Kornimate/medical-research-clean huggingface dataset:
living longer and stronger with spinal cord injury (sci)

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to develop a health promotion group intervention to meet the unique health promotion needs of people aging with sci, to test the efficacy of the adapted intervention program, living longer and stronger with sci, in a randomized controlled trial and to assess the mechanisms through which the intervention may enhance physical, psychological, and social health.


Eligibility criteria:
inclusion criteria: * traumatic spinal cord injury (sci) * have traumatic sci for at least 15 years or be over the age of 45 * use a manual or power wheelchair for mobility at least some of the time * reside in the u.s. * speak and read english * access to a smart phone, tablet, or a computer with internet access * have or be willing to obtain email for study correspondence exclusion criteria: * cognitive impairment that significantly limits their ability to give informed consent, participate in the intervention, or complete study assessments as determined by an inability to correctly answer questions demonstrating study comprehension * have a significant visual or hearing impairment that would prohibit their ability to participate in the interactive online intervention with accommodations * report active suicidality or significant problems with alcohol or other drug use * live in an institution

Keywords: spinal cord injury aging health promotion intervention randomized controlled trial
visionrt-based deep inspiration breath-hold (dibh) respiratory motion management strategy, a pilot study for thoracic and abdominal tumors

Conditions: Thoracic Cancer; Abdominal Cancer

Summary: a more recent competing technology for implementing the dibh technique is real-time surface photogrammetry using the alignrt system (vision rt ltd., london, uk). alignrt system use non-ionization near infrared light to track patient surface motion. the system has one projector projecting near infrared optical pattern on patient surface. the optical pattern is imaged by optical cameras (two per pod) at \~25 hz. the user selects a region-of-interest (roi) on the surface and the software calculates and displays the real-time position in six degrees (3 translations and 3 rotations) in real-time. once the patient has matched the pre-determined dibh position (within threshold accuracy), the radiation beam is enabled to be turned on for treatment.

vrt-dibh has already applied to left breast radiotherapy to spare lung and heart. compared to abc-dibh, vrt-dibh has several potential advantages: 1. vrt monitors patient (surface) position in addition to dibh signal, while abc only check the tidal volume, which can remain the same even if the patient shifts slightly on the couch; 2. vrt is more cost effective, as patient tubing needs to be replaced daily for abc; 3. vrt potentially has advantage on patient compliance, as with abc breath is forced impeded while with vrt breath-hold is voluntary. in this study, we renovate the established dibh motion management strategy by adopting alignrt system. the purpose of this study is to develop, validate, and prove the feasibility of vrt-dibh technique for lung and liver sbrt.

Eligibility criteria:
inclusion criteria: 1. patients must be willing and capable to provide informed consent to participate in the protocol. 2. patient with presumed pulmonary function capable of holding breath for at least 30 seconds - later to be confirmed. 3. all men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and until study imaging is complete. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 3.1 a female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * has not undergone a hysterectomy or bilateral oophorectomy; or * has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 3.2 patients must be compliant to all required pretreatment evaluations exclusion criteria: 1. pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus 2. patients are not compliant to all required pretreatment evaluations
tgv:use of the quick diagnostic test of the influenza and the infection with rsv by the paediatric emergency unit

Conditions: Influenza; Respiratory Syncytial Viruses

Summary: the aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with rsv and influenza virus on the assumption of clinical responsibility of the children consulting at the paediatric emergency unit.


Eligibility criteria:
inclusion criteria: * age less than 5 years * isolated fever and/or * infection of the higher air routes (congestive otitis, feverish rhinitides, tracheitis or laryngitis) and/or infection of the lower air routes (cough, pneumonia, bronchitis, asthma) * signed consent form exclusion criteria: * evocative clinical of a urinary and/or bacterial infection * purulent acute otitis media * typical acute bronchiolitis * suspicion of acute lobar pneumonia * acute gastro-enteritis * anginas * serious chronic respiratory pathology * other infection whose etiologic viral diagnosis is established * congenital or acquired immunizing deficits * congenital cardiopathy

Keywords: influenza a influenza b rsv
performance and safety evaluation of a novel non-invasive glucose monitoring device

Conditions: Diabetes Mellitus

Summary: this pivotal multicenter study has been launched to collect spectral raman data paired with validated glucose reference values in diabetic patients.

participants will be enrolled at six different sites in four different countries. all participants will undergo identical procedures, which include four steps: baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days. the calibration period consists of 23 home-based days and two in-clinic days. at the two in-clinic days, measurement sessions are performed every 30 minutes. a measurement session consists of two reference measurements (contour next one) and three measurements on the investigational medical device. the glucose level of the participants is manipulated by administration of a glucose rich drink. at home-based days, the subject must perform four measurement sessions a day. during the validation period, participants perform up to four home-based measurement sessions a day.

