Kornimate/medical-research-clean huggingface dataset:
pilot trial: comparison of flow patterns

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Summary: the purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement. our approach to address this question is the combination of clinical data with the application of specifically validated experimental and computer based analyses to compare the performance of these valves under patient-specific conditions.


Eligibility criteria:
inclusion criteria: * patient underwent open aortic valve replacement with either an edwards magna ease or an edwards intuity valve * implanted valve size 23mm * surgical access via full sternotomy or hemisternotomy * intuity valve system implanted by one of the clinical investigators of the triton trial (http://clinicaltrials.gov/show/nct01445171) at the medical university of vienna * post-operative ejection fraction ≥50% * sinus-rhythm * ability to understand and comply with study procedures * signed informed consent exclusion criteria: * under 18 years of age * emergency surgery * pregnancy * previous aortic root replacement * previous aortic valve replacement * previous or concomitant root enlargement * previous or concomitant repair of the ascending aorta * paravalvular leakage * ectasia of the ascending aorta * previous or concomitant myomectomy * concomitant replacement or repair of valves other than aortic * usage of more than 3 sutures for implantation of the intuity valve system * heavily calcified aortic root * glomerular filtration rate (gfr) \< 30 ml/min * inability to understand or comply with study procedures * known allergic reaction to iodinated, non-ionic contrast agents

Keywords: aortic valve replacement aortic valve bioprosthesis hemodynamics
clinical trial of mglitt for medical refractory epilepsy

Conditions: Epilepsy

Summary: multicenter, open-label, prospective designed study to characterize the performance of mri-guided laser interstitial thermal therapy (mglitt) using the sinovation laser ablation system for the treatment of medical refractory epilepsy.

the sinovation laser ablation system uses robot-assisted, precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to adjacent healthy tissue. mglitt has the advantages of precision, minimal invasive procedure and real-time thermal monitoring. subjects who meet the study eligibility criteria and sign the informed consent form will undergo the mglitt procedure. subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning after surgery. the study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health. subjects treated with sinovation laser ablation system will have at least 9 months of follow-up. throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.

Eligibility criteria:
inclusion criteria: * the age ranged from 6 months to 70 years old; * previous diagnosis of drug-resistant epilepsy with focal lesions; * the average seizure frequency was more than 2 times/month within 3 months; * surgical treatment is suitable for epilepsy; * the subjects or their guardians can understand the purpose of the trial, show adequate compliance with the trial protocol, and sign the informed consent form. exclusion criteria: * mri contraindication; * patients with severe coagulation dysfunction; * pregnant or lactating women; * subjects who have participated in clinical trials of any other drugs or medical devices within 3 months; * evidence of severe or uncontrollable systemic diseases, as judged by the researchers; * subjects considered unsuitable for the clinical trial.

Keywords: stereotactic surgery thermal ablation medical refractory epilepsy epilepsy surgery
colchicine for the treatment of cardiac injury in hospitalized patients with covid-19 (colheart-19)

Conditions: Covid19

Summary: this is an open-label unblinded, randomized study to treat hospitalized covid-19 patients with colchicine plus current care (per institution treating physicians) vs. current care per institution treating physicians alone (the control arm)

we aim to determine if colchicine improves short-term outcomes in hospitalized coronavirus disease-19 (covid-19) patients with cardiac manifestations of disease. myocardial injury has been described in up to 30% of covid-19 infected patients, and portends a poor prognosis with currently no known treatment. colchicine is a widely available, well-established, inexpensive, oral anti-inflammatory agent that has been fda approved for the treatment of inflammatory disorders including gout and familial mediterranean fever. trials have also shown its benefit to prevent post-cardiotomy syndrome, to treat acute and recurrent pericarditis, and reduce cardiovascular events after myocardial infarction. we extrapolate based on these indications and studies that colchicine may also help improve outcomes in hospitalized covid-19 patients with evidence of cardiac injury. this is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)

Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age * covid-19 positive * hospitalized patients able to provide informed consent * cardiac injury (as evidenced by any of the following) 1. elevated troponin level 2. elevated bnp level 3. new ischemic or arrhythmogenic ecg/telemetry changes 4. new decrease in left ventricular ejection fraction (lvef) or new pericardial effusion on echocardiogram exclusion criteria: * pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes: 1. intrauterine devices (iud), contraceptive implants, or tubal sterilization 2. hormone method with a barrier method 3. two barrier methods 4. if a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction * history of severe hematologic or neuromuscular disorder * co-administration of cytochrome p450 3a4 (cypa3a4) and p-glycoprotein transport inhibitor * severe renal impairment with concomitant hepatic impairment * concurrent use of colchicine and strong or p-glycoprotein inhibitor with renal or hepatic impairment
the effect of cold steam application on nausea and vomiting

