Kornimate/medical-research-clean huggingface dataset:
randomized controlled trial of vitamin d3 supplementation for viral upper respiratory tract infections (uri) prevention

Conditions: Viral Upper Respiratory Tract Infection

Summary: background: vitamin d has been shown to be an important immune system regulator. vitamin d insufficiency during the winter may cause increased susceptibility to infections, particularly viral upper respiratory tract infections (uris). objective: to determine whether vitamin d supplementation during the winter season prevents or decreases uri symptoms in adults. methods: a randomized, double-blind, placebo-controlled trial was conducted in 162 adults. participants were randomized to receive vitamin d3 50 mcg (2000 iu) daily or matching placebo for 12 weeks from december 2006 to march 2007. a biweekly questionnaire was used to record the incidence and severity of uri symptoms


Eligibility criteria:
inclusion criteria: * ambulatory adult age 18-80 and stable medical condition with no change in medications for 6 months prior to study entry. exclusion criteria: * morbid obesity (body mass index \> 35 kg/m2) * current tobacco use * history of hypercalcemia, nephrolithiasis or sarcoidosis * pregnancy * recent hospitalization * current liver or kidney disorders, malignancy and malabsorption * use of immunosuppressants or medications that interfere with vitamin d metabolism such as phenytoin and carbamazepine.

Keywords: vitamin d viral uri influenza colds
treatment for patients with secondary hyperparathyroidism of end-stage renal disease (esrd)

Conditions: End Stage Renal Disease

Summary: the purpose of this research is to study the efficacy and safety of amg 073 in patients with kidney failure who are being treated with hemodialysis or peritoneal dialysis and who also have secondary hyperparathyroidism (hpt).


Eligibility criteria:
inclusion criteria: - completed one of the qualifying studies (i.e., patient previously took part in an amgen study investigating the drug amg 073 and its effects on secondary hyperparathyroidism \[hpt\]; in particular parathyroid hormone \[pth\], calcium and phosphorus levels in blood associated with kidney failure) - must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study exclusion criteria: - pregnant or nursing females - experienced a myocardial infarction within 3 months before day 1 - have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator

Keywords: sensipar® secondary hpt mimpara® cinacalcet calcimimetic end-stage renal disease (esrd)
mandibular advancement devices tali® in patients with syndrome of obstructive sleep apnea and hypopneas

Conditions: Syndrome of Obstructive Sleep Apnea and Hypopneas

Summary: the main objective is to evaluate middle term compliance (≥ 2 years) of the mandibular advancement devices tali® in patients with syndrome of obstructive sleep apnea and hypopneas.


Eligibility criteria:
inclusion criteria: * patients \> 18 years treated with mandibular advancement device tali® from at least 2 years and at the latest 5 years. * patients who agree to participate to the study.
influence of of cream with the silver fir wood extract (belinal) on skin

Conditions: Wrinkles; Ageing; Photoprotection; Skin Care; Skin Cream

Summary: objective of the study is to determine the influence of the cream with silver fir wood (abies alba) extract (belinal) on the skin parameters and functions in comparison to the placebo cream. 10 healthy female subjects will use the test cream on one half and placebo cream on the other half of the face and of the gluteal part twice a day for 12 weeks. various face skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12 weeks of the cream use. to evaluate the photoprotective potential of belinal the minimal erythema dose (med) will be determined before (the baseline) and after 12 weeks of the cream use at the gluteal area.

objective of the study is to determine the influence of the cream with silver fir wood (abies alba) extract (belinal; 2% cream) on the skin parameters and functions in comparison to the placebo cream. 10 healthy female subjects will use the test cream on one half and placebo cream on the other half of the face and of the gluteal area (split-face and split-gluteal area ) twice a day for 12 weeks. face skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12 weeks of the cream use. the photoprotective potential of belinal will be evaluated with a determination of the minimal erythema dose (med) at the gluteal area before (the baseline) and after 12 weeks of the cream use. comparison will be done as the mean of the individual ratios. the differences between the before-after condition will be analyzed with the statistical test of analysis of variance. in case of failure to find homogeneity in the variances the nonparametric anova, the willcoxon test, will be used. the results will be expressed as mean ± standard error for each group with a significance level of 0.05 for all the statistical tests.

Eligibility criteria:
inclusion criteria: * signs of skin aging (mimic wrinkles/ fine lines/ poor skin tone/ photoaged skin), * phototype ii and iii. exclusion criteria: * allergy to ingredients of tested products * diagnosed diabetes * thyroid disease * inflammatory dermatoses * regular use of dietary supplements 6 months or less before start of the study, * invasive rejuvenation treatments (botox injections, hyaluronic acid fillers, needle rollers, needle mesotherapy, etc.) 6 months or less prior to start of the study, * non-invasive rejuvenation treatments (radiofrequency, electrotherapy, ultrasound therapy, no-needle mesotherapy, etc.) 3 months or less prior to start of the study, * regular, at least 14 day use of anti-aging cosmetic products containing peptides/ polyphenols/ stem cells extracts/ vitamins in high concentration/ ahas/ bhas/ vitamin a or its derivatives) three months or less prior to start of the study, * gluteal hyperpigmentation, * expected sunbathing (also in solariums) within the study period.

