Kornimate/medical-research-clean huggingface dataset:
ganglion stellate block for treatment of electric storrm (gangster trial)

Conditions: Ventricular Arrythmia; Ventricular Tachycardia; Ventricular Fibrillation; Arrhythmic Storm; Block

Summary: this study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.

* the study will include patients with drug-refractory arrhythmic storm indicated for left ganglion stellate block (lgsb) before or after catheter ablation. * included participants will be dived based on the need for mechanical ventilation and catheter ablation performed \<5 days before the study * subsequently, the participants will be randomized to lgsb or to a sham (placebo) procedure. * the primary endpoint will be a reduction of the burden of clinical arrhythmia \>50% 24 hours after lgsb without escalation of antiarrhythmic therapy. * the study will include 80 patients over 4 years.

Eligibility criteria:
inclusion criteria: 1. arrhythmic storm \<24 hours before inclusion: * 3 or more episodes of sustained ventricular tachycardia (vt) or ventricular fibrillation (vf) terminated by external or internal shock, * or incessant vt lasting \>30 minutes, * or very frequent nonsustained or sustained vt leading to hemodynamic instability with the need of escalation of the therapy 2. clinical indication for lbgs based on the judgment of the physician, independent of the study exclusion criteria: 1. known allergy to bupivacaine 2. prior lbgs performed \<7 days before the study 3. known reversible provoking trigger of the arrhythmias 4. ventricular arrhythmias triggered by premature ectopic beats during bradycardia 5. hemodynamically tolerated idiopathic vt in patients without structural heart disease
an innovative rehabilitating meals-on-wheels service for frail old people

Conditions: Undernutrition; Rehabilitation

Summary: the aim of the project is to assess the beneficial effect of offering frail old people a targeted meals-on-wheels service in 8 weeks in a randomized controlled trial

the aim of the project is to assess the beneficial effect of offering frail old people a targeted meals-on-wheels service in 8 weeks in a randomized controlled trial. the target group is, respectively old people discharged from an hospital stay, old people referred for exercise rehabilitation in the municipality and old people already receiving meals-on-wheels

Eligibility criteria:
inclusion criteria: * 65+ year, * able to speak and understand danish. * has accepted to participate * is discharged from hospital, or * is referred to exercise rehabilitation in the municipality or * is receiving meals-on-wheels exclusion criteria: * terminal disease, * living in a nursing home, * receives a specific diet (e.g. diabetes, dysphagia, vegetarian or vegan)

Keywords: meals-on-wheels home-dwelling older people
ginko biloba versus desmopressin in treatment of children with monosymptomatic nocturnal enuresis

Conditions: Enuresis, Nocturnal

Summary: bedwetting among children is a common disorder, affecting 30% at age 4, 10% at age 6, 3% at age 12, and 1% at age.untreated, the spontaneous cure rate is about 15% a year. treatment is dominated by two approaches, enuresis alarm and drugs. treatment with drugs has largely been focused on tricyclic antidepressants especially imipramine or, more recently, antidiuretic agents such as desmopressin . for imipramine the proportion of total remission is 10-50% during treatment and a long term cure in 5-40%.8 however, numerous reports of side effects, some lethal, have led to a decline in its use. since dimson in 1977 reported on the effects of desmopressinl" several double blind, placebo controlled studies have shown the efficacy of the drug often with rapid effect but also often with immediate relapse after ending treatment. while one of theory of nocturnal enuresis is deep sleep in children , this the main cornerstone in using alarm as line of management . on the other hand drugs used in rehabitation of sleep rhythm seems to be with great benefits in management as ginko biloba ginkgo biloba leave extract is among the most widely sold herbal dietary supplements in the united states. its purported biological effects include: scavenging free radical; lowering oxidative stress; reducing neural damages, reducing platelets aggregation; antiinflammation; anti-tumor activities; anti-aging , and improve night sleep rhythm

bedwetting among children is a common disorder, affecting 30% at age 4, 10% at age 6, 3% at age 12, and 1% at age.untreated, the spontaneous cure rate is about 15% a year. treatment is dominated by two approaches, enuresis alarm and drugs. treatment with drugs has largely been focused on tricyclic antidepressants especially imipramine or, more recently, antidiuretic agents such as desmopressin . for imipramine the proportion of total remission is 10-50% during treatment and a long term cure in 5-40%.8 however, numerous reports of side effects, some lethal, have led to a decline in its use. since dimson in 1977 reported on the effects of desmopressinl" several double blind, placebo controlled studies have shown the efficacy of the drug often with rapid effect but also often with immediate relapse after ending treatment. while one of theory of nocturnal enuresis is deep sleep in children , this the main cornerstone in using alarm as line of management . on the other hand drugs used in rehabitation of sleep rhythm seems to be with great benefits in management as ginko biloba ginkgo biloba leave extract is among the most widely sold herbal dietary supplements in the united states. its purported biological effects include: scavenging free radical; lowering oxidative stress; reducing neural damages, reducing platelets aggregation; antiinflammation; anti-tumor activities; anti-aging , and improve night sleep rhythm

