Kornimate/medical-research-clean huggingface dataset:
elderly with locally advanced lung cancer: deciding through geriatric assessment on the optimal treatment strategy

Conditions: NSCLC

Summary: there is no detailed information available on benefits and harms of intensified treatment with concurrent rcht among a subpopulation of elderly patients. reliable tools are needed to distinguish the subgroup of fit patients from frail patients.

lung cancer is a problem of the elderly: 30% of the lung cancer patients are aged ≥ 75 years. due to underrepresentation of elderly patients in clinical trials there is a lack of evidence to select the optimal treatment strategy for these patients. concurrent radiochemotherapy (rcht) has been recognised as the standard treatment of stage iii nsclc patients with a good performance status. evidence for this treatment was gained in clinical trials that mostly excluded elderly patients. furthermore, the survival gain obtained with combined rcht, comes with a significant increase in toxicity. therefore, information on benefits and harms of intensified treatment with concurrent rcht among a subpopulation of medically fit elderly patients is still lacking. moreover, reliable tools are needed to distinguish the subgroup of fit patients from frail patients, i.e. those expected to experience important toxicity.

Eligibility criteria:
* any subtype of pathologically proven nsclc, primary uicc stage iii disease; * age ≥ 75 years; * no surgery or adjuvant chemotherapy for nsclc in the last year; * no prior radiotherapy to the ipsilateral thorax or mediastinum; * no clinical superior vena cava syndrome; * no diagnosis of other cancer within the last 3-years (except in situ carcinoma's and / or non-melanoma skin cancer); * written informed consent

Keywords: nsclc
dynasplint therapy for trismus in head and neck cancer

Conditions: Trismus

Summary: the purpose of this study is to compare the use of the dynasplint trismus system to routine trismus treatment in improving the ability of opening the mouth in a randomized trial. this study will also determine what effects, good and/or bad, this procedure has on the participant. participants will be randomly assigned to the dynasplint trismus system or to routine treatment with tongue depressors.

this trial is a single-institution, randomized study to evaluate the effectiveness of the dynasplint trismus system (dts) for patients with trismus. improvement of mouth opening and quality of life of participants using dts will be compared to improvement of mouth opening and quality of life of participants using standard therapy. standard therapy will be the use of tongue depressors. crossover from standard therapy to dts will be implemented if at three months there is no improvement in mouth opening when using tongue depressors.

Eligibility criteria:
inclusion criteria: 1. patients with \<= 30mm mouth opening who have undergone treatment for head and neck cancer. (if the patient is edentulous then mouth opening must be \<= 40mm.) 2. patients who are receiving or have completed treatment for head and neck cancer (surgery, radiation, chemotherapy alone or in any combination). 3. patients must be completely recovered from any radiation induced oral mucositis. 4. age =\>19 years. 5. patients must sign informed consent. exclusion criteria: 1. severe periodontal or gum disease that has caused teeth to be loose. 2. any systemic disease that causes blistering of the oral mucosa. 3. any condition that renders the patient unable to understand the informed consent. 4. participants who are not able to comply with protocol activities.

Keywords: trismus head and neck cancer
duocor ventricular assist system early feasibility study

Conditions: Heart Failure

Summary: feasibility study of the duocor ventricular assist system as a treatment for advanced total heart failure patients.


Eligibility criteria:
inclusion criteria: 1. requiring a biventricular mechanical circulatory support, defined by either of the following criteria: * persistent total heart failure despite under optimal medical management based on current heart failure practice guidelines. or * development of refractory right heart failure following left ventricular assist device (lvad) implantation, unresponsive to pharmacological interventions for right heart failure. 2. patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements. exclusion criteria: 1. intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patient's health status. 2. technical obstacles which pose the implantation as unsuitable, obtaining the body type, body surface area, and anatomical conditions related to the planned implantation site, in the judgment of the experienced investigators. 3. pregnancy. 4. age \> 75 years. 5. presence of an active, uncontrolled infection. 6. brain death. 7. history of confirmed, untreated abdominal aortic aneurysm (aaa) or thoracic aortic aneurysm (taa) \> 5 cm in diameter. 8. irreversible cognitive dysfunction, psychosocial issues, or psychiatric disease, likely to impair compliance with the study protocol and duocor vas management which, in the opinion of the investigator, could interfere with the ability to manage the therapy.
closure of perimembranous ventricular septal defects with the amplatzer® membranous vsd occluder

Conditions: Membranous Ventricular Septal Defects

Summary: the purpose of this feasibility study is to investigate the safety of the amplatzer® membranous vsd occluder for the treatment of hemodynamically significant perimembranous ventricular septal defects.


