Kornimate/medical-research-clean huggingface dataset:
use of clinical-trials and simulation models to estimate cost-effectiveness of non-steroidal mineralocorticoid antagonists, rasi and sglt2i as triple therapy with type 2 diabetes and chronic kidney disease

Conditions: Patients With Type 2 Diabetes

Summary: to evaluate triple therapy with nsmra, rasi and sglt2i on albuminuria in individuals with t2d and ckd


Eligibility criteria:
inclusion criteria: * adults aged 18 years or above * diagnosis of type 2 diabetes at least 6 months * ckd (egfr by ckd-epi 25-90 ml/min/1.73m2 with uacr 30 to \ 60 ml/min/1.73m2. * patients should have a serum potassium \<4.8 mmol/l at screening * on sglt2i (dapagliflozin or empaglifozin) at screening at stable doses for at least 4 weeks. * on acei or arb at maximum tolerated dose per manufacturer's label that did not cause unacceptable side effects * in the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate. exclusion criteria: * type 1 diabetes * allergy, contraindications or intolerance to acei/arb * contraindications or intolerance to mineralocorticoid receptor antagonists * allergy, contraindications to sglt2is * currently pregnant or planning pregnancy * hba1c \>9% at enrolment * uncontrolled hypertension sbp \> 160mmhg or hypotension \<90 mmhg at enrolment * concomitant therapy with eplenerone, spironolactone that cannot be discontinued. * history of stroke or worsening heart failure in the past 6 months prior to screening * diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction in the six months prior to screening * patients on renal replacement therapy or likely require kidney transplant or dialysis during the study period * on concomitant strong cyp3a4 inhibitors that cannot be discontinued * adrenal insufficiency * currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection. * an identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

Keywords: finereone, triple therapy, type 2 diabetes, chronic kidney disease
computed tomography coronary angiography in patients with a previous coronary artery bypass graft surgery trial

Conditions: Coronary Artery Bypass Surgery

Summary: this randomized, multi-center, prospective study seeks to compare the conventional invasive coronary angiography with the recently described method of performing ct-coronary angiography prior to the invasive coronary angiography, in post - cabg patients subjected to coronary angiography or percutaneous coronary intervention.

conventional invasive coronary angiography is currently used to depict coronary arteries, however in recent years, the use of ct-coronary angiography has emerged in the literature for being a non-invasive and well tolerated examination, with imaging findings often equivalent to standard coronary angiography, especially for imaging grafts in patients undergone coronary artery bypass graft surgery (cabg). these patients present with complex anatomy of the coronary arteries making invasive coronary angiography a demanding and time-consuming examination in which the patient is exposed to large doses of radiation and volume of contrast. multislice computed tomography shows high diagnostic accuracy in the detection of obstruction of the grafts while the advancement of technology continuously improves the diagnostic accuracy of the imaging findings. of course, axial coronary angiography is more sensitive and specialized in the imaging of grafts, compared to the native coronary arteries of the heart. therefore, the use of ct-coronary angiography before performing the respective invasive procedure is believed that it may reduce the overall duration of the procedure, the radiation received by the patient and the amount of contrast administered. the aim of the present study is to compare the performance of ct-coronary angiography before invasive coronary angiography compared with the performance of invasive coronary angiography alone. τhe extent to which the information obtained from ct-coronary angiography contributes to the guidance of invasive coronary angiography that will follow will be studied, regarding the total procedure time, the volume of the contrast administered the radiation to which the patient is exposed and the patient's course over a period of 30 days.

Eligibility criteria:
inclusion criteria: * prior cabg-operation * age\>18 years * indication for coronary angiography * informed consent exclusion criteria: * stemi * nstemi very high risk or high risk (grace score \>140, dynamic new st/t ecg changes) * hemodynamic instability * high probability of patient's non-compliance with the study's procedures. * severe kidney disease with gfr\<30 ml/min/1.73m2 * known allergic reaction to contrast * uncontrolled arrhythmias (mostly afib) with heart rate over 80 bpm or frequent ectopic beats which could affect the ecg-gated ccta protocol. * bmi\>40

Keywords: coronary angiography ct-coronary angiography post-artery bypass graft surgery coronary artery disease
clinical and economic burden of uncontrolled epilepsy: analyses from a medicaid database and a private health plan database

