Kornimate/medical-research-clean huggingface dataset:
biomarkers in the retina for prognosticating mental health treatments

Conditions: PTSD; Posttraumatic Stress Disorder

Summary: title: erg as a potential biomarker of ssri-responsive ptsd: a pilot study posttraumatic stress disorder (ptsd) affects many individuals who experience a traumatic event. previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (erg) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like ptsd. the goal of this observational study is to examine the erg waveform in veterans with ptsd before and after a single dose of the selective serotonin reuptake inhibitor (ssri), sertraline. sertraline is one of two fda-approved medications for the treatment of ptsd. the main questions this pilot study aims to answer are: 1. how does sertraline, an ssri, influence the erg waveform in veterans with ptsd? 2. is there a significant correlation between baseline erg signals and the change in erg following ssri treatment? participants will be asked to: * undergo erg recordings before and after a single dose of sertraline. * provide relevant clinical information related to ptsd symptoms and treatment history. following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up erg recording.

in this study, individuals will undergo an assessment that includes taking a history of their previous exposure to traumatic events, an assessment of current mental health symptoms including those associated with ptsd, and an assessment of physiologic measures, including erg as well as vital sign measurements, blood draw, and saliva sampling. participants will be given a single dose of sertraline (50mg), and a repeat erg will be administered. an optional open label phase of the study will follow, in which participants who undergo treatment with an antidepressant will be invited back for a follow-up assessment with repeat erg.

Eligibility criteria:
inclusion criteria: * veteran of the u.s. armed forces * current diagnosis of ptsd exclusion criteria: * known diagnosis of a primary psychotic or major neurocognitive disorder * significant bilateral visual loss * history of acute angle closure glaucoma * known inherited retinal disease * previous erg deficits * known photosensitive epilepsy * known current pregnancy or lactation * allergy or previous adverse reaction to sertraline or ssri * allergy to sensor strip gel * hepatic failure * damage to orbit structure or open lesion in soft tissue surrounding the eye * any use in the time period of at least 6 half-lives prior to baseline of sertraline or other drugs acting on serotonin and/or unwillingness to avoid these medications for the duration of the study.

Keywords: ptsd posttraumatic stress disorder ssri antidepressant serotonin electroretinogram erg
the effect of vıdeo-based fıstula care educatıon on hemodıalysıs

Conditions: Hemolysis

Summary: objective: this study aimed to determine the effect of face-to-face and video-based education for fistula care on hemodialysis patients' self-care behaviors. methods: the study was conducted as a randomized controlled experimental study. fistula care training was given to the patients in the control group using face-to-face education technique. fistula care training was given to the patients in the experimental group using a video based technique.

experimental group: the researcher provided the patient education the on fistula care. in this training, the researcher first verbally explained fistula care to the patients. after the verbal training, a video recording about fistula care was shown to the patients. the patients watched the video recording during dialysis using the tv unit at the bedside. the training took 20 minutes. patients were allowed to watch the training video twice, at a one-week interval, when they came for hemodialysis treatment after the condition of the patients on dialysis stabilized. topics: video recordings on of fistula care was done by the researchers in the vocational skills laboratory. the video flow plan included the introduction of the materials to be used in fistula care as well as the researcher's presentation of how to manage the fistula. fistula care steps were performed on the simulation model. in addition, the precautions to be taken during the application and what to do in case of possible complications were also shown. literature review, research results, clinicians' opinions, and experts and practices were used in editing the content of verbal training and video recording,

Eligibility criteria:
inclusion criteria: * being 18 years or older, * receiving hemodialysis treatment for more than 6 months, * having arteriovenous fistula, * being able to read, understand and speak turkish, * not having any physical, mental or mental disability restricting daily activities, * having no visual-hearing impairment, perception and psychiatric problems, * volunteering to participate in the study exclusion criteria: * not having arteriovenous fistula, * declining to participate in the study

Keywords: fistula care education self care
the association between radiation dermatitis and skin microbiome in breast cancer patients

Conditions: Radiation Dermatitis; Skin Microbiome; Breast Cancer; Reconstructive Surgery

Summary: the breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. the skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find out whether the skin microbiome is associated with the severity of radiation dermatitis.

