Kornimate/medical-research-clean huggingface dataset:
research on the treatment of metastatic colon cancer patients treated by folfoxiri

Conditions: Colorectal Cancer

Summary: colon cancer with metastase in the diagnose time account for one significant rate and has a increasing trend. the treatment result of this patient group rests modest. the biological therapeutic treatment is still expensive for major part of vietnamese patients. so that, research on a new affordable and efficacious chemotherapy combination for these patients is extremely necessary in our country the purpose of the study is to comment somes clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable. the second aim is to evaluate the treatment result and toxicity of folfoxiri in these patients

in the world, colorectal cancer is the third most common cancer in male and the second most common cancer in female. in vietnam, the disease is the fourth cancer in male, the sixth cancer in female and increasing recently. about 20-40% of the colon cancer patients had distant metastasis at the time of diagnose, those treatment outcome remains poor (5years survival is about 11%). the targetted therapy medications are still not affordable for majority of vietnamese patients. so that, 3 cytotoxic drugs (5-fluoro-uracil, oxaliplatin and irinotecan) remain back-bone in the treatment of metastatic colon cancer. according to one meta-analysis, the overall survival rate significantly correlated to the use of all 3 these drugs in the treatment time. if patients were give two drugs as the doublet in a line (folfox/xelox, folfiri/xeliri), not 100% of patients are treated with all 3 these drugs because some abandonned the following treatment lines. so, the trials that give all 3 drugs in a line (first-line) as triplet (folfoxiri) were carried out and had primirily good outcome. in 2010, folfoxiri were recommended in nccn guideline. in vietnam, folfoxiri has been applied to treat patient since 2013. however, since then there was no clinical trial to evaluate the efficacy and the toxicity of this combination. therefore, we carried out the work "research on the treatment of metastatic colon cancer patients treated by folfoxiri"

Eligibility criteria:
inclusion criteria: * 39 colon cancer patients with metastase at the diagnotic time, impossiblity of radical resection, adenocarcinoma, treated by at least 3 cylces of folfoxiri in the first-line in the oncology and palliative care department, ha noi medical university hospital, from september 2013 to april 2017
healthy body & mind program for older adults living with osteoarthritis and cognitive decline

Conditions: Cognitive Decline; Osteoarthritis

Summary: the goal of this pilot randomised clinical trial is to compare a 12-week healthy body \& mind program to usual care in older adults living with cognitive decline and osteoarthritis. the main questions it aims to answer are: * does the healthy body \& mind program improve health-related quality of life in older adults living with cognitive decline and osteoarthritis (pre/post and intervention/control)? * does the healthy body \& mind program improve other health outcomes (cognition, pain, anxiety/depression, physical function) in older adults living with cognitive decline and osteoarthritis (pre/post and intervention/control)? participants will complete a co-designed and multidisciplinary 12-week program that includes physical activity and lifestyle education (nutrition, social activity and managing anxiety/depression). researchers will compare outcomes between the intervention group and a wait-list control to see if there are difference in outcome measures (quality of life, cognition, pain, anxiety/depression, physical function).


Eligibility criteria:
inclusion criteria: * adults aged 55 or above. * montreal cognitive assessment score 18-25 indicating mild cognitive decline or mild dementia. * diagnosed with osteoarthritis. * able to safely undertake study assessments and complete exercise without assistance. exclusion criteria: * montreal cognitive assessment score below 18. * display an abnormal cardiovascular response to exercise (as seen during the baseline exercise test) and your doctor does not provide medical clearance to exercise. * are unable to speak english and do not have a translator. * have orthopedic or neuromuscular limitations that prevent you from performing the exercise. * are deemed unsuitable for group exercise sessions following initial assessment by an accredited exercise physiologist within the unsw lifestyle clinic.

Keywords: dementia lifestyle multidisciplinary physical activity nutrition depression anxiety pain osteoarthritis cognitive decline
adjuvant radiation therapy vs. watchful waiting following radical prostatectomy in high risk prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to determine whether adjuvant radiotherapy following radical prostatectomy in prostate cancer patients with positive margins or capsular penetration improves biochemical, overall and/or cancer specific survival and whether adjuvant radiotherapy is reasonably well tolerated when compared to watchful waiting.

in this study the investigators will evaluate adjuvant radiation therapy vs. watchful waiting in prostate cancer patients with positive margins or capsular penetration after radical prostatectomy. this is a randomized, open label, multicentre, collaborative study of finnprostate group and finnish radiation oncology group.

