Kornimate/medical-research-clean huggingface dataset:
hyperprolactinaemia management in reproductive services at university hospital of coventry and warwickshire

Conditions: Hyperprolactinemia; Subfertility; Subclinical hypothyroïdism

Summary: hyperprolactinaemia and thyroid disorders can significantly reduce fertility by causing ovulatory dysfunction. there is no evidence to suggest treatment of hyperprolactinaemia in the presence of regular ovulatory menstruation will improve fertility. however, anecdotal observation of practice at uhcw nhs trust suggested that dopamine agonists are often prescribed irrespective of whether symptoms of hyperprolactinaemia are present. the aim of the study was to establish the prevalence of hyperprolactinaemia and incidence of subclinical hypothyroidism in patients undergoing subfertility investigations at uhcw nhs trust. also, to examine management of patients with hyperprolactinaemia and a normal pituitary mri scan, and explore the trends in treatment; and finally, to explore how this could improve reproductive services. 107 patients were identified as having a high prolactin reading between january 2014 and january 2017. hospital records were examined for patient demographics, relevant blood and scan results, medical history, any treatment, and treatment outcomes. the prevalence of hyperprolactinaemia was 23%. 20.6% of patients had suboptimal thyroid function and were started on levothyroxine. prolactin levels, and presence of relevant symptoms, only had a partial bearing on whether dopamine agonists were used in those with normal pituitary mri results (or where no scan was performed). the use of dopamine agonists appeared to correlate with assisted conception and a lower incidence of birth complications (inc. miscarriage, prematurity), though the significance of this was limited by the size of the dataset. dopamine agonists often appeared to be used in more complex patients, rather than exclusively those with a higher prolactin reading and/or the presence of related symptomatology. patients frequently underwent a pituitary mri scan in the absence of symptoms, contrary to evidence. the findings suggest that less patients should be scanned and less treated with dopamine agonists. a health economics evaluation study would be useful to elucidate the potential cost saving this could represent. it may be better to prioritise optimisation of thyroid function, particularly when noting the similarities in the prevalence of suboptimal thyroid function and that of hyperprolactinaemia.


Eligibility criteria:
inclusion criteria: * undergoing care through subfertility services at uhcw * referred and seen in subfertility services between january 2014 to october 2017 * identified as having had at least one episode of hyperprolactinaemia within the study period (jan 2014 to january 2017) exclusion criteria: * referred outside of study period * hyperprolactinaemia reading outside of study period
skeletal health of klinefelter patients

Conditions: Osteoporosis

Summary: this study compared the bone health of ks patients who were actively monitored in our clinic by dual-energy x-ray absorptiometry (dxa) with that of a control group of healthy volunteers.

klinefelter syndrome (ks) is the most common chromosome number abnormality of men, occurring in 1/500 to 1/1000 live births . it was first described in 1942 as an endocrine disorder characterised by small, hard testicles androgen deficiency, gynaecomastia and increased follicle stimulating hormone (fsh). osteoporosis is a progressive bone remodelling disorder in which bone loss exceeds bone formation. the resulting micro-architectural defects and bone fragility are associated with increased fracture risk and mortality. in ks, testosterone deficiency is associated with decreased bone mass and low bone mineral density (bmd) , and a positive correlation of total serum testosterone and bmd has been reported . there are some exceptions ; however, most studies have reported that ks increases the risk of osteopenia and osteoporosis compared with age-matched control groups.

Eligibility criteria:
inclusion criteria: * diagnosis of klinefelter exclusion criteria: * klinefelter subjects with a history of hip or waist surgery or trauma * for control group with known bone disease, unknown fertility hypogonadism findings on physical examination (e.g. low testicular volume or abnormal body hair), known hypogonadism, previous androgen replacement therapy any drug therapy affecting bone metabolism

Keywords: klinefelter osteoporosis dual-energy x-ray absorptiometry
tiotropium +olodaterol fixed dose combination (fdc) versus tiotropium and olodaterol in chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol fdc (delivered by the respimat inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the respimat inhaler) in patients with copd.


