Kornimate/medical-research-clean huggingface dataset:
a study of molidustat for maintenance treatment of renal anemia in non-dialysis subjects

Conditions: Anemia; Renal Insufficiency, Chronic

Summary: the purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with erythropoiesis-stimulating agents (esas)


Eligibility criteria:
inclusion criteria: * subjects with estimated glomerular filtration rate (egfr)\< 60 ml/min/1.73m\^2 (chronic kidney disease \[ckd\] stages 3 to 5) * have used the same esa for 8 weeks prior to screening * treated with darbepoetin alfa with bi-weekly or monthly dose, epoetin beta pegol with monthly, or epoetin alfa/beta weekly or bi-weekly, and having had no more than one dose change within 8 weeks prior to randomization * body weight \> 40 and ≤ 160 kg at screening * male or female subject ≥ 20 years of age at screening * not on dialysis and not expected to start dialysis during the study period * mean screening hb level ≥ 10.0 and \< 13.0 g/dl (mean of all central laboratory hb levels \[at least 2 measurements must be taken ≥ 2 days apart\] during the 8-week screening period, and all hb level must be measured by the central laboratory, and the difference between the lowest level and highest level is \< 1.2 g/dl), with the last screening hb level measurement within 14 days prior to randomization * ferritin ≥ 100 ng/ml or transferrin saturation ≥ 20% exclusion criteria: * new york heart association (nyha) class iii or iv congestive heart failure * history of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization * sustained and poorly controlled arterial hypertension (defined as systolic bp (blood pressure)≥ 180mmhg or diastolic bp ≥ 110mmhg) or hypotension (defined as systolic bp \< 90mmhg) at randomization * proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)

Keywords: renal anemia
evaluation of the distortion correction data collection (dcdc) app software

Conditions: Age-related Macular Degeneration

Summary: the purpose of the research study is to evaluate how well the distortion correction data collection (dcdc) app works. the dcdc app is an experimental software application that is being developed at the university of nebraska omaha. the dcdc app will map and draw the visual distortions of patients with age-related macular degeneration.

this research study is a phase 1 clinical trial to evaluate the efficacy of the distortion correction data collection (dcdc) app on a computer tablet system. there are two objectives in this study. the primary objective is to evaluate the functionality of the visual distortion app on the tablet computer. patients will draw their distortions on the tablet screen, and the app will record and correct the distortions.the second objective is to create a distortion data repository (ddr) that contains retinal maps, data pertaining to the anatomical and functional aspects of patients retinas and the distortions. this ddr will be used to correlate retinal health to distortions.the correlation will be key in improving the correction software of the app. long term, the app will be used to create a diagnostic tool and improve image processing in retinal prosthesis systems. participating subjects must be at least 55 years of age or older with age-related macular degeneration (amd). after consent, a chart review will be performed. at the baseline visit, subjects will have an electroretinogram (erg). at the single study visit, to be scheduled within 2 weeks of the baseline visit, subjects will use the dcdc app on a tablet computer to trace their visual distortions on an amsler grid. up to 5 subjects who meet the inclusion/exclusion criteria will be enrolled. the duration of the study is a 2 hour baseline visit and a 1 hour study visit, all within 2 weeks.

Eligibility criteria:
inclusion criteria: * 55 years of age or greater * diagnosed with age-related macular degeneration (amd). * best corrected visual acuity (bcva) of (20/40 to 20/200 snellen equivalent). * visual distortion is present in at least one eye, as determined by amsler grid evaluation. * have had the following imaging tests completed within the past three months as part of standard of care: optical coherence tomography (oct), scanning laser ophthalmoscopy (slo), and fluorescein angiography (fa). * capable of understanding the requirements of the study, willing to follow study instructions, able to provide written informed consent to participate, and willing to comply with all study requirements. * women who are post-menopausal or not otherwise of child-bearing potential - exclusion criteria: * visual field loss from diseases other than amd. * visual distortions from the following conditions other than amd: epiretinal membrane, diabetic macular edema, central retinal vein occlusion (crvo) with edema, and cystoid macular edema. * a medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease ability to follow study instructions.
study evaluating denosumab on vascular and bone metabolism in osteoporotic chronic kidney disease (hdenobs)

