Kornimate/medical-research-clean huggingface dataset:
prospective puraply™ am case series study

Conditions: Pressure Ulcers; Venous Ulcers; Diabetic Ulcers; Surgical Wounds; Trauma Wounds

Summary: the puraply am case series is a prospective, observational study for patients who have received puraply am which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (phmb) and is intended for the management of wounds; no experimental intervention is involved.

the purpose of the case series is to assess the ability of puraply am to meet wound specific treatment goals including management of bioburden, support of granulation tissue formation, and support of wound closure. patients will undergo clinical assessments and receive the standard of care as determined by the treating physician. the case series is being undertaken to better understand puraply am utilization and subsequent healing outcomes as well as to evaluate the effects of concomitant wound therapy on healing. patient's participation may involve follow-up for up to 12 weeks following application of puraply am.

Eligibility criteria:
inclusion criteria: 1. participant is at least 18 years of age 2. participant has read, understood and signed and institutional review board (irb) approved informed consent form (icf). 3. participant has at least 1 wound appropriate for receiving puraply am, including * partial and full-thickness wounds * pressure ulcers * venous ulcers * diabetic ulcers * chronic vascular ulcers * tunneled/undermined wounds * surgical wounds (donor sites/grafts, post-mohs' surgery, post-laser surgery, podiatric, wound dehiscence) * trauma wounds (abrasions, lacerations, second-degree burns, skin tears) * draining wounds exclusion criteria: 1. participant has a known sensitivity to porcine materials 2. participant has a third-degree burn 3. participant has a known sensitivity to polyhexamethylene biguanide hydrochloride (phmb) 4. participants receiving concurrent treatment with other topical antimicrobials or skin substitute products

Keywords: antimicrobial collagen bioburden biofilm phmb chronic wounds acute wounds
comparison of sphincter preservation surgery and abdominoperineal resection (apr): prospective clinical trial

Conditions: Rectal Cancer

Summary: sphincter preservation surgery in low rectal cancer has been increased due to better understanding of tumor biology and advances in surgical technology. furthermore, a majority of patients prefer sphincter preservation rather than living with permanent colostomy. but it is not clear whether sphincter preservation is directly related with better quality of life. there have been many studies comparing sphincter preservation surgery and abdominoperineal resection in many aspects including oncologic and functional outcomes, and the quality of life. however, the conclusion remains controversial because of the different results between studies.

this prospective study was designed to compare the quality of life after sphincter saving surgery and abdominoperineal resection. because of ethical issues, it is difficult to conduct as a randomized trial. on the basis of tumor location, extent, and preoperative anal function, patient will be attributed to two different operative method groups. on the assumption that 10% of the patients are lost to follow-up at 1 year, at least 74 patients undergoing apr and 220 patients undergoing sps will be recruited. the study will be continued until the target sample size will be achieved.

Eligibility criteria:
inclusion criteria: * low rectal cancer (5cm from anal verge by surgeon's digital rectal exam / rigid rectoscopy) * patient who understands and accepts to sign the informed consent form * confirmed preoperative colonoscopic biopsy (adenocarcinoma) * proper bone marrow function * proper renal function * proper liver function * no severe comorbidity exclusion criteria: * metastatic lesion detected in preoperative assessment * previous history of cancer disease. (except patients with skin cancer) * severe heart disease, congestive heart disease. * severe lung disease, respiratory failure. * mental illness. * invasion to prostate, bladder and combined resection needed (partial or radical.• legally prohibited for clinical trial. * pregnancy or breast feeding. * previous disease or disability expected to influence the assessment of postoperative quality of life.

Keywords: low rectal cancer sphincter preservation abdominoperineal resection quality of life sexual function urinary function oncologic outcome
covid-19 observational research collaboratory

Conditions: COVID-19; SARS-CoV-2 Infection

Summary: this study aims to examine the long-term outcomes in veterans infected and uninfected with sars-cov-2 using electronic health record information and structured surveys.

