Kornimate/medical-research-clean huggingface dataset:
the direct-physio trial

Conditions: Low Back Pain; Physiotherapy

Summary: previous research showed that direct access to physiotherapy, and the associated early physiotherapeutic treatment of patients with low back pain (lbp), results in improved clinical outcomes, as well as reduced health-related costs. however, despite these results, the effectiveness of direct access to physiotherapy and its impact on costs has never been investigated in belgium. therefore, the goal of this study is to compare the (cost-)effectiveness of direct access to physiotherapy compared to usual care by the general practitioner (gp) for patients with acute lbp. in this study, 600 patients with acute lbp (lasting \>24 hours and \<6 weeks) will be divided into two groups (dutch-speaking: n=2x150; french-speaking n= 2x150). one group will receive treatment through direct access to the physiotherapist, without prescription by a gp. the other group will follow the traditional care pathway through the gp. th effects on pain, disability and cost-effectiveness will be analysed using questionnaires obtained before and at the end of treatment, after 3 months, after one and after two years. primary outcomes include pain and disability. secondary outcomes include clinical outcomes, beliefs related to lbp, quality of life, patient satisfaction, but also direct health care costs, health care resource use, as well as absenteeism and productivity loss. the results of this study will answer the question whether direct access to physiotherapy is (cost)effective for acute lbp. in the long term, these results might be used to optimize the care pathway in belgium for patients with acute low back pain.


Eligibility criteria:
inclusion criteria: * patients with non-specific acute lbp defined as (based on nicol et al. 2020): * pain between the 12th rib and buttocks * associated or not with non-dominant leg pain * looking for lbp care for the first time in case of first episode, or for the first time for the current episode in case of recurrent or persistent lbp * lasting \> 24 hours and \< 6 weeks * with an average pain intensity during the past 24 hours of ≥ 3 on an 11-point numerical pain rating scale * with an oswestry disability index score (version 2.1a) of at least 20% (denteneer et al. 2018). * patients aged between 18 and 65 years exclusion criteria: * recent lumbar surgery (\< 1 year) * pregnancy * history of (any) treatment for the current pain episode * red flags suggesting specific lbp (e.g. resulting from infection or neoplasm, cauda equina), based on the belgian health care knowledge center (kce, bel) who published evidence-based guidelines to manage lbp and radicular pain (van wambeke et al. 2017), leads to exclusion from treatment within the study. * generalized musculoskeletal pain (based on fibromyalgia criteria) (galvez-sánchez and reyes del paso 2020).

Keywords: direct access
reduce medication errors by translating aesop model into cpoe systems

Conditions: Hypertension

Summary: medication errors are common, life-threatening, costly but preventable. information technology and automated systems are highly efficient for preventing medication errors and therefore widely employed in hospital settings. in this study, investigators would perform a cluster randomized controlled trial of a clinical reminding system that uses dnn and probabilistic models to detect and notify physicians of inappropriate prescriptions, giving them the opportunity to correct these gaps and increase prescriptions completeness. this study aim is to assess whether or not this system would improve prescription notation for a broad array of patient conditions.

this paper focuses on "big data" in the knowledge base, using "data minig" study of dm (disease-medication) and mm (medication-medication) of relevance to develop associated decision resources system-"the intelligent safety system" (advanced electronic safety of prescriptions,aesop model), and test the system in the clinical environment in hospital can assist physicians when open orders reduce medication errors, the system is named "aesop model".

Eligibility criteria:
inclusion criteria: * physicians who are working at the outpatient clinics in hospitals. * physicians who sign the consent form exclusion criteria: * physicians who are unable to participate in this trial for the whole process * physicians who do not sign the consent form

Keywords: aesop model big data medication error data mining patient safety cpoe cdss alarm fatigue association rule mining.
icu-acquired colonization and infection related to mdr in immunocompromised patients

Conditions: Immunocompromised Host; Critical Care

Summary: the number of immunocompromised patients hospitalized in the intensive care units (icu) is increasing. they are at higher risk of colonization and/or infection with multi-resistant bacteria (mdr). however this risk is not well characterized. icu acquired infections related to mdr are associated with increased morbidity and mortality. the aim of this study is to compare the incidence of icu-acquired colonization and icu-acquired infection related to mdr between immunocompromized and immunocompetent patients. the risk factors for icu-acquired colonization and icu-acquired infections, and their impact on outcome will also be evaluated and compared between immunocompromised and immunocompetent patients.