Keywords: skin rejuvenation anti-ageing effects minimal erythema dose dermis structure physiological skin condition wrinkling
genetic correlates of wasting: a pilot study with children attending a tertiary feeding clinic

Conditions: Undernutrition; Eating Disorders; Underweight

Summary: this is a pilot study of children attending the glasgow feeding clinic (gfc) which looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness. the investigators want to find out if these children are more likely to carry genetic markers of thinness.

thinness occurs as a result of undereating, but it is not always clear why an individual child has not eaten enough, or how to get them to eat more. there is a need to understand the child characteristics that predispose to undereating and the how these operate, in order to design more effective treatment and prevention programmes. the glasgow feeding clinic (gfc) looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness. the investigators want to find out if these children are more likely to carry genetic markers of thinness. the investigators will invite up to 60 families to complete a standardised online questionnaire (icfet) about their child's eating behaviour and collect a saliva sample from their child, sent by post. the investigators will identify how many genetic markers for thinness each carries and relate this to their icfet appetite scores and existing growth measurements as well as their feeding history.

Eligibility criteria:
inclusion criteria: all participants currently attending glasgow feeding clinic or assessed there within the last 2 years. nb current ethical application is restricted to children aged 1-7 years, but the investigators plan to apply to extend that to age 16 years. exclusion criteria: sample not to be collected with 2 weeks of any symptoms or recent contact with covid 19

Keywords: genetics child eating behaviour tube feeding avoidant restrictive food intake disorder
pre-pregnancy weight loss and baby behavior study

Conditions: Obesity; Familial; Pregnancy Related; Infant Behavior

Summary: this study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest suck effect on the challenging compared with the typical nipple.

the researchers will recruit babies from the original cohort in the plan study (nct03244722), regardless of which arms they participated in. however, the researchers will test the study arms from the original plan study for effects on the study's dependent variables. their between-subjects arms included pre-pregnancy obesity with intensive weight loss intervention, pre-pregnancy obesity with standard of care intervention, and pre-pregnancy healthy weight with no intervention. so, although the researchers are not assigning babies to any arms, their original assignment will still be assessed the study analysis.

Eligibility criteria:
to be eligible to participate in this study... mother -current or previous participation in the plan study resulting in a live birth. child * mother participated in plan study during child's gestation * infant birth weight (from plan study records) appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on us natality data set (oken et al, bmc pediatrics 2003). * infant is 3.0 to 6.0 months old at consent. * biological mother is legal guardian by maternal report. * biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time). * infant typically consumes at least 2 ounces in one feeding from an artificial nipple and bottle at least once per week by maternal report. * stated willingness by mother to comply with all study procedures and availability for the duration of the study.
prevention of recurrent vulvovaginal candidiasis with lactibiane candisis 5m®

Conditions: Vaginal Candidiasis

Summary: vulvovaginal candidiasis (vvc) is a common infection among women that is associated with considerable morbidity and health-care cost. 75% of women will suffer of candida infection for at least one time in their life. 20% of women who suffer from vvc will have ≥ 4 episodes of vvc during the one year prior to the survey. 80% of these vvc are caused by candida albicans. current treatments, based on imidazoles, face many failures or recurrences. the type of probiotic lactobacillus may participate in the prevention of recurrent vulvo-vaginitis in reducing the proliferation of intestinal candida albicans, its adherence to the vaginal walls, the potentiation of its propagation. the primary objective of this study was to investigate if our supplementary treatment could improve the initial cure rate after vaginal econazole therapy.


Eligibility criteria:
inclusion criteria: * women * 18-65 years * suffering from 4 or more episodes of vvc during the 1 year prior to the survey * all participants must be symptomatic with a microbiological proof of infection with candida albicans exclusion criteria: * pregnancy, lactation being * hiv infection, chemotherapy or illness serious enough to induce an immune deficiency. a diabetic patient will not be systematically excluded; * vulvo-vaginitis and / or cervicitis specific, defined in a bacteriological examination by the presence of herpes virus, gonorrhea or chlamydia; * bacterial vaginosis or trichomonas; * use of vaginal probiotics in the months before inclusion; * cure of probiotics in the months preceding the inclusion; * contraindication to gynopévaryl lp
lung tumor protein synthesis rates in lung cancer patients

Conditions: Lung Cancer

Summary: the current study will recruit lung cancer patients to measure tissue protein synthesis rates of non-small cell lung carcinomas and healthy lung tissue. the protein synthesis rates of healthy lung tissue will be compared to lung tumor tissue to establish the remodeling characteristics of healthy versus cancerous lung tissues. we will also examine whether tissue protein synthesis rates of non-small cell lung carcinomas are associated with various tumor- (i.e., size, subclassification) and patient-derived (i.e., inflammation, lung function, smoking status, and smoking history) parameters.


