Kornimate/medical-research-clean huggingface dataset:
effects of green light exposure on epileptic spikes in patients with refractory epilepsy

Conditions: Epilepsy; Epilepsy Intractable

Summary: the purpose of this study is to obtain preliminary data in advance of a larger clinical trial aimed to test whether a single session of green light exposure can lead to a clinically significant reduction in epileptic spikes in patients with medically-refractory epilepsy. as this is a potentially fragile patient population, the study will test safety and tolerability as well as efficacy.

the trial is designed to detect (1) change in spike frequency on eeg before and after exposure to low intensity green light, and (2) presence or absence of neurologic/systemic symptoms referable to exposure of the pre-selected duration, intensity, and band of green light. our primary aim is to determine whether prolonged exposure (120 minutes) to a narrow band of green light (520-540 nm) at low intensities (1-10 cd/m2) alters the pattern of electrical activity in the cortex of epilepsy patients. the primary outcome measure for this aim will be the fraction of patients in which the number of epileptiform discharges (spikes or sharp waves) decrease, per recording, in response to green light exposure, as determined by spike frequency detected via scalp eeg before and after green light exposure. the investigators anticipate that the primary outcome measures of safety and tolerability will not differ from the previously established measures of green light exposure for migraine (noseda et al. 2016). the investigators will use only low intensities (1-10 cd/m2) of green light which is well tolerated in adults and children (main et al. 2000). in addition, given limited experience with conventional green light exposure in epilepsy, the investigators predict that post-exposure to green light, patients will have an improvement on the post-exposure eeg (decreased spike frequency).

Eligibility criteria:
inclusion criteria: * 6 months-30 years of age * epileptic spike frequency ≥1 epileptic spike per minute at baseline, as determined by scalp eeg recording * admitted to the boston children's hospital epilepsy long term monitoring unit at the time of enrollment exclusion criteria: * cataracts * retinol disease * any history of or currently not well controlled ophthalmic disease that prevents transmission from the retina to the optic nerve * clinical seizure 4 hours or less before anticipated green light exposure

Keywords: refractory epilepsy green light exposure epileptic spikes
exit strategy after percutaneous nephrolithotomy: large or small bore tube?

Conditions: Urolithiasis; Nephrolithotomy; Percutaneous Nephrolithotomy (PNL); Nephrostomy Tube (NT); Pain

Summary: regarding to the distribution of nephrostomy tube (nt) size usage by country. there was a clear distinction between countries that used solely the small bore (sb) nt (chile and australia) and those that used solely the large bore (lb) nt (czech republic and japan). there is also a trend toward sb nt in north america (\~75% in usa and canada) and toward lb nt in south america (\~80% in argentina and mexico). in europe the trend is equal (\~50% in germany, france, greece and uk). based on previous data and in view of conflicting data about postoperative complication including extravasation, bleeding and hemoglobin change and pain between previous studies, we will conduct this randomised trial comparing sb and lb nt following pnl. our aim to evaluate the safety of small versus large bore nt reporting complications using the clavien-dindo system with categorisation of pnl-specific complications


Eligibility criteria:
inclusion criteria: 1. staghorn calculi 2. renal pelvis stones =\>2 cm 3. lower pole stones= \>1.5 cm 4. upper ureteral calculi =\>1.5 cm 5. swl-resistant stones exclusion criteria: 1. age \<18 years or pregnancy 2. tubeless pnl 3. need for 3 percutaneous tracts intraoperative 4. morbid obesity (bmi \>40) 5. refuse to complete study requirements 6. tumour in the presumptive access tract area or potential malignant kidney tumour

Keywords: percutaneous nephrolithotomy (pnl) nephrostomy tube (nt) pain patient satisfaction
effect of cnsi vs. icg in lymph node tracing during gastrectomy

