Kornimate/medical-research-clean huggingface dataset:
biolimus a9™ (ba9™) drug coated balloon (dcb) study

Conditions: Coronary Artery Disease; In-Stent Restenosis

Summary: the study is a prospective, randomized, non-inferiority trial to determine the safety and efficacy of the ba9™ drug coated balloon for the treatment of in-stent restenosis. it is a first-in-man trial.

this clinical trial will serve as a first-in-human (fih) experience for the ba9™ dcb in a population of patients with coronary artery disease who have an indication for interventional treatment of in-stent restenosis (isr) in a bare-metal stent (bms) or drug-eluting stent (des). the study uses a prospective, multi-center, single blind, randomized controlled trial design to enroll 195 patients. the study will seek to prove that the ba9-dcb is non-inferior to the approved ce marked sequent please® paclitaxel coated balloon with respect to % diameter stenosis and has similar safety characteristics.

Eligibility criteria:
inclusion criteria: * patients presenting with in-stent restenosis (isr) and clinical symptoms of ischemia and/or (i) evidence of ischemia on non-invasive testing or (ii) hemodynamically relevant lesion defined by ffr ≤ 0.80 or ifr ≤ 0.89 or \> 90% stenosis. * patient presenting with a lesion that can be fully covered with one dcb length. - patients can have up to two index lesions with isr, which can both be treated and evaluated. * patient has provided written informed consent * age ≥ 18 years. * patient is willing and able to comply with the study procedures and follow-up. exclusion criteria: * patient presents with a st-elevation myocardial infarction (stemi) or had an acute mi within 48 hours prior to presentation (according to the universal definition of myocardial infarction). * patient with acute cardiac decompensation or acute cardiogenic shock * documented left ventricular ejection fraction (lvef) ≤ 30% * patient with impaired renal function (glomerular filtration rate \< 80 ml/min/1.73 m2). * more than 2 epicardial vessels requiring revascularization * significant left main stenosis (by visual estimation) or an isr located in the left main (lm). * patient has an isr lesion that cannot be covered with one dcb length. * patient has an isr in the target segment in a stent of a smaller diameter than 2.5mm. * severe calcification that might prevent a sufficient expansion of the dcb, if not pre-treated with rotablation or a shockwave application device. * known hypersensitivity or contraindication to biolimus, paclitaxcel, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated. * pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study. * subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached. * anticipated difficulties to complete the angiographic follow-up study. * patient with a life expectancy of less than 12 months. * patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.

Keywords: drug-coated balloon
linezolid pharmacokinetics (pk) in multi-drug resistant (mdr)/extensively-drug resistant (xdr) tuberculosis (tb)

Conditions: Multi-Drug Resistant Tuberculosis; Extensively Drug Resistant Tuberculosis

Summary: this is a one-period, double-blind, single-center pharmacokinetic study of linezolid in patients with mdr or xdr tuberculosis treated with linezolid and an optimized background therapy (defined as treatment with \> 4 drugs with activity against tuberculosis to which the patient's isolate is believed to be sensitive by history or based on drug sensitivity testing).

this is a one-period, double-blind, single-center pharmacokinetic study of linezolid in patients with mdr or xdr tuberculosis treated with linezolid and an optimized background therapy (defined as treatment with \> 4 drugs with activity against tuberculosis to which the patient's isolate is believed to be sensitive by history or based on drug sensitivity testing).

Eligibility criteria:
inclusion criteria: * enrolled in the tbtc study 30 * provision of informed consent for the study exclusion criteria: * severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the pk study).

Keywords: multi-drug resistant tuberculosis extensively drug resistant tuberculosis mdr tb xdr tb mdr xdr
effectiveness of a treatment protocol for lower urinary tract symptoms in general practice

Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Summary: ageing and the availability of medication has led to an increase of elderly male patients being treated for lower urinary tract symptoms (luts), or voiding problems ("prostate problems"). however, guidelines are vague as to which patients should and which should not be treated, and how. although several treatment modalities have proven efficacy in selected populations, it is unclear how effective these treatments are in daily practice. this study investigates the hypothesis that a treatment protocol in which clear indications are formulated for all treatment modalities is more effective, as compared to current usual primary care, in reducing both symptoms as related to the quality of voiding in elderly males.

guidelines fail to provide specific diagnostic criteria and clear indications for therapy in elderly male patients with lower urinary tract symptoms. consequently, the group of patients diagnosed with luts in primary care is very heterogeneous, and daily care varies widely. consequently, efficacy trials of alpha-blockers, 5-alpha-reductase inhibitors and surgery performed in selected, well defined homogeneous populations cannot easily be generalised to the heterogeneous primary care situation. a practical randomised trial enrolling patients on the basis of symptoms have the advantage of being of immediate practical value. we compare a treatment protocol with clear indications for therapy with current usual care in a population selected on symptoms rather than well defined diseases or definite test results. two hundred eight subjects were randomised into intervention (n=104) and control (n=104) conditions. after two years of follow-up, ipss scores, bother scores, maximum urinary flow rates and the incidence of acute urinary retention and urinary tract infections have been compared.

