Kornimate/medical-research-clean huggingface dataset:
renoir: a randomised, double-blind, controlled trial to evaluate the effects of a new human milk fortifier on growth and tolerance in preterm infants.

Conditions: Subjects in Need of a Human Milk Fortifier (HMF); Growth; Tolerance; Safety

Summary: preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment. preterm infants have much higher nutrient requirements than term infants. the preferred nutrition for all infants including preterm infants is human milk from the infant's own mother, or alternatively donor human milk, provided it is fortified with several nutrients as human milk alone does not sufficiently meet the nutritional needs of preterm infants. human milk fortifiers (hmfs) are multicomponent enrichments that can be added to human milk (own mother´s milk or donor milk) to meet the increased nutritional needs of preterm infants. the current nutricia hmf (control product) has been available in its current composition since 2010. it is a multicomponent hmf providing protein, energy, minerals, and vitamins in accordance with the espghan recommendations. recent investigation suggests positive effects on growth and development of preterm infants when lipids are added to their nutrition. therefore, nutricia has added lipids to their hmf (test product) for a nutritionally more complete fortification of human milk aiming for optimal growth and optimal cognitive and brain development. the renoir study will investigate the difference between both hmfs with regards to the growth velocity as well as the safety and tolerance of the new hmf.


Eligibility criteria:
inclusion criteria: 1. preterm infants fed own mother's milk (or donor human milk) in need of a hmf (as decided by the investigator) 2. gestational age \<32 weeks and birth weight \<1500 g 3. receiving enteral feeding 4. expected to need a hmf for minimally 21 days 5. written informed consent from custodial parent(s) exclusion criteria: 1. any relevant proven or suspected chromosomal anomaly, metabolic disorder, genetic syndrome or congenital central nervous system malformation; 2. presence or history of any gastrointestinal malformation, including necrotising enterocolitis (nec) (defined as bell's stage two or higher); 3. no realistic prospect of survival at the discretion of the attending physician; 4. participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study; 5. expected or foreseen inability of the subject and/or their families to adhere to protocol instructions.
a single center real-world study of donafenib in the treatment of hepatocellular carcinoma in routine clinical practice

Conditions: Donafenib; Hepatocellular Carcinoma

Summary: this trial is a single center observational real-world study. it is planned to include 300 patients with unresectable hepatocellular carcinoma (uhcc) treated with donafenib. the purpose of the study was to observe the effectiveness and safety of donafenib in the real world.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old; 2. histologically confirmed hcc or meet the clinical diagnostic criteria of hcc; 3. unresectable hcc; 4. the doctor decided to use donafenib before the patient was enrolled in the study； 5. informed consent and willing to complete the study according to the protocol. exclusion criteria: 1. those who are participating in clinical trials of other antitumor drugs; 2. allergic to any component of donafenib tablets; 3. patients with active bleeding, active peptic ulcer, drug uncontrollable hypertension or severe liver dysfunction; 4. pregnant or lactating women.
readmission in the case of patients with heart failure

Conditions: Heart Failure

Summary: heart failure (hf) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. the management of hf is complex: long, often difficult and costly. in france, nearly one million people suffer from hf and 120,000 new cases are diagnosed every year. with the aging population, this number will continue to evolve and become a real public health problem. within 10 to 20 years ahead, who projects that heart failure in either the 3 most common diseases in industrialized countries. investigators goals are to make an inventory of prado-ic project in terms of its effectiveness on readmission of patients with heart failure.


Eligibility criteria:
inclusion criteria: * patient aged 18 or over * patient readmitted for heart failure exclusion criteria: * population whose age is less than 18 years

Keywords: heart failure heart disease left ventricular
safety and effectiveness of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

in this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. the experimental group receive basic treatment and remote ischemic conditioning for 200mmhg, 2 times within 6 hours to 24 hours from thrombolysis. the control group receive basic treatment and remote ischemic conditioning control for 60mmhg, 2 times within 6 hours to 24 hours from thrombolysis . two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

