Kornimate/medical-research-clean huggingface dataset:
do self-rated performance status scores correlate with health-care-provider-scores?

Conditions: Cancer

Summary: the purpose of this study is to determine if patients are able to self-rate their physical abilities and how these ratings compare to the ratings of their health-care provider.

the karnofsky performance scale (kps) is a highly validated and essential measuring tool across the cancer population. the scale relates to purely physical ability and covers 11 stages, ranging from normal health to death, with each stage scored as a percentage. the score is determined by the health-care provider and is based on observation and narrative patient descriptions. the purpose of this study is to compare the scores rated by the health-care provider to the scores that patients assign to themselves.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of brain or spinal tumor. * receiving medical care under the supervision of the principal investigator. * written informed consent. exclusion criteria: none.

Keywords: qol quality of life kps karnofsky performance status cancer
study on utilization of cabergoline for compliance with risk minimization activities (sucre)

Conditions: Parkinson's Disease; Hyperprolactinemia

Summary: the overall goal of this study will be to assess and monitor the adherence to and effectiveness of the new prescribing guidelines for cabergoline. specific objectives will be to assess: 1. the indication for use of cabergoline (parkinson, hyperprolactinemia, other) 2. prior treatment strategies in patients who start cabergoline treatment for parkinson's disease 3. the percentage of cabergoline users who are prescribed doses above 3 mg per day 4. whether cabergoline users are monitored by echocardiography prior and during treatment. 5. the incidence and prevalence of valvular fibrosis

does not involve random selection

Eligibility criteria:
inclusion criteria: * treated with cabergoline during the study period (january 1st, 2006 and will end on july 1st 2012) and identified in one of 6 databases: the health information network, health search database, integrated primary care information database, pharmo, aarhus hospital databases, and the universitaet bremen - bremen institute for prevention exclusion criteria: * patients with eligibility dates that start after july 1st 2007 (meaning that they would have less than one year of valid data before publication of the results of the emea review), will be excluded as well as patients whose eligibility ends before july 1st 2008 (date of smpc changes).

Keywords: compliance study effectiveness study hyperprolactinemia parkinson's disease retrospective cohort study
smart textile technology for scoliosis

Conditions: Spinal Deformities; Scoliosis; Kyphosis

Summary: the investigators hypothesize that a garment-integrated sensing system will be able to detect with clinical accuracy the position of the spine. the investigator will evaluate this using healthy adult volunteers, who will don sensing garments and assume a series of spinal postures. concurrent with garment sensing, the participant's spine position will be measured using a motion-capture system that uses reflective markers to detect positions of markers in 3d space. the motion-capture system provides a gold-standard reference measure to which the sensing garments will be compared. because the investigators are evaluating the accuracy of the sensing garment, it is only necessary that the investigator test the garments on participants with subtly different body shapes. healthy adult volunteers provide an adequate input to the sensing signal.


Eligibility criteria:
inclusion criteria: * healthy adults exclusion criteria: * under age 18 or over age 65 * any medical condition that impairs movement or makes movement painful or difficult.
colchicine in percutaneous coronary intervention

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Summary: inflammation in the arteries of the heart may increase the risk of cardiac death. the proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of the heart. with its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of major adverse events related to the heart. this research also seeks to better understand the role of neutrophils, the most common type of inflammatory white blood cell in the body, when there is damage to the heart.

the investigators will use colchicine as a tool to elucidate the role of neutrophil activation during acute vascular injury, and to explore the association between neutrophil activation and adverse cardiovascular outcomes. colchicine reduces cell surface expression of selections, adhesion molecules key to neutrophil recruitment after vascular injury. daily colchicine use is associated with reduced adverse cardiovascular events in stable atherosclerosis. using a clinical percutaneous coronary intervention (pci) model, the investigators evaluate whether pre-procedural colchicine (1.8 mg oral load over one hour) reduces the rate of post-pci adverse cardiovascular outcomes in the context of a double-blind placebo-controlled randomized study. the investigators will also characterize neutrophil biology in acute vascular injury and the effects of colchicine on neutrophil biology in this setting.

