Kornimate/medical-research-clean huggingface dataset:
sleep position may reduce acid reflux symptoms at night

Conditions: Extra-esophageal Reflux

Summary: this study is designed to determine if the addition of the medclinetm sleep assist device will decrease night-time gastroesophageal reflux disease events.

the medcinetm sleep assist device was recently developed by amenity health, inc and is designed to elevate the head and torso and maintain a patient in the left-lateral position in order to decrease night-time/nocturnal acid reflux. the medcinetm sleep assist device is composed of a 9-inch incline base and a wrap-around body pillow. traditionally wedge pillows have been recommended for patients with acid reflux. the addition of the body pillow helps to maintain the patient in the left-lateral position (llp) during sleep, which has been shown to reduce night-time reflux compared to wedge alone, right lateral position and/or sleeping flat. in healthy controls, sleeping in the left-lateral position with this device system significantly decreased esophageal acid exposure and overall episodes of acid reflux. to date, there has been no study in patients with extra-esophageal reflux (eer) and nocturnal heartburn. primary objectives the primary objective of the this study is to evaluate the effect of a reflux pillow on esophageal acid exposure in patients complaining of nocturnal eer. secondary objectives to evaluate the effect of the reflux pillow on nocturnal eer symptoms, sleep quality, daytime eer symptoms, and overall quality of life.

Eligibility criteria:
inclusion criteria: * male and female patients between the ages of 18 and 65; * between 5'4" and 6'2" * body mass index\<32 * willing and able to provide written informed consent; * understands the clinical study requirements and is able to comply with the follow-up schedule set forth in the protocol; * clinically diagnosed with gastroesophageal reflux disease with extra-esophageal symptoms (i.e. chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing); * presents with reflux symptom index (rsi) \> 13; * undergoing esophagogastroduodenoscopy (egd) as part of routine care; * undergoing 96-hour ph monitoring via bravo capsule as part of routine care. exclusion criteria: * currently being treated with another investigational medical device and/or drug; * currently receiving treatment for sleep apnea with continuous positive airway pressure (cpap); * female patients who are of child-bearing potential and not using an acceptable method of birth control, or is pregnant or breast-feeding; * suspected esophageal cancer; * confirmed nasopharyngeal cancer; * previously undergone nissen fundoplication; * hiatal hernia \> 4 cm
packing versus no packing for cutaneous abscess

Conditions: Cutaneous Abscess

Summary: the goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if routine packing of the abscess cavity affects the need for further interventions such as repeat incision and drainage, antibiotic administration or hospital admission.

study protocol: 1. identification of a patient with a cutaneous abscess requiring incision and drainage 2. written consent obtained from the patient 3. study materials will be obtained * enrolling physician fills out pre-procedure information (see data sheet) * enrollment data sheet has instructions indicating whether patient is to receive packing or not * use of random number generator to randomize all packets * provider does abscess incision and drainage with or without packing according to the instructions * enrolling physician fills out post-procedure information (see data sheet) * patient returns within 48 hours for wound check with removal of packing if performed * research coordinator or study physician calls the patient within 14 and 30 days after the procedure for follow-up * information from a return visit and/or the telephone follow-up

Eligibility criteria:
inclusion criteria: 1. all patients 18 years of age and above 2. patients that require a cutaneous abscess incision and drainage 3. english-speaking subjects only exclusion criteria: 1. unable to return for 48-hour follow-up. 2. patients being admitted to the hospital or going to the operating room for incision and drainage 3. pregnant patients 4. patients less than 18 years of age 5. prisoners or persons in police custody 6. patients with infected bursa 7. non-english speaking subjects
clinical efficacy of tranexamic acid and ε-aminocaproic acid in reducing blood loss following total knee replacement

Conditions: Osteoarthritis

Summary: tranexamic acid (txa) and ε-aminocaproic acid (eaca) are two drugs shown to limit blood loss following major surgery, from cardiac to orthopedic procedures. yet compared to tranexamic acid (txa), research on the clinical impact of ε-aminocaproic acid (eaca) in total knee arthroplasty (tka) is limited. the primary aim of this study is to determine whether txa and eaca provide similar blood decreasing effects following tka or whether one drug provides a superior effect over the other in reducing patients' blood loss.


