Kornimate/medical-research-clean huggingface dataset:
topical tranexamic acid for the prevention of postpartum hemorrhage in women undergoing elective cesarean section

Conditions: Cesarean Section Complications

Summary: in hypertensive women having an elective cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.

patients were allocated to one of two groups after induction of anesthesia. they received temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo

Eligibility criteria:
inclusion criteria: * hypertensive women undergoing elective cesarean section exclusion criteria: * patients with cardiac, hepatic, renal, or thromboembolic disease. , * patients with the high possibility of the morbid adherent placenta, * known coagulopathy and * those presented with severe antepartum hemorrhage * refuse to participate
real-time engagement for learning to effectively control type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Lifestyle; Hyperglycemia; Physical Inactivity

Summary: this is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. the goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with t2d. glycemic control will be monitored using continuous glucose monitors (cgm), and health behavior data will be collected via a fitbit activity tracker and a research app (healthmine). participants will be prompted to view and reflect on glycemic trends and health behavior data (fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the healthmine app and engagement with cgm in the following 90-day observation period.

the objective of reflect2d (real-time engagement for learning to effectively control type 2 diabetes) is to evaluate whether pairing real-time glycemic and health behavior data leads to improved glycemic control among adolescents and young adults with type 2 diabetes. participants will use a mobile app that integrates continuous glucose monitor data, fitbit activity tracker data, and diet logging, with the aim of increasing capability to interpret glycemic data (including impacts of physical activity and dietary intake), providing opportunity to plan and implement behavior change, and increasing motivation to engage in health behaviors. after a session with a registered dietitian and diabetes educator who will support participants in forming diet and activity goals, a 90-day micro-randomized trial (mrt) period will involve once daily randomization of each participant to: 1) physical-activity focused prompt, 2) dietary intake-focused prompt, or 3) no prompt. prompts will include reviews of glycemic trends in the past 24 hours (e.g., periods of hyperglycemia, max glucose) and will ask participants to use visual summaries of activity or diet and glucose to reflect on and revise their behavioral management goals as needed. after the mrt, a 90-day observation period without prompts but with ongoing availability of continuous glucose monitor data, fitbit, and healthmine app will examine persistence of glycemic and behavior changes.

Eligibility criteria:
inclusion criteria: * type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes * hba1c ≥7.0%, stable medication use (≥3 months) * hba1c 6.0-6.9% without short-acting insulin, any other stable diabetes medication use (≥3 months) * english-speaking (app in english) exclusion criteria: * current pregnancy * hydroxyurea use (cgm sensor inaccuracies) * cognitive impairment or severe psychiatric condition that could interfere with participation in behavioral intervention for diabetes self-management * current or previously diagnosed eating disorder
a phase iib, randomized, assessor-masked, multicenter clinical trial to assess the safety and efficacy of subretinal implantation of the cpcb-rpe1 implant in subjects with advanced, dry amd (geographic atrophy)

Conditions: Dry Age-related Macular Degeneration; Geographic Atrophy

Summary: this is a phase iib randomized, clinical trial designed to assess the safety and efficacy of unilateral implantation of the cpcb-rpe1 implant in subjects with geographic atrophy involving the fovea. up to 6 surgical implantation sites will deliver the cpcb-rpe1 in this phase iib clinical trial. additional study sites may serve as referral or follow-up sites. twenty-four (24) subjects will participate in the trial and will be randomized 3:1 to one of 2 groups: * the treatment group receiving the cpcb-rpe1 implant (up to 18 subjects). * the control group receiving a simulated "sham" implantation procedure (up to 6 subjects)


Eligibility criteria:
eligible participants include: 1. age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry amd. 2. clinical findings consistent with advanced dry amd with evidence of one or more areas of ≥4.0mm2 but not exceeding 10.0 mm2 of geographic atrophy involving the fovea. 3. geographic atrophy defined as attenuation or loss of rpe as observed by biomicroscopy, oct, or faf. 4. the best-corrected visual acuity (bcva) of the eye to receive the implant will be ≥20/200 (35 edtrs letters) to 20/63 (60 edtrs letters) inclusive. the bcva of the eye that is not to receive the implant will be better or equal to the eye that will receive the implant. 5. medically suitable to undergo pars plana vitrectomy and the surgical implant procedure, including being able to position post-operatively and use post-operative medications as required. 6. medically suitable for general anesthesia or monitored intravenous sedation, if needed. 7. pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy. 8. participants also must be willing and able to provide written, signed informed consent for this study. 9. participants able to complete the baseline microperimetry retinal sensitivity testing. 10. on baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 db.
cmr in t2dm: the nsr cohort

