Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety and efficacy of ilv-094 in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to assess the safety and efficacy of different dose regimens of ilv-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.


Eligibility criteria:
inclusion criteria: * meets the american college of rheumatology (acr) 1987 revised criteria for classification of rheumatoid arthritis (ra) for at least 6 months prior to screening * active ra at the time of screening and baseline consisting of \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following at screening: c-reactive protein \>= 10 mg/l or erythrocyte sedimentation rate \>= 28 mm/h * must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit. exclusion criteria: * subjects with other rheumatic diseases * cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer) * any prior use of b cell-depleting therapy

Keywords: rheumatoid arthritis acr methotrexate interleukin-22
time and type dependent evaluation of different techniques for correction of cleft maxillary hypoplasia

Conditions: Maxillary Hypoplasia; Cleft Lip Palate; Orthognathic Surgery

Summary: maxillary hypoplasia in clp deformities results from congenital reduction in midfacial growth and the effects of the surgical scar from clp repair.turvey et al. suggested that this disproportionate jaw growth is the biologic consequence of prior surgical intervention for closure of the soft tissues and is not related to the congenital cleft deformity, midfacial hypoplasia is commonly treated by performing conventional le fort surgery to displace the maxilla anteriorly and stabilization afterward with rigid fixation along with orthodontics treatment. . midface hypoplasia cleft patient has the following characteristics: concave facial profile, inverted nasal tip, wide alar base, acute nasolabial angle, and excessive exposure of sclera. intraoral findings are anterior and posterior crossbite, clp, accentuated curve of spee, class iii dental malocclusion, multiple missing teeth, oronasal communication, and residual cleft. speech disturbances are also usually present due to velopharyngeal incompetency and oronasal communication.


Eligibility criteria:
inclusion criteria: * cleft patients either cleft alveolus or cleft alveolus and palate. * surgically fit patients. * patients ready for orthognathic assessment undergoing either surgical or orthodontics correction. exclusion criteria: * non- cleft cases . * previous correction. * history of active infection or underlying disease such as hematologic disorders neoplasm, and immune deficiency. * patient refused to sign an informed consent.

Keywords: cleft maxillary hypoplasia
exergame on sleep and emotion among students

Conditions: Depression; Sleep; Anxiety; Stress

Summary: this study aims to investigate the feasibility and the potential efficacy of using xbox 360 kinect game among healthcare undergraduate students. thirty-six participants will be recruited and randomly allocated into the intervention and control group. the session will be 30 minutes per session for three times per week. two outcome measures will be used at pre and post intervention.

sleep deprivation and emotional problems such as stress, anxiety and depression commonly occur in university students. exercise is beneficial to ameliorate those problems however university students are not serious to uptake physical activity. commercially available exergame such as xbox 360 kinect is one of the alternatives. this study aims to investigate the feasibility and the potential efficacy of using xbox 360 kinect game among healthcare undergraduate students. a pilot two-armed parallel randomized controlled trial was implemented. a total of 36 undergraduate students was recruited and randomly allocated into the intervention group (playing xbox 360 kinect) or the control group (continue with normal daily routine). the intervention group received 30 minutes of xbox kinect activity, three times per week for six weeks. information on psychology (dass-21) and sleep (fosq-30) status were collected at pre- and post-experiment. the researcher-developed feasibility questionnaire was given to the participants in the intervention group at post-experiment. repeated-measures anova analysis was used to investigate within-between group comparison and significant value was set at p≤0.05. the analysis found potential improvement on sleep (p=0.039) and psychological health (p=0.002-0.067). the intervention protocol is feasible and highly accepted by the participants. required optimum amount of dosage, sample size and used of outcome measures are suggested from the findings. this pilot and feasibility study support the use of xbox 360 kinect games in practice and to be implemented for future research.

Eligibility criteria:
inclusion criteria: * undergraduate healthcare students * able to read and understand english version questionnaire * having bmi \<25 exclusion criteria: * person with condition (i.e. asthma, heart problem) that prevent from participating in active physical activities. * known history of mental health issues * visually impaired students iv. postgraduate students

Keywords: xbox kinect gaming technology stress anxiety depression randomised control trial sleep quality intervention
blue light intraocular lenses (iols) and photostress

Conditions: Cataract

Summary: to determine what effect a blue light filtering intraocular lens (iol) has on macular pigment levels.


