Kornimate/medical-research-clean huggingface dataset:
nurse-or surgeon-led follow-up after rectal cancer

Conditions: Rectal Cancer

Summary: follow-up programmes consume a large amount of resources with less time for the surgeon to take on new patients. the aim of this randomised study was to compare patient satisfaction, resource utilisation, and medical safety in patients curatively operated for rectal cancer that were followed-up by a surgeon or a nurse.


Eligibility criteria:
inclusion criteria: * patients curatively operated for rectal cancer. * patients had to be more than 18 years of age and written and oral informed consent was obtained. exclusion criteria: * those with psychiatric disorders, dementia and whose general condition had deteriorated with an expected survival of less than six months were not eligible.

Keywords: rectal cancer follow-up specialist nurse
eeg guidance of anesthesia (engages-canada)

Conditions: Post-operative Delirium

Summary: this study examines the potential link between deep levels of anesthesia and delirium.

engages canada is a parallel study to the engages study which has been published in jama, doi:10.1001/jama.2019.5161. due to the difference in practice models and types of anesthesia principles, engages canada is an important study. delirium is a relatively common postoperative complication in the geriatric population, affecting 20% to 70% of surgical patients over the age of 60. delirium manifests as confusion, inattention and the inability to think logically, and may affect the patient's postoperative healing and rehabilitation. it is associated with persistent cognitive decline, longer hospital stay, increased incidence of injurious falls, and increased mortality. patients undergoing major cardiac surgery are at a significant risk of postoperative delirium. to date, there is no proven method to prevent postoperative delirium in this patient population and often delirious events remain unrecognized. randomized controlled studies in diverse surgical patient populations suggest that intraoperative electroencephalography (eeg) guidance during general anesthesia may decrease postoperative delirium and adverse postoperative outcomes. patients who experience postoperative delirium report persistently decreased quality of life and it is a risk factor for incident psychiatric disorders and psychotropic medication use. one potential key mechanism in the relationship between delirium and incident psychiatric illness may be the experience of dissociation (disturbed awareness, impaired memory, or altered perceptions) in the perioperative period in those who are delirious. the co-occurrence of psychiatric illness and delirium can put older adults at greater risk of negative long terms effect such as functional decline. this study will compare the effectiveness of two anesthetic protocols in reducing postoperative delirium and postoperative health-related quality of life in a high risk population.we expect that eeg-guided anesthetic management of patients during their operative procedure will result in improved health-related outcomes, specifically decreased incidence of postoperative delirium and improved postoperative mental and physical health outcomes.

Eligibility criteria:
inclusion criteria: 1. adults 60 years or older; 2. competent to provide informed consent; 3. undergoing elective cardiac surgery requiring cardiopulmonary bypass. exclusion criteria: 1. unable to provide informed consent; 2. preoperative delirium; 3. unable to participate adequately in delirium screening including those who are blind, deaf, illiterate or not fluent english or french; 4. history of intraoperative awareness

Keywords: anesthesia delirium surgery electroencephalography burst suppression ptsd anxiety depression falls
covid-19 in-vitro diagnostic test and androgen receptor gene expression

Conditions: Covid19; Androgen Receptor Gene Overexpression

Summary: this research study will evaluate the association of androgen receptor (ar) gene expression and covid-19 disease severity and mortality. the research procedure involves collection of a single saliva sample which will be mailed to the participants by the study team. this saliva will be used in a covid-19 androgen sensitivity test (covast) which will detect ar gene expression. eligible participants are males, at least 18 years or older, and have tested positive for covid-19.


Eligibility criteria:
inclusion criteria: * male over the age of 18 * laboratory confirmed sars-cov-2 infection * able to give verbal informed consent exclusion criteria: * unable to give informed consent * diagnosed with an additional respiratory co-infection * xxy males

Keywords: androgen receptor severity mortality
ultrasound therapy and manual therapy in digital ischemic ulcers

Conditions: Systemic Sclerosis

Summary: the objective of this before-after non-randomized trial study is to evaluate the efficacy of ultrasound therapy in combination with manual therapy in the management of systemic sclerosis patients with idu. the main questions it intends to answer are: • is this combination of treatments effective in these patients in terms of improvement in hand functional ability, pain relief, injury healing, and quality of life? participants will receive rehabilitation treatment consisting of a combination of manual therapy (mcmennel joint manipulation, pumping, and connective tissue massage) and us water immersion. the researchers will compare the group of participants, called the treatment group, with a control group to see if: • is the combined treatment of ultrasound therapy and manual therapy more effective in these patients than manual therapy alone?


Eligibility criteria:
inclusion criteria: * diagnosis of ssc according to the acr and eular criteria * presence of idu in active phase * naïve to rehabilitation treatment for their hands and upper limbs * written in-formed consent to participate in the study. exclusion criteria: * presence of skin lesions due to other conditions (e.g., trauma); * pregnancy; * infectious diseases (e.g. hiv, hbv, hcv); * myositis; * arthritis; * other rheumatological diseases and immunodepression.

