Kornimate/medical-research-clean huggingface dataset:
vitamin d inadequacy in rural populations, evaluation of correction by food supplementation

Conditions: Vitamin D Insufficiency; Vitamin D Deficiency

Summary: the purpose of the research is to describe vitamin d levels and bone status in a rural wisconsin population. it is probable that individuals of varying age and ethnicity require different amounts of d to achieve optimal status. these likely scenarios will be explored in various populations. we hypothesize that the increase in serum 25(oh)d resulting from daily d3 ingestion is less pronounced with advancing age and different in native than caucasian americans. in addition, the women in the middle age group, between the ages of 55 and 65, will have ultrasound tests completed to assess the impact of the vitamin d supplementation on cardiovascular health.


Eligibility criteria:
inclusion criteria: * healthy, community-dwelling ambulatory women. * able and willing to sign informed consent. * ages: 20-30, 55-65 or \>75 * baseline serum 25ohd concentration \> 10 ng/ml and \< 60 ng/ml * not pregnant * willing to avoid use of cod-liver oil and non-study vitamin d supplementation; standard multiple vitamins containing ≤ 400 iu used no more than once daily will be allowed. * willing to utilize sunscreen of spf-15 or higher when sun exposure for more than 15 minutes is expected. exclusion criteria: * current hypercalcemia (serum calcium \> 10.5 mg/dl) or untreated primary hyperparathyroidism. * history of nephrolithiasis * baseline 24-hour urine calcium \> 250 mg * known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, paget's disease. * history of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma. * renal failure; defined as a calculated creatinine clearance (using the cockroft-gault approach) of ≤ 25 ml/minute. * severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study. * treatment with any drug known to interfere with vitamin d metabolism, e.g., phenytoin, phenobarbital. * known malabsorption syndromes, e.g., celiac disease, active inflammatory bowel disease, etc. * known allergy to chocolate. * use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, parathyroid hormone, testosterone or calcitonin. * treatment with high dose vitamin d (≥ 50,000 iu weekly) or any active metabolites of vitamin d, e.g., calcitriol, within six months of screening. * use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer.
the role of maintaining external carotid artery flow in graft interposition after carotid endarterectomy

Conditions: Carotid Artery Diseases; Stroke; Carotid Atherosclerosis

Summary: analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.

surgical and endovascular treatment have been shown as effective treatment modalities in symptomatic and asymptomatic patients at high risk of stroke on medical therapy with significant carotid artery stenosis. eversion carotid endarterectomy (ecea) has proven effective as a surgical treatment modality. in highly selected instances carotid bypass may be indicated as a bailout procedure or primarily as a preoperatively planned maneuver. usually, the decision for substitution of carotid bifurcation with a synthetic graft is made due to an extensive, severe atherosclerotic process on the distal part of the extracranial internal carotid artery, the presence of uncontrollable atherosclerotic plaque after endarterectomy, and in cases when an exceptionally thin artery wall remains after endarterectomy. several techniques have been described for substituting carotid bifurcation with a synthetic graft. the most common technique involves complete resection and excision of the carotid bifurcation and reconstruction with graft interposition between the undiseased segment of the common carotid artery (cca) proximally and the internal carotid artery (ica) distally by creating proximal and distal end-to-end anastomoses. this technique requires ligation and exclusion of the external carotid (eca) and the superior thyroid artery from circulation. the less common techniques that preserve flow through the external carotid artery are performed as a primary option for treatment without previous endarterectomy and are seldom applied. currently, there are no recommendations regarding the administration of carotid bypass, nor comparisons of these techniques. in this study, the investigators are comparing a technique with graft interposition between endarterectomized cca (creation of side-to-end anastomosis) and the distal segment of the ica (end-to-end anastomosis) after failure of ecea to provide technical success with the described common interposition by end-to-end anastomoses proximally and distally. therefore, the role of flow preservation through the eca could be defined.

Eligibility criteria:
inclusion criteria: * symptomatic carotid stenosis (\> 50%) * unilateral asymptomatic carotid stenosis (\> 60%) * bilateral asymptomatic carotid stenosis (\> 60%) exclusion criteria: * carotid restenosis * "major surgery" in previous 6 months * previous brain trauma or surgery * malignant disease * epilepsy * carotid artery aneurysm
somatostatin receptors imaging in relapsing and refractory multiple myeloma patients

Conditions: Multiple Myeloma

Summary: this study wil assess somatostatin receptor (sstr) expression via the uptake of gallium-68 labelled dota-conjugated sstr targeting peptide using pet/ct imaging in multiple myeloma lesions pre-identified on 18f-fdg pet/ct in order to evaluate the feasibility of molecular radionuclide therapy in refractory and relapsing mutiple myeloma using the lutetium-177 radiolabelled targeting peptide.


