Kornimate/medical-research-clean huggingface dataset:
music application in patients undergoing percutaneous coronary intervention

Conditions: Healthy; Nurse's Role; Patient Satisfaction

Summary: this study was planned to examine the effect of music application on recovery in patients undergoing coronary angiography (cag) and to obtain the opinions of patients and nurses about music.this study was conducted to examine the effect of music application on recovery in patients undergoing cag and to obtain the opinions of patients and nurses about music.the study was planned as a pre-test, post-test design, single-center, randomized controlled experimental study. the study is planned to be conducted in the cag unit of a university hospital between july 2023 and december 2023, the study sample will be composed of a total of 210 individuals, 105 in each group (music applied group before and after the procedure = 105, control group = 105) to collect data in the study, the "patient information form", vital signs evaluation form", "numerical rating scale", state-trait anxiety inventory, "perianesthesia comfort scale" and "patient satisfaction survey on nursing care quality" were used.

in the study, before the patients in the music group (mg) who would undergo planned cag listened to music, while the patients were in the ward before the procedure; patient information form, vital signs registration form, numerical rating scale, state-trait anxiety scale were applied, then 15-20 minutes. music prepared with expert suggestions (rast, acemasiran, and huseyni modes) 15-20 min. was listened to. after the procedure, patients in mg are given 15-20 minutes before being discharged. music was played. then, the vital signs registration form, numerical rating scale, state-trait anxiety scale, perianesthesia comfort scale, and patient satisfaction survey on nursing care quality were administered for the last time. the specified survey forms were applied to the patients in control group before and after the procedure, and they were not allowed to listen to music.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * being literate, * having no communication or hearing impairment or neurological-psychiatric disease, * not taking sedatives before the procedure * not having undergone pci before * being in the waiting room at least 20 minutes before the procedure. exclusion criteria: * under the age of 18 * do not speak turkish * have a hearing problem * without a place and time orientation * have any psychiatric illness * using sedative or analgesic drugs in the last 24 hours * to be intervened outside the femoral area * previous angiography procedure * non-volunteer individuals will not be included in the study

Keywords: nursing care recovery anxiety pain vital signs confor quality of care
comparison of efficacy in removal of advanced glycation end products (ages) between super high-flux hemodialysis and postdilution online hemodiafiltration: a single-center, prospective, open-label, crossover randomized controlled trial

Conditions: End Stage Renal Disease

Summary: the goal of this clinical trial is to compare efficacy in advanced glycation end products removal between super high-flux hemodialysis and high-volume post-dilution online hemodiafiltration. the main question it aims to answer are * efficacy : endothelial dysfunction biomarker (ages) in super high-flux hemodialysis compared to online hdf * safety profile : dialysate albumin loss, intradialytic complication participants will be asked to randomized in 2 groups : super high-flux hd or post dilution ol-hdf researchers will compare shf-hd and ol-hdf to see whether shf-hd could remove ages better than ol-hdf


Eligibility criteria:
inclusion criteria: * chronic hd \> 3 months * adequate small molecule uremic toxins removal * kt/v \> 1.8 in hd 2 times/week * kt/v \> 1.2 in hd 3 times/week * bfr \> 300 ml/min * rkf \< 100 ml/day * hemodynamically stable for \> 2 weeks exclusion criteria: * contraindicated to anticoagulant * active malignancy * advanced liver disease

Keywords: hemodiafiltration super high-flux hemodialysis advanced glycation end products
precision dosing of vancomycin in critically ill children

Conditions: Vancomycin

Summary: the overall objective of this project is to investigate the large-scale utility of mipd of vancomycin at point-of-care in icu children. this evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.

vancomycin is an antibiotic with a narrow therapeutic-toxic margin. this means that the minimum and maximum target blood target levels differ little from each other. too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. vancomycin dosing tailored to the critically ill child is challenging. currently, the starting dose of vancomycin is calculated on a milligram per kilogram basis, which is the same for all patients. the dose is then adjusted based on a measured vancomycin blood concentration (if too high or too low). despite this measurement, quickly achieving target concentrations remains a major challenge. this multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in critically ill children, compared to the current standard-of-care. specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney, a reduction in patient burden, and a reduction in time to cure and duration of hospitalization.

