Kornimate/medical-research-clean huggingface dataset:
carolina: cardiovascular outcome study of linagliptin versus glimepiride in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. elevated glycosylated haemoglobin (hba1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin or an alpha-glucosidase inhibitor) therapy) 3. pre-existing cardiovascular disease or specified diabetes end-organ damage or age =\> 70 years or two or more specified cardiovascular risk factor 4. bmi =\< 45kg/m² 5. age between \>= 40 and =\< 85 years 6. signed and dated written international conference of harmonisation( icf) 7. stable anti-diabetic background for at least 8 wks before study start exclusion criteria: 1. type 1 diabetes 2. treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, glucagon-like peptide 1 (glp-1) analogue/agonists, dipeptidyl-peptidase iv (dpp-iv) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent) 3. treatment with any anti-obesity drug less than 3 months before icf 4. uncontrolled hyperglycemia 5. previous or planned bariatric surgery or intervention 6. current or planned system corticoid treatment 7. change in thyroid hormones treatment 8. acute liver disease or impaired hepatic function 9. pre-planned coronary artery revascularization within 6 months of icf 10. known hypersensitivity to any of the components 11. inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information 12. congestive heart failure class iii or iv 13. acute or chronic metabolic acidosis 14. hereditary galactose intolerance 15. alcohol or drug abuse 16. participation in another trail with imp given 2 months before investigational medicinal/medical product (imp) start 17. pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control 18. patients considered reliable by the investigator 19. acute coronary syndrome =\< 6 wks before icf 20. stroke or transient ischemic attack (tia) =\< 3 months prior to icf
predicting hypotension related to spinal anesthesia for caesarean section with ultrasonography

Conditions: Pregnancy

Summary: spinal anesthesia is the main technique for caesarean section. this anesthesia is followed by a hypotension in 40% to 90% despite preventing tools. hypotension is responsible of foetale and maternal suffering. it would be interesting to have a tool that could detect patient who are at risk to have hypotension.this study consist in measuring variations of under aortic velocity peak (δitvao) which estimate the modification of the cardiac output by trans thoraciq echography.

spinal anesthesia is the main technique for caesarean section. this anesthesia is followed by a hypotension in 40% to 90% despite preventing tools (fluid challenge and vasoactives drugs). hypotension is responsible of foetale and maternal suffering. fluid challenge is able to upgrade cardiac output for some patient, for some other it is unusefull or it can deteriorate it. actually fluid challenge is not individualized. it would be interesting to have a tool that could detect patient who are at risk to have hypotension. trans thoraciq echography is an easy non invading tool. dynamic criteria which is recognized for predicting vascular filling , with spontaneus breathing, is the passive leg rising (plr). plr mime à vascular filling of 500 ml. modification of this cardiac outpout is measured whith the echocardiograph. this consist in measuring variations of under aortic velocity peak (δitvao) which estimate the modification of the cardiac output.

Eligibility criteria:
inclusion criteria: * included patient are all women having a spinal or spinal-epidural anesthesia for elective caesarean section. all patients are more 18 years old and more 37 weeks pregnancy. physical statut score (asa):1 or 2 exclusion criteria: * woman presenting a contraindication to the spinal epidural anesthesia : constitutional or acquired disorder of the haemostasis * allergy in the local anesthetics, * infectious context (hypertherm \> 38.5 ° c) · cardiac, right or left insufficiency * eclamptic toxemia

Keywords: pregnant women
comparison of the effects of balance-proprioception and aerobic exercises on functional status and strength parameters in patients with fibromyalgia.