Conditions: Nausea and Vomiting, Postoperative

Summary: the aim of this study was to determine the effect of cold vapour applied to patients undergoing laparoscopic abdominal surgery primarily on nausea and vomiting and secondarily on antiemetic requirement, patient satisfaction and thirst. h1: cold steam application after surgical intervention has a decreasing effect on postoperative nausea. h2: cold steam application after surgical intervention has a decreasing effect on postoperative vomiting. h3: cold steam application after surgical intervention reduces the need for antiemetic drugs. h4: cold steam application after surgical intervention has a satisfactory effect on reducing nausea and vomiting.

the research will be conducted with the participation of surgical patients who underwent laporoscopic abdominal surgery between december 2024 and march 2025 in the general surgery department of trakya university hospital. effect size of 0.2 was predicted, the smallest possible significant correlation coefficient between repeated measurements was accepted as 0.3, and the minimum number of people to be included in the sample was calculated as 80, consisting of 40 patients from each group with a 95% confidence level, 5% margin of error and 80% power value. in case of possible data loss, drop out rate was accepted as 10% and 44 patients were included in each group.

Eligibility criteria:
inclusion criteria: * undergoing abdominal surgery under general anaesthesia, * admitted to the general surgery ward after surgery, * who volunteered to participate in the research, * no mental disability, * 18 years of age, * literate, * accepting random selection, * without turkish communication problems, * no preoperative oncological treatment, * undergoing elective surgery, * postoperatively without a nasogastric catheter, * with an operation time \<4 hours, * laparoscopic surgery performed, * no postoperative nausea and vomiting or mild/moderate nausea, * patients with asa score 1, 2 or 3 were determined as inclusion criteria. exclusion criteria: * severe nausea or active vomiting prior to administration, * migraine, vertigo, etc. who may experience nausea and vomiting due to vestibular disease, pregnancy, * copd, asthma, etc. with respiratory problems, * not accepting the application of cold steam, * not accepting random selection, * those with a history of chemotherapy or radiotherapy before surgery, * patients who underwent sudden movement changes (bed change, patient transfer, etc.) during the data collection period (0 to 2nd hour),
ultra-processed food consumption, gut microbiota, and glucose homeostasis

Conditions: Insulin Sensitivity; 24-hour Glucose Control

Summary: advancing age is associated with gut dysbiosis, low-grade chronic inflammation, progressive insulin resistance, and increased risk of type 2 diabetes (t2d). prediabetes is present in 45-50% of middle-aged/older adults, and declines in glucose tolerance are evident in the third or fourth decade of life. thus, there is an urgent need to identify new approaches for the prevention of type 2 diabetes among middle-aged adults. observational research has linked intake of ultra-processed foods (upf), which comprise \~60% of total energy intake in us adults, with increased risk of t2d. ex vivo and animal research suggests that components of upf alter gut microbiota composition and initiate a cascade of events leading to intestinal inflammation and impaired glycemic control. whether mid-life adults (aged 45-65 yrs) are susceptible to the adverse impact of upf consumption on glucose homeostasis is unknown. the overall objective of this study is to establish proof-of-concept for an impairment in glucose homeostasis following increases in upf consumption in mid-life adults, in order to conduct a larger, more comprehensive and mechanistic trial in the future. in addition, changes in gut microbial composition and function, intestinal inflammation and permeability, serum endotoxin concentrations, and inflammatory cytokines as potential mechanisms by which upf consumption influences glucose homeostasis will be investigated.


Eligibility criteria:
inclusion criteria: * weight stable for previous 6 months * sedentary to recreationally active * no plans to gain/lose weight or change physical activity level * willing to pick up food daily and consume foods provided for an 8-week period * verbal and written informed consent * approval by medical director * estrogen or testosterone usage is acceptable, if on stable dose for \>6 months exclusion criteria: * bmi \>35 kg/m2 * diabetes or diabetes medication * antibiotic, prebiotic or prebiotic use in prior 3 months * tchol \>6.2 mmol/l; tg \>4.5 mmol/l * blood pressure (bp) \> 159/99 mmhg (stable bp on antihypertensive medications used for \>6 months is acceptable) * diagnosed inflammatory bowel disease * past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease * vegetarian or vegan * pregnant or plans to become pregnant * food allergies or aversions * 3 or fewer stools per week or regular laxative use
beovu versus eylea in the treatment of diabetic macular edema

Conditions: Macular Edema

Summary: diabetic macular edema degeneration occur is a vision threatening condition. the investigators compare the efficacy of beovu and eylea intravitreal treatment in the management

baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. procedure included randomized intravitreal injection of brolucizumab(beovu®, genentech, south francisco, ca) and of aflibercept (eylea;regeneron, tarrytown,ny)

Eligibility criteria:
inclusion criteria: * diabetic macular edema exclusion criteria: * other causes of macular edema * other macular diseases