Eligibility criteria:
inclusion criteria: * male and female subjects ≥18 years of age * diagnosed with diabetes, all types except gestational diabetes * skin phototype 1-4 * willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days * subject has a wireless internet connection at home to be used in the study exclusion criteria: * for female subjects: pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration * for female subjects: breastfeeding * subject currently participating in another study * subject not able to understand and read the local language * in investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol * subject not able to hold hand/arm steady (including tremors and parkinson's disease) * subject diagnosed with cardiovascular diseases * reduced circulation in right hand evaluated by allen's test * subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity * radiotherapy for the past six months * extensive skin changes, tattoos or diseases on right hand thenar (probe application site) * known allergy to medical grade alcohol used to clean the skin * medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate * comorbidity or concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff

Keywords: non-invasive glucose monitoring raman spectroscopy
gelatin tannate as treatment for acute childhood gastroenteritis

Conditions: Acute Gastroenteritis

Summary: oral rehydration therapy is the only treatment recommended by the world health organization in acute diarrhea in children. the aim of this study was to compare the efficacy and safety of a therapy with gelatin tannate plus oral rehydration versus oral rehydration alone in children with acute gastroenteritis. this is a single-blind, prospective, randomized and parallel study performed in two pediatric services of tertiary referral hospitals. patients, ages 3 to 36 months with acute gastroenteritis randomized to receive an oral rehydration solution (or), or an oral rehydration solution plus gelatin tannate (or+g). the primary outcomes evaluated were: the number of bowel movements after 48 and 72 hours after initiating treatments. secondary outcomes were: duration of diarrhea (days), stool characteristics and adverse events. other clinical variables, as weight, fever, vomiting, appetite and the acceptability of the two treatments were also recorded.


Eligibility criteria:
inclusion criteria: * children of both sex, aged 3 months to 5 years of age * clinical diagnosis of acute gastroenteritis, as defined by having at least 3 loose stools within the previous 24 hours and/or a change in stool consistency to loose or liquid according to bristol stool form scale for children (m-bsfs-c) lasting for no longer than 3 days. exclusion criteria: * patients with gastroenteritis lasting more than 5 days * patients with chronic gastrointestinal conditions * patients receiving other antidiarrheal drugs within 2 weeks prior to enrollment (i.e. antibiotics, probiotics, salicylates, loperamide, racecadotril, disomectite)
analgesia regimens following trans-sphenoidal surgery for pituitary tumors

Conditions: Pituitary Tumor; Pain

Summary: a randomized, double-blind, placebo-controlled intervention trial involving 100 treated subjects undergoing endonasal trans-sphenoidal (ents) resection of pituitary lesion. subjects will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in the standard post-operative medication arm.

post-operative pain control is a common concern patients have when they consider undergoing a surgical procedure. although effective for treating acute pain, opioid analgesics are also associated with dose-dependent adverse effects, including constipation, nausea and vomiting, altered mental status, and respiratory depression, all of which have been shown to increase patient length of stay. the use of non-opioid analgesics with different mechanisms of actions for acute pain control via a multi-modal approach is efficacious in reducing opioid consumption, decreasing the incidence of adverse effects, improving patient satisfaction and recovery time, and decreasing hospital costs.certain minimally invasive procedures may afford many patients the opportunity to achieve adequate post-operative pain control with minimal to no requirement of opioid analgesics, thereby sparing the patient known adverse effects that can increase length of stay and costs. the ents approach for resection of pituitary tumors is the standard surgical procedure for these lesions, and is associated with pain that is more easily managed post-operatively, making it an ideal procedure for an opioid-sparing post-operative pain regimen. anecdotally, the investigators note that in the investigator's post-operative pituitary patient population that post-operative pain can frequently be adequately managed with scheduled non-opioid analgesics, often without requiring breakthrough opioid doses. another safe and effective non-opioid analgesic that is widely used in multi-modal pain management for moderate pain is iv caldolor (ibuprofen). after literature review, the investigators were unable to find a study that had attempted to use an opioid-sparing analgesic regimen for post-operative pain control following ents approach for resection of pituitary tumors.

