Kornimate/medical-research-clean huggingface dataset:
the icare study: education modules for fracture prevention

Conditions: Osteoporosis; Frailty; Chronic Conditions, Multiple; Fracture

Summary: a large proportion of older adults living in long term care homes are frail and have osteoporosis. with age, there is a gradual and progressive decline in bone quality and quantity and an increase in frailty, which is associated with increased fracture risk. additionally, fractures pose a significant burden to the health and quality of life of long term care residents and contribute to high healthcare costs. despite the high prevalence of osteoporosis, falls, and fractures in long term care, the management of osteoporosis is not optimal among long term care residents at risk of fracture. the aim of this study is to co-design a service provision (i.e., prevent - person-centred routine fracture preevention) with healthcare providers in long term care and to determine the feasibility of implementing prevent in long term care settings.

fractures pose a significant burden on health, quality of life, and mortality of older adults in long term care (ltc) and contribute to high health care costs. prevent (person-centred routine fracture preevention) is a scalable model for delivering routine assessments and interventions on diet and supplements, multifactorial fall and fracture prevention strategies, and medications to long term care teams to treat residents at high risk of fracture. the purpose of the icare study is to create a fall and fracture educational program (i.e., prevent) for ltc healthcare providers to deliver routine assessments for the management and treatment of osteoporosis. the benefit of such a guide may help to reduce the devastating impact of fractures in older adults residing in ltc homes. the aim of this pilot study is to: 1) determine feasibility and 2) adaptations through facilitators and barriers. before a larger trial can be implemented to determine the effectiveness of the prevent program in practice, the icare study seeks to determine the feasibility of implementing prevent in practice and identify strategies to tailor the program to the individual long term care home and care team through design thinking solutions.

Eligibility criteria:
organizational level inclusion criteria: five long ltc homes in ontario that * have a minimum of 70 residents * are publicly owned and private for-profit and private not-for-profit homes in both urban and rural sites individual level inclusion criteria: * at least one internal champion * five professional advisory committee (pac) care teams from five long term care homes in ontario that provide osteoporosis care to residents.

Keywords: frailty service provision education knowledge translation knowledge mobilization osteoporosis fracture prevention long term care
intensity modulated radiation therapy (imrt) radiotherapy for treating prostate pelvic nodes

Conditions: Prostate Cancer

Summary: the purpose of this study is to examine the clinical feasibility and efficacy of uing imrt to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. an increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 gy at 2 gy/fraction). the prostate will receive standard "short course" imrt of radiation (70 gy at 2.5 gy/fraction).


Eligibility criteria:
inclusion criteria: * prostate cancer stage t-t3 * predicted risk of lymph node involvement \> 15% * gleason \> 7 exclusion criteria: * distance metastases * use of anti-coagulant therapy
maggot therapy for wound debridement

Conditions: Pressure Ulcers

Summary: the main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. the secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. we performed a randomized, double-blind, multicenter, controlled, prospective phase iii trial in three referral institutional centers of hospitalized care in caen, lisieux and lyon, france. a total of 120 patients with a non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index (abpi) ≥ 0.8 were included, from march 2005 to december 2008. during two weeks´ hospitalization, patients received either maggot debridement therapy (mdt, changes of bagged larvae twice a week) or classical treatments (mechanical debridement and classical dressings performed three times a week). at discharge, classical dressings were applied and a follow-up visit performed at d30. main outcome measure was the comparison of the reduction of fibrin percentage on wounds treated with mdt and classical treatments at d15. the percentages of fibrin were measured using a computerized planimetry software package, canvas (acd systems, british columbia, canada), which enables the quantification of color surface variations in a wound after manual delimitation (using a mouse) on a series of photographic images.


Eligibility criteria:
inclusion criteria: * patient between 18 and 90 years old * patients with a non-healing fibrinous wound ≤ 40cm2 (pressure ulcer or venous ulcers * pressure ulcers were less than 2cm-deep * limb wounds were venous ulcers with an ankle-brachial pressure (abp)≥ 0.8 * signed informed consent exclusion criteria: * patients pregnant or lactating * patients with neuropathy * patients perforant ulcer of the foot * patients with dementia
epoetin alfa biosimilar in the management of chemotherapy-induced symptomatic anemia in haematology and oncology

Conditions: Chemotherapy-induced Symptomatic Anemia; Solid Tumors; Malignant Hemopathies; Lymphomas; Myelomas

Summary: the main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.

this is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with adults patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anemia and being treated with biosimilar of epoetin to correct haemoglobin levels.

