Kornimate/medical-research-clean huggingface dataset:
panretinal photocoagulation for diabetic retinopathy with pascal laser

Conditions: Diabetic Retinopathy

Summary: this study will investigate the clinical efficacy and safety of the pascal laser (pattern scan laser) for diabetic retinopathy. patients with proliferative or severe nonproliferative retinopathy will be treated with panretinal photocoagulation utilizing different treatment strategies. the investigators believe that using "lower" laser parameters, the clinical response may be equivalent with less adverse effects.


Eligibility criteria:
inclusion criteria: * proliferative or severe nonproliferative diabetic retinopathy (type 1 or type 2) * best corrected visual acuity of 20/50 or better * capability to read and follow instructions * capability to sign the consignment term exclusion criteria: * best corrected visual acuity worse than 20/50 * significant macular edema responsible for visual acuity lower than 20/50 * media opacities (includes vitreous hemorrhage in the visual axis, but not a reabsorbing inferior vitreous hemorrhage) * previous laser treatment (prp, focal or macular grid) * glaucoma (confirmed or suspicious) * other diseases of the retina and optic nerve * previous ocular surgery in the last 6 months * impossibility to obtain good quality images of retinography, angiography or oct

Keywords: diabetic retinopathy photocoagulation pascal laser
neoadjuvant study of pyrotinib in her-2 positive breast cancer

Conditions: Breast Cancer Female

Summary: this is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.


Eligibility criteria:
inclusion criteria: * female, aged ≥18 and ≤70 years * histologically confirmed invasive her2 positive breast cancer, early disease(stage ⅱa-ⅲ) * subjects with at least one evaluable lesion * ecog 0-1 * adequate organ function exclusion criteria: * metastatic disease (stage iv) * subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption * treated or treating with t-dm1, lapatinib and neratinib before study entry * history of immunodeficiency, including hiv-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation * subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) any heart diseases judged by investigator as unsuitable to participate in the trial * female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test. female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period * evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study

Keywords: neoadjuvant pyrotinib trastuzumab paclitaxel cisplatin
gut hormone, nociceptors, neurotrophic factors expression in functional dyspepsia

Conditions: Functional Dyspepsia; H. Pylori Infection

Summary: the pathophysiology of functional dyspepsia is still unclear but several peptides have been indicated in the etiological factors in fd. ghrelin and leptin are involved in regulation of appetite and gut motility and serotonin is a typical neurotransmitter related with sensory and motor functions of gut. on the other hand, transient receptor potential vanilloid receptor 1 (trpv1) has been proposed to be involved with functional gastrointestinal disorder, and expression of this receptor could be regulated by nerve growth factor (ngf) or glial cell-line derived neurotrophic factor (gdnf). the investigators aimed to determine whether expressions of ghrelin,leptin, serotonin,trpv1,gdnf and ngf in blood or gastric mucosa of fd patients are different from those in healthy controls, and whether some changes of their expression correlate with certain dyspeptic symptoms. the investigators also investigated the effect of h. pylori infection by comparing their expressions before and one year after h. pylori eradication.


Eligibility criteria:
inclusion criteria: * subjects who completed upper gi endoscopy and questionnaire about gastrointestinal symptoms exclusion criteria: * daily user of nsaid or anticoagulants * with concomitant systemic diseases such as diabetes mellitus or any malignancy * participants with major depression, psychosis, eating disorder * participants with typical reflux symptom * patients with benign gastric ulcer or duodenal ulcer * patients with past gastrointestinal surgery
iris tissue in primary congenital glaucoma

Conditions: Primary Congenital Glaucoma

Summary: to present the histopathological features of the iris tissue in primary congenital glaucoma which may play a role in pathogenesis

primary congenital glaucoma etiology still remains obscure . originally barkan , and later worst , proposed that a membrane covered the anterior chamber angle and blocked aqueous outflow , but the presence of that membrane has not been established histopathologically to date . now most authors believe that the site of obstruction is the trabecular meshwork rather than an overlying membrane . maldevelopment of the anterior segment is present in all forms of congenital glaucoma . this maldevelopment may involve the trabecular meshwork alone or the trabecular meshwork in combination with the iris or cornea or both. in approcimately 50% of patients , isolated trabeculodysgensis is the only developmental ocular anomaly found .this is the classic defect found in primary congenital glaucoma .these eyes have no developmental anomalies of iris or cornea present except abnormal insertion of the iris into the angle

Eligibility criteria:
inclusion criteria: 1. typical symptoms of epiphora , photophobia and blepharospasm 2. corneal diameter \> 13 mm 3. increased ocular tension \> 25 mmhg uga using schiotz tonometer exclusion criteria: 1. infants with history of previous surgery 2. secondary glaucoma 3. glaucoma associated with other congenital anomalies
psychostimulant abuse - novel treatment approaches - 1

Conditions: Cocaine-Related Disorders

Summary: to determine if acute assessments of profasi and factrel affect plasma cocaine levels and cocaine-induced behavioral changes in men.


