Kornimate/medical-research-clean huggingface dataset:
safety study of topical human fgf-1 for wound healing

Conditions: Diabetic Foot Ulcers

Summary: the purpose of the study is to see if fgf-1 is safe when applied topically to the surface of a wound.

dermal ulcers pose a significant healthcare problem in the united states, ultimately affecting 10-15% of the approximately 20 million patients with diabetes and a similar number of patients with chronic venous insufficiency. dermal leg and foot ulcers can result from compromised arterial inflow, microvascular perfusion or venous outflow which can lead to amputation unless vascular perfusion is improved. fgf-1 for topical administration offers the possibility of improved microvascular perfusion by promoting the formation of new blood vessels in the wound bed resulting in enhanced development of granulation tissue and accelerated healing.

Eligibility criteria:
inclusion criteria: 1. sign an informed consent form prior to the initiation of any study procedures. subjects must be competent to give written informed consent. 2. age must be between 18 to 75 years of age. 3. female subject must be post-menopausal or sterilized, or if she is of childbearing potential, she is not breast feeding, and her serum pregnancy test is negative. 4. subjects must be willing to change their wound dressings daily and demonstrate to study personnel the ability to follow the dressing care instructions indicated in the appendix. subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. in the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. subjects must be competent to give written informed consent. exclusion criteria: 1. subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy. 2. subjects who, at study entry, are taking systemic antibiotics. 3. subjects who are immunosuppressed. 4. subjects experiencing bacterial or viral infection or who may otherwise be febrile. 5. past history or current presence of any type of cancer (except past history of basal cell carcinoma that is not on the limb being treated). subjects with existing bcc will be excluded from the study. 6. life expectancy of less than 1 year. 7. active alcohol or drug abuse within 6 months prior to study entry. 8. screening liver function tests of more than 2.0 times the upper limit of normal. 9. serum creatinine of ≥ 2.5 mg/dl. 10. hemoglobin a1c (hgba1c) of \>10%. 11. exposure to any other investigational drugs or devices or participation in any other investigational studies within 30 days prior to study entry. 12. any other medical, social, or geographical factor that would make it unlikely that the subject will comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or a history of non-compliance).

Keywords: diabetes dermal ulcers
exploratory study of the modulation of the immune system by vegf blockade in patients with glioblastoma multiforme (gbm)

Conditions: Glioblastoma Multiforme

Summary: blood samples will be obtained from newly diagnosed gbm patients treated with combined radiotherapy (rt), temozolomide (tmz) and bevacizumab (bev) at specific time points. the primary outcome is the shift in t reg cell fraction a defined by determining the proportion of cd4 cells that are cd4+ cd25.

glioblastoma multiforme (gbm) is the most frequent malignant brain tumor and it remains a lethal disease. approximately 4 weeks post surgery for tumor resection, patients will proceed to standard of care treatment which currently consists of temozolomide (tmz) with concurrent radiation therapy (rt) for 6 weeks. this study will add bevacizumab (bev) to the standard of care regimen in newly diagnosed patients. the bevacizumab will be added 2 weeks post start of rt/tmz. administration of bevacizumab will continue concurrently with tmz every 2 weeks for 12 months. blood samples will be obtained from these patients at 3 different time points during this study.

Eligibility criteria:
inclusion criteria: * histologically proven gbm * karnofsky status equal to or greater than 60% exclusion criteria: * inadequately controlled hypertension * prior history of hypertension crisis or hypertensive encephalopathy * history of stroke or transient ischemic attach within 12 months

Keywords: gbm grade iv glioma
laser and high intensity tesla magnetic stimulation (hits) for stress urinary incontinence (sui)

Conditions: Stress Urinary Incontinence

Summary: to investigate the efficacy of combined laser and hits treatment for female stress urinary incontinence (sui)

this study is a single-centre, two-arm randomized control trial study conducted according to helsinki declaration. women with symptoms of stress urinary incontinence (sui) (stress or mixed with stress incontinence as the predominant symptom) will be enrolled. the efficacy and safety of combined treatment with non-ablative intravaginal er:yag laser procedure and high intensity tesla magnetic stimulation will be compared to the treatment of non-ablative intravaginal er:yag laser alone.