radiotherapy is an important treatment for breast cancer patients. about 95% of patients receiving radiotherapy will develop a degree of radiation dermatitis. radiation dermatitis is usually limited to the site of radiation treatment. symptoms vary and can range from itching, burning and pain to open or bleeding ulcers, which can greatly affect the quality of life of patients. severe acute radiation dermatitis can lead to interruption or delay of treatment. at present, there is no standard for the prevention and treatment of radiation dermatitis. our skin is home to millions of bacteria, fungi and viruses which compose the skin microbiota. skin microbiota interacts with skin and affects physiology and immunity of the skin. previous studies have reported the effects of radiotherapy on skin and immune system. however, so far, no studies have analyzed the effects of radiotherapy on skin microbiome and how skin microbiome affects the skin immune responses after radiotherapy. in this study, the breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. the skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find out whether the skin microbiome is associated with the severity of radiation dermatitis. the long-term goal of this study is to deepen the understanding of the role of skin microbiome in the occurrence and development of radiation dermatitis, and provide a basis for subsequent exploration to reduce radiation dermatitis by regulating skin microecology.

Eligibility criteria:
inclusion criteria: 1. female patients 2. invasive breast cancer confirmed by pathology 3. underwent mastectomy and breast reconstruction 4. radiotherapy after breast reconstruction 5. ecog score 0-1 6. signed informed consent exclusion criteria: 1. previous breast or chest radiotherapy 2. other serious skin diseases (systemic lupus erythematosus, skin sclerosis, et al) and cannot receive radiotherapy 3. pregnant women 4. patients who are unwilling or unable to receive regular follow-up.
electronic study for anastrozole pharmacovigilance evaluation

Conditions: Early Breast Cancer

Summary: collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer


Eligibility criteria:
inclusion criteria: * post-menopausal early invasive breast cancer patients who are under anastrazole treatment, who have normal renal and hepatic functions. exclusion criteria: * metastatic breast cancer patients, previous hormonal therapy, other malignancies.

Keywords: anastrazole safety early breast cancer
clinical care of autosomal polycystic kidney disease: retrospective analysis and prospective pkd genotyping

Conditions: ADPKD

Summary: this is a retrospective analysis to include demographic, clinical, biochemical, and genetic data that will further explore the natural history of adpkd and assess the factors that are likely to be associated with the progression of disease and the incidence of complications including progressive chronic kidney disease, cardiovascular disease, and cerebrovascular disease.

to explore questions regarding the natural history of pkd, as well as other, unforeseen issues, a comprehensive database of demographic, clinical, biochemical, and genetic data is required. this descriptive retrospective study can serve as a source of information regarding either the entire adpkd population, or subsets of patients with specifically targeted characteristics. this will inform future prospective studies that will be designed to address issues regarding the natural history and complications of adpkd. the goal of this project is to collect data from a large population of patients with pkd. based upon the estimated prevalence of pkd (1:500 and 1:1000 live births), it is estimated that there may be 10,000 pkd patients in the new york city area. this sample size far exceeds any database established thus far. as many as 40% of affected pkd patients are reportedly unaware of a family history of this disease, in part because many patients may go undiagnosed until they present with a medical complication (e.g., hypertension, kidney failure). furthermore, this initiative will provide an opportunity to compare data from racially diverse populations.

Eligibility criteria:
inclusion criteria: * subjects should have a confirmed adpkd diagnosis. exclusion criteria: * unable to provide informed consent for pkd genotyping.

Keywords: adpkd chart review pkd genotyping
application of therapeutic photography and expressive writing in the management of patients with marfan syndrome

Conditions: Marfan Syndrome

Summary: this study explores the efficacy of therapeutic photography and expressive writing as interventions in routine practice for patients with marfan syndrome.

the objective of the study is to assess the feasibility of including structured therapeutic photography and expressive writing activities in routine practice as an adjunct to standard treatment for patients with marfan syndrome in a national reference centre for rare diseases. this will include measuring the adherence rate to the programme and evaluating the subjective experience of the patients involved.

Eligibility criteria:
inclusion criteria: subjects with marfan syndrome referred to the cardiovascular genetic center in irccs policlinico san donato; - signed informed consent. exclusion criteria: * patients who are currently going through a period of severe medical or psychological instability reported in medical history. * subjects who are unable to provide informed consent due to cognitive, language, or other limitations that prevent full understanding of the purpose and nature of the study.

Keywords: therapeutic photography expressive writing activities marfan syndrome standard practice mixed methods study
biomarkers for monitoring dementia progression

Conditions: Alzheimer Disease

Summary: the variable course of alzheimer's disease (ad) and the paucity of adequate cures urges to implement new strategies for its early detection and clinical intervention. studying the etiopathogenesis and pathophysiological mechanisms of ad is a necessary prerequisite for the development of new biomarkers and innovative therapies. contrarily to anatomical structures, cortical connectivity networks are already deteriorated in early ad and could be a reliable marker of early cognitive decline. our aim is to characterize the neurophysiological parameters in mild ad, in patients with mild cognitive impairment and in matched healthy subjects to identify discriminating criteria. concurrently, the study of ad onset and progression in a mouse model, will allow evaluating the causal effect of inflammation on disease progression and to develop a new class of biomimetic anti-inflammatory nanoparticles formulated to have the intrinsic ability to induce brain's activated microglia to an m2 phenotype.