Eligibility criteria:
please contact site for information.

Keywords: cocaine dependence
joint awareness after total knee replacement

Conditions: Knee Osteoarthritis; Arthroplasty Complications

Summary: total knee replacement (tkr) is accepted as treatment of choice for end stage gonarthrosis. it is performed cemented or cementless and although cemented implants were shown to decrease bone density more than cementless fixations there is no evidence-based difference between them in the literature. as far as the investigators are concerned, the effect of cementation on patients' joint perception has never been studied so far.

in this longitudinal case-control study, joint awareness in prosthetic reconstruction was evaluated in 150 knees (75 cemented tkr, 75 cementless tkr) of 136 patients. they were operated between 2015 and 2017 in our institution with minimum 5 years of follow up. all the patients in each group were operated by two senior surgeons that were experienced for more than 10 years in arthroplasty. to reduce selection bias, logistic regression was used to develop propensity-matched pairs based on gender, age, body mass index (bmi), preoperative coronal plane deformity, preoperative range of motion (rom) and appropriateness for tka indication. demographic and clinical data including sex, age and time since surgery were collected. the subjects' joint perception and the womac clinical scores were recorded and compared. joint awareness is assessed with forgotten joint score (fjs) which has 12 questions and with patient's joint perception questionnaire (pjp) which is a single question with 5 possible answers, rating from the highest expected result "like a native or natural joint" to the worse possible case "a non-functional joint". other than clinical scores, laboratory parameters, blood transfusion needs, tourniquet time, complications (septic/aseptic loosening, periprosthetic fracture, instability) and revision rates were also compared.

Eligibility criteria:
inclusion criteria: * primary knee osteoarthritis * "appropriate'' tka indication according to modified escobar system exclusion criteria: * secondary osteoarthritis * previous surgery to the knee * valgus knee * uncontrolled diabetes

Keywords: joint awareness total knee replacement cementless forgotten joint score patient's joint perception
efficacy and safety of cnv2197944 versus placebo in patients with diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: to investigate the effect of repeat oral dosing of cnv2197944 75 mg tid on the pain experienced in diabetic peripheral neuropathy (dpn) as measured by changes in pi-nrs after three weeks of treatment compared to the baseline period.

a 3 week randomised crossover study to investigate the effect of repeat oral dosing of cnv2197944 75 mg tid versus placebo for on the pain experienced in diabetic peripheral neuropathy (dpn). each 3 week treatment period is seperated by a 2 week washout period. the primary outcome measure is the change from baseline in the pi-nrs after three weeks of treatment. secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the neuropathic pain symptom inventory.

Eligibility criteria:
inclusion criteria: * male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent * diabetes mellitus (type i or ii)with hba1c \<9% * evidence of symmetrical bilateral pain in lower limbs with evidence of decreased sensation or impaired reflexes and a michigan neuropathy screening -instrument score of \>3 on physical examination * patients with diabetic peripheral neuropathy (dpn) with pain at screening present for more than 6 months. the maximum duration of dpn will be no longer than 5 years exclusion criteria: * patients having other severe pain, which may impair the self-assessment of the pain due to dpn * patients who have received nerve blocks for neuropathic pain within 4 weeks -patients on other concomitant medications used to relieve the pain of dpn * patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin
response prediction for anti-angiogenic treatment in recurrent glioblastoma

Conditions: Adult Glioblastoma; Magnetic Resonance Imaging; Bevacizimab

Summary: this study aims to evaluate whether pre-treatment mri can be used to predict treatment response for anti-angiogenic treatment in glioblastomas.

although overall the effects on prolonging survival in bevacizumab-treated patients is modest at best, it is still unclear whether there is not a more substantial positive effect in a subset of patients, potentially identifiable by imaging markers. allowing for prediction of good or bad responder from anti-angiogenic therapy prior to treatment completion is important to select patients most likely to benefit from anti-angiogenic treatment. this is a prospective observational study and no active comparator will be used. study participants include adult patients with recurrent glioblastoma. we hypothesized that quantifying changes in multi-modal advanced mr imaging techniques would allow early treatment response and long-term prediction in glioblastomas.

