Kornimate/medical-research-clean huggingface dataset:
abraxane in treatment of metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this observational project is collecting tolerability, safety and efficacy data with the routine use of abraxane in the treatment of metastatic breast cancer. additionally data on the dosage of abraxane and general data on the disease and the health status of the patient will be collected.

this observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of abraxane in its labelled indication in metastatic breast cancer. additionally data on real life dosing in daily clinical routine will be analyzed. a detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy. this data might also be supportive for further treatment optimization of abraxane in metastatic breast cancer (mbc).

Eligibility criteria:
inclusion criteria: 1. patients with metastatic breast cancer (according to european summary of product characteristics (smpc) 2. signed informed consent 3. participants \> 18 years of age exclusion criteria: 1. pregnant or lactating females 2. neutrophils \<1.5 x 10\^9/l 3. hypersensivity to nab-paclitaxel

Keywords: metastatic breast cancer nab-paclitaxel abraxane
low fructose diet in diabetes type 2

Conditions: Fructose Metabolism Disorder

Summary: diabetes is one of the most common and chronic diseases in the world, with the prevalence and incidence of this disease rising in most societies, especially in iran. suitable treatments for type 2 diabetes include changing lifestyle with exercise, nutrition, and drug use. new research suggests that added sugar, especially fructose, is the main trigger for diabetes and pre-diabetes even more potent than other carbohydrates. fructose has a low glycemic index (23μg =) and slowly increases blood glucose levels. therefore, it is thought that replacing fructose instead of glucose can have a positive effect on glycemic control of diabetic patients..


Eligibility criteria:
inclusion criteria: 1. age of 70-40 years 2. body mass index(bmi) between 18.5 and 27 3. type 2 diabetes people who only control their diabetes by using glucose lowering tablets type 2 diabetes (1 to 10 years) exclusion criteria: 1. pregnancy and lactation 2. thyroid gland disorders 3. kidney disease and inflammation 4. follow the weight loss regimen 6 months before starting the study 5. usage of fatty and fatty foods, fiber powder vitamin a mineral supplements, omega 3 6. taking glucocorticoid drugs and non-steroidal anti-inflammatory drugs
probiotics combined with enteral nutrition reduces postoperative infectious complications in pd

Conditions: Infectious Complications

Summary: probiotics combined with enteral nutrition reduces postoperative infectious complications in pd


Eligibility criteria:
inclusion criteria: * adult patients greater than 18 years of age; * indication for elective pancreaticoduodenal surgery; * patients who understand the nature of the trial and are willing and able to provide written consent exclusion criteria: . current or recent (within the previous 1 month) use of probiotic-based products or antibiotic therapy medications. inability to tolerate pd due to cardiopulmonary function and other parameters * received radiotherapy before surgery * emergency pd surgery * pregnant and breastfeeding women
digital cognitive-behavioral therapy for insomnia in spanish speaking latinas/os (dormir mejor study)

Conditions: Insomnia

Summary: the primary objective of the proposed study is to examine the effectiveness of a culturally adapted digital program of cognitive behavioral therapy for insomnia (cbt-i) compared to minimally enhanced usual care (meuc) on primary outcomes: reduction in insomnia symptoms at 9 weeks and 6 months post-intervention, using a standard scale among spanish-speaking latina/o adults with chronic insomnia.

chronic insomnia is associated with significant public health burden and most adults seek care for insomnia in the primary care setting. while latina/os are at greater risk for insomnia than non-hispanic whites, access to the recommended first-line of treatment, cognitive behavioral therapy for insomnia, is limited especially for spanish-speakers. recent advances in health information technology such as self-guided digital health treatments represent an innovative and scalable means to address the supply and demand imbalance that perpetuate mental health care disparities, however its implementation in underserved communities remains elusive. the purpose of this study is to compare the effectiveness of a culturally adapted digital version of cognitive behavioral therapy for insomnia with minimally enhanced usual care on reduction of insomnia symptoms among spanish-speaking latina/os adults with chronic insomnia. the study will also examine barriers and facilitators to implementation, and examine cost-effectiveness of the intervention.