Eligibility criteria:
inclusion criteria: 1. adult female, 18 years of age or older 2. clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom (sui or mui) exclusion criteria: 1. very severe urinary incontinence (international consultation on incontinence questionnaire-urinary incontinence short form (iciq-ui sf) iciq-ui )score at baseline \>18 or pad test \> 50 gr) 2. pregnancy 3. bmi\>35 4. acute urinary tract infections (utis) 5. history of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body) 6. active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection 7. prolapse grade 2 or higher 8. history of radiotherapy for cervical or uterine cancer 9. medical condition that may interfere with participants' compliance to the protocol 10. medical condition for which the hits and laser therapy are contraindicated 11. previous laser or hits treatment for sui

Keywords: sui incontinence laser high intensity tesla magnetic stimulation
effect evaluation of individual placement and support (ips)

Conditions: Psychosis; Substance Abuse; Depression; Anxiety

Summary: roughly one third of disability pensions issued in norway are classified as mental and behavioral disorders. the proposed study aims to evaluate the effect of an innovative intervention for returning people with moderate to severe mental health disorders to work: individual placement and support (ips).

the current employment schemes offered to this diagnostic group are primarily based on a train-and-place principle with assisted or sheltered employment. building on a place-and-train principle, rather, the ips model of supported employment in real-life competitive work settings has proven largely successful in previous studies, but has never been tested in this group in the norwegian context.

Eligibility criteria:
inclusion criteria: * participants must be undergoing treatment for moderate to severe mental health problems. * participants must have an expressed desire to work. * participants must have sufficient norwegian reading and writing skills. exclusion criteria: * participants are not undergoing treatment for moderate to severe mental health problems. * participants do not have an expressed desire to work. * participants do not have sufficient norwegian reading and writing skills.

Keywords: disability individual placement and support mental health quality of life randomized controlled trial rehabilitation return to work supported employment
a study to compare efficacy, pharmacokinetics, pharmacodynamics and safety of ct-p53 and ocrevus in patients with relapsing-remitting multiple sclerosis

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: this is a double-blind, randomized, active-controlled, parallel group, phase 1/3 study to compare efficacy, pk, pd and overall safety of ct-p53 with ocrevus in patients with relapsing-remitting multiple sclerosis.

ct-p53, containing the active ingredient ocrelizumab, is a humanized monoclonal antibody that is being developed as a proposed biosimilar medicinal product to ocrevus. the purpose of this study is to demonstrate similar efficacy, pk, pd and safety of ct-p53 and ocrevus in patients with relpasing-remitting multiple screlosis.

Eligibility criteria:
inclusion criteria: * patient diagnosed as multiple sclerosis (ms) in accordance with the revised mcdonald criteria. * patient has evidence of recent ms activity as defined in the study protocol * patient has neurological stability for ≥30 days. * patient with 0 to 6.0 (both inclusive) on the edss score. exclusion criteria: * patient diagnosed with primary or secondary progressive ms. * patient diagnosed with ms for more than 15 years duration with an edss score ≤2.0 at screening. * patient unable to complete or has a contraindication to an mri * patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol. * patient who has currently or history of any of medical conditions described in the study protocol. * patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.
fibrinolytic deficit in patients with acute pe

Conditions: Acute Pulmonary Embolism; Fibrinolytic Deficit

Summary: fibrinolysis is the body's process that prevents blood clots. the investigators hypothesize that patients presenting with acute pulmonary embolism (pe) or blood clots in the lungs differ in their fibrinolytic deficit phenotype. the investigators aim to use biomarkers directly involved in endogenous fibrinolytic cascade including pai-1, alpha-2-antiplasmin (a2a), tafi, d-dimer, and fibrinogen to phenotypically characterize patients presenting with acute pe and to correlate these biomarkers with clinical, echocardiographic, computed tomography (ct), and functional status outcomes.

patients (n=100) identified by the pulmonary embolism response team (pert) suffering from a pe will be identified by the pi. blood plasma samples from these patients which have been drawn for routine lab tests will be identified and the sub-i who will pick the samples up from the clinical lab after the routine analysis has been completed. these samples will be de-identified by giving them a study number. these samples will be recentrifuged and aliquoted. samples will be stored in a -80ᵒc freezer in the hemostasis \& thrombosis research laboratory. when all 100 de-identified samples have been collected they will be analyzed blindly by the technical staff of the hemostasis laboratory for the fibrinolytic parameters pai-1, alpha-2-antiplasmin, tafi, tpa, d-dimer, plasminogen, and fibrinogen. pai-1 and tafi will be quantified with an enzyme linked-immuno-sorbent assay (elisa), while a2a is measured using functional assay. pai-1 is measured as ug/ml, while tafi and a2a are measured as % of normal controls. normal controls are derived from pooled normal human plasma from volunteers purchased from outside vendor. results will be compiled and sent to the pert team for analysis and correlation withclinical, echocardiographic, computed tomography (ct), and functional status outcomes.

