Kornimate/medical-research-clean huggingface dataset:
a rct to assess the performance of cytosorb for shock reversal in patients with vasoplegic septic shock

Conditions: Septic Shock

Summary: to assess the performance of the cytosorb® 300 ml device for shock reversal in patients with vasoplegic septic shock.


Eligibility criteria:
inclusion criteria: 1. patients treated with standard of care (soc) according to guidelines for sepsis/septic shock for \> 6 and \< 30 hours prior to randomization 2. vasoplegic septic shock\*, requiring na ≥ 0.2 µg/kg/min at the time of randomization, despite adequate fluid resuscitation to maintain map ≥ 65 mmhg after at least 6 hours of guideline-oriented initial therapy, including continuous na administration 3. lactate \>2 mmol/l and \<8 mmol/l at baseline 4. il-6 ≥ 1000 ng/l at screening 5. minimum 18 years of age 6. provide voluntary consent to participate in the study either directly or via a legally authorized representative (lar) or in accordance to the procedure after determination of an emergency situation according to art. 68 (1) mdr, as applicable * (septic shock is defined according to the sccm / eiscm task force sepsis-3 definition \[singer 2016\]) exclusion criteria: 1. patients with an abdominal source of infection without a source control intervention at the time of randomization or a planned additional surgical intervention within the first 28 hours after randomization 2. administration of any other vasopressors than na at time of randomization and within the first 28 hours after randomization 3. indication for va-ecmo at baseline or a planned va-ecmo within the first 28 hours after randomization 4. patients with a steroid therapy above cushing-threshold dose (e.g. 30 mg hydrocortisone/d or 6 mg prednisolone/d) for more than 30 days prior to baseline 5. cytokine-specific antibody therapy before inclusion 6. anticipated interruption of cytosorb® therapy for more than 2 hours within the first 26 hours after start of intervention 7. conditions with a poor 90-day chance of survival because of an uncorrectable medical condition such as poorly controlled neoplasm, or other moribund end-stage disease states in which death was perceived to be imminent 8. cancer patients currently on chemotherapy with cytostatics, tyrosine kinase inhibitors, or a treatment with antibodies (e.g. pd-1-inhibitors) 9. acute traumatic brain injury 10. decision to limit or withdraw treatment within the study and/or observation period in the icu 11. pregnancy / breast feeding 12. participation in another interventional study
postoperative analgesia in patients undergoing elective lumbar fusion operations under general anesthesia

Conditions: Post Operative Pain

Summary: it was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. ultrasound guided erector spinae plane block (espb) was first described in 2016.recent case reports suggest a positive effect of ultrasound guided espb on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) 25 to 35 kg/m². * american society of anesthesiologist (asa) physical status i or ii. exclusion criteria: * patient's refusal * altered mental status * known allergy to study drugs (bupivacaine or morphine) * local infection at site of puncture. * known case with any pulmonary disease * known case with obstructive sleep apnea (osa) * coagulopathy and /or thrombocytopenia * severe hepatic or kidney impairment
safety and effectiveness of giving l-743,872 to patients with thrush that has not been cured with fluconazole

Conditions: Candidiasis, Oral; HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give l-743,872 to patients with thrush, an aids-related yeast infection of the mouth, that has not been cured with fluconazole treatment.

patients are randomized to treatment with l-743,872 at one of two doses administered intravenously by a peripheral line once-daily. patients are treated for 48 hours beyond resolution of symptoms or for a maximum of 14 days. each patient is expected to complete the study, including the 14-day follow-up, within approximately 4 weeks. a physical examination is performed daily during the antifungal treatment period and at the follow-up visits 7 and 14 days post-therapy. laboratory tests of blood and urine for safety are performed every three days during treatment and at follow-up 7 days post-therapy. liver enzymes are drawn at the 14-day follow-up visit.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * have thrush that has not responded to fluconazole treatment. * are 18-65 years old.

Keywords: aids-related opportunistic infections dose-response relationship, drug fluconazole antifungal agents candidiasis, oral pharyngeal diseases mk 0991
effect of the consumption of a fermented milk enriched with plant sterols (spain)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.


