Kornimate/medical-research-clean huggingface dataset:
study of aldafermin (ngm282) in participants with impaired renal function

Conditions: Impaired Renal Function

Summary: this is a single-center evaluation of aldafermin (ngm282) in an open-label, single-dose and parallel group study in participants with impaired renal function.


Eligibility criteria:
inclusion criteria: * current diagnosis of stable chronic kidney disease and egfr, as assessed by the modification of diet in renal disease (mdrd) estimate: 1. mild renal impairment: egfr 60-89 ml/min/1.73m² 2. moderate renal impairment: egfr 30-59 ml/min/1.73m² 3. severe renal impairment: egfr \< 30 ml/min/1.73m² * healthy control subjects with normal renal function will be matched (age ± 10 years; sex, race, bmi ± 15%) to their respective subject in the impaired renal function groups and have egfr ≥90 ml/min/1.73m . healthy control subjects should have no systemic chronic disease. * males and females age 18-75 * body mass index (bmi) 25-40 kg/m² exclusion criteria: * renal allograft recipients * history of renal cell carcinoma or any history of metastatic disease involving the kidney * end stage renal disease, requiring or not requiring dialysis * subject requiring or anticipated requirement of dialysis within 3 months of study entry * diagnosis of acute kidney injury/acute renal failure, or hospitalization for kidney related issue within 3 months of screening * any renal disease or related condition actively being treated other than chronic kidney disease * any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact renal function within 2 weeks of screening * history of treatment for a chronic condition with a medication that is known to have nephrotoxic potential, and after treatment, renal function/status has not been fully evaluated * uncontrolled hypertension * uncontrolled diabetes
duration of silicone oil tamponade on foveal and parafoveal thickness in rhegmatogenous retinal detachment

Conditions: Retinal Detachment

Summary: our study observes and analyses the influence of the duration of tamponade with silicone oil on the foveal and parafoveal thickness.

retrospective cohort study retrospective review of records of eyes with rhegmatogenous retinal detachment (rrd, for whom pars plana vitrectomy and silicone oil had been performed, in the period between january 2019 and december 2021. after checking inclusion and exclusion criteria; we will enroll all the cases. we shall observe the duration of silicone oil tamponade, and then divide the cases; accordingly; into 2 groups (cohort). * group a: 3 months so tamponade * group b: 6 months so tamponade

Eligibility criteria:
inclusion criteria: * • silicone oil (so) tamponade ( up to 6 months) * attached retina under so * attached retina 3 months after silicone oil removal (sor) * normal fellow eye ( no retinal detachment or macular disease) * oct scan performed for the operated eyes (before sor, and 3 months after sor), and for the fellow eye (at any time during the study) exclusion criteria: * • rhegmatogenous retinal detachment (rrd) with other tamponades ( e.g.: gas, densiron) * so tamponade less than 3 months, or more than 6 months * recurrent rd under so * recurrent rd within 3 months after sor * one eyed * vitrectomized fellow eye * retinal detachment, or macular disease in the fellow eye. * posterior staphyloma * anisometropia (history, refraction if possible, spectacles prescription) * absence of any of the oct scans performed for the operated eyes (before sor, and 3 months after sor), and for the fellow eye (at any time during the study)
effect of proton pump inhibitor and mosapride on acid pocket in gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: the gastric acid pocket is believed to be the reservoir from which acid reflux events originate. the risk for acidic reflux is mainly determined by the position of the gastric acid pocket. little is known about how changes in position and size of the acid pocket contribute to the therapeutic effect of proton pump inhibitors(ppi) plus mosapride in patients with gastroesophageal reflux disease. investigators will conduct a prospective randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing the acid pocket position and size.


Eligibility criteria:
inclusion criteria: * patients with diagnosed gerd(gastro-esophageal reflux disease), defined by the presence of oesophagitis obtained during a previous upper endoscopy or typical gerd symptoms(heartburn, acid reflux). exclusion criteria: * who had organic gastrointestinal disease including inflammatory bowel disease, cancer and ulcer * who took drugs which could affect evaluation of the treatment; other ppis, h2ras(h2 receptor antagonists), prokinetics,mucosal protective agents, antacids, cholinergic and anticholinergic agents, and antidepressants for at least 4 weeks prior to study start * who had severe systemic diseases including hepatic and nephrotic disease * who had previous gastrectomy history * who was in state of pregnancy
a trial to learn how well regn7508 works for preventing blood clots after a knee replacement in adult participants

