Kornimate/medical-research-clean huggingface dataset:
study evaluating the pharmacokinetics of venlafaxine er and desvenlafaxine sr in healthy subjects

Conditions: Healthy

Summary: the purpose of this study is to determine if the relative difference in pk between extensive metabolizers (ems) and poor metabolizers (pms) is the same with desvenlafaxine sr and venlafaxine er when a single dose is administered.


Eligibility criteria:
inclusion criteria: * healthy men and women between 18 to 55 years of age * healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and no clinically significant abnormalities on 12-lead electrocardiogram (ecg) * history of nonsmoker for at least 1 year exclusion criteria: * presence or history of any disorder or significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure), or psychiatric disease that may prevent the completion of the study * known or suspected alcohol abuse or consumption of more than 2 standard units per day within past 6 months or known or suspected abuse of prohibited drugs or other substances * use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day -1 until the end of the study

Keywords: healthy subjects major depressive disorder depression cytochrome p-450 cyp2d6 pharmacokinetics health
weekly cisplatin/irinotecan and radiotherapy in patients with locally advanced esophageal cancer: phase ii trial

Conditions: Esophageal Neoplasms

Summary: the standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. one of the alternative regimen which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy. this multicentric phase ii clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival.

chemotherapy with weekly cisplatin 30 mg/m2 and irinotecan 60 mg/m2 was administered at days1,8,22,29 and concurrently with radiotherapy t days 43,50,64,71. radiotherapy was delivered day 43 to 75 with 50gy in 25 fractions/5 weeks.

Eligibility criteria:
inclusion criteria: * esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed * performance status \<or=2 (ecog) * caloric intake\>1500 kcal/d * serum albumin \>32 gr/l * serum creatinine\<120 microgr/l * total serum bilirubin \< 1.5 mg/ml * no prior chemotherapy or radiotherapy or surgery for esophageal neoplasm * no prior history of malignancy other than cell carcinoma of the skin, in siyu cervical carcinoma, or head and neck carcinoma with complete response since 3 years * written informed consent exclusion criteria: * gilbert's syndrome * cardiac disease as nyha class 3 or 4 * myocardial infarction within the previous 6 months * metastatic disease * histologically proved invasion of tracheobronchial tree * metastatic disease
robot-assisted training

Conditions: Spinal Muscular Atrophy (SMA)

Summary: the goal of this clinical trial is to evaluate the long-term effects of isokinetic rehabilitation training in patients with spinal muscular atrophy (sma). the main question it aims to answer is: • does isokinetic training at fixed angular velocity improve muscle strength and functional recovery in sma patients? participants will: * perform isokinetic training using a portable device with a fixed angular velocity. * undergo long-term rehabilitation sessions, with assessments of muscle strength and overall functional improvement over the training period.


Eligibility criteria:
inclusion criteria: 1. age range: 5-30 years old. 2. patients with spinal muscular atrophy (sma). 3. the subject or guardian is willing and able to sign an informed consent form. exclusion criteria: 1. simultaneously suffering from other major diseases or illnesses. 2. special populations such as pregnant and lactating women. 3. refusing to sign the informed consent form or being unable to complete the entire research process. 4. currently infected with human immunodeficiency virus (hiv), infectious hepatitis b or c, or corresponding medical history. 5. simultaneously suffering from medical problems, including but not limited to the following: uncontrolled hypertension (systolic blood pressure ≥ 160mmhg and/or diastolic blood pressure ≥ 95mmhg), congestive heart failure (new york heart association status classification iii or iv). the participant is mentally incapable or unable to understand the requirements for participating in the study.
adaptive ct acquisition for personalised thoracic imaging

Conditions: Cancer, Lung

Summary: in this trial, respiratory motion guided (rmg) 4dcbct will be implemented for the first time on lung cancer patients. rmg-4dcbct adapts the image acquisition as the patient's breathing changes (i.e. if the patient breathes faster, imaging data is acquired faster). by adapting the acquisition to the dynamic patient, personalised images of a patients lungs are able to be acquired for radiotherapy treatments.

four dimensional cone beam computed tomography (4dcbct) continues to play a pivotal role in the safe delivery of radiotherapy treatments for lung cancer patients. 4dcbct meets exacting tumour localisation requirements by allowing radiation therapists to measure the tumour as a patient breathes (4d=volumetric images plus respiratory induced tumour motion). despite the success of 4dcbct to date, it suffers from relatively poor image quality, very long scan times (4min) and higher imaging doses than are necessary. the primary reason for these problems is that although the purpose of 4dcbct is to acquire information about tumour motion due to respiration, there is no feedback from the patients breathing signal to adapt and optimise the image acquisition process. this clinical trial is a phase 1 first in human's pilot study and the aim is therefore to prove feasibility of rmg-4dcbct, not necessarily efficacy. as such, patient scans will be acquired across a broad range of patient breathing conditions to optimise the rmg-4dcbct technique and also to plan a hypothesis driven clinical trial to follow.