Conditions: Fibromyalgia Syndrome

Summary: in this study, it was aimed to examine the effects of aerobic exercise and balance-proprioception exercises on pain, functionality and strength parameters of fibromyalgia patients and to compare the two exercise types.

in the study planned to evaluate the effect of aerobic and balance-proprioception exercises on the symptoms of the disease and the superiority of the two exercise models in patients with fibromyalgia syndrom (fms), 62 women who meet the inclusion criteria will be randomly divided into two groups. aerobic exercise group (n = 26) and balance-proprioception exercise group (n = 26) will be applied for 3 weeks a week, 6 days a week under the supervision of a physiotherapist in the exercise laboratory of the istanbul medical faculty sports medicine department. pain (vas), functional status (fi̇q) and knee extension muscle strength (cybex isokinetic dynamometer) will be evaluated before and after the program. cognitive status will be evaluated with standardized mini mental test only before the program.

Eligibility criteria:
inclusion criteria: * being between the ages of 18 and 60, * symptoms lasting longer than 3 months, * according to the 2013 acr criteria, the pain settlement score (pli) is ≥17, * according to the 2013 acr criteria, the symptomatic impact scoring (siqr) is ≥21, * acceptance of treatment that will continue 3 days a week for 6 weeks, * the possibility of any change in medical treatment due to fms during the study is not foreseen. exclusion criteria: * known central or peripheral nervous system disease, progressive neurological damage, * any serious cardiovascular pathology, * sense, loss of sense of position, unhealed fracture or a surgical wound, * presence of uncontrolled hypertension, * failure to understand or perform simple commands.

Keywords: fibromyalgia, aerobic exercise, balance, proprioception, pain, strength
bone health in type 1 diabetes

Conditions: Type 1 Diabetes; Osteoporosis

Summary: an increased skeletal fracture risk in diabetes has only recently been recognized. this human study is designed to elucidate the effect of type 1 diabetes on bone remodeling and on structure.

an increased skeletal fracture risk in diabetes has only recently been recognized. human studies of patients with diabetes using bone mineral density and bone markers have noted low bone mass and mixed results on remodeling activity. mouse models of diabetes have suggested that low bone turnover is the underlying problem. low bone turnover could lead to an accumulation of microdamage that is not repaired causing compromised bone strength. low bone turnover has not yet been confirmed in humans. this human study is designed to elucidate the effect of type 1 diabetes on 1) bone remodeling, including histomorphometric and biochemical measures of bone formation and resorption, and 2) on structure, including micro architectural arrangement of trabeculae and bone mineral density.

Eligibility criteria:
inclusion criteria: * age \> 19 yrs or \< 50 yrs. * the diabetic subjects must have a diagnosis of type 1 diabetes clinically defined as diabetes onset before age 50, acute presentation or diabetic ketoacidosis, with normal bmi. if history is equivocal, gad antibodies \> 1.45 u/ml will be used to define diagnosis. * diabetic subjects must be on insulin treatment. * all subjects must have bmi between 18-30 exclusion criteria: * on any medications that are known to interfere with bone metabolism including loop diuretics, steroids, anticonvulsants, bisphosphonates, metformin, glitazones * have normal or only mildly impaired kidney function defined as a calculated gfr greater than 60 ml/min/1.73m2 * history of cancer other than skin cancer * unstable angina, myocardial infarction, uncontrolled hypertension, malabsorption, active rheumatoid or collagen disease.

Keywords: type 1 diabetes bone
safety and performance study to evaluate access to pulmonary veins for treatment of paroxysmal af

Conditions: Atrial Fibrillation

Summary: the study is intended to assess the safety and performance of the vado™ steerable sheath in facilitating ease of access to the pulmonary veins (pv) for the treatment of paroxysmal atrial fibrillation and persistent atrial fibrillation (af). the study will be a prospective, single-center, non-randomized investigation.

the design for this study involves the sequential enrollment of patients with documented paroxysmal atrial fibrillation who have had two (2) or more af episodes for at least 30 seconds in length within six (6) months prior to enrollment. target population shall be selected from the treatable af population that meets both inclusion/exclusion criteria.it is intended that the vado steerable sheath will be used as part of standard clinical workflow procedures, with no procedural deviations relative to other procedures requiring steerable sheaths. individual subjects will be studied during mapping and ablation procedures and followed until release from hospital post procedure per institutional standard of care.