Conditions: Venous Thromboembolism

Summary: this study is researching an experimental drug called regn7508 (called "study drug"). the study is focused on adults undergoing elective, unilateral (one side) total knee replacement (tkr) surgery. the aim of the study is to see how effective the study drug is at preventing venous thromboembolism (vte) and other related diseases after unilateral total knee replacement surgery. the study is looking at several other research questions, including: * what side effects may happen from taking the study drug * how much study drug is in the blood at different times * whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. undergoing a primary elective unilateral tka 2. has a body weight ≤130 kg at screening visit 3. is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ecg's) performed at screening and/or prior to administration of initial dose of study drug as described in the protocol 4. is in good health based on laboratory safety testing obtained during the screening period as described in the protocol key exclusion criteria: 1. history of bleeding in the past 6 months prior to dosing requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis 2. history of thromboembolic disease or thrombophilia 3. history of major surgery, including brain, spinal, or ocular, within approximately the past 6 months 4. history of major trauma within approximately the past 6 months prior to dosing 5. hospitalized (\>24 hours) for any reason within 30 days of the screening visit 6. has an estimated glomerular filtration rate (gfr) of \<45 ml/min/1.73m\^2 at the screening visit using one of the following formulas: the modification of diet in renal disease (mdrd) equation, the chronic kidney disease epidemiology collaboration equation, or equivalent equation note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: anti-factor xi (fxi) monoclonal antibody venous thromboembolism (vte) unilateral total knee arthroplasty (tka)
prognostic value of arterial spin labeling brain perfusion mri in term neonates with hypoxic-ischemic encephalopathy

Conditions: Neonatal Hypoxic Ischemic Encephalopathy

Summary: the main purpose of this study will be to evaluate the prognostic value at 3 months of life of brain perfusion mri determined by arterial spin labeling technique in the first week of life of term newborns with hypoxic-ischemic encephalopathy requiring management in neonatal intensive care unit.

hypoxic-ischemic encephalopathy is the result of birth asphyxia due to transitory cerebral blood flow drop during perinatal period. it is the leading cause of neonatal encephalopathy, and thus a major cause of perinatal mortality, morbidity and adverse neurodevelopmental outcome. usual care brain mri is critically important in the diagnosis and prognosis. lasting about 30 to 40 minutes, mri exam includes successive sequences providing complementary information but none relatively to brain perfusion. perfusion mri without contrast media injection is possible using arterial spin labeling (asl) sequence. asl is highly suitable for neonates, noninvasiveness, and lasts only 5 minutes. however, only one study assessed asl as a prognostic factor. the purpose of the study is therefore to perform asl sequence within usual care brain mri.

Eligibility criteria:
inclusion criteria: * neonates with a term ≥ 36 weeks of amenorrhea and birth weight ≥ 1800 g. * presenting with perinatal asphyxia defined as combination of: * an acute perinatal event (such as placental abruption, cord prolapse, and/or severe foetal heart rate abnormalities); * and at least one of the following criteria: * apgar score ≤ 5 at 10 minutes of life, * mask ventilation or intubation at 10 minutes of life, * metabolic acidosis defined as ph \< 7 or base deficit ≥ 16 mmol/l or lactates ≥ 11 mmol/l within the first 60 minutes of life on cord or other arterial venous or capillary blood sample. * patient treated or not with therapeutic hypothermia for 72 hours. * affiliated patient or beneficiary of a social security scheme. * informed and signed parental consent. exclusion criteria: * perinatal arterial ischemic stroke. * congenital neuro-metabolic disorder. * severe malformative abnormalities. * mri contra-indication. * poor understanding of the holders of parental authority

Keywords: hypoxic-ischemic encephalopathy neonate perfusion mri arterial spin labeling
effectiveness of a valsartan based vs an amlodipine based treatment strategy in naïve patients with stage 1 or stage 2 hypertension or in patients uncontrolled on current monotherapy

Conditions: Hypertension

Summary: essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. it contributes to cardiovascular disease development, a major and well established risk factor. a patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.


