Kornimate/medical-research-clean huggingface dataset:
ischemic postconditioning in carotid surgery

Conditions: Ischemic Postconditioning; Carotid Surgery; Stroke; Carotid Artery Diseases

Summary: analyzing changes in cerebral oximetry, transcranial doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (ipct).

eversion carotid endarterectomy (ecea) has proven effective in preventing ischemic brain damage resulting from atherosclerotic disease in the extracranial segment of the carotid arteries. over time, advancements in surgical techniques have led to a reduction in the incidence of perioperative stroke. to better understand the concept of stroke complications following cea, a clear distinction between intraprocedural and postprocedural strokes is necessary. periprocedural strokes are attributed to hypoperfusion or embolization from the site of endarterectomy, while defined causes of postprocedural strokes include local carotid artery thrombosis or cerebral hyperperfusion syndrome (chs). chs, occurring in 1-3% of cases, is a potentially catastrophic event following ecea, primarily resulting from impaired autoregulation mechanisms and post-revascularization changes in cerebral hemodynamics. patients with significant carotid stenosis are particularly vulnerable to chs due to prolonged cerebral hypoperfusion, where collateral circulation serves as a protective mechanism. another pathway leading to chs involves increased free radical concentrations, damaging the blood-brain barrier. identified risk factors for chs development include advanced age, prior ischemic cerebrovascular events, and contralateral stenosis \> 70%. various methods for predicting chs development and collateral circulation insufficiency include cerebral oximetry, transcranial doppler sonography, perfusion computed tomography, and quantitative magnetic resonance imaging. cerebral oximetry, with real-time detection of cerebral oxygenated hemoglobin saturation, exhibits promising sensitivity and specificity in predicting chs occurrence. analyzing changes in biomarkers of neuronal ischemic injury and blood-brain barrier integrity offers insight into chs pathophysiology and indirectly assesses the safety and efficacy of ischemic postconditioning of the carotid artery (ipct) in high-risk patients. ipct, shown to have a protective effect in animal models, recently demonstrated encouraging results in human trials. utilizing intraoperative neuromonitoring with cerebral oximetry and transcranial doppler enables real-time monitoring of cerebral oxygenated hemoglobin saturation and flow characteristics during and after ipct, validating its protective effect and safety in high-risk chs scenarios.

Eligibility criteria:
inclusion criteria: * unilateral carotid artery stenosis \>90% * bilateral stenosis \>80% * unilateral stenosis \>80% with contralateral occlusion/subocclusion exclusion criteria: * urgent carotid endarterectomy * carotid restenosis * "major surgery" in the last 6 months * malignant diseases * previous brain trauma or surgery * epilepsy

Keywords: ischemic postconditioning carotid surgery
oral duloxetine as a premedication for postoperative pain control

Conditions: Anesthesia

Summary: the purpose of the study is to use duloxetine as premedication in anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control.

we designed this randomized, double-blind study to evaluate the effectiveness of administration of oral duloxetine 2 hours preoperatively on the onset and the duration of the spinal anesthesia in arthroscopic anterior cruciate ligament (acl) repair and the role of duloxetine on postoperative analgesia.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists i or ii. * sex: both sexes. * age between 18 and 50. * height 155-180 cm. * patients scheduled for arthroscopic anterior cruciate ligament (acl) repair under spinal anesthesia. exclusion criteria: * declining to give written informed consent. * history of allergy to the medications used in the study. * had a history of drug or alcohol abuse. * taking opioids or sedative medications. * inability to communicate with patients to evaluate the postoperative pain. * need for postoperative icu hospitalization. * hepatic or renal failure. * patients with a history of taking duloxetine or any ssris. * contraindications to regional anesthesia (including coagulopathy and local infection). * psychiatric disorders with antipsycotics or antidepressants (tricylic or maois). * antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin). * quinolones (ciprofloxacin).
motivational assessment program to initiate treatment