Eligibility criteria:
inclusion criteria: * suitable candidate for intra-cardiac mapping for arrhythmias with documented paf defined by hrs criteria. * eighteen to eighty years of age * signed informed consent exclusion criteria: * intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement * severe cerebrovascular disease or history of cerebrovascular event within one (1) month * patients with severely impaired kidney function as measured by a cockcroft-gault glomerular filtration rate (gfr) 3 with a gfr \< 29. * active gastrointestinal bleeding, infection or fever (\> 100.5/38c) * severe co morbidity or short life expectancy (\<1 year) due to other illnesses such as cancer, pulmonary, hepatic or renal disease * structural heart disease of clinical significance including * symptoms of congestive heart failure including, but not limited to, nyha class iii or iv chf and/or documented ejection fraction \< 40% measured by acceptable cardiac testing * stable/unstable angina or ongoing myocardial ischemia * myocardial infarction (mi) within three months of enrollment * aortic or mitral valve disease \> grade ii * congenital heart disease (not including asd or pfo without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure * enrollment in any other ongoing arrhythmia study protocol * any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study * active infection or sepsis * female patient is pregnant or lactating * untreatable allergy to contrast media * any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes * history of blood clotting (bleeding or thrombotic) abnormalities * known sensitivities to heparin or warfarin * severe copd (identified by an fev1 \<1)
bupropion in sexual dysfunction among methadone maintenance treatment men

Conditions: Sexual Dysfunctions, Psychological; Hypoactive Sexual Desire Disorder; Erectile Dysfunctions

Summary: the purpose of this study is to assess the tolerability, safety, and efficacy of bupropion hydrochloride sustained-release in the treatment of sexual dysfunction in men on methadone maintenance therapy.

this is a single-center (university malaya medical centre), randomized, double-blind, placebo-controlled versus bupropion hydrochloride sustained-releases study trial on 70 men who have methadone emergent sexual dysfunction. bupropion hydrochloride sustained-release (wellbutrin sr) 150mg once a day for 7 days then 150mg twice a day for 42 days. taken orally by the subjects.the total duration of the study is expected to be 24 months. 20months for subject recruitment and 4 months for final subject follow-up. the primary endpoint is mean improvement in scores on the clinical global impression scale adapted for sexual function (cgi-sf). secondary endpoints are change from baseline international index of erectile function (iief-15) score. mean improvement in scores on the sexual desire inventory 2 (sdi2). other evaluation included: montgomery-åsberg depression rating scale (madrs- malay version ), mini international neuropsychiatric interview (m.i.n.i), opiate treatment index (oti), world health organization quality of life-brief scale (whoqol-brief, malay version), malay version of the golombok-rust inventory of marital state (mal-grims) and rapid urine drug test. safety evaluation included: incidence of adverse events. data will be analyzed using linear mixed-effects model.

Eligibility criteria:
inclusion criteria: * had a diagnosis of opioid dependence base on diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria * while taking a stable dose of methadone in ummc (university malaya medica centre) and university malaya centre of addiction science (umcas) outpatient clinic for ≥ 6 months * were experiencing constant sexual dysfunction for ≥ 4 weeks * were in a stable sexual relationship with a female partner for ≥ 6 months exclusion criteria: * severe behavior disturbances or psychotic symptoms * obvious organic illnesses caused the sexual dysfunction (such as diabetics or patients with heart and vascular disease) * those with history of sexual dysfunction before methadone therapy * receiving antiviral treatment for viral hepatitis or hiv, or androgen replacement treatment. * history of an eating disorder (eg, anorexia, bulimia) or seizures (eg, epilepsy) * using other psychotropic medications other than methadone * clinical significant abnormal laboratory values. * clinically significant abnormal ecg. documented history of other psychiatric diagnosis (schizophrenia, bipolar disorder, major depressive disorder, organic brain disorder, dementia etc.) * refused to give participate.