Eligibility criteria:
inclusion criteria: * male and female aged 18-75 years; * bmi between 19 and 30 kg/m2 , * ldl-cholesterol higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or * higher than 100 mg/dl in individuals with a 10-year risk \> 20% or with ischemic cardiopathy (according to ncep atpiii guidelines), * with or without statin monotherapy, * willing to respect the dietary advising delivered at the screening visit, * agreeing to a written informed consent exclusion criteria: * subject with plasma triglycerides (tg) levels \> 400 mg/dl, * with any cardiovascular event in the last 6 months, * subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy, * diabetic (type i and type ii), * presenting known allergy or hypersensitivity to milk proteins, soy or lactose, * receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, * with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study, * pregnant or breast feeding women

Keywords: plant sterol hypercholesterolemia diet dairy ldl-c mildly hypercholesterolemic subjects
soy derivatives for control of hot flashes in men on androgen deprivation therapy

Conditions: Prostate Cancer

Summary: to determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (lhrh) agonist therapy for control of advanced prostate cancer

literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of prostate with treatment of prostate cancer (radical prostatectomy, radiation therapy, etc.) * had biochemical/clinical relapse and started on antiandrogens * have documented history of hot flashes exclusion criteria: * history of mi, dvt, cva * peanut allergy * untreated hypothyroidism * must be off other medical treatment for hot flashes for 2 weeks before enrollment in this study
implantation with the nucleus ci532 cochlear implant in adults

Conditions: Hearing Loss

Summary: the aim of this study is to investigate the clinical benefit for patients implanted with the nucleus® ci532 cochlear implant. the nucleus® ci532 has a pre-curved, perimodiolar array, the ea32, which is introduced into the cochlea through a straightening sheath.


Eligibility criteria:
inclusion criteria: * meet current cochlear implant criteria at the implanting center * 18 years or older with bilateral sensorineural hearing loss * limited benefit from appropriate binaural hearing aids * moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies * preoperative unaided threshold between 40 and 65 db hl, inclusively, at 250 hertz (hz) and 500 hz in the ear to be implanted * fluent speaker in the language used to assess clinical performance exclusion criteria: * evidence of hearing loss prior to age 5 * sensorineural severe to profound hearing loss greater than 20 years at and above 2000hz * simultaneous bilateral implantation prior to the study * medical or psychological conditions that contraindicate undergoing general anesthesia or surgery * cochlear anomaly that might prevent complete insertion of the electrode array * hearing impairment due to lesion or neuropathy of the acoustic nerve, viii nerve, or central auditory pathway * active middle ear infection * tympanic membrane perforation * unrealistic expectations * unwillingness or inability co comply with all investigational requirements * patients with existing cerebral shunts or drains * recurrent episodes of bacterial meningitis
3 snip punctoplasty with and without mitomycine c.

Conditions: Punctal Stenosis

Summary: punctal stenosis is a progressive constriction of the puncta with resultant epiphora. one of the most effective treatment options is 1- to 4-snip punctoplasty combined with or without mitomycin-c.


Eligibility criteria:
inclusion criteria: * patients with recurrence of punctal stenosis at the end of 1 month following punctal dilatation. exclusion criteria: * patients with associated lacrimal passage obstruction
delphinus softvue™ roc reader study (dmt sv rrs3)

Conditions: Breast Cancer Detection; Dense Breast Parenchyma; Benign Breast Findings; Normal Breast Screening; Abnormal Breast Screening

Summary: the purpose of this multi-reader, multi-case (mrmc) reader study is to evaluate reader performance when softvue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. this reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under delphinus protocol #dmt-2015.001 (nct03257839) arm 1 phase b. the reader study image case set will be enriched with cancer cases.


Eligibility criteria:
radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. all readers must meet the following base inclusion criteria: * hold a current united states medical license * be american board of radiology certified * be mqsa-qualified * be experienced in reading dm images on a monitor * be experienced in reading breast ultrasound images on a monitor * have completed a financial disclosure showing no conflicts of interest * have provided a current curriculum vitae (cv) * have provided a signed readers' agreement * have provided written informed consent all qualified and confirmed readers will complete a multi-module softvue™ training program prior to their participation in a reading session for this study.

Keywords: breast screening breast imaging softvue mammography ultrasound reader study roc auc dense breasts breast density dense breast tissue breast neoplasms
efficacy and tolerability of combination antihypertensive drug in non-responders to arb monotherapy using 24h abpm

Conditions: Hypertension

Summary: a majority of korean doctors tend to add other antihypertensive rather than to titrate the same drug. however, we try to induce doctors to titrate the sevikar than to add other antihypertensive if patients are not controlled with sevikar 5/20mg(amlodipine 5mg + omlesartan 20mg). as above, for patients who are not controlled with sevikar 5/20mg, doctors will proceed to other prescription pattern with other choices of titration to sevikar 5/40, 10/40mg. it is important to evaluate bp lowering efficacy of sevikar through the titration step in patients uncontrolled with sevikar low dose. thus, this study is designed to demonstrate the efficacy of sevikar by titration in patients who are not controlled their bp with low dose of sevikar.


