Kornimate/medical-research-clean huggingface dataset:
evaluation of early conversion to everolimus from cyclosporine in de novo renal transplant recipients

Conditions: Renal Function

Summary: this study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy


Eligibility criteria:
inclusion criteria: * first or second single renal transplant from deceased or living donor exclusion criteria * recipient of organs other than a renal transplant * present malignancy (within the last 2 years) other than excised basal cell or squamous cell carcinoma of the skin * severe liver disease * at the time of randomization 7 weeks after transplantation in addition to the above criteria the following must be met at time of randomization: inclusion criteria: * patients maintained on a triple immunosuppressive regime consisting of cyclosporine, enteric coated mycophenolate, and corticosteroids * patients completed the first 7 weeks without experiencing any rejection exclusion criteria: * graft loss * low hemoglobin value, low number of white blood cells or platelets * high cholesterol values * proteinuria * wound healing problems * current severe major local or systemic infection * renal insufficiency other protocol-defined inclusion/exclusion criteria may apply.

Keywords: de novo renal transplantation
optimized treatment and regression of hbv-induced early cirrhosis

Conditions: Liver Cirrhosis

Summary: patients with chronic hepatitis b histologically confirmed of early cirrhosis s4 (similar to metavir f4, ishak 5/6) are randomly assigned in a 1:1 ratio. one arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. patients will be assessed at baseline, at every six months for blood count, liver function test, hbvdna, afp, prothrombin time, liver ultrasonography, and fibroscan. the second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.


Eligibility criteria:
inclusion criteria: 1. patients from age 18 to 65 years old; 2. male or female; 3. treatment-naive patients with chronic hepatitis b histologically confirmed of early cirrhosis s4 (similar to metavir f4, ishak 5/6) who consent to undergo liver biopsy before and after treatment; 4. patients with hbeag-positive, hbvdna\>2×10\ iu/ml or patients with hbeag-negative, hbvdna\>2×10\ iu/ml； 5. agree to be followed up regularly; 6. signature of written informed consent. exclusion criteria: 1. patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma; 2. patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for drugs used in this study; 3. patients with hcv or hiv infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases; 4. patients with baseline afp level higher than 100 ng/ml and possible malignant lesion on image, or afp level higher than 100 ng/ml for more than three months; 5. creatinine \>1.5×uln; 6. patients with other uncured malignant tumors; 7. patients with severe diseases of heart, lung, kidney, brain, blood or other organs; 8. patients with any other reasons not suitable for the study.

Keywords: hepatitis b liver cirrhosis regression efficacy
sofosbuvir and ribavirin in treatment-naive and treatment-experienced subjects with chronic genotype 2 or 3 hcv infection

Conditions: Hepatitis C

Summary: this study will evaluate the safety, tolerability, and antiviral efficacy of gs-7977 with ribavirin (rbv) in participants with genotype 2 or 3 hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * age \> 18 with chronic genotype 2 or 3 hcv infection * hcv rna \> 10,000 iu/ml at screening * subjects must be treatment naive or treatment experienced * presence or absence of cirrhosis; a liver biopsy may be required * healthy according to medical history and physical examination with the exception of hcv diagnosis * agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication exclusion criteria: * prior use of any other inhibitor of the hcv ns5b polymerase * history of any other clinically significant chronic liver disease * evidence of or history of decompensated liver disease * hiv or chronic hepatitis b virus (hbv) infection * hepatocellular carcinoma (hcc) or other malignancy (with exception of certain resolved skin cancers) * chronic use of immunosuppressive agents or immunomodulatory agents * history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator

Keywords: hcv genotype 2 genotype 3
the rescue study: survival and functional outcomes following salvage surgery for residual or recurrent squamous cell carcinoma of the head and neck

