Kornimate/medical-research-clean huggingface dataset:
cortical priming to optimize gait rehabilitation in stroke: a renewal

Conditions: Stroke

Summary: achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. in the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. this project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. the project will also aim to understand the neural mechanisms that are associated with response to the intervention.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * first ever monohemispheric stroke \> 3 months since onset * residual hemiparetic gait deficits (e.g. abnormal gait pattern) * able to walk for 5 minutes at self-paced speed. handheld assistive device is acceptable. * walking speed lesser than 1.2 m/s * lower limb fugl-meyer motor score between 15-30 * at least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task exclusion criteria: * general exclusion criteria * severe osteoporosis * contracture-limiting range of motion of lower limb * score of more than 2 on the modified ashworth scale (indicating increased muscle tone through ankle range of motion) * uncontrolled anti-spasticity medications during the study period * score less than 6 on the fugl-meyer sensory assessment scale for the lower limb * cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema) * unhealed decubiti, persistent infection * significant cognitive or communication impairment (mini-mental state examination (mmse)\<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task. * lesions involving the brainstem and cerebellum * failure to pass the graded exercise stress test tms exclusion criteria * implanted cardiac pacemaker * metal implants in the head or face * unexplained, recurring headaches * history of seizures or epilepsy * currently under medication that could increase motor excitability and lower seizure threshold * skull abnormalities or fractures * concussion within the last 6 months * currently pregnant tdcs exclusion criteria * skin hypersensitivity * history of contact dermatitits * history of allodynia and/or hyperalgesia * any other skin or scalp condition that could be aggravated by tdcs

Keywords: tdcs walking
an extension study of omalizumab in participants with chronic rhinosinusitis with nasal polyps

Conditions: Nasal Polyps; Chronic Rhinosinusitis

Summary: the overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, phase iii studies ga39688 (nct03280550) or ga39855 (nct03280537). participants will be eligible for enrollment in the study at, or within 28 days after, the week 24 visit of studies ga39688/ga39855. after enrollment into this open-label extension (ole) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. baseline in this ole study is defined as the last pre-treatment measurement prior to randomization in studies ga39688/ga39855 (i.e., baseline of studies ga39688/ga39855). the data that will be reported from baseline to week 24 inclusive will come from studies ga39688/ga39855.


Eligibility criteria:
inclusion criteria: * ability to comply with the study protocol, in the investigator's judgment * participation in study ga39688 or ga39855, including completion of endoscopy and other assessments at week 24, without discontinuation of study drug * completion of ediary daily assessments for at least 4 out of 7 days in the week prior to the week 24 visit of study ga39688 or ga39855 * for women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 60 days after the last dose of study drug exclusion criteria: * anaphylaxis/hypersensitivity related to study drug in study ga39688 or ga39855 * serious adverse events related to study drug in study ga39688 or ga39855 that the investigator or sponsor determines may jeopardize the patient's safety if he or she continues in the study * uncontrolled epistaxis within study ga39688 or ga39855 * pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab * any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
sevoflurane protective effect on ischemia reperfusion injury in microvascular surgery

Conditions: Microvascular Breast Flap in Plastic Surgery

Summary: this study aimed to evaluate the possible protective effect of anesthetic technique balanced (bal) compared to total intravenous anesthetic technique (tiva-tci) in ischemia reperfusion injury in microvascular flap in plastic surgery. the investigators will evaluate the viability of the flap using tissue oximetry monitoring and the level of biochemical markers in a circle at the end of the intervention.


Eligibility criteria:
inclusion criteria: * age \> 18 yr * asa (american society of anesthesiology) i-ii exclusion criteria: * known unusual reaction to anesthetic drugs * evaluation of anesthesia increased risk for malignant hyperthermia. * history of vascular disease. * history of bleeding diathesis. * tabagism
cd0104 vest ii post marketing surveillance study

Conditions: Coronary Artery Bypass Surgery

Summary: this study is designed to collect post market data on use of the vest, particularly on saphenous vein grafts to the right territory of the heart.

the primary objective is to test the early-mid term patency rate of vest supported right coronary artery (rca) bypass grafts. the research participants will undergo cabg preparations and cabg procedure routinely as is the standard of care. during the procedure the vest will be implanted on the vein graft to the right coronary artery according to the ifu. perioperative care is according to standard of care. upon discharge patient will be prescribed statins and aspirin for 6 months. patient will attend a routine clinic visit 4-6 weeks post operatively. the last study visit will occur 3-6 months post operatively. patients will undergo a noninvasive coronary ct angiography.