Eligibility criteria:
inclusion criteria: * referred for possible pci exclusion criteria: * colchicine use within 1 month * history of colchicine intolerance * glomerular filtration rate \<30ml/minute or on dialysis (due to the need to adjust colchicine dose in this setting) * active malignancy or infection (major confounder with increased inflammatory markers) * history of myelodysplasia (due to suggested cautionary use of colchicine in this setting) * high-dose statin load \<24 hours prior to procedure (major confounder that is known to reduce inflammatory levels in 12 to 24 hours) * use of anti-inflammatory agents (except aspirin) within 5 halflives of the individual drug * use of strong cytochrome p450, family 3, subfamily a, polypeptide 4 (cyp3a4) and/or p-glycoprotein inhibitors (e.g. ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil, again due to drug interactions) * unable to consent * participating in a competing study * any significant condition or situation that may put the subject at higher risk, confound the study results or interfere with adherence to study procedures

Keywords: inflammation percutaneous coronary intervention coronary artery disease colchicine
the use of over-the-scope-clip for prevention of rebleeding in high risk peptic ulcers

Conditions: Ulcer Bleeding; Upper Gastrointestinal Tract Bleeding

Summary: non-variceal acute gastrointestinal bleeding is a common and potentially life-threatening problem. the conventional treatment of this condition is for esophagogastroduodenoscopy (ogd) for haemostasis. treatment methods include heater probe, clipping and injection of adrenaline. recently, a new device called the over-the-scope clip (otsc) has been device to treat perforations and bleeding in the gastrointestinal tract. therefore, the aim of the study is to compare between the treatment outcomes between otsc and conventional endoscopic haemostatic methods in ulcers that are of high risk for rebleeding.

acute upper gastrointestinal bleeding is a common and potentially life-threatening condition. non-variceal bleeding accounts for more than 80-90% of the cause with gastroduodenal peptic ulcer being the major cause. endoscopic haemostasis has significantly improved the outcome of these patients. recurrent bleeding remains one of the most important predictors of mortality. previous studies have identified ulcers that are high risk for rebleeding. conventionally, endoscopic haemostasis is achieved by injection therapy, thermocoagulation or mechanical therapy such as haemostatic clips. however, there are limitations to thermo-coagulation and conventional haemostatic clips. over the past few years, a novel endoscopic clipping device, the over-the-scope clip (otsc; oversco endoscopy ag, tübingen, germany) has become available. the device provides a robust and strong tissue apposition. the system was developed to close perforations and treat bleeding in the gastrointestinal tract. in chronic ulcers, an anchor device can be used to pull the ulcer base toward the aspiration cap to facilitate accurate clip application. with a larger jaw width and greater strength, the otsc is expected to have superior haemostatic properties when compared to hemo-clips. case series have been published on the clinical experience of otsc on gastrointestinal bleeding with promising results. therefore, in this randomised controlled trial, we aim to compare the efficacy of the otsc to standard endoscopic therapy in primary treatment of patients with peptic ulcer bleeding that are of high-risk for rebleeding. the hypothesis is that the use otsc can significantly decrease the rebleeding rate in this group of patients.

Eligibility criteria:
inclusion criteria: 1. actively bleeding peptic ulcers (forrest ia, ib), ulcers with non-bleeding visible vessel or forrest iia ulcer (defined as protuberant discoloration, or ulcers with an initial clot and upon irrigation shows a vessel) and 2. ulcer size ≥ 1.5 cm as determined by an opened biopsy forceps; exclusion criteria: 1. patients aged below 18 2. peptic ulcer with concomitant perforation 3. tumor bleeding 4. variceal bleeding 5. patients who are pregnant or lactating 6. moribund patients or patients with terminal malignancy or end-stage non-malignant conditions, in whom life expectancy is less than 30 days

Keywords: over-the-scope clip endoscopic haemostasis
a crossover study of patients with hf to compare natriuretic effects of ir torsemide vs. er torsemide over 12 hrs

Conditions: Heart Failure

Summary: this is a randomized double-blind crossover study of the patients with stable heart failure, who are taking a loop diuretic. during the study period, the participants' loop diuretics will be replaced by the equivalent dose of immediate release/extended release torsemide for one week. after a one week period, they will report to the site and will receive a single dose of either immediate release or extended release torsemide. the sodium excretion will be measured for six hours after dosing and for an additional six hours after a high salt lunch.

the goal of this randomized double-blind crossover study is to assess whether extended release torsemide has a better efficacy than immediate release torsemide to induce renal sodium excretion after a salty lunch in patients with heart failure. the study will address if: * the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide is different from the amounts after the immediate release torsemide. * the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amounts after the immediate release torsemide. * the amount of excreted sodium in the urine during the 24 hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amount after the immediate release torsemide.

