Kornimate/medical-research-clean huggingface dataset:
retrospective case study to validate existing chemoresponse marker test in ovarian, peritoneal or fallopian cancer cases

Conditions: Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Summary: the purpose of this study is to improve upon and validate the prognostic and/or predictive accuracy of a drug response marker by the development of improved alternative algorithms based on the actual clinical outcome of retrospective cases.

this is a multicenter, retrospective chart review study of de-identified drug response marker results and a limited data set of clinical outcome data. data from approximately 512 cases will be collected from approximately 30 sites and correlated to the secondary endpoints identified in order to produce a training set that will incorporate additional improvements to the existing chemofx scoring system. the outcome of progression free survival will be defined as the period of time between the first dose of chemotherapy following the report of the marker result until clinical progression or death. objective response will be measured from the first dose of chemotherapy following the report of the marker result until progression or change in therapy.

Eligibility criteria:
inclusion criteria: * case has an original pathology report showing, epithelial ovarian, peritoneal, or fallopian tube carcinoma. * cases must meet one of the following classifications: recurrent: complete response following primary therapy and a period of absence of no measurable disease; persistent: partial response following 6 cycles of a platinum based therapy with measurable disease remaining or refractory: stable disease or progressive disease during primary platinum therapy. * case must have a commercial chemofx drug response marker final report exclusion criteria: * cases with evidence of synchronous primary endometrial cancer or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than i-b; less than 3 mm invasion without vascular or lymphatic invasion; no poorly differentiated subtype, including papillary serous, clear cell, or other figo grade 3 lesion.
association between increased oxidative stress, anti-inflammatory fatty acid formation, and airway infection in people with asthma and chronic obstructive pulmonary disease

Conditions: Asthma; Pulmonary Disease, Chronic Obstructive

Summary: chronic obstructive pulmonary disease (copd) and asthma are common respiratory diseases in which people experience long-term inflammation of the lungs. exacerbations, or prolonged worsening of symptoms, of asthma and copd are often life-threatening and can lead to frequent need for hospitalization. even with the proper use of bronchodilators, corticosteroids, and other currently available medications, clinical responses among people with copd and asthma are variable. there remains a significant unmet clinical need for new therapeutic approaches and insights, including the identification of biomarkers to accurately assess the presence of airway infection and intensity of airway inflammation. this study will investigate potential natural biological causes and new biomarkers for increased susceptibility to persistent airway infection in asthma and copd.

copd and asthma are chronic lung diseases that result in impaired air flow in the lungs, often causing coughing, wheezing, and shortness of breath. in uncontrolled copd and asthma, people may experience a rapid worsening of symptoms, which may include fever, difficulty breathing, and chest pain. these exacerbations are the most serious expression of asthma and copd and are usually caused by lung infections or air allergens. however, the biological basis for susceptibility to airway infection and inflammation is not well understood. increased oxidative stress within the airways has been linked to several airway diseases. this increase in oxidative stress may reduce production of key fatty acid anti-inflammatory mediators. in turn, this may disrupt the airway's natural immune response mechanisms, making the airways more vulnerable to infection or inflammation during copd and asthma exacerbations. this ancillary study will determine whether susceptibility to persistent airway infection in asthma and copd stems from increased oxidative stress that impairs the natural formation of protective fatty acid mediators. this ancillary study will use data biological samples, including blood and sputum, from participants currently enrolled in the macrolides in asthma (mia; nct00318708) and the antileukotriene therapy for copd exacerbations (kia; nct01097694). biological samples will undergo fatty acid mediator analysis and rna isolation. there will be no study visits for this study.

Eligibility criteria:
inclusion criteria: * no change from the mia and leuko trials exclusion criteria: * no change from the mia and leuko trials

Keywords: copd airway inflammation infection lipid mediators oxidative stress
covid-19 in tunisia: an observational cross-sectional registry study

Conditions: Covid 19; BCG Vaccination

Summary: covid-19 in tunisia: an observational cross-sectional registry study


Eligibility criteria:
inclusion criteria: * covid-19 (+), inpatient or outpatient, confirmed by pcr test * covid-19 (-) confirmed by pcr test having been in contact with covid-19 (+) exclusion criteria: * covid(+) and covid(-) diagnosed by other tests than pcr * covid-19 (-) not having been in contact with covid19(+)

Keywords: covid 19 bcg vaccination
evaluation of the response to tyrosine kinase inhibitors in localized non-small cell lung cancer (nsclc) patients with egfr mutation in a patient-derived organoid model