Conditions: Diabetes Mellitus, Type 2; Diabetic Cardiomyopathies; Cardiovascular Magnetic Resonance Imaging; Coronary Microvascular Dysfunction; Myocardium; Fibrosis

Summary: this study aims to investigate the myocardial phenotype of patients with type 2 diabetes. from 2016-2019 the investigators recruited a cohort of 296 subjects with type 2 diabetes. all subjects underwent clinical examinations including a gadolinium contrast cardiac mri. the current study is a clinical follow-up study of the subjects, thus, the investigators will invite all participants to a reevaluation with cardiac mri. additionally, the investigators will aim at recruiting additionally 400 patients with type 2 diabetes. the aim it to characterize the phenotype of diabetic cardiomyopathy. uniquely using cardiac mri we can measure myocardial microvascular function, myocardial localised and diffuse fibrosis in addition to the quantification of myocardial structure and systolic and diastolic function.


Eligibility criteria:
inclusion criteria: few and simple, allowing for a broad cohort. * male or female fully capable of providing informed consent * informed consent * age 18-80 (both included) * t2dm diagnosed at least 3 months prior to inclusion in the study exclusion criteria:
syr-472 open-label study

Conditions: Diabetes Mellitus

Summary: to evaluate the efficacy and safety of treatment with syr-472 in diabetic patients.


Eligibility criteria:
inclusion criteria: -1. the participant is judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator. 2. the participant can sign and date a written, informed consent form prior to the initiation of any study procedures. exclusion criteria: -1. the participant has concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease . 2. the participant is assessed to be ineligible for the study by the investigator or subinvestigator.
real-world clinical outcomes of the mitris resilia mitral valve

Conditions: Mitral Stenosis; Mitral Valve Insufficiency

Summary: collect real-world data on acute and long-term safety and performance of the mitris resilia mitral valve, model 11400m, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

momentis is a prospective, observational, single-arm, multicenter global study designed to collect real-world clinical outcomes in up to 500 subjects who have received the mitris resilia mitral valve, model 11400m.

Eligibility criteria:
inclusion criteria: * 18 years or older at the time of informed consent * has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery * provides written informed consent * willingness to follow protocol requirements exclusion criteria: * active endocarditis 3 months prior to the procedure * stage 4 renal disease or requiring dialysis * less than 2-year life expectancy due to non-cardiovascular life-threatening disease * high predicted risk of mortality prior to procedure * society of thoracic surgeons (sts) predicted risk of mortality (prom) score of \> 8 or * surgeon estimated risk of mortality of \> 8

Keywords: mitral valve replacement
self-management compared to care-as-usual for men with lower urinary tract symptoms

Conditions: Lower Urinary Tract Symptoms

Summary: research question: does offering an online self-management program lead to more efficient use of care by men with urinary complaints? hypothesis: many men with urinary symptoms receive medication from their gp. advice on how to self-manage complaints is often skipped. this while self-management is effective. by offering self-management instead of visiting a gp the use of care by men with urinary complaints may decrease and treatment may become more efficient. study design: men are randomized to receive either care-as-usual by their gp or the online self-management program. men will be followed for six months and the cost-effectiveness of the online self-management intervention will be compared to the care-as-usual

rationale: although self-management can be difficult to implement because it is time consuming to explain, it has proven effective for luts. for this reason, we developed an online intervention that can be used at home by men with luts, giving tailored advice to each case. objective: to assess the effectiveness and cost-effectiveness of providing an online personalized self-management program as a first-line intervention to men with lower urinary tract symptoms (luts) compared to care as usual (cau). study design: a pragmatic non-inferiority randomized controlled trial in the general population. study population: men with luts (\>18 years of age) who are considering visiting a general practitioner for their complaints. intervention: access to an online program offering personalized selfmanagement advice compared to care as usual main endpoints: outcomes will be assessed at 6 weeks, 3 months and 6 months.

Eligibility criteria:
inclusion criteria: * men with lower urinary tract symptoms who are thinking about visiting a gp for their complaints exclusion criteria: * men with complicated luts who should seek urgent care, including those with nocturnal incontinence (e.g., chronic urinary retention), the inability to void despite urgency (e.g., acute urinary retention), and with sudden onset or worsening luts (e.g., urinary tract infections). * men receiving treatment from a pelvic physiotherapist, gp, or urologist (including at any point in the previous year). * men with a history of prostate cancer, bladder cancer, or urinary tract surgery

Keywords: lower urinary tract symptoms ehealth self-management primary care
ibuprofen vs. continuous indomethacin in the treatment of pda