Eligibility criteria:
inclusion criteria: * patients with hemodynamically significant perimembranous ventricular septal defects exclusion criteria: * patients \< 8 kg * supracristal ventricular septal defects * left ventricle to right atrium shunting * prolapse of the aortic valve * right to left shunting through the defect * perimembranous vsd with an aneurysm and multiple shunts which can not be successfully closed with one device * patients with \<2mm aortic rim * sepsis (local/generalized) * complex heart lesions such as atrioventricular canal defect or tetralogy of fallot. * patients who are asa intolerant * unable to be followed for the duration of the clinical trial * inability to obtain informed consent

Keywords: membranous ventricular septal defect vsd
medical record, physical and neurological data that orient to the diagnosis of sacroiliac joint dysfunction

Conditions: Sacroiliac Joint Somatic Dysfunction; Low Back Pain

Summary: there are many patients coming daily to our office with the complaint of chronic lumbosacral pain radiating or not to the legs that need a proper diagnosis before any treatment is decided. the diagnosis, based mostly on radiological exams, carries a risk of failure to diagnose the sacroiliac joint as the cause of the pain. the study proposes that a quick interrogatory followed by a physical exam with the adequate provocative testing can raise the suspicion of the diagnosis that the pain is originating from the sacroiliac joint. thereafter, a diagnostic sacroiliac joint block can be performed. the study aims to correlate findings from patient history and physical examination with eventual diagnosis.

this is a prospective cohort study of patients seeking care for chronic low back pain. all patients will undergo a detailed history and physical examination, followed by other indicated diagnostic testing. the analysis will correlate findings from patient history and physical examination testing with the eventual diagnosis. the goal of the study is to identify key historical and physical examination criteria that raise the suspicion for sacroiliac joint pain, which is commonly underdiagnosed. failure to diagnose a health condition could lead to inappropriate surgery.

Eligibility criteria:
inclusion criteria: * patient being evaluated in clinic for chronic low back or buttocks pain with or without radiation to the legs exclusion criteria: * patient has already undergone surgery for the condition of interest * inflammatory condition * active cancer
venous thromboembolism prevention in outpatients with glioma

Conditions: Glioblastoma; Astrocytoma; Venous Thromboembolism

Summary: this is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.

patients with primary brain tumors, including glioblastoma and astrocytoma, are at high risk of developing venous thromboemboli (vte) as a comorbid condition. prior studies have demonstrated safety and efficacy of primary pharmacological prevention of vte using blood thinning medications, including apixaban. these studies have included a small cohort of patients with grade 4 glioma. the purpose of this study is to gather additional safety data regarding the use of apixaban for primary prevention of vte in patients with newly diagnosed grade 4 glioma.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of malignant glioma, world health organization (who) grade 4, including glioblastoma and astrocytoma, based on recent biopsy or resection. * age 18 and old * karnofsky performance status (kps) 60-100 * acceptable labs, including platelets of greater than or equal to 100,000, glomerular filtration rate (gfr) greater than or equal to 25. * ability to provide informed consent. * planning for treatment with radiation and chemotherapy. exclusion criteria: * evidence of deep venous thrombosis (dvt), pulmonary embolism (pe), or cerebral vein thrombosis (cvt) within 6 months prior to enrollment on the study. * pregnancy. * significant bleeding risk including: history of symptomatic intracranial hemorrhage, active bleeding at time of study registration, clinically significant bleeding within 14 days of study registration, intracranial trauma in the past 6 months, including stroke or traumatic brain injury, major surgery or major procedure within 48 hours. * allergy to apixaban or contraindication to prophylactic anticoagulation. contraindications include patients who are currently on unfractionated heparin, low molecular weight heparin, heparin derivatives (examples: fondaparinux), or other direct oral anticoagulants (examples: dabigatran, edoxaban, rivaroxaban), who are either unable or unable to discontinue these agents in favor of the investigational drug. apixaban is also contraindicated in patients who are on strong cyp3a4 inhibitor and p-glycoprotein inhibitors. * indication for full anticoagulation (i.e. atrial fibrillation, mechanical valve, etc.). * estimated life expectancy of \<3 months.

