Kornimate/medical-research-clean huggingface dataset:
effects of chemotherapy on cognitive function in breast cancer patients & non-cancer control subjects with optional sub-study research brain mri

Conditions: Cancer Related Cognitive Difficulties; Breast Cancer Female

Summary: study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and age-matched control participants. the investigator is trying to better understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to the general population as well as what biological mechanisms may play a role in the development of these difficulties. patients will be asked to complete six assessments over the course of approximately 5 months. assessments 1,3, 4.5 and 5 include computerized and paper and pencil cognitive testing as well as blood draws. assessments 2 and 4 only involve the collection of a blood sample. an optional sub study is offered after assessment 1. it involves a research brain mri at assessment 4.5 and cognitive testing and another research brain mri at assessment 6.


Eligibility criteria:
inclusion criteria, breast cancer patient participants: * females with a diagnosis of invasive non-metastatic breast cancer (stage i-iiic) * scheduled to begin a course of chemotherapy with adriamycin and cytoxan * chemotherapy naïve * able to speak and read english * 21 years or older * give written informed consent exclusion criteria, breast cancer patient participants: * must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness * must not be diagnosed with a neurodegenerative disease (e.g., alzheimer's disease, parkinson's disease) * must not have any central nervous system disease (e.g., movement disorder, multiple sclerosis) * subjects could have had a tia (transient ischemic attack) or stroke in the past if the tia or stroke was greater than 1 year ago and the subject does not have any remaining symptoms * must not be scheduled to receive concurrent radiation treatment while receiving chemotherapy. * must not be colorblind inclusion criteria, control participants: * must be female and within 5 years of the age of the subject receiving chemotherapy * able to speak and read english * give written informed consent * 21 years or older exclusion criteria, control participants: * must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness * must not be diagnosed with a neurodegenerative disease (e.g. alzheimer's disease, parkinson's disease) * must not have central nervous system disease (e.g., movement disorder, multiple sclerosis) * subjects could have had a tia (transient ischemic attack) or stroke in the past if the tia or stroke was greater than 1 year ago and the subject does not have any remaining symptoms * must not have been diagnosed with cancer or previously have received chemotherapy * must not be colorblind for optional sub-study: mr safety assessed via rochester center for brain imaging magnetic resonance (mr) safety screening form to confirm eligibility to participate
prevention of incisional hernia with an onlay mesh visible on mri

Conditions: Incisional Hernia

Summary: it has been demonstrated that incisional hernia incidence after laparotomy can be safely reduced with the addition of a mesh to the conventional closure of the abdominal wall. there still some debate about which is the best position to place this mesh: onlay or sublay. in europe we have now meshes with cee approval to be used as reinforcement of abdominal wall closure. the investigators have planned to include 200 patients in a multi center study using an onlay pdvf mesh that can be tracked by magnetic resonance. the patients included will be patients with risk factors for the development of an incisional hernia. the incidence of incisional hernia will be assessed clinically and radiologically after 1 and 2 years follow-up. the incidence of surgical sites occurrences and pain will be also assessed.


Eligibility criteria:
inclusion criteria: any known risk factor for development of incisional hernia * \> 60 years * bmi \> 30 * dm * chronic bronquitis * smoking * neoplasia * renal failure * liver failure * immnusupression * urgent operation exclusion criteria: * previous supraumbilical midline laparotomy * previous incisional hernia * emergency surgery * life expectancy of less than 12 months * patient´s rejection to participate * unable to understand and participate

Keywords: incisional hernia mesh prevention mesh augmentation
effect of eplerenone on novel biomarkers of mineralocorticoid receptor activation (enova)

Conditions: Hypertension

Summary: this blinded cross-over clinical trial will enroll participants with mild stage 1 hypertension to evaluate whether urinary extracellular transcript abundance predicts response to an mineralocorticoid receptor (mr) antagonist, eplerenone. eligible participants will have a 2 week wash-in period followed by 4 weeks of treatment with placebo or eplerenone. there will be a 2 week wash out period from study medications and then participants will take the other drug (placebo or eplerenone) for 4 weeks. in addition, participants will also provide urine and blood samples during the trial, have physical assessments, and be monitored for safety.


