Kornimate/medical-research-clean huggingface dataset:
partners in control, phase ii: using remote monitoring technology with community health workers to support hypertension management for latinx patients

Conditions: Hypertension

Summary: this study seeks to evaluate the impact of a remote patient monitoring (rpm)-specific tech-enabled community health worker workforce on the use of rpm for the management of hypertension among latinx patients. this study is a step-wedge randomized controlled trial that aims to assess the effectiveness and implementation of rpm-enabled community health workers (chws) compared to standard of care rpm hypertension management on blood pressure reduction and evaluate the implementation of the rpm-enabled chws for hypertension (htn) management. the study aims to examine adoption, acceptability, fidelity, cost, sustainability, and equity as outcomes of implementation effectiveness.


Eligibility criteria:
inclusion criteria: 1. self-identify as latinx 2. be fluent in english or spanish 3. be age 18 years or older 4. receiving care at one of the 10 safety-net primary care clinics 5. have uncontrolled htn documented in the electronic health record (ehr) on at least two visits in the past year (defined as an average bp ≥ 140/90 mmhg) 6. have been prescribed at least one anti-hypertensive medication and be non-adherent to their medications, defined as adherence \<80% in the preceding 12 months, as determined by prescription orders obtained from the clinic ehr. exclusion criteria: 1. being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks) 2. participation in other hypertension-related clinical trials 3. have significant psychiatric comorbidity or reports of substance abuse (as documented in the ehr) 4. plan to discontinue care at the clinic within the next 15 months
prospective observational trial to evaluate quality of life after neoadjuvant radiation or chemoradiation followed by surgery in patients with rectal cancer

Conditions: Rectal Cancer; Quality of Life; Radiation Therapy; Chemoradiation

Summary: observational study to evaluate longitudinal quality of life according to standardized eortc questionaires as well as functional outcome, oncological outcome and toxicity in patients treated with neoadjuvant short term radiation or long-term chemoradiation followed by surgery

observational study to evaluate longitudinal quality of life in patients treated with neoadjuvant short-course irradiation or neoadjuvant long-course chemoradiation followed by surgery. qol will be evaluated by standardized eortc questionaires qlq c30 and cr29. acute and late toxicity will be assessed according to ctcae 4.03. oncological outcome will be assessed with regard to local and distant control, patterns of recurrence, freedom from treatment failure and overall survival. correlations of physicians- and patient-assessed functional outcomes are planned.

Eligibility criteria:
inclusion criteria: * histologically proven rectal cancer without distant metastases * indication for neoadjuvant radiation or chemoradiation therapy according to multidiciplinary evaluation * age \>=18 years * written informed consent * ability to answer the standardized questionaires according to the treating physician exclusion criteria: * age \< 18 years * prior systemic therapy with regard to rectal cancer * distant metastasis * second malignancy

Keywords: rectal cancer quality of life neoadjuvant radiation therapy chemoradiation
correlation between smartphone addiction and back dysfunction and core muscle morphology and performance in asymptomatic young adults

Conditions: Back Disorder; Smartphone Addiction

Summary: the purpose of this study is to investigate the association between smartphone addiction and back pain, function, and lumbar stabilizer cross-sectional area and thickness compared with non-addicted teenagers.

smartphone prolonged use has been suggested as a risk factor for psychological, visual, and musculoskeletal dysfunctions. the musculoskeletal dysfunction may be related to direct contact use with smartphones as in thumb, elbow, and neck pain. moreover, indirect long use of smartphones may affect thoracic, lumbar, and lower limbs. covid-19 pandemic occurred in a time of outstanding scientific progress and global digitalization. therefore, smartphone usage became a must for human connection, learning, and entertainment, providing psychological and social support. in the meantime, it was observed a significant increase in overuse and addiction, especially in young and teenage females. the addiction is associated with more musculoskeletal abnormalities when compared to non-addict users. several studies found an association between smartphone usage and back pain, concomitant with a reduction in thoracic extensors activity. this back pain may affect their quality of life and work-related productivity. however, the relationship between back dysfunction and smartphone addiction is still unclear. a few attempts were done to elucidate this relationship. yet if proven correct, then preventive measures such as recommendations and precautions regarding smartphone use could be distributed to users by the manufacturers. furthermore, engineering solutions are needed to optimally design smartphones to alter their weight and sizes to minimize potential adverse effects.

