Kornimate/medical-research-clean huggingface dataset:
fch vs fdg pet/ct in detection of lesions in patients with multiple myeloma (mim)

Conditions: Multiple Myeloma

Summary: hybrid positron emission tomography/computed tomography (pet/ct) has now become available to detect tumors in patients with multiple myeloma. the radioactive glucose 18f-fluorodeoxyglucose (fdg) is the most widely used tracer but findings suggest that pet/ct reveal more lesions when using fch. in this study, fdg is compared with a more recent metabolic tracer, 18f-fluorocholine (fch), for the detection of multiple myeloma lesions at time of initial extension assessment. the principal objective of this sudy is to compare the number of suspected hypermetabolic foci of myeloma detected by 18f-fluorocholine pet and by 18f-fluorodeoxyglucose pet during the initial extension assessment.


Eligibility criteria:
inclusion criteria: * patient with initial diagnosis of multiple myeloma has just been established * therapeutic indication and eligible for a hsc autograft (if the hsc autograft could not be performed, the patient will still be retained in the study). * status ecog 0, 1 or 2 * age ≥ 18 and \< 75 ans years * effective contraception for women * informed consent signed * patient able to lie flat for 30 minutes * patient affiliated to a social security scheme exclusion criteria: * patient diagnosed with a diagnosis of mgus (monoclonal gammapathy of undetermined significance = monoclonal gammopathy of undetermined significance), indolent myeloma ("smoldering myeloma"), non-secreting myeloma or recurrent myeloma, * patient already under treatment for myeloma. * patient not eligible for intensive treatment followed by a hsc autograft. * patient with concomitant neoplasia * patient with a history of hematological or solid neoplasia, except if it is a basal cell carcinoma of the skin or an adenocarcinoma in situ of the uterine cervix. * patient with a history of sarcoidosis * uncontrolled diabetes. * patient treated with long-term corticosteroids * patient being treated with hematopoietic growth factors * patient in sepsis. * claustrophobic patient. * refusal of patient consent. * pregnant or lactating woman. * women of childbearing potential without effective contraception. * person deprived of liberty or under guardianship * impossibility to submit to the medical follow-up of the trial for geographic, social or psychological reasons. * history of allergic reaction attributed to 18f-fluorodeoxyglucose or to 18f-fluorocholine.

Keywords: pet/ct fdg fluorocholine (18f) fch
a study of pf-04449913 in select hematologic malignancies

Conditions: Hematologic Malignancies

Summary: this study examines the effect of a small molecule inhibitor to the sonic hedgehog pathway on select hematologic malignancies.


Eligibility criteria:
inclusion criteria: * patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies. they may be newly diagnosed and previously untreated, but not eligible for standard treatment options, or for whom standard therapies are not anticipated to result in a durable response. * ecog performance status 0 to 2 * adequate organ function exclusion criteria: * patients with active cns disease * patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical or skin cancer * active gvhd other than grade 1 skin involvement * known malabsorption syndrome * patient has an active, life threatening or clinically significant uncontrolled systemic infection

Keywords: chronic myeloid leukemia myelofibrosis myelodysplastic syndrome acute myeloid leukemia hedgehog inhibitor
quinolone resistance in bloodstream isolates of escherichia coli

Conditions: Bacterial Infections

Summary: this proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of e. coli. additionally, the adequacy of empiric antibiotic therapy for e. coli bloodstream infections will be assessed. finally, outcome will be recorded - this is all-cause mortality at 28 days from the time of the first positive blood culture. hypothesis: ciprofloxacin resistant strains are associated with admission from nursing home and with prior quinolone use.

the following information will be collected: age, sex, occupation, hospital location at the time of positive culture (er, medical ward, icu etc), date of positive culture, prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. we will collect information retrospectively.