Eligibility criteria:
inclusion criteria: * patients age 18 - 90 years * patients suffering an acute pe * blood collected for clinical evaluation of pe exclusion criteria: * blood not collected or not sufficient quantity/quality

Keywords: acute pulmonary embolism fibrinolytic system fibrinolysis
a phase ii study of velcade (bortezomib) in combination with bendamustine and rituximab in subjects with relapsed or refractory follicular lymphoma

Conditions: Follicular Lymphoma

Summary: this is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of velcade, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. subjects may be sensitive or refractory to prior therapies, including rituximab.


Eligibility criteria:
inclusion criteria: * male or female subject 18 years of age or older * pathological diagnosis of follicular lymphoma (any grade) * documented relapse or progression following prior antineoplastic therapy * have received 4 or more prior doses of rituximab * at least 1 measurable tumor mass (\>1.5 cm in the long axis and \>1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation * no clinically significant central nervous system lymphoma * karnofsky performance status (kps) ≥50 (equivalent to eastern cooperative group oncology group \[ecog\] status ≤2 exclusion criteria: * diagnosed or treated for a malignancy other than non-hodgkin's lymphoma (nhl) within 2 years of first dose, or who were previously diagnosed with a malignancy other than nhl and have any radiographic or biochemical marker evidence of malignancy. subjects with prostate cancer who were treated with definitive radiotherapy and have a serum prostate-specific antigen (psa) \<1 ng/ml are not excluded. subjects are also not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated. * prior treatment with velcade® or bendamustine * antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before day 1 of cycle 1 * nitrosoureas within 6 weeks before day 1 of cycle 1 * radioimmunoconjugates within 10 weeks before day 1 of cycle 1 * autologous stem cell transplant within 3 months before day 1 of cycle 1, or prior allogeneic stem cell transplant at any time * major surgery within 2 weeks before day 1 of cycle 1 * platelet transfusion within 7 days of day 1 of cycle 1 (applies to subjects enrolled in the dose escalation phase only. this does not apply to subjects enrolled in phase 2 of the study). * ongoing therapy with corticosteroids. prednisone ≤15 mg per day or its equivalent is allowed.
shiga toxin producing escherichia coli (stec) volume expansion

Conditions: Hemolytic-Uremic Syndrome

Summary: this study will provide feasibility data regarding the conduct of a clinical trail evaluating the use of early aggressive inpatient intravenous rehydration in children with shiga toxin producing e. coli infection.

background: shiga toxin-producing escherichia coli (stec) cause a spectrum of disease, ranging from asymptomatic carriage to bloody diarrhea and the hemolytic uremic syndrome (hus). hus is caused by a toxin that destroys red blood cells, consumes platelets and impairs kidney function. hus results in morbidity and even death in otherwise healthy children. over the last 30 years however, there has been extremely limited progress in preventing acute and long-term complications in children with stec infection. however, it is believed that shiga toxins generate clots or blockages in the kidneys that damage it much the way strokes cause brain damage. there is emerging evidence that if children with stec infection are recognized early, then the interval between diarrhea onset and the presence of hus could be exploited to preserve kidney function through the use of intravenous rehydration. study design: the investigators propose to conduct the first randomized clinical trial of volume expansion therapy in children with stec infection. employing alberta's unique province-wide microbiology network and its only two pediatric tertiary care centres, the investigators will conduct a proof of principal feasibility study that evaluates novel technologies to identify stec infected children and those at risk for hus. objectives: the primary outcome will be process: number of children recruited. secondary outcomes will include: 1) resources: retention; refusal; compliance; eligibility criteria; questionnaires; data collection tools; and time requirements; 2) management: capacity and impact on clinical services; 3) scientific: utility of point-of-care stec diagnostics; use of urine biomarkers to identify high risk children, monitoring of kidney injury and response to therapy; and safety. significance: this pilot will provide the necessary data to integrate novel technologies into the design and conduct of a multicentre, multinational, clinical trial that will reduce morbidity and mortality from stec infection.