Eligibility criteria:
inclusion criteria: * persons aged 18 - 90 years who are scheduled to undergo a unilateral total knee replacement surgery exclusion criteria: * non-english speaking individuals * individuals with a history of deep vein thrombosis or pulmonary embolism within one year * individuals with a history of coagulopathy * heart stent within one year * pre-operative autologous blood donation * unwilling or unable to take coumadin for deep vein thrombosis (dvt) prophylaxis * received nonsteroidal anti-inflammatory drug (nsaid) or platelet antiaggregant treatment within five days prior to surgery * pre-operative creatinine greater than 1.5mg/dl

Keywords: tranexamic acid 6-aminocaproic acid arthroplasty osteoarthritis arthritis joint diseases musculoskeletal diseases rheumatic diseases antifibrinolytic agents fibrin modulating agents pharmacologic actions coagulants therapeutic uses
biomarkers in tissue samples from patients with breast cancer treated with bevacizumab

Conditions: Breast Cancer

Summary: rationale: dna analysis of tumor tissue may help doctors predict how well patients will respond to treatment. purpose: this research study is studying biomarkers in tissue samples from patients with breast cancer treated with bevacizumab.

objectives: primary * to demonstrate that vascular endothelial growth factor-a (vegfa) haplotypes that are associated with an increased vegfa expression will predict superior outcome for patients with metastatic breast cancer receiving bevacizumab in ecog-e2100 (but not for the control arm). * to demonstrate that candidate single nucleotide polymorphisms (snps) will further improve the predictive capacity of outcome (efficacy and toxicity) in patients enrolled in ecog-e2100. * to demonstrate that tumor vegfa amplification or borderline amplification (estimated 14% frequency) will predict superior outcome for patients with metastatic breast cancer receiving bevacizumab on ecog-e2100 whereas those with vegfa deletion (estimated 11% frequency) will predict inferior outcome. * to demonstrate that vegfa amplification/deletion will not predict outcome in the control arm of ecog-e2100. secondary * to demonstrate that tumor vegfa amplification will predict increased protein expression as ascertained by ihc. * to demonstrate that a combined algorithm calculated from tumor-specific variability (vegfa amplification/deletion) and host-specific variability (snps) will optimally predict outcome (efficacy) with bevacizumab in patients enrolled on ecog-e2100. outline: this is a multicenter study. previously collected tumor-derived dna is analyzed for vegfa amplification/deletion and haplotype as biomarkers for outcome after bevacizumab treatment. gene expression, polymorphism, protein expression analysis, and ihc are performed on the samples.

Eligibility criteria:
disease characteristics: * enrolled on ecog-e2100 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: male breast cancer stage iv breast cancer recurrent breast cancer
a double-blind randomized controlled trial of a thickened amino-acid-based formula in children allergic to cow's milk and to protein hydrolysates

Conditions: Cow Milk Allergy

Summary: the purpose of this study is to evaluate the impact of a new amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;


Eligibility criteria:
inclusion criteria: * less than 18 months old * with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive skin prick test (\>=6mm) or specific immunoglobulin e \>= 5 kilo-unit/l or combination * still symptomatic while fed an extensively hydrolysed formula exclusion criteria: * exclusively breast fed infants * non allergic digestive enteropathy

Keywords: hypersensitivity milk hypersensitivity immune system diseases food hypersensitivity
quarto-ii study to evaluate the management of patients resynchronized with the quartettm lv quadripolar lead

Conditions: Heart Failure

Summary: optimization and evolution of the patient will be evaluated over 6 months after the implant.

patient will be enrolled into the study after informed consent signature and crt-d+quadripolar (quartettm) lv lead.

Eligibility criteria:
inclusion criteria: * patient with implanted crt-d device and a quartettm quadripolar lead by st. jude medical in the left ventricle. * patient with an echocardiographic study performed during 1 month prior to the implant and in whom end systolic volume of the left ventricle (lvesv) has been measured * patients who have granted their informed consent. * patients above 18 years. exclusion criteria: * patients that have been previously resynchronized. * patients with aortic stenosis or aortic valve prosthesis * patients who are or may potentially be pregnant. * patients with a life expectancy \<12 months. * patients who cannot attend the monitoring visits established by the protocol.

Keywords: crt optimization responders
survival according to the feeding artery obliteration by chemoembolization for unresectable hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Transarterial Chemoembolization

Summary: the aim of this study was to evaluate whether survival of patients who underwent tace with unresectable hcc can benefit from intermediate-levels of embolization.

subjective angiographic chemoembolization endpoints (sace) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (tace) for hepatocellular carcinoma (hcc). it determined the antegrade arterial flow and residual tumor blush as follows: i, normal-normal; ii, reduced-reduced; iii, reduced-none; iv, none-none. sace level ii and iii indicates intermediate-levels of embolization, whereas iv indicates overembolization. the aim of this study was to evaluate whether survival of patients who underwent tace with unresectable hcc can benefit from intermediate-levels of embolization.