Conditions: Substance-Related Disorders

Summary: substance abuse treatment in the criminal justice system can reduce drug use and related criminal behavior. although drug and alcohol treatment are common mandates in criminal justice programs, only a minority of clients actually initiate treatment. this proposal will compare two intervention formats that target motivation to initiate and engage in treatment among a group of probationers who have drug or alcohol treatment conditions. six hundred drug and alcohol offenders in two probation sites (baltimore, md and dallas, tx) will be randomized to receive: 1) an in-person motivational interviewing session (mi), 2) a motivational computer program (mc), or 3) supervision intake and monitoring as usual (sau). the mi condition will be structured along the lines of the "check-up" format which consists of an assessment and personalized feedback delivered in an mi style; the content of the mc condition will be drawn from previous literature on effective motivational computer programs. both interventions will be delivered at the start of the probation process, with follow-up assessments at 2 and 6 months. primary outcomes include engagement and participation in substance abuse treatment; secondary outcomes include drug and alcohol use, probation progress, criminal behavior, and hiv testing and care. this project will be the first to develop and test two interventions for encouraging criminal justice clients to follow through with treatment recommendations, with the goal of increasing treatment initiation, and reducing subsequent drug use and criminal behavior. it also contributes to ongoing partnerships with two large probation agencies-the dallas county supervision and corrections department and the maryland division of parole and probation.

specific aims * develop two intervention formats (motivational interviewing (mi) and motivational computer (mc)) for increasing motivation to initiate and engage in substance abuse treatment and/or hiv / aids testing and, if appropriate, hiv care. * test the efficacy of mi and mc on treatment initiation and participation, substance abuse, hiv testing/care, and recidivism, as compared to supervision as usual (sau); * evaluate offender characteristics (e.g., risk level, gender, ethnicity, motivation) as potential moderators of the intervention effect; and, * assess the relative cost and cost-effectiveness of mi and mc on substance abuse treatment and/or linkage to or participation in hiv/aids care, supervision outcomes, recidivism, and substance abuse.

Eligibility criteria:
inclusion criteria: * \>=18 years old * drug or alcohol use in the last 90 days exclusion criteria: * \<18 years old * cannot speak english * already participate in a substance abuse treatment

Keywords: motivational interviewing internet treatment substance-related disorders criminal justice
idroflog® for treatment of dry eye disease (idroflog)

Conditions: Dry Eye Disease

Summary: this study aims at demonstrating the non-inferiority of idroflog compared to sodium hyaluronate 0.18% for the disease improvement of people with documented history of dry eyes and use of tear substitutes for at least 3 months.

this is a randomized, controlled, multicenter, assessor-blinded, non-inferiority trial comparing idroflog® (sodium hyaluronate and hydrocortisone) with sodium hyaluronate in participants with dry eye disease (ded). ded is a common, multifactorial ocular condition, which affects between 5% and 35% of adults worldwide and significantly affects their quality of life. ded treatment is based on the management of contributing factors (local environment, elimination of harmful systemic and topical drugs), eyelid hygiene and the use of artificial tears. the gold standard of the latter is sodium hyaluronate solutions, which, however, lack any anit-inflammatory activity necessary for ded's management. in comparison to these, idroflog containing both sodium hyaluronate and hydrocortisone in addition to the usual activities of sodium hyaluronate artificial tears (diluent, diffusive, protective, nutrient, lubricant) also provides steroidal anti-inflammatory activity. therefore, this study aims at showing that idroflog® performs as well as current standard of care (sodium hyaluronate artificial tears) in the treatment of moderate ded, while providing a potential benefit on the control of the sub-clinical inflammatory component of ded and maintaining the excellent safety profile of sodium hyaluronate artificial tears treatment.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * aged ≥ 18 years * documented history of dry eyes and use of tear substitutes for at least 3 months within the last year * presence of corneal fluorescein staining (oxford scale, score ≥ 2) in at least one eye * ocular surface disease index (osdi) ≥ 23 * reduced tear break-up time (\< 11 seconds) exclusion criteria: * women who are pregnant or lactating * best far corrected visual acuity \< 1/10 in both eyes * known hypersensitivity to one of the components of the study medications or test products * use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period * ocular surgery (of any type, including laser surgery and punctal plugs) or ocular trauma within the 4 months prior to screening * active ocular infection * active allergies requiring treatment * glaucoma

Keywords: dry eye idroflog ocular
an observational study to explore clinical characteristics of the patients with t1 non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the real-world observational study was designed to explore the odd factors of lymph metastases in the patients with t1 non-small cell lung cancer, the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.

the trial is a multi-centre, real-world non-interventional observational study. in the study, the patients with t1 non-small cell lung cancer enrolled in clinics from 2015 to 2017 were included via a retrospectively review method and the study data on patient demographic/tumor biological characteristics, and clinical treatments were collected to explore the clinical odd factors of lymph metastases, evaluate the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.

