Kornimate/medical-research-clean huggingface dataset:
hdl-atherosclerosis treatment study (hats)

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia

Summary: to measure the effects of lipid-lowering drugs and/or antioxidant vitamins on progression or regression of coronary heart disease as measured by quantitative angiography in patients with low high density lipoprotein (hdl) cholesterol.

background: more than one-third of patients with coronary disease have "low" high density lipoprotein cholesterol (hdlc) levels (less than 35 mg/dl; united states 20th percentile) and "normal" low density lipoprotein cholesterol (ldlc) (less than 145; united states mean), a group for whom current treatment guidelines are not based on clinical trial data. low hdlc levels are strong, independent predictors of cardiovascular disease and cardiovascular mortality risk, equally so for both men and women. this high coronary artery disease risk may be due to an imbalance between delivery of cholesterol into the arterial intima by ldl and its removal by hdl. also, since hdl serve as antioxidants and cytoprotectants, an important hdl role may be to prevent ldl oxidation and thus limit macrophage-mediated intimal lipid accumulation or to prevent vascular cell toxicity. recent epidemiologic, experimental, and clinical trial evidence suggests that a 15 mg/dl rise in hdl cholesterol would reduce coronary artery disease incidence and mortality by 30 to 70 percent and that antioxidant vitamins e, c, and beta-carotene might reduce coronary artery disease events and atherogenesis. the potential absolute benefit is much greater in those with existing coronary artery disease. it has also been shown that hdlc rises in response to exercise, smoking cessation, weight reduction, and monounsaturated fats. design narrative: randomized, phase iii. each patient was randomly assigned to a lipid-altering strategy or its placebo and to an antioxidant vitamin strategy or its placebo, in a 2 x 2 factorial design. the four groups were simvastatin-niacin plus an antioxidant vitamin cocktail; simvastatin-niacin plus vitamin placebo; antioxidant vitamins alone plus simvastatin-niacin placebo; or placebos for both strategies. all groups were counseled with respect to diet, exercise, and smoking cessation. the primary endpoint was the average change in proximal obstructive disease during the 2.5 year interval between baseline and the followup study. secondary endpoints included the frequency of cardiac events, including cardiac death, confirmed non-fatal myocardial infarction, cerebrovascular accident, or revascularization by bypass or angioplasty for medically refractory unstable ischemia. the trial ended in august, 1999.

Eligibility criteria:
men and women with low hdl cholesterol, with at least one 50% stenotic coronary lesion or three 30% stenotic coronary lesions. women range in age from 35 to less than 68 and men from 35 to less than 63.
reasons for recourse and diagnoses associated with early recourse to an emergency structure after initial treatment

Conditions: Urgent Care Centers

Summary: to date, studies have been carried out on emergency department revisits but most are studies carried out in anglo-saxon territories. the studies carried out in france, for their part, concern the elderly geriatric population, or populations with specific pathologies such as child psychiatrists or patients with acute heart failure, but not the general adult population. nevertheless, these studies have shown that knowledge of the risk factors for early readmission of a patient makes it possible to carry out targeted prevention actions in order to reduce this early recourse rate. however, in a context of increasing emergency flow and increasing tension in the field with limited healthcare resources, returning home and outpatient care are increasingly favored. however, these strategies only make sense if outpatient follow-up is organized when early reconsultation is possible for certain indications that remain to be determined. in this context, it would be interesting to have information on the reasons for which patients return to the emergency room early after initial treatment. this would indeed make it possible to consider carrying out preventive actions in the long term in order to reduce this revisit rate on the one hand and on the other hand to identify the signs of seriousness which should bring the patient back to the emergency room as soon as possible.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject treated in the emergency room of the nhc or hautepierre and having consulted the emergency room of one of the two sites 7 days after their first visit for an identical reason for recourse between january 1, 2017 to january 31, 2023. * patient who has not expressed his opposition to the reuse of his data for scientific research purposes. exclusion criteria: * patient having expressed his opposition to the retrospective reuse of his data

Keywords: emergency department urgent care centers
safety and efficacy study of small interfering ribonucleic acid (rna) molecule (cand5) to treat wet age-related macular degeneration

Conditions: Macular Degeneration

Summary: the objective of this study is to evaluate the safety and preliminary efficacy of three doses of cand5. cand5, a small interfering rna molecule that selectively silences the mrna encoding for vegf.


