Kornimate/medical-research-clean huggingface dataset:
effect of music therapy in pain and anxiety management for patients treated with stitches

Conditions: Wound

Summary: the aim of this study is to measure the effect of music therapy on pain and anxiety levels during stitches procedure in an adult emergency department.

wounds represent a frequent reason for admission to emergency department (5 to 7% of visits), inducing pain and anxiety due to the trauma itself and also to the treatment, stitches being the most frequently used procedure. alternative, non-pharmacologic strategies may help reduce pain and anxiety associated with painful bedside procedures. music is one of them, easy to use and without any side effects. music therapy has already been shown to reduce pain and anxiety levels in children during medical procedures (blood test, vaccination, lumbar puncture) and in adults during surgical or anaesthetic procedures. our objective is to apply this technic to adults in emergency departments during stitches wound management. this is a study before / after the implementation of a music therapy protocol during stiches wound management. during the music period, the participant will choose and listen to one of the five playlists (vocal jazz, instrumental jazz, piano, world music, mozart) created by a professional music therapist, via headphones. there will be no change in stitches wound management. pain and anxiety levels will be measured by visual analog scale before, during and after the stitches procedure.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * acute skin wound with need for stitches * national health service coverage * no opposition exclusion criteria: * conditions interfering with consent or measures (no french-fluent, acute intoxication, neurologic or psychiatric pathology) * wound requiring surgical exploration * wound localized on or around an ear * major insufficiency of auditory function

Keywords: wound stitches pain anxiety music
intensive versus standard hemodialysis cvc dysfunction protocol

Conditions: Chronic Renal Insufficiency

Summary: central venous catheters (cvcs) are used for vascular access by approximately 56% of our 380 hemodialysis (hd) patients at the capital health renal program. the major complication of these catheters includes thrombosis and infection. catheter locking solutions such as recombinant tissue plasminogen activator (rt-pa), alteplase (cathflo®) are used to treat and prevent clotting of the catheter during hd treatments and during the interdialytic period. evidence to guide the use of rt-pa is limited. this quality assurance project will compare the effectiveness and cost of an intensive versus a standard catheter dysfunction protocol for rt-pa in hd patients.

the proposed study will be a retrospective cohort study of consecutive hd patients conducted at a hd unit using two catheter dysfunction protocols during january 2013 to septebmer 2013. in the intensive protocol, rt-pa intervention is administered to all catheters based on blood flow and/or line reversal. in the standard protocol, rt-pa intervention is administered to all catheters based only on blood flow.

Eligibility criteria:
inclusion criteria: * all adults undergoing hd with a tunneled cvc (both newly inserted cvcs as well as pre-existing cvcs) will be included. exclusion criteria: * patients were excluded from using the cvc dysfunction protocols if they had a known allergy or intolerance to rt-pa. * a physician order to proceed with the cvc dysfunction protocols was required if they met one of the following criteria: * cvc line insertion or exchange within 72 hours; * any surgery, organ biopsy, obstetrical delivery within 72 hours; * active bleeding; bleeding disorders; hemoglobin decrease greater than 20 g/l over 2 weeks; * active pericarditis; arterial puncture within 48 hours; * bacteremia with positive blood cultures.

Keywords: central venous catheters hemodialysis thrombosis tissue plasminogen activator
a multi-center study on the metoprolol optimal dosing pathway of metoprolol application in chinese patients with acute coronary syndrome

Conditions: ACS - Acute Coronary Syndrome

Summary: this study is to test the feasibility and tolerability of the metoprolol optimal dosing pathway by observing the percentage of patients achieving target dose followed the pathway on acs patients during hospitalization.

acute coronary syndrome(acs) is one of the main manifestations of cardiovascular disease and one of the main causes for hospitalization in adults. previous studies showed that β-receptor blockers can reduce acs patients' cardiovascular risk in both acute phase and secondary prevention. we summarized the metoprolol optimal dosing pathway based on chinese and foreign guidelines as well as chinese clinical practice. primary endpoint is the percentage of patients achieving target dose at time of discharge. secondary endpoints are the mean hr \& bp at discharge and during the follow up period of the patients who have achieved target dose at discharge.

