Kornimate/medical-research-clean huggingface dataset:
telehealth home-monitoring for frailty in cardiac surgery

Conditions: Frailty; Surgery; Cardiac Event

Summary: cardiac surgical interventions are increasingly offered to vulnerable patients or patients living with frailty. unfortunately, frailty has been shown to be an independent predictor of poorer outcome and increased health care resources in terms of readmission to hospital or visit to the er after discharge. we hypothesize that the use of a comprehensive telehealth home-monitoring program could reduce emergency room visits and re-hospitalization after heart surgery. frailty in all patients will be determined using the edmonton frailty scale (efs) as is part of the current standard of care for all patients at the nbhc since 2018. we plan to implement the telehealth intervention on all 120 consecutively enrolled patients identified as vulnerable and/or frail and discharged from hospital within 10 days of their surgery. the primary outcome of interest will be rates of er visit and readmission to hospital within 30 days of discharge compared to propensity score matched historical control patients. a power calculation suggests that 120 patients per group are necessary explaining why the intervention group will be 120 patients. we chose to compare our intervention to a matched group of 240 individuals from historical data which already captures follows patients 30 days after surgery but is limited in its telehealth intervention. duration of the study is 12 months.


Eligibility criteria:
inclusion criteria: 1. patients, aged 55 years or older, undergoing elective isolated coronary artery bypass grafting (cabg), aortic valve repair/replacement, mitral valve repair/replacement or combined cabg/valve procedures. 2. patients defined as pre- vulnerable, vulnerable or frail based on the edmonton frailty scale (\> 4 considered pre- vulnerable) as defined prior to surgery exclusion criteria: 1. medical reasons for exclusion 1. patients who have unstable or recent unstable cardiac syndrome requiring urgent (within 24hr) or emergent surgery 2. acute endocarditis who are at higher risk for adverse events 2. dialysis dependent who are at higher risk for adverse events 3. patients who have cognitive deficits, visual impairments, inability to read or major difficulties with electronic devices that would preclude use of the intervention 4. patients who do not have any support or potential caregivers to help facilitate their transition home 5. patients undergoing minimally invasive surgery which has been shown to enhance recovery 6. patients unable to be discharged home within 10 days of their surgery. the average length of hospitalization is 5 days with frail patients often requiring additional time but usually within 10 days unless some major barrier exists in allowing discharge home. 7. patients who are transferred to another hospital for recovery or care.

Keywords: technology outcomes hospital readmission feasibility follow-up remote care
optimizing photodynamic therapy of cutaneous neoplastic diseases via structured illumination and real-time dosimetry.

Conditions: Skin Cancer; Signs and Symptoms

Summary: the purpose of this study is to evaluate native tissue optical properties and photosensitizer optical properties in vivo with a novel, non-contact optical imaging device call modulated imaging to help optimize the laser exposure in future photodynamic treatment for patients with skin cancer. photodynamic therapy involves the administration of a tumor-localizing photosensitizing agent that, when illuminated with the proper wavelength of light, can result in photochemical processes that cause irreversible damage to tumor tissues. photodynamic therapy is non-invasive and has been shown to be effective in the treatment of skin cancer while producing excellent aesthetic appearance and psychological well-being in patients that normally would require invasive excisions.

the current standard of care for skin cancer is excision, curettage and electrodesiccation and/or cryosurgery. the modulated imaging can measure tissue optical properties that effect the photodynamic therapy treatment process can show spectral absorption and scattering coefficients, oxy- and deoxy-hemoglobin, water, melanin and use that information to provide customized laser light treatment. the researchers can use an imaging system that can characterize the tissue and photosensitizer optical properties and use that information to drive a treatment light projection system that can spatially optimize the light irradiance for personalized treatment, thus improving outcomes.