Eligibility criteria:
inclusion criteria: * age above or equal to 18 years * written informed consent in accordance with institutional guidelines and obtained prior to any study procedures * confirmed diagnosis of multiple myeloma according to the salmon and durie criteria * has received at least 3 lines of treatment, exposed and refractory (or non-eligible) to the 5 major drugs (lenalidomid, pomalidomid, bortezomib, carfilzomib, daratumumab) * life expectancy above 3 months * active (relapsing or refractory) and measurable disease (on 18f-fdg pet/ct (performed within 4 weeks prior sstr pet/ct) and biologically) * adequate renal function with gfr above or equal to 30ml/min/1.73m² * bone marrow aspiration and biopsy sample available within 30 days prior study enrolment with positive sstr2 ihc exclusion criteria: * pregnant or lactating patients * other active neoplastic disease * treatment by another molecule that is object of investigation within 30 days prior sstr pet/ct * eastern cooperative oncology group performance status above or equal to 3 * corticoids administration at a therapeutic level (total dose of 160 mg of dexamethasone or equivalent) two weeks prior enrolment
ketamine continuous infusion on opioid consumption and pain management in severe burned patients

Conditions: Pain, Burning

Summary: the purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in the control of pain intensity, the impact on the consumption of opioids and observe the side effect profile in patients suffering from great extent of burns.

despite advances in pharmacology and in analgesic techniques, pain in burned patients is unwieldy yet, this occurs in such cases due to the complexity and intensity and the need for multidisciplinary medical team. the burn pain is classified as nociceptive, but can also present a neuropathic component. overall this is a pain at rest and during movement, being aggravated by procedures like changing dressings. in the weeks after the burn there is intense pain due to injury and the management of the framework, which often involves dressing changes and other procedures such as surgery in donor area skin. the use of opioids in high doses can lead to unwanted side effects.to reduce the adverse effects resulting from the use of opioids in high doses, we purpose the use of intravenous continuous infusion of ketamine. in controlling the pain of major burned patient there is evidence only of the use of ketamine in the form of intermittent boluses, especially during dressing changes or in the perioperative period. the use of ketamine in continuous infusion lacks evidence in this group of patients the purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in the control of pain intensity, the impact on the consumption of opioids and observe the side effect profile in patients suffering from great extent of burns.

Eligibility criteria:
inclusion criteria will be considered: 1. patients admitted to the burn unit of the clinical hospital with burnt body area of 25% or more; 2. aged between 18 and 60 years; 3. with surgical risk classification according to the "american society of anesthesiologists' (asa) i and ii; 4. has no known allergy or any other contraindications of the drugs that are used in the treatment protocol; 5. hemodynamically stable, considering systolic blood pressure greater than 90 mmhg; 6. with preserved consciousness level, measured by the glasgow coma scale, with a score equal to 15; 7. with the possibility of drug administration orally or by naso-gastric tube exclusion criteria will be considered: 1. patients younger than 18 or older than 60 years; 2. with surgical risk classification according to the "american society of anesthesiologists' (asa) iii or higher; 3. with known allergy or any contraindications of the drugs that are used in the treatment protocol; 4. patients with q chronic pain or chronic analgesic users prior to burning in treatment; 5. hemodynamically unstable, considering systolic blood pressure below 90 mm hg; 6. with changing level of consciousness; 7. without the possibility of administering drugs orally or by nasogastric tube.

Keywords: ketamine continuous infusion severe burned patients
ngs combined with rnaseq on tumor immune escape in nsclc

Conditions: Non-small Cell Lung Cancer

Summary: study on the tumor immune escape in advanced non-small cell lung cancer patients with egfr and alk mutant negative by ngs combined with rnaseq

study on the tumor immune escape in advanced non-small cell lung cancer patients with egfr and alk mutant negative by ngs combined with rnaseq. detecting non-small cell lung cancer patient ngs and rnaseq data before first-line chemotherapy, after two cycles chemotherapy and after disease progression.

Eligibility criteria:
inclusion criteria: non-small cell lung cancer patient first-line chemotherapy with platinum-based chemotherapy exclusion criteria: egfr mutant positive alk mutant positive

Keywords: ngs rnaseq
intervention to reduce sugar-sweetened beverage (ssb) consumption in children and families

Conditions: Obesity, Childhood

Summary: pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.

this is a pilot 2-arm randomized trial among 60 families of 1-8 year old children who currently over-consume sugary drinks. the study team will randomize families to either an intervention group, that will receive a behavioral intervention consisting of an educational video, water promotion toolkit, mobile phone app, and series of educational phone calls, or to a control group that will not receive this intervention. the study team will compare 6-month change in child and parental beverage consumption between groups. exploratory analyses will examine child weight (kg) and body mass index (bmi) z-score (bmiz) outcomes, and compare intervention effects across race/ethnic groups.

