Kornimate/medical-research-clean huggingface dataset:
music for anxiety in critically ill patients

Conditions: Anxiety

Summary: rationale: anxiety is common in critically ill patients, and has likely become more prevalent in the recent decade due to the imperative of the recent padis guidelines to use low levels of sedation and strive for wakefulness. administration of sedative and analgesic medication is often chosen to reduce anxiety, especially when associated with agitation, but especially sedatives are associated with prolonged mechanical ventilation, delirium and muscle wasting and are therefore preferably minimized. previous studies have suggested positive effects of music interventions on anxiety in the critically ill, next to other physiological signs such as pain. however, management of anxiety has not been included in the padis guidelines, and there is lack of evidence to treat it in spite of its growing importance. therefore, we aim to study the effect of music intervention on anxiety in adult critically ill patients. objective: the primary objective is to assess the effect of music intervention on the level of anxiety. study design: a randomized controlled trial. study population: adult patients admitted to the intensive care unit, with whom communication is possible (richmond agitation sedation scale of -2 or higher). intervention (if applicable): the music group will be offered to listen to music two times per day for three days after inclusion, during 30-60 minutes per session. chosen music will be based on the preference of the patient. the control group will receive standard of care during the entire study. main study parameters/endpoints: the primary outcome is the effect of music on the visual analogue scale for anxiety (vas-a). secondary outcomes include effect of music on sedation and agitation level, medication requirement, pain, sleep, delirium, heart rate, mean arterial pressure, and icu memory and experience.


Eligibility criteria:
inclusion criteria: * patient is hemodynamically stable and communicable (rass of -2 or higher in the 24h before intended inclusion: meaning patient is at least briefly awakened with eye contact to voice). * expected icu stay upon randomisation of at least another 48 hours. * written informed consent acquired from the patient or legal representative. exclusion criteria: * patients with severe hearing impairment, defined as no verbal communication possible. * neurological condition (e.g. severe stroke), when deemed to interfere with processing of music (e.g. not applicable to patients with minor stroke in past medical history without significant residual neurological deficits; those patients could be included). * insufficient knowledge of the dutch or english language for informed consent. * participation in another study that may possibly intervene with the primary outcome measure

Keywords: music anxiety intensive care unit critically ill
ckd-828(80/2.5mg) pharmacokinetic study_2nd

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the pharmacokinetic characteristics of ckd-828(fixed dose combination tablet; telmisartan and s-amlodipine) in healthy volunteer.


Eligibility criteria:
inclusion criteria: * a healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight. * have not any congenital or chronic diseases and medical symptom. * appropriate for the study judging from examinations(interview, vital signs, 12-lead ecg, physical examination, blood, urinalysis result on screening). * able to participate in the entire trial. * signed the informed consent form prior to the study participation. exclusion criteria: * take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first ip administraion. * take oriental medicine inside st john's wort or metabolism of cyp3a4 enzyme or inhibite the cyp enzyme or increase the making drugs(itraconazole, ketoconazole, erythromycine, clarithromycine, telithromycin, hiv protease inhibitor) * disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s). * relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication. * hypersensitivity telmisartan or amlodipine. * sbp\<90mmhg, 150mmhg\<sbp or dbp\<50mmhg, 100mmhg\<dbp. * abnormal laboratory result(s): ast or alt \> 1.25 times of upper limit / total bilirubin \> 1.5 times of upper limit. * creatinine clearance\<80ml/min * clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, nervous system or hyperpotassemia (past history or present) * history of drug abuse(sleeping tablet, nucleus action painkiller, an opiate or psychotrope etc the central nervous system drug)or showed a positive for the urine screening exam. * any abnormal diet which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. drinking grapefruit juice(more than 1l per a day) during 7 weeks prior to the first ip administration.) * a heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first ip administration. * previously donate whole blood within 60 days or component blood within 30 days prior to the first ip administraion. * medication within 7 days in the first ip administraion professional medical, medicine, otc taking * participated in the other clinical trials within 60days prior to the first ip administraion. * an impossible one who participates in clinical trial by investigator's decision

Keywords: ckd-828 hypertension primary hypertension healthy volunteer s-amlodipine telmisartan amlodipine pharmacokinetic phase 1
bipolar radiofrequency ablation -role in prevention of postoperative atrial fibrillation

Conditions: Postoperative Atrial Fibrillation

Summary: atrial fibrillation (af) is one of the most common postoperative complications after coronary artery bypass grafting (cabg). postoperative af produces a substantial impact on hospital resources with an estimated annual expenditure of over $1 billion. this includes the cost of pharmacological treatment and the cost of the increased length of stay. the incidence of af is about 30-40% in cabg patients and increases with age of the patient. as the average age of the patient that undergoes cabg surgery is increasing, it is critical to find a way to prevent or reduce the incidence of this complication. we propose a prospective, randomized, controlled study to determine the role of pulmonary vein isolation by bipolar ablation in the prevention or reduction of postoperative af. the block- randomization plan will be used to maintain balance of the study and control arms throughout the study.


