Kornimate/medical-research-clean huggingface dataset:
the effects of omega-3 fatty acids on metabolic syndrome

Conditions: Metabolic Syndrome X

Summary: the purpose of this study is to determine the effects of omega-3 fatty acids in the form of fish oil supplementation (approximately 2 grams per day) on the carotid intima-media (cimt)progression (primary objective) and 2)(secondary objective) lipid markers such as ldl, apo-b, and ldl buoyancy, on inflammatory burden as measured by crp, on oxidative stress as measured by urinary isoprostanes, urine microalbumin/creatinine, and serum adiponectin a fat derived hormone in subjects with metabolic syndrome.

this translational pilot study will have a double-blind, placebo-controlled, parallel design. we will enroll one hundred subjects who meet at least 3 of the 5 criteria for metabolic syndrome as per ncep guidelines/who guidelines and who do not have known cardiovascular disease or diabetes. they will receive either placebo or omega-3 fatty acids in the form of fish oil capsules for a two-year period. assessment of, c-imt, serum lipoprotein profile, ldl- buoyancy, adiponectin, crp, saa, apolipoprotein b and a-1, fasting glucose, fasting insulin levels, and plasma fatty acids will be measured at baseline, one year, and two years.

Eligibility criteria:
inclusion criteria: * adults with metabolic syndrome (meets 3 of the following 5) * abdominal obesity, waist circumference in men greater than 40 in. \& in women greater than 35 in. * serum triglycerides greater than or = 150 mg/dl (1.7 mmol/l) * serum hdl cholesterol less than or = 40 mg/dl in men and less than 50 mg/dl in women * blood pressure greater than or = 130/85 mmhg or drug treatment for elevated blood pressure * fasting plasma glucose greater than 100 mg/dl exclusion criteria: * diabetes * known or documented chd (including ecg consistent with prior mi), cva (including tia), pvd (including symptoms of claudication) * angina or other chest pain that may indicate chd * clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable) * known abnormal lfts greater than 2x uln * smoker, illicit drug use, or excessive alcohol use * medications: lipid lowering therapy, daily nsaid or greater than 325 mg asa (prn use ok), clopidogrel (or equivalent), coumadin, omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months * pregnancy or planning pregnancy during the study period * sensitivity or allergy to fish

Keywords: fatty acids, omega-3
efficacy and safety of aclidinium bromide at two dose levels versus placebo administered in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in copd patients and the benefits of the product in disease-related health status, copd symptoms and copd exacerbations.


Eligibility criteria:
inclusion criteria: * adult male and female patients aged ≥40 with stable moderate to severe copd (gold guidelines). * post-salbutamol (fev1) \< 80% and ≥30% of predicted normal value and post-salbutamol fev1/fvc \< 70%. * current or ex-smokers of ≥10 pack-years. exclusion criteria: * patients with no history or current diagnosis of asthma. * no evidence of an exacerbation within 6 weeks prior to the screening visit. * no evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities. * no contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

Keywords: chronic obstructive pulmonary disease antimuscarinic copd
the impact of hospitalization on ambulatory blood pressure and intraocular pressure

Conditions: Blood Pressure

Summary: the purpose of this study is to assess the effect of hospital admission on 24-hour ambulatory blood pressure (abp) in hypertensive subjects.treated or untreated hypertensive adults with open angle glaucoma underwent in-hospital and outpatient 24-hour abp monitoring, in random order 4 weeks apart.


Eligibility criteria:
inclusion criteria: * age \>30 years old. * subject has signed an informed consent. * patient has untreated ocular hypertension (iop at 10:00 between 22-34 mm hg) * patient has stage 1 arterial hypertension with or without therapy exclusion criteria: * secondary hypertension. * stage 2 or 3 hypertension, history of renal disease. * sleep apnea. * diabetes mellitus * acute or chronic inflammation. * myocardial infarction or unstable angina within the past 6 months. * heart failure nyha class iii-iv. * active liver disease. * pregnancy. * history of drug or alcohol abuse, or any other condition with poor prognosis. * treatment with non-steroid anti-inflammatory agents, corticosteroids, beta-blockers, or any other regimen that could affect bp levels. * smoking

Keywords: hypertension ambulatory measurement
correlation of clinical frailty scale and modified frailty index in intensive care patients

Conditions: Frailty

Summary: the purpose of our study is to evaluate the correlation of the clinical frailty scale, which is a judgment-based measure, and the modified frailty index, which interrogates the patient's current diseases, in the frailty assessment of intensive care patients and the effect on the estimation of mortality, mechanical ventilation need, intensive care stay, hospital stay and discharge status.


