Kornimate/medical-research-clean huggingface dataset:
sinopsys lacrimal stent indicated for sinus irrigation

Conditions: Ethmoid Sinusitis

Summary: the purpose of this study is to collect preliminary clinical data related to the safety and performance of the sinopsys lacrimal stent.

for purposes of this clinical study, the sinopsys lacrimal stent is intended to provide a means of administering saline sinus irrigation via a transcaruncular-ethmoid sinus access in patients with moderate to severe chronic rhinosinusitis with ethmoid involvement. the purpose of the administration of saline irrigation is to reduce the intensity of symptoms of chronic rhinosinusitis in this patient population.

Eligibility criteria:
inclusion criteria: 1. the investigator has determined that the potential study subject has moderate to severe chronic rhinosinusitis with ethmoid involvement and has followed at least twelve (12) weeks of appropriate medical therapy prior to enrollment 2. age ≥ 22 years 3. the potential study subject meets the american academy of otolaryngology - head and neck surgery (aao-hns) criteria for chronic rhinosinusitis 12 weeks or longer of two or more of the following signs and symptoms: * mucopurulent drainage (anterior, posterior, or both) * nasal obstruction (congestion) * facial pain-pressure-fullness, or * decreased sense of smell and inflammation is documented by one or more of the following findings: * purulent (not clear) mucus or edema in the middle meatus or ethmoid region * polyps in nasal cavity or the middle meatus, and/or * radiographic imaging showing inﬂammation of the paranasal sinuses 4. snot-20 total score ≥ 41 5. ct scan (coronal view) confirms inflammation / involvement of the ethmoid sinuses 6. ct scan (coronal view) confirms depth of olfactory fossa is keros classification 1 or 2. exclusion criteria: 1. sinus opacification score of ≤ 8 or ≥ 18 measured using the ct derived lund -- mackay scoring system 2. isolated sinus disease evident on ct scan that would be unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid or frontal disease) 3. severe polyposis defined as grade iii or grade iv polyposis using the adapted scale from meltzer, 2006. 4. prior ocular and/or sinus surgery for crs 5. ct scan (coronal view) shows depth of olfactory fossa is keros classification 3. 6. prior surgical history, physical exam, nasal endoscopy and/or imaging studies suggest significant distortion of the craniofacial anatomy thus prohibiting adequate placement of the sls 7. presence of a sinonasal encepholocele as determined by ct scan 8. presence of active heent infection including acute dacryocystitis 9. febrile illness within 2 weeks and/or active pus from nose 10. any sign of active ophthalmic disease, infection, or inflammation including the presence of severe ocular surface inflammatory disease or signs and symptoms of "dry eye disease" as determined by physical exam which could be exacerbated by the presence of the device 11. current use of topical medications for the eye to treat an active ophthalmic disease 12. hba1c level of ≥ 7.5% at the time of screening, current chemotherapy, or other immune compromised conditions
limits of the social benefit motive among high-risk patients: a field experiment on influenza vaccination behaviour

Conditions: Influenza Vaccine; Behavioral Intervention; Self-benefit; Social-benefit

Summary: influenza vaccine uptake remains low worldwide, inflicting substantial costs to public health and health systems. messages promoting social welfare have been shown to increase vaccination intentions, and it has been recommended that health professionals communicate the socially beneficial aspects of vaccination. this study aims to provide the first test whether this prosocial vaccination hypothesis applies to the actual vaccination behaviour of high-risk patients by comparing the effects of two motivational messages for promoting vaccination at a tertiary care public hospital in istanbul, turkey.


Eligibility criteria:
inclusion criteria: * patients hospitalized at medical departments of the hospital who are on the day of discharge exclusion criteria: * egg ellergy * previous allergic reaction to influenza vaccine * pregnancy * cognitive disability
comparision of two different feeding method in preterms

Conditions: Enteral Feeding Intolerance

Summary: achievement of optimal postnatal growth by adequate enteral nutrition in critically ill preterm infants is a challenge of nicu. signs like abdominal distension, reflux, vomiting, nec is a factors of discontinuing fedding in preterm. this factors plays a role in decisions about which method of gavage feeding is adopted. we compare two different feeding method to achive less fedding tolerence.

\<1750 gr, \<33 gw infants will enroll study. exckusion criteria: major congenital anomalies major gis anomalies the study infants are enrolled within 24 hours of birth and sequently randomized to either intermitten feeding (if) and bolus feeding (bf). intermittent feeding is defined as delivering enteral nutrition and generally giving 60 min and 2 hours no feeding. this circle repeats 8 times in 24 hours. bolus feeding is the amount of nutrition put into the syringe was kept 10 cm above the baby and the fluidity was obtained by gravity through the orogastric tube. the data of the patients such as feeding intolerance (gastric residual volume more than %50 of the previous feeding volume, gastric regurgitation, abdominal distension and/or emesis ), whether there is a week-by-week feeding intolerance were noted, nec, time to reached birth weight, time to achieved full enteral feeding, every 5 minutes during feeding, saturation, respiratory rate and heart rates will record.

