Kornimate/medical-research-clean huggingface dataset:
effects of virtual reality, cold-vibration due to intravenous catheterization on pain, fear and anxiety on children

Conditions: Procedural Anxiety; Fear; Procedural Pain; Child, Only

Summary: this is a randomized controlled trial. the aim of the study is to the effects of virtual reality and local cold-vibration applications in reducing anxiety, fear and pain due to intravenous catheterization (pic) in children aged 5-10 years. pic was found to be effective in reducing anxiety, fear and pain due to peripheral intravenous catheterization.

peripheral intravenous catheterization is an administration method that is frequently used in children and causes pain. there are different non-pharmacological methods for reducing pain due to invasive procedures. the use of non-pharmacological methods is an important part of nursing care to reduce the short and long-term negative effects of painful interventions on children.this study was planned to compare the effectiveness of virtual reality and local cold-vibration applications in reducing anxiety, fear and pain caused by pic in children aged 5-10 years. it was planned as a randomized controlled experimental study in pre-test, post-test design. the sample of the study was carried out in the pediatric emergency unit of akdeniz university medical faculty hospital. the applicant will consist of 120 children aged 5-10 years. there will be a total of three groups in the research, 2 of which are the intervention group (virtual reality, local cold-vibration) and the control group (routine application). data will be collected using the "child-parent description form", "child anxiety scale-state scale", "child fear scale", "wong- baker faces pain scale". data will be collected before and within the first 5 minutes after im injection administration. scales; to be filled in separately by the child, one of the parents, and the nurse administering the pic. as a result of this study, it was concluded that the use of virtual reality glasses and local cold-vibration methods are effective in reducing the pain, anxiety and fear that due to pic placement in children aged 5-10 years.

Eligibility criteria:
inclusion criteria: the child; * between the ages of 5-10 * pic application will be made * no visual, auditory or sensory loss * mental and language deficiencies * those who have not taken any analgesic medication in the last 4 hours * do not have a chronic disease (such as oncological diseases, chronic kidney failure) that causes repeated admissions or hospitalizations to the hospital. exclusion criteria: * unsuccessful pic application in the first time * the child in the group with local cold-vibration application removes the device during the procedure (pic application). * the child in the group in which virtual reality was applied, removing the virtual reality glasses during the procedure (pic application). * suspecting 'covid 19' (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat)

Keywords: procedural anxiety fear procedural pain peripheral intravenous catheter virtual reality local-cold vibration distraction method nonpharmacological method
carbohydrate quality and its impact on sleep and depression in type 2 diabetes

Conditions: Type 2 DM

Summary: the aim of this study was to evaluate the effect of carbohydrate quality on sleep quality and depression in patients with type 2 diabetes. data were collected from 150 patients with type 2 diabetes mellitus using a demographic structure questionnaire, the sleep quality scale (sqs), the depression, anxiety, and stress scale (dass), and a food consumption frequency form. the data were analyzed using spss 26.

objective: the aim of this study was to evaluate the effect of carbohydrate quality on sleep quality and depression in patients with type 2 diabetes. method: a total of 150 individuals with type 2 diabetes were included in the study. a demographic questionnaire, the sleep quality scale (sqs) (where a higher sqs score indicates lower sleep quality), and the depression anxiety and stress scale were administered to the participants. additionally, data on the frequency of food consumption for 132 foods were obtained from the participants. to determine the carbohydrate quality index (cqi) score, each of these four components (fiber intake, whole grain ratio, glycemic index, and total carbohydrate ratio) was evaluated on a scale of 1 to 5 points. the score for each component was then calculated, with q5 indicating the best and q1 indicating the worst carbohydrate quality. the data were analyzed using spss 24 software. detailed description: this study will evaluate carbohydrate quality index ranges (q1-q5), sleep quality scale score, depression, stress, anxiety score, body mass index, diabetic age, sleep duration, body weight, daily macro and micro nutrients. conclusion: results will be analyzed and interpreted after data collection is completed, and conclusions will be drawn accordingly.

