Kornimate/medical-research-clean huggingface dataset:
white noise and therapeutic touch on pain and comfort level in newborns during heel lance

Conditions: Pain, Acute; Newborn

Summary: this randomized controlled study was planned to evaluate the effects of listening to white noise and therapeutic touch on physiological parameters, pain and comfort level during the heel blood collection procedure on infants who gave birth at 32 weeks and above and were given to their mothers in atatürk training and research hospital.

hypotheses h1: newborns who listen to white noise during heel blood collection feel less pain and have a higher comfort level. h2: newborns who are treated with therapeutic touch during heel blood collection feel less pain and have a higher comfort level. h3: newborns who listen to white noise and apply therapeutic touch during heel blood collection feel less pain and have a higher comfort level. h4: there is a difference between the pain and comfort levels of newborns in terms of group, group-time and time according to the intervention applied. methods mothers of newborns whose heel blood will be taken will be informed about the research. the mothers will be informed about the fact that heel blood collection is a routine practice, the data will be recorded by the nurse and 2 observers who take heel blood in the study, and they will also be informed about the white noise and therapeutic touch practices to be listened to, and their written consent will be obtained. after obtaining informed written consent, it will be determined which group the newborn belongs to by stratified randomization. stratified randomization was applied according to gender and week of birth. a standard approach will be applied to all newborns. standard approach; if the baby is asleep, the heel blood will be taken, he will be woken up, put on a denim bed, his upper extremities will be gently wrapped with a blanket, and the procedure will be performed by the nurse. babies to be included in the study in each group; until 30 minutes before the start of the procedure, they will be in their beds, in the rest period, where they are not disturbed. all babies; 5 minutes before, during and up to 5 minutes after blood collection; observational findings including heart rates, spo2 values, pain and confort scores will be recorded in the data form. no additional care will be given to ensure physiological stability in all groups.

Eligibility criteria:
inclusion criteria: * babies who are 32 weeks and older given to their mothers who were born healthy exclusion criteria: * newborns 32 weeks and over * delivery of the newborn to the mother after birth * no congenital anomalies or genetic disorders * the newborn has passed the audiology test * obtaining consent form from parent
faslodex registry: fulvestrant in current clinical practice

Conditions: Metastatic Breast Cancer

Summary: the sequential administration of endocrine therapies to patients with advanced breast cancer requires the availability of therapies with different modes of actions, so that tumours developing resistance to one agent are not cross resistant to another. because of its mechanism of action, fulvestrant is distinct from other hormonal therapies, which therefore limits the possibility of cross-resistance with other therapies such as tamoxifen and the aromatase inhibitors (ais) * in this way, patients may benefit from an extended period of endocrine treatment, which has considerable tolerability and quality-of-life advantages over cytotoxic chemotherapy. * in belgium, fulvestrant is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. however, little information is currently available on how fulvestrant is actually being used by physicians in belgium. the optimum sequence of endocrine treatment for advanced breast cancer has yet to be defined and may depend on certain patient or disease characteristics. fulvestrant has been granted reimbursement by the belgian health authorities (riziv/inami) with the recommendation to collect the real life data necessary to assess the patients' breast cancer treatment history that may influence the actual endocrine treatment sequence according to physicians current clinical practice..


Eligibility criteria:
inclusion criteria: * postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer exclusion criteria:

Keywords: breast cancer, fulvestrant, postmenopausal, women locally advanced, hormone receptor-positive.
strength profile of hip joint in females with primary dysmenorrhea during menstrual cycle

Conditions: Primary Dysmenorrhea

Summary: the goal of this observational study is to investigate the effect of primary dysmenorrhea on strength of hip joint muscles in females.

the menstrual cycle is a physiological process in females manifested as periodic vaginal bleeding due to the shedding of the uterine lining (menstruation). characterized by dynamic fluctuations in serum concentrations of several female sex steroid hormones. estrogen, progesterone, follicle-stimulating hormone (fsh), and luteinizing hormone (lh) play a critical role in regulating the precise timing and events of the ovulatory cycle. dysmenorrhea is considered a menstrual disorder and defined as painful menstrual cramps of uterine origin. it is classified as either primary or secondary dysmenorrhea (sd). primary dysmenorrhea (pd) constitutes a prevalent gynecological condition in the absence of any identifiable pelvic pathology, characterized by cramping and severe pain localized within the lower abdomen. the prevalence of primary dysmenorrhea in females of reproductive age ranges from 45.0% to 94.0% in countries worldwide with 2% to 29% experiencing severe pain. a greater prevalence (70% to 90%) was generally reported among younger women (\&lt;24 years). moderate and severe dysmenorrhea has even become a major reason for absenteeism from academic and professional settings and physical activity limitation in young women. physical activity from standing, walking and balance to high impact sports was found to be directly influenced by the strength, power, and endurance of lower limb (ll) muscles especially hip muscles. previous studies showed that the strength of ll muscles is influenced by the hormonal fluctuation that occurs during menstrual cycle phases. these trial participants; will be divided into two groups: (group a): female with symptomatic pd according to wallid scale. (group b): female with asymptomatic pd according to wallid scale.

