Kornimate/medical-research-clean huggingface dataset:
irinotecan and paclitaxel in treating patients with metastatic or recurrent cancer

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of irinotecan and paclitaxel in treating patients with metastatic or recurrent cancer.

objectives: i. determine the maximum tolerated dose (mtd) of irinotecan administered in combination with paclitaxel in patients with metastatic or recurrent malignancies. ii. evaluate the toxicity and safety of this combination regimen in this patient population. iii. determine the pharmacokinetic profile of irinotecan in combination with paclitaxel on a weekly schedule and if the sequence of administration influences irinotecan pharmacokinetics in these patients. iv. determine pharmacodynamic models of irinotecan and its sn-38 and sn-38g metabolites when administered in this weekly combination schedule. outline: this is a dose escalation study of irinotecan. patients receive irinotecan iv concurrently with paclitaxel iv weekly. patients demonstrating stable disease or partial or complete clinical response continue with treatment as long as dose limiting toxicities are not observed and adequate performance status is maintained. cohorts of 3 patients receive escalating doses of irinotecan until the maximum tolerated dose is determined or 150 mg/m2 is reached. projected accrual: a total of 36 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed non hematologic malignancy refractory to standard therapy, or for which no known effective therapies exist patient characteristics: age: 18 and over performance status: karnofsky 70-100% life expectancy: at least 3 months hematopoietic: platelet count at least 100,000/mm3 absolute neutrophil count at least 2,000/mm3 absolute lymphocyte count at least 1,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl transaminase no greater than 2.5 times upper limit of normal renal: creatinine no greater than 1.4 mg/dl cardiovascular: no myocardial infarction within 6 months no current, uncontrolled cardiac arrhythmias other: no history of anaphylactic reactions not pregnant fertile patients must use effective contraception no serious uncontrolled, concurrent medical disorder prior concurrent therapy: biologic therapy: not specified chemotherapy: prior paclitaxel allowed no prior irinotecan at least 4 weeks since prior chemotherapy endocrine therapy: no concurrent steroids radiotherapy: at least 4 weeks since prior radiotherapy surgery: not specified

Keywords: unspecified adult solid tumor, protocol specific
a study of detection of paroxysmal events utilizing computer vision and machine learning (usf)

Conditions: Epilepsy

Summary: increased computational power has made it possible to implement complex image recognition tasks and machine learning to be implemented in every day usage. the computer vision and machine learning based solution used in this project (nelli) is an automatic seizure detection and reporting method that has a ce mark for this specific use. the present study will provide data to expand the utility and detection capability of nelli and enhance the accuracy and clinical utility of automated computer vision and machine learning based seizure detection.

this is a prospective, blind comparison to the clinical gold standard for seizure characterization. this study is intended to compare the nelli software's ability to identify seizure events to veeg review in adults with suspected nighttime seizures. simultaneously, nelli will continuously record audio and video while video-electroencephalography (veeg) is recorded per typical standard of care. events with positive motor manifestations will be independently identified, following standard clinical practice, by three epileptologists using clinical veeg data. nelli software will review the audio and video data and independently identify events with positive motor manifestations. the outcomes of event identification will be compared between epileptologists and the nelli software. for each category of event captured the positive percent agreement will be calculated using the exact binomial method. the primary endpoint of this study is to demonstrate that nelli is able to identify seizures that have a positive motor component with a sensitivity of \> 70%.

Eligibility criteria:
inclusion criteria: * all patients undergoing video-eeg monitoring for clinical purposes who are suspected of having seizures. exclusion criteria: -

Keywords: nelli
application of dried human amnion graft to improve postprostatectomy incontinence and potency

Conditions: Continence; Potency; Complication; Biochemical Recurrence

Summary: the investigators present a randomized trial of patients undergoing placement of dehydrated human amnion membrane (dham) around the neurovascular bundle (nvb) and vesicourethral anastomosis (vua) during radical retropubic prostatectomy (rrp) in a tertiary center in germany.

patients suffer under incontinence and impotence after rrp, improving techniques and studies are missing. the human amniotic membrane includes growth factors and unique immune tolerance which can improve tissue regeneration. the preliminary studies could prove the potential value of dham in the reconstruction of the urinary tract and nerve protection. the investigators initially present a randomized trial to improve postoperative continence and potency of patients undergoing placement of dehydrated human amnion membrane (dham) around the neurovascular bundle (nvb) and vesicourethral anastomosis (vua) during rrp for the treatment of prostate cancer. rrp is performed in a standardized way by one experienced surgeon. the patients are randomized 1:1 to dham vs. placebo and blinded during the study period. the primary outcome is a postoperative continence measure as 24hrs pad test up to 12mos postoperatively. secondary outcomes are potency, insufficiency of vua, postoperative complications and biochemical recurrence. using the t-test with an alpha of 0.05 and a power of 80% and expecting a drop-out of 20% of the patients, an adjusted sample size per arm of 164 patients is required.

