Kornimate/medical-research-clean huggingface dataset:
effect of saccharomyces boulardii on indirect hyperbilirubinemia and phototherapy duration in very low birth weight infants

Conditions: Indirect Hyperbilirubinemia

Summary: indirect hyperbilirubinemia is frequently observed in premature infants.probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system. in this study we aimed to compare the effect of s. boulardii on severity of hyperbilirubinemia and duration of phototherapy on very low birth weight infants.


Eligibility criteria:
inclusion criteria: * very low birth weight infants exclusion criteria: * chromosomal anomalies

Keywords: indirect hyperbilirubinemia very low birth weight infants
analysis of epa® (a food intake assessment tool) as a screening test for malnutrition in general medicine

Conditions: Malnutrition

Summary: the main objective is to evaluate the sensitivity of the epa® for screening for malnutrition in general medicine in adults.


Eligibility criteria:
inclusion criteria: * to be an adult, * consulting the principal investigator, a general practitioner in his activity of substitute doctor, * during the inclusion period, * not opposed to participating in the study. exclusion criteria: * patients benefiting from artificial nutrition, * patients with advanced dementia, * pregnant or postpartum women, * patients who do not understand or speak french, * patients treated with diuretics who have had a change in treatment dosage during the last 6 months, * patients for whom weight measurement is not possible in the office (wheelchair, disability ...), * patients who have already been included once, * patients who have had surgery for obesity, * major persons subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty, ...
ultra-widefield fluorescein angiography-based targeted retinal photocoagulation versus conventional panretinal photocoagulation in the preservation of visual function and regression of proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy - High Risk

Summary: proliferative diabetic retinopathy is a vision-threatening disease that can lead to irreversible visual loss. the treatment options for proliferative diabetic retinopathy are anti-vegf injection and retinal photocoagulation. the study aims to compare ultra-widefield fluorescein angiography-based targeted retinal photocoagulation and panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.


Eligibility criteria:
inclusion criteria: * proliferative diabetic retinopathy (pdr) with neovascularization on the disc or elsewhere in the retina exclusion criteria: * participants with a history of previous history of: * retinal photocoagulation * vitreoretinal surgery * tractional retinal detachment * epiretinal membrane * vitreomacular traction * glaucoma * uveitis * media opacities like cataract, corneal opacity, vitreous hemorrhage * anti-vegf injections in last 3 months

Keywords: diabetic retinopathy laser photocoagulation fluorescein angiography
antioxidant supplements, genetics and chemotherapy outcomes

Conditions: Node Positive Breast Cancer; Node Negative Breast Cancer

Summary: this study will investigate the null hypothesis that use of antioxidant supplements during adjuvant chemotherapy will have no impact on toxicities and disease-free, as well as overall, survival, and also evaluate the role of polymorphisms in genes related to oxidative stress in relation to treatment outcomes.

this study will enroll 3000 women from s0221with node positive or high-risk node-negative breast cancer receiving ac+t onto this ancillary study to address the following specific aims: 1. to characterize use of antioxidant supplements with a survey instrument prior to and at completion of treatment, and to evaluate reported use pre and post treatment in relation to toxicity and disease-free survival. the potential effects of diet, physical activity, and other lifestyle factors on relationships between supplement use and treatment outcomes will also be considered. 2. to evaluate if variants (polymorphisms) in genes that produce reactive oxygen species (ros) (mpo) and in genes that protect cells from the effects of ros are associated with treatment-related toxicities and with disease-free survival.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of operable stage 1, ii, or iii invasive breast cancer with known estrogen or progesterone receptor status * high risk by meeting at least one of the following criteria: 1. tumor \>= 2 cm in greatest diameter 2. one or more axillary or intramammary nodes are involved by metastatic breast cancer * had either a modified radical mastectomy or local excision of all tumors plus axillary node dissection or sentinel node resection * not received prior chemotherapy or radiation therapy for the current malignancy * no history of congestive heart failure or angina pectoris * normal creatinine and bilirubin, alkaline phosphatase and sgot or sgpt 2 x the institutional upper limits of normal * anc greater than or equal to 1,200 ul and platelet count of greater than or equal 100,000 u1 * no previous malignancies * age 18 or greater * performance status of 0 -2 by zubrod criteria * hiv negative (if known)
emervel® deep lidocaine vs. juvederm® ultra plus in treatment of moderate to severe facial wrinkles and folds

Conditions: Skin Wrinkling

Summary: the purpose of the study was to compare the effectiveness and safety of emervel deep lidocaine versus juvederm ultra plus in the treatment of moderate to severe facial wrinkles and folds.

this was a randomized, evaluator-blinded, active-controlled, multi-center, split-face comparison study of emervel deep lidocaine versus juvederm ultra plus in the treatment of moderate to severe facial wrinkles and folds. two physicians, an unblinded injecting investigator and a blinded evaluating investigator, were required at each study center. the unblinded injecting investigator was different from the blinded evaluating investigator.