Eligibility criteria:
inclusion criteria: patients with pt3an0m0 or pt2n0m0 prostate cancer with a positive margin, gleason score 2-10, preoperative psa \< 20 ug/l, postoperative psa \<0.5 ug/l after surgery (within 8 weeks), the who performance status 0-2, life expectancy at least 3 months, informed consent obtained. exclusion criteria: other simultaneous cancer therapy including systemic endocrine therapy; more than 12 weeks has elapsed since surgery for prostate cancer; metastatic disease (n+ or m1); cancer invasion to the seminal vesicles; any other previous malignancy within the last 5 years except basalioma or squamous cell carcinoma of the skin; any contraindication to irradiation (severe locoregional infection, prior radiation therapy to the prostate/bladder); any physical or mental condition, which in the opinion of the investigator, may interfere with patient's ability to comply with scheduled visits.

Keywords: radiotherapy, adjuvant prostatectomy
buphenyl therapy for byler's disease

Conditions: Byler Disease

Summary: this is a single patient compassionate use protocol to determine whether buphenyl (4-phenylbutyrate) will improve the poor bile flow associated with byler disease.


Eligibility criteria:
inclusion criteria: * byler disease * cholestasis unresponsive to pharmacologic therapy exclusion criteria: * allergy/hypersensitivity to buphenyl
mr evidence of cardiac inflammation post-stroke

Conditions: Stroke, Ischemic; Inflammation; Myocardial Injury

Summary: the present study is an investigator initiated, single-centre, prospective, proof-of-concept cohort study aiming to enroll 44 patients with acute middle cerebral artery (mca) ischemic stroke, involving the right (n=22) and left (n=22) mca territories and 24 control patients with acute focal neurological symptoms but no evidence of acute brain infarct on dwi-mri.

the present study is an investigator-initiated, single-center, prospective cohort study. the study aims to enroll 44 patients with acute/subacute middle cerebral artery (mca) ischemic stroke. the investigators will compare inflammatory markers among 44 patients with mca ischemic stroke within 10 days post-stroke vs. 60±15 days post-stroke. other measures to be determined at both time points include b-type natriuretic peptide and systemic inflammatory markers.

Eligibility criteria:
inclusion criteria: • acute ischemic stroke in the right or left mca territory. acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on head computed tomography or diffusion-weighted imaging (dwi) mri of the brain showing restricted diffusion. exclusion criteria: * history of known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention. * previous stroke (occurred within 3 months before the index event) * impaired renal function defined as a creatinine clearance \<97 ml/min in men or \<88 ml/min in women, according to the cockcroft formula. * hs-tnt \>100 on routine acute stroke baseline bloodwork upon admission. * clinically or neurologically unstable patients as per the treating physician. * ongoing infection or recent infection within the previous 3 months * surgery within 3 months before the stroke * concurrent and active inflammatory conditions (connective tissue diseases, rheumatological disease, etc.) or use of anti-inflammatory medications * pregnancy, stage iv renal insufficiency, egfr \<30, and any other contraindications to the use of gadolinium. * stroke with symptomatic hemorrhagic transformation * subjects will be excluded if they fail the lhsc standard mri screening questionnaire (cardiac pacemakers/wires, aneurysm clips, shunt/surgical clips, shrapnel/bullets, dentures or metal braces, intra-uterine devices, heart valves, ear implants, prostheses, medication patches such as nicoderm, habitrol, or transderm-nitro, claustrophobia, history of a head or eye injury involving metal fragments.
effect of melatonin on sleep quality in patients dementia

Conditions: Sleep Disorders; Dementia

Summary: introduction: patients with dementia may suffer from poor sleep quality. disturbance in the metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in dementia. objective: to evaluate the efficacy of low dose exogenous melatonin in improving sleep quality. design: a single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations. participants: the investigators calculated a 40 individuals aged 65 years or over with a diagnosis of mild-moderate dementia (clinical dementia rating 1-2). intervention: patients were randomized to receive either 5 mg of melatonin or placebo every night for 8 weeks. measurements: the primary outcome was sleep quality according to the pittsburgh sleep quality index (psqi).

this is a single-center study. the study protocol, informed consents, and amendments were approved in writing by the appropriate local site independent ethics committee (iec)/institutional review boards (irb) (ethics committee of the universidad autónoma de nuevo león, school of medicine). the patients were recruited as outpatients from the geriatrics clinic. a total of 67 patients were screened out of which 40 male and female patients diagnosed with mild to moderate dementia were recruited to the study. following inclusion, all patients underwent randomization to treatment with melatonin (5 mg orally) or placebo for 8 weeks. to prevent bias, matching placebo tablets, which were identical in appearance, taste, and odor, were used. the treatment was double-blinded, with two parallel treatment groups. selection for a treatment group was determined by a computer-generated randomization list, in a 1:1 ratio using the randomized permuted blocks method.