Eligibility criteria:
inclusion criteria: * patients with localized prostate cancer * indication for radical prostatectomy * no other treatment of prostate cancer * availability to informed consent exclusion criteria: * preoperative incontinence (24hrs pad-test) * preoperative erectile dysfunction (iief-5 \< 20) * metastasized or locally advanced prostate cancer in preoperative assessment * previous radiation of pelvis * previous prostate cancer therapy * psychiatric disease * participation at another study
development of an intelligent power rehabilitation cluster machine and its clinical testing and assessment

Conditions: Frailty Syndrome; Intelligent POWER Rehabilitation Cluster Machine

Summary: elderly care has become one of the most important subjects in taiwan and "frailty syndrome" are the most common problems among the elderly. in view of this trend, taipei veteran memorial hospital imported power rehabilitation from japan in 2008. while showing significant clinical benefits, investigators have found that the system still has certain limitations (e.g. high cost, requires large space, patients must commute to the center, lacks real-time objective feedback , boring routines makes staying power to motivate patients for long term rehabilitation programs.) to overcome the above limitations, this project proposes an evidence-based rehabilitation model that accounts for actual clinical need and collaborates with our engineering team to develop a "cluster" , "wearable" and "brain-computer interface system" version of power rehabilitation system. combining cloud technology, investigators now introduce internet-of-things into the power rehabilitation procedure. the result will lower the burden of clinical support personnel, and provide an opportunity to quantify "frailty syndromes" so as to allow objective and quantitative scientific evaluation, leading to a more objective clinical diagnosis. in addition, this project further proposes a virtual-reality (vr) system for power rehabilitation, as well as designs for the vr sceneries. through the use of different animated 3d vr sceneries and interactive game design, investigators can make rehabilitation interesting and fun for the patients, motivating long-term compliance of the patients, thereby, improving the clinical outcome of power rehabilitation. this project has the potential to create an innovative solution to address the current bottlenecks of our rehabilitation treatment model. successful development of the system will offer rehabilitation clinicians more treatment options, lower the cost of supporting staff, reduce commuting cost for the patients, and elevate patient desire to comply with the treatment program. finally, the system will not only enhance taiwan's academic reputation in the international arena, it will also generate new commercial opportunities for taiwan and contribute to taiwan economic development.


Eligibility criteria:
inclusion criteria: * aged 60 to 85 * cardiovascular health study (chs) frailty criteria * willing to sign agreement exclusion criteria: * fracture w/o healing * severe joint injury * acute stroke or myocardial infarction (\< 3 months) * cardiac arrhythmia / unstable blood pressure * disorientation or intellectual deterioration * muscle contracture deformity * pregnancy

Keywords: frailty syndrome, intelligent power rehabilitation cluster machine, internet of things, wearable
manipulation effects on abdominal muscles

Conditions: Low Back Pain

Summary: the purpose of this study is to understand how different physical therapy interventions affect the use of certain abdominal muscles in patients with low back pain.

patients with low back pain will undergo ultrasound imaging of the lateral abdominal wall to measure resting and contracted thickness of the transversus abdominis muscle. following the pre-intervention measurement, patients will receive one of two physical therapy interventions (side lying thrust joint manipulation or side lying non-thrust oscillations into slight rotation) which will have been randomly assigned. immediately after intervention, ultrasound imaging will be repeated on the resting and contracted thickness of the transversus abdominis.

Eligibility criteria:
inclusion criteria: * currently receiving physical therapy treatment for back pain or back pain symptoms * 18-70 years of age * able to perform the abdominal drawing in maneuver exclusion criteria: * presence of a serious pathology * diagnosis of spinal stenosis or symptoms in both lower legs (changes in sensation, muscle weakness) * any history of low back surgery, rheumatoid arthritis, osteoporosis, osteopenia, or ankylosing spondylitis

Keywords: back pain
evaluation the tecnis iol in both eyes vs the rezoom iol in one and tecnis iol in the opposite

Conditions: Cataract

Summary: the purpose of this study is to evaluate the visual performance of two cohorts of patients who received multifocal intraocular lenses following cataract and clear lens extraction surgeries. comparing visual outcomes of patients who were implanted with tecnis multifocal iols in both eyes versus patients implanted with tecnis multifocal in one eye and rezoom multifocal iol in the opposite eye.

stable post operative cataract and clear lens extraction patients who have been implanted with either the tecnis multifocal iol in both eyes or tecnis multifocal iol in one eye and therezoom multifocal iol in the opposite eye. study design-a retrospective chart review to collect visual outcomes to determine lens performance. patient satisfaction questionnaire will be administered to determine spectacle independence.