Eligibility criteria:
inclusion criteria: * history of mild stage 1 systemic hypertension as defined by: 1. systolic blood pressure (sbp) ≥ 140 millimeters of mercury (mmhg) or diastolic blood pressure (dbp) ≥ 90 mmhg on 2 occasions and 2. treatment with 1-2 antihypertensive medications (stable dose for 6 weeks) exclusion criteria: * pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. * stage 2 hypertension (history of blood pressure ≥ 160/100 mmhg) * history of hypertensive urgency, hypertensive crisis, or hospitalizations for hypertension * current mineralocorticoid antagonist use * type ii diabetes with microalbuminuria * primary adrenal insufficiency * current glucocorticoid use * electrolyte abnormality on baseline laboratory assessment * current potassium supplementation * positive test for leukocyte esterase on urinalysis * creatinine clearance \< 50 ml/min on baseline laboratory assessment * hyperkalemia * potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene) * serum potassium \>5.0 milliequivalents per liter (meq/l) on baseline laboratory assessment * current use of strong cyp3a4 inhibitors (some include: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir). * serum creatinine \> 1.5 mg/dl in males on baseline laboratory assessment * serum creatinine \> 1.3 mg/dl in females * current beta blocker use * any other condition thought by the principal investigator to place the participant at increased risk of injury during the clinical trial or compromise the scientific integrity of the study

Keywords: mineralocorticoid mineralocorticoid receptor aldosterone eplerenone blood pressure
study of eteplirsen in young participants with duchenne muscular dystrophy (dmd) amenable to exon 51 skipping

Conditions: Duchenne Muscular Dystrophy

Summary: this is a multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, and pk of once-weekly iv infusions of eteplirsen in approximately 12 male participants, ages 6 months to 48 months (inclusive), who have genotypically confirmed dmd with a deletion mutation amenable to exon 51 skipping.


Eligibility criteria:
inclusion criteria: * male between 6 months to 48 months of age (inclusive) * diagnosis of dmd with a deletion mutation amenable to exon 51 skipping * parent(s) or legal guardian(s) who is willing to provide written informed consent exclusion criteria: * received treatment that might have an effect on muscle strength or function within 12 weeks prior to dosing * received previous or current treatment with any experimental treatment * clinically significant illness other than dmd * clinically significant laboratory abnormality * any other condition that could interfere with the participation in the study.

Keywords: dmd duchenne eteplirsen dystrophy dystrophin exon 51
the safety and efficacy of tet enema in the treatment of uc

Conditions: Ulcerative Colitis Chronic Mild; Ulcerative Colitis Chronic Moderate

Summary: colonic transendoscopic enteral tubing(tet) is a novel, safe, convenient, and reliable procedure for fecal microbiota transplantation(fmt).this clinical trail aims to evaluate the efficacy and safety of mesalazine and compound glutamine enema in the treatment of ulcerative colitis through colonic tet.

enema is a conventional treatment for ulcerative colitis(uc). mesalazine is suitable for the patients with mild to moderate uc.but for the uc with extending lesions, the conventional anema with mesalazine or other medicine can not very effective.colonic transendoscopic enteral tubing(tet) is a novel, safe, convenient, and reliable procedure for fecal microbiota transplantation(fmt).compared with the conventional enema, which is only used for local administration, the colonic tet enema can achieve total colonic administration.this study aims to evaluate the efficacy and safety of colonic tet for uc.patients in this study will be divided into 5 groups according to certain criteria: the mesalazine conventional enema group, the mesalazine tet enema group, the compound glutamine conventional enema group, the compound glutamine tet enema group, the mesalazine and compound glutamine tet enema group.each group was given enema for 7 days.the primary outcome measure was the clinical remission efficacy rate in each group. the secondary outcome measure was the safety of tet.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged between 18 and 65 2. patients with chronic relapsed mild to moderate active ulcerative colitis(left semicolon or extending colonic lesions) 3. patients who can fully understand this study and voluntarily sign an informed consent; 4. accept re-examination, follow-up examination and specimen retention in time 5. suitable for colonoscopy and colonic tet; 6. a history of using mesalazine and compound glutamine safely exclusion criteria: 1. anti-tumor necrosis factor or methotrexate was used within the first 8 weeks 2. cyclosporine was used within 4 weeks 3. antibiotics or probiotics was used within 4 weeks 4. patients with risk of toxic megacolon, colon cancer or atypical hyperplasia found in pathology 5. history of colon surgery 6. patients with moderate or severe renal impairment ,abnormal liver function,severe hypertension and cerebrovascular accident 7. accompanied by other serious diseases, such as cancer or aids, that may hinder their enrollment or affect their survival 8. patients with anxiety, depression, mental or legal disabilities 9. history of suspected or proven alcohol/drug abuse 10. patients with explosive, massive bloody stools and severe illness who cannot tolerate the colonoscopy 11. patients who are allergic to salicylic acid or aspirin 12. patients with food allergies 13. patients who are preparing to become pregnant during the study period 14. patients considered by the researchers as unsuitable for enrollment