Eligibility criteria:
inclusion criteria: 1. patient scheduled for on-pump cabg on clinical grounds 2. at least one vein graft bypass indicated for right coronary artery and lima indicated for the lad on clinical grounds 3. appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed, as assessed from the pre-operative cardiac angiography. exclusion criteria: 1. concomitant non-cabg cardiac procedure 2. prior cardiac surgery 3. emergency cabg surgery (cardiogenic shock, inotropic pressure support, iabp) 4. contraindication for on-pump cabg with cardioplegic arrest (e.g. severely calcified aorta) 5. calcification at the intended anastomotic sites, as assessed upon opening of the chest and before vest implantation. 6. prior debilitating stroke less than 1 year before surgery 7. severe renal dysfunction (cr\>2.0 mg/dl) 8. concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
liposomal amphotericin b for the treatment of cryptococcal meningitis

Conditions: Cryptococcal Meningitis

Summary: to evaluate the safety and efficacy of liposomal amphotericin b and amphotericin b deoxycholate with or without flucytosine followed by fluconazole for the treatment of cryptococcal meningitis.

subjects who meet all eligible requirements will be randomized into study group （lipo-ab）or control group（amphotericin b deoxycholate） in 2:1 ratio. subjects will be treated with induction therapy in study group or in control group with flucytosine for at least 14 days, and followed by consolidation therapy for another 56 days after csf sterilization.

Eligibility criteria:
inclusion criteria: 1. adults with age of at least 18 years. 2. within 7 days prior to, or at the time of screening visit, patient with cryptococcus meningitis, diagnosed by : 1. csf india ink staining positive or 2. csf cryptococcal antigen test positive or 3. csf culture positive 3. patient or his/her legally acceptable representative has signed the written informed consent form. exclusion criteria: 1. patients have laboratory abnormalities within 3 days prior to screening visit : 1. alt \> 5x unl, 2. ast \> 5x unl, 3. creatinine \> 2mg/dl 2. patient is pregnant or lactating. 3. patient participate other investigational drug trial within 1 month before entering this study. 4. patient has some indications that another systemic antifungal drug would be needed in addition to assigned drugs in study. 5. patient had contraindication of amphotericin b or azole. 6. patient is not available for lumbar puncture. 7. patient with life expectancy less than 5 days.

Keywords: cryptococcal meningitis
alcohol and breast cancer (abc) trial

Conditions: ER+ Breast Cancer; Breast Cancer; Aromatase Inhibitors

Summary: this research study is a pilot study, which is the first time investigators are examining the effect of light alcohol consumption on sex hormones among postmenopausal women with estrogen receptor-positive (er+) breast cancer taking an aromatase inhibitor the names of the study exposures involved in this study are: * white wine * white grape juice

this research study is trying to to help understand whether light alcohol consumption causes short-term changes in the levels of estrogen, progesterone and testosterone, called sex hormones, among postmenopausal women with estrogen and/or progesterone receptor positive breast cancer taking estrogen-blocking medications called aromatase inhibitors. the research study procedures include one screening visit to obtain informed consent, four study visits with blood draws, and ten weekly phone calls and online questionnaires over the ten weeks of the study. this research study involves 10 weeks of participation, including 3 weeks consuming one serving of white wine daily, 3 weeks consuming one serving of white grape juice daily, and 2 weeks of drinking neither alcohol nor grape juice before each of these 3-week drinking periods. in this experimental study, participants will be asked to drink white wine and white grape juice, which are not consumed as the standard of care. the u.s. food and drug administration (fda) has not approved alcohol as a treatment for any disease. it is expected that about 20 women will take part in this research study.

