Kornimate/medical-research-clean huggingface dataset:
reducing anxiety in children undergoing procedures

Conditions: Ambulatory Surgery

Summary: this is a small pilot, feasibility study designed as a quality improvement project. the purpose is to identify anxiety in children aged 4-12 years who will receive a sedated procedure and to see if the use of an ipad as a focused activity will decrease the level of anxiety through a small randomized control trial in the children's perioperative unit.

description: the study is a quality improvement project and designed as a small pilot randomized control trial. participants will be randomly assigned to either group 1 (no intervention) or group 2 (ipad intervention) via a number generator. children randomized to group 1 receive the standard of care with observation and scoring of the mypas-sf occurring at three time points (t1 pre-operative holding area-patient room which is private, t2 induction of anesthesia, t3 awakening from sedation post procedure). children randomized to group 2 will be observed at the same time points (t1, t2, t3) but will additionally interact with an ipad that has a selection of 3 games downloaded (3 games for children ages 4-7 and 3 games for children ages 8-12). the ipad is introduced in between t1 and t2 and then resumed at t3 until discharge from the clinical unit. process: following irb approval, the steps of the study are: 1. . subjects meeting inclusion criteria (age, first sedated procedure, english speaking) will be identified through daily review of scheduled patient lists by study team members. (cpu nurse champions, pi). 2. . potential subjects will be approached in a private area when they arrive for the procedure to make sure they meet the eligibility criteria. information concerning the study will be presented by the cpu nurse champion, pi or research assistant. 3. . if the family is interested in participating in the study, further explanation and consent and assent (as appropriate) will be obtained by the pi or the research assistant from the parent and the child. 4. . a demographic questionnaire will be completed following project consenting and enrollment for both groups. 5. . the mypas-sf (screening tool that requires a 30 second observation at three distinct time points) will be completed for both groups. 6. . the ipad will be given to participants randomized to group 2 t1- child observed in the private holding room area (observation occurs after getting settled in the private room prior to the procedure) t2-child observed prior to the induction of anesthesia (observation occurs just prior to the administration of anesthesia). t3-child observed upon return to private holding area and awakening from anesthesia (observation occurs when child awakens from the anesthesia).

Eligibility criteria:
inclusion criteria: * children admitted for a sedated procedure * must be first sedated procedure * english speaking * ages 4-12 exclusion criteria: * non english speaking * children younger than 4 and older than 12 years * children with developmental disabilities

Keywords: pre-procedural anxiety children pediatric sedation
tetracycline in preventing skin rash in patients who are receiving drugs such as gefitinib and cetuximab for cancer

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: tetracycline may be effective in preventing skin rash that is caused by treatment with drugs such as gefitinib or cetuximab. purpose: this randomized clinical trial is studying tetracycline to see how well it works compared to placebo in preventing skin rash in patients who are receiving drugs such as gefitinib or cetuximab for cancer.

objectives: * compare the 1-month incidence and severity of gefitinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with tetracycline vs placebo. * compare the toxicity of these drugs in these patients. * compare the quality of life of patients treated with these drugs who develop vs those who do not develop a rash. * determine whether patients who discontinue tetracycline at 1 month develop a rash. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. patients are stratified according to prior chemotherapy regimen (first-line therapy vs other), concurrent epidermal growth factor receptor inhibitor therapy (gefitinib vs cetuximab vs other), and concurrent corticosteroid therapy (yes vs no). patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral tetracycline twice daily. * arm ii: patients receive oral placebo twice daily. in both arms, treatment continues for 4 weeks in the absence of unacceptable toxicity. quality of life is assessed at baseline and then weekly for 8 weeks. patients are followed at weeks 4 and 8. projected accrual: a total of 126 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of cancer * began therapy within the past 7 days or plans to begin therapy within 7 days after study entry with one of the following epidermal growth factor receptor inhibitors: * gefitinib * cetuximab * erlotinib * monoclonal antibody abx-egf * icr-62 * ci-1033 * emd-72000 * no rash at study entry patient characteristics: age * 18 and over hepatic * bilirubin ≤ 2 mg/dl renal * creatinine ≤ 2 mg/dl other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective non-hormonal contraception * able to take oral medication * no history of skin condition that may flare during study treatment * no prior allergic reaction or severe intolerance to tetracycline or one of its derivatives * no severe nausea or vomiting that would preclude retaining study drug prior concurrent therapy: other * more than 1 week since prior tetracycline * no milk products, antacids, or calcium supplements for 2 hours before until 2 hours after drug administration * no other concurrent tetracycline

Keywords: unspecified adult solid tumor, protocol specific
observational study in japanese patients with peripheral t-cell lymphoma who received second-line therapy