Keywords: rehabilitation skin ulcer ultrasound therapy disability
effect of off-site assistance on success rate of selective cannulation during hands-on ercp training

Conditions: ERCP Training; Biliary Tract Diseases; Pancreatic Diseases

Summary: endoscopic retrograde cholangiopancreatography (ercp) is a technically challenging procedure. it takes time to learn the basic skills and need at least 180 - 200 cases for trainees to achieve competency in ercp. hands-on practice in patients remains the gold standard for ercp training. traditional hands-on ercp training requires the trainer to be on-site to assist the trainee with ercp operations. we hypothesized that the trainee can be safely guided by trainer off-site with interactive audio and endoscopic and fluoroscopic view. technology-enabled health care at a distance has profound scientific potential and accordingly has been met with growing interest. teleguidance facilitated ercp cannulation is a strategy to provide expert cannulation guidance to trainee in settings where such expertise is not on-site. teleguidance not only reduces unnecessary radiation exposure of endoscopist, but also provides remote assistance for trainees to complete training or further improve skills. given the advantages of the off-site teleguidance, it could be an attractive substitute for on-site hands-on ercp training. the primary aim of this study was to evaluate whether off-site assistance (off group) could achieve a comparable success rate to on-site assistance (on group) regarding the rates of successful selective biliary cannulation during ercp training.


Eligibility criteria:
inclusion criteria: * age 18-90 years old * with native papilla exclusion criteria: * history of partial or total gastrectomy (billroth i/ii, roux-en-y) * type ii duodenal stenosis * previously failed cannulation * chronic pancreatitis with stones in the pancreatic head * hemodynamic instability * lactating or pregnant women * inability to give written informed consent
an observational study of pegasys (peginterferon alfa-2a) in patients with hbeag-positive chronic hepatitis b in vietnam

Conditions: Hepatitis B, Chronic

Summary: this prospective, multicenter, observational study will evaluate the sustained response in patients with hbeag positive chronic hepatitis b who are treated with pegasys according to standard of care and in line with the current local labeling in routine clinical practice in vietnam. eligible patients will be followed for the duration of their treatment and for up to 2 years thereafter.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * hbeag-positive serologically proven chronic hepatitis b with or without cirrhosis * elevated serum alt \> uln (upper limit of normal) but \</= 10 x uln * patients with no contra-indications to pegasys therapy as detailed in the label * written informed consent where local regulations allow or require it exclusion criteria: * patients should not receive concomitant therapy with telbivudine * co-infection with hepatitis a, hepatitis b or hiv * pregnant or breastfeeding women * patients with depression/mental diseases * neutrophil at baseline \> 90.000/mm3 * abnormal t4 or tsh
prophylactic antibiotic in treatment of fingertip amputation

Conditions: Infection Rate After Fingertip Amputation

Summary: fingertip amputation is a common injury. considerable controversy exists as to whether prophylactic antibiotics are necessary for this injury. the investigators goal was to compare the rate of infections among subgroups with and without prophylactic antibiotic treatment. the study hypothesis was that infection rates were similar in the two groups.


Eligibility criteria:
inclusion criteria: * fingertip amputation with bone exposed exclusion criteria: * under the age of 18 years * if the patient had diabetes * oncological disorder * immune deficiency * bleeding disorder * used steroids regularly * presented with a grossly contaminated wound or other injury requiring antibiotic treatment * were currently taking antibiotics, or had a previous allergic reaction to cephalosporins.
multi-disciplinary care for brain metastases

Conditions: Brain Metastases, Adult

Summary: this is a health services intervention study aimed at understanding the impact of intensive multi-disciplinary care compared with standard care on patient-reported symptom outcomes and prognostic awareness in patients with brain metastases.

this is a cohort study of patient with newly diagnosed brain metastases assigned to standard of care (soc) or intensive multi-disciplinary care (imdc). care for all patients with brain metastases involves complex medical decision making and requires input for multiple stakeholders, including medical oncology, neurosurgery, radiation oncology, and neuro-oncology. palliative care should be an essential component of the care team for all patients with brain metastases by the very nature of this advanced malignancy. at the university of vermont, our current process for diagnosis and management of patients with brain metastases relies heavily on the physician and team who make the initial diagnosis to consult others as they see appropriate. this process may look different for different patients. we rationalize that a systematic approach with intensive multidisciplinary care (imdc) will benefit patients with brain metastases by providing consistent access to multi-disciplinary discussion.