Eligibility criteria:
inclusion criteria: * have the ability to give informed consent * a diagnosis of lung cancer with an indication for radiotherapy either curative or palliative * radiotherapy treatment involving the routine acquisition of cbct for patient setup provided that 4dcbct is to be acquired during the course of treatment. * at least two radiotherapy fractions during the course of treatment. exclusion criteria: * pregnant women. * patient who in the opinion of the treating physician could not tolerate the extra time on the treatment couch for two days of treatment.

Keywords: lung cancer radiotherapy 4dcbct
the effects of sglti on diabetic cardiomyopathy

Conditions: Type2 Diabetes; Heart Failure With Reduced Ejection Fraction

Summary: diabetic cardiomyopathy is associated with significant morbidity and mortality. it is considered as a cardiac muscle disorder secondary to diabetes mellitus (dm). certain studies show the clinical benefit of sglt-s inhibitors on reducing cardiovascular outcomes amongst patients with type ii dm that go beyond the correction of hyperglycemic perse. thus an observational imaging study is proposed to identify mechanistic insights of the drug group over cardiovascular events.

diabetic cardiomyopathy is defined as ventricular dysfunction in diabetic patients in the absence of coronary artery disease and hypertension. it is considered as a cardiac muscle disorder due to the metabolic consequences of dm characterized by left ventricular hypertrophy, left ventricular diastolic dysfunction (in the early stage), and/or systolic dysfunction. to date, there is no specific treatment proven effective for the condition due to the incomplete understanding of the pathogenesis. recent studies however prove the efficacy of sglt-2 inhibitors on reducing the primary composite end point of cardiovascular outcomes including hospitalization for heart failure, cardiovascular death, and all-cause death amongst patients with type ii dm. such clinical benefit is apparently mainly stemmed from the reduction in heart failure related mortality and sudden cardiac death rather than the macro-vascular events such as myocardial infarct and stroke, suggesting addition benefits going beyond the correction of hyperglycemia perse. these studies thus raise the possibility that the drug may have direct effects on the myocardium that conferring the clinical benefit not related the modification of traditional risk factors such as glycemic control, lipid, blood pressure, and obesity. a single-arm, observational cardiac magnetic resonance imaging study is proposed in type ii diabetic patients before and 2 months after initiation of dapagliflozin. the aim is to identify mechanistic insights leading to the unexpected clinical benefit of sglt inhibition.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * 40-90 years old * hba1c \>= 6.5% * history of heart failure with reduced ejection fraction * indications for sglt inhibition on clinical ground exclusion criteria: * angina pectoris or chest discomfort * prior coronary artery bypass grafts * coronary artery stenting within 6 months of study enrolment * pervious myocardial infarct * any contraindication for stress cmr testing * renal impairment with egfr \<45ml/min/1.73m2 * limited life expectancy \<5 years, for example due to pulmonary disease, cancer or * significant hepatic failure * contraindication to dapagliflozin or other sglt2 inhibitors * unable to take dapagliflozin * patients currently on and sglt2 inhibitor * planned need for concomitant cardiac surgery or coronary intervention * refusal or inability to sign an informed consent * potential for on-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
fimasartan (br-a-657) single oral dose in healthy subjects

Conditions: Essential Hypertension

Summary: the objective of this study is to determine the safety and tolerability and to determine the pharmacokinetic and pharmacodynamic (pk/pd) of ascending single oral dose of br-a-657 in healthy male subjects.

br-a-657 20, 50, 120, 240, 360, 480mg or placebo were administered once to healthy male subjects. pharmacokinetic and pharmacodynamic(pk/pd) parameters were monitored at pre-specified times from each subjects. pk parameters: area under the curve(auc), cmax, half-life, etc. pd parameters: aldosterone, plasma renin activity, angiotensin i, angiotensin ii adverse events are reported.