Eligibility criteria:
inclusion criteria: * adult patient undergoing ents surgery for resection of pituitary tumor. * adults \>18 years and \<80 years of age. * english speaking and literate or able to understand the use of a pain scale. * body mass index \>19 and \<40 kg/m2 exclusion criteria: * renal failure (acute or chronic) or creatinine \>2.0 * allergy or intolerance to acetaminophen, ibuprofen, or opioids * pre-operative opioid tolerance, dependence, or abuse * anaphylaxis to opioids * history of peptic ulcer disease or recent gastrointestinal bleed requiring surgery * cirrhosis, hepatitis, liver transplant, or liver function studies out of normal range, defined as aspartate aminotransferase (ast)/alanine aminotransferase (alt)/bilirubin\> 3x upper limit of normal range * subject unwilling or unable to sign informed consent for the study * pregnancy * incarcerated patients
preoperative anxiolysis with intravenous midazolam on intraoperative sevoflurane gas consumption

Conditions: Midazolam; Sevoflurane

Summary: this prospective, randomized, double-blind, placebo-controlled study is performed after obtaining written informed consent of patients who are scheduled for elective general surgery. after the admission to the preoperative unit 30 minutes before the surgery, the preoperative anxiety of patients is evaluated by the state-trait anxiety inventory (stai). patients are randomly assigned to one of two groups in a 1:1 ratio by a computer-generated list. patients receive midazolam iv at 0.04 mg/kg (group m) and an equal volume of saline iv (group c, control group). anesthesia is induced with 2mg/kg of iv propofol. at a dose of 0.6 mg/kg, iv rocuronium bromide is given for neuromuscular blockade. anesthesia is maintained at 2% sevoflurane. at the end of the surgery, anesthesia is terminated and the awake patients are extubated.

an equal depth of anesthesia is achieved by evaluating an entropy value of 40-50 during the operation. heart rate, blood pressure, the amount of sevoflurane consumed (ml), end-tidal sevoflurane concentration (%), sevoflurane mac, inspiratory sevoflurane (%) are recorded at baseline and 15-minute intervals.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status 1 and 2 * patients who are scheduled for elective surgery * bmi \<30 exclusion criteria: * history of psychiatric disease * use of psychotropic medications * neurological disorders * cancer * chronic pain * cardiovascular, respiratory, and hepatic diseases.

Keywords: midazolam sevoflurane anxiety
watchful waiting versus repair of oligosymptomatic incisional hernias

Conditions: Incisional Hernia

Summary: watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic incisional hernias in terms of pain and discomfort during normal activities.

incisional hernias are one of the most frequent complications in abdominal surgery. in germany, 44.000 incisional hernia repairs per year are performed. incisional hernia repair is not a low risk operation associated with high recurrence rate and high percentage of postoperative pain. treatment of incisional hernias represents a significant surgical and socioeconomic problem. until now, surgical treatment is recommended for patients with incisional hernia independent of symptoms due to the risk of an acute incarceration with serious complications. studies defining the exact indications for incisional hernia repair and describing the natural course of an incisional hernia including the risk of an acute incarceration are not available to date. randomized controlled trials having been performed in the past few years show that observation is a reasonable option in mildly symptomatic inguinal hernias. in this study, watchful waiting vs. surgical repair of oligosymptomatic incisional hernias are compared in a prospective-randomized setting for the first time. the primary endpoint is pain during normal activities measured on the surgical pain scales (sps) after 24 months follow-up. sps are a numeric analog scale (nas) from 0 (no pain) to 150 (maximal pain). the primary endpoint will be dichotomized to no/minimal pain (sps 0-30) and pain interfering with everyday activities (sps \> 30). watchful waiting is non-inferior to surgical repair in case the upper border of the 95 % confidence interval will not include the value of 2. secondary outcomes are pain and discomfort during during sports, at rest, patient satisfaction, quality of life, and the frequency of incarceration. the investigators hypothesize that pain intensity during everyday activities is not different in the compared groups and that incarceration frequency is low. if this was the case, a watchful waiting strategy could be applied in oligosymptomatic incisional hernias and risks and costs for surgery could be saved.