Eligibility criteria:
inclusion criteria: * patients who have undergone surgery and received either the tecnis multifocal intraocular lens in one eye and the rezoom multifocal intraocular lens in the other will be evaluated. males and females with ages ranging from 42 years to 86 years old. exclusion criteria: * patients who have subsequently developed any visual limiting problems (e.g. corneal, retinal, infection) which could potentially limit their post operative visual potential.

Keywords: visual outcomes patient satisfaction
phase ⅱ dose response study of npo-13 in patients undergoing total colonoscopy

Conditions: Bowel Disease

Summary: patients who require screening colonoscopy will receive an intraluminal spraying of npo-13 per contraction region of large bowel up to fifth times during the colonoscopy. the efficacy of npo-13 will be evaluated based on the proportion of the splayed region with no contraction after npo-13 dosage (primary outcome measure). the colonic spasm will be assessed by an independent committee using recorded video images. the safety of npo-13 will be evaluated based on adverse events and adverse drug reactions (adrs) observed between administration and seven days after administration.


Eligibility criteria:
inclusion criteria: inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected colonic disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. patients have to provide written informed consent for voluntary participation in the study. 1. patients who need colonoscopy 2. patients who are older than 20 years at the time of consent exclusion criteria: 1. patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation 2. patients with contraindication to colonoscopy including the paralytic ileus 3. patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil) 4. patient with contraindication to bowel cleansing preparation 5. patients on cancer treatment (chemotherapy or radiotherapy) 6. patients who need sedative colonoscopy 7. patients who receives a therapeutic colonoscopy 8. pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study 9. patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies 10. patients who have been exposed to npo-13 11. patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
the effect of transcutaneous electrical nerve stimulation (tens) in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: in this study the researchers want to investigate the effects of long-term transcutaneous electrical nerve stimulation on the cortical excitability of persons with multiple sclerosis.


Eligibility criteria:
inclusion criteria: * expanded disability status scale (edss) scores between 2 and 6.5 * stable ms (no relapse during the last 3 months before study onset) * sensory impairment * age: between 18 and 68 years old exclusion criteria: - patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication

Keywords: multiple sclerosis transcutaneous electrical nerve stimulation cortical excitability
metabolic effects of betaine supplementation

Conditions: Obesity; Dysglycemia

Summary: betaine is important in cellular metabolic pathways. few epidemiologic studies link betaine levels to diabetes and cardiovascular disease. small human studies suggest benefit for non-alcoholic liver disease. in this study we will determine if administration of betaine improves metabolic measures, liver fat and/or endothelial function in humans with glucose intolerance who are overweight.

this study is a single site, prospective, randomized (1:1), double masked, placebo controlled trial to assess metabolic effects of betaine compared to placebo on glycemia and insulin sensitivity, liver fat and endothelial function.

Eligibility criteria:
inclusion criteria: * 1) men and women aged 21-65 years old; * 2) dysglycemia/prediabetes is defined as impaired fasting glucose (≥100 mg/dl), impaired glucose tolerance (2 hour post 75 g oral glucose load 140-200 mg/dl) or hba1c 5.7-6.5%); * 3) overweight to grade 3 obesity (bmi 25 to 45 kg/m2). exclusion criteria: * 1) cystathionine beta-synthase (cbs deficiency); * 2) presence of liver disease other than nafld; * 3) use of medications causing steatosis; * 4) known alcohol consumption ≥ 2 drink per day; * 5) use of medications known to cause insulin resistance; * 6) use of weight loss drugs (or program) within 3 months of screening; * 7) treatment with any experimental drug within the past 6 months; * 8) subjects must be willing to abstain from use of phosphodiesterase type 5 (pde-5) inhibitors; * 9) pregnancy or lactation, and women of child bearing potential must use adequate contraception; * 10) surgery within 30 days of screening; * 11) heart disease defined as new york heart association class iii or iv cardiac status or hospitalization for congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months; * 12) uncontrolled hypertension; * 13) egfr \<60; 14) history of acquired immune deficiency syndrome; * 15) history of malignancy within 5 years; * 16) hemoglobin \<12 g/dl (males), \<10 g/dl (females); * 17) triglycerides (tg) \>500 mg/dl; * 18) poor mental function or any other reason to expect patient difficulty in complying with study requirements; * 19) metal clips or implants that preclude magnetic resonance imaging.

