Kornimate/medical-research-clean huggingface dataset:
the effects of omega-3 fatty acids in renal transplantation

Conditions: Disorder Related to Renal Transplantation

Summary: omega-3 fatty acids are provided through dietary intake of fish and seafood. several dietary supplements containing omega-3 fatty acids are also commercially available. some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and lipid-modulating effects. other studies have not confirmed these findings. this study will investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients.

there have been few interventional studies regarding the clinical effect of omega-3 fatty acids in renal transplantation. the aim of this study is to investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients. this study is a randomized double blinded placebo controlled interventional study of 132 norwegian renal transplant recipients. it will investigate, on the one hand, the effect of omega-3 fatty acids on renal function and, on the other, the effect of omega-3 fatty acids on cardiovascular risk markers in renal transplant recipients. 8 weeks after transplantation, if renal function has stabilized, patients with a egfr\>30 will be randomized to receive either 2,7 g eicosapentaenoic plus docosahexaenoic acid (3 capsules of omacor a 1 g) daily or placebo. baseline measurements will be performed before they start taking the study medication. the same measurements will performed again1 year after transplantation and the patients stops taking the study medication.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 who have received a kidney transplant. patients with a functioning kidney transplant, defined as egfr\>30 ml/min. signed informed consent. exclusion criteria: * patients participating in clinical trials with other investigational drugs. patients who received a deceased donor kidney from a donor \>75 years. patients with a history of an allergic reaction or significant sensitivity to the study drug or drugs similar to the study drug.

Keywords: renal transplantation interventional study glomerular filtration rate renal function proteinuria cardiovascular risk markers blood pressure flow mediated vasodilation heart rate variability pulse wave velocity lipids blood glucose bone mineral density body composition fat distribution body mass index fatty acid composition tacrolimus pharmacokinetics omega-3 fatty acids marine n-3 fatty acids fatty acids gas chromatography interstitial fibrosis inflammation
health behaviors in patients who have finished treatment for stage i, stage ii, or stage iii colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: gathering information over time from patients who have finished treatment for colorectal cancer may help doctors predict which cancer survivors will improve their physical activity and diet. purpose: this clinical trial is studying health behaviors in patients who have finished treatment for stage i, stage ii, or stage iii colorectal cancer.

objectives: primary * to characterize patterns and identify predictors of post-treatment physical activity and dietary changes made by colorectal cancer survivors. secondary * to identify the affective and cognitive effects of post-treatment physical activity and dietary changes in these patients. * to identify these patients' preferences regarding diet and physical activity health promotion programs. outline: this is a multicenter study. patients complete surveys at baseline and at 3 and 6 months. a randomly selected subset of 84 patients also receive an activity monitor to be use at each of the 3 time points. the acceptability of their use is assessed and whether activity levels change across the 3 time points and the extent to which they are convergent with self-reported physical activity are examined. during each survey, questionnaires are administered to assess the following areas: physical/medical characteristics (self-reported), self-efficacy for physical activity, fruit and vegetable consumption, and dietary fat intake; outcome expectations for physical activity, fruit and vegetable consumption, and dietary fat intake; physical activity and diet behavioral self-regulation; illness representations (causal attributions and controllability of recurrence); perceived risk of colorectal cancer (crc) recurrence; emotional representations of crc (cancer-related anxiety and worry about cancer recurrence); healthcare provider recommendations to alter physical activity and dietary intake; social influence from important others; current physical activity and dietary intake; and diet and physical activity program preferences. patients who received the activity monitor are asked feedback on acceptability of them. measures of sociodemographics and disease/treatment characteristics (via medical chart review) are recorded.

Eligibility criteria:
disease characteristics: * diagnosis of localized or regional colorectal cancer * stage i, ii, or iii disease * completed treatment within the past 6 weeks * no previous diagnosis of colorectal cancer patient characteristics: * english speaking * no current evidence of neoplastic disease except for nonmelanoma skin cancer * no evidence of severe cognitive impairment prior concurrent therapy: * see disease characteristics

Keywords: cancer survivor stage i colon cancer stage ii colon cancer stage iii colon cancer stage i rectal cancer stage ii rectal cancer stage iii rectal cancer
the copacc study: utilization, health and economic evaluation of a community-based primary care geriatric hub at whampoa

Conditions: Delivery of Health Care; Health Services; Costs and Cost Analysis; Quality of Life

