Kornimate/medical-research-clean huggingface dataset:
evaluating the effect of surgical drain securement on patient quality of life and postoperative drain-related complications

Conditions: Surgical Drain

Summary: the objective of this study is to evaluate whether surgical drain securement with a novel sutureless device (k-locktm) will improve patient quality of life and reduce postoperative drain-related complications compared to drain securement with traditional suture-based methods. the k-lock™ device is a novel sutureless drain securement device that may improve patient experiences with surgical drains.

patients will be identified as potential subjects where the study team will speak with them, determine eligibility, and obtain consent prior to surgery. on the day of surgery, patients will be randomized to either a) drains being secured with the k-lock device or b) drains being secured with the suture-based technique. all drains will be secured according to randomization. postoperatively: the study team will follow the subjects weekly via the electronic medical record documenting (in redcap) calls made to the triage nurse, visits to the emergency department, requests for additional pain medications, unexpected drain removal, need for additional drain placement, etc. subjects will return to clinic at their regularly scheduled follow-up appointments with no additional study related activities and will be followed by the study team weekly, via chart review for a total of 3 months from their surgery date. when the subjects return to clinic to have their final drain removed they will be asked to complete a survey asking about their experience with their drains and drain securement. we will also have a blinded evaluator complete a short survey evaluating the skin around the drain insertion site. photos will be taken of the drain site upon drain removal and again at the 3 month follow-up visit.

Eligibility criteria:
inclusion criteria: * age 18 years or older * patient of the department of plastic and reconstructive surgery * able to sign english language consent form * undergoing a surgical procedure where placement of one or more surgical drains is anticipated exclusion criteria: * unable to sign english language consent form * incompatible drain size placed * allergy or sensitivity to skin adhesives

Keywords: drain insertion site drain site complication plastic and reconstructive surgery
feasibility and acceptability of a complex intervention to improve initial medication adherence

Conditions: Adherence, Medication

Summary: this pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using real-world data.

a cluster non-randomised pilot study with an embedded process evaluation was carried out to test the feasibility of the definitive cluster randomised controlled trial (crct). the crct will aim to evaluate the effectiveness and cost-effectiveness of the initial medication adherence (ima) intervention in comparison to usual care, to increase initiation of pharmacological treatments for cvd and diabetes (antihypertensive drugs, hypolipidemic drugs, antiplatelet drugs, and insulin and oral antidiabetics) prescribed in primary care (pc). the pilot study was conducted in five pc centres (pcc) in catalonia (spain), two were assigned to the control group and three to the intervention group. there were two target participants, the implementation targeted professionals (general practitioners (gp), nurses, and community pharmacists), and the population targeted by the intervention, pc patients. the ima intervention provided healthcare professionals with the knowledge, skills, and tools to help the patient make an informed and shared decision with the gp to initiate a new cvd or diabetes treatment. professionals were trained on the problem of non-initiation, communication skills, health literacy, and the use of decision aids (leaflets, website).

Eligibility criteria:
inclusion criteria: primary healthcare professionals and pharmacists who: • agree to participate in the pilot study. primary care patients who: * are prescribed a new treatment of cardiovascular disease o diabetes by a gp who participates in the clinical trial. * are \>18 years old. * do not reject to participate.

Keywords: pilot study feasibility study complex intervention real-world data cardiovascular disease diabetes mellitus
effects of serotonin agonist buspirone on multimodal esophageal stimulation in healthy volunteers

Conditions: Gastroesophageal Reflux

Summary: to investigate if buspirone, a partial 5-ht-1a receptor agonist, is able to modify esophageal sensitivity, assessed by the multimodal stimulation.


Eligibility criteria:
inclusion criteria: * hv aged between 18 - 60 years exclusion criteria: * history of psychiatric disease or a positive first degree psychiatric family history * pregnancy or lactation * concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, ...) * medication affecting esophageal motility * significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic) * prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure * history of gastrointestinal disease
hand motor rehabilitation using a emg-biofeedback: a cross-sectional study

Conditions: Stroke; Stroke Hemorrhagic; Stroke, Ischemic; Hemiparesis; Hemiplegia

Summary: recovery of upper limb and hand gestures is fundamental for autonomy restoration after stroke. innovative technologies are a valid support for the delivery of rehabilitation treatments. embedding surface electromyographic (semg) into wearable devices, allows the customisation of rehabilitation exercises, based on the clinical profile of each patient.