Conditions: Osteoporosis; Chronic Kidney Disease 5D

Summary: aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab: * on coronary artery calcification scores evolution after 24 months of followup * on abdominal aorta calcification scores evolution after 24 months of followup * on bone mineral density (femoral t-score) at 24 months * on bone mineral density evolution (femoral t-score) after 24 months of follow-up * on bone mineral density evolution (lumbar t-score) after 24 months of follow-up * on parameters of bone remodelling after 24 months of follow-up * on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up * the tolerance after 24 months of follow-up

aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab: * on coronary calcification scores evolution (by multidetector computed tomography) after 24 months of follow-up * on abdominal aorta calcification scores evolution (by plain abdominal xray) after 24 months of follow-up * on bone mineral density (femoral t-score) (by bone densitometry) at 24 months * on bone mineral density evolution (femoral t-score) (by bone densitometry) after 24 months of follow-up * on bone mineral density evolution (lumbar t-score) (by bone densitometry) after 24 months of follow-up * on parameters of bone remodelling after 24 months of follow-up * on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up * the tolerance after 24 months of follow-up

Eligibility criteria:
inclusion criteria: * chronic kidney disease stage 5d patient, hemodialyzed with extracorporeal treatment for at least 3 months * osteoporosis exclusion criteria: * pregnancy or breastfeeeding female * current corticoid treatment * pth and calcium outside the kdigo guidelines * adynamic bone disease suspicion * cancer or myeloma * serious hepatic cytolysis * serious dental troubles * positive hiv serology * hypersensibility to active substance or one of excipients of denosumab
comparison of 2 different indomethacin dosing protocols to treat infants delivered at <28 weeks gestation with a persistent patent ductus arteriosus

Conditions: Patent Ductus Arteriosus

Summary: the purpose of this study is to examine if a higher dose of indomethacin will increase the rate of ductus arteriosus closure in extremely premature infants without increasing the side effects. the long term objective is to find the optimal dosing of indomethacin for permanent closure of the ductus and prevent the morbidity related to pda and the complications of surgical ligation.

this study is a phase ii randomized, masked, controlled trial that compares the current standard dose of indomethacin to a higher dose for the closure of pda in premature infants less than 28 weeks of gestation. neonates (\<28 weeks gestation) who are started on indomethacin treatment (with an initial 3-dose course: 0.2, 0.1, and 0.1 mg/kg of indomethacin) within the first 96 hr after birth will be eligible for this trial if they continue to have doppler evidence of ductus patency before the third dose of indomethacin. this group of infants have greater than 65% chance of developing symptomatic pda and surgical ligation even after our standard extended course of indomethacin. those infants who do not fit the exclusion criteria will be randomized to either a standard dose group or to a higher dose group after obtaining consent. the infants randomized to the standard group will receive a 4th, 5th, and 6th dose of indomethacin (0.1 mg/kg) at 24 hr intervals (starting at 24 hr after the 3rd dose). the higher dose group infants delivered between 26-27 weeks gestation will receive a 4th, 5th, 6th, 7th, 8th and 9th dose of indomethacin (0.1mg/kg) at 12 hr intervals (starting 12 hr after the 3rd dose). the higher dose group infants between 24-25 weeks gestation will receive a 4th, 5th, 6th, 7th, 8th and 9th dose of indomethacin (0.25mg/kg) at 12 hour intervals (starting 12 hr after the 3rd dose). to keep the study blinded, the standard group will receive 3 extra doses of saline to match the 3 additional doses given to the higher dose group.

Eligibility criteria:
inclusion criteria: 1. newborn infants of less than 28 weeks gestational age who are treated with indomethacin during the first 48 hours after birth 2. presence of patent ductus arteriosus (pda) by doppler echocardiography between the second and third dose of indomethacin. 3. creatinine ≤1.8 mg/dl 4. platelets ≥ 50,000 exclusion criteria: 1. chromosomal disorders. 2. major congenital anomalies. 3. contraindications for indomethacin 1. necrotizing enterocolitis, by clinical or radiological evidence 2. evidence of bleeding diathesis as evidenced by pulmonary hemorrhage, persistent oozing from puncture sites, grossly bloody stool (note: infants with an intracranial hemorrhage can be enrolled in this study).

Keywords: prematurity chronic lung disease necrotizing enterocolitis indomethacin ductus arteriosus
central apnoea monitor study

Conditions: Sleep Apnea

Summary: an initial small study on 15 children that are already being investigated for central sleep apnoea in the sleep unit at sheffield children's hospital. the central apnoea monitor will be placed around the child's abdomen overnight alongside the sensors already being used for the clinical sleep study and the signals from the two systems will be compared to evaluate the accuracy of the new device.


