Kornimate/medical-research-clean huggingface dataset:
the effect of semaglutide on cardiovascular markers and liver function

Conditions: Diabetes Type 2

Summary: fifty patients with diabetes mellitus type 2 and non-alcoholic fatty liver disease (nafld) will be enrolled in the study. 25 patients will treated with semaglutide and 25 patients with dipeptidyl peptidase 4 (d-pp4) inhibitors. at baseline, at four and at 12 months will evaluate the endothelial, cardiovascular and liver function.

the cardiovascular benefits of semaglutide are established; however, its effect on surrogate vascular markers and liver function is not known.the aim of our study is to investigate the effects of semaglutide on vascular,endothelial and liver function in patients with type 2 diabetes and non-alcoholic fatty liver disease. a.overall, 50 patients with diabetes mellitus type 2 and nafld will be studied at baseline ,at four and twelve months of treatment: 25 patients will be treated with semaglutide 25 patients will be treated with d-pp4 inhibitors. b. in all patients, the investigators will measure the pulse wave velocity (measured in m/s), pulse wave augmentation index \[which is calculated by the formula (p2-p1)/pp x 100, where p1 stands for peak systolic pressure, p2 stands for second peak systolic pressure due to wave reflection and pp stands for pulse pressure \], central systolic blood pressure (sbpao, measured in mm hg) and central pulse pressure (ppao, measured ) with arteriograph, mobilograph and complior, and perfused boundary region of sublingual vessels (5-25 μm in size) using a high-resolution camera with sideview darkfield imaging technique (microscan, glucockeck). perfused boundary region consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. increased perfused boundary region is considered to be an accurate indicator of the reduction of endothelial glycocalyx thickness due to plasma penetration into the glycocalyx.liver steatosis and stiffness will be measured using fibroscan® mini+ 430 (echosens, paris, île-de-france). controlled attenuation parameter (cap) score will be used as an index of liver fat content, with normal values being \< 238 db/m. e score will be used as an index of liver fibrosis, with normal values being 2- 6 kpa. the examination will be carried out at the laboratory of preventive cardiology of the 2nd department of cardiology of the university of athens at "attikon" hospital.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * nafld exclusion criteria: * malignancies * chronic inflammatory disease * chronic kidney disease (estimated glomerular filtration rate \<60 ml/min/m2 for a period of at least 90 days) * peripheral vascular disease * retinopathy * previous therapy with a glucagon-like peptide-1 agonist. * none of the female patients was on hormone replacement treatment.
high dose omeprazole in patients with pancreatic cancer

Conditions: Exocrine Pancreatic Cancer

Summary: the purpose of this study is to test the safety of high dose omeprazole and see what effects that it has on patients with exocrine pancreatic cancer.

during this study patients will receive treatment of omeprazole at the dose depending on group enrollment * group a will receive omeprazole 80 mg, twice a day for 12-14 days unless unacceptable toxicity * group b, will receive omeprazole 20 mg, once a day for 12-14 days patients will receive treatment for 2\~3 weeks during the study, and 2 months of follow up. total accrual is anticipated to take 2 years.

Eligibility criteria:
inclusion criteria: * newly diagnosed exocrine pancreatic cancer with either pathology, histology, or radiology imaging documented as adenocarcinoma * patient is a candidate for surgical resection of pancreatic cancer * ≥ 18 years old at the time of informed consent * ecog performance status 0-2 * patients with or without neoadjuvant chemotherapy will be eligible * ability to provide written informed consent and hipaa authorization * women of childbearing potential definition must have a negative pregnancy test within 14 days of registration. all women (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) are considered to have childbearing potential unless they meet one of the following criteria: * prior hysterectomy or bilateral oophorectomy; * has not had menses at any time in the preceding 24 consecutive months * candidate for surgery per standard of care of per surgeon's discretion exclusion criteria: * patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies * positive pregnancy test, pregnant, or breastfeeding * known hypersensitivity to any component of the formulation or substituted benzimidazoles * any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study * any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study * medical condition that might affect the absorption of study medications in the opinion of the investigator.

