Kornimate/medical-research-clean huggingface dataset:
diagnosing vesicoureteric reflux in children by direct isotope cystography and contrast enhanced voiding ultrasonography

Conditions: VUR - Vesicoureteric Reflux

Summary: the purpose of this study is to examine the applicability of contrast enhanced voiding ultrasonography in diagnosing vesicoureteral reflux (vur) in pediatric patients compared to direct isotope cystography. the aim of the study is to find a modality allowing the accurate diagnosis of vur and the classification of the degree of vur with the least possible harm from the examinations. the investigators recruit 100 under 6 years old patients who have had at least 2 culture positive urinary tract infections. exluding criteria are abnormal bladder function and posterior uretral valves. the investigators perform direct isotope cystography and contrast enhanced voiding urosonography during the same day to diagnose and grade vur. the investigators use standardized volume and speed of bladder filling. the examinations are done by a radiologist and an isotope specialist and they are blinded to the result of the other examination.


Eligibility criteria:
inclusion criteria: * under 6 years old patients who have had at least 2 culture positive urinary tract infections exclusion criteria: * abnormal bladder function * posterior uretral valves
facbc prostate therapy response

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess if using anti-1-amino-3-\[18f\]fluorocyclobutane-1-carboxylic acid (facbc or fluciclovine) pet scan will be useful in determining if participants are responding to chemotherapy treatment. investigators will enroll participants whose cancer has been treated with hormone therapy and now the cancer is not responding to the treatment (castration -resistant), and so therefore will be started on chemotherapy. investigators aim to enroll thirty participants in this study.

the goal of the investigation is to examine therapeutic monitoring of chemotherapy in castrate resistant prostate carcinoma with anti-3-\[18f\]facbc in prostate carcinoma to determine if anti-3-\[18f\]facbc amino acid imaging can serve as an accurate and efficient imaging biomarker. investigators will perform a baseline anti-3-\[18f\]facbc pet-ct of the whole body. all participants will also undergo conventional staging including 99mtc methylene diphosphonate (mdp) bone scanning and computed tomography scan (ct) or magnetic resonance imaging (mr) of the abdomen and pelvis which are standard of care at the enrolling institution. this study will not interfere with standard patient evaluation or delay therapy. all 30 participants will receive chemotherapy every 3 weeks for 6 cycles. participants will undergo a repeat anti-3-\[18f\]facbc pet-ct after 1 and 6 cycles and also repeat conventional imaging including bone scanning ct or mr of the abdomen and pelvis after 6 cycles. at the end of the study, the study team will then record the response (or lack thereof) on anti-3-\[18f\]facbc pet-ct and correlate that response with response per standard clinical criteria including bone scan uptake for skeletal lesions, ct or mr for soft tissue and skeletal lesions, prostate-specific antigen (psa) progression or regression, and other clinical parameters such as declining performance status.

Eligibility criteria:
inclusion criteria: * primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone (lhrh) agonists (lupron or trelstar), other anti-androgens, and/or abiraterone or enzalutamide may be in use.) * ability to lie still for pet scanning * ability to provide written informed consent exclusion criteria: * age less than 18 years * inability to lie still for pet scanning * inability provide written informed consent * currently undergoing chemotherapy for organ confined or systemic disease. this does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting.

Keywords: imaging nuclear medicine oncology radiology urogenital disorders
usability study for soberlink system

Conditions: Alcoholism; Alcohol Dependence

Summary: the soberlink cellular device, in its original packaging, along with the quickstart guide will be provided to the end user in a simulated home use environment or by rx in clinic. the patient labeling will be in the format intended for distribution. ten (10) rx subjects will be provided instruction for use in clinic for the soberlink cellular device while an additional ten (10) rx subjects will be provided instruction for use in clinic for the soberlink cellular device and sober sky web portal. an additional ten (10) simulated home use subjects will be provided instruction for use for the soberlink cellular device while an additional ten (10) simulated home use subjects will be provided instruction for use in clinic for the soberlink cellular device and sober sky web portal. all subjects will be provided with a post-test questionnaire on how to operate the device. the post-test questionnaire will collect information regarding device use. the device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. additionally, measurable usability criteria for specific, critical steps will be evaluated.