Eligibility criteria:
inclusion criteria: * patients who have been referred for a cardio-respiratory polygraphy sleep study. * patients aged 1 month up to 5 years old. exclusion criteria: * subjects whose parents/legal guardians/carers are not fluent in english, or who have special communication needs. * child anticipated to become distressed with additional sensor. * child too clinically unwell to take part (as decided by clinical staff).
react-01: reversing autoimmunity through cell therapy

Conditions: Systemic Lupus Erythematosus

Summary: this is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research participants with treatment-refractory systemic lupus erythematosus (sle), to examine the safety, feasibility, and efficacy of administering t cell products derived from peripheral blood mononuclear cells (pbmc) that have been genetically modified to express cd19 specific chimeric antigen receptor (car) a child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their t cells collected. the t cells will then be bioengineered into a car t cell that targets circulating and tissue residing b cells.


Eligibility criteria:
inclusion criteria: * male and female subjects aged between 2-30 years old. the first 3 subjects will be aged ≥ 17. the fda will review safety data to determine if the age can be lowered first to ≥ 12 then, following the treatment of 3 further subjects aged 12-17, to ≥ 2 * serologically active systemic lupus erythematosus that is refractory to treatment * able to tolerate apheresis or already has an apheresis product available for use in manufacturing. * ≥ 24 weeks post last rituximab or related b cell depleting therapy * ≥ 12 weeks post last belimumab / anifrolumab therapy * ≥ 4 weeks post last calcineurin inhibitor treatment * for subjects receiving non-calcineurin immunosuppressive therapy, on a stable dose for ≥ 8 weeks before enrollment * for subjects receiving corticosteroid therapy, on a stable dose for ≥ 2 weeks before enrollment * adequate organ function * adequate laboratory values * subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial * subjects must be willing to remain within 1 hour's drive of seattle children's hospital for 4 weeks following car t cell infusion. * subject and/or legally authorized representative has signed the informed consent form for this study exclusion criteria: * history or presence of active cns lupus or other cns disease * kidney dysfunction requiring renal replacement therapy * pregnant or breastfeeding * insufficient pulmonary reserve including history of copd, \>10 pack year smoking history or sle lung disease with hypoxia at rest with oxygen saturation ≤92% on room air * unable to tolerate repletion with any formulation of igg. * active or prior malignancy, unless the malignancy was treated and there is no evidence of recurrent disease \<5 years from enrollment. * prior solid organ transplantation. * presence of an active severe infection * presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol

Keywords: car t cells lupus systemic lupus erythematosus sle
immunogenicity and safety of a booster dose of pneumo 23® in 12 to 18 months-old children primed with prevnar

Conditions: Streptococcus Pneumoniae

Summary: the present study intends to investigate the use as a booster of a dose of sanofi pasteur's pneumo 23 vaccine in the second year of life following 3-dose priming with wyeth's prevnar vaccine. the researchers will use a cohort of subjects who have received 3 doses of prevnar® at 2, 4, 6 months of age in the context of the clinical study a3l12 on hexavalent combined vaccine (dtap-ipv-hb-prp\~t)


Eligibility criteria:
inclusion criteria: * aged 12 to 18 months on the day of inclusion * informed consent form signed by the parent/legally acceptable representative and by an independent witness if requested by local ethics committee regulation or/and if the parent/legally acceptable representative is illiterate * child having completed the three-dose primary vaccination of prevnar® in the hexavalent combined vaccine study (study a3l12). * subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures exclusion criteria: * participation in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination * planned participation in another clinical study during the present study period * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or to a vaccine containing any of the same substances * chronic illness at a stage that could interfere with study conduct or completion, in the opinion of the investigator * receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response * receipt of any vaccine in the 4 weeks preceding the study vaccination * planned receipt of any vaccine in the 4 weeks preceding or following study vaccination * history of seizures known personal human immunodeficiency virus (hiv), hepatitis b (hb) antigen or hepatitis c seropositivity * history of pneumococcal infection (confirmed either clinically, serologically or microbiologically) * previous booster vaccination against the pneumococcal disease with either the study vaccine(s) or another vaccine * thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating im vaccination * febrile illness (temperature ≥ 38°c) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.

Keywords: streptococcus pneumoniae
bone marrow derived mononuclear cells for myocardial regeneration

Conditions: Left Ventricular Dysfunction

Summary: evaluative pilot study for safety and feasibility with administration of autologous bone bone marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo the ischemic lesion.