Keywords: inflammatory bowel disease transendoscopic enteral tubing mesalazine compound glutamine
postoperative sleep quality of patients sedation with i.v. dexmedetomidine or midazolam undergoing turp

Conditions: Sleep Quality of Patients Undergoing TURP

Summary: the investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.

the investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.the bispectral index score (bis) was monitored during the operation and the first postoperative night

Eligibility criteria:
inclusion criteria: * participants were deemed eligible if they were candidates for spinal anesthesia undergoing turp exclusion criteria: * the exclusion criteria were body mass index exceeding 30 kg/m2, preoperative pittsburgh sleep quality index global scores higher than 6, anesthesia time longer than 3 hours, allergy to drugs used in the study and treatment with sedatives and analgesics during the postoperative bis-vista monitoring period.

Keywords: dexmedetomidine midazolam sleep quality delirium
genetic variation in the transporters and hypoglycemic agents

Conditions: Type 2 Diabetes

Summary: type 2 diabetes have become a major global health problem. currently, metformin is used as first-line therapy in combination with lifestyle changes, and sitagliptin can be added to metformin in case of insufficient glycemic control by metformin alone, and fixed-dose combination of sitagliptin and metformin is available. in clinical practice, inter-individual variations in response to sitagliptin and metformin treatment are commonly found, which may reflect inter-patient differences in disposition of these medications. sitagliptin and metformin are known as substrates of some transporters (p-gp, oat3, oct1 and oct2) and some functional variations of these transporters were reported. this study is designed to clarify the effect of these transporter variants on response to sitagliptin and metformin in type 2 dm patients.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes patients * 20-80 years old * taking sitagliptin and metformin for more than 3 months exclusion criteria: * taking other oral hypoglycemic agents * taking medications can induce or inhibit transporters

Keywords: newly diagnosed type 2 diabetes patients
health-related quality of life in rare kidney stone

Conditions: Primary Hyperoxaluria; Cystinuria; Adenine Phosphoribosyl Transferase Deficiency; Dent Disease

Summary: assessment of health-related quality of life in rare kidney stone formers in the rare kidney stone consortium

the purpose of this study is to learn about health-related quality of life (hrqol) in patients enrolled in the rare kidney stone consortium (rksc) registries. quality of life studies look at different aspects of both physical and mental components of people's lives. hrqol data for people affected by kidney stones are not currently available for people followed over time.

Eligibility criteria:
inclusion criteria: * qualify to participate in one of the rare kidney stone registries. * be at least 5 years old (for sf-10) * are able to communicate using the english language * consent to participate in the study (or "assent" if under 18 years old) * have internet access with an email account or a valid home address exclusion criteria: none, if inclusion criteria are met
a clinical study to evaluate the safety, tolerability and activity of a new phosphate binder (sbr759) in patients with chronic kidney disease on hemodialysis

Conditions: Chronic Kidney Disease

Summary: the primary objective of this study is to assess the safety, tolerability and activity of escalating multiple doses of sbr759 in patients with chronic kidney disease on hemodialysis.


Eligibility criteria:
inclusion criteria: * patients must be treated with maintenance hemodialysis and prescribed a phosphate binder. * a controlled serum phosphorus. * constant dose of concomitant medications. * women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). all female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study. exclusion criteria: * patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study. * patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major gi tract surgery, or a history of hemochromatosis. * patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic kidney disease, hemodialysis, serum phosphorus, phosphate binders
the effect of plant sterol supplement on blood cholesterol

Conditions: High Blood Cholesterol Level

Summary: the purpose of this study is to determine whether supplement of plant sterol could lower blood cholesterol.


Eligibility criteria:
inclusion criteria: * men and women 18-80 years old * total cholesterol: 4.5-7.5 mmol/l * triglycerides at or below 4.0 mmol/l exclusion criteria: * bmi at or above 35 kg/m2 * secondary hyperlipidemia, included diabetes * hypertension (at og higher than 170/110) * coronar, perifery or cerebral vascular disease last 3 months * familial hypercholesterolemia * change in dose of statins, oestrogen or contraceptives last 3 months * taking drugs which are known to interfere with the plasma level of cholesterol * chronic rheumatoid diseases or other diseases known to affect c-reactive protein * pregnancy * lactation * planning to reduce weight * taking plant sterols
comparison of effectiveness of tonic, high frequency and burst spinal cord stimulation in chronic pain syndromes

Conditions: Failed Back Surgery Syndrome; CRPS (Complex Regional Pain Syndromes)

