Kornimate/medical-research-clean huggingface dataset:
triathlon all-polyethylene tibia outcomes study

Conditions: Arthropathy of Knee; Replacement; Knee Arthritis

Summary: the purpose of this study is to evaluate the clinical functional results of the triathlon all-polyethylene tibia knee device.

this study is a retrospectively enrolled, prospective evaluation of the triathlon all-polyethylene tibia (apt) for patients who meet the eligibility criteria. the enrolled cases will be followed for outcomes measured to 10 years. a modular, triathlon metal-backed tibia (mbt) and polyethylene insert construct will be used as a historical control.

Eligibility criteria:
inclusions: * patient underwent primary tka and is currently implanted with the triathlon all- polyethylene tibia as well as compatible stryker femoral and patellar components with no pending revision or removal. * patient has signed an irb-approved, study specific informed patient consent form. * patient is a male or non-pregnant female and is 18 years of age or older at the time of study device implantation. * patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations. exclusions: * patient had an active or suspected latent infection in or about the affected knee joint at time of study device implantation. * patient had distant foci of infection which could have caused hematogenous spread to the implant site at time of study device implantation. * patient was skeletally immature at time of study device implantation. * patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. * patient's bone stock was compromised by disease, infection, or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. * patient had severe instability of the knee joint secondary to the absence of collateral ligament integrity and function. * patient was immunologically suppressed or receiving steroids in excess of normal physiological requirements at the time of surgery (e.g. \> 30 days). * patient is a prisoner.
aancart research project on lay health workers and asian americans

Conditions: Colorectal Cancer

Summary: this is a behavioral research study to evaluate the effectiveness of a type of health education, lay health worker (lhws), on increasing the use of a routine health behavior, colorectal cancer (crc) screening, among asian americans, who underutilize such screening. using quantitative and qualitative methods and a community-based participatory research (cbpr) approach, the project will develop and implement a group randomized controlled trial to evaluate lhw effectiveness in promoting crc screening among asian americans age 50 to 75. the investigators will conduct focus groups and individual interviews with community participants to revise training and survey materials developed in prior projects. the investigators will recruit lhws to be randomly assigned to the intervention arm and to the comparison arm. the lhws will each recruit 15 participants from their social network. intervention lhws will be taught to teach their participants about crc screening through 2 outreach sessions and 2 telephone calls aimed at increasing their crc screening receipt. lhws and participants in the comparison group will receive a bilingual crc brochure as well as 2 lectures on healthy nutrition for cardiovascular health delivered by a health educator and an optional post- intervention lhw outreach session on crc screening. effectiveness of the intervention will be measured by pre-intervention and post-intervention surveys of community participants' crc screening behaviors. the investigators will also conduct ethnographic observations of lhws and their participants during the small group sessions and post- intervention focus groups to understand how such a health education approach may work.


Eligibility criteria:
inclusion criteria: * self-identified as filipino, hmong, or korean americans * age 50 to 75 * speak a language that the lay health worker (lhw) can speak such as tagalog, ilocano, hmong, korean, or english * live in relevant area and intend to stay there for at least 12 months * are willing to participate in a study about health behaviors involving nutrition or crc screening. exclusion criteria: * personal history of crc * medical problems which may prevent them from attending 2 educational sessions

Keywords: asian americans colorectal cancer screening cancer prevention filipinos americans hmong americans korean americans randomized controlled trials
thrombin generation in crohn's disease

Conditions: Crohn Disease; Blood Clot; Thrombosis

Summary: one hundred and fifty patients with crohn's disease involving the terminal ileum or the colon, in clinical remission, with or without endoscopic activity will be included. thrombin generation will be measured and correlated with the simplified endoscopic activity score. the patients will be evaluated for development of deep vein thrombosis after one-year of follow-up.

one hundred and fifty patients with crohn's disease involving the terminal ileum or the colon, in clinical remission defined by the crohn's disease activity index below 150 and harvey-bradshaw index below 5, with or without endoscopic activity defined by simplified endoscopic activity score for crohn's disease (ses-cd) will be included in this study (75 patients with a complete mucosal healing defined by ses-cd below 3 and 75 with endoscopic activity defined by ses-cd above 6) in multiple centers specializing in the treatment of inflammatory bowel diseases in brazil; study data will be collected and managed using redcap electronic data capture tools hosted at the clinical hospital of university of são paulo. redcap (research electronic data capture) is a secure, web-based application designed to support data capture for research studies. all thrombin generation tests will be performed at the clinical hospital of university of são paulo, são paulo, sp through automatically calibrated thrombogram (cat- calibrated automated thrombogram®, maastricht, the netherlands), with and without thrombomodulin. those patients will be followed for at least one year after the colonoscopy with measurement of the d-dimer and clinical evaluation every 3 months to verify the developing of deep vein thrombosis.