Eligibility criteria:
inclusion criteria: clinical information is collected by chart review of "case" and "control" patients. a "case a" patient is defined as follows: * one or more blood cultures are positive for e. coli. the organism is ciprofloxacin resistant. a "case b" patient is defined as follows: * one or more blood cultures are positive for e. coli. the organism is ciprofloxacin susceptible. additionally, 4 controls who are in hospital at the same time as cases will be selected for each case. exclusion criteria: * if they do not meet inclusion criteria

Keywords: positive isolates ecoli blood cultures positive cultures for ecoli blood stream infections
effectiveness of external vibration for pain relief during intravenous access in adult patients

Conditions: Pain Management; Anxiety

Summary: a large number of dentoalveolar (tooth extraction) procedures performed by oral and maxillofacial surgeons utilize intravenous sedation. procedures commonly performed may include surgical removal of teeth, bone grafting, surgical placement of dental implants, and removal of cysts or tumors from the jaws, among others. obtaining peripheral intravevenous (iv) cannulation often proves to be a very stressful and anxious event for the patient. the anxiety and stress from the venipuncture alone affects not only the psychological stability of the patient, but also the patient's physiology. the buzzy vibration external stimulation device has shown to be an effective tool in pediatric venipunture procedures. the aim of this study is to investigate the effects of the buzzy stimulation device in pain and anxiety reduction during peripheral intravenous cannulation in an adult population. enrollees in this study will be patients who will undergo dental surgery with intravenous sedation. the patients who are enrolled will receive an iv either with or without the buzzy. the buzzy is a small vibration device which will be placed next to the iv placement site.

the participants will be randomized into two groups, those who use the buzzy system (experimental), and routine iv start (control). prior to knowing their group, all patients will answer the "before intravenous catheterization" portion of the form in order to eliminate bias. after this portion is complete, their group (experimental vs control) will be determined from opening a blinded envelope. a tourniquet will be placed, followed by the buzzy stimulation device (if in the experimental group). an alcohol swab will be used and then a 22 gauge iv catheter will be inserted, connected to fluids, and secured with tape. the antecubital fossa or the dorsal hand/wrist will be the only sites used in the study. all participants will fill out the post-insertion questions on the form and those patients that used the buzzy system will then fill out the several specific questions related to the experimental group. this will conclude the patient's involvement in the study. the patient will then continue with treatment as planned. we will plan to exclude cases where the iv is not obtained on the first attempt, if a smaller or larger gauge iv catheter is required, or if an insertion site not listed above is required. the case will be excluded if adjunctive steps are taken to obtain iv access (i.e. oral sedation, nitrous oxide, heat packs).

Eligibility criteria:
inclusion criteria: * ages 18 and 40. * eligible for third molar removal with sedation. exclusion criteria: * not eligible for surgery. * not eligible for sedation.

Keywords: pain anxiety intravenous access
study of amrubicin with or without herceptin in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of the study is to evaluate the incidence of cardiac toxicity of amrubicin when administered to patients with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of breast cancer. * metastatic or recurrent disease, either her2+ (fish+ or 3+ ihc) or her2-. * maximal dose of prior adjuvant anthracycline: 300 mg/meters squared doxorubicin or equivalent. relapse greater than one year after trastuzumab adjuvantly; two years following adjuvant anthracycline therapy (without trastuzumab). * one prior chemotherapy for metastatic breast cancer allowed (may include trastuzumab for her2+ patients), but no prior doxil, adriamycin or epirubicin for metastatic breast cancer. * at least 18 years of age. * ecog performance status of 0, 1, or 2. * adequate organ function including the following: * adequate bone marrow reserve. * cardiac: left ventricular ejection fraction (lvef) greater than or equal to 55% by muga. * negative serum pregnancy test at the time of enrollment for women of child-bearing potential. * ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments. exclusion criteria: * pregnant or nursing women. * concurrent anticancer therapy. * participation in any investigational drug study within 28 days prior to study entry. * concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, uncontrolled hypertension, coronary artery disease, congestive heart failure, severe arrhythmia) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study. * symptomatic central nervous system metastases. patients with asymptomatic brain metastases are allowed. the patient must be stable after radiotherapy for greater than or equal to 2 weeks and off corticosteroids for greater than or equal to 1 week. * history of interstitial lung disease or pulmonary fibrosis.

