Kornimate/medical-research-clean huggingface dataset:
observational study for the extended follow-up of the patients enrolled in the therapeutic clinical trial iss t-002

Conditions: HIV Infection

Summary: an observational study to prospectively follow-up the patients enrolled in the iss t-002 clinical trial up to 132 weeks. the primary endpoint of this study is to evaluate the persistence, in term of frequency, magnitude and quality, of the anti-tat humoral and cellular immune response in the hiv-1 infected individuals who participated to the iss t-002 and who have received at least 3 immunizations. the secondary endpoint is to define and validate novel laboratory tests for future efficacy clinical trials.


Eligibility criteria:
inclusion criteria: * previous participation in the iss t-002 trial, having received at least 3 immunizations; * a follow-up of at least 48 weeks during the iss t-002 study; * availability to participate in the extended follow-up study; * signed informed consent. exclusion criteria: * the absence of any of the above criteria will exclude the subjects from the study.

Keywords: hiv haart tat protein
the association between central aortic blood pressure indices and severity of coronary artery disease

Conditions: Coronary Artery Disease

Summary: abstract objectives: primary: to study the association between central aortic blood pressure indices and coronary artery disease in patients undergoing elective angiography. secondary: (a) to study whether any association exists between central aortic pressure indices and the incidence of major adverse cardiovascular events (mace) in the same patients during a 6 month follow up period. (b) to study whether any association exists between the central aortic pressures and peripheral pressures. methods: the investigators conducted a prospective observational study in consecutive patients undergoing coronary angiography. central and peripheral pressures were invasively recorded and coronary artery disease (cad) classified into obstructive and non-obstructive group. cad severity was graded using the gensini score and subjects were divided into tertiles. patients were followed up and the role of central aortic pressure indices in the prediction of cardiovascular events were analysed.


Eligibility criteria:
inclusion criteria: * patients undergoing elective angiography for diagnosis of cad. * age \> 18 years exclusion criteria: * patients with acute myocardial infarction, unstable angina or thromboembolism in the preceding 3 months. * more than mild valvular heart disease. * renal impairment with serum creatinine \> 1.5 mg%. * unable to obtain a full study of the coronary arteries. * peripheral vascular occlusive disease. * post coronary artery bypass grafting( cabg) * heart rate \ 120/min and other arrhythmias. * contraindications for coronary angiography. * unable to provide written informed consent

Keywords: central pressure gensini score pulsatility coronary artery disease
multi-marker stool test for detection of colorectal neoplasia: marker panel selection and technical development studies

Conditions: Colorectal Neoplasms; Digestive System Diseases; Colonic Diseases; Colorectal Cancer

Summary: the objective of this study is to confirm the sensitivity of a stool dna test for detection of colorectal cancer and pre-cancer. another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.

patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days after colonoscopy) and will have the option of submitting blood and tissue samples for future colo-rectal cancer-related test development.

Eligibility criteria:
inclusion criteria: 1. subject is male or female, 40-90 years of age, inclusive. 2. subject has a diagnosis of crc, at any stage, confirmed with a tissue biopsy and/or ≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy. 3. subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. exclusion criteria: 1. subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer). 2. subject has a history of any inflammatory bowel disease. 3. subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (lynch) syndrome, or other hereditary cancer syndromes. 4. individual has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Keywords: cancer colorectal cancer neoplasm colorectal neoplasm intestinal neoplasms gastrointestinal neoplasms digestive system neoplasms neoplasms by site neoplasms digestive system diseases gastrointestinal diseases colonic diseases intestinal diseases rectal diseases
an open therapeutic project to confirm the efficacy tolerability and safety profile of lantus in everyday medical practice

Conditions: Diabetes Mellitus

Summary: the objective of this survey on this registered product is to confirm the efficacy, and safety profile of lantus in every day medical practice. this program will also help to obtain information about the use of the insulin titration regimen and handling of the lantus insulin analogue.


Eligibility criteria:
inclusion criteria: * all newly diagnosed diabetics and existing diabetics uncontrolled on other anti-diabetic therapy, where treatment with basal insulin is required to control hyperglycaemia, and who the treating investigator considers may benefit from the treatment with lantus, could enter in this program. exclusion criteria: -
insulin resistance and vessel function after meals: does early intervention make a difference?