Eligibility criteria:
inclusion criteria: * age: 0-18 years * admitted to icu or pho unit * suspected or confirmed gram positive infection * planned to start on intravenous intermittent or continuous infusion vancomycin treatment * informed consent signed by parents or legal representatives * not previously enrolled in this trial exclusion criteria: * extracorporeal treatment at inclusion or started during treatment (extracorporeal membrane oxygenation, dialysis, body cooling) * n or p rifle category failure at inclusion (day 0) (see section 8.1.2. screening) * known chronic kidney disease as defined by the kdigo definition as: structural or functional abnormalities of the kidney regardless of gfr for \< 3 months or gfr \< 60ml/min/1.73m² for ≥ 3 months. egfr is estimated using the modified schwartz equation * patient death is deemed imminent and inevitable

Keywords: vancomycin model-informed precision dosing critically ill children dose calculator
bio-integrative, fiber-reinforced kneebar for treating subchondral insufficiency of the knee

Conditions: Subchondral Insufficiency Fracture

Summary: the ossiofiber® trimmable fixation nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). our hypothesis is that the use of ossiofiber® trimmable fixation nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. the primary objective of this study is to evaluate the effectiveness of implanting bio-integrative ossiofiber® trimmable fixation nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. this use is not considered off-label because we are using the tfns in the way they are intended to be used via fda approval.


Eligibility criteria:
inclusion criteria: 1. has had knee pain in study knee lasting at least 3 months 2. candidate for knee arthroscopy due to meniscal tear, loose body, unstable articular cartilage or mechanical symptoms. exclusion criteria: 1. current tobacco use or has quit within 3 months of study enrolment. 2. substance abuse history. 3. diabetes mellitus, hba1c\>8 4. high surgical risk due to pre-existing conditions. 5. currently pregnant or has plans to become pregnant prior to surgery. 6. active infection or history of chronic infection in study knee. 7. will require concomitant procedures within study knee, including but not limited to ligament reconstruction, tendon repair, meniscus repair, microfracture, osteotomy, or osteochondral transplantation. (meniscal tears, including chronic, are acceptable if no repair is required)

Keywords: ossio kneebar fracture subchondral insufficiency tibial overload femoral overload
real-world study evaluating the efficacy and safety of azvudine in nursing home patients

Conditions: COVID-19

Summary: this study was a multicenter, non-intervention, real world study. to evaluate the efficacy and safety of azvudine in nursing homes with mild/common covid-19 patients. the primary outcome measure was the proportion of patients with severe/critical illness within 28 days.


Eligibility criteria:
inclusion criteria: 1. living in a nursing home who has taken or intends to take azvudine tablets depending on their condition; 2. mild/normal subjects who are sars-cov-2 rt-rcr positive or antigen-positive; 3. subjects have at least one or more of the following clinical symptoms of covid-19 in the 24 hours prior to initial administration, including but not limited to: fever, cough, sore throat, stuffy or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or difficulty breathing, chills or chills; 4. volunteer to participate in the experiment and sign the informed consent in person or complete the informed consent over the phone. exclusion criteria: 1. subjects have received antiviral therapy, such as paxlovid and sars-cov-2 monoclonal antibody therapy (except previous treatment for covid-19 infection) before entering the study; 2. shortness of breath, rr≥30 times/min or resting state, oxygen saturation of finger when sucking air ≤93%; 3. mechanical ventilation is required or expected to be urgently required; 4. severe infections requiring systemic treatment within 14 days prior to initial medication; 5. use of other antiviral drugs (such as anti-hiv, hepatitis b, and hepatitis c drugs) within 14 days prior to the first medication.
an observational, multicenter study evaluating the safety of real-lifepertuzumab and trastuzumab fixed dose combination: the rapid study

Conditions: Breast Cancer

Summary: this is a single arm prospective, observational multi-centre study in patients with her-2 positive breast cancer who have completed concurrent chemotherapy with pertuzumab and trastuzumab administered iv and are currently receiving or will be receiving maintenance therapy with ph fdc sc and have at least 6 cycles of therapy expected with ph fdc sc to conclude pre-established oncological treatment. treatment of the patients will not be determined or assigned by study procedures but will be based on normal clinical practice. only data available per clinical practice will be collected within this study. the treatment decision must have been taken prior to and irrespective of patient's inclusion in the study.

primary objective • the primary objective of the study is to evaluate the safety of pertuzumab and trastuzumab (ph) fixed-dose combination (fdc) for subcutaneous (sc) administration in patients with her-2 positive breast cancer who have completed concurrent chemotherapy with pertuzumab and trastuzumab administered intravenously (iv) and are currently receiving or will be receiving maintenance therapy with ph fdc sc. secondary objectives the secondary exploratory objectives of the study are: * to assess the patient's social cost saving by means of a specific questionnaire; * to assess the patient's health related quality of life (hrqol).