Eligibility criteria:
inclusion criteria: 1. age ranged from 18 years to 30 years. 2. bmi between 19.0-29.9 kg/m2. exclusion criteria: 1- previous history of spinal trauma or dysfunction. 2 - any systemic disease that may affect spine such as ankylosing spondylitis and rheumatoid arthritis. 3 - cognitive or memory impairment in memory or cognitive function.
steroids and cross-linking for ulcer treatment

Conditions: Keratitis Bacterial

Summary: steroids and cross-linking for ulcer treatment (scut ii) is an international, randomized, double-masked, clinical trial. the purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus collagen cross-linking (cxl), as well as to further evaluate findings from subgroup analyses of scut. patients presenting to the aravind eye care system (india), kaiser permanente northern california (usa), or the university of california, san francisco (usa) with smear-positive and/or culture-positive typical (i.e. non-nocardia or mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as snellen visual acuity of 20/40 or worse, will be eligible for inclusion. those who agree to participate will be randomized to one of three treatment groups: group 1: standard therapy, topical 0.5% moxifloxacin plus topical placebo plus sham cxl group 2: early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham cxl group 3: cxl plus early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus cxl


Eligibility criteria:
inclusion criteria: * corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-nocardia or mycobacteria) * moderate to severe vision loss, defined as snellen visual acuity of 20/40 (6/12) or worse * corneal thickness ≥350 µm, as measured on as-oct * age over 18 years * basic understanding of the study as determined by the physician * commitment to return for follow up visits exclusion criteria: * evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthameoba on gram stain) * impending or frank perforation at recruitment * involvement of sclera at presentation * non-infectious or autoimmune keratitis * history of corneal transplantation or recent intraocular surgery * pinhole visual acuity worse than 20/200 in the unaffected eye * participants who are decisionally and/or cognitively impaired
bp limb length of 60cm vs 100cm in roux-en-y gastric bypass

Conditions: Osteopenia

Summary: patients will be randomized into 2 groups: * group 60: patients will undergo a roux-en-y gastric bypass with a biliopancreatic limb length of 60cm * group 100: patients will undergo a roux-en-y gastric bypass with a biliopancreatic limb length of 100cm bone mineral density will be evaluated before surgery and 2 years after it.

patients will be randomized into 2 groups: * group 60: patients will undergo a roux-en-y gastric bypass with a biliopancreatic limb length of 60cm * group 100: patients will undergo a roux-en-y gastric bypass with a biliopancreatic limb length of 100cm alimentary limb will be constant in both groups (150cm length) bone mineral density will be evaluated before surgery and 2 years after it, by means of x ray absorptiometry (dexa). changes in bone mineral density in lumbar column will be assessed.

Eligibility criteria:
inclusion criteria: * body mass index \>40 kg/m2 * body mass index \>35 kg/m2 associated to obesity related comorbidities exclusion criteria: * bone pathologies * active neoplasms * disorders in calcium or vitamin d metabolism
dissemination of prostate cancer screening to pcp's in african american communities

Conditions: Prostate Cancer

Summary: the aims of this project are to adapt and extend the use of academic detailing to the dissemination of prostate cancer (cap) screening findings to primary care physicians practicing in african american communities. the objectives of this study are: 1. to test the hypothesis that a community physician-based educational intervention (multi-component academic detailing, including an interactive, digitized, web-based program for informed decision-making about prostate cancer, and patient education materials designed for low literacy patients) will increase physician knowledge, positive attitudes/beliefs toward screening and screening options, and prostate cancer screening (using the digital rectal exam, and the serum prostate specific antigen test) at baseline, 6-, and 12-months post- randomization, compared to the rate observed in a service- as-usual control. 1a. to demonstrate the feasibility of disseminating the american cancer society guidelines for prostate cancer screening among primary care practitioners using multi-component academic detailing. 2. to develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of pc screening guidelines to different physician subgroups. the long term goal of this project is to increase prostate cancer screening among african american communities, thus decreasing cancer-related morbidity and mortality.

we will conduct a two-arm trial, recruiting, obtaining consent, then assigning 200 physicians' offices at random to one of two arms: intervention (multi-component academic detailing including an interactive, digitized cd-rom, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients) or to a service-as-usual control arm. we will query 200 physicians about their pc knowledge, attitudes/beliefs toward screening and screening options, and psa testing at baseline, 6, and 12months post-randomization, compared to the rate observed in a service-as-usual control. physician counseling in cancer control will be verified by a chart review at baseline and at 12months post-randomization (n=750). the instruments will assess prostate cancer knowledge, attitudes and beliefs toward screening, and uptake of the psa. the nested design uses the physician's office as the unit of randomization, and the office as the unit of analysis.

