Kornimate/medical-research-clean huggingface dataset:
the effect of nimodipine on the postoperative cognitive dysfunction

Conditions: Mild Cognitive Impairment

Summary: the calcium channel blocker nimodipine dilates cerebral blood vessels and can pass through the blood-brain barrier, providing neuroprotective effects by selectively improving cerebral blood flow and inhibiting neuronal necrosis and apoptosis. nimodipine significantly inhibited the production of tumor necrosis factor tnf-α and interleukin il-1β, and also of nitric oxide and prostaglandin e2 from lipopolysaccharide-stimulated microglia. abnormal cytokine networks are important in the development of nerve cell damage that leads to cognitive impairment.

all patients aged above 60 years undergoing planned neurosurgical operations in the duration up to 4 hours under general anesthesia will be included in the study. the patients will not be sedated by any type of benzodiazepine. a dose of 30 mg nimodipine or placebo will be applied 45 minutes before the surgery according to the randomization. anesthesia will be managed according to the standardised protocol. concentration of desflurane will be adjusted according to entropy values (target 40-50). analgetics will be applied according to surgical pleth index (spi) values. sufentanil will not be applied in the last 15 minutes. extubation will be performed at the operating theatre when meeting all extubation criteria including train of four ratio (tofr) above 92%. neither syntophylline, nor pharmacological decurarization (syntostigmine) will be applied to the patients.during the surgery, blood pressure will be maintained within ± 15% of the patient's normal blood pressure. cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day.

Eligibility criteria:
inclusion criteria: * glascow coma scale gcs 15 preoperatively * american society of anesthesiologists asa risk i - iii * planned brain surgery * duration of procedure up to 4 hours. exclusion criteria: * blood pressure below 130/80 torr preoperatively * previous vascular surgery * concomitant use of antiepileptic drugs, rifampicin * allergy to nimodipine * known liver cirrhosis

Keywords: postoperative cognitive dysfunction nimodipin anesthesia
genetic and environmental risk factors for hemorrhagic stroke-gerfhs iii

Conditions: Stroke

Summary: the purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ich). ich, a type of bleeding into brain tissue, is a type of stroke that can result in death or disability in a large number of people. our study hopes to identify a specific genetic risk factor that will help identify at risk individuals and target treatment strategies.

our case-control study will enroll subjects with a spontaneous ich in the greater cincinnati region. for each subject enrolled we will also enroll a healthy control subject(matched by age , race and gender). both the cases and control will undergo the same interview and have blood drawn for genetic analysis. the cases will have a chart abstraction done on their event medical record and be contacted for 3 and 6 month follow up(short interview). the genetic sample will be genotyped using the affymetrix 6.0 gene chip looking for snps of interest and to identify genetic variants associated with ich. the most promising snps identified through this process will be replicated in the external cohort from massachusetts general hospital.

Eligibility criteria:
inclusion criteria: * age 18 years or older * resident (6 months or longer) within 100 miles of university of cincinnati. * fulfillment of the criteria for spontaneous ich * no evidence of trauma, brain tumor/metastases, hemorrhagic transformation of ischemic stroke or infectious processes as a cause of the hemorrhage. * ability of the patient or legal representative to provide consent for an interview, blood pressure determinations and dna sampling. exclusion criteria: * n/a

Keywords: stroke brain attack hemorrhagic stroke risk factors
a trial investigating lu af28996 in adult japanese participants with parkinson's disease (pd)

Conditions: Parkinson Disease

Summary: this trial will evaluate the effects of lu af28996 in adult japanese men and women with parkinson's disease (pd). the main goals of the trial are to learn more about a) the safety and tolerability of lu af28996 (any new or worsening medical issues the participants have with treatment), and b) the pharmacokinetic parameters of lu af28996 (how the drug is absorbed, distributed, and processed by the body). participants will take lu af28996 capsules orally once a day (od). the participants will start with a low dose of lu af28996, which will be increased gradually over a period of 2 weeks, and then decreased gradually over a period of about 2 weeks.


