Kornimate/medical-research-clean huggingface dataset:
comparison of three liraglutide formulations in healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in oceania. the aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at ph 7.9 and 8.15 and the planned phase 3 formulation at ph 7.7.


Eligibility criteria:
inclusion criteria: * healthy subjects * good general health as judged by the investigator, based on medical history, physical examination including 12-lead ecg (electrocardiogram), vital signs and blood and urinary laboratory assessments. * body mass index (bmi) of 18-27 kg/m\^2, both inclusive exclusion criteria: * history of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, * metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders * that may interfere with the objectives of the study, as judged by the investigator * family or personal history of primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia * impaired renal function * uncontrolled treated/untreated hypertension * any clinically significant abnormal ecg * active hepatitis b and/or active hepatitis c * positive hiv (human immunideficiency virus) antibodies * known or suspected allergy to trial product(s) or related products * pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures * prescription or non-prescription medication, except for paracetamol and vitamins * history of alcoholism or drug abuse during the last 12 months * smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products * habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
identifying mental health distress in em physicians

Conditions: Burnout, Professional

Summary: this project seeks to develop and test provider-centered strategies that improve the detection and facilitate the treatment of physiologic and mental health symptoms in emergency medicine physicians. this will be done by investigating the feasibility and acceptability of wearable device and ema feedback with personalized linkage to an evidence-based mental health platform at the university of pennsylvania health system.

this proposal aims to conduct a 3-month pilot randomized control trial (n=60) testing feasibility, acceptability, and the exploratory effectiveness of digital data feedback (wearables and ema) with tailored, symptom-specific linkage to mental health and resilience resources versus control on mental health symptoms (depression, anxiety, ptsd) and burnout in em clinicians. the study will recruit and enroll 60 emergency medicine physicians, residents, and advanced practice providers via email and inperson outreach. once enrolled, both arms be asked to take a baseline survey which will measure their level of well-being, burnout, depression, and anxiety. study participants will be randomized following consent and completion of baseline surveys. participants will be randomly assigned to usual care or intervention. we will use 2:1 randomization. we will randomize in block sizes of 3 and 6. intervention: the intervention arm will then be given a wearable device and will be asked to wear it for 3 months. the device will collect biometric data on stress levels, sleep patterns, and other physiological measures of well-being. the intervention group will receive biweekly ema short surveys, personalized bi-weekly reports from their ema data, biometric feedback from wearable devices (sleep, heart rate variability, physical activity), and linkage to tailored and symptom-specific cobalt resources on health and resilience. after 3 months, we will survey providers to complete a post-survey followed by a survey at 6-months following a 3-month washout period. control: the control arm will be asked to complete a baseline survey as well as one assessment at the end of the three-month study period. they will receive usual care, or clinician-initiated use of penn cobalt. they will then complete additional surveys at 3-months and 6-months.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * emergency medicine (em) physician or advanced practice provider * daily access to smart phone * ability to use a wrist-worn wearable device * has or is willing to create a gmail / google account * provides at least 20 hours per week of clinical care. exclusion criteria: * under 18 * not a penn em physician or advanced practice provider * does not have daily access to a smart phone * unwilling or unable to wear a wearable device * does not have or is unwilling to create a gmail / google account * does not provide at least 20 hours per week of clinical care
potential improvements in the pre-emergency department care for cancer patients

Conditions: Cancer; Emergencies

Summary: the goal of this single center prospective cross-sectional study is to identify the facilitators and barriers in the course of the disease that starts when symptoms first arise until patients with solid and hematologic malignancies arrive in the emergency department (ed). the main question it aims to answer are: is there a potential relation between the lag-time and the ed length of stay (los) and the chance of admission. participants will be asked to participate in a one-time interview, that focusses on the pre-admission process.

the goal of this single center prospective cross-sectional study is to identify the facilitators and barriers in the course of the disease that starts when symptoms first arise until patients with solid and hematologic malignancies arrive in the emergency department (ed). the main question it aims to answer are: is there a potential relation between the lag-time and the emergency department length of stay and the chance of admission. participants will be asked to participate in a one-time interview, that focusses on the pre-admission process. the interview focuses on several parts of the (pre-)admission process: the first part is regarding the timeline that led to an ed visit. the investigators will establish, when and which symptoms were first detected. the second part are regarding the number and type of health care workers that were contacted before visiting the ed. the third part will be about the actions that were taken before the ed visit.