Summary: this study evaluates the community for successful ageing (comsa) patient-centered medical home (pcmh), a model of community-based primary care geriatric hub at whampoa, singapore.

this study evaluates the community for successful ageing (comsa) patient-centered medical home (pcmh), a model of community-based primary care geriatric hub at whampoa, singapore. this study aims to evaluate the impact of comsa pcmh on health service utilisation, healthcare cost, clinical quality and effectiveness, as well as patient activation, quality of life, satisfaction and experience of care. the first component of the study is a single arm prospective pre-post cohort design, which aims to evaluate the impact on enrolled patients' self-reported health outcomes, experience of care, and cost effectiveness. the second component of the study evaluates the quality of the implementation processes via clinical quality indicators. the third component is a match-controlled retrospective pre-post study design, which aims to evaluate the impact on healthcare utilisation. data sources include both survey data and administrative data.

Eligibility criteria:
key inclusion criteria: i. aged 40 years and above ii. lives in whampoa, singapore iii. enrolled in pcmh after 1 september 2017 exclusion criteria: i. aged less than 40 years ii. does not live in whampoa singapore

Keywords: patient-centred care patient-centred medical home older adults complex needs healthcare utilisation economic evaluation cost analysis health services research
protocol biopsies in high-risk renal transplant recipients

Conditions: Kidney Transplant Rejection; Kidney Transplant Failure; Kidney Transplant Infection; Kidney Transplant Failure and Rejection

Summary: the present study aims to evaluate the usefulness of protocol biopsies in a cohort of renal transplant patients of high immunological risk for graft injury and loss.

this will be a prospective study undertaken at the renal transplant unit of hospital of clinics of porto alegre. in addition to the routine evaluation commonly carried-out at this post-transplant period, protocol biopsies will be performed at the 10th-week post-transplantation in high-risk transplant recipients. biopsy fragments will be evaluated for tissue immune aggression (mainly cellular and antibody-mediated rejections) and other conditions such as infections, particularly polyomavirus and cytomegalovirus and medication toxicities. the presence of donor-specific antibodies and graft-damaging infectious agents will also be searched in the peripheral blood at the time of biopsy.one hundred patients will be randomized to a protocol biopsy and noninvasive assessment or only for noninvasive assessment. the hypothesis of the study is that biopsies will lead to treatments that may allow better outcomes of renal transplants, related to lowering the progression of subclinical aggressions, avoiding or delaying graft loss and preserving or decreasing the rate of loss of the glomerular filtration rate. therefore, this strategy has the possibility of reaching clinical practice routine and thus contribute positively to the management of renal transplant patients.

Eligibility criteria:
inclusion criteria: adult kidney transplants, with high immunological risk, who consented to participate in the study by signing the informed consent form. the high immune risk is defined by: * positive pre-transplant t-lymphocyte cross-test by flow cytometry (channel deviation greater than 62); * flow cytometry pre-transplantation positive b lymphocyte cross-test (channel deviation greater than 112); * calculated panel reactivity greater than 50% in class i and / or class ii; * presence in the pre-transplantation serum of donor class i and / or ii anti-human leukocyte antigen antibodies with intensity and fluorescence greater than 1000; * occurrence of cellular or antibody-mediated rejection within 30 days prior to the date of the protocol biopsy. exclusion criteria: * patients with contraindication to renal graft biopsy; * patients whose biopsy fragments are not representative; * patients with graft dysfunction in whom renal graft biopsy is indicated within 4 weeks prior to protocol biopsy.

Keywords: kidney transplantation protocol biopsies kidney transplant rejection
treatment of primary coronary artery vascular lesions with biolimus coated coronary balloon dilation catheter

Conditions: Coronary Artery Disease

Summary: the purpose of the study was to further evaluate the long-term safety and efficacy of the biolimus coated coronary artery balloon dilation catheter in the real world. the study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.

study design: 1. prospective, international multi-center clinical study; 2. it is planned to recruit 300 subjects in china and a total of 100 subjects in indonesia and thailand who meet the criteria for study inclusion to use at least one biolimus coated coronary balloon dilation catheter (bioascend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions; 3. in the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis. 4. register and collect data using the edc system; 5. enrollment method: competitive enrollment; 6. follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * primary coronary artery stenosis with a vessel diameter of 2.0 mm to 2.75 mm; * patients with residual stenosis of ≤ 30 percent after pretreatment and ≤ type b dissection; patients who voluntarily participate in and sign the informed consent form, and who are willing to undergo follow-up as required by the protocol. exclusion criteria: * pregnant or lactating females; * patients with cardiogenic shock; * patients with severe congestive heart failure or severe heart failure with nyha class iv; * patients with severe valvular heart disease; * patients with a life expectancy of less than 24 months or factors that make clinical follow-up difficult; * patients who are considered unsuitable for inclusion by the investigator for other reasons. * those who are known to be allergic to melcrolimus and contrast media.
h-29 delta multihole tt study.

