Kornimate/medical-research-clean huggingface dataset:
validation and reliability testing of dysphagia trained nurse assessment

Conditions: Dysphagia Following Cerebral Infarction; Dysphagia Following Nontraumatic Intracerebral Hemorrhage

Summary: nurses at royal derby hospital, uk have been trained to use a comprehensive protocol based dysphagia assessment (dysphagia trained nurse assessment (dtnax)) to assess all acute stroke patients on admission. this study aims to validate the tool by comparing it to the gold standard assessment - videofluoroscopy and usual assessment by a speech and language therapist. inter-rater and intra-rater reliability will also be tested by comparing the assessment results of two different nurses or the same nurse.

speech and language therapists (slts) at royal derby hospital (rdh) have developed a tool that trained nurses can use to carry out swallowing assessments with patients following a stroke. it consists of checks to ensure the patient is alert/well enough, checks any abnormalities in the muscles of the mouth or throat and trials different types of foods/drinks. if they 'pass' the assessment patients are started with regular diet and fluids. if they have dysphagia the nurses can recommend modified foods/drinks if they have found to be safe during the assessment. if the patients 'fail' with all trials - they remain nil by mouth. around 50% of patients who have a stroke have difficulties swallowing (dysphagia). if dysphagia is identified early it reduces secondary complications such as pneumonia. there are no similar tools in the uk that have been tested to check they are doing what they say they are doing (validity) or the results are the same no matter which trained nurse uses the tool (reliability). this study aims to test the validity and reliability of the dysphagia trained nurse assessment dtnax that is currently used in the acute stroke pathway at rdh. over an 18 month period we aim to recruit 50 patients admitted to rdh with a new stroke and who have had an initial dtnax. the results of the dtnax will be compared to the gold standard dysphagia assessment - videofluoroscopy - a video xray of swallowing and also compared to the usual slt assessment. we can calculate whether the tool identifies dysphagia and whether the recommendations made by using the tool are accurate and safe. to test reliability - the dtnax will be repeated by the same nurse or by a different nurse. the patients will be involved in the study for approximately 24 hours.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 * clinical diagnosis of stroke (ischaemic or haemorrhagic) exclusion criteria: * dysphagia of another cause * unable to tolerate vfs due to agitation or severe cognitive difficulties (patients need to be able to sit in a suitable chair - rea assist, 9l, mangar porter, tilt and space etc. for vfs) * not medically well enough to undertake assessments (as determined by the clinical care team) * pregnant women
palliative short course radiotherapy for advanced thoracic cancer

Conditions: Palliative Care

Summary: the study wants to define the maximum tolerated dose (mtd), safety and efficacy of a short course radiation therapy in patients with symptomatic advanced thoracic cancer.

the study wants to define the maximum tolerated dose (mtd) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of advanced thoracic cancer.

Eligibility criteria:
inclusion criteria: * histologically proven advanced thoracic cancer * excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status * age \> 18 years * eastern cooperative oncology group (ecog) \<3 exclusion criteria: - prior radiotherapy to the same region

Keywords: palliative care thoracic cancer radiotherapy pain quality of life
victor study - a study of valcyte (valganciclovir po) compared to ganciclovir iv in patients with cytomegalovirus (cmv) disease who are solid organ transplant recipients

Conditions: Cytomegalovirus Infections

Summary: this 2 arm study will evaluate the efficacy and safety of oral valcyte compared with intravenous ganciclovir for the treatment of cmv disease in solid organ transplant recipients. eligible patients will be randomized to receive either 1)valcyte 900mg po bid or 2)ganciclovir 5mg/kg iv bid. the anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * recipients of solid organ(s) transplant; * virologic and clinical evidence of cmv disease after transplantation; * patients of childbearing potential must be prepared to use effective contraception throughout, and for 90 days after the end of the study. exclusion criteria: * life-threatening cmv disease according to the investigator's judgment; * pregnant or lactating women.
a phase i safety and immunogenicity trial of ubi hiv lipopeptide immunotherapeutic p3c541b in hiv-1 seropositive human subjects