Eligibility criteria:
inclusion criteria: * older than 60 years; * circadian cycle sleep disorder with insomnia (according to diagnostic and statistical manual of mental disorders- v criteria); * mild or moderate dementia (clinical dementia rating 1 and 2); * medications such as anti-depressants, acetylcholinesterase inhibitors, antipsychotics or memantine were allowed as long as they were initiated for over 8 weeks. exclusion criteria: * they had other diagnoses of sleep disorders, known hypersensitivity to melatonin, use of stimulants or hypnotics, recent diagnosis (within 8 weeks) of mood disorders or neuropsychiatric symptoms.

Keywords: melatonin sleep dementia cognition
apoptotic signaling pathways in rats with endometrial hyperplasia

Conditions: Apoptotic Signal Pathways in Endometrial Hyperplasia

Summary: the purpose of the study is to determine apoptotic signaling pathways such as survivin, bcl-2, bax, c-myc and caspase-9 expression levels in rats model with iatrogenic endometrial hyperplasia after metformin and medroxyprogesterone acetate administration.


Eligibility criteria:
inclusion criteria: forty-eight weeks old female wistar-albino rats, weighting between 180 and 260 g exclusion criteria. we have no exclusion criteria because we examine drugs effects in the experimental rats

Keywords: apoptotic signal pathway survivin bcl-2 bax c-myc caspase-9 endometrial hyperplasia endometrium cancer
safety & immunogenicity of glaxosmithkline biologicals' herpes zoster vaccine 1437173a

Conditions: Herpes Zoster

Summary: the purpose of this observer-blind study is to evaluate the safety and immunogenicity of glaxosmithkline biologicals' investigational herpes zoster vaccine gsk1437173a when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (hct) recipients.

the protocol posting has been updated following protocol amendment 2, sep 2009. the sections impacted are: eligibility criteria.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol; * male and female subjects at least 18 years old at the time of vaccination; * serological evidence of prior vzv infection for all subjects born in 1980 or later and for subjects born outside the us before 1980 in a tropical or sub-tropical region. no testing for serological evidence of prior vzv infection is required for us subjects born before 1980; * has undergone autologous hct within the past 50-70 days for treatment of hodgkin lymphoma, non-hodgkin lymphoma (t or b cell), myeloma or acute myeloid leukemia, and there are no plans for additional hcts * written informed consent obtained from the subject; * if the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. exclusion criteria: * use of any investigational non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period; * administration or planned administration of a vaccine that is not part of the study protocol since transplantation. however licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1; * administration of immunoglobulins since transplantation; * previous vaccination against varicella or hz; * history of hz within the previous 12 months; * known exposure to vzv since transplantation; * evidence of active infection at the time of enrollment including a temperature of ≥ 37.5° c or any serious hct-related complication; * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine; * hypersensitivity or intolerance to acyclovir or valacyclovir; * pregnant or lactating female.

Keywords: vaccine safety herpes zoster immunogenicity stem cell transplantation
nimotuzumab in combination with chemoradiation in patients with locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: neoadjuvant (preoperative) concomitant chemoradiotherapy (crt) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (egfr) has been reported to improve the therapeutic effect of radiotherapy in some cancers. this study is a clinical phase ii trial designed to evaluate the efficacy of the combination of nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. age:18-75 years 3. histologically confirmed locally advanced colorectal cancer (adenocarcinoma) 4. the lower edge of the tumors located below 12 cm from the anal verge 5. karnofsky performance scale ≥70 points, life expectancy ≥ 6 months 6. no prior chemotherapy was used 7. no history of regional radiation treatment inthe pelvic cavity 8. adequate hematologic function: hb ≥ 100 g/l , wbc≥3.5×109, anc ≥ 1.5×109 /l，plt ≥ 100×109 /l adequate renal function: cr ≤ 1.5×uln, tb≤2.5 × uln adequate hepatic function: alt/ast ≤ 2.5×uln, alkaline phosphatase ≤ 2.5×uln 9. patients without peripheral neuropathy exclusion criteria: 1. other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ 2. rectal cancer patients with concurrent colon cancer 3. pregnant or lactating women 4. fertile female patients without using any contraceptives 5. allergic to cisplatin and fluorouracil 6. patients with previous peripheral neuropathy 7. serious complications: myocardial infarction, heart failure (nyha classification\>ii grade),psychiatric history and severe diabetes 8. treatment with other anti-cancer therapy(including chinese herbal medicine) 9. organ transplant patients

Keywords: locally advanced rectal cancer neoadjuvant chemoradiotherapy nimotuzumab
travoprost intraocular implant in conjunction with cataract surgery

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from iop-lowering medication, if applicable. eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (pc-iol) will receive a travoprost intraocular implant and followed up for 12 months.


