Kornimate/medical-research-clean huggingface dataset:
validation of the respirio flu test for the rapid identification of influenza a/b

Conditions: Influenza A; Influenza B

Summary: the primary purpose of this study is to validate the sensitivity and specificity of the respirio flu test in detecting influenza a, when used by subjects, as compared to the gold standard for detection, reverse transcriptase polymerase chain reaction (rt-pcr). the secondary aims are to: * validate the sensitivity and specificity of the respirio flu test in detecting influenza b , when used by subjects, as compared to the gold standard for detection, reverse transcriptase polymerase chain reaction (rt-pcr). * assess agreement (positive and negative) between respirio flu test and sofia® influenza a+b test in detecting influenza a; * assess agreement (positive and negative) between respirio flu test and sofia® influenza a+b test in detecting influenza b; * evaluate the correct interpretation of the respirio flu test results by subjects with influenza-like illness symptoms; * evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the respirio flu test; * evaluate the subjects' comprehension of the respirio flu test labelling; and * establish the minimum sample weight required to achieve a result with the respirio flu test.


Eligibility criteria:
inclusion criteria: * male and female subjects aged ≥ 1 year; * rhinorrhea; * ≤ 72 hours from onset of influenza-like illness symptoms; * subject (or parent/legal guardian) capable and willing to give informed consent/assent. * subject (or parent/legal guardian) able to read and write in english. exclusion criteria: * has undergone treatment with antivirals within the previous 7 days; * has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days; * recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months; * currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent; * has had prior exposure to the respirio flu test; * subject (or parent/legal guardian) residing at the same residential address as a subject currently enrolled in this study.
the diagnostic value of fapi pet/ct in staging of newly diagnosed prostate cancer

Conditions: Prostate Cancer; Prostate Cancer Metastatic

Summary: this study aims to investigate the diagnostic value of fapi pet/ct, relative to standard-of-care imaging using psma pet/ct, in staging of newly diagnosed pca. fapi pet/ct will be visually and quantitatively correlated to psma pet/ct resulting in detection rates and target-to-background ratios. if available, histopathology of resected specimens will serve as reference test for operated patients in order to determine diagnostic accuracy. all outcomes are descriptive and serve as pilot for a potential subsequent larger prospective diagnostic study.


Eligibility criteria:
inclusion criteria: * male, aged ≥ 18 years; * who performance status 0, 1 or 2; * written informed consent; * biopsy-proven newly diagnosed pca; * international society of urological pathology (isup) grade group (gg) ≥ 3 and/or psa ≥ 20 ng/ml and/or ≥ct3a. if all of the criteria above are met, a subject must also meet all of the following subgroup specific criteria: group 1 (n=15): - psma pet/ct with psma-avid primary tumor with psma-avid loco-regional and/or distant metastases. group 2 (n=15): * psma pet/ct with psma-avid primary tumor with no psma-avid loco-regional or distant metastases; * increased risk of nodal metastases according to the briganti 2019 nomogram (briganti ≥40%) \[22\]; * scheduled for (laparoscopic) prostatectomy including eplnd. exclusion criteria: * known second malignant disease that may complicate image interpretation. * inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions.
mri based active selection for treatment trial

Conditions: Prostate Cancer

Summary: the main purpose of this study is to determine if magnetic resonance imaging (mri), along with mri targeted biopsy of suspicious lesions, is of value in detecting patients who would be likely to require treatment earlier.


Eligibility criteria:
inclusion criteria: 1. biopsy confirmed adenocarcinoma of the prostate within 18 months prior to enrollment; 2. pre-enrollment prostate biopsy must consist of at least 8 cores; 3. biopsy reviewed by a university of miami pathologist; 4. serum prostate-specific antigen (psa) ≤ 20 ng/ml within 3 months of study enrollment; 5. age ≥ 35 and ≤ 85 years; 6. ability to understand and willingness to sign a written informed consent document; 7. patients must agree to undergo serial multiparametric mri and mri-guided biopsy; 8. patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life. exclusion criteria: 1. greater than 4 cores positive, of any gleason score, on the university of miami (um) review, 2. greater than 2 cores positive for gleason 3+4 cancer, 3. gleason 4+3 or higher cancer in any single biopsy core. 4. extracapsular extension suspected on digital rectal exam with confirmation on mri. suspicion of extracapsular extension on mri alone is not an exclusion for study enrollment. 5. subject is not a candidate for multiparametric mri with contrast. some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers. 6. no prior pelvic radiotherapy. 7. no prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment). 8. no concurrent, active malignancy, other than non-metastatic skin cancer of any type, superficial bladder cancer, or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) or \<stage iv follicular lymphoma. if a prior malignancy is in remission for ≥ 3 years then the patient is eligible. 9. bilateral hip replacement.