Eligibility criteria:
inclusion criteria: * charts of male patients age 45 -75, (using the average age of death in this population) with at least one visit to the primary care provider over the last two years will be reviewed. exclusion criteria: exclusion criteria will include: * diagnosis of cancer other than non-melanotic skin cancer.

Keywords: prostate cancer prostate cancer screening prostate specific antigen african american males
plaque stability and metabolomics in coronary heart disease

Conditions: Coronary Artery Disease

Summary: at present, the investigators don't know the relationship between plaque stability and the metabonomics changes. in the present study, investigators will evaluate the plaque stability by intravascular unltrasound in stable coronary heart patients, and metabonomics was also assessed by high throughput sequencing. statistic analysis were carried out to analyze the correlation between plaque stability and metabonomics changes among these study patients.


Eligibility criteria:
inclusion criteria: * patients who diagnosed with stable coronary heart disease and evaluated for plaque stability by ivus will be recruited. exclusion criteria: * renal insufficiency with serum creatinine \> 20 mg/l; * regnant/lactating women, or the women receive hormone replacement therapy in premenopausal or postmenopausal; * patients have a history of abusing alcohol or other drugs in the past two years, active hepatitis, cirrhosis; * endocrine abnormalities without therapy (diabetic ketoacidosis, thyroid disease, etc.); * the body's inflammatory disease, rheumatoid arthritis, osteoarthritis, ulcerative bowel disease, systemic lupus erythematosus (sle), etc.), myositis/myopathy, cancer; * dilated cardiomyopathy, valvular heart disease, persistent atrial fibrillation; * patients recently injured;（8）other researchers don't agree to join this study.

Keywords: plaque stability metabonomics
safety, tolerability and efficacy of the depigmented modified allergen extract of two mites in subjects with allergic rhinitis or rhinoconjunctivitis, with controlled allergic asthma

Conditions: Rhinitis; Rhinoconjunctivitis; Asthma

Summary: this is an open-label, non-controlled, non-randomised, prospective safety study in patients with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically relevant sensitisation to dust mites from the pyroglyphidae and glycyphagidae families.

the objective is to evaluate the safety and tolerability of the administration of two allergen extracts of dust mite mixtures at 200 dpp/ml (dp/mg/14-1 dermatophagoides pteronyssinus / blomia tropicalis and dp/mg/14-2 dermatophagoides pteronyssinus / lepidoglyphus destructor) using a rush build-up phase in patients with allergic rhinitis or rhinoconjunctivitis, with controlled asthma.

Eligibility criteria:
inclusion criteria: 1. subject has provided appropriately signed and dated written informed consent. 2. men and women aged 18 years and 70 years of age at visit 1. 3. has an fev1 value 80% of predicted normal value at visit 1. 4. individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis moderate-severe for at least the preceding year, with controlled asthma, caused by double sensitization against dermatophagoides pteronyssinus (dpt) and lepidoglyphus destructor or dermatophagoides pteronyssinus and blomia tropicalis. 5. patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelials cannot participate in the study if they are symptomatic. 6. if a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile. 7. if a female is of childbearing potential, the subject must be non-lactating and non-pregnant and must correctly use an effective method of contraception during the study. exclusion criteria: 1. any contraindication for treatment with allergen specific immunotherapy. 2. subjects with a previous history of anaphylaxis. 3. patients with hospital admission due to asthma exacerbations within 1 year prior to v1. 4. has uncontrolled asthma, according to global initiative for asthma guidelines (gina 2010). 5. acute or chronic infectious conjunctivitis. 6. has acute or chronic inflammatory or infectious airways disease. 7. has chronic structural diseases of the affected organ (e.g. eye, nose, lung). 8. history or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance. 9. has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism). 10. has a severe uncontrolled disease that could increase the risk to the subjects while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disord
cytogenetic and molecular genetic studies in bone sarcomas

Conditions: Lung Cancer

Summary: to establish a serial ascertainement of specimens from patients with bone sarcomas to be used in ongoing cytogenetic and molecular genetic analyses. these data will be integrated and correlated with the established orthopaedic service clinical database.


