Kornimate/medical-research-clean huggingface dataset:
role of probiotics for prevention of nec in preterm vlbw infants

Conditions: Necrotizing Enterocolitis

Summary: this prospective randomized double-blind control trial is carrying out in the neonatal unit of sylhet mag osmani medical college hospital, sylhet between july 2012 to december 2015 with the diagnosis of preterm (\<33 weeks gestation) vlbw (birth weight \<1500g) and fulfilling the inclusion criteria (able to tolerate oral feed and survive beyond 48h of life) were included in this study. babies with suspicion of clinical sepsis, presence of perinatal asphyxia, major congenital anomaly and babies who expired due to other neonatal illness were excluded. gestation was assessed from history of last menstrual period and after birth by new ballard scores. a study protocol was approved by the institutional ethics committee of sylhet m.a.g osmani medical college, sylhet.

background: necrotizing enterocolitis (nec) is the most common acquired disease of the gastrointestinal tract in preterm very low birth weight infants and associated with increased morbidity and mortality. prophylactic enteral probiotic supplementation may play a role in reducing nec and potentially provide benefits to preterm very low birth weight neonates. the objective was to evaluate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis (nec) in preterm very low birth weight (vlbw) infants. this prospective, randomized double blind controlled trial is undergoing in 102 preterm (28-33 weeks gestation) vlbw (birth weight 1000-1499g) neonates fulfilling the inclusion criteria. the study group was fed with probiotics once daily with breast milk from first feeding and the control group only breast milk without the addition of probiotics. the primary outcome was the development of nec (stage ii and iii). nec is categorized by modified bell's classification. probiotic supplementation reduces the frequency of necrotising enterocolitis in preterm neonates with very low birth weight. it is also associated with faster achievement of full enteral feeding and shorter duration of hospital stay.

Eligibility criteria:
inclusion criteria: * all newborn infant preterm (\<33 weeks gestation to 28 weeks gestation) vlbw (birth weight \<1500gm to 1000 gm) * able to tolerate oral feed * informed consent by the parents or guardian exclusion criteria: * evidence or suspicion of clinical sepsis before the baby is randomised * presence of perinatal asphyxia * presence of major congenital anomali * death within first week of life due to other neonatal illness

Keywords: necrotizing enterocolitis probiotics very low birth weight
angiographic evaluation of the everolimus-eluting stent in chronic total occlusions - the ace-cto study

Conditions: Coronary Occlusions

Summary: chronically total occlusions (cto) are difficult to treat and have high risk for restenosis. although everolimus-eluting stents (ees) \[(xience, abbott vascular) or promus (boston scientific)\] are very promising for the treatment of ctos due to their low late loss and excellent deliverability, there are currently no published data on ees implantation in ctos. the specific aim of this proposal is to examine the 8-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of \> 50% of the minimum lumen diameter of the target stent) after implantation of the ees in cto. it is the investigators hypothesis that ees-treated cto lesions will have ≤ 20% 8-month in-stent binary angiographic restenosis rate.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years old 2. successful treatment of a native coronary artery cto (defined as a lesion with 100% angiographic stenosis that is at least 3 months old as estimated by clinical information, sequential angiographic information, or both) using everolimus-eluting stents 3. able and willing to return for angiographic follow-up after 8 months and to be followed clinically for 12 months 4. agree to participate and provide informed consent exclusion criteria: 1. planned non-cardiac surgery within the following 12 months 2. recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy 3. coexisting conditions that limit life expectancy to less than 12 months 4. patients who have a creatinine above 2.5 mg/dl (unless they require hemodialysis, in which case they are eligible to participate) 5. history of an allergic reaction or significant sensitivity to everolimus

Keywords: coronary chronic total occlusions
hs-20089 for injection in patients with platinum-resistant recurrent epithelial ovarian cancer

Conditions: Ovarian Cancer

Summary: this study is a randomized, open-label, controlled, phase iii study to evaluate the efficacy and safety of hs-20089 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.


Eligibility criteria:
inclusion criteria: 1. voluntary participation and written informed consent. 2. 18 years and older, female. 3. pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. 4. patients must have platinum-resistant disease 5. be able to provide fresh or archived tumor tissue. 6. at least one measurable lesion according to recist v1.1. 7. eastern cooperative oncology group (ecog) score: 0-1. 8. with a life expectancy \> 12 weeks. 9. adequate bone marrow reserve and organ function. 10. contraception is required during the trial. exclusion criteria: 1. prior treated with top1 inhibitors or adcs with top1 inhibitors as payload. 2. previous or co-existing malignancies. 3. uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention. 4. received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment. 5. unresolved ctcae ≥grade 2 toxicities from previous anticancer therapy. 6. history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of hs-20089. 7. any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with the study participation or study drug administration. 8. other inappropriate situation considered by the investigator.