Conditions: Gastric Cancer

Summary: the purpose of this study is to assess the efficacy and safety of carbon nanoparticle suspension injection and indocyanine green tracer-guided lymph node dissection during gastrectomy in patients with gastric cancer

da vinci robot surgery xi system has fluorescence imaging function, which can realize indocyanine green lymph node tracking navigation technology in the operation. at the same time, the lymph node tracking effect of nano carbon suspension injection is not affected by equipment. the flexible mechanical arm of da vinci robot combined with the application of lymph node tracing technology makes the lymph node dissection of gastric cancer surgery more thorough, and also reduces the difficulty of surgery. indocyanine green navigational lymphadenectomy can also be performed by fluorescence laparoscopy. by comparing the two tracer techniques, the lymph node tracer technique which is more suitable for robot or laparoscopic surgery system is selected to provide help and choice for clinical surgeons.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 75 years 2. primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. clinical stage tumor 1-4a (ct1-4a), n-/+, m0 at preoperative evaluation according to the american joint committee on cancer (ajcc) cancer staging manual seventh edition 4. no distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations 5. performance status of 0 or 1 on eastern cooperative oncology group scale (ecog) 6. american society of anesthesiology score (asa) class i, ii, or iii 7. written informed consent exclusion criteria: 1. women during pregnancy or breast-feeding 2. severe mental disorder 3. history of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. history of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection 5. enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 6. history of other malignant disease within past five years 7. history of previous neoadjuvant chemotherapy or radiotherapy 8. history of unstable angina or myocardial infarction within past six months 9. history of cerebrovascular accident within past six months 10. history of continuous systematic administration of corticosteroids within one month 11. requirement of simultaneous surgery for other disease 12. emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. fev1\<50% of predicted values 14. diffuse; widespread; plastica
effect of a combination of hyaluronic acid, chondroitin sulphate and magnesium trisilicate on subjects with gastroesophageal reflux disease

Conditions: Gastro Esophageal Reflux

Summary: the aim of this study is to investigate whether a 3-week treatment with an oral melt in mouth medical device, made up with hyaluronic acid, chondroitin sulphate and magnesium trisilicate, can lead to a reduction of gastroesophageal reflux disease symptoms and to an improvement of the integrity of esophageal mucosa in patients who are to experiencing esophagus symptoms. the study is a randomized, double-blind cross-over placebo controlled study. every patient will get both the active study device during one study period and placebo during another another period.


Eligibility criteria:
inclusion criteria: * males and females, age 18 to 75 years * gerd as defined by an acid exposure time \>4% on ph/impedance monitoring and/or esophagitis la grade a or b on endoscopy * heartburn at least twice per week over the last 1 month * request symptoms sum score \>3,37 at screening * gerd patients not treated with a ppi in the previous 2 months * subjects capable of understanding and be willing to provide signed and dated written voluntary informed consent exclusion criteria: * patients suffering from gastrointestinal diseases other than gerd * esophagitis la grade c or d or barrett's esophagus on endoscopy * impaired kidney or liver function * significant cardiac, pulmonary or psychiatric comorbidity as judged by the investigator * medication use (including nsaids) that may interfere with gerd symptom assessment within 2 weeks before the start of the study or during the study * pregnancy or breast-feeding * females of childbearing potential in the absence of effective contraceptive methods * history of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent * history of alcohol or drug abuse that would interfere with ability to comply with protocol requirements * treatment with any investigational drug within the previous 30 days * active malignancy of any type, or history of cancer, including solid tumors and hematological malignancies (except patients with malignancies that have been surgically removed and/or with no evidence of recurrence for at least five years before study enrolment) * inability to conform to protocol procedures
intraoperative monitoring for the lateral lumbar interbody fusion procedure

Conditions: Intervertebral Disc Degeneration; Stenosis, Spinal; Spondylolisthesis; Spinal Deformity; Spinal Instability

Summary: this study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (ssep) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (llif) procedure.


Eligibility criteria:
inclusion criteria: * at least 18 years of age at the time of planned surgery. * indicated for 1- or 2-level instrumented llif surgery (in either prone or lateral decubitus positions), inclusive of the l4-5 disc space. * written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. exclusion criteria: * patients requiring surgical treatment at more than 2 lumbar levels. * patients with peripheral neuropathy such as from diabetes or other conditions that might affect the reliability of intraoperative neuromonitoring. * patients with prior history of partial/full hip or knee joint replacement surgery (i.e., arthroplasty or resurfacing) on the leg targeted for saphenous monitoring and electrode placement. * patients with presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. * female patients who are pregnant or wanting to become pregnant during the timeframe of study participation. * patients participating in another clinical study which may compromise this study's results or compliance with this study's procedures.

