Kornimate/medical-research-clean huggingface dataset:
improving how older adults at risk for cardiovascular outcomes are selected for care coordination

Conditions: Cardiovascular Diseases; Myocardial Infarction; Atrial Fibrillation; Diabetes Mellitus; Heart Failure; Hyperlipidemias; Hypertension; Ischemic Heart Disease; Stroke; Transient Ischemic Attack

Summary: this pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to older adults at risk for cardiovascular outcomes. the hypothesis is that assigning care coordinators to older adults based on perceived need will be more effective at preventing emergency department visits and hospitalizations compared to usual care.

this project will use a pragmatic clinical trial embedded in an accountable care organization (aco) to determine the comparative effectiveness of two different approaches for selecting older adults at risk for cardiovascular outcomes to receive support from care coordinators: (1) an approach that assigns older adults to care coordinators based on self-reported difficulty with care coordination, or (2) usual care, which generally assigns older adults to care coordinators after hospital discharge, regardless of perceived need. the investigators will include community-dwelling medicare beneficiaries ≥65 years old with cardiovascular disease (cvd) or 1 or more cvd risk factors who have been attributed to the newyork quality care aco and who have fragmented care. the investigators will randomize the participants into two groups. this study is highly pragmatic, and the intervention is sustainable and scalable. moreover, the proposed approach has the potential to improve care delivery and outcomes for older adults at risk for cardiovascular outcomes.

Eligibility criteria:
inclusion criteria: * medicare beneficiaries 65 years and older, * attributed to the newyork quality care accountable care organization, * are community-dwelling, * have cardiovascular disease or 1 or more cardiovascular risk factors, and * had highly fragmented ambulatory care in the prior year (defined as a reversed bice-boxerman index greater than or equal to 0.85) exclusion criteria: * those who reside in long-term care or nursing home facilities (based on addresses in medicare claims) * enrolled in home hospice * dementia (as measured in claims using the bynum standard 1-year definition)

Keywords: care coordination accountable care organization
study of seasonal influenza vaccine against h5n1 avian influenza virus

Conditions: Influenza

Summary: this will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against h5n1. vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.


Eligibility criteria:
inclusion criteria: 1. aged 18-49 years. 2. healthy as determined by the pi or designate 3. willing to give informed consent. 4. willing to attend follow-up appointments and undergo study procedures. 5. us passport holder residing in bangkok 6. if military, have a letter of approval for participation from the chain of command (unit commander). exclusion criteria: 1. history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine. 2. severe or life-threatening reaction to any previous vaccine. 3. history of chronic respiratory illness, including asthma and sinusitis. 4. history of heart disease 5. history of kidney disease 6. metabolic disease such as diabetes 7. immunocompromised as determined by the pi, or a household contact of an immunocompromised individual. 8. history of guillain-barre syndrome. 9. blood disease including sickle cell disease and/or bleeding tendency (by history or based on medical records). 10. any influenza vaccination within the previous 6 months, or any other vaccine within 30 days of either dose of influenza vaccine. 11. pregnant woman or nursing mother or unwilling to use reliable contraception during the study period until the final day of follow-up. 12. blood donation within the preceding 3 months, or screening hemoglobin value of \<12.5 g/dl. 13. receipt of blood products including immunoglobulins within the preceding 3 months. 14. receiving any of the following therapies: aspirin, warfarin, theophylline, phenytoin, aminopyrine, immunosuppressive drugs, 15. receipt of any antiviral agents within 48 hours of vaccine administration. 16. hiv positive on screening blood tests. 17. any other condition that in the opinion of the study investigator warrants exclusion from the study.

Keywords: seasonal influenza vaccine avian influenza h5n1 cross reactivity prime boost
evaluation of inflammatory cytokines during covid-19

Conditions: Covid19

Summary: the aim of this study is to evaluate pro-inflammatory cytokines as well as microvesicles during the course of sars-cov2 infection in the context of clinical parameters.

in this prospective trial, 100 patients with an acute sars-cov2 infection are enrolled. after confirmation of covid-19, blood samples are taken for evaluation of various inflammatory cyokines and microvesicles at day 1, 5, 9 and 13 during hospitalisation and are interpreted in the context of clinical parameters.

