Kornimate/medical-research-clean huggingface dataset:
an open-label study to evaluate the clinical and economic benefits of i-ray in patients with choroidal neovascularization secondary to age-related macular degeneration

Conditions: Age-Related Macular Degeneration; Wet Macular Degeneration; Macular Degeneration; Eye Diseases; Retinal Diseases

Summary: the purpose of this study is to confirm the clinical and economic benefits of iray treatment with respect to the number of anti-vegf injections and frequency of visits during the first year after treatment for patients with wet age-related macular degeneration (amd).

the objective of this study is to confirm the clinical and economic benefits of low voltage external beam radiotherapy with the iray with respect to number of anti-vegf injections and frequency of ophthalmic assessments during the one year interval following treatment in subjects with neovascular amd.

Eligibility criteria:
inclusion criteria: * must have neovascular amd and have received an anti-vegf injections within 1 month prior to entering the study, and have the need for further treatment with anti-vegf therapy. * must have a total lesion size of \<12 disc areas and a cnv lesion with the greatest linear dimension of \<6 mm, but not greater than 3 mm from the center of the fovea to the furthest point on lesion perimeter. * must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form. * must be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study. * must be at least 50 years of age. * women must be post-menopausal ≥1 year or surgically sterilized. * must have best corrected visual acuity of greater than or equal to 24 letters in the study eye and at least 20 letters in the fellow eye (if both eyes meet all the study criteria, then the eye with the worst vision should be selected as the study eye). exclusion criteria: * present with any implanted device, where the device labeling specifically contraindicates subjects undergoing x-rays. * an axial length of \ 26 mm (to exclude subjects with pathologic myopia). * evidence of diabetes or retinal findings consistent with diabetic retinopathy, or retinopathy for any cause. * prior or concurrent therapies in the study eye for age related macular degeneration (other than intravitreal anti-vegf), including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (ttt) and ocular photodynamic therapy.

Keywords: amd wet amd
perifoveal vascular network assessed by oct-angiography in type i diabetes mellitus

Conditions: Retinal Vascular; Retinal Disease; Retinal Ischemia; Retinal Ischaemia Due to Type 1 Diabetes Mellitus; Diabetes Mellitus; Diabetic Retinopathy; Diabetes Mellitus, Type 1; Vessels; Retina, Tortuous

Summary: this study is directed to evaluate the role of optical coherence tomography angiography (oct-a) in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between oct-a-derived parameters and demographic and clinical factors, as metabolic control and duration of the disease.

diabetic retinopathy (dr) is the leading cause of blindness in type 1 diabetes mellitus (dm) patients, as a consequence of impaired blood flow in the retina. optical coherence tomography angiography (oct-a) is a newly developed, non-invasive, retinal imaging technique that allows detection of perfused and non perfused areas of the retina without the injection of dye. this oct-based method permits adequate delineation of the perifoveal vascular network, and allows objective identification of microvascular changes, such as capillary dilation or presence of microaneurisms. it is also capable to detect paramacular areas of capillary non perfusion and/or enlargement of the foveal avascular zone (faz), representing an excellent tool for assessment of diabetic retinopathy. given that all these features are commonly seen in diabetic patients, the relationship of these microvascular changes with systemic factors such as metabolic control or duration of the disease still need to be elucidated. interestingly, further studies are required to investigate whether these changes reflect those occurring elsewhere in the body affected by diabetic microvascular disease, as the kidneys or the brain. if these relationships were demonstrated, early detection of these microvascular changes could lead to modifications in the pharmacological management of diabetic patients, as a way to reduce the risk of future complications in both the eye and other organs. the aim of this study is to evaluate the role of oct-a in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between these oct-a-derived parameters and demographic and clinical factors, as metabolic control and duration of the disease.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * healthy controls exclusion criteria: * ocular pathologies other than diabetic retinopathy (i.e. age-related macular degeneration, retinal vein occlusions, uveitis, glaucoma, etc.) * axial length: \ +3.00 diopters * media opacities * unability to capture oct images

Keywords: retina oct optical coherence tomography optical coherence tomography angiography systemic blood diabetes mellitus diabetic retinopathy
study of epratuzumab versus placebo in subjects with moderate to severe general systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with systemic lupus erythematosus (sle)