Conditions: Osteoarthritis, Hip

Summary: this study is aimed to provide a clinical and radiographic evaluation of 50 suitable subjects who underwent a complex primary or a revision total hip arthroplasties with delta multihole tt acetabular cup in 2019 onwards.


Eligibility criteria:
inclusion criteria: * male or female subjects who underwent a total hip arthroplasty with delta multihole tt acetabular cup, as per indications for use, in 2019 onwards * age ≥ 18 years old * subjects who have signed the written informed consent approved by the reference ethics committee (ec) * subjects able to comply with the protocol and to perform all scheduled follow-up visits exclusion criteria: * male or female subjects who underwent a total hip arthroplasty with delta multihole tt acetabular cup, but showed any of the contraindications reported in the instruction for use * age \< 18 years old * any clinically significant pathology based on clinical history that the investigator feels may affect the study evaluation including, but not limited to: 1. significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery. 2. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device. 3. known metabolic disorders leading to progressive bone deterioration. * hip replacement on the contralateral side performed within less than one year. * female subjects who are pregnant, nursing or planning a pregnancy.
a real-world study of bispecific antibodies in multiple myeloma

Conditions: Multiple Myeloma

Summary: bispecific antibody (bsab) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. the results are very encouraging but complicated adverse events, particularly infectious. this study analyzes survival data in patients treated with bsab, as well as safety data, in particular the proportions and locations of infectious events. the results are compared to a control cohort. this study is multicentric on all the university hospitals of paris (ap-hp).

bispecific antibody (bsab) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. the results are very encouraging but complicated adverse events, particularly infectious. this study analyzes survival data in patients treated with bsab, as well as safety data, in particular the proportions and locations of infectious events. the results are compared to a control cohort. this study is multicentric on all the university hospitals of paris (ap-hp).

Eligibility criteria:
inclusion criteria: * adult ≥ 18 years old * patients with multiple myeloma * patients who received at least one administration of the following therapies: teclistamab, elranatamab exclusion criteria: - patients opposed to the collection of their personal data

Keywords: multiple myeloma teclistamab elranatamab bispecific antibody
a randomized trial of nsaid dosing strategies

Conditions: Musculoskeletal Pain; Acute Pain

Summary: this study will compare the efficacy of two different non-steroidal anti-inflammatory drugs (nsaids) ketorolac and ibuprofen for people with acute moderate or severe musculoskeletal pain. the investigators will also determine whether taking acetaminophen prior to the nsaid impacts efficacy


Eligibility criteria:
inclusion criteria: * acute musculoskeletal pain: any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months * pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity exclusion criteria: * contraindication to nsaids (allergy to nsaid or allergy to aspirin without history of tolerating nsaids, history of gastrointestinal bleeding, daily medication for gastritis or pud, chronic kidney disease 2-5, heart failure) * contraindication to acetaminophen (hepatitis or cirrhosis) * use of an nsaid within the previous eight hours * use of acetaminophen within the previous eight hours * chronic pain, defined as any pain on \>50% of days for at least 3 months prior to onset of acute pain * recurrent pain in the same body part as the presenting complaint
a registry study on rimegepant for the treatment of migraine participants in guangdong-hong kong-macao greater bay area

Conditions: Migraine

Summary: this study is a single-arm, prospective, multicenter, observational registry study. it plans to enroll 120 migraine patients who meet the inclusion criteria and are treated with rimegepant in selected hospital outpatient clinics in the greater bay area. the main purpose of this study is to observe the effectiveness of rimegepant in treating migraines in a real-world clinical setting, including the impact of rimegepant on the quality of life, functioning, productivity status of migraine patients, and patients' satisfaction with the use of rimegepant in treating migraines.