Eligibility criteria:
inclusion criteria: 1. diagnosis of chronic obstructive pulmonary disease. 2. relatively stable airway obstruction with post fev1\< 80% predicted normal and post fev1/fvc \<70%. 3. male or female patients, 40 years of age or older. 4. smoking history of more than 10 pack years. exclusion criteria: 1. significant disease other than copd 2. clinically relevant abnormal lab values. 3. history of asthma. 4. diagnosis of thyrotoxicosis 5. diagnosis of paroxysmal tachycardia 6. history of myocardial infarction within 1 year of screening visit 7. unstable or life-threatening cardiac arrhythmia. 8. hospitalization for heart failure within the past year. 9. known active tuberculosis. 10. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 11. history of life-threatening pulmonary obstruction. 12. history of cystic fibrosis. 13. clinically evident bronchiectasis. 14. history of significant alcohol or drug abuse. 15. thoracotomy with pulmonary resection 16. oral ß-adrenergics. 17. oral corticosteroid medication at unstable doses 18. regular use of daytime oxygen therapy for more than one hour per day 19. pulmonary rehabilitation program in the six weeks prior to the screening visit 20. investigational drug within one month or six half lives (whichever is greater) prior to screening visit 21. known hypersensitivity to ß-adrenergic drugs, anticholinergics, bac, edta 22. pregnant or nursing women. 23. women of childbearing potential not using a highly effective method of birth control 24. patients who are unable to comply with pulmonary medication restrictions
continued safety monitoring of solanezumab (ly2062430) in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study is an open-label extension study in alzheimer's patients who have completed participation in either solanezumab clinical trial h8a-mc-lzam (nct00905372) or h8a-mc-lzan (nct00904683).


Eligibility criteria:
inclusion criteria: * meets national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria for probable alzheimer's disease * has completed participation in solanezumab study lzam or study lzan through 80 weeks * must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study * must have good vein access to administer infusions * agrees not to participate in studies of any other investigational compounds for the duration of their participation in study lzao exclusion criteria: * are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study * meets lzam or lzan discontinuation criteria at the end of treatment in lzam or lzan study
the opal - covid-19 study

Conditions: COVID-19

Summary: in collaboration with involved healthcare professionals and a patient advisory committee, this study tests the feasibility of using the opal smartphone app to daily capture self-reported physical and psychological symptoms and vital signs among 50 people who are self-isolating at home with covid-19. a healthcare team at montreal's muhc will remotely monitor their condition and offer advice and teleconsultations, as needed.

in the context of the current pandemic, guidelines were issued by public health authorities to follow the progression of covid-19 in the community, identify and treat affected people, and limit transmissions. about 90% of people with covid-19 only exhibit mild symptoms and recover. however, a small percentage of people experience serious symptoms and require hospitalization for severe shortness of breath or low oxygen levels. the current public health protocol is to identify people with covid-19 and isolate them from others at home to prevent the virus from spreading. currently, there is no consensus on how to effectively follow-up and treat individuals with covid-19 who are self-isolating at home. research is urgently needed. this pilot study will assess the feasibility of one strategy for home-based covid-19 follow-up . the opal app for covid is a mobile application that will allow the completion of a daily symptom and vital sign follow-up questionnaire that will be monitored by a healthcare team. educational material will also be provided through the app. the study will especially assess the acceptability and usability of the smartphone app.

Eligibility criteria:
inclusion criteria: * 18 years or older * fluent in english and/or french * confirmed positive for pcr+ sars-cov-2 * willing and able to understand the requirements of study participation and provide oral informed consent * access to a smartphone, tablet or computer at home * access to an internet connection at home or data plan on their smartphone * comfortable with the idea of using a new smartphone application to complete daily questionnaires, access educational material, and communicate with the healthcare team, or having someone to assist them with technology * prescribed self-isolation at home * proof of identity (passport, ramq, driver's license) exclusion criteria: * have received a negative laboratory test result for the infection with covid-19 * confirmed negative for pcr+ sars-cov-2 and hospitalized * has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving a smartphone application * enrollment in any study involving an investigational drug for covid-19 disease during the study period

Keywords: covid-19 self-isolation mhealth patient portals
a prospective non-interventional study to evaluate clinical outcomes of ribociclib combined with endocrine therapy in elderly patients with hr+her2 - advanced breast cancer in routine clinical practice in russian federation

Conditions: HR+HER2- Advanced Breast Cancer

Summary: this is а prospective, non-interventional, primary data collection study to evaluate the effectiveness, safety and quality of life in older patients (≥65 years) with hr+her2- advanced breast cancer receiving ribociclib with et in the first or second line in the real-life settings in russia.

in this study, an index event is a start of ribociclib+et treatment. post-index follow-up period is 24 months or until treatment discontinuation. the recruitment period is planned for 12 months. the interim analyses will be performed after enrollment is complete, and further one year later. patients will visit the sites in accordance with routine clinical practice. it is assumed according to the clinical practice that visits will be conducted every 3-4 months. patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement.

