Kornimate/medical-research-clean huggingface dataset:
relief from side effects: clinical use of electrodes with direction

Conditions: Deep Brain Stimulation; Directional Lead; Essential Tremor

Summary: deep brain stimulation (dbs) uses electrical pulses sent through a lead (insulated wire) to help stop unwanted symptoms in a variety of brain diseases, including the tremor seen in patients with essential tremor (et). the current standard lead allows this stimulation to spread out uniformly in all directions. as these diseases progress, however, the amount of electrical stimulation required to stop the symptom usually increases. this may become problematic because the increased electrical stimulation required for advanced symptoms may spread outside the desired targeted area, and effect other parts of the brain and causing unwanted side effects. a new type of dbs lead has been developed which can steer, or focus, the electrical stimulation in a given direction toward the desired target area and away from areas that would cause side effects. we would like to quantify the benefit seen in patients who have been switched from the traditional lead to this new directional lead.

patients implanted with a dbs may experience unwanted side effects such as motor contractures, paresthesia, or dysarthria. this occurs when the electrical field of the stimulation spreads out beyond the targeted area. this is especially common in patients whose disease has progressed, and must use increasingly higher currents in order to regain control of their tremor. unfortunately, because the electrical field affects neurons in a symmetrical sphere around the dbs, it is often impossible to reach the additional desired neuronal elements without simultaneously affecting equidistant brain regions responsible for side effects. for many of our advanced patients, this means choosing between a debilitating tremor or disabling side effects.the directional lead is a fda and health canada approved dbs lead which features radially segmented electrodes which can selectively steer the electrical field in a predefined direction, orthogonal to the lead trajectory. this will allow dbs clinicians to steer current towards desired structural areas, while avoiding locations, which produce negative side effects.

Eligibility criteria:
inclusion criteria: * participants must have been implanted with the dbs * participants must have been diagnosed with essential tremor * participants must experience negative side effects from their dbs which limit control over their tremor * participants must be able to receive benefit from their stimulator, but at the cost of negative side effects exclusion criteria: * all individuals who meet criteria outlined in "inclusion criteria" may be eligible for this study

Keywords: deep brain stimulation directional lead essential tremor
trial of essential amino acid supplementation in protein deficient patients following total knee arthroplasty

Conditions: Quad Atrophy

Summary: the goal of this trial is to assess the efficacy of essential amino acids (eaa) on muscle atrophy and malnutrition compared to a placebo in patients following a total knee arthroplasty. the investigators specific objectives included analysis of (1) muscle strength, (2) change in malnutrition, (3) perioperative complications (4) physical activity.

three orthopedic surgeons will participate in the study (mbc, djm, saj). the surgical procedure will be performed as per each surgeon's routine practice. patients will be asked to ingest 20g of eaa or placebo two times a day between meals 1 week prior and 2 weeks postoperatively. patients will be given a pill organizer that has two doses per day with either eaa or placebo. thigh circumference will be measured at baseline, 2 weeks and 6 weeks post-operatively. the mid-thigh measurement will be taken while the patient stands erect with their feet slightly apart and their weight equally distributed. the girth measurement is taken perpendicular to the long axis of the thigh. the tape measure will be placed at the level midway between the trochanterion and tibiale laterale sites each time to ensure that the same location is measured each time. the investigators will measure strength using a handheld dynamometer and performing a straight leg raise and knee extension at 90 degrees on the operative and the non-operative leg preoperatively, 2 weeks and 6 weeks post-operatively. the medial and lateral epicondyles of the femur will be used to position the subject's knee joint through the axis of rotation on the dynamometer. strength will be tested at 30, 45 and 60 degrees of flexion. physical activity will be collected using the knee society score at baseline and at 6 weeks postoperatively. after the trial is commenced, there will be no additional enrollment once study numbers have been met.

Eligibility criteria:
inclusion criteria: * all patients will be undergoing a primary unilateral total knee arthroplasty for a diagnosis of osteoarthritis exclusion criteria: * all patients who were wheelchair bound preoperatively * all patients who cannot participate in an outpatient physical therapy program for 3 days per week after surgery

Keywords: total knee arthroplasty
erlotinib re-challenge for recurrent egfr-mutant lung cancer in patients who previously received adjuvant erlotinib or gefitinib

Conditions: Lung Cancer

Summary: the purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an egfr mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.


