Kornimate/medical-research-clean huggingface dataset:
a clinical effectiveness study examining the efficacy and safety of ons-5010 in subjects with neovascular age-related macular degeneration (amd)

Conditions: Age-related Macular Degeneration; Neovascular Age-related Macular Degeneration; Wet Macular Degeneration

Summary: this research study will examine the safety and effectiveness of ons-5010 in participants with amd. the goal is to prevent vision loss by evaluating the effectiveness of ons-5010 as compared with ranibizumab.


Eligibility criteria:
inclusion criteria: * active primary or recurrent subfoveal choroidal neovascularization lesions secondary to age-related macular degeneration (amd) in the study eye * best corrected visual acuity of 20/40 to 20/320 * study eye must: * have active leakage on fluorescein angiogram involving the fovea * have edema involving the fovea * be free of foveal scarring * be free of foveal atrophy exclusion criteria: * previous use of anti-vegf or bevacizumab within 6 weeks * previous subfoveal focal laser photocoagulation in the study eye * laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization * any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year * active intraocular inflammation (grade trace or above) in the study eye * current vitreous haemorrhage in the study eye * polypoidal choroidal vasculopathy (pcv) confirmed by indocyanine green angiography (icga) * history of idiopathic or autoimmune-associated uveitis in either eye * infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmhg despite treatment with anti-glaucoma medication) * premenopausal women not using adequate contraception * current treatment for active systemic infection * known allergy to any component of the study drug or history of allergy to fluorescein or indocyanine green, not amenable to treatment

Keywords: subfoveal choroidal neovascularization
efficacy study regarding the beneficial effects of omega-3 fatty acids on cardiometabolic health

Conditions: Metabolic Syndrome X

Summary: fish oil supplements (which are rich in omega-3 fatty acids) have been shown to provide cardiometabolic benefits to individuals of all ages. specifically, the daily consumption of fish oil supplements has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and whole-body inflammation. however, recent evidence highlights important gaps in our understanding with respect to the impact of fish oil supplements on health; specifically, not everyone responds to these supplements in the same manner. the goal of this research is to explore how an individual's genetic make-up may modify their response to fish oil supplements.

the typical western diet is now recognized to have insufficient amounts of omega-3 fatty acids (in particular epa and dha). these fatty acids have several known health benefits, including improvements in heart health, metabolic syndrome, and inflammation. these benefits occur because omega-3 fatty acids can regulate a myriad of cellular functions. in order to increase the levels of these omega-3 fatty acids in the body, individuals must either consume more marine products or take an omega-3 rich dietary supplement, such as fish oil. while fish oil supplements are commonly consumed by people, it is now recognized that not everyone responds to these supplements in the same manner. therefore this study aims to improve our understanding of why people respond differently to the same dietary supplement. the goals of this research will be accomplished using a number of approaches: 1. the investigators will examine how fish oil supplementation leads to an enrichment of epa and dha in various cells throughout the body (erythrocytes, adipose tissue, etc). 2. the investigators will determine the dynamic changes in epa and dha incorporation into different cell-types during distinct phases of our dietary intervention study (e.g. during supplementation and subsequent wash out periods). 3. the investigators will study how fish oil supplements influence various blood markers of cardiometabolic health (e.g. triglycerides, cholesterol, glucose, c-reactive protein, etc) and whether this is modulated by an individual's genotype.

Eligibility criteria:
inclusion criteria: * between 18-25 years old * male * good general health exclusion criteria: * currently taking a fish oil supplement * currently taking an omega-3 supplement * currently consuming a diet high in omega-3 (high in ala, epa, or dha) * not able to maintain a consistent lifestyle routine throughout the study duration * have an allergy which would prevent them from taking a fish oil pill * schedule conflict with study visits * overweight or obese

Keywords: fish oil epa dha fatty acids genetic variation gene expression
clofarabine/ara-c treatment combined with reduced-intensity conditioning allogeneic stem cell transplantation for acute myeloid leukemia in primary treatment failure

Conditions: AML

Summary: the present trial will establish a prospective sequential allogeneic stem cell transplantation (allo-sct) treatment combining both salvage chemotherapy and reduced intensity conditioning (ric) for primary treatment failure acute myeloid leukemia (aml), to which future innovative strategies can be compared.