Eligibility criteria:
inclusion criteria * mssbp\> 140 mm hg, and/or msdbp\> 90 mm hg and currently treated with either valsartan 320 mg/ hctz 25 mg or amlodipine 10 mg/hctz 25 mg at end of core study exclusion criteria * premature discontinuation in the core study or failure to comply with the core study protocol * any patient that the investigator decides should not participate in the extension other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, stage 1 hypertension, stage 2 hypertension, valsartan, amlodipine,
a study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis

Conditions: Psoriasis

Summary: a study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis


Eligibility criteria:
inclusion criteria: * clinical diagnosis of plaque psoriasis exclusion criteria: * skin disorder other than plaque psoriasis in the areas to be treated. * disease on only elbows, knees, and scalp

Keywords: treatment outcome tacrolimus safety psoriasis
outpatient exclusive human milk diet for single infant with complex congenital heart disease

Conditions: Growth Delay

Summary: a single patient observational trial to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet including a human milk based human milk fortifier formulated for term infants fluid restricted due to surgically correctable congenital conditions.

a single patient observational study to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet. human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier. the study hypothesis is that this infant if fed an exclusive human milk diet will have improved growth in part due to data greater tolerability of the diet. it is estimated that the study will require 90 days to complete. growth in safety observations will be collected only during the time the patient is receiving the diet. the primary objective is to evaluate growth velocity (weight velocity \[g/kg/day\] of a single infant receiving a 100% human milk diet including a human milk based human milk fortifier formulated for term infants who are fluid restricted due to surgically correctable congenital conditions. this will be compared to the infant's growth velocity prior to the initiation of said diet.

Eligibility criteria:
inclusion criteria: * complex congenital heart disease in presence of poor linear and head circumference growth and unable to tolerate cow's milk protein exclusion criteria: * n/a
a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'ursa complex soft cap. (udca-004)' in patients with physical fatigue.

Conditions: Fatigue

Summary: a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'ursa complex soft cap. (udca-004)' in patients with physical fatigue.


Eligibility criteria:
inclusion criteria: * cis greater than or equal to 76, hads less than or equal to 10 exclusion criteria: * subjects who have diseases that can cause fatigue * subjects who are taking medication that can cause fatigue
assessment of dementia nutrition intervention needs among care recipients and caregivers

Conditions: Dementia

Summary: nutrition is critical for disease prevention and brain health. malnutrition and weight loss often affect persons with alzheimer's dementia (pwd), worsening overall health and dementia. informal caregivers (usually family members) perform many nutrition-related tasks as part of daily care such as food preparation and feeding. limited research, however, suggests informal caregivers experience high rates of caregiver burden, malnutrition and low health literacy. more research is needed to uncover these and other factors that may contribute to malnutrition for both pwds and their caregivers. nutrition literacy, or ability to navigate nutrition information to select healthy food, may be an important caregiving factor that protects both individuals from experiencing nutritional decline. although the nih has increased funding to support caregiver research, caregiver interventions that include nutrition are lacking. the purpose of this study is to inform the design of a future nutrition intervention study.


Eligibility criteria:
inclusion criteria: * person with dementia: must be an adult of any age, diagnosed with alzheimer's dementia or other dementia, reside at home with a family caregiver or domestic partner, and have weight records at a minimum of 2 timepoints. * caregiver: must be at least 18 years old, english speaking, primary caregiver who is responsible for food planning, and no overt cognitive impairment. exclusion criteria: * person with dementia: frontal-temporal dementia, alcohol-related dementia, huntington's disease, schizophrenia, manic-depressive disorder, or actively participating in nutrition intervention research. * caregiver: visual impairments that prevent completing questionnaires or actively participating in nutrition intervention research.

Keywords: nutrition assessment
niclosamide role in diabetic nephropathy

Conditions: Diabetic Nephropathies

Summary: this study is randomized, controlled, parallel, prospective clinical study will be conducted on 60 patients diagnosed with type 2 diabetes mellitus at least five years ago. patients will be recruited from tanta university hospital, tanta, egypt. accepted patients will be randomized into 2 groups as the following: control group: 30 patients will receive maximum tolerated dose of acei plus placebo pills for six months treatment group: 30 patients will receive maximum tolerated dose of acei plus niclosamide tablets 1 gram once daily for six months the primary end point will be the change in urinary albumin to creatinine ratio (uacr) and estimated glomerular filtration rate (egfr) after six months of treatment


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus at least 5 years ago * stage 2 and 3 diabetic nephropathy (persistent micro- or macroalbuminuria with urinary albumin creatinine ratio (uacr) \>30mg/g) despite treatment with maximum tolerated dose of ace inhibitors for at least 8 weeks prior to the screening * hemoglobin a1c \> 6.5 % with regular use of insulin and/or oral glucose lowering agents exclusion criteria: * type 1 diabetes mellitus * severe renal impairment (egfr\< 30 ml/min/1.73 m2 at screening) * pregnant or lactating women * chronic heart failure * inflammatory or autoimmune disease * history of kidney disease other than diabetic nephropathy