Eligibility criteria:
inclusion criteria: * intensive care patients exclusion criteria: * patients with a life expectancy of less than 24 hours * do not speak turkish
nausea and vomiting in patients receiving consecutive days of cisplatin

Conditions: Metastatic Melanoma; Nausea

Summary: the purpose of this study is to observe the incidence of nausea with systemic chemotherapy that includes consecutive days (more than one day)of cisplatin medication.

questionnaires are completed on week of chemotherapy treatment referred to as dartmouth regimen.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis metastatic melanoma * 18 years and older * undergoing chemotherapy with dartmouth regimen * medically stable to receive chemotherapy per physical and clinical laboratory tests exclusion criteria: * no medical conditions that interfere with assessment of nausea and vomiting during chemotherapy * no cognitive disorder that impairs symptom assessment * no other investigational agent * inability to swallow medications for nausea and vomiting * no gastric outlet obstruction
evaluation of the sanitary safety of a healthcare professional conference held 9-11 june 2021 in paris

Conditions: Covid19

Summary: the covid-srlf study will evaluate the sanitary safety of the french intensive care society (fics) annual meeting held in paris congress center from june 9th to june 11th 2021 in the coronavirus disease 2019 (covid-2019) pandemic situation. the primary objective is to determine the proportion of attendees with a positive antigenic covid-19 screening test at day 7 (+/- 1) of their participation to the meeting. this rate will be compared to a cohort of health care professionals (medical doctors and paramedical professionals) from the same hospital ward as the attendees but who did not attend the meeting (stratified on centers, gender, age (\ = 40 years, vaccination status (0, 1 or 2 doses) and socio-professional status (medical doctor, nurse, nurse assistant).


Eligibility criteria:
inclusion criteria: * healthcare professional healthy volunteer * absence of covid-19 symptoms in the 2 weeks prior to inclusion * not being a covid-19 contact case in the 2 weeks prior to inclusion * participation to at least one day of the fics annual meeting (june 9-11 2021) exclusion criteria: * non-healthcare professional (exhibitors, congress center employees) * refusal to participate to the study * person under legal protection * absence of social security affiliation
a multi-method early intervention program for inhibited and anxious preschoolers

Conditions: Behavioral Inhibition; Anxiety

Summary: this project aims to develop and evaluate a novel early intervention program that targets the specific risk factors implicated in the development and persistence of shyness, social reticence, and withdrawal in children. the project includes a program development phase, phase i (pilot test of full study procedures using developed treatment protocol), and phase ii (randomized controlled trial/rct). outcomes that will be assessed include change in child behavioral inhibition and parenting, using parent and teacher reports and observational data. families are assessed at three time points: baseline, post-treatment (or at approximately 8 weeks for the control group), and 2 month follow-up.


Eligibility criteria:
inclusion criteria: * child must be attending preschool; child must score within top 15% on parent-rated behavioral inhibition questionnaire; child has a biological parent with at least 50% physical custody who consents to participate exclusion criteria: * child has a diagnosis of pervasive developmental disorder or mental retardation; child scores above clinical cutoff on social communication questionnaire; child is currently receiving treatment for anxiety
surgical interventions for the treatment of humeral shaft fractures

Conditions: Fracture of Shaft of Humerus; Humerus Fracture

Summary: this study intends to determine the best surgical treatment for humeral shaft fractures. one third of the patients will be treated with open reduction and internal fixation with plate; one third, with bridge plate technique and the remaining third with locked intramedullary nail.

humerus diaphyseal fractures are amongst the most common of the appendicular skeleton. despite the fact that the conservative treatment is still the gold standard for the majority of these fractures, this method was not proven to be superior when compared to the surgical treatment. surgical options for the treatment of humeral shaft fractures range from open reduction and internal fixation with plate to minimally invasive methods (bridge plate and intramedullary nail) and the best method has yet to be determined. the goal of this study is to determine the best surgical option for the treatment of humeral shaft fractures. for this, will be recruited 105 patients with humeral shaft fractures, wich will be allocated, randomly, in 3 distinct groups. each patient will be submitted to one of three possible methods of humerus osteosynthesis: open reduction and internal fixation with plate (orif), closed reduction and fixation with bridge plate or closed reduction and fixation with intramedullary nail. all data will be paired according to the age, gender, fracture classification, patient comorbidities and smoking habit. the pearson's chi-square" test will be used to analyze the results of the three groups regarding categorical variables, and student t-test (parametric) will be used to compare groups with respect to the numerical variables. the investigators expect to conclude that the methods of minimally invasive osteosynthesis of humeral shaft fractures have similar or better functional and radiographic outcomes, compared to the method of open reduction and internal fixation with a plate, with lesser risk of complications and an earlier return to activities.

