Kornimate/medical-research-clean huggingface dataset:
psychosomatic effects of implantable cardioverter defibrillator with home monitoring function (quantum)

Conditions: Arrhythmia; Quality of Life

Summary: quality of life (qol) and psychological well-being of patients with implantable cardioverter-defibrillators (icds) are significantly influenced by the experience of shock therapies. a close therapeutic relationship between patients and physicians, resulting in short reaction times to icd-treated arrhythmic events and, in an optimised antiarrhythmic therapy, may help the patients to deal with their situations in the best possible way. the researchers investigate the influence of automatic remote patient monitoring on qol, anxiety, and depression in icd patients, and kind and frequency of (un-)scheduled patient-physician contacts. they also evaluate monitoring-induced changes in patient mobility and in patients' perceptions of icd therapy.

our study investigates the influence of automatic remote patient monitoring on quality of life (qol), anxiety and depression in patients with implantable cardioverter-defibrillators (icds), and frequency of (un-)scheduled patient-physician contacts. the study also evaluates monitoring-induced changes in patient mobility and in patients' perceptions of icd therapy. the patients will receive biotronik lexos-t or lumos-t icd models, with the integrated home monitoring capability. the latter allows wireless, everyday transfer of the essential status and therapy data from the icd memory to a website accessible by the attending physicians. the website is managed by biotronik home monitoring service center. patients will be randomised into: * group 1: home monitoring is established from the outset. * group 2: home monitoring is introduced 9 months after icd implantation. follow-up for both groups is 18 months. study hypothesis: home monitoring improves the hospital anxiety score in icd patients. preoperatively, hads (hospital anxiety and depression scale), questionnaire on type d personality (ds 14), and sf-12 questionnaire will be applied. at follow-up visits every 3 months, hads, sf-12 questionnaire, shock sensation questionnaire, number of shocks since preceding follow-up visit, and medications (cardiovascular drugs, psychopharmacological drugs and barbiturates) will be evaluated. home monitoring icd impact questionnaire will be collected at the final 18-month follow-up.

Eligibility criteria:
inclusion criteria: * indication for icd implantation either as primary or secondary prevention * patient informed consent exclusion criteria: * icd replacement indication * indication for cardiac resynchronisation therapy * inability to fully understand psychosomatic questionnaires, especially cognitive impairment or german language deficits * co-morbidities with a resulting life expectancy of less than one year * psychosomatic disease (requiring psychiatric therapy) * age \<18 years * patients who are already enrolled in another study

Keywords: implantable cardioverter-defibrillator telemedicine home monitoring psychosomatic ventricular tachyarrhythmia quality of life electric countershock
influence of different methods of measurement in the accuracy of des-osa and p-sap scores

Conditions: Sleep Apnea, Obstructive

Summary: des-osa and p-sap scores have been validated to detect osa (obstructive sleep apnea). one item of p-sap and des-osa is the measurement of neck circumference. the aim of this study is to compare the influence of different methods of neck circumference measurement in the accuracy of des-osa and p-sap scores to detect osa.


Eligibility criteria:
inclusion criteria: * all patients scheduled for an anesthetic preoperative consultation exclusion criteria: * \< 18 years
study to evaluate the efficacy and safety of combination aliskiren/amlodipine in patients with hypertension not adequately responding to amlodipine alone

Conditions: Hypertension

Summary: this study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.


Eligibility criteria:
inclusion criteria: * newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to visit 1 must have a msdbp ≥ 95 mmhg and \< 110 mmhg at visits 1 and 2 * patients who have been treated for hypertension within the 4 weeks prior to visit 1 must have a msdbp ≥ 90 mmhg and \< 110 mmhg at visit 2 * all patients must have a msdbp ≥ 90 mmhg and \< 110 mmhg at visit 5 (randomization) exclusion criteria: * severe hypertension * pregnant or nursing (lactating) women * pre-menopausal women not taking accepted form of birth control * serum potassium ≥ 5.3 meq/l (mmol/l) at visit 1 * history of cardiovascular conditions * uncontrolled type 1 or type 2 diabetes mellitus * hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures other protocol-defined inclusion/exclusion criteria may apply