Eligibility criteria:
inclusion criteria: 1. age ≥ 65 years at the moment of ribociclib+et initiation 2. female/male gender 3. confirmed diagnosis of locally advanced/metastatic not eligible for curative surgery hr+her2- bc for whom the treating physician took the decision to initiate treatment with ribociclib+ia/ful in the first or in the second line of the treatment 4. patient who initiated treatment with ribociclib+ia/ful no longer than 4 weeks (28 days) prior to written informed consent for this study 5. provision of written informed consent. exclusion criteria: 1. patients with a life expectancy of less than 3 months per the investigator's judgment 2. patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (patients participating in other investigator initiated research or nis can be included as long as their standard of care is not altered by the study) 3. patients on active treatment for malignancies other than abc within 3 years before bc diagnosis 4. patients with active cardiac disease, or history of cardiac dysfunction, including prolonged qt interval corrected using fridericia's formula (qtcf \> 450 msec).

Keywords: hr+her2- advanced breast cancer, ribociclib, elderly patients
sleep well for healthy brain

Conditions: Poor Quality Sleep

Summary: the purpose of this study is to slow down the aging of the participant's brain by improving sleep quality.


Eligibility criteria:
inclusion criteria: * english-speaking healthy subjects age 55 years and older capable and willing to consent to participate in the study. in addition, subject should be cognitively normal and have well documented sleep issues that results with poor sleep quality based on self-reported assessment. exclusion criteria: * pregnant women * cognitively impaired subjects not able to provide consent * prisoners * subjects 55 years of age and older that meet criteria for mild cognitive impairment. * subjects with any neurological disorder. * any other condition that in the opinion of the investigator may affect the participation in this study
leaders free ii: biofreedom™ pivotal study

Conditions: Acute Coronary Syndrome; High Bleeding Risk

Summary: this study aims to confirm non-inferiority of the biofreedom™ drug coated stent to the gazelle™ bare metal stent arm of the leaders free study (nct01623180) in high bleeding risk patients.

in this study all patients will receive the biofreedom™ drug coated stent and one month of dual anti platelet therapy

Eligibility criteria:
inclusion criteria: any indication for percutaneous coronary intervention with stent placement (pci-s) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (dapt). this includes candidates with stable angina, silent ischemia, acute coronary syndrome (stemi and non-stemi), non-native lesions and in-stent restenosis. patients must provide written informed consent. reasons of unsuitability for \> 1 month dual antiplatelet treatment must include one or more of the following: 1. adjunctive oral anticoagulation treatment planned to continue after pci 2. age ≥ 75 years old 3. baseline hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure) 4. any prior intracerebral bleed 5. any stroke in the last 12 months 6. hospital admission for bleeding during the prior 12 months 7. non skin cancer diagnosed or treated \< 3 years, with a perceived increased risk for bleeding 8. planned daily nonsteroidal anti-inflammatory drugs (nsaid) (other than aspirin) or steroids for \>30 days after pci 9. planned surgery that would require interruption of dapt (within next 6 months) 10. renal failure defined as: creatinine clearance \<40 ml/min 11. thrombocytopenia (plt \<100,000/mm3) 12. severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice 13. expected non-compliance to prolonged dapt for other medical reasons exclusion criteria: 1. pregnant and breastfeeding women 2. patients expected not to comply with 1 month dapt 3. patients requiring a planned staged pci procedure more than one week after the index procedure 4. procedure planned to require non-study stents, or stand-alone plain old balloon angioplasty (poba) or stand-alone atherectomy 5. active bleeding at the time of inclusion 6. reference vessel diameter \ 4.0mm 7. cardiogenic shock 8. compliance with long-term single anti-platelet therapy unlikely 9. a known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, biolimus a9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated 10. pci during the previous 12 months for a lesion other than the target lesion of the index procedure 11. participation in another clinical trial (12 months after index procedure) 12. patients with a life expectancy of \< 12 months 13. patients under judicial protection, tutorship or curatorship (for france only)

Keywords: acute coronary syndrome percutaneous coronary intervention drug coated stent drug eluting stent
evaluation of cemiplimab in combination with platinum-doublet chemotherapy in first-line (1l) treatment of advanced non-small cell lung cancer (nsclc) in adult united states (us) patients

Conditions: Advanced Non-small Cell Lung Cancer

Summary: this multi-year cohort study will assess the real-world safety and effectiveness of 1l treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced nsclc patient subgroups defined by age, sex, race, and ethnicity. patients will be retrospectively identified from at least two us electronic health record (ehr)-based databases.

patients and baseline variables will be captured retrospectively, but outcome measures will be prospectively ascertained.