primary endpoint: to improve the 2 year overall survival in patients with primary treatment failure \* secondary endpoints: * feasibility of early transplantation within a multicenter trial * leukemia-free survival (lfs) at 2 years from transplantation * leukemia response rate at day +30, +90 and 6 months * cumulative incidence of relapse, death from leukemia, and non-relapse mortality (nrm) * incidence and severity of acute and chronic graft-versus-host disease * feasibility and safety of early discontinuation of immunosuppressive therapy

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of aml in the status of primary induction failure (i.e. persistent leukemia after 2 courses of induction chemotherapy or persisting bone marrow hypoplasia fol-lowing induction chemotherapy +/-minimal residual disease) * age: 18-55 years * availability of an hla identical family donor or unrelated donor with matching in 10/10 alleles (hla-a, b, c, drb1, dqb1) or maximum of 1 allele or antigen mismatch or family donor with maximum 1 allele mismatch. * have adequate renal and hepatic functions as indicated by the following laboratory values: * serum creatinine ≤1.0 mg/dl; if serum creatinine \>1.0 mg/dl, then the estimated glomerular filtration rate (gfr) must be \>60 ml/min/1.73 m² as calculated by the modification of diet in renal disease equation where predicted gfr (ml/min/1.73 m2) = 186 x (serum creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female) * serum bilirubin ≤1.5 mg/dl × upper limit of normal (uln) * aspartate transaminase (ast)/alanine transaminase (alt) ≤2.5 × uln * alkaline phosphatase ≤2.5 × uln exclusion criteria: * documented chloroma * patients having aml m3 * documented leukemic infiltration of cns/cerebrospinal fluid * karnofsky performance score below \< 60% * acute or chronic heart failure * hiv infection, chronic viral hepatitis * severe neurological or psychiatric disorders * any circumstances that preclude the use of the drugs used within the protocol * prior allogeneic or autologous stem cell transplantation * \> 3 courses of prior chemotherapy * denied informed consent * pregnancy or denied of effective contraceptive method

Keywords: aml primary induction failure
registry for patients with erdheim-chester disease and other histiocytoses

Conditions: Erdheim-Chester Disease

Summary: the investigators want to understand more about what kinds of health problems are caused by histiocytosis, what happens as a result of different treatments, and how ecd affects people's lives, their feelings and their attitudes. the investigators also want to learn how these things change over time for people with these conditions. to try to figure this out, doctors would like to collect information about people who have histiocytosis and how they are treated for this disease. some participants will be asked to complete a brief interview over the telephone. only a limited number of interviews will take place, and not everyone will be asked to participate in the interview. it is okay if the participant does not want to participate in the interview portion. if this is the case, the participant should let the study team member know when contacted.


Eligibility criteria:
inclusion criteria: * diagnosis of erdheim-chester disease, langerhans cell histiocytosis, rosai dorfman disease, or another histiocytic neoplasm by either 1) documented histopathologic establishing ecd or hn or 2) documented histopathologic findings compatible with erdheim-chester disease or hn in the context of corroborating clinical and/or radiologic findings or 3) documented radiologic findings, in the absence of a biopsy having been performed or yielding evaluable tissue, that are felt by the principal investigator to unequivocally represent an ecd/hn diagnosis given the clinical context or 4) self reported with supporting documentation upon medical record collection. * proficiency in english, in the determination of the investigator or by self report. * willing to have historical and future hn-related health records sent to registry review. exclusion criteria: * patients unwilling to sign consent. * participants under the age of 18.

Keywords: registry other histiocytoses langerhans cell histiocytosis rosai dorfman disease 17-516
the comparison of a technology-based system and an in-person behavioral weight loss intervention

Conditions: Obesity

Summary: the primary aim of this study is to compare the changes in body weight between a technology-based system, an in-person behavioral weight loss intervention, and a combination of both during a 12 month behavioral weight loss intervention in adults. sedentary, healthy overweight and obese adults will be recruited to participate. assessments will be conducted at 0, 6, and 12 months. this is a randomized trial in which participants will be randomized to one of three groups: standard behavioral weight loss (sbwl), standard behavioral weight loss plus technology (sbwl+tech), and technology alone alone (tech).


