Kornimate/medical-research-clean huggingface dataset:
clinical trial of peer support in the ed (pcori)

Conditions: Psychomotor Agitation; Behavioral Disorder

Summary: the purpose of this study is to conduct a clinical trial that tests the acceptability, fidelity, and feasibility of a peer support modified intervention for agitation management within the emergency department.

the purpose of this study is to address the increasing burden of behavioral crises and agitation in the emergency department (ed). there are multiple significant gaps in patient centered care for agitation management and use of restraints in the context of behavioral crises, leading to increased patient risks and reduced workplace safety. through expanding our previous agitation code team (act) protocol with the addition of peer support workers, we plan to develop a peer-support enhanced agitation code team (pact). the pact will address systems challenges experienced by staff, safety threats to ed patients with mental illness and substance abuse disorders and reduce known structural biases in marginalized patient populations during restraint/sedation decision making. additionally, peer support workers delivery of trauma informed care is the key mechanism for mitigating bias in agitation management. this study will build on our team's extensive experience in using a patient-centered approach for investigating best practices in management of agitation in the ed. thus, we propose a patient centered, trauma informed, structured team-based care delivery approach through the use of a multi-level, multi-component peer-support enhanced agitation code team (pact) intervention. pact will address systems challenges experienced by staff, safety threats to ed patients with mental illness and substance use disorders, and known structural biases against marginalized individuals during decisions in use of restraints for behavioral crises in the ed. we hypothesize that the pact intervention will improve patient outcomes related to behavioral crisis (i.e., reduction in use of restraints, engagement to follow-up care, decrease in repeat ed visits) and improve patient experience of behavioral acute care in the ed for patients presenting with behavioral health chief complaints, especially those from racial/ethnic minority groups and historically marginalized populations compared to usual care.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * english-speaking * arrives to one of the yale-new haven health emergency departments (yale-new haven \[york street \& st. raphael's\], greenwich, bridgeport, lawrence \& memorial, and westerly campuses) * presents with a behavioral-related chief complaint (inclusive of neurocognitive, substance use/intoxication, mental health and other behavioral related presentations) as well as additional individuals at risk of developing agitation defined via a score of \>2 on the brøset violence checklist exclusion criteria: * pregnant women, minors (\<18 years old), prisoners, and institutionalized individuals

Keywords: agitation peer support
ts gene polymorphism predicts effect in patients with advanced lung cancer

Conditions: Non-small-cell Lung Cancer; Adenocarcinoma

Summary: the investigators performed a multicenter, open trial of using ts gene polymorphism to predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.

1. main eligibility criteria were histologic or cytologic proof of advanced non-small-cell lung cancer (nsclc) primary treatment, normal organ function, and eastern cooperative oncology group performance status 0 to 2. 2. all patients were delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 for not less than 4 cycle, administered intravenously every 3 weeks. response assessment was performed every 6 weeks; toxicity assessment was performed every 3 weeks. 3. primary end point was time to progression (ttp); secondary end points were objective response rate (orr), overall survival (os), and toxicity. 4. the study was designed to evaluate ts(thymidylate synthase) gene polymorphism as a predictor for advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment. 5. polymorphisms of thymidylate synthase were investigated in peripheral wbc（white blood cell）of all patients.

Eligibility criteria:
inclusion criteria: * histologic or cytologic proof of advanced lung adenocarcinoma * primary treatment * normal organ function * eastern cooperative oncology group performance status 0 to 2 exclusion criteria: * symptomatic patients with brain metastases * major organ dysfunction and severe heart disease

Keywords: ts polymorphism lung cancer adenocarcinoma pemetrexed
open-label trial in parkinson's disease (pd)

Conditions: Parkinson Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with parkinson's disease.


