Kornimate/medical-research-clean huggingface dataset:
functional and molecular characterization of treatment response in tumors in the oral cavity using optical spectroscopy

Conditions: Head and Neck Cancer

Summary: the objective of this pilot study is to estimate the sensitivity and specificity of diffuse reflectance spectroscopy (drs) and raman spectroscopy (rs) at detecting treatment-resistant disease when drs and rs are used together to measure treatment-induced reoxygenation and molecular changes in tumors of the oral cavity. this study will be performed in a total of 90 patients that have stage 3 or 4 head and neck squamous cell carcinoma (hnscc) with primary tumors located in the larynx or one tonsil.

the objective of this pilot study is to estimate the sensitivity and specificity of diffuse reflectance spectroscopy (drs) and raman spectroscopy (rs) at detecting treatment-resistant disease when drs and rs are used together to measure treatment-induced reoxygenation and molecular changes in tumors of the oral cavity. this study will be performed in a total of 90 patients that have stage 3 or 4 head and neck squamous cell carcinoma (hnscc) with primary tumors located in the larynx or one tonsil. this study is a single-arm, single-center observational pilot study of the accuracy of drs+rs at distinguishing early between treatment-resistant and treatment-responsive disease in study-eligible subjects undergoing first-line chemoradiation therapy for stage 3 or 4 hnscc of the larynx or tonsil. three (3) optical spectra each will be collected from the tumor, an adjacent normal site, and a normal tissue site on the buccal mucosa prior to treatment. the subject will undergo 4 repeat post-treatment measures taken after radiation therapy begins (marked as day 1). repeat measures will be taken on day 2(+1), day 4(±1), day 7(±1), and day 10(±1). the probe will be performed at the beginning of the radiation therapy visit, prior to the radiation dose that day.

Eligibility criteria:
inclusion criteria: * age 18 years and older * diagnosis of stage 3 or 4 hnscc with documentation of hpv status * tumor located in one of the tonsils and/or larynx * expected to have ability to tolerate laryngoscope procedure * must sign informed consent form * scheduled for chemoradiation therapy exclusion criteria: * previous oral cavity or tonsil or pharyngeal surgery or therapy related to the disease * disease in both tonsils * patients who, in opinion of investigator, should not participate * women who are pregnant or breastfeeding
preoperative fulvestrant with or without enzalutamide in er+/her2- breast cancer

Conditions: Breast Cancer

Summary: this is a randomized two arm phase ii study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced ar+/er+/her2- bc who will have local surgery after \~4 months on treatment.

this is a randomized two arm phase ii study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced ar+/er+/her2- bc who will have local surgery after \~4 months on treatment. after consent, all patients will get a tissue biopsy, and than half the patients will get fulvestrant alone (standard dosing) and the other half of the patients will get fulvestrant plus enzalutamide. at \~4 weeks, a biopsy will be done and therapy will be continued. hormone therapy will continue for \~4 months at which point the patients will undergo surgical resection.

Eligibility criteria:
inclusion criteria: * er+ her2- breast cancer * stage at least t2 or greater * planned to get local surgery * postmenopausal, or if pre- or peri- menopausal, then will need to have concurrent ovarian suppression. * at least 18 years of age * not on anticoagulants * ps 0-2 * able to swallow study drug and comply with study requirements * anc \>1000/ul, platelets \>75,000/ul at screening visit * total bilirubin \< 1.5 times upper limit of normal (uln) at the screening visit unless an alternate nonmalignant etiology exists (eg, gilbert's disease) * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \< 3 times uln or \< 5 times uln if patient has documented liver metastases * creatinine \< 1.5 times uln * inr \< 1.5 times uln, or if on warfarin, can safely transition off for biopsy * willing to donate blood for research at 4 time points * willing to undergo core biopsies for research at study entry and at \~4 weeks. * willing to donate tissue to research from the surgical specimen * written informed consent obtained prior to biopsies and blood samples exclusion criteria: * current or previously treated brain or leptomeningeal metastases * history of seizures * prior treatment with an anti-androgen (abiraterone, arn-509, bicalutamide, enzalutamide, odm-201, tak-448, tak-683, tak-700, vt-464). * systemic estrogens or androgens within 14 days before initiating therapy. vaginal estrogens are allowed if necessary for patient comfort.