Keywords: aliskiren amlodipine non-responder to amlodipine
myeloablative consolidation therapy and tandem autologous stem cell rescue in patients with high-risk neuroblastoma

Conditions: Neuroblastoma

Summary: this is a phase ii single center study to administer two courses of myeloablative consolidation chemotherapy each followed by an autologous peripheral blood stem cell (pbsc) rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy (independent of this study). ideally, patients should begin consolidation chemotherapy no later than 8 weeks after the start of induction cycle #5; however it is strongly recommended to begin consolidation within 4-6 weeks after the start of induction cycle #5.


Eligibility criteria:
* less than 30 years of age at diagnosis of neuroblastoma * end of induction disease evaluation demonstrating cr, pr, mr or sd * hematopoietic recovery from last induction course of chemotherapy * no uncontrolled infection * minimum frozen pbscs of 2 x 10\^6 cd34 cells/kg for each transplant are mandatory and a pbsc of 2 x 10\^6 cd34 cells/kg for back-up are strongly recommended (thus, pbsc of no less than 6 x 10\^6 cd34 cells/kg is encouraged). these must all be collected prior to the initiation of consolidation. * adequate organ function defined as: * hepatic: ast and alt \ 1.0 1.5 x baseline if baseline was abnormal * cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 45%, no clinical congestive heart failure * pulmonary: no evidence of dyspnea at rest and norequirement for supplemental oxygen * renal: creatinine clearance or gfr \> 60 ml/min/1.73m\^2. if a creatinine clearance is performed at end induction and the result is \< 100 ml/min/1.73m\^2, a gfr must then be performed using a nuclear blood sampling method or iothalamate clearance method. camera method is not allowed as measure of gfr prior to or during consolidation therapy for patients with gfr or creatinine clearance of \< 100 ml/min/1.73m\^2 * recovery from acute toxicities of last cycle of induction chemotherapy * appropriate written consent - adult or parent/guardian if patient is \ 8 years of age

Keywords: high-risk neuroblastoma neuroblastoma myeloablative chemotherapy myeloablative consolidation chemotherapy autologous peripheral blood stem cell rescue pbsc autologous stem cell rescue
to evaluate hu-014 in the treatment of post stroke upper limb

Conditions: Post Stroke Upper Limb Spasticity

Summary: investigational product: liztox inj 100unit(hu-014) title : multi center, phase iii clinical trial to evaluate the efficacy and safety of liztox inj in the treatment of post stroke upper limb spasticity sites and investigators : asan medical center(seoul), min-ho chun, m.d, ph.d objective : to evaluate the efficacy and safety of liztox inj in the treatment of post stroke upper limb spasticity


Eligibility criteria:
inclusion criteria: * a subject who is diagnosed with stroke at least six weeks prior to screening. * a subject who has modified ashworth scale(mas) score which wrist flexor is ≥ 2 and flexor or finger flexor is ≥ 1. * a subject with a disability assessment scale(das)of at least ≥ 2 in one of the categories of hand hygiene, clothing, upper extremity, or pain for evaluation. exclusion criteria: * a subject who has medical history following. (allergy, chemodenervation(within 6 months), tendon lengthening(within 6 months), intrathecal baclofen.aspiration pneumonia, etc.) * a subject who has history of any diseases following. (neuromuscular junction disorder, nmj, myasthemia gravis, mg, lambert-eaton myasthenic syndrome, amyotrophic lateral sclerosis, als, skin disease, dysphagia, etc.) * from screening, subject who get a plastic surgery including fascioplasty, prosthesis implantation within 6 weeks * subject who takes a medication including skeletal muscle relaxants, aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc. * a subject who tend to bleed or are taking anti-coagulant drugs. * a sugject who is undergoing rehabilitation(physical therapy, occupational therapy, exercise therapy) or splinting in the area where medication for clinical trials is scheduled to be administered. * a sugject who has muscle atrophy, fixed joint/muscle contracture in the area where medication for clinical trials is scheduled to be administered. * any condition that, in the view of the investigator, would interfere with study participation.
comparison between conventional and model-based infusion strategy of iv pca in patients undergoing ralp