Conditions: HIV Infections

Summary: to evaluate an hiv lipopeptide immunotherapeutic, p3c541b, at two dose levels administered subcutaneously in hiv-seropositive patients.

patients are randomized to receive p3c541b or placebo within each of two study groups. enrollment in the first group will be independent of hla type, whereas all but two of the patients enrolled in group 2 must have one or more hla types a33, b8, b27, or bw62. treatment in group 2 will not begin until those in group 1 have reached day 14 without serious toxicity.

Eligibility criteria:
inclusion criteria patients must have: * hiv positivity. * cd4 count \>= 500 cells/mm3. * no evidence of aids, persistent diarrhea, fever, oral hairy leukoplakia, herpes varicella-zoster (multidermatomal), oral candidiasis, opportunistic infections, severe cytomegalovirus infection, or disseminated or chronic herpes simplex. * successful establishment of ebv transformed b lymphoblastoid cell line. note: * most patients in group 2 must possess one or more hla types a33, b8, b27, or bw62. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * active syphilis. * positive circulating hepatitis b virus antigen. * active clinically significant medical problems. * evidence of psychiatric, medical, or substance abuse problems that would affect ability to participate on study. * occupational or other responsibilities that would prevent completion of study. concurrent medication: excluded: * other hiv immunotherapeutic. * zidovudine or analog. * investigational therapies for hiv. patients with the following prior conditions are excluded: * history of cancer unless surgically excised with reasonable assurance of cure. * history of anaphylaxis or other serious adverse reactions to vaccines. * history of serious allergic reaction to any substance that required hospitalization or emergent medical care (e.g., stevens-johnson syndrome, bronchospasms, or hypotension). * history of autoimmune disease or use of immunosuppressive medications. * history of suicide attempts or past psychosis. prior medication: excluded within the past 6 months: * hiv immunotherapeutic. * zidovudine or analog. * investigational therapies for hiv. illicit drug use within past 30 days.

Keywords: vaccines, synthetic aids vaccines
clinical trial at neoadjuvant peritoneal and systemic chemotherapy plus hipec in gastric carcinomatosis

Conditions: Peritoneal Carcinomatosis; Gastric Cancer

Summary: implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric cancer. the goal is to get 1c level of evidence (patient died with "standard" treatment, with this treatment some of them survive) in terms of disease free survival and overall survival. methodology: prospective, phase ii, multicentric in spain. recruitment of 50 patients(to have 31 on treatment) in three years. this strategy is based on neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy(nips),to treat peritoneal disease by bi-directional approach; next step is cytoreductive surgery and hipec. once patients are discharged, they will follow a systemic adjuvant chemotherapy protocol.

patients with peritoneal carcinomatosis with gastric cancer who meet all inclusion criteria(and none of exclusion) will follow the next treatment scheme(40 week period of treatment): phase i (after one week of peritoneal catheter implant; total treatment 5-8 weeks): intraperitoneal infusion of docetaxel(30 mg/m2) and cisplatin (30mg/m2) in 1000 cc of saline. intravenous administration 5-fu (200 mg/m2/day, 7 days a week for 2 weeks) simultaneously with 2 cycles of intraperitoneal administration. these patients receive between four and six cycles of nips. until phase ii 4-6 weeks. phase ii:cytoreduction (cr) plus hipec (total treatment 4 weeks). maximal efforts to optimum cytoreduction. hipec: intraperitoneal administration: mytomicin c (15mg/m2)plus adriamycin (15mg/m2) at 42-43ºc for 60 minutes. intravenous simultaneously administration 5-fu (400mg/m2) plus leucovorin (20mg/m2) for 10 minutes at the beginning of peritoneal perfusion. phase iii: adjuvant chemotherapy 8-12 weeks after surgery. those cases reaching optimum cytoreduction (cc0) will be treated with systemic chemotherapy: first day: docetaxel (75 mg/m2) cisplatin (75mg/m2). days 1-5: 5-fu (750mg/m2/d).