Keywords: beovu eylea diabetic macular edema
pharmacokinetic and safety comparison of two capecitabine tablets in patients with colorectal or breast cancer

Conditions: Patient Participation

Summary: a multicenter, randomized, open-label, three-period, and reference-replicated crossover study was conducted in 48 patients with colorectal or breast cancer under fed conditions to assess the bioequivalence between two formulations of capecitabine.

this was a multicenter, open, random, balanced, three-period, three-sequence and semi-repetitive cross study with 48 subjects. eligible subjects were randomly assigned in a 1:1:1 ratio to receive one period of test formulation or two period of reference formulation, followed by a 1-day washout period and administration of the alternate formulation. serial blood samples for pharmacokinetic assessment were collected at 0 hours (predose) up to 8 hours postdose. the plasma concentrations of capecitabine were analyzed by lc/ms-ms. pharmacokinetic parameters (non-compartmental model) were assessed with winnonlin software. the pharmacokinetic parameters assessed were area under the plasma concentration-time curve from time 0 to the time of last measurable concentration (auc0-t), auc from time zero to infinity (auc0-∞), the peak plasma concentration of the drug (c max ), time needed to reach maximum concentration (tmax), the elimination half-life (t1/2), and terminal elimination rate (λz). all were analyzed using an anova model after logarithmic transformation of the data. for establishing bioequivalence (be) for capecitabine， reference-scaled average bioequivalence (rsabe) acceptance criteria and average bioequivalence (abe) acceptance criteria were used. safety and tolerability was assessed during the entire study period.

Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically conﬁrmed colorectal or breast cancer receiving capecitabine monotherapy or combination chemotherapy. * eligible patients were within 18-70 years of age. * ecog score was 0-2. * left ventricular ejection fraction (lvef) \> 50%. * there was no serious persistent toxicity to capecitabine treatment before screening (laboratory tests ≤ grade 1 (nci ctcae 5.0 standard) * hand-foot syndrome ≤ grade 2 after recovery from the previous treatment period). exclusion criteria: * patients were known allergy to fluorouracil or 5-fluorouracil. * patients with complete lack of known dihydropyrimidine dehydrogenase (dpd) activity. * patients with abnormal hepatic and renal function (serum creatinine≤ 1.5 ×uln; clcr ≥ 51 ml/min; bilirubin≤ 1.5 ×uln; ast, alt≤2.5×uln) * needed to accept phenytoin, warfarin, other coumarin derivatives anticoagulants, folic acid, and cyp2c9 substrates during the research. * patients with brain metastases or other metastases of the central nervous system (except those who were treated at least 6 months prior to the start of the study and were stable and asymptomatic).

Keywords: capecitabine bioequivalence pharmacokinetics
cultivating well-being in subclinical paranoia

Conditions: Wellbeing

Summary: the intervention is called feliz-mente, with third generation therapy components that aims to improve wellbeing and self-enhancement. without intervening directly on the symptoms, it is expected to increase positive experiences, the use of personal strengths and positive relationships, and aims to build a more meaningful self-narrative in persons with subclinical paranoia. feliz-mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions by the use of a mobile application to improve treatment adherence and daily practice. the design for the present study is a randomized controlled trial, which compares the post-intervention measures of the experimental group (group receiving the intervention and the daily use of a mobile application of the program) with the post-intervention measures of the control group (treatment as usual + waiting list).


Eligibility criteria:
inclusion criteria: * participants between 18 and 35 years old * at least two standard deviations above mean on the scales of distress, suspicion and /or interpersonal sensitivity in the scl-90 questionnaire. exclusion criteria: * participants with borderline personality disorder * participants with substance use disorders and /or * participants with severe cognitive impairment.
impact of hemo-dialysis therapy on blood levels of treprostenil in end stage renal disease patients with pulmonary hypertension

Conditions: Pulmonary Hypertension; End-Stage Renal Disease; Hemo-dialysis Therapy

Summary: remodulin (treprostenil sodium) is synthetic prostacyclin analog available as a solution for administration in the intravenous route. it is approved for treatment of class i - pulmonary hypertension functional capacity stage iii-iv. a key factor for the success of pulmonary hypertension therapy is maintaining near constant blood level of a given medications along the day. a sudden decrease in the blood levels might lead to rebound phenomenon; abrupt increase in the pulmonary artery pressure which might lead to acute right ventricular failure and even to sudden death. as some pht patients suffer are on hemo-dialysis therapy due to end-stage renal disease there is a need to document the variation of the blood level along the dialysis cycle.

after giving informed consent 10 ml of blood will be drawn from the study population at the following occasions. * baseline measurement immediately before starting hd therapy. * during the hemo-dialysis therapy - every one hour. * after the end of the hemo-dialysis therapy - every one hour (a total of four measurements) to record recovery of treprostenil blood levels.