Eligibility criteria:
inclusion criteria: * patients who received surgeries from 2015 to 2017; * pathologically diagnosed patients with t1 non-small cell lung cancer; exclusion criteria: - patients with tumor treatments (including chemotherapies, radiotherapies, biological therapies, intervention therapies)

Keywords: chinese t1 non-small cell lung cancer lymph metastases
to evaluate the drug-drug interaction between telmisartan and atorvastatin in healthy male volunteers

Conditions: Diseases of the Circulatory System; Essential Hypertension

Summary: the study design was composed of 2 parts, 2-way crossover and multiple-dose. there are having 2 groups in each part that have divided period 1 and period 2, and wash-out period is 16 days between periods. each group is taking telmisartan (80mg) and/or atorvastatin (80mg) once a day for 6 days.


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 19 and 55 years * subjects who don't have congenital or chronic diseases and have no abnormal medical examination results within 3 years * healthy subjects (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator * subjects who signed and dated in informed consent form indicating that the subject has decided to participate in the study after being informed of all pertinent aspects of the study * subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (but excluding untreated, asymptomatic, seasonal allergies at time of dosing) * any condition possibly affecting drug absorption, distribution, metabolism, and excretion (e.g. gastrectomy) * twofold or more than upper limit of normal range in laboratory test for alt or ast * participating in other clinical trial study within 2 month preceding the first dose of investigational product * history of significant alcohol abuse or drug abuse within one year prior to the screening * whole blood donation within 2 months prior to dosing, or apheresis donation within 1 month prior to dosing * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study * unwilling or unable to comply with the lifestyle guidelines described in this protocol * subjects who are inadequate for this study to participate judged by investigator
phase 1 study of safety and biological effects of c326, an inhibitor of il-6, in crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether c326, a new inhibitor of il-6, is safe in patients with crohn's disease.

determination of safety is the most important goal of this first study with c326. other goals of the study are to examine: * pharmacokinetics (change in serum concentrations over time), * biological activity (change in blood markers relecting activity of crohn's disease), * effects on symptoms of crohn's disease. participants may receive either a single or several intravenous infusions of c326 or matching placebo.

Eligibility criteria:
inclusion criteria: * adults 18 - 65 * stable, moderately active crohn's disease * otherwise in generally good health exclusion criteria: * variety of concurrent medical conditions * various concomitant medications
a research study of how overdosing of a new once weekly medicine nnc0148-0287 c (insulin 287) influences the blood sugar level in people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is comparing the effect of a long-acting insulin analogue (insulin 287) with insulin glargine (lantus®) in subjects with type 2 diabetes. in addition, the study is looking at symptoms of low blood sugar, awareness of low blood sugar and the time and amount of glucose needed to recover from low blood sugar after injecting 2 and 3 times the basal dose of insulin 287 and glargine. the purpose of the study is to make a once-weekly injectable basal insulin treatment for people with type 2 diabetes. participants will get insulin 287 as well as insulin glargine - which treatment any participant gets first is decided by chance. insulin 287 is a new medicine; insulin glargine can already be prescribed. the study medicines will be in a pen, and must be injected with a needle in the thigh once per day (insulin glargine) or once per week (insulin 287). the study will last for minimum 3 months and up to approximately 6 months. participants will have 21 clinic visits and at least 2 phone calls with the study doctor. the participants' health will be monitored carefully and blood samples will be taken at the clinic visits.