Conditions: Insulin Resistance; Impaired Fasting Glucose

Summary: the purpose of this study is to determine whether attenuation/normalization of elevated blood sugar after meals ameliorates vessel wall (endothelial) function in individuals with insulin resistance.

background:insulin resistance (ir) is accompanied by a high incidence and prevalence of cardiovascular disease. ir is present in individuals with pre-diabetes/ type 2 diabetes. epidemiological data demonstrate a tight relationship between postprandial blood sugar, insulin resistance and cardiovascular disease (cvd). endothelial dysfunction seems to be the very first sign of cvd. purpose: we propose to determine whether attenuation /normalization of post-prandial hyperglycaemia, through the administration of an oral hypoglycaemic agent of ultra rapid action (nateglinide), ameliorates endothelial function in the ir. we extrapolate that a better endothelial function in the brachial artery reflects regression of atherosclerotic changes in the coronary system. method and study design: prospective, open, parallel, group comparison study of 1 intervention group, 1 intervention control group and 1 disease control group. the intervention group and the intervention control group each consist of 30 individuals with ir. individuals in the intervention group receive an individually adjusted dose of nateglinide 3 times daily during 12 weeks. the third group consists of 10 healthy, young individuals. all groups are followed during 3 months with an otherwise unchanged lifestyle. endothelial function is measured with the flow mediated dilation method before and after the intervention/observation period.

Eligibility criteria:
inclusion criteria: * insulin resistance, impaired glucose tolerance exclusion criteria: * unstable chronic disease, acute disease

Keywords: postprandial endothelial function
durable effect of imeglimin on the glycemic control in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: study subjects will be randomly assigned to the three groups and receive the study drug for maximum of 156 weeks and undergo blood samplings and other diabetes mellitus-related tests. the aim of the present study is to evaluate the durability of glycemic control over 3 years for patients with type 2 diabetes on diet and exercise therapy treated with oral hypoglycemic drug monotherapy.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent. 2. patients being treated with diet and exercise therapy only at the time of eligibility test however, if the patient is taking one oral hypoglycemic drug at the time of obtaining consent, the patient must be able to wash out the oral hypoglycemic drug for at least 12 weeks before the start of study treatment. 3. patients whose hba1c level is between 7.0% and 9.0% as measured at the time of the eligibility test. 4. patients who have given written consent to participate in this study. exclusion criteria: when consent is obtained 1. patients with type 1 diabetes mellitus 2. patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks 3. patients who have received glucagon like peptide-1 receptor agonist (short-term use of insulin for trauma or educational admission) within 1 year or less 4. patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy) 5. patients with severe diabetic neuropathy (patients with severe symptoms and significant support for daily life) 6. patients with a contraindication to imeglimin, metformin, or vildagliptin 7. patients with severe obesity (bmi 35 kg/m\^2 or more) 8. patients with nyha (new york heart association) cardiac function classification of grade iii or iv within 1 year of evaluation 9. excessive regular drinkers 10. patients with a previous history of lactic acidosis 11. patients with severe cachexia, diabetic coma or precoma 12. patients with severe infections, surgical patients and those with serious injuries 13. patients who are pregnant, who are planning to be pregnant, or who are breastfeeding 14. patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years 15. patients who are participating in a clinical study with other interventions 16. patients to whom a responsible physician/investigator judged inappropriate for participating in the study in case of eligibility testing 17. patients with an estimated glomerular filtration rate(egfr) of 45 ml/min/1.73m\^2 or less including those undergoing dialysis 18. patients with severe hepatic disorders (child-pugh classification grade c)
solid state vs. balloon esophageal catheter for estimation of pleural pressure

Conditions: Respiratory Failure; Mechanical Ventilation

Summary: measurements of esophageal pressure (pes) as surrogate for pleural pressure are routinely performed in selected icu patients to facilitate lung-protective ventilation and assess breathing effort. pes is clinically measured via a nasogastric esophageal catheter. current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. a solid-state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice. this method-comparison study in adult mechanically ventilated icu patients evaluates the accuracy of pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard.

