Kornimate/medical-research-clean huggingface dataset:
an open, single-center clinical study of surufatinib combined with temozolomide and s-1 in the first-line treatment of advanced neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: this is a prospective, open, single-center study evaluating the efficacy and safety of surufatinib combined with temozolomide and s-1 as the first-line treatment of advanced neuroendocrine tumors


Eligibility criteria:
inclusion criteria: * aged 18-75years (inclusive); * histopathologically confirmed diagnosis of advanced mgmt0/1+ (g1, g2 or g3) neuroendocrine tumor (locally advanced, unresectable or distant metastasis); * previously untreated with systemic therapy; * have at least one measurable lesion according to recist v1.1; * ecog performance status: 0-2(determined by investigator); * expected survival time \> 3 months; * adequate hepatic, renal, heart, and hematologic functions; * urine protein \< ++ . if urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g; * before the first dose, serum hcg examination of potential childbearing-women must be negative; men/women of childbearing potential must agree to use a highly effective contraceptive method (such as double barrier contraceptive method, condom, oral or injectable contraceptives and intrauterine device) throughout treatment and for at least 90 days after study completion. exclusion criteria: * neuroendocrine cancer, adenocarcinoid, goblet cell carcinoid, * functional nets which need to control symptoms by long-acting somatostatin analogues; * received a major surgery which requires at least 3 weeks after recovery time, to undergo surgery on treatment of this research within 4 weeks prior to treatment; * have uncontrolled hypertension, defined as systolic blood pressure \>140 mmhg or diastolic blood pressure \>90 mm hg, while under anti-hypertension treatment; * patients with active ulcer, intestinal perforation and intestinal obstruction; * with active bleeding or bleeding tendency; * severe history of cardiovascular and cerebrovascular diseases; * other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.

Keywords: surufatinib temozolomide and s-1 first-line treatment
transverse coloplasty vs. side-to-end anastomosis following low anterior resection (lar): csar trial

Conditions: Rectal Cancer; Rectal Neoplasms; Rectal Tumors; Fecal Incontinence

Summary: csar trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.

this study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. its focus is on the functional results. besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.

Eligibility criteria:
inclusion criteria: * scheduled low anterior resection in patients with distal rectal carcinoma and planned anastomosis in mid/distal third of rectum * local curative approach * normal continence preoperatively * non-ibd-associated carcinoma * possible sphincter salvage * signed informed consent exclusion criteria: * non-curative approaches * emergency surgery in cases of tumor perforation, abscess, sepsis * proximal rectal carcinoma (\> 12 cm from anocutaneous line) * lack of informed consent * age \<18 years * inclusion in other trials with interference of endpoints * life expectancy less than 24 months (as estimated by the treating physicians) * pregnancy * immunosuppression

Keywords: rectal cancer low anterior resection coloplasty pouch side-to-end anastomosis continence quality of life
the influence of short-term starvation on hepatitis b virus load

Conditions: Starvation; Infection

Summary: hepatitis b virus is a small dna virus that affects 400 million people worldwide. the virus infects the liver and previous studies, done in tissue culture and in animals, have shown that viral replication is affected by metabolic changes occurring in the liver. specifically, starvation induces hbv gene expression and replication, in parallel to the activation of the gluconeogenesis response, and feeding attenuates viral activity. in this study we are going to recruit hbv patients with detectable viremia and analyze their viral load after an over night starvation versus after a morning meal. our hypothesis is that following an over-night starvation viral load will be higher than that in the fed state.


Eligibility criteria:
inclusion criteria: * hepatitis b virus patients with detectable viremia * \>18 years old * signed a consent form exclusion criteria: * patients with malignancy * patients with diabetes mellitus * alcohol consumption of more than 140grams a week * advanced liver disease * hcv or hiv infection * pregnancy * mental retardation or unable to understand basic explanation about the study -

Keywords: hepatitis b virus metabolovirus
leveraging the hiv platform for hypertension control in uganda (integrated hiv/htn) study

Conditions: HIV; Hypertension

Summary: the integrated hiv/htn is a hybrid type-1 effectiveness/implementation cluster randomised trial evaluating the introduction of a multi-component integrated hiv/htn care model intervention, randomised to 13 districts in the intervention arm compared to 13 districts in the control. selected health facilities within the 13 intervention districts will receive the intervention while those in the 13 control districts will continue implementing the standard of care as per the ministry of health (moh) guidelines. all the participating facilities will receive blood pressure (bp) machines, and non- communicable diseases (ncds) registers as a standard of care.