Eligibility criteria:
inclusion criteria: * age range from 20 to 25 years. * bmi ranges from 20 to 25 kg/m2. * having a regular menstrual cycle (28 ± 7 days with no intermittent bleeding). * no pathology related to the pelvis. * having no injury in the lower limb. * not consuming contraceptives, dietary supplements and steroid drugs. exclusion criteria: * menstrual irregularity. * pregnancy or suspicion of pregnancy. * having given birth. * using an intrauterine device. * oral contraceptives or antidepressant use. * having a diagnosis of secondary dysmenorrhea. * surgical history involving the abdominal region, pelvic region, and/or the spine in the last year. * having musculoskeletal problems related to lower extremities. * having any psychiatric or gynecological problems. * suffering from premenstrual syndrome.

Keywords: dysmenorrhea primary dysmenorrhea hip joint strength isokinetic strength profile
effect of influenza vaccination on global systemic inflammatory markers in patients with stable coronary artery disease

Conditions: Coronary Artery Disease; Inflammatory Response; Atherosclerosis

Summary: observational and randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. beyond classical view of indirect effect, linked to the neutralisation of the virus, it is currently considered whether the vaccination may have a direct effect on inflammatory process.atherosclerosis is known to be driven both by lipid stress and inflammation both at local and systemic level. the investigators suggest that influenza vaccination could have a positive effect on atherosclerosis by regulating plasma inflammation. the aim of this pilot study is therefore to assess the impact of influenza vaccination in patients with stable coronary artery disease on the circulating inflammatory response, in order to validate its potential immunomodulatory effect. if it is found to be beneficial, it could also constitute a future adjuvant therapeutic tool to traditional pharmacotherapy in the prevention of cardiovascular events.

a multi-center, open-label, randomized delayed-start pilot study in 2 parallel groups will be conducted: participants will be randomized as to when the influenza vaccine will be administered, according to a 1:1 ratio between influenza vaccination immediately after inclusion or at 1-month follow-up. blood tests for plasmatic inflammation analyses will be collected at baseline and at 1 month after study inclusion.

Eligibility criteria:
inclusion criteria: * subjects aged ≥ 60 years. * with documented stable coronary artery disease. * subjects who, in the opinion of the investigator, can comply with the protocol requirements (i.e., show up for the follow-up visit and be able to converse with study staff). * signature of free, written and informed consent by the patient. * affiliation to a french social security system. exclusion criteria: * history of serious reaction to influenza vaccine or refusal of vaccination or contraindication to vaccination. * participant has received the influenza vaccine within \<6 months or another vaccine. * acute infection within \<3 months or acute worsening of chronic diseases. * severe neurocognitive disorders (inability to give informed consent). * pre-existing medical conditions or medications involving the immune system (rheumatoid arthritis or other inflammatory conditions or active cancer, recent use (within the past year) of immunosuppressive or modulating agents, including oral steroids, chemotherapy, or radiation therapy) . * cardiovascular surgery or other interventions within 6 months preceding the study or planned during the follow-up period. * patient's wish or clinical situation requiring co-administration with other vaccines or any factor hindering monitoring. * patient under guardianship, curatorship or safeguard of justice.

Keywords: influenza vaccination inflammation atherosclerosis, coronary disease
physical therapy program for prevention of shoulder pain after device implant

Conditions: Shoulder Pain

Summary: this is a clinical research study to determine if a prescribed physical therapy intervention after subcutaneous implantation of an implanted cardioverter-defibrillator (icd) or pacemaker reduces the incidence of rotator cuff tendonitis when compared to usual post procedural care.