Eligibility criteria:
inclusion criteria: * patients with existing bilateral iols of given type, age-matched patients with normal vision and no cataract surgery. exclusion criteria: * age related

Keywords: acrysof iq iol
clinical characteristics and microbiology of healthcare associated pneumonia

Conditions: Healthcare Associated Pneumonia

Summary: background the prediction of multi-drug resistant (mdr) pathogens is a key issue in the management of health-care associated pneumonia (hcap). multiple risk factors have been proposed, some of which overlap with items of the pneumonia severity index (psi). the aim of this study was to investigate the relationship between psi and presence of mdr pathogens. methods patients who were admitted to a tertiary-care hospital from january 2005 to december 2010 were screened by a discharge diagnosis of pneumonia. patients were enrolled if they fulfilled the definition of hcap by 2005 ats/idsa guideline.

mdr bacteria were defined as pseudomonas aeruginosa (p. aeruginosa), enterobacter species, those not sensitive to second and third generation cephalosporins, acinetobacter species, extended-spectrum β-lactamase (esbl) enterobacteriaceae such as escherichia coli (e. coli) and klebsiella pneumoniae (k. pneumoniae), burkholderia cepacia (b. cepacia), stenotrophomonas maltophilia (s. maltophilia), and methicillin resistant staphylococcus aureus (mrsa). the criteria for hcap is defined as follows: patients who had been hospitalized in an acute care hospital for two or more days within the past 90 days; residents of a nursing home or long-term care facility; recipients of recent intravenous antibiotic therapy, chemotherapy or wound care within the past 30 days; or patients who attended a hospital or hemodialysis clinic.

Eligibility criteria:
inclusion criteria: * patients who had been hospitalized in an acute care hospital for two or more days within the past 90 days; * residents of a nursing home or long-term care facility; * recipients of recent intravenous antibiotic therapy, chemotherapy or wound care within the past 30 days; * or patients who attended a hospital or hemodialysis clinic. exclusion criteria: -

Keywords: healthcare associated pneumonia drug-resistant bacteria pneumonia severity index
mechanisms behind antidiabetic effects by gastric by-pass

Conditions: Diabetes Mellitus Typ 2 and Obesity

Summary: the aim of the study is to develop new strategies in treatment of continuous increasing number of patients with type 2 diabetes by understanding how bariatric surgery cures or improves this condition.


Eligibility criteria:
inclusion criteria: * diabetes typ 2 * 18-70 years * bmi \> 35 kg/m2 * treated with oral antidiabetic agents and/or insulin * laparoscopic surgery exclusion criteria: * pharmacological treatment (other then above) witch could affect glucose metabolism * open surgery
alternative paracetamol treatments for the neonate with a hspda

Conditions: Ductus Arteriosus, Patent

Summary: early targeted treatment of a hemodynamically significant patent ductus arteriosus (hspda) during the first week of life in preterm neonates is often recommended. our standard first line therapeutic approach is enteral acetaminophen. however many extremely low birth weight infants may be on limited or no feeds when pda closure is determined to be indicated, thus restricting the use of enteral acetaminophen. several studies have suggested that intravenous acetaminophen is less effective than enteral. thus, in this study, we propose to compare two alternative modes of administration when enteral acetaminophen is not an option.

once parental consent for entrance into the study is obtained, eligible babies will be randomized to receive either iv acetaminophen (perfalgen) by continuous infusion at 2.5 mg/kg/h following a loading dose of 15 mg /kg/ over 20 minutes or rectal acetaminophen at 15 mg/kg every 6 hours for a period of 3 days.

Eligibility criteria:
inclusion criteria: inborn preterm neonates, \< 1000 gm birth weight; \< 28 weeks' gestational age; who are admitted to the neonatal intensive care unit of the shaare zedek medical center and are diagnosed with a hemodynamically significant patent ductus arteriosus within the first week of life and who are on limited or no enteral feeds - exclusion criteria: other congenital heart disease, major congenital anomalies, sepsis; and/or nec.

Keywords: acetaminophen
radiomics-based ai model for predicting para-aortic lymph node metastasis in gastric cancer patients

Conditions: Gastric Cancer; Para-Aortic Lymph Node Metastasis; Lymphatic Metastasis; Preoperative Imaging Assessment; Radiomics; Artificial Intelligence

Summary: this study aims to develop and validate an artificial intelligence (ai) model based on radiomics features extracted from preoperative ct images to predict para-aortic lymph node (paln) metastasis in patients with gastric cancer. accurately identifying paln metastasis before surgery can help doctors make better treatment decisions, such as whether to proceed with surgery, consider chemotherapy, or use other treatment strategies. the study will prospectively enroll patients who are diagnosed with gastric cancer and scheduled for surgery. all participants will undergo routine imaging tests, and their data will be analyzed using advanced ai techniques. the results of this study may improve the precision of preoperative staging and support personalized treatment planning for gastric cancer patients.