Conditions: Lung Cancer; Lung Adenocarcinoma; EGFR Activating Mutation; KRAS Mutation-Related Tumors; Non Small Cell Lung Cancer

Summary: lung cancer is a major public health problem and remains the leading cause of cancer mortality worldwide. moreover, in france, it is the 3rd most common cancer in terms of incidence. its prognosis remains poor despite the emergence of new therapies, notably the epithelial growth factor receptor (egfr) specific tyrosine kinase inhibitors which can be used in patients with adenocarcinoma presenting an activating mutation of egfr. in addition, a number of questions remain regarding the use of these molecules, including the possibility of combining them with other therapies such as chemotherapy or radiotherapy. in addition, the duration of treatment with tyrosine kinase inhibitors is a matter of debate, mainly in localised forms (adaura trial). for this reason, we have proposed tests using tkis on an in vitro platform based on organoid formation from tumour biopsies of nsclc patients. this model will allow to test different molecules, in particular osimertinib which is a third generation tyrosine kinase inhibitor. in this way, it will be possible to evaluate in vitro responder patients within a timeframe compatible with the timeframe proposed by the inca (4-6 weeks). for non-responders, it will also be possible to screen them in vitro and seek the ideal alternative therapy. this model therefore aims to develop personalised medicine in thoracic oncology and could be used as a decision aid during multidisciplinary consultation meetings.


Eligibility criteria:
inclusion criteria: * age 18 years or older * patient affiliated to a social security scheme * having given their agreement to participate in the study * with non small cell lung cancer of any stage undergoing surgical resection at the nancy university hospital exclusion criteria: * refusal to participate * hepatitis * hiv * legal guardianship * guardianship * inability to give informed information to the patient * pregnant women-

Keywords: tyrosine kinase inhibitors lung adenocarcinoma egfr activating mutation kras mutation-related tumors
a first-in-human, single- and multiple-ascending dose study of yh35995 in healthy adult male participants

Conditions: Healthy Participants

Summary: this is a randomized, double-blind, first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of yh35995

yh35995 is being developed as a treatment for the neurological symptoms of gaucher disease type 3. this study is a first-in-human (fih), phase 1, randomized, double-blind, placebo-controlled study of yh35995, which consists of two parts. in part a (sad), single ascending dose of yh35995 is administered to healthy male participants to assess its safety, tolerability, pk, and pd. in part b (mad), multiple ascending dose of yh35995 is administered to healthy male participants to assess its safety, tolerability, pk, and pd.

Eligibility criteria:
inclusion criteria: * male between the ages of 19 and 45 at the time of providing written consent * participants who weigh at least 50 kg at screening and have a body mass index (bmi) of at least 18.0 kg/m2 and less than 30 kg/m2 * participants who have been fully informed about and fully understand this study, have voluntarily decided to participate, and have agreed in writing to comply with the guidelines of the study during the duration of the study exclusion criteria: * participation in a bioequivalence trial or any other clinical trials within 6 months prior to the first scheduled dose of the ip (within 1 month of the first scheduled dose for participants who have taken part in a dietary supplement clinical trial) * individuals with clinically significant abnormal results that do not match any other inclusion/exclusion criteria, as determined by the principal investigator and the delegated persons(investigator) * individuals who are unwilling or unable to comply with the participant guidelines described in this protocol

Keywords: yh35995 gaucher disease
a randomised control trial of integrative cognitive behavioural therapy for alopecia

Conditions: Alopecia

Summary: this randomised control trial (rct) aims to test a novel alopecia-tailored, protocolled, integrative individual psychological intervention offered to patients with enduring alopecia. the pilot study aims to assess the impact of the intervention on 8 patients, by assessing changes in their psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to 7 patients in the wait-list control group.

alopecia is a stress-related auto-immune skin condition that results in hair-loss on the scalp and around the body. this pilot rct aims to test a newly developed alopecia-specific, psychological intervention with 8 patients diagnosed with enduring alopecia. the intervention is an integrative cognitive behavioural therapy, implemented through a protocolled programme entailing 12 weeks of hourly individual sessions. the trial will be delivered at the dermatology department at the royal free hospital in hampstead, london. the pilot study aims to evaluate the impact of the intervention on patients' psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to the wait-list control group.