Eligibility criteria:
inclusion criteria: * insomnia severity index score for moderate insomnia symptoms (score\>10 on iss) * spanish-speaking or bilingual (english and spanish) and self-identify as hispanic or latina/o * report experience of sleep disturbances for at least 3x/week and for at least 3 months exclusion criteria: * pregnancy * excessive sleepiness (score\>=16 on ess) * caregivers of infants (\< 3 months) and/or of adults who require care at night * participants who are deemed unable to complete the study protocol due to dementia, severe cognitive impairment, severe medical or mental illness, or active substance use disorder * untreated moderate to severe obstructive sleep apnea or self-reported narcolepsy * unstable depression or insomnia medication regimen * patients who have full-time transportation/moving occupations * participation in another treatment/intervention study within the time period of initial baseline until the 6-month follow-up assessments * participation in regular night shift work, more than 1x/week, or non-standard sleep patterns

Keywords: insomnia behavioral sleep medicine digital health hispanic latino sociocultural
beta blockers plus intravenous flecainide for paroxysmal atrial fibrillation: a real-world chios registry (betaflec-chios)

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

Summary: betaflec-chios, is a single-center registry that was initiated in the "skylitseion" general hospital of chios in january 2020 and is ongoing. the inclusion criterion is iv flecainide administration for recent-onset af lasting less than 48 hours. oral b-blockers are co-administered in all patients. the main exclusion criteria are severe structural or ischemic heart disease and conduction system dysfunction. continuous monitoring is applied during and after administration of iv flecainide. if no conversion to sinus rhythm is achieved at 2 hours after flecainide infusion, the patient is recorded as "unsuccessful conversion attempt".

patient population betaflec-chios, is a single-center registry that was initiated in the "skylitseion" general hospital of chios in january 2020 and is ongoing. patients are included in the registry if presenting with recent-onset atrial fibrillation (af) (≤48 hours of onset) and lasting ≥30min, documented by a 12-lead ecg and having received intravenous (iv) flecainide on treating physician's discretion. exclusion criteria are severe structural or ischemic heart disease (previous cardiac surgery, any cardiomyopathy, myocardial infarction at any time), atrial flutter, sick sinus syndrome, high degree atrioventricular block, bifascicular block, abnormal electrolyte levels (especially hypo- or hyperkalemia) or known sensitivity to flecainide. continuous monitoring is applied during and after administration of iv flecainide. if no conversion to sinus rhythm is achieved at 2 hours after flecainide infusion initiation, the patient is recorded as "unsuccessful conversion attempt" and forwarded for direct current cardioversion (dcc). all patients were anticoagulated according to the current european society guidelines (esc) or the management of af \[esc afib 2020\]. flecainide administration flecainide is given as an iv infusion of 1.5 mg/kg (max 150 mg) in dw 5% over 10 min under continuous monitoring. concomitant administration of a b-blocker is also applied in all patients. the dose and type of b-blocker are selected according to heart rate during the af and patient's medical history. "time to conversion" is calculated as the time interval from the end of the infusion up to when sinus rhythm is observed on the monitor and confirmed subsequently with a 12-lead ecg.

Eligibility criteria:
inclusion criteria: 1. informed written consent. 2. recent-onset atrial fibrillation (af) (≤48 hours of onset) and lasting ≥30min, documented by a 12-lead ecg 3. administration of intravenous flecainide 4. administration of an oral b-blocker exclusion criteria: 1. age \<18 years 2. severe structural or ischemic heart disease (previous cardiac surgery, any cardiomyopathy, myocardial infarction at any time) 3. atrial flutter, sick sinus syndrome, high degree atrioventricular block, bifascicular block 4. abnormal electrolyte levels (especially hypo- or hyperkalemia) 5. known sensitivity to flecainide
effects of buspar on depressive symptom improvement and neuroprotection in patients with anxiety disorder

Conditions: Anxiety Disorder

Summary: this research aims to investigate the efficacy and safety of buspirone in treating generalized anxiety disorder with depressive symptoms and to evaluate its neuroprotective effects using magnetic resonance imaging.


Eligibility criteria:
patient inclusion criteria: * men and women aged between 20 and 65 * diagnosis of generalized anxiety disorder as assessed by structured clinical interview for dsm-iv (scid-iv) * depressive symptom scores measured by hamilton depression rating scale at screening and baseline assessments: \>=8 and \<=16 healthy control subject inclusion criteria * healthy men and women aged between 20 and 65 exclusion criteria: * presence of any major physical or neurological illness (e.g.， head trauma, epilepsy， seizure， stroke， cerebral tumor， multiple sclerosis，cerebrovascular disease， narrow-angle glaucoma， drug hypersensitivity， etc.) * drug abuse in past 3 months * contraindications to magnetic resonance imaging (e.g., pacemaker implantation，claustrophobia, etc.) * diagnosis of any axis i disorder other than generalized anxiety disorder or presence of symptoms requiring hospitalization * major depressive episode during past 12 months * depressive symptom scores measured by hamilton depression rating scale: \>=17 * women who are pregnant, breastfeeding, or planning pregnancy * contraindications to drugs used in the study (e.g., allergy, intolerance, etc.) * unstable medical illness or severe abnormality in laboratory test at screening assessment * use of psychoactive medications that may affect brain imaging findings * intelligence quotient below 80
evaluation of the clinical effectiveness of a collagen-orc antimicrobial matrix in full-thickness, neuropathic diabetic foot ulcers