Eligibility criteria:
inclusion criteria: 1. adults aged 18-80 years. 2. histologically confirmed gastric adenocarcinoma. 3. planned to undergo radical gastrectomy with or without para-aortic lymph node dissection. 4. preoperative contrast-enhanced abdominal ct scan available within 3 weeks before surgery. 5. no evidence of distant metastasis on imaging. 6. ecog performance status 0-2. 7. provided written informed consent. exclusion criteria: 1. history of other malignant tumors within the past 5 years. 2. received neoadjuvant chemotherapy or radiotherapy prior to ct imaging. 3. poor-quality or incomplete ct images not suitable for radiomics analysis. 4. severe comorbidities that may affect prognosis or surgical decision-making. 5. pregnancy or breastfeeding. 6. inability to provide informed consent or comply with study procedures.
the effect of semi-solid feeding after percutaneous endoscopic gastrostomy (peg) on the incidence of aspiration pneumonia and postoperative length of stay

Conditions: Gastrostomy; Aspiration Pneumonia

Summary: percutaneous endoscopic gastrostomy (peg) is a minimally invasive procedure for long-term enteral tube feeding in patients with insufficient oral intake. although peristomal site infection is often noted as the most common adverse event after peg tube placements, it is seldom life-threatening and considered a minor adverse event. feeding-related adverse events have been identified as the main cause of death after peg, with up to 50% of postoperative early mortality (30 days) being attributed to aspiration pneumonia. this may be related to the persistence of gastroesophageal reflux (ger) of enteral feed after gastrostomy, even though peg have been demonstrated to be superior to nasogastric tube feeding in terms of preventing ger. it has been more than a decade since semi-solid feeds were developed as an alternative to conventional liquid feeds to prevent feeding-related adverse events. unfortunately, there is limited published literature on this topic despite the wide usage of this feeding method in japan. amidst the growing popularity of this method and the introduction of national healthcare insurance coverage for semi-solid feed prescriptions, we initiated a semi-solid feed protocol along with our existing post-peg feeding protocols in 2014.


Eligibility criteria:
inclusion criteria: * patients receiving gastrostomy tube placement in our hospital for enteral nutrition. exclusion criteria: * patients receiving gastrostomy tube placement for decompression * patients with no gut usage more than 2 weeks before procedure
pose - pos surgery endometrial cancer

Conditions: Endometrial Cancer

Summary: this phase i/ii feasibility study of hypo-fractionated, image-guided volumetric modulated arc therapy (vmat) stereotactic body radiotherapy (sbrt) to the vaginal cuff in intermedium and high risk endometrial cancer. the primary endpoints are sbrt feasibility and dosimetrical reproducibility to hdr brachytherapy, inter/intra-fractional target motion assessment and toxicity rates. secondary endpoints are quality of life measures, local control, disease free survival and overall survival.

this phase i/ii feasibility study of hypo-fractionated, image-guided volumetric modulated arc therapy (vmat) stereotactic body radiotherapy (sbrt) to the vaginal cuff aims to reproduce adjuvant high dose rate (hdr) brachytherapy dose distributions in patients operated for intermediate and high risk endometrial carcinoma. the study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time on-line tracking. eligible patients will receive three sbrt sessions to a prescription dose of 7 gy to the vaginal cuff (with 4 to 7 days interval). sbrt will start within 4 to 8 weeks post-hysterectomy. the study will enroll a total of 30 patients. after treatment, patients will be followed-up at 3 months (+/- 6 weeks), at 6 (+/- 6 weeks) and every 6 months (+/- 6 weeks) thereafter for a total of 2 years. the duration of accrual in the study will be up to 3 years. toxicity and outcome will be compared to published data on the standard modality of care (hdr brachytherapy). patients' quality of life measures will be collected with validated questionnaires at the baseline and during follow up. recurrence rates and survival data will be reported.

Eligibility criteria:
inclusion criteria: * pathology proven adenocarcinoma of the endometrium * national comprehensive cancer network (nccn) intermediate and high risk * unstaged patients with \< 50% myometrium invasion; * age ≥ 18; * world health organization - eastern cooperative oncology group (who-ecog) performance status 0-2 or karnofsky performance status (kps) ≥ 70; * hemoglobin ≥ 8.0 g/dl; white blood cells count (wbc) ≥ 1,500/mm3 ; platelets ≥ 40,000 cells/mm3 . * signed informed consent exclusion criteria: * evidence of post-surgical macroscopic residual disease; * patients with anatomical incompatibility with online tracking device; * psychiatric conditions; * prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; * prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields; * severe active co-morbidities.
risk factors for co-existence of cervical elongation in uterine prolapse

Conditions: Pelvic Organ Prolapse

Summary: the presence of co-existence of cervical elongation in women of uterine prolapse may decrease the patients' satisfaction of uterine-preservation surgery for uterine prolapse, and additional surgery, such as manchester surgery, may be needed to solve the problem.thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse.

purpose: thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse. patients and methods: between january 1994 and october 2014, all women underwent vaginal total hysterectomy in a medical center were enrolled in this study. medical records were reviewed. cervical elongation is defined as the presence of cervical length \>3.38 cm or cervix to corpus ratio \>0.79. expected results: the investigators will get the risk factors of co-existence of cervical elongation in uterine prolapse, and the result should be helpful for preoperative consultation, especially for uterine-preserving pelvic floor reconstruction surgery.