Eligibility criteria:
inclusion criteria: * men and women aged 18-65 years old * histological evidence of peritoneal carcinomatosis from gastric cancer * no distance metastasis * ecog 0-1-2 * no contraindication for complex surgery * no other malign disease except skin cancer (different from melanoma or cervix cancer cin iii) * willing to consent and sign icf. exclusion criteria: * no histological evidence of peritoneal carcinomatosis from gastric cancer * previous gastrectomy due to gastric cancer. * patients with gastric cancer and previous systemic chemotherapy * peritoneal recurrence due to gastric cancer. * distance metastasis * sp \>2 at recruitment or sp\>1 at surgery * previous radiotherapy treatment * pregnant or breastfeeding women

Keywords: peritoneal carcinomatosis gastric cancer nips hipec
real-time mri for evaluating cardiac volumetry

Conditions: Left Ventricle Abnormality

Summary: this study will compare the accuracy of a real-time cine sequence in assessing cardiac volumetry.

this is a single-centre prospective study involving up to 570 patients with known or suspected cardiac disease referred for routine clinical cardiovascular magnetic resonance (cmr) assessment at glenfield general hospital, leicester. in addition to standard multi-breath-hold steady-state free precession (ssfp) imaging (undertaken as part of the routine scan), each patient will also undergo additional imaging with a non-breath-hold multi-slice real-time cine sequence. the primary outcome is the assessment of cardiac volumetry and function (end-diastolic volume, end-systolic volume, stroke volume, ejection fraction and myocardial mass) as measured by (1) the standard multi-breath-hold ssfp technique and (2) the non-breath-hold multi-slice real-time cine sequence. secondary outcome measures will be (1) the time required for each scan, and (2) image quality for each scan. an additional secondary outcome will be to compare indexed cardiac volumes with those indexed according to measured body-surface area.

Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 18 years 2. referred for routine cmr imaging 3. willing and able to give informed consent 4. willing and able to comply with the requirements of the study 5. able to understand written english exclusion criteria: 1. severe claustrophobia 2. absolute contraindications to cmr (those with cmr conditional or safe devices will be eligible for inclusion) 3. unable to provide informed consent 4. participants unable to understand written english
fetal outcomes among pregnant emergency general surgery patients

Conditions: Pregnancy Complications; Acute Appendicitis; Acute Cholecystitis; Biliary Pancreatitis; Bowel Obstruction; Acute Diverticulitis

Summary: approximately 1 in 500 pregnant women require non-obstetric surgery. surgical care for the pregnant woman raises concern for complications adversely affecting pregnancy outcomes. the most common reason for surgery is acute appendicitis followed by gallbladder disease. despite the common incidence of non-obstetric surgery among pregnant women, little is known regarding fetal outcome and the impact of laparoscopic interventions versus traditional open procedures. even less is known about the role of non-operative management of general surgical disease in the pregnant population. however, fetal outcome is not compromised by emergency general surgery condition interventions.

approximately 1 in 500 pregnant women require non-obstetric surgery. surgical care for the pregnant woman raises concern for complications adversely affecting pregnancy outcomes. the most common reason for surgery is acute appendicitis followed by gallbladder disease. despite the common incidence of non-obstetric surgery among pregnant women, little is known regarding fetal outcome and the impact of laparoscopic interventions versus traditional open procedures. even less is known about the role of non-operative management of general surgical disease in the pregnant population. however, fetal outcome is not compromised by emergency general surgery condition interventions. the primary objective of this study is to establish best practices for management of pregnant patients requiring emergency non-obstetric general surgery. this is a prospective multi-center observational study of pregnant women and their fetus/neonate (birth to 30 days) with acute general non-obstetric surgical diseases, including those undergoing operative and non-operative management. data collected will be purely observational and involve no study-based therapeutic interventions or alterations in patient care. the patients will be managed per institutional standard of care. data collection will occur in the following format: * initiated upon admission for general surgery until discharge for that admission * upon the birth of the child * post-delivery of the child, through that admission until discharged, for a maximum of 30 days post- delivery all of the data will be collected from the medical record, as long as the subject's providers utilize epic. otherwise, an approved member of the research team may need to contact the patient via telephone to obtain access to their non-epic record.