Eligibility criteria:
inclusion criteria: * age \> 18 years * confirmation of acute sars-cov2 infection * ability to provide informed consent
early intervention of high tension in the pancreatic duct on the outcome of severe biliary pancreatitis

Conditions: ERCP

Summary: the investigators hypothesized that naso-pancreatic duct suction could benefit for patients with severe biliary pancreatitis undergoing ercp. so, the investigators designed this experiment to verify it.

this project intends to conduct treatment based on different interventions for enrolled subjects according to international and domestic standardized treatment procedures, including 1.ercp stone extraction, duodenal papillary pressure measurement, bile duct pressure measurement, and nasal bile duct placement; 2.ercp+ duodenal papillary pressure measurement, biliopancreatic duct pressure measurement + nasopancreatic duct + determine whether nasopancreatic duct negative pressure attraction.compare the advantages of two different treatment methods.this paper attempts to explore new treatment methods that are more conducive to the rehabilitation of patients and provides an important preliminary research basis for the future clinical application of standardized treatment. patients from the people's hospital of wuhan university were recruited and selected into groups. the incidence, recurrence rate, operation time and hospital stay of the two independent samples will be compared.

Eligibility criteria:
inclusion criteria: ages 16 to 75. apach-ii score of patients diagnosed with pancreatitis was greater than 8 points. liver function can be damaged. elevated indicators of pancreatitis (hematuria amylase, lipase). identify patients with biliary tract infection or obstruction. exclusion criteria: older than 75 or younger than 16. the duration of admission was more than 72 hours. gastrointestinal obstruction endoscopy cannot be operated. patients with duodenoscopy contraindications.

Keywords: pancreatic duct negative-pressure suction
dose-escalating safety study of isis 301012 in homozygous familial hypercholesterolemia subjects on lipid lowering therapy

Conditions: Hypercholesterolemia, Familial

Summary: the aim of this study is to assess the safety and efficacy of varying doses of isis 301012 as add-on therapy in subjects with homozygous familial hypercholesterolemia


Eligibility criteria:
inclusion criteria: * weight ≥ 40 kg for cohorts a, b, \& c; weight ≥ 50 kg for cohort d * diagnosis of homozygous familial hypercholesterolemia. * female must be non-pregnant and non-lactating. * on stable lipid lowering therapy for at least 4 weeks. * lipid values that meet the pre-specified criteria. exclusion criteria: * subject had heart problems in the prior 6 months. * subject has elevated alt, ast, or cpk. * history of renal disease, liver disease, or malignancy. * use of oral anticoagulants, unless the dose has been stable for 4 weeks * have any other conditions, which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in or completing the study.

Keywords: ldl-cholesterol apob-100 homozygous familial hypercholesterolemia
a study to evaluate the human tolerance and pharmacokinetics of ly03003

Conditions: Parkinson Disease

Summary: this study is to evaluate the human tolerance and pharmacokinetics of ly03003.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 45 years, no less than one-third of a single sex ratio; 2. normal physical examination items (including general physical examination, blood and urine, blood biochemistry, anti-hbv, anti-hcv, anti-hiv, pregnancy test, ecg, chest x-ray); 3. body weight not less than 50 kg, body mass index between 19 and 24 kg/m2; 4. during 2 weeks not using any drugs; 5. no history of drug allergy or drug allergy; 6. voluntarily participate in this clinical trial, can cooperate to complete the specified examinations, and sign the informed consent form exclusion criteria: 1. abnormal health examination and clinical significance; 2. history of allergy to non-ergot dopamine agonists, or history of allergy to other drugs and food; 3. bronchial asthma, epilepsy, mechanical intestinal obstruction, urinary tract obstruction; 4. history of liver and kidney disease, cardiovascular system, respiratory system, hematopoietic system, nervous and mental illness; 5. women of childbearing age who have a positive pregnancy test or a negative pregnancy test but cannot ensure to take appropriate contraceptive measures during the study; 6. lactating women; 7. male subjects who are unwilling to take appropriate contraceptive measures. appropriate measures include the use of condoms, spermicides, or female partners using intrauterine devices (iuds), ovarian caps, oral contraceptives, injected or subcutaneously implanted progestins, and tubal ligation surgery. female partners must not be pregnant or lactating women; 8. smokers, alcoholics and drug abusers; 9. drinkers within 24 hours before medication; 10. used any drugs within 2 weeks before the trial; use of drugs with effect on liver and kidney function within 11.3 months; participated in other drug trials within 12.3 months, donated blood loss (≥ 200ml), or sampled as subjects; 13. researchers believe that the participants are not suitable.