Keywords: platinum-resistant recurrent epithelial ovarian cancer hs-20089 randomized phase iii
tremor retrainer software application for functional tremor

Conditions: Functional Movement Disorder; Functional Neurological Disorder; Functional Neurological Symptom Disorder

Summary: the purpose of this clinical trial is to learn about the tremor retrainer smartphone application and simplified functional movement disorder rating scale in patients with functional tremor. the main questions the study aims to answer are: 1. is the tremor retrainer application usable for patients and are there signs that it can help functional tremor? 2. can a televideo administration of the simplified functional movement disorder rating scale give enough information to use this scale via televideo in future studies?

following a one-week observation period, 20 subjects will complete the one-week four hour tremor retrainer smartphone protocol. the study will consist of 4 in-person visits over 3-4 months and one televideo visit the same day as study visit 1. for objective 1, the investigators will evaluate mhealth application usability questionnaire scores after subjects complete tremor retrainer protocol and compare simplified functional movement disorder rating scale (s-fmdrs) scores before (study visit 2) and after (study visits 3 and 4) intervention between groups. for objective 2, the investigators will evaluate which components can be scored after televideo administration of s-fmdrs and measure correlation between randomly-ordered sequential in-person and televideo s-fmdrs administration. for objective 3, the investigators will measure change and variability in s-fmdrs between study visit 1 and 2. s-fmdrs scoring will be completed via video review by a movement disorder neurologist blinded to timing of visit relative to treatment.

Eligibility criteria:
inclusion criteria: 1. age 10 years and older, any gender, any race 2. functional tremor as defined by espay and lang25, diagnosed by a movement disorders neurologist, involving at least 1 arm and ongoing at time of enrollment. 3. access to internet and a laptop or tablet with a videocamera. 4. informed consent obtained and signed 5. subject understands study procedures and is able to comply with study procedures for duration of study exclusion criteria: 1. parkinson's disease, essential tremor, or other disorders causing involuntary movements in addition to functional tremor 2. cognitive impairment with previously diagnosed intellectual disability (iq\<70) or dementia 3. hearing impairment not addressed by hearing aids 4. prior enrollment in clinical trial involving the tremor retrainer application

Keywords: functional tremor
na-phenylbutyrate vascular trial

Conditions: Diabetes

Summary: this study will investigate if the drug sodium phenylbutyrate (napb) impacts blood pressure and vascular function in healthy volunteers and in patients with diabetes.


Eligibility criteria:
inclusion criteria: * over 18 years of age and less than 60. * healthy subjects will have no history of diabetes or prediabetes. * diabetes subjects can be either insulin dependent or not. * able to provide written consent and to comply with the procedures of the study protocol. exclusion criteria: * age \ 60 * pregnant or lactating women. * subjects with hypertension or taking any vasodilatory medications, any steroidal drugs, haloperidol, or valproic acid. * patients with congestive heart failure, severe renal insufficiency, hepatic failure, or known sodium retention with oedema. * active alcohol or substance abuse. * use of tobacco within the previous six months. * unble to provide written consent and to comply with the procedures of the study protocol.
study of muscle wasting and altered metabolism in patients with myotonic dystrophy

Conditions: Myotonic Muscular Dystrophy

Summary: objectives: i. examine the interrelationships between muscle wasting (phenotype), the degree of myotonic dystrophy (dm) gene expression (genotype) in patients with dm. ii. characterize the insulin resistance in these patients. iii. assess the glucose uptake in the leg and forearm tissues of these patients. iv. determine the stability of the dm gene lesion in muscles over a 5-10 year period.

protocol outline: patients are placed on a meatless diet 3 days prior to study entry. during the first 5-day hospital stay, patients receive an oral glucose tolerance test, an intravenous glucose tolerance test, and an intravenous infusion of insulin and glucose (dextrose) to determine the degree of insulin resistance. patients also receive dual x-ray absorptiometry (dexa) scan and total body potassium count to measure muscle mass. patients undergo strength testing and physical fitness screening. a needle biopsy is performed to investigate the genetic alterations associated with this disease. during the second 3-day hospital stay, patients receive an intravenous infusion of insulin, stable isotopic glucose, and stable isotopic glycerol. during the third 3-day hospital stay, a catheter is placed in the femoral artery, femoral vein, and in each arm. patients receive an infusion of stable isotopic glucose, stable isotopic phenylalanine, and insulin. measurements of the balance of amino acids and glucose across the forearm and leg are completed. green dye is infused to measure blood flow in the leg.