Eligibility criteria:
inclusion criteria: * age \> 18 years * biopsy proven diagnosis of a basal cell carcinoma in a non-facial area exclusion criteria: * age \< 18 years * pregnancy * breast feeding. * photosensitivity
dose safety, tolerability, and immunogenicity of a new smallpox vaccine in adults without previous smallpox vaccination

Conditions: Smallpox

Summary: the purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.

in addition to assessment of safety parameters, the objective of this study is to determine the minimum dose of acam1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine. specifically, the objectives of this study are to: 1. compare the safety and tolerability of three dose levels of acam1000 and a standard dose of dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis. 2. determine the immunogenicity of three dose levels of acam1000 and a standard dose of dryvax® in healthy adults 18-29 years of age by comparing: (a)the proportion of subjects at each dose level who develop a major cutaneous reaction; (b)the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between baseline and day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on day 30. 3. determine the minimum dose of acam1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine.

Eligibility criteria:
inclusion criteria: * in good general health. * not pregnant and using effective birth control * agreed to participate in entire study and comply with protocol requirements. exclusion criteria: * military service prior to 1989. * no previous smallpox vaccination. * no contact with with children 1 year of age or younger * immunodeficiency individuals or close contacts who are immunodeficient * past history or current renal disease * diagnosis or past history of eczema * known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin b). * known allergy or past allergic to blood products. * known allergy or past allergic reaction to cidofovir or sulfa-containing drugs. * transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the screening visit. * serology positive for hiv, hepatitis b or hepatitis c. * current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness. * inoculation with any other live vaccine within 30 days of day 0 or participation in another drug or vaccine trial within 30 days of day 0.
observational study evaluating etanercept (enbrel®) in subjects with plaque-type psoriasis in usual care settings

Conditions: Psoriasis

Summary: this prospective observational cohort study will assess the average duration of the drug free interval between etanercept treatment cycles in usual care settings in germany.

non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria:
inclusion criteria: * subjects with moderate to severe plaque psoriasis on etanercept treatment according to the summary of product characteristics (smpc), and applicable local guidelines * subjects for whom the decision has already been made to initiate treatment with etanercept exclusion criteria: * sepsis or risk of sepsis * current or recent infections, including chronic or localized, e.g. tuberculosis (tb) infection * vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study * pre-existing or recent onset cns demyelinating disease. * class iii or iv congestive heart failure as defined by the new york heart association classification or uncompensated congestive heart failure. * previous or ongoing treatment with etanercept * participation in other clinical or observational studies. * patients with psoriatic arthritis requiring continuous etanercept treatment.

Keywords: plaque-type psoriasis
efficacy of locally delivered rosemary extract gel in management of periodontitis

Conditions: Periodontitis (stage 3); Periodontal Pocket

Summary: rosemary extract is known for its antibacterial, anti-inflammatory and anti-oxidant properties that make it a promising therapeutic aid as a local delivery drug in deep periodontal pockets in adjunct to non-surgical periodontal therapy in management of periodontitis. these properties are due to the high content of phenolic compounds such as carnosic acid, urolic acid, rosmarinic acid or chlorogenic acid. rosemary extract was previously investigated and proved its effectiveness against periodontopathogens in-vitro. thus, its selected for this study to be administered in a gel form to assess its efficacy in management of periodontitis.

sixteen patients with deep periodontal pockets more than 5 mm will be randomly assigned into 2 equal groups. the test group will receive the rosemary extract gel in adjunct to non-surgical periodontal therapy, while the control group will receive placebo gel. clinical evaluation of the clinical parameters including probing depth, gingival index, plaque index and clinical attachment level will be recorded. microbiological analysis using pcr test will be performed using perio-papers.

Eligibility criteria:
inclusion criteria: 1. both genders aged between 25-45 years. 2. healthy adult patients as evidenced by burket's oral medicine health history questionnaire. 3. stage iii grade b periodontitis with at least two non-adjacent sites in posterior teeth with pd ≥ 6 mm, cal ≥ 5 mm showing bop and ≤ 4 teeth lost due to periodontitis. 4. patients ready to comply with oral hygiene measures. exclusion criteria: 1. smokers. 2. pregnant or lactating females. 3. drug abusers. 4. patients taking antibiotics or performed any periodontal treatment in the previous 6 months. 5. patients who have a known allergy or hypersensitivity to rosemary, its constituents, or other members of the lamiaceae family. 6. patients with parafunctional habits.