Keywords: ly03003
online positive emotion skills intervention for symptoms of depression

Conditions: Depression; Psychological Stress; Affect

Summary: major depressive disorder affects over 120 million people worldwide. only 50% of americans with depression receive adequate treatment, and one-third of those receiving treatment do not benefit. in this pilot project investigators will bring together two approaches that have the promise to reach large numbers of depression sufferers: a skills-based intervention for increasing positive affect and experiences in depressed individuals, delivered in an inexpensive self-paced mobile format. the study will make use of smartphone technology to improve conventional outcome measurement via in-the-moment emotion sampling and mobile assessment of heart rate variability, a predictor of cardiac health that may mediate some of the health effects of depression. the aims are: 1) retool the existing web-based positive emotion intervention for use on smartphones, with innovative exercises that help participants bring the skills they are learning into real-life situations; 2) perform a small feasibility trial of the mobile intervention on individuals with clinical depression recruited online 3) eventually incorporate feedback from the small feasibility trial to improve the online intervention and conduct a full randomized trial on a larger scale


Eligibility criteria:
inclusion criteria: * daily internet access * cell phone ownership * score of 5 or higher on phq-8 scale * lives in us or canada * speaks and reads english, able to provide informed consent

Keywords: depression depressive disorder psychological stress behavioral symptoms mental disorders mood disorders
natural topical treatment for vulvar and vaginal atrophy

Conditions: Genitourinary Syndrome of Menopause

Summary: genitourinary syndrome of menopause (gsm) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause.

the aim of this prospective observational study is to evaluate safety and efficacy of zantogin® gel (zg) a class ii medical device developed for intravaginal use in the treatment of signs and symptoms of post-menopausal vulvovaginal atrophy (vva), in terms of improvement of objective parameters assessing vaginal health (vaginal health index score) and subsequent patients' sexual quality of life (female sexual distress scale).

Eligibility criteria:
inclusion criteria: * age between 45-65 years * menopause and symptomatic vulvovaginal atrophy (vva) (vaginal dryness, dyspareunia, vaginal irritation, vaginal itching, dysuria) * no previous treatment for vva * informed written consent signed exclusion criteria: * pregnancy * previous or concurrent neoplasms * uncompensated concomitant diseases (i.e., diabetes, cardiac diseases) * previous or concurrent hormone replacement therapy (hrt) or radiotherapy or chemotherapy.
skin cancer screening and education at beaches

Conditions: Skin Cancer

Summary: this study was an evaluation of the dana-farber cancer institute blum family resource center van's existing skin cancer screening and education program. this program occurred over 2 summers. this study will fill a critical gap in the investigators' knowledge about how best to address the high-risk behaviors that regularly occur during the summertime at beaches. the investigators randomized beaches to receive different combinations of the van program components in order to determine how services should optimally be configured to maximize impact. the investigators hypothesized that providing all three components (1-skin cancer prevention education; 2-biometric feedback using a dermascan analyzer that illustrates skin damage due to sun exposure and ultra violet (uv) reflectance photography; and 3-dermatologist skin exam) will maximize knowledge and behavior change, relative to education alone.


Eligibility criteria:
inclusion criteria: * beachgoers eligible to participate in the study included: * those who were 18 years and older * caucasian * able to understand, speak and read english * ability to give informed consent * had not already enrolled in the study at another participating beach

Keywords: skin cancer prevention shade beach
resistive diaphragmatic training vs volumes-oriented spirometer in asthmatic parients

Conditions: Asthma

Summary: asthma, a chronic lung disease characterized by airway inflammation and constriction, presents ongoing challenges despite advancements in treatment. the aim of this study to deliver non-pharmacological interventions, particularly comparing resistive diaphragmatic training (rdt) and volume-oriented spirometry, to assess their efficacy in enhancing pulmonary function and functional capacity among asthmatic patients. it will compare resistive diaphragmatic training (rdt) with volume-oriented spirometry in asthmatic patients to pinpoint the superior method for enhancing lung function and daily capabilities.

asthma is a chronic lung disease characterized by airway inflammation and constriction, presents ongoing challenges despite advancements in treatment.the aim of this study is to deliver non-pharmacological interventions, comparing resistive diaphragmatic training (rdt) and volume-oriented spirometry, to assess their efficacy in enhancing pulmonary function and functional capacity among asthmatic patients. method: this study will be conducted at "gulab devi chest hospital" lahore, it is randomized clinical trial (rct) which will divided into two groups: group a include rdt along conventional physiotherapy treatment and group b include volume-oriented spirometry along conventional physiotherapy treatment. total 50 subjects will be recruited according inclusion and exclusions criteria by convenient sampling technique. data collection procedure will follow standardized procedures like pre-assessment and post-assessment which will be after 6 weeks with spirometry, 6mwt, and the act. hypothesis postulated that rdt will show greater mprovements in pulmonary function and functional capacity compared to volumes oriented spirometry. however, null hypothesis will suggest that there is no significant difference between the two interventions.