Eligibility criteria:
inclusion criteria: * clinically mild or moderate myotonic dystrophy (dm), proximal myotonic myopathy (promm), facioscapulohumeral muscular dystrophy (fsh) or, charcot-marie-tooth (cmt) * mild or moderate dm defined as: mild muscle weakness in the limbs, modest facial weakness, and mild grip myotonia; moderate muscle weakness in the limbs, typical dm facies, and prominent grip myotonia exclusion criteria: * prior or concurrent therapy * obese * concurrent acute illness

Keywords: genetic diseases myotonic muscular dystrophy facioscapulohumeral muscular dystrophy cmt rare disease
faslodex advanced breast cancer local chinese study

Conditions: Advanced Breast Cancer

Summary: this study will evaluate the efficacy and safety of faslodex as secondary-line treatment compared with arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.


Eligibility criteria:
inclusion criteria: * postmenopausal advanced breast cancer with oestrogen receptor positive * progression under first-line anti-oestrogen therapy. exclusion criteria: * life-threatening metastasis; contraindication to anastrozole * \>2 regimens of hormonotherapy for advanced breast cancer

Keywords: advanced breast cancer fulvestrant anastrozole
brain-physical optimization conditioning

Conditions: Physical Performance

Summary: brain-physical optimization conditioning (b-poc) aims to enhance physical performance by expanding the traditional focus of endurance training from purely physical training to the domain of cognitive endurance (staiano et al., 2015; dallaway et al., 2017). the current study seeks to isolate neurocognitive mechanisms of performance, particularly under high stress (e.g., physical or cognitive load) conditions, and to develop corresponding cognitive optimization tools.

brain-physical optimization conditioning (b-poc) aims to enhance physical performance by expanding the traditional focus of endurance training from purely physical training to the domain of cognitive endurance (staiano et al., 2015; dallaway et al., 2017). b-poc uses an acute mentally fatiguing task during routine exercise with the aim of optimizing the effects of physical endurance (e.g., aerobic exercise). b-poc differs from other types of cognitive training by increasing the cognitive demands of a specific concurrent task rather than teaching a cognitive strategy and relying on task transfer effects. similar to strengthening a muscle, cognitive trainings may be one means of increasing soldier's cognitive capacity and improving performance (walton et al., 2018).

Eligibility criteria:
inclusion criteria: * healthy active duty soldiers * 18-40 years old * available for study duration exclusion criteria: * failure of an army physical fitness/combat test (apft/acft) test * on a physical profile that prevents them from 1) engaging in intense aerobic exercise, 2) running on a treadmill, 3) riding the stationary bike, and 4) performing a cognitive task on a computer screen. * medically non-deployable * impaired cognitive function due to medication, injury or illness, * have been advised by a medical professional not to engage in aerobic exercise * are a pregnant female

Keywords: cognitive fatigue demand endurance performance perceived exertion effort
hypnosis versus sivoc by remifentanil during tavi procedures : iloact on peripoperative confusion

Conditions: Confusion

Summary: tavi has become a credible alternative to conventional cardiac surgery in aged high-risk patients with aortic valve stenosis. a large part of these procedures are performed with sedation using remifentanil target-controlled infusion plus local anesthesia. however, a significant proportion of the patients experience postoperative delirium, with subsequent worsened outcomes, time-consuming interventions, and increased costs. the use of hypnosis before and during tavi could decrease the incidence of postoperative delirium thanks to less opioids and hypnotics consumption. thus, the investigators ought to evaluate the potential advantages of hypnosis vs. remifentanil target controlled-infusion during tavi procedures.

each included patient will randomly be assigned either to the hypnosis group or to the remifentanil group. patients of the hypnosis group will have one preoperative and one perioperative hypnosis session with a qualified anesthesiologist. patients of the remifentanil group will receive sedation with remifentanil, administered using a pre specified target controlled-infusion protocol. incidence of delirium will be recorded in the cardiac intensive care unit (cicu) during the first 72 postoperative hours, using the confusion assessment method in the icu (cam-icu). incidence of other complications such as episodes of oxygen desaturation, vascular wound, stroke, general anesthesia requirement and inhospital death will be recorded, as well as procedure duration, hospital length of stay, patient satisfaction and operator comfort. transcatheter aortic valve implantation (tavi) procedures are frequently complicated with postoperative delirium.

Eligibility criteria:
inclusion criteria: * patients requiring transfemoral approach tavi without general anesthesia * for adult patients : age greater than or equal to 18 years * patients affiliated to a social security scheme exclusion criteria: * patient whose age is less than 18 years * approach with general anesthesia * patient not responding to hypnosis: unmotivated, non-cooperating, not confident * other than transfemoral approach : carotid, trans-apical or sternotomy or thoracotomy procedure * chronic psychosis, bilateral deafness without hearing aids, * emergency procedure, * inability to communicate (severe dementia, non-french speaker), * declined participation

Keywords: hypnosis delirium transcatheter aortic valve implantation
a study of flexible dose brexpiprazole as monotherapy or combination therapy in the treatment of adults with post-traumatic stress disorder (ptsd)

Conditions: Stress Disorders, Post-Traumatic

Summary: to evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with zoloft (sertraline) in adults with ptsd.

this trial is designed to assess the efficacy, safety and tolerability of flexible dose brexpiprazole as monotherapy or as combination therapy with zoloft (sertraline) in adult participants with ptsd. this study will consist of a continuous 12-week, double-blind treatment period with a 14-day follow-up.