Conditions: Epilepsy

Summary: antiepileptic drugs (aeds) are the main therapeutic option for patients with epilepsy; however, complete seizure control remains elusive for many patients. uncontrolled or refractory epilepsy is associated with a higher risk of mortality, physical injuries, and depression or anxiety compared with patients with controlled epilepsy. higher resource utilization for patients with poor control is likely to be associated with higher economic costs. while diagnostic criteria for uncontrolled epilepsy are debated by neurologists, recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one seizure per month and 2.) a history of drug failures. the objective of this study is to identify patients with uncontrolled epilepsy in both a medicaid database and a private health plan database, to describe patient characteristics and aed treatment patterns between cohorts of patients with uncontrolled versus well-controlled epilepsy, and to evaluate the economic burden of uncontrolled versus well-controlled epilepsy. for this evaluation, the data sources are medical and pharmacy claims in medicaid databases from florida (third quarter 1997 to second quarter 2008), iowa (first quarter 1998 to second quarter 2006), kansas (first quarter 2001 to second quarter 2009), missouri (first quarter 1997 to second quarter 2008) and new jersey (first quarter 1997 to fourth quarter 2008) and medical and pharmacy claims in an private health plan database. the study design is a retrospective, longitudinal, matched-cohort study. eligible patient records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy (at least 2 consecutive changes in aed therapy in at least 30 days, and at least 1 epilepsy-related inpatient or emergency department (ed) visit within 365 days), well-controlled epilepsy (no aed changes and no epilepsy-related inpatient or ed visits), and intermediate epilepsy (not classified as uncontrolled or well-controlled).


Eligibility criteria:
inclusion criteria: * at least 18 years of age at the initiation of anti-epileptic drug (aed) treatment as noted in the database * a record of at least one medical visit with a diagnosis of epilepsy (icd-9-cm 345.xx) or at least two diagnoses of non-febrile convulsions (icd-9-cm 780.30 or 780.39) occuring more than 30 days apart * at least one pharmacy claim for an anti-epileptic drug (aed) * continuous enrollment throughout the observation period (minimum of 365 days). patients with gaps in medicaid enrollment will be observed only during their period of continuous enrollment, provided that all the above criteria are met exclusion criteria: * age less than 18 years

Keywords: epilepsy anti-epileptic drug polytherapy adherence medicaid
lv thrombus pilot study for comparing enoxaparin vs. warfarin

Conditions: Coronary Artery Disease; Acute Myocardial Infarction

Summary: to prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of echocardiographic indices of lv mural thrombus. the primary outcome is the presence of lv mural thrombus at 3.5 months. the secondary outcome is cost analysis comparing the two arms.

patients with anterior q-wave mis and ejection fractions\<=40% will be enrolled within the first 4 days of infarction. patients will be randomized to receive either enoxaparin 1mg/kg (maximum 100mg) subcutaneously every 12 hours for one month or heparin followed by oral warfarin for 3 months. clinical and safety evaluations, 2-d echocardiograms at baseline and at 3.5 months and cost analysis will be performed.

Eligibility criteria:
inclusion criteria: * age 18 to 80 * anterior myocardial infarction with: 1. pathological q-waves in at least 3 contiguous anterior precordial leads, assumed to be new 2. ck peak\>5 times the upper limit of normal with positive mb bands * ejection fraction \<=40% or anterior dyskinesis or documented lv thrombus * mi onset \< 7 days from randomization exclusion criteria: * inability to give written informed consent * medical conditions that would prohibit discharge within 48 hours with the exception of need for anticoagulation * cardiogenic shock, rest angina unresponsive to medical therapy or serious ventricular arrhythmia in the 24 hours prior to randomization * patients scheduled for surgical procedure in the next 4 months that would prevent use of enoxaparin or warfarin * anemia: baseline hgb\<=9 gm for women, \<=10 gm for men or platelet count\<100,000 * renal insufficiency (creatinine \>2.0 mg/dl) * serious liver disease as reflected by inr\>1.3 * stroke within past 6 months or a prior documented intracranial or subarachnoid hemorrhage * active bleeding or major surgery within 2 weeks prohibiting the use of anticoagulants * acute pericarditis * women of childbearing potential unless pregnancy test negative * cardiac or non-cardiac condition with expected survival\< 6 months * severe peripheral vascular disease * patients who undergo cardiac surgery, including cabg, as a result of their index myocardial infarction * allergy to aspirin, heparin or warfarin, pork or pork products * history of recurrent thromboembolic disease or a history of protein c, protein s, antithrombin iii deficiency or known bleeding disorder. * current use of warfarin or need for chronic anticoagulation * current participation in other trials using investigational drugs or devices * prior enrollment in this trial

Keywords: myocardial infarction left ventricular mural thrombus low molecular weight heparin enoxaparin warfarin echocardiograms
effects of sleep body temperature on body composition