Eligibility criteria:
inclusion criteria: * patients of more than 18 years of age * patients presenting with anemia following chemotherapy * patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following chemotherapy -- the patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle) * patients eligible for epoetin alfa biosimilar treatment exclusion criteria: * patients are not receiving chemotherapy * patients already included in an epoetin zeta trial * patients presenting with a contraindication to epoetin zeta * patients presenting with hypersensitivity to the active principle or any of the excipients * patient with erythroblastopenia or acquired pure red cell aplasia (aprca) * patient with uncontrollable arterial hypertension * patients who cannot receive adequate prophylaxis by antithrombotic agents

Keywords: chemotherapy-induced anemia epoetin biosimilar
study of avandamet® with or without insulin in type ii diabetes mellitus patients. avandamet® is a registered trademark of the gsk group of companies.

Conditions: Diabetes Mellitus, Type 2

Summary: this study was designed to test the safety and efficacy (how well it works) of avandamet in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. avandamet capsules contain a fixed dose of avandia and metformin. both avandia and metformin are medicines which are individually licensed for the treatment of type ii diabetes mellitus. because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.


Eligibility criteria:
inclusion criteria: * patients must have been diagnosed with type ii diabetes mellitus and not have adequate glycaemic controlled while receiving at least 1.5g of metformin. * patients must have a body mass index of greater than 25 kg/m2 and must not suffer from ankle swelling. exclusion criteria: * patients cannot have any form of congestive heart failure or severe or unstable angina. * patients cannot be currently receiving insulin, but be prepared to begin insulin treatment.

Keywords: avandamet insulin type 2 diabetes
electrophysiologic changes in blacks treated with cbt for insomnia

Conditions: Insomnia

Summary: insomnia is a highly prevalent, often debilitating, and economically burdensome condition. reviews of the literature indicate that there are ethnic differences in sleep behavior, with african americans objectively and subjectively reporting more disordered sleep than caucasian americans.chronic insomnia can have a significant impact on mental and physical health outcomes and has been associated with impaired cognitive performance, particularly, in areas of speed, attention, working memory, and executive function. in order to understand the brain mechanisms in sleep disorder both during resting state as well as during cognitive processing, the investigators will assess resting state eeg (during eyes-closed and eyes-open conditions) as well as erp tasks for assessing decision-making and reward processing. the primary objective of the study is to evaluate the effect of a tailored, telephone-delivered cognitive behavioral intervention, versus a self- monitoring control condition, on symptoms of insomnia and its neurodynamic correlates. hypotheses: among blacks subjectively reporting symptoms of insomnia, those randomized to the tailored, telephone-delivered cbt-i, compared with those randomized to the self-monitoring control group, will have: hyp. 1: greater reduction in symptoms of insomnia as measured by the pittsburgh sleep quality index. hyp. 2: greater neurophysiologic improvement (erp, ero) in the intervention condition in response to laboratory paradigms hyp 3: greater improvement in psychosocial functioning including reduction in depression and increase in quality of life.


Eligibility criteria:
inclusion criteria: * a positive endorsement of insomnia items on the sleep disorders questionnaire * self- reported race/ethnicity as black (men and women) * ages 30 to 50 years * accessible by telephone * no plans to move away from the region within the year following enrollment * consent to participate. exclusion criteria: * documented co-existing sleep apnea * self-reported use of sleep medication * impaired cognitive or functional ability precluding meaningful participation * stated intention to move within the same year of enrollment.
applicability of 3d-hdra in patients with primary liver cancer: a randomized controlled trial

Conditions: Liver, Cancer of, Primary Resectable

Summary: this randomized controlled trial was to clarity the clinical feasibility of 3d-hdra results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.

data of patients who received 3d-hdra after primary liver cancer radical reaction and received transarterial chemoembolization #will be collected #excluding incomplete data. the primary endpoint was the one-year disease-free survival(dfs) rate #secondary endpoint was the adverse event.