Eligibility criteria:
inclusion criteria: 1. patients had histologically confirmed glioblastoma with progression diagnosed on the basis of clinical data and mri after standard treatment of operation, concurrent chemoradiotherapy, and adjuvant temozolomide; 2. patients were more than 3 months from chemoradiotherapy to avoid the confounding factor of radiation necrosis (pseudoprogression); 3. ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and health insurance portability and accountability act (hipaa) authorization in accordance with institutional guidelines exclusion criteria: 1. patients were not subject to therapies other than anti-angiogenic treatment, including re-operation, re-irradiation, or immunotherapies, because of the patient's clinical status and indication 2. patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction

Keywords: recurrent glioblastoma; bevacizumab; imaging
encapsulated cell biodelivery of nerve growth factor to alzheimer´s disease patients

Conditions: Alzheimer's Disease

Summary: cholinergic neurons in the basal forebrain project widely to the cerebral cortex and hippocampus. these neurons depend on nerve growth factor (ngf) from their target areas for survival. impaired ngf supply is part of the alzheimer's disease (ad) pathology, and the degeneration of these neurons correlates with the cognitive decline in these patients. the objective of encapsulated cell biodelivery (ecb) is to maintain normal levels of ngf to support cholinergic function. nsgene's ngf secreting ecb device (nsg0202) combines the potential benefits of targeted gene therapy with the safety of a retrievable implantable device. the study is an open label, single centre, 12-month, dose-escalation phase ib study in patients with mild to moderate ad. the primary objective is safety and tolerability, while secondary outcomes measure include cognition, behaviour, neuropsychology, activities of daily living (adl), positron emission tomography (pet) imaging and electroencephalography (eeg).


Eligibility criteria:
inclusion criteria: 1. age 50-80 years 2. all patients must fulfil the nindnds-ardra criteria of alzheimer's disease. 3. the subject must have a score between 15-24 inclusive, on the mini-mental state examination (mmse). 4. the subject must have a caregiver who is able and committed to assist the subject to comply with the trial protocol, and who is willing to provide the information required at assessment interviews. 5. informed consent must be obtained from the subject together with a close caregiver, in accordance with the requirements of the ethical committee. exclusion criteria: 1. a diagnosis of schizophrenia, schizo-affective disorder or paranoid disorder according to dsm iv without any suspicion cognitive decline. 2. patients with the following co-existing medical conditions: 3. history of seizures. 4. brain tumor including meningeoma. 5. clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances. 6. clinically significant back pain. 7. bleeding disorders. 8. patients who, in the opinion of the investigator, are otherwise unsuitable for a trial of this type.
influence of sevoflurane and propofol on maximum muscular strength, speed of contraction and relaxation

Conditions: Anesthesia, General; Neuromuscular Transmission Disorders

Summary: many drugs have an influence on neuromuscular transmission. in clinical practice, neuromuscular blocking agents are commonly used, but even in the absence of neuromuscular blocking agents, anesthetic drugs can influence neuromuscular transmission. especially volatile anesthetic agents have a clinical impact on neuromuscular transmission, they have been shown to prolong and deepen the effect of neuromuscular blocking agents. but even in the absence of neuromuscular blocking agents, volatile anesthetics can impair neuromuscular transmission. one mechanism of action is the desensitization of the acetylcholine receptors by shifting them from a normal to a desensitized state. this effect can weaken neuromuscular transmission by reducing the margin of safety that normally exists at the neuromuscular junction, or can cause an apparent increase in the capacity of neuromuscular blocking agents to block transmission. in this study, the influence of sevoflurane and propofol on the maximum force, maximum speed of contraction and relaxation will be measured at the adductor pollicis in patients having general anesthesia without the use of neuromuscular blocking agents. maximum force and speed of contraction and relaxation will be measured before and after anesthesia by either sevoflurane or propofol. primary outcome is the influence of either anesthetic agent on maximum muscular force and speed of contraction - relaxation, and if this influence is greater for volatile anesthetic agents than for intravenous anesthetic agents.


