Kornimate/medical-research-clean huggingface dataset:
geri-tbi: a prospective multi-center evaluation of geriatric patients with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: this multicenter prospective observational study is designed to prospectively record data on patients who are managed per institutional standard of care. the objectives of this study are to establish an aggregate database of information on baseline clinical and demographic characteristics, medication use, markers of frailty, injury characteristics, management strategies, and outcomes following tbi in geriatric patients, determine best practices for management of geriatric patients with tbi, and establish how markers of frailty correlate with outcome in geriatric patients with tbi.

this is a prospective multi-center observational study of geriatric patients with tbi. data collected will be purely observational and involve no study-based therapeutic interventions or alterations in patient care. due to the purpose of this study being the creation of a registry and the absence of demographic information being collected, all patients meeting the inclusion criteria will be enrolled without informed consent. we plan to complete the data collection and analysis by 12/31/2018.

Eligibility criteria:
inclusion criteria: * age ≥40 * ct-verified tbi exclusion criteria: 1. any other body region injury ais \>2 2. presentation at enrolling center \>24 hours after injury 3. pregnant women 4. prisoners
assessment of two postoperative techniques used to predict voiding efficiency after gynecologic surgery

Conditions: Urinary Incontinence

Summary: after gynecologic surgery, it may be difficult to void (urinate). this problem is usually short-term with normal function returning within a few days to a few weeks. for this reason, patients may require drainage of their bladder with a catheter immediately after surgery. currently in our office, we use two different tests to see how well you are able to urinate and how quickly the catheter can be removed. the purpose of this study is to see which voiding test is better after gynecologic surgery.

postoperative voiding dysfunction is commonly encountered following gynecologic surgery. this dysfunction is usually short term, with normal function returning within a few days. following uro/gynecologic surgery, most patients require drainage with either a transurethral or suprapubic catheter in the immediate postoperative period. within our practice, we prefer drainage with a transurethral catheter. at some point after surgery, the urethral catheter is removed and normal bladder function allowed to resume. at present, there is no generally accepted regimen to assess voiding efficiency. in our practice, we currently employ two regimens to both assess voiding efficiency and expedite catheter removal. in one technique, the catheter is removed and the patient's bladder is allowed to fill spontaneously. patients are asked to void when they experience a strong urge. the voided volume is recorded and a post-void residual (pvr) is then measured by transurethral straight catheterization. in the second technique, the patient's bladder is retrogradely filled with 300 cc of sterile fluid and the catheter removed. they are asked to void within 15 minutes of instillation and the voided volume is measured. the pvr is then obtained by transurethral straight catheterization. in both cases, if the patient voids \>2/3 the total volume (voided volume + residual) the trial is considered "passed" and the catheter is removed. if a patient voids \< 2/3 of the total volume, the trial is considered "failed" and indicative of urinary retention. in this case the catheter replaced. we aim to assess the ability of these techniques to accurately predict voiding efficiency and to determine if one technique is superior to the other.

Eligibility criteria:
inclusion criteria: * all women \> 18 years of age presenting to the division of urogynecology at the university of rochester medical center/strong memorial hospital and undergoing gynecologic surgery which requires postoperative placement of a transurethral catheter. * subjects must be competent to give informed consent. exclusion criteria: * any patient less than 18 years of age. * patients with suprapubic catheters postoperatively. * patients undergoing surgery that does not require transurethral catheterization postoperatively. * patients not competent to give informed consent. * patients who are pregnant. * patients undergoing procedures requiring prolonged bladder decompression (i.e. fistula repair).
the effects of passive and active vibration therapy on grip strength and myoelectric activity

Conditions: Strength

Summary: this pilot study is designed to analyze the effects of vibration therapy (vt) on grip strength and level of forearm contraction by measuring hand grip dynamometry and surface electromyography (semg) using the biopac semg and digital dynamometry devices after the application of both passive and active vibrational therapy (vt) using the powerplate.


Eligibility criteria:
inclusion criteria: * participants will be logan students, faculty and staff 18-65 yoa * asymptomatic subject will be included in the study * participants must complete a survey and consent form * only participants that meet the criteria of the survey will be accepted in the study exclusion criteria: * participant with any recent or past disease/injuries/trauma/fracture (i.e., arthritis, carpal tunnel, etc.) * who have had joint replacements * who are currently engaging in physical rehabilitation * who are pregnant will be excluded from the study * history of cardiovascular disease * history of cancer * history of epilepsy * history of diabetes mellitus, or past retinal surgeries * participants cannot have chiropractic manipulation or engage in weight lifting or other extreme exercise throughout the duration of the study
cpap device in-lab assessment nz

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements

existing adult continuous positive airway pressure (cpap) therapy users will be recruited for an overnight polysomnography (psg) sleep study. the participants will use the investigational cpap device and be connected to a psg during their session. the device performance during the session will be assessed. outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and psg data.

Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosed with osa by a practicing physician and prescribed pap therapy (fixed or auto cpap) * fluent in spoken and written english. exclusion criteria: * be contraindicated for pap (fixed or auto cpap) therapy. * have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia). * have obesity hypoventilation syndrome or congestive heart failure. * require supplemental oxygen with your pap (fixed or auto cpap) device. * have any implanted electronic medical devices (e.g. cardiac pacemakers). * be pregnant or think they might be pregnant.
deciphering the molecular traits of non-canonical responders to advance personalized therapy in gastric cancer

Conditions: Metastatic Gastric Cancer

Summary: retrospective-prospective observational study in which a novel whole-exome sequencing (wes) approach will be used in association with whole-transcriptome sequencing (wts) to analyze two independent and equally sized cohorts of patients with mgc.

a workflow specifically designed for this project will be adopted, using clinical outcomes as a benchmark for comparative analyses, to generate a molecular classifier applicable to all patients affected by metastatic gastric cancer mgc and predict atypical tumor responses. molecular features differently represented in exceptional responders and fast progressors will be monitored by liquid biopsy in patients included in cohort b, consisting of a validation set, leveraging a high-sensitivity technological level that allows to detect both genomic alterations and expression at the transcription level. in addition, cscs isolated from fast progressors will be studied with over 1,000 antitumor agents to discover vulnerabilities not currently known.

Eligibility criteria:
inclusion criteria: * age \>18 years; * histological diagnosis of locally advanced or metastatic gastric cancer (gc) or gastroesophageal junction carcinoma (ejc); * adequate biological material for molecular analysis, collected (at surgery or by biopsy) before the administration of any anti-tumor treatment (chemotherapy and/or radiotherapy); * ecog ps 0-2; * adequate hematological, hepatic and renal function; * measurable disease according to recist criteria; * written informed consent. exclusion criteria: * previous chemotherapy for metastatic disease; * comorbidities not controlled with adequate medical therapy; * brain metastases; * patient unable to give adequate consent to the study.
effects of inspiratory muscle training in elders

Conditions: Muscular Atrophy; Sensitivity Training Groups; Aging

Summary: aging causes anatomical and physiological changes in the respiratory system and respiratory muscle strength with decline in its maximum function. this study aimed to evaluate the effects of inspiratory muscle training on respiratory muscle strength, thickness of the diaphragm and diaphragmatic mobility in older women. the investigators' hypothesis is that inspiratory muscle training improves respiratory muscle strength, the thickness of the diaphragm and diaphragmatic mobility in older women.


Eligibility criteria:
inclusion criteria: elderly women are able to walk without aid and cognitive integrity. exclusion criteria: * participation in other training or rehabilitation protocol; * contraindication or difficult to perform the evaluation; * difficulty adapting or adherence in training protocol; * smoking; * hemodynamic instability; * degenerative neuromuscular disease; * pulmonary comorbidities; * heart disease; * users of drugs that interfere in bone metabolism or muscle strength.

Keywords: breathing exercises aged
effectiveness of bilateral ultrasound-guided erector spinae plane block

Conditions: Erector Spinae Plane Block

Summary: the proposed mechanism of action of the espb is via blockade of the dorsal and ventral rami of the spinal nerves and sympathetic nerve fibers. radiographic evidence suggests that local anesthetic injected into at the esp spreads both cranially and caudally as the plane is continuous along the vertebral column . espb reportshave demonstrated analgesia at cervical, thoracic, and lumbar levels for procedures such aspyeloplasty, lipoma excision, breast reconstruction,malignant mesothelioma, inguinal hernia repairs, and hip reconstructions

one of these local analgesia is the erector spinae plane block (espb). it was first described in 2016 as a regional block for the treatment of thoracic neuropathic pain. this has shown promise as an alternative to neuraxial blockade for a variety of surgeries with good effect. in addition, the block has a reduced risk of epidural hematoma, direct spinal cord injury, and central infection . the proposed mechanism of action of the espb is via blockade of the dorsal and ventral rami of the spinal nerves and sympathetic nerve fibers. radiographic evidence suggests that local anesthetic injected into at the esp spreads both cranially and caudally as the plane is continuous along the vertebral column . espb reportshave demonstrated analgesia at cervical, thoracic, and lumbar levels for procedures such aspyeloplasty, lipoma excision, breast reconstruction,malignant mesothelioma, inguinal hernia repairs, and hip reconstructions