Eligibility criteria:
inclusion criteria: * a history of stage i-iiib nsclc * previously underdone definitive surgery or radiation * received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time * stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence * pathologic evidence of recurrent lung cancer, confirmed at mskcc egfr sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor * tissue from their recurrent tumor must be submitted for egfr mutation testing, and to evaluate for the presence of the t790m mutation (results do not need to have been reported to be eligible) * measurable disease by recist; if received prior irradiation, then must have a target lesion outside the irradiated field * signed informed consent * age \> or = to 21 years old * persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped exclusion criteria: * prior progressive disease while receiving erlotinib or gefitinib therapy * patients with known pre-existing interstitial lung disease * total bilirubin greater than 1.8 mg/dl, excepting patients known to have gilbert's syndrome * ast or alt greater than five times the upper limit of normal * pregnant or lactating women * medically unfit for erlotinib therapy as determined by treating oncologist

Keywords: osi-774, tarceva (erlotinib) lung recurrent 10-097 gefitinib
ensite navx-guided coronary sinus mapping during crt implant

Conditions: Congestive Heart Failure

Summary: use of the ensite navx system to map the coronary vasculature during crt implant

objective(s): to determine the feasibility of cs mapping with navx during biventricular implantable cardioverter defibrillator (biv icd) implantation. inclusion criteria: * subject is between the age of 18 and 75 years * subject is willing and able to sign a study specific informed consent * subject is able to fulfill study requirements * meet the conventional criteria for implant of a biv icd, including; lvef of ≤35%, qrs ≥ 120 ms and nyha iii-iv * have persistent chf symptoms despite contemporary chf medical therapy * stable and optimal medical therapy (stability is no changes in past 3 months). * documented history of ischemic or non-ischemic cardiomyopathy. exclusion criteria: * have any standard device exclusions including tricuspid valve prosthesis/ replacement. * have a positive urine or serum pregnancy test (if female and of childbearing potential) * be currently participating in an ide or ind study.

Eligibility criteria:
inclusion criteria: * meet criteria for crt implant including ef\ 120ms, nyha class iii or iv * persistent chf symptoms despite optimization * stable/optimal medical therapy * history of ischemic or non-ischemic cardiomyopathy exclusion criteria: * any standard device exclusion including tvr * positive pregnancy test * currently participating in ide/ind study
evaluation of inhalation technique in patients with copd, asthma or acos using a dry powder device (dpi)

Conditions: COPD Asthma; Asthma-COPD Overlap Syndrome; Inhalation

Summary: this study analyzes the prevalence of patients using inhalation devices via incorrect technique and access the adherence of patients to correct inhalation technique when taught along with their subjective improvement of symptoms.

this is a one group pretest- posttest design conducted in all patients presenting in chest clinic of dhulikhel hospital-kathmandu university hospital, nepal from march 2017 to may 2017. patients diagnosed of having copd, asthma or asthma-copd overlap syndrome (acos) and were under inhalation bronchodilators in the form of dry powder device via rotahaler were included. enrolled patients are assessed for inhalation technique compliance at their routine medical (pre-training) visits by physician. the use of inhaler device is evaluated in a practical manner by asking the patients to demonstrate their inhalation technique. after the assessment, instructions and training are given until they can use the device correctly. one month later (post-training), all patients are re-evaluated in regards to inhalation technique and subjective improvement of symptoms.

Eligibility criteria:
inclusion criteria: * age \>18 years, * diagnosed of having of asthma or copd or acos * using dry powder inhaler therapy with rotahaler exclusion criteria: * use of inhaler devices other than rotahaler * newly started on dry powdered inhalational therapy or patients who had recently received face-to-face training program on inhalation technique within the past one month * patients in acute exacerbation * patients failing to give consent

Keywords: acos asthma copd inhalation technique
evaluation of astaxanthin properties on anti-fatigue

Conditions: Healthy Volunteer

Summary: ten young, healthy, physically active male college students were crossed over for ast or placebo supplements randomized into placebo or ast trials and orally consumed placebo or ast (28 mg/d) supplements for four days. short-term ast supplementation enhanced endurance performance and effectively reversed cycling challenge-induced muscle damage and lipid peroxidation.

ast is composed of two β-ionone ring systems that are linked by a polyene chain and contain oxygenated keto and hydroxyl moieties, which are responsible for its powerful antioxidant activity. ast has been shown to have numerous health benefits in humans, including improved antioxidant and inflammatory status under different stress conditions. therefore, this study will explore ast supplement to improve exercise-induced muscle damage and/or physiological anomalies in adults. ten physically active male adults were randomized into placebo or ast trials and consumed placebo or ast (28 mg/d) supplements orally for 4 days. on day-4, participants performed an exhaustive cycling challenge at 75% v̇o2max, and the time to exhaustion (tte) was recorded. blood and gaseous samples were collected before, during, and immediately after cycling to determine changes in muscle damage, inflammation, oxidative stress, and substrate utilization.