Conditions: Blood Pressure Check (Hypertension Screening); Heart Rate; Aldosterone Disorder

Summary: this will be a crossover controlled trial designed to recruit 40 participants, who will be divided into two groups of 20 subjects each. the participants will be randomly assigned to either group a or group b. group a will receive the sleep electric blanket intervention for a period of 7 days, while group b will serve as the control group without any additional intervention. after the intervention period, there will be a washout period of 7 days to ensure that any effects of the intervention have subsided before the crossover. following the washout period, the groups will switch roles: group b will then receive the sleep electric blanket intervention, and group a will become the control group. this second phase will also last for 7 days, preceded and followed by the same assessment procedures as the initial phase. this design will allow for a comparison of the intervention's effects against a control period within the same group of participants, enhancing the study's internal validity.


Eligibility criteria:
inclusion criteria: - participants aged 18-30 years, inclusive of both male and female genders. exclusion criteria: * individuals suffering from serious diseases such as heart, liver, kidney, brain, hematopoietic, immune, thyroid, malignant tumors, etc.; * those with familial hereditary hypertension (both parents are hypertensive) or those diagnosed with hypertension; * individuals with cognitive or mental impairments that prevent the completion of the questionnaire; * persons with physical disabilities that hinder normal walking; * persons who have experienced a weight change of \>3.0 kg within 1 month or \>10 kg within 6 months prior to screening (as per the study in nutrients. 2020 oct 21;12(10):3221); * individuals required to take antibiotics from one week before the trial starts until its conclusion; * those with habitual diarrhea or who have experienced diarrhea from one week before the trial starts until its end; * subjects who have participated in other ambient temperature-related trials within the last 6 months; * individuals with extreme sleep schedules (i.e., not falling asleep between 21:00 and 2:00 a.m. the following morning, or waking up before 5:00 a.m.); * those with sleep latency (the time it takes to fall asleep after going to bed) greater than one hour; * pittsburgh sleep quality index (psqi) scores greater than 16; * participants who do not sign the informed consent form or are deemed unsuitable by the investigator for any other reason.
a study to evaluate the effect of co-administration of itraconazole or diltiazem on the pharmacokinetics of bms-986177 in healthy subjects

Conditions: Thrombosis

Summary: the study is being conducted to assess the effects of co-administration of itraconazole or diltiazem, respectively, on the pharmacokinetic (pk) parameters cmax, auc(inf), and auc(0-t) of bms-986177


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. target population: healthy subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ecg), and clinical laboratory determinations. 3. subjects with body mass index of 18 to 30 kg/m2, inclusive 4. men, and women of nonchildbearing potential. women must have documented proof that they are not of childbearing potential and are not breast feeding 5. males who are sexually active with women of childbearing potential (wocbp) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of the study drug (3 days) plus 90 days (duration of sperm turnover) for a total of 92 days for subjects in the bms-986177 - diltiazem sequence, and 99 days for subjects in the bms-986177 - itraconazole sequence. exclusion criteria: 1. any significant acute or chronic medical illness, including hepatic disease, or any other condition listed as a contraindication in the diltiazem or itraconazole package inserts. 2. evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation. 3. history of chronic constipation, gi disease, arrhythmias, sinus bradycardia, significant head injury, dizziness or headaches, hemophilia, rosenthal syndrome, or fx1a deficiency or other coagulopathies, systemic lupus erythematosus. 4. evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg, or clinical laboratory determinations beyond what is consistent with the target population 5. history of allergy to bms-986177, itraconazole, diltiazem, or related compounds.
special drug use investigation for arixtra® (fondaparinux) injection

Conditions: Thromboembolism

Summary: this post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism. (arixtra® is a trademark of the glaxosmithkline group of companies.)


Eligibility criteria:
inclusion criteria: * subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism exclusion criteria: * not applicable
electrical impedance tomography-based prognostic model for ards

Conditions: Acute Respiratory Distress Syndrome (ARDS); Ventilator-induced Lung Injury

Summary: this multicenter, prospective, observational study aims to develop and validate an eit-based prognostic model for ards. by focusing on the pathophysiological characteristics of ards and the causes of ventilator-induced lung injury, the investigators intend to establish a prognostic model that reveals lung injury and heterogeneity, enabling risk stratification and guiding individualized treatment.


