Kornimate/medical-research-clean huggingface dataset:
epidemiology of diabetes interventions and complications (edic)

Conditions: Type 1 Diabetes Mellitus

Summary: the diabetes control and complications trial (dcct,1983-1993) compared intensive therapy aimed at near-normal glycemia versus conventional therapy with no specific glucose targets in 1441 subjects with type 1 diabetes (t1dm) over a mean follow-up of 6.5 years. intensive therapy reduced the risks of retinopathy, nephropathy, and neuropathy by 35-76%. the level of glycemia was the primary determinant of complications. we also described the adverse effects of intensive therapy; assessed its effects on cardiovascular disease (cvd) risk factors, neurocognition and quality of life; and projected the lifetime health-economic impact. after the primary dcct results were reported in 1993, intensive therapy aiming for a hba1c \<7% was adopted world-wide as standard-of-care for t1dm. the epidemiology of diabetes interventions and complications (edic, 1994-present) is the observational follow-up study of the dcct cohort. micro- and cardio-vascular complications and a wide range of established and putative risk factors, including genetic and epigenetic factors, have been measured with standardized methods, carefully documented and events adjudicated. edic has notably shown that the early beneficial effects of intensive versus conventional therapy on complications persisted for \~15 years despite the convergence of hba1c levels in the two groups during edic, a novel concept termed metabolic memory. prior intensive therapy was also shown to reduce substantially the risk of cvd events and mortality. the overarching goals for the current cycle (2022-2027) are to study the occurrence and identify potentially modifiable risk factors of the more advanced microvascular and cardiovascular complications and physical and cognitive dysfunction that are occurring with increasing diabetes duration and age. with increasing longevity, the increased adiposity that has affected patients with t1dm, including edic participants, has potential adverse consequences. thus, the impact of diabetes duration, aging and adiposity on morbidities and their underlying risk factors will be studied. the results will guide treatment priorities as t1dm patients age.


Eligibility criteria:
participants originally enrolled in the diabetes control and complications trial (dcct) (n01-dk-6-2204-a).
vldl and ldl particle types as coronary heart disease risk factors

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Infarction; Diabetes Mellitus; Diabetes Mellitus, Non-insulin Dependent

Summary: to evaluate very low density lipoprotein (vldl) and low density lipoprotein (ldl) particle types as predictors of initial coronary events.

background: plasma triglyceride concentration is an independent although relatively weak risk factor for coronary heart disease (chd). the relative weakness of plasma triglycerides to predict chd may be due to the substantial diversity of lipoprotein particles that carry the triglycerides, some being related to atherosclerosis and chd more than others. the investigators have shown in patients who have had a myocardial infarction that the rather weak association between triglycerides and subsequent coronary events is secondary to a stronger relationship with specific types of vldl remnants, those in the ldl density range that contain apociil. design narrative: the study will evaluate vldl and ldl particle types as predictors of initial coronary events in men from the health professional follow-up study (hpfs) and women from the nurses health study (nhs). a prospective nested case-control design will be used with a total of 1000 chd cases and 1000 matched controls, with equal numbers of men and women. the investigators will specifically investigate the role of apociii containing vldl and ldl particles in diabetes by over sampling so that 50% of the patients will have type 2 diabetes mellitus. their previous work shows that ldl apociii particles are independent predictors of recurrent chd in diabetic patients who survived a myocardial infarction. they hypothesize that apociii may have a special role in dyslipidemia and chd in diabetes. secondary aims: besides apociii, other small apolipoproteins, apo c1, cii, and all are components of vldl and ldl and modulate the metabolism of apob lipoproteins. it is likely that these apolipoproteins have a relationship with human atherosclerosis. they will measure these apolipoproteins in vldl and ldl and evaluate their relationship to chd. they will also investigate the associations between these new lipoprotein risk factors and intake of foods and nutrients, physical activity, and other risk factors, including smoking, bmi, age and gender. the results will provide new means to identify nondiabetic and diabetic persons who are at high risk of developing chd and the environmental determinants, and could form the basis for new lipoprotein targets for lipid management by diet and medicines.