background: early evidence suggests that the frequency and type of long term complications stemming from sars-cov-2 infection may depend on the severity of initial presentation. however, additional unidentified factors may also play a role including those related to the individual, the environment and/or the specific strain of the virus. the long-term health impacts of sars-cov-2 will have major implications for health care utilization, care processes and quality and costs of care for veterans, both within the va and in the community. over 200,000 veterans have had covid-19. although the long term consequences of this novel illness are unknown, it is clear they will often be significant. the overarching goal in the long-term outcome study (lto) is to advance va hsr\&d research into the consequences and care of covid-19 infection by developing and releasing integrated multi-modal data and results on long-term outcomes of covid for use by va clinical, research and operations communities. the investigators will do so via a coordinated program of data production and analysis using the va electronic health record (ehr) and other administrative sources (e.g., medicare), de novo longitudinal survey, and qualitative inquiry. this work will be closely coordinated with the covid-19 observational research collaboratory (corc) coordinating center (ccc) and the burgeoning community of hsr\&d-funded covid researchers. this study aims to examine the long-term outcomes in veterans infected and uninfected with sars-cov-2. aim 1: using vinci-cdw data, patients will be identified who had a sars-cov-2 test since february 2020. the investigators will use a combination of traditional epidemiologic studies, and machine learning algorithms to determine the long term, multi-systemic and functional adverse outcomes and/or syndromes related to sars-cov-2. members of the research team are currently developing methods to identify new onset and exacerbations in comorbidities following sars-cov-2 illness in veterans. aim 2: determine veteran-reported outcome effects using structured survey on domains such as self- reported symptoms, disability, and financial impacts, measured repeatedly over 36 months.

Eligibility criteria:
inclusion criteria: all va enrollees since february 2020, which includes all patients who were tested for sars-cov-2 and are included in the va covid-19 shared data resource in cdw. exclusion criteria: va employees

Keywords: covid-19 sars-cov-2 infection
the effect of vitamin k supplementation on bone health in adult crohn's disease patients

Conditions: Supplementation; Bone Health; Crohn's Disease

Summary: to assess the impact of a 12 month vitamin k supplementation intervention on bone health in adult crohn's disease patients

to assess the impact of 12 months of vitamin k1 supplementation (plus vitamin d and calcium supplementation to avoid deficiency of these problematic nutrients) at a level which leads to dramatically (i.e greater than 70%) reduced levels of undercarboxylated osteocalcin - a functional marker of vitamin k status, on vitamin k status, the rate of bone formation and bone resorption, using biochemical markers of bone turnover, and bone mineral density in adult patients with longstanding crohn's disease.

Eligibility criteria:
inclusion criteria: * long-standing crohn's disease - disease diagnosis \> 5 years * in clinical remission at baseline - harvey-bradshaw score (\< 5) * aged between 18-70 years exclusion criteria: * use of steroid medications to treat disease or flare up * use of blood thinning medications (warfarin, heparin, asprin, dicoumarol derivatives) which may influence vitamin k metabolism * use of bisphosphonates, calcitonin medications (to treat osteoporosis) * use of experimental drugs (in the last 30 days) or inclusion in another intervention trial * bone mineral density \< -2.5 (indicative of osteoporosis) or previous diagnosis of osteoporosis * use of vitamin/mineral/fish liver oil dietary supplements * use of other alternative supplements (i.e herbal) * if the patient is under 18 or over 70 years of age * presence of a significant acute or chronic coexisting illness (cardiovascular, immunological or a condition which in the investigator's judgement, contraindicates involvement in the study) * presence of malignant or any concomitant end-stage organ disease

Keywords: vitamin k supplementation bone health indices adult crohn's disease
ethically accepted with code 851/2971 a comparison of class ⅱ malocclusion treatment using van beek-headgear activator versus andresen activator

Conditions: Class II Growth Modification

Summary: the aim of this study is to compare the treatment results when treating class ii division 1 malocclusion using the van beek-headgear activator combination (vbhga) appliance versus using the andresen activator.