Eligibility criteria:
inclusion criteria: * lvef \<40% * pci at latest 6 hours after infarction * bmi \>20 kg/m² and \<30 kg/m² exclusion criteria: * pci elder than 14 days * relevant valvular disease * left ventricular dysfunction caused by other reasons than ischemic cardiomyopathy * history of stroke, chronic atrial fibrillation, multivessel disease, thromboembolic event * scheduled for cabg * dm type 1 \& extensive hypercholesterinemia * pacemaker * systemic disease * pregnancy

Keywords: left ventricular dysfunction myocardial infarction left ventricular dysfunction (lvdf) after acute myocardial infarction
assessment of digital consultations on clinical impact and efficiency

Conditions: Heart Failure

Summary: healthcare workers have a high workload as compared to other sectors and this burden is projected to increase due to an aging society. it is and will in the future be challenging to deliver optimal hf care because of personnel shortages, the high costs of healthcare, intensive gdmt uptitration schedules, and an epidemic rise in hf patients.this study aims to evaluate the impact of digital consultations (dc) on efficiency and clinical impact in heart failure (hf) patients. a randomized controlled trial on multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an elearning, and 3) digital guideline recommendations to treating physicians. included patients will be randomly (1:1) assigned to the intervention group or standard care. the administer trial is expected to offer the first robust randomized controlled multicenter data of gdmt prescription rates, time till full gdmt optimization, time spent on healthcare, patient satisfaction and quality of life of digital consults in gdmt optimization.

introduction: many heart failure (hf) patients do not receive optimal guideline-directed medical therapy (gdmt) despite clear benefit on morbidity and mortality outcomes. digital consultations (dc) have the potential to improve efficiency on gdmt optimization to serve the growing hf population. hence, the investigator initiated administer trial was designed as a pragmatic multicenter randomized controlled trial to evaluate efficacy and safety of dc in patients on hf treatment. methods: patients (n = 150) diagnosed with hf with a reduced ejection fraction (hfref) will be randomized to dc or standard care (1:1). the intervention group receive multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an elearning, and 3) digital guideline recommendations to treating physicians. the consultations are performed remotely unless there is an indication to perform the consult physically. the primary outcome is the gdmt prescription rate score, secondary outcomes include time till full gdmt optimization, patient and clinician satisfaction, time spent on healthcare, and kansas city cardiomyopathy questionnaire. results will be reported in accordance to the consort statement. conclusion: the administer trial will offer the first randomized controlled data on gdmt prescription rates, time till full gdmt optimization, time spent on healthcare, quality of life, and patient and clinician satisfaction of the multifaceted patient and clinician targeted dc for gdmt optimization.

Eligibility criteria:
inclusion criteria: * hfref exclusion criteria: * patients not in possession of any attributes to perform the consults digitally

Keywords: digital consultations, gdmt optimization, hfref
a multicenter multinational observational study of children with hypochondroplasia

Conditions: Hypochondroplasia

Summary: this study will assess growth over time and the clinical course of hch in children by collecting growth measurements and other variables of interest.


Eligibility criteria:
inclusion criteria: * participants must be ≤ 15 years old at the time of signing the informed consent * participants must have genetic confirmation of hypochondroplasia diagnosis exclusion criteria: * have a diagnosis of another genetic short stature condition other than hypochondroplasia or a genetic variant known to cause another genetic syndrome associated with short stature * received an investigational product or medical device within 6 months before the screening visit
evaluation of wp200 with the unified probe (wp200u)

Conditions: Sleep Disorders

Summary: the prevalence of osas is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. the severity of the disorder is expressed by the apnea hypopnea index (ahi) which is the number of apnea/hypopnea episodes per hours of actual sleep and the respiratory disturbances index (rdi) which is an extended index incorporating in addition to the previous episodes also respiratory effort related arousal episodes. the high cost of in-lab full night psg, together with long waiting lists for sleep studies, have led to the development of a variety of ambulatory sleep study systems. the primary objective of the study is to evaluate the newly developed wp200 with the unified probe (wp200u) compared to the currently used configuration of wp200 that uses an incorporated nonin oximetry module in the sleep lab or in the home sleep environment.


Eligibility criteria:
inclusion criteria: * age between 5-90 * subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are either referred or volunteering to undergo an overnight sleep study in the clinical sleep laboratory or at home exclusion criteria: * permanent pacemaker. * severe lung disease. * severe peripheral neuropathy. * finger deformity that precludes adequate sensor appliance. * using one of the following medications: short/long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).

Keywords: sleep disorders sleep apnea ambulatory device watchpat