Eligibility criteria:
inclusion criteria: * patients aged from 18 to 60 years. * genders eligible for study: both sexes. * asa i-ii. * undergoing lumbar spine surgeries in any 2 levels(l1-l5). * bmi from 18.5 to 30 kg/m2 exclusion criteria: * patient refusal * contraindications to regional anesthesia (bleeding disorders, use of any anti-coagulants, local infection, etc.). * known allergy to local anesthetics. * asa iii-iv. * patients aged less than 18 or more than 60. * body mass index \>35. * patients with difficulty in evaluating their level of pain. * patients with secondary surgery or surgery involving more than two intervertebral spaces were excluded.
the impact of tissue micro-rna profile from eus-fna in pancreatic adenocarcinoma

Conditions: Pancreatic Adenocarcinoma

Summary: pancreatic adenocarcinoma still represents one of the "hot-topics" worldwide. endoscopic ultrasonography was a breakthrough, bringing us closer to personalized treatment by getting histopathological samples through fine-needle-aspiration or fine-needle-biopsy. these samples can be analyzed and offer the possibility to detect a micro-rna profile. micro-rnas are small non-coding rna molecules that interfere in genic expression. many studies focused on seric microrna profile, though there are many implications in tissue micro-rna profile, thus overexpression or under expression of these molecules might help us not only understand different cellular processes, but also interfere in personalized medicine in the future. the investigators propose a prospective, multicenter, randomized, cohort study on 60 patients with solid pancreatic masses to evaluate tissue microrna profile obtained by eus-fna. the primary hypothesis is to correlate the microrna tissular expression in pancreatic adenocarcinoma with tumor aggressive behavior, survival and response to treatment. the samples will be obtained from the participants during endoscopic ultrasonography, through fine needle aspiration, after consent was given to be a part of the study prior to the intervention. the probe will be preserved in a special recipient that stabilizes rna and inhibits rna-lazes, thus preventing rna degradation by endogenous ribonucleases. the analysis of mirna profile will be made using qrt-pcr array method, by miscript ii rt kit, miscript sybr green pcr kit și miscript mirna pcr array human cancer pathway finder (mihs-102z) (qiagen, gmbh). thus a kit containing a number of 84 mirnas will be analysed in every participant.


Eligibility criteria:
inclusion criteria: * pancreatic solid mass, with or without a cystic component * age over 18 years old * signed informed consent exclusion criteria: * cystic pancreatic mass with no solid component * abnormal coagulation (elevated inr \>1.5, thrombocytopenia\ 42 seconds), participant on anticoagulant treatment that cannot stop the treatment * european cooperative oncology group status 4 * pregnancy * age under 18 years old * the participant does not want to sign the consent form, or is unable to * difficult puncture position during endoscopic ultrasonography: vessels or wirsung duct positioned in front of the needle (decision of the endoscopist)

Keywords: microrna endoscopic ultrasonography fine needle aspiration
comparing hydrocortisone and prednisolone for acute exacerbation of chronic obstructive pulmonary disease (aecopd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the goal of this cluster randomized controlled trial is to determine the optimal treatment for acute exacerbation of chronic obstructive pulmonary disease. the study compares the effects and side effects of hydrocortisone and prednisolone in patients above 40 years old diagnosed with chronic obstructive pulmonary disease with acute exacerbation. the main question is whether there is a difference in readmission for copd excerbation or all cause mortality within thirty days. participants will randomized to receive treatment with either hydrocortisone or prednisolone.


Eligibility criteria:
inclusion criteria: * age ≥40 years * chronic obstructive pulmonary disease with acute exacerbation, unspecified: icdj44 exclusion criteria: * all diagnoses that would merit treatment with a specific corticosteroid * pregnant or breastfeeding women * active tuberculosis or invasive fungal infection
molecular mechanisms characteristics in systemic lupus erythematous autoimmune disease

Conditions: Systemic Lupus Erythematosus

Summary: it is well known that the deregulation of immune responses plays a major role in many autoimmune diseases, such as systemic lupus erythematosus (sle). the main objective of this protocol is to determine whether the expression and/or function of specific molecules are deregulated in the immune cells of patients with sle. by examining irf4, irf5, ibp/def6, swap-70, rock1, rock2, and specific signaling molecules involved in the responsiveness to sex hormones, the investigators hypothesize that the deregulation in the expression and function of these molecules will result in abnormalities in the functioning of the immune cells, which is a key factor in autoimmunity. peripheral blood lymphocytes from healthy controls and patients with sle will be collected and compared in order to determine if specific immune cells (il-17 and il-21) are deregulated in patients with sle and if this deregulation affects their functioning. specifically, immune cells will be isolated from the blood and then subject to scientific testing (qpcr, western blotting, immunofluorescence assays, elisa and facs analysis) to see if the expression and function of these cells is related to the mechanism behind sle. this will be a case control study, where cases of sle will be compared to controls of healthy volunteers to assess risk factors. as these healthy volunteers are providing samples solely for research purposes, there is no standard of care for these volunteers, with the exception of a positive hiv result during screening. the department of genetic medicine will enroll healthy controls and the hospital for special surgery will enroll subjects with systemic lupus erythematosus (sle) for a comparative analysis of the two cohorts. laboratory testing on all blood samples will be done at the hospital for special surgery.