Eligibility criteria:
inclusion criteria: * class ii division 1 indicated by anb angle value ≥ 4º * class ii division 1 with overjet \> 5mm. * an age range between 8 and 13 years growing patient using cervical vertebral stage assessment (cvs). * no previous orthodontic treatment * no indications or symptoms of periodontal disease in the past or present, as determined by clinical and radiographic examination exclusion criteria: * missing teeth (excluding 3rd molars). * craniofacial anomalies. * medical condition or prescription medication that may affect growth. * lack of compliance whenever documented in the charts.
post-marketing safety study of glaxosmithkline (gsk) biologicals' synflorix™ vaccine, in healthy infants and children in sri lanka

Conditions: Immunisation Against Streptococcus Pneumoniae

Summary: this pms study aims to collect safety and reactogenicity data of synflorix™ in healthy infants and children of the local population as per the licensing requirement of the sri lankan regulatory authority.

the participating physicians (investigators) will be asked to enrol only those subjects to whom they administer synflorix™ in the course of their normal clinical practice according to the locally approved prescribing information. since there is lack of clarity regarding the pms study requirement (both from regulatory agency and ethics committee), it was decided that gsk will submit local psurs on a regular basis as desired by local regulatory agency. the same is communicated to regulatory agency and if they want something more they are requested to revert back with specific requirements.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/ lar(s) can and will comply with the requirements of the protocol should be enrolled in the pms study. * infants aged 6 weeks and above and children. * written, signed or thumb-printed informed consent obtained from the parent(s)/lar(s) of the child. where subject's parent(s)/lar(s) are illiterate, the consent form will be countersigned by an impartial witness. note: consent for this pms study is solely for collection of safety and reactogenicity data and not for vaccination that is per routine practice. data for demography, medical history and previous vaccination history, and concomitant medication/vaccination will also be collected. exclusion criteria: * subjects with contraindications according to the locally approved pi. * child in care. * previous administration of three doses of synflorix™. * previous vaccination with a pneumococcal vaccine other than synflorix™. * planned administration of another pneumococcal vaccine other than synflorix™ during the pms study.

Keywords: post-marketing surveillance prescribing information (pi) healthy infants and children streptococcus pneumoniae synflorix™ sri lanka
pain management for head and neck cancer survivors

Conditions: Head and Neck Carcinoma

Summary: this clinical trial improves an existing pain management program and tests its effect on head and neck cancer survivors. this trial aims to find a better program to improve pain-related physical functioning, mood, and quality of life in a sample of individuals who have undergone treatment for head and neck cancer.

primary objectives: i. adapt an existing telehealth pain management intervention to target improvement of pain-related physical functioning, mood, substance use, and quality of life in a local sample of veteran head and neck cancer (hnc) survivors. ii. conduct a pilot of the adapted intervention to examine the feasibility (accrual, adherence, attrition) and acceptability (participant satisfaction) that will form the basis of a well-powered, randomized clinical trial submitted for funding to the national institutes of health (nih), american cancer society (acs), or veterans affairs (va). outline: patients attend 5 sessions of mobile pain coping skills training for 45 minutes each over 8 weeks. after completion of study, patients are followed up at 2 months.

Eligibility criteria:
inclusion criteria: * clinically confirmed diagnosis of hnc for which the participants have completed curative cancer treatment at the va hospital or oregon health \& science university (ohsu) within the 3-12 months following treatment * self-reported current pain of 4 or higher, using the 0-10 numeric pain rating (nrs) (0="no pain" to 10="the worst pain imaginable") * self-report of pain 4 or higher on two occasions, more than three weeks apart, since the completion of curative treatment exclusion criteria: * enrolled in hospice * have substantial hearing or visual difficulties that would impair ability to participate * have inadequate cognitive functioning as indicated by medical record review and/or interactions with clinical staff. if needed the investigators can follow up with the st. louis university mental state examination (score of \< 22/30) (slums); or * have untreated severe psychiatric illness that would impact the ability to consent and participate in the intervention * had only surgical treatment for their hnc
validation of the utility of myopia intelligent diagnostic system

Conditions: Myopia

Summary: the screening of myopia via artificial intelligence represents an challenge in computational medicine. here, the investigators use "deep learning" to create an automatic diagnostic system for myopia screening using ocular appearance images. the investigator also use this system and conduct clinical trial to validate its performance.