Conditions: Head and Neck Cancer

Summary: the rescue study is a combined retrospective and prospective multicentre cohort study investigating the survival and functional outcomes in patients undergoing salvage surgery for recurrent, residual, and new primary head and neck squamous cell carcinoma (scc). additionally, the rescue study will contain an exploratory molecular analysis of consenting patients to assess the relationship between cancer genomics, previous radiotherapy, and recurrence in head and neck cancer.

the rescue study is a combined retrospective and prospective multicentre cohort study investigating the survival and functional outcomes in patients undergoing salvage surgery for recurrent, residual, and new primary head and neck squamous cell carcinoma (scc). additionally, the rescue study will contain an exploratory molecular analysis of consenting patients to assess the relationship between cancer genomics, previous radiotherapy, and recurrence in head and neck cancer. the aim of this study is to determine the survival, functional and quality of life outcomes of patients undergoing all salvage surgery for recurrent, residual and new primary head and neck scc, and to establish the genetic architecture and clonal evolution h\&n scc after previous treatment for radiotherapy cancer.

Eligibility criteria:
inclusion criteria: 1. aged over 18 2. previous h\&n scc treated with radiotherapy with or without chemotherapy 3. local or regionally recurrent, residual, or new primary scc of the oropharynx, oral cavity, larynx, and hypopharynx 4. ability to give informed consent for biological sample collection (molecular analysis study only) exclusion criteria: 1. nasopharyngeal and cutaneous scc of the h\&n 2. thyroid, salivary gland, and non-squamous cell h\&n cancers 3. presence of distant metastasis (m1) or surgically inoperable t4b tumours
adjuvant taxotere in patients with high risk prostate cancer post prostatectomy and radiation

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate time to progression (ttp) by psa in patients with high risk prostate cancer after definitive therapy.


Eligibility criteria:
inclusion criteria: * patients who have undergone a radical prostatectomy (should have unmeasurable psa) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following: * node positive disease post-operatively * capsule involvement * seminal vesicles involvement * gleason score ≥ 8 * \>50% of core biopsies that are positive * clinical stage t2c and t3 * pre-op psa \> 15 plus gleason score of 7 * age greater than 18 * ecog performance status 0-1 * serum creatinine \<= 1.5 mg/dl * granulocyte count \>= 1500/m3, hemoglobin \> 8.0 g/dl, and platelet count \>= 100,000/m3 * total bilirubin \<= uln * ast, alt and alkaline phosphatase must be within the range allowing for eligibility. * signed patient informed consent. * men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter. exclusion criteria: * peripheral neuropathy \> grade 1 * history of severe hypersensitivity to taxotere® or other drugs formulated with polysorbate 80. * patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent. * active infection within 14 days of beginning treatment * patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection. * patients with a current malignancy. patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.

Keywords: prostate cancer taxotere
study to test the safety and efficacy of padsevonil as adjunctive treatment of focal-onset seizures in adult subjects with drug-resistant epilepsy

Conditions: Drug-Resistant Epilepsy; Focal-Onset Seizures

Summary: the purpose of the study is to evaluate the long-term safety and tolerability of padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.


Eligibility criteria:
inclusion criteria: * subject is an adult (18 years of age or more ) * subject with epilepsy who has completed 1 of the previous padsevonil (psl) studies which allow access to the present study * female subjects of child bearing potential must have a serum negative pregnancy test at the entry visit, which is confirmed to be negative by urine testing prior to further dispensing at each study visit thereafter. subjects will be withdrawn from the study as soon as pregnancy is known. female subjects will use an efficient form of contraception for the duration of the study and for a period of 3 months after their final dose of psl. exclusion criteria: * subject has any severe medical, neurological, or psychiatric condition, or laboratory value which may have an impact on the safety of the subject * subject has active suicidal ideation as indicated by a positive response ('yes') to either question 4 or question 5 of the 'since last visit' version of the columbia-suicide severity rating scale (c-ssrs) * subject has \>2x upper limit of normal (uln) of any of the following: alanine aminotransferase (alt), aspartate aminotransferase (ast), alkaline phosphatase (alp), or \>uln total bilirubin (\>= l.5x uln total bilirubin if known gilbert's syndrome) at the entry visit * subject has a clinically-significant abnormality on electrocardiogram (ecg) that, in the opinion of the investigator, increases the risks associated with participating in the study * subject has an abnormality on echocardiogram at last echocardiogram assessment, or foreseen in parent study as assessed by central reader that is accompanied by clinical symptoms or a grade 2\* (or higher)/moderate severity abnormality, or a history of rheumatic heart disease, or other known valvular abnormalities (\*according to the ase guidelines, 2017; zoghbi et al 2017) * female subject who plans to be pregnant or is breastfeeding