Eligibility criteria:
inclusion criteria:patients with pah who receive chronic (more than 3 months) treprostenil treatment administered intravenously as a single agent therapy who maintain chronic hemo-dialysis therapy. patients must be in stable condition for at least one month. patients other than class i pah will be not included in this study. exclusion criteria: * none

Keywords: pulmonary hypertension remodulin (treprostenil sodium) end-stage renal disease hemo-dialysis
68ga fapi pet/ct evaluation of axillary lymph node status after neoadjuvant therapy in patients with clinical axillary lymph node positive breast cancer

Conditions: BREAST CANCER; PET/CT

Summary: the goal of this observational study is to learn whether 68ga-fapi pet/ct may be used as a new effective methods for evaluating axillary lymph node efficacy after neoadjuvant treatment for breast cancer. the main question it aims to answer is: could 68ga-fapi pet/ct effectively evaluate axillary lymph node after neoadjuvant treatment for breast cancer? participants will have a 68ga-fapi pet/ct test between last neoadjuvant therapy and surgery.

previous studies have shown that compared with conventional 18f-fdg pet/ct, 68ga-fapi pet/ct has the characteristics of not being affected by blood glucose, good tumor specificity, and high tumor-to-background ratio, and studies have shown that 68ga- fapi pet/ct can detect parts of breast cancer primary lesions and lymph node metastases with low 18f-fdg uptake, thereby increasing the lesion detection rate and improving the sensitivity of imaging examinations. therefore, 68ga-fapi pet/ct may be used as a new effective methods for evaluating axillary lymph node efficacy after neoadjuvant treatment for breast cancer. therefore, we plan to conduct this study to explore the ability of 68ga-fapi pet/ct to detect residual disease in axillary lymph nodes in patients with clinically positive axillary node (cn+) breast cancer after neoadjuvant treatment. by this way, we may explore an accurate and non-invasive assessment of axillary lymph node status after neoadjuvant therapy in breast cancer patients.

Eligibility criteria:
inclusion criteria: * female patients aged 18 and above * ecog score 0-2 points * pathological confirmation of malignant breast tumor * clinical axillary lymph node positivity (cn+) * completed at least 3 courses of neoadjuvant therapy and subjected to undergo surgical treatment * informed consent form signed exclusion criteria: * distant metastasis * unable to complete the proposed neoadjuvant therapy plan * pregnancy

Keywords: breast cancer pet/ct
efficacy and safety of intraspine® associated with discectomy in the treatment of lumbar disc herniation.

Conditions: Disk Herniated Lumbar

Summary: intraspine® is a novel device that, unlike interspinous positioned implants, is unique in being placed more anteriorly in an interlaminar position, closer to the normal center of rotation of the motion segment. mechanical advantages are thus conferred over more posteriorly positioned devices through the possibility of more physiological 'rocking' type movements in flexion and extension . this enables intraspine® to off-load the facet joints in extension without blocking movement. having a more anteriorly placed fulcrum also helps control excessive flexion movements by virtue of an improved lever arm in conjunction with an intact posterior tension band. the underlying hypothesis of this work is that a clinical gain is achieved by adding an intraspine® interlaminar device to discectomy in patients suffering from a lumbar disc herniation. this should result in an improvement in incapacity level and a reduction in pain.


Eligibility criteria:
inclusion criteria: disease-related criteria: * single segment l4-l5 or l5-s1 lumbar disc hernia identified on imaging (lumbar spine mri) * median or posterolateral disc hernia. * failure of correct medical treatment which has not provided lasting symptom relief absence of contraindications to surgical discectomy and implantation of the intraspine®. population related criteria: * subjects of either sex and over 18 years old * who have given their free informed signed consent to participate in the study * patients who are able to respond to the questionnaires and who can communicate in the language of the study country * and who are affiliated to a social security system or have rights from a social security system. exclusion criteria: disease-related criteria: * recurrent disc hernia post-discectomy at any level * foraminal and extra-foraminal disc hernia * paralysing disc hernia (score of 3/5 or less) and cauda equina syndrome * any grade of spondylolisthesis * degenerative scoliosis ≥ 15° * osteoporosis or paget's disease * bmi \> 30 * procedure required on more than one vertebral level * endoscopic microdiscectomy prohibiting insertion of the intraspine® * chronic infection * systemic or metabolic disorders * active ongoing malignant disease (liable to prevent the study being conducted and does not carry a risk of vertebral lysis) * occupational disorder responsible for the disease treatment or device-related criteria * allergy to any of the constituents of the medical device population-related criteria: * past history of spinal procedure. * withdrawal of consent * pregnant women * breast-feeding women * participation in a clinical study within 3 months before the initial visit. * drug addiction * predictable lack of availability during the study. patients deprived of their freedom or under legal guardianship.