Kornimate/medical-research-clean huggingface dataset:
a phase 3b, single-arm study of aflibercept 8 mg dosed every 4 weeks in adult participants with neovascular age-related macular degeneration (namd) or diabetic macular edema (dme)

Conditions: Neovascular Age-Related Macular Degeneration; Diabetic Macular Edema

Summary: this study is researching aflibercept high dose (hd), referred to as "study drug", with an experimental dosing regimen. the study is focused on participants with namd and dme that have been previously treated with anti-vascular endothelial growth factor (anti-vegf) medications. the aim of the study is to see how safe and effective aflibercept hd injections are when given as frequently as every 4 weeks. the study is also looking at what side effects may happen from taking the study drug.


Eligibility criteria:
key inclusion criteria for participants with namd: 1. ≥50 years of age 2. history of choroidal neovascularization (cnv) lesions secondary to namd in the eye study, requiring continued anti-vegf treatment, as determined by the investigator. key inclusion criteria for participants with dme: 3. ≥18 years of age 4. history of dme with central involvement (in the central subfield on spectral domain optical coherence tomography \[sd-oct\]) in the study eye, requiring continued anti-vegf treatment, as determined by the investigator key inclusion for all participants: 5. previously treated with ≥3 anti-vegf ivt injections in the study eye in the 5 months (\~150 days) prior to visit 1 key exclusion criteria for participants with namd: 1. evidence of cnv due to any cause other than namd in either eye key exclusion criteria for participants with dme: 2. evidence of macular edema due to any other cause other than diabetes mellitus in the study eye 3. active proliferative diabetic retinopathy (dr) in the study eye note: other protocol defined inclusion / exclusion criteria apply.
pain and smoking study - interactive voice response

Conditions: Smoking; Pain; Smoking Cessation

Summary: pass2 aims to expand upon the recently completed study (pass intervention), which tested the telephone delivery of a cognitive behavioral intervention (cbi). this study will use interactive voice response (ivr) to optimize the intervention's effectiveness for smoking cessation among veteran smokers with chronic pain.

veterans with chronic pain represent an important population in which to focus smoking cessation efforts. smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (\>50%) with chronic pain continue to smoke. this study aims to: 1. determine whether the existing integrated pain and smoking cessation (pass intervention) augmented with ivr (pass-ivr) is superior to treatment as usual (e.g., referral to standard va smoking cessation clinic) enhanced with pharmacotherapy tele-consult (e-tau) at 6 (primary endpoint) and 12 months on cigarette abstinence rates among non-depressed veterans with chronic pain. 2. determine whether pass-ivr is superior to e-tau at 6 (primary endpoint) and 12 months on pain interference. 3. examine critical components of the intervention process to inform future program implementation.

Eligibility criteria:
inclusion criteria: * being an enrolled veteran at vachs; * current tobacco use; * willingness to make a quit attempt; * significant chronic pain defined as \>/=4 on the pain intensity portion of the brief pain inventory (bpi) for more than 90 days. exclusion criteria: * active diagnosis of dementia or psychosis in medical record; * severely impaired hearing or speech; * lack of telephone access; * enrollment in concurrent research study that might affect main outcomes of this study; * terminal illness; * non-english speaking; * pregnancy; * provider advising against exercise; * planned surgeries; and * clinically significant depressive symptoms (\>10 phq-9).
improving adolescent-dentist interaction through digital technology

Conditions: Dental Anxiety

Summary: the aim of the present study is to assess the impact of a digital tool on the interaction between the dentist and the adolescent patient, concerning the level of dental anxiety and communication. to achieve this purpose, a randomized controlled clinical trial will be performed using a short version of e-said (survey of anxiety and information for dentists) in portuguese (fale). that is, the intervention to be tested is an application usage, which will contain a questionnaire with questions supposedly made by the dentist, about feelings regarding the dental appointment and preferences for coping with dental treatment. thus, the use of this digital tool aims to facilitate communication, favoring the adolescent-dentist relationship, and establishing empathy.

the target population consists of patients between 10 and 19 years old, attending the adolescent clinic in the dental school of the federal university of pernambuco (ufpe), campus of recife. the sample will consist of 184 adolescents, 92 in each group (intervention and control). randomization will be stratified according to sex, age and presence or absence of dental anxiety. in the waiting room, before the dental appointment, the adolescents in the intervention group (ig) will use the fale application to answer the questionnaire and assess the level of anxiety. those in the control group (cg) will only record their level of anxiety. the undergraduates responsible for attending the ig participants will receive, prior to dental care, a report of the answers given by the adolescents through the application. during the dental consultation, a psychologist, who will be observing the care, will evaluate the adolescents behavior, considering cooperation. after the appointment, the adolescent will evaluate how much he/she felt benefited by the use of the app; how he evaluates the communication between him/her and the dentist; if he/she thinks that the app contributed with this communication; his/her satisfaction with dental treatment; and his/her satisfaction with the undergraduate attendance. the undergraduate will also evaluate his/her level of satisfaction with the application's use; how he/she evaluates the communication between him/her and the adolescent patient; how much the application has helped with this communication; and the degree of patient's cooperation during the dental consultation. descriptive and inferential statistical analysis will be performed using appropriate tests through the statistical package for social sciences software version 21 and significance level of 5%.