Eligibility criteria:
inclusion criteria: * age over 18 * ecog performance status 0-2 * hepatocellular carcinoma diagnosed histologically or clinically * tumor numbers of 5 or less * no history of treatment for hepatocellular carcinoma * patients with informed consent exclusion criteria: * extrahepatic metastasis * rupture of hepatocellular carcinoma * infiltrative hepatocellular carcinoma * malignancy other than hepatocellular carcinoma

Keywords: hepatocellular carcinoma transarterial chemoembolization
metabolomics study on postoperative intensive care acquired muscle weakness

Conditions: Metabolomics; Critical Care; Critical Illness; Critical Illness Myopathy; Critical Illness Polyneuropathy; Intensive Care (ICU) Myopathy; Muscle Weakness

Summary: in this mono-center pilot trial, surgical patients who are at high risk to be admitted to intensive care will be screened and asked for participation. we are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing. aim of the study is to investigate (1) changes of the blood metabolome in patients with icuaw (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for icuaw or can be used as marker for icuaw.


Eligibility criteria:
inclusion criteria: * invasive mechanically ventilated critically ill patient with expected intensive care unit stay \> 3 days * postoperative patient * ≥ 18 years old * american society of anesthesiology (asa) classification ≥ iii exclusion criteria: * moribund patient * non-curative care (comfort care)

Keywords: pilot trial muscle biopsy blood metabolome
effects of continuous bilateral ql analgesia after open abdominal surgery

Conditions: Pain, Postoperative

Summary: eligible patients will be randomized 1:1 without stratification to bilateral continuous ql catheters with local anesthetic continuous infusion (ql block + iv patient-controlled analgesia group) or normal saline continuous infusion (iv patient-controlled analgesia group). in the postanesthesia care unit (pacu), patients will be given intravenous boluses of hydromorphone or fentanyl as needed. following immediate recovery from anesthesia, patients will be provided with a hydromorphone iv patient-controlled analgesia pump with standard initial settings and an option of clinician dose for breakthrough pain. iv patient-controlled hydromorphone pump settings will be titrated to comfort level (pain score\<4) by blinded clinicians. each of the catheters will be connected to patient controlled infusion pump running at a basal rate of 6ml/hour of 0.1% bupivacaine or normal saline with on-demand bolus of 5 ml every 60 minutes to be started in the operating room before the surgical incision. opioid consumption first 72 hours or until discharge, whichever comes first will be recorded. pain scores during first 72 hours or until discharge, whichever comes first will be recorded with a verbal rating scale and obtained from the patient's electronic medical records. the morning of post operative day 1 and post operative day 3 the orsds and qor surveys will be completed. morning of the day of discharge, the overall patient satisfaction with pain management survey will be completed.


Eligibility criteria:
inclusion criteria: * adults scheduled for elective colorectal surgery with a midline incision; * american society of anesthesiologists (asa) physical status 1-3. exclusion criteria: * contraindication or intolerance to opioids and/or local anesthetics; * inability to use iv pca system; * history of chronic pain defined as use of opioids for more than 30 consecutive days within the 3 preoperative months at the dose equal or greater than equivalent of 15 mg of morphine and/or abdominal pain for more than 6 months, present most days of the weeks; * history of neurological illness and/or neuropathy - peripheral neuropathy, paralysis; * pregnancy and/or breastfeeding; * chronic renal failure, defined by estimated gfr \<60 ml/min; * chronic liver failure, defined by cirrhosis, portal hypertension, or history of variceal bleeding. * bmi \> 35
self-mobilization versus kinesio-taping on the cervical region in electronic device users

Conditions: Neck Pain

Summary: the purpose of this clinical trial is to compare the effectiveness of kinesio-taping versus self-mobilization applied to the cervical region of long-duration electronic device users.

there is increasing use of electronic devices among individuals due to technological advancement and increasing work demands. the prolong use of these devices may result to discomfort in the neck and impairments in cervical range of motion, proprioceptive sense, muscle activities, and disability among users of electronic devices. kinesio-taping and self-mobilization in the cervical region may improve function, and reduce disability. therefore the aim of this study is to compare the effectiveness of kinesio-taping against self-mobilization among long-duration electronic device users. participants will be randomized into either a kinesio-taping or self-mobilization group. treatment will be administered within a four-week period. participants will be evaluated at baseline, post-intervention and at one-month follow-up.

Eligibility criteria:
inclusion criteria: * complain of pain in the neck * using electronic devices (including smart phones, desktop computers, laptops, tablets) for at least 4 hours a day, * using electronic devices for at least 6 months, * volunteering to participate in the study exclusion criteria: * having a history of allergic reaction, * having previous cervical pathologies such as cervical spondylolisthesis, disc herniation, rheumatoid arthritis, muscle or ligament injury or strain, * having had neck or shoulder surgery, * having a neurological deficit (eg numbness, muscle weakness and loss of sensation).