Conditions: Prostate Cancer

Summary: comparing postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia in patients who undergoing robot assisted laparoscopic radical prostatectomy group a: conventional intravenous patient-controlled analgesia, group b: model-based infusion strategy of intravenous patient-controlled analgesia

the investigators compared postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia (iv pca) in patients who undergoing robot assisted laparoscopic radical prostatectomy (ralp) group a: conventional iv pca, group b: model based iv pca 1. primary endpoint: comparison of postoperative analgesic requirements in patient undergoing robot assisted laparoscopic radical prostatectomy (ralp) between conventional patient controlled analgesia (pca) (group a) and effective-compartment based dosing strategy of pca (group b) 2. secondary endpoint: 1) vas analysis between two groups, 2) postoperative nausea and vomiting analysis between two groups, 3) complication evaluation between two groups

Eligibility criteria:
inclusion criteria: * patient who is scheduled to get a robot assisted laparoscopic radical prostatectomy * patient who agree to get a patient controlled analgesia exclusion criteria: * american society of anesthesiologist (asa) physical status over iii * history of alcohol or drug addiction * history of acute or chronic pain or pain treatment * allergic to opioid analgesics * bmi over 30 kg/m2 * history of sleep apnea or respiratory complications
ischemic injury and ischemic preconditioning in diabetes

Conditions: Diabetes Mellitus, Insulin-Dependent; Ischemia-Reperfusion Injury

Summary: in this proof-of-concept study, forearm vulnerability to ischemic exercise is studied in patients with type 1 diabetes mellitus with and without prior ischemic preconditioning (short period of ischemia that protects against subsequent ischemic exercise). annexin a5 scintigraphy is used to quantify subtle signs of mild and reversible forearm injury that results from ischemic exercise. the following hypotheses are tested: 1. patients with type 1 diabetes are not more vulnerable to ischemic injury as compared with previously studied healthy volunteers. 2. ischemic preconidtioning is still present in patients with type 1 diabetes. depending on the validity of hypothesis 2, the effect of short pharmacological interventions are studied on vulnerability to forearm ischemia/reperfusion injury in the absence or presence of local forearm ischemic preconditioning.

all patients will be studied in supine position after an overnight fast, while plasma glucose levels are monitored. in the first 8 patients intravenous insulin is administered as needed, to reach target glucose levels between 5-7 mmol/l. patients will be subjected to 10 minutes of forearm ischemia (non-dominant arm), combined with handgripping at 50% of maximal force until exhaustion. upon reperfusion, tc-99m-hynic-annexin a5 will be injected intravenously. targeting of annexin a5 to thenar muscle and forearm flexor muscle will be quantified as the percentage difference in radioactivity between experimental and control side. this procedure will be performed twice (randomized cross-over design), with at least 2 week interval, either with or without 10 minutes ischemia followed by 10 minutes of reperfusion prior to ischemic exercise. depending on the results of this study, substudies will be performed to study the effect of diazoxide (k-atp channel opener, may mimic ischemic preconditioning), glibenclamide (k-atp channel blocker, may inhibit ischemic preconditioning) or adenosine (infusion into brachial artery of non-dominant arm as a substitute for ischemic preconditioning).

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * age 18-50 years exclusion criteria: * hypertension (systolic blood pressure \> 140 mmhg and/or diastolic blood pressure \> 90 mmhg * cardiovascular disease (coronary artery insufficiency,cva/tia, peripheral artery disease * hba1c \> 9% * body mass index \< 25 kg/m2 * unable to stop co-medication (other than insulin) for 1 week * previous exposure to radiation (diagnostic or therapeutic) in the past year

Keywords: diabetes ischemia annexin a5 scintigraphy
a clinical evaluation of the tension-free vaginal tape obturator system for treatment of stress urinary incontinence (urinary leakage)

Conditions: Stress Urinary Incontinence

Summary: stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.patients in the study will have an operation to improve urinary incontinence symptoms. this will involve inserting a mesh sling to help support the urethra (tube leading into your bladder). during the operation, the study doctor will use tension-free vaginal obturator system. the study will include women diagnosed with stress urinary incontinence who have completed their families.