Eligibility criteria:
inclusion criteria: 1. meet the new 2023 ards global definition; 2. age 18-80 years exclusion criteria: 1. expected death within 24 hours of screening; 2. metastatic cancer (active malignancy with distant metastases); 3. severe psychiatric disorders; 4. pregnancy or postpartum status; 5. pneumothorax or moderate to large pleural effusion without adequate drainage; 6. chronic respiratory failure; 7. patients with pulmonary embolism or pulmonary hypertension; 8. heart failure patients: ef \<50% or nyha class iii or iv; 9. patient/family refusal to participate; 10. participation in another interventional trial within 3 months prior to enrollment
effect of different diaphragmatic myofascial release approaches on low back pain and quality of life among young females with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: this study will be conducted to investigate the effect of different diaphragmatic myofascial release approaches on low back pain and quality of life among young females with irritable bowel syndrome

irritable bowel syndrome (ibs) is a functional gastrointestinal disorder linked to disruptions in autonomic nervous system regulation, gut inflammation, alterations in stool frequency, and visceral hypersensitivity. irritable bowel syndrome (ibs) is a chronic condition affects 7 to 21% of the general population.the symptoms usually include abdominal cramping, discomfort or pain, bloating, loose or frequent stools and constipation.the diaphragm has a fundamental role in defining posture, its maintenance, and body position changes; dysfunction of the diaphragm is one of the recognized be causes of low back and sacroiliac joint pain. people with low back pain often experience early fatigue of the diaphragm muscle, altered and reduced excursion during respiration, and inadequate proprioceptive activation.

Eligibility criteria:
inclusion criteria: * subjects with irritable bowel syndrome * young female subjects * all patients will have low back pain. * all subjects will be clinically and medically stable when attending the study exclusion criteria: * lack of attention and cooperation * history of cancer and any systemic disease * pregnancy * history of any structural gastrointestinal pathology or surgery * history of repeated inflammatory gastrointestinal pathology * diabetes mellitus and lactose intolerance. * abuse of laxative * depression * celiac disease * endocrine disorders as hypothyroidism and hyperthyroidism. * gastrinoma * recent/unhealed rib fracture * history of any lumbar spine serious pathology ( tumor, infection fracture, osteoporosis , long term use of steroid, rheumatoid arthritis and surgery )

Keywords: diaphragmatic myofascial release low back pain irritable bowel syndrome
cle and oct in acute respiratory insufficiency

Conditions: Acute Respiratory Failure (Non Resolving)

Summary: acute respiratory distress syndrome is a severe complication of critical illness. the diagnosis of ards is difficult, and it could be important to differentiate ards from other causes of acute respiratory failure. innovative probe-based imaging techniques such as 'confocal laser endomicroscopy' (cle) and optical coherence tomography (oct) are high resolution optical techniques that, combined with conventional bronchoscopy, have been found to provide non-invasive, real-time near-histology information about the alveolar compartment in non ventilated non-critically ill patients.

it is important to identify the underlying cause of respiratory failure, in order to determine the appropriate treatment. histopathology would help treatment decisions, however is in the fast majority of this critically ill patient-group not available. cle is enables near histology/microscopic analysis during bronchoscopy, by tissue illumination with a low-power laser. optical coherence tomography is the optical equivalent of b-mode ultrasonography, that consists of a small rotating optical fibre. both the cle and oct techniques are minimally invasive and little time consuming. therefore different areas of the lung can be sequentially imaged. with this pilot study the investigators aim to describe normal alveolar areas and areas with abnormalities in critically ill patients with non resolving acute respiratory failure mandating a standard bronchoscopy or laryngoscopy with or without bronchoalveolar lavage.

Eligibility criteria:
inclusion criteria: * admitted to intensive care unit of academic medical center in amsterdam * indication for a procedure to investigate the airways that can be combined with pcle/oct exclusion criteria: * inability and willingness to provide informed consent by family-members * inability to comply with the study protocol

Keywords: confocal laser endomicroscopy optical coherence tomography
healthy bodies, healthy hearts: a physical activity intervention trial

Conditions: Obesity; Cardiovascular Disease; High Blood Pressure

Summary: the overall aim of healthy bodies, healthy hearts research study is to promote physical activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. the investigators are conducting an intervention for 12 weeks that promotes physical activity through support groups, group exercise sessions or through information that is given at the baseline appointment. participants will be randomly assigned to a group.


Eligibility criteria:
inclusion criteria: * not currently exercising for at least 100 minutes per week * have a body mass index (bmi) of 25 or greater * has a physician in one of the three participating practices exclusion criteria: * not able to walk 1/2 mile or 1 flight of stairs without assistance from another person or an assistive device

Keywords: women menopause cardiovascular disease physical activity weight loss