Eligibility criteria:
inclusion criteria: * patients of all genders must be at least 18 years of age. * patients must have histologically confirmed, newly diagnosed brain metastases from known or suspected solid tumor primary neoplasms. * patients must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact). * patients must be able to complete questionnaires in english. * patients must have the ability to provide informed consent. exclusion criteria: * patients who are \< 18 years of age are not eligible. * patients who are pregnant are not eligible.
on-demand ppi therapy is effective on controlling symptoms in patients with barrett's esophagus.

Conditions: Barrett Esophagus; Proton Pump Inhibitor; Symptom; Reflux

Summary: on-demand ppi therapy is feasible for the long-term treatment of patients with barrett's esophagus.

consecutive patients with symptomatic barrett's esophagus are recruited and receive biopsy for esophageal metaplastic mucosa and gastric mucosa over the antrum and body during endoscopy on enrollment. the biopsy protocol for esophageal metaplastic mucosa is following seattle protocol. gerd q score will be conducted on enrollment. additionally, blood sampling for cyp2c19 genotyping is also conducted on enrollment. the eligible subjects will be treated by 8-week esomeprazole, and are then randomly assigned to receive either maintenance or on-demand esomeprazole therapy (40 mg q.d.) for 40 weeks. the patients were asked to come back every four weeks for the recording of symptom days and ppi tablet consumption numbers. follow-up endoscopy with biopsy for esophageal and gastric mucosa is performed at the end of the 48th weeks. we will compare the effects of maintenance and on-demand ppi therapy on (1) histological changes of esophageal metaplastic mucosa (2) symptom control (3) tablet consumption number

Eligibility criteria:
inclusion criteria: * patients between the ages of 20 and 80 years * having symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach * having barrett's esophagus proven by histology confirmation * length of esophageal metaplastic mucosa equal to or longer than 1 centimeter exclusion criteria: * pregnancy, * coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia) * previous gastric surgery, * allergic to esomeprazole, * presence of dysplastic esophageal mucosa * equivocal endoscopic diagnosis of barrett's esophagus

Keywords: barrett's esophagus erosive esophagitis proton pump inhibitor on-demand therapy continuous therapy
intranasal fentanyl as an adjunct to lidocaine infiltration in adults undergoing abscess incision and drainage

Conditions: Abscess

Summary: this randomized clinical trial aims to compare the analgesic efficacy of intranasal fentanyl to placebo as analgesic adjunct to conventional local anesthesia for the treatment of pain of the overall procedure in adult patients undergoing lidocaine infiltration and subsequent abscess incision and drainage in the emergency department (ed).


Eligibility criteria:
inclusion criteria: * presenting to the ed for an abscess requiring incision and drainage * ed attending physician's judgment that the patient has capacity to provide informed consent. * patients must be able to understand english or spanish. exclusion criteria: * use of opioids or tramadol within past 7 days. * prior adverse reaction or allergy to opioids. * patients who are pregnant * patients weight \> 100kg * chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies. * medical condition that might affect metabolism or opioid analgesics such as cirrhosis (child pugh a or worse) or kidney impairment (ckd 3 or worse) * chronic malnutrition, severe hypovolemia (dehydration of blood loss) or hepatic disease * alcohol intoxication: history of alcoholism or the presence of alcohol intoxication as judged by the treating physician may alter pain perception and has previously increased adverse events. * sbp \<100 mmhg: opioids can produce peripheral vasodilation causing orthostasis. * hr \< 60/min: opioids can cause bradycardia. * oxygen saturation \< 95% on room air: for this study, oxygen saturation must be 95% or above on room air in order to be enrolled. * use of mao inhibitors in past 30 days: mao inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma. * patients using transdermal pain patches or oral opioid use \> 10 days in the prior month: frequent opioid use may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments. * patients with a history of traumatic brain injury, seizures or hallucinations * patients with anatomical anomalies or medical conditions precluding intranasal administration
high-resolution optical coherence tomography for detection of retinal nerve fiber layer loss in band atrophy of the optic nerve

Conditions: Band Atrophy; Chiasmal Compression; Neural Loss

Summary: the purpose of this study is to compare the abilities of high-speed,high-resolution (hr) optical coherence tomography (oct) and stratus oct for detection of retinal nerve fiber layer (rnfl) loss in eyes with band atrophy (ba) of the optic nerve.