Eligibility criteria:
inclusion criteria: * participants with headaches that meet the diagnostic criteria for migraines according to the international classification of headache disorders, 3rd edition (ichd-3), with or without aura. * patients prescribed rimegepant by the attending physician for the treatment of migraines. * signed informed consent form. * age greater than 18 years. * not concurrently participating in other interventional clinical studies. exclusion criteria: * patients diagnosed with secondary headaches. * patients with severe visual, auditory, language, intellectual, memory, consciousness impairments or other conditions that prevent them from completing the questionnaire and follow-up. * pregnant or lactating female patients. * patients deemed by the investigator as unsuitable for participation in the study or unable to complete the 4-week follow-up. * patients with a known history of hypersensitivity reactions to rimegepant or its components. * evidence in the medical history suggesting the presence of uncontrolled or unstable cardiovascular diseases (such as ischemic heart disease, coronary artery vasospasm, or cerebrovascular ischemia), or a history of myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke, or transient ischemic attack within the past 6 months before the screening visit.
effect of tetrix on alleviation of burning,itching associated with lesions of contact dermatitis

Conditions: Contact Dermatitis

Summary: to determine if tetrix cream, when applied to the skin lesions on patients with contact dermatitis, improves the symptoms of burning and itching.


Eligibility criteria:
inclusion criteria: 1. normal subjects with sensitivity to nickel 2. subjects with hand eczema exclusion criteria: under 18 years of age

Keywords: tetrix cream, contact dermatitis, effect on burning and itching
prevalence and clinical severity of cutaneous lupus erythematosus

Conditions: Cutaneous Lupus Erythematosus (CLE)

Summary: the cutaneous lupus erythematosus (cle) database, established in 2006, is a multi-site database between the university of pennsylvania and the university of texas southwestern (utsw).

the database has yielded valuable information and clinical insights into the pathophysiology, disease processes, treatments and quality of life associated with cle. the cle database incorporates the clasi (cutaneous lupus activity and severity index), a validated outcome measure of disease responsiveness in patients and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with cle (cutaneous lupus erythematosus). the cle database has led to publication of significant studies on lupus and its clinical course, the effect of lupus on quality of life (qol), including the effect of photosensitivity on qol, and the effect of first line medications. the cle database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease.

Eligibility criteria:
inclusion criteria: * subjects who meet the criteria for having cle, using the gilliam classifications, and/or a diagnosis of systemic lupus erythematosus (sle), using the american rheumatism association/american college of rheumatology criteria. subjects must be 18 years or older. exclusion criteria: * all subjects who do not meet the criteria for having cle. subjects who meet the criteria for cle but who are not yet 18 years old

Keywords: cle lupus lupus erythematosus
myokines role during obesity

Conditions: Obesity, Adolescent

Summary: we showed, for the first time, that z-score increase during obesity was dependent on sex, severity of obesity and age but also on the bone site. although the increase in bmd at bearing areas seems to be logically explained by the assumption that mechanical stresses have an osteogenic effect on bone tissue, bmd can in no way respond to the concomitant increase in bmd at non-load bearing areas such as the radius. these results suggest that changes in certain systemic compounds, induced by obesity, may interfere with bone metabolism. moreover, the fact that the bmd or z score is positively and only correlated with muscle mass and not with fat mass confirm that mechanical stresses are not the only factors acting on bone tissue. our objectives are to determine the relationship between plasma concentration of myokines, adipokines, bone markers and bmd in obese subjects.

we showed, for the first time, that z-score increase during obesity was dependent on sex, severity of obesity and age but also on the bone site. although the increase in bmd at bearing areas seems to be logically explained by the assumption that mechanical stresses have an osteogenic effect on bone tissue, bmd can in no way respond to the concomitant increase in bmd at non-load bearing areas such as the radius. (maïmoun l and col bone 2015 dec 1. s8756-3282 (15) 00421-4). these results suggest that changes in certain systemic compounds, induced by obesity, may interfere with bone metabolism. moreover, the fact that the bmd or z score is positively and only correlated with muscle mass and not with fat mass confirm that mechanical stresses are not the only factors acting on bone tissue. our objectives are to determine the relationship between plasma concentration of myokines, adipokines, bone markers and bmd in obese subjects. our objectives are to determine the relationship between plasma concentration of myokines (myostatin, follistatin), adipokines (leptin, adiponectin) and bone markers (ctx, trap5, p1np, ostéocalcin) in a cohort of obese patients, with differents obesity severity, differents ages.

Eligibility criteria:
inclusion criteria: * obese patients age above 18 years old exclusion criteria: * non agreement of inclusion

Keywords: bone mineral density myokines adipokines