Eligibility criteria:
inclusion criteria: * male and female participants between the years of 18-65 with a diagnosis of ptsd (diagnosis can be made at screening) exclusion criteria: * index trauma event \>15 years before screening * index trauma event at age \<16 * any traumatic event within 3 months of screening
blood pressure assessment in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this is a cross-sectional study including patients with permanent atrial fibrillation. assessment will include: * clinic blood pressure measurements (mercury sphygmomanometer and automated oscillometric device) * 24-hour ambulatory blood pressure monitoring * determination of various serum markers and cardiac ultrasound. * evaluation of a 24h ambulatory blood pressure monitoring device (microlife watchbpo3) in terms of its diagnostic value for the detection of atrial fibrillation compared with the reference 24h holter ecg


Eligibility criteria:
inclusion criteria: * hypertensives adults in atrial fibrillation exclusion criteria: * renal disease (cr \> 2 mg/l). * patients with pacemaker rhythm during the study. * each patient with acute disease (inflammation, surgery), malignancy, collagen diseases, pulmonary fibrosis, renal failure, liver failure, chronic inflammatory diseases.

Keywords: blood pressure measurement atrial fibrillation blood pressure measurement in atrial fibrillation atrial fibrillation diagnosis
postoperative adjuvant sintilimab in hepatocellular carcinoma with microvascular invasion

Conditions: Hepatocellular Carcinoma

Summary: to compare the impact on recurrence risk of adjuvant sintilimab (a recombinant fully human anti-pd-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (mvi) after hepatectomy.

this study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with mvi-positive hcc who have undergone surgical resection. the patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with sintilimab (200 mg every three weeks for a total of 18 cycles), and the active surveillance group will be closely followed postoperatively. a maximum of one postoperative adjuvant tace is permitted.

Eligibility criteria:
inclusion criteria: * subjects with a histopathological diagnosis of hcc * undergone a curative resection * pathologically confirmed hcc with microvascular invasion (mvi) * aged 18-75 years * no previous systematic treatment and locoregional therapy for hcc prior to randomization * absence of major macrovascular invasion * no extrahepatic spread * full recovery from curative resection within 4 weeks prior to randomization * child-pugh: grade a or b(7) * ecog-ps score: 0 or 1 * subjects with hcv- rna (+) must receive antiviral therapy * adequate organ function exclusion criteria: * known fibrolamellar hcc, sarcomatoid hcc, mixed cholangiocarcinom or recurrent hcc * any preoperative treatment for hcc including local and systemic therapy * have received more than 1 cycle of adjuvant tace following surgical resection * any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency * known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug * subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy * cardiac clinical symptom or cardiovascular disease that is not well controlled * thrombosis or thromboembolic event within 6 months prior to the start of study treatment * any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months * abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment * inability or refusal to comply with the treatment and monitoring

Keywords: programmed cell death 1 checkpoint inhibitor immunotherapy adjuvant hepatocellular carcinoma microvascular invasion
a study on the control of chronic obstructive pulmonary disease (copd) in patients taking the combination of tiotropium and olodaterol using the respimat® inhaler

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: open-label observational study which includes copd patients that are receiving treatment with spiolto® respimat® for approximately 6 weeks, which is the average time between two medical consultations.


Eligibility criteria:
inclusion criteria: * written informed consent prior to participation * female and male patients ≥40 years of age * patients diagnosed with copd and based upon the investigator's decision requiring a new prescription of spiolto respimat® (combination of two long-acting bronchodilators) according to spiolto® respimat® smpc, gold copd strategy document 2018 (gold copd groups b to d) and local copd guidelines exclusion criteria: * patients with contraindications according to spiolto® respimat® smpc * patients already on a laba/lama combination (free and fixed dose) in the last 6 weeks before study entry * patients continuing laba/ics treatment should not be additionally treated with spiolto® respimat® in order to avoid a double dosing of long-acting beta-agonists * pregnancy and lactation * current participation in any clinical trial or any other non-interventional study of a drug or device.
mechanical structure complications after acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: to determine the incidence and factors associated with heart rupture (hr) in acute myocardial infarction patients.

we compared characteristics and angiographic patterns of heart rupture and without heart rupture patients enrolled in the trial.

Eligibility criteria:
inclusion criteria: 1. patients be admitted for acute myocardial infarction (stemi or nstemi) exclusion criteria: 1. non-cardiovascular comorbidity for ami

Keywords: heart rupture acute myocardial infarction