Kornimate/medical-research-clean huggingface dataset:
the effects of three different nonpharmacological methods used during vascular access in children on pain and anxiety

Conditions: Pain; Anxiety; Nurse's Role

Summary: the research was conducted to evaluate the effects of three different non-pharmacological methods (playing a music video, buzzy application, listening to a music video + buzzy application) on the pain and anxiety levels of children in the 4-12 age group during vascular access. h0.1. playing music (music video) during the vascular access procedure has no effect on children's pain and anxiety levels. h0.2. applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels. h0.3. listening to a music video + applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.

design: it is a randomized controlled experimental study. methods: this study was conducted between february and december 2023 with 126 children between the ages of 4 and 12 who were hospitalized in the pediatric ward of a public hospital in a province in eastern turkey and had vascular access. the sample consisted of four groups: a music video listening group (n=31), a buzzy group (n=32), a music video listening + buzzy group (n=31), and a control group (n= 32). children were selected into groups by simple randomization method. data were collected 60 seconds before starting the vascular access procedure and as soon as the procedure was completed. introductory information form, child fear and anxiety scale and wong-baker facial expression rating scale were used to collect data. the data was analyzed on spss (version 25, chicago, il, usa). the gaussian curve and shapiro-wilk test were used to assess whether or not the data were normally distributed. descriptive statistical tests (arithmetic mean, standard deviation, number, and percentage) were also conducted. the conformity of the measurement values to normal distribution was tested with "shapirow-wilk" analysis. pearson chi-square test was applied to the dependency relationship of frequency measurement values. one-factor anova test was used to compare whether there was a statistically significant difference between the means of independent groups. kruskal wallis h-test was used to compare groups that did not show normal distribution. mann whitney u test was used in further analysis to determine the difference between two independent groups. wilcoxon test was used to test the significance of the difference between the scores of two related measurements. p values \<0.05 were considered statistically significant.

Eligibility criteria:
inclusion criteria: * being between the ages of 4-12 * being willing to participate in the study, * being accompanied by their parents (mother or father). exclusion criteria: * failure to establish vascular access on the first try

Keywords: pain anxiety nurse's role child
efficacy and safety of topical clascoterone (winlevi) cream 1% in patients with facial acneiform rosacea

Conditions: Papular-pustular Rosacea; Papulopustular Rosacea (PPR); Papulopustular Rosacea

Summary: to demonstrate the efficacy of clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.


Eligibility criteria:
inclusion criteria: * men and women ages 18+. * diagnosis of rosacea type 2 (papulopustular). * available and willing to comply with study instructions and attend all study visits. * able and willing to provide written and verbal informed consent. * subject has used the same type and brand of make-up, other facial products, and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the baseline visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study. exclusion criteria: * subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy. * subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. * pregnant, lactating, or is planning to become pregnant during the study. * subject is currently enrolled in an investigational drug or device study. * subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline). * study participant has facial hair that could interfere with the study assessments in the opinion of the investigator. * study participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. * subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles. * subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.

Keywords: rosacea papulopustular rosacea acneiform rosacea ppr
the effect of liberal vs. restrictive transfusion strategies on rehabilitation after hip fracture surgery

Conditions: Hip Fracture

Summary: to examine the effect of two different transfusion regimens on rehabilitation after hip fracture surgery.

the effect of liberal vs restrictive transfusion regimens after hip fracture surgery is unresolved. liberal transfusion regimens (transfusion trigger hgb. 6.25 mmol/l) leads to an increased use of blood products but may impact positively on rehabilitation outcome, a restrictive transfusion trigger (hbg. 5.0 mmol/l) saves blood products but may also impair postoperative rehabilitation and outcome. the study randomizes 120 elderly patients with hip fractures to either a restrictive or a liberal perioperative transfusion therapy and measures postoperative rehabilitation outcomes within a well defined multimodal rehabilitation regimen.

Eligibility criteria:
inclusion criteria: * primary hip fracture * capable of informed consent * independently dwelling * able to ambulate independent of human assistance * no active heart condition defined as no ami within 3 months, no unstable angina or present incompensation/pulmonary oedema * no regular transfusion demand or terminal disease. exclusion criteria: * multiple fractures * postop. immobilization due to to surgical reasons * patient refusal to participate in relevant rehabilitation * reoperation within 4. postoperative day.

Keywords: hip fracture rehabilitation transfusion outcome
implanted drop foot stimulator for hemiparetic patients

Conditions: Gait, Hemiplegic

Summary: the aim of this study is to investigate the effects of the implantable drop foot stimulator "actigait" (ottobock health care, duderstadt, germany) on gait in hemiparetic patients. while several studies investigated the effects of implanted systems on walking speed and gait endurance, only a few studies have focused on the system's impact on kinematics and long-term outcomes. therefore, our aim was to further investigate the effects of the implanted system actigait on gait kinematics and spatiotemporal parameters with a 1-year follow-up period.

patients with a neurologic condition leading to drop foot during swing phase in gait are treated by the implentation of the acitgait system (which has a ce-certificate in europe). the aim of this study is to investigate the effect of the device on gait with a follow-up period of one year. patients are assessed before implantation and at one-year follow up. at baseline, they are asked to walk without any assistive device, as well as with surface electrical stimulation of the peroneal nerve. at follow-up, they are asked to walk with the actigait system switched off and switched on. outcome assessments include a 10m-walking test and gait analysis with a vicon 3d-camera system. this allows to extract spatio-temporal parameters (as steps per minute, step length,...) as well as kinematic data (e.g. joint ankles during the gait cycle). all outcome data is analyzed using statistical tests.