forty (40) subjects identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. subjects will be asked to sign informed consent. the soberlink cellular device, in its original packaging, along with the quickstart guide will be provided to the patient in a simulated home-use environment and rx clinical setting. the patient labeling will be in the format intended for distribution. ten (10) rx subjects will be provided instruction for use in clinic for the soberlink cellular device while an additional ten (10) rx subjects will be provided instruction for use in clinic for the soberlink cellular device and sober sky web portal. an additional ten (10) simulated home use subjects will be provided instruction for use for the soberlink cellular device while an additional ten (10) simulated home use subjects will be provided instruction for use in clinic for the soberlink cellular device and sober sky web portal. all subjects will be provided with a post-test questionnaire on how to operate the device. the post-test questionnaire will collect information regarding device use. the device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. additionally, measurable usability criteria for specific, critical steps will be evaluated.

Eligibility criteria:
inclusion criteria: * male and female participants between the ages of 18-99 years old in a clinical setting under the care of a healthcare provider. * male and female participants between the ages of 18-99 years old in an over-the-counter setting (home use setting). exclusion criteria: * participants with lung disease unable to exhale for 4 seconds.

Keywords: rehabilitation
psychosocial, cognitive, and behavioral consequences of sleep-disordered breathing after sci

Conditions: Spinal Cord Injuries; Sleep Apnea

Summary: this clinical trial will examine the efficacy of continuous positive airway pressure (cpap) therapy in improving psychosocial, neurocognitive and behavioral consequences of moderate-to-severe sleep-related breathing disorders (srbds) in people living with spinal cord injury (sci).

sci is a potentially catastrophic event for individuals who may sustain motor, sensory, and autonomic deficit, as well as secondary conditions including srbds. the srbds include central, obstructive and mixed sleep apnea that can occur in up to 50% of the paraplegics and up to 91% of the motor complete tetraplegics. although the frequency of srbds after sci is much greater than in able-bodied people, this condition is still a largely under-recognized in the sci population. with this, the investigators hypothesize that regular use of cpap for treatment of moderate-to-severe srbds in individuals living with sci significantly improve their fatigue, depressive symptoms, anxiety, cognitive impairment, quality of life, and social and work participation. this research project will include: (i) a single-arm clinical trial to evaluate the efficacy of nightly use of cpap for 4 consecutive months in the management of moderate-to-severe srbds among 24 adults with subacute to chronic, cervical or thoracic, complete or incomplete sci; and (ii) a qualitative study of the challenges experienced by the 24 people with sci who undergo an unattended-hospital or home-based sleep study for diagnosis of srbds followed by cpap therapy. overall, this clinical study has the potential to ultimately improve fatigue, mood, cognition, quality of life, and social and work participation of people living with sci, by examining under-explored links with the srbds.

Eligibility criteria:
inclusion criteria: * english-speaking adults 18 years of age or older * have traumatic cervical/thoracic (injury level at c5 to t10), severe or moderate (ais a, b, or c) sci who were not diagnosed with a sleep disorder prior to the injury. * at least 2 months after injury * clinical warning symptoms and/or signs for srbds exclusion criteria: * patients with a non-traumatic spinal cord disease at risk for neurologic progression * concomitant diseases of the central nervous system * preinjury chronic pain * psychiatric disorders that may prevent the participant to be compliant to the study protocol requirements * neuromuscular diseases * current substance misuse * history of primary hypersomnia * hypothyroidism * moderate or severe iron deficiency anemia * active infection * kidney failure * epilepsy * chronic fatigue syndrome * vitamin b12 deficiency

Keywords: spinal cord injuries sleep-related breathing disorders
diabetes prevention for black men

Conditions: Diabetes

Summary: geographic analyses of diabetes burden have found that poor glycemic control, high rates of diabetes-related hospital utilization, and a high prevalence of microvascular diabetic complications all cluster in the same neighborhoods.this proposed study seeks to identify black barbers with undiagnosed diabetes or prediabetes using point-of-care hba1c testing, perform qualitative interviews to identify health behaviors that may explain poor sugar control, and develop a workplace-based food intervention to promote primary prevention and test its effect on sugar control in these individuals.