Eligibility criteria:
inclusion criteria: * international prostate symptom score \> 7 * age \> 55 years exclusion criteria: * heart failure * diabetes type i * psychiatric disorder/cognitive dysfunction * history of prostate surgery * active treatment for lower urinary tract symptoms

Keywords: bph benign prostatic hyperplasia
fluorescence image guided surgery in cholangiocarcinoma

Conditions: Hilar Cholangiocarcinoma

Summary: cholangiocarcinoma is an epithelial cell malignancy arising from varying locations within the biliary tree and is difficult to diagnose due to the often-silent clinical nature. the best chance of long-term survival and potential cure is surgical resection with negative surgical margins, but many patients are unresectable due to locally advanced or metastatic disease at diagnosis. because cholangiocarcinoma is difficult to diagnose at an early stage and extends diffusely, most patients have unresectable disease at clinical presentation, and prognosis is very poor (5-year survival is 0-40% even in resected cases) there is a need for better visualization of tumor tissue, lymph nodes and resection margins during surgery for perihilar cholangiocarcinoma (phcc). optical molecular imaging of phcc associated biomarkers is a promising technique to accommodate this need. the biomarkers vascular endothelial growth factor (vegf-a), epidermal growth factor receptor (egfr) and c-met are all overexpressed in phcc versus normal tissue and are proven to be valid targets for molecular imaging. currently, tracers that target these biomarkers are available for use in clinical studies. in previous studies with other tumor types, the investigators tested the tracer bevacizumab-irdye800cw for the biomarker vegf-a with very promising results. since all markers show roughly similar expression in ex vivo studies, the initial study will be performed with bevacizumab-irdye800cw as the investigators have the most experience with this tracer. the investigators hypothesize that the tracer bevacizumab-irdye 800cw accumulates in phcc tissue, enabling visualization using a nir intraoperative camera system and ex vivo nir endoscopy. in this pilot study, the investigators will determine if it is possible to detect phcc intraoperatively and by ex vivo nir endoscopy using bevacizumab 800cw, and which tracer dose gives the best target-to-background ratio. the most optimal tracer dose will be selected for a future phase ii trial.

see brief summary

Eligibility criteria:
inclusion criteria: * patients with clinical suspicion of phcc who are scheduled to undergo surgical intervention with curative intent * who performance score 0-2. exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent. * other invasive malignancy * pregnant or lactating women. * history of infusion reactions to bevacizumab or other monoclonal antibody therapies. * inadequately controlled hypertension with or without current antihypertensive medications * within 6 months prior to inclusion: myocardial infarction, tia, cva pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
interactions between intravenous (iv) cocaine and lofexidine

Conditions: Cocaine Related Disorders

Summary: the purpose of this study is to assess potential interactions between intravenous (iv) cocaine and treatment with lofexidine.

to determine the safety of daily oral lofexidine alone and concurrent with iv cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.

Eligibility criteria:
inclusion criteria: * be volunteers who meet diagnostic and statistical manual of mental disorders fourth edition (dsm-iv) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study. * be between 18 and 50 years of age, inclusive. * be currently use cocaine. use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period. * be able to verbalize understanding of the consent form and provide written informed consent. * females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. they must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control: * diaphragm and condom by partner * intrauterine device (that does not contain progesterone) and condom by partner * sponge and condom by partner * complete abstinence from sexual intercourse note: oral contraceptives, depo-provera, norplant, patch, and intrauterine progesterone contraceptive system are not allowed. exclusion criteria: * please contact site for more information
comparative analysis of large macular hole surgeries

Conditions: Macular Holes

Summary: this study compares the anatomical and visual outcomes in a large series of patients affected by idiopathic macular holes larger than 400 µm treated using pars plana vitrectomy and gas tamponade combined with internal limiting membrane (ilm) peeling or the inverted internal limiting membrane flap technique. a part of the participants will receive internal limiting membrane peeling,whil the other will receive the inverted internal limiting membrane flap technique.

vitrectomy is the standard treatment for idiopathic macular holes (imhs) and is combined with removal of the internal limiting membrane (ilm) to improve anatomical outcomes.however, surgical closure is not achieved after a single operation in all cases, and patients with long-standing mhs or highly myopic eyes are challenging to treat.various surgical strategies have been introduced to improve postoperative outcomes for these cases. michalewska et al. have reported an inverted ilm flap technique for large mhs. the ilm around the mh was left to cover or fill the hole and showed a better anatomical closure rate and visual outcome than ilm peeling for large mhs. nevertheless, the functional and anatomic outcomes of the ilm flap technique have not been investigated as extensively as the ilm peeling technique and have yet to be confirmed by research comparing the ilm flap technique with the conventional procedure.