Eligibility criteria:
inclusion criteria: * 1) age≥18 years, \< 80 years, regardless of sex; * 2) patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis; * 3) baseline nihss \>= 5, and \<= 25; * 4) baseline gcs ≥8; * 5) signed and dated informed consent is obtained exclusion criteria: * 1) patients who undergo endovascular treatment; * 2) mrs ≥ 2 before the onset of the disease; * 3) double upper limbs or lower limbs paralysis was found in this case; * 4) active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on; * 5) other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain; * 6) concurrent use of anticoagulation drugs including warfarin, dabigatran, rivaroxaban; * 7) severe organ dysfunction or failure; * 8) patients suffering from severe hematological diseases or severe coagulation disorder dysfunction * 9) those who have a history of severe trauma or had major surgery within 6 months prior to admission; * 10) those who have a history of atrial fibrillation; * 11) the patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb#acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc; * 12) pregnant or lactating women; * 13) previous remote ischemic conditioning therapy or similar treatment; * 14) patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons; * 15) severe hepatic and renal dysfunction; * 16) unwilling to be followed up or treated for poor compliance; * 17) he/she is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission; * 18) other conditions that the researchers think are not suitable for the group.
micronutrient and malnourished elderly

Conditions: Malnourished Elderly

Summary: the purpose of this study is to evaluate the micronutrient status of malnourished elderly after oral nutritional supplementation.


Eligibility criteria:
inclusion criteria: * age : above or equal to 70 years and : * weight loss above or equal to 5% in one month * or weight loss above or equal to 10% in 6 months * or bmi between 18 and 21 * or albuminaemia between 30 and 35 g/l * or mna-sf less or equal to 7 exclusion criteria: * severe malnutrition * contraindication to oral nutrition * severe pathologies * inflammatory syndrome (crp \> 30 mg/l) * severe dementia (mini mental score \< 10)
cognitive recovery with cannabis abstinence among high school-aged adolescents

Conditions: Cannabis Use; Cognitive Change; Adolescent Behavior

Summary: this study will use a randomized controlled design to test whether 30 days of cannabis abstinence, compared to 30 days of monitoring, is associated with improvements in cognitive functioning. non-using controls will also be enrolled to determine the clinical significance of any cognitive improvements with abstinence.

this is a 5-year randomized, longitudinal trial of cannabis abstinence designed to determine (1) if performance improves with abstinence beyond that observed with continued cannabis use, and if so, (2) when during abstinence cognitive improvement occurs, and (3) whether performance in abstinent individuals "returns" to performance levels observed in non-using peers. we hypothesized that abstinent adolescent cannabis users would have more neurocognitive improvement over four weeks compared to non-abstinent cannabis users, and performance would continuously improve throughout four weeks of abstinence. we will recruit 210 adolescents with and without regular cannabis use. eligible cannabis users will be randomized to either a contingency management intervention which will incentivize 4 weeks of cannabis abstinence (n = 70), or non-contingent monitoring with no abstinence requirement (n = 70). all participants (including non-users; n = 70) will complete cognitive assessments, toxicology testing, self-report questionnaires and semi-structured mood and substance use interviews during the 4-week study as well as one 30-day follow-up visit. abstinence will be indexed by decreasing levels of cannabis metabolites in urine.

Eligibility criteria:
general inclusion criteria for school-aged study component: * male and female adolescents from the boston area who are between the ages of 10 and 19 (inclusive); * have a parent or legal guardian who is able and willing to provide written informed consent for the active study phase (if under the age of 18); * competent and willing to provide written informed assent for the active study phase (if under the age of 18); * competent and able to provide written informed consent (if age 18 or older) * able to communicate in english language * able to commit to 9 study visits in approximately 60 days * no severe developmental delays (including, but not limited to, autism spectrum disorder, intellectual disability, and down syndrome) * able to safely participate in the protocol and appropriate for outpatient level of care cannabis-using group inclusion criteria: * use of cannabis at least once per week on most weeks * cannabis use reported within 7 days of both baseline visits * no immediate plan to discontinue cannabis use non-using group inclusion criteria: * use of cannabis less than 5 times in lifetime * no cannabis use in the past year * no cannabis use before age 16 exclusion criteria for school-aged study component - passive consent for initial school-wide assessment withdrawn by parent or legal guardian or written parental consent not provided prior to screening
bleeding in partial upper hemisternotomy versus full sternotomy aortic valve replacement

Conditions: Aortic Valve Stenosis; Heart Valve Diseases

Summary: this is a single-center, open-label, randomized controlled trial. patients scheduled for aortic valve replacement (avr) at karolinska university hospital in stockholm, sweden will be eligible. one-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy avr (50 patients). inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery. mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. clinical characteristics will be registered. clinical postoperative outcomes including bleeding outcomes will be registered. routine blood sampling will be performed pre- and postoperatively. all available data will be collected prospectively. informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography * referred for medically indicated aortic valve replacement * sinus rhythm * provide written informed consent exclusion criteria: * inclusion in other trial * left ventricular ejection fraction less than 0.45 * presence of any coexisting severe valvular disorder * previous cardiac surgery * urgent or emergent surgery
assessment of the efficacy of rosuvastatin in patient groups with a dissimilar risk profile in an observational study (heros)