Eligibility criteria:
inclusion criteria: * er+ breast cancer * female sex at birth * postmenopausal, either natural or induced * self-reported consumption of at least one alcoholic drink per week but not more than one serving per day * currently prescribed aromatase inhibitors including anastrozole (arimidex®), letrozole (femara®), and exemestane (aromasin®) * documented liver function test results below 1.5x the upper limit of normal within 12 months of screening exclusion criteria: * self-reported consumption of more than one drink per day, a previous or current history of alcohol abuse based on standard questionnaires (audit≥8), or consumption of more than 4 or more drinks in one day within the last 6 months * currently undergoing cytotoxic chemotherapy or radiation or planned in the next two months * any surgery planned in the next two months * alcohol flushing syndrome * current use of any pharmaceutical agent contraindicated with alcohol, including warfarin, dual antiplatelet therapy, and metronidazole * hemoglobin a1c\>8% or a fasting glucose result above 180 mg/dl within 6 months of screening * unable to speak or understand english * unable to understand and provide informed consent, as judged by the study team

Keywords: er+ breast cancer breast cancer aromatase inhibitors anastrozole letrozole exemestane
"all comers" post market clinical follow-up (pmcf) with multi-loc for flow limiting outcomes

Conditions: Peripheral Arterial Occlusive Disease

Summary: the aim of the study is to assess the safety and efficacy of the multi-loc® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (isr), no restenosis post drug coated balloon (dcb) after flow limiting plain old balloon angioplasty (poba) and/or dcb dilatations in the superficial femoral artery (sfa) and popliteal segments (p1, p2 \& p3)

this study is an non-randomized, prospective, multi-center, non-interventional study (registry, for germany: §23b mpg)

Eligibility criteria:
inclusion criteria: * willingness to treat flow-limiting dissections/recoil after plain old balloon angioplasty (poba)/drug coated balloon (dcb) interventions * patients in rutherford classes 2 through 5 * patients eligible for peripheral revascularization by means of percutaneous transluminal angioplasty (pta) and stenting * patients must be at least 18 years of age * patient with a life expectance of at least 12 months * patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol * patients must agree to undergo at least the 6-month clinical follow-up * patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of other suitable stent devices. patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document. * lesions with unsatisfying angiographic results due to recoil and/or dissections after poba/dcb interventions * infra-inguinal lesions in the superficial femoral artery (sfa) and popliteal segments (p1,p2 \& p3) reference vessel diameters between 4 and 7.0 mm, lesion length suitable for the release of at least 2 stent (up to 6) segments implanted with a minimum inter-stent distance of 1 cm * diameter stenosis pre-procedure must be larger or equal to 70% * vessels must have adequate distal run-off with at least one vessel to the foot or with collaterals in the calf supplying sufficient flow to the foot. (lesions separated by less than 2 cm are considered as one lesion) exclusion criteria: * patient not suitable for revascularization by interventional means
traditional print communication methods, simple electronic communication methods, or usual care in increasing how often older women undergo colorectal cancer screening

Conditions: Colorectal Cancer

Summary: rationale: finding out which communication method affects a participant's decision to undergo colorectal cancer screening may help increase the number of participants who undergo screening. it is not yet known which communication method is more effective in increasing how often participants undergo colorectal cancer screening. purpose: this randomized clinical trial is studying traditional print communication methods to see how well they work compared with simple electronic communication methods or usual care in increasing how often older women undergo colorectal cancer screening.

objectives: * compare traditional print versus simple electronic communication versus usual care, in terms of increasing colorectal cancer (crc) screening rates, in average-risk women attending a routine ob/gyn visit. * explore the moderating role of attentional style and background variables on the impact of the interventions in these participants. * determine the mediating effect of potential cognitive-affective factors related to crc screening in these participants. * investigate the comparative cost-effectiveness of these interventions to improve crc screening adherence. outline: this is a randomized study. participants are randomized to 1 of 3 screening arms. * arm i: participants are contacted by simple electronic communication methods by an email message linked to a personalized website. * arm ii: participants are contacted by traditional print communication methods. * arm iii: participants are observed (usual care). participants in arms i and ii are randomized a second time to receive messages about colorectal cancer screening that are matched or mismatched to their attentional style. projected accrual: a total of 5,000 participants will be accrued for this study.