Eligibility criteria:
inclusion criteria: * visual acuity better than 20/30 * refractive error less 5 spherical diopter and 3 cylinder diopter * temporal field defect exclusion criteria: * presence of glaucoma and optic nerve anomalies * a normal nasal field

Keywords: high-resolution optical coherence tomography retinal nerve fiber layer band atrophy
clinical and radiographic evaluation of intra coronal bleaching of primary anterior teeth

Conditions: Dental Trauma

Summary: clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique

this study will be conducted for the clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique

Eligibility criteria:
inclusion criteria: * children aged between 3-5 years. * parents/caregivers acceptance. * traumatized anterior teeth with sensitivity to percussion and palpation with gray discoloration. * discolored anterior teeth indicated for intracoronal bleaching. * traumatized anterior teeth no response to an electric pulp test. * discolored teeth with satisfactorily previously obturated root canal . * absence of preapical lesions or apex resorption. exclusion criteria: * teeth with signs tooth mobility indicated for extraction. * teeth with vertical root fracture. * teeth with preapical lesions or apex resorption. * teeth with discolorations from restorative materials. * children with lack of cooperation for post-operative recall and follow up.
reducing hypoxia in patients with coronavirus disease (covid-19) using topotecan with standard of care

Conditions: COVID-19 Respiratory Infection

Summary: the primary objective of the phase 1 trial is to identify a dose of topotecan that will be safe to take forward into a phase 2 trial, with no unexpected toxicities or drug-drug interactions with standard therapy for covid-19. the investigators hypothesise that a single dose of low-dose topotecan will blunt the expression of inflammatory genes in patients with moderate covid-19, without cytotoxic side effects.

4 fixed dosing levels (0.25 -0.5mg) of topotecan will be evaluated in this trial, using sub-cytotoxic doses of topotecan which are well below typical chemotherapy levels and shown not to cause myelosuppression in previously tested populations. the dose escalation will be in a standard 3+3 dose escalation design with 0.25 mg increments of topotecan. the study aims to establish the recommended phase 2 dose (rp2d) of topotecan in hypoxic patients with moderate to severe covid-19.the rp2d is defined as the maximum safe dose at which 3 or more patients are found to have clinically relevant concentrations of topotecan in the blood stream, without reaching anti-cancer concentrations in plasma (defined as area under the curve (auc)\>150000) and without causing grade 2/3/4 neutropenia (ctcae5).

Eligibility criteria:
inclusion criteria: * severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection confirmed by at least 1 positive polymerase chain reaction (pcr) test * moderate covid as evidenced by oxygen saturation \<93% on room air (or \<88% if prior cld) * admission to emergency department for monitoring and/or supportive care: * the following biochemical markers: * absolute neutrophil count (anc) ≥ 1.5 x 109/l. platelets ≥ 100 x 109/l, haemoglobin ≥ 9x 109/l. * bilirubin \< 1.5 times upper limit of normal (uln). alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 2.5 times uln. * calculated creatinine clearance of ≥ 30ml/min calculated using the formula of cockcroft and gault: (140-age) x mass (kg)/)72x creatinine mg/dl); multiple by 0.85 if female. * laboratory features of cytokine release, as defined by any 1 of the following: i. c-reactive protein (crp)\> 75mg/l ii. lactate dehydrogenase (ldh) \> uln iii. d-dimer \> 1.0 mg/l iv. ferritin \> 500ng/ml v. elevated interleukin-6 levels exclusion criteria: * patients requiring mechanical ventilation * any immunosuppressive medication including chemotherapy(excluding steroids) administered concurrently or within last 14 days. * patients with uncontrolled diabetes mellitus (hba1c within 1 month \>8) * pregnancy or breastfeeding. * known allergy to topotecan. unconjugated hyperbilirubinemia on a fasting liver function test (lft), which can indicate gilberts syndrome. * suspected active bacterial, fungal, or other infection in addition to covid-19. * any condition that would, in the opinion of the investigator, increase the risk of the participant * by participating in the study. * inability to provide consent. * unable to comply with study procedures.

Keywords: topotecan hypoxia
repeated dosing study to assess safety and tolerability in ckd-3 patients on stable ace-i treatment

Conditions: Chronic Kidney Disease

Summary: primary objective: * to assess the tolerability and safety of repeated oral ascending doses of sar407899a in patients with moderate chronic kidney disease (ckd) on stable angiotensin converting enzyme-inhibitor (ace-i) secondary objectives: * to assess in patients with moderate ckd the effect of concomitant multiple dose of sar407899a and ace-is on office and 24-hr ambulatory blood pressure and heart rate * the effect of repeated multiple doses of sar407899a on the pharmacodynamic response to ace-is (acsdkp) * the pharmacokinetic profile of repeated oral administration of sar407899a during co-administration of ace-is

the total duration for this study will be around 8 weeks.

Eligibility criteria:
inclusion criteria: * male and female patients aged between 18 and 79 * patients with chronic kidney disease (ckd-3) * patients should be on stable ace-i treatment (same type and regimen) for at least 2 months prior to screening * body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 100 kg inclusive if female * if female, patients must be permanently sterilized for more than 3 months or postmenopausal * having given written informed consent prior to the study. exclusion criteria: * women of child bearing potential. * uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness * active hepatitis, hepatic insufficiency * acute renal failure * patients requiring dialysis during the study * presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * any history of orthostatic dysregulation (including but not limited to neurocardiogenic syncope, postural orthostatic tachycardia syndrome) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.