Eligibility criteria:
inclusion criteria: * aged 18 years or above; * hospitalized due to acute coronary syndrome; * able and willing to provide written informed consent and to comply with the study. exclusion criteria: * cardiac shock; * unstable heart failure; * beta-agonist therapy on a continuous or intermittent basis; * hypotension (bp\<90/60 mmhg) or bradycardia (hr\<50 bpm) with symptoms; * sick sinus syndrome; * ⅱ\~ⅲ atrioventricular block; * killip \>ⅱ; * suspected acute myocardial infarction with heart rate\ 0.24 sec or systolic blood pressure \<100 mmhg; * existing contraindication for metoprolol or allergic to metoprolol or any excipients; * participation in another clinical study with an investigational product during the last 3 months; * previous enrolment in the present study; * subjects the investigator thinks not suitable for this study. e.g. cancer etc.; * inability to sign the informed consent form; * pregnancy or lactation.
speech therapy in the management of chronic cough

Conditions: Cough; Speech Therapy

Summary: speech and language intervention (speech therapy) is one of the few methods which seem to be useful in management of persistent chronic cough. this method has not been available for patients with cough in poland so far.the aim of the study is to implement speech therapy to the management plan of patients with difficult-to-treat chronic cough and to analyze its efficacy in this particular group. patients with difficult-to treat chronic cough will be offered speech and language intervention as an added therapy. the effectiveness of speech therapy will be measured by changes in cough severity, its influence on quality of life and cough challenge test before and after speech therapy measured in every patient.

the efficacy of management of chronic cough in adults is limited. speech and language intervention (speech therapy) is one of the few methods which seem to be useful in management of persistent chronic cough. this method has not been available for patients with cough in poland so far. the aim of the study is to implement speech therapy to the management plan of patients with difficult-to-treat chronic cough and to analyze its efficacy in this particular group. patients, who are diagnosed and unsuccessfully managed because of difficult-to treat chronic cough, will be offered speech and language intervention as an added therapy. it is based on the technique described by vertigan et al.the entire therapy will consist of eight sessions once a week. cough severity, its influence on quality of life and cough challenge test with capsaicin will be assessed by visual analogue scale, leicester cough questionnaire and cough challenge test with capsaicin will be performed before and after speech therapy in every patient to analyze its effectiveness

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years, 2. chronic cough lasting more than six months 3. earlier thorough diagnosing of cough reason 4. unsuccessful cough management despite at least 3 months of earlier treatment 5. no symptoms of any airway infection during last 4 weeks. exclusion criteria: 1. lack of opportunity to participate in speech therapy sessions 2. cough lasting less than 6 months 3. active cigarette smoking 4. taking ace inhibitors 5. symptoms of airway infection (other than cough).

Keywords: chronic cough speech and language intervention difficult-to-treat cough
validation of the stamp screening tool

Conditions: Malnutrition

Summary: insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss or insufficient weight gain, is related to an increase in morbidity and mortality and exposes the child to medical complications. in addition, obesity is also related to complications during hospitalization and complications in general, and therefore early identification of these children is extremely important. studies show that malnutrition is frequent among children upon hospitalization, where the risk of pediatric nutritional deterioration increases, even in the presence of mild stress factors. this risk is frequent mainly among children that arrive at the hospital with an initial poor nutritional status. improving the nutritional status as part of the standard of care already at the ambulatory setting might improve the prognosis of children when ill. in israel, nutritional screening in not conducted among children since there is no proper validated screening tool. study objectives: to test the accuracy of the stamp screening tool for pediatric nutritional risk which is designed to be used by nurses, and to compare it to a complete nutritional assessment conducted by a dietician in clalit health care services clinics. in addition, the investigators wish to examine the effects of using a screening tool for nutritional risk on the medical staff's attention to the nutritional status; this is measured by the collection of nutritional status-related data and their recording in the patient file. methods: 100 boys and girls aged 1 to 6, attending clalit health care services pediatric centers, will undergo an assessment using the stamp tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. these children shall also undergo a complete dietician assessment in order to examine the validity of the stamp tool. in addition, 150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements. a statistical analysis to examine the validity of the stamp tool shall be carried out using the kappa test (k) (30). the effect of the stamp tool use shall be calculated using the chi square test.