Keywords: er+/her2 - breast cancer preoperative fulvestrant enzalutamide
oasis-ipf (idiopathic pulmonary fibrosis) study

Conditions: Idiopathic Pulmonary Fibrosis

Summary: descriptive prospective non-interventional multicenter study based on newly collected data of idiopathic pulmonary fibrosis patients followed-up for one year in secondary care settings (pulmonology services)


Eligibility criteria:
inclusion criteria: * female and male patients ≥ 40 years of age * patients diagnosed with idiopathic pulmonary fibrosis (ipf) according to last ats/ers/jrs/alat ipf guideline for diagnosis and management consensus * written informed consent prior to participation exclusion criteria: * inability for the patient to understand or complete the written inform consent or patients questionnaires or to understand spanish * current participation in any clinical trial * patients for whom further follow-up is not possible at the enrolling site
effects of fermented vegetables on gut microflora and inflammation in women

Conditions: Inflammation; Women's Health; Gastrointestinal Microbiome

Summary: this proposal will examine whether daily consumption of fermented vegetables for 6 weeks can impact the gut microflora and markers of inflammation of women between the ages of 18-70 years.

interested participants will be invited to an orientation where study procedures will be explained in detail. once the consent form is signed participants will schedule a visit to provide blood, urine and stool samples at the beginning of the intervention at which point they will be randomized into one of three groups: a fermented vegetable group (1/2 cup per day for 6 weeks), a non-fermented vegetable group (1/2 cup per day for 6 weeks) and a control group (usual diet). both vegetable groups will receive weekly deliveries of the vegetables to be consumed. following 6 weeks, participants will provide blood, urine and stool samples one more time. participants will also fill out questionnaires related to dietary intake, demographics, physical activity, prescription medication use and gastrointestinal function. compliance will be monitored weekly via a gastrointestinal function log where participants will be asked to enter whether they consumed or not the vegetable provided each day, as well as any side effects of consumption.

Eligibility criteria:
inclusion criteria: * bmi: 18.5-40 kg/m2 * non-smoker * no previous diagnosis of cancer * no thyroid disease * no diabetes * willing to consume 1/2 cup of vegetables daily for 6 weeks * no use of psychotic or depression medication * no medication to lose weight * not on a weight loss diet * no use of antibiotics over the past 3 months * no consumption of fermented vegetables on a regular basis * no history of autoimmune disease, including gastrointestinal disease exclusion criteria: * bmi \ 40 kg/m2 * smoker * taking medications that affect appetite or body weight * uncontrolled hypertension * diabetes * not willing to consume 1/2 cup of vegetables daily for 6 weeks * willing to show up at two appointments * following a fad diet * using antibiotics frequently * diagnosed with autoimmune disease, like psoriasis, rheumatoid arthritis, thyroid disease, colitis * regular consumption of fermented vegetables
reminiscence therapy in individuals with dementia

Conditions: Dementia

Summary: this research will be carried out with the aim of determining the effect of reminiscence therapy applied to individuals with dementia on cognitive functions, anxiety, depression and activities of daily living. the research will be conducted with a pre-test post-test single group, quasi-experimental research design.

dementia; it is a disease that requires intensive use of health services, has a high care burden, and has medical, social, psychological and economic burdens for the patient, family and society. dementia is characterized by many disorders in cognitive functions, especially memory, thought and social skills. progressive disorders in cognitive functions cause behavioral changes, decrease in activities of daily living, and neuropsychiatric symptoms such as anxiety and depression.