Eligibility criteria:
inclusion criteria: 1. aged 18-65 years 2. compos mentis 3. diagnosed with lung cancer, with treatment requiring a thoracotomy or vats lobectomy exclusion criteria: 1. neoadjuvant chemo- or radiotherapy in the past four weeks 2. use of systemic steroids in the past four week 3. insulin-dependent diabetes mellitus 4. pregnancy
the menopause after cancer study

Conditions: Menopause; Cancer; Insomnia

Summary: this study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (mht) is contraindicated for any reason. this study will examine if the addition of psycho-social support and digital cognitive behavioral therapy (cbt) for insomnia to standard non-hormonal pharmacotherapy can improve quality of life for these women.

patients who are eligible and provide informed consent will be enrolled into this single arm study. patients will be prescribed non-hormonal pharmacotherapy tailored to the timing of their predominant symptoms. they will be given access to an evidence based platform for digital cbt for insomnia and asked to identify a partner or other companion who will commit to providing psychosocial support to the research participant throughout the study period.

Eligibility criteria:
inclusion criteria: 1. females over 18 years of age at the time of recruitment and onboarding. 2. vasomotor symptoms of menopause 3. previous or current cancer diagnosis 4. conventional menopausal hormone therapy contraindicated for any reason 5. can speak and read english proficiently 6. competent using the internet and has access to smartphone or similar device exclusion criteria: 1. ecog performance status \>3 2. use of study medications to manage menopausal symptoms in the preceding 6 months 3. use of cbt for insomnia in the preceding 6 months 4. any contraindication to study medications 5. no internet access or competency issue with internet use 6. unable to complete questionnaires or give informed consent 7. current major mental illness
flexible endoscopy biopsies for submucous tumors with a new drill instrument

Conditions: Gastric Tumor

Summary: the purpose of this study is to determine whether the newly constructed ce (conformité européenne) marked drill biopsy instrument for flexible endoscopes can make possible representative biopsies of the increasing numbers of submucosal tumours in the gastrointestinal tract. the amount of submucous tissue ( micrograms and in % of all the biopsy) harvested with the new drill biopsy instrument used in flexible endoscopy investigations is measured in the study and compared to the amount of submucous tissue harvested with the existing biopsy forceps.

background: with the existing biopsy instruments for flexible endoscopy it's only possible to achieve superficial biopsies comprising the mucosa and very seldom some small fragments of the submucosa. it is, however, increasingly important to get biopsies from the submucous tissues because the tumors that are on the increase more than any other in the stomach is the gist (gastrointestinal stroma tumours) that grows in the submucosa. cytology is not enough for a reliable diagnosis and to often not representative. furthermore there is a well-known risk for tract seeding when sampling through the abdominal wall with a fine needle instrument. the investigators have invented a new biopsy instrument for flexible endoscopy that is a drill within a cylinder that can be used for biopsies of the submucous tissues, for instance gist-tumours, see www.bibbinstruments.com. hypothesis: will it be possible to achieve representative submucous tissue from the gastrointestinal tract with the newly constructed drill biopsy instrument for flexible endoscopy. the investigators hypothesize that the amount of tissue harvested with the new drill biopsy instrument will give significantly more amount of tissue to evaluate for the pathologist than the existing biopsy forceps. method: ten patients with tumours in the submucosa of the stomach are examined with a gastroscope. the investigator decides where the first biopsy should be taken and randomly the investigator blindly get the new drill instrument or the conventional biopsy forceps and take the biopsy on the decided localization. the next site of the tumour is decided and again blindly the investigator get one of the two biopsy instruments according to a previously decided scheme. six biopsies (three with each of the two biopsy tools) in every patient are harvested in ten patients. with altogether 30 specimen for each biopsy instrument and a difference of 1/3 which is a low calculated difference 10 patients as above will give a 80 % power (chi-2 = 5.40, p = 0.02\*). the amount of submucous tissue harvested with the two biopsy instruments are measured in microgram and as percentage of all the biopsy and compared. the quality of the specimens are also calculated.