Eligibility criteria:
inclusion criteria: * positive antinuclear antibodies (ana) at screening (visit 1) * current clinical diagnosis of systemic lupus erythematosus (sle) by american college of rheumatology (acr) criteria such that at least 4 of the 11 criteria are met * active moderate to severe sle activity as demonstrated by the british isles lupus assessment group index (bilag) * active moderate to severe sle disease as demonstrated by sledai total score. * on stable sle treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials exclusion criteria: * subjects who are breastfeeding, pregnant, or plan to become pregnant * subjects with active, severe sle disease activity which involves the renal system * subjects with active, severe, neuropsychiatric sle, defined as any neuropsychiatric element scoring bilag level a disease. * subjects with the evidence of an immunosuppressive state * subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection * history of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma. * subjects receiving any live vaccination within the 8 weeks prior to screening (visit 1). * subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis b or c * subjects with substance abuse or dependence or other relevant concurrent medical condition * subjects with history of thromboembolic events within 1 year of screening visit. * subjects with significant hematologic abnormalities * subject has received treatment with other anti- b cell antibodies within 12 months prior to screening (visit 1) * subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (nsaids) within 12 weeks prior to screening (visit 1) * subject has previously participated in this study or has previously received epratuzumab treatment.

Keywords: lupus monoclonal antibody b-cell immunotherapy epratuzumab
tardive dyskinesia and cognitive function

Conditions: Tardive Dyskinesia; Neurocognitive Function

Summary: previous researchers indicate that impaired cognitive flexibility was the primary factor distinguishing patients with from those without tardive dyskinesia (td)1, and cognitive dysfunction correlates positively with the severity of td2. longitudinal data raised the possibility that the association between cognitive dysfunction and td may reflect not organic vulnerability to but rather a state marker for this movement disorder as "tardive dementia"3. atypical antipsychotic had been reported to alleviate the severity of td4 and improved neurocognitive function separately5. but no researchers ever investigated the correlation of the two effects simultaneously. this randomized, single-blind and controlled study compared the effect of atypical antipsychotic on td, neurocognitive function and associated factors for these changes.

eighty chronic schizophrenia inpatients who received conventional antipsychotics for more than one year, and met schooler and kane's criteria for persistent td were enrolled in the study. the subjects were randomized to three groups: the olanzapine, amisulpride and fga (first generation antipsychotic) controlled groups. neurocognitive function were assessed using wisconsin card sorting test (wsct) and continuous performance test (cpt) at baseline, 12th week and 24th week. clinical successive ratings were performed with brief psychiatric rating scale (bprs), aims (abnormal involuntary movement rating scale), simpson-angus rating scale (sas), udvalg for kliniske undersogelser side effect ratings (uku) and barnes akathesia scale (bas).to evaluate the influences of prognostic factors on tardive dyskinesia and neurocognitive function and to control for all potential confounding variables, longitudinal analyses on the repeated measures data were conducted using generalized estimating equation models (gee).

Eligibility criteria:
inclusion criteria: * schizophrenia inpatients who received conventional antipsychotics for more than one year, * those who met schooler and kane's criteria for persistent td. exclusion criteria: * mental retardation, * organic mental disorder, * pregnancy and allergy to trial drugs.

Keywords: tardive dyskinesia neurocognitive function
efficacy and safety of pf-00885706 for the relief of symptoms in subjects with gastro-esophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease

Summary: to understand the dose-response characteristics of pf-00885706 for efficacy in terms of symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump inhibitor \[ppi\] treatment), in subjects with gastro-esophageal reflux (gerd) who have inadequate relief with ppis.


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of gerd who fulfill the following criteria: who have symptoms for least six months prior to enrollment; who are currently on daily treatment with a ppi and have been on such treatment for at least 3 months; whose symptoms are persistent, troublesome and that include heartburn and/or regurgitation as their predominant symptoms despite treatment with a ppi; who are seeking relief of persistent symptoms. exclusion criteria: * subjects with erosive esophagitis - an endoscopy within the last 5 years is required to verify absence. * subjects with any esophageal or gastric diseases/conditions that may contribute to their gerd symptoms. * if female; pregnant, lactating or positive serum or urine pregnancy tests.

Keywords: ppi partial responders with non-erosive gerd.
facial lacerations repaired with dermabond compared with dermabond with underlying steristrips in pediatric patients

Conditions: Facial Laceration

Summary: the purpose of the study is to compare cosmetic outcomes of simple facial lacerations in children repaired with dermabond (skin glue) compared with dermabond (skin glue) with underlying steristrips (skin adhesive strips).