Conditions: Peripheral T-cell Lymphoma

Summary: the purpose of this study is to describe the therapeutic practices and the prognosis of patients with relapsed or refractory peripheral t-cell lymphoma in japan


Eligibility criteria:
inclusion criteria: * male or female participants with a confirmed diagnosis of the specific subtypes of peripheral t-cell lymphoma (ptcl) according to the world health organization (who) classification of lymphoid neoplasm, 4th edition defined by who and international agency for research on cancer (iarc). * participates aged ≥18 years of age at diagnosis of ptcl. * participates who have been treated with a systemic therapy for ptcl and have initiated a systemic therapy as a second-line therapy for relapsed or refractory ptcl between april 1, 2018 and march 31, 2023. exclusion criteria: * participates who have medical history of peripheral t-cell lymphoma (ptcl) treatment by unapproved drug in japan as of 31 march 2024 or off-label drug for ptcl in japan as of 31 march 2024. * participates who have medical history of participation to a separately defined registration study for regulatory approval in ptcl. * participates who have medical history of ptcl treatment in a separately defined clinical study with intervention by on-label regimen for ptcl. * participates judged to be inappropriate for enrollment in this study by the site investigator.
4d phase contrast mr: hypertrophy in liver cancer

Conditions: Liver Cancer; Cancer of the Liver

Summary: the investigators hypothesize that 4dimensional phase contrast magnetic resonance angiography (4d pc mra) evaluation of portal venous flow predicts underlying liver function and hypertrophic potential in patients with liver cancer presenting for portal vein embolization (pve). 4d pc mra may provide a non-invasive measure of liver function that could help determine which patients could safely and successfully undergo pve and subsequent resection of tumor. by comparing 4d pc mra results with invasive catheter measurements the investigators will validate the flow findings. further regression/correlation analysis with functional measures of the liver (hida scans), volumetrics, doppler flow analysis, histology, and outcomes will help the investigators to determine the ability of 4d pc mra to predict functional status and hypertrophic potential of the liver prior to pve and hepatectomy allowing for better patient selection and reduced morbidity/mortality.


Eligibility criteria:
inclusion criteria: * diagnosis of malignant liver tumor * clinically referred for portal vein embolization * at least 18 years of age * willing and able to provide informed consent exclusion criteria: * documented or reported contrast allergy * unable to receive or tolerate mri scan after evaluation of mri screening form * gfr (glomerular filtration rate) \< 30 on labs drawn within 6 weeks of imaging.
culturally adapted family intervention for psychosis

Conditions: Psychosis

Summary: aim: to assess the feasibility of culturally adapted family intervention for psychosis. design: randomized control trial setting: psychiatric department of different hospitals participants: a total of 36 caregivers of psychosis patients will be randomized to psychological intervention and treatment as usual arm. intervention: culturally adapted family intervention for psychosis outcome measure: positive and negative syndrome scale (panss) experience of care -giving inventory(eci) care well-being \& support(cws)

the purpose of the study is to test the feasibility of culturally adaptive family intervention for psychosis primary objective : * to test whether pakistani families caring for someone with psychosis will engage with a model of family intervention which has been culturally adapted to meet their needs. * to evaluate the acceptability of the intervention to the families who receive it and to gather feedback regarding any changes that might improve the intervention. * to gain an impression of whether the intervention has the potential to address unmet psychological and social needs of the families and how this affects their levels of stress the investigators will conduct a feasibility pilot study to test whether pakistani families offered the intervention will want to receive it. the participants will be recruited from psychiatric department of different hospitals. they will be randomly divided into two groups; intervention group and treatment-as-usual group. a total of thirty six participants will be recruited in the pilot study and divided equally into two arms. this will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (fda guidance http://www.fda.gov/cder/guidance/5356fnl.pdf).randomization will be carried out by the on offsite statistician. this will provide a reliable geographically remote service. for intervention group ten sessions of family intervention will be provided by trained research clinician during the period of three months. relatives of patients in the treatment as usual (tau) group will be given details of intervention at the end of the study and interested families will be offered family intervention

Eligibility criteria:
inclusion criteria: 1. living with or with at least 10 hours per week face to face contact with an individual with psychosis who has a caring role. plus the individual with psychosis themselves. 2. individuals aged between 18-65. 3. resident of karachi. 4. participant is able to give informed written consent. exclusion criteria: 1. severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to icd10 rdc). 2. unstable residential arrangements such that the likelihood of being available for the duration of the trial is low. .

