prior chemotherapy regimen. * ecog performance status of 0-2 at study entry * patients have not received prior therapy with bendamustine * prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease. for inclusion in the research part of maintenance therapy (phase b): * at least a partial response (pr or better; hallek et al, 2008) must be achieved after induction of br (phase a) exclusion criteria: * any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment. * pregnant or breast-feeding females. * known to be positive for human immunodeficiency virus (hiv) or infectious hepatitis (type b or c). * patients are not eligible if there is a prior history or current evidence of central nervous system or leptomeningeal involvement. * richter syndrome or chronic prolymphocytic leukemia. * uncontrolled autoimmune hemolytic anemia or thrombocytopenia. * concurrent use of other anti-cancer agents or treatments. * laboratory test results within these ranges: anc ≤ 1000/μl, platelet count ≤ 75,000/μl. * total bilirubin total bilirubin ≥ 2x upper limit laboratory normal (uln). patients with non-clinically significant elevations of bilirubin due to gilbert's disease are not required to meet these criteria. * serum transaminases ast (sgot) and alt (sgpt) ≥ 3 x uln, and/or serum alkaline phosphatase ≥ 5 x uln. * new york heart association class 3-4 heart failure.

Keywords: chronic lymphocytic leukemia bendamustine hydrochloride rituximab maintenance
lung cancer robotic comparative study

Conditions: Lung Cancer

Summary: to compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.

detection of lung cancer is occurring at increasingly earlier stages due to improved screening and the discovery of incidental nodules. coinciding with this trend is recent data from two international randomized, control trials, raval - (robotic lobectomy vs. thoracoscopic lobectomy for early stage lung cancer) and, jcog0802 (the japan clinical oncology group) that show oncologic outcomes from segmentectomy are equivalent to lobectomy for cancers ≤2 cm. however, segmentectomy is a more complex technical operation that may not be easily feasible using video assisted thoracic surgery (vats) but could be facilitated by robotic-assisted thoracic surgery (rats), allowing improved vision, precision and controlled anatomic dissection. the larcs study is designed to understand the perioperative outcomes of patients and identify the real-world selection process of either vats and rats segmentectomy and lobectomy for lung cancers ≤2 cm. it aims to generate evidence to support integration of patient-centered care using minimally invasive technology. in addition, health related quality of life captured in the study will also provide valuable insight into time to recovery, determining burden of the disease, and guide future treatment strategy.

Eligibility criteria:
inclusion criteria: * patient diagnosed with clinical stage ia1-2 non-small cell lung cancer at time of procedure * patient scheduled to undergo minimally invasive surgery for nsclc with either da vinci robotic assisted surgery or vats * aged ≥ 18 years * must be willing and able to comply with study requirements * must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form exclusion criteria: * patients with clinical stage ia3, ii, iii, and iv lung cancer * patient receiving a lobectomy/segmentectomy as an emergency procedure * patients receiving a lobectomy/segmentectomy for metastatic cancer * patients scheduled to receive a bilobectomy or sleeve-lobectomy * mental incapacity to understand or consent to study procedures * anticipated difficulty for patient to comply with protocol requirements * unable to comply with the follow up schedule * pregnant or are planning to become pregnant during the study * life expectancy \< 12 months

Keywords: minimally invasive surgery robotics
outcomes of mcrpc patients treated with ra-223 concomitant with abiraterone or enzalutamide- a chart review study

Conditions: Prostatic Neoplasms, Castration-Resistant

Summary: there are no real-world data that describes how radium-223 (ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mcrpc). to address these data gaps a cohort of mcrpc patients will be chosen who received ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. for the purpose of this study concomitant use will be defined as ra-223 initiated after at least 6 months from the start of first line abi/enza. the specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mcrpc patients treated with ra-223 concomittantly with abi/enza in first line treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of mcrpc and bone metastases * ≥ 40 years of age at diagnosis of mcrpc * initiated first line treatment for mcrpc with abi/enza (use of sipuleucel-t prior to initiation of abi or enza is allowed) * receipt of at least one cycle of radium-223 after 15 may 2013 * first cycle of ra-223 occurs while receiving first line treatment with abi/enza * treated with abi/enza for at least 28 days (1 cycle) following initiation of ra-223 * initiation of ra-223 at least 6 months after the start of treatment with abi/enza * completion of ra-223 treatment prior to the receipt of any chemotherapy for mcrpc * at least 12 months of follow-up (or until death) from date of initiation of ra-223 * known date of death (if patient deceased) exclusion criteria: * receipt of any prior chemotherapy during hormone sensitive disease or any time before mcprc * active participant in an interventional clinical trial for crpc in first line * presence of visceral metastases at initiation of ra-223 treatment * treated with abi/enza (with or without docetaxel) prior to the development of metastatic and/or castration resistant disease

Keywords: prostate cancer, bone metastases, xofigo, zytiga, xtandi.
effects of curcumin on postprandial blood glucose, and insulin in healthy subjects

Conditions: Diabetes

Summary: previous animal studies have shown that extracts of curcumin lowers blood glucose.

to study the effect of curcumin on postprandial blood glucose and plasma concentrations of insulin in fifteen healthy subjects.

Eligibility criteria:
inclusion criteria: * fifteen healthy subjects without symptoms or a history of gastrointestinal disease, abdominal surgery or diabetes mellitus, were included in this crossover study. exclusion criteria: * connective tissue disease or cerebrovascular or endocrine disease.
sleep disordered breathing in acute congestive heart failure

Conditions: Obstructive Sleep Apnea; Heart Failure; With Decompensation

Summary: the goal of this study is to determine if sleep disordered breathing results in a measurable degree of overnight myocardial stress/injury in patients with acutely decompensated congestive heart failure. a secondary goal is to determine of a period of medical management attenuates this sleep disordered breathing-induced cardiac injury in this patient population.

consecutive patients admitted to the hospital with acutely decompensated heart failure will be identified for potential enrollment in this study. enrolled patients will first be asked to complete questionnaires to assess their symptoms and risk of having sleep apnea. relevant information will be obtained from the electronic medical record (age, gender, body mass index, co-morbidities, medications, prior echocardiography results). subjects will then undergo a "type iii" portable monitoring sleep study on the first or second night of their hospital admission, which measures respiratory effort, nasal airflow, oxyhemoglobin saturation, and heart rate. blood samples will be collected on the evening before (08:00 pm +/- 2 hours), and the morning after (06:00 am +/-2 hours) sleep apnea testing. if not otherwise obtained clinically, echocardiography will be obtained within 48 hours of admission. after a period of medical management for acutely decompensated heart failure, subjects will then have a second portable sleep apnea study (with associated pre and post-sleep blood draws) on the evening prior to discharge (approximately hospital day 5 or 6). later, clinical outcomes such as incidence of renal dysfunction, hospital length of stay etc. will be collected from the electronic medical record. blood samples will be processed, stored, and subsequently analyzed for high-sensitivity cardiac troponin t and i.

Eligibility criteria:
inclusion criteria: * patients age 18-80 years admitted to university of california san diego la jolla campus (sulpizio cardiovascular center, jacobs medical center, and thornton hospital) with acute decompensated heart failure will be identified in the emergency department, or upon admission to the cardiology or inpatient general medical services. exclusion criteria: * known diagnosis of sleep disordered breathing and on treatment while hospitalized. * suspected acute coronary syndrome as determined by the primary clinical team. * intensive care unit level care. * requiring advanced heart failure therapy such as inotrope infusion, mechanical circulatory support etc. * intolerance of study procedures. * clinical attending physician refusal

Keywords: sleep osa csa chf heart failure troponin