Eligibility criteria:
inclusion criteria: * \<1750 gr preterm infants * \<33 gw * admitted to our nicu in first day of life exclusion criteria: major congenital anomalies gis anomalies septic shock exitus in 3 days of life -

Keywords: preterm feeding intolerence
mindfulness based stress reduction for parents of children with ibd

Conditions: Inflammatory Bowel Diseases

Summary: parents of children with chronic diseases often report increased level of stress and anxiety. the aim of the study is to assess the effect of mindfulness based stress reduction (mbsr) intervention on stress and anxiety of parents of children with inflammatory bowel diseases (ibd). the intervention is consisted of 8 group sessions managed by a certified psychologist. 30 parents will participate. the efficacy of the intervention will be assessed by 3 validated questionnaires which will be filled by each participant prior to intervention, at the end of intervention and 3 months following interventions.

parents of children with chronic diseases often report increased level of stress and anxiety. inflammatory bowel diseases (ibd), including crohn's disease and ulcerative colitis are chronic debilitating conditions with significant implications of both patients and parents. thus, there is a necessity to address the stress and anxiety derived from parenting a child with ibd. mindfulness is the psychological process of bringing one's attention to the internal and external experiences occurring in the present moment,which can be developed through the practice of meditation and other training. clinical studies have documented both physical and mental health benefits of mindfulness in different patient categories as well as in healthy adults and children. the aim of the study is to assess the effect of mindfulness based stress reduction (mbsr) intervention on stress and anxiety of parents of children with inflammatory bowel diseases (ibd). the intervention is consisted of 8 group sessions managed by a certified psychologist. 30 parents will participate in 4 separated courses. the efficacy of the intervention will be assessed by 3 validated questionnaires which will be filled by each participant prior to intervention, at the end of intervention and 3 months following interventions: profile of mood states (poms), the brief symptom inventory (bsi) and perceived stress scale (pss). differences in questionnaires' scores will be analyzed.

Eligibility criteria:
inclusion criteria: * a parent to an ibd patient who is younger than 18 years of age exclusion criteria: * none
ph 1 adi-peg 20 plus doxorubicin; patients with her2 negative metastatic breast cancer

Conditions: HER2 Negative Metastatic Breast Cancer

Summary: certain cancers require the amino acid arginine. arginine deiminase (adi) is an enzyme from microbes that degrade arginine. adi has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. in this study, adi will be combined with the well known chemotherapy doxorubicin and the safety and potential efficacy of this combination will be explored in patients with her2 negative metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. biopsy proven her2 negative metastatic breast cancer (dose escalation portion and mtd expansion portion) or advanced solid tumor (dose escalation portion). 2. ass deficiency (defined as \<50% ass expression) demonstrated on tissue specimen by immunohistochemistry (ihc). cytology and fine need aspirate specimens are not acceptable for ass testing. 3. unresectable disease or subject refused surgery. 4. measurable disease as assessed by recist 1.1 criteria (appendix a). 5. failed available therapy known to confer clinical benefit but no more than 4 prior lines of chemotherapy for metastatic disease. 6. time to treatment failure from doxorubicin containing regimen ≥ 12 months if previously treated with doxorubicin. 7. age ≥ 18 years. 8. ecog performance status of 0 - 2. - exclusion criteria: 1. serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment. 2. prior epirubicin exposure of \> 600 mg/m2. 3. pregnancy or lactation. 4. expected non-compliance. 5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (new york heart association class iii or iv), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements. 6. subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ grade 1 aes, or deemed irreversible from the effects of prior cancer therapy. aes \> grade 1 that are not considered a safety risk by the sponsor and investigator may be allowed upon agreement with both. 7. subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect subject outcome in the setting of breast cancer diagnosis. 8. subjects who had been treated with adi-peg 20 previously.

Keywords: her2 negative metastatic breast cancer
food effect study of bms-984923 in healthy older adult volunteers

Conditions: Alzheimer Disease; Dementia

Summary: this project is developing a novel disease-modifying compound for alzheimer's disease (ad).

the primary objective of this study is to evaluate for an effect of food consumption on the pharmacokinetics profile of bms984923. safety and tolerability is also assessed.