Keywords: periodontitis local delivery drug microbiological analysis
effect of nicotine on neurocognitive performance of cigarette smokers

Conditions: Nicotine Dependence; Smoking; Tobacco Use Disorder; Nicotine Use Disorder

Summary: this research project addresses the hypothesis that a neurocognitive profile characterized by impairment of response inhibition and sustained attention may be a risk factor for smoking initiation and nicotine dependence among young women. nicotine has short- term, facilitating effects on attention and response inhibition. therefore, individuals who are impaired on cognitive functions such as these and initiate cigarette smoking may be more likely to maintain the habit and develop nicotine dependence. the research protocol specifically tests whether administration of nicotine to non-abstinent, regular cigarette smokers improves cognitive function in those domains where the participants had previously been shown to manifest performance deficits


Eligibility criteria:
inclusion criteria: * reported smoking cigarettes on a daily basis at the time of the original study and continue to smoke currently * manifested poor performance on the mfft (the neurocognitive test that yielded differences between smokers and non-smokers) * competent and willing to give written informed consent exclusion criteria: * pregnancy, breast-feeding, non-use of contraception such that the possibility of pregnancy cannot be excluded * intake of any medication that may potentially interact with nicotine. * any current or past medical condition that represents a contra-indication to nicotine administration.

Keywords: nicotine dependence smoking tobacco use disorder nicotine use disorder
a single-arm pilot study with low-dose rituximab plus standard oral prednisone in idiopathic autoimmune hemolytic anemia

Conditions: Autoimmune Hemolytic Disease (Cold Type) (Warm Type)

Summary: the aim of this prospective study was to evaluate the activity, safety and the duration of the response of low dose rituximab associated with standard oral prednisone as first line therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease, and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral prednisone. further aim was to correlate the clinical response to biological parameters (cytokine and anti-erythrocyte antibody production in cultures).


Eligibility criteria:
inclusion criteria: * newly diagnosed "warm" or "cold" aiha, defined by symptomatic anemia and positive dat, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single center diagnostic criteria). * idiopathic "warm" or "cold" aiha relapsed after first line treatment with oral prednisone. * aged \>18 years * ecog performance status grade 0, 1 or 2 * no psychiatric illness that precludes understanding concepts of the trial or signing informed consent * patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice. exclusion criteria: * cell or humoral immunologic deficit (congenital or acquired) * any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent * active bacterial, viral, or fungal infection requiring systemic therapy hiv or hbsag positive (with hbv-dna+) or hcv-ab positive (with hcv-rna+) patients * history of malignancies within 3 years prior to study entry * concomitant immunosuppressive or cytotoxic treatment * positive pregnancy test. lactation. * the presence of associated organ-specific autoimmune diseases do not constitute exclusion criteria. previous splenectomy does not constitute exclusion criteria

Keywords: low dose rituximab waiha chd
investigating the impact of environmental factors on the transcriptomics profile in healthy individuals

Conditions: Healthy Volunteers

Summary: changes in biology will be reflected by changes in the composition of ribonucleic acid (rna) in the blood. an example of that would be environmental changes, e.g. diet, acute illness, temperature. the main goal of this study is to study the impact of environmental changes in blood transcriptomics in healthy individuals over time.

the project is aiming to evaluate the impact of environmental changes on the blood transcriptome and to assess the feasibility of different sample collection materials for this purpose. transcriptome from edta-dbs. performing rnaseq from edta-dbs, finger-prick- dbs and paxgene rna tubes has resulted in different levels of analytical "background noise". to measure the reflection of this noise, we aim to collect and evaluate blood samples of participating healthy individuals on different time points, to discover how suitable, the dbs is in detecting changes caused by environmental factors (diet, acute disease, temperature). the environmental factors should have variable severity of changes.