Conditions: Hypercholesterolemia; Coronary Heart Disease; Peripheral Vascular Disease; Cerebrovascular Accident; Diabetes

Summary: in an observational multi-centre study (heros), the effects of starting treatment with rosuvastatin were assessed, on low-density lipoprotein cholesterol (ldl-c) goal achievement, in patients with a dissimilar high-risk profile who had not been treated with cholesterol lowering drugs at least in the past three months. also set-up costs of rosuvastatin treatment and proportional changes in ldl-c and high-density lipoprotein cholesterol (hdl-c) were studied.


Eligibility criteria:
inclusion criteria: * patients who had not been treated with cholesterol lowering drugs at least in the past three months, with an ldl-c 3.2 mmol/l. * according to the advise of the cbo, and could be included in one of the following risk groups: secondary prevention, dm or primary prevention. * the general practice investigator made the decision to start treatment with rosuvastatin irrespective of study participation. * patient approved to place anonymous results at the disposal of astrazeneca exclusion criteria: * patients with symptoms of myalgia, myopathy or liver function insufficiency (including raised serum transaminases) which bear a causal relation to the treatment with statins, patients with familiar dyslipidemia and/or patients with contra-indications for treatment with rosuvastatin

Keywords: cholesterol coronary heart disease rosuvastatin ldl-c goal hypercholesterolemia secondary prevention primary prevention cva
apomorphine effects on experimental pain

Conditions: Healthy

Summary: the aims of this study were to assess the effects of the dopamine agonist apomorphine on experimental pain models in healthy subjects and to explore the possible association between these effects and a common polymorphism within the dopamine transporter gene.

healthy volunteers (n=105) participated in this randomized double-blind, placebo-controlled, cross-over trial. heat pain threshold and intensity, cold pain threshold, and the response to tonic cold pain (latency, intensity, and tolerance) were evaluated before and for up to 120 min after the administration of 1.5 mg apomorphine/placebo. a polymorphism (dat-1) within the dopamine transporter gene (slc6a3) was investigated.

Eligibility criteria:
inclusion criteria: - healthy and free from chronic pain of any type did not use any medications other than oral contraceptives were able to understand the purpose and instructions of the study. exclusion criteria: - any type of medical or painful condition use of medications or recreational drugs pregnancy.

Keywords: apomorphine dopamine transporter gene slc6a3 cold pressor test tolerance experimental pain dopamine agonist
emergency/compassionate use pfo occluder

Conditions: Patent Foramen Ovale; PFO

Summary: emergency/compassionate use for the amplatzer pfo occluder


Eligibility criteria:
inclusion criteria: * emergency/compassionate use for patients not meeting the inclusion criteria for the amplatzer pfo access registry.

Keywords: patent foramen ovale pfo
multi-center trial of valveclamp

Conditions: Evaluate the Safety and Efficacy of the ValveClamp

Summary: the valveclamp (hanyu medical technology, shanghai, china) is the first edge-to-edge mitral valve repair system for interventional operation in china, which is composed of the front clamp, the rear clamp and the closed ring. the purpose of the multi-center trial is to evaluate the safety and efficacy of the valveclamp for degenerative mirtal regurgistation.

the transcatheter edge-to-edge mitral valve repair device mitraclip (abbott vascular, santa clara, ca, usa) is the most mature device for mitral regurgitation. another transcatheter edge-to-edge mitral valve repair device, the pascal system, has been shown to be feasible to reduce mr severity. both the mitraclip and pascal devices need a complex steerable deliver system and thus complex process to steer the device to mitral valve. an easy-to-operate transcatheter edge-to-edge mitral valve repair system (valveclamp) with larger coaptation width was thus recently developed in china. the valveclamp (hanyu medical technology, shanghai, china) is the first edge-to-edge mitral valve repair system for interventional operation in china, which is composed of the front clamp, the rear clamp and the closed ring. the purpose of the multi-center trial is to evaluate the safety and efficacy of the valveclamp for degenerative mirtal regurgistation.