Eligibility criteria:
inclusion criteria: * all patients with monosymptomatic nocturnal enuresis exclusion criteria: * patients with day and night enuresis

Keywords: nectornal enuresis
projected peripheral defocus using a wearable device

Conditions: Myopia

Summary: acucela inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in asian demographics. acucela is working towards a spectacle-like device (especs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. this study will establish the changes seen during a proof-of-concept that projected defocus in the periphery utilizing a wearable device will stimulate physiological changes similar to those in the literature.


Eligibility criteria:
inclusion criteria: * spherical equivalent +2.00 to -4.00 diopters * refractive cylinder ≤ 0.75 diopters * visual acuity 20/20 -3 or better exclusion criteria: * pregnant or lactating * active ocular infection * history of dry eye, strabismus, or amblyopia * previous or planned ocular surgery * use of medication known to affect vision or accommodation
effects of palmitoylethanolamide on inner retinal function in glaucoma patients by pattern electroretinogram

Conditions: Glaucoma

Summary: the general purpose of the study is to evaluate the potential beneficial effects of pea 600 mg supplementation on rgcs function in subjects with glaucoma by pattern electroretinogram after three months of therapy. secondary objectives are to assess effects on intraocular pressure (iop) values, if any; to record visual acuity, visual field, central corneal thickness (cct), and optical coherence tomography (oct) (ganglion cell complex - gcc) changes, if any and to follow quality of life (ql) perception (general vision -gv and general health - gh of national eye instutute visual functioning questionnaire 25 items - nei vfq25)

monocentric, randomized, prospective, single blind, two treatment and two period crossover study. the investigators have proposed a cross-over trial to avoid or to detect the bias due to intra-individual variability and because, from preliminary observation, it has been noted that the effects of pea on pattern-electroretinogram (perg) are completely reversible after withdrawal, within one month. the investigators didn't considered a placebo treated group because the patient cannot interfere with the pattern-electroretinogram perg measurement that is objective and totally patient-independent. study duration 12 months enrolment period 6 months minimum follow-up 6 months start: january, 2015; end january, 2016 total sample size: 40 patients

Eligibility criteria:
inclusion criteria: * -age 18 years or older * diagnosis of primary open angle glaucoma (poag) * controlled iop (\<18 mmhg, morning value) with any topical lowering medication (beta-blockers, carbonic anhidrase inhibitors, alpha2agonists, prostaglandin analogues as monotherapy or as associative therapy; betablocker/carbonic anhydrase inhibitor, betablocker/alpha2agonist, prostaglandine/betablocker and alpha2agonist/carbonic anhidrase inhibitor fixed combinations as monotherapy or in association); * stable iop\<18 mmhg in the last 2 years * stable disease in the last 2 years (no more than -1 decibell-db/year at md of visual field) * at least two reliable visual fields per year in the last 2 years * no filtering surgery or other ocular surgery in the preceding 6 months * written consent to participate to study procedures and data utilization in an anonymous form exclusion criteria: * ocular hypertension with normal optic nerve and visual field * contraindication to pea * glaucomatous scotomas within 10 degree from fixation * any condition limiting the patient's ability to participate in the study; * other causes of visual field changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion
assessment of biomarker profile in diabetic macular edema with intravitreal aflibercept injection

Conditions: Diabetic Macular Edema

Summary: to assess the biomarker profile in diabetic macular edema patients in response to intravitreal aflibercept injection. patients with diabetic macular edema who meet study requirements will receive monthly intravitreal injections of aflibercept as approved by fda for a period of 6 months. a small quantity of fluid will be removed from the vitreous at each injection for laboratory evaluation of biomarkers present before, during and after treatment with aflibercept.

study objective is to better understand the pathophysiology of diabetic macular edema (dme) by defining the factors that participate in the disease process or may be good biomarkers for disease progression. study will investigate the temporal relationship between the course of treatment with anti-vegf therapy and levels of candidate biomarkers previously identified to determine which biomarkers are affected by anti-vegf therapy with aflibercept. study will correlate response to therapy to particular biomarkers and attempt to identify those associated with resistance to therapy for dme. biomarker data will be correlated with serial clinical evaluation of disease progression. 40 subjects with clinically significant dme who plan to undergo anti-vegf therapy will be treated with intravitreal aflibercept monthly for 6 months. at each visit aqueous humor will be collected and stored (6 samples per patient). at termination of study all specimens will be analyzed for biomarkers identified from previous studies.