Keywords: cbt, psychosis, cultural adaptation, pakistan
off-pump versus on-pump coronary artery bypass grafting in frail patients

Conditions: Frail Elderly; Coronary Artery Disease

Summary: frailty is defined as a geriatric syndrome of impaired resiliency to stressors (such as cardiac surgery) that has been delineated recently in the cardiovascular literature. one of the most controversial areas of cardiac surgery has been whether off-pump coronary artery bypass grafting (opcab) surgery is superior to conventional on-pump coronary artery bypass grafting (cabg) surgery. there is an ongoing debate about the benefits and disadvantages of opcab surgery and we believe that this remains an important technique for the improvement of coronary surgery. the benefits of cabg surgery in frail patients are still undetermined. the aim of this study is to clarify the potential benefit of opcab surgery in pre-frail and frail patients by comparing off-pump versus on-pump cabg in these patients.

the fragile protocol is a national multicenter randomized controlled trial (rct), conducted in 6 brazilian institutions. the study is already approved by a certified ethics committee. funding is provided by a grant from são paulo research foundation (fapesp), which otherwise will not have any role in the conduct of the study nor in the analysis nor in the reporting of data. a confidentiality agreement regarding data use and the data safety will be monitored by an independent monitoring board. all the authors will provide revisions and comments and be testifying for the accuracy and completeness of the report, as well as for the fidelity of the report to the study protocol.

Eligibility criteria:
inclusion criteria: - participants aged ≥60 years with the indication of myocardial revascularization with ≥2 criteria of frailty by fried frailty criteria, and suitable to undergo either off-pump or on-pump cabg. exclusion criteria: - patients with the indication of angioplasty or another procedure in addition to cabg; patients who underwent an emergency operation (within 24 hours after hospital admission); patients who underwent previous cardiac surgery, even with other approaches than median sternotomy; patients who do not have free, prior and informed consent to participate in this study.

Keywords: frail elderly coronary artery bypass surgery off-pump on-pump randomized controlled trial
repeatability, reproducibility and comparison of cirrus oct, rtvue oct, ms-39 oct, and insight 100 vhfdu

Conditions: Corneal Thickness Measurement; Epithelial Thickness Measurement; LASIK Flap Thickness Measurement; SMILE Cap Thickness Measurement

Summary: the purpose of this study is to evaluate the repeatability and reproducibility of corneal, epithelial, and lasik flap thickness using the carl zeiss meditec cirrus hd oct 5000, optovue rtvue oct, cso ms-39 oct, and arcscan insight 100 very high-frequency digital ultrasound arc-scanner.

very high-frequency (vhf) digital ultrasound was first used in 1993 to obtain images and measure the thickness of the cornea (the window at the front of the eye) and the layers within the cornea, such as the epithelium (the layer of skin on the surface of the cornea). a commercially available instrument, known as the artemis, has been used in routine clinical practice since 2001. the arcscan insight 100 vhf digital ultrasound scanner is an updated version, which obtained ce mark in 2016. optical coherence tomography (oct) is another method of measuring the thickness of the cornea and the corneal epithelium. oct has been used for measuring corneal thickness since 1997 and the technology had evolved to also measure epithelial thickness since 2012. there are currently three oct scanners capable of measuring epithelial thickness; carl zeiss meditec cirrus hd oct 5000, optovue rtvue oct, cso ms-39 oct. the aim of the study is to establish the repeatability (i.e. the variability in measurements taken by a single examiner during a single visit) and reproducibility (i.e. the variability in measurements taken in the same conditions between two examiners) for each of the four devices for measuring corneal thickness and epithelial thickness.

Eligibility criteria:
inclusion criteria: only patients who are medically suitable for corneal laser refractive surgery can be included in the study. as general inclusion criteria the following aspects are defined: * subjects should be 21 years of age or older. * contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses. * patient will be able to understand the patient information and willing to sign an informed consent. for the normal eye populations: * eyes with no ocular pathology * eyes with no previous ocular or corneal surgery for the post-op eye populations: • eyes between 3 and 9 months after lasik or smile exclusion criteria: * previous ocular or corneal surgery (for normal eyes) * patient not being able to tolerate local or topical anesthesia * patient has active conjunctivitis or any active ocular infection or inflammation * patient has a corneal ulcer * patient has an open wound on the corneal epithelium * patient has compromised epithelium (e.g. ≥grade 3 superficial punctate keratitis) * pregnancy

Keywords: vhf digital ultrasound optical coherence tomography corneal thickness epithelial thickness lasik smile
range of motion of standard and high-flexion posterior cruciate retaining total knee prostheses

Conditions: Osteoarthritis

Summary: the purpose of this prospective, randomized study was to compare pain, functional outcome and ranges of motion of the knees in patients receiving either a standard posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.

the main goals of total knee arthroplasty are pain relief and improvement of function and range of motion. the purpose of this study was to compare ranges of motion of the knees in patients receiving either a standard posterior crucaite-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.