Eligibility criteria:
inclusion criteria: * black or african american men who work as barbers at black-owned barbershops * barbershop clients. * workplace in neighborhood geographically identified as having higher diabetes burden * no prior history of clinical diagnosis of diabetes * identified on initial and second point-of-care testing to have an hba1c of 5.7 or greater exclusion criteria: * individuals with a history of blood loss or blood disorder that would lead to incorrect results on point-of care hba1c testing * individuals with a history of food allergies that requires specific dietary restrictions * individuals who are not english speaking * individuals who have a significant cognitive impairment that will be a barrier to communication, valid consent and participation
a pragmatic trial of chronic disease approaches to ameliorate tobacco related cardiovascular disease health disparities

Conditions: Tobacco Use Cessation; Cardiovascular Diseases; Tobacco Use; Smoking; Smoking Cessation

Summary: this project will evaluate a proactive outreach intervention for tobacco cessation among primary care bipoc populations who smoke in two health systems across the region. compared with whites, bipoc populations in the us experience disproportionate health consequences from commercial cigarette use. few evidence-based cessation treatments (ebcts) have been specifically developed, evaluated, or implemented for bipoc populations. moreover, uptake of ebct (e.g. medication, counseling) is lower among bipoc populations. reasons for the failure to engage bipoc patients in ebcts are complex and multi-level (e.g., patient, provider, healthcare system). to address these gaps, the investigators will assess the added effectiveness of an approach to augment the standard of care with longitudinal proactive outreach to connect bipoc adults with ebct. the proposed multi-level intervention leverages the electronic health record to identify patients who smoke, who can then be proactively engaged via culturally tailored outreach to connect them to ebct. the proactive approach may circumvent experiences of bias within the healthcare system and thus enhance engagement.


Eligibility criteria:
inclusion criteria: * english or spanish-speaking bipoc patients within the hennepin healthcare or mchs system. bipoc patients are any patients with a chart identified race that is not white, and will be verified by self-report from the baseline survey. * currently smoke \>1 cigarette over the past 30 days * must have address or telephone number in the electronic health record exclusion criteria: * electronic health record documented cognitive impairment or legal guardianship * patients who have opted out of reserach studies
evaluation of liver regeneration with autologous peripheral stem cells

Conditions: Liver Cirrhosis

Summary: for patient with liver cirrhosis who need to right or extended right hepatectomy, we will treat with autologous peripheral stem cells transplantation to facilitate liver regeneration. we will asses liver regeneration by evaluation of liver volume and liver function test.

1. patients: 30 patients (10 patients in each 3 group) 2. indication: * patients with primary hepatocellular carcinoma combined liver cirrhosis (hepatitis b, c, non-b non-c) * planned to right hepatectomy or extended right hepatectomy * patients who need right portal vein embolization due to insufficient expected remnant liver volume (\ 10%) * child a classification * icg r15 \< 25% * age : 20 - 70 years old * expected life period \> 3months * the patients who agreed to this study. 3. contraindication * patients who planned liver transplantation * age \ 70 years old * pregnant women * patients on acute infection * acute hepatic failure * child class b or c * heart failure * existence of bleeding tendency : platelet \ 2.2, cr \>2.5 * patients who did not agree to this study. 4. allocation: we will allocate patients randomly to three group including control group. 5. methods * group 1: 4 days injection of g-csf -\> plasma pheresis, selection of cd34 cell -\> right portal vein embolization and infusion of cd34 cell into left portal vein. * group 2: 4 days injection of g-csf -\> plasma pheresis -\> right portal vein embolization and infusion of mononuclear cell into left portal vein. * group 3 (control): right portal vein embolization ( -\> after 4 weeks, operation will be performed) 6. evaluation: change of liver volume, liver function test before and after portal vein embolization