Eligibility criteria:
inclusion criteria: * the subject was a male or female 18 years of age or older * the subject had bilateral nasolabial folds that, in the opinion of both the blinded evaluating investigator and the unblinded injecting investigator, was corrected with an injectable dermal implant * the subject had the same wrinkle severity rating scale (wsrs) score of 3 or 4 (moderate or severe) for each nasolabial fold exclusion criteria: * the subject had active skin disease or inflammation on or near a nasolabial fold that, in the principal investigator's opinion, would interfere with the study device injections and/or study assessments. * the subject had a history of sensitivity to hyaluronic acid * the subject had a history of sensitivity to lidocaine or other amide type anesthetics * the subject was, in the principal investigator's opinion, at undue risk based on the precautions, warnings and contraindications for local lidocaine anesthetics.
quality of life of adults with diffuse large b-cell lymphoma treated with tisagenlecleucel

Conditions: Lymphoma, Large B-Cell, Diffuse

Summary: the aim of this non-interventional multi-center study is to evaluate quality of life (qol) and other patient reported outcomes (pros) among adults with diffuse large b-cell lymphoma (dlbcl) following chimeric antigen receptor (car) t-cell therapy with tisagenlecleucel (kymriah). up to 100 individuals will be enrolled prior to tisagenlecleucel infusion in either the inpatient or ambulatory setting and followed for 6 months post-enrollment to evaluate changes in qol from baseline to post-treatment, as measured by the functional assessment of cancer treatment- lymphoma (fact-lym). secondary outcomes will assess patient self-efficacy in assessing for and managing treatment-related toxicities including cytokine release syndrome (crs) and immune effector cell-associated neurotoxicity syndrome (icans) and communicating these and other concerns across care settings. to support patients and facilitate the collection of key pros, a digital health coaching solution provided by pack health will be provided to each participant over the 6-month study enrollment. the digital coaching program provides an evidence-based curriculum focused on monitoring and managing car t-cell associated toxicities, enhancing overall wellness post-treatment, and navigating within and between referring and treating facilities. the participating site(s) will collect longitudinal pro data focused on qol across physiologic and psychosocial domains that coaching personnel will access and review with participants.


Eligibility criteria:
inclusion criteria: * adults aged 18 and older * able to read, speak and consent in english * diagnosis of diffuse large b-cell lymphoma * confirmed treatment with tisagenlecleucel (kymriah) * internet access via smartphone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments. exclusion criteria: * individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment) * individuals for whom there is documentation of inability to provide consent in the medical record

Keywords: quality of life digital health coaching adult receptors, chimeric antigen
resilience in persons following spinal cord injury

Conditions: Spinal Cord Injuries

Summary: this study aims to quantify resilience in survivors of a spinal cord injury. the study will consist of structured interviews and self-reported surveys. we will look for common themes between participants at different stages of injury (1-5 years, 5-15 years, \>15 years).

the goal of this project is to broaden the understanding of the lived experience of aging with a disability, from the perspectives of individuals with physical disabilities resulting from spinal cord injury (sci). the specific objectives of this project are to: 1. learn how people with sci attain and maintain optimal quality of life as they age. 2. understand how people with sci develop resilience as they grow older. 3. understand how individual quality of life is related to the degree and mechanism of resilience among people with sci. 4. learn which resources and practices have been most helpful and useful to people with sci as they age with their disability. 5. assess personal, behavioral, and environmental factors that contribute to resilience and quality of life among people aging with sci. 6. refine and confirm a holistic model for the relationships among the concepts of resilience, quality of life, and person-centered factors (resources, behaviors). through in-depth interviews and detailed surveys, we will explore how people with sci attain and maintain optimal quality of life as they age, and how their quality of life relates to resiliency as they traverse the path of aging with sci. we will explore with participants the resources and practices that have been most helpful and useful to them as they age with their disability.