Eligibility criteria:
inclusion criteria: * child 1-8 years old who receives health care attention at wake forest pediatric or family medicine practices * child consumes 2 or more ssb and/or fruit juice total per day * child with no chronic health condition * child has not seen nutritionist or visited our family-based weight management clinic in the past year * parent/caregiver who has not watch educational video "get in the zero zone" * parent/caregiver has a smartphone and reliable internet * parent/caregiver able to communicate well in english exclusion criteria: * child doesn't meet age criteria * child consumes less than 2 ssb and/or fruit juice total per day * child with a chronic health condition * child has seen nutritionist or visited our family-based weight management clinic in the past year * parent/caregiver has watched educational video "get in the zero zone" * parent/caregiver has completed interview or usability test * parent/caregiver doesn't have a smartphone or reliable internet * parent/caregiver not able to communicate well in english
efficacy of a dementia family caregiver support intervention in vietnam

Conditions: Dementia

Summary: this is a cluster randomized controlled trial to test the efficacy of a psychosocial intervention to support family caregivers of persons living with dementia in vietnam.

the objective of this study is to conduct a cluster randomized controlled trial (rct) to test the efficacy of a psychosocial intervention to support alzheimer's family caregivers in vietnam. the cluster rct will test the hypothesis that family caregivers who receive the intervention will show lower psychological distress and lower caregiver burden compared with those in the control group (primary outcomes). in addition, we will conduct secondary analyses to examine whether the intervention group has lower perceived stress and somatic symptoms. exploratory analyses will be conducted to determine if intervention effects are mediated by caregiver self-efficacy or knowledge gain.

Eligibility criteria:
inclusion criteria: * to be eligible for the cluster rct, the family member will need to be the identified adult (age 18 and above) primary caregiver (i.e. the person spending who provides the most time day-to-day providing care) to an older adult with dementia who is living in the community. in the event that the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 hours/day) to the older adult with dementia will be eligible. * caregivers will need to score ≥ 6 on the zarit burden inventory 4-item version. * all participants will be living in designated clusters in hai duong, vietnam. * to be eligible, clusters will have a minimum of 5 participants and a maximum of 15 participants. clusters will be defined as geographic areas serving local health stations. exclusion criteria: - significant cognitive impairment or sensory deficit.

Keywords: family caregiving
donor-derived cell-free dna in kidney transplant recipients

Conditions: Kidney Transplantation; Acute Rejection of Renal Transplant

Summary: donor-derived cell-free dna (dd-cfdna) is a promising non-invasive biomarker of kidney allograft rejection. in this prospective, single center, observational monitoring study, we aim to evaluate a role of dd-cfdna in predicting kidney allograft injuries, i.e. rejection and non-rejection injuries within 12 months, and to monitor the effect of anti rejection treatment.

kidney transplantation represents the best therapeutic option in patients with end-stage kidney disease. among main causes of graft loss belongs kidney allograft rejection which is diagnosed based on histology/molecular assessment of biopsy sample. this is invasive procedure, but provides more precise result regarding type of rejection. contrary, donor-derived cell-free dna (dd-cfdna) is a novel non-invasive biomarker of allograft rejection with excellent negative predictive power. moreover it may be useful for predicting allograft injuries and resolution of injuries after treatment. in the prospective cohort, 100 renal allograft patients will be enrolled and dd-cfdna levels determined from blood collected at predefined time points (pretx, pod14, m1, 2, 3, 4, 6, 9, 12). in the second cohort, 40 patients will be enrolled at the time of biopsy with histological and/or molecular diagnosis of rejection and dd-cfdna levels measured just before initiation of treatment and then at week 1, 2 and 3 after biopsy. peripheral blood will be collected in 2x 10 ml cfdna (streck) collection tubes for each study visit and dd-cfdna will be quantified by the prospera™ test (natera inc., austin, texas). all patients will receive standard of care treatment according to centre protocol and no patients or providers will receive the results of dd-cfdna testing during the study. study protocol and patient informed consent were approved by ethical committee.