Eligibility criteria:
cases having first coronary event
high school success: vocational soft skills program for transition-age asd youth

Conditions: Autism Spectrum Disorder

Summary: by utilizing community-based participatory research methods, this research was conducted in collaboration with the community through our partnership of researchers, educators, providers and consumers (active collaborative hub for individuals with asd to enhance vocation and education- achieve) to adapt a vocational soft skills program, supported, comprehensive cognitive enhancement \& social skills (success), for transition age youth (tay). the first step (years 1-2) involved adapting the intervention for autistic tay by including feedback from multiple stakeholders and developing a curriculum to be implemented in both high schools and transition programs for the specific needs of autistic tay and alpha piloting it. it involved understanding further the educational context for tay students and current services available to prepare students for secondary outcomes of employment and/or college through a county wide survey. step 2 (years 2-3) included pilot testing the feasibility, acceptability, implementation procedures and initial youth outcomes of the tay success intervention and further refining the curriculum and protocols. findings demonstrated improvements in executive functioning and social functioning targets as well as distal outcomes of self-efficacy, mental health, educational and work behaviors and attitudes. the study results were disseminated through the achieve group as well as at conferences, website and publication.

aim: with our achieve partners , develop the high school supported, comprehensive cognitive enhancement and social skills (success) program to fit the needs of transition-age youth with asd within the community educational system. 1. standardize the tay success program by developing a facilitator manual, student workbook and corresponding support person materials. 2. develop a training protocol that can be individualized and implemented within the hs educational system to provide initial training and ongoing coaching for educators to reach and sustain intervention fidelity. aim: conduct a pilot study to examine the feasibility, acceptability, and implementation procedures (recruitment, randomization, retention \& training strategies) of tay success and to obtain estimates of effects to support a future large-scale effectiveness trial. 1. examine intervention feasibility, acceptability, satisfaction, and sustainability. 2. examine preliminary outcomes (executive functioning and social functioning)

Eligibility criteria:
inclusion criteria: * autism spectrum disorder * 15-22 yrs * communicative english language * enrolled in participating high school or transition program exclusion criteria: * intellectual disability * other significant mental health

Keywords: executive functioning social cognitions social communication transition age youth
hypersensitivity to phosphodiesterase 3 inhibition in post-traumatic headache

Conditions: Post-Traumatic Headache

Summary: to investigate whether cilostazol (phosphodiesterase 3 inhibitor) induces headache with migraine-like features in people with persistent post-traumatic headache (pth) attributed to mild traumatic brain injury (mtbi).


Eligibility criteria:
inclusion criteria: * age 18 to 65 years of age upon entry into screening * history of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the international classification of headache disorders, 3rd edition (ichd-3) * ≥ 4 monthly headache days on average across the 3 months prior to screening * provision of informed consent prior to initiation of any study-specific activities/procedures. exclusion criteria: * \> 1 mild traumatic injury to the head * history of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache) * history of moderate or severe injury to the head * history of whiplash injury * history of craniotomy * history or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion * the subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior * female subjects of childbearing potential with a positive pregnancy test during any study visit * cardiovascular disease of any kind, including cerebrovascular diseases * hypertension (systolic blood pressure of ≥150 mmhg and/or diastolic blood pressure of ≥100 mmhg) prior to the start of infusion on the experimental day * hypotension (systolic blood pressure of ≤90 mmhg and/or diastolic blood pressure of ≤50 mmhg) * initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion * intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start * baseline headache intensity of \>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache) * baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features
risk stratification of patients with suspected covid-19 presenting to the ed

Conditions: Covid19

Summary: this project is an unfunded collaboration of approximately 30 emergency departments across europe led by the eusem research network. it involves collection of data in relation to determining the epidemiology and outcome of adult patients who present to emergency departments with a suspected covid infection.

over the past 6 months, the world has faced a novel infection disease outbreak, due to a novel coronavirus, the severe acute respiratory syndrome coronavirus (sars-cov2), with a massive impact on healthcare resource. in europe, numbers of confirmed cases continue to rise. europe is currently one of the regions with the highest number of covid-19 cases and deaths due to this emergent diseases. most covid-19 infected patients present with mild to moderate acute respiratory symptoms, including cough, fever, dyspnea and pneumonia. about 20% will present with severe or critical manifestations of the disease, including pneumonia, respiratory failure and acute respiratory distress syndrome (ards). anticipating the needs for hospitalization in ward and/or intensive care is crucial. emergency departments are at the front line for triaging patients with suspected covid-19 and referring them to the appropriate level of care. in europe, the number of ed patients with suspected covid-19 is variable; rate of hospitalization from ed reaches 40% for this population. risk stratification and management decisions of patients presenting to the ed with suspected covid-19 is a challenge for emergency physicians.