the investigators propose to evaluate a multi-component integrated hiv/htn care intervention through a cluster randomised controlled trial. a cluster has been defined at the level of the district which is the randomisation unit. a total of 26 districts will be randomised. selected health facilities within the 13 intervention districts will receive the multi-component intervention of combined hiv and (hypertension) htn care which includes; 1) training and capacity building on the integrated hiv/htn model and ncd care; 2) the integrated hiv/htn care delivery model by promoting htn screening and care in hiv clinics; 3) health management information system (hmis) enhancements through mentorship and coaching on the use of ncd registers and ncd patient cards and htn data capture in the emr system; and 4) short messaging system (sms) and/or whatsapp for data coordination and communication among providers, dhos and the study team (who acts as mentors). the 13 control districts will continue implementing the current standard of care as per moh guidelines. the investigators will test the hypothesis that a multi-component intervention of combined hiv and htn care, based on the precede framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of hiv/htn among adults in hiv care in the intervention compared to control facilities. specific objectives are as follows; 1. to determine the effectiveness of an integrated hiv/htn care model on htn and dual hiv/htn control among adult patients in hiv clinics. 2. to assess the barriers and facilitators of the integrated hiv/htn care model for hiv patients at different levels. 3. to determine the cost, cost-effectiveness and incremental gain costs of the integrated hiv/hypertension care model approach.

Eligibility criteria:
inclusion criteria: * adults 18 years and above with hiv for one category * adults 18 years and above with hiv and hypertension for the second category * willing to consent exclusion criteria: * patients who are very sick * patients not willing to continue seeking care from the study health facility
next generation pathogen sequencing for prediction of infection in rheumatic disease

Conditions: Infection

Summary: the majority of patients diagnosed with rheumatic disease, such as systemic lupus erythematosus, inflammatory myositis, and vasculitis, will experience fever or infection during their course of therapy. the most common microbiologically documented infection is bacterial, virus, and fungal, which can be associated with the severity and mortality of disease. current methods of diagnosis require a significant load of pathogen making early detection difficult. delayed diagnosis and delayed optimal therapy of infection are associated with increased morbidity and mortality. this study seeks to identify whether next generation sequencing (ngs) of pathogens can identify patients with infection treated with corticosteroid and immunosuppressive agents. this would enable preemptive targeted therapy to replace prophylaxis treatment which often leads to some adverse events and antibiotic resistance.

plasma/serum samples collected but not required for clinical care (discarded samples) will be collected and stored. results of ngs will be compared between patients who develop definite infection immediately (within 72 hours) after sample collection, and those who remain well. clinical data describing baseline information about the patient and rheumatic diseases, antibiotic and steroid or immunosuppressor therapy exposure, pathogen testing, immunology results, and infection-related events will be collected prospectively from the electronic medical record. an initial exploratory phase will examine approximately 50 participants to determine whether the effectiveness of predicting infections. the study may then enroll up to 200 participants to collection additional data for analysis.

Eligibility criteria:
inclusion criteria: * 18 years to 70 years; * undergoing care for rheumatic disease at peking university people's hospital; * in a category of patients who are considered by the investigator to be at high risk of infection exclusion criteria: * any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
promoting optimal treatment for community-acquired pneumonia in the emergency room (pioneer)

Conditions: Community-acquired Pneumonia

Summary: pneumonia in children can be caused by different types of germs such as bacteria and viruses. giving antibiotics to children with bacterial bugs is helpful while giving antibiotics to children with viruses will not help them. unfortunately, it is difficult for doctors to tell when a child's pneumonia is caused by bacteria or viruses. most young children are given antibiotics even though it doesn't help them. our study wants to test a new way to care for children with pneumonia so that only children who will benefit from antibiotics will receive them. the study will use a combination of the child's symptoms, x-rays results, and lab testing to better determine if a child needs antibiotics. the study team will then review the testing results and follow up with the patient and their family in the following days to ensure that the child is improving. pioneer will test a novel care pathway for treating non-severe pediatric pneumonia with the goal of decreasing antibiotic prescription while maintaining equal clinical outcomes to standard care.