Eligibility criteria:
inclusion criteria: 1. children between 1 and 6 years old 2. children treated at the clinics participating in the study exclusion criteria: 1. lack of consent or lack of hebrew proficiency 2. children that not receiving treatment in day hospitalization at any hospital

Keywords: nutritional assessment children malnutrition
observational study to assess optimal ecpr settings after resuscitation

Conditions: Extracorporeal Cardiopulmonary Resuscitation; Cardiac Arrest

Summary: rationale: veno-arterial extracorporeal membrane oxygenation (vaecmo) during cardiopulmonary resuscitation (ecpr) might improve outcome after cardiac arrest. however, it is well established that reperfusion injury of the brain can cause microvascular and endothelial dysfunction, leading to cellular necrosis and apoptosis. while performing ecpr, following the european resuscitation guidelines, it is yet unknown how to set the ecmo settings in order to minimize ischemia-reperfusion injury of the brain. objective: in this study, we want to elaborate on the optimal ecmo settings in the first three hours after initiation of ecpr. study design: prospective, multi-centre, observational study study population: all patients receiving ecpr in the age between 18 and 70 years, with low flow duration\<60min and receiving cerebral oximetry monitoring intervention: application of an adhesive regional oximetry sensor on the patient's forehead and withdrawal of 12 ml extra blood in all patients. main study parameters/endpoints: cerebral performance category at 6 months. neuron-specific enolase (nse) will be determined from routine blood drawings.


Eligibility criteria:
inclusion criteria: * witnessed cardiac arrest or signs of life during cpr (such as gasping or movement) * age\>18 and \< 70 years * duration of low-flow \< 60 min before decision to proceed with ecpr * high quality cpr (defined as end-tidal carbon dioxide (co2et) \>10 mmhg) provided for a minimum of 15 minutes without return of spontaneous circulation (rosc) * presumed cardiac cause of cardiac arrest (such as chest pain before collapse, ventricular tachycardia/ventricular fibrillation (vt/vf) as initial rhythm or st-elevation on ecg) * cerebral oxymetry monitoring initiated during cpr preceding ecpr exclusion criteria: * patients with a gcs\<15 before cpr. * known pre-arrest cerebral performance category cpc ≥ 3 * presumed noncardiac cause * unwitnessed collapse * suspected or confirmed pregnancy * rosc within 5 minutes of advanced cardiopulmonary life support (acls) performed by emergency medical service (ems) team * conscious patient * known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding * suspected or confirmed acute stroke * known severe chronic organ dysfunction or other limitations to therapy * "do not resuscitate" order or other circumstances that make 180 day survival unlikely
long term safety study of nasalfent (fentanyl citrate nasal spray) for treatment of breakthrough cancer pain

Conditions: Cancers, Pain

Summary: cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. nasalfent contains fentanyl in a patented drug delivery system called pecsys and is given via a simple nasal spray. this study will examine the long-term safety of nasalfent in the treatment of breakthrough cancer pain.

current treatments for breakthrough cancer pain (btcp) work too slowly to meet the fast onset of most btcp episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. in addition most cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. the nasal route is a common way to administer medication for example in the treatment of migraine or allergy. at any time during the study the patient may take their regular treatment for btcp should they so wish. this study will examine the long-term safety of nasalfent treatment for breakthrough cancer pain. after the study is completed, patients may continue to take medication if their doctor feels it is in the patient's best interest to do so. safety information will continue to be collected during this period. treatment may continue on study for as long as the patient requires treatment or until nasalfent becomes commercially available.

Eligibility criteria:
inclusion criteria: * able and willing to give consent * women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception * diagnosis of cancer * taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain * experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication * able (or via caregiver) to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary * able to be up and about for 50% of the day or greater exclusion criteria: * intolerance to opioids or fentanyl * rapidly increasing/uncontrolled pain * pain that is not cancer related

Keywords: pain cancer breakthrough
the prognostic role of lymph node dissection in men with prostate cancer treated with radical prostatectomy

Conditions: Prostate Cancer

Summary: an extended pelvic lymph node dissection (eplnd) is the most accurate staging method to assess the presence of lymph node metastases in prostate cancer (pca) patients. the therapeutic value, however remains unclear. prospective randomized trials to address this void are lacking. since in intermediate and a proportion of high risk pca the risk of nodal metastases is generally below 25%, the vast majority of men undergo a procedure that has no oncological benefit, but is not without toxicity. therefore, the investigators aim to compare the oncologic outcomes of intermediate- and high-risk pca patients with an estimated risk of lymph node invasion of 5-20% undergoing a radical prostatectomy (rp) with or without an eplnd.

the role of an extended pelvic lymph node dissection (eplnd) in patients undergoing radical prostatectomy (rp) remains controversial. an eplnd is the most accurate staging method to assess the presence of lymph node metastases. lymph node involvement is associated with a significantly worse prognosis and may require immediate or delayed adjuvant therapy. however, an eplnd is associated with an increased risk of complications such as lymphoceles, thromboses and lymphedema, and prolongs surgery and patient recovery. thus, the diagnostic advantage of plnd should be weighed against the potential morbidity. the therapeutic value of an eplnd remains especially unclear in pca patients with an estimated risk of lymph node invasion (lni) ≤ 20%, where only a minority of patients will have nodes harbouring metastases. prospective trials to address this issue are still lacking.