Eligibility criteria:
inclusion criteria: * patient has objective demonstrable signs of stress urinary incontinence (sui), including patients with isd. objective testing includes: standing stress test, urodynamics evaluation, or pad test. * patient is age 18 or older. * patient had a hysterectomy, tubal ligation or is otherwise incapable of pregnancy, or had a negative pregnancy test prior to study entry and has decided to cease childbearing. * patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the irb/ec-approved informed consent. exclusion criteria: * patient has an associated or suspected neurological disease. * patient is on anti-coagulation therapy. * patient has received an investigational drug or device in the past 60 days. for patients having urp measurements at selected sites: * patient has an active lesion or present injury to perineum or urethra.patient has a urethral obstruction. * patient has an unreduced cystocele \> stage 1. (reduction of prolapse prior to urp testing is required.) reduction of cystocele (if applicable). patients should be seated in a semi-fowler's position with head of bed at 40-60 degrees. carefully place a half of a speculum into the vagina, reducing prolapse to less than stage 1. be careful not to over extend or elongate the vaginal length. the half of a speculum must be placed with pressure emphasis on the posterior and apical areas. anterior wall pressure or urethral pressure must be avoided at all times. * the subject has active infection upon urine dipstick analysis, defined as ≥+1 leukocytes or ≥+1 nitrates (must reschedule appointment after uti resolves.)
dexmedetomidine and renal transplants

Conditions: Renal Failure

Summary: investigators aim to retrospectively research patients undergoing renal transplants that received dexmedetomidine perioperatively to see if dexmedetomidine use protects renal function. investigators hope to elucidate any association between renal transplant patients and perioperative dexmedetomidine administration, these include (but are not limited to) uop, cr/gfr, morbidity, mortality, in hospital complications and failure rate. investigators will research both living and cadaveric renal transplants.


Eligibility criteria:
inclusion criteria: patients greater than or equal to 18 years old that underwent renal transplant at uc davis medical center - exclusion criteria: patients that did not undergo renal transplants and patients less than 18 years old will be excluded from the study. -
retrievability and incidence of complex retrieval in celect versus denali filter

Conditions: Deep Venous Thrombosis

Summary: the primary purpose of this study is to compare the celect and denali filters in terms of complicated filter retrieval and indwelling complications after a 2-month indwelling time.

with anticoagulation being the standard treatment for deep venous thrombosis and pulmonary embolism, inferior vena cava filter placement plays an important role in patients who are amenable to anticoagulant therapy. currently, many different types of retrievable filters are being used in clinical practice and the choice of the filters depends on operators' preference and institutional availability. each filter has different designs to maximize retrievability and minimize indwelling complications. up until now, the prior studies on the filter retrievability and indwelling complications have been retrospective in nature and had relatively long dwell times. comparative data regarding the retrievability of the inferior vena cava filters may help to choose filter selection. therefore, the aim of this trial is to compare two commonly used inferior vena cava filters (denali and celet filters)

Eligibility criteria:
inclusion criteria: * 1. patients who develop deep venous thrombosis and/or pulmonary embolism but are good candidates for anticoagulant therapy * 2. inferior vena cava filtration before mechanical thrombectomy for deep venous thrombosis * 3. prophylactic filter placement because of trauma or major surgery exclusion criteria: * 1. sepsis * 2. those who need permanent filter placement * 3. congenital anatomical anomaly (ivc duplication, interrupted ivc) * 4. patients who need filter placement in the suprarenal inferior vena cava

Keywords: inferior vena cava filter deep venous thrombosis pulmonary embolism complex retrieval
gastric residual volumes in infants fed at 4 and 6 hours prior to general anaesthesia