Keywords: spine surgery adult neuromonitoring electromyography somatosensory evoked potentials
a study to evaluate the safety and efficacy of ipx066 in advanced parkinson's disease (advance-pd).

Conditions: Parkinson's Disease

Summary: this is a study to evaluate the safety and efficacy of ipx066 in advanced parkinson's disease.

a randomized, double-blind, active-control, parallel-group 13-week comparison of ipx066 versus regular carbidopa-levodopa (cd-ld). prior to randomization, subjects on a stable regular ld regimen will enter a 3-week dose-adjustment period for ir cd-ld, followed by a 6-week dose-conversion period to ipx066.

Eligibility criteria:
inclusion criteria: 1. diagnosed with idiopathic pd. 2. at least 30 years old at the time of pd diagnosis. 3. currently being treated with ir ld (cd-ld or benserazide-ld) and on a stable regimen of ir ld for at least 4 weeks and: * requiring a total daily ir ld dose of at least 400 mg * having a minimum dosing frequency of four times per day. 4. able to differentiate "on" state from "off" state. 5. have predictable "off" periods. 6. amantadine, anticholinergics, selective monoamine oxidase (mao) type b inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are allowed as long as the doses and regimens have been stable for at least 4 weeks prior to screening and the therapy is intended to be constant throughout the course of the study. 7. agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward. exclusion criteria: 1. diagnosed with atypical parkinsonism or any known secondary parkinsonian syndrome. 2. nonresponsive to ld therapy. 3. prior functional neurosurgical treatment for pd (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation. 4. received within 4 weeks or planning to take during participation in the clinical study: any controlled-release ld product, additional cd (e.g., lodosyn®) or benserazide (e.g. serazide®), catechol-o-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective mao inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder. 5. allergic to yellow dye #5 (tartrazine). 6. history of or currently active psychosis. 7. active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with ld absorption. 8. active or history of narrow-angle glaucoma. 9. a history of malignant melanoma or a suspicious undiagnosed skin lesion. 10. history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis. 11. received any investigational medications during the 4 weeks prior to screening. 12. unable to swallow large pills (e.g., large vitamin pills). 13. pregnant or breastfeeding. 14. subjects who are unable to complete a symptom diary.

Keywords: parkinson's disease
vaccine therapy and qs21 in treating patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: vaccines may help the body build an effective immune response to kill tumor cells. giving vaccine therapy together with qs21 may cause a stronger immune response and kill more tumor cells. purpose: this clinical trial is studying the side effects and how well giving vaccine therapy together with qs21 works in treating patients with metastatic breast cancer.

objectives: primary * determine the safety of sialyl lewisª -keyhole limpet hemocyanin conjugate vaccine and qs21 immunoadjuvant in patients with metastatic breast cancer. * determine the igg and igm antibody response to this regimen in these patients. * determine the proportion of breast cancer cells expressing this antigen in these patients. secondary * monitor the presence of circulating tumor cells prior to, during, and after this regimen in these patients. outline: patients receive sialyl lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (sc) and qs21 immunoadjuvant sc once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease. blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl lewisª antigen in elisa and/or immunoprecipitation-western blot assays. after completion of study treatment, patients are followed every 3 months.

Eligibility criteria:
disease characteristics: * histologically confirmed stage iv breast cancer meeting 1 of the following criteria: * no evidence of disease * stable disease on hormonal therapy * stable disease must be present for ≥ 2 months and include \< 30% decrease or \< 20% increase in the sum of the longest diameter of target lesion * no new target lesions or unequivocal progression of non-target lesions * elevation in the ca 153 (br2729) or cea values allowed * hormone receptor status not specified patient characteristics: * female or male * menopausal status not specified * karnofsky performance status 80-100% * lymphocyte count ≥ 500/mm³ * wbc ≥ 3,000/mm³ * creatinine ≤ 1.5 times upper limit of normal (uln) * ast ≤ 1.5 times uln * alkaline phosphatase ≤ 1.5 times uln * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no history of allergy to seafood * no nyha class iii-iv cardiac disease * no other active cancers except basal cell or squamous cell carcinoma of the skin * no active infection requiring antibiotic treatment * no known history of immunodeficiency or autoimmune disease prior concurrent therapy: * see disease characteristics * at least 4 weeks since prior chemotherapy * at least 4 weeks since prior radiotherapy * at least 4 weeks since prior surgery * at least 6 weeks since prior immunotherapy * no prior sialyl lewisª antigen * no concurrent immunosuppressive medications (i.e., corticosteroids) * concurrent hormonal therapy allowed