the aims of this study are to determine safety and feasibility of a prototype emg-control wearable device (remo) and to individualise clinical features of stroke survivors able to control the emg armband targeted to hand rehabilitation. the device remo consists in an armband composed by 8 bipolar electrodes able to record and process the electromyography of forearm muscles. the patterns of muscle activations are classified and used to perform emg-biofeedback exercises in stroke rehabilitation training. the device is developed by clinicians of irccs san camillo hospital and spin-off morecognition srl. a total of 100 stroke patients patients has been recruited. they are clinically assessed and then tested on the ability to control the semg wearable device. the test is composed of 10 hand and fingers gestures to be performed with the paretic hand. baseline and activation semg signals are recorded and compared for each movement. three conditions representing absent, partial or full control of the device are defined and logistic multivarialbes regression models are used to identify clinical features describing the group each patient belongs to. clinical cut-off for each strata is identified by odds ratio.

Eligibility criteria:
inclusion criteria: * single ischemic or haemorrhagic stroke; * score lower than 100 out of a total of 126 at the functional independence measure (fim) scale exclusion criteria: * untreated epilepsy; * major depressive disorder; * fractures; * traumatic brain injurj; * severe ideomotor apraxia; * severe neglect; * severe impairment of verbal comprehension.

Keywords: neurological rehabilitation upper extremity electromyography hand gesture
feasibility and acceptability of use of daily oral rinse in pregnant women in rural nepal

Conditions: Periodontitis; Premature Birth of Newborn

Summary: in nepal, investigators are conducting a cohort study to estimate the relationship between signs of periodontal disease in pregnant women and preterm delivery. within that cohort study, investigators plan to conduct an individually randomized trial of the acceptability and effect chlorhexidine, cetylpyridinium chloride, and salt water oral rinses on gingival crevicular fluid and plaque during pregnancy. women for this pilot trial will be chosen from a subset of the area currently engaged in the larger cohort study, to simplify logistics. the pilot trial will have four arms (three oral rinse arms, and one control group). * arm 1: twice daily oral rinse containing chlorhexidine 0.12% w/v (n=25 women with periodontitis * arm 2: twice daily oral rinse with cetylpyridinium chloride (n=50; 25 women with/without periodontitis) * arm 3: twice daily oral rinse with salt and water (n=50: 25 women with/without periodontitis) * arm 4: no oral rinse (n=50) to select and enroll these 175 participants, data collectors will use the information they collected during an oral health clinical examination conducted at the time of enrollment into the broader cohort study; this information will be used to classify women by signs of periodontitis. those selected through this above process will be read an additional consent form; those agreeing to participate will be provided with a supply of their assigned rinse (and instructions on its use and handling/storage), or no rinse. those in the three rinse groups will be asked to use the provided rinse twice per day after brushing and to save the empty bottles for collection by the health care worker. at the end of this first visit, women will additionally provide a venous blood sample to measure systemic inflammation markers and fluoride. women receiving the rinse will be visited by study workers periodically to provide more oral rinse and check on their adherence to the rinse. all 175 women will be visited after 12 weeks to undergo a second oral health clinical examination and provide a second set of gingival crevicular fluid and plaque samples, to allow for evaluation of the effect of each of the oral rinses as compared to the normal physiological changes in gingival inflammation and biofilm composition during the course of pregnancy. at this final visit, the women in the three rinse arms will also answer a short questionnaire to gather feedback on acceptability and adherence to the oral rinse.


Eligibility criteria:
inclusion criteria: * pregnant * \<26 weeks gestation at enrollment * enrolled in the broader cohort study exclusion criteria: * already previously enrolled * not pregnant

Keywords: chlorhexidine cetylpyridinium chloride gingival crevicular fluid
diagnosing adult growth hormone deficiency

Conditions: Growth Hormone Deficiency

Summary: the purpose of this study was to validate the growth hormone releasing hormone (ghrh) plus arginine (ghrh+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (gh) immulite 2000 xpi assay calibrated against the is 98/574 from the world health organization. a specific aim was to study the effect of gender and age on the peak gh response in the ghrh+arg test

adult growth hormone deficiency (aghd) is a clinical entity including increased abdominal fat mass, decreased muscle mass, low bone density and adverse effects on quality of life and cardiovascular morbidity. these signs are nonspecific, and accurate diagnosis with laboratory tests in needed. the ghrh+arg test is used to diagnose aghd, but the cut-off values vary based on controls used. at moment consensus cut-off criteria are bmi specific, but gender and age may also affect the gh response in the ghrh+arg.

