Kornimate/medical-research-clean huggingface dataset:
relationship between dyslipidemia and the response of diabetic macular edema to intravitreal injection of anti vascular endothelial growth factor agents

Conditions: Diabetic Macular Edema

Summary: diabetic retinopathy (dr) is considered the main etiology of blindness among working-age adults, and diabetic macular edema (dme) is the main reason for vision loss related to dr . retinal oedema is responsible for retinal micro-structural alterations, retinal atrophy of photoreceptors and ganglion cell disorders . in addition, it might be considered consensual that the best improvements in va could be accomplished when retinal oedema is managed. in the context of a chronic and progressive disease, dme has to be faced as a state to control as effectively and rapidly as possible . vascular endothelial growth factor (vegf) is a protein that promotes the growth of new blood vessels. it also makes the blood vessels more leaky. anti- vegf medicines stop the growth of these new blood vessels. this prevents damage to the retinal light receptors and loss of central vision. the dme treatment has been shifted from the laser photocoagulation to anti-vegf therapy . the advantages of anti-vegf therapy in decreasing dme and improving patient's vision have been reported in many studies . ranibizumab, in addition to aflibercept, have been reported as the first line therapies among the other anti-vegf . there are several data demonstrating the efficiency of ranibizumab in treatment of patients with dme . on the other hand, there are studies that revealed poor response of some patients to anti-vegf therapies even after 3 or more injections non-modifiable risk factors for diabetic retinopathy are gender and dm duration. modifiable risk factors contributing to the development of diabetic retinopathy are elevated blood sugar levels, blood pressure, and dyslipidemia which is the imbalance of lipids such as cholesterol, low-density lipoprotein cholesterol, (ldl-c), triglycerides, and high-density lipoprotein (hdl). this condition can result from diet, tobacco exposure, or genetic . hard exudates are thought to be induced by the leakage of lipids from dysfunctional retinal capillaries . therefore, theses were formulated that higher levels of total cholesterol, ldl-c and triglycerides could be considered biomarkers of the development of hard exudates in dm patients . aim of the work - correlate between dyslipidemia and the response of patients with diabetic macular oedema to intravitreal anti-vegf injection


Eligibility criteria:
inclusion criteria: * patients with type ii dm and center involving dme with central foveal thickness more than 280 um. exclusion criteria: 1. evidence of macular ischemia 2. evidence of macular traction 3. previous intravitreal injections 4. previous macular laser therapy 5. previous pars plana vitrectomy
evaluation of long-term safety of pirfenidone (esbriet) in participants with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with ipf. the enrolment of participants will be completed within approximately 24 months. participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.


Eligibility criteria:
inclusion criteria: * a clinical decision has been made, prior to study enrolment, to prescribe esbriet * participants who are newly prescribed esbriet therapy * initiation of esbriet therapy is not more than 30 days prior to study enrolment exclusion criteria: * participants receiving an investigational agent defined as any drug that has not been approved for marketing for any indication in the country of the participating site * participant has received esbriet therapy 30 days or more prior to current treatment course (e.g., prior participation in clinical trials) * participant has any contraindication for the use of esbriet, according to the current local version of the summary of product characteristics (spc)
place of the 18f-fdg-pet/ct in the diagnostic workup in patients with classical fever of unknown origin (fuo)

Conditions: Fever of Unknown Origin

Summary: objective : to explore the diagnostic contribution of the 18f-fdg-pet/ct in a population of patients with classical fever of unknown origin (fuo), to precise its place in the diagnostic decision tree in a real-life setting and to identify factors associated with a diagnostic 18f-fdg-pet/ct. methods: all adult patients (age≥18 years) with a diagnosis of classical fuo who underwent a 18f-fdg-pet/ct in the university hospital of montpellier (france) between april 2012 and december 2017 were included. true positive 18f-fdg-pet/ct which evidenced a specific disease causing fuo were considered to be contributive.


Eligibility criteria:
inclusion criteria: * age≥18 years * a diagnosis of classical fuo who underwent a 18f-fdg-pet/ct exclusion criteria: -refusal to participate-

Keywords: fever of unknown origin 18f-fdg-pet/ct
a study of ac682 in chinese patients with er+/her2- locally advanced or metastatic breast cancer

Conditions: Breast Cancer

Summary: this clinical trial is evaluating ac682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (er+/her2-) locally advanced or metastatic breast cancer. the main goals of this study are to: 1. to evaluate the safety and tolerability of ac682 2. to evaluate the pharmacokinetic of ac682 3. to evaluate the preliminary anti-tumor activity of ac682

this is a phase i, open-label dose-escalation study of ac682, an orally available estrogen receptor degrader, given as a single agent.