Eligibility criteria:
inclusion criteria: * recipient age ≥ 18 years and \<85 years * written informed consent cohort 1 * deceased donor kidney transplant recipient cohort 2 * patients with kidney allograft biopsy at center showing any type of rejection which is going to be treated * patient wishing to repeatedly travel to center exclusion criteria: cohort 1 * living donor * multiple transplant * dual transplant * haematopoetic stem cell transplant in a history

Keywords: kidney transplantation acute rejection of renal transplant dd-cfdna non-invasive test
long-term sequelae of sars-cov-2 infection: diabetes mellitus

Conditions: COVID-19; Diabete Mellitus

Summary: hospitalized patients with severe covid-19 have an increased incidence of insulin resistance, impaired beta cell function, glucose intolerance (prediabetes), and overt type 2 diabetes (t2d) compared to non-hospitalized patients with covid-19 and covid-19 negative individuals on long-term follow up.

the purpose of this research study is to understand the long-term effects of covid-19 infection on individuals without any prior history of diabetes. this study will look at several measures of diabetes, such as glycemic control (blood glucose/sugar levels), function of beta cells (cells that make insulin to control sugar), insulin secretion and insulin sensitivity (fasting insulin levels). the following participants will be enrolled: 1) have had covid-19 infection and were hospitalized and recovered, or 2) have had mild covid-19 infection and were seen at outpatient clinics or er and were not required to be hospitalized, or 3) have not had covid-19 infection but were seen in outpatient clinics or er during the same time period. the researchers hope to learn the long-term effects of covid-19 infection in hospitalized patients. specifically, they will be focusing on the subsequent development of diabetes and associated metabolic disturbances, such as impaired insulin secretion and insulin resistance. a relationship between covid-19 and diabetes needs to be investigated.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \< 40 kg/m2 exclusion criteria: * history of diabetes prior to sars-cov-2 infection * took medications used to treat diabetes prior to sars-cov-2 infection * history of myocardial infarction or stroke within 6 months * history of major organ system disease prior to covid-19 infection

Keywords: glycemic control long term medical effects of covid-19 blood glucose control insulin sensitivity
a study in subjects with parkinson's disease to evaluate the safety and tolerability of titration and continuous subcutaneous infusion of abbv-951 in an outpatient environment

Conditions: Parkinson's Disease (PD)

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with abbv-951 in adult subjects with parkinson's disease (pd).


Eligibility criteria:
inclusion criteria: * subject with a diagnosis of definite idiopathic parkinson's disease (pd) that is levodopa-responsive according to the united kingdom parkinson's disease society brain bank criteria. * subject must be taking an optimized and stable regimen of oral medications for pd, which has remained stable and unchanged for at least 30 days before enrollment in this study. * subject is judged inadequately controlled on current therapy in the opinion of the investigator and must experience a minimum of 2.5 hours of "off" time per day prior to enrollment. * subjects with a mmse score greater than or equal to 24 and considered by the investigator to not have dementia. exclusion criteria: * subjects with clinically significant electrocardiogram (ecg) values. * history of significant skin conditions or disorders that in the investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments. * receipt of an investigational product within at least 6 weeks prior to study drug administration. * subjects with moderate to severe kidney disease. * consideration by the investigator for any reason that the subject is an unsuitable candidate to receive abbv-951. * patient/caregiver that cannot demonstrate proper use of the devices (drug pump and wearable device) will not be allowed to participate.

Keywords: carbidopa levodopa
a non-interventional, observational study for quality of life (overall health assessment) in patients with chronic severe pain during targinact® treatment

Conditions: Chronic Severe Pain

Summary: this non-interventional, observational study evaluates the efficacy of targinact with regard to quality of life in daily clinical practice in belgium compared to the previous analgesic treatment.

patients are treated with targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. parameters assessed are overall health assessment of the patient, pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of targinact® treatment. these parameters, except for safety assessment, are compared between targinact® treatment and previous analgesic treatment.

Eligibility criteria:
inclusion criteria: patients enrolled in the study are patients who * are eligible for targinact® treatment according to the targinact® spc and * who have previously been treated with who step 1, 2 or 3 analgesics exclusion criteria are based on the targinact® spc.

Keywords: chronic pain severe pain oxycodon naloxon opioid-induced constipation opioid quality of life laxative analgesic rescue medication
acquired resistant mechanism of the first-generation egfr tkis

Conditions: Non-small Cell Lung Cancer; Aquired Resistance; EGFR TKIs

Summary: patients with advanced non-small-cell lung cancer (nsclc) harboring sensitive epithelial growth factor receptor (egfr) mutations invariably develop acquired resistance to egfr tyrosine kinase inhibitors (tkis). identification of actionable genetic mutations can be helpful for guiding the subsequent treatment. this study aimed to analyze the genetic profile of nsclc harboring acquired resistance to the first-generation egfr tkis using next generation sequencing (ngs).


Eligibility criteria:
inclusion criteria: * histologically proven stage iiib or iv non-small cell lung cancer * patients harboring sensitive egfr mutations and received first-generation egfr-tkis who developed acquired drug resistance * patients who can provide pre-treatment (egfr tkis) tumor tissues * patients with tumor lesions to be re-biopsy after drug resistance * patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital. exclusion criteria: * history of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix * patients with other systemic diseases