Eligibility criteria:
inclusion criteria: 1. male and female subjects \> 55 years 2. subject who has consent to participate by signing on the informed consent form 3. uncontrolled hypertensive patients defined as: * uncontrolled hypertensive: subjects who are mean sbp ≥ 140 mmhg after being treated with arb(valsartan 80mg or candesartan 8mg) monotherapy during at least 4 weeks. exclusion criteria: 1. secondary hypertension 2. sesbp ≥ 180mmhg 3. sesbp difference ≥ 20mmhg or sedbp difference ≥ 10mmhg 4. a history of hypertensive encephalopathy, unstable angina, transient ischemic attack, mi, or any type of revascularization procedure within the last 6 months 5. heart failure, second- or third-degree heart block, significant arrhythmia or valvular heart disease 6. significant cardiovascular, cerebrovascular, renal, gastrointestinal, or hematologic disease, at the discretion of investigator 7. creatinine clearance\<20ml/min and renal artery stenosis, renal transplantation, patients with only one kidney 8. evidence of liver disease as indicated by alanine transaminase (alt) and aspartate transaminase (ast) and/or total bilirubin ≥ 3 × the upper limit of normal (uln) 9. hyperkalemia (\>5.5mmol/l) 10. patients with sodium depletion is not correct or patients with fluid depletion is not correct 11. chronic inflammation 12. patients with severe eye-related disorders (retinal bleeding within 6 months, blindness, hypertension complications with retinal micro-aneurysms) 13. diabetes mellitus 14. hematologic/oncologic, neurologic and psychiatric diseases 15. females who were pregnant, breastfeeding, planning a pregnancy or who were of childbearing potential 16. contraindications for amlodipine, losartan, olmesartan medoxomil, or other arbs 17. with known allergic reaction, lack of response or contraindication to angiotensin ii receptor antagonists 18. mean dbp \> 110 mmhg 19. patients who took antihyperlipidemic agents within 30 days 20. subject who have participated in other clinical trial within the last one month 21. any subjects who are unable to cooperate with protocol requirements and follow-up procedures or who are in medical condition that is not eligible to be entered in investigators' discretion
mk0249 for the symptomatic treatment of alzheimer's disease (mk0249-011)

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to test the efficacy and safety of an investigational medication for improving symptoms of alzheimer's disease. subjects will receive either active medication or placebo for 28 days. tests of memory, concentration will be included. safety will be monitored using routine clinical and laboratory tests.


Eligibility criteria:
inclusion criteria: * male or females * age at least 55 years or older * mild-to-moderate alzheimer's disease, with mini mental state examination (mmse) between 18 and 26, inclusive, modified hachinski ischemic scale (mhis) score =/\<4, global cdr score of 1 or 2, and who have a reliable informant/caregiver to accompany patient to all clinic visits * if using symptomatic alzheimer's disease treatments, patients must be on the medication for 3 months and on a stable dose for at least 2 months exclusion criteria: * patients cannot be living in a skilled nursing facility * patients cannot have poorly-controlled hypertension * patients cannot have the following conditions within 6 months of screening: significant cardiovascular disorders, active major depressive disorder, gastroesophageal reflux disease (gerd), or clinically significant sleep disorder * various concomitant therapy restrictions
kinematics of movements provoked by an augmented reality app

Conditions: Stroke; Healthy Aging

Summary: introduction: home-based rehabilitation has the potential to reduce healthcare costs. however, due to less supervision in the home situation, it is possible that movements are made incorrectly. therefore it is important to gain insight in which movements are made with a home-based rehabilitation system and what effects instructions could have on these movements. the current study investigated these movements made by the rehabilitation gaming system (rgs) app, this app uses augmented reality to provoke upper limb movements. methods: 16 healthy elderly and 16 stroke survivors participate in this study. each participant was invited to the rehabilitation clinic for a one time measurement of 1.5 hours. during this measurement, four therapy exercises and four games on the rgs-app are performed. each game should provoke a similar movement as one of the therapy exercises. participants start with performing the therapy exercises for two minutes each. thereafter they receive a video instruction on how to perform one of the games of the rgs-app, and they will play this game for 2 minutes. thereafter the group is randomized into two conditions. the first group receives the same video instruction, while the second group receives a personalized live instruction based on the first two minutes of playing. after the new instruction, participants will play the game for two minutes again. this is repeated for all four games. both the order of the therapy exercises and rgs-app games are randomized. during the study, participants wear inertial measurement units (imu's).