Eligibility criteria:
inclusion criteria: * patients with solid or hematological malignancies and receiving systemic therapy or having received systemic therapy within the last 3 months. * presented at or admitted from the emergency department for the oncology, hematology, neuro- or lung-oncology clinical unit. * awake and conscious. * possible to answer questions within 48 hours after presentation at the emergency department (ed). exclusion criteria: * \<18 years old * only received a surgical intervention as cancer treatment * admitted to the ed for the surgical department * not willing or able to give written informed consent
thalidomide in treating patients with relapsed or progressive systemic mastocytosis

Conditions: Non Neoplastic Condition; Precancerous Condition

Summary: rationale: thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to the disease. purpose: this phase ii trial is studying how well thalidomide works in treating patients with relapsed or progressive systemic mastocytosis.

objectives: primary * determine the objective response rate at 6 months in patients with systemic mastocytosis treated with thalidomide. secondary * determine the tolerability of this drug in these patients. outline: this is a multicenter study. patients receive oral thalidomide once daily for 6 months in the absence of disease progression.

Eligibility criteria:
disease characteristics: * diagnosis of systemic mastocytosis * aggressive or borderline (smoldering) disease (in first line or more) * relapsed or progressive disease * measurable or evaluable disease * presence of c-kit d816v mutation in the skin, spine, or infiltrated organs * no nonsymptomatic mastocytosis patient characteristics: * life expectancy \> 3 months * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception for 1 month prior to, during, and until first menstrual cycle after completion of study treatment * bilirubin \< 2 times normal (unrelated to disease) * liver enzymes \< 2 times normal (unrelated to disease) * creatinine ≤ 300 mmol/l * no central or peripheral neuropathy leading to psychiatric concerns * no hiv positivity * no active infection or other serious underlying illness that would preclude treatment * no history of thromboembolism or deep vein thrombosis * no geographical, social, or psychological reasons preventing medical monitoring prior concurrent therapy: * more than 4 weeks since prior antitumor therapy (e.g., chemotherapy, radiotherapy) * no other concurrent treatment specific for this disease * no concurrent participation in another experimental drug trial

Keywords: aggressive systemic mastocytosis smoldering systemic mastocytosis
burger allen exercises in knee oa with type ii diabetes

Conditions: Knee Osteoarthritis; Type II Diabetes

Summary: there is a potential link between diabetes mellitus (dm) and severity of osteoarthritis .type 2 diabetes is a part of the metabolic syndrome (mets) accompanied by ageing and mechanical stress are also a risk factor to osteoarthritis. every anatomical component of the joint demonstrated faster joint deterioration and elevated inflammation at microcellular environment of individuals with dm. normal chondrocytes capacity to adapt to the local glucose level is impaired by oa and there is a significant risk of glucose toxicity and increased glucose absorption. the most dependable and effective treatment for mild to early joint osteoarthritis is exercise. active free exercises i.e. buerger allen exercises are used as a conservative perfusion therapy because they rely on how gravity affects the smooth muscles in the valves. synovial fluid supports the joint's ability to recover while also reducing inflammation and enhancing overall joint function. the aim of the study is to determine the effect of buerger allen exercise and low intensity high repetition exercises on pain, range of motion and disability in knee osteoarthritis with type 2 diabetes. the study would be randomized controlled trial. total thirty-six subjects will be assigned randomly by using lottery randomization into two groups. group a will receive conventional therapy and an additional buerger allen exercise while group b will be a control group receiving only baseline treatment. numeric pain rating scale (nprs), ankle brachial index, koos and goniometer will be used as outcome measure tools for pain, range of motion and disability. measure will be taken at baseline and at the end of treatment session. the collected data will be analyzed in statistical package for the social sciences (spss) 25.0.if data will be normally distributed then parametric if not normally distributed than non-parametric

one of the most common joint conditions, osteoarthritis (oa), causes diarthrodial articular cartilage to deteriorate, which in turn causes disability in adults. osteoarthritis (oa) and type 2 diabetes mellitus (t2dm) are common illnesses whose prevalence is projected to increase. the association between diabetes mellitus and oa was originally identified in 1961.after adjusting for body mass index, type 2 diabetes was recently discovered to be an independent risk factor of severe oa, with a hazard ratio (hr) of 2.1. one of the most popular forms of exercise for diabetic patients is the buerger allen exercise, which improves lower extremity perfusion and alleviates symptoms in those with lower limbs arterial insufficiency by using postural changes, stimulation of peripheral circulation, and application of muscle contraction. it has been found that nurses can prevent foot ulcers and lower limb amputations by educating the public, screening high-risk individuals, and giving medical care.