Keywords: sexual dysfunctions erectile dysfunctions hypoactive sexual desire dysfunctions
study of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma in china

Conditions: Multiple Myeloma Proved by Laboratory Tests

Summary: intravenous injection is the standard administration route of bortezomib; however, subcutaneous administration is an important alternative. we want to compared the pharmacokinetic of subcutaneous versus intravenous bortezomib at the approved 1•3 mg/m2 dose and twice per week,on days1, 4, 8 and 11 of 21-day cycles, schedule in newly diagnosed patients of multiple myeloma.

the new diagnosed multiple myeloma patients are randomized to receive bortezomib by standard intravenous bolus (n=10) or subcutaneous injection (n=10) at the recommended dose and schedule (1.3 mg/m2), days 1, 4, 8, 11;eight 21-day cycles). patients discontinued treatment due to progressive disease, insufficient efficacy, unacceptable toxicity, or serious protocol violation. dose modifications are specified for unexpected pharmacokinetic observations or toxicity. bortezomib-related neuropathic pain and/or peripheral sensory neuropathy were managed using established dose-modification guidelines. blood samples for pharmacokinetic/pharmacodynamic analysis are collected on days 1 and 11, cycle 1:before bortezomib administration, and at 2, 5, 15, 30, and 60 min, and 2, 4, 6, 10, 24, 32, 48, and 72 hours post-dosing. pharmacodynamic analyses were performed using a whole-blood 20s proteasome specific activity inhibition assay.

Eligibility criteria:
inclusion criteria: * must be multiple myeloma proved by laboratory tests * must have the ability to observe the efficacy and events * patient must have the ability to understand and willingness to provide written informed consent in the study and any related procedures being performed exclusion criteria: * if have uncontrolled intercurrent illness including ongoing or active infection,heart failure,unstable angina pectoris,or psychiatric illness/social situations that study requirements * if have severe side-effects on bortezomib

Keywords: multiple myeloma bortezomib subcutaneous
pharmacokinetic (pk) study of twice daily vs once daily lamivudine (3tc) and abacavir (abc) as part of combination antiretroviral therapy (art) in hiv infected children

Conditions: HIV Infection

Summary: cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3tc (4mg/kg/dose bd) with once daily 3tc (8mg/kg/dose od) and twice daily abc (8mg/kg/dose bd) with daily abc (16mg/kg/dose od) where one or both drugs are being taken as part of combination antiretroviral therapy.


Eligibility criteria:
inclusion criteria: * children with definitive hiv infection * age \> 2 and \< 13 years * currently on combination art including 3tc and / or abc, for at least 6 months, with stable cd4 cell count and hiv rna viral load and expected to stay on this regimen for at least a further 3 months. exclusion criteria: * • intercurrent illness * receiving concomitant therapy except prophylaxis against pneumocystis carinii pneumonia (pcp) * abnormal renal or liver function (grade 3 or above)

Keywords: hiv paediatric abacavir lamivudine
pilot study evaluating sulforaphane in atypical nevi-precursor lesions

Conditions: Atypical Nevi; Melanoma

Summary: this is a pilot study to see if oral administration of freeze dried, powdered broccoli sprouts have any effect on whether moles end up becoming melanoma.

this study is designed as a pilot evaluation of sulforaphane as a candidate natural nutritional chemopreventive agent able to modulate key steps in melanoma progression and the expression of stat proteins in melanocytic and stromal elements of atypical nevi, which are precursor lesions and risk markers of melanoma. eighteen individuals in total will receive oral broccoli sprout extract rich in sulforaphane (bse-sfn) standardized for 3 different concentrations of actual sulforaphane content which will be utilized in our study. three groups of six patients will be randomly assigned to receive oral bse-sfn at sfn dosages of 50 µmol, 100 µmol, or 200 µmol daily. due to the established safety of sfn at all of the proposed dosage levels, there is no plan to complete a lower dosage level prior to escalating to the next higher dosage level; i.e., subjects will be randomized across all of the proposed sfn dosage levels. however, the safety of bse-sfn administration will continue to be evaluated through laboratory studies (cbc, chemistry) performed before and following 28 days of administration.