Eligibility criteria:
inclusion criteria: for health patients: 1. age 20-60 years, 2. no symptoms indicative of disease. for patients: 1. age 16-90 years 2. previous pituitary disease 3. suspicion of growth hormone deficiency exclusion criteria: for healthy controls: 1. pregnancy, 2. a known or suspected disease, 3. any symptoms indicating disease 4. use of medication
laser-assisted hyaluronic acid delivery by fractional co2 laser in facial skin remodeling

Conditions: Facial Skin Remodeling

Summary: the main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery by fractional co2 laser in facial skin remodeling. the secondary endpoint will be to confirm the safety of this protocol compared to a standard treatment by fractional co2 laser.

fractional co2 lasers are already used in skin remodeling. they can also create vertical channels to enhance topical drug delivery deep into the dermis. combining the efficacy of fractional co2 laser to laser-assisted hyaluronic acid delivery has not yet being studied, the combination of these two techniques could improve facial skin remodeling. the main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery by fractional co2 laser in facial skin remodeling. the secondary endpoint will be to confirm the safety of this protocol compared to a standard treatment by fractional co2 laser.

Eligibility criteria:
inclusion criteria: * patients admitted to the laser center for facial skin remodeling, * aged from 30 to 70 years old, * with phototype i to iv (fitzpatrick scale), * agreeing to participate in this study, signing the informed consent form * not fitting in any non-inclusion criterion exclusion criteria: * pregnancy or breastfeeding, * active infection, history of oral or genital herpes * suspected neoplasia, * active inflammatory or infectious facial dermatitis, * oral retinoid treatment in the last 6 months, * phototype v or vi (fitzpatrick scale) * age \ 70 years, * patients under guardianship or curatorship, * hemostasis disorders, thrombolytic or anticoagulant therapy, c * ongenital methaemoglobinaemia, * porphyria, * known hypersensitivity to hyaluronic acid, local anesthetics of the amide group or to any other component of anesderm cream ge 5%
randomized controlled trial on the treatment effects of melatonin and light therapy on delayed sleep phase syndrome

Conditions: Delayed Sleep Phase Syndrome

Summary: in this study the investigators will examine the effects of melatonin and light therapy on delayed sleep phase syndrome in adolescents 16 up to 20 years old. 60 subjects will be randomized into four different groups; melatonin + light therapy (n=15), melatonin + placebo light (n=15), placebo + light therapy (n=15) and placebo + placebo light. this is a double-blinded treatment and the participants will receive this treatment for 2 weeks. then they will be re-randomized into two groups; full treatment with light therapy + melatonin (n=30) and no treatment (n=30) for 3 months unblinded. the investigators will test the subjects pre-treatment, post 2 week treatment and after 3 months.

delayed sleep phase syndrome (dsps) is a circadian rhythm sleep disorder where the sleep-wake rhythm is significantly delayed according to the environmental demands. hence, the symptoms consist of major difficulties falling asleep and problems awakening in due time and patients often experience work- and school related impairments (the international classification of sleep disorders: diagnostic and coding manual, 2005). however, correct diagnosis is often not made and the treatment offered is, accordingly, often inadequate. dsps normally develops in interplay between dysfunctional habits/behaviour and biological vulnerability. bright light therapy and administration of exogenous melatonin comprise the most common interventions. timed bright light has been shown to effectively phase advance the rhythm (rosenthal et al., 1990), but no standardized guidelines regarding the duration, intensity or timing of light exposure have been established. compliance to the treatment is often poor because it involves structuring the daily schedule, which may be hard for the relevant age group. similarly, administration of melatonin in the evening has been shown to phase advance the rhythm (lewy et al., 1998; mundey, benloucif, harsanyi, dubocovich, \& zee, 2005), but a standardized approach for dose, duration and timing is lacking. it is important to establish effective treatment guidelines for delayed sleep phase syndrome. large scale studies on the effects of melatonin and bright light treatment in randomized placebo-controlled designs are needed. in a clinical trial we aim to investigate the efficacy of bright light and melatonin treatment using a 4 armed randomized placebo controlled design.