Eligibility criteria:
inclusion criteria stroke survivors: * people who suffered from a stroke at least 2 months ago. * smartphone users * mild to moderate upper limb impairment (medical research council scale for muscle strength (mrc) ≥ 2) exclusion criteria stroke survivors: * severe cognitive impairment (montreal cognitive assessment \< 19) * visual impairments (which cannot be corrected with glasses) * upper limb impairments not caused by the stroke inclusion criteria healthy elderly: * 60 years or older * smartphone users exclusion criteria healthy elderly: * visual impairments (which cannot be corrected with glasses) * upper limb impairments which can affect smartphone use

Keywords: home-based rehabilitation augmented reality upper limb
biopsy versus resection in elderly glioblastoma patients. a prospective cohort study.

Conditions: Glioblastoma

Summary: this trial is set up as a prospective observational cohort study to identify if either biopsy or resection should be the surgical modality of choice in elderly glioblastoma patients with a newly diagnosed tumor. patients who are considered eligible for gbm resection or biopsy will be included. through shared-decision making patients and their treating physicians will decide upon resection or biopsy. written informed consent will be obtained. participants will be followed for 1 year postoperative to assess potential differences in health-related quality of life and overall survival. follow-up will consist of health-related quality of life questionaires and neurological assessment at 6 weeks, 3 months, 6 months and 12 months postoperative. additionally cognitive and neuro-linguistic tests will be done at 3 months postoperative. these will be compared to results pre-operative. after surgery, patients will receive standard adjuvant treatment with concomitant temozolomide and radiation therapy, and standard follow-up. patients in whom the diagnosis gbm is not confirmed in histological analyses will be excluded from the study. total study duration will be 4 years, of which 3 years will comprise patient inclusion, with a follow-up duration of 1 year.


Eligibility criteria:
inclusion criteria: 1. age ≥70 years 2. tumor diagnosed as glioblastoma on mri with distinct ring-like pattern of contrast enhancement with thick irregular walls and a core area reduced signal suggestive of tumor necrosis as assessed by the surgeon. 3. karnofsky performance score (kps) ≥70 4. written informed consent exclusion criteria: 1. tumors of the cerebellum, brain stem or midline 2. multifocal contrast enhancing lesions 3. substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation 4. medical reasons precluding mri (e.g. pacemaker) 5. inability to give consent as assessed by neurosurgeon (e.g. language barrier) 6. severe aphasia prohibiting neurolinguistic testing and comprehension of informed consent 7. previous brain tumor surgery 8. previous low-grade glioma 9. second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin.

Keywords: glioblastoma high grade glioma surgical management biopsy resection
the effect of darbepoetin upon rehabilitation for colorectal cancer surgery

Conditions: Colorectal Cancer

Summary: the study is investigating whether randomization to perioperative darbepoetin alfa treatment improves the rehabilitation following surgery for colonic and rectal cancer.

major surgery elicits a metabolic stress response that is followed by a loss of body mass, fatigue, and an impaired physical performance including a reduced work capacity. to perform ordinary daily activities many elderly people exert close to their maximum physical capacity, and even a small reduction of performance capacity may cause significant impairment in physical and social activity. postoperative decline in strength and work capacity may thus cause previously independent living persons to become dependent upon assistance from others. hence, it is important to avoid the postoperative reduction of physical performance and to minimize postoperative fatigue. it has been shown that erythropoietin treatment reduces the need for blood transfusions in patients undergoing planned colonic surgery. however, the effect of erythropoietin treatment upon postoperative rehabilitation has not yet been studied. therefore the main hypothesis in this study is that perioperative treatment with darbepoetin alfa would improve the physical capacity in aspects by reducing postoperative fatigue and improve work capacity, balance and quality of life compared to placebo treatment. furthermore, the researchers expect darbepoetin treated patients to have fewer perioperative complications and less need for blood transfusions.

Eligibility criteria:
inclusion criteria: * planned colonic and rectal surgery because of presumed cancer disease in the colon and rectum exclusion criteria: * psychiatric disease or dementia * diseases, that renders participation in the study impossible * thromboembolic disease within the last three months * dysregulated hypertension (systolic blood pressure\>175 mmhg and/or diastolic blood pressure\>105 mmhg) * other diseases or causes that will contraindicate treatment with darbepoetin alfa * other diseases or causes that will contraindicate further treatment with darbepoetin alfa * patients that preoperatively and/or four days postoperatively have a hemoglobin concentration \> 14 g/dl * former cancer disease * disseminated cancer disease * rectal cancer stage t4

Keywords: colorectal cancer erythropoietin rehabilitation physical capacity