Eligibility criteria:
inclusion criteria: * all women with uterine prolapse underwent vaginal total hysterectomy * \> 20 years old. exclusion criteria: * nil

Keywords: uterine prolapse cervical elongation pelvic floor reconstruction surgery
protein intake in patients with coronary heart disease

Conditions: Coronary Heart Disease; Low Protein Intake; Sarcopenia

Summary: sarcopenia is a skeletal muscle disease, characterised by low muscle strength and muscle mass, and associated with higher medical care costs, shorter life expectancy and physical dependence. sarcopenia affects around 1 in 10 older adults in the general population. however, in patients with coronary heart disease (chd), this number is almost 3 in 10. patients who have chd are offered cardiac rehabilitation (cr); a multicomponent programme designed to improve long-term health outcomes. nutritional education is an important part of cr and typically focuses around modifying fat and carbohydrate intake to lower cholesterol levels and achieve a healthy weight. currently there is little focus on increasing protein intake, which might reduce the risk of sarcopenia. eligible patients with chd and low protein intake will receive the standard nutritional education delivered during cr. next, participants will be randomised to one of two groups: protein education (intervention), or standard information (control). whilst covid-19 restrictions are in place, education will be delivered remotely via pre-recorded video. outcome measures, including protein intake, sit to stand performance, sarcopenia risk score (modified sarc-f), physical activity vital signs (pavs) and waist circumference, will be assessed at baseline, at the end of the standard cr programme and after a follow-up period of the same duration as the cr programme.


Eligibility criteria:
inclusion criteria: * aged 50 years or older. * recent diagnosis of coronary heart disease or a cardiac event related to coronary heart disease. * have been offered standard cardiac rehabilitation in a newcastle upon tyne hospitals nhs foundation trust. * usually receive dietary education as part of their cardiac rehabilitation program. * able to understand and undertake the tasks described as part of this study. * able to provide written informed consent. exclusion criteria: * patients advised against participation in light exercise by a medical professional. * patients younger than 50 years. * patients unable to alter their diet due to medical reasons; including patients that have been prescribed artificial feeding, texture modified diets, and specialist renal diets. * patients with known stage 4 or 5 chronic kidney disease. * patients without access to teleconferencing technology or without another adult present (≥18 years; and with capacity to supervise the activity) will be excluded from participating in the remote sit-to-stand test for their safety.

Keywords: protein coronary heart disease rehabilitation telehealth
integrated eye tracking and neural monitoring for tbi: optimization

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) is one of the most frequent injuries affecting service members. unfortunately, current neurocognitive assessment tools are unable to reliably detect mild tbi more than a few days post- injury. therefore, development of advanced systems for assessment and diagnosis of tbi are a top priority within department of defense. this project aims to evaluate a combined electroencephalography (eeg) and eye tracking system capable of assessing compromised cognitive function stemming from tbi, with the goal of enhancing operational readiness and aiding in diagnosis, improving health care and rehabilitation for affected military personnel.

this study (n=100) will be a correlational study to assess cognitive function in healthy controls, individuals with mild tbi, and individuals with moderate-to-severe tbi. in general, participants will provide demographic information, medical history, and details of their head injury. participants will also complete a brief neuropsychological assessment to obtain an index of cognitive ability, along with the fusion test with eye tracking and linked eeg. mri data may also be obtained.

Eligibility criteria:
inclusion criteria: all groups: * ability to use dominant hand to complete cognitive and motor tasks * fluent in english mild tbi group: * history of mild tbi \> 3 months and \< 10 years prior to enrollment * self-report of post-concussive symptoms moderate-to-severe tbi group: - history of moderate or severe tbi \> 3 months and \< 10 years prior to enrollment exclusion criteria: control group: history of possible or confirmed brain injury all groups: * history of a medical condition (other than brain injury) that would be expected to affect cognitive or motor abilities (e.g. muscular dystrophy, multiple sclerosis, or psychotic disorders such as schizophrenia) * presence of neurological condition, such as brain tumor, brain infection, seizure, or stroke * presence of visual impairment that is uncorrected by glasses or contacts (including color blindness) * evidence of current suicidal or homicidal ideation

Keywords: traumatic brain injury, eye tracking, eeg, cognition