Eligibility criteria:
inclusion criteria: * ages of 21-55 years * body mass index (bmi) between 25-39.9 kg/m2 exclusion criteria: * currently pregnant, pregnant in the last 6 months, or plan on becoming pregnant in the next 6 months. * currently participating in regular exercise for over 60 minutes/week. * taking any medications that affect body weight or metabolism (e.g. synthroid). * have any physical limitations that would prevent exercise. * currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer. * have a history of myocardial infarction or other heart-related surgeries. * have a resting systolic blood pressure \> 150 mmhg or diastolic blood pressure of \> 100 mmhg or currently taking any medications that affect blood pressure or heart rate (e.g. beta blockers). * currently enrolled in a commercial weight loss program, participating in another weight loss study, or in a weight loss study in the last 12 months. * have lost \> 5% of current body weight in the past 6 months. * currently being treated for any psychological problems or taking any psychotropic medication. * currently do not have access to a computer and the internet that can be used for this study. this requires a pc computer, the ability to load software for the technology system, an existing internet connection provided by the participant, and a dedicated usb port to allow the armband from the technology system to be connected to the computer for the download of information.
bronchoscopic cryo-immunotherapy of lung cancer

Conditions: Advanced Non-small Cell Lung Cancer

Summary: this is a safety and feasibility study of bronchoscopic cryo-immunotherapy (bci) of peripheral lung tumors in advanced non-small cell lung cancer for the intention of inducing anti-tumor immune responses. the sample size for this study will be 15 patients. pre- and post- bci peripheral blood samples will be analyzed to assess for anti-tumor immune responses. post-bci peripheral blood will be collected 7 and 14 days after the procedure.


Eligibility criteria:
inclusion criteria: * peripheral lung tumor on pre-procedure chest ct scan, which is known or suspected to be advanced, inoperable non-small cell lung cancer (stages iiia/b/c and iva/b) based on the 8th edition tnm staging guidelines * pre-procedure chest ct scan with the presence of a bronchus or airway path leading directly to the peripheral lung tumor (also known as a "bronchus sign") * undergoing bronchoscopy for diagnostic and/or palliative purpose unrelated to this study. * documentation of non-small cell lung cancer either prior to procedure or via on-site pathology review during bronchoscopy (prior to proceeding with planned bci) * ability to provide informed consent * concomitant chemotherapy, immunotherapy, and/or radiation therapy are allowed * ecog performance status less than or equal to 2 exclusion criteria: * pregnancy * currently on a platelet inhibitor (such as clopidogrel) other than aspirin or nsaids, or on a blood thinner (such as heparin, enoxaparin, or a novel oral anticoagulant), which is unable to be held for planned bronchoscopy * inr \>= 1.5 (post correction) * platelets =\< 100,000 (post correction) * bleeding diathesis * contraindication to bronchoscopy * absence of tissue diagnosis of non-small cell lung cancer either prior to procedure or during on-site pathology review at time of bronchoscopy.
revisiting survey investigating why patients are not receiving home anti-convulsant medication prior to surgery/or procedure involving general anesthesia

Conditions: Seizures

Summary: children with seizure disorder face unique challenges during the perioperative period. fasting, sleep-deprivation, and missed doses of medications while patients are required to have nothing per mouth (npo) are a few factors that decrease the seizure threshold. the incidence of seizures in this population is unknown but correlated with patient's underlying condition and missed doses of anti-convulsant. previous work has determined this is not a unique problem. the investigators initially found compliance extremely poor at 60%. the investigators have made improvement to about 80% compliance through various interventions: education of nursing, availability of anticonvulsant intravenous dosing alternatives, and re-wording the hospital npo policy. the investigators feel that a new, more focused, survey will help identify, perioperative reasons for non-compliance on part of the parents. this information will be utilized to guide further interventions aimed at improving compliance.


Eligibility criteria:
inclusion criteria: * we plan to include all children 0-18 years of age on anticonvulsant(s) for seizure disorder. exclusion criteria: * none.
mechanisms of pharyngeal collapse in sleep apnea, study a

Conditions: Obstructive Sleep Apnea; Pathophysiology

Summary: in obstructive sleep apnea, the upper airway recurrently closes during sleep. the mechanisms that lead to airway closure are not completely understood. while the airway of some people narrows and airflow decreases during inspiration due to increasing inspiratory effort, others maintain constant airflow throughout inspiration. airway neuromuscular reflexes may protect against airway narrowing that occurs due to increasing inspiratory effort. to test this hypothesis, the investigators will initially measure airway neuromuscular reflex and inspiratory flow and then attenuate neuromuscular reflex through topical pharyngeal anesthesia to observe the effects on inspiratory flow.

the mechanisms that lead to airway closure are not completely understood. while the airway of some people narrows and airflow decreases during inspiration due to increasing inspiratory effort, others maintain constant airflow throughout inspiration (negative effort dependence, ned). the investigators hypothesize that upper airway neuromuscular reflexes may protect against narrowing that occurs due to increasing inspiratory effort. topical oropharyngeal anesthesia has been shown to reduce neuromuscular reflexes. thus, the investigators also hypothesize that patients with stable inspiratory flow will develop ned once the reflexes have been impaired with topical anesthetic. the investigators plan to: 1. measure upper airway muscle emg to assess how it corresponds to the presence or absence of ned. this aim will allow us to test the hypothesis that robust upper airway muscle reflexes can protect against ned. 2. reduce upper airway muscle activity and reflexes by topical oropharyngeal anesthesia. this will allow us to test the hypothesis that attenuated upper airway muscle activity induced by topical anesthesia can induce ned.