Eligibility criteria:
inclusion criteria: * drop foot after stroke, brain haemorrhage or multiple sclerosis * a minimum of six months after the acute infarction/onset of the disease * passive extension of the ankle to at least at neutral position * no sufficient active ankle extension * free walking without any aid for at least 20 meters in less than 2 minutes * a walking speed of ≤ 1,2m/sec (measured with 10 meter walking test) * use of surface electrical stimulation for at least three months * be able to stand freely exclusion criteria: * damage to the peripheral nervous system * epilepsy * adiposity * substance abuse * no cognitive ability to follow the study instructions * pregnancy * use of other implanted devices * instable ankle joint or fixed contracture

Keywords: hemiplegic gait peroneal nerve stimulation gait analysis
remote patient management for cardiac implantable electronic devices

Conditions: Arrhythmia, Cardiac

Summary: this is a pilot study to assess barriers, evaluate and implement a patient oriented cied management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote cied monitoring and programming. the advancement in technology is very important as it addresses several potential gaps and barriers in the care of patients with cieds: 1. long, expensive travel for patients 2. morbidity to patients due to delay in receiving appropriate treatment 3. efficiency in health care delivery 4. patient satisfaction

canada is a country with a diverse geography, of which 19% of the inhabitants are in communities classified as 'rural', but many may still have long distances to travel to reach a health care facility. this results in challenges in uniform delivery of health care throughout the country. there are 25,000 pacemaker (pm) implants and 7000 implantable defibrillator (icd) implants yearly in canada, with approximately 120 000 patients living with these devices. the recommended follow-up for these devices are based on consensus and position statements, with the majority of patients requiring at least yearly visits to a specialized device clinic during the lifetime of their device. during the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated. while remote monitoring technology is currently available and has permitted surveillance and device assessment from any patient location accessible to a landline or mobile phone, the use has been inconsistent in canada. in addition, new technology has become available that not only permits surveillance, but also remote programming of these devices. the incorporation of remote programming capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team and no longer require travel to the specialized 'hub' clinics for follow-up.

Eligibility criteria:
inclusion criteria: 1. patients with an implanted pacemaker/cardiac resynchronization therapy with a pacemaker(crt-p) capable of remote patient management would be eligible for the study that will be followed by the site where the implantation occurred or patients with an implanted defibrillator/crt-d capable of remote patient management where the patients reside in a community outside of the site where the implantation occurred. the device may be de novo, existing or a patient undergoing a pulse generator change that now has remote patient management capabilities. 2. able to provide consent.

Keywords: cardiac implantable electronic devices
study to evaluate the immunogenicity and safety of an investigational influenza vaccine (h1n1) in children

Conditions: Influenza

Summary: the objective of this study is to evaluate the immunogenicity and safety of gsk biologicals' investigational vaccine gsk2340272a in children aged between 3 and 17 years.

this protocol posting has been updated following protocol amendment 1, october 2009. the impacted section are the study design section, the outcomes measures section and the intervention section.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) (lar) can and will comply with the requirements of the protocol. * children, male or female, aged between 3 and 17 years at the time of the first study vaccination. * written informed consent obtained from the subject parent(s) or lar(s) of the subject. assent obtained from the subject when applicable. * healthy children as established by medical history and clinical examination when entering into the study. * parent/lar with access to a consistent means of telephone contact, land line or mobile, but not a pay phone or other multiple-user device. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. * clinically or virologically confirmed influenza infection within six months preceding the study start. * planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. * acute disease and/or fever at the time of enrolment * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * previous administration of any h1n1 a/california-like vaccine. * administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * if the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series. * any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine. * known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination. * child in care.

Keywords: gsk bio's influenza vaccine gsk2340272a influenza infection
combined treatment of cetuximab and paclitaxel in basal like breast carcinoma

Conditions: Breast Neoplasms

Summary: basal like breast carcinoma is a her2, estrogen receptor (er) progesterone receptor (pr) negative breast cancer. it is notable for the high level of epidermal growth factor receptor (egfr) expression in this tumor subtype . thus the investigators wanted to combine the use of anti egfr therapy in the form of erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of these women. this is a small phase i/ii study.

basal like breast carcinoma is a her2, er pr negative breast cancer. it is notable for the high percentage of egfr expression in this tumor subtype.weekly taxol (paclitaxel) is widely used in breast cancer patients with metastatic disease. erbitux (cetuximab) is a monoclonal antibody that shown its ability to enhance activity of chemotherapy in colon carcinoma. thus we wanted to combine the use of anti egfr therapy in the form of erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of women with basal like breast carcinoma. this is a small phase ii study that will hopefully provide initial data as to the general tolerability and response rate of this combination in this disease. furthermore, pathologic analysis will be used to try and assess relation of response with the presence of immunohistochemical markers such as egfr expression.