Eligibility criteria:
inclusion criteria: * men or women between the ages of 50 and 80 years, inclusive * no history of cognitive impairment * capable of providing written informed consent and willing to comply with all study requirements and procedures * participant is not pregnant, lactating, or of childbearing potential exclusion criteria: * body mass index (bmi) \>38 kg/m2 or body weight \<50 kg. * significant cerebrovascular disease * any significant neurologic disease * a current diagnostic and statistical manual of mental disorders, fifth edition (dsm v) diagnosis of active major depression, schizophrenia or bipolar disorder * clinically significant or unstable medical condition * any disorder or medication that could interfere with the absorption, distribution, metabolism or excretion of drugs * history of cholecystectomy * history of acute/chronic hepatitis b or c and/or carriers of hepatitis b (seropositive for hepatitis b surface antigen \[hbsag\] or anti-hepatitis c virus \[hcv\] antibody). * use of psychoactive medications * use of medications with potential drug-drug interactions * use of another investigational agent * clinically significant abnormalities in screening laboratories * any suicidal ideation of type 4 or 5 on the columbia-suicide severity rating scale * acceptable geriatric depression scale (gds) score
virtual reality vs. standard-of-care for comfort during minor plastic surgery procedures in children

Conditions: Minor Plastic Surgery

Summary: children often experience pain and anxiety during minor medical procedures. in addition to pain medication, distraction may help children cope with the pain. this may include interacting with books, tv, toys or videogames. virtual reality (vr) is an immersive experience using sight, sound, and position sense. using vr may enhance distraction during the painful procedure and may reduce attention to pain. this study will randomize children (6 - 16 years old) to receive virtual reality or standard of care in addition to local anesthetics during minor painful procedure in the plastic surgery clinic. pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. outcome measures will be compared between the two groups.


Eligibility criteria:
inclusion criteria: * children age 6 to \< 17 years * patients scheduled for minor elective plastic surgery procedure * parents will sign a consent form and children will sign an assent form exclusion criteria: * children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay) * facial features or injury prohibiting wearing the vr goggles * procedure in the face, where the vr system may interfere with plastic surgeon work

Keywords: virtual reality pain anxiety
effect of probiotics on oral candida among denture wearers

Conditions: Oral Candida Albicans Infection

Summary: forty-eight denture wearers with detectable levels of candida colonization without clinical symptoms will be randomly allocated into two groups: probiotics and placebo. all patients will take a daily dose of chewable tablets (probiotics or placebo according to the assigned group) for 8 weeks. samples of mouth rinse will be collected from patients at baseline, 4 weeks from the beginning of the intervention, 8 weeks (the end of intervention), and after another 4 weeks for post-intervention follow up. samples will be tested for both candida count and candida species identification


Eligibility criteria:
inclusion criteria: * detectable levels of candida in palatal mucosa without clinical symptoms of active candidiasis. * completely edentulous arches with newly formed denture . * patients with controlled hypertension, and diabetes will be included in this study as they are considered very common problems in the targeted population. exclusion criteria: * inability to understand/ follow the experimental procedures, * administration of topic or systemic antifungal or antibacterial agents in the previous 60 days. * consumption of probiotics. * gitdisorders. * heartdisease. * diseases that significantly influence immunity such as; kidney problems, head and neck cancer, or radiotherapy, aids, or immunosuppressive therapy. * clinical manifestations of oral candidiasis.
pain management in geriatric hip fracture

Conditions: Geriatric Hip Fracture Pain Management

Summary: the null hypothesis is that there is no association between pain regime and the functional performance among geriatric patients having traumatic hip fracture. two limbs are being assessed:1. three weeks of regular oral panadol and tramadol after hip fracture 2. oral panadol and tramadol taking in p.r.n. basis. functional outcome including numerical rate scale for pain assessment, functional independency measure and elderly mobility score are chosen.

200x2 patients are recruited during two periods within the study period where regular oral analgesics is given for the first 200 patients while the rest of patient will receive oral analgesics upon demand

Eligibility criteria:
inclusion criteria: * both sex of age \> 65 * traumatic non-pathological fracture neck of femur or trochanteric or subtrochanteric fracture having operative intervention exclusion criteria: * age \< 65 * pathological fracture * multiple lower limb fractures * old fracture

Keywords: geriatric hip fracture pain management
efficacy of extract of trigonella foenum-graceum as topical phytoestrogen in skin aging treatment of post menopausal women

Conditions: Skin Aging

Summary: skin is subjected to intrinsic aging and extrinsic aging. intrinsic aging is influenced by genetic and hormonal factors. estrogen has significant role in modulating skin physiology. in post menopausal women, skin aging is accelerated because of hypoestrogenism. administration of estrogen can delay the process of skin aging. phytoestrogens are estrogen-like compounds which can be found naturally in plants. the investigators intend to study the efficacy of trigonella foenum-graceum extract as topical phytoestrogen in skin aging treatment of post menopausal women.

in this double-blinded unmatched randomized controlled trial, the investigators intend to study the efficacy of trigonella foenum-graceum extract as topical phytoestrogen in skin aging treatment of post menopausal women. the investigators have gathered 21 participants that will be divided into 2 groups, experimental group and control group. experimental group will get treatment with topical cream containing trigonella foenum-graceum extract, while control group will get treatment with placebo cream. the study will be held in esthetic cluster, kencana cipto mangunkusumo hospital, and radiology cluster, kencana cipto mangunkusumo hospital from august 2019 until november 2019.