Summary: spinal cord stimulation (scs) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. the indication for scs is an ineffective conservative treatment of chronic pain syndromes. the effectiveness of scs in the case of neuropathic pain is high. the positive result of scs treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain. the efficacy of scs in different modes of stimulation is evaluated. patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. it is said that in one type of stimulation they would feel parestesias and in other three they would not. patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. the test is double-blinded

patients with fbss and crps are evaluated for vas,, dissability scale, quality of life (qol), sleep disorders and mental disorders. all patients undergo percutaneus (1 or 2) 8-contact scs electrode implantation with trial. all patients are blindly randomized to tonic or burst or high frequency or off stimulation. after 2-week period each participant is adequately switched to another type of stimulation for next 2 weeks. alltogether crossover takes 8 weeks: four 2-week periods of tonic, burst, hf and off stimulation. at the end of trial period patients are subjected to the mode of stimulation which is the most efficent. the final 2-week stimulation is performed with final renewed evaluation for vas, amount of taken medications, dissability scale, quality of life (qol), sleep disorders and mental disorders. follow-up observation will last up to 12 months.

Eligibility criteria:
inclusion criteria: 1. fbss, crps patients with neuropathic and mixed pain in low-back and/or legs refractory to conservative therapy 2. chronic pain as a result of fbss that exists for at least 6 months 3. ≥ 18 years of age 4. written consent of the patient to participate in study procedures. exclusion criteria: 1. active malignancy 2. addiction to any of the following: drugs, alcohol and/or medication 3. evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator 4. local infection or other skin disorder at site of surgical incision 5. pregnancy

Keywords: fbss crps scs burst tonic high-frequency
re-operation rates of concorde bullet device versus conduit titanium interbody graft for lumbar fusion

Conditions: Degenerative Spondylolisthesis; Lumbar Spondylosis; Lumbar Spondylolisthesis

Summary: the purpose of this early study is to compare the clinical results of the new conduit interbody device to the traditional concorde bullet device. the primary objective is to explore the rates and reasons for re-operation between both constructs at 2 years.

the demand for lumbar fusion continues to rise with the growing and aging population. additionally, new and innovative technologies continue to bring new devices to the market. however, our understanding of how emerging constructs compare with existing technology is lacking. the purpose of this study is to compare the clinical results of the new conduit interbody device to the traditional concorde bullet device in lumbar fusion, one or two levels between l2-s1 will be included. both transforaminal lumbar interbody fusion (tlif) and posterior lumbar interbody fusion (plif) approaches will be included in the patient cohort. the primary objective is to explore the rates and reasons for re-operation between both constructs at 2 years.

Eligibility criteria:
inclusion criteria: * patients aged 18 or older with symptomatic degenerative lumbar spondylotic disease, either spondylosis, and/or spondylolisthesis * who have failed conservative management of at least 6 weeks requiring 1 or 2 level lumbar interbody fusion (either plif or tlif) * all patients included will be index surgeries (no re-operations). exclusion criteria: * patients who improve with consecutive management and do not undergo lumbar fusion surgery * surgery performed in the thoracic or cervical spine * surgery performed for tumor, infection, or trauma patients who have an unstable fracture, tumor, and osteoporosis with t score exceeding -2.0

Keywords: lumbar fusion
early antiplatelet therapy after hemorrhagic infarction in acute ischemic stroke treated with intravenous thrombolysis (hits)

Conditions: Antiplatelet Therapy; Hemorrhagic Infarction

Summary: previous study showed that the proportions of hemorrhagic infarction after intravenous thrombolysis were 24.2% and 32.5% in the control group and the alteplase group, and most of them were asymptomatic. hemorrhagic infarction was a part of the natural progression after acute ischemic stroke. previous study have shown no significant relationship between hemorrhagic infarction and poor outcome in acute ischemic stroke (ais) patients. in this study, a randomized controlled trial will be conducted to explore the efficacy and safety of early antiplatelet therapy after hemorrhagic infarction in acute ischemic stroke treated with intravenous thrombolysis.


Eligibility criteria:
inclusion criteria: 1. acute ischemic patients receiving intravenous thrombolysis within 24 hours upon stroke onset 2. be confirmed as hemorrhagic infarction at 24 to 36 hours after intravenous thrombolysis by computerized tomography 3. the patient or family member signed an informed consent exclusion criteria: 1. early use of anticoagulant drugs within 1 week after intravenous thrombolysis; 2. tirofiban was used after receiving endovascular treatment; 3. intraoperative stent placement after receiving endovascular treatment; 4. subarachnoid hemorrhage or ventricular hemorrhage; 5. there are contraindications for aspirin use;

Keywords: acute ischemic stroke intravenous thrombolysis hemorrhagic infarction antiplatelet therapy