Eligibility criteria:
inclusion criteria: * recruit people who are healthy are 20-40 years male and have exercise habits in college students exclusion criteria: * have smoking and drinking habits. * those who have implanted artificial joints in the past six months and have had recent surgery. * people who feel unwell due to other reasons during the experiment. * take any drugs or nutrition supplements in the past 3 months.

Keywords: cycling performance fatigue ergogenic aids lipid peroxidation
one week adjuvant radiotherapy for breast cancer

Conditions: Breast Carcinoma

Summary: * cancer is the second leading cause of death after cerebrovascular strokes and is a significant obstacle to each nation's future growth. * worldwide, breast cancer is the most common cancer in women and the 5th leading cause of cancer related deaths that comes after lung cancer, colorectal cancer, liver cancer and gastric cancer. * more than half of all breast cancer cases in the world occur in developing countries. egypt has a high mortality rate from breast cancer, with a rate of 21.3 per 100,000 cases. breast cancer is diagnosed at an advanced stage in 60 to 70% of cases in egypt. the median age at diagnosis in egypt is 48.5 years, which seems to be a decade younger than in europe and north america.


Eligibility criteria:
inclusion criteria: * female patients 45 years of age or older who have had oncoplastic breast surgery (obs) or total mastectomy with adequate axillary clearance and a negative margin. * breast carcinomas that is invasive (txn1-3m0, t0n2-3 m0, t1n2-3m0, t2n2-3m0, t3n0-3m0, t4n0-3m0) whatever type of tumors biology. * all patients with locally advanced breast cancer who received neoadjuvant chemotherapy and underwent either oncoplastic breast surgery or modified radical mastectomy exclusion criteria: * metastatic breast cancer at the time of diagnosis proved clinically or radiologically. * postoperative positive margin. * carcinomas in situ. * mesenchymal breast lesions. * locoregional recurrent breast cancer. * synchronous bilateral breast cancer. * very early breast cancer (t1-2n0m0,t1n1m0).
the efficacy of probe-based confocal laser endomicroscopy in staging olgim

Conditions: Probe-based Confocal Laser Endomicroscopy; the Operative Link on Gastric Intestinal Metaplasia

Summary: gastric intestinal metaplasia (gim) is an important premalignant lesion for gastric cancer. precisely surveillance of patients with gim may result in early detection and improved prognosis. though important, it is not necessary to recommend surveillance endoscopy for all patients with gim, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.


Eligibility criteria:
inclusion criteria: * patients aged 40 years or older with helicobacter pylori infection; * histologically verified gim, atrophic gastritis or dysplasia. exclusion criteria: * patients with gastrectomy, acute gi bleeding and advanced gastric cancer; * conditions unsuitable for performance of pcle, such as coagulopathy, impaired renal function or allergy to fluorescein sodium; * pregnancy or breastfeeding; * inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
children with aluminium contact allergy: cutaneous exposure study

Conditions: Contact Dermatitis; Contact Allergy; Aluminum Allergy

Summary: aluminium is used in many different cosmetic products, including make-up, deodorants and sunscreen. the purpose of this study is to investigate whether these everyday skin products with small amounts of aluminium can cause skin reactions in children diagnosed with contact allergy to aluminium. the study is conducted as a repeated open application test study (roat), a method originally developed to clarify the clinical relevance of questionable and positive patch samples, by imitating everyday use of a skin product.

the study is conducted as a repeated open application test study (roat), a method originally developed to clarify the clinical relevance of questionable and positive patch samples, by imitating everyday use of a skin product. the skin products will consist of ordinary sunscreens with and without aluminium, with colour code red and blue, respectively (masked for both investigator and participants). at the beginning of the trial, the study participants will be given the two creams. on the lower back of the children, two areas each 10 cm2 are marked with red and blue, respectively. in each area, sunscreen corresponding to the generally recommended amounts must be applied twice a day. the children should be seen on day 0 for interviews and objective examination. they must then be seen again on day 7 and day 14. on day 14 of the roat, a patch test is made to validate the results of the roat study. the study is scheduled to last for a maximum of 21 days with 4-5 consultations per child. if there is a skin reaction in connection with the roat study before the 14 days have elapsed, the study will end and a patch test will be performed.