Conditions: Fasting; Anesthesia; Pediatric ALL

Summary: the safety implications of prolonged fasting in young children prior to general anaesthesia are well described. current uk guidance recommends a fasting time of 6 hours for formula milk prior to general anaesthesia. european guidance published in 2022 recommended a reduced fast of 4 hours for infants taking formula milk, albeit with a downgraded level 2b of evidence given the paucity of high quality research in this area. although pulmonary aspiration of gastric contents under anaesthesia in children is a rare event, animal studies suggest that aspiration of particulate matter at volumes greater than 0.8 ml/kg gastric volume are associated with demonstrable lung injury and mortality. although rate of gastric emptying of formula preparations has been extensively studied in neonatal intensive care settings for preterm babies using ultrasound, few studies have measured gastric volume directly in healthy term infants undergoing anaesthesia.

traditional fasting guidelines of 6 hours for formula milk may be unnecessarily long. in practice, children also tend to be fasted for longer than the guidelines advise, as they may not always feed on cue, and delays in the hospital can occur on the day of surgery. prolonged fasting in young children and infants is less well tolerated than in adults and can lead to hunger, dehydration and low blood sugar, as well as distress for the child and parents. we know from previous research in smaller babies that after a formula feed, the stomach empties by half in around 80 minutes, and empties completely by around 3 hours. the investigators want to find out if young children and infants who are fed with formula milk 4 hours prior to an anaesthetic have similar levels of stomach contents at the time of their anaesthetic as those who are fed at 6 hours. the investigators will carry out a clinical trial where children are randomised into 2 groups. parents of children in group 1 will be asked to offer a formula feed to their child 6 hours prior to the planned start time of their anaesthetic. parents of children in group 2 will be asked to offer a formula feed to their child 4 hours prior to the planned start time of their anaesthetic. prior to having their anaesthetic a study team member will perform an abdominal ultrasound scan to check and record antral cross sectional area. once asleep, gastric aspiration will be performed via naso-gastric tube. volume, colour and ph of the fluid will be measure the volume and acidity of any stomach contents will be compared between group 1 and group 2.

Eligibility criteria:
inclusion criteria: term or term corrected (\> 37 weeks) upto 12 months formula fed asa 1-3 exclusion criteria: significant reflux co-administration of drugs known to impact gastric motility or ph of gastric contents significant respiratory comorbidity including chronic lung disease on home oxygen significant cardiac comorbidity

Keywords: gastric volume
neurophysiological effects of tpcs and tdcs on patients with disorders of consciousness

Conditions: Disorders of Consciousness

Summary: this study aims at comparing the effects of transcranial direct current stimulation and transcranial pulsed current stimulation on neurophysiological outcomes on patients with disorders of consciousness. this study also aims to evaluate the effects of these techniques on patients' level of consciousness.


Eligibility criteria:
inclusion criteria: * fluent in english or french * legally authorized surrogate available to provide informed consent * history of non-traumatic brain injury with loss of consciousness caused by stroke, cerebral hemorrhage, hypoxic ischemic insult, metabolic disorder or infection. * has been followed clinically on the crs-r for a minimum two weeks and has undergone a minimum of 4 assessments with the crs-r. * serial crs-r scores show at least one subscale on which there is no behavioral sign of conscious awareness (ie, command following, visual fixation or pursuit, object localization or recognition, localization to noxious stimulation, object manipulation, automatic motor responses, functional object use, discernable speech, discernable yes no communication, based on clinically obtained scores contained in the medical record). * crs-r screening examination completed by research staff confirms the absence of a behavioral sign of consciousness on a least one crs-r subscale. * medically stable (i.e., no systemic illness or disease) and capable of independent ventilation exclusion criteria: * history of developmental, neurologic, or major psychiatric disorder resulting in functional disability up to time of enrollment. * evidence or surrogate report of uncontrolled seizure disorder * metallic brain implant or implanted electronic brain medical devices or pacemaker * subjects with craniectomy * history of cranioplasty in the frontal region or recent cranioplasty that has not yet fully healed * pregnancy