Eligibility criteria:
inclusion criteria: * both genders from age:45-65 year exclusion criteria: * joint instability

Keywords: buerger allen exercises diabetes mellitus knee osteoarthritis
a study to evaluate p-glucose, safety and tolerability after oral single dosing of azd6370 in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess the effect of azd6370 on blood sugar and to study safety and tolerability in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * treated with diet or metformin. stable glycemic control indicated by no changed treatment within 3 months * diabetes mellitus diagnosis \<5 years exclusion criteria: * clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the investigational product * clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results

Keywords: type 2 diabetes
the effects of including almonds in a weight loss trial

Conditions: Overweight; Obesity

Summary: the purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

the purpose of this study is to determine whether inclusion of almonds in a weight loss regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive function.

Eligibility criteria:
inclusion criteria: adult participants * overweight or obese (bmi 25-40 kg/m2) * fasting blood glucose ≤6.9 mmol/l via capillary finger-stick blood samples * no nut allergies * willing to comply to study protocol and to eat test meals exclusion criteria: those not meeting inclusion criteria.

Keywords: almonds energy restriction obesity body weight body fat blood pressure cognitive function
real world analysis on lymphocyte reconstitution after lymphopenia in participants treated by tecfidera

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Summary: the primary objective of the study is to describe absolute lymphocyte count (alc) reconstitution after dimethyl fumarate (dmf) discontinuation, in relapsing-remitting multiple sclerosis (rrms) participants with lymphopenia. the secondary objectives of the study are characterization of lymphopenia in overall population; characterization of lymphopenia in participant with dmf discontinuation ; description of the evolution of alc during dmf treatment; description of the time to reach a discontinuation of dmf treatment; exploration of the time to reach clinical outcomes (expanded disability status scale \[edss\] and relapse) according to lymphopenia; description of the event rate of the serious or opportunistic infections in overall population from dmf initiation and according to dmf discontinuation and lymphopenia; description of the event rate of serious and opportunistic infections in overall population from dmf initiation and according to lymphopenia; estimation of the associations between the baseline demographic and clinical characteristics and the risk to reach a lymphopenia; estimation of the associations between the baseline demographics and clinical characteristics and the risk to reach an alc reconstitution after dmf discontinuation in participants with lymphopenia; and investigation of the changes of absolute cluster of differentiation 4 (cd4) and cluster of differentiation 8 (cd8) count in overall population on dmf if available.

the study will select participants initiating treatment from 01 jan 2016 to 15 dec 2020.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of rrms at dmf initiation * minimum of 3 months of continuous treatment with dmf\* * initiation of dmf between january 1st, 2016 and december 15th, 2020 * minimum of 2 alc assessments: 1. 1 alc at dmf initiation (or within 6 months before dmf initiation); or under dmf treatment 2. 1 alc before the database extraction (15/06/2021). * to avoid the early dmf discontinuations for reasons other than lymphopenia. exclusion criteria: * participants will be excluded from the study entry if they express their opposition to collect the data upon the information.
randomized study to evaluate the efficacy of fluvastatin on inflammatory markers in patients with aortic stenosis.

Conditions: Aortic Valve Stenosis

Summary: atherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in common. we hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease.

this study will be a prospective, phase iv-iii, randomized, double blinded, active controlled study, to evaluate the efficacy of fluvastatin on inflammatory markers in the haemodynamic progression of degenerative aortic stenosis. we hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease. eligible patients with degenerative aortic stenosis will be randomized 1:1 to fluvastatin 80 mg once daily or placebo. the treatment should be continued until the study end (12 months). follow up investigations will be performed after 3 months and at the end of the study (12 months).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. asymptomatic 3. aortic stenosis defined as aortic valve leaflet thickening with reduced systolic opening (maximum aortic jet velocity \>2 m/s) 4. written informed consent to participate in the study 5. patients capable to follow all conditions along the study. exclusion criteria: 1. symptomatic patients caused by aortic stenosis. 2. patients on statins anytime in the year before inclusion. 3. patients diagnosed of dyslipidemia requiring statins. 4. temperature ³37,8 ºc in the week before inclusion. 5. any cardiovascular event succeeding in the three months before inclusion 6. known thyrotoxicosis 7. renal failure requiring hemodialysis 8. any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations. 9. any surgery succeeding in the three months before inclusion. 10. patients with any hepatopathy that in the view of the investigator prohibits participation in the study. 11. patients with known muscular disease. 12. patients with any severe medical condition that in the view of the investigator prohibits participation in the study 13. use of corticoids, immunosuppressors or non steroid drugs. 14. any known sensitivity to study drug (fluvastatin) or class of study drug. 15. patients participating in any study in the last year. 16. women of childbearing potential not using the contraception method(s) specified in this study, suspicion of pregnancy, as well as women who are breastfeeding