measurements of esophageal pressure (pes) as surrogate for pleural pressure are routinely performed in selected icu patients to facilitate lung-protective ventilation and assess breathing effort. pes is clinically measured via a nasogastric esophageal catheter. current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. a solid state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice. this method-comparison study in adult mechanically ventilated icu patients evaluates the accuracy of pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard. subjects will receive a standard balloon esophageal catheter and a solid-state pressure catheter for simultaneous measurements of pes. study population will be post-surgical icu patients. measurements will be performed during clinical mechanical ventilation settings which include a first phase of passive controlled ventilation (patient is still sedated after surgery) as well a phase of partially-assisted ventilation where the patient's breathing effort has resumed and is assisted by the ventilator. during both phases, 10-15 minutes of tidal breathing will be recorded.

Eligibility criteria:
inclusion criteria: * signed informed consent * patient requiring mechanical ventilation at the icu following cardiothoracic or abdominal surgery * age ≥ 18 year exclusion criteria: * pregnancy * upper airway/esophageal/mouth or face pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia) * nasal bleeding within the last \<2 weeks * presence of pneumothorax * use of anticoagulants that increase the risk of catheter insertion

Keywords: esophageal manometry respiratory monitoring mechanical ventilation pleural pressure
a biomarker study in patients with her2-negative metastatic breast cancer treated with bevacizumab and paclitaxel

Conditions: Breast Cancer

Summary: to explore molecular biomarkers and/or gene expression signatures that predict response to bevacizumab given in combination with paclitaxel as first line therapy in her2 negative metastatic breast cancer (mbc).

this is a prospective, randomized, 2-arm, open-label, single-center, phase ii trial. a total of 30 patients will be included during a period of 2 years. the study will be initiated with a non-randomized, feasibility stage including ten patients who will be treated with bevacizumab and paclitaxel, in order to determine the safety of metastatic tumor biopsies during therapy with bevacizumab. in the second phase, patients will be randomized (1:1) between two treatment arms: a. bevacizumab + paclitaxel and b. paclitaxel

Eligibility criteria:
inclusion criteria: 1. age 18-70 years. 2. performance status ecog 0-2. 3. clinically and / or radiologically proven stage iv or recurrent her2 negative breast cancer. 4. at least one tumor lesion accessible for biopsy. this lesion may not have been treated previously with irradiation. 5. clinically and/or radiographically documented measurable disease according to recist v1.1 criteria. at least one site of disease must be unidimensionally measurable as follows: 1. ct-scan, physical exam ≥ 10 mm} chest x-ray ≥ 20 mm }see eisenhauer et al. for more details 2. lymph node short axis ≥ 15 mm } 3. all radiology studies must be performed within 28 days prior to registration (35 days if negative). 6. adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment: 1. haematology: absolute granulocytes \> 1.5 x 109/l platelets \> 100 x 109/l 2. biochemistry:bilirubin within normal limits serum creatinine within normal limits 7. aptt and inr within normal limits within 7 days prior to enrollment. 8. adequate cardiac function with left ventricular ejection fraction (lvef) within normal limits determined by echocardiogram or muga within 28 days prior to inclusion. 9. written informed consent must be given. exclusion criteria: 1. previous systemic treatment for mbc. 2. major surgery less than 28 days prior to enrollment. 3. concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix. 4. bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs. 5. major cardiac comorbidity. 6. previous treatment with bevacizumab. 7. previous allergic reaction to taxane analogs. 8. ongoing pregnancy or lactation. 9. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Keywords: metastatic breast cancer
aqueous mushroom extract and intraocular pressure

Conditions: Glaucoma

Summary: the purpose of this study is to determine the effect of aqueous mushroom extract (ame) on intra ocular pressure (iop) in humans or as a potential anti glaucoma drug.