Eligibility criteria:
inclusion criteria: * diagnosis of alopecia received by medical profession over 1 year prior to beginning trial * fluent in written and verbal english exclusion criteria: * another more dominant skin condition * another more dominant severe and enduring mental illness * women who are pregnant * learning difficulties, brain injuries or dementia * drug and alcohol dependency * received therapy in the last year

Keywords: cognitive behavioural therapy mindfulness narrative therapy alopecia areata alopecia universalis alopecia totalis psychology health psychology
effects of drospirenone-ethinylestradiol and/or metformin on cardiovascular risk in hyperinsulinemic women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: to evaluate long-term effects of drospirenone (drsp)/ethinylestradiol (ee) alone, metformin alone and drsp/ee plus metformin on some cardiovascular risk factors in hyperinsulinemic pcos patients

polycystic ovary syndrome (pcos), one of the most common endocrine disorders affecting women on reproductive age , seems to be associated with an increased incidence of cardiovascular disease. at present, insulin-sensitizing drugs, such as metformin, represent one of the most important line treatment for hyperinsulinemic pcos women. metformin is able to produce favourable outcomes on the metabolic derangements in insulin-resistant normal weight and obese pcos patients. oral contraceptives represent the traditional medical therapy for the long-term treatment of pcos women, in order to obtain regular menstrual cycles and to improve the clinical signs of hyperandrogenism.based on the above mentioned evidences, the aim of the present study was to evaluate the effects of drps/ee alone versus metformin alone versus drps/ee plus metformin on the cd4+cd28null t cells frequency and on endocrino-metabolic parameters, in hyperinsulinemic pcos patients

Eligibility criteria:
inclusion criteria: * age 18-35 * hyperinsulinemic pcos exclusion criteria: * chronic or acute inflammatory disease, cancer, autoimmune disease, treatment with clomiphene citrate, oral contraceptives, antiandrogens, drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, dm2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).

Keywords: pcos
does the new fall- and fracture prevention initiative in oslo have effect?

Conditions: Fall Injury; Hip Fractures

Summary: the goal of this controlled before and after study is to evaluate a new patient pathway for patients 65 years and older who have suffered a fall injury. the main questions the study aims to answer are whether this preventive initiative with improved care coordination reduces risk of subsequent hip fractures, admittance to nursing homes or death. researchers will compare two boroughs in oslo who implemented the new patient pathway with the 13 other boroughs who did not reorganize their follow-up, but continued their care as usual.

the study is an evaluation of a new patient follow-up for fall prevention in oslo with improvement of coordination of care for elderly at risk of fall injuries. the intervention were introduced to the boroughs of nordstrand and østensjø, which are compared to the other 13 boroughs of oslo in this controlled before and after study. the cohort all persons 65 years and older in oslo are included in oslo fall cohort and we follow all cohort participants prospectively. outcome variables * hip fracture * long term admittance to nursing home * death timeline the investigators have defined the following dates as the start of intervention: 1. start of intervention in nordstrand borough is set to january 1, 2015. 2. start of intervention østensjø borough is set to september 1, 2016. in the main analysis, fallers from the two intervention boroughs, nordstrand and østensjø, will be compared with fallers from the control boroughs during the intervention. any differences between the intervention and control boroughs before the intervention started will be taken into account. data on all participants are available from 2010, and the participants will be followed from january 2012 until december 2019. for each analysis, persons with a hip fracture or living in a nursing home at baseline will be excluded. the analysis in the evaluation is based on registry data and no analysis relating the intervention to the outcomes has been done before registration in clinicaltrials.gov.

Eligibility criteria:
inclusion criteria: * 65 years or older * living on oslo, norway in the period january 1. 2012 - december 31. 2019 exclusion criteria: * hip fracture before baseline * living in nursing home at baseline
pancreatoduodenectomy in pancreatic and periampullary tumors

Conditions: Pancreatic and Periampullary Tumors

Summary: background: recently it has been observed in pancreatic cancer that after apparently complete surgical resection, histological examination of the surgical specimen according to a standard protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. to increase the resection margin and reduce such high infiltration rate, a new surgical approach based on the initial dissection of the superior mesenteric artery has been advocated. aims: to compare the rate of free resection margin (r0) and oncological results of two possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area: the classic approach versus the initial approach of the superior mesenteric artery. methodology: prospective, randomized, multicenter study in which patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy. in a group the classical approach from the superior mesenteric vein will be performed and in the other group an initially dissecting the superior mesenteric artery approach will be carried out. 116 patients are required and the main variables considered are: free margin rates (r0) or infiltrated by tumor (r1), postoperative morbidity, mortality, local and systemic recurrence, disease-free interval and survival at 1, 3 and 5 years.