Eligibility criteria:
inclusion criteria: * written informed consent of the patient; * female and male patients aged ≥ 18 years (no upper limit); * patients with her-2 positive breast cancer, who have completed concurrent chemotherapy with pertuzumab and trastuzumab iv and are currently receiving or will be receiving maintenance therapy with ph fdc sc according to locally approved indication; * patients with expected at least 6 cycles of therapy with ph fdc sc to conclude pre-established oncological treatment; exclusion criteria: * life expectancy \< 6 months; * presence of any contraindication with regard to treatment with ph fdc sc as specified in the corresponding summary of product characteristics (smpcs) approved in italy; * concomitant participation in another interventional or non-interventional trial. * patients with less than 6 remaining cycles of therapy with ph fdc sc to conclude pre-established oncological treatment
efficacy and safety of levemir® used as basal insulin

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this study is to evaluate efficacy and safety of insulin detemir (levemir®) used as basal insulin on the glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes treated with insulin nph under normal clinical practice conditions in slovakia.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes treated with insulin nph
study to assess perfusion and patient satisfaction in nipple-areola mastectomy with immediate reconstruction

Conditions: Ductal Carcinoma in Situ - Category; Breast Cancer; Prophylactic Mastectomy

Summary: the investigators hypothesize that nipple-areola skin sparing mastectomy (nassm) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. the addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the spy elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. these quantifiable, objective measures will justify the use of nassm and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.


Eligibility criteria:
inclusion criteria: * patient must be scheduled to undergo either a single or bilateral elective nipple-areola skin sparing mastectomy (nassm) procedure with planned immediate reconstruction. * patient must be 18 years of age or older. * karnofsky performance scale of at least 80%. * patient must be able to understand and willing to sign a written informed consent document. exclusion criteria: * cognitive impairment. * bmi \ 35 * breast \>800 grams or \ 100 g and \<800 g. * history of radiation to the chest wall or breast being studied * patients who have a history of allergy to iodides or iodinated contrast agents * surgeon's opinion at the time of surgery that the subject's well-being would be compromised (e.g. significant comorbidities, intraoperative findings of a higher stage cancer or other independent acute health problems). if the contralateral breast is undergoing a nipple-sparing mastectomy with reconstruction as well, then the contralateral breast can be studied so long as there is no compromise to any element of their care.

Keywords: nipple-areola skin sparing mastectomy immediate reconstruction prophylactic mastectomy breast-q breast cancer ductal carcinoma in situ - category
relationship between cognitive function and pain

Conditions: Cognitive Ability, General

Summary: patients with chronic pain can experience considerable changes in their cognitive function such as forgetfulness, increased absentmindedness, confusion etc. opioids (e.g. morphine and morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead to worsening of the cognitive function. the interaction between pain, treatment and cognitive function is very complex and is far from understood. the hypothesis of the present study is that by use of experimental pain in healthy volunteers it will be possible to elucidate the interaction between pain, treatment and cognitive function.


Eligibility criteria:
inclusion criteria: * healthy men aged 18-65 years * normal vision and hearing * no disease associated with cognitive dysfunction exclusion criteria: * allergic to remifentanil or patches * any use of pain killers or alcohol 48hours before study start * current participation in other clinical studies or participation within the last 14days before study start * prescribed medication * risk of developing * previously alcohol- or drug addict * mmse score \< 26

Keywords: cognitive function experimental pain
naf positron emission tomography/computed tomography (pet/ct)imaging to assess treatment responsiveness to tak-700 in patients with castrate resistant prostate cancer (crpc) with bone metastasis

Conditions: Prostatic Neoplasms; Prostate Cancer

Summary: the purpose of this study is to assess whether naf pet/ct scans can be used to evaluate treatment response in bone metastases in subjects with prostate cancer treated with the investigational drug, tak-700.