Eligibility criteria:
inclusion criteria: * complete fracture with angulation greater than 20 degrees, rotation greater than 30 degrees and/or shortening greater than 3 cm. * fractures located from 4 cm distal to the surgical neck to 2 cm proximal to the end of the medullary canal. exclusion criteria: * fractures older than 3 weeks * pathologic fractures * fractures with extension to elbow or shoulder joint * patients with ipsilateral upper extremity fracture or injury * fractures with associated neurologic injury * patients with previous pathology of the shoulder, arm or elbow that cause pain or range of motion limitation * patients who do not agree with the terms of the study

Keywords: humerus shaft diaphyseal fractures
trial to optimize just-in-time adaptive intervention for binge eating & weight-related behaviors

Conditions: Binge Eating; Obesity

Summary: the purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence.


Eligibility criteria:
inclusion criteria: * adults age 18 years or older * obesity (bmi ≥30) * recurrent binge eating (≥12 episodes in the past 3 months) * interested in losing weight and reducing binge eating * willing to use a mobile application * has a smartphone with internet access and capacity for calls and text messaging * has a valid email address * has access to a scale * not pregnant * english-speaking exclusion criteria: * diagnosis for which the study/intervention is not clinically indicated * not currently receiving clinical services for weight management or binge eating
evaluation of neuroinflamation of sah

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: the investigators are planning that can these markers be used a predictive marker at sah and for this aim we will study both patiens' blood sample and their ct image.

an ideal marker which could be used clinically should meet numerous criteria, such as high sensitivity or the possibility of easy and quick assessment of its concentration in blood or blood plasma.the fisher's scale presents an alternative for evaluating patients with subarachnoid hemorrhage . the investigator are going to evaluate both plasma markers and fishers scale at sah.

Eligibility criteria:
inclusion criteria: * ruptured subarachnoid aneursym exclusion criteria: * without aneursymal sah * patient's positive for rheumatoid factor and anti-ccp or with chronic inflammatory diseases (such as ankylosing spondylitis or rheumatoid arthritis), systemic diseases (such as hypercholesterolemia, hypertension, diabetes mellitus, myocardial infarction, stroke, peripheral artery disease), active infection, a history of term medication, trauma to the hip and smoking were excluded from the study.
study of ism3412 in participants with locally advanced/metastatic solid tumors

Conditions: Locally Advanced/Metastatic Solid Tumors

Summary: the study has consists of two parts, a dose escalation part (part 1) and a dose selection optimization part (part 2). the primary objectives of this study are to evaluate the safety and tolerability of ism3412 in participants with locally advanced/metastatic solid tumors, and to determine the rp2d of ism3412.


Eligibility criteria:
inclusion criteria: 1. male or female participants with age ≥18 years at the time of signing the informed consent. 2. histologically confirmed unresectable locally advanced or metastatic solid tumors with confirmed homozygous mtap deletion, who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists. 3. have measurable or evaluable lesions in part 1 and at least one measurable target lesion in part 2 as defined by response evaluation criteria in solid tumors (recist) criteria. 4. participants must provide a documentary evidence of homozygous mtap deletion; or provide archival formalin-fixed paraffin-embedded (ffpe) tumor tissue blocks or at least 15 ffpe tumor tissue slides, or perform tumor tissue biopsies for a confirmatory genetic test indicating homozygous mtap deletion. 5. ecog ps (eastern cooperative oncology group performance status) ≤1. 6. life expectancy of ≥12 weeks as judged by the investigator. 7. adequate organ function as determined by medical assessment. 8. capable of providing signed icf and complying with the requirements and restrictions listed in the icf and in this study protocol. exclusion criteria: 1. prior treated with other mat2a inhibitors and/or prmt inhibitors. 2. participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment. 3. anti-tumor therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-tumor therapy, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogues, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment. 4. toxicities of prior therapy have not resolved to grade ≤1 or to baseline (as evaluated by nci ctcae version 5.0) 5. history of another primary tumor that has been diagnosed or required therapy within the past 3 years. 6. previous history of, or presence of gilbert's syndrome. 7. previous history of myelodysplastic syndrome. 8. prior solid organ or hematopoietic stem cell transplant. 9. known active central nervous system (cns) primary tumor or untreated cns metastases. 10. have serious cardiovascular or cerebrovascular disease as per protocol. 11. presence of uncontrolled systemic infection as per protocol. 12. unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition. other protocol inclusion and exclusion criteria may apply.