Eligibility criteria:
inclusion criteria: * male of 18-55 years old * body mass index(bmi) 19-29kg/m2 * subjects in good health * subjects with written informed consent exclusion criteria: * subjects with multiple drug allergy or allergy to angiotensin receptor blocker(arb) * subjects with medication that affect drug absorption or elimination within 30days. * subjects with orthostatic hypotension of \>20mmhg decrease of systolic blood pressure(sbp) * subjects with history of neurologic, liver, renal, gastrointestinal, cardiovascular, psychological or other major disorder

Keywords: single-dose pharmacokinetic pharmacodynamic safety
sh-lps system in preoperative planning for liver resection

Conditions: Liver Tumor; Surgery; 3D Printing; Preoperative Planning

Summary: effective preoperative planning and real-time intraoperative guidance are crucial for performing accurate liver resections. to address this need, the researchers have designed advanced 3d-printed liver models using a self-healing elastomer, created through the copolymerization of 4-acryloylmorpholine (acmo) and methoxy poly(ethylene glycol) acrylate (mpega). these models demonstrate outstanding healing properties, swiftly restoring their structure within minutes at room temperature, and quickly recovering after incisions. in previous studies, professor yuhua zhang, the project applicant, collaborated with a team from zhejiang university to develop a 3d-printed liver model that is self-healing and reusable for repeated cutting. they preliminarily explored the feasibility of applying this model for preoperative planning and surgical training for liver surgeries. the results were published in nature communications (lu et al., nat commun. dec 19;14(1):8447). building on this, the applicant intends to establish a personalized liver surgery planning system (personalized liver surgery planning system based on high-fidelity 3d printed self-healing liver models, sh-lps), which will assess, through a randomized controlled trial, the value of sh-lps in improving liver surgery efficiency and safety.


Eligibility criteria:
inclusion criteria: * 18-80 years old; * patients with a resectable tumor in the liver; * eastern cooperative oncology group performance status score: 0; * child-pugh classification: a; * the laboratory test results meet the following criteria and patients can tolerate surgery: haemoglobin≥90g/l, neutrophil count≥1.5×10⁹/l, platelet count≥100×10⁹/l, aspartate or alanine aminotransferase≤5 upper limits of normal(uln）, alkaline phosphatase≤2.5 uln, serum albumin≥30g/l, serum creatinine\<1.5 uln, international normalized ratios（inr）≤2 or rothrombin time（pt）exceed uln≤6s, creatinine clearance≥60 ml/min. exclusion criteria: * patients with extra-hepatic metastasis; * anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation in 28 days prior to the surgery; * clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy; * severe lung disease (eg, acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease), uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/l); * there are other unsuitable candidates for clinical trials, such as mental illness or alcohol dependence.
effects of real-time continuous glucose monitoring system on hospital-to-home transitional blood glucose control

Conditions: Diabetes Mellitus, Type 2

Summary: glucose monitoring is an important part of self-management for patients with diabetes. the results of glucose monitoring not only help to assess the degree of glucose metabolism disorders in patients, but also help physicians to make clinical decisions and guide patients in self-management. despite extensive efforts and advances in diabetes management during hospitalization, glucose control after patients is discharged home remains a challenge. this trial aims to explore the effect of real-time continuous glucose monitoring (rt-cgm) system compared to self-monitoring of blood glucose (smbg) group on glucose and self-efficacy of type 2 diabetes patients treated with insulin after discharge from the hospital.

glycemic management of patients with diabetes after discharge home is extremely challenging, especially for those requiring insulin therapy. the use of a real-time continuous glucose monitoring (rt-cgm) system may improve glycemic control and self-efficacy in patients with type 2 diabetes treated with insulin after discharge from the hospital. one hundred and fifty insulin-treated adults with type 2 diabetes were randomly assigned to receive either rt-cgm or self-monitoring of blood glucose (smbg) at hospital discharge for a 12-week monitoring intervention and a 36-week follow-up.

Eligibility criteria:
inclusion criteria: 1. 18 years old ≤ age ≤ 80 years old. 2. type 2 diabetes admitted to department of endocrinology and metabolism. 3. 8% ≤ hba1c ≤ 12% in the last 1 month. 4. insulin therapy within 1 month of planned discharge from hospital. 5. frequency of self-monitoring of blood glucose \<4 times per week and no use of real-time continuous glucose monitoring system in the 3 months prior to hospitalisation. 6. willing and able to provide written informed consent and comply with the requirements of this study. exclusion criteria: 1. oral steroid hormone therapy. 2. patients with acute complications of diabetes (including diabetic ketoacidosis, hyperglycemia and hyperosmolality, lactic acidosis) 3. patients with severe liver disease (alanine aminotransferase or glutamine aminotransferase exceeding more than three times the upper limit of normal). 4. patients with severe kidney injury or end-stage renal disease (egfr \< 30 ml/min/1.73 m2). 5. participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area. 6. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 7. pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period.