Eligibility criteria:
inclusion criteria: * brazilian adolescents literate in portuguese * brazilian adolescents able to use smartphone exclusion criteria: * adolescents with intellectual, sensory or physical disabilities * adolescents not capable to read and write/type

Keywords: technology assessment, health dental anxiety adolescent clinical trial
usi and/or do in women with cystocele before and after cystocele repair

Conditions: Urodynamic Stress Incontinence; Detrusor Overactivity

Summary: the changes of lower urinary tract function after cystocele repair are important for perioperative consultation and management. thus, the aim of this retrospective study was to evaluate the prevalence of urodynamic stress incontinence and/or detrusor overactivity in women with ≥ stage ii cystocele and the changes of incontinence function after cystocele repair.

between november 2010 and october 2020, all women with ≥ stage ii cystocele who visited the urogynecological department of a medical center for cystocele repair were reviewed. those women who had complete data of preoperative and postoperative 3-month follow-up urodynamic data were excluded from this study. urodynamic stress incontinence was diagnosed by the finding of involuntary leakage during filling cystometry or stress urethral pressure profile, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction. detrusor overactivity was defined as the occurrence of involuntary detrusor contractions during filling cytometry. stata software was used for statistical analysis. chi2 test, univariate and multivariable logistic regression tests were used for statistical analysis as appropriate. a p \< 0.05 was considered as statistically significant.

Eligibility criteria:
inclusion criteria: * women with ≥ stage ii cystocele * received cystocele repair * complete urodynamic study before and after surgery exclusion criteria: * incomplete data * chronic infection * recurrent surgery for cystocele

Keywords: urodynamic stress incontinence detrusor overactivity cystocele
effect of sar153191 (regn88) with methotrexate in patients with active rheumatoid arthritis who failed tnf-α blockers

Conditions: Rheumatoid Arthritis

Summary: primary objective: - to demonstrate that sarilumab (sar153191/regn88) on top of methotrexate (mtx) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (ra), in participants with active ra who had failed up to 2 tumor necrosis factor-alpha (tnf-α) antagonists. secondary objectives: * to assess the safety of sarilumab; * to document the pharmacokinetic profile of sarilumab.

the duration of the study period for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period. participants who completed the 12-week treatment period were offered enrollment in a separate long-term extension study (lts11210/nct01146652).

Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis ≥6 months duration and american college of rheumatology (acr) class i-iii functional status at screening and baseline visits; * active disease defined as: * at least 6 of 68 tender joints and 6 of 66 swollen joints at screening and baseline visits, and * hs-c-reactive protein (hs-crp) \>10 g/l or erythrocyte sedimentation rate (esr) \>28 mm/hr at screening visit; * continuous treatment with methotrexate for at least 12 weeks and on stable dose (minimum 10 mg/week) for at least 6 weeks prior to the screening visit; * participant considered as primary tnf-α blocker nonresponder. i.e.: * appropriate for previous tnf-α blocker therapy * lack of adequate clinical response after at least 3 months tnf-α blocker therapy with mtx or other synthetic disease modifying anti-rheumatic drug (dmard) co-therapy. exclusion criteria: * age \ 75 years; * pregnant or breastfeeding woman or woman of childbearing potential, unwilling to utilize adequate contraception or not to become pregnant during the entire study; * fever (\>38°c), or chronic, persistent, or recurring infection(s); * history of demyelinating disease; * current underlying hepatobiliary disease. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
yes study - newly diagnosed/metastatic intervention

Conditions: Breast Cancer; Symptom, Behavioral

Summary: this research study is being done to monitor common symptoms and behavior, and to provide supportive care information and peer support, as well as research opportunities for young women ages of 18-39 years old who have been diagnosed with stage 0-iv stage breast cancer using a web-based portal (yes), built for smartphones, tablets, and computers.