Eligibility criteria:
inclusion criteria: * man or woman over the age of 18 years. * willing and able to sign the informed consent. * a clinical diagnosis of chronic hf that is considered by patient's cardiologist/physician or an experienced clinician to be stable over the one-month period prior to randomization. * receiving oral furosemide (or equivalent doses of torsemide or bumetanide) for about 30 days prior to randomization. * no anticipated changes in hf medications during the study period. * premenopausal women of child-bearing potential have a negative pregnancy test prior to beginning of the study and agree to use effective contraceptive methods during the study period exclusion criteria: * requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or sglt2 inhibitors, at randomization and during the study. * myocardial infarction, stroke, transient ischemic attack, acute kidney injury or acute hf requiring admission to hospital within the last 30 days prior to randomization. * severe / symptomatic lung disease or respiratory symptoms distinct from hf. * urinary incontinence or inability to empty bladder. * uncontrolled diabetes mellitus or uncontrolled hypertension. * estimated gfr \< 30 ml/min/1.72m2. * history of flash pulmonary edema or amyloid cardiomyopathy. * female patients who are breastfeeding.
adalat xl vs diltiazem on proteinuria and blood pressure in hypertensive diabetic patients

Conditions: Diabetic Nephropathies; Hypertension

Summary: the study consists of a 12 week run-in period when all subjects are stabilized on a single dose of avalide (300 mg/12.5 mg or 300mg/25mg dose) per day. after this 12 week run-in ends, subjects will be randomly assigned to start the addition of either adalat xl or tiazac xc for 18 weeks of treatment. subjects will have a 1 in 2 chance of receiving the study drug adalat xl and a 1 in 2 chance of receiving the drug tiazac xc. an end of treatment visit will be done 18 weeks after start of study drug. the expected duration of the study is 30 weeks. the purpose of this study is to compare the change in proteinuria, through a urine test, while taking study drug until high blood pressure (bp) is reduced to near normal levels in study subjects with diabetic nephropathy and hypertension.


Eligibility criteria:
inclusion criteria: * \>/= 18 and \< 80 years old. * diagnosed with hypertension. * diagnosed with diabetes mellitus type 2 for at least 6 mths prior to entry and on stable medication for diabetes for at 1 mth prior to screening. * treated on arb, ace inhibitor with or without hydrochlorothiazide and suitable to receive combination therapy with avalide at 300mg/12.5mg per day or 300mg/25mg per day. * diagnosed with diabetic nephropathy and have proteinuria between 0.8g/day and 5.0g/day at screening and then between 0.8g/day and 3.0g/day at randomization. * medically appropriate to receive adalat xl or tiazac xc. exclusion criteria: * history of alcohol or substance abuse. * significant cv disorder such as ischemic heart disease, arrhythmias within the last 6 mths, or any history of severe congestive heart failure. * myocarditis or pericarditis within last 30 day of screening. * ecg showing evidence of major arrhythmia or conduction disturbances requiring treatment with anti-arrhythmic medication. * females with child-bearing potential or males with a partner of child-bearing potential unless willing to use effective contraception during the study and 3 mths after the end of study. * females who are pregnant, lactating or planning pregnancy during the study and for 3 mths after the study end. * known hypersensitivity to adalat xl or tiazac xc or other calcium channel blockers of the dihydropyridine class. * resting heart rate \ 110 bpm. * presence of secondary or malignant hypertension. * dbp \>/= 180 and/or sbp \>/= 110 mmhg.

Keywords: adalat xl diltiazem tiazac xc proteinuria
pilot study on eeg and behavioral effects of two different treatments on sexual life

Conditions: Multiple Sclerosis; Spinal Cord Injuries

Summary: in this study patients with multiple sclerosis or spinal lesions will participate in two different types of treatments that aim to improve sexual and sentimental life. behavioral (via questionnaires) and brain (via high-density electroencephalogram) effects associated with treatment will be studied.

people with neurological diseases can experience sexual disorders that can affect their quality of life. there are cognitive treatments to improve these aspects, but their effectiveness is not clear. the aim of this study is to test the potential efficacy of two treatments (mindfulness and sezual therapy) in two neurological populations (patients with multiple sclerosis and patients with spinal injury). to verify the effects of the treatment, questionnaires and brain activity measurements, measured by electroencephalogram, will be used.

Eligibility criteria:
inclusion criteria: * medical diagnosis of ms or spinal injury. * ability to sign informed consent. exclusion criteria: * other relevant previous neurological or psychiatric pathologies.