Keywords: continuous glucose monitoring
multiple myeloma (mm) profile in brazil: a retrospective observational analysis

Conditions: Multiple Myeloma

Summary: the purpose of this study is to present a descriptive analysis of demographic and clinical characteristics of the participants, as well as of the treatment patterns for multiple myeloma (mm) in brazil.

participants with a diagnosis of mm will be observed in this retrospective study. data collected for the study will include identification, demographic, baseline data on mm, additional baseline laboratory, initial treatment for mm, subsequent treatment for mm, and outcome. the study will enroll approximately 1000 participants. this multi-center trial will be conducted in five geographic regions of brazil. for each participant, data collection will comprise the longest possible period of time since the diagnosis of mm (within the eligibility window of time, between january 1, 2008 and december 31, 2016) and the cut-off date for data collection (december 31, 2016), unless a participant has died or been lost to follow-up before that. the study is planned to last for approximately 24 months since its initiation (initiation defined as the initiation visit for the first site).

Eligibility criteria:
inclusion criteria: 1. provision of written informed consent, for participants who are alive and not lost to follow-up (for participants already deceased or lost follow up, informed consent should have been waived by the corresponding ethics review board \[erb\]). 2. documented diagnosis of mm by the responsible physician between january 1, 2008, and december 31, 2016. 3. absence of any plasma-cell disorder other than mm. 4. absence of any immunoglobulin-related disorder other than mm.

Keywords: real world evidence , multiple myeloma profile, brazil
clevidipine in the perioperative treatment of hypertension (eclipse-ntg)

Conditions: Hypertension

Summary: the purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. approximately 500-900 patients with perioperative hypertension undergoing coronary artery bypass grafting (cabg), off-pump coronary artery bypass (opcab) or minimally invasive direct coronary artery bypass (midcab) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nitroglycerin.

the primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, mi and renal dysfunction in the clevidipine and nitroglycerin treatment groups from the initiation of study drug infusion through postoperative day 30. secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (bp) lowering effect, and additional safety variables.

Eligibility criteria:
prerandomization inclusion criteria: * provide written informed consent before initiation of any study related procedures. * be at least 18 years of age * be scheduled for coronary artery bypass grafting (cabg), off pump coronary artery bypass (opcab), minimally invasive direct coronary artery bypass (midcab) surgery, and/or valve replacement/repair surgery prerandomization exclusion criteria: * women of child-bearing potential (unless they have a negative pregnancy test) * recent cerebrovascular accident (within 3 months before randomization) * known intolerance to calcium channel blockers * known or suspected hypersensitivity to nitroglycerin * allergy to soybean oil or egg lecithin (components of the lipid vehicle) * pre-existing permanent ventricular pacing * any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial * participation in another therapeutic drug or therapeutic device trial within 30 days of starting study postrandomization inclusion criteria: * determined to be hypertensive perioperatively as determined by the investigator

Keywords: preoperative hypertension
quality improvement to reduce mortality or severe intracranial hemorrhage in neonatal extracorporeal life support

Conditions: Extracorporeal Life Support; Extracorporeal Membrane Oxygenation; Quality Improvement; Intracranial Hemorrhage; Mortality; Neonate

Summary: this is a three-year pre- and post- interventional study to assess the effectiveness of collaborative quality improvement interventions on reducing mortality and severe intracranial hemorrhage (ich) for neonates receiving extracorporeal life support (ecls) in china.

this is a three-year pre- and post- interventional study from 2022 to 2024. the population of this study will be all neonates who receive ecls support within 28 days of life in the participating hospitals of chinese neonatal extracorporeal life support registry (chi-nels). the intervention will be collaborative quality improvement interventions for each of the participating hospital. detailed interventions include standardized ecls data feedback and benchmark, establishment of potential better practice list, training on quality improvement, implementation of practice change using plan-do-study-action cycles, report and monitor of practice change and collaborative learning. the first year will be pre-intervention baseline period and serves as the control period. collaborative quality improvement interventions will be introduced from the start of the second year and the second and third years will be the intervention period. the primary outcome, which is the incidence of mortality or severe ich of the third year, will be compared to that of the baseline year.

Eligibility criteria:
inclusion criteria: * ≤28 days of life * receive ecls support exclusion criteria: * infants with severe congenital anomalies * infants with pre-ecls ich