Eligibility criteria:
inclusion criteria: * children with contact allergies to aluminium, demonstrated by patch tests at the skin and allergy department, gentofte hospital and thus registered in the clinical database for contact allergy. * activity (itching) of the granulom within the last six months * written consent obtained from all custodians. * self-assessed worsening of skin symptoms after contact with aluminium-containing sunscreens. exclusion criteria: * treatment with systemic steroid preparations within 1 week. * treatment with topical steroid preparations at or near the test area within 1 week. * treatment with systemic immune suppression. * treatment with antibiotics within 1 week. * if the children become ill during the study, they should contact the project manager who will clinically assess the child and evaluate whether the child can continue to participate in the study or should be excluded due to the possibility of misinterpretation of any rash. * active eczema or other skin symptoms on the tested area

Keywords: vaccination granuloma aluminium contact allergy children contact dermatitis repeated open application test patch test
continuous and non-invasive measurements by task force® core/cardio in autonomic function testing (aft)

Conditions: Autonomic Dysfunction; Orthostatic Intolerance

Summary: background: the investigational device, "task force® core" (tfc, cnsystems medizintechnik gmbh, graz, austria) together with the "task force® cardio" (tfcardio, cnsystems medizintechnik gmbh, graz, austria) medical device software, is a new ce-marked medical device for continuous non-invasive determination of blood pressure (bp), cardiac output (co) and derived parameters based on the well established cnap® (continuous non-invasive arterial pressure) technology by cnsystems. aim: the primary aim of this prospective, method comparison, open study is data acquisition for the performance evaluation of the tfc during autonomic function testing in comparison with an clinically accepted reference method. setting: the setting of the clinical investigation will be the autonomic function testing laboratory at the department of neurology, the university hospital center zagreb. inclusion criteria: patients who are over 18 years and who provide written informed consent. sample size: the study has an calculated sample size of 70 patients. considering a drop-out rate of 5%, a total of 75 patients will be included. statistics: descriptive statistics, values for the percentage error and correlation estimates will be derived. furthermore, scatterplot, bland-altman analysis, concordance analysis of parameter changes and further comparative statistics will be performed.


Eligibility criteria:
inclusion criteria: * adult patients (patients aged ≥ 18 years) * patients giving written informed consent to participate in the study. * patients with intact perfusion of both hands evidenced by a positive allen's test. * patients with orthostatic intolerance will be included exclusion criteria: * patients with vascular implants at the sites of non-invasive bp measurement (fingers or upper arms) * very low perfusion in the periphery * arterial vascular diseases (arteriosclerosis, raynaud's syndrome, endarteritis obliterans, collagenosis, severely advanced vascular diseases (paod)) * patients with significant edema in the fingers * patients with atrial fibrillation * patients with valvular disease of grade 2 or above * patients with ventricular assist devices * subjects not passing the allen's test for both hands. * patients with a large lateral difference in bp (\> 15 mmhg for systolic bp and/or \>10 mmhg for diastolic bp) or with same arm measurement differences \> 10 mmhg in systolic or diastolic bp during assessment of lateral differences

Keywords: blood pressure hemodynamics non-invasive continuous autonomic function testing
efficacy of albumin dialysis to treat patients with hepatic encephalopathy using the molecular adsorbent recirculating system (mars)

Conditions: Hepatic Encephalopathy; Liver Failure; Hepatitis, Chronic; Liver Cirrhosis

Summary: the primary objective of the study was to compare the efficacy, safety and tolerability of extracorporeal albumin dialysis (ecad) using the molecular adsorbent recirculating system (mars®) device in improving severe he by 2 grades compared to standard medical therapy (smt) in patients with chronic end stage liver disease (esld) during a 5 day study period.

the trial was a two-group unblinded multicenter clinical trial. patients were randomized to receive either smt or smt plus five days mars® treatment. the trial design called for patients to receive a baseline hepatic encephalopathy (he) assessment on admission, and at 12-hour intervals, giving 10 he measurements during treatment using a refinement / adaptation of the conn west haven he criteria he scoring system

Eligibility criteria:
inclusion criteria: 1. signed written informed consent by patient or patient's legally appointed representative 2. be at least 18 years of age; male or female 3. have chronic end stage liver disease with worsening hepatic encephalopathy (grades 3,4). exclusion criteria: 1. clinically significant bleeding from gastrointestinal or other site within the last 24 hours and requires 2 or more units of blood to maintain a stable hemoglobin level 2. hemodynamically unstable or on vasopressor agents for blood pressure support (except for renal-dosed dopamine) 3. on acute or chronic hemodialysis or continuous renal replacement therapy (crrt) 4. pregnancy 5. inability to obtain informed consent 6. uncontrolled sepsis as defined by hemodynamic instability 7. post-liver transplant 8. fulminant hepatic failure 9. irreversible brain damage as indicated by the neurologic examination and ct imaging 10. endocarditis 11. pulmonary edema 12. massive aspiration pneumonia secondary to hepatic encephalopathy 13. active alcohol consumption as determined by a positive blood ethanol level on enrollment/admission 14. acute main portal vein thrombosis in patients with hepatocellular carcinoma

Keywords: hepatic encephalopathy end stage liver disease cirrhosis mars albumin dialysis