Eligibility criteria:
inclusion criteria: * the participant is diagnosed with idiopathic pd (consistent with the united kingdom parkinson's disease society brain bank criteria for the diagnosis of parkinson's disease) and should not have more than 1 first-degree relative with pd. * the participant's modified hoehn and yahr score is ≤3 in the on state and ≤4 in the off state. * the participant experiences well-recognizable and predictable motor fluctuations (≥1.5 hours of off-periods in the awake time, predictable morning off episodes included) causing clinically significant disability during the 7-week screening period. * the participant currently has a good response to levodopa and has been receiving a stable dose of levodopa (≥3 doses per day of levodopa/dopa decarboxylase inhibitor therapy) ≥4 weeks prior to screening. * the participant is japanese, defined as having four japanese grandparents and being born in japan. exclusion criteria: * the participant has or had one or more of the following conditions that are considered clinically relevant in the context of the study; other neurological disorder, psychiatric disorder, seizure disorder or encephalopathy, respiratory disease, hepatic impairment or renal insufficiency, metabolic disorder, endocrinological disorder, hematological disorder, infectious disorder, any clinically significant immunological condition, or a history of narrow-angle glaucoma. * the participant has a positive test result for sars-cov-2 at the baseline visit. * the participant has undergone a neurosurgical intervention for pd (such as pallidotomy, thalamotomy, fetal or stem cell transplantation or deep brain stimulation). note: other inclusion and exclusion criteria may apply.
efficacy and safety of st. john´s wort/valerian extract versus placebo in children and adolescents with adhd

Conditions: ADHD

Summary: this study will determine the safety and efficacy of an herbal treatment in children and adolescents with adhd. study design: * randomized * double blind (subject, caregiver, investigator, outcomes assessor) * placebo control * parallel assignment

adhd is a common childhood disorder associated with attention problems and disruptive behavior. clinical evidence suggests that a herbal drug combination of st. john´s wort /valerian extract may be effective in treating adhd symptoms in methylphenidate and atomoxetine naive patients. this study will determine the safety and efficacy of an herbal treatment in children and adolescents with adhd. participants will be randomly assigned to receive either an herbal product or placebo twice a day for the duration of 8 weeks. participants will come in for study visits after 2 and 8 weeks for the assessment of adhd symptoms, performance and spontaneous movements. side effects will be monitored continuously and also assessed by rating scales.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of adhd * score of adhdrs-iv-parent version ≥24 * sufficient knowledge of the german language * written informed consent by parents and patients * ability to swallow study medication * sexually mature and active adolescents with highly effective methods of birth control: * contraception according to pearl-index \< 1 * when use of oral contraceptives, additional methods of contraception (e.g. condoms) are necessary, i.e. double-barrier exclusion criteria: * known hypersensitivity against st. john´s wort or valerian root or one of the excipients * known hypersensitivity of the skin when exposed to sunlight * all serious internal diseases, and for this reason: current intake of the following medication: * ciclosporin, tacrolimus, indinavir and other protease inhibitors in the anti-hiv treatment * irinotecan and other cytostatics * anticoagulants of the cumarin-type, digoxin, amitriptylin, nortriptyline * midazolam, theophylline or other medication with photosensitive effects * all severe psychiatric diseases except oppositional defiant disorders (according to items 21-28 snap-iv) and conduct disorders (according to items 41-45 snap-iv), and for this reason current intake of the following medication: antidepressants and other psychotropic medication * indication for hospitalization * suicidality (including suicidal thoughts): score ≥3 in item 10 of madrs * pregnancy, lactation * iq \< 70 * positive screening for metabolites of illegal drugs in urine * previous medication with stimulants and/or atomoxetine * psychotropic co-medication * placement in an institution on official or judicial ruling * parallel participation in another clinical trial according to german drug law (amg), or less than 4 weeks ago * patients requiring a primary medication with methylphenidate during the study period of 8 weeks

Keywords: adhd children adolescents st. john's wort valerian extract safety efficacy
statins for the early treatment of sepsis

Conditions: Sepsis

Summary: we propose a phase ii, randomized, placebo-controlled clinical trial to test the hypothesis that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and clinical outcomes in adults hospitalized with sepsis. as our animal models suggest pretreatment with statins are required for their beneficial effects, we propose a study design intended to identify patients and initiate treatment early in their hospital stay. this phase ii study is intended to assess the feasibility of conducting a large-scale investigator-initiated translational research protocol that involves multiple clinical services within the department of medicine.