Eligibility criteria:
inclusion criteria: 1. patients must be ≥18 years-of-age at the time of signing of the icf 2. histologically and/or cytologically confirmed advanced estrogen receptor positive (er+) human epidermal growth factor 2 negative (her2-) breast cancer 3. female patients must be postmenopausal 4. at least 1 measurable lesion according to response evaluation criteria in solid tumors (recist) version 1.1 or at least 1 predominantly lytic bone lesion in the absence of measurable disease 5. previously received at least 1 endocrine therapy regimen; concomitant use of cyclin-dependent kinase (cdk) 4/6 inhibitor(s) is acceptable; previous chemotherapy is not required, but up to 2 prior regimens of cytotoxic chemotherapy is allowed. 6. patients who have adequate organ functions at baseline exclusion criteria: 1. treatment with any of the following: systemic anti-cancer chemotherapy, biologic, or hormonal agent from a previous treatment regimen or clinical study within 4 weeks prior to the first dose of ac682; systemic small molecules from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is longer) prior to the first dose of ac682 (at least 10 days must have elapsed between the last dose of such agent and the first dose of study drug) 2. received radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of ac682 3. major surgery (excluding placement of vascular access) within 4 weeks of first dose of ac682 4. with known metastasis to the brain 5. any condition that impairs a patient's ability to swallow whole pills. impairment of gastrointestinal function (gi) or gi disease or other condition at baseline that will interfere significantly with the absorption, distribution, or metabolism of ac682. 6. use of prophylactic growth factors and blood transfusions ≤14 days prior to the first dose of ac682 and during dose limiting toxicity observation period

Keywords: estrogen receptor positive er positive er+ human epidermal growth factor receptor 2 negative her2 negative ac682 phase i
pelvic floor muscle assessment at 3-and 4-dimensional transperineal ultrasound

Conditions: Pelvic Floor Disorders

Summary: injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). pelvic floor muscle injuries are not easy to diagnose as they are not visible when looking at surface anatomy during a standard gynaecological examination. the investigators are therefore in urgent need of better tools to diagnose these injuries. having a reliable and easily accessible tool enables studies of the consequences of such pelvic floor muscle injuries. it also makes it possible for us to explore the effect of interventions such as pelvic floor muscle training and surgery in patients with and without pelvic floor muscle injuries. the investigators have previously presented data to support the reliability and the validity of the three and four dimensional (3 and 4d) ultrasound technique used to define pelvic floor muscle anatomy in healthy volunteers and have now a tool to study women before and after delivery.

at the department of obstetrics and gynaecology, cairo university hospital there are approximately 29000 deliveries annually and 10000 women are giving birth for the first time. challenges: the invitation to participate in the study will be given to all women expecting their first child fulfilling inclusion criteria. the biggest challenges in the project will be logistical. to be able to inform, recruit and follow women having their first child is a challenge in itself. applications: if it is possible to identify a risk group for pelvic floor injuries before delivery, it might be ethical to recommend a prophylactic cesarean section to avoid disabling incontinence and prolapse later in life.

Eligibility criteria:
inclusion criteria: * women giving birth to their first child at cairo university hospital, egypt and university hospital würzburg, germany. exclusion criteria: * previous pregnancy of more than 16 weeks. * preterm delivery less than 32 weeks gestation.
internalized stigma in patients with bipolar disorder or schizophrenia

Conditions: Stigma

Summary: the aim of this study is to explore the levels of internalized stigma in a sample of young patients with bipolar disorder or schizophrenia.

the stigma is considered by patients, government organizations and health professionals a key point in mental illness (griffiths et al, 2006). the related literature has focused on individuals with schizophrenia although there are indications that stigma act negatively in patients with bipolar disorder; this, in turn, is described in a few studies, always with heterogeneous samples, chronic and symptomatic patients (perlick et al, 2001). it is also known that there is a significant association between affective symptoms and the presence of stigma, (vázquez et al, 2010). there are reports of higher levels of public stigma towards people with schizophrenia, compared to patients with bipolar disorder or unipolar depression, however there are no studies available on internalized stigma in such samples, especially in remitted patients . since schizophrenia coexists with significant impairment of insight, such individuals may exhibit more difficulty internalizing the external bias and stereotypes. on the other hand, patients with bipolar disorder - despite being less discriminated by the public in relation to schizophrenia - probably have a high potential for self-stigma and its fearsome consequences, justified by higher levels of insight. the investigators would like to examine whether the lower impairment of insight in young bipolar patients(in relation to young people with schizophrenia) could be accompanied by an increase in internalized stigma in this sample. it´s an observational, cross-sectional study with no intervention. hypothesis: the internalized stigma in young adults with bipolar disorder is identical to that of young patients with schizophrenia.