Keywords: diabetes - niclosamide - diabetic kidney disease
uterosacral ligament suspension vs robotic sacrocolpopexy

Conditions: Pelvic Organ Prolapse

Summary: this cross sectional, two cohort study seeks to investigate both anatomic outcome and subjective, functional outcome of uterosacral ligament suspension versus robotic sacrocolpopexy and compare patient satisfaction, bladder function, sexual function and complication rate for each procedure.this study will provide a better understanding about the durability of these procedures and long term complication.

pelvic organ prolapse is a common problem affecting many women and there is a 12.6% lifetime risk of undergoing reconstructive pelvic surgery. there are several surgical options available to patients undergoing reconstruction for pelvic organ prolapse, however addressing the apex is recommended to achieve the most durable outcomes. two of the most commonly performed procedures for apical prolapse repair are uterosacral ligament suspension and robotic sacrocolpopexy. high uterosacral ligament suspension is a native tissue repair which is performed by affixing the vaginal apex to the bilateral uterosacral ligaments using permanent or delayed-absorbable sutures. this is performed typically in a vaginal approach. sacrocolpopexy is a performed by attaching the anterior and posterior vaginal walls to the sacral promontory using synthetic mesh, typically polypropylene. this procedure can be performed by an abdominal approach, a laparoscopic approach or with the assistance of the da vinci robotic system. in recent years, robotic sacrocolpopexy has largely replaced the abdominal approach, and become the procedure of choice for minimally invasive surgeons. most studies evaluating sacrocolpopexy outcomes were performed prior to the popularity of robotics and therefore concentrate on abdominal sacrocolpopexy. this cross sectional, two cohort study will compare outcomes of uterosacral ligament suspension versus robotic sacrocolpopexy and will give pelvic surgeons a better understanding about the durability of these procedures, and possible longer term complication rates. subjects will be contacted and asked to come to the office for a visit and completion of questionnaires. if they cannot come to the office, an informed consent form (icf) and questionnaires will be mailed to them to complete and return separately.

Eligibility criteria:
inclusion criteria: * women aged 18 years of age or older who spent 3-7 years following uterosacral ligament suspension or robotic sacrocolpopexy. * concurrent procedures such as suburethral sling, bilateral salpingoophorectomy, hysterectomy, rectopexy. * concurrent procedures such a s takedown of sling exclusion criteria: * concurrent procedure to remove vaginal mesh at time of their index surgery * unwillingness to participate in the study * dementia or inability to provide informed consent
risk factors of icu-acquired weakness

Conditions: ICU Acquired Weakness

Summary: we conducted a retrospective study of critical ill patients who used ecmo during their icu stay. icu-aw was diagnosed at the time when patients discharged and had a medical research council (mrc) sum score \< 48 out of a maximal score of 60. we divided patients to icu-acquired weakness group and no icu-acquired weakness group and compared their clinical characteristics. baseline characteristics and therapy details were collected from the case report forms and inspection reports. univariable analysis and logistic regression analysis were used to analyze clinical characteristics of individuals and to find risk factors of icu-aw.


Eligibility criteria:
inclusion criteria: * critical ill patients who used extracorporeal membrane oxygenation during their icu stay. patients were recruited from the general icu of the second affiliated hospital of zhejiang university, between march 2017 to march 2020. exclusion criteria: * patients who was less than 18 years old, had been proven or suspected neurological impairment, using extracorporeal membrane oxygenation less than 24 hours, severe head or spinal cord injury and pregnant woman.

Keywords: icu acquired weakness extracorporeal membrane oxygenation
safety and efficacy of bosutinib

Conditions: Chronic Myelogenous Leukemia

Summary: the objective of this surveillance is to collect information about 1. adverse drug reaction not expected from the lpd (unknown adverse drug reaction) 2. the incidence of adverse drug reactions in this surveillance 3. factors considered to affect the safety and/or efficacy of this drug.

the patients should be registered by central registration system.

Eligibility criteria:
inclusion criteria: * chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug * newly-diagnosed chronic phase chronic myelogenous leukemia patients there is no experience with this drug exclusion criteria: * patients with a history of hypersensitivity * women who may possibly be pregnant or become pregnant

Keywords: drug use investigation in japan