Eligibility criteria:
inclusion criteria: * age \> 18 years * initial presentation to the emergency department or university of chicago md office/dialysis center for current hospital admission * sepsis (accp/sccm criteria) 1. clinically suspected infection as per the treating physician or confirmed infection 2. 2 or more of the following: temperature 38ºc (100.4ºf)or 36ºc (96.8ºf), heart rate (hr) \> 90/min, respiratory rate (rr) \> 20/min or paco2 \ 12,000/mm3 or \ 10%immature neutrophils * initiation of antibiotics by treating physician for sepsis * hospitalized from the emergency department or university of chicago md office/dialysis center to an inpatient medical service (intensive care unit (icu)or non-icu service) or admission to the medical icu (micu) from a non-icu inpatient medical floor. * assent of the primary treating physician at the time of enrollment. * the meeting of sirs criteria is due to an infection as per the treating physician. exclusion criteria: * pregnancy * alt \>3 times above the upper limit of normal * elevated creatine phosphokinase (cpk) (\>3 times the upper limit of normal) * concurrent treatment with any of the following drugs: daptomycin, fenofibrate, ketoconazole,triaconazole, amiodarone, clarithromycin, cyclosporine, erythromycin,nefazodone, niacin, protease inhibitors, telithromycin, verapamil,danazol, gemfibrozil * history of allergy or intolerance to statins * greater than 16 hours after meeting inclusion criteria * use of 1 more doses of statins in the previous 4 weeks * clinical indication for treatment with statin during hospital admission (per treating physician) * sufficiently poor prognosis prior to enrollment that treating physicians have elected to employ comfort care or plan to discharge to hospice * transfer from surgical service to medical service * needing transfusion for either active bleeding or severe hemolysis.

Keywords: sepsis statin infection immunomodulatory
compassionate use of metvix® (methyl aminolevulinate) photodynamic therapy (pdt) in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (bccs), or bowen's disease

Conditions: Field Actinic Keratoses; Basal Cell Carcinoma; Bowen's Disease

Summary: the aim of this study is to provide this investigational drug to patients who cannot be optimally treated with conventional therapies and to collect efficacy and safety data on the use of metvix pdt in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (bccs) or bowen's disease.


Eligibility criteria:
inclusion criteria: * male or female subject older than 18 years. * subject presenting with: * either field actinic keratoses (aks) (mild to moderate, multiple and clustered aks on a severely sun-damaged skin); or * biopsy-confirmed large, or multiple (several in the same anatomical area) primary superficial bcc lesions that are macroscopically and histologically consistent with superficial basal cell carcinoma (sbcc) and have no histological evidence of aggressive growth patterns; or * histologically confirmed diagnosis of bowen's disease from a biopsy taken within 3 months * any subject presenting with the aforementioned lesions must not be able to be treated optimally by conventional therapies. * female subject of childbearing potential, using an effective birth control method (see case report form) and having a negative pregnancy test at the beginning of the study, or female subject of non childbearing potential * subject must be willing and capable of cooperating to the extent and degree required by the protocol. * subject has to read patient information sheet and read and sign the informed consent form prior to any study related procedure. exclusion criteria: * a recurrent superficial bcc lesion that has previously been treated. * subject whose lesions on the selected treatment zone (including a 5 cm margin around the treatment area) have been treated with any of the following topical treatments within the specified washout period: * 5-fu - 3 months * cryotherapy - 3 months * imiquimod - 3 months * pdt - 3 months * diclofenac sodium - 3 months * surgery, radiotherapy, curettage, electrodesiccation, retinoids, dermabrasion, laser resurfacing, salicylic acid - 3 months * a primary superficial bcc located close to or involving a scar of scc * subject with known porphyria. * subject with target lesions on the genitals. * subject with known xeroderma pigmentosum. * pigmented lesion(s) on the treated area. * morpheaform lesion(s) on the treated area. * infiltrating lesion(s) on the treated area. * female subject who is pregnant, nursing or planning a pregnancy during the study. * subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound or excipients of the cream. * subject who has participated in another investigational drug or device research study within 30 days of enrolment.

Keywords: actinic keratoses superficial basal carcinomas bowen's large or multiple superficial basal carcinomas
the clinical value of an artificial intelligence system using abbreviated protocol of breast mri facilitates classification of breast lessions

Conditions: Breast Cancer

Summary: this study aims to use a combination of abbreviated protocol and artificial intelligence to automatically identify lesions and make diagnosis without decreasing the diagnostic accuracy of breast cancer, thus enhancing the comfort of patient examination, accelerating the flow of examination and reducing the load of clinical work.