Eligibility criteria:
inclusion criteria: * current diagnosis type 1 or type 2 diabetes * clinical dme as assessed by oct * well controlled glaucoma on medications but not on prostaglandin analogues * mild age related macular degeneration (amd) * visual acuity between 73 and 5 etdrs letters (20/40 -20/800 on eye chart) * willing and able to participate and to comply with clinic visits and procedures * provide signed informed consent exclusion criteria: * unwillingness to participate or inability to understand or sign informed consent * poor eye fluid that would preclude adequate testing * prior intraocular treatment with anti-vegf or focal laser treatment within 90 days * corticosteroid injections within 120 days * active proliferative diabetic retinopathy * intraocular pressure greater than 25 mm hg * any previous vitrectomy surgery * current use of systemic anti-vegf agents * shallow anterior eye chamber in eye with natural lens * non-diabetic related macular swelling (retinal vein occlusion) * history of ocular disease * systemic disease other than diabetes mellitus * pregnant or breast feeding women * sexually active men or women of childbearing potential who are unwilling to practice adequate birth control during study
bia guided-fluid management in postinjury open abdomen

Conditions: Damage Control; Trauma Abdomen; Acute Compartment Syndrome

Summary: fluid overload (fo), resulting from high volume fluid therapy, is frequent and contributes to excessive visceral edema, delayed fascial closure, and adverse outcomes among postinjury open abdomen (oa) patients. bioelectrical impedance analysis (bia) is a promising tool in monitoring fluid status and fo. thus, we sought to investigate the efficacy of bia-directed resuscitation among postinjury oa patients.


Eligibility criteria:
inclusion criteria: * adult trauma patients admitted to sicu with oa after emergent abbreviated laparotomy were considered eligible. exclusion criteria: * (a) age less than 18 years; (b) pregnancy; (c) lactation; (d) limb amputations; (e) mental disorders; (f) diabetes mellitus; (g) pre-existing blood disorders; (h) pre-existing abdominal fistulas; (i) pre-existing terminal illness; (j) liver dysfunction (child-pugh class c); (k) new york heart association (nyha) class iv; (l) chronic renal failure requiring dialysis; (m) therapy with an extra-corporeal membrane oxygenator (ecmo); (n) enrolled in an ongoing, interventional rct; (o) received prior fluids for resuscitation during their icu stay; (p) expected to die within 1 hour of icu admission for devastating injuries; (q) activated opt-out process for bgfm trial.

Keywords: trauma open abdomen fluid resuscitation fascial closure bioelectrical impedance analysis
prevention of skin cancer in high risk patients after conversion to a sirolimus-based immunosuppressive protocol

Conditions: Skin Cancer

Summary: transplant recipients have a high risk to develop skin malignancies. this effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on the dosage (i.e., calcineurin-inhibitors). based on the encouraging results of previous, retrospective studies on patients treated with sirolimus (srl), these patients should be switched to an immunosuppressive regime including srl, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. a conversion to a srl-based therapy is effective in immunosuppression and safe regarding graft and patient survival. this study was designed to assess whether a switch to a srl-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.

patients who meet all inclusion criteria will be included into the study and randomised. if converted to srl, patients will take srl according to the investigator's instructions and medication label, once daily preferably 4 hours after calcineurin-inhibitor medication or in case without calcineurin-inhibitor co-medication in the morning. the dose of srl will be correlated to the former immunosuppressive therapy according to the study's conversion protocol.

Eligibility criteria:
inclusion criteria: * recipients of renal allograft with current actinic keratosis i or ii or successfully treated actinic keratosis iii (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (scc), basal cell carcinoma and/or premalignant neoplastic skin lesions * age 18 years and older * minimum period of 6 month after renal transplantation * stable renal function and a calculated creatinine clearance of at least 40 ml/min * written informed consent * proteinuria ≤ 800 mg/d at time of enrolment * successfully treated solid tumor (no recurrence or metastasis in the last 2 years) exclusion criteria: * current sirolimus- or everolimus- intake * instable graft function (creatinine clearance \< 40 ml/min) * graft rejection within the 3 previous months * proteinuria \> 800 mg/d * non-controlled hyperlipidemia (cholesterol \>7,8 mmol/l, triglycerides \> 4) * leucopenia \< 2500/nl * thrombocytopenia \< 90/nl * pregnancy or breastfeeding * women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year)) * known allergy to macrolides * current participation in other studies * refusal to sign informed consent form * neoplasm other than defined as inclusion criteria * all contraindications to srl (see package insert, appendix) * persons who are detained officially or legally to an official institute