Eligibility criteria:
inclusion criteria: * expected icu stay \> 48 hours * all patients (immunocompromised or immunocompetent). exclusion criteria: * patients aged \< 18 years * refusal to take part in the study * icu-stay \< 48 hours * non availability of initial mdr or subsequent screening * participation in another study that could interfere with the risk of icu-acquired colonization and infection with mdr bacteria

Keywords: immunocompromised host critical care drug resistance, multiple
effects of intranasal oxytocin on satiety signaling in people with schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to test a single dose of intranasal oxytocin, compared to placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety signaling (behaviorally and/or by self report) compared to placebo. if this single dose pilot paradigm shows an increase in satiety, it may be tested in follow-up studies as a prevention or treatment for weight gain and overeating in people with schizophrenia.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia or schizoaffective disorder * male or female * age: 18 to 54 years * caucasian or non-caucasian * body mass index of ≥ 27 kg/m2 * one month of stable antipsychotic treatment (same medication regimen and same dose) exclusion criteria: * history of organic brain disease * dsm-iv diagnosis of mental retardation * dsm-iv diagnosis of alcohol or substance dependence within the last six months (except nicotine) * dsm-iv diagnosis of alcohol or substance abuse within the last one month (except nicotine) * are pregnant or lactating * meet dsm-iv criteria for a past and/or current eating disorder via the scid, or if they have a past medical history of an eating disorder, received treatment/counseling for an eating disorder and/or required hospitalization for an eating disorder. (if an otherwise undiagnosed eating disorder is detected during screening, referral to treatment will be provided.) * are taking weight-loss medications, whether over-the-counter (i.e. hydroxycut, stacker products, metabo-plus, cortislim), or prescribed, including appetite suppressants (didrex, tenuate, sanorex, mazanor, adipex-p, meridia, and phentermine) and fat-absorption inhibitors (xenical). * have cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires. this is defined an as a score of less than 10 on the evaluation to sign consent (esc). * have a medical illness, dietary restrictions, or food allergies that, in the view of the investigators, would compromise participation. * are taking prostaglandins such as dinoprostone or misoprostol (because they interact with oxytocin).

Keywords: schizophrenia appetite oxytocin
clinical study of neoantigen vaccine combined with targeted drugs in the treatment of non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: neoantigen vaccine is a new field of research in tumor immunotherapy, and some studies have been conducted with success on melanoma and glioblastoma. nearly 80% of lung cancers are diagnosed in an advanced stage (iiib, and iv) and egfr mutant non-small cell lung cancer will be resistant after targeted drug treatment. neoantigen vaccine is a new treatment method for lung cancer, especially for patients with drug resistance.

this is a phase i clinical study of individualized neoantigen peptide vaccine combined with targeted drugs in the treatment of egfr mutant non-small cell lung cancer aimed to evaluated the safety and immune response of the neoantigen vaccine treatment.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed locally advanced or metastatic non-small-cell lung cancer (stage iii or stage iv). 2. with egfr-tki sensitive mutations and no t790m. 3. first generation egfr-tki treatment is in progress, the treatment time is 5-6 months and there is no disease progression. 4. patients aged 18 to 85 5. life expectancy of at least 3 months. 6. ecog performance status 0 to 3. 7. no previous immunotherapy, including anti-pd-1/pd-l1 or co-suppressive t cell receptor drug therapy, peptide / mrna neoantigen immunotherapy and cell therapy. 8. ability to follow research and follow-up procedures. able to understand and willing to sign an irb approved written informed consent document. exclusion criteria: 1. pregnant and/or breastfeeding. 2. with active, known or suspected autoimmune diseases or other concurrent immune system diseases. 3. receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before the start of neoantigen treatment, excluding egfr-tki and anti-angiogenesis targeted drugs. 4. patients participated in other anticancer drug clinical trials within 4 weeks. 5. liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and impaired hematopoietic function. 6. systemic infection. 7. any uncertainties that have an impact on the safety or compliance of the patient. 8. any disease, treatment, abnormal laboratory history or medical history that affects the participant's participation in the entire research process, or the investigator believes that it is not suitable to participate in this study.