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder and schizophrenia according to dsm-iv-tr, presenting in euthymia (bipolar disorder) or without positive symptoms (schizophrenia), based on clinical assessment and confirmed by structured clinical interview scid-p * age between 18 and 40 years * literate and able to understand the tasks required. * residents of greater sao paulo. * patients and / or legal representatives must understand the nature of the study and sign an informed consent. exclusion criteria: * patients with schizoaffective disorder or mental retardation. * unstable serious diseases including kidney disease, gastroenterology, respiratory, cardiovascular, endocrine, neurological, immunological or haematological.

Keywords: internalized stigma insight social adequacy bipolar disorder schizophrenia
neural markers of balance in adults with brain injury

Conditions: Brain Injuries

Summary: the feasibility study is designed to assess the feasibility of conducting a group yoga intervention and acquiring neuroimaging data in adults with chronic brain injury.

in the united states in 2014, nearly 2.9 million individuals sustained traumatic brain injuries that resulted in emergency department visits, hospitalizations, and death. traumatic brain injury (tbi) is caused by trauma, or an external force that creates rapid acceleration and deceleration of the brain within the skull creating lasting neurophysiological dysfunction. although there are many effective treatment strategies for the weeks and months post-injury (e.g. intensive, multi-disciplinary in-patient rehabilitation), millions of individuals are living with residual disability from brain injury following discharge to home. this residual disability can include significant social, cognitive, emotional, and physical impairment. to date, there are limited strategies for treating the residual deficits of chronic brain injury. one such physical deficit is balance impairment, which is associated with increased fall risk, reduced community integration, and decreased quality of life. the use of intensive, holistic rehabilitation may be effective for improving balance and other impairments in individuals with chronic brain injury. yoga, a holistic treatment option, is thought to be more therapeutic than traditional exercise because of the integration of the mind, body, and spirit. further, yoga can be modified to accommodate individual abilities and needs. and, unlike formal rehabilitation, yoga does not need to be approved by insurance or prescribed by a physician and adapted yoga is available in the community. thus, yoga is readily available, so long as yoga instructors are trained to appropriately modify activities. recently, the research team found that group yoga improved balance performance in seven adults with chronic brain injury. this study is designed to test the feasibility of conducting another group yoga intervention and acquiring neuroimaging data before and after the intervention.

Eligibility criteria:
inclusion criteria: * adults, ages 18+ * diagnosis of traumatic brain injury (tbi) or acquired brain injury (abi) that occurred ≥ 6 months prior, * self-reported balance limitations. exclusion criteria: * ability to engage in non-adapted (i.e. mainstream) yoga classes * standard contraindications for mri (e.g. metal plates in head, claustrophobia, etc.)\* * individuals could still participate in the group yoga intervention even if they could not complete mri scans.
prehabilitation for prostate cancer surgery

Conditions: Prostate Cancer Patients Undergoing Radical Prostatectomy

Summary: radical prostatectomy is the most common and effective treatment for localized prostate cancer. unfortunately, radical prostatectomy is associated with significant adverse effects, such as urinary incontinence, sexual dysfunction, and reduced physical function that collectively diminish health-related quality of life which may persist for up to two years postoperatively. the primary objective of this trial is to assess the feasibility of conducting of a multi-site randomized controlled trial to test the effect of a comprehensive prehabilitation program versus standard care for men with prostate cancer undergoing radical prostatectomy. we hypothesize that men with prostate cancer undergoing radical prostatectomy in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle exercises) will report better health-related quality of life, urological symptoms, and physical fitness, physical activity, and pain, as well as a shorter postoperative length of stay than participants receiving standard preoperative care (pelvic floor muscle exercises alone). our secondary objective is to report estimates of efficacy on several clinically important outcomes for this population that will be used for sample size calculations in an adequately powered trial.