Eligibility criteria:
inclusion criteria: 1. patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to amd. 2. patients must have etdrs best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 snellen equivalent) in the study eye. 3. patients must be age 50 or older exclusion criteria: 1. patients who have received prior treatment with any investigational new drug or device for wet amd in the study eye within 24 weeks of the screening visit. 2. patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmhg in the study eye. 3. patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye. 4. patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye. 5. patients whose cnv lesion in the study eye contains more than 25% scarring and/or atrophy. 6. patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit. 7. patients who received treatment with an investigational drug within 4 weeks prior to the screening visit.

Keywords: wet age-related macular degeneration
postoperative environment on pain following pelvic reconstructive surgery

Conditions: Postoperative Pain

Summary: this study is to determine if patients following prolapse repair including vaginal vault suspension have decreased pain measured via a visual analog scale (vas) on postoperative day one and just prior to discharge when exposed to the diad of music and positive images compared to patients receiving standard care.

over the past decade, interest has grown in improving the patient experience. as part of this movement, studies have sought to evaluate the mechanisms by which the postoperative environment affects a patient's outcome and perception of healing. literature review reveals efforts by both medical and design teams towards improving the experience of the patient and developing an environment that promotes healing. changes to the physical environment have been shown to have an impact on satisfaction. these parameters have included music and art. considering the effort that is now going into improving the patient experience and developing this theory of healing spaces, there has yet to be a randomized controlled trial evaluating these alternative therapies in the urogynecologic patient population. although each of these modalities appears beneficial, we believe that a combination of these would be even more useful. indeed, these treatments are also relatively easy to implement without undue cost or burden to the hospital. this study seeks to determine the influence of applying music and art to the post operative environment for patients recovering from major urogynecologic surgery on pain.

Eligibility criteria:
inclusion criteria: * adults 18-85 years of age * english speaking * undergoing surgery for pelvic organ prolapse to include an apical vaginal vault suspension by a physician at cincinnati urogynecology associates, trihealth * concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy will be included * ability to complete the questionnaires and provide consent * willingness to listen to music at the minimum recommended time intervals exclusion criteria: * unwillingness to participate in the study * physical or mental impairment that would affect the subject's ability to utilize the modified environment such as deafness, blindness or dementia * patients who take daily narcotics or nsaids * patients with history of drug or alcohol abuse * patients with chronic pain syndromes * non english speaking * patients that do not undergo a vaginal apical suspension procedure
diabetes nutrition education for american indian and alaska native communities

Conditions: Type 2 Diabetes

Summary: this study involves pilot testing a newly developed diabetes nutrition education program for american indian and alaska native adults with t2d. the first phase of this study (comirb protocol 18-006) included a qualitative needs assessment to inform the development of this program. the study aims include: piloting the newly adapted program at 6 ai/an collaborating sites to gain feedback on satisfaction, likability, usability and clinical outcomes such as hga1c (measure of blood sugar control), blood pressure, and body mass index (bmi).

this study involves pilot testing a newly developed diabetes nutrition education program for american indian and alaska native adults with t2d. the first phase of this study (comirb protocol 18-006) included a qualitative needs assessment to inform the development of this program. the second phase involves pilot testing the study at 6 collaborating ai/an sites across the us. the study aims include: piloting the newly adapted program at 6 ai/an collaborating sites to gain feedback on satisfaction, likability, usability and clinical outcomes such as hga1c (measure of blood sugar control), blood pressure, and body mass index (bmi).