Eligibility criteria:
inclusion criteria: 1. patients who require an isolated elective cabg surgery on cpb. 2. both male and female patients of age 18 years to 90 years. exclusion criteria: 1. pre existing atrial fibrillation or history of previous atrial fibrillation. 2. inability to provide informed consent. 3. pregnant or nursing patients. 4. reoperative sternotomy 5. emergency cabg surgery.
high intensity light therapy in alzheimer's disease

Conditions: Alzheimer's Disease; Dementia

Summary: the purpose of this study is to determine whether bright light improves the sleep, mood, and behavior of persons with alzheimer's disease and related dementias (ad) who live in long-term care settings and, if so, to determine the best timing for the light therapy. the light levels being used in the study have been shown to improve depression in persons with seasonal affective disorder (sad) and to relieve sleep problems in persons with jet lag and other body rhythm disturbances. because persons with ad often will not remain still in front of a fluorescent panel, this project has involved renovations in the study units that provide for even, regulated, high-intensity light in all public areas of the study settings.

see brief summary

Eligibility criteria:
inclusion criteria: * diagnosis of dementia * residence on study units exclusion criteria: * bipolar disorder * severe retinal (eye) disease

Keywords: alzheimer's disease light therapy long-term care depression sleep agitation
angiocomb antiangiogenic therapy for pediatric patients with diffuse brain stem and thalamic tumors

Conditions: Brainstem Glioma

Summary: the purpose of this study is to determine whether initial local irradiation with topotecan and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective in the treatment of pediatric diffuse brainstem tumor.

all pediatric patients (aged 1-16 yrs) with newly diagnosed diffuse brain stem tumor or inoperable thalamic tumor which infiltrate brain stem from the pediatric oncology units in denmark, finland, iceland, norway and sweden will be eligible. a possible tumor biopsy with histologic findings is not taken into account. the diagnosis is based on mri. the patients are given a conventional local radiotherapy of 54 gy, during which the patient also receives topotecan as radiosensitizer. within four weeks after completed radiotherapy, the investigational drugs are started. if the family for some reason refuses radiotherapy, the investigational therapy may still be considered. the guardians and age-appropriate patients are asked for written informed consent. if the family is not willing to participate in the trial, the patient is treated according to the currently best available therapy (meaning rt without topotecan as palliative therapy). the family has the right to withdraw from the study, whenever they so wish. brain mri at initial diagnosis, before the start of triple medication, and q 3 mo after initiation of triple medication, if not otherwise clinically indicated. in case it is decided to continue medication with progression in mri, repeat mris are recommended every month. mri should also be registered, if feasible, at the discontinuation of the medication. the clinical follow-up, as well as mri follow-up, on clinical indications will continue also after discontinuation of therapy. pet-ct and/or mri spectroscopy should be considered at diagnosis and at 3 mo after the start of triple medication.

Eligibility criteria:
inclusion criteria: -pediatric diffuse brainstem tumor exclusion criteria: * wish of the family * need for strong painrelievers * decreased level of consciousness * inability to swallow.
nostril side on epistaxis

Conditions: Nasotracheal Intubation

Summary: the purpose of the study is to investigate the effect of the nostril side on epistaxis during nasotracheal intubation.

this prospective randomized controlled study was approved by the irb of our institute. patients requiring nasotracheal intubation will be screened for eligibility for the study. then, patients will be randomized to one of two groups; (group i: tube will be inserted through the left nostril and advanced into the oral cavity / group ii: tube will be inserted through the right nostril and advanced into the oral cavity). after induction of anesthesia and muscle relaxation, the preformed nasal rae (ring-adair-elwyn) tube will be inserted via the nostril, which is assigned to each patient according to the group, approximately 3-4 cm. next, an anesthesiologist will advance the tube into the oral cavity. after the tube is placed in the oral cavity, the anesthesiologist will perform nasotracheal intubation with magill forceps. after that, an investigator will check the occurrence of epistaxis due to nasotracheal intubation and its severity with a fiberoptic bronchoscope. after obtaining all data, investigators will analyze the incidence of epistaxis and its severity between the two groups.

