Kornimate/medical-research-clean huggingface dataset:
effectiveness of a bivalent killed whole cell based oral cholera vaccine

Conditions: Cholera

Summary: various field studies has found that the modified , bivalent, whole cell - based oral cholera vaccine (ocv) to be safe, immunogenic and effective with protective efficacy of 67 % in earlier clinical trials. however, the effectiveness of the vaccine in "real" life situation using the public health system is unknown. it is critical to follow up in the same population, where pilot introduction of ocv was introduced and evaluate vaccine proactive effectiveness at individual as well as at population level. the follow - up and determination of effectiveness of mass ocv vaccination was requested by state government.

the overall goal of this study is to evaluate the protective effectiveness of one or two doses of modified, bivalent, killed whole cell based ocv, given at least 14 days apart, when delivered through community - based mass vaccination campaign using existing public health infrastructure in a high - risk population in satyabadi block of puri district, orissa, india. this study has following objectives primary objectives: \* to evaluate the individual level protective effectiveness of one or two doses of ocv against culture confirmed cholera episodes, severe enough to seek a formal health care. secondary objectives: * to evaluate population - level effectiveness (herd effects)of ocv delivered through a community based mass vaccination when the vaccine is delivered to more than half of population at risk. * to determine inverse correlation between vaccine coverage and cholera incidence among diverse geographical clusters.

Eligibility criteria:
inclusion criteria for cases of the main case-control study are as follows: * giving verbal informed consent/assent, or in the case of minors, a parent or guardian give informed consent to participate in the study * living in the study area since the start of the mass vaccination * submitted a faecal specimen * whose residence could be located * whose stool specimens yield v. cholera o1 or o139 * belonging to study population through census database exclusion criteria: * not giving verbal informed consent/assent, or in the case of minors, a parent or guardian does not give informed consent to participate in the study * not living in the study area since the start of the mass vaccination * no faecal specimen * whose residence could not be located * whose stool specimens does not yield v. cholera o1 or o139 * not belonging to study population through census database

Keywords: oral cholera vaccine herd risk population matched control case bias
early detection of and intervention towards chronic diseases among individuals without formal education

Conditions: Smoking; Health Behavior; Chronic Disease

Summary: in this randomized controlled study it is investigated if a proactive action by the general practitioner offering individuals without formal education a preventive health check will lead to a larger number of diagnoses in form of chronic obstructive pulmonary disease, cardiovascular diseases, and diabetes among participants in the intervention group compared to the control group. furthermore it will be investigated if the proactive action by the general practitioner will be associated with a higher smoking cessation rate at 12 month follow-up.

the study will be conducted at vesterbro and amager in copenhagen, denmark, and general practitioners with a medical practice in this area will be invited to enter the study. from the patient lists of the participating general practitioners all persons aged 45-64 years will be identified and baseline questionnaires will be mailed to these persons. the questionnaire information will be entered electronically into the general practitioners electronic chart system using the danish quality unit of general practice (dak-e) system. thus, the questionnaire information will provide the general practitioners with information in the electronic form on health behavior, symptoms and socioeconomic information on all his patients in this age group that would not normally have access to in a systematic way. persons who answer the baseline questionnaire and who do not have any formal education will randomly be divided into two groups - one intervention group and one control group. all persons allocated to the intervention group will receive a personal invitation to an appointed health check from their general practitioner. the health check at the general practitioner includes measurement of weight, height, hip and waist circumference, blood pressure, lung function, blood sugar, total cholesterol, and thyroidal status. participants with abnormal screens at the health check will, depending of the severity, either receive the offer of the referral to the municipality health center for a lifestyle change program and/or follow the procedures for diagnostics and treatment. for individuals with abnormal screens or health behavior amenable to intervention at the first health check an additional health check will be scheduled six months after the first health check. persons allocated to the control group will receive a baseline questionnaire and other than that follow normal procedure in general practice. at 12 month follow-up questionnaires will be send out to all participants at the intervention group as well as the control group.

Eligibility criteria:
inclusion criteria: * participants must be 45-64 years old with no formal education beyond secondary school * participants must live in copenhagen * participants' general practitioner must be participating in the study exclusion criteria: -

Keywords: health behavior chronic disease proactive action general practitioner preventive health check social inequality in health randomised controlled trial
non-dispensing evaluation of an investigational galyfilcon a soft contact lens

Conditions: Myopia

Summary: the purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational galyfilcon a contact lens and an approved galyfilcon a contact lens.