Eligibility criteria:
inclusion criteria: * ai/an status (self-reported) * age \> 18 years * fluent in english * a current diagnosis of t2dm. exclusion criteria: * a major medical issue that may interfere with participation (e.g., prior cardio- or cerebrovascular disease including a recent myocardial infarction or major stroke; cancer not in remission; dialysis; active alcohol and/or substance abuse.) * a planned move from the area within the 3 to 6 month data collection time period that would not allow completion of all the study visits
vitamin d in patients with heart failure

Conditions: Heart Failure

Summary: to investigate the prevalence of vitamin d deficiency in patients with heart failure. to investigate if vitamin d levels are correlated to the degree of heart failure.


Eligibility criteria:
inclusion criteria: * patient in the heart failure clinic, hvidovre hospital * willing to participate and sign informed consent over 18 years of age

Keywords: heart failure, vitamin d status, nt-probnp
evaluation of ald403 (eptinezumab) in the prevention of chronic migraine

Conditions: Migraine Disorders

Summary: the purpose of this study is to assess the efficacy and safety of ald403 in the prevention of migraine headache in chronic migraineurs.


Eligibility criteria:
inclusion criteria: * males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening. * during the 28 day screening period, subjects must adequately complete the headache ediary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must be migraine days. * headache ediary was completed on at least 24 of the 28 days prior to randomization. exclusion criteria: * confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome). * psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. patients with a lifetime history of psychosis, mania, or dementia are excluded. * any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 4 months prior to screening and during the screening period. * history or diagnosis of complicated migraine (ichd-iii beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine. * receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening. * previously dosed with ald403 or any monoclonal antibody targeting the cgrp pathway.
68ga-fapi-fs pet/ct and pet/mr in pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a preliminary study of 68ga-fapi-fs pet/ct or pet/mr in patients with confirmed or suspicious pancreatic cancer. the goal is to determine the safety, biodistribution, and tumor uptake of 68ga-fapi-fs.

this is a preliminary phase 0 study in patients with confirmed or suspicious pancreatic cancer. each patient will receive one dose of 68ga-fapi-fs by intravenous route. dedicated whole-body pet/ct imaging will be performed. a comparative 18f-fdg pet/ct will also be performed within a week.

Eligibility criteria:
inclusion criteria: 1. pancreatic cancer confirmed by histopathological results or pancreatic lesions with typical radiological appearance. 2. expected survival of at least 3 months 3. ecog ≤ 2 4. written informed consent provided for participation in the trial 5. in the opinion of investigator, willing and able to comply with required study procedures. exclusion criteria: 1. pregnancy or breastfeeding. 2. severe claustrophobia.

Keywords: 68ga-fapi-fs pet/ct
a comparison between two formulations of nn5401 in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in the united states of america (usa). the aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (nn5401) in healthy subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ecg), as judged by the physician * body mass index between 18.0 and 27.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to trial start * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
integrating depression services into dm management

Conditions: Type 2 Diabetes Mellitus; Depression

Summary: the goal of this proposal is to integrate depression services into improving adherence for oral hypoglycemic agents so that a single program can assist patients. the investigators hypothesized that patients in the intervention would demonstrate improved adherence to patients' oral hypoglycemic agents and antidepressants as well as improved clinical outcomes.

many older patients do not take their medications for type 2 diabetes mellitus (dm) as prescribed by their physician. depression is common among patients with type 2 dm and may be the reason why patients do not take their medications as prescribed. a program in which type 2 dm and depression are treated together in primary care would improve the health of older patients with both type 2 diabetes and depression and would be practical in real world practices with competing demands for limited resources. there is an urgent need for research that can bring potentially life-extending strategies to older patients with both diabetes and depression. people can better control their type 2 dm if they treat their depression and the same strategies can be used to help patients take their medications for both conditions. in this program patients were involved in identifying problems with taking their medicines and working on solutions. the aims of this program were to improve how patients take their medications for type 2 dm and depression as well as blood glucose control and symptoms of depression over 3 months. to see whether this program works the investigators compared the results of patients receiving this program to those who do not receive the program. findings may lead to the development of other programs in which depression and chronic medical conditions are treated together.