Eligibility criteria:
inclusion criteria: * male, aged ≥ 18 years * prostate cancer patients with a briganti calculated risk of ln metastases of 5-20% without evidence of metastases on prostate-specific membrane antigen (psma) pet/ct requiring an eplnd in the standard treatment * scheduled for a (robot-assisted) laparoscopic radical prostatectomy * written informed consent exclusion criteria: * american society of anaesthesiology (asa) classification \> 3 * patients with a contradiction for a lymphadenectomy * neoadjuvant hormone deprivation therapy * absence or withdrawal of an informed consent * evidence of metastases on pre-operative psma pet/ct

Keywords: prostate cancer lymph node dissection prostatectomy
post-traumatic growth following eye movement desensitization and reprocessing therapy versus ssris in patients with post-traumatic stress disorder

Conditions: PTSD - Post Traumatic Stress Disorder

Summary: this randomized controlled trial investigates the comparative effectiveness of eye movement desensitization and reprocessing (emdr) therapy and selective serotonin reuptake inhibitors (ssris) in fostering post-traumatic growth among patients diagnosed with post-traumatic stress disorder (ptsd). participants will be randomized to receive either emdr therapy or standard ssri pharmacotherapy. the primary objective is to evaluate the extent of psychological growth and recovery achieved through each intervention, aiming to guide future therapeutic strategies for ptsd.


Eligibility criteria:
inclusion criteria: clinical diagnosis of post-traumatic stress disorder (ptsd) based on dsm-5 criteria willingness to participate and provide informed consent ability to comply with study procedures exclusion criteria: current diagnosis of psychotic disorder, bipolar disorder, or severe major depressive episode with psychotic features active substance use disorder within the past 6 months severe cognitive impairment or inability to complete study assessments

Keywords: ptsd post-traumatic stress disorder post-traumatic growth emdr eye movement desensitization and reprocessing
antiremodeling effect of aldosterone receptors blockade with canrenone in mild chronic heart failure. area in-chf study

Conditions: Heart Failure

Summary: the rales study has shown that spironolactone reduces the risk of morbidity and mortality both from progressive heart failure and sudden death, in patients with nyha iii or iv heart failure. this favourable effect was clearly independent from a diuretic effect. antialdosterone drugs may be effective because they opposes the effects of aldosterone on sodium retention, loss of magnesium and potassium, sympathetic activation, baroreceptor function and vascular compliance. antialdosterone treatment may also antagonize the effect of aldosterone in promoting cardiac fibrosis. in a rales substudy baseline serum piiinp, a marker of cardiac fibrosis synthesis showed an independent negative correlation with survival and chf hospitalizations in the placebo group. therefore it seems interesting to evaluate the effect of an aldosterone receptor blocker on progression of left ventricular dysfunction in patients with mild heart failure assuming standard therapy.

the protocol is sponsored by and independent organization and partially supported by therabel

Eligibility criteria:
inclusion criteria: * established diagnosis of congestive heart failure in nyha class ii * left ventricular ejection fraction \<= 45% measured within 6 months from enrolment * stable standard heart failure therapy (if patients are on beta blocker drugs, treatment must have been started at least three months before enrolment) * informed consent (obtained prior of any study procedures) exclusion criteria: * age \ 80 * serum creatinine level \> 2.5 mg per deciliter * serum potassium level \> 5.0 mmol per liter * valvular heart disease amenable to surgical treatment * congenital heart disease * unstable angina and/or acute myocardial infarction and/or coronary revascularization procedure within three months before enrolment * intravenous therapy with inotropic drugs within three months before enrolment * history of resuscitated ventricular fibrillation or tachycardia, unless these occurred within 24 hours of an acute myocardial infarction or the subject has an implanted an automatic cardioverter defibrillator * chronic active hepatitis or cirrhosis * malignant neoplasm or any life threatening non cardiac disease * history of hypersensitivity to study drug * pregnancy or lactating or childbearing age women who are not protected by an accepted method of contraception * history of drug or alcohol abuse * legal incapacity and/or other circumstances rending the patient unable to understand the nature, scope and possible consequences of the study. * evidence of uncooperative attitude * any condition other than heart failure that does not permit an optimal participation to the trial * participation to other rcts during the last 3 months * treatment with: lithium salts, potassium sparing diuretics, oral positive inotropic drugs or any investigational drug