Keywords: drug-resistant epilepsy padsevonil
influence of lidocaine infusion on motor evoked potential thresholds

Conditions: Spinal Disease; Anesthesia; Post Operative Pain

Summary: the purpose of this study is to determine the effect of lidocaine infusion on intraoperative neuromonitoring in patients undergoing spine surgery.

the investigators will compare the stimulation threshold for motor evoked potentials (meps) for patients undergoing spine surgery with intraoperative neurophysiologic monitoring (ionm) who receive a lidocaine infusion vs. normal saline (ns) infusion. the endpoint for this objective will be the final stimulation threshold for meps at the end of the surgery. the stimulation threshold for meps is a commonly used metric to determine the effects of anesthetic agents on mep signals. secondary objectives will somatosensory evoked potentials (sseps) with an endpoint of amplitude and latency of sseps throughout the surgery. other secondary outcomes will include, intraoperative mean arterial pressure (map), intraoperative propofol consumptions, and post-operative visual analog scale (vas) and opioid consumption.

Eligibility criteria:
inclusion criteria: * patients undergoing elective cervical or thoracolumbar spine surgery with intraoperative neurophysiological monitoring exclusion criteria: * inability to provide informed consent in english * pregnancy (based on patient report or a positive test on the day of surgery) * contraindication to lidocaine * planned post-operative intubation * current incarceration

Keywords: lidocaine intraoperative neuromonitoring spine surgery post operative pain
lung function monitoring during hypoxemia episodes

Conditions: Hypoxemia of Newborn

Summary: premature infants commonly have desaturation episodes due to different reasons such as cessation of breathing or loss of lung volume. the purpose of this study is to differentiate the mechanisms of desaturation episodes with continuous lung volume monitoring. as we better understand the mechanisms underlying the desaturation episodes, newer strategies directed at underlying pathophysiology can potentially by evaluated for mitigation of these episodes.

this is an observational study evaluating changes in lung volume during hypoxemia episodes (hes or desaturation episodes) in spontaneously breathing very preterm infants. we postulate that hes can be differentiated into distinct subtypes based on alterations in lung volume. additionally, the severity and duration of hes correlates with the degree of changes in lung volumes. therefore, we are performing an observational study in very preterm infants with spontaneous hes and classifying these episodes into different subtypes of apnea, forced exhalation, mixed, and unclassified subtypes according to changes in lung volume. lung volume will be measured non-invasively using electrical impedance tomography (eit) device (sentec inc, ri, usa). in brief, the device consists of a soft belt with 32 embedded electrodes which is placed around the chest of the infant and applies a weak alternating current and measures returning voltage. the measured returning voltage is dependent on the electrical conductivity of the underlying tissue. the reconstruction algorithm creates an image of regional impedance distribution in real time. these data are then used to compute lung volume parameters at different phases of respiratory cycle providing end expiratory lung impedance reflective of eelv, tidal impedance reflective of tidal volume, and regional distribution of ventilation. the changes in lung volume parameters will be used to differentiate hes into different subtypes and correlated with degree and severity of hes. in addition, we will also measure cerebral tissue oxygen saturation (crso2) to monitor changes in tissue oxygenation with hypoxemia episodes and changes in lung volume.