Eligibility criteria:
inclusion criteria: * age range between 35 years to 50 years who must have a confirm diagnosis of asthma and fev1% \>60% \& \<80%, both male and female with moderate asthma. outpatients from regional medical centre. exclusion criteria: * asthma patients whose condition require hospitalization asthmatic patients with physical limitation patients, with exercise-induced asthma, asthma patients with heart dis¬ease with evidence of cardiovascular osteoarticular, inability to consent or cooperate, long-term, home oxygen therapy, active tuberculosis or other infectious disorders as well as stroke, are excluded

Keywords: diaphragm training pulmonary function test rehabilitation spirometry six-minute walk test
short duration hyperbaric oxygen therapy to improve hba1c, leukocyte, and serum creatinine

Conditions: Hyperbaric Oxygen Therapy; Diabetic Foot Ulcer; Type II Diabetes Mellitus

Summary: the investigators want to evaluate the short duration hbot can improve glycohemoglobin (hba1c) levels, leukocyte count, and serum creatinine levels in patients with dfu (diabetic foot ulcer) wagner 3-4.

this study uses pretest and posttest control group design. all dm (diabetes mellitus) patients with dfu at sanglah general hospital, denpasar who meet the inclusion and exclusion criteria and willing to follow the research procedure. all patients are signing the agreement paper after getting research explanation. all patients were briefed on the study research using hbot. if the patients are willing to participate in the study and use hbot was grouped to combination therapy, if the patients are willing to participate in the study but do not want to use hbot was grouped to standard therapy, but if the patients are not willing participate then excluded. all patients were taken blood test for hba1c levels, leukocyte count, and serum creatinine levels before debridement, then grouped for standard therapy or standard therapy with 10 sessions of hbot. one session of hbot uses oxygen at 2.4 ata (atmosphere absolute) for 90 minutes per day at multiplace hyperbaric chamber. this therapy is given five sessions in a week, so it takes two weeks. at the end of therapy, all blood tests were performed again in both groups. the inclusion criteria were patients who had type 2 diabetes and dfu wagner class 3 or 4, aged over 18 years, and underwent debridement with or without toe amputation. the exclusion criteria were patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke. statistical analysis using spss 17.0 (spss inc., chicago, illinois, usa). all variables were described before and after treatment. analysis pretest and posttest values on both groups were used paired t-test and independent t-test. the statistical test results are significant if p \< 0.05.

Eligibility criteria:
inclusion criteria: * patients who had type 2 diabetes and dfu wagner class 3 or 4, aged over 18 years, and underwent debridement with or without toe amputation. exclusion criteria: * patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke.

Keywords: hyperbaric oxygen therapy diabetic foot ulcer hba1c leukocyte serum creatinine
assessment of oral health related quality of life after full mouth rehabilitation under ga

Conditions: Quality of Life

Summary: to assess oral health related quality of life (ohrqol) after full mouth rehabilitation under ga in a group of egyptian children below 5 years


Eligibility criteria:
inclusion criteria: * age range 2 to 5 years . * children with untreated early childhood caries . * children who will undergo dental treatment under general anesthesia. exclusion criteria: * participation in any other concurrent clinical trials. * the presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, aids etc. * children with special healthcare needs. * children whose parents had no home or mobile phone to enable postoperative contact. * parent that will not sign the consent.

Keywords: rehabilitation full mouth rehabilitation quality of life
cadonilimab combination with chemotherapy with or without ak117 in resectable gastric or gastroesophageal junction adenocarcinoma

Conditions: Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Summary: this trial is a phase ii study. all patients are resectable gastric or gastroesophageal junction adenocarcinoma, eastern cooperative oncology group (ecog) performance status 0-1.the purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without ak117 neoadjuvantin treatment of resectable gastric or gastroesophageal junction adenocarcinoma.


Eligibility criteria:
inclusion criteria: * be able and willing to provide written informed consent. * 18 to 75 years old. * has an eastern cooperative oncology group (ecog) performance status of 0 or 1. * has a histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma(g/gej). * has stage t3-4n+m0 g/gej (american joint committee on cancer \[ajcc\]) * has measurable disease based on response evaluation criteria in solid tumors (recist) 1.1. * has adequate organ function. exclusion criteria: * are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage. * is currently participating in a study of an investigational agent or using an investigational device. * has undergone major surgery within 30 days of study day 1. * has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * has known active hepatitis b (e.g., hbsag reactive) or hepatitis c (e.g., hcv rna \[qualitative\] is detected). * history of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * has received a live virus vaccine within 30 days of the planned first dose of study therapy.