Eligibility criteria:
inclusion criteria: * patients aged 19 to 64 years * diagnosed with type 2 diabetes mellitus * voluntary participation exclusion criteria: * patients with cancer * pregnant and lactating women * individuals with alcohol or drug addiction * individuals diagnosed with psychiatric or neurological disorders

Keywords: carbohydrate quality type 2 diabetes mellitus sleep quality depression stress
cervical alignment changes after correction of thoracic adolescent idiopathic scoliosis with thoracic hypokyphosis

Conditions: AIS; Cervical Alignment; Thoracic Kyphosis

Summary: the sagittal alignment of adolescent idiopathic scoliosis (ais) curves has attracted growing interest in recent years, to the extent that it has become a pivotal point in the lenke classification, with the introduction of a sagittal modifier. in particular, thoracic curves, partly due to the theory of anterior overgrowth, are almost invariably characterized by thoracic hypokyphosis, which can be severe (t5-t12 thoracic kyphosis \< 10°, that corresponds to a lenke - sagittal modifier). however, the development of such a severely abnormal sagittal alignment has consequences that are not limited only to the thoracic region, but it rather results in a disruption of the entire sagittal spinal alignment. in fact, thoracic hypokyphosis tends to shift the c7sva backward and to decrease the t1 slope. as a compensation, this ultimately leads to the development of a cervical kyphosis in order to translate the head forward and maintain global sagittal balance. while the interplay relationship between thoracic hypokyphosis and the development of cervical kyphosis has been well established in modern literature, the results regarding the amount of spontaneous correction of cervical kyphosis achieved after hypokyphotic ais correction are conflicting. there are several papers in literature that study the complex relationship between ais and cervical kyphosis, and they did not report any improvement in cervical lordosis after ais correction, even when successful restoration of thoracic kyphosis (tk) was achieved. conversely, other authors did report an improvement in cervical sagittal alignment after ais correction. the aim of the present paper is firstly to assess the amount of spontaneous change in cervical sagittal alignment after correction of ais with associated severe thoracic hypokyphosis (\<10°). secondly, the aim of the study is to seek for any radiographical parameter able to predict the postoperative cervical sagittal alignment in these patients, via a multivariate regression analysis.


Eligibility criteria:
inclusion criteria: * ais patients with a major thoracic curve (lenke 1, 2 , 3 patterns), with associated severe thoracic hypokyphosis (tk \< 10°; lenke - modifier) who underwent surgical correction at the participating centers was performed. exclusion criteria: * non-idiopathic scoliosis, infantile, juvenile, or adult idiopathic scoliosis diagnosis were considered exclusion criteria
osseodensification drills versus piezoelectric surgery

Conditions: Edentulous; Alveolar Process, Atrophy

Summary: implant stability is the first requirement for implant success. the aim is to assess whether different implant site preparation technique may impact the value of the primary stability.

impianti stability represents one of the most fundamental issue for implant success. different techniques of implant site preparation are available such as twist drill, osteotome, piezosurgery and lastly, osseodensification. due to their different approach an biological rationale, piezosurgery and osseodensification might show diverse impact on implant first and secondary stability, therefore the aim of the present study was the assessment of primary and secondary stability changes of values between implant sites prepared with piezoelectric bone surgery and with specific osseodensification drills. patients with bilateral single maxillary edentulism will randomly receive implant site preparation with piezoelectric approach or with osseodensification drills. standardized implants will be therefore inserted and primary stability will be assessed at the time of implant insertion and during the subsequent timepoints.

Eligibility criteria:
inclusion criteria: * bilateral single maxillary edentulism exclusion criteria: * smoking habit * history of periodontal disease * uncontrolled diabetes * pregnancy or breastfeeding * head and neck radiotherapy or chemotherapy * bone antiresorptive therapy * coagulopaties
safety, tolerability, pk, pd, immunogenicity and efficacy of twp-102 in patients with advanced malignancies.

Conditions: Advanced Malignancies

Summary: this is a multi-center, phase i, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of twp-102 injection in patients with advanced malignancies. this study consists of two parts, including a dose escalation study and a dose expansion study. the criteria for dose escalation will be based on the bayesian optimal interval (boin) design with sequentially enrolled cohorts.


Eligibility criteria:
inclusion criteria: * pathologically confirmed advanced malignancies that failed, or not suitable for standard treatments; * at least 1 measurable lesion. * ecog score 0 or 1; * life expectancy of ≥ 3 months; exclusion criteria: * known hypersensitivity to any ingredient of twp-102; * receiving any anti-cancer drugs within 4 weeks; * history of serious systemic diseases; * history of serious autoimmune diseases; * persistent toxicity of national cancer institute (nci) common terminology criteria for adverse events (ctcae) version 5.0 grade \> 1 severity that is related to prior anti-cancer therapy. (except alopecia) * pregnancy or lactating women.
study of the functioning of prospective memory in breast cancer and the influence of sleep

Conditions: Breast Cancer; Memory Disorders

Summary: the results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. in the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.