Eligibility criteria:
inclusion criteria: 1. diagnosed primarily with community-acquired pneumonia as per the ed md and are well enough to be discharged home. 2. they also must have any one of: 1. tachypnoea; 2. cough; 3. increased work of breathing; or 4. auscultatory findings consistent with pneumonia; exclusion criteria: children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease (requiring treatment or with exercise restrictions), history of repeated aspiration/velopharyngeal incompetence, malignancy (current or past), immunodeficiency (primary, acquired, or iatrogenic), pneumonia previously (clinically) diagnosed within the past month, or lung abscess diagnosed within the past six months. children who present with ongoing fever after 4 or more days of beta-lactam therapy active against s. pneumoniae (ie. amoxicillin, amoxicillin-clavulanate, cefprozil, cephalexin, cefadroxil), levofloxacin/moxifloxacin, or doxycycline will not be eligible. children will not be eligible to participate more than once.

Keywords: community-acquired pneumonia diagnostics respiratory viruses mycoplasma
factors associated with post-induction hypotension in inph patient undergoing vp and lp shunt

Conditions: The iNPH Patients Scheduled for VP or LP Shunt Procedures

Summary: this study is a retrospective work involving the review of patients who were scheduled for vp or lp shunt in siriraj hospital, mahidol university, thailand. the sample size calculation was based on the rule of thumbs of the logistic regression comprising 18 risk factors. the incidence of post-induction hypotension according to our institution's pilot study november 2019-january 2020) was 47%. with 10% addition for missing data and other possible reasons, the sample size was 426. the primary objective of the study is to report the factors associated with post-induction hypotension in inph patients undergoing vp or lp shunt procedures. our secondary objective is to determine the incidence of post-induction hypotension in these patients.


Eligibility criteria:
inclusion criteria: * elective cases of inph scheduled for vp and lp shunt * patients aged \> 18 years old exclusion criteria: * emergency cases
multi-center assessment of grafts in coronaries: long-term evaluation of the c-port device

Conditions: Heart Disease

Summary: the study plan is a post-market prospective, multi-center, open-label registry. the vein graft failure rates for the currently commercialized c-port devices will be compared to an a priori rate taken from the peer-reviewed literature.

to satisfy the requirements set forth in post-market surveillance orders issued by the us fda to cardica, inc., the following outcomes will be evaluated: 1. acute, midterm, and one-year graft failure rates for coronary revascularization using the c-port® xa™ distal anastomosis system, c-port® flexa™ distal anastomosis system, and c-port® xchange™ distal anastomosis system when in general use in the united states compared to hand-sewn anastomoses. 2. technical failure rates when attempting to complete an anastomosis using the c-port xa, flexa, and xchange distal anastomosis systems. 3. the technical success rate of hand-sewn anastomoses following technical failures of the c-port devices and the hand-sewn graft patency rates and clinical sequelae at one year.

Eligibility criteria:
inclusion criteria: * able to give informed consent. * willing and able to have follow-up visits and examinations. * less than 80 years old. * have an ejection fraction of \>30 %. * have a life expectancy of \>1 year. pre-operative exclusion criteria: * currently participating in other clinical trials that would conflict with this protocol. * unable to meet study requirements. * currently pregnant. * require preoperative use of an intraaortic balloon pump. * have a history of a bleeding disorder or history of a thromboembolic disease requiring anticoagulation therapy. * have congestive heart failure or been classified as nyha class iv. * have an aspirin allergy or other contraindications to aspirin use. * previous coronary artery bypass surgery. * vasculitis or other nonatherosclerotic cause for coronary artery disease. intra-operative exclusion criteria: * at least one target vessel site where the c-port anastomosis will be placed that is free from severe calcification or severe atheromas * target vessel wall properties where the c-port anastomosis will be placed are suitable for hand-sewn anastomosis * target vessel diameter is ≥ 1.3 mm * target vessel has a single wall thickness ≤ 0.75mm * hemodynamically stable
prevalence of covid-19 in children admitted to paediatric emergency departments during the pandemic period in france

Conditions: Coronavirus; COVID; Infection Viral

Summary: arriving in december 2019, coronavirus covid-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. the child appears little or no affected by this infection. it is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. for this reason, measures have been taken to close schools and contain populations in a large number of countries, including france. however, there are no data on the prevalence of covid-19 in children.