Eligibility criteria:
inclusion criteria: * 18-80 years old * history of traumatic spinal cord injury at least 1 year prior * ability to self-report on factors affecting health and well being exclusion criteria * progressive spinal cord injury

Keywords: resilience
interleukin-2 in metastatic kidney cancer

Conditions: Renal Cell Cancer Metastatic; Kidney Cancer Metastatic

Summary: the purpose of this study is to determine whether interleukin-2 at the dose and schedule used in this study will help increase tumor shrinkage.

in this phase ii study, the il-2 schedule (daily il-2 for 5 days (per week) every 3 weeks) will be tested in a cohort of kidney cancer patients to attempt to determine the response rate, median duration of response, and median survival. the dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (\> 1440 million iu/m2/year).

Eligibility criteria:
inclusion criteria: 1. patients must have a histologic diagnosis of metastatic kidney cancer. patients may have received prior systemic therapy or may be previously untreated 2. patients must have bi-dimensional measurable disease on physical exam or radiologic studies. 3. ecog performance status of 0 or 1 and estimated survival of at least 3 months. 4. white blood count of \> 3500/mm3, platelet count \> 100,000/mm3, hemoglobin \> 9.0 gm/dl; bilirubin, alt, ast \< 3 x upper limit of normal; serum creatinine \< 2.0 mg/dl. 5. patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. patients with a positive stress test would be excluded from this trial. 6. patients with elevated temperatures \> 100.5 f must have sources of occult infection excluded. 7. patients must be felt to have recovered from effects of prior therapy, such as \> 2 weeks after prior chemotherapy. 8. patient consent must be obtained prior to entrance onto study. 9. women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment exclusion criteria: 1. medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate. 2. autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy. 3. prior history of psychiatric disorder which could be exacerbated by interleukin-2. 4. lactation or pregnancy. 5. evidence of significant cardiovascular disease including history of recent (\< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional pvc's, angina, positive low-level stress test, or cerebrovascular accident. 6. current brain metastasis.

Keywords: metastatic renal cell metastatic kidney cancer
immediate effects of dry needling and tens in chronic neck pain

Conditions: Myofascial Neck Pain

Summary: the aim of this study is to determinate the effects of percutaneous electrical nerve stimulation in the short-term for pain in patients with myofascial chronic neck pain.


Eligibility criteria:
inclusion criteria: * neck pain for more than six months of evolution. * active myofascial trigger point number 2 on trapezius muscle. * score of more than 2 points in a visual analog scale. exclusion criteria: * neck pain specific. * radiculopathies. * whiplash. * dizziness and migraines * cervical surgical intervention * previous treatment of dry needling

Keywords: neck pain myofascial pain syndrome soreness
mindfulness and placebo for pain (mapp) study

Conditions: Chronic Pain

Summary: this study proposes a three-arm randomized-controlled trial (rct) that evaluates the feasibility and acceptability of combining a mindfulness-based therapy (mbt) and open-label placebo (olp) treatment for individuals with chronic pain. individuals with chronic pain will be recruited to participate in an 8-week trial, with a subsequent 3-month post-treatment follow-up. participants will be randomly assigned to one of the following three conditions: 1. mindfulness-based stress reduction (mbsr) 2. olp treatment 3. combination of mbsr and olp treatment


Eligibility criteria:
inclusion criteria: 1. ≥18 years old; 2. ability to speak, write, and read in english; 3. physical pain present on at least half the days in the past 3 months; and 4. average past week pain severity rating ≥3 on a 0-10 numerical rating scale. exclusion criteria: 1. acute pain due to recent injury or surgery; 2. self-reporting of chronic malignant pain (e.g., cancer, hiv); 3. self-reporting of raynaud's disease (those who can be contraindicated for cold pressor testing); 4. severe psychopathology (e.g., a psychotic disorder) or significant cognitive deficits judged to interfere with study procedures; 5. currently pregnant or breastfeeding; 6. inability to discontinue use of vitamin b2 supplements or a multivitamin containing vitamin b2 throughout the study period (these interfere with riboflavin tracer-olp treatment adherence-monitoring); 7. inability to commit to study period.

Keywords: chronic pain pain mindfulness placebo
chromoendoscopy for ulcerative colitis surveillance

Conditions: Ulcerative Colitis; Crohn's Disease

Summary: long-standing ulcerative colitis is associated with an increased cancer risk. chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. the purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.

patients with ulcerative colitis (uc) are at increased risk for colon cancer. current guidelines recommend periodic surveillance colonoscopy in individuals who fulfill certain high-risk criteria. endoscopists must perform a high number of biopsies (over 33 per patient) in order to increase the yield of such procedures. chromoendoscopy (ce) has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. whether ce can replace standard colonoscopy in the surveillance of patients with uc is unknown. comparison: both standard biopsies and targeted biopsies will be obtained during colonoscopy from patients with uc who are candidates for surveillance colonoscopy. the yield of the two methods will be compared based on the number of biopsies required to identify one dysplastic (precancerous) lesion.