one hundred patients who undergo subcutaneous icd or pacemaker implant and consent to inclusion in the trial will be randomized to one of two groups. one group will receive standard of care instructions after implant. these standard instructions include: no pushing or pulling movements with arm on side of implant, no lifting over 5 lbs., and no movements above the level of the shoulder for six weeks post implant. this will be the control group. the second group, the exercise group, will be instructed verbally on a series of specific exercises (appendix a) to be completed at least three days per week for 6 weeks. after the patient signs informed consent, a demographic form will be completed. at this enrollment visit, both groups will be asked to use a visual analog scale to report level of shoulder and/or extremity discomfort. physical exam will include the impingement test, assessment of shoulder elevation, and measurement of the angle of abduction at which discomfort occurs. subjects will be given the quickdash questionnaire (appendix b) to complete. this questionnaire is an 11 item self-report questionnaire designed to assess the physical function and symptoms during certain activities. at the 1 week follow-up visit, the patient will be informed of their randomization group. the patients in the control group will receive standard of care instructions. the patients in the exercise group will have specific exercises demonstrated to them and written instructions with pictures will be provided for home reference. follow-up for both groups will occur at 1, 3 and 6 months post implant and it will include a physical exam, the quickdash questionnaire, and the visual analog scale. patients in the exercise group will be asked to complete an exercise log and return it to the study staff after the 6 week of exercise is complete. in addition, telephone follow-ups will be completed for the exercise group at 2, 3, 5, and 6 weeks post implant. patients will be asked how often they complete the exercises.

Eligibility criteria:
inclusion criteria: * subjects undergoing icd or pacemaker device implant exclusion criteria: * prior shoulder injury or surgery * mastectomy on affected side * cva with ipsilateral arm involvement * inability or refusal to perform exercises as prescribed. * subjects who would not be able to come in for follow-up visits at one, three, and six-month intervals will also be excluded.

Keywords: physical therapy program
evaluation of a novel horizontal ridge augmentation technique in dentistry

Conditions: Bone Augmentation; Bone Loss, Alveolar

Summary: this case series aimed to assess the efficacy of a novel horizontal ridge augmentation modality using histomorphometry and raman spectroscopy. combinations of "sticky bone" and tenting screws without autologous bone were used as augmentative materials.

this case series aimed to evaluate the efficacy of the horizontal augmentation technique using the tenting screw technique with "sticky bone." the main aim was to determine whether this method provides similar results to the gold standard gbr or autologous onlay block grafts. in addition, the validity of neglecting autologous graft and its possible substitution with growth factor concentrate were examined. the novelty of this study is that no human histological examination of the described procedure has been conducted previously. it is hypothesized that the "stick bone" containing autologous platelet concentrate can substitute the use of particulate autologous bone graft in these type of procedures. in this prospective case series study five patients were enrolled and treated with the same type of bone augmentation in order to increase the alveolar ridge in the horizontal dimension with the previously mentioned technique. after 5 months of healing a second reentry surgery was performed in order to harvest the bone core for biopsy, to asses the chemical compound composition by raman spectroscopy in vivo and to place the dental implants at the same time. newly formed tissues were evaluated clinically during reentry, radiologically by cbct acquisition, qualitatively and quantitatively by histological processing and physicochemically by means of raman spectroscopy.

Eligibility criteria:
inclusion criteria: * one or more missing teeth in the jaw's posterior area, where horizontal bone width is ≤5 mm. * no deficiency in the vertical dimension. * the tooth must have been removed ≥4 months before augmentation. * the patient should understand the nature of the research and be compliant in study-related activities exclusion criteria: * pregnancy * smoking * uncontrolled diabetes * systemic diseases or drug consumption affecting bone metabolism, and clinically relevant osteoporosis

Keywords: platelet concentrate horizontal bone augmentation "sticky bone" histology raman spectroscopy
dermatologic patterns of tuberous sclerosis patients and somatic mutation relationship

Conditions: Tuberous Sclerosis Complex

Summary: tuberous sclerosis is a rare genetic disorder that affects about one in 15,000 individuals. it is part of the phacomatoses: a germline mutation of the gene tuberous sclerosis complex 1 (tsc1) or tsc2 causes a protein dysfunction, hamartin and tuberin respectively, leading to mtor signaling pathway activation, thus tumors rise on the skin but also brain, eyes, kidneys, heart. thanks to the advent of sequencing techniques of the human genome, genes involved were found twenty years ago. most commonly, these are de novo private mutations and autosomal dominant mendelian transmission. about 15% of patients have a phenotype corresponding to the disease but no mutation is found. although the initial clinical description was in 1880, publications regularly describe new signs in tuberous sclerosis, especially for skin. cutaneous manifestations are important in the diagnostic criteria of the disease and often even the first sign of appeal. however, no data is available on the relationship between genotype and dermatological phenotype. therefore the investigator intend to review all cutaneous finding in tuberous sclerosis patient and try to link with their mutation.