Eligibility criteria:
inclusion criteria: * born at ≤32w ga * post menstrual age between 30w to 36w * 4 or more episodes of hes in the previous 24h (defined as spo2\<90≥5s) exclusion criteria: * major congenital malformation * receiving invasive mechanical ventilation * severe neurological injury * hemodynamic instability requiring inotropes in last 72h

Keywords: electrical impedance tomography hypoxemia episodes lung volume
knowledge-based iterative model reconstruction at low-kilovoltage (kv) cardiac computed tomography (ct)

Conditions: Coronary Artery Disease

Summary: the purpose of this study was to compare fbp-, hybrid ir-, and imr techniques to assess their role in the identification of coronary artery disease and abnormalities in cardiac structures.


Eligibility criteria:
inclusion criteria: * a bmi of 27 kg/m2 or less and a coronary calcium score of less than 1,000 agatston units. exclusion criteria: * bmi exceeded 27 kg/m2 * renal dysfunction (serum creatinine level \> 1.5 mg/dl) * atrial fibrillation * prior coronary artery bypass grafting * heart failure (new york heart association class iii-iv)

Keywords: computed tomography
morphological and functional evaluation of irvine-gass syndrome

Conditions: Irvine Gass Syndrome

Summary: purpose: to evaluate morphological and functional characteristics of irvine gass syndrome methods: 30 patients suffering on cystoid macular edema (cme) secondary to cataract surgery will be observed and evaluated by fluorescein-angiography, sd-oct, reading performance, contrast sensitivity and microperimetry in a fixed time schedule


Eligibility criteria:
inclusion criteria: * \> 18 years * st.p cataract surgery * able to read * informed consent * with fluorescein angiography and sd-oct diagnosed irvine gass syndrome exclusion criteria: * \< 18 years * cme of other origin * diabetic macular edema

Keywords: irvine gass syndrome multimodal imaging sd-oct cme secondary to cataract surgery in vivo correlation of morphology and function
apart: prevention and automatic therapy of atrial arrhythmias in patients with paroxysmal supraventricular tachycardias

Conditions: Tachyarrhythmia

Summary: the goal of apart is the assessment of the therapeutic and preventive stimulation algorithms of the medtronic at500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to the german guidelines. medication is controlled throughout the study with a beta-blocker as the only antiarrhythmic drug.


Eligibility criteria:
inclusion criteria: * indication for cardiac pacing according to the german guidelines * documented (electrocardiogram; ecg) atrial arrhythmia during the last three months before enrollment * willingness to terminate antiarrhythmic drugs until the first recurrence of an atrial arrhythmia * sinus rhythm during 24 hours before implant of the device exclusion criteria: * ejection fraction below 40% * mechanic prosthesis of the tricuspid valve * indication to implantable cardioverter defibrillator (icd)-implantation * pregnancy

Keywords: indication for cardiac pacing atrial arrhythmia indication for the implantation of a pacemaker according to the german guidelines documented (ecg) atrial tachyarrhythmia within the last three months before enrollment
comparing the effects of ondansetron versus dexamethasone on the incidence of post-dural puncture headache (pdph) , nausea and vomiting after spinal anaesthesia of parturients undergoing caesarean section

Conditions: Post-Dural Puncture Headache

Summary: comparing dexamethasone and ondanestrone injection in ncidence of postdural puncture headache and post-partum nausea and vomiting


Eligibility criteria:
inclusion criteria: * a total of one hundred and fifty parturients in child bearing period (20-40 years), with bmi of 23-27, and asa physical status ii, who were candidate for elective caesarean section, were enrolled in this prospective randomized study. exclusion criteria exclusion criteria: 1 - lady refusal to participate. 2. all pregnant women candidate for emergency caesarean section elligible for general anaesthesia (ga). 3.presence of any contraindications of dexamethasone (as dm and uncontrolled infection ) or any contraindication of ondansetron (as prolonged qt interval 6. presence of cardiac, respiratory, hepatic, renal and mental diseases. 7. coagulopathy, or any contraindication to spinal anaesthesia. 8. presence of complicated pregnancies (such as pregnancy induced hypertension, placenta previa or eclmpsia).
identification of preoperative parameters to predict acute kidney injury risk following vascular or digestive surgery