Eligibility criteria:
inclusion criteria: * being diagnosed with mild to moderate dementia according to dsm-5 criteria (whether individuals have an official diagnosis of neurocognitive disorder according to dsm-5 criteria and their medical diagnosis will be verified from the health records at the institution), * getting a score between 13-23 for the educated (literate) and 10-23 for the uneducated (illiterate) on the mini mental state examination, * being 65 years of age or older, * being able to communicate, * no vision or hearing problems, * consent to participate in the research. exclusion criteria: * getting a score below 13 and above 23 for the educated (literate) and below 10 and above 23 for the uneducated (illiterate) from the mini mental state examination, * having an acute illness that prevents participation in intervention sessions, * having serious sensory and physical limitations that prevent participation, * having severe neuropsychiatric symptoms (agitation, psychosis, apathy, uncontrolled delirium, etc.), * having a traumatic life history, * having recently participated in a similar program.
comparison of video laryngoscopy and direct laryngoscopy for nasotracheal intubation during pediatric dental surgery

Conditions: Airway Complication of Anesthesia; Peroperative Complication; Intraoperative Hypertension; Tachycardia, Sinus; Desaturation of Blood

Summary: background and objective: airway control is a condition that should be evaluated primarily in anesthesia practice in the pediatric age group. failed intubation or prolonged intubation duration can cause atelectasis and hypoxia in children. the aim of this study was to examine the effects of macintosh laryngoscopy and mcgrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia. methods: sixty-six patients were divided into two groups according to the procedure used during intubation, namely, direct laryngoscopy or video laryngoscopy. the cormack-lehane and mallampati scores, intubation duration, heart rate at minutes 0, 1, 3 and 5 during intubation, mean arterial pressure, etco2and spo2 values were recorded for all the patients.

many techniques in the management of a difficult airway have been used in adult patients. in pediatric patients, awake fiberoptic intubation is difficult or even impossible . the video laryngoscope is a new tool produced by combining video technology and laryngoscope. published studies on the video laryngoscope were mostly performed in adults . in this study, we used a macintosh laryngoscope, which is a routinely used tool in anesthesiology, and a mcgrath video laryngoscope, which is a type of a newly developed video laryngoscope that has not widely been used in the pediatric age group. the aim of this study was to examine the effects of macintosh laryngoscopy and mcgrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia. we also evaluated whether macintosh laryngoscopy and mcgrath videolaryngoscopy improved the stress response and whether these approaches facilitated the intubation procedure.

Eligibility criteria:
inclusion criteria: healthy children between the ages of 4-13 * ordu university school of medicine ,pediatric age group ,elective oral surgery 4-13 years and who were scheduled for elective oral surgery under general anesthesia with intubation if patients with a cormack -lehane score 1,2 or 3 and if mallampathy score of 1,2 or 3 were inccluded from the study exclusion criteria: 1. with malignancy disease patients 2. with norological disorders 3. with congenital heart disease 4. with airway abnormality 5. with airway disease patients 6. patients age under 4 years , above 13 years 7. if patients with a cormack -lehane score 4 and if mallampathy score of 4 were excluded from the study -

Keywords: pediatric oral surgery direct laryngoscopy video laryngoscopy nasotracheal intubation
anal incontinence after obstetrical anal sphincter injury

Conditions: Obstetric Trauma; Anal Sphincter Injury; Anal Incontinence

Summary: obstetrical anal sphincter injury is an identified risk factor for anal incontinence. the mechanisms and the risk factors for anal incontinence in obstetrical anal sphincter injury women are not well known. anal incontinence in such women is not well documented and probably underestimated. cohort studies estimated that up to 53% of obstetrical anal sphincter injury women are incontinent but that most of them does not complain their doctor.


Eligibility criteria:
inclusion criteria: * childbirth between 2005 january 1st and 2019 december 31th * obstetrical anal sphincter injury -≥ 18 y exclusion criteria: * patients' refusal * lost of view or deceased * anal incontinence before the obstetrical anal sphincter injury
respiratory syncytial virus infection in neonatal intensive care units throughout turkey: prospective multicenter study (turknicu-rsv trial)

Conditions: Respiratory Syncytial Virus Infections; Infections, Epidemics

Summary: the principle purpose of this multicenter trial is to determine the definition, timing and the percentage of nosocomial rsv epidemics throughout turkey. in addition, secondary purpose of the trial is to determine the prevention strategies of further spread of respiratory syncytial virus (rsv) in the neonatal intensive care unit (nicu).