Eligibility criteria:
inclusion criteria: * adult patients requiring nasotracheal intubation for elective surgery exclusion criteria: * refuse to participate in the study * severe deformity in the nose * current severe epistaxis * cannot insert the tube into a specific nostril side due to any reason
paliperidone extended-release [er] dosing and clinical response in acute schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the efficacy of paliperidone extended-release (er) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

this is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone extended release(er) in participants with schizophrenia. the total study duration will be approximately of 104 weeks per participant. the study consists of following parts: screening (that is, 14 days before study commences on day 1); acute treatment phase (single-oral dose of paliperidone for 12 weeks, dose ranging from 3 to 12 milligram); extension phase 1 (12 weeks) and maintenance treatment which will be followed by additional extension phase 2 and long-term maintenance treatment. efficacy of the participants will primarily be evaluated by clinical global impression-improvement (cgi-i) scale score. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants with clinical global impression-severity (cgi-s) score greater than or equal to 4 points (moderately ill) at screening * childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) * participants who are capable of and willing to fill out the questionnaire for themselves * participants who are compliant with self-medication or can receive consistent help or support * have schizophrenia diagnosis by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) exclusion criteria: * participants with the past history of neuroleptic malignant syndrome (nms) * participants with treatment resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration) * participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (the study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.) * participants who have been exposed to the study drug within one month before screening * participants with significant risk including suicide or aggressive behavior

Keywords: paliperidone r076477 schizophrenia
modulation of type 1 diabetes susceptibility through the use of probiotics

Conditions: Type1diabetes; Type1 Diabetes Mellitus

Summary: investigators aim to further the understanding of environmental factors that underlie the progression to type 1 diabetes (t1d). dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing t1d in those with genetic susceptibility. dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed western diet, or by widespread use of antibiotics. here, investigators propose to examine the impact of dysbiosis on the endogenous innate inflammation known to exist within families affected by t1d and if probiotic supplementation may beneficially modulate this inflammatory state. participants will be asked to take the probiotic vsl#3 daily for six weeks. stool and blood samples will be analyzed before and after the six week course of probiotics.


Eligibility criteria:
inclusion criteria: 1. males and females 5-17 years of age 2. full-sibling of an individual with a clinical diagnosis of type 1 diabetes 3. treatment naïve of any immunomodulatory agent 4. naïve of any probiotic supplement within the past 12 months exclusion criteria: 1. presence of severe/active disease that interferes with dietary intake 2. chronic use of medications known to affect gastrointestinal function, such as stool softeners or laxatives 3. diagnosis of celiac disease and/or following a gluten-free diet 4. presence of significant and sustained gastrointestinal symptoms within the prior 6 weeks (e.g., severe abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting) 5. chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids 6. use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics) 7. any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results 8. female participants of child-bearing age must not be pregnant

Keywords: siblings
msc for severe agvhd

Conditions: Steroid-resistant Severe aGVHD

Summary: steroid-resistant acute graft-versus-host disease (agvhd) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (hsct), which cannot be significant benefit from the second-line therapies.the mesenchymal stem cells (mscs) possess extensive immunomodulatory properties and are very promising to rescue the refractory agvhd.this study aims to assess the efficacy and safety of mscs for the treatment of the refractory agvhd.


Eligibility criteria:
inclusion criteria: * signed written informed consent * aged \<65 years * patients with steroid-resistant severe agvhd * cardiac: left ventricular ejection fraction ≥ 50% * adequate renal and hepatic function * performance status: karnofsky ≥ 70% exclusion criteria: * pregnant or lactating females. * any co-morbidity precluding the administration of mscs.
comparative study for the optimal treatment method of lateral epicondylosis

Conditions: Tennis Elbow

Summary: the purpose of this study is to find the optimal treatment method for chronic lateral epicondylosis, and focused on the 'healing mechanism' and 'pain modulation' of degenerated tendon.the hypothesis is that there will be significant difference between treatment groups and control group (physiotherapy) and also there will be significant difference among treatment groups.