full sequence of mri scan is: mr scan protocol: 1. magnetic fields and coils: use mr scanners with high fields of 1.5 t and above with dedicated breast coils. 2. scanning position: prone position with bilateral breasts naturally draped over the center of the breast coil. the position should ensure that all breast tissue is located in the coil, the skin and breast are not folded, the bilateral breast is symmetrical, the nipple is perpendicular to the ground, and the midline of the sternum is located in the middle line of the coil. 3. scanning sequence and parameters: t1wi non-fat suppressed sequence, t2wi fat suppressed sequence, dynamic five-phase enhanced t1wi fat suppressed sequence, and diffusion weighted imaging (dwi); delayed sagittal t1w1 fat suppressed sequence. imaging parameters: the thickness of the scanned layer should be ≤3 mm, the resolution within the layer should be \<1.5 mm, and the single scan time should be \<2 min. enhancement scan: gadobutrol used as the contrast agent, and the injection dose was 0.1 ml/kg, which was injected through the elbow vein at a rate of 2-3 ml/s using a pressure syringe, and 10-20 ml of saline was injected into the tube at the same rate after the contrast agent injection. the t1wi sequences before and after enhancement were preferably fat-suppressed and bilateral mammary glands were imaged simultaneously, and subtraction treatment was recommended. the recommended duration of delayed enhancement scan is 7 min, not less than 5 min. abbreviated sequences : t1wi + dynamic enhanced t1 phase i + maximum density projection images generated by automatic reconstruction in three directions. no extra sequences are required. by adding artificial inteeligence, a diagnostic performance comparable with full sequences is expected.

Eligibility criteria:
inclusion criteria: 1. patients with breast lesions detected by ultrasound and mammography that cannot be characterized 2. patients who were consecutively included in our hospital for breast mri without treatment 3. underwent preoperative full-protocol breast mri 4. pathological results are available, of which benign lesions can be determined by follow-up exclusion criteria: 1. poor mri image quality 2. patients who have been received the biopsy

Keywords: artificial intelligence breast cancer magnetic resonance imaging maximum intensity projection abbreviated protocol
a study of ly2605541 versus insulin glargine on blood sugar

Conditions: Healthy Volunteers; Diabetes Mellitus, Type 1

Summary: ly2605541 is an investigational drug being developed for the treatment of diabetes mellitus. this study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. this study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. the study has 2 parts: part a will be conducted in healthy participants. part b will be conducted in participants with type 1 diabetes mellitus (t1dm). this study will take approximately 10-14 days spread over 6-20 weeks, not including screening. screening will be performed within 30 days of the start of the study.


Eligibility criteria:
inclusion criteria: all participants * are healthy males or participants with t1dm * have a screening body mass index (bmi) of 20.0-29.9 kilograms per square meter (kg/m\^2) healthy participants only * are overtly healthy, as determined by medical history and physical examination * have a fasting blood glucose \<108 milligrams/deciliter (mg/dl) (6.0 millimoles/liter \[mmol/l\]) at screening participants with t1dm only * have a diagnosis of t1dm for at least 1 year based on medical history * have a screening c-peptide \<0.5 nanograms/milliliter (ng/ml) * have a hemoglobin a1c (hba1c) of 6.0 to 9.0% at screening * have had no episodes of severe hypoglycemia in the past 6 months exclusion criteria: all participants * have a hemoglobin level \<12.0 grams/deciliter (g/dl) * are currently a smoker, used tobacco products on a regular basis in the 6 months prior to screening, or are intending to smoke during the study healthy participants only • regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen). participants with t1dm only * regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing * are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing * require a total daily insulin dose exceeding 100 units (u) * have fasting triglycerides \>400 mg/dl
intervention for diabetes with education, advancement and support

Conditions: Diabetes Mellitus

Summary: this study aims to evaluate a culturally appropriate, low cost and sustainable management plan for patients with type 2 diabetes mellitus (t2dm). various randomized controlled trials confirmed that t2dm can be delayed with lifestyle intervention and programmes which promote improvements in diet, increased physical activity and weight loss. translation of lifestyle intervention to real-life settings however remains a major challenge. the investigators therefore propose a diabetes management trial for t2dm patients using telemedicine. this project's innovations include the use of information technology to deliver messages to the physicians while similarly involving family members of diabetics to manage the patient's condition collectively. this creates a sense of well-being, empowering the individual as well as the community to be responsible for their own health and well-being


Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosed by a physician at least six months prior to study enrollment * hba1c of \> 7.5% but less than 11.0% within the most recent 3 months * access to internet and an e-mail address , or access to a smartphone with 3g services * not pregnant or history of heart diseases, serious illness, cancer diagnosis or any other conditions that can impede participation exclusion criteria: * unable or unwilling to give informed consent or communicate with local study staff * current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder * hospitalization for depression in past six months * plans to relocate to an area or travel plans that do not permit full participation in the study * lack of support from primary health care provider or family members * history of bariatric surgery, small bowel resection, or extensive bowel resection * currently pregnant or nursing * cancer: requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., stage 1 cervical cancer) * cardiovascular disease (heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months) * other medical, psychiatric, or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol

Keywords: type 2 niddm