Keywords: non-small cell lung cancer individualized neoantigen peptides vaccine targeted drugs clinical trial phase i
laparoscopy-assisted pylorus-vagus nerve preserving gastrectomy in the treatment of early gastric cancer

Conditions: Early Gastric Cancer

Summary: the safety and efficacy of laparoscopy-assisted pylorus-preserving gastrectomy (lappg) for the treatment of early gastric cancer (egc) remain controversial. the investigators conducted a randomized controlled trial to compare lappg and laparoscopic distal gastrectomy with d2 lymph node dissections for egc.

during the procedure, the distal part of the stomach is resected, but a pyloric cuff 2-3 cm wide is preserved. the right gastric artery and the infrapyloric artery are preserved to maintain the blood supply to the pyloric cuff. in addition, the hepatic and pyloric branches of the vagal nerves are preserved to maintain pyloric function. the celiac branch of the posterior vagal trunk is sometimes preserved. all regional nodes except the suprapyloric nodes (no. 5) should be dissected as in the standard d2 procedure. however, there are technical challenges associated with completing all of these procedures.the five-year survival rate after ppg with modified d2 lymph node dissection ranges from 95% to 98%. this rate is comparable to the five-year survival rate after gastric resection for egc, which ranges from 90% to 98%. in terms of oncologic safety, ppg seems reasonably safe for egc when the accuracy of preoperative diagnosis can be assured

Eligibility criteria:
inclusion criteria: * age older than 18 and younger than 75 years * primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy * ct1-2n0-3m0 at preoperative evaluation according to ajcc cancer staging manual, 7th edition * expected curative resection via distal subtotal gastrectomy with d2 lymphadenectomy * written informed consent exclusion criteria: * pregnant or breast-feeding women * severe mental disorder * previous upper abdominal surgery (except laparoscopic cholecystectomy) * previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection * other malignant disease within the past 5 years * previous neoadjuvant chemotherapy or radiotherapy * unstable angina, myocardial infarction, or cerebrovascular accident within the past 6 months * continuous systematic administration of corticosteroids within 1 month before the study * requirement of simultaneous surgery for other diseases * emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer
abuse potential of orally administered crushed embeda compared to crushed controlled-release morphine and placebo in non-dependent recreational opioid users

Conditions: Nondependent Opioid Abuse, Episodic

Summary: the primary purpose of this study is to determine the abuse potential of embeda compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed embeda relative to placebo and and to compare the pharmacokinetics and safety of crushed embeda with crushed controlled-release morphine and crushed placebo.


Eligibility criteria:
inclusion criteria: * subject is a recreational opioid user who is not physically dependent on opioids based on diagnostic and statistical manual of mental disorders-fourth edition-text revision (dsm-iv-tr) criteria, and the naloxone challenge. a recreational opioid user is defined as recreationally abusing opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks prior to visit 1. * subject is in generally good health as determined by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ecg). exclusion criteria: * has a history or current diagnosis of substance dependence (excluding caffeine and nicotine), as assessed by the investigator using the dsm iv-tr criteria. * has participated in, is currently participating in, or is seeking treatment for substance- and/or alcohol-related disorders (excluding nicotine and caffeine). * history or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results. * has a known allergy or history of hypersensitivity to morphine sulfate, opioids in general, naltrexone hydrochloride (hcl) or similar compounds and/or the known excipients in the investigational drug products. * has any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus). * females who are pregnant, lactating, or are planning to become pregnant during the course of the study. females with a positive serum pregnancy test at visit 1 or at any subsequent study visit will be excluded from participating in the study.

Keywords: abuse potential abuse liability recreational opioid use morphine
predictors of unsuccessful endoscopic mucosal resection of complex colon polyps

Conditions: Colon Polyps

Summary: a prospective outcomes study in patients referred for endoscopic mucosal resection of complex colon polyps.

colon cancer is the third leading cause of cancer-related death in the united states. the number of these deaths has significantly decreased due to screening colonoscopies. a colonoscopy is a procedure in which a physician examines the rectum and large intestines for abnormalities through the use of a specialized camera called an endoscope. colonoscopies decrease the mortality associated with colon cancer through two main ways: by detecting and removing pre-cancerous lesions called polyps; and by detecting colon cancer at earlier stage, when therapies can still be effective at treating or removing the cancer. most colon polyps are small and can be completely removed during a standard colonoscopy. however, there is a growing awareness amongst endoscopists of polyps that are too large or inaccessible to be safely removed during a routine colonoscopy. previously, these lesions required surgery for removal of the affected part of the colon. there is a growing body of evidence that suggests these more complex colon polyps can be entirely removed endoscopically through a procedure called endoscopic mucosal resection (emr), thereby avoiding costly and debilitating surgery. given that it is a novel procedure, it is only available at specialized care centers. emr is a procedure identical to a colonoscopy, with more steps involved in the lifting and removal of complex polyps. as many as 80-90% of complex polyps can be successfully removed with emr. however, it has been noted that removal of the polyp in pieces, rather than as a whole can result in a 20-30% recurrence rate at the resection site. any manipulation of the polyp prior to emr may impair the ability to fully remove the lesion. some factors that have previously been suggested to increase the difficulty of emr include previous dye injections, removal attempts, and polyp sampling. however, the true impact of previous manipulations of ccps remains unclear. this study aims to be one of the largest prospective, multi-centered studies investigating factors that predict the failure of emr in the removal of complex colon polyps.