this is a prospective, interventional cohort study with an embedded phase ii randomized controlled clinical trial with a parallel design. * the research study procedures include screening for eligibility, consent, enrolled, randomization into 1 of 4 groups. * the study interventions including the (web-based portal ) yes portal use including regular assessments, serial outcome surveys, medical record review, and tumor/blood collection. * the yes portal is a web-based portal designed for access by smartphone, tablet, or laptop/desktop. the portal is designed to help monitor cancer related issues and to share self-management information and resources to those interested in particular issues or who score high enough on the symptom measures designed to assess and track noticeable symptoms (and thus might benefit from such), as well as to share potential research opportunities when available. the portal is also designed to create a community among participants through the yeschat.org discussion board * participants will be in this research study for up to 5 years with the option to opt out of portal assessment component follow-up after only 1 year. * it is expected that about 400 people will take part in this research study

Eligibility criteria:
inclusion criteria: * stage 0-3 * female * diagnosed with breast cancer between the ages of 18-39 years * less than 3 months post diagnosis date of new primary or local recurrence (prior history of other cancer is allowed as long as treated with curative intent and no evidence of disease from that cancer) * has not started treatment for breast cancer diagnosis yet * is planning to get care at dfci * be fluent in and able to read english * have internet access on a regular basis at the time of consent that can support the web-based platform * stage iv * female * initial diagnosis of breast cancer between the ages of 18-39 years * be fluent in and able to read english * have internet access on a regular basis at the time of consent that can support the web-based platform exclusion criteria: -

Keywords: breast cancer symptom, behavioral
stress and personality profiles in ibd

Conditions: Inflammatory Bowel Disease

Summary: main aim is to evaluate the role of stress in the evolution of inflammatory bowel disease (ibd) and the quality of life of these patients. a second aim is to establish the existence of any psicopathological profile in these patients. we designed a prospective experimental study were patients are randomized to receive or not a cognitive-behavior program. patients will be evaluated at 3 and 12 months after the program and study variables will be measured: stress level, coping strategies, quality of life, activity of disease and biological variables related to ibd.


Eligibility criteria:
inclusion criteria: * age 18-85 years * informed consent * crohn's disease or ulcerative colitis diagnosis * active disease in the last 18 months exclusion criteria: * severe mental disease * other severe concomitant disease
a study of drug-induced kidney disease

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to identify incidence of chinese herb nephropathy in a medical center

this is a retrospective study, by computer screening, chart review and phone survey to find herbal nephropathy and determine the cause-relationship. using icd-9-cm code as a tool to screen the newly diagnosed esrd in ntuh computer data base, and divided patients into those with underlying disease(s) that cause the renal failure and those without.

Eligibility criteria:
inclusion criteria: * patient who was newly diagnosed as end stage renal disease who need dialysis exclusion criteria: * started dialysis before 2000

Keywords: herbal nephropathy chinese herbal nephropathy nephrotoxicity renal disease adverse drug reaction chinese herbal medicine
clinical study of ivonescimab for first-line treatment of metastatic nsclc patients with high pd-l1

Conditions: Non-Small Cell Lung Cancer

Summary: clinical study of ivonescimab for first-line treatment of metastatic nsclc patients with high pd-l1. evaluating overall survival and progression free survival.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old at the time of enrollment * eastern cooperative oncology group (ecog) performance status score of 0 - 1 * expected life expectancy ≥ 3 months * metastatic (stage iv) nsclc * histologically or cytologically confirmed squamous or non-squamous nsclc * tumor demonstrates high pd-l1 expression ( tps\>50%) based on a 22c3 immunohistochemistry ( ihc) clinical assay approved / cleared by local health authorities. * at least one measurable noncerebral lesion according to recist 1.1 * no prior systemic treatment for metastatic nsclc. exclusion criteria: * histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. for patients with non-squamous histology, actionable driver mutation testing results are required before randomization. * has received any prior therapy for nsclc in the metastatic setting. * concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up. * known actionable genomic alterations for which first-line approved therapies are indicated * symptomatic cns metastases, cns metastasis ≥ 1.5 cm, cns radiation within 7 days prior to randomization, potential need for cns radiation within the first cycle, or leptomeningeal disease * other prior malignancy (including previously treated nsclc) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization * active autoimmune or lung disease requiring systemic therapy * has pre-existing peripheral neuropathy that is ≥ grade 2 by ctcae version 5 * severe infection within 4 weeks prior to randomization * major surgical procedures or serious trauma within 4 weeks prior to randomization * history of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
contrast enhanced ultrasound to evaluate response to chemoembolization in patients with liver tumors