Conditions: Acute Kidney Injury

Summary: the study aims to identify the preoperative parameters associated with the risk of postoperative acute kidney injury (in particular the parameters of the spark score) in patients of the besançon university hospital who have undergone digestive or vascular surgery.


Eligibility criteria:
inclusion criteria: * digestive surgery or vascular surgery at besancon university hospital between 01/01/2019 and 31/12/2019 (retrospective) or between 01/01/2023 and 31/12/2023 (prospective) exclusion criteria: * no preoperative creatinine value * outpatient surgery * surgery other than digestive or vascular (organ procurement surgery/nephrectomy surgery/renal transplantation) * kidney/urinary tract surgery * arteriovenous fistula surgery * end-stage renal disease or renal replacement therapy, except for renal transplant patients * acute kidney injury kdigo≥1 within 2 weeks before surgery * patients in need of emergency surgery for ongoing haemorrhage * legal incapacity or limited legal capacity * subjects with no social security coverage.

Keywords: vascular surgical procedures digestive surgery vascular surgery
safety and effectiveness of omega 3-fatty acids, epa versus dha, for the treatment of major depression

Conditions: Major Depressive Disorder

Summary: this study examines the difference in the effectiveness of two natural compounds, eicosapentanoic (epa) and docosahexanoic (dha)omega-3 fatty acids, in treating major depressive disorder. both types of omega-3 fatty acids are commonly found in fish oils. it is believed that a deficiency in these omega-3 fatty acids may lead to the development of major depression.

the study lasts for eight weeks and involves four visits after the screen and baseline visits (biweekly). participants will be randomized, or chosen by chance, to enter into one of three groups. people in the first group will take 1 g/day or epa omega-3 fatty acid, those in the second group will take 1 g/day of dha omega-3 fatty acid, and those in the third group will take a placebo. this study is double-blind, which means that neither the participant, nor the doctor, nor the research staff will know which group each person is in. at the end of the study the participant will be offered three months of follow-up care at the depression clinical and research program.

Eligibility criteria:
inclusion criteria: * men or women aged 18-80 years old. * must meet criteria for current major depressive disorder. exclusion criteria: * serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease * history of seizure disorder. * substance use disorders, including alcohol, active within the last six months (past history is ok). * history of multiple adverse drug reactions or allergy to the study drugs.

Keywords: depression omega-3 boston
type one diabetes and low carb study

Conditions: Diabetes Mellitus, Type 1

Summary: the investigators have identified a support group on social media with \~1500 members (children and adults), the majority of whom have t1dm and follow a carbohydrate-restricted diet. many participants report exceptionally low hba1c and insulin requirements. if these anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical trial would be warranted. the investigators propose to survey the above-mentioned group and their professional diabetes care providers to characterize glycemic control and explore associated dietary and diabetes care factors.

the surveys will address questions in the following domains: 1) diabetes diagnosis and treatment; 2) carbohydrate-restricted diet; 3) insulin regimen; 4) other diabetes related care; 5) diabetes complications; 6) other related health and healthcare; 7) patient provider interactions; 8) socio-demographics. drafts of these surveys are included in the appendix of this protocol.

Eligibility criteria:
inclusion criteria: * adult patients with a diagnosis of t1dm who are currently on insulin treatment or * adults who are a parent or guardian of a child with t1dm who is currently on insulin treatment and * self-reported use of a regimen including carbohydrate restriction for at least 3 months exclusion criteria: * women who are pregnant or breastfeeding.

Keywords: low carbohydrate diet