Eligibility criteria:
inclusion criteria: * age ≥18 years * asymptomatic/ oligosymptomatic incisional hernia exclusion criteria: * no hernia detectable by physical examination * acute incarcerated hernia * emergency hernia repair * pain or discomfort associated with the hernia during normal activities * local or systemic infection * asa score \>3 * inability to complete or comprehend the preoperative questionnaire * repair with biologic prothesis

Keywords: asymptomatic minimally symptomatic
impact of non-commercialism policy in seattle schools

Conditions: Obesity

Summary: this is a 3-year pilot study funded by national institute of health will assess and evaluate obesity-related health outcomes of a real-life policy decision, recently voted on and adopted by the seattle school board.


Eligibility criteria:
inclusion: all students who attend cleveland and rainier beach high schools are eligible. exclusion: those who are no longer attending those schools.
treatment of chronic obstructive pulmonary disease (copd) with iodinated activated charcoal

Conditions: Chronic Obstructive Lung Disease

Summary: the purpose of this study s to determine whether treatment with iodinated active charcoal can improve lung function and physical capacity in patients with chronic obstructive lung disorders. the rational for the study is the observation that copd patients have an increased tissue load of mercury interfering with the function by neuroepithelial endocrine (nee) cells in the respiratory tract. mercury binding to these nee cells leads to an increased smooth muscle tonus and a reduced response to bronchodilator treatment. initial observational data have shown an improved lung function and improved functional capacity after treatment motivating a larger placebo controlled poc study


Eligibility criteria:
inclusion criteria: * male and \>1 year post-menopausal, or surgically sterile female. * 45-80 years old. * smokers and ex-smokers, at least 15 pack years. * copd according to gold ii. fev% \ 50 \< 80 % of predicted value * co diffusion capacity \< 75 %. * active symptomatic copd with a copd assessment test (cat) score \>10. exclusion criteria: * alpha-1 antitrypsin deficiency * iodine allergy * abnormal thyroid function * severely reduced kidney function (cystatin c \> 1.5 mg/l. * exacerbation within 4 weeks prior to the study. * use of per oral steroids within 4 weeks prior to the study. * alcohol/drug abuse. * psychiatric disease. * severe cardio-vascular or other severe disease, according to the clinical investigator. * oxygen treatment. * participation in another ongoing clinical trial or participation in drug
effect of the color of the intra-eye implant in the cataract surgery on the sleep

Conditions: Cataract

Summary: the cataract surgery (550 000 operations per year in france) is to replace the cloudy lens with a refractive implant. two colors of implants are available: white implants, filtering out ultraviolet and yellow implants, filtering and more blue light. no clinical data are available to assert the superiority of an implant according to its color and the choice is made according to the preference of the surgeon and / or "markets". it is established in humans that blue light has an important role on the secretion of melanopsin, a key mediator of the circadian cycle. this "clock" regulates most neuroendocrine functions in the nycthémère (sleep, mood, temperature, cortisol, ..). the question of the impact of these neuro endocrine functions of the installation of a blue light filter into the eyes of patients operated thus arises.


Eligibility criteria:
inclusion criteria: * female or male subject * subject between 60 and 90 years old * visual acuteness \< or = with 2 eyes * indication operating of the cataract exclusion criteria: * na

Keywords: cataract
safety and efficacy of 12-wk treatment with two doses of tiotropium respimat in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the respimat device on lung function in patients with cystic fibrosis. the selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations


Eligibility criteria:
inclusion criteria: 1. male or female patients 2. diagnosis of cystic fibrosis (positive sweat chloride test or two identifiable mutations) 3. pre-bronchodilator fev1 greater/equal 25% of predicted values exclusion criteria: 1. significant history of allergy/hypersensitivity 2. hypersensitivity to study drug 3. participation in another trial 4. female patients who are pregnant or lactating 5. female patients of childbearing potential 6. patients who have started a new medication for cf within 4 weeks of screening 7. patients with known substance abuse 8. clinically significant disease other than cf
the effects of exenatide on oral contraceptive pharmacokinetics in healthy females

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is the examine the effect of taking exenatide on the blood levels (pharmacokinetics) of orally-administered contraceptives.


Eligibility criteria:
inclusion criteria: * pre-menopausal female of child-bearing potential. * body mass index (bmi) between 19 and 35 kg/m\^2, inclusive. exclusion criteria: * on implanted contraceptives for 6 months, or injectable contraceptives for 12 months prior to the study. * evidence of diabetes mellitus. * participation in a study involving administration of an investigational compound within the past 3 months.

Keywords: diabetes exenatide amylin lilly