Keywords: metastatic breast cancer amrubicin
external nitric oxide measurement through sno degradation

Conditions: Healthy; Unconscious

Summary: in this study, we aim to explore the feasibility of a novel, noninvasive sno assay to acquire physiological sno quantification from various parts of the human body and test this new method of analysis. this study aims to help with the currently cumbersome and invasive procedures used to measure snos in the body. the proposed activities do not unnecessarily duplicate previous experiments.

s-nitrosylation is the covalent attachment of a nitric oxide group to cystine thiol within a protein to form an s-nitrosothiol (sno); it has diverse regulatory roles in all mammalian cells and thus operates as a fundamental mechanism for cellular signaling and accounts for a large part of nitric oxide activity. though snos are relevant to many biological disciplines like neuronal, muscular, respiratory, and cardiovascular biology, currently there is no way to measure snos that is both easy to use in a clinical setting and accurate in detecting low concentrations; detection is challenging due to the labile nature of the molecules. low or high concentrations of these molecules could be vital indicators of incoming dangerous issues in the body. a system to easily and accurately measure snos could prove useful in preventative treatments. ultra violet (uv) light can break snos and can be used to measure nitric oxide release, but this method is not fully developed and further research is needed on the potential effect for uv to measure nitric oxide release.

Eligibility criteria:
inclusion criteria * adult males or females age ≥ 1 day and ≤ 75 years at time of enrollment exclusion criteria * subjects meeting the following criteria will be excluded: * smokers. * any chronic skin conditions. * pregnant. * subjects that are unable or unwilling to cooperate with specimen collection. * subjects with diagnosis of any medical condition that in the investigator's opinion would make them unsuitable for study participation. * (for subjects ≥ 18) subjects that lack the capacity to consent for themselves.
tailored case management for diabetes and hypertension

Conditions: Diabetes; Hypertension

Summary: diabetes and hypertension co-exist in approximately 10 million people in the usa and constitute severe risk factors for the development of such complications as heart and kidney disease. the investigators propose a randomized controlled trial in patients of community primary care practices to study a tailored telephone-administered behavioral intervention to improve control of blood pressure and blood sugar in patients with both hypertension and diabetes. the investigators hypothesize that 20% more patients talking to a nurse every other month about ways to improve blood pressure and blood sugar control will bring their blood pressure under control when compared to patients who talk with the nurse only about general health issues. if successful in improving control of these diseases this intervention can easily be adopted in other community primary care practices to lessen the burden of diabetes and hypertension in the usa.


Eligibility criteria:
inclusion criteria: * enrolled and receiving primary care at one of 9 participating clinics in north carolina * diagnosis of diabetes as determined by billing data * taking medication for diabetes * diagnosis of hypertension as determined by billing data * taking medication for hypertension * most recent (within one year) hemoglobin a1c \>= 7.5% exclusion criteria: * active psychosis * hospitalization for stroke, myocardial infarction (mi), or coronary artery revascularization in the past 6 months * type i diabetes * does not speak english * no access to a telephone * institution-dwelling or receiving comprehensive professional home health care * hearing or speech inadequate for long interactive phone conversations * terminal illness or active treatment for cancer * cognitive impairment too severe to understand instructions

Keywords: diabetes hypertension physical activity diet medication adherence
prospective aneurysm trial: high angle aorfix™ bifurcated stent graft

Conditions: Abdominal Aortic Aneurysms

Summary: purpose of this study: the purpose of the study is to evaluate the safety and effectiveness of the lombard medical endovascular aorfix™ aaa bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°. study hypothesis: the primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months. efficacy: the 12 month, all cause mortality rate in the aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the open control group. safety: the rates of early serious adverse events between 0 and 30 days post-operative in the aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the open control group.


Eligibility criteria:
inclusion criteria: * diagnosed abdominal aortic aneurysm \> 4.5 cm in diameter, or 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), or documented aaa growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or * iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter. exclusion criteria: * less than 21 years of age, * life expectancy less than 2 years, * pregnant, * religious cultural or other objection to the receipt of blood or blood products, * unwilling to comply with follow-up schedule, * unwillingness or inability to provide informed consent to both trial and procedure. * patients not expected to live more than 2 years from enrollment * patient has a ruptured aneurysm * aneurysm extends above renal arteries * proximal neck of aneurysm has significant loose thrombus associated with it * patient with an acute or chronic aortic dissection or mycotic aneurysm * patient has current non-localized infection (may be recruited following remission of the infection) * patient is allergic to device materials * patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl * patient is clinically and morbidly obese such that imaging would be severely adversely affected * patient has renal failure (serum creatinine \> 2.5 mg/dl) * patient has an uncorrectable bleeding abnormality * patient has unstable angina * patient is receiving dialysis: * inflammatory aneurysm * mi in last 6 months * end stage copd * patient has connective tissue disease (eg marfan syndrome, ehlers-danlos syndrome) * significant (\>80%) renal artery stenosis which cannot be readily treated