Eligibility criteria:
inclusion criteria: * voluntary, informed consent is obtained from the subject before enrollment in the study * the subject is 18 years or older (≥18 years) * healthy participants, as declared by the subject * healthy status is defined by the absence of evidence of any active or chronic disease at the beginning of the study * available to participate for the planned duration of the study for which the screening is being done exclusion criteria: * • the subject had any clinically significant disease * any clinically relevant history or the presence of e.g., respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, etc. chronic disease * concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study * a condition in which repeated blood draws poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access * in the opinion of the investigator, subject is at high risk of non-compliance and is unsuitable in any other way to participate in this study * no informed consent obtained from the subject

Keywords: healthy volunteers
the effect of exercise on dialysis patients' survival

Conditions: Kidney Disease, Chronic; End Stage Renal Disease; Hemodialysis

Summary: the purpose of this study is to check if patients' exercise during their dialysis sessions can prevent their early deaths.

dialysis patients suffer from a number of problems, one of which is reduced ability, decreased functional capacity, and consequently reduced physical capability. forced inactivity due to immobility in dialysis sessions and the need to rest and relieve fatigue for a few hours after each session cause patients to become more inactive day by day, and according to various studies, inactivity in these patients along with reduced physical capabilities increase the risk of cardiovascular disease, which is a risk factor for mortality in these patients. on the other hand, inactivity is an independent predictor of hospitalization and mortality in these patients. studies have shown that exercise can produce many different effects in these patients. however, exercise interventions are often short-term, and even in long-term cases, the aim of studies is only to examine a number of hematological factors or factors such as functional capacity in these patients. a study is currently being designed to directly evaluate the impact of exercise on patients' survival. to test this hypothesis, patients do exercise for 6 months during dialysis. and then will be monitored for a year to determine patients' survival. during 6 months of intervention, hematological parameters, nutrition index and functional capacity of patients are evaluated. in the analyzes, the survival rate of patients in one year follow-up period is compared between patients who took part in intradialytic sessions (intervention group) and patients who did not do any physical activity during dialysis (control group). in addition, by analyzing the variables measured during the 6 months of the intervention, the effect of exercise on parameters relating to survival is evaluated.

Eligibility criteria:
inclusion criteria: * dialysis history ≥ 1 year * without myocardial infarction within past 3 months * regular dialysis 3 times a week * ability to consent * doctor's consent exclusion criteria: * unstable cardiac status (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias, etc.) * active infection or acute medical illness * hemodynamic instability * labile glycemic control * unable to exercise (lower extremity amputation with no prosthesis) * having severe musculoskeletal pain at rest or with minimal activity * unable to sit, stand or walk unassisted (walking device such as cane or walker allowed) * having shortness of breath at rest or with activities of daily living (nyha class iv)

Keywords: mortality exercise during dialysis physical function sarcopenia hematological parameters
a study to learn about paxlovid (a commercial medicine) in people with covid-19

Conditions: SARS-CoV-2 Infection

Summary: the purpose of this post marketing observational study is to learn about the safety and effects of the commercial medicine (called paxlovid) for the treatment of covid-19. this study is intended to be registered with the participants who: * have taken paxlovid pack and have no history of using this medicine. * are 12 years and older all participants will receive paxlovid, a standard treatment for covid-19. participants will take paxlovid 2 times a day by mouth or as prescribed. we will examine the experiences of people taking paxlovid. this will help us determine if paxlovid is safe and effective. participants will be followed up for 28 days after taking paxlovid. during this time, participants will be closely watched for the safety and effects of paxlovid.

this is a multicenter cohort study to be conducted in individuals with sars-cov-2 infection who are treated with this product, and the investigator will enter the information required in this study in the case report forms (crfs) based on the information obtained through medical records.

Eligibility criteria:
inclusion criteria: * subjects who are administered paxlovid pack and have no history of using this drug. exclusion criteria: * there are no exclusion criteria for this study.

Keywords: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) coronavirus disease 2019 (covid-19) paxlovid nirmatrelvir