Keywords: active surveillance mri-guided biopsy multi-parametric mri mp-mri
a study of tirzepatide (ly3298176) in participants with nonalcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis

Summary: the purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for nonalcoholic steatohepatitis (nash).


Eligibility criteria:
* participants must have a body mass index (bmi) ≥27 kilograms per square meter (kg/m²) and ≤50 kg/m² with stable body weight for at least 3 months * participants with or without type 2 diabetes mellitus (t2dm) * if with t2dm, hemoglobin a1c (hba1c) ≤9.5% * participants must be willing to undergo baseline and endpoint liver biopsies * participants must have histologic diagnosis of nash with stage 2 or 3 fibrosis by liver biopsy * participants must not have known or suspected alcohol abuse (\>14 units/week for women and \>21 units/week for men) or active substance abuse * participants must not have evidence of cirrhosis or other forms of liver disease * participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 6 months * participants must not have active cancer within the last 5 years * participants must not have uncontrolled high blood pressure * participants must not have renal impairment with estimated glomerular filtration rate (egfr) \<30 milliters/minute/1.73m²; for participants on metformin, egfr \<45 ml/min/1.73m² * participants must not have a diagnosis of type 1 diabetes * participants must not have a history of pancreatitis (acute or chronic) * participants must not have calcitonin ≥35 nanograms per liter * participant must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative) * female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
prospective, observational study in sickle cell disease patients on crizanlizumab treatment in middle east countries and india

Conditions: Sickle Cell Disease

Summary: this is a multicenter, prospective, single-arm observational non-interventional study (nis), which will be conducted in various countries in the middle east and india.

the study is designed to collect information on the utilization and effectiveness of crizanlizumab treatment in scd patients under routine clinical practice conditions, to which the physician has made an independent decision to prescribe crizanlizumab.

Eligibility criteria:
inclusion criteria: 1. male and female patients with clinical diagnosis of scd (based on laboratory parameters) of any genotype. 2. patients newly initiated on treatment with locally approved crizanlizumab. 3. patients aged 16 years or older at crizanlizumab initiation. exclusion criteria: 1. patients who did not provide informed consent. 2. patients who received a stem cell transplant at time of enrollment. 3. patients who participated in or are participating in a clinical trial at time of enrollment or in the 12 months prior to starting commercial crizanlizumab. 4. according to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reasons such as unavailability or severe concomitant illnesses.

Keywords: nis sickle cell disease scd crizanlizumab
withdrawal of artificial nutrition at the end of life (percepal)

Conditions: Palliative Care Nursing

Summary: withdrawing artificial nutrition in palliative care is an issue that often leads to ethical dilemmas among health care providers, despite clinical guidelines.

the benefit of artificial nutrition in terminally ill patients has been a highly debated issue for the past 30 years, and abundant data are available regarding its effects on patients. several clinical guidelines have specified the criteria to be considered before initiating artificial nutrition or hydration. if these guidelines appear consensual in theory, the situation is much less straightforward in practice. the attitude of physicians appeared very variable when it came to prescribing or withholding artificial nutrition or hydration, and the lack of training, among other parameters, seemingly encouraged health care professionals to prescribe artificial nutrition or hydration. furthermore, the decision of the care provider is unconsciously complicated due to figurative representations associated with food regarding, among other aspects, the mother-child relationship, social cohesion, or religious beliefs. these differences are more important since the opinion of physicians and nurses is the one that carries the most influence on the patients' decision when deciding to initiate artificial nutrition and because artificial nutrition and hydration are a common source of ethical dilemmas in health care teams. furthermore, stopping artificial nutrition or hydration could be misconstrued as euthanasia.

Eligibility criteria:
inclusion criteria: * nurses, and nurses' aides working in medicine, surgery, and palliative care departments of the regional hospital of metz-thionville exclusion criteria: * care providers working in pediatrics, gynecology and obstetrics, psychiatry, and emergency departments
pelacarsen roll-over extension program

Conditions: Atherosclerotic Cardiovascular Disease

Summary: this non-randomized, rollover extension study will provide post-trial access to pelacarsen (tqj230) to participants who have successfully completed either of the double-blind parent studies (ctqj230a12303 or ctqj230a12304).

this study will evaluate long-term safety and tolerability of pelacarsen (tqj230) 80 mg once a month (qm) in patients with elevated lp(a) and established ascvd. all consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Eligibility criteria:
inclusion criteria: * participants who have provided informed consent prior to initiation of any study-specific activities/procedures. * participants who have completed the parent study and received the assigned study treatment at the time of its completion exclusion criteria: * participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study * any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation * participants who are receiving another investigational drug or device before the open-label treatment period * participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator other protocol-defined inclusion/exclusion criteria may apply.