Conditions: Liver Neoplasms

Summary: this phase ii trial evaluates the diagnostic performance of contrast-enhanced ultrasound (ceus) for assessing treatment response in patients undergoing transarterial chemoembolization (tace) for liver tumors. tace is a hepatic artery embolization technique involving the injection of a blocking agent and a chemotherapy agent to treat liver cancers. currently, contrast enhanced magnetic resonance imaging or computed tomography are used to assess disease response 1-2 months after tace treatment, but ultrasound may be a less expensive, earlier alternative. ceus is an imaging procedure that uses high-frequency sound waves to generate images of the body after administering lumason, an imaging agent used to enhance visualization of blood flow on ultrasounds. ceus is able to be performed during the tace procedure, making it possible to evaluate treatment response earlier than standard techniques. ceus may be an effective method to evaluate treatment response more accurately and much earlier than current standard evaluation methods.

primary objective: i. to evaluate the sensitivity and specificity of ceus for the evaluation of tace treatment response in a variety of solid liver tumors (years 1-4). secondary objectives: i. to determine the ability of ceus to identify residual tumor vascularity intraoperatively, thereby enabling immediate retreatment when necessary (years 1-4). ii. to explore a variety of advanced imaging approaches to improve on the suboptimal specificity of ceus for identifying residual viable tumor following tace (years 1-5). iii. to investigate the ability of ceus obtained prior to tace to quantitatively assess tumor vascular morphology and predict response to therapy (years 2-5). exploratory objective: i. use acquired b-mode in-phase and quadrature (iq) data for h-scan imaging. outline: patients receive sulfur hexafluoride lipid microspheres (lumason) intravenously (iv) and undergo ceus 2 weeks prior to tace, during tace, 1-2 weeks after tace, and then 1-2 months after tace. after completion of study treatment, patients are followed up at 6 months.

Eligibility criteria:
inclusion criteria: * scheduled for tace therapy of a liver tumor * be at least 18 years of age * be medically stable * if a female of child-bearing age, must have a negative pregnancy test * have signed informed consent to participate in the study exclusion criteria: * patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable * patients with known sensitivities to the components of lumason
epap, interviewstudy

Conditions: Food Allergy; Food Allergy Peanut; Allergy; Anaphylactic Shock

Summary: the goal of this observational study is to learn about repetitive anaphylactic reactions in food allergic patients and to compare the frequency of repetitive reactions between different elicitors in food allergic patients. the main question it aims to answer are: • is there an elicitor specific difference in the occurrence of anaphylactic reactions once the elicitor has been identified and the patient received counselling about its avoidance? participants will answer questionnaires via a link they will receive via e-mail at baseline and 3, 6, 12 and 24 months after inclusion in the study.

the aim of the study is to establish a cohort of patients who were included in the anaphylaxis registry with an anaphylactic reaction to legumes, tree nuts, seeds, grains or pseudocereals within the previous twelve months. patients are requested to provide information about the occurrence of new allergic reactions at defined time-points over a period of two years (at baseline, 3, 6, 12, and 24 months). in addition, their eating behavior and the food allergy-specific quality of life will be captured. the investigators intend to track self-management in dealing with anaphylaxis, especially the use of emergency medication. it is examined whether patients react again and whether these are reactions to a known or previously unknown allergen to the patient. by recording the symptoms, it will be checked whether there are certain reaction patterns to specific foods or whether these are patient specific. in addition, the influence of the previous anaphylactic reaction and knowledge of the existing allergy on quality of life, dietary behavior and the ability to use emergency medication should be examined. this is intended to help improve the care for future patients in order to minimize the risk of repeat reactions.

Eligibility criteria:
inclusion criteria: * anaphylactic reaction to peanuts, other legumes, tree nuts, seeds (e.g. sesame seed, sunflower seed), cereals (e.g. wheat, oat) or pseudocereals (e.g. quinoa) * participation in the european anaphylaxis registry (clinical trials identifier: nct05210543) * possibility and consent to receive links to the follow-up electronic surveys via e-mail and fill out the questionnaires electronically exclusion criteria: * if inclusion criteria are fulfilled there are no further exclusion criteria

Keywords: food allergy repetitive reactions quality of life
study of denufosol tetrasodium in patients with cystic fibrosis lung disease

Conditions: Cystic Fibrosis

Summary: the objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of ins37217 (denufosol tetrasodium) inhalation solution in patients with cystic fibrosis (cf) lung disease.


Eligibility criteria:
inclusion criteria: * have confirmed diagnosis of cf * have an fev1 greater than or equal to 60% or less than or equal to 90% of predicted normal * have oxygen saturation greater than or equal to 90% on room air * be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation * be able to reproducibly perform spirometry maneuvers exclusion criteria: * have changed their physiotherapy technique or schedule within 7 days prior to screening * have clinically significant comorbidities * using prior and concurrent medications according to the protocol

Keywords: lung disease