Eligibility criteria:
inclusion criteria: * be of legal age (i.e., at least 18 years old) * sign a written informed consent * have contact lens distance sphere requirement in the range -1.00d to -6.00d * have spectacle astigmatism \<1.25d in each eye * currently wear acuvue® advance™ (for at least 6 months) with documentation of current prescription. * have normal eyes with no evidence of abnormality or disease. exclusion criteria: * required concurrent ocular medication * any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear. * eye injury or surgery within eight weeks immediately prior to enrollment for this study. * abnormal lacrimal secretions * pre-existing ocular irritation that would preclude contact lens fitting. * keratoconus or other corneal irregularity. * pregnancy, lactating or planning a pregnancy at the time of enrolment. * participation in any concurrent clinical trial * known allergy to silver, silver ions, or silver containing compounds.
comparison between high-sensitivity cardiac troponin t and standard tnl assays in early cardiac ischemia detection

Conditions: Acute Coronary Syndrome

Summary: it is crucial to rapidly identify cardiac ischemia in the care of patients with suspected acute coronary syndrome (acs). cardiac troponins are a major factor in the diagnostic of myocardial infarction. new methods have been developed to improve the accuracy of the assay and determine low troponin concentrations. elecsys® (highly sensible t troponin) tnt-hs assay is supposed to help early detection of myocardial infarction after onset of symptoms. it should therefore shorten the transit time to emergencies by a more rapid intervention or a faster return home. the aim of the study is to compare tnt-hs assay to the standard troponin assay in the detection of early cardiac ischemia in patients with acs.

patients with suspected acs with 2/2 negative results of conventional troponin i assay and 1/3 positive result of highly sensitive troponin assay will have a non invasive cardiac rb82 pet/ct performed within 24 hours of admission. this exam is recognized by associations of cardiology for its high sensibility and specificity in coronary disease detection.

Eligibility criteria:
inclusion criteria: * chest pain of ≥ 5 minutes during the last 24 hours, or other symptoms suggestive of acs (unstable angina or nstemi) with 2 negative standard troponin values(\<0.09 µg/l) * age ≥ 18 exclusion criteria: * patients with st- segment elevation myocardial infarction (stemi) * detection of tni standard values \> 0.09 (limit of positivity) in one of two blood samples (t0 and t6) * detection of heart disease or extra-cardiac disease that could explain the elevated conventional troponin values * presence of major organ dysfunction, infection or major underlying medical condition that could compromise the patient's ability to perform a stress test for myocardial ischemia * cancer with prognosis \< 6 months

Keywords: acute coronary syndrome myocardial ischemia high-sensitivity cardiac troponin t
non-invasive peri- and postoperative monitoring of femoral artery balloon angioplasty

Conditions: Cardiovascular Diseases

Summary: this study evaluates a novel noninvasive method to dynamically monitor the effect of percutaneous transluminal angioplasty on arterial pulse wave

patients with stenosis of superficial femoral artery referred for percutaneous transluminal angioplasty are monitored before, during and after the procedure and pulse wave analysis is conducted.

Eligibility criteria:
inclusion criteria: 1. the patient has been clinically examined at policlinic of vascular surgery 2. the patient has undergone measurement of ankle-brachial index (abi) and toe-brachial index (tbi) at policlinic of vascular surgery and exhibits abnormal abi\ 1.3 3. the patient is considered to have an indication for vascular procedure (critical limb ischemia, intermittent claudication) 4. the patient has been examined with magnetic resonance imaging (mra) 5. the patient has been considered a candidate for superficial femoral artery percutaneous transluminal balloon angioplasty (pta) and/or stenting exclusion criteria: 1. pacemaker 2. measurement disturbs or risks the subject's treatment process withdrawal: 1. emergency cases 2. by subject's denial 3. inability to detect signals -
steroids on intra-dialytic hypotension

Conditions: Dialysis Hypotension

Summary: symptomatic hypotension during (or immediately following) hemodialysis complicates 5 to 30 percent of all dialysis treatments and is associated with increased morbidity and mortality. kidney disease outcomes quality initiative (kdoqi) and european best practice guidelines define intradialytic hypotension as the presence of a decrease in systolic blood pressure ≥20 mmhg or a decrease in mean arterial pressure by 10 mmhg, providing the decrease in blood pressure is associated with clinical events and need for nursing interventions. common causes of intradialytic hypotension include excessive or rapid ultrafiltration, high blood flow during dialysis, chf, taking the antihypertensive medications prior to hd, and others. one of the possible reasons that is surprisingly has not been approached worldwide for intra-dialytic hypotension could be more prevalent adrenal insufficiency in esrd patients or a delay in the appropriate rise of endogenous serum cortisol given hemodialysis is considered by all means a stressful condition to the body. investigators will assess first the prevalence of intradialytic hypotension at juh dialysis unit. investigators will screen patients who developed intradialytic hypotension for adrenal insufficiency by ordering random am cortisol. then investigators will give iv hydrocortisone 100 mg prior to hd to patients who developed intra-dialytic hypotension and monitor their bp response during the hd treatments for 3 hd sessions (1 week, 3 hd sessions). after that, the same patients will receive 100 mg normal saline for 3 hd sessions. both the administrator and the patient will be blinded for the interventions.