Keywords: tqj230 lp(a) ascvd
patisiran-lipid nanoparticle (lnp) pregnancy surveillance program

Conditions: Hereditary Transthyretin-mediated (hATTR) Amyloidosis; Polyneuropathy

Summary: the purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-lnp.


Eligibility criteria:
inclusion criteria: * documentation that the patient was exposed to patisiran-lnp at any point starting from 12 weeks before lmp or at any point during pregnancy exclusion criteria: * there are no exclusion criteria for participation in this program.

Keywords: hereditary neuropathic amyloidosis familial amyloidosis amyloidosis amyloidosis senile cardiac amyloidosis
a health economic study evaluating the brain sentinel® gtc seizure detection and information systems impact on epilepsy and healthcare utilization

Conditions: Epilepsy

Summary: this is an open label prospective study of the impact on healthcare utilization of a surface electromyography (semg) based seizure detection system for detecting generalized tonic-clonic (gtc) seizures.

the brain sentinel® gtc seizure detection and information system is an ambulatory system designed to continuously monitor and perform real-time analysis of surface electromyography (semg) data to detect gtc seizures and to provide an alarm to alert caregivers within 30 seconds of bilateral, appendicular, tonic extension that a seizure is occurring. the system is for recording and storing semg data, which is subsequently reviewed by a trained healthcare professional in the outpatient clinical setting. the brain sentinel® gtc seizure detection and information system is intended for real time monitoring of pediatric and adult patients who have an arm circumference ranging from at least 16 cm to no greater than 51 cm at the biceps. it may be used in the home or healthcare facilities for real-time monitoring during the day, night, or for continuous monitoring, including during the titration of, or the withdrawal from anti-epileptic drugs.

Eligibility criteria:
inclusion criteria: * subject has a history of gtc seizures, either primary gtc or partial onset seizures with secondary generalization * male or female greater than 2 years of age * has an upper arm circumference which is adequate for proper fit of the emg monitor (at least 16-51 cm) * be able to tolerate wearing the device on the upper arm * can understand and sign written informed consent, or will have a parent or a legally authorized representative (lar) who can do so, prior to the performance of any study assessments * subject and/or primary caregiver must be competent to follow all study procedures. * is able to read, speak and understand english * at least 2 or more emergency department visits in the previous 12 months for seizure related care exclusion criteria: * the subject is homeless or in a home without a power supply. * the subject is allergic to adhesives or any component of the electrode patch assembly. * the subject self-reports that she is pregnant or planning to become pregnant while using the device.

Keywords: gtc seizures
registry of malignant arrhythmias and sudden cardiac death - influence of diagnostics and interventions

Conditions: Ventricular Tachycardia; Ventricular Fibrillation; Sudden Cardiac Death; Coronary Angiography; Electrophysiologic Testing (EP); Catheter Ablation; Percutaneous Coronary Intervention (PCI); Internal Cardioverter Defibrillator (ICD)

Summary: the "registry of malignant arrhythmias and sudden cardiac death - influence of diagnostics and interventions (race-it)" represents a mono-centric registry of patients being hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation) and sudden cardiac death (scd). detailed findings of patients' clinical outcome regarding mortality and co-morbidities related to the presence of invasive diagnostics or therapies including coronary angiography, percutaneous coronary intervention (pci), electrophysiological testing (ep), catheter ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will be documented. patients will be included when being hospitalized from the year 2004 until today.


Eligibility criteria:
inclusion criteria: hospitalization due to: * ventricular tachycardia * ventricular fibrillation * sudden cardiac death exclusion criteria: * not diagnosed with one or more of the above
bilateral recto-intercostal fascial plane block in epigastric hernia repair

Conditions: Recto-intercostal Fascial Plane Block; Epigastric Hernia; Analgesia

Summary: the aim of this study is to evaluate the efficacy and safety bilateral recto-intercostal fascial plane block (rifpb) in epigastric hernia.

epigastric hernias are usually occult in obese patients, and their symptoms may mimic peptic ulcer or gallbladder disease . hernia repair is associated with considerable postoperative pain. the recto-intercostal fascial plane block (rifpb) is a new novel approach that was developed by tulgar et al., 2023 who hypothesized that when we inject a local anesthetic into the interfacial plane just inferolateral to the xiphoid, between the rectus abdominis muscle and the 6-7th costal cartilages (hence, between the cartilages and the intercostal muscles between them), blockade of the anterior branches of the nerves passing through this area can be guaranteed.