Keywords: renal transplant-patients with high-risk for skin cancer
role of dexamethasone in multimodal analgesia for postoperative pain in thoracic surgery

Conditions: Dexamethasone Adverse Reaction; Postoperative Pain; Postoperative Thoracic Procedure Complication; Analgesia

Summary: the aim of the study is to evaluate the analgesic properties of dexamethasone and to quantify the possible associated postoperative complications, such as wound infections and hyperglycaemia, in patients who underwent lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or video-assisted thoracoscopic surgery (vats).

we designed an observational study, aimed to evaluate the possible reduction in morphine consumption in thoracic patients, who were administered dexamethasone compared to who didn't received the drug. the research wants to assess the presence of additional analgesic properties, besides the well known antiemetic effect, in the intraoperative administration of dexamethasone, and the possible postoperative complications, such as wound infections and hyperglycaemia. the rational is to ameliorate the anaesthesiological management, in particular with a view to a opioid-sparing analgesia in thoracic patients. to do so, we enrolled thoracic patients, who underwent elective lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or video-assisted thoracoscopic surgery (vats). we selected two groups: one in which patients were administered dexamethasone 8 mg at the moment of induction, and the other one in which patients didn't received dexamethasone, but ondansetron 4 mg at the end of surgery. both groups received other antiemetic drugs based on apfel score and multimodal analgesia, comprising loco-regional analgesia, opioids and other analgesic drugs administration. the we checked morphine consumption and numerical rating scale (nrs) values for pain in the first 24 hours after surgery. moreover we evaluate post-operative nausea and vomiting (ponv), intra- and post-operative blood glucose levels and wound infection.

Eligibility criteria:
inclusion criteria: * bmi \< 30 kg/m2 * asa i-iii * lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or vats exclusion criteria: * refusal by the patient to participate or patient unable to express his own consent * chronic therapy with medium-high doses of corticosteroids * chronic therapy with opioids * mets ≤ 4, defining an overall decreased cardiovascular fitness * urgent or emergency surgery * allergy to the active ingredient of the drug used * kidney failure at stage iii or more * liver failure * pregnancy * drug addiction, patients with a history of drug abuse * corrected qt interval (qtc) \> 0,45 for males and 0,47 for women

Keywords: thoracic surgery postoperative complications dexamethasone postoperative nausea and vomiting hyperglycaemia video assisted thoracoscopy (vats) multimodal analgesia
pharmacokinetics and safety study of two cp-690,550 controlled release formulation following single dose in healthy volunteers

Conditions: Healthy

Summary: this study will explore the drug behavior and safety following single dose of two 20 milligram cp-690,550 osmotic capsules in 12 healthy volunteers. these will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * clinically significant infections within the past 3 months.

Keywords: relative bioavailability controlled release phase 1 cp-690 550
state vs. trait alterations in low back pain

Conditions: Low Back Pain

Summary: the primary goal of this study is to investigate whether different alterations observed in patients with non-specific episodic low back pain (compared to healthy volunteers), detected using several assessments: psychophysical and neurophysiological testing, imaging, and blood sampling, are dependent or independent of the presence and type of pain experienced at the time of investigation.

the study consists of three visits (healthy volunteers will only have one pain-free visit), in which patients will be tested in a different "pain state" at each visit: 1. pain-free visit: will be carried out when the patients have no or little (numerical pain rating scale (nprs) \</= 2/10) clinical pain. 2. clinically relevant low back pain visit: will be carried out with patients experiencing a low back pain episode with an intensity of 3/10 or more on the nprs. 3. experimental pain / clinically irrelevant pain visit: will be carried out with the application of a high concentration (8%) qutenza® capsaicin patch at the arm. each of the visits will consist of psychophysical testing, neurophysiological assessement of sweat activity in response to pain, brain resting state magnetic resonance imaging and magnetic resonance spectroscopy. additionally, and depending on the type of session, a lumbar spine magnetic resonance image (only pain-free session, as characterization) and a blood sample (only pain free and low back pain visit) will be performed.

Eligibility criteria:
inclusion criteria: * german or english proficiency * informed consent * low back pain for more than 3 months * low back pain clinically not attributable to "red flags" (e.g. infection, fractures, inflammation) * fluctuating course of pain (with on and off pain periods). exclusion criteria (applicable to both groups): * inability to give informed consent / follow study instructions (e.g. due to language problems) * major medical or psychiatric condition. e.g. severe heart disease, diabetes, autoimmune disorders, rheumatic disorders, major depressive disorder, etc. * symptomatic radiculopathy, manifested through motor and/or sensory deficits / or signs of nerve root involvement on lumbar mri. * back operation * bmi \> 30 * pregnancy

Keywords: trait vs. state alterations