this will be a case control study, where cases of sle will be compared to controls of healthy volunteers to assess risk factors. as these healthy volunteers are providing samples solely for research purposes, there is no standard of care for these volunteers, with the exception of a positive hiv result during screening. the department of genetic medicine will enroll healthy controls and the hospital for special surgery will enroll subjects with systemic lupus erythematosus (sle) for a comparative analysis of the two cohorts (table i). laboratory testing on all blood samples will be done at the hospital for special surgery. table i. site recruitment1 wcmc healthy subjects 20 hss subjects with sle 20 total 40

Eligibility criteria:
inclusion criteria: * must provide informed consent * males and females, age 18 years and older * healthy nonsmokers exclusion criteria: if the subject has * rheumatic disease * diabetes * sle or lupus * autoimmune disease * active infection or pregnancy * hiv infection
evaluation of the 1-year prognosis of patients under veno-arterial extracorporeal membrane oxygenation for cardiogenic shock with blood transfusion requirement

Conditions: Extracorporeal Membrane Oxygenation Complication; Blood Cells Transfusion; Transfusion Related Complication

Summary: the primary objective of this work is to study the 1-year prognosis of patients who received veno-arterial extracorporeal membrane oxygenation for cardiogenic shock with the need for blood transfusion. secondary objectives are to determine whether the transfusion strategy used (liberal or restrictive) still has an impact on overall mortality. we will also determine the factors associated with overall in-hospital mortality and look at the impact of transfusion in relation to the risk of hemolysis on the consequences in the occurrence of long-term chronic renal failure.

the study of the prognostic impact of blood transfusion at 1 year in patients assisted by veno-arterial extracorporeal membrane oxygenation in the context of cardiogenic shock would provide objective answers and optimize the decision to set up this assistance with regard to the possible long-term consequences. this decision currently remains at the discretion of the expert teams managing these patients. the inclusion of patients in a state of cardiogenic shock under veno-arterial extracorporeal membrane oxygenation with the need for transfusion, will therefore allow the elaboration of a multicentric observational study interested in the prognosis at 1 year of patients under va ecmo according to the adopted transfusion threshold.

Eligibility criteria:
inclusion criteria: * patient of legal age (\> 18 years) at the time of data collection. * hospitalization in intensive care unit * cardiogenic shock of medical or surgical etiology according to the scai definition (stage b to e) * need for cardio-circulatory assistance such as veno-arterial extracorporeal membrane oxygenation for at least 24 hours exclusion criteria: * - age \< 18 years * in-hospital and out-of-hospital cardiac arrest. * veno-arterial extracorporeal membrane oxygenation set up at a center other than the study centers. * veno-arterial extracorporeal membrane oxygenation set up for less than 24 hours * death within 24 hours
oral appliance in obstructive sleep apnea. a randomized controlled blinded multicenter study comparing two devices

Conditions: Obstructive Sleep Apnea

Summary: the hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same. the goal is primarily to compare the apnea-hypopnea index (ahi) after 6 weeks of treatment and the cost of treatment during one year. this randomized controlled parallel group multicenter study includes 316 subjects referred for the treatment of moderate to severe obstructive sleep apnea (osa). the subjects visit the clinic at 5 scheduled occasions.

the study includes 2 arms. secondary measures are obtained by respiratory analysis and questionnaires. electromyography (emg) of the masseter muscle is recorded and the influence of bruxism is evaluated in terms effect on efficacy and adverse events

Eligibility criteria:
inclusion criteria: * the diagnosis of obstructive sleep apnea with ahi \> 15 * odontological status that allows retention of oral devices and with at least one molar in each quadrant * maximal protrusion \>6 mm * subject giving his/her informed concent * understands and can communicate in swedish * subject understands the instruction on how to put on the polygraphy equipment at home * valid ahi data at baseline respiratory analysis exclusion criteria: * age\< 18 år * bmi \>35 * jaw complaints requiring treatment the past year * pain or locking of the jaw at the enrollment visit * at the discretion of the investigator judged not being able to attach to the study directives * hypersensitive to the material of the devices * ongoing continuous positive airway pressure (cpap) treatment or oral device treatment or such treatment terminated within a month from enrollment

Keywords: human sleep apnea adults oral appliance efficacy safety polygraphy bruxism cost