Eligibility criteria:
inclusion criteria: 1. patients voluntarily cooperated with the study and signed an informed consent form. 2. any gender, age 18 or older, 75 or younger. 3. patients who need to confirm the maximum tumor load (the maximum diameter of a single tumor lesion) before performing radical surgery; patients with a confirmed diagnosis of primary liver cancer after postoperative pathological histological examination. 4. patients with r0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery). 5. child-pugh score of 5-7 (a or b), patients with a score of 7 must be free of ascites. 6. ecog physical fitness status score of 0-1. 7. women of childbearing age with a negative pregnancy test and willing to use effective contraception for the duration of the study. exclusion criteria: 1. patients with recurrent liver cancer. 2. patients with existing extrahepatic distant metastases (including local lymph node metastases or distant organ metastases: e.g., lung, brain, bone, etc.) at the time of diagnosis. 3. treatment with other experimental drugs or other interventions after radical resection. 4. patients with other malignant tumors that have not been cured within 5 years. 5. patients with non-radical resections (r1 and r2 resections). 6. patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery. 7. patients in whom death occurred within 30 days after surgery.
restoring neural oscillatory communication in developmental dyslexia

Conditions: Developmental Dyslexia

Summary: developmental dyslexia (dd) is a multifactorial disorder that hampers the education of about 10% of individuals across cultures and is associated to both phonological and visual deficits. the latter have been linked to a deficit in the magnocellular-dorsal (m-d) visual stream, that has a critical role in guiding the activity of ventral visual stream areas where letters identity is extracted. here, we will test the efficacy of transcranial alternate current stimulation (tacs) of the m-d stream combined with reading trainings in adult participants with dd, assessing the neurophysiological underpinnings of these new trainings with eeg and fmri/dti.


Eligibility criteria:
inclusion criteria: * adult patient (age between 18 and 35) * official diagnosis of developmental dyslexia (dd) * normal or corrected-to-normal vision and hearing * normal motor skills exclusion criteria: * participants that cannot sign the consent form * participants unable to read or understand and correctly complete the procedures foreseen by the study * participants with a diagnosis or personal history of epilepsy or patients with a positive family history of epilepsy * pregnant or breastfeeding patients * participants with major psychiatric or neurological disorders and/or currently in psychopharmacological treatments. * participants with metal implants in the brain, pacemakers, brain stimulators, cochlear implants. * participants with claustrophobia (only for fmri)
kidney function in obese women

Conditions: Kidney Function Tests

Summary: the goal of this clinical trial is to investigate the impact of a 10-week moderate intensity interval walking training (miiwt) program on kidney function markers in obese postmenopausal women. the main question it aims to answer is: does miiwt improve kidney function markers in this population? researchers will compare miiwt (designed to training group) to non-training intervention (designed to control group) to see if the training program works to improve kidney function markers. participants in training group will: perform a 10-week miiwt program, four sessions per week (5 repetitions of 6-min-walking-test (6mwt) at 60-80% of 6mwtdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). participants in control group will : not perform any physical training and maintain their usual daily activities.

the convergence of the obesity pandemic and the postmenopausal status is likely associated with renal function decline. regular aerobic training have been shown to prevent adverse health outcomes in obese. the main purpose of this study was to evaluate changes in kidney function markers and white blood cell (wbc) subpopulations in obese postmenopausal women participating in moderate intensity interval walking training (miiwt). a total of 36 obese postmenopausal women were randomized to miiwt (con, n=18) or control group (con, n=18), four times a week for 10-week. the miiwt consisted on 5 repetitions of walking for 6-min at 60-80% of the 6-min-walk-test-distance with 6-min of active recovery between repetitions. before and after the miiwt, body composition, kidney function markers (serum creatinine \[scr\], blood urea nitrogen \[bun\], serum uric acid \[sua\] and glomerular filtration rate \[gfr\] and white blood cells (wbc) count and its specific subpopulations (neutrophils \[neu\], lymphocytes \[lym\], monocytes \[mon\], eosinophils \[eosi\] and basophils \[baso\]) were assessed.