Keywords: methionine adenosyltransferase 2a (mat2a) homozygous mtap deletion mat2a inhibitor ism3412
professional consequences of ocular trauma hospitalized at the hospital centre of clermont-ferrand

Conditions: Eye Injuries; Work Performance; Occupational Stress

Summary: ocular trauma are a real public health issue. according to who, it is estimates at 750,000 hospital admissions per year in the world for ocular trauma, including 200,000 for open globe injuries in the world. consequences can be severe with a significant number of definitive low vision or blindness which can lead to professionnal reclassifications for active patients. however, no study exists on professional consequences of those ocular trauma. some studies showed that fonctionnal loss of an eye can also have psychological consequences such as post traumatic depression or can impair the quality of life but studies are scarce on this subject. the primary objective is to study the professional reclassification of workers at least 6 months after their hospitalization for ocular trauma. secondary objectives are to assess, at least 6 months after an hospitalized ocular trauma, characteristics of eye injuries, characteristics of patients, mid-term consequences at work after eye injury and on personal aspects.

use of the ophthalmologic consultation report, the ophthalmologic hospitalization report and a telephone questionnaire to carry out the study. at least 6 months after the traumatism, an ophthalmologist member of the team, m. vincent jawad, will call each patient for answering a telephone questionnaire after obtention of his oral consent. if the traumatism occur after the beginning of the study, the patient will be informed, by m. vincent jawad, of the modalities of the study during his hospitalization and an information letter will be given to the patient in the same time (annex 2). his non opposition will be asked by telephone, remote from the hospitalization, before proceeding to the telephone questionnaire. if the traumatism occur before the beginning of the study or if the information and non opposition letter has not been given to the patient during the hospitalization, the information letter (annex 2) will be sent by mail to the patient before the telephone call. in all cases, the patient's consent (or non opposition) will be collected orally before proceeding to the telephone questionnaire (annex 1). medical data will be obtained from the medical report of hospitalization and the last report consultation of his ophthalmologist.

Eligibility criteria:
inclusion criteria: * adults, with a job * hospitalized for ocular trauma in the ophthalmology unit of the university hospital of clermont-ferrand * from january the first of 2005 to december the 31st of 2022. exclusion criteria: * patient without job at the time of the ocular traumatism * refusal to participate in the study * unable to answer to the telephone questionnaire (difficulties understanding, cognitive disorders...) * impossibility to contact the patient

Keywords: workers eye injuries work abilities
the effect of prostaglandin i2 on the endothelial cell function disorder in type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus; Peripheral Microvascular Symptoms

Summary: this study attempts to examine the effect of oral prostaglandin i2 (beraprost na), administered for eight weeks, on the endothelial cell functional disorder among asymptomatic high risk diabetes mellitus patients.

this study plans to include those subjects who have complaint of peripheral microvascular symptoms but have evidences of having neither a coronary arterial disease nor a peripheral arterial disease and show normal findings in the vascular stiffness test (pwv and abi)) and plethysmography of the legs (pvr)) ,among type ii diabetes mellitus patients of forty-five (45) years old or older, this study is conducted by using a randomized double blind method. these drugs are distributed through a pharmacy in the clinical study center and administered randomly for eight weeks while this study allots patients by using a double blind method. beraprost na is administered along with a placebo that was manufactured by the same manufacturer to have the identical exterior look and weight of beraprost na. after eight weeks of drug administration, this investigation attempts to verify symptomatic improvement and change in the endothelial function by using vendys® and icg perfusion imaging.

Eligibility criteria:
inclusion criteria: * type ii diabetes mellitus patient * patients with symptoms of a minute peripheral blood flow disorder exclusion criteria: * cases with either an already-diagnosed coronary arterial disease or a peripheral vascular disease * cases with a history of stroke * cases with an abnormal finding of vascular stiffness test (pwv and abi) and plethysmography of legs (pvr) * pregnant women or fertile women with an unclear pregnancy

Keywords: prostaglandin i2 beraprost na endothelial cell function
predisposing factors for the incidence of adrenal crisis

Conditions: Adrenal Insufficiency

Summary: within this clinical study patients with chronic adrenal insufficiency will be investigated by clinical and biochemical examination as well as questionnaire to identify predisposing factors for adrenal crisis.

patients with chronic adrenal insufficiency (ai) are at risk of suffering from life-threatening adrenal crisis (ac), despite established hormone replacement therapies and patient education. recent retrospective analyses observed different risk factors for ac, e.g. primary ai and comorbidities. furthermore, patients that already experienced an ac seem to have an increased risk to develop further ac. the aim of the study is to evaluate potential risk factors/predisposing factors for ac in patients with chronic primary and secondary ai (pai/sai). patients with chronic ai are assessed by clinical and biochemical examination and questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor. ai patients with a high frequency of ac will be compared to matched controls (age, sex and cause of ai) with no ac or a low frequency of ac in the past.

Eligibility criteria:
inclusion criteria: * age \>18 years * patient´s written informed consent * ability to comply with the protocol procedures * patients with chronic primary or secondary adrenal insufficiency under established stable replacement therapy (disease duration at least 2 years) exclusion criteria: * age \<18 years * pregnancy or breast feeding * intake of cyp3a4-inducting-drugs

Keywords: adrenal crisis predisposing factors