Eligibility criteria:
inclusion criteria: * submucous gastrointestinal tumours exclusion criteria: * no gastrointestinal submucous tumor * submucosal hemangioma

Keywords: gastric tumor
immune response to seasonal influenza vaccine in hiv infected individuals

Conditions: Influenza, Human; Human Immunodeficiency Virus I Infection

Summary: investigators in the division of infectious diseases are carrying out a study to determine if human immunodeficiency virus (hiv)-seropositive patients receiving the seasonal influenza vaccination develop an adequate antibody response. the study group will consist of individuals seen in the infectious diseases clinic who are hiv-seropositive and receive the seasonal influenza vaccine.

this is a study to establish the immunologic response in hiv-seropositive individuals to the fda approved seasonal influenza vaccine when it is available. hiv-seropositive individuals seen in the infectious diseases clinic at george washington university, medical faculty associates and receive this vaccination, on label, as part of standard of care will be invited to participate. the study will require a 10-ml sample of whole blood to be drawn from each participant prior to the dose of the seasonal influenza vaccine and at 3 weeks after the vaccine dose and at 3 months after the vaccine dose. no additional samples are envisioned. serum will be separated and will frozen and stored in the clinical trials unit until all patient samples have been obtained. at that time the antibody levels to the vaccine antigens will be measured. data that will be collected from the subject's medical record includes the following: * age, gender, race * cd4 count * hiv viral load * history of prior influenza immunization including the 2009-2010 trivalent vaccine * hiv antiviral medication history data that will be collected from the subject during participation in study * antibody levels prior to vaccination * dose date of the seasonal influenza vaccination * antibody levels 3 weeks after the vaccination

Eligibility criteria:
inclusion criteria: * males or female patients ages 18 or older * diagnosis of hiv infection * no contraindications to being able to receive influenza vaccine by the treating physician * no acute active illness * able to provide informed consent exclusion criteria: * previous history of hypersensitivity reaction to influenza vaccine * unable to return for follow-up blood draw
our lifestyles our lives

Conditions: Pediatric Obesity; Weight Loss

Summary: the purpose of the study was to examine the influence of step goals with pedometers to improve children's weight loss, physical activity, and psychosocial health during behavioral treatment. children with overweight or obesity were assigned to receive the behavioral treatment alone, plus pedometers, or plus pedometers with step goals.

a total of 105 overweight and obese children ages 8 to 17 years participated in a 10-week family-based weight management intervention focusing on physical activity, nutrition, and behavioral modification. a quasi-experimental design was used to group cohorts into three conditions: two cohorts had no pedometer (n=24); two cohorts had pedometer only (n=25); and four cohorts had pedometer with step goals (i.e. 500 steps/day weekly increase above baseline; n=56). height and weight were measured at baseline and week 10 and used to calculate body mass index (bmi). analysis of covariance was performed to examine difference by condition for change in weight, bmi, and bmi z-score, controlling for age and baseline value. differences in steps/day and psychosocial health were compared between the two pedometer conditions.

Eligibility criteria:
inclusion criteria: * aged 8-17 years old * bmi ≥ 95th percentile or have a bmi ≥ 85th percentile with comorbidities (e.g. hypertension, heart disease, type 2 diabetes, insulin resistance, sleep apnea, orthopedic problems, or fatty liver disease) exclusion criteria: * none.

Keywords: behavior goals self-monitoring pedometer physical activity
study to evaluate the effectiveness of the device in detection of abnormal findings on x-ray

Conditions: Pulmonary Disease

Summary: this study aims to evaluate the effectiveness of the investigational device (lunit insight cxr) in the detection of chest abnormalities.

in the study, the standalone performance of lunit insight cxr was primarily assessed by comparing the analysis results from the investigational device and reference standards in the detection of 10 abnormal radiologic findings - atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule/mass, pleural effusion, pneumoperitoneum, and pneumothorax. in addition, to investigate the effect of lunit insight cxr assistance on the interpreting physician's interpreting performance, a multi-reader, multi-case (mrmc) study was conducted.

Eligibility criteria:
inclusion criteria: * chest radiographs of aged 14 years or older * conventional pa or ap chest radiographs * chest radiographs with confirmed radiology reports exclusion criteria: * chest radiographs taken in postures other than pa and ap e.g.) decubitus, oblique, lordotic, or lateral view * invert-grayscale chest radiographs * image quality not suitable for interpretation due to incorrect patient positioning, inadequate image collimation, severely damaged lung presence of external materials such as jewelry
vashe wound therapy study

Conditions: Burns

Summary: this study will evaluate the efficacy, safety, and tolerability of topical vashe™ wound therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist versus 5% mafenide acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 years and over requiring hospitalization for burn injury * burn injury requiring wound excision and auto-grafting * less than or equal to 20% total body surface area burns exclusion criteria: * pregnant or lactating females * individuals with chlorine sensitivity * electrical, chemical and cold injury * burns to the face, hands, feet and or perineum area * steroid therapy

Keywords: burn burn wound management burn graft