Eligibility criteria:
inclusion criteria: * student aged 6-18 exclusion criteria: -
myocardial characterization of arrhythmogenic mitral valve prolapse (stamp: stretch and myocardial characterization in arrhythmogenic mitral valve prolapse)

Conditions: Mitral Valve Prolapse

Summary: mitral valve prolapse (mvp) is a frequent affection of the mitral valve or its sub-valvular apparatus with a prevalence of 2-3% in the general population. this valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia. mitral valve prolapse is routinely diagnosed using transthoracic echocardiography and only patients with significant mitral regurgitation will undergo subsequent examination (24-hour external loop recording, exercise ecg, cardiac mri) and a close follow-up. external loop recording and exercise ecg have an interest in the identification of patients presenting with arrhythmic complications, such as premature ventricular contractions, and in the global evaluation of hemodynamic consequences of the mitral regurgitation. more recently, detection of myocardial fibrosis among patients with mvp and severe ventricular arrhythmia has been identified. fibrosis could evolve independently of the valvular regurgitation's severity and could be a substrate (myocardial scar) leading to ventricular arrhythmia. however, no study has specifically characterized myocardial lesions among patients with mvp and none, or not significant, mitral regurgitation. using cardiac magnetic resonance imaging (mri), gold standard technique in myocardial imaging and characterization, and echocardiography, particularly speckle-tracking imaging, identification of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using speckle-tracking strain) myocardial lesions. identification of patients with impaired deformation patterns, fibrosis or with premature ventricular contractions may isolate a sub-group of patients with a higher risk of severe ventricular arrhythmia for whom a closer follow-up could be justified.


Eligibility criteria:
inclusion criteria: * mitral valve prolapse diagnosed in echocardiography * signed written consent * affiliation to social security * no contraindication to mri or exercise ecg * age above 18 exclusion criteria: * mitral valve prolapse with severe regurgitation and instable hemodynamic state requiring urgent surgery * prior mri with contrast within the last month * prior diagnosis of primary cardiomyopathy potentially responsible for myocardial fibrosis * contraindication to exercise ecg: severe handicap, poor physical capacity * contraindication to mri: implantable device, claustrophobia, metal debris * renal insufficiency with creatinine clearance \<30 ml/min or prior serious side effect related to infusion of a magnetic contrast agent * pregnant or breast-feeding women * minors \<18 years old * mental illness or incapacity with incapacity to obtain informed consent

Keywords: ventricular premature complexes
intraoperative neuromonitoring recording with a novel scs paddle

Conditions: Chronic Pain; Neuropathic Pain; Failed Back Surgery Syndrome; Complex Regional Pain Syndromes

Summary: the purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. the research electrode ("study electrode") is designed to answer basic physiological clinical research questions. it may inform future device therapy development, but the study electrode is not a product that will be marketed or sold. the investigators believe the protocol is a non-significant risk study answering basic physiological research questions, which may be performed under hospital irb approval.


Eligibility criteria:
inclusion criteria: * patients undergoing a spinal cord stimulation procedure for neuropathic pain * must be fluent in english as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams. * subjects must be able to give informed consent. exclusion criteria: * patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain

Keywords: spinal cord stimulation chronic pain
pre-hospital tourniquet in extremity injury

Conditions: Extremity Injury

Summary: 2.1. objective: • primary objective: to compare outcomes of patients with extremity injuries presenting with or without pre-hospital tourniquet placement. 2.2. study outcome measures * primary outcome: incidence of arrival in shock (sbp \<90) * secondary outcomes: demographics, comorbidities, mechanism of injury, cause of injury, diagnosis codes, procedure codes, injury severity scale, abbreviated injury scale, operative management vs. non-operative management, radiologic findings, pathologic findings, tourniquet effectiveness (as determined both subjectively by trauma surgeon and objectively by presence vs. absence of pulse below level of tourniquet application), total number of units of blood products transfused within first 24 hrs, total number of units of blood products for index admission, type of blood products or other fluid given, hospital length of stay, icu length of stay, ventilator days, infectious complications, other complications, discharge disposition, 24 hr mortality, overall mortality.

this is a prospective, observational study. all patients who present to the participating ed's who meet inclusion/exclusion criteria will be identified by the treating trauma surgeons. data collected will include basic patient demographics, data regarding the patient's injuries, data regarding tourniquet use, and data regarding outcomes. please see the attached data collection tool for specifics (appendix 12.1). data will be collected prospectively in an observational manner using the data collection tool. data collected on individual collection sheets will be de-identified. we plan to complete the data collection and analysis by 01\\01\\2021.

Eligibility criteria:
inclusion criteria: ≥ 18 y/o patients with extremity injuries * with a tourniquet in place or * who the treating physician deems could have benefited from tourniquet placement exclusion criteria: * children * prisoners * pregnant women * patients with non-traumatic bleeding requiring tourniquet use