Eligibility criteria:
inclusion criteria: * patients must be undergoing diagnostic biopsy or resection of their primary or metastatic bone sarcoma for therapeutic purposes. * the specimen must be large enough to allow routine pathological analysis, with the specimen for research excised from residual tissue that would otherwise be discarded. exclusion criteria: * n/a

Keywords: bone soft tissue
post-op massage in infants with congenital heart disease

Conditions: Congenital Heart Disease

Summary: the primary aims of the proposed study are to pilot test the effectiveness of daily massage on pain and clinical outcomes in infants who have undergone cardiothoracic surgery. the secondary aim is to explore relationships among massage, pain scores, and other variables potentially affecting pain scores, including parental anxiety, severity of cardiac defect, and severity of pain. specific aim 1: to compare effects of massage on infant pain and clinical outcomes between two groups over time: infants receiving post-operative massage seven days post-operatively and infants receiving a comparable time of restricted non-essential caregiving seven days post-operatively. specific aim 2: to compare pain scores and physiologic responses before and after intervention in two groups: infants receiving post-operative massage and infants receiving a comparable time of restricted non-essential caregiving. specific aim 3: to examine potential moderators of pain response in the massage intervention group before and after receiving massage.

we used a two-group randomized clinical trial design with a sample of 60 infants with complex congenital heart disease (cchd) between 1 day and 12 months of age following their first cardiothoracic surgery. both groups received standard post-operative care. in addition, group 1 received a daily 30-minute restricted non-essential direct caregiving time (quiet time), and group 2 received a daily 30-minute massage. interventions continued for seven consecutive days. pain was measured 6 times daily using the face, legs, activity, cry, consolability pain assessment tool (flacc). average daily doses of analgesics were recorded. heart rates (hr), respiratory rates (rr), and oxygen saturations (spo2) were recorded continuously. daily averages and pre- and post- intervention flacc scores and physiologic responses were analyzed using descriptive statistics, generalized linear mixed models (glmm) for repeated measures, latent growth models, and/or regression discontinuity analysis. fentanyl-equivalent narcotic values were used as a time-varying covariate.

Eligibility criteria:
inclusion criteria: * infants born with complex congenital heart disease requiring surgical intervention * less than 12 months old * undergoing first surgical procedure exclusion criteria: * on paralytics post-operatively * cardiorespiratory instability * on-going cardiac pacing

Keywords: congenital heart disease massage pediatric pain
development and validation of a deep learning system for multiple ocular fundus diseases using retinal images

Conditions: Ophthalmological Disorder

Summary: retinal images can reflect both fundus and systemic conditions (diabetes and cardiovascular disease) and firstly to be used for medical artificial intelligence (ai) algorithm training due to its advantages of clinical significance and easy to obtain. here, the investigators developed a single network model that can mine the characteristics among multiple fundus diseases, which was trained by plenty of fundus images with one or several disease labels (if they have) in each of them. the model performance was compared with those of both native and international ophthalmologists. the model was further tested by datasets with different camera types and validated by three external datasets prospectively collected from the clinical sites where the model would be applied.


Eligibility criteria:
inclusion criteria: * the quality of fundus images should clinical acceptable. more than 80% of the fundus image area including four main regions (optic disk, macular, upper and lower retinal vessel archs) are easy to read and discriminate. exclusion criteria: * images with light leakage (\>30% of area), spots from lens flares or stains, and overexposure were excluded from further analysis.
effect of pectoralis block on analgesia after simple mastectomy

Conditions: Mastectomy; Nerve Block; Analgesia, Postoperative

Summary: the pectoralis block, including pecs i and ii block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. the research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.

the pectoralis block, including pecs i and ii block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. the concept involves injecting local anesthetic near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs i), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs ii). this is a prospective, double-blinded, randomized controlled trial in subjects undergoing mastectomy under general anesthesia. the research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.

Eligibility criteria:
inclusion criteria: * asa 1, 2, and 3 patients (according to asa classification of comorbid conditions and general health) * patients undergoing simple mastectomy exclusion criteria: * -patient refusal * allergy to local anesthetics * inability to communicate in english * use of 8 mg morphine equivalents or greater currently and for a period of longer then 2 weeks prior to surgery * existing nerve injuries or sensory deficits * conversion to anesthesia via an endotracheal tube

Keywords: ropivacaine