Eligibility criteria:
inclusion criteria: * idiopathic mhs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy. exclusion criteria: * high myopia (≥6 diopters,al≥26.5mm), increased intraocular pressure (iop, \>21 mm hg) or glaucoma, severe cataract, severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery.

Keywords: inverted internal limiting membrane flap technique large macular hole macular hole surgery
metanx effects on nerve fiber density in neuropathic diabetics

Conditions: Diabetes; Peripheral Neuropathy

Summary: this study focuses on the use of metanx® as the sole treatment for improving and reversing nerve damage in type 2 diabetic patients with peripheral neuropathy. there will be two equal study groups enrolled in this randomized double blinded study. the minimum sample size of enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. the maximum number of participants will be set at 100 (50 per group). patients who are pre-diabetic or patients who have been diagnosed with diabetes type ii for less than five years are included in this study. the control group will receive placebo pill twice daily versus the treatment group which will receive one metanx® tablet twice daily. each group will have intraepidermal nerve fiber densities obtained by skin biopsies taken at the beginning of the study before any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of twelve months to re-biopsy. in addition each group will answer three sets of questionnaires relating to their peripheral neuropathy at initial, three months, twelve month visitations. if metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density and an improvement in the subjective score versus the placebo group.


Eligibility criteria:
inclusion criteria: * type 2 diabetics * pre-diabetics * symptoms of peripheral neuropathy exclusion criteria: * pregnancy * under age 18 * hiv (+)

Keywords: small fiber neuropathy metanx effect on small fiber neuropathy metanx effect on diabetic peripheral neuropathy
safety and effectiveness of acthar gel for inflammation of the eye's uvea (middle layer)

Conditions: Uveitis, Posterior; Uveitis, Intermediate; Panuveitis

Summary: the main reason for this study is to see if acthar gel can reduce inflammation in the uvea. also, safety information when using it for this purpose will be collected.


Eligibility criteria:
inclusion criteria: * is male or nonpregnant, nonlactating female * has been diagnosed with current severe nippu * has active disease at the baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone (or oral corticosteroid equivalent): 1. has active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion 2. has ≥ 2+ anterior chamber cells \[standardization of uveitis nomenclature (sun) criteria\] 3. has ≥ 1.5+ vitreous haze * is willing to taper current doses of corticosteroid and immunomodulatory therapy to the minimum effective dose during the study. * if under treatment with any immunosuppressants, immunomodulators, or biologic agents for a comorbid condition, has been on a stable dose for 2 weeks before screening exclusion criteria: * has proliferative or severe nonproliferative diabetic retinopathy, clinically significant macular edema due to diabetic retinopathy, neovascular/wet age-related macular degeneration, abnormality of vitreoretinal interface with the potential for macular structural damage independent of the inflammatory process or severe vitreous haze that precludes visualization of the fundus at the baseline visit * has type 1 or type 2 diabetes mellitus, tuberculosis, history of hepatitis, peptic ulcer, active infection, or any contraindication for treatment with acthar gel
mscs with or without peripheral blood stem cell for treatment of poor graft function and delayed platelet engraftment

Conditions: Stem Cell Transplantation, Hematopoietic; Poor Graft Function; Delayed Platelet Engraftment; Hematological Diseases

Summary: the purpose of this study is to compare the efficacy of mesenchymal stem cells (mscs) with or without granulocyte colony-stimulating factor (g-csf) mobilized peripheral stem cells (pbsc) in treating patients experiencing poor graft function or delayed platelet engraftment after allogeneic hematopoietic stem cell transplantation.

allogeneic hematopoietic stem cell transplantation(allo-hsct) is the only cure for many hematologic diseases. however, about 5-27% of patients would suffer from poor graft function (pgf) and more recipients might develop delayed platelet engraftment (dpe) after allo-hsct. these complications are associated with considerable mortality related to infections or hemorrhagic complications. treatment of pgf and dpe usually involves hematopoietic growth factors such as granulocyte colony-stimulating factor (g-csf) and thrombopoietin (tpo), or second transplantation, but these methods have dismal effect or even a significant risk of graft-versus-host disease (gvhd). mesenchymal stem cells (mscs) are a form of multipotent adult stem cells that can be isolated from bone marrow (bm), adipose tissue, and cord blood. clinical applications of human mscs include improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-hsct and so on. some studies have shown that mscs combined with pbsc or cord blood could be useful to improve engraftment after hsct. several reports suggested mscs might be effective in the treatment of pgf. however, the efficacy of mscs as single-drug treatment for pgf or dpe is unsatisfactory in our previous study. therefore, in the present study, g-csf mobilized pbsc will be used combined with mscs in the patients with pgf or dpe after allo-hsct.