Eligibility criteria:
inclusion criteria: * adult patients (\>= 18 years old) attending the ed with a clinical suspicion of covid-19 based on the presence of the following criteria * fever \>= 38 °c * respiratory symptoms (dyspnea, cough, expectorations) * any other symptoms suggestive of covid-19 including digestive signs (diarrhea, anosmia...) exclusion criteria: * none

Keywords: covid19 emergencies epidemiology prognosis
comparison of nn5401 with insulin glargine in insulin naive subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the aim of this trial is to investigate the efficacy and safety of nn5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in japan. depending on pre-trial oral anti-diabetic drugs (oads), subjects continued at the same dose and dosing frequency.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * hba1c 7.0-10.0% (both inclusive) by central laboratory analysis * body mass index (bmi) below or equal to 35.0 kg/m\^2 * insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (oads) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling allowed are: a. previous short term insulin treatment up to 14 days; b. treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days) exclusion criteria: * anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (mao) inhibitors * use of glucagon-like peptide-1 (glp-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation * cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
effects of supplementary oxygen on dyspnoea and exercise tolerance in copd patients given ltot

Conditions: COPD

Summary: the aim of the study is to evaluate effects of supplementary oxygen during exercise on dyspnoea and exercise tolerance in copd-patients given long-time oxygen treatment


Eligibility criteria:
inclusion criteria: * copd patients (male/female)given long-term oxygen treatment * able to perform two separate walking tests exclusion criteria: * severe heart failure
prevention of c.difficile infections with oral vancomycine in patients undergoing allogeneic hematopoietic stem cell transplant

Conditions: Clostridium Difficile Infections; Stem Cell Transplant Complications

Summary: clostridium difficile (cd) infection are an important cause of morbi-mortality in patients undergoing allogeneic hematopoietic stem cell transplant (hsct). the vancallo trial aims at evaluating oral vancomycine reducing the risk of cd infection relying on a placebo controlled 1:1 randomized design, including one interim analysis.


Eligibility criteria:
inclusion criteria: * age ≥15 ans * hospitalization since less than 72 hours, for an allogeneic stem cell transplant, whichever the indication and conditioning * for men and women of reproductive age: use of contraceptives * informed consent * healthcare insurance exclusion criteria: * know allergy or history of adverse events with vancomycine * pregnancy * clostridium difficile infection within 30 days prior to inclusion or at inclusion * history of total colectomy and/or inflammatory bowel disease * progressive diarrhea at inclusion, whichever the etiology * digestive decontamination protocol for the stem cell transplant procedure * participation to another drug clinical trial or being in the exclusion period from a prior clinical trial participation
genetic risk estimation of breast cancer prior to preventive medication uptake

Conditions: Breast Cancer

Summary: the primary aim of this study is to determine if the addition of an individual polygenic risk score (prs), in addition to the standard national cancer institute's breast cancer risk assessment tool (bcrat) or tyrer-cuzick (ibis) score, will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer

this trial is a prospective pilot study looking to integrate a novel and retrospectively validated polygenic risk score (prs), based on 77 single nucleotide polymorphisms (snps), into a standard breast cancer prevention consultation for non-brca women. in order to be eligible for trial participation, women will need to have a bcrat estimate of ≥3% for the 5 year risk of developing breast cancer (which corresponds to the united states preventative services task force threshold for moderate to strong benefit from breast cancer preventing medications such as tamoxifen or raloxifene. at the time of the breast cancer prevention consultation, women will be offered participation in this study by a clinical trials nurse and informed written consent will be obtained. for consenting patients, a single 7 to 10 ml blood sample will be taken and couriered to the mayo clinic for sample analysis and several surveys will be administered. one of the surveys will assess the participants understanding and intention to take or not take breast cancer preventing medications. the decision to take or not take a breast cancer preventing medication will be deferred until a subsequent follow up visit. on the second visit, the prs test results will be reviewed with the patient and a recommendation regarding preventive medications will be made. the prs score will risk stratify patients into one of three lifetime risk categories of developing breast cancer (low risk (\ 40%)). participants will then answer a second survey in which their understanding of their breast cancer risk and intention to take breast cancer preventing medications will be assessed.