Eligibility criteria:
inclusion criteria: * male or female, aged between 18 and 72 years (both inclusive) at the time of signing informed consent. * body mass index between 18.5 and 37.9 kg/m\^2 (both inclusive). * diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening. * glycosylated haemoglobin type a1c (hba1c) less than or equal to 9.0% (less than or equal to 74 mmol/mol) at screening. * current total daily insulin treatment between 0.2 and 1.0 u/kg/day (both inclusive). exclusion criteria: * known or suspected hypersensitivity to trial products or related products. * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. * presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus).
impact of vitamin d supplementation in patients with multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting; Vitamin D Deficiency

Summary: vitamin d is important risk factor for developing multiple sclerosis (ms) and for disease progression. patients with ms who had lower vitamin d levels were at increased risk for more clinical attacks and faster disease progression. it was also shown that patients with ms had lower vitamin d levels in serum than healthy controls. it is not clearly defined, which are the levels of vitamin d in serum, that are high enough to trigger immunomodulatory effect and are safe for patients. this double-blind randomized clinical trial was designed to compare impact of vitamin d supplementation in two different doses (1000 iu/day vs 4000 iu/day) in patients with relapsing remitting ms. the main goal of this trial is to compare dose response on vitamin d supplementation and to estimate more closely appropriate level of vitamin d in serum which triggers some of experimentally shown immunomodulatory actions.

vitamin d is important risk factor for developing multiple sclerosis (ms) and for disease progression. patients with ms who had lower vitamin d levels were at increased risk for more clinical attacks and faster disease progression. it was also shown that patients with ms had lower vitamin d levels in serum than healthy controls. it is not clearly defined, which are the levels of vitamin d in serum, that are high enough to trigger immunomodulatory effect and are safe for patients. this double-blind randomized clinical trial was designed to compare impact of vitamin d supplementation during four months in winter time in two different doses (1000 iu/day vs 4000 iu/day) in patients with relapsing remitting ms. the main goal of this trial is to compare dose response on vitamin d supplementation and estimate more closely appropriate level of vitamin d in serum which triggers some of experimentally shown immunomodulatory actions. to define immunomodulatory response different laboratory, clinical and genetic tests will be performed.

Eligibility criteria:
inclusion criteria: * relapsing remitting ms * treatment with immunomodulatory drug * age 18-60 years and * edss (expanded disability status scale) score less than 5. exclusion criteria: * use of vitamin d supplements in the past 3 months * pregnancy, planning pregnancy or nursing * relapse of disease and corticosteroids use in past month * active inflammation at the start of the study (flu, cystitis etc.) * renal disease * elevated levels of calcium or parathormone * hypersensitivity to vitamin d preparations * switching of immunomodulatory drug in past 3 months * other autoimmune disease * history of hyperparathyroidism, liver disease, tuberculosis, sarcoidosis or kidney stones
treatment of chronic lymphocytic leukemia in patients previously exposed to rituximab

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this research is to evaluate the safety and effectiveness of the drugs lenalidomide and ofatumumab in the treatment of chronic lymphocytic leukemia (cll).


Eligibility criteria:
inclusion criteria: 1. subjects must have confirmed diagnosis of chronic lymphocytic leukemia (cll). 2. prior therapy with at least one regimen containing rituximab 3. age \> 18 years. 4. life expectancy greater than 12 months. 5. ecog performance status \<2 6. patients must have normal organ function as defined in the protocol. 7. patients must have adequate bone marrow function as defined in the protocol. 8. ability to understand and the willingness to sign a written informed consent document. 9. all study participants must be registered into the mandatory revassist® program, and be willing and able to comply with the requirements of revassist®. 10. females of childbearing potential (fcbp)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing. men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy. 11. able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to asa may use warfarin or low molecular weight heparin. exclusion criteria: 1. patients who have had chemotherapy or radiotherapy within 4 weeks or received any monoclonal antibody within 6 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 2. patients may not be receiving any other investigational agents or other anti-cancer agents or treatments. 3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to ofatumumab or lenalidomide. 4. uncontrolled concomitant illness. 5. pregnant women are excluded from this study because lenalidomide is believed to be teratogenic. 6. hiv-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ofatumumab or lenalidomide. 7. prior treatment with lenalidomide 8. evidence of laboratory tls by cairo-bishop definition of tumor lysis syndrome. subjects may be enrolled upon correction of electrolyte abnormalities. 9. all patients will undergo screening for hepatitis b and may or may not be eligible based on the results as outlined in the protocol.

Keywords: relapsed chronic lymphocytic leukemia