Keywords: recurrent breast cancer stage iv breast cancer male breast cancer
influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting

Conditions: Diabetes Mellitus

Summary: it has been recently suggested, that not the diet by itself, but also patient's adherence to dietary recommendations and all actions performed to improve dietary compliance, may be a significant factor influencing blood glucose control. there are no clinical data on the influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting in poland. thus, the aim of this study was to assess the influence of different approaches to dietary advisory on the effects of acarbose treatment (reflected by changes in hba1c) in obese dm patients. we also intended to assess the influence of different approaches to dietary advising on the appearance of potential adverse events in acarbose treated obese dm patients.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * age\>18 years exclusion criteria: * hypersensitivity to acarbose or any of the excipients * age\<18 * pregnancy and in nursing * inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction * chronic intestinal diseases associated with marked disorders of digestion or absorption * states which may deteriorate as a result of increased gas formation in the intestine, (e.g. roemheld's syndrome \[an angina pectoris-like syndrome or aggravation of an angina pectoris due to the post-prandial filling of the stomach\] and larger hernias) * hepatic and severe renal impairment (creatinine clearance \<25 ml/min/ 1,73m2)

Keywords: diabetes acarbose diet compliance advising
longitudinal study of chronic postsurgical pain in children and adolescents

Conditions: Chronic Post Operative Pain

Summary: chronic postsurgical pain is defined as pain that develops or intensifies following a surgical procedure. after major surgery, around 20% of children and adolescents develop chronic postsurgical pain, and, as part of it, negative consequences on their quality of life. emotion-related factors such as the variability of emotions, how emotions are regulated, and how well someone is able to differentiate between different emotions have in part been studied in other types of chronic pain. to date, no study examined emotion-related factors in the development and maintenance of chronic postsurgical pain. this observational study includes five assessment time points, one before and four after major surgery, with the goal to identify emotion-related factors that increase or decrease the risk for the development of chronic postsurgical pain.


Eligibility criteria:
inclusion criteria: * children and adolescents aged between 8 and 18 years * planned orthopedic surgery requiring in-patient care in one of the participating children's hospitals * able to read and understand german exclusion criteria: * serious comorbid health condition (e.g., cancer, severe neurological impairment, chronic illness requiring daily medication) * prior major orthopedic surgery (e.g., prior spine surgery) * parent/caregiver and child not able to read and understand german
interventional x-ray and scintigraphy imaging of 99mtc-maa during the radioembolisation pretreatment procedure

Conditions: Liver Cancer

Summary: to establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization


Eligibility criteria:
inclusion criteria: 1. participants must have given written informed consent and comply with the requirements of the study protocol. 2. must be aged 18 years or over. 3. must be selected to undergo a 99mtc-maa procedure as part of their radioembolisation treatment. 4. sufficiently fit to undergo an additional examination time of 30-90 minutes. 5. have a ct acquired less than 6 weeks before the pre-treatment radioembolisation procedure. exclusion criteria: 1. patients expected to require more than two injection positions for radioembolisation treatment. 2. pregnancy or nursing. 3. patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression. 4. patients who are declared incompetent. 5. previous enrollment in the present study 6. claustrophobia 7. the last dose of prior chemotherapy has been received less than weeks prior to the planned 99mtc-maa pre-treatment procedure. 8. radiation therapy within the last 4 weeks before the planned 99mtc-maa pre-treatment procedure 9. major surgery within the last 4 weeks prior to the planned 99mtc-maa pre-treatment procedure 10. any unresolved toxicity greater than common terminology criteria for adverse events (ctcae version 5) grade 2 from previous anti-cancer treatment 11. body weight over 250 kg (because of maximum table load) 12. patient length over 1.90 m (to fit ixsi geometry) 13. patient bust line over 135 cm (to fit ixsi geometry)