Eligibility criteria:
inclusion criteria: 1. age \<18.0 years; 2. stec infection \[positive culture or antigen or polymerase chain reaction test for stx/gene\]; 3. day of illness 1-10: children who develop hus will do so by day #14 of illness;8 restricting enrolment to the first 10 days will ensure all participants are at risk of hus. exclusion criteria: 1. evidence of evolving hus: a) hematocrit \<30% or b) platelet count \<150 x 109/l; 2. responsible physician desires patient admission (therefore unable to randomize); 3. unable to contact family within 48 hours of positive stool test; 4. patient with history of atypical hus; 5. chronic disease limiting fluid volumes administered (e.g. impaired cardiac function)

Keywords: shiga-toxigenic escherichia coli child
intravitreous pegaptanib sodium injection in patients with exudative age-related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: to provide pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (cnv) secondary to amd, who are unable to participate in any of the sponsor's other clinical studies with this drug for amd, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.


Eligibility criteria:
inclusion criteria: * best corrected visual acuity in the study eye between 20/40 and 20/320. * subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size \[including blood, scar/atrophy \& neovascularization\] of \< 12 total disc areas, of which at least 50% must be active cnv. * any subretinal hemorrhage must comprise no more than 50% of total lesion size. general criteria: * patients of either gender, aged greater than 50 years. * women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. if of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. the two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication. * written informed consent. exclusion criteria: * any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy. * patients who are eligible for pdt with visudyne * patients who are eligible for any other of the sponsor's ongoing amd studies still open to enrollment.

Keywords: amd age-related macular degeneration exudative subfoveal age related macular degeneration with subfoveal choroidal neovascularization
reduction or discontinuation of tnf-α inhibitor in non-infectious uveitis patients

Conditions: Uveitis; Adalimumab

Summary: tnf-α inhibitors, like adalimumab, have good efficacy in non-infectious uveitis, but long-term use can increase the risk of drugs, and the patient's financial burden is large. the objective of this study was to explore the reduction or withdrawal of adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.

tnf-α inhibitors, like adalimumab, have good efficacy in non-infectious uveitis, but long-term use will increase the risk of drugs, and the patient's financial burden is large. previous studies have reported that tapering or discontinuation of adalimumab may be considered in patients with stable disease. in clinical practice, some important questions about the feasibility of dose reduction in individual patients and the withdrawal plan remain unanswered. the objective of this study was to explore the reduction or withdrawal of adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of non-infectious uveitis * nflammation was controlled for 6 months after drug remission was achieved using adalimumab in combination with immunosuppressant therapy * family members and patients who are willing to stop should agree and accept relevant examinations * the informed consent is read and signed by the patient or a legally authorized represent exclusion criteria: * unwilling to sign informed consent * there is systemic autoimmune disease uncontrolled situation * patients who may require surgery in the near future * vision meets the standards of low vision and blindness * silicone oil or gas filling after vitreous surgery

Keywords: uveitis adalimumab tnf-α inhibitor
everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stents in patients with diabetes mellitus

Conditions: Coronary Artery Disease; Diabetes Mellitus

Summary: prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus.


Eligibility criteria:
clinical inclusion criteria: * age ≥18 years * dm type i or ii based on the definitions of the american diabetes association * angiographically proven cad * angina pectoris, equivalent symptoms, and/or positive stress test, and/or instantaneous flow reserve ≤0.86, and/or fractional flow reserve ≤0.80 * negative pregnancy test in women with childbearing potential angiographic inclusion criteria: * de-novo lesion in at least one native coronary artery * luminal diameter reduction 50-99% assessed by visual estimation * target reference vessel diameter 2.5 - 4.0 mm clinical exclusion criteria: * limited long-term prognosis with a life-expectancy \<12 months * contraindications to antiplatelet therapy * known allergy against cobalt chrome, everolimus, or polylactic acid angiographic exclusion criteria: * target lesion located in the left main trunk * severe calcification of the target lesion as determined by angiography * in-stent restenosis * bifurcation lesion with planned two-stent strategy * chronic total occlusion * indication for cabg