Eligibility criteria:
inclusion criteria: * 30 years and older * a current diagnosis of type 2 dm * current prescription for an oral hypoglycemic agent * current prescription for an antidepressant * able to communicate in english * willing to give informed consent. exclusion criteria: * inability to give informed consent * significant cognitive impairment at baseline (mini-mental state examination (mmse) \<21) * residence in a care facility that provides medications * unwillingness or inability to use the medication event monitoring system

Keywords: adherence diabetes mellitus depression primary health care
a safety and efficacy study of tavilermide (mim-d3) ophthalmic solution for the treatment of dry eye

Conditions: Keratoconjunctivitis Sicca

Summary: the purpose of this study is to assess the safety and efficacy of tavilermide ophthalmic solution compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.


Eligibility criteria:
inclusion criteria: be at least 18 years of age provided written informed consent have a reported history of dry eye have a history of use or desire to use eye drops for dry eye exclusion criteria: be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at visit 1, or have been diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months have any planned ocular and/or lid surgeries over the study period have corrected visual acuity greater than or equal to +0.7 as assessed by early treatment of diabetic retinopathy study (etdrs) scale in both eyes at visit 1 have an uncontrolled systemic disease be a woman who is pregnant, nursing or planning a pregnancy be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; iud; or surgical sterilization of partner. for non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study have a known allergy and/or sensitivity to the test article or its components have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of visit 1 be unable or unwilling to follow instructions, including participation in all study assessments and visits

Keywords: dry eye
clinical study of su 11248 (sutent) combined with standard chemotherapy in patients with flt3 mutated aml over 60 years

Conditions: Acute Myeloid Leukemia

Summary: in this study safety and tolerability of two dose levels of su 11248 (sutent) with standard chemotherapy in patients with flt3 mutated aml over 60 years will be evaluated.


Eligibility criteria:
inclusion criteria: * patients with primary or secondary acute myeloid leukemia (any fab type, except m3). * no prior systemic chemotherapy for aml except hydroxyurea. cytoreductive therapy with hydroxyurea is recommended if wbc is \> 50.000/µl, but should cease at least one day prior to starting study medication * patient age equal or of greater than 60 years * patients must have flt3 mutated aml, either itd or kinase domain mutations * ecog performance score 3 or less (karnofsky performance score \>40%). * life expectancy more than four weeks. * adequate hepatic and renal function, as defined by serum transaminases \<2.5x uln, bilirubin \<1.5x uln. creatinine \<1.5x uln. * patients must provide written informed consent to participate in the trial. * normal heart function on cardiac ultrasound * prothrombin time (pt) and partial thromboplastin time (ptt) \<=1.5 x uln * serum albumin \>=3.0 g/dl * serum amylase and lipase \<=1.0 x uln * willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. exclusion criteria: the presence of any of the following will exclude a subject from study enrollment: * treatment with any investigational agent within four weeks. * known hiv infection * presence of any medical or psychiatric condition which may limit full compliance with the study, including but not limited to: * presence of cns leukaemia * unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery. * any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event. * current treatment with therapeutic doses of anticoagulant (low dose coumadin up to 2 mg po daily for deep vein thrombosis prophylaxis is allowed). * hypertension that cannot be controlled by medications (\>150/100 mmhg despite optimal medical therapy). * pre existing thyroid abnormality of thyroid function that cannot be maintained in the normal range with medication. * ongoing cardiac dysrhythmias of nci ctcae grade \>=2, atrial fibrillation of any grade, or prolongation of the qtc interval to \>450 msec for males or \>470 msec for females. * other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Keywords: aml flt3 acute myeloid leukemia flt 3 inhibitor flt3 mutated aml