Eligibility criteria:
inclusion criteria: * pregnant women 18 or older with non-obstetric acute general surgical disease (acute appendicitis, acute cholecystitis, acute biliary pancreatitis, bowel obstruction, acute diverticulitis exclusion criteria: * trauma patients
respiratory disease cohort studies of chinese medicine for ild (research-ild)

Conditions: Interstitial Lung Disease

Summary: this study is a traditional chinese medicine cohort for interstitial lung disease（ild） in china, including at least 5000 patients with ild and followed up for at least 5 years. the aim is to focus on the demographic characteristics, clinical features, disease occurrence and development characteristics, tcm syndrome evolution patterns, and clinical efficacy of tcm treatment for ild in the real world.

this study focuses on ild patients and adopts a prospective cohort study design, with traditional chinese medicine treatment as the exposure factor. the subjects are divided into a traditional chinese medicine cohort and a non traditional chinese medicine cohort, with demographic characteristics, mortality rate, lung transplant rate, annual acute exacerbation frequency, traditional chinese medicine syndrome, 6mwt, lung function, dyspnea score, quality of life, and other observation indicators. follow up for at least 5 years will be conducted, and at least 5000 ild patients will be included, focusing on the demographic characteristics, clinical characteristics, disease occurrence and development characteristics, traditional chinese medicine syndrome evolution rules, and clinical efficacy of traditional chinese medicine treatment for ild in the real world.

Eligibility criteria:
inclusion criteria: 1. patients who meet the diagnosis of ild; 2. age≥18 years old; 3. ability to provide independent informed consent. exclusion criteria: patients with acute ild caused by known reasons, but the lesions disappear within 2 weeks after treatment. example: interstitial pneumonia caused by infections such as mycoplasma/virus, and those who recover after treatment are excluded.

Keywords: interstitial lung disease traditional chinese medicine cohort study
assessment of lung mechanics in covid-19 acute respiratory distress syndrome

Conditions: Covid19; ARDS

Summary: this study is meant to assess the lung mechanics in sars-cov-2 induced acute respiratory failure. a precise characterisation of lung mechanics and heart-lung-interactions might allow a better understanding of sars-cov-2 induced acute respiratory failure and thus lead to better mechanical ventilation strategies. this monocentric, observational study of critically ill covid-19 patients in the icu, will employ impedance tomography, right-heart catheterization, oesophageal pressure measurements, indirect calorimetry as well as classic mechanical ventilation parameters to characterise the mechanical characteristics of the lung as well as the heart-lung interactions in sars-cov-2 induced acute respiratory failure.


Eligibility criteria:
inclusion criteria: * sars-cov-2 infection * moderate to severe ards after berlin classification at peep 5 * admission to the institute of intensive care of the university hospital zurich * invasive mechanical ventilation * signed study informed consent or emergency procedure according to article 30 hfg exclusion criteria: * pregnant or breast feeding patients * age \<18 years * presumed rejection of the study intervention

Keywords: lung mechanics heart-lung interaction
espb vs.combination of espb and superficial pipb in cardiac surgery

Conditions: Anesthesia; Analgesia; Acute Pain; Patient Controlled Analgesia

Summary: cardiac surgery is associated with significant postoperative pain. pain control is an essential part of enhanced recovery protocols. the aim of this study is to evaluate and compare the analgesic efficacies of erector spinae plane block (espb) and the combination of espb and superficial parasternal intercostal plane block (pipb) in patients undergoing elective cardiac surgery.