Eligibility criteria:
inclusion criteria: * women with minimum 2 years post menopausal and maximum 8 years post menopausal * have skin aging problems that manifested as wrinkles on forehead, crow's feet, and nasolabial fold region * estradiol level \< 30 pg/ml * willing to terminate the routine use of facial cream or treatment during the study duration and at least for 30 days before the study commence * willing to follow the study protocol and sign the informed consent exclusion criteria: * dermatitis in the region of face * using oral/topical hormonal supplement in the last 12 months * using products containing retinoic acid or it's derivatives in the last 30 days * underwent radiotherapy, facelift, dermabrasion, botox, or facial filler procedures in the last 5 years * breast lump or other breast abnormality * history of cancer or malignancy * vein thrombosis * history of hormonal contraception allergy * history of ovariectomy
effect of home exercise program on various parameters in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Exercise Program; Telerehabilitation; Autoimmune Disorder

Summary: multiple sclerosis (ms) is a chronic, inflammatory, neurodegenerative, and autoimmune disease that progresses with progressive neurological dysfunction and affects the central nervous system. a multidisciplinary rehabilitation approach is crucial in the systematic and supportive treatment of ms. exercise training is a therapeutic approach that minimizes functional capacity loss and slows progression in ms. randomized controlled studies have shown that exercise training improves physical fitness, reduces motor fatigue, and improves the quality of life and psychological state in individuals with ms. when the literature is examined, it is seen that popular exercises such as pilates, yoga, and tai-chi are used in addition to aerobics, strengthening, endurance, and stretching exercises in the treatment of individuals with ms. in order to eliminate the economic burden, which is one of the exercise barriers of individuals, and to gain exercise habits, home exercise programs should be expanded. when the literature is examined, it is emphasized that the importance of home exercise programs is emphasized, and it is very important in the treatment of patients who cannot attend an exercise program, especially by going to any center for various reasons. however, there is little information on the effectiveness and content of home exercise programs in patients with ms. from this point of view, this study is capable of supporting the missing part of the literature.


Eligibility criteria:
inclusion criteria: 1. to be between the ages of 18-65 2. being diagnosed with ms according to mcdonald criteria 3. having an edss score between 0-5.5 4. being in the relapsing remitting class as a clinical subtype of ms 5. not having any nervous system pathology other than ms 6. not having an ms attack in the last 1 month 7. to ensure full cooperation and adaptation throughout the study. exclusion criteria: 1. being in an exacerbation period 2. to have participated in a regular physical activity program in the last 6 months 3. having an orthopedic, cardiopulmonary or psychiatric disease that prevents exercise 4. continuing another exercise therapy 5. not volunteering to participate in the study 6. having problems with reading comprehension

Keywords: ms (multiple sclerosis) exercise, physical exercise therapy physical exertion
non-nutritive sucking and breastfeeding in preterm infants

Conditions: Infant,Premature; Infant Development; Infant, Very Low Birth Weight

Summary: the main objective of this study is to assess whether non-nutritive sucking on an emptied breast will lead to more success with direct breastfeeding than non-nutritive sucking on a pacifier in preterm infants.

breast milk is vital in the nourishment of premature infants. early interventions which focus on enhancing infants' oral motor skills required for breastfeeding are needed. there is very limited evidence on early interventions aimed at maintaining rudimentary sucking skills needed for breastfeeding in this high risk population. the main objective of this study is to assess whether non-nutritive sucking on an emptied breast will enhance breast feeding performance in preterm infants. the target population will consist of clinically stable preterm infants born less born less than or equal to 34 weeks gestational age and whose mother's intention are to breastfeed. infants will be randomized into the non-nutritive sucking on emptied breast or pacifier group. both interventions will be administered by mothers. time to transition to full oral feeding, breastfeeding acquisition at hospital discharge and breastfeeding duration at six months of age will be monitored.

Eligibility criteria:
inclusion criteria: * born less than or equal to 34 weeks gestational age (ga); * appropriate size for their ga; * receiving nasal continuous positive airway pressure; * receiving only enteral feedings (orogastric or nasogastric); * mothers are pumping their milk. exclusion criteria: * congenital anomalies * mother not expressing milk * transferred in hospital

Keywords: oral feeding early intervention premature infant sucking