Eligibility criteria:
inclusion criteria: * established crohn's disease diagnosis for at least 6 months * disease involvement of the terminal ileum and/or colon * clinical remission * stable treatment for at least 3 months exclusion criteria: * colectomy * neoplasia * surgery in the last 6 months * anticoagulant treatment * major liver disease
predictive properties of the hyperventilation provocation test for the diagnosis of the hyperventilation syndrome

Conditions: Hyperventilation Syndrome

Summary: the hyperventilation provocation test (hptest) associated with end-tidal co2 pressure (petco2) measurement is a diagnostic tool for idiopathic hyperventilation syndrome (hvs). however, interpretation of hptest remains unclear regarding the relevant petco2 values to consider and the occurrence of subjective symptoms. this case-control study aims to identify accurate hptest measurements for the diagnosis of hvs, regardless of symptoms occurrence.

in a first stage, the investigators will analyze in a prospective way a training cohort of hptest datas from 74 subjects, involving 37 subjects with complaints and a nijmegen questionnaire score of ≥23/64 (hvs+) matched on gender, age, height, weight and bmi category with 37 healthy controls without complaints and a nijmegen questionnaire score of \<23/64 (hvs-)(16). all data will have to be collected by the same equipment and by the same operators in the pulmonology department of the chu-st pierre-brussels between june 2018 and october 2021. to rule out confounding respiratory pathology, each participant will have completed spirometry and methacholine testing, that will have a result within expected normal values. for both cohorts, kinetics of the petco2 recorded during each of the 3 phases of the hptest (adaptation, hyperventilation and recovery) will be mathematically modeled by an curvilinear model with the parameters (a, a', a and a') noted from the kinetic equation (tau) : tau \[petco2(t)〖=a+a(1-exp〗\^((b-t)/c))\]. for any observed differences in parameters between groups, the area under curves will be estimated at the cut-off that offers the best sensitivity and specificity. false negative and false positive rates will be estimated. the probability of a type i error is set at 5%. in a second stage, in order to confirm/infirm the results, a retrospective validation cohort from another care setting, including subjects without confounding pathology, who completed a nijmegen questionnaire and a hvtest between 2018 and 2021, will be analysed in the same way than the training cohort.

Eligibility criteria:
inclusion criteria: * anyone over 18 years of age who has completed an hptest and a nijmegen questionnaire between 2015 and 2020 exclusion criteria: -
vitamin d treatment to patients suffering from chronic pain and vitamin d hypovitaminosis

Conditions: Back Pain; Hypovitaminosis D

Summary: the objective of this study is to check whether vitamin d will lead to a decrease in pain intensity compare to placebo, in patients suffering from chronic pain.

vitamin d is a complex nutrient that functions as a hormone to benefit numerous body tissues. vitamin d is naturally produced by skin exposed to ultraviolet b. despite the fact that israel is a sunny country, a majority of all patients, and particularly those with pain, have inadequate intake of vitamin d. vitamin d therapy is easy for patients to self administer, well tolerated, and very economical. in this study, we'll check whether vitamin d will lead to a decrease in pain intensity in patients suffering from chronic low back pain.

Eligibility criteria:
inclusion criteria: * men and women over 18, who suffer from chronic pain and hypovitaminosis d exclusion criteria: * patients that are treated with vitamin d

Keywords: back pain hypovitaminosis d
effect of caffeine on fetal growth

Conditions: Birth Weight

Summary: the purpose of this study is to determine whether caffeine has any effect on birth weight.


Eligibility criteria:
inclusion criteria: * pregnant * consumption of at least 3 cups of coffee/day at recruitment exclusion criteria: * gestational age more than 20 weeks at recruitment * chronic kidney disease * epilepsy * insulin dependent diabetes * metabolic disorder * previous low birth weight delivery * previous preterm delivery

Keywords: caffeine coffee randomized birth weight
observational study in infants who are prescribed treatment with keppra® (levetiracetam) oral solution

Conditions: Epilepsy

Summary: the purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of keppra® (levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice. their data will be collected until they reach the age of 13 months.

this non-interventional sentinel sites post-authorization safety study (pass) aims to collect additional data on use of keppra® (levetiracetam) oral solution in clinical practice, and on efficacy and safety of keppra® (levetiracetam) in infants younger than12 months. epileptic patients between the age of 1 month and 11 months inclusive can be invited for participation to the non-interventional sentinel sites pass, after the physician has decided to initiate therapy with keppra® (levetiracetam) oral solution (100 mg/ml bottle) and patient has so far been treated with keppra® (levetiracetam) for no longer than 10 days. the patients will be followed and their data will be collected until they reach the age of 13 months.

Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy * being treated with keppra® oral solution * aged between 1 month and 11 months inclusive at study baseline exclusion criteria: * none

Keywords: levetiracetam keppra® oral solution keppra® in children
able (arts-based exercise enhancing longevity)

Conditions: Aging; Fall; Muscle Weakness; Mobility Limitation

Summary: older adults who are referred to home care physiotherapy often only get to see the physiotherapist three to five times and are expected to continue exercising on their own. we have developed an interactive technology called able that helps older adults do exercise in their homes by making it fun and interactive. we want to see if we can help 25 older adults to exercise with able for three months and if exercising with able for three months changes older adults' strength and balance. a physiotherapist will visit the older adults three times in their homes and show them how to use able and which exercises to do. we will measure older adults' strength and balance before and after using the program and ask them and their family members for feedback about using able. the results of our study will help us decide if we can do a bigger study to test the effect of using able in a larger group of older adults, and to see what effect able might have on strength and balance. the study will also help us incorporate feedback from the older adults and their families to improve able for the next study.


Eligibility criteria:
inclusion criteria: * able to stand and walk independently with or without an assistive aid (e.g., walker, cane) * may have a diagnosis of dementia or cognitive impairment (moca \< 25, mmse \<24, mini-cog \<3) if they have caregiver willing to assist with exercises and consent exclusion criteria: * have a diagnosis of dementia or cognitive impairment (moca \< 25, mmse \<24, mini-cog \<3) and have no family member to assist with exercises and consent * documented absolute contraindications to exercise
safety and efficacy analysis of fred™/fred™jr embolic device in aneurysm treatment

Conditions: Intracranial Aneurysm

Summary: a prospective, multicenter, observational evaluation of the safety and efficacy of the fred® device in the treatment of intracranial aneurysms

this is a multi-center observational study. treatment and follow-up visits will be done as per standard of care. the purpose of this study is to demonstrate that use of the fred/fred jr embolic device in intracranial aneurysm treatment is safe and effective when assessed at 1, 6 and 12 month post procedure. 100 patients will be enrolled over an 18-month recruitment period. all patients will be followed for 12 months.

Eligibility criteria:
inclusion criteria: 1. patient older than 18 years old 2. patient harboring an unruptured intracranial aneurysm: * for which endovascular treatment is indicated * for which use of fred or fred jr has been deemed appropriate * being the only one to require treatment over the period of the study * and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized 3. patient with a modified rankin scale (mrs) ≤ 2 4. patient or patient's legally authorized representative has received information about data collection and has signed and dated an informed consent form exclusion criteria: 1. patient has suffered an ich within the 30 days prior to the procedure. 2. the aneurysm to be treated is associated with an cavm 3. the aneurysm to be treated is a dissecting or blister-like aneurysm 4. the aneurysm to be treated or any other aneurysm is in the posterior circulation 5. the aneurysm to be treated has a stenosis of its parent artery 6. patient has another aneurysm previously treated with a stent or a flow diverter * on the same parent vessel at any time (except in the case of the proximal carotid if the treatment occurred more than 3 months prior to the procedure) * on a different parent vessel, less than 3 months prior to the procedure 7. patient has another aneurysm requiring treatment within the study period 8. patient with a known allergy to antiplatelet, to heparin, to contrast products or nickel titanium 9. patient with a contra-indication to antiplatelet or heparin 10. pregnancy or child breastfeeding 11. patient unable or unlikely to complete required follow up 12. patient has severe or fatal comorbidity or a life expectancy of less than 1 year 13. treatment with a flow diverter other than fred/fred jr or in addition to fred/fred jr is planned.
a trial of shr3680 in prostate cancer patients who are candidates for radical prostatectomy

Conditions: Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Summary: the study is being conducted to evaluate the efficacy and safety of shr3680 plus androgen deprivation therapy (adt) vs. placebo plus adt in patients with high-risk localized or locally advanced prostate cancer using pathologic complete response (pcr) rate and metastasis-free survival (mfs).


Eligibility criteria:
inclusion criteria: 1. age of ≥ 18 years old; 2. ecog ps score of 0 or 1; 3. pathologically diagnosed as prostate adenocarcinoma; 4. high-risk patients 5. no distant metastasis (clinical staging of m0) as determined by bicr of imaging examinations; 6. subjects who are candidates for and plan to undergo radical prostatectomy (removal of the entire prostate and seminal vesicle plus pelvic lymphadenectomy); exclusion criteria: 1. subjects who received any prior treatment for prostate cancer, except medical adt and/or first-generation androgen receptor antagonists (such as bicalutamide) for not more than 4 weeks; 2. subjects who received any other investigational products or underwent major surgery within 4 weeks prior to randomization; 3. subjects who are planning bilateral orchidectomy during the treatment period of the study; 4. subjects with dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption; 5. subjects with a history of epilepsy, or diseases that can induce seizures occurred within 12 months prior to randomization (including a history of transient ischemic attack, stroke, traumatic brain injury, and cognitive impairment, requiring hospitalization); 6. subjects with active heart disease within 6 months prior to randomization, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment;
a study to determine how and why hiv-infected subjects on anti-viral treatment develop lipodystrophy