Eligibility criteria:
inclusion criteria: * mild ad and patients with mild cognitive impairment (mci). exclusion criteria: * major psychosis, genetic, metabolic and other neurological disorders, acute or chronic non-compensated medical illness * any medical or drug-related condition affecting cognitive or mood status * history or current alcohol/illicit drug abuse.

Keywords: eeg functional connectivity neuroinflammation nanoparticles
effect of lifestyle intervention among patients with hypertension or high-normal blood pressure

Conditions: Hypertension; High-normal Blood Pressure

Summary: hypertension is a major risk factor for cardiovascular disease and cardiovascular events. healthy lifestyle factors are widely recommended for hypertension prevention and control, and cardiorespiratory fitness is a strong and independent predictor of the progression of hypertension. increased cardiorespiratory fitness through lifestyle modifications is associated with lower mortality in hypertensive or high-normal blood pressure individuals. the aim of the study is to evaluate the effects of supervised lifestyle intervention that include diet and exercise and base on intelligent application and continuous physiological monitoring on improvement of cardiopulmonary fitness, blood pressure and other health outcomes among participants with hypertension or high-normal blood pressure.


Eligibility criteria:
inclusion criteria: 1. who is ≥18 years old and \< 70 years old; 2. hypertension or high-normal blood pressure; 3. who has a smart phone and can use it (android phones are preferred). exclusion criteria: 1. with acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other serious circulatory diseases or respiratory diseases; 2. with acute cardiovascular and cerebrovascular diseases; 3. poor blood pressure control; 4. with physical limitations(e.g., restricting injuries of the musculoskeletal system, such as fractures, unstable joints and other physical diseases); 5. with skin disease or skin damage at the site of wearable device; 6. with mental disorder, epilepsy or other diseases resulting in inability to control the body; 7. pacemaker installation; 8. woman who is during pregnancy or prepare for pregnancy; 9. sensitive skin for wearable devices; 10）refuse to provide written informed consent.
phase ii study of midodrine for neurogenic orthostatic hypotension

Conditions: Orthostatic Hypotension

Summary: objectives: i. study further the safety and efficacy of the alpha-receptor agonist midodrine in patients with neurogenic orthostatic hypotension. ii. assess the quality of life in these patients with this treatment regimen.

protocol outline: this is a partially randomized, multicenter study. patients receive oral midodrine three times a day during weeks 1 and 3-5, then either oral midodrine or placebo for weeks 6-8. quality of life is assessed at weeks 3, 6, and 8.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- orthostatic hypotension due to autonomic nervous system failure, i.e.: fall in systolic blood pressure (supine to standing) of at least 15 mm hg and symptoms of dizziness, lightheadedness, unsteadiness with a severity of 4.5 or less on a 10 point scale in 2 of 3 evaluations over a 3 day period --prior/concurrent therapy-- no concurrent sympathomimetics or alpha-receptor agonists or antagonists no concurrent drug with significant smooth muscle relaxant or constrictive properties e.g., calcium channel blockers at least 30 days since other prior investigational agents --patient characteristics-- hepatic: no coagulopathy renal: no acute nephritis or chronic renal failure cardiovascular: no sustained supine hypertension greater than 180/110 mm hg no congestive heart failure no myocardial infarction within the last 6 months no uncontrolled arrhythmia (ventricular tachycardia or second or third degree heart block not treated with pacemaker) no unstable angina pectoris no history of cerebral vascular accident other: no pheochromocytoma no thyrotoxicosis no seizure disorder not pregnant or nursing negative pregnancy test fertile patients must use effective contraception

Keywords: cardiovascular and respiratory diseases disease-related problem/condition orthostatic hypotension quality of life rare disease
effects of indacaterol in symptomatic copd patients with low risk of exacerbations

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study compared the efficacy of indacaterol versus placebo in copd patients classified as gold 2014 patient group b. this was a 2-arm parallel group study that recruited copd patients classified by gold patient gorup b. on successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus: 1. indacaterol 150ug or 2. placebo for indacaterol all once daily (od) for 26 weeks. the primary objective (trough fev1) was assessed after 12 weeks.