Eligibility criteria:
inclusion criteria: - diagnosis of tuberous sclerosis complex established of confirmed by a geneticin, with a genetic study done or processing, patients accepting to be exanimated exclusion criteria: - none

Keywords: tuberous sclerosis complex mtor associated protein neurocutaneous syndromes high-throughput nucleotide sequencing
high resolution wavefront-guided vs. wavefront optimized lasik

Conditions: Nearsightedness; Astigmatism

Summary: the investigators are comparing outcomes of lasik surgery using a high definition wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with and without astigmatism.

the patients will have a comprehensive eye examination once they express an interest in the study. this includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. if there is any pathology noted that would exclude the patient from the study, then the investigators will inform the patient and make an appropriate referral. if the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. the patient will undergo bilateral simultaneous eye surgery. which eye is treated with the customvue and which eye is treated with wavelight will be randomized so there is a 50% chance for either eye to receive one treatment. the patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. the patient will receive topical antibiotics in each eye for one week following the procedure. the patient will receive pred forte 1% ophthalmic drops for one week after treatment. the patient will also receive vigamox ophthalmic drops for four days after treatment. all of this is within the usual and customary standard of care for the treatment of patients undergoing lasik surgery.

Eligibility criteria:
inclusion criteria. * subjects age 21 and older with healthy eyes. * nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters. exclusion criteria. * subjects under the age of 21. * patients with excessively thin corneas. * patients with topographic evidence of keratoconus. * patients with ectatic eye disorders. * patients with autoimmune diseases. * patients who are pregnant or nursing. * patients must have similar levels of nearsightedness and farsightedness in each eye. they can not be more than 1.5 diopter of difference between eyes. * patients must have similar levels of astigmatism in each eye. they can not have more than 1.5 diopter of difference between eyes.
research on precise immune prevention and treatment of glioma based on multi-omics sequencing data

Conditions: Transcriptomics; Radiomics; Glioma

Summary: this project intends to use multiple types of biological samples from glioma patients and mouse intracranial tumor models as research objects, and comprehensively apply a series of omics sequencing technologies and molecular biology technologies to jointly define the following research objectives :

1. through high-throughput sequencing technologies such as， genome sequencing, transcriptome sequencing and single-cell sequencing, proteomics，metabonomics and metagenomics， the similarities and differences of the glioma immune microenvironment within and between individuals were revealed from the multi-dimensional and big data level, and the immune molecular typing of glioma was established. 2. establish and verify that the neoantigen polypeptides predicted by ai algorithm after analyzing multi-omics data (genome, transcriptome, etc.) have good killing effect on individual tumor cells. 3. to establish an intelligent evaluation model of glioma immunotyping by integrating imaging, pathology, high-throughput sequencing data and other omics information, and to provide a visual tool for monitoring changes in the intratumoral microenvironment of glioma patients, with the expectation of helping timely intervention of immunotherapy in patients with recurrence.

Eligibility criteria:
inclusion criteria: * the patients with glioma in the department of neurosurgery of huashan hospital affiliated to fudan university who meet the following three conditions can be enrolled 1. they were 18-80 years old, male and female; 2. the pathological diagnosis was glioma; 3. on the basis of not affecting the clinical routine diagnosis, tissue (6 mm \* 6 mm) or paraffin section (5 pieces) can be used for research; 4. sign informed consent or ethics committee approval exclusion criteria:
a randomised trial comparing efficacy and safety after intensification with either insulin aspart once daily as add-on or changing to basal bolus treatment with insulin degludec and insulin aspart in subjects with type 2 diabetes previously treated with insulin degludec/insulin aspart twice daily

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of the trial is to compare efficacy of insulin degludec/insulin aspart (idegasp) twice daily (bid) + insulin aspart (iasp) once daily (od) versus basal bolus with insulin degludec (ideg) od + iasp three times a day (tid) in controlling glycaemia by evaluating glycosylated haemoglobin (hba1c). the trial is an extension to trial nn5401-3941 (nct01680341).


Eligibility criteria:
inclusion criteria: * hba1c equal to or above 7.0% measured after 26 weeks of treatment in nn5401-3941 (nct01680341), by central laboratory exclusion criteria: * uncontrolled or untreated severe hypertension defined as systolic blood pressure equal to or above 180 mmhg and/or diastolic blood pressure equal to or above 100 mmhg * impaired liver function, defined as alanine aminotransferase (alat) or aspartate aminotransferase (asat) equal to or above 2.5 times upper limit of normal * impaired renal function defined as serum-creatinine equal to or above 125 micromol/l (equal to or above 1.4 mg/dl) for males and equal to or above 110 micromol/l (equal to or above 1.3 mg/dl) for females