Eligibility criteria:
inclusion criteria: * be aged between 50 and 60 years. * be postmenopausal (absence of menses \> 12 months). * present a bmi greater than or equal to 30 kg/m2. * be free of any special diets in the three months prior to the start of the intervention. * have a sedentary lifestyle (exercise less than 2 h/week). exclusion criteria: * suffering from any cardiovascular/renal/pulmonary/metabolic disease. * being under menopausal hormone therapy. * presenting any orthopedic limitations interfering the ability to perform the study intervention.

Keywords: glomerular filtration rate neutrophils obesity serum creatinine walking training white blood cells
the effect of ventilation on cerebral oxygenation in the sitting position

Conditions: Cerebral Ischemia

Summary: the aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (bcp)

recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (scto2) using non-invasive probes. a high incidence cerebral desaturation events (cde-defined as a decrease in scto2 values below 20% of baseline measures or absolute scto2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in bcp with hyperventilation. the investigators hypothesize that the incidence of cde will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (etco2) of 40-42 mm hg) when compared to subjects hyperventilated (etco2 of 30-32 mm hg) in the operating room. patients undergoing shoulder surgery in the bcp will be randomized to a hypocapnic group (etco2 of 30-32 mm hg) or a normocapnic group (etco2 of 40-42 mm hg). cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative scto2 values and the incidence of cde. the investigators previously observed an association between cde in the operating room and postoperative nausea and vomiting. therefore, the effect of ventilatory pattern and intraoperative scto2 on clinical recovery will also be determined.

Eligibility criteria:
inclusion criteria: * patients presenting for elective shoulder arthroscopy under general anesthesia in the bcp. exclusion criteria: * exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age \< 18 years 3) american society of anesthesiologists physical status iv or v.

Keywords: cerebral desaturation events cerebral oximetry beach chair position
osteoprotegerin before and after periodontal surgery

Conditions: Chronic Periodontitis

Summary: the study hypothesis: is osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?

assessment of osteoprotegerin in patients with chronic periodontitis before and after periodontal surgery in gingival crevicular fluid, saliva and gingival tissues.

Eligibility criteria:
inclusion criteria: * severe chronic periodontitis, having pocket depth of ≥ 5 mm and clinical attachment level ≥ 5 mm exclusion criteria: * pregnant women * subjects had \<22 permanent teeth * having any given systemic disease * taking any type of medication and/or antibiotic therapy during the 3 months before the study * received periodontal treatment within the past 12 months * current or former smokers.

Keywords: osteoprotegerin biomarker chronic periodontitis open flap debridement
a clinical trial comparing efficacy and safety of sunitinib and capecitabine

Conditions: Breast Neoplasms

Summary: to compare efficacy and safety of sunitinib and capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

patient enrollment in this trial was discontinued based on statistical assessment for futility. an independent data monitoring committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25mar2009. patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. there were no safety concerns leading to the decision to terminate the study.

Eligibility criteria:
inclusion criteria: * breast adenocarcinoma * prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. no more than 1 chemotherapy regimen in the advanced setting exclusion criteria: * prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments. * any prior regimen with capecitabine

Keywords: advanced breast cancer metastatic breast cancer treatment resistant treatment failure
conventional vs. distal radial access outcomes in stemi patients treated by pci

Conditions: STEMI - ST Elevation Myocardial Infarction; Myocardial Infarction; Acute Coronary Syndrome

Summary: this clinical trial aims to compare conventional radial access versus distal radial access in patients with stemi undergoing pci. the main question it aims to answer is: • mayor adverse cardiac events (mace) at 30 days in stemi patients treated by pci are not inferior when comparing the distal radial approach versus the conventional radial approach ? participants will: * sign the informed consent to enroll in the clinical trial. * will agree to be treated by pci * will be randomized 1:1 to perform pci by conventional radial or distal radial approach. if there is a comparison group: researchers will compare conventional radial access vs distal radial access to see if the distal approach is not inferior compared to the conventional radial access in order to offer less or equal mace and a similar rate of a successful procedure.


Eligibility criteria:
inclusion criteria: * stemi patients underwent pci. * patent radial access (distal and conventional) * patients who agree to participate in the study and sign the informed consent form. exclusion criteria: * cardiogenic shock. * previous coronary artery bypass grafting (cabg). * absence of palpable radial pulse. * arteriovenous fistula for hemodialysis. * previous radial artery occlusion.

Keywords: stemi distal radial access conventional radial access mace