Keywords: aaa abdominal aortic aneurysms endovascular evar aorta stent graft stent tortuous high angle angled necks
transfer strategy in an oocyte donation programme

Conditions: Oocyte Donation; Infertility, Female; Embryo Transfer

Summary: it has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (d2), it is expressed on day 3 (d3). without this activation, the embryo can not continue its development. therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. the purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.


Eligibility criteria:
inclusion criteria: * patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle. exclusion criteria: * preimplantation genetic screening or diagnosis cycles. * patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.
¿can mysugr app improve knowledge and self-management of people with type 1 diabetes mellitus?

Conditions: Diabetes Mellitus, Type 1

Summary: this project is based on the contribution that an app can offer for improving knowledge and self-management of people with type 1 diabetes. the main objective of this study is to assess mysugr app as a tool for empowering people with type 1 diabetes. the study population are type 1 diabetes people, aged more than 18 years old and with more than one year from diagnosis. they will be randomised to standard care or use of mysugr app and will be followed-up during 48 weeks. control group will attend 5 face-to-face visits (baseline, 3, 6, 9 and 12 months) with the possibility of telephone contact and hospital assistance if necessary. intervention group will attend 3 face-to-face visits (baseline, 6 and 12 months) and 2 telematic visits (at 3 and 9 months) and will also have the possibility of telephone contact and hospital assistance if necessary.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * people with type 1 diabetes (\> 1 year diagnosis) * treatment with insulin in basal-bolus regimen * glucometer that connects automatically with the app * hba1c 7-9% * understanding of carbohydrate counting and concepts of ratio and factor of sensitivity * have a smartphone or tablet exclusion criteria: * use at the time of randomization of another app for diabetes management * use of continuous monitoring or flash glucose systems * pregnancy * any other disease or condition that may interfere with the completion of the protocol or completion of the study

Keywords: diabetes mellitus, type 1 mobile applications telemedicine
trial of l-dopa as a treatment to improve vision in albinism

Conditions: Albinism

Summary: this project will evaluate the effect of two doses of levodopa (l-dopa) in a randomized, placebo-controlled, double-masked clinical trial to see if vision can be improved in individuals with albinism. the hypothesis is that providing l-dopa to the retinas of these individuals may increase melanin pigment production. increased melanin has previously been shown to be associated with improved vision.

a group of 45 individuals with the clinical findings of oculocutaneous albinism (oca) will be randomly assigned to one of 3 treatment groups: treatment with 0.76 mg/kg/d with 25% carbidopa, 0.51 mg/kg/d levodopa with 25% carbidopa \[divided into 3 doses/d), or placebo. subjects will be between ages 3 and 60 years. blood will be drawn to determine the mutation(s) in the genes that causes oca. primary outcome will be binocular best-corrected visual acuity measured with the eva. enrollment and 20 week examination will be complete eye exam with fundus photos. at weeks 5, 10, and 15, exams will include just vital signs and bcva. at all visits, a review of potential side effects will be conducted. between visits, subjects will be contacted to determine if any side effects have occurred. the study will remain double masked until the last study examination on the last subject has been performed. at that time, the data will be statistically analyzed and subjects will be informed re: treatment assignment, mutations found, and the study results.

Eligibility criteria:
inclusion criteria: * age 3 to 60 years with albinism exclusion criteria: * glaucoma or at increased risk of glaucoma * history of dystonia * history of melanoma * planning to undergo eye muscle surgery during study time frame * undergoing vision therapy * taking iron supplements or vitamins with iron * taking medication for adhd * known liver or gastrointestinal disease * previous treatment with levodopa * psychological problems * ocular abnormalities other than those associated with albinism * pregnant, nursing or planning to become pregnant during study * known allergy to levodopa/carbidopa

Keywords: levodopa albinism vision