Eligibility criteria:
inclusion criteria: * major patients under the age of 70; * patients who have been treated by surgery or radiotherapy for non-metastatic breast cancer * radiotherapy completed for about 6 months * level of study 3 "end of primary studies" minimum (barbizet scale); * french mother tongue; * menopausal women for at least 1 year before the selection visit * absence of primary cancer of the central nervous system or brain metastases; * absence of previous neurological damage; * absence of personality disorders and progressive psychiatric pathology; * having signed the informed consent to participate in the study. exclusion criteria: * primary cancer other than breast * metastatic cancer * treated by chemotherapy * cognitive function disorders pre-existing to cancer diagnosis * patients with paraneoplastic syndrome; * evolutionary psychiatric pathology; * refusal of participation; * patients unable to respond to cognitive tests; * drug use or excessive consumption of alcohol.
dino egg in neonatal intensive care unit

Conditions: Premature Birth

Summary: dino egg mother's voice exposure and multisensory processing in neonatal intensive care unit infants. this is a 2 phase prospective comparative effectiveness trial of our parents' voice intervention with 290 hospitalized preterm infants. as a part of a previous project, an early technology development award from the nationwide children's hospital (nch) technology office allowed us to develop 10 functioning prototypes of the dino egg speakers, a nicu-safe and developmentally appropriate music player that delivers parent's voice to the bedside of nicu infants. the device passed nch nicu-safe products committee and has been used in the clinical setting delivering clinical music therapy services (available at bedside to play parents' voice). the first phase of the current study is to test an updated prototype version of the device that replicates a previously fda (and nch nicu-safe products) proved device called pacifier activated lullaby (pal), used and described in irb15-01035, but being discontinued by the company. the discontinuation is not due to safety or health benefits concerns. therefore, no device available on the market currently exists to accomplish nicu parents' voice delivery in a consistent and safe manner, the investigators modified a 510k-approved feeding device that is no longer available and whose intellectual property rights have expired. the device's air displacement sensor, which fits into a standard nicu pacifier, allowed the investigators to deliver processed and developmentally appropriate recordings of parent's voice, contingent upon the infant producing effort to receive it. intellectual property rights were filed for the modifications and use process through the technology transfer and legal office at nch. therefore, phase i will test the usability of the device (safety for the nicu was confirmed), not the effectiveness of the parents' voice delivery for the infant. parent and nursing questionnaires about the importance of the device availability and its usability will be collected from parents and registered nurse (rn) staff that choose to provide the feedback.


Eligibility criteria:
inclusion criteria: * inclusion criteria will be post menstrual age (pma) 32 0/7-34 6/7. exclusion criteria: * ventilation using an endotracheal tube * major congenital malformations * family history of genetic hearing loss * use of sedatives or seizure medications * presence of severe neural injury on neuroimaging (intraventricular hemorrhage grade ii or iv, periventricular leukomalacia, cerebellar hemorrhage, ischemic or thrombotic injury) * presence of systemic inflammatory conditions (history of necrotizing enterocolitis bell's stage iia or above or culture-documented sepsis or meningitis).

Keywords: music therapy nicu infants multisensory processing
ph-797804 versus placebo for the treatment of neuropathic pain associated with post-herpetic neuralgia

Conditions: Neuralgia, Postherpetic

Summary: this is a proof-of-concept study to determine if ph-797804 reduces neuropathic pain associated with post-herpetic neuralgia. suitable patients will be randomized to receive either ph-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales.


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age * patients must have pain present for more than 3 months after healing of the herpes zoster skin rash. there is no upper limit on the duration of phn. * patients at screening visit (v1) must have a score ≥40 mm on the pain visual analog score (vas). exclusion criteria: * patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia * history within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, new york heart association (nyha) class iii-iv congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (cabg) or cerebrovascular accident (including transient ischemic attacks). * tuberculosis without treatment and/or positive tuberculin reaction to ppd (purified protein derivative) without known (documented) vaccination with the bacilli calmette-guerin vaccine (bcg). * a positive approved immunoassay/elisa blood test for tb (e.g. tb t-spot™, quantiferon-gold * any clinically significant skin lesions as described in common terminology criteria for adverse events for dermatology (ctcae) version 3.0 * ecg abnormalities at screening or randomization * evidence of organ dysfunction or hematopoietic disorder
spy angiography to assist with ulnar nerve transposition at the elbow

Conditions: Cubital Tunnel Syndrome

Summary: patients with vascular disease, thyroid disease or an allergy to indocyanine green (icg) will be excluded. patients with either median or ulnar nerve compression will be treated with nerve decompression. spy angiography will be used to assess the vascularity of the nerve both pre and post release as the primary outcome measure.

the purpose of this study is to use laser imaging to determine the extent of nerve decompression (release) while patients are still in surgery. commonly, this is determined by electrodiagnostic tests or physical examination. the researchers will use the spy elite device along with an injection of a drug called spy agent green (indocyanine green) in an imaging procedure called fluorescence angiography to visualize the change in blood supply to the nerve, following the nerve decompression surgery and assess if spy is a useful tool for evaluating the success of nerve decompression surgery. the use of fluorescence angiography with the spy elite device and spy agent green is food and drug administration (fda) approved.