Eligibility criteria:
key inclusion criteria: 1. advanced non-small cell lung cancer (ansclc) (defined as stage iiib/c or stage iv) treated with cemiplimab in combination with platinum-doublet chemotherapy in the 1l setting from nov 2022 to jun 2026 as described in the protocol key exclusion criteria: 1. patients who have egfr, alk or ros1 variants 2. treatment with egfr, alk or ros1 inhibitors at any time prior to the index date 3. patients actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: advanced non-small cell lung cancer (ansclc) epidermal growth factor receptor (egfr) anaplastic lymphoma kinase (alk) c-ros oncogene receptor tyrosine kinase (ros1)
effects of e-cigarette flavors on adults tcors 2.0

Conditions: Nicotine Use Disorder

Summary: this study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.

this study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. this will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.

Eligibility criteria:
inclusion criteria: * ages 18-24 years or 35 -50 years * able to read and write * smoking \> 10 cigarettes or cigars/day * willing to abstain from regular smoking for 2 weeks and use only e-cigarettes * not seeking treatment to stop smoking * no regular use of e-cigarettes exclusion criteria: * daily use of other drugs including prescribed psychoactive drugs * any significant current medical or psychiatric condition * known hypersensitivity to propylene glycol * pregnant or lactating females
correlates of angiographic changes and coronary events

Conditions: Cardiovascular Diseases; Coronary Disease; Coronary Arteriosclerosis; Heart Diseases

Summary: to examine the appropriateness of angiographic and ultrasound endpoints as predictors of subsequent clinical coronary events. follow-up data from the cholesterol lowering in atherosclerosis study (clas) were used.

background: a multitude of coronary angiographic trials have been conducted using various endpoint measures based on repeated coronary angiograms. relative to coronary event trials, angiographic trials require both a smaller sample size and reduced trial length. while such trials have assumed that angiographic endpoints are valid surrogate measures for clinical coronary events, this assumption has not been completely tested. although several coronary angiographic endpoints are available for trial outcomes, no single method has been uniformly accepted as optimal. because of this, the utility and validity of coronary angiographic progression for predicting future clinical coronary events remains unsettled. the recent advent of carotid ultrasonography to assess arterial intima-media thickness (imt) offers the exciting potential for a noninvasive measure of atherosclerosis. because of its noninvasiveness, carotid imtallows the extension of anti-atherosclerotic trials to both asymptomatic and frail subjects, for whom coronary angiography might be medically unethical. because there is currently only limited support for the association of carotid imt with clinical events or coronary atherosclerosis, the validity of carotid imt as a potential surrogate for either endpoint has not been established. the cholesterol lowering atherosclerosis study (clas) was a coronary angiographic trial testing the efficacy of colestipol-niacin therapy in 188 nonsmoking, 40-59 year old men with previous coronary artery bypass graft surgery. coronary artery atherosclerosis change was evaluated both by human consensus panel and by quantitative coronary angiography (qca). in addition, b-mode ultrasounds of the common carotid artery was conducted every six months to provide measures of carotid imt. since the competion of the two-year clas study, subjects have been followed for up to 12 years. this long term follow-up of the clas cohort permits examination of the appropriateness of angiographic and ultrasound arterial endpoints as predictors of subsequent clinical coronary events. angiographic and ultrasound (carotid imt) endpoints also allow for testing of the associations between these various serial measures of atherosclerotic progression. the results of these analyses will provide important information on the validity of these measures, which are in current use as trial endpoints, as surrogates for clinical coronary events. design narrative: the study used angiographic and ultrasound carotid intima medial thickness endpoints for testing the associations between these various serial measures of atherosclerotic progression and subsequent coronary heart disease.

Eligibility criteria:
male nonsmoker prior coronary artery bypass graft surgery