Keywords: kinesio-taping self-mobilization neck disability neck pain electronic device users
safety evaluation of herpes simplex candidate vaccine (gd2t) with adjuvant in hsv seropositive / seronegative subjects

Conditions: Prophylaxis for Herpes Simplex

Summary: this study will evaluate, versus a placebo, the safety of herpes simplex candidate vaccine with adjuvant in initially hsv seropositive or seronegative subjects who have no genital herpes disease.

this study was monitored by a data safety monitoring board. at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham.

Eligibility criteria:
inclusion criteria: * 18 years of age and over at the time of first vaccination * written informed consent * females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control exclusion criteria: * any previous history of or current clinical signs or symptoms of genital herpes disease. * any previous vaccination against herpes simplex. * any previous administration of mpl. * history of herpetic keratitis. * history of erythema multiforme. * female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose * patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. topical corticoid therapy is allowed. * hiv positive at the time of enrollment * clinical signs of acute or febrile illness at the time of entry into the study. * any continuous suppressive antiviral oral therapy within the 6 months prior to entry. * any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination. * any vaccine administration less than one week before or after a study vaccination. * previous known hypersensitivity to vaccination or to any component of the vaccine. * simultaneous participation in any other clinical trial of an investigational drug or vaccine concurrent with this study or during the period beginning 30 days prior to entry into the study or 5 half-lives of the drug * recent history of alcoholism or drug abuse * recent clinical history or evidence of significant hepatic disease * history of a current acute or chronic auto immune disease. * recent clinical history or evidence of renal dysfunction * life-threatening or serious cardiac (nyha grades iii-iv), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study. * inability or unwillingness to comply with the protocol or not expected to complete the study period

Keywords: herpes simplex, herpes simplex candidate vaccine
the patients' experience after stem cell transplant

Conditions: Stem Cell Transplant Complications

Summary: this study will examine how adults ≥ 60 years old thinking and memory abilities are affected by stem cell transplant; whether these changes affect day-to-day activities and quality of life and how thinking and memory abilities are affected by genetics, depression, anxiety and physical function. genetics and other factors may affect the brain's chemicals or structure, and may increase risk for negative effects on thinking and memory.

in this study, the investigators are looking to understand: 1) how adults ≥ 60 years old thinking and memory abilities are affected by stem cell transplant; 2) whether these changes affect day-to-day activities and quality of life; and 3) how thinking and memory abilities are affected by genetics, depression, anxiety and physical function. genetics and other factors may affect the brain's chemicals or structure, and may increase risk for negative effects on thinking and memory. participants will undergo neurocognitive testing along with the collection of a saliva sample and completing a battery of questionnaires and assessments.

Eligibility criteria:
inclusion criteria: * between the ages of 60-85 * diagnosed with a hematological malignancy * is considering an autologous or allogeneic stem cell transplant or has undergone stem cell transplant in the past 12 months and seen by the pi for pre-transplant evaluation. * is able to read, write, speak, and understand english exclusion criteria: * as per self report or medical record, history of central nervous system involvement and/or history of cranial irradiation or intrathecal chemotherapy except for patients with history of prophylactic intrathecal chemotherapy. * as per self report or medical record, history of stroke, head injury, neurosurgery, seizure disorder, or demyelinating disorder. * as per self report or medical record, history of substance use disorder. * as per self report or in the judgement of the consenting professional, uncorrected vision loss. * as per self report or medical record, primary psychiatric disorder necessitating inpatient treatment in the last 12 months. * as per self report or medical record, history of allogeneic and or autologous stem cell transplant.

Keywords: stem cell transplant
national study "aec covid-19"

Conditions: Mortality

Summary: currently there is an important need to know the evolution, results and associated mortality of patients undergoing surgical intervention in spain during the sars-cov-2 pandemic. with a national data collection, information could be obtained to guide the management of this group of complex patients operated on during the covid-19 pandemic, with the aim of improving their treatment in the event of a second wave. the great spread of the virus and the difficulty in controlling it over time makes it a high priority for the scientific community in order to face new outbreaks. the national study "aec covid-19" is a collaborative study (in the style of those carried out at european level such as eurosurg, globalsurg, etc.) that aims to know the evolution, results and associated mortality of patients undergoing surgical intervention in spain during the sars-cov-2 pandemic. it is an observational study, with anonymized and coded data, which aims to demonstrate the following hypotheses: * patients with covid-19 have high mortality. * patients with both oncological and benign pathologies have high morbidity. the situation / follow-up at 7 days and 30 days after the intervention will be included in each patient.


Eligibility criteria:
inclusion criteria: adult patients who undergo a surgical procedure during the pandemic exclusion criteria: -

Keywords: covid surgery