Eligibility criteria:
inclusion criteria: * age ≤17 years old * presents with simple, linear facial laceration requiring repair * english or spanish speaking parents or guardians exclusion criteria: * laceration to lips, nose, ear, eyelids, eyebrows * laceration requiring multi-layer closure * laceration requiring sub-specialty care * laceration that has previously been repaired * animal/human bites * lacerations \>5cm in length * allergy to adhesive

Keywords: facial laceration pediatric dermabond skin glue steristrips skin adhesive scar cosmesis
cutaneous microcirculation and nervous sensitivity in psoriasis

Conditions: Psoriasis

Summary: psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the french population. among psoriatic patients, 80% feel pain or cutaneous discomfort related to their pathology. neurogenic inflammation's role in psoriasis has recently been put forward by a study showing that trpv1 ion channels are necessary to establish psoriasiform inflammation in mice. the investigators hypothesize that there is a link between cutaneous sensory neuropathies and altered cutaneous microcirculation during psoriasis. in order to test this hypothesis, local vasodilators will be delivered to patients by iontophoresis and their skin blood flow in response to these molecules will be followed by laser doppler recordings. two recordings will be performed for each patient, both on a psoriasis plaque and on uninvolved skin, in order for the patient to be his own internal control.


Eligibility criteria:
inclusion criteria: * type i psoriasis * psoriasis plaques on the patient's back exclusion criteria: * bmi \> 25 * diabetic patient * arteriovenous disease history * ongoing anti-inflammatory treatment * major cardiovascular history (\<3 months) * hypertension * topical treatment on the back skin (\<7 days) * systemic treatment (steroids, methotrexate, retinoids, cyclosporine) or phototherapy (\<1 month) * pregnant women * subject within exclusion period following a previous or ongoing biomedical study

Keywords: psoriasis microcirculation trpv1
mrgfus in the treatment of hand and hip osteoarthritic pain

Conditions: Osteoarthritis; Hip Osteoarthritis; Hand Osteoarthritis

Summary: this project aims at performing a pilot study to provide data on safety and potential efficacy of magnetic resonance guided focused ultrasound surgery (mrgfus) in the treatment of pain caused by trapeziometacarpal osteoarthritis (oa) and/or scaphotrapezial oa, and by hip oa, while exploring the potential application of mrgfus to two different and central joints burdened by oa.

pain caused by osteoarthritis is a matter of huge impact, in terms of quality of life, social and economic burden. global aging of the population is going to worsen the problem. the hand is the most affected site in the upper limb, and involvement of the trapeziometacarpal joint is highly prevalent, with significant limitation of functionality when it happens. in the lower limb, the hip and the knee share the leading position in the clinical scenario, with the former being historically the most frequently submitted to joint replacement. at any site, the vast majority of joint replacement surgery procedures are performed because of pain. mrgfus has recently demonstrated a great potential in treating pain caused by different medical conditions, including osteoarthritis. the aim of the work is to study the feasibility, the safety and the potential efficacy of mrgfus in treating pain from osteoarthritis in two "hot" spots: the hip and the trapeziometacarpal/scaphotrapezial joint.

Eligibility criteria:
inclusion criteria: * male and female aged between 45 and 90 years * presence of activity-related joint pain * patients who have either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes * patients who have not responded to previous treatments, * patients with a baseline pain intensity of 4 to 8 on a 10-cm vas * patients who are not candidates for immediate surgery * signed statement of informed consent (approved by ethics committee) exclusion criteria: * prior surgery or previous local treatment (infiltration, other) in the past 3 months * changes in medications used during the previous 2 months * intravenous drug use * corticosteroid use of more than 3 months within the preceding year * diagnosis of other rheumatologic disorders * trauma, fracture, or osteomyelitis of the investigated joints within the preceding year * any neurological disease or disorders potentially affecting pain perception * fibromyalgia * pregnancy * patients with large scar at skin or deeper soft tissue potentially included in the planned path of the ultrasound beam * general contraindications to mri and/or to anaesthesiological procedures planned for the patient * presence of internal hardware or devices potentially affecting mr thermometry

Keywords: mrgfus pain hip trapeziometacarpal joint osteoarthritis
study of the corelation between circulating nuclearsome and sirs happened after congential cardiac surgery

Conditions: Congential Cardiac Surgery

Summary: in this study，the investigators want to determine the corelation between circulating nuclearsome and the development of sirs occured after congenital cardiac surgery, including the serverity of organ damage and inflamation.