the prophet of islam (peace be on him) was reported to have said that 'mushroom are like manna and their water heals eye diseases'(sahih bukhari 1985). this statement is being investigated in view of the link between blood pressure and intra ocular pressure. glaucoma which is a sight threatening disease and is associated with raised intraocular pressure has been treated for a long time with beta blockers. nowadays the drugs of choice are prostaglandin analogs. this study seeks to discover the effect of pleurotus tuberregium on raised intraocular pressure and to compare its effect on i.o.p with that of known glaucoma drugs. this study also seeks to find out at what concentration pleurotus is effective significantly on raised intraocular pressure clinical investigation will be conducted in the ophthalmological unit of ubth in two phases. in the first phase 21 relatively young healthy subjects aged less than 50 yrs will be recruited for this study after their informed consent. they will have no previous systemic or ocular diseases and have an intraocular pressure of 19mmhg or less and a visual acuity of 6/6. base line investigations will include the systolic and diastolic blood pressure, horizontal pupillary diameter and applanation tonometry. the subjects will be divided into three groups of seven each (a1, a2 and a3). the study will at first constitute two weeks mushroom treatment, two weeks no mushroom treatment and then two weeks mushroom treatment. treatment will be with aqueous extract of oyster medicinal mushroom extract (4g/100ml) dose: п gutt tid x 1/52 for a1, 2g/100ml dose: п gutt tid x 1/52 for a2 and 1g/100ml dose: п gutt tid x 1/52 for a3. investigations of the baseline parameters will be done at the start and after each seven days. the subjects will be monitored to ensure full compliance with the designed protocol. the second phase will involve an equal number of age matched ocular hypertensive or glaucoma patient undergoing treatment in ubth. they will also be divided into three groups of seven each and the treatment regimen above repeated. the iop in this case will be taken by a masked observer.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of open angle glaucoma * intraocular pressure above 23mmhg exclusion criteria: * close angle glaucoma * end stage of glaucoma visual field loss * ocular disease other than glaucoma that will interfere with result

Keywords: glaucoma
multimodal treatment of phonological alexia: behavioral & fmri outcomes

Conditions: Aphasia; Stroke; Dyslexia, Acquired

Summary: this study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. specifically, this study is designed to improve skill in sounding out words for reading and spelling. the overall time commitment for participation in this study is approximately 11-30 weeks.

the proposed study is a mixed-effects (single-subject aba repeated-probe and small group elements) design with 90-120 hours of a modified multi-modal treatment of alexia replicated across up to 18 adults with post-stroke phonological alexia. the short-term goals of this research proposal includes the following: 1) determine if a modified multimodal treatment of phonological alexia can improve pseudoword reading skills (providing a basis from which training will also treat real word reading skills), 2) determine if a modified multimodal treatment of phonological alexia can improve real word reading skills, 3) determine how brain lesion extent and location relate to participants' response to treatment, and 4) identify relationships between changes in functional brain activity in specified regions of interest and participants' response to treatment.

Eligibility criteria:
inclusion criteria: * adults with post-stroke reading difficulties (phonological alexia) * \>3 months post-stroke * native english speaker * can go in mri scanner (3 to 6 scans), * participate in 90 to 120 free treatment sessions * return for 3-month post-treatment follow-up assessment \& mri. exclusion criteria: * mental illness * degenerative disease, visual or auditory acuity impairment * drug abuse * english is not first language * claustrophobia * pregnancy

Keywords: dyslexia reading aphasia stroke
atraumatic restorative treatment sealants in first permanent molars

Conditions: Caries, Dental

Summary: the aim of this bi-center study was to evaluate the retention and caries-preventive effect of atraumatioc restorative treatment (art) sealants, using two glass ionomer cement (gic) versus non-sealant on first permanent molars of schoolchildren. the null hypothesis is that there is no difference in the retention rates of the two gic, as well as in caries prevention between sealants application and non-sealant. four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in brazil. they were randomly divided into two groups, according to the gic used (fuji ix or maxxion). all children had their four first permanent molars included in the research and two molars were sealed with a gic, while the other two molars remained unsealed. clinical evaluations were performed up to 36 months by one independent examiner at each city.


Eligibility criteria:
inclusion criteria: * patients presenting the four first permanent molars without gingival tissue covering the occlusal surface and without clinically detectable dentine caries lesion, assessed as scores 0, 1 and 2 of icdas criteria \[ismail ai, sohn w, tellez m, et al (2007) the international caries detection and assessment system (icdas): an integrated system for measuring dental caries: methods. community dent oral epidemiol 35:170-178 \]. exclusion criteria: * patients presenting any physical and/or medical health issues and having non-cooperative behavior.

Keywords: dentition, permanent glass ionomer cements