Eligibility criteria:
inclusion criteria: * men with localized prostate cancer (stage ct1- ct2) who have consented for radical prostatectomy * between the ages of 40 and 80 years. exclusion criteria: * i) severe coronary artery disease (canadian cardiovascular society class iii or greater); * ii) significant congestive heart failure (new york heart association class iii or greater); * iii) uncontrolled pain; * iv) neurological or musculoskeletal co-morbidity inhibiting exercise; * v) diagnosed psychotic, addictive, or major cognitive disorders; * vi) no more than two of the following coronary risk factors as defined by the american college of sports medicine : family history of coronary disease, cigarette smoking, hypertension (sbp \> 140 mmhg; dbp \> 90 mmhg), known dyslipidemia, known impaired fasting, glucose (\>110 mg/dl), obesity (bmi \> 30 kg/m2 or waist circumference \> 102cm), or physically inactive (\<150 min of moderate intensity physical activity per week).

Keywords: prostate cancer radical prostatectomy prehabilitation pelvic floor muscle exercises
stopping and preventing epileptic seizures using a partial rebreathing mask

Conditions: Epilepsy

Summary: by enabling a partial rebreathing of expired gas, a moderate respiratory acidosis is induced, without causing hypoxia in the patient. based on the scientific literature on the subject, the study hypothesis is that the fall in body ph will be able to stop and/or prevent epileptic brain activity.


Eligibility criteria:
inclusion criteria: * epilepsy * 18-80 years exclusion criteria: -
persistence of immunogenicity following reduced pcv dosing schedules in south african children

Conditions: Pneumonia; Meningitis

Summary: this study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent pneumococcal conjugate vaccine (pcv10, pcv13). this is the follow-up of a randomized controlled trial in which children received a single priming dose of pcv10 or pcv13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 pcv schedule (6, 14 weeks of age and 9 months of age).

between 2017 and 2019, we conducted an open-labelled, randomized controlled trial to evaluate for non-inferiority in the post-booster serotype-specific geometric mean concentrations (gmc's) in children randomized to receive either pcv10 or pcv13 as a 1+1 schedule (with the first dose occurring either at 6 or 14 weeks of age) compared to infants who received a two dose primary series (6 and 14 weeks of age). all six study groups received a booster dose at 40 weeks of age, and serotype-specific igg and opsonophagocytic activity was measured one-month post booster. subjects were planned to be followed-up until 18 months of age as part of the initial study. in the present study, we propose to extent the follow-up of the cohort to include annual visit at 3, 4 and 5 years of age, to evaluate the sustainability of the humoral immune response of the different pcv dosing schedules.

Eligibility criteria:
inclusion criteria: 1. children between and including the ages of 36 - 38 months of age at the time of first blood sampling; 2. subjects who previously participated in the pcv1+1 study and received the full study vaccination regime as per protocol; 3. the parent or legal guardian of the child must be able and willing to provide written informed consent for all 3 visits and comply with all study requirements; 4. the parent or legal guardian of the child must indicate the intention to remain in the study area for the duration of the trial - or be willing to bring the child for all visits. exclusion criteria: 1. receipt of any additional pneumococcal vaccine since the end of participation in the pcv1+1 study; 2. any known or suspected immunodeficiency condition which could affect immune response to vaccination, including living with hiv; 3. receipt of any immunoglobulins and/or blood products less than 6 months prior to blood sampling; 4. parent/legal guardian unable or unwilling to attend scheduled study visits.
application of digital infrared thermal imaging (diti) in graves' disease

Conditions: Graves' Disease

Summary: graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy. pathogenesis involves autoimmune process. the investigators think temperatures of the area involved in the inflammation may change. thus the investigators plan to take temperature pictures of graves' patients using digital infrared thermal imaging system and observe the change.

we will recruited patients of graves' disease from out patient clinics. we will perform thyroid echo and soft tissue echo first. then we let patients sit before the thermal camera and take thermal images of eyes necks and tibia. after data collection, we analyse the relation between temperature and laboratory data such as thyroid function and autoimmune profiles.

Eligibility criteria:
inclusion criteria: * graves' disease patients. healthy people exclusion criteria: * pregnancy. \ 60 years old
safety and efficacy study of brimonidine/timolol fixed combination in patients with glaucoma or ocular hypertension

Conditions: Ocular Hypertension

Summary: the purpose of this study is to assess the safety and efficacy of brimonidine/timolol fixed combination in patients with glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes * patient requires iop-lowering drug in both eyes exclusion criteria: * uncontrolled medical conditions * contraindication to beta-adrenoceptor antagonist or brimonidine therapy