Conditions: Patent Ductus Arteriosus

Summary: the purpose of this study is to determine whether closure of the pda in premature neonates using iv ibuprofen vs continuous iv indomethacin has different side effects, eg. effects on renal function, on blood flow velocity in the superior mesenteric artery, the anterior cerebral artery, and the renal artery.

despite the fact that ibuprofen appears to minimize the renal side effects seen following bolus indomethacin, other concerns regarding both short and long-term safety remain. indomethacin, on the other hand, has been used to treat premature neonates for many years. other than transient vasoconstrictive effects, no significant toxicity has been noted. thus, if we were to be able to eliminate the differential renal effects, indomethacin would remain, for many, the therapy of choice for the premature neonate with a persistent pda. we hypothesized that continuous administration of indomethacin would provide this option. ibuprofen therapy has not, to date, been compared with indomethacin administered by continuous infusion. hence, in the current study we attempted to determine whether continuous indomethacin administration could potentially offer the same advantages as ibuprofen in treating pda, specifically in terms of mitigation of renal side effects. specifically, our primary objective was to show no differences in urine output and/or in serum creatinine between the treatment groups. as a secondary objective, we aimed to show no other potentially vascular-mediated clinical differences, eg. necrotizing enterocolitis (nec), intraventricular hemorrhage (ivh), retinopathy of prematurity (rop) and on bilirubin albumin binding between the groups. b-type natriuretic peptide (bnp) is released by ventricular myocytes in response to ventricular volume load. it, in turn, mediates vasodilation, natriuresis and diuresis. serum bnp levels have been shown to be clinically useful in differentiating between respiratory and cardiac disease, in monitoring heart failure therapies and in serving as early diagnostic biomarkers of ductal patency in premature neonates. as secondary objectives we intend to determine whether a decrease in bnp levels would be an equally reliable indicator of therapeutic efficacy in infants treated with ibuprofen as with indomethacin.in addition we will look at comparative effects on other vascular beds which might mediate long term side effects described above.

Eligibility criteria:
inclusion criteria: * \< 1500 gm birth weight with pda confirmed by echocardiography exclusion criteria: * additional congenital heart lesions * significant congenital malformations * documented infection * thrombocytopenia (\<60,000) * ivh grade 4

Keywords: patent ductus arteriosus indomethacin ibuprofen renal effects
dotatate to locate coronary plaques at high-risk of myocardial infarction

Conditions: Atheroscleroses, Coronary

Summary: to assess whether vulnerable coronary plaques have more uptake of 68ga-dotatate than non-vulnerable plaques.


Eligibility criteria:
inclusion criteria: * aged 50 years and older * underwent ccta imaging within 78 weeks from the screening visit * either cad-rads 4 or higher or 0/1 on ccta. * able to provide written informed consent exclusion criteria: * history of chronic kidney disease stage 3b - 5, defined as a ckd-epi value of \< 45 ml/min/1,73m2. * cvd events/revascularization in history * malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator. * chronic or recent (\< 1 month) infections and/or clinical signs of acute infection. * history of auto-immune diseases. * standard contra-indications to 68ga-dotatate pet, and ct based on physicians experience and current practices. * inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. * elevated liver enzymes (\> 2 uln of liver transaminases), acute liver failure or known liver disease.
external validation of clinical prediction tools for estimating salt and potassium intake in nephrology patients.

Conditions: Chronic Kidney Diseases

Summary: there is no validated self-questionnaire to assess salt and potassium intake in nephrology patients. using bayesian models, researchers developed clinical prediction tools to estimate salt and potassium intake in nephrology patients. these prediction tools performed well, with an accuracy of 89% for salt and 74% for potassium, and have undergone internal validation. currently, the investigators wish to conduct an external validation study of these clinical prediction tools using data from patients followed at 3 nephrologic centers to generalize the performance results of the tools.


Eligibility criteria:
inclusion criteria: * male or female 18 years of age or older * consultant or inpatient in the nephrology department * having performed a 24-hour urinary assessment as part of his usual management with analysis of natriuresis and/or kaliuresis. exclusion criteria: * patient having lost salt by vomiting, diarrhea and intense sweating (sport) in the week preceding the 24-hour urine collection. * person protected by the french law

Keywords: salt diet potassium diet prediction tools bayesian network kidney disease epidemiology
efficacy of baricitinib in treatment of delayed-type hypersensitivity versus irritant skin reactions in healthy adult male subjects

Conditions: Allergic Contact Dermatitis

Summary: the treatment of allergic contact dermatitis (acd) can be unsatisfactory, and that other skin diseases such as atopic dermatitis have an increased likelihood of acd, improved systemic treatments are needed. this research study explores the effectiveness of baricitinib in treating delayed-type hypersensitivity (allergic) versus irritant skin reactions. subjects for this study need to be healthy males between the ages of 18 and 40. this study will evaluate this by injecting antigens as well as applying them on top of the skin to the forearm then measure the effects of baricitinib by skin and blood testing.