Eligibility criteria:
inclusion criteria: * subjects must have at least two atypical nevi of ≥ 4 mm diameter and prior diagnosis of melanoma. * subjects must be ≥ age 18. * subjects must not have received any form of systemic antineoplastic treatment for melanoma within the last year from day 1. * subjects should not have known allergies to cruciferous vegetables. * subjects must agree to abstain from dietary sources of glucosinolates and isothiocyanates beginning three days prior to study and throughout duration of the active study (28 days). participants will be asked to keep a food diary. a list of food and supplements to abstain from is provided in appendix a. patients will be asked to record instances of accidental ingestion of these foods, with patients being removed from the study if this occurs 7 or more times. * female subjects must not be pregnant or breast feeding within 6 months prior to and during course of study. * cbc including diff \& platelets - without clinically significant abnormalities * cmp (na, k, cl, co2, glucose, bun, creatinine, calcium, total protein, albumin, ast, alt, alk phos, total bilirubin) - within 2x uln exclusion criteria: n/a

Keywords: atypical nevi melanoma sulforaphane broccoli lesions stat1 stat3
mri in staging ovarian cancer using mri contrast agent

Conditions: Ovarian Cancer

Summary: can mri be used to stage ovarian cancer?

staging of ovarian cancer can best be performed with ct or mri compared to ultrasound. studies have shown an increase in pos. predictive value by adding contrast i.v. to the mr-examination protocol. we compare staging of ovarian cancer by 1.mri without contrast (standard method) to 2.mri with contrast agent i.v. (new method)in the same patient. golden standard are findings at operation.

Eligibility criteria:
inclusion criteria: * suspicion of ovarian cancer exclusion criteria: * recurrence of disease * contraindication to mri, contrast agent * inoperable patients for other reasons

Keywords: ovarian cancer mri contrast agent
breathing adapted radiotherapy for mediastinal lymphoma

Conditions: Lymphoma

Summary: in this study, radiation therapy plans will be made for 20 consecutive patients with mediastinal hodgkin lymphoma or aggressive non-hodgkin lymphoma. one plan is done using a breathing adapted pre-chemo pet-ct scan fused with a post-chemo planning ct scan and another plan is done using the standard procedure with pre-chemo pet-ct fused with post-chemo planning ct scan. dose levels to the lymphoma and to the organs of risk will be compared in each patient. the best radiation therapy plan will be used to treat the patient.

radiotherapy using a breathing adapted therapy scan is a routine technique in breast cancer. breathing adapted radiotherapy may also reduce radiation dose to organs at risk, e.g. heart and lung, in patients with mediastinal hodgkin lymphoma and aggressive non-hodgkin lymphomas. optimal radiation therapy of these lymphoma patients includes radiotherapy planning using pre-chemotherapy pet-scanning, fused with a post-chemo planning ct-scan. this makes accurate treatment of pre-chemo involved volume possible and also accurate radiation of the post-chemo involved volume possible. thus, the optimal breathing adapted radiation requires planning using a breathing adapted pre-chemo pet-ct scan fused with a breathing adapted post-chemo planning ct scan. in this study, 20 consecutive patients with mediastinal hodgkin lymphoma and aggressive non-hodgkin lymphomas will have combination therapy with chemotherapy and radiation therapy to involved nodes. two radiation therapy plans will be made for each patient: one using a breathing adapted pre-chemo pet-ct scan fused with a post-chemo planning ct scan, and one using the standard procedure of a pre-chemo pet-ct scan fused with post-chemo planning ct scan. dose levels to the lymphoma and to the organs of risk will be compared in each patient. the best radiation therapy plan will be used to treat the patient.

Eligibility criteria:
inclusion criteria: * stage i/ii mediastinal hodgkin lymphoma or aggressive non-hodgkin lymphomas * treatment plan includes radiotherapy exclusion criteria: * not able to comply to breathing adapted therapy

Keywords: lymphoma radiotherapy positron-emission tomography ct scan