Eligibility criteria:
inclusion criteria: * patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy exclusion criteria: * patients with hepatic or peritoneal metastasis * patients with irresectable tumor * patients with r2 resection * patients grade iv of the american society of anesthesiology score * patients with neoadjuvant treatment

Keywords: pancreatoduodenectomy pancreatic tumors periampullary tumors
healing of the esophageal mucosa after rfa of barrett's esophagus

Conditions: Barrett Esophagus

Summary: radiofrequency ablation (rfa) is a mainstay of treatment for patients who have barrett's esophagus (be) with dysplasia. for unclear reasons, barrett's esophagus recurs after successful rfa treatment in approximately 1/3 of patients. the aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after rfa for non-dysplastic and dysplastic barrett's esophagus.

radiofrequency ablation (rfa) is a mainstay of treatment for patients who have barrett's esophagus (be) with dysplasia. for unclear reasons, barrett's esophagus recurs after successful rfa treatment in approximately 1/3 of patients. little is known of how the esophagus heals after rfa treatment, and a better understanding of this healing process might provide insights into how to prevent barrett's metaplasia from recurring after successful ablation. the aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after rfa for non-dysplastic and dysplastic barrett's esophagus. patients with barrett's esophagus will undergo surveillance endoscopy with biopsy. this will be followed by rfa treatment of the be and follow up endoscopy will be performed 1, 2, and 4 weeks after rfa. healing at each time point will be assessed endoscopically, and molecular markers related to healing will be studied. stem cell expression markers, immune cells and markers of epithelial-mesenchymal transition will be compared with baseline expression for each patient. protocol has been modified to provide a collaborative effort between the dallas vamc and baylor scott \& white medical center in dallas, tx. veteran participants electing to participate will receive initial screening and endoscopy at the dallas vamc and will continue with rfa and follow-up endoscopies at baylor. an identical protocol has been approved at baylor scott \& white medical center. patients who are screened and enrolled at baylor will receive all treatments at that location.

Eligibility criteria:
inclusion criteria: - barrett's esophagus exclusion criteria: * inability to provide informed consent * esophageal varices * treatment with warfarin * coagulopathy that precludes safe biopsy of the esophagus (including platelet count \ 1.5) * allergy to fluorescein sodium * comorbidity that precludes safe participation in the study * pregnancy or breastfeeding status
improving sleep quality during pregnancy using an oral appliance

Conditions: Snoring; Sleep Fragmentation

Summary: many pregnant women suffer from poor sleep quality and snoring. evidence shows an increasing association between (1) sleep disordered breathing and (2) maternal cardiovascular disease and in-hospital death. snoring is a variant of obstructive sleep apnea (osa) and osa during pregnancy is associated with higher risks for cesarean delivery, gestational hypertension, preeclampsia and preterm delivery. it may also impact fetal outcomes negatively. the purpose of this study is to determine whether sleep quality can be improved in pregnant women who snore by means of an oral appliance that opens the airway. sleep quality is evaluated objectively using an un-intrusive home sleep test system.

as many as 20 percent of women suffer from snoring and poor sleep quality while pregnant. the purpose of this study is to determine whether sleep can be improved in pregnant women who snore by means of a midline traction oral appliance (oa) that opens the airway. this is an interventional study to objectively evaluate oa therapy on breathing during sleep as well as its effect on sleep quality. pregnant women from all trimesters will be recruited. each subject is expected to participate in the study for at least five (5) consecutive weeks. home sleep recordings will be collected at three time points: t0 - baseline prior to oa use for two consecutive nights; t1- first two consecutive nights wearing the oa; t2 - for two consecutive nights after 4 weeks of appliance use. in addition to the sleep studies performed at each of these time points, subjects will also complete several brief surveys. all participants will be given the opportunity to use their oas after the 4 week period, and have their sleep recorded at 8 week intervals through the remainder of their pregnancies. participants will get to keep and use their oas after the study. pregnant women who snore (or otherwise have poor sleep), may qualify to participate in this study. those who do not want to wear an oral appliance, but are interested in learning about sleep quality while pregnant, may also qualify to participate as a control subject.

Eligibility criteria:
inclusion criteria: * pregnant adults who snore * at least 8 teeth per arch * mallampati score from i to ii * palatine tonsils grade 0,1 or 2 * capable of giving verbal and written informed consent * able to apply the sleep recorder and the oral appliance. exclusion criteria: * pregnant \> 32 weeks * uncontrolled serious health issues * cardiovascular or cardiac rhythm disorders * pharmacological dependency * concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol * ongoing temporomandibular joint disorders * loose teeth or periodontal disease * history of uvulopalatopharyngoplasty (uppp)