Keywords: pancreatic cancer omeprazole
reversal of dabigatran with prothrombin complex concentrate

Conditions: Drug Action Reversal

Summary: the purpose of this study is to investigate whether prothrombin complex concentrate (pcc) is effective in reversing the anticoagulant effect of dabigatran, as assessed by two modified skin-bleeding tests.

there is currently no treatment widely available for immediate reversal of dabigatran anticoagulant effects, e.g. in case of major bleeding or when emergency surgery or invasive procedures are indicated. treatment with prothrombin complex concentrate (pcc) seems effective in reducing blood loss in animal models, but previous studies in humans have failed to show an effect on blood coagulation parameters. recently, two novel methods of skin blood loss, one called "shed blood" and another "washed blood" were able to measure effects of anticoagulation, either as the inhibition of fibrin formation at the wound site by measuring fibrinopeptide a (fpa) or as elevated blood loss, respectively, after oral administration of dabigatran in healthy volunteers. the investigators hypothesise that the shed/washed blood methods are able to measure dabigatran reversal following administration of pcc (beriplex). the study will be performed as a randomised double blind cross-over study and 12 healthy human male subjects will be enrolled. subjects will take dabigatran 300 mg b.i.d. on day -2, -1 and 0. after the fifth dose (on day 0), subjects will be randomised to receive beriplex (50 iu/kg) or a similar volume of saline as a single bolus dose i.v. over 20 minutes. after a 10 day minimum wash-out period this procedure will be repeated, and the alternative treatment (saline or beriplex) is administered. the shed / washed blood measurements will be performed at different time points before and after starting oral anticoagulants and before and after administration of beriplex/saline. in addition to the shed / washed blood tests, several ex vivo standard coagulation tests will be performed. these include: activated partial thromboplastin time (aptt), prothrombin time (pt), diluted thrombin time (dtt/hemoclot), dabigatran plasma levels (using liquid chromatography-tandem mass spectrometry (lc-ms/ms)), endogenous thrombin generation (etg) and pre and post factor ii, vii, ix and x.

Eligibility criteria:
inclusion criteria: * healthy males * age between 18 and 50 years * weight \<100 kg * signed informed consent * egfr ≥ 80ml/min\*1.73m2 exclusion criteria: * history of allergic reaction to blood products * current participation in any other investigational drug study or within the past 30 days * increased bleeding tendency or history of thrombosis * anticoagulant medication, platelet aggregation inhibitors or nsaids * use of any medication 14 days before start of dabigatran intake

Keywords: direct thrombin inhibitor prothrombin complex concentrate dabigatran etexilate beriplex shed blood washed blood fibrinopeptide a
the study to compare cypher versus cypher select in treating cornary artery lesions.

Conditions: Coronary Artery Disease

Summary: the main objective of this study is to assess the safety and effectiveness of the cypher select™ sirolimus-eluting coronary stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the cypher ™ sirolimus-eluting coronary stent.

this is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the cypher select™ sirolimus-eluting coronary stent as compared to the cypher™ sirolimus-eluting coronary stent. a total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the cypher select™ stent or the cypher™ stent. 100 patients with de novo native coronary artery lesions \<23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.

Eligibility criteria:
inclusion criteria: 1. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b\&c, i-ii-iii) or patients with documented silent ischemia; 2. single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion; 3. target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate); 4. target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent; 5. target lesion stenosis is \> 50% and \< 100% (visual estimate). exclusion criteria: 1. a q-wave or non-q-wave myocardial infarction within the preceding 72 hours unless the ck and ck-mb enzymes are back to normal; 2. unprotected left main coronary disease with more than 50% stenosis; 3. significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff; 4. have an ostial target lesion; 5. angiographic evidence of thrombus within target lesion; 6. calcified lesions which cannot be successfully predilated; 7. ejection fraction less than 30%; 8. totally occluded vessel (timi 0 level); 9. direct stenting;
blue light emitting diode therapy on vulvovaginal candidiasis

Conditions: Recurrent Vulvovaginal Candidiasis

Summary: with the knowledge that vvc is an infectious disease of the genitourinary tract that is common in women of reproductive age, and because of the shortage of non-drug therapies for this condition, this study will aim to evaluate the effect of ultraviolet a/blue led with a wavelength of 401 ± 5 nm in patients with a clinical manifestation of candidiasis and its ability to prevent recurrence.

vulvovaginal candidiasis (vvc) is an infection of the vulva and vagina caused by the abnormal growth of several candida species. this pathology is one of the most common diagnoses in gynecological practice and the second most common genital infection. studies have shown that 15 to 25% of adult women present with fungal colonization despite being asymptomatic and that 75% of them will develop the disease at some point in their lives. the treatment of vvc involves the use of antifungal agents, either orally or topically, which resolves 80 to 90% of the cases. however, the use of these agents can lead to the development of adverse reactions such as dysuria, pruritus, and gastrointestinal disorders. accordingly, a hypothesis arises that the blue/violet light- emitting diode (led) may be an alternative treatment for women with vvc because of its antimicrobial effect that has been proven by several studies. moreover, it is considered a safe, non-invasive, painless, and non-toxic technique for use in several types of tissue.