Keywords: sexuality
hypocaloric enteral nutrition in the critically ill patient

Conditions: Critically Ill

Summary: the aim of this study is to compare two nutritional regimes in critically ill patients. patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). both regimes will recive 1,7 g/kg/dia the main outcome will be the sofa (sequential organ failure assessment) score. the hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients.

the research site will be the intensive care unit (icu) of hospital universitario san ignacio; eligible patients will \>18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. in all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in iu), presence of hyper or hypoglicemia, presence of infections, among others. the sofa score will be assessed every two days until discharge from icu.

Eligibility criteria:
inclusion criteria: * \>18 years * estimated fasting period of at least 96 hours * icu patients exclusion criteria: * parenteral nutrition * pregnancy * diabetes * liver failure * transplantation or in transplant protocol * previous nutrition support * chronic renal failure

Keywords: critically ill enteral nutrition
a music-with-movement exercise program for community-dwelling older adults suffering from chronic pain: a pilot randomized controlled trial

Conditions: Chronic Pain; Elderly; Music-with-movement Exercise; Pain Management

Summary: background: the high prevalence of chronic pain in community-dwelling older adults requires attention from nurses. the aim of the present study is to use a music-with-movement exercise program to improve the pain situations of older adults with chronic pain. aims and objectives: the aim of this study is to implement a music-with-movement exercise program (mmep) for older adults suffering from chronic pain. the objectives of this study are: * to evaluate the effects of a music-with-movement exercise program on improving the pain intensity, pain self-efficacy, mood, and quality of life of the older adults with chronic pain * to observe the participants' level of adherence to the music-with-movement exercise by using an exercise logbook and measurements of heart rate anticipated outcomes: this study will be a pilot randomized controlled trial. an 8-week music-with-movement exercise program will be used as the intervention for older adults with chronic pain in district elderly centers in hong kong. it will consist of four sessions of center-based, face-to-face activities and four weeks home-based and digital-based activities delivered through a whatsapp group. a music therapist, in consultation with the physiotherapist, will lead the center-based activities. each center-based session will consist of 30 minutes of music-with-movement exercise and 10 minutes of instruction on pain knowledge and pain management. each participant will receive an exercise logbook to practice and record the frequency of their engagement in the music-with-movement exercise at home. they will receive whatsapp reminders to remind them to continue the home-based sessions. outcome measures include pain intensity, pain self-efficacy, mood, heart rate and physical activity intensity, and quality of life. data will be collected before and after the intervention. participants need to complete the exercise logbook to record their adherence to the intervention. the findings of this study will provide clinical implications for nurses to integrate music with movement exercise to manage pain.


Eligibility criteria:
inclusion criteria: * aged 60 or above * can understand cantonese * have a history of non-cancer pain in the past 3 months * have a pain score of at least 2 as measured by the numeric rating scale (on an 11-point numeric scale) * able to take part in an exercise and stretching program * owns a smartphone and can access the internet exclusion criteria: * have severe visual and/or auditory deficits * have a serious organic disease or malignant tumor * have a mental disorder diagnosed by neurologists or psychiatrists * had surgical treatments in the past two months * experienced drug addiction
eyefill® c. -us viscoelastic clinical investigation

Conditions: Cataract

Summary: the purpose of this multicenter, prospective, randomized clinical study is to determine the safety and effectiveness of the eyefill® c.-us viscoelastic in patients undergoing cataract extraction and intraocular lens (iol) implantation surgery. eyefill® c.-us viscoelastic is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues, and to manipulate tissues during surgery. eyefill® c.-us viscoelastic may also be used to coat intraocular lenses and instruments during cataract extraction and intraocular lens insertion.


Eligibility criteria:
inclusion criteria: * any race * older than 21 years * cataract requiring cataract extraction in at least 1 eye * clear intraocular media other than cataract * able to provide written informed consent * able and willing to comply with required follow-up schedule * competent to understand the procedure and the actions asked of him/her as a research subject exclusion criteria: * monocular * ocular infection * history of glaucoma, ocular hypertension (iop \> 21 mmhg) likely to require iop lowering medications, ocular condition requiring iop lowering medication, condition preventing reliable goldmann applanation tonometry, known steroid responder * previous intraocular surgery in the operative eye * previous serious corneal disease or known endothelial cell loss / damage (in operative eye) * history of chronic or recurrent inflammatory eye disease (in operative eye) * evidence of retinal vascular disease (in operative eye) * uncontrolled diabetes or proliferative diabetic retinopathy * acute or chronic disease or illness that would increase the operative risk * allergy to anesthetics or other postoperative medications * known hypersensitivity to sodium hyaluronate or other components in viscoelastic * patient in any other clinical trial within the 30 days prior to the start of the study

Keywords: cataract intraocular lens iol aphakia