231 patients were randomized using a random sequence generator (random.org) into 4 groups: group a (physiotherapy as a control, n=58), group b (eswt, n=62), group c (prolotherapy, n=56) and group d (prp, n=55). in group a, patients were educated to do stretching and eccentric strengthening exercise of wrist extensor muscles. in group b patients were treated with 3 sessions of high-energy shock wave therapy eswt (evotron, switech medical, kreuzlingen, ch) in 2 weeks interval. total energy flux density ranged from 0.1 to 0.14 mj/mm2 (1500 impulses). shockwave was targeted over lateral epicondyle where maximum tenderness was located. in group c, injection of 20% dextrose (3cc mixed with 0.3cc of lidocaine) to ecrb tendon was done under ultrasound guidance and in group d, 3 cc of prp (harvest smartprep 2 apc 30 process kit, harvest technologies, plymouth, ma) was injected into ecrb tendon under ultrasound guidance. 22g needle was used for injection in group c and d. the primary outcome measure is dash scoring system which is recorded on the initial, 3rd, 6th, 18th and 24th month. secondary outcome measures were ultrasonography (measured on initial, 6th and 24th month) and sss (subjective satisfaction score) measured on initial and 24th month. after 24 months from the last procedure, all serial questionnaires and physician-filled-sss sheets were gathered and analyzed by a one-way analysis of variance and scheffe post-test. a value of p\<0.01 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * 35 to 80 years of age * history of elbow pain in the region of the lateral epicondyle for more than 6 months * more than 3 months of treatment for lateral epicondylosis before enrollment in the study with no subjective improvement * pain on resisted extension of wrist * local tenderness to palpation at the lateral epicondyle * confirmed as lateral epicondylosis on ultrasound imaging exclusion criteria: * history of steroid or botulinum injection(s) within 6 months before study enrollment * other elbow pathology including nerve compression, previous elbow fracture, limited elbow range of motion, abnormal simple radiographic findings, history of elbow surgery and inflammatory arthropathies * upper extremity pain or discomforts from shoulder or wrist or hand

Keywords: tennis elbow lateral epicondylosis lateral epicondylitis platelet-rich plasma extracorporeal shockwave therapy prolotherapy physiotherapy
fractionated stereotactic radiosurgery for large brain metastases

Conditions: Large Brain Mets

Summary: this is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (fsrs) which may make the treatment feasible. fractionated sterotatcic radiation, the risks of fsrs, and possible costs will be described later in this document. this clinical trial is for people who have had no prior whole brain radiation.


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 18 years of age * a life expectancy of at least 12 weeks with a karnofsky performance status of at least 70 (appendix ii) * the target lesion(s) can be accurately measured in at least one dimension according to recist * no prior radiotherapy to the brain * previous or concurrent systemic or targeted chemotherapy is allowed * patients must have an extra-cranial primary tumor diagnosis * patients will have no more than 3 distinct lesions within the brain. at least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm which will be treatable by fractionated stereotactic radiosurgery * the additional lesions will each be treated with single fraction stereotactic radiosurgery * patient may be on steroids or anti-epileptics * must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts * patients do not need a histologically proven diagnosis of brain mets exclusion criteria: * symptomatic patients in need of surgery to the "target" lesion * four or more newly-diagnosed lesions * prior surgical resection of targeted tumor * prior wbrt * primary brain tumor * pregnant or breast-feeding patients * primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
the effect of preoperative parameters on success after dmek surgery

Conditions: Fuchs' Endothelial Dystrophy; Pseudophakic Bullous Keratopathy; Descemet's Membrane; Defect; Herpetic Keratitis; Angle's Classification; Endothelial Dysfunction

Summary: the aim of this study is to evaluate the effect of preoperative parameters on surgical results in descemet membrane endothelial keratoplasty (dmek) surgery.

in patients undergoing descemet membrane endothelial keratoplasty (dmek) surgery; preoperative anterior chamber depth, angle parameters, axial length and corneal parameters will be evaluated. the effects of these parameters on surgical results will be examined.

Eligibility criteria:
inclusion criteria: * scheduled to undergo descemet membrane endothelial keratoplasty(dmek) * aged 18 old older exclusion criteria: * patients with corneal pathology other than endothelial insufficiency * glaucoma patients, * patients who have previously had any keratoplasty procedure

Keywords: descemet membrane anterior chamber depth axial length endothelial count descemet membrane endothelial keratoplasty