Eligibility criteria:
inclusion criteria: subject selection will be according to the following criteria: 1. age will range between 18- 50 years. 2. all patients will be confirmed by culture and examination of fresh vaginal samples, to have vvc. 3. all patients who will be enrolled to the study will have their informed consent. exclusion criteria: the participants will be excluded if they meet one of the following criteria: 1. individuals on any other antifungal drugs. 2. individuals with cardiopulmonary conditions. 3. individuals undergoing another radiation therapy. 4. sensory impairment
study to evaluate the safety and efficacy of topical minocycline fxfm244 in rosacea patients

Conditions: Rosacea

Summary: acne rosacea is a chronic acneiform disorder affecting both the skin and the eye. it is a syndrome of undetermined etiology characterized by both vascular and papulopustular components involving the face and occasionally the neck and upper trunk. this is a pilot phase ii study to evaluate the tolerability and safety and to monitor the clinical efficacy of topical minocycline foam fxfm244 in moderate to severe rosacea patients.

a pilot, randomized, double blind, placebo controlled, parallel group, dose range finding study. the study will involve three treatment groups. eligible patients will be randomized to receive either fxfm244 - 1%, fxfm244 - 4% or placebo, in a blinded fashion. patients will be treated twice daily for 12 weeks. following the screening period and baseline visit, study subjects will return at weeks 3, 6, 9 and 12. a follow up visit will take place at week 16. at each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.

Eligibility criteria:
inclusion criteria: 1. patients with clinical diagnosis of moderate to severe facial rosacea as determined by: * at least 8 but no more than 50 total papules and/or pustules (inflammatory lesions) * presence of moderate to severe erythema * presence of telangiectasia. * an overall rosacea severity score ≥2.5 2. patient is male or female over 18 years of age. 3. no known medical conditions that, in the investigator's opinion could interfere with study participation 4. patient is willing and able to comply with all requirement of the protocol 5. patient is willing and able to give written informed consent prior to participation in the study exclusion criteria: 1. presence of skin diseases at or near the investigational area 2. immunosuppressed state or other serious systemic disease 3. signs and/or symptoms of systemic infection 4. concomitant medication: * use of oral and/or topical antibiotic treatment within 14 days prior to study entry. * use of any topical anti-rosacea agent except antibiotics within 14 days prior to study entry. * use of cyproterone acetate, cpa-containing contraceptives (e.g. diane) or other corticosteroids (during the last 3 months); * use of retinoids (during the last 4 weeks) 5. use of artificial sun bath or having a sun holiday during the last 2 weeks 6. alcohol or drug abuse, according to assessment by the investigator 7. known or suspected hypersensitivity to minocycline or any of the excipients in the study medication 8. use of another investigational drug within 30 days prior to entry into this study 9. pregnant or lactating women.

Keywords: rosacea topical minocycline foam phase ii
comparing the visual outcome, visual quality, and satisfaction among three types of multi-focal intraocular lenses

Conditions: Cataract

Summary: the investigators are going to investigate the comparative efficacy of the patients who underwent cataract surgery with three different multifocal iols.

going to analyze the clinical results of 60 patients who underwent bilateral cataract surgery and multifocal iol implantation. the patients were divided into the following three groups: mix-and-match, edof, and trifocal. the clinical assessments included uncorrected near, intermediate, distance and best corrected distance visual acuity, defocus curves, contrast sensitivity, and reading speed. patient satisfaction was evaluated by questionnaire. all outcomes were compared among the three groups.

Eligibility criteria:
inclusion criteria: * patients with bilateral senile cataracts and the desire to be spectacle-free for all distances exclusion criteria: * patients younger than 21 years, had corneal astigmatism \>1.00 d, previous ocular surgery or trauma, or ocular disease other than cataracts

Keywords: multifocal intraocular lens
ultrasound exam with doppler for the etiological diagnosis of orbital masses (puce)

Conditions: Tumor of the Orbit

Summary: orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. these masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation. pathology is of considerable importance for the diagnosis and the treatment of those masses. however, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers. the identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients. quantitative analysis of the ultrasound exam with doppler of those masses could identify diagnostic criteria, especially for the lacrimal gland, easily explorable.