Eligibility criteria:
inclusion criteria: 1. age older than 60 years; 2. moderate to severe or severe mitral regurgitation; 3. symptoms (new york heart association \[nyha\] cardiac function class ≥2) related to mr; 4. the primary regurgitant jet originated from malcoaptation of the a2 and p2 scallops of the mitral valve; 5. high risk for surgery according the mvarc criteria; 6. providing signed informed consent. exclusion criteria: 1. acute myocardial infarction in the prior 4 weeks of the intended treatment; 2. any interventional or surgical cardiac procedure performed within 30 days prior; 3. the need for any other cardiac surgery; 4. echocardiographic evidence of intracardiac mass, thrombus, or vegetation; 5. life expectancy within 12 months; 6. moderate or severe aortic stenosis or regurgitation; 7. mitral valve orifice area \<3.5 cm2; 8. untreated significant coronary stenosis; 9. history of mitral valvuloplasty; 10. infective endocarditis and rheumatic heart disease; 11. untreated cardiogenic shock, acute pulmonary congestion; 12. unfavored mitral valve anatomy that may preclude device implantation including: calcification or significant cleft in area of the a2 and/or p2 scallops, significant regurgitation beyond a2 or p2 scallops and short posterior leaflet (\<10mm). 13. other clinical trials that the subjects participated in have not reached the end point.
vetc is an effective marker for postoperative adjuvant immunotherapy

Conditions: HCC; Recurrence

Summary: vessels that encapsulate tumor clusters (vetc) is an invasive metastatic factor in hcc independent of the epithelial mesenchyme transition (emt), and vetc-positive patients have a higher rate of postoperative recurrence. however, it is not clear how the surgical prognosis of vetc-positive patients can be improved.

previous studies have identified vetc as a new metastatic pattern independent of emt that may be associated with immunosuppression as well as poor prognosis. multiple retrospective studies find higher rates of postoperative recurrence, distant metastasis in vetc-positive patients. how to improve surgical prognosis in vetc-positive patients needs to be explored. there is no consensus on postoperative adjuvant therapy for hcc. in recent years, adjuvant immunotherapy (sintilimab) and adjuvant immunotherapy combined with targeted therapy (t+a) have been shown to be effective in improving the surgical prognosis. therefore, the investigators retrospectively collected three surgical resection cohorts, the surgical resection alone group, the postoperative adjuvant pd-1 monotherapy group, and the postoperative adjuvant pd-1 monotherapy combined with lenvatinib group, to compare these postoperative adjuvant therapies in a subgroup of vetc patients.

Eligibility criteria:
inclusion criteria: * underwent radical hepatectomy * no preoperative treatment * pathological confirmed hcc * high-risk recurrent hcc * not receiving any adjuvant therapy or receiving adjuvant therapy with pd-1 monotherapy or receiving adjuvant therapy with pd-1 monotherapy in combination with lenvatinib after surgery exclusion criteria: * macrovascular invasion * no available wax blocks * no complete clinical information
the effect of a medication coordinator on the quality of patients medication treatment

Conditions: Medication Review; Polypharmacy; Potentially Inappropriate Medication; Quality of Life; Medication Therapy Management

Summary: to examine the effect of a medication coordinator, who facilitates medication reviews in close collaboration with patients using my medication plan to reduce the risk of post-hospital inappropriate medication usage.

patients' safety can be compromised in the transition of care between healthcare sectors. optimal information flow across healthcare sectors and individualized medication treatment tailored to each patient is key to prevent adverse events and optimize patient treatment. particularly, the inclusion of the general practitioner is important in this process; it could become a challenge to keep medication changes if this communication link is missing. the framework for complex intervention allows flexibility and adaption in meeting patients' needs by implementing tailored, possibly complex interventions in different healthcare settings. to examine the effect of a medication coordinator, who facilitates medication reviews in close collaboration with patients using my medication plan. the primary outcome is the proportion of potentially inappropriate medications. secondary outcomes include patient-reported outcomes i.e., quality of life and medication burden. additional outcomes include the patient's individual medication risk score, if the patients are readmitted, and if the patients have contacted the staff at the hospital unit after the hospital discharge.

Eligibility criteria:
inclusion criteria: * all hospitalized patients, who are prescribed at least five medications specified in the electronic patient journal (epj) used at ward exclusion criteria: * unable to communicate in danish, cognitively impaired e.g. suffering from dementia or alzheimer's, or cannot cooperate due to e.g. hallucination or aggressive behavior

Keywords: polypharmacy medication review patient care management empowerment potentially inappropriate medication list hospital to home transition medication quality medication optimization treatment burden