Keywords: high grade glioma glioblastoma astrocytoma venous thromboembolism apixaban
soon home study about preterm infants

Conditions: Preterm Birth Complication

Summary: the goal of this randomized controlled trial without medication neither device (for procedure) is to compare the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams versus infants weaned at a weight greater than or equal to 1600 grams. the main questions it aims to answer are: * is it possible to reduce the average hospital stay in the early weaning group compared with the standard weaning group? * is this procedure safe and without adverse outcomes between the two groups during the hospital stay and during the first week after discharge?

premature or low-birth-weight infants have low thermoregulatory abilities, higher risk of hypothermia and thus require a heated environment to survive. in the neonatal intensive care unit, these infants are placed from birth in an appropriately heated and humidified incubator. when they gain thermal competence they are gradually transferred to the open crib, normally when they reach a weight of about 1600-1800 grams, although the practice varies widely among neonatal units. recent studies have concluded that clinically stable preterm infants can be transferred to an open crib at a body weight of less than 1600 grams. the abilities to maintain a normal body temperature in an open crib, good feeding autonomy, stable cardio-respiratory function, and acceptable growth rate are the physiological skills generally required for discharge of infants from the hospital. the study compares the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams versus infants weaned at a weight greater than or equal to 1600 grams, as well as the incidence of adverse outcomes between the two groups (lower growth rate, inadequate breastfeeding, thermal lability and need for the incubator, readmission to the hospital) during the ward stay and during the first week after discharge, the degree of psychological stress of the parents, and the quality of the parent-child relationship in the two different groups.

Eligibility criteria:
inclusion criteria: * infants with birth weight less than 1400 grams in incubator who have reached a minimum weight of 1400 grams * stable clinical condition: normal heart rate and respiratory rate, no need for invasive respiratory assistance, no episodes of apnea, stable axillary temperature not less than 36.5°for at least 72 hours. * no need for phototherapy * stable or increasing weight for at least 48 hours * signature by both parents of an informed consent exclusion criteria: * severe congenital anomalies at birth * need for invasive respiratory support at the time of enrollment * ongoing phototherapy * major surgical pathology with need for surgery * failure by both parents to sign up for informed consent
treatment patterns and clinical outcomes among talazoparib-treated adults with her2-negative mbc with gbrca1/2m

Conditions: Metastatic Breast Cancer; Breast Neoplasms

Summary: this non-interventional retrospective study will describe real-world treatment patterns and clinical outcomes among adults with her2-negative metastatic breast cancer with germline brca1/2 mutations who initiated talazoparib as a first or later line of therapy. patients will be identified from the flatiron electronic health record database.


Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: * diagnosed with breast cancer (icd-9 174.x or 175.x or icd-10 c50x) * at least two visits in the flatiron database on or after january 1, 2011 * pathology consistent with breast cancer * has evidence of stage iv or recurrent metastatic breast cancer with a metastatic diagnosis date on or after january 1, 2011. this includes patients who were diagnosed with stage iv at diagnosis or were diagnosed with earlier stage disease, then developed a distant metastasis later on, or had recurrence of the disease via a distant metastasis * confirmed receipt of talazoparib as treatment for mbc via abstraction initiated between january 1, 2018 and september 30, 2020 * her2 negative test result on or before the start of patient's first talazoparib-containing line of therapy, as defined by flatiron's line of therapy rules * brca1, brca2, brca1 and brca2 germline mutation, or brca germline mutation not otherwise specified, identified on or before the start date of patient's first talazoparib-containing line of therapy, as defined by flatiron's line of therapy business rules * age 18 years or older at the time of first talazoparib-containing line of therapy exclusion criteria: * lacking relevant unstructured documents in the flatiron database for review by the abstraction team * receipt of drug as part of a clinical trial (captured in the database as "clinical study drug" without additional information about active ingredient or whether the patient received placebo), defined as any non-cancelled order, administration, or oral episode for a drug used in a clinical trial, on or prior to start of first talazoparib line of therapy, as defined by flatiron's line of therapy business rules

Keywords: metastatic breast cancer breast neoplasms
the affect of orthodontic treatment on the periodontal status of patients with aggressive periodontitis

Conditions: Aggressive Periodontitis

Summary: orthodontic treatment will affect the periodontal status of periodontally treated aggressive periodontitis patients.


Eligibility criteria:
inclusion criteria: * patients with aggressive periodontitis in maintenance that had completed orthodontic treatment * age 13-40 * with full records of periodontal treatment * with full records of orthodontic treatment exclusion criteria: * smoking over 10 cigarets/day * non controlled diabetes * pregnancy * alcohol consumption

Keywords: aggressive periodontitis orthodontic stability
european sepsis care survey

Conditions: Sepsis

Summary: the objective of this survey is to investigate the current state of sepsis care around europe. the study is aiming at hospital structure, emergency departments, wards, intensive care units and clinical diagnostic and microbiological service.