Eligibility criteria:
inclusion criteria: * patients on hemodialysis who develop intra-dialytic hypotension. exclusion criteria: * adrenal insufficiency

Keywords: hemodialysis cortisol hydrocortisone
xpede clinical study

Conditions: Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder); Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)

Summary: the purpose of this clinical study is to confirm the efficacy and safety of the kyphon®xpede™ bone cement in human use in china.


Eligibility criteria:
inclusion criteria: 1. subject being diagnosed as having painful pathological vertebral body fracture, who is suitable for vp/bkp procedure (1-3 levels) according to clinic practice. 2. subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration. 3. subjects are at least 18 and ≤80 years old . exclusion criteria: 1. subject has a local or systemic infection. 2. subject has pains caused by other spine disease than painful pathological vertebral compression fracture. 3. subject has a medical condition with less than 1 year of life expectancy. 4. subject is grossly obese, i.e. bmi≥40. 5. subject has medical conditions that represent contraindications for the use of bone cement by investigator's decision. 6. subject has an allergy or an intolerance to bone cement component. 7. subject has past spinal surgeries at the target level(s) for which the vp/bkp procedure is suitable. 8. subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the medtronic study manager and medtronic medical advisor. 9. pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence. 10. subjects with exclusion criteria required by local law (age or other). 11. subjects with medical condition which precludes them from participation in the opinion of the investigator.
camrelizumab plus chemoradiotherapy for patients with locoregional cancer of nasal cavity and paranasal sinuses

Conditions: Nasal Cavity Cancer; Paranasal Sinus Cancer; Camrelizumab; Induction Chemotherapy; Intensity Modulated Radiotherapy; Concurrent Chemotherapy

Summary: patients with locoregional cancer of nasal cavity and paranasal sinuses are candidate for this study. all the eligible patients receive three cycles of induction chemotherapy (docetaxel 60mg/m2+cisplatin 60mg/m2+5-fu2.5g/m2,civ48h, q3w) followed by concurrent two cycles of cisplatin (80mg/m2,q3w) with curative intensity modulated radiotherapy. besides, camrelizumab (200mg) is administrated every three weeks for a total of 11 cycles since the first day of induction chemotherapy. we aim to evaluate the three years failure free survival of these patients by the combination of camrelizumab with curative radiotherapy and chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cancer of nasal cavity and paranasal sinuses * t4bn0-3m0 (ajcc8th) or unresectable lymph nodes or refusal of surgery * kps≥70 * ne≥ 1.5×10e9/l, hgb ≥ 100g/l and plt ≥100×10e9/l * alt≤ 1.5 upper limit of normal (uln), ast≤ 1.5uln and bilirubin ≤ 1.5uln * creatinine clearance rate ≥ 60 ml/min (calculated by cockcroft-gault) exclusion criteria: * older than 65 or younger than 18 * hbsag (+) and hbv dna \>1×10e3 copiers /ml * hcv (+) * hiv (+) * autoimmune diseases * interstitial lung diseases * had other cancers before
gore viabahn endoprosthesis with heparin bioactive surface in the treatment of sfa obstructive disease (viper)

Conditions: Peripheral Vascular Diseases

Summary: the objective of the study is collect data on the gore viabahn endoprosthesis with heparin bioactive surface in the treatment of chronic superficial femoral artery disease. device patency at 12 months is the primary endpoint.


Eligibility criteria:
inclusion criteria:\> * lifestyle limiting claudication, rest pain or minor tissue loss\> * abi (ankle-brachial index) \ 0.9 * stenosis (\>50%) or occlusion of native sfa (superficial femoral artery) \>5cm * orifice and 1 cm of sfa are patent * popliteal artery is patent at the intercondylar fossa of the femur to the trifurcation * at least 1 patent run off vessel * guidewire and deliver system successfully traversed the lesion exclusion criteria:\> * untreated flow-limiting aortoiliac occlusive disease * any previous stenting or surgery in the target vessel * femoral or popliteal aneurysm of target vessel * no patent tibial arteries * prior ipsilateral femoral artery bypass * major distal amputation (above the transmetatarsal) in either limb * patients with known sensitivity to heparin

Keywords: peripheral arterial disease peripheral vascular disease
stress from in charge relative facing the announcement of decisions limiting or stopping treatments in emergency room during the covid-19 epidemic