Keywords: obesity glucose intolerance
the effect of pre-rehabilitation and rehabilitation period on functional status in inpatient stroke patients

Conditions: Stroke; Rehabilitation

Summary: patients who underwent inpatient rehabilitation for the last 5 years were retrospectively scanned. the pre-rehabilitation and rehabilitation periods of the patients were determined. at the beginning and end of rehabilitation, patients were evaluated with the brunsstrom, barthel and stroke impact scale. the effect of the specified durations on these scales was investigated.


Eligibility criteria:
inclusion criteria: * 40-90 years old * have hemodynamic stability to participate in rehabilitation * having had an ischemic or hemorrhagic stroke exclusion criteria: * having a serious comorbidity that may preclude rehabilitation * malignancy * aphasia * having a serious perception problem or psychiatric illness * having a history of stroke
impact of lipodystrophy on the inflammatory state of non-diabetic dunnigan reunion island subjects

Conditions: Lipodystrophy; Dunnigan Syndrome

Summary: few data and small numbers affect the inflammatory profile of dunnigan patients. the levels of certain pro-inflammatory biomarkers would be found higher in these subjects compared to control individuals. however, in these studies, several confounding factors were not taken into account such as smoking, an underlying chronic inflammatory disease such as diabetes and could limit the interpretation of the results. there is no other observation of the anti-inflammatory status of these patients.


Eligibility criteria:
inclusion criteria: * adult subject (\>18 years old) affected by partial dunnigan lipodystrophy in the homozygous or heterozygous state (genetic search for the positive mutation carried out before inclusion in the study). * person affiliated to or beneficiary of a social security scheme. * free, informed and written consent signed by the participant and the investigator. exclusion criteria: * - minor * persons placed under judicial protection, person participating in another research including a period of exclusion still in progress, severely impaired physical and/or psychological health, which, according to the investigator, may affect the participant's compliance with the study * previous known diabetes * pregnant woman * woman who gave birth less than 6 months ago * breastfeeding in progress * participation in other research that may have an impact on the evaluation of the main judgment criteria * hemoglobin b level \< 7 mg/dl or \< 9-10 mg/dl for patients with cardiovascular or respiratory pathology. * proven inflammatory pathologies * anti-inflammatory treatment: taking corticosteroids in the last 3 months. * active smoking
memory training and neural plasticity

Conditions: Mild Cognitive Impairment

Summary: this study will evaluate the efficacy of working memory training in older adults with amnestic mild cognitive impairment (mci).

working memory (wm) is the ability to hold information actively in mind and is fundamental for higher-order cognition. this pilot study aims to (1) evaluate the efficacy of wm training in older adults with mci and (2) understand if and how it works. the study will use behavioral and brain imaging assessments to see whether wm training changes how participants learn and remember information. functional magnetic resonance imaging (fmri) and functional near infrared spectroscopy (fnirs) methods will be used. the study will also use cognitive tests and questionnaires to determine whether participants' cognitive abilities change with training. the study will enroll participants with a diagnosis of mci as well as cognitively intact older adults (healthy controls, hc).

Eligibility criteria:
inclusion criteria: * mci diagnosis * right-handedness * mri-eligibility for mri participants exclusion criteria: * history of other contributing neurological or medical conditions known to affect cognitive functioning * significant mental illness * sensory impairments that limit ability to participate * history of alcohol or drug abuse/dependence

Keywords: working memory training fmri
efficacy and safety of belimumab in patients with active lupus nephritis

Conditions: Lupus Nephritis

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.

study participants receive standard therapy (induction and maintenance) for lupus nephritis in addition to receiving either placebo (no active medicine) or belimumab. induction therapy starts before the first dose of study drug (belimumab or placebo). maintenance therapy begins after completion of induction therapy and continues for the remainder of the study. participants receive study drug throughout the entire study, during both induction and maintenance periods. the controlled period of the study is 104 weeks. the random assignment in this study is "1 to 1" which means you have an equal chance of receiving treatment with belimumab or placebo. participants who successfully complete the 104-week study may enter into a 6-month open-label extension. all participants in the open-label extension receive belimumab.

Eligibility criteria:
key inclusion criteria: * clinical diagnosis of sle by american college of rheumatology (acr) criteria. * biopsy confirmed active lupus nephritis. * clinically active lupus renal disease at screening requiring /receiving induction therapy with standard of care medications. * autoantibody-positive. key exclusion criteria: * pregnant or nursing. * on dialysis within the past year. * treatment with belimumab within the past year . * receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy for the study. * receipt of any b cell targeted therapy (for example, rituximab), investigational biological agent within the past year. * severe active central nervous system (cns) lupus. * required management of acute or chronic infections within the past 60 days. * current drug or alcohol abuse or dependence. * tested positive for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c. * history of severe allergic reaction to contrast agents or biological medicines.

Keywords: antibodies systemic lupus erythematosus autoimmune disease glomerulonephritis belimumab lupus nephritis kidney diseases sle