blood was collected from study participants at 6 time points; 1) post-anesthesia induction, 2) post-op hour 0, 3) post-op hour 4, 4) post-op hour 24, 5) post-op hour 48, and 6) post-op hour 72. at each of the 6 time points blood was analyzed for levels of the following:histone,blood routine test , c-reaction protein, procalcitonin, n-terminal pro-brain natriuretic,the hepatorenal function，cardiac function and pulmonary function

Eligibility criteria:
inclusion criteria: * children with congenial heart disease exclusion criteria: * less than 2.5kg * prematurity less than 37 weeks estimated gestational age * renal failure as described by the pediatric rifle criteria

Keywords: congential cardiac surgery nuclearsome systemic inflammation response syndrome
physiotherapy program for breast cancer women following surgery: a pilot clinical trial

Conditions: Breast Cancer

Summary: pilot study on physical therapy in women with breast cancer immediately following surgery

a pilot, single-arm non-randomized clinical trial was conducted between the period september 2018 and june 2019 on a convenient sample of bc women. primary study outcomes were pain, disabilities of the arm, shoulder, and hand (dash), handgrip strength, and quality of life (qol). the secondary outcome was to assess the feasibility of this pilot study. all outcomes were recorded at three time- intervals (t0=day 1 post-operation), (t1=day 30), and (t1=day 90) under standardized conditions. the interventions were delivered by the physiotherapist early within 24 hours post-operatively, t1, and t2. in addition, home-based exercise was provided with written instructions during hospitalization with rehearsal sessions to ensure the patient's understanding and compliance

Eligibility criteria:
inclusion criteria: * women with breast cancer who require surgical resection exclusion criteria: * in ability to undergo 3 months of physical therapy program
incidence and prognostic value of delirium in patients with acute coronary syndrome: an observational study

Conditions: Delirium; Acute Coronary Syndrome

Summary: to evaluate the incidence of delirium in patients with acute coronary syndrome and its correlation with adverse events


Eligibility criteria:
inclusion criteria: * acute coronary syndrome patients undergone coronary revascularization or referred to conservative strategy * age ≥ 70 years * diagnosis of delirium by the confusion assessment method in the icu (cam-icu) scale exclusion criteria: * none
single ascending dose safety study of bms-962476 in healthy subjects and patients with elevated cholesterol on statins

Conditions: Atherosclerosis

Summary: to obtain safety and tolerability information in healthy subjects is administered as a single dose

* study classification: pharmacokinetics and pharmacodynamics * intervention model: single ascending dose (sad) study * allocation: randomized non-stratified

Eligibility criteria:
inclusion criteria: * healthy population * untreated low density lipoprotein cholesterol (ldl-c) ≥ 130 and ≤ 190 mg/dl and triglycerides ≤ 200 mg/dl * body mass index (bmi) of 18 to 35 kg/m2 inclusive * men and women, ages 18 to 65 years, inclusive * statin population * patients with hypercholesterolemia on stable statin therapy for 6 weeks prior to enrollment * at enrollment, ldl-c ≥ 100mg/dl and triglycerides ≤ 200 mg/dl * patients with controlled hypertension on a stable dose of no more than two antihypertensive drugs * bmi of 18 to 37 kg/m2 inclusive * men and women, ages 18 to 75 years inclusive exclusion criteria: * healthy population * subjects with fasting ldl-c \ 190 mg/dl, or fasting triglycerides \> 200 mg/dl * subjects at increased 10-year cardiovascular risk of ≥ 20% based on framingham risk score * subjects with any significant acute or chronic medical illness at the time of screening, including history of cancer, known history of sickle cell disease or trait, and known history of thalassemia * statin population * patients with fasting ldl-c \ 200 mg/dl on statin therapy * patients on prescription or over the counter lipid-lowering therapy other than statin therapy * patients with established atherosclerotic vascular disease * patients with diabetes who are requiring oral or injectable anti-diabetic drug therapy * patients with uncontrolled hypertension or controlled hypertension requiring more than two antihypertensive drugs * patients with any significant acute or chronic medical illness that is severe, progressive or uncontrolled at the time of screening * use of any lipid lowering medication including over the counter products (eg, niacin \> 500 mg; omega-3 fatty acids \> 1000 mg; red rice yeast; phytosterols or stanol esters) for lipid lowering within 30 days prior to screening visit (42 days for fibrates) with the exception of stable statin therapy in the target disease population * prior treatment with any monoclonal antibody or investigational protein biologic within the preceding one year before study drug administration * concurrent or use within 3 months of study drug administration of marketed or investigational systemic or inhaled corticosteroids or other immunosuppressant drugs, and within 6 weeks for topical corticosteroids