Conditions: Covid19; Post Traumatic Stress Disorder; Anxiety

Summary: in the context of the covid-19 pandemic, the emergency reception services had to be radically reorganized. in this tense environment, professionals must face ethical dilemmas, make referral decisions and prioritize patients. due to the limited number of visits to many hospitals, interactions with relatives and families of patients are mainly conducted by phone. these limitations will continue as long as the context of uncertainty over the course of the pandemic persists. limitation or discontinuation of treatment (ldt) announcements were therefore also impacted and the exceptional situation related to covid-19 reinforces the difficulties encountered by professionals in usual time (place of announcement, inappropriate lack of time, etc.). thus, ldts are most often done over the phone without the families being able to go to the hospital. because of this, these announcements can be more traumatic. investigators have already highlighted in a recent study the lack of communication between caregivers and families in the context of ldt announcements and the context of covid 19 exacerbated these aspects given the limitations of visits. the investigators therefore propose to study the experiences of families who are notified of a decision to limit or stop treatment by phone in the emergency room during the covid-19 crisis.


Eligibility criteria:
inclusion criteria: * age over 18 years old. * person of trust designated in writing or contact person if designated by the family or primary caregiver or failing that the family member or person of trust of an adult patient deemed unfit to receive the information (advanced dementia (lower mms) to 10), disturbance of consciousness). only one person per family will be included. * having been informed of a lat decision in the emergency room by telephone during the pandemic * having consented to participate in the study * affiliated with social security exclusion criteria: * person of trust, family or close friend unable to understand or write in french.

Keywords: hads ies-r family limitation or discontinuation of treatment
application of dietary guidelines for the brazilian population by teleconsultation in obesity in primary care

Conditions: Obesity

Summary: obesity is a chronic disease that is highly prevalent in brazil. it is associated with diabetes and hypertension. obesity may decrease quality of life. communication tools, such as mobile devices and social media, are helping to control and prevent obesity. in this 2-arm randomized clinical trial, the investigators aim to evaluate the efficacy of the dietary guidelines for the brazilian population through 8 weekly video nutritional monitoring sessions with nutritionists. both groups will receive guidance from reference professionals from primary health care (physician and nurse). throughout the intervention program, both groups will be equally evaluated in order to verify at the end of the study effectiveness in weight loss and life quality improvement.

obesity is a multifactorial disease of epidemic proportions worldwide. the use of telecommunication tools has been used in health and nutrition in different contexts, seeking to reduce the burden of non-communicable chronic diseases. telehealth interventions are effective to increase quality of life and to improve the dietary food intake of participants; this kind of treatment seems feasable, cost-effective and has promising results to induce weight loss in obese individuals. this project will evaluate the impact of a remote nutritional intervention in short (8 weeks) and long term (24 and 48 weeks) on the weight fo obese individuals. the intervention will be based on the dietary guidelines for the brazilian population. it will focus on primary care patients and will have a multidisciplinary approach. it is an open-label pragmatic multicentre randomized controlled trial, with an 1:1 allocation: (1) intervention group (n = 289): remote consultation with nutritionists based on the dietary guidelines for the brazilian population; (2) control group (n = 289): usual follow-up in primary health care (phc). the primary outcome will be weight change at 8 weeks. additionally, the investigators will evaluate food consumption and quality of life at 8 and 24 weeks as secondary outcomes.

Eligibility criteria:
inclusion criteria: * female and male individuals, with bmi ≥30 kg/m²; * age over 18 years; * internet access by phone or tablet or computer and whatsapp multi-platform application (facebook inc.); * weekly time availability (10-20 minutes). exclusion criteria: * individuals who do not have access to the whatsapp multi-platform application (facebook inc.).

Keywords: obesity chronic disease noncommunicable diseases telemedicine diet, healthy primary health care unified health system
computed tomography angiography accuracy in brain death diagnosis

Conditions: Brain Death

Summary: the purpose of this study is to assess the reliability of computed tomography angiography (cta) to diagnose brain death, face of several conditions that make impossible to define such diagnosis using clinical criteria exclusively.

critically ill patients, presenting glasgow coma score 5 or lower, will be submitted to the computed tomography angiography (cta) of the skull assessment, and follow a clinical evaluation for brain death, additionally, transcranial doppler would be applied as the gold standard for brain death. we will exclude patients whose do not can be submitted to contrast injection, or if a brain death clinical evaluation has been performed prior the cta.

Eligibility criteria:
inclusion criteria: * individuals of any age or sex with brain death suspicion raised, before clinical test. * comatose patients presenting glasgow coma score as or under 5 points, under sedative agents or not. exclusion criteria: * brain dead patients clinically confirmed. * contraindications to the use of contrast medium (renal failure or allergy).

Keywords: brain death neurological death cerebral circulatory arrest computed tomography angiography