Eligibility criteria:
inclusion criteria: * clinically significant age-related cataract eligible for phacoemulsification in the study eye * open-angle glaucoma or ocular hypertension in the study eye * successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber iol exclusion criteria: * unmedicated (washed out) iop of \>36 mmhg in the study eye * hypersensitivity to travoprost or any other components of the travoprost intraocular implant * vertical cup/disc ratio \> 0.8 in the study eye * best spectacle corrected visual acuity of worse than 20/80 in the fellow eye * any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
manual chest physiotherapy and active cycle of breathing techniques (acbt) in patients of cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis is a genetic disease (autosomal recessive) which involves malfunction of the exocrine glands, leading to abnormal secretions in the body. it is a progressive disease that causes persistent lung infections and limits the ability to breathe over time. clinical symptoms include persistent coughing, at times with phlegm, wheezing or shortness of breath, fatigue, difficulty with bowel movements sinus infections, poor growth, clubbing of the fingers and toes, and infertility in most males. the disease must be managed throughout life with diet, medication and preventive chest physical therapy as soon as any symptoms are noted in the young child. the purpose of the study was to evaluate the difference between the effects of manual chest physiotherapy (cpt) and active cycle of breathing techniques (acbt) in patients of cystic fibrosis. the tools of our study were modified borg dyspnea scale and quality of well-being scale. the total sample of our study was 14 out of which 7 were included in group a and 7 group b. spss 23 was used for statistical analysis and parametric tests were used for analysis


Eligibility criteria:
inclusion criteria: * age limit 5-25 * patients with confirmed diagnosis of cystic fibrosis * male and female. * clinically stable patients exclusion criteria: * hypertensive patients. * intolerant patients. * compromised renal function. * other comorbidities
low dose total skin electron beam radiation therapy and mechlorethamine hydrochloride gel in treating patients with mycosis fungoides

Conditions: Mycosis Fungoides

Summary: this phase ii trial studies how well low dose total skin electron beam radiation therapy and mechlorethamine hydrochloride gel work in treating patients with mycosis fungoides. total skin electron beam radiation therapy uses high energy x-rays directed at the entire surface of the body to kill cancer cells and shrink tumors. mechlorethamine hydrochloride gel may help patients in remission of disease, reduction in disease staging, and enhanced quality of life. giving total skin electron beam radiation therapy and mechlorethamine hydrochloride gel may work better in treating patients with mycosis fungoides.

primary objectives: i. to assess the time to progression of patients treated with total skin electron beam therapy (tsebt) followed by the year-long maintenance mechlorethamine hydrochloride gel (valchlor) regimen. secondary objectives: i. to assess the response rate (complete response \[cr\] and partial response \[pr\]) of patients treated with total skin electron beam therapy (tsebt) followed by the year-long maintenance valchlor regimen.

Eligibility criteria:
inclusion criteria: * documentation of diagnosis as evidenced by one or more clinical features consistent with mycosis fungoides cutaneous t-cell lymphoma * written informed consent obtained from subject or subject's legal representative and ability for subject to comply with requirements of the study * skin biopsy specimen of representative lesion obtained at screening of study and deemed diagnostic of mycosis fungoides by principal investigator * mycosis fungoides patients that have stage t2-4 n0-1 m0b0 disease * availability of subject to be observed for up to 18 months post-screening evaluation * life expectancy greater than 6 months exclusion criteria: * pregnant or breast-feeding females * 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 * patients diagnosed with sezary syndrome; sezary syndrome is equivalent to mycosis fungoides that develops to stage iva/b with b2 (high blood tumor burden) involvement, and as such requires a more aggressive treatment regimen than valchlor or tsebt * underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatment * minimum 3 weeks since prior systematic treatment or phototherapy * exclusion of people that do not understand the risks, such as decisionally-impaired individuals, prisoners, and vulnerable populations
emerging biomarkers in hypertension

Conditions: Hypertension

Summary: first of all to evaluate the relationship between non-conventional biomarkers and essential hypertension; then to evaluate the effects of various anti-hypertensive drugs on blood pressure control and non-conventional biomarkers in naive hypertensive patients


Eligibility criteria:
inclusion criteria: * essential hypertension * naive to treatment * \< 65 years exclusion criteria: * secondary hypertension * previous cardiovascular events