Eligibility criteria:
inclusion criteria: 1. women \> 35 years old and \< 75 years old 2. women with either of the following: a. a nci-bcrat 5 year risk of ≥ 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the us preventative services task force (32); or b. women with a ibis (tyrer-cuzik) score for the 10 year risk of breast cancer of ≥5% 3. able to participate in all aspects of the study 4. understand and signed the study informed consent exclusion criteria: 1. women whose bcrat falls below the threshold (\<3 % 5 year risk) of moderate benefit according to the us preventative task force and women whose ibis score is \<5% for the 10 year risk 2. women with known brca1 and brca2 mutations 3. women with known contra-indications to tamoxifen, raloxifene or exemestane 4. unable to give informed consent 5. prior history of invasive breast cancer or ductal carcinoma in situ 6. at risk due to prior radiation therapy to the chest

Keywords: bcrat ibis prs breast cancer tyrer-cuzick
ards esophageal balloon pressure changes with positioning study

Conditions: ARDS; Respiratory Failure

Summary: the use of esophageal balloon catheters, which use esophageal pressure as a surrogate measurement for transpleural pressure, shows promise in improving outcomes of patients with severe acute respiratory distress syndrome (ards) requiring mechanical ventilator. the investigators hope to measure changes in in transpleural pressures in patients undergoing treatment with mechanical ventilation while switching from the supine, upright (head of bed \>30 degrees), and prone positions. the goal will be to measure the changes in chest wall and lung compliance in mechanically ventilated patients with changes in position.

the use of esophageal balloon catheters shows promise in improving outcomes of patients with severe ards. the estimation of pleural pressure (ppl) has been validated in the upright position in humans with few studies commenting on the changes in supine positioning and almost none on prone positioning aside from radiographic analysis. an abstract presented at the annual american thoracic society meeting recently reported a series of 18 patients undergoing spinal surgery. in this population of patients without ards, esophageal pressure (pes) decreased when shifting from supine to prone positioning. this suggests that transpleural pressure (ptml) would be increased at a given airway pressure. the investigators hope to measure changes in ptml in patients undergoing treatment with mechanical ventilation while switching from the supine, upright (head of bed \>30 degrees), and prone positions. the esophageal balloon catheter will be placed using standard techniques and secured with tape to the patients' nares during changes in positioning. the goal will be to measure the changes in chest wall and lung compliance in mechanically ventilated patients with changes in position.

Eligibility criteria:
inclusion criteria: * age at least 18 years old, need for mechanical ventilation, moderate or severe ards, and the ability to tolerate prone positioning. exclusion criteria will be patients who: * are deemed too ill by their clinicians to be included in the study * have esophageal or nasopharyngeal pathology (such as tumors, sinusitis, epistaxis, ulcerations, recent surgery or bleeding varices) preventing insertion of the esophageal balloon catheter * diverticulitis * bronchopulmonary fistula * solid-organ transplantation * history of difficult intubation or airway management * or contraindications to prone positioning (per the unc medical intensive care unit pronation therapy protocol, attached)
measurement of natriuretic hormone peptides in exacerbation of asthma

Conditions: ASTHMA

Summary: the investigators hypothesize that there is a statistically significant decrease of natriuretic hormone peptides (nhps) in subjects with asthma exacerbation compared to levels following treatment of an exacerbation of asthma.

overall study design 1. measurement of natriuretic hormone peptides in individuals suffering from exacerbation of asthma. 2. measurement of natriuretic hormone peptides 5-7 days after initiation of treatment of exacerbation of asthma. 3. measurement of natriuretic hormone peptides 10-14 days after initiation of treatment of exacerbation of asthma. 3 comparisons of natriuretic hormone peptides levels will be made: 1. exacerbation compared to 5-7 days after initiation of treatment 2. exacerbation compared to 10-14 days after initiation of treatment 3. 5-7 days after initiation of treatment compared to 10-14 days after initiation of treatment. samples of blood will be secured in the division of allergy/immunology at the university of south florida, joy mccann culverhouse airways disease center. all samples will be appropriately coded to maintain confidentiality. blood specimens will be held at minus 20 degrees celsius.

Eligibility criteria:
inclusion criteria: * both genders, age 18-85. * females who are pregnant or lactating are not eligible. * read and comprehend english. * ability to give informed consent. * seen in the outpatient setting at one of the clinic. * the subject must have a history of physician diagnosed asthma for at least 1 year and must have an exacerbation of asthma for entry into the study.

Keywords: asthma acute exacerbation of asthma
somatosensory processing in depression

Conditions: Depression

Summary: aim of this study is to investigate neuronal differences (eeg/evoked potentials; functional mri) between patients with major depression and healthy controls concerning brain activity after acute pain as well as changes of pain related brain activity during treatment with escitalopram.


Eligibility criteria:
inclusion criteria: * psychiatric in or outpatients with acute depressive episode * indication for pharmacological treatment exclusion criteria: * acute suicidal tendency * neurological or severe somatic disorders * women during pregnancy or lactation