Eligibility criteria:
inclusion criteria: * males 18-40 years of age at the time of signing the informed consent document * understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted * able to adhere to the study visit schedule and other protocol requirements * must be in good health as judged by the investigator, based on medical history and physical examination, and no laboratory abnormalities exclusion criteria: * any known severe allergies to yeast products * currently active skin diseases such as psoriasis, atopic dermatitis, allergic contact dermatitis or irritant contact dermatitis * inability to understand informed consent * any medical condition that the investigator feels would interfere with study * any abnormalities on physical exam or screening laboratory studies (to progress to part ii) * agree to discontinue use of prohibited medications at least 4 weeks prior to screening: topical corticosteroids, oral or injectable systemic steroids, systemic immunomodulators (cyclosporine, methotrexate, etc.), oral or topical antihistamines * positive reaction to tuberculin test (ppd) or negative control * negative reaction to initial skin testing for candida, trichophyton, or sodium laurel sulfate
improving quality of life and daily life activities with bioarginine in patients with copd

Conditions: COPD; Dyspnea; Argininemia

Summary: different studies have suggested that copd is associated with elevated alveolar no and increased expression of nos2 in alveolar walls, small airway epithelium and vascular smooth muscle. furthermore, arginase activity in copd is shown to correlate inversely with total no metabolite in sputum and with pre- and post- bronchodilator fev1; at the same time adma levels in serum is shown to be correlated with airway resistance and adma in copd airways was documented to be able to shift the l-arginine metabolism towards the arginase pathway. as demonstrated in a guinea pig model, the arginase inhibition can shift the l-ornitine: l-citrulline ratio towards l-citrulline, preventing neutrophilia, mucus hypersecretion and collagen synthesis. thus, increasing substrate availability for nos by arginase inhibition or supplementation of l-arginine or l-citrulline or a combination thereof, may represent a window of opportunity in patients with copd. the present study was constructed in order to investigate as a primary objective whether in symptomatic patients with copd, daily bioarginine on top of chronic inhaled therapy can improve patients' respiratory symptoms and dyspnea during daily life activities. the secondary objective of the study is to determine whether there is any correlation between improvement in respiratory symptoms and distance walked at the 6mwt and lung function parameters. in order to do so, the investigators designed a multi center, interventional, prospective, randomized, controlled vs placebo, proof of concept study: copd patients will be randomized to receive bioarginine twice daily on top of chronic inhaled therapy or to continue their chronic inhaled therapy plus placebo for 6 weeks. in order to evaluate the impact on respiratory symptoms and dyspnea the crq (chronic respiratory disease questionnaire) and the lcadl (london chest activities of daily living) scale, as well as the 6mwt, will be used.


Eligibility criteria:
inclusion criteria: * \> 40 years old * smoke history \>10 pack years (pys) * forced expiratory volume (fev1 70-40% predicted) * copd assessment test score \>= 10 * stable inhaled therapy in the three months prior to study enrollment exclusion criteria: * exacerbations in the three months prior to study enrolment * dementia and inability to perform study test bundles * interstitial lung disease * history of asthma * patients unable to perform a 6mwt or necessitating a walker to ambulate * long term oxygen therapy (excluding patients on nocturnal o2 therapy) * patients enrolled in pulmonary rehabilitation programs during the study or that have completed a pulmonary rehabilitation program in the 6 months before study enrollment

Keywords: copd arginine
a trial of maintenance treatment with fluzoparib versus placebo in relapsed ovarian cancer patients

Conditions: Ovarian Cancer

Summary: to evaluate the efficacy, safety tolerability of maintenance therapy with fluzoparib(a parp inhibitor) versus placebo in chinese patients with recurrent ovarian cancer who achieved a complete response (cr) or partial response (pr) after platinum-based chemotherapy


Eligibility criteria:
inclusion criteria: 1. histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer) 2. completion of ≥2 previous platinum-containing regimens 3. complete response (cr) or partial response (pr) achieved with last platinum-based chemotherapy regimen as determined by investigator 4. ability to be randomized ≤8 weeks after last dose of platinum exclusion criteria: 1. prior treatment with a poly (adp-ribose) polymerase (parp) inhibitor 2. patients who have received other study drug treatment within 4 weeks prior to the first administration(\< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs). 3. patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.