Eligibility criteria:
inclusion criteria: * osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties exclusion criteria: * inflammatory arthritis * osteoarthritis of the hip causing pain or restricted mobility * a foot or ankle disorder which limited walking * dementia or a neurological disorder including a past history of stroke which affected mobility
comparative effects of a2 skim milk on mild cognitive impairment in older adults

Conditions: Mild Cognitive Impairment; Adults

Summary: the aim of the study is to compare the effects of powdered skim milk containing a2 β-casein only versus conventional powdered skim milk containing a1 and a2 β-casein milk on cognition, inflammation, and dietary intake in adults aged 65-75 years.


Eligibility criteria:
for inclusion in the study, participants must meet all of the following criteria: 1. adults aged 65-75 years; 2. complaint of memory loss for more than 6 months; 3. base on the chinese version of mini mental state examination (mmse), cognitive ability score is lower than the standard cut-off value according to age and education levels: mmse score≤ 17 points if years of education is 0 year; ≤ 20 points if 6 years or less of education; ≤ 24 points if more than 6 years of education 4. living and social functions are reduced: activities of daily living (adl) score ≤18; 5. not meeting the diagnostic criteria for dementia (diagnostic and statistical manual of mental disorders - fourth edition), alzheimer disease (national stroke institute for neuropathic speech disorders and association for alzheimer disease and related disorders); no mental disorder, brain damage, or other physical disorders that can lead to cognitive impairment. 6. agreed not to participate in another interventional clinical research study during the present study; 7. signed informed consent participants must be excluded from the study if they meet any of the following criteria: 1. \ 75 years 2. neurological examination showed focal signs of central nervous system disorder such as hemiplegia, dysesthesia, aphasia; history of cerebrovascular diseases (including hemorrhagic and ischemic types), internal brain trauma or fracture; 3. asthmatic bronchitis, severe hypertension, angina and severe infection; 4. mental disorders such as depression and anxiety; endocrine system diseases (such as hyperthyroidism, hypothyroidism, systemic lupus erythematosus, rheumatoid arthritis); 5. newly diagnosed, progressing or advanced tumors; 6. visual, reading, hearing impairment or language communication difficulties that significantly affect cognitive function tests; 7. history of alcohol dependence and abuse of psychoactive substances (e.g., antipsychotics, benzodiazepines, cholinesterase inhibitors, sedatives), or use of drugs that affect cognitive function; 8. neurological diseases (e.g. parkinson's disease, epilepsy); 9. antibiotic treatment in previous 2 weeks; 10. administered immunosuppressive drugs in the 4-weeks preceding screening; 11. allergy to milk or dairy; 12. diagnosed lactose intolerance; 13. other diseases that investigators judged as unsuitable to participate the study.
first trimester fetal thymus volume may predict preeclampsia

Conditions: Preeclampsia

Summary: the exact etiology of preeclampsia remains unclear but is known to involve immunological factors. the thymus is one of the main organs involved in the development of the fetal immune system. the aim of this study was to explore the association between fetal thymus volume on ultrasound and preeclampsia by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 11-14 week of gestation. investigators performed a prospective clinical study in 100 pregnant women in their first trimester of pregnancy who attended the fetal medicine unit of the medicine faculty of karadeniz technical university during the study period. maternal age, gravida, para, bmi, blood pressure, gestational age, crl and fetal timus volume measured with vocal programme are recorded. for all patients routine clinical and ultrasound examinations were performed during pregnancy. gestational age at birth, way of birth and newborn birthweight were recorded. the results were statistically compared in the spss 13.0 program. student-t test and chi-square test were used for statistical analysis. roc curve analysis was used for limit values. the data of patients with preeclampsia and without preeclampsia were compared. the ability of the thymus volume to predict the preeclampsia was tested using binary logistic regression analysis. p value \<0.05 was considered statistically significant.

the exact etiology of preeclampsia remains unclear but is known to involve immunological factors. the thymus is one of the main organs involved in the development of the fetal immune system. the aim of this study was to explore the association between fetal thymus volume on ultrasound and preeclampsia by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 11-14 week of gestation.

Eligibility criteria:
inclusion criteria: * 11-14 weeks pregnancy with no abnormal ultrasonography evidence. exclusion criteria: any history of obstetric complications chronic hypertension diabetes mellitus infectious or autoimmune disease.

Keywords: fetal thymus volume preeclampsia screening prediction