Eligibility criteria:
inclusion criteria: 1. patients with primary hepatocellular carcinoma combined liver cirrhosis (hepatitis b, c, non-b non-c) 2. planned to right hepatectomy or extended right hepatectomy 3. patients who need right portal vein embolization due to unsufficient expected remnant liver volume (\ 10%) 4. child a classification 5. icg r15 \< 25% 6. age: 20 - 70 years old 7. expected life period \> 3months 8. the patients who agreed to this study exclusion criteria: 1. patients who planned liver transplantation 2. age \ 70 years old 3. pregnant women 4. patients on acute infection 5. acute hepatic failure 6. child class b or c 7. heart failure 8. existence of bleeding tendency : platelet \ 2.2, cr \>2.5 9. patients who did not agree to this study

Keywords: liver cirrhosis liver regeneration liver volume liver function hepatocellular carcinoma, extensive hepatectomy
safety study of ciclopirox olamine cream for dermatomycoses in children

Conditions: Dermatomycoses

Summary: ciclopirox olamine (ciclochem®) is a pyridone broad spectrum antifungal drug which has shown activity on dermatophytes, yeasts, moulds, actinomycetes and some bacteria. its mechanism of action is based on a fungicidal activity by inhibiting the cellular captation of essential substances needed for the metabolism and growth of the fungi. on the other hand, this drug binds irreversibly with cell structures as mitochondria, ribosomes, microsomes and cell wall. after dermal application, ciclopirox olamine undergoes skin penetration, being only absorbed a 1,5% of the applied dose. clinical efficacy has been studied in patients above 10 years with superficial dermatomycoses (dermatophytoses, candidiasis and pityriasis versicolor) and the percentage of clinical healing ranged from 77% to 91% after 2-4 weeks of twice a day topical application. in all the studies, the safety profile has been very good, showing only a very low rate of adverse events of mild to moderate intensity. there are very few previous available data on the application of this compound in children under 10 years of age. a single study had been performed with a solution formulation in patients from 6 to 29 months with diaper candidiasis, showing good efficacy and tolerability in these patients. the present study aims to show the safety and tolerability of ciclopirox olamine in a cream formulation in patients from 3 months to 10 years with dermatomycoses.

a multicenter, open, prospective, phase iv study of ciclopirox olamine on patients from 3 months to 10 years with all kinds of dermatomycoses. all body areas were treatable except scalp and nails (no tinea on the scalp nor onychomycoses) . cream applied bid between 6.00 and 10.00am and 7.00 and 10.00pm daily for 4 weeks.control visit after 4 more weeks without treatment was performed in order to evaluate the relapse rate.

Eligibility criteria:
inclusion criteria: * patients from 3 months to 10 years of age. * patients diagnosed of dermatomycoses produced by yeasts or dermatophytes by koh technique at the inclusion moment, which has to be confirmed by culture. * obtention of the informed consent of the parents or legal representatives of the patients exclusion criteria: * previous treatment with oral or topical antifungal drugs. * hypersensitivity to ciclopirox olamine or some of the cream excipients. * use of topical or oral steroids concomitantly. * patients with mycoses on the scalp or nails.