Eligibility criteria:
inclusion criteria: * all patients referred to each of the participating tertiary care centers for endoscopic mucosal resection (emr) exclusion criteria: * does not meet inclusion criteria

Keywords: endoscopic mucosal resection
detection of pitnet tissue during tss using bevacizumab-800cw

Conditions: Pituitary Tumor; Pituitary Adenoma; Pituitary Macroadenoma

Summary: there is a need for improved visualization of presence and extent of pituitary neuroendocrine tumor (pitnet) tissue during transsphenoidal surgery (tss), especially in tumors invading the cavernous sinus (cs). optical molecular imaging of pitnet associated biomarkers is a promising technique to accommodate this need. vascular endothelial growth factor (vegf-a) is overexpressed in pitnet tissue compared to normal pituitary tissue and has proven to be a valid target for molecular imaging. bevacizumab is an antibody that binds vegf-a. by conjugating a fluorescent dye to this antibody, the fluorescent tracer molecule bevacizumab-800cw is created, which binds to vegf-a. the investigators hypothesize that bevacizumab-800cw accumulates in pitnet tissue, enabling visualization using a molecular fluorescence endoscopy system. in this pilot intervention study the investigators will determine the feasibility of using microdoses (4.5, 10 and 25 mg) of bevacizumab-800cw to detect pitnet tissue intraoperatively.


Eligibility criteria:
inclusion criteria: * patients with an established diagnosis of pitnet with a knosp grade of 3 or 4 who are scheduled to undergo tss. * who performance status 0-2 * signed written informed consent exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent * pregnant or lactating women. documentation of a negative pregnancy test must be available for woman of childbearing potential. woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause * history of infusion reactions to bevacizumab or other monoclonal antibody therapies. * inadequately controlled hypertension with or without current antihypertensive medication * within 6 months prior to inclusion: myocardial infarction, tia, cva, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris
correlations among functional performance, muscle strength and weaning rate in mechanically ventilated patients

Conditions: Respiratory Failure; Functional Performance; Physical Therapy

Summary: to assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate.

to assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate. investigators use the demmi and fss-icu to evaluation the physical functional performance. and mrc score and hand dynamometer to record the muscle strength. the weaning parameters include pi, pe, rsi,minute ventilation, tidal volume and cuff leak will be recorded. after the participant enters the respiration care center, doctor and physical therapist evaluate the consciousness and meet the inclusion criteria and the participant will received the first evaluation. the second evaluation will be held before the ventilator weaning timing.

Eligibility criteria:
inclusion criteria: * respiratory failure with mechanical ventilator use * 48 hours after transferring to respiratory care center * consciousness clear and can obey orders * vital signs stable exclusion criteria: * conscious disturbance * neuromuscular disease * stroke * fracture * patho fracture * bmi\>45

Keywords: functional performance respiratory failure weaning mechanical ventilator physical therapy cardiopulmonary physical therapy
effects of photobiomodulation on changes in cognitive function and rcbf in mci

Conditions: Regional Cerebral Blood Flow; Mild Cognitive Impairment; Cognitive Function

Summary: this pilot study has two goals. the first is to see if the cognitive improves when va and ca are stimulated in mci patients, and the second is to do an explanatory data analysis to see if that improves cognitive in relation to the rcbf improvement.

after being informed about the study and potential risks, all patients giving written informed codsent sill undergo a 1 day screening period to determine eligibility for study entry. subjects who pass the screening test will receive a registration number within 7 days and proceed with the pre-intervention test as follows.

Eligibility criteria:
inclusion criteria: * the patients with mild cognitive impairment(mci). the mci was diagnosed based on medical history and neurological examination * a sufficient level of education to understand study procedures and be able to communicate with site personnel exclusion criteria: * any psychiatric disorders such as schizophrenia that would compromise participation * those with central nervous system disease * serious cognitive problems(moca score 7 or less).

Keywords: photobiomodulation