Eligibility criteria:
inclusion criteria: * patients with metastatic breast carcinoma of the basal like subtype with available biopsy for analysis and ecog ps of 2 or less exclusion criteria: * pregnancy * bun, blood creatinine, ast, alt \> x3 of upper limits of normal * more than previous 2 chemotherapy lines in the metastatic settings or the use of previous inhibitors of egfr

Keywords: breast basal like carcinoma metastatic egfr
safety and efficacy of hormone therapy with letrozole in postmenopausal women with breast cancer

Conditions: Breast Cancer

Summary: the aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to permit breast conserving surgery.


Eligibility criteria:
inclusion criteria: 1. postmenopausal women able to comply with the protocol requirements with confirmed primary invasive breast cancer whose tumours are estrogen-and/or progesterone-receptor positive 2. clinical stage t2 or \>t2 tumours which in the investigators' opinion would not be eligible for breast-conserving surgery. the nodal status will be evaluated by palpation and/or ultrasound. 3. postmenopausal status defined by one of the following: * women with an intact uterus and * ≥ 55 years of age, or * \< 55 years of age without menses for the last 5 years, or * \< 55 years of age and have not had menses for at least the last 12 months (but have had menses in the last 5 years) and have postmenopausal levels of follicle-stimulating hormone. * women without an intact uterus and * ≥ 55 years of age, or * \< 55 years of age and postmenopausal levels of follicle-stimulating hormone * both ovaries removed (prior to the diagnosis of breast cancer). 4. tumour measurable by clinical examination, mammography and ultrasound 5. adequate bone marrow function as shown by: * wbc ≥ 3.5 x 10\^9/l * anc ≥ 1.5 x 10\^9/l * platelets ≥ lln * hb \> 10 g/dl exclusion criteria: 1. multifocal disease (cancer that starts in several different sites) 2. patients with bilateral breast tumours. 3. patients who are eligible for breast conserving surgery. 4. evidence of inflammatory breast cancer or distant metastasis. 5. simultaneous anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers, endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. note: bisphosphonate therapy for osteoporosis is not excluded, and can be continued. patients who have received hormone replacement therapy will not be excluded if it is discontinued at least 2 weeks before starting the study. the following additional treatments are not allowed during the treatment phase of the study: * any other anti-cancer therapy * hormone replacement therapy. * estrogen cream (including any intra-vaginal preparation). * steroids other than creams or inhalers. * megestrol acetate for the treatment of hot flushes. * radiation therapy. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: letrozole breast conserving surgery neoadjuvant early breast cancer
aripiprazole in the treatment of bipolar depression

Conditions: Bipolar Disorder

Summary: a systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.

study is 6 weeks long with 7 clinical visits.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of bipolar disorder, any subtype; madrs \>16; mrs \< 10; not currently taking other mood stabilizers; women of reproductive potential must use an acceptable method of birth control exclusion criteria: * current substance abuse within past month; serious unstable medical condition; active suicidal ideation; pregnant, trying to become pregnant, or nursing; intent to continue or initiate herbal preparations
diffusion -and perfusion weighted mri for response prediction of symptomatic leiomyomas following uterine artery embolization

Conditions: Leiomyomas

Summary: it is known that volumetric response of leiomyomas following uterine artery embolization correlates well with patients clinical outcome. the aim of this study is to assess diffusion -and perfusion weighted mri for the prediction of volumetric response following uterine artery embolization in patients with symptomatic leiomyomas.


Eligibility criteria:
inclusion criteria: * women with symptomatic leiomyomas exclusion criteria: * women with known contra-indications for mri (cardiac pacemaker, cochlear implants, claustrophobic patients) * women with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; gfr \< 30 ml/min)

Keywords: leiomyoma diffusion weighted mri perfusion mri uterine artery embolization volumetric response women with symptomatic leiomyomas
study on the patient-ventilator asynchrony analysis function

Conditions: To Study the Incidence of Patient-ventilator Asynchronization in Two Groups of Patients Under Two Conditions With PVA Unsynchronization Analysis Function

Summary: in this study, the incidence of patient-ventilator asynchronism in two groups of patients was studied when the ventilator was prompted by the pva asynchronism analysis function

incidence of patient-computer dyssynchrony events: defined as the proportion of patient-computer dyssynchrony events in the total number of cycles during the patient trial. the observation period began 48 hours after the participants met the inclusion and exclusion criteria and signed the informed consent, and the data collection was stopped 48 hours later.

Eligibility criteria:
inclusion criteria: 1. adults (≥18 years) requiring invasive mechanical ventilation 2. patiens had spontaneous breathing; 3. agreed to participate in the trial and signed an informed consent exclusion criteria: 1. patients with contraindications to esophageal catheter insertion and inability to monitor esophageal pressure; 2. pregnant women; 3. patients with severe central nervous system damage or neuromuscular related diseases; 4. participating in other clinical research projects; 5. patients deemed unsuitable by the investigator