Eligibility criteria:
inclusion criteria: * normal subjects or patients with osa exclusion criteria: * any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems. * any medication known to influence breathing, sleep/arousal or muscle physiology * concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia) * claustrophobia * inability to sleep supine * allergy to lidocaine or oxymetazoline hcl * for women: pregnancy

Keywords: obstructive sleep apnea pathophysiology
transforming nanoparticle dressing for management of chronic venous ulcers

Conditions: Chronic Venous Hypertension With Ulcer

Summary: the present randomized controlled study aims to evaluate the role of transforming nanoparticle dressing n management of chronic venous ulcers.

the present randomized controlled study was conducted at helwan university hospitals, cairo, egypt. the study protocol was approved by the local ethical committee and all patients gave informed consent before enrollment. the study included 60 patients with cvu. patients were diagnosed on the basis of clinical findings and vascular doppler ultrasonography. exclusion criteria were associated infection and associated ulcers of other etiologies. patients randomization was achieved using computer generated numbers and sealed envelope technique. randomization and patients' allocation to the study interventions was performed by an independent researcher who wasn't aware of the study interventions and outcome. upon recruitment, patients were subjected to careful history taking, thorough clinical examination, standard laboratory investigations and vascular ultrasound examination. the recorded parameters included demographic data (age, sex and body mass index), associated morbidities, duration and size of cvu and history of previous interventions. after randomization, patients in the treatment group (n=30) had transforming nanoparticle dressing while the control group (n=30) received conventional compression dressing. before applications of both dressings, the wound area was thoroughly cleaned. in the treatment group, the dressing powder was applied as a thin layer to the ulcer surface. any excess powder surrounding the ulcer area was removed. in both groups, a secondary protective gauze dressing was applied. patients were follow up at weekly intervals until complete healing occurs. the primary end-point in the present study is the time to complete healing. the secondary end-point the rate of healing (percent of reduction in ulcer area).

Eligibility criteria:
inclusion criteria: * chronic venous ulcers. exclusion criteria: - associated infection and associated ulcers of other etiologies.
percutaneous electric neurostimulation of dermatome t7 improves glycemic profile in obese and typo 2 diabetic patients

Conditions: Diabetes Mellitus Type 2 in Obese; Type 2 Diabetes Mellitus With Features of Insulin Resistance

Summary: percutaneous neurostimulation of dermatome t7 increases insulin segregation by the apancreas and improves glycemic profile in diabetic patients


Eligibility criteria:
inclusion criteria: * bmi\>30 kg/m2 * type 2 diabetes mellitus * treatment with metformin exclusion criteria: * under insulin treatment * endocrinological disorders causing diabetes mellitus

Keywords: percutaneous neurostimulation; dermatome t7, type 2 diabetes
role of ketamine in treatment-resistant major depressive disorder and its effect on suicidality

Conditions: Treatment Resistant Depression

Summary: in this study we will assess the effect of ketamine infusion on depressive symptoms and in particular its effect on suicidal behavior, ideation and thoughts in patients with treatment- resistant mdd.

a twice repetition of iv infusion of 0.5 mg/kg of ketamine produces an antidepressant response in individuals with treatment-resistant mdd the work aims to: 1. to assess the onset of action and degree of improvement and the duration of antidepressant effect of ketamine in a sample of patients with treatment -resistant major depressive disorder. 2. to find out whether the onset of ketamine antidepressant effect is associated with an improvement of suicidality in those patients.

Eligibility criteria:
inclusion criteria: 1. patients fulfilling diagnostic criteria of treatment-resistant mdd. 2. presence of suicidal risk. 3. no comorbid medical or neurological conditions. 4. age above 18 years old. 5. both gender. 6. informed written consent from the patient or his legitimate. exclusion criteria: 1. presence of perceptual disturbance. 2. history of sensitivity to ketamine. 3. refusal to participate in the study.