Conditions: Foot Ulcer

Summary: this is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of collagen-orc antimicrobial matrix, a new wound dressing, on diabetic foot ulcers.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * ambulatory (i.e. walking is the primary method of mobilization. crutches, walker, walking frame or other ambulation aids are permitted). * diagnosed type 2 diabetic (i.e. not juvenile onset). * have a dfu on the plantar surface of either foot. * have a dfu of \>4 wks but \<6 months duration. * willing and capable of cooperating to the extent and degree required by the study protocol exclusion criteria: * be \ 10cm2 in area, by planimetry. * demonstrate overt signs of infection. * be located on the dorsal, lateral, or posterior heel area of the foot (change 2, amendment 1). * have visible exposed bone or tendon. * have an adjacent thermal injury or wound of an etiology other than diabetes. * be within 5 cm of any other wound, regardless of etiology. * have received enzymatic debriding agents in the past 7 days. * have received topical antibiotic therapy in the past 7 days. * be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement. * have exposed bone or tendon, after debridement the study subject must not: * have received previous treatment for the study ulcer by this investigator. * have more than 3 full thickness ulcers, in total. * be pregnant or nursing an infant * have a concurrent illness or condition which may interfere with wound healing, such as carcinoma, vasculitis, immune system disorders or connective tissue disorder. * be a known alcohol or drug abuser. * have received systemic corticosteroids, immunosuppressive or chemotherapeutic agents in the past 30 days. * have received radiotherapy, which includes the lower extremity, at any time. * have a marked charcot foot or claw foot deformity which would limit the ability of the subject to wear or be compliant with the wearing of the standardized off-loading device used in this study. * have received an investigational drug or device in the past 30 days. * have a known hypersensitivity to bovine collagen, oxidized regenerated cellulose (orc) or silver. * be unwilling or unable to be fitted or compliant with the wearing of an ulcer off-loading device. * known to be non-compliant or unlikely to complete the study. * have abpi \ 1.0 and toe pressure \>0.6. * have serum creatinine \> 3 mg/dl25. have hgb a1c\>9%
nephroureterectomy with and without lymph node dissection for upper tract urothelial cell carcinoma

Conditions: Urothelial Carcinoma

Summary: the goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. the main questions it aims to answer are: * to determine oncologic outcomes, specifically 2-year recurrence-free survival * to determine other oncologic outcomes including treatment-free, cancer-specific and overall survival * to determine time to recurrence and recurrence patterns * to determine use of adjuvant therapies * to determine perioperative complications participants will undergo nephroureterectomy with or without lymph node dissection. researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection.

upper tract urothelial carcinoma (utuc) is a rare disease with complex management. some participants with clinically negative nodes may still receive a lymph node dissection (lnd) with nephroureterectomy, and currently, no randomized controlled trial exists to evaluate the oncologic efficacy of this practice. according to current american urologic association guidelines, nephroureterectomy is the standard of care intervention for high-risk utuc and low-risk utuc is endoscopically unresectable. the aim of the present study is to determine the efficacy, specifically 2-year recurrence-free survival, of lymph node dissection at time of nephroureterectomy for participants with utuc, compared to no lymph node dissection, as well as examine other oncologic outcomes and complication rates

Eligibility criteria:
inclusion criteria: * adults \> 18 years * diagnosis of utuc as determined by upper tract biopsy (either low or high grade) * planned for nephroureterectomy by their urologic surgeon * disease that is ≤ct4, n0m0. participants must have complete tnm staging prior to surgery. ct disease can be determined by biopsy of the mass (if biopsy was deep enough) or imaging (ct/mri). cn and cm stage must be determined by preoperative imaging of the chest, abdomen and pelvis. * no concomitant muscle-invasive bladder cancer * subjects must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (\>cn0) * presence of distant metastases * concomitant muscle invasive bladder cancer * the participant is in a reduced general condition or has a life-threatening disease. * the participant has a psychiatric disorder that precludes them from understanding the consent process.