Eligibility criteria:
inclusion criteria: * male patients 18 years or older * voluntary written consent * histologically proven adenocarcinoma of the prostate * evidence of radiographic bone metastases * may have received prior chemotherapy for metastatic disease, but prior chemotherapy is not a requirement for eligibility * eastern cooperative oncology group performance status 0-2 * serum testosterone level is less than or equal to 50 ng/dl * has undergone orchiectomy or plan to continue receiving gonadotropin releasing hormone (gnrh) analogue therapy * adequate organ function as measured by screening laboratory values specified in the protocol * must agree to use appropriate contraceptives prior to study procedures, during duration of study participation and for 4 months after last dose of tak 700 * must be able to lie flat for greater than or equal to 30 minutes during pet/ct imaging * screening calculated ejection fraction of greater than or equal to 50% by multigated radionuclide angiography (muga) scan or echocardiogram exclusion criteria: * received strontium-89, samarium-153, or other radioisotope within 3 months of registration * history of allergic reactions attributed to compounds similar to sodium fluoride f-18 (naf) * history of seizure disorder * known history of brain metastases * concurrent treatment with any herbal products within 7 days of study entry * received radiotherapy less than or equal to 4 weeks prior to registration * known hypersensitivity to tak-700 or related compounds * prior therapy for treatment of metastatic castrate resistant prostate cancer with any androgen biosynthesis inhibitor or androgen signaling pathway inhibitor such as: enzalutamide (mdv-3100), abiraterone, ketoconazole, or aminoglutethimide * current bladder neck outlet obstruction * current spinal cord compression * current bilateral hydronephrosis * history of adrenal insufficiency * history of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias (over grade 2), thromboembolic events, or any other cardiac condition within 6 months prior to first dose of study drug. * uncontrolled high blood pressure * known history of human immunodeficiency virus (hiv) infection, hepatitis b, or hepatitis c * major surgery less than or equal to 4 weeks before the first dose of study drug * serious infection less than or equal to 2 weeks before the first dose of study drug * known gastrointestinal (gi) disease or gi procedure that could interfere with oral absorption or tolerance of tak-700, including difficulty swallowing capsules

Keywords: prostate, prostate cancer
ketofol versus fenofol as procedural sedation for carpal tunnel release

Conditions: Procedural Sedation

Summary: there are different methods of anesthesia for ctr surgery. procedural sedation will allow rapid recovery and fewer complications than regional or general anesthesia (ga). attempts have been made in the past to use additives with propofol to reduce its dose. ketofol (ketamine/propofol combination) was used for procedural sedation and analgesia. ketamine and propofol administered in combination have offered effective sedation for spinal anesthesia and for gynecologic, ophthalmologic, and cardiovascular procedures in all age groups. the opposing hemodynamic and respiratory effects of each drug may enhance the utility of this drug combination, increasing both safety and efficacy and allowing reduction in the dose of propofol required to achieve sedation. propofol alone had a significantly greater number of apnea with desaturation (spo2 \< 90%) episodes. further, it has been shown that during colonoscopies, propofol in combination with fentanyl provided similar patient satisfaction with shorter recovery times even at lower depths of sedation as compared to propofol. the addition of fentanyl to propofol has been shown to result in better operator feasibility with no difference in recovery time, cognitive impairment, or complications as compared to the use of propofol only for sedation.

sample size: assuming that the sedation using modified ramasy sedation score was 6±0.01 in ketofol group versus 5.38±0.87 in fenofol group so the sample will be 56 patients, 28 patients in each group using openepi at power 80 and ci 95 a computer-generated randomization table divided patients into 2 equal groups. * group (k) (n=28): patients will receive iv ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified ramasy sedation score of ≤ 4. * group (f) (n=28): patients will receive iv fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified ramasy sedation score of ≤ 4. the depth of sedation will be assessed by modified ramsay sedation

Eligibility criteria:
inclusion criteria: * age: 21-55 years old. * sex: both sex (males or females). * physical status: asa i \& ii. * bmi: 25-30 kg/m2. * type of operation: elective unilateral ctr under local anesthesia. * written informed consent from the patient. * cooperative patient. exclusion criteria: * patient refusal. * altered mental status. * patients with known history of allergy to study drugs. * severe hepatic, renal, cardiovascular and respiratory diseases. * patients on regular sedative or pain killer medications.