many regional techniques have been used to manage postoperative pain in cardiac surgery, including thoracic epidural anesthesia, paravertebral, intercostal nerve block, intrathecal spinal morphine, and local infiltration. increased risk of epidural/spinal hematoma secondary to systemic heparinization, potential hemodynamic instability, technical difficulties and complications such as pneumothorax are potential serious drawbacks. due to the aforementioned reasons, anesthetists are understandably preferring ultrasound (us) guided interfascial plane blocks, which are generally thought to provide safer and more effective analgesia in cardiac surgery. this study aims to evaluate and compare the effects of espb versus espb plus superficial pipb on pain scores and opioid consumption in patients undergoing elective cardiac surgery. patients will be divided into two groups: group espb: in this group, patients will be administered bilateral espb (total of 40 ml, %0.25 bupivacaine) in addition to iv morphine patient-controlled analgesia (pca) for the first 24 postoperative hours. group espb+superficial pipb: in this group, patients will be administered bilateral espb (total of 40 ml, %0.25 bupivacaine) and bilateral superficial pipb (total of 20 ml, %0.25 bupivacaine). in addition, iv morphine pca will be administered for the first 24 postoperative hours.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) 2-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery +/- valve replacement or isolated valve surgery) * bmi \<35 kg / m2 exclusion criteria: * emergent surgeries, redo cases, minimally invasive procedures * patients who do not want to participate * patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale) * hypersensitivity or history of allergies to local anesthetics * major liver or kidney dysfunction or other pre-existing major organ dysfunction * left ventricular ejection fraction \<30 * individuals with mental health disorders (for example bipolar disorder or depression) * pregnancy or breastfeeding * presence of hematological disease * patients with alcohol-drug addiction

Keywords: regional anesthesia acute pain scores morphine consumption
from brain currents to interpersonal flow: investigating the social processing stream of schizophrenia

Conditions: Schizophrenia; Cognitive Impairment; Social Competence

Summary: the overall objective of this project is to identify the neural signature of the impaired ability to relate socially seen in individuals with schizophrenia. a hypothesized path from the neural processes of social cognition, to social cognition assessed behaviorally, to real-life social interactions is examined. secondary aims are to compare electrophysiological measures of high vs low level social cognition; to develop assessment methods of real-life behavior; and to increase the ecological validity of schizophrenia research. much research within the field is devoid of personal meaning and interpersonal context. this project's use of personalized assessment allows for an ecologically valid approach to the social deficits of schizophrenia.


Eligibility criteria:
inclusion criteria: * schizophrenia * schizoaffective disorder exclusion criteria * diabetes * hyperthyroidism * severe head trauma * neurological disease
light treatment to shift-working nurses

Conditions: Shift-Work Sleep Disorder

Summary: this project examines 1) the effects of appropriately timed bright light on adaptation (in terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule after the night shift period.

shift workers frequently experience sleepiness during night shifts, which may have consequences for performance. sleep duration is often shortened after a night shift. properly timed bright light treatment is efficient in delaying the circadian rhythm and can enhance alertness, increase performance and prolong sleep after night shifts. there is a lack of studies on light treatment to rotating shift workers. this study is a randomized controlled crossover trial evaluating the effect of bright light treatment on sleep and sleepiness in rotating shift workers with three consecutive night shifts. the aim is to evaluate whether bright light treatment improves adaptation to three consecutive night shifts (reduces sleepiness during night shifts and improves sleep after night shifts), as well as whether such treatment affects re-adaptation to a day-oriented schedule after the night shift period.

Eligibility criteria:
inclusion criteria: * a rotating shift work schedule involving three days without night shifts, followed by three consecutive night shifts, followed by three days without night shifts * problems with sleepiness during night shifts exclusion criteria: * pregnancy

Keywords: bright light sleepiness sleep psychomotor vigilance