Keywords: nephroureterectomy kidney and ureter upper tract urothelial cell carcinoma
self-management intervention to improve adolescents' asthma control

Conditions: Asthma

Summary: approximately 1.1 million children and young people in the united kingdom (uk) are living with asthma, making it the most common chronic disease in children in the uk. our recent observational study found that poor asthma control, poor medication adherence, and a poor understanding of asthma were key unmet needs of secondary school children. following the findings from an earlier study, the investigators have developed a preliminary theory-based multi-faceted intervention, aimed at improving asthma self-management and control in young people.

the investigators have developed a theory-driven self-management intervention for children and young people which addresses the barriers to successful self-management, which were identified in an earlier study. the intervention will engage asthmatic teenagers and their peers, and will be delivered in two components. the first component includes a theatre workshop for all children aged 11-13 years in london secondary schools. the aim of this component is to raise awareness of asthma in schools among peers. the second component is a series of four self-management workshops for children with asthma. the aim of this component is to teach children about asthma, using interactive role plays and games. the main topics will include asthma general knowledge and understanding; general practitioner (gp) communication; asthma triggers and symptoms; medication and emergency response; and self-management techniques and goal setting. the children will also receive a toolkit to take home with them, which will include a copy of the workbook that they have used during the day, containing information on what they have learnt. there will also be information on where they can get more help for their asthma. the toolkit will also include information about a smartphone gaming app, which will be about asthma knowledge.

Eligibility criteria:
inclusion criteria: * doctor-diagnosed asthma * aged 11-14 years (uk school years 7-8) * attending the secondary school in which the study is implemented * all children in years 7 and 8 in uk secondary schools are eligible to watch the theatre performance exclusion criteria: * no diagnosis of asthma * not aged 11-14 years (uk school years 7-8) * not attending the school at the time the intervention is delivered

Keywords: self-management children and young people schools
effect of electroacupuncture at different acupoints on bladder function after spinal cord injury

Conditions: Neurogenic Bladder

Summary: neurogenic bladder after spinal cord injury can be divided into detrusor hyperreflexia and detrusor non reflexia. acupuncture is recognized as a safe and effective treatment. the most commonly used acupoints are guanyuan, zhongji and sanyinjiao. the purpose of this study is to clarify the therapeutic effects of different acupoints on different types of bladder. main process: routine urodynamic examination was performed first, and then electroacupuncture was given to guanyuan, zhongji and sanyinjiao points respectively, and urodynamic examination was performed again to observe the effect of electroacupuncture on urodynamic parameters in real time.


Eligibility criteria:
inclusion criteria: * patients diagnosed with traumatic suprasacral sci. * the period of the spinal shock has passed. * patients with voiding dysfunction after sci. * patients had stable condition, and suitable for treatment. * agreed to engage in our study and sign the informed consent. exclusion criteria: * patients with severe primary diseases such as heart, liver, kidney, hematopoietic system, endocrine system and psychosis. * dysuria caused by non spinal cord injury, such as prostatic hypertrophy, urethral obstruction, operation. * patients who have already taken cystostomy and sacral electrode implantation. * patients with urinary tract infection. * autonomic hyperreflexes were obvious. * unable to cooperate with the healer.

Keywords: electroacupuncture neurogenic bladder spinal cord injury
study to characterize demographics, compliance, tolerability and safety in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis prescribed adalimumab (humira®) as part of routine clinical care

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis

Summary: the primary objective of this post-marketing observational study was to obtain data on the characteristics (patient age/gender; disease type, severity and duration; disease specific treatment history; current concomitant medications; other relevant medical history) of patients prescribed adalimumab (humira®) for rheumatoid arthritis (ra), ankylosing spondylitis (as) and psoriatic arthritis (psa) as part of routine clinical care in russia.

this is a non-interventional, observational study in which adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. no data currently exist that characterize patient types and adalimumab administration within the russian population. further, it is important to characterize the compliance, acceptability of patient self-injection, tolerability and safety profile of this therapy option with the routine clinical care. the total follow-up for each participant was planned to be 12 months, with approximately 6 follow-up visits occurring at average intervals of 2-3 months. however, since this was an observational study, follow-up was performed according to routine clinical practice; for 127 participants the follow-up period consisted of more than 12 months and the maximum observation period lasted 18.2 months. follow-up visits were designated sequential visit numbers (visit 1-6), regardless of the time point at which they occurred.

Eligibility criteria:
inclusion criteria: patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria: * patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history. * patients who completed abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter. exclusion criteria: the following patients will not be included in the study: * patients who are being treated or will be treated with drugs at risk of interactions with adalimumab. * hypersensitivity to adalimumab * pregnancy * lactation * age below 18 * infectious diseases including tuberculosis * patients currently participating in another clinical trial.

Keywords: rheumatoid arthritis psoriatic arthritis ankylosing spondylitis