Eligibility criteria:
inclusion criteria: * patient aged 18 years or more * with an orbital mass for which a biopsy and/or a surgical removal is planned * before surgery or biopsy exclusion criteria: * pregnancy * breast feeding * patient under a legal protection procedure * patient denying to participate to the study * lack of affiliation to a social security system
a radiopharmacokinetic and radiodosimetric phase i imaging study of 18f-faza

Conditions: Hypoxic Tumours

Summary: hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's tumour that may help predict patient outcomes and/or help inform patient management decisions. 18f-faza positron emission tomography (pet) can detect hypoxic tumours because 18f-faza accumulates in hypoxic tissues. this study is being done to learn more about the processes by which 18f-faza is absorbed, distributed, metabolized (built-up and broken down) and eliminated by the body.

a phase i radiopharmacokinetic and radiodosimetric study of 18f-faza. prior to treatment, subjects will receive a single injection of 18f-faza. subjects will undergo a series of 5-5 pet scans, and will have 8-13 blood samples and 2 urine samples taken at specified time points over a 4.5-5.5 hour period. 18f-faza pet images will be reviewed to develop a dynamic uptake model, and blood and urine samples will be analyzed for unchanged 18f-faza and its metabolites.

Eligibility criteria:
inclusion criteria: * male of female \> or = to 18 years of age. if female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test required * subjects with known primary or suspected metastatic scc head and neck; nsclc; sclc; gbm; lymphoma, or net with at least one lesion \> 1 cm in diameter * able and willing to follow instructions and comply with the protocol * provide written informed consent prior to participation in the study * karnofsky performance scale score of 70-100 exclusion criteria: * previous treatment for their primary or metastatic scc head and neck, nsclc, sclc, gbm, lymphoma, or net * bilirubin \> or = to 200 umol/l * creatinine \> or - to 150 umol/l * ast or alt \> or = to 5 times the upper limits of normal * serious medical conditions such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes * nursing or pregnant females

Keywords: 18f-faza positron emission tomography radiation dosimetry pharmacokinetics
enhanced medical rehabilitation for disablement

Conditions: Hip Fracture; Depression

Summary: this study will develop and test a new program of enhanced medical rehabilitation for elderly people who have had an acute disabling medical event and are admitted to a skilled nursing facility for post-acute rehabilitation.

disabling medical events are common for elderly people, causing immobilization, requiring extensive rehabilitation, and generating fears of loss of function and need for institutionalization. existing acute medical rehabilitation settings-skilled nursing facilities (snfs) and inpatient rehabilitation facilities (irfs)-often do not adequately meet the needs of depressed elders, resulting in a missed opportunity for effective and functional recovery. this study will test a new program that will enhance acute rehabilitation in snfs to target mood, motivation, and functional recovery in the 2 to 4 weeks after hospitalization. this program, developed by the research team, increases the intensity and engagement of physical therapy (pt) and occupational therapy (ot). participation in this study will last until discharge from the snf, with follow-up assessments lasting until 3 months after entry. participants will be randomly assigned to receive either the enhanced acute medical rehabilitation or treatment as usual. participants receiving the enhanced care will complete up to 3 hours of enhanced pt and ot per day from study entry until discharge, excluding weekends. participants receiving treatment as usual will receive standard pt and ot. study assessments will take place at baseline, after 8 and 15 days, and after discharge. follow-up assessments will occur after 30, 60, and 90 days. assessments will include questionnaires and interviews measuring positive and negative affect, and functional impairment and disability.

Eligibility criteria:
inclusion criteria: * admitted to barnes extended care nursing home * acute disablement * (criterion dropped) clinically depressive symptoms, including a score of 15 or greater on the hamilton depression rating scale (ham-d) and depressed mood or anhedonia present more days than not since the fracture exclusion criteria: * unable to provide informed consent due to dementia and severe persistent delirium * inability to cooperate with the protocol * cardiac or other medical instability that would preclude carrying out high intensity exercises * language, visual, or hearing barriers to participation * presence of pelvic fractures that do not involve the proximal femur * presence of metastatic cancer, including cancer that causes a pathological fracture * bilateral acute hip fractures * lifetime psychosis or mania * alcohol or substance dependence within 6 months, or current (prior to hip fracture) alcohol or substance abuse

Keywords: elderly acute medical rehabilitation