Eligibility criteria:
inclusion criteria * patients (male or female) from 18 - 80 years * scheduled for surgery without the use of neuromuscular blocking agents * health care insurance in belgium * written informed consent exclusion criteria: * any pathology involving neuromuscular transmission * confirmed neuropathy of any origin * expected anesthesia duration \< 30 min * renal insufficiency defined as a glomerular filtration rate \< 40 ml/min/m2 * hepatic insufficiency defined as an increase \> 1.5 \* normal value of hepatic enzymes * confirmed or suspected pregnancy * language barrier * any patient which will receive unplanned neuromuscular blocking agents during surgery * any history of personal or familial suspected malignant hyperthermia
testing the effectiveness of telephone-based early childhood developmental screening

Conditions: Child Development; Developmental Disabilities; Ambulatory Care; Screening

Summary: the purpose of this research study is to test the effectiveness of telephone-based early childhood developmental screening and care coordination, compared to usual care in a primary care pediatrics clinic. investigators randomized 152 participants to one of two study arms, with the intervention families receiving developmental screening over the phone, and control families receiving usual care with their pediatricians.

although the american academy of pediatrics (aap) recommends universal early childhood developmental screening as part of routine well-child care, there have been many studies documenting that many pediatricians do not follow the aap guidelines. one intervention that has the potential to improve care, especially for low-income families, is centralized, telephone-based developmental screening, and care coordination for families whose children have developmental or behavioral concerns. 2-1-1 los angeles developed such an intervention and this study aims to test its effectiveness, in partnership with a local community clinic, using a randomized, controlled study design. investigators partnered with the clinica oscar a romero, a federally-qualified health center in los angeles, serving predominantly low-income latino families. investigators hope to enroll up to 300 families in the study. eligible families will have children ages 12 to 42 months of age who receive well-child care at the clinic. as investigators obtain informed consent and enroll families, they will randomize study participants into intervention and control groups. intervention group families will be transferred to 211 los angeles to complete developmental screening over the phone, while control group families will go to their pediatricians for well-child care as usual.

Eligibility criteria:
inclusion criteria: * child receives well-child care at the clinic * child is not already receiving intervention services for a developmental disability * parent speaks spanish or english well enough to be interviewed exclusion criteria: * child is younger than 12 months or older than 42 months at time of enrollment * child is already receiving intervention services for a developmental disability * parent is unable to speak spanish or english well enough to be interviewed
oral-only antibiotics for bone and joint infections in children

Conditions: Osteomyelitis; Septic Arthritis; Bone Infection; Joint Infection; Bone and Joint Infection

Summary: a nationwide, multicenter, randomized, non-inferiority trial of children with bone and joint infections. the primary objective is to determine if oral-only antibiotics (experimental arm) is non-inferior to initial intravenous antibiotics followed by oral therapy (control arm). children will be randomized 1:1. the total treatment duration is identical in both groups. the study is open label with blinding of the primary endpoint assessor.


Eligibility criteria:
inclusion criteria: * children aged 3 months to 18 years with antibiotic treatment of uncomplicated bone or joint infection. exclusion criteria: 1. severe disease, e.g. septic shock, or any concomitant infection, e.g. necrotizing fasciitis, requiring iv antibiotics in the opinion of the treating clinician. 2. complicated bone or joint infection, e.g. prosthetic material, infection secondary to or complicated by trauma, severe pyomyositis or other substantial soft tissue infections. 3. expected need of major surgery within the first 24 hours of treatment, e.g. drilling, debridement, fenestration, surgical drainage, synovectomy. minor surgery as diagnostic surgical bone biopsy or diagnostic joint fluid aspiration including lavage is not a criterion for exclusion. 4. significant co-morbidities that might influence the choice of treatment or the course of the infection, e.g. immunodeficiency, immunosuppressive therapy, sickle cell anemia. 5. previous bone or joint infection. 6. antibiotic therapy for more than 24 hours before inclusion. 7. documented pathogen with limited treatment options that do not permit randomization, e.g. the pathogen is only sensitive to intravenous antibiotics. 8. prior enrolment in the trial
reverse-loop upper arm arteriovenous graft

Conditions: Blood Vessel Prosthesis

Summary: background: a conventional configured prosthetic arteriovenous graft (avg) usually wastes most upper arm vessels that a reverse-loop design may conserve. this study examined the feasibility of the avg construction and its outcome. methods: retrospective review of clinical outcomes of reverse-loop upper arm avg patients. measures included hemodialysis function, duplex scan, procedural complications, and follow-up interventions


Eligibility criteria:
inclusion criteria: * compromized forearm and elbow options exclusion criteria: * unstable