Eligibility criteria:
inclusion criteria: * confirmed rsv infection with either rsv-strip test or polymerase chain reaction (pcr). * admission to the nicu or hospitalized in the nicu between 1 october 2013 and 01 april 2014. exclusion criteria: * refused informed consent

Keywords: respiratory syncytial virus infections epidemics neonatal intensive care unit newborn infants
a phase 1 study of medi0562 in adult subjects with selected advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: to evaluate the safety and tolerability of medi0562 in adult subjects with selected advanced solid tumors

this is a first-time-in-human (ftih) phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of medi0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected advanced solid tumors.

Eligibility criteria:
inclusion criteria: * subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies. * subjects must have at least 1 measurable lesion. * consent to provide archived tumor specimens * willingness to undergo pre-treatment and on-treatment biopsy. * adequate organ function. * use of highly effective contraception (females) or male condom plus spermicide (males). exclusion criteria: * prior treatment with tnfrsf agonists. * subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll. o must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event. * history of severe allergic reactions to any unknown allergens or any components of the study drug formulations. * receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of medi0562. * any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment. * unresolved toxicities from prior anticancer therapy. * any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.

Keywords: advanced solid tumors; immunotherapy; ox40; immuno-oncology
treating the endothelium to restore insulin sensitivity

Conditions: Obesity; Insulin Resistance; Impaired Glucose Tolerance; Pre-diabetes

Summary: a study of 12 weeks' treatment with losartan or placebo, to test the hypothesis that ras inhibition will improve insulin' vascular actions and therefore improve insulin sensitivity in skeletal muscle.

recent studies suggesting an effect of cardiovascular therapies to prevent diabetes remain unexplained. we hypothesize that these therapies improve vascular endothelial function allowing improved actions of insulin in the vasculature, which comprise a significant portion of insulin's metabolic action. we therefore propose to measure insulin-mediated glucose disposal and insulin-mediated vasodilation before and after 12 weeks' therapy with losartan (an angiotensin receptor blocker) or placebo, in a randomized design. subjects will include 28 subjects with impaired glucose tolerance, which is generally accompanied by both insulin resistance and impaired vascular function. with this number of participants we have a 90% chance of showing a statistically significant and clinically meaningful effect of insulin on leg vascular resistance, and an even higher chance of showing a difference in insulin's metabolic effects. exclusion criteria will include frank hypertension, diabetes, or hypercholesterolemia, and biochemical or other contraindications to losartan therapy. the primary endpoint for statistical analysis will be the invasive measure of insulin-stimulated endothelial function. we anticipate an improvement in both vascular and metabolic measures of insulin action following losartan therapy but no change from untreated baseline following placebo.

Eligibility criteria:
inclusion criteria: * healthy * age 20-55 * male and female * obese, defined as males: bmi \>28 or \> 30% fat by dexa scan or bod pod; females: bmi \>30 or \> 33% fat by dexa scan or bod pod * weight stable over at least 4 months exclusion criteria: * diabetes mellitus (ada criteria) * age \ 55 yrs * blood pressure \>160/90 or \< 90/65 mmhg * total cholesterol \>240 or ldl cholesterol \>160 mg/dl * baseline elevations in ast or alt \> 3x uln * baseline elevation in creatinine \>1.6 ng/ml * unexplained baseline elevation in creatine kinase \> 3x uln * concurrent significant chronic medical illness including, but not limited to, human immunodeficiency virus infection, syphilis, hepatitis b infection, or hepatitis c infection * pregnancy * known hypersensitivity or intolerance to the study agents

Keywords: obesity insulin resistance impaired glucose tolerance pre-diabetes
tolerance and acceptability evaluation aymes cardiff

Conditions: Malnutrition

Summary: to evaluate tolerance and acceptability of 'cardiff' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

to evaluate tolerance and acceptability of 'cardiff' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of gi effects, compliance, product preference, convenience etc. to obtain data to support an acbs submissions for 'cardiff' (to allow for prescription in the community at nhs expense).

Eligibility criteria:
inclusion criteria: * male and female patients. * ≥ 18 years of age. * patients of the intended target group (e.g. must score ≥ 1) with an anticipated period of nutritional support ≥ 30 days. * patient is able and willing to provide written informed consent. exclusion criteria: * patients with medical or dietary contraindication to any feed ingredients. * patients requiring sole enteral tube feeding or parenteral nutrition. * patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.) * patients with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids. * patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms. * patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements. * participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study.