Keywords: dermatomycoses, tinea, candidiasis, children
comparative study of safety and efficacy of two hyaluronic acids for the treatment of knee osteoarthritis pain

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine the comparative safety and efficacy of intra-articular injection of hyaluronic acid, obtained from two different sources, in the treatment of osteoarthritic pain of the knee.

this is a multicenter, randomized, double blind, parallel-controlled clinical trial using a non-inferiority comparison to evaluate the efficacy and safety of an intra-articular injection of durolane® vs artz® in the treatment of knee osteoarthritis. subjects will be randomized 1:1 to receive either durolane or artz. all subjects will be followed up for 26 weeks from the initial treatment.the screening period is expected to be up to 2 weeks in duration before the baseline visit. each subject will provide a written informed consent and undergo a qualifying screening. assessment at screening will include postero-anterior view of standing weight-bearing semi-flexed radiographs of the study knee. the osteoarthritis changes of the study knee will be graded 0,1,2,3 or 4 according to the kellgren-lawrence radiographic scoring criteria. radiographic assessment will be made by an assigned and well trained investigator at each study center. the study knee and contralateral knee will use the likert womac 5-point scoring for pain assessment. physical examination of the knees and vital signs will be performed (this examination will be repeated at end).

Eligibility criteria:
inclusion criteria: * subject (female or male) 40-80 years of age, inclusive * documented diagnosis of mild to moderate osteoarthritis of the study knee that fulfil the acr(american college of rheumatology) criteria * radiographic evidence of osteoarthritis in the study knee (kellgren lawrence radiographic score is 2 or 3) exclusion criteria: * clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella * kellgren-lawrence radiographic score 0, 1 or 4 in the study knee * symptomatic osteoarthritis of the contralateral knee or of either hip that is not responsive to acetaminophen/paracetamol and/or requires any protocol prohibited therapies
the utility of circulating tumour cells and plasma microrna in esophageal adenocarcinoma

Conditions: Esophageal Cancer

Summary: circulating microrna (circ mirna) and circulating tumor cell (ctc) levels are hypothesized to be associated with response to chemoradiation in patients undergoing treatment for locally advanced esophageal adenocarcinoma. the goal of this project is to assess the use of circulating microrna (mirna) and circulating tumour cells (ctc) as biomarkers of cancer and predictive markers for neoadjuvant therapy.

recently, different groups have discovered that mirnas can be detected in body fluids such as plasma, serum or saliva. these cell-free mirnas are secreted by cells under different forms. levels of these circulating mirnas (circ mirna), like tissue mirna, were closely related to pathologies and could be used as diagnostic or prognostic tools for several pathologies, including cancer. furthermore, a recent report showed that circ mirnas released by tumor cells have the ability to transfer their metastatic potential to nonmetastatic cells. the detection and analysis of circulating mirna represent a new step towards non-invasive diagnostic screening and early cancer detection. circulating tumor cells also hold promise as biological markers, which can be assessed noninvasively. as more than 90% of cancer deaths are associated with metastasis, it is crucial to understand the mechanisms of dissemination of cancer cells. during the past decade, a multitude of techniques have been developed to track down and to characterize ctc. clinical studies in various cancers reveal the potential of ctc as prognostic and predictive markers. the characterization of ctc will help to design personalized treatment to eradicate the sub-clones of the primary tumour, which give rise to metastasis. also, the numbers of ctc in patient blood can be followed to monitor the efficacy of the neoadjuvant treatment. most of the research in esophageal cancer has been done on squamous cell cancer as this is the dominant cell type worldwide. however, beginning the in 1980s esophageal adenocarcinoma (eac) has increased in frequency such that it now represents 80% of esophageal cancer in north america and europe. there is an urgent need to develop new techniques and diagnostic tests to combat eac. by combining circ mirna and ctc, we not only combine 2 promising clinical biomarkers, we will also be able to access new data that will complement tissue biopsy data. furthermore, by acquiring a blood sample during various time points of patient treatment, we will be able to create a dynamic ctc and circ mirna profile.

Eligibility criteria:
inclusion criteria: * patients who are at least 18 years of age * patients with esophageal adenocarcinoma who will undergo neo-adjuvant therapy with surgical resection. * patients with esophageal adenocarcinoma who will be treated with chemotherapy, chemotherapy and radiation or radiation alone or * healthy volunteers who are at least 18 years of age exclusion criteria: * patients who are treated with surgery alone for esophageal cancer * patients who have a history of invasive cancer