Conditions: HIV Infections; Lipodystrophy

Summary: hiv infection is a major global health problem. survival and quality of life for hiv subjects has tremendously improved with the advent of a class of antivirals called protease inhibitors and the utilization of highly active combination therapy. however, such therapy has been associated with a syndrome called lipodystrophy. this lipodystrophy syndrome causes body shape changes; typically thinning and loss of fat from the arms, legs and face, with increased fat appearing in the abdomen and neck. there are also metabolic changes which occur, and subjects can develop increased triglycerides, increased cholesterol and an increased risk for diabetes as indicated by increasing insulin resistance. this study will take hiv positive subjects who have not yet started antiviral medications (treatment naive)and randomly assign them to one of two treatment arms. these treatment arms will be: sustiva/zerit/epivir vs. viracept/zerit/epivir the subjects will be treated and followed for two years and have extensive metabolic testing, skinfold thickness measurements, mri scans and other measures to determine if and how they are experiencing changes in metabolism or body shape and to discover the mechanism of why this occurs. understanding the mechanism should allow researchers to design interventions for subjects who have lipodystrophy and strategies to prevent lipodystrophy from occurring to subjects treated with antivirals in the future.


Eligibility criteria:
inclusion criteria: * cd4 count \> 200 cells/mm * hiv rna (viral load) \<= 100,000 copies/ml * no previous antiviral therapy exclusion criteria: * aids or opportunistic infections * active intravenous drug users * use of: corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, oxandrolone, megace, dehydroepiandrosterone. * subjects with diabetes mellitus * subjects who consume \> 2 alcoholic drinks per day * pregnant women, premenopausal women unless adequate birth control is in use. * acute or chronic liver diseases, liver enzymes elevations \> 2.5 times the upper limit of normal. * anemia, an hct \< 35% for men, or \< 32% for women. * abnormal thyroid function tests.

Keywords: lipoproteins insulin resistance adipose tissue
dynamic contrast-enhanced mri combined with ivim-dwi for early prediction of chemosensitivity in liver mbc

Conditions: Metastatic Breast Cancer in the Liver

Summary: the purpose of this study is to further use dce-mri and ivim-dwi to predict the chemotherapy sensitivity of liver metastasis of breast cancer at an early stage, and to predict the treatment response of tumor at an early stage by using the changes of their functional parameters, and to compare the efficacy and advantages of ivim functional parameters and dce-mri parameters in predicting the efficacy.to explore the efficacy of "perfusion" and "diffusion" parameters of magnetic resonance imaging as "biomarkers" for early prediction of chemotherapy response and prognosis of breast cancer patients with liver metastasis. and to provide guidance for optimizing the clinical treatment scheme of breast cancer patients with liver metastasis. at the same time, this study will use the method of artificial intelligence to deeply mine the images, and further find out the indicators for early prediction of the therapeutic effect of liver metastasis of breast cancer.

the first mr examination was arranged within 7 days before treatment (baseline). the mri scanning sequence included conventional t1, t2 weighted imaging, t1+dynamic contrast enhanced imaging, and ivim-dwi imaging.the second and third mr examinations were arranged within 7 days after the first chemotherapy and the second chemotherapy. the examination steps and parameters were the same as those of the first examination.

Eligibility criteria:
inclusion criteria: 1. the primary lesion was pathologically confirmed to be breast cancer, and the patients diagnosed by two imaging methods or pathologically confirmed to be liver metastasis of breast cancer had at least one liver metastasis with the longest diameter ≥ 10mm; 2. no second primary malignant tumor; 3. ecog score, 0-2 ; 4. the organ function is normal and can tolerate chemotherapy and other anti-tumor treatments; 5. the patient plans to receive systemic chemotherapy or systemic anti-tumor treatment, and the whole process of cooperative treatment. the patient has good compliance with the planned treatment and follow-up, can understand the research process of this study and sign a written informed consent； 6. contraception during the study period and within 6 months after treatment, non lactation period. exclusion criteria: 1. for patients contraindicated to mr examination, such as built-in metal instruments and allergy to contrast agents; 2. the patient had diffuse liver metastasis or the number of liver metastatic tumors was more than 5; 3. patients who cannot complete 2 cycles of chemotherapy or systemic anti-tumor treatment; 4. unable to cooperate with follow-up； 5. patients who are not suitable for the study according to the investigator.

Keywords: liver metastasis breast cancer efficacy prediction