Eligibility criteria:
inclusion criteria: * age 18-65 years. * both sexes. * american society of anesthesiology (asa) physical status i-ii. * scheduled for elective epigastric hernia repair. exclusion criteria: * obese patients with body mass index (bmi) \>35 kg/m2. * patients with a large hernia containing bowel. * patients with local anesthetic allergy.
validation of pulsewave blood pressure monitor in hypertensive and normotensive pregnant and postpartum women

Conditions: Hypertension

Summary: the purpose of this study is to test the accuracy of the pulsewave wrist blood pressure cuff in pregnant and postpartum women who have either normal blood pressure or high blood pressure.

the study will include a series of nine blood pressure measurements. the measurements will alternate between a gold standard auscultatory blood pressure measurement and the pulsewave monitor. a trained clinician will be used for gold standard measurements using an appropriately sized cuff around the upper arm, a sphygmomanometer, and a stethoscope. systolic blood pressure is defined by the first korotkoff sound; diastolic blood pressure is defined by the fifth korotkoff sound. measurements by the pulsewave monitor will be performed using a proprietary oscillometric wrist cuff automated by a computer tablet and software made by clouddx inc. women will be seated for 5 to 10 minutes before the first blood pressure measurement. during this time, 4 circumference measurements will be taken of the arm and wrist. 1. the armpit will be measured as proximally as possible. 2. the mid upper arm will be recorded by measuring at the halfway point between the acromion and the olecranon process. 3. the distal upper arm measurement will be taken approximately 2 cm proximal to the antecubital crease. 4. the wrist will be measured approximately 2 cm proximal to the wrist flexion crease. the first two blood pressure measurements will be used as a way to orient the subject to each device and the methods so that they are comfortable with the cuff and the process. the seven subsequent measurements will be used for analysis. there will be a 30 second to 60 second period between blood pressure measurements.

Eligibility criteria:
inclusion criteria: * pregnant or admitted to the postpartum unit * normotensive women - no diagnosis of hypertension * hypertensive women - diagnosis of hypertensive disorder of pregnancy exclusion criteria: * women in active labor * women \< 18 years of age * non-english speakers

Keywords: hypertension pregnant preeclampsia gestational hypertension blood pressure pregnant women postpartum women
angiogenic/angiostatic mediators in patients with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: we propose to examine several angiogenic/angiostatic mediators in the skin and serum of subjects with ssc and compare it to levels found in the skin and serum of healthy subjects.

systemic sclerosis (ssc) is a connective tissue disease that is characterized by fibrosis of the skin and internal organs. one of the earliest pathologic changes in patients with ssc is damage to the blood vessels. many abnormalities have been found in the inner layer of the blood vessel, the enothelial tissue. it is known that there are mediators in the blood and tissues of the body that affect the endothelial tissue. these are called angiogenic (promote blood vessel formation) and angiostatic (inhibit blood vessel formation) mediators. many of these mediators have been examined in the peripheral blood of patients with ssc, but fewer of these mediators have been examined at the site of action, in the tissue near the microvasculature. we hypothesize that there are differences in the levels of angiogenic/angiostatic mediators between healthy subjects and subjects with ssc. in addition, we propose that there are differences at skin sites that have varying levels of involvement with ssc of these angiogenic/angiostatic factors in subjects with ssc.

Eligibility criteria:
inclusion criteria: 1. meet american college of rheumatology criteria for systemic sclerosis 2. subjects with systemic sclerosis must have involvement proximal to the knee or elbow, excluding the face 3. persons with no chronic health conditions exclusion criteria: 1. persons with systemic sclerosis as a result of being exposed to chemicals or drugs that can cause a sceroderma-like illness 2. persons with autoimmune diseases other than systemic sclerosis 3. persons treated with cyclophosphamide in the last 8 weeks 4. persons with active infections, including but not limited to hepatitis c, hepatitis b, and hiv 5. persons prone to bleeding because they are treated with medications that thin the blood or have a low platelet count

Keywords: systemic sclerosis angiogenesis