Eligibility criteria:
inclusion criteria: * age：14-65 years * pgf or dpe after allo-hsct * subjects (or their legally acceptable representatives) must have signed an informed consent document exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)

Keywords: poor graft function delayed platelet engraftment peripheral blood stem cell mesenchymal stem cells allogeneic hematopoietic stem cell transplantation
new conservative technique for placenta accreta spectrum

Conditions: Placenta Accreta Spectrum

Summary: participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery. investigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed. data were collected about the outcome.

demographic data, detailed history taking, routine blood tests were done. trans-abdominal and trans-vaginal ultrasound to diagnose placenta accreta spectrum ( pas). detecting new signs to help sure diagnosis of pas. cesarean section will be performed through extended transverse supra-pubic incision bladder dissection from anterior uterine wall using electro-coagulation instruments and double ligation of large caliber bridging vessels. uterine incision above the placental bulge by at least 5 mm then complete separation of the placenta starting from least resistance plans to high resistant one leaving a clear defect which will be closed by running sutures from inside the uterus and controlling placental bed hemorrhage then closing the uterine incision with compressing the bed from outwards ( double compression sutures ) internal iliac artery ligation may be done as a complementary measure to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain and closure of abdominal wall in layers.

Eligibility criteria:
inclusion criteria: * pregnant women diagnosed as placenta accreta spectrum with previous cesarean section, with or without other uterine surgeries and less than 40 years of age. exclusion criteria: * pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders. pregnant women had 5 or more previous cesarean sections or their age more than 40 years
disease-modifying properties of lithium in the neurobiology of alzheimer's disease

Conditions: Cognitive Impairment; Alzheimer Disease

Summary: lithium salts have been used for the treatment of psychiatric disorders for over five decades, mostly as a mood-stabilizing drug. recent evidence points to the inhibition of the enzyme glycogen synthase kinase-3beta (gsk3) as one of its mechanisms of action. the overactivity of this enzyme has been implicated in the pathogenesis of alzheimer's disease (ad), given its involvement in mechanisms related to the hyperphosphorylation of tau protein and the production of beta-amyloid peptide. these are key events leading respectively to the formation of neurofibrillary tangles and senile plaques, which are the neuropathological hallmarks of the disease. several in vitro and animal studies have shown that the inhibition of gsk3 by lithium and other agents attenuates these pathological processes, reinforcing the notion that gsk3 is a likely target for future disease-modifying therapies for ad. indeed, a recent study published by our group showed that chronic lithium use is associated with a decrement in the expected prevalence of dementia, in a sample of elderly individuals with bipolar disorder. to investigate this putative neuroprotective effect in a prospective way, the investigators started 24-month randomized, double-blinded controlled trial of lithium for the prevention of dementia in a sample of elderly individuals with amnestic mild cognitive impairment (mci), a condition associated with increased risk for the development of ad. the clinical and biological outcomes of this trial include the attenuation of cognitive deficits, and the modification of certain biological markers of the disease (as measured in the cerebrospinal fluid, leukocytes and platelets). the objective of the present application is to enable the extension of this ongoing trial to an additional 2-year follow-up. a longer follow-up (48 months) will increase the statistical power to ascertain the primary outcome variables of this study, particularly the con-version from mci to alzheimer's disease. this will warrant a more consistent conclusion about the potential of lithium treatment in the prevention of dementia, in addition to a better evaluation of safety and tolerability profiles of the long-term use of lithium in older individuals.


Eligibility criteria:
inclusion criteria: * patients with amnestic mild cognitive impairment; * age: 60 to 80 years-old; exclusion criteria: * sensory deficiencies that might preclude the administration of cognitive tests; * active major psychiatry disorder; * unstable clinical conditions such as cardiac insufficiency, uncontrolled diabetes mellitus, renal failure; * previous use of lithium salts; * concurrent participation in other clinical trial or intervention studies;

Keywords: mild cognitive impairment alzheimer's disease lithium disease-modification cognition early alzheimer's disease