Keywords: c reactive protein inflammation aortic valve stenosis progression
a comprehensive registry study of the whole life cycle of patients with chd

Conditions: Congenital Heart Disease

Summary: this observational study aims to collect data on the prevalence, intervention, and prognosis of congenital heart disease (chd) in chinese patients across their entire lifecycle. from the diagnosis of chd in fetuses, to early treatment of severe chd in neonates, to standardized perinatal diagnosis and treatment of chd patients with concurrent pregnancy, the study employs a cyclical model consisting of evaluation, training, improvement, and re-evaluation. the goal is to enhance the diagnostic and treatment capabilities of participating hospitals, especially for complex chd cases, and promote standardized clinical practices in cardiovascular disease treatment among these hospitals. this will ultimately improve the quality of medical services provided to cardiovascular patients and serve as a basis for exploring chd treatment guidelines suitable for china. the project will be implemented by capital medical university affiliated beijing anzhen hospital and the national clinical research center for cardiovascular diseases. the plan is to involve more than 20 hospitals over the next five years. an independent website will be created for data collection, education and training, as well as experience sharing among participating hospitals. starting from january 1, 2024, each hospital will continuously collect chd inpatient cases on a monthly basis. the project team will regularly analyze and report on the completion of key medical quality evaluation indicators for each hospital. they will provide guidance measures such as education, training, experience sharing, and on-site investigations to address identified issues, helping hospitals improve medical quality. hospitals that demonstrate excellence and significant improvement will be recognized and commended, driving overall improvement in the quality of cardiovascular medical care in china.


Eligibility criteria:
inclusion criteria: * patients with various congenital heart diseases exclusion criteria: * none
fibre specific signalling in the locomotor myopathy of chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: skeletal muscle is composed of two fibre types which are intertwined. skeletal muscle weakness, particularly of the walking muscles, is an important complication of chronic obstructive pulmonary disease (copd) but so far the investigators do not know what mechanisms drive the process. all existing studies have investigated signalling pathways in the whole muscle so they have been forced to consider type i and type ii fibres together. it is possible that disease selectively affects one fibre type, most likely type i fibres which are in fact lost in copd patients. for this reason mechanisms of disease may have been overlooked by current studies. the applicants have acquired the technology which allows type i and type ii fibres in a muscle specimen to be split (by laser capture microdissection) and so signalling pathways can be assessed separately in type ii and type i fibres which is what this proposal sets out to do. the proposal therefore aims to capture well characterised clinical data from 60 copd patients and 20 age matched controls, from whom a biopsy of the main walking muscle, the quadriceps, will be taken. in the samples the investigators will assess at a fibre specific level inflammatory signalling. surplus material will be retained for subsequent fibre specific analysis.


Eligibility criteria:
inclusion criteria: * male or female aged 40 - 90 years inclusive. * a clinical diagnosis of copd based on spirometry (fev1/fvc ratio \< 70% on entry to the study with fev1 \< 80% predicted) exclusion criteria: * history or current diagnosis of alpha 1-anti-trypsin deficiency, asthma, lung cancer, bronchiectasis or other significant respiratory disease (including treated tb in the past 10 years) * contraindication to biopsy for research purpose (e.g. use of anticoagulant in the 1 week prior to biopsy) * joint or neurological disease which on its own would preclude exercise
gbr 12909 study in cocaine experienced african american volunteers - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to assess gbr 12909 in cocaine experienced african american volunteers.

double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of gbr 12909 in cocaine experienced african american volunteers. particular interest is being given to the hematological safety data.

Eligibility criteria:
inclusion criteria: * must be within 20% of ideal body weight and must weigh at least 45 kg. * must understand the study procedures and provide written informed consent. * must meet dsm-4 criteria for abuse or dependence on cocaine. * must be non-treatment seeking at the time of the study. exclusion criteria: * please contact the study site for more information.