Eligibility criteria:
inclusion criteria: * 1st line consultation in pediatric emergencies * all reasons for consultation during working hours * informed and written consent of a parent holder (only 1 authorized companion) and a child of understanding age exclusion criteria: * refusal of participation by parents/child of decision age * no membership of a social security scheme (beneficiary or entitled) * no understanding of french

Keywords: pediatric emergencies pandemia
series of n-of-1 crossover trials of antihypertensive therapy in adolescents with essential hypertension

Conditions: Essential Hypertension

Summary: children are increasingly being diagnosed with essential hypertension and the absence of comparative effectiveness research in antihypertensive therapies has contributed to considerable differences in prescribing practices among physicians treating children with essential hypertension. this study will consist of a series of systematically-administered n-of-1 trials among children to verify the need for ongoing antihypertensive treatment and if so, to identify the preferred single drug therapy.

this is a series of systematically-administered n-of-1 trials among children with essential hypertension to verify the need for ongoing antihypertensive treatment and if so, to identify the preferred single drug therapy from among the three major classes of drugs commonly used for essential hypertension (angiotensin converting enzyme inhibitors, calcium channel blockers, and diuretics). the investigators will determine whether there is one that is preferred for the great majority of patients. the "preferred" therapy will be defined as the drug which produces normal ambulatory blood pressure, with the greatest reduction in awake mean systolic blood pressure without unacceptable side effects. for each patient, the order of the 3 drugs will be assigned randomly and each drug will be taken for 2 weeks. the effectiveness of each drug will be measured with 24-hour ambulatory blood pressure monitoring, and tolerability will be assessed using a side effect questionnaire. participants will rotate through treatment periods, repeating drugs and adjusting doses until the preferred therapy is identified. in assessing whether one the medications is most effective for the great majority of subjects, the primary outcome will be the percentage of participants for whom each drug is selected as the preferred therapy. primary hypothesis: no drug will be selected for the majority of the subjects, a finding that would support consideration of clinical use of n-of-1 trials. secondary analyses will explore whether patient characteristics predict which medication will be selected as a preferred drug.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of essential hypertension * treating physician has determined that pharmacologic therapy is necessary exclusion criteria: * compelling indication to select one particular medication * specific contraindication for any of the 3 therapies

Keywords: anti-hypertensive medications pediatrics n-of-1 trial
the effect of instrument- assisted soft tissue mobilization on upper crossed syndrome

Conditions: Upper Cross Syndrome

Summary: this study will be a randomized controlled trial conducted to investigate the effect of myofascial release with iastm on pain intensity level, cervical rom, chest expansion, craniovertebral angle and kyphotic angle in upper crossed syndrome patients. a sample size of 52 will be randomly allocated to two group ,(26 participants in each group), by using computer-generated random number list control group will recieve conventional physical therapy in form of stretching and strengthening and experimental group will recieve firstly myofascial release with iastm then applying the same conventional physical therapy of control group . both groups will recieve 3 sessions per week for 4 weeks .

upper crossed syndrome is characterized by the altered activation of specific muscles and postural deviations of the head, neck, and shoulders. alterations in muscle activation include tightness of suboccipital and short erector spinae muscles of the neck, levator scapulae (ls), and upper trapezius (ut) muscles on the dorsal side crossed by tightness of pectoralis major (pm) and minor, sternocleidomastoid (scm), and scalene muscles on the ventral side, and weakness of deep neck flexors (dnf) on the ventral side crossed by weakness of rhomboids, serratus anterior (sa), and middle and lower trapezius (lt) muscles on the dorsal side . because of ucs described as muscle imbalance pattern which located within the cervical and thoracic spine region. these imbalances have been shown to produce elevation and forward movement of the shoulders, winging of the scapula, and a forward extension of the head. these changes lead to overstress of the cervical cranial junction and shoulders, which can cause neck and/or jaw pain, headaches, and shoulder problems . in this syndrome, the increased activity of accessory muscles of respiration disturbs the breathing, and the temporomandibular joint (tmj) may develop osteoarthritis, resulting in chronic neck pain . for the available literature, with the lack of evidence supporting about the effects of using myofascial release with iastm on ucs patients. so the aim of this study was to investigate the effect of myofascial release with iastm on pain intensity level, cervical rom, chest expansion, craniovertebral angle and kyphotic angle in ucs patients.

Eligibility criteria:
inclusion criteria: - 1-age ranged from 18 to 45 years . 2- all participants had intensity of neck pain on vas (4-8) (moderate cases) . 3 - all participants had mechanical neck pain and fhp (craniovertebral angle cva \< 49) cva of \< 49) .. 4- all participants had kyphosis angle ≥45°. exclusion criteria: * 1- malignancy. 2- fractures of the cervical spine. 3- cervical radiculopathy or myelopathy. 4- vascular syndromes such as vertebrobasilar insufficiency. 5- rheumatoid arthritis. 6- neck or upper back surgery. 7- taking anticoagulants. 8- local infection.