Eligibility criteria:
inclusion criteria 1. male or female adults aged ≥40 years, who have provided their consent and signed an informed consent form. written informed consent must be obtained before any assessment is performed. 2. patients diagnosed with copd at 40 years of age or older. 3. patients with smoking history of at least 10 pack years, both current and ex-smokers are eligible. (ten pack years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc) 4. patients with stable copd in patient group b according to gold 2014. exclusion criteria 1. use of other investigational drugs within 5 half-lives of enrollment, or \[within 30 days /until the expected pd effect has returned to baseline\], whichever is longer. 2. history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 3. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test. 4. patients who have had 2 or more copd exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation resulting in hospitalization in the 12 months prior to visit 1. 5. patients who have copd exacerbation or infection 6 weeks prior to visit 1. 6. patients who develop a moderate or severe copd exacerbation during the period between visit 1 and visit 2. 7. patients with a history of asthma.

Keywords: copd, fev1, indacaterol
a study to evaluate efficacy and safety of gw117 tablets in major depressive disorder

Conditions: Major Depressive Disorder (MDD)

Summary: the study aims to evaluate the efficacy and safety of gw117 tablets compared to placebo in adults participants with mdd over a period of 8 weeks.


Eligibility criteria:
inclusion criteria: * outpatients aged 18 to 65 years (including both limits), either male or female; * meet the diagnostic criteria for depression in dsm-5 (the fifth edition of the diagnostic and statistical manual of mental disorders), without psychotic symptoms; * have a total score of ≥ 22 on the 17-item hamilton depression rating scale (ham-d17) at both screening and baseline visits; * have a clinical global impression - severity (cgi-s) score of ≥ 4 at both screening and baseline visits; * voluntarily participate in this trial and sign the informed consent form, and be able to comply with the planned visits, treatment plan, laboratory tests and other research procedures. exclusion criteria: * allergic constitution (such as those allergic to two or more drugs or foods) or known to be allergic to similar products like agomelatine; * have previously received adequate and full-course treatment with agomelatine but showed no effect, or treatment-resistant depression (those who have used at least two antidepressants in adequate and full-course treatment but still showed no effect); * ham-d17 scale score reduction rate is ≥25% compared to the baseline period; * high suicide risk; history of suicide attempts within one year before screening; suicidal or self-harming behavior during the screening period; score of ≥3 on item 3 (suicide item) of the ham-d17 scale; * diagnosed with any disease other than depression according to dsm-5, including anxiety disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, trauma and stress-related disorders, dissociative disorders, anorexia or bulimia nervosa, personality disorders, etc.; * depression secondary to other mental or physical diseases. note: other inclusion/exclusion criteria may apply
efficacy of airglove in difficult venous access

Conditions: Cancer

Summary: to determine whether airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (wwi) method.

failure to cannulate to gain intra-venous access is a common occurrence in patients undergoing chemotherapy, obese patients, intravenous drug users and those with chronic medical problems leading to peripheral venous collapse. difficulty in gaining iv-access is a serious medical consequence since important life-saving drugs, fluids, blood transfusions, and other medication are usually given via the intravenous route. most chemotherapy units in the uk rely on venous dilation by immersing the forearm of patients with "difficult to cannulate veins" (dtcv) into a bucket of warm water. there are however, limitations in this method such as controlling water temperature and ensuring proper sterility. a new device airglove™ has been developed which directs warm air over the forearm in a polythene sleeve causing venodilation. preliminary studies in chemotherapy patients suggest that the airglove™ causes venodilation to the extent of the warm water immersion technique, however further evidence is required with testing on normal healthy volunteers. aims and objectives: to determine whether airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (wwi) method.

Eligibility criteria:
inclusion criteria: * participants \> 18 years old * able to give written informed consent * able to understand and complete questionnaire forms independently exclusion criteria: * participants \< 18 years old * participants with cancer and/or undergoing chemotherapy * participants with difficult to cannulate veins (dtcv) * participants with lymphoedema in either hand * participants with pre-existing raynaud's disease * participants with diabetes (type 1 \& 2) * participants with generalised anxiety disorder * participants with diagnosis of hypertension * participants with any cardiovascular disease, previous stroke, episodes of dvt, recent treatment for venous thromboembolism (vte), recently administered heparin, participants on warfarin or any anticoagulant treatment (including noacs). * participants not able to give written informed consent * participants not able to comprehend or complete questionnaire forms independently

Keywords: cannulation, chemotherapy difficult venous access difficult venepuncture cancer