Eligibility criteria:
inclusion criteria: * hospitals of all strata exclusion criteria: -
safety & effectiveness of nurse performed colonoscopies under supervision

Conditions: Colorectal Cancer

Summary: there is no theoretical or practical reason why non-medical personnel such as nurses could not be trained to perform diagnostic colonoscopy with comparable proficiency as medical endoscopists. nurse endoscopists have been widely accepted in the united kingdom for the past 15 years as a valuable resource to cope with the increasing demand for endoscopic service, in particular diagnostic colonoscopy for colorectal screening. a pilot study performed in hong kong in 2008 has shown that endoscopy nurses can be trained to perform diagnostic endoscopy safely and reliably. this study aims to demonstrate that properly trained nurse endoscopists have a comparable proficiency in performing colonoscopy procedures as their medical counterparts.


Eligibility criteria:
inclusion criteria: * 1. subjects receiving screening colonoscopy * 2. age ≥ 18 * 3. informed consent exclusion criteria: * 1. subjects have undergone colonoscopy in the past 5 years * 2. patients with prior colorectal surgery * 3. subjects with a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of familial adenomatous polyposis or familial non-polyposis syndrome * 4. pregnant or lactating women * 5. lack of consent
csf leak following microvascular decompression: the benefit of routine postoperative lumbar tap

Conditions: Cranial Nerve Diseases; Facial Neuralgia; Trigeminal Neuralgia; Hemifacial Spasm

Summary: even at centers with very large experience, the risk of cerebrospinal fluid (csf) leakage in surgery for microvascular decompression is reported up to 3%. prevention of leakage is important since meningitis may follow. also, leakage usually means longer hospital stay and increased cost. in case of detected leakage extra sutures may be applied, placement of a lumbar drain may be considered or a revision and improved closure may be attempted. with leakage in the subcutaneous tissue, but not through the skin, a local accumulation causing local symptoms may also occur. in addition to being burdensome and being associated with longer hospital stays with possible revision surgery, such complications are also very costly. the best way to reduce cost and burden, and to improve patient care, is to prevent csf leakage. the aim of this study is to determine if prophylactic lumbar tap is beneficial for prevention of cerebrospinal fluid leakage following microvascular decompression, by comparison of surgical approaches in 3 geographical areas in the scandinavian health system. hypothesis: there is no difference in cerebrospinal fluid leakage between the group subject to prophylactic spinal tap versus the group without prophylactic spinal tap.


Eligibility criteria:
inclusion criteria: * microvascular decompression surgery for neurovascular conflict (hemifacial spasm, trigeminal neuralgia) * surgery between 1990 and 2013 * follow-up visit registered in medical charts \> 30 days postoperatively (at either local hospital, treating neurologist or at neurosurgical clinic) exclusion criteria: -

Keywords: microvascular decompression surgery cerebrospinal fluid leakage postoperative complications
li-hep vs. non-li-hep coated transfer device

Conditions: Acute Coronary Syndrome; Chest Pain; Myocardial Infarction; Cardiac Ischemia

Summary: this study is a prospective, diagnostic, cohort study within the standard care of acute coronary syndrome (acs) patients. it compares the analytical performance of siemens® point-of-care high sensitive troponin i testing in venous, plasma and capillary sample types. the investigators hypothesize that there is a good correlation between the siemens® poc hs ctni assay results for the three sample types and that the bias between different poc sample types reduces from \~10% to ≤ 5% when using heparinized transfer device for the capillary sample.

in september 2019, the validation study 1.0 started, in which the ctni result of the siemens poc device on three sample types are compared. interim analysis of the sample comparison was performed by regression analysis using passing and bablock, and calculating the pearson correlation coefficient. the li-hep plasma vs li-hep venous blood show a very good correlation of 1.00-1.03 with an r of \>0.99, so the results between these sample types can be used interchangeably. for the capillary sample vs the li-hep sample (both blood and plasma) the slope is 8-12% higher. with a 8-12% higher response, the capillary test results may not be interchangeably used with the other 2 sample types. it is remarkable that capillary samples give a higher response, since it was anticipated that the result may be slightly lower due to the possible dilution by interstitial fluid. the investigators hypothesize that the presence of the li-heparin anti-coagulant in the venous draw lead to a slight reduction of the apparent ctni concentration. by using a heparin coated transfer device for the capillary samples instead of an uncoated transfer device, this hypothesis will be tested.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * referred to cardiac ed with chest pain suspected of acs; inclusion at arrival (t=0) or one hour after arrival (t=1). * subacute stemi or nstemi patients admitted at the ccu who have an indication for coronary angiography but do not need rescue/emergency pci. * stemi patients who already underwent rescue/emergency pci; inclusion post pci. exclusion criteria: * out of hospital cardiac arrest. * patients with sudden onset tachycardia and a frequency of 110 bpm or higher (supraventricular or ventricular). * patients who are hemodynamically unstable or in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc. * patients recently already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site. * patients not willing or not able to provide informed consent due to their medical condition as judged by the physician.

Keywords: troponin point-of-care acute coronary syndrome siemens chest pain