Eligibility criteria:
inclusion criteria: * 18 years old or older; male and female patients * ulnar nerve compression at the elbow * failed conservative treatment (i.e. hand therapy, pain medications, splinting) * able to provide informed consent exclusion criteria: * pregnancy/breastfeeding * thyroid disease * vascular disease * known allergy to any study drug
pg2 treatment among stage ii/iii breast cancer patients receiving adjuvant chemotherapy

Conditions: Cancer-related Fatigue; Neutropenia, Malignant

Summary: adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. anthracycline-based regimens, including doxorubin or epilubicin, are the breast cancer adjuvant chemotherapy standards of care. fatigue has also been identified as the most problem for breast cancer patients under adjuvant chemotherapy. in the current study, it is aimed to show that pg2 (astragalus polysaccharides) treatment among stage ii/iii breast patients under adjuvant ec regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy.


Eligibility criteria:
inclusion criteria: * women who are able to provide informed consent * age 20 years and older * diagnosis of stage ii to iii breast cancer * patients who had undergone surgery for breast cancer treatment. * planning to receive anthracycline -based adjuvant chemotherapy * have adequate bone marrow, liver, and renal function * ecog ≦1 * willing and able to complete quality of life questionnaires. exclusion criteria: * pregnancy or lactating women. * baseline bfi score \>3. * history of chronic fatigue syndrome, uncontrolled active infection, active cardiac disease, poor controlled hypertension or diabetes mellitus, any serious medical condition, psychiatric illness, and regular steroid therapy as determined by investigators. * history of previous breast cancer or other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer. * known severe allergy to astragalus membranaceus or its mayor extracts (polysaccharides).

Keywords: astragalus polysaccharides breast cancer adjuvant chemotherapy
the efficacy of erythropoietin oral gel versus erythropoietin mouthwash in the management of recurrent aphthous stomatitis

Conditions: Recurrent Aphthous Stomatitis

Summary: erythropoietin (epo) exerts anti-inflammatory effects by inhibiting nf- kappa b-dependent formation of pro-inflammatory cytokines, thus it reduces local and circulating levels of these disease (recurrent aphthous stomatitis ras) related cytokines. so, it is considered as a potent anti-inflammatory cytokine in inflammatory disorders and infectious disease. it also accelerates wound-healing and decreases the extent of apoptosis and the areas of the open wound. this drug seems to be a promising therapeutic option in oral lesions. the effectiveness of epo oral gel and epo mouth wash were compared on patients with recurrent aphthous stomatitis and investigated therapeutic mechanism by examining treatment effect on expression of il-2 in ras.

thirty patients with recurrent aphthous stomatitis were randomly assigned into three equal groups to receive topical erythropoietin oral gel four times per day (after meals and at bedtime) (group i). erythropoietin mouthwash 4 times per day (after meals and at bedtime) (group ii), and placebo isotonic (normal saline) with concentration 0.90% of sodium chloride (nacl) (group iii). all patients were followed up four 1 week, photographs were taken at the beginning and end of the treatment. patients were assessed using pain visual analogue scale (pvas), clinical assessments for the size of the ulcers and rate of their recurrence. pretreatment and post treatment salivary samples were taken to detect the expression and levels of salivary il-2.

Eligibility criteria:
inclusion criteria: * all patients should be free from any systemic disease or behcet syndrome. * patients ≥18 years of age, male or female are eligible. * oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration. * patient has only aphthous ulcer and it should had not been passed more than 4 days from beginning of their ulcer. exclusion criteria: * • patients with poor oral hygiene or not willing to perform oral hygiene measures. * smoking and alcohol use. * pregnant and lactating females * patients with history of any topical or systemic medication or steroid therapy 1 month prior to the investigation. * the vulnerable group; prisoners, mentally or physically disabled patients.

Keywords: erythropoietin il-2 recurrent aphthous stomatitis