Eligibility criteria:
disease characteristics: * at average risk for colorectal cancer (crc) as defined by the following criteria: * asymptomatic without a personal history of colorectal polyps or cancer * no inflammatory bowel disease * no family history of familial adenomatous polyposis or hereditary nonpolyposis crc * no crc in more than one first-degree relative * nonadherent with standard crc screening recommendations at the time of index ob/gyn appointment patient characteristics: * email accessible at home and/or work * able to communicate with ease in english prior concurrent therapy: * not specified

Keywords: colon cancer rectal cancer
multiple dose japanese bridging study

Conditions: Alzheimer Disease

Summary: the purpose of this study is to assess the safety and tolerability of multiple oral daily doses of bms-708163 in healthy young male subjects


Eligibility criteria:
inclusion criteria: * healthy japanese and non-japanese subjects * japanese subjects must be first generation japanese and must demonstrate both maternal and paternal japanese ancestry * non-japanese subjects must not be of japanese or asian descent, ie, neither parent nor grandparent was born in japan or in any asian country * bmi of 19 to 25 kg/m², for japanese and non-japanese subjects * men ages 20 to 45 years exclusion criteria: * serum creatinine values above the normal range * urine protein or blood levels above the normal range * liver function tests above the normal range * tsh, free t3, or free t4 outside the normal range * amylase or lipase levels above the normal range * positive fecal immunochemical test (fit™)
genicular nerve block in juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis; Persistent Knee Arthritis; no Intra-articular Injection in the Last 3 Months; no Other Cause for Chronic Kneearthritis

Summary: n=104 juvenile idiopathic arthritis patients diagnosed after ilar criteria with unilateral persistent knee arthritis. they will be randomly assigned into two groups; group 1 will receive genicular nerve block, group 2 intra-articular triamcinolone. both groups will be examined by solar ultrasound scoring system, visual analogue scale and lysholm score at 0, 2 and 12 weeks. a semi-quantitative score will be used to assess tenderness and swelling at the same intervals.


Eligibility criteria:
inclusion criteria: * juvenile idiopathic arthritis with persistent knee arthritis * age below 16 exclusion criteria: * severe knee osteoarthritis * peripheral neuropathy, * psoriatic arthritis, * those under anticoagulant therapy, skin infection, * prior knee injection in the last 3 months3 * those who have an allergy to bupivacaine

Keywords: juvenile rheumatoid arthritis knee joint nerve block
nocturnal continuous positive airway pressure in chronic obstructive pulmonary disease patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: static hyperinflation is frequent in chronic obstructive pulmonary disease (copd) , resulting in increased end expiratory lung volume and positive end expiratory pressure (peepi) at the end of a normal expiration. static hyperinflation worsens the work of breathing is increases patient's dyspnea. the application of a continuous positive airway pressure (cpap) has been shown to improve static hyperinflation and to decrease the work of breathing. sleep is deteriorated in copd patients, and causal factors includes static hyperinflation. the purpose of our study is to assess the effect of nocturnal cpap on sleep quality and functional respiratory parameters.

chronic obstructive pulmonary disease (copd) is characterized by an airflow obstruction, inducing a flow limitation. as a consequence, we observe in these patients an increased end expiratory lung volume and a positive end expiratory pressure (peepi) at the end of a normal expiration. patients are breathing at higher pulmonary volumes: this is the concept of static hyperinflation. this worsens the breathing pattern because in this situation, the work of breathing is increased such that dyspnea increases. the application of a continuous positive airway pressure (cpap) has been shown to improve static hyperinflation and to decrease the work of breathing. sleep is deteriorated in copd patients, and causal factors includes static hyperinflation, cough, depression. moreover, normal physiological changes occuring during sleep in copd patients are leading to deterioration of gaseous exchanges. the purpose of our study is to assess the effect of nocturnal cpap on sleep quality and functional respiratory parameters.

Eligibility criteria:
inclusion criteria: * stable chronic obstructive pulmonary disease patients exhibiting a fev1\<80 %, exclusion criteria: * known sleep apnea syndrome or other sleep disease interfering with sleep quality * body mass index \> 30 kg/m2 * heart failure * hypnotics intake