Eligibility criteria:
inclusion criteria: * ulcerative colitis, pancolitis \> 8 years; left-sided \> 15 years or * history of psc or * history of previous dysplasia on colon biopsies or * family history of colon cancer in first degree relative exclusion criteria: * any condition that precludes colonoscopy * expected survival less than 1 year

Keywords: ulcerative colitis crohn's disease chromoendoscopy dysplasia neoplasia
trajectories of chronic multimorbidity patterns in older patients

Conditions: Chronic Disease

Summary: following the mrisk-covid project, mtop (multimorbidity trajectories in older patients) study was developed. it is a retrospective observational study using real world data that aims to identify patterns of chronic multimorbidity in patients aged ≥65 years and their evolution and trajectories in the previous 10 years. the secondary objective is to identify the relationship between the trajectories of multimorbidity patterns in the previous 10 years and the severity of the infection by covid-19.

multimorbidity is associated with negative results and presents difficulties in clinical management. recently, new methodologies are emerging based on the hypothesis that chronic conditions are associated in a non-random way forming multimorbidity patterns. however, there are few studies that study the temporal evolution and trajectories of these multimorbidity patterns, which could be associated with different prognoses and could allow better forecasting and planning. the primary objective of this analysis is to identify patterns of chronic multimorbidity in patients aged ≥65 years and their evolution and trajectories in the previous 10 years, using part of the mrisk-covid project data. as a secondary objective, the investigators want to identify the relationship between the trajectories of multimorbidity patterns in the previous 10 years and the severity of the covid-19 infection. this retrospective observational study has a historical cohort of 3958 patients ≥65 years of age suspected and confirmed of covid-19 infection from february 1 to june 15, 2020 in the reference area of parc taulí university hospital. the available data (real-world data) are socio-demographic and diagnostic variables provided by the data analytics program for research and innovation in health (padris), which include sex, age and primary care diagnoses. to identify patterns of multimorbidity, the clinical classification software, chronic condition indicator, multiple correspondence analysis and cluster analysis using the fuzzy c-means algorithm will be used. then, a clinical consensus process (delphi-like) will be made of the clusters obtained. to identify the most probable trajectories along the three time points, each patient will be assigned to the cluster with the highest probability of membership. descriptive and bivariate statistics will be performed.

Eligibility criteria:
inclusion criteria: * positive results of covid-19 laboratory tests * covid-19 related clinical profile verified by healthcare professionals exclusion criteria: * males \>90 years (re-identification risk)

Keywords: multimorbidity cluster analysis trajectories older patient covid-19
electromyography-biofeedback on the motor activation of the extension of the hand

Conditions: Stroke, Complication

Summary: background: biofeedback-surface electromyography (bio-semg) is a relatively recent physiotherapy technique. although its use is widespread in sports science and sports performance, its use for the rehabilitation of patients with neurological pathologies is less studied. objective: the purpose of this research was to determine the changes that occur in the application of bio-semg in the muscles responsible for the extension and the dorsiflexion of the hand and the foot in subjects with cerebrovascular damage. design: a randomized, double-blind, two-arm parallel group study was performed. patients: a sample of 28 subjects with limited extension of the hand and dorsiflexion of the foot as a consequence of a stroke was randomized divided in intervention or control groups. methods: the subjects of the intervention group underwent 12 sessions of bio-semg, of 15-minute duration each of them, in the upper and lower members. on the other hand, the control group underwent another 12 sessions of 15-minute duration, in which manual physiotherapy techniques were performed.


Eligibility criteria:
inclusion criteria: * patients with a stroke * limitation of the hand and foot extension exclusion criteria: * patients with some contraindication against the surface electromyography biofeedback technique, for instance, people with pacemaker, with cardiovascular antecedents, etc. * patients receiving other physiotherapy treatment 2 months before the beginning of the study * patients that decline to sign the informed consent.
brief mindfulness intervention for orthopedic patients: mechanistic investigation

Conditions: Pain

Summary: this is a single-site, two-arm, parallel-group randomized clinical trial (rct). the analgesic effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. analgesic mechanisms of mindfulness will also be investigated.


Eligibility criteria:
inclusion criteria: * age ≥18 * seeking treatment at the tallahassee orthopedic center exclusion criteria: * cognitive impairment preventing completion of study procedures. * other unstable illness judged by medical staff to interfere with study involvement.