Eligibility criteria:
inclusion criteria: * 16-25 years old * lives in the bergen area * has delayed sleep phase disorder exclusion criteria: * pregnant or nursing women * other sleep disorders (i.e. sleep apnoea or plms) * moderate to serious psychiatric disease * use of psychopharmacological medicines * in psychotherapeutic treatment
study of quality of life in older vs. younger adult patients undergoing allogeneic hematopoietic cell transplantation for myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes; Hematopoietic Cell Transplant

Summary: this is a multi-center, phase ii, cross-sectional study comparing quality of life (qol) as assessed by patient-reported outcomes (pros) in older (≥65 years) adults vs younger (55-64 years) undergoing allogeneic hematopoietic cell transplantation (hct) for myelodysplastic syndromes (mds).

transplant recipients who have met the inclusion and exclusion criteria and from participating study sites will be asked to complete an online consent and survey for the study. this survey is the patient-reported outcomes survey and will be used to assess quality of life. the survey results will then be compared by age group and by time post transplant, between 6 months and a year post transplant, 1 year to 3 years post transplant, and 3 years or more post transplant.

Eligibility criteria:
inclusion criteria: in order to be eligible to participate on this study, an individual must meet all of the following criteria: 1. underwent an allogeneic hct for mds on the 10-cmsmds-1 protocol 2. prior consent to research and future contact by the cibmtr 3. ability to provide rci bmt protocol 17-epro signed and dated informed consent form (icf) 4. age ≥55 years at time of transplant 5. fluent in english or spanish 6. greater than 6 months post-hct exclusion criteria: an individual who meets any of the following criteria will be excluded from participation on this study. 1. no access to an internet browser or email account 2. within 6 months of first hct for mds on the 10-cmsmds-1 protocol
effect of the known antihypertensive drug telmisartan on red blood cells and circulation in the smallest blood vessels

Conditions: Arterial Hypertension; Diabetes Mellitus Type 2 IRC or NIR

Summary: the hypothesis of the presented study is: telmisartan induces an increase of enos activity in rbc resulting in an enhanced intravascular no bioavailability, an ameliorated rbc deformability and a reduction of rbc and platelet aggregation. this could be a potential mechanism of the improvement of microcirculatory disorders, especially in patients with diabetes mellitus and arterial hypertension, treated with telmisartan.

recently, it could be shown that the renin-angiotensin-system (ras) influences different signal transduction pathways within the red blood cells (rbc). this includes the na+/h+ exchange activity, the ca2+-atp-ase mediated ca2+efflux, the erythropoietin- dependent production of rbc, the rbc deformability, rbc aggregation and the interaction of rbc and platelets. recent studies and experiments, done by our group, focus on the oxidative and nitrosative metabolism of no within the blood. the interactions of the ras and endothelial no are well known and described in detail. based on a wide experience in this research field of no metabolism, we characterized recently an active endothelial-type no-synthase in rbc on the biochemical, functional and molecular level. erythrocyte-derived no formation serves important regulatory functions essential for adequate passage of blood through the vasculature. here we aimed to treat patients with diabetes mellitus and arterial hypertension with telmisartan as an angiotensin receptor antagonist. efficacy parameters studied in this study should be: i) rbc deformability, rbc aggregation, ii) rbc dependent production of nitric oxide as well as detection of enos activity in rbc and iii) indices of microcirculatory perfusion. this project could broaden the view of effects of telmisartan in the treatment of microcirculatory disorders in patients with diabetes mellitus and arterial hypertension, who exhibit a reduced no bioavailability and rbc function.

Eligibility criteria:
inclusion criteria: * men older than 18 years * diabetes mellitus type 2 defined according to the criteria of the american diabetes association arterial hypertension defined according to the criteria of the joint national committtees (jnc 7) * given informed consent exclusion criteria: * serve heart failure * serve aortic valve stenosis or hypertrophy obstructive cardiomyopathy * relevant cardiac arrhythmias * acute myocardial infarction within the last 4 weeks * renal failure * bilateral renal artery stenosis * liver diseases * primary hyperaldosteronism * orthostatic hypotension (systolic blood pressure \<100mmhg) * hypokalemia, hyponatremia, hypercalcemia, symptomatic hyperuricemia * inflammatory disease * malignant disease * previous intolerance to at1 receptor antagonists and/or sulfonamides * current therapy with insulin sensitizer * current therapy with digoxin * known abuse of alcohol or drugs

Keywords: perfusion microcirculation rbc function no metabolism at receptor blocker
association between crsa and osa

Conditions: Chorioretinopathy; Obstructive Sleep Apnea

Summary: this goal of this study is to know the association between the central serous chorioretinopathy and the obstructive sleep apnea. many studies have been done in order to assess the association between the central serous chorioretinopathy and obstructive sleep apnea and the results are always controverses actually.


Eligibility criteria:
inclusion criteria: * central serous chorioretinopathy since 6 months at least * patients beyond 18 years old exclusion criteria: - all retina pathology will be excluded : diabetes with affected retina, maculopathy, retina central veinous oclusion, epithéliopathy