Eligibility criteria:
key inclusion criteria: rollover participants are eligible for the study if they met the following inclusion criteria: * participants who complete the 27-week double-blind treatment period of trial cvl-751-pd-001 (nct04201093) or trial cvl-751 pd-003 (nct04542499) or the 27-week double-blind treatment period and 10-day safety/withdrawal assessment period of trial cvl-751-pd-002 (nct04223193) and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. rollover participants from trial cvl-751-pd-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial. * sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment. * participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the icf and in the protocol. * participants who are willing and able to refrain from any pd medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial. * participant who, in the judgement of the investigator, demonstrated adequate compliance with the imp and protocol requirements in the double-blind trial. key exclusion criteria: rollover participants are excluded from the trial if any of the following met: * participants who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial * participants who answer "yes" on the c-ssrs suicidal ideation item 4 or item 5 (active suicidal ideation with some intent to act, without specific plan, or active suicidal ideation with specific plan and intent) and whose most recent episode meeting the criteria for c-ssrs item 4 or item 5 occurred within the last 6 months, or participants who answer "yes" on any of the 5 c-ssrs suicidal behavior items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 c-ssrs suicidal behavior items occurred within the last 2 years, or participants who, in the opinion of the investigator, present a serious risk of suicide. * participants who had previously been enrolled in this open-label trial and had subsequently withdrawn.

Keywords: parkinsonian disorders brain diseases central nervous system diseases nervous system diseases movement disorders neurodegenerative diseases
preempti̇ve para-cervi̇cal block for postoperati̇ve pain after laparoscopic hysterectomy

Conditions: Pain, Postoperative

Summary: total hysterectomy is one of the most common surgical procedure in gynecology. the laparoscopic route for the performance of hysterectomies are on the rise \[1\]. the laparoscopic hysterectomy (tlh) procedure has several advantages over open surgery such as better cosmetic outcomes, faster recovery earlier return to normal activities and work \[1-3\]. nonetheless, postoperative pain (pp) remains an issue that scuppers these advantages \[1-3\]. the incidence of pp after tlh has been reported to vary from 35% to 63% \[4,5\]. the origin of pp after laparoscopy is multifactorial and complex such as perioperative predicaments, including pneumoperitoneum, stretching of the intraabdominal cavity, the blood left in the abdomen, and dissection of the pelvic region \[6-7\]. a randomized controlled trial has demonstrated that there may be more intense pain and greater analgesia requirements in the immediate postoperative period after laparoscopic surgery than after laparotomy \[8\]. further inquiry to intercept the advancement and decrease the severity of pp is prominent to further improve tlh. women undergoing tlh experience two different pain characteristics including incisional pain and visceral pain in the first hour after the operation \[6\]. these pains were most intense 30 min after tlh, gradually decreasing thereafter for postoperative 72 hr \[6\]. high levels of acute postoperative pain (app) are pertain with an increment risk of chronic postsurgical pain so control of these acute pains in the urgent postoperative period is vital for faster amelioration. many attempts have been tried to control app after thl, such as transverse abdominal plane blocks, superior hypogastric plexus block, local anesthetic injection to the port side, and reduced port caliber \[9-12\]. para-cervical bloc (pcb) is believed to block the frankenhouser nerve plexus that supplies the visceral sensory fibers to the uterus, cervix, and top of the vagina. only two randomized studies have assessed the effect of pcb in thl, but several limitations such as the small sample size preclude drawing conclusions on pp after tlh. thus, the primary goal of this randomized clinical trial was to investigate if pcb at the onset of surgery, as a part of enhanced recovery protocol, could improve patient recovery after thl.


Eligibility criteria:
inclusion criteria: -patients undergoing total type a laparoscopic hysterectomy with or without additional surgery, such as salpingo-oophorectomy or salpingectomy exclusion criteria: * age \< 18 years * refusal to provide consent * inability to understand the study questionnaire * severe psychiatric or mental disorder * american society of anesthesiologists (asa) physical status classification \> iii * history of regular narcotic use within 6 months of the surgery * conversion to laparotomy * operation time \> 90 min * additional procedures
suicide prevention intervention for schizophrenia-spectrum disorders

Conditions: Schizophrenia; Suicide

Summary: the current project is a pilot randomized controlled trial to test the coping long-term with active suicide program for schizophrenia-spectrum disorders (clasp-s) for patients following a psychiatric hospitalization. participants will be assigned to enhanced treatment as usual (etau) alone vs clasp-s plus etau. participants complete assessments at baseline during their psychiatric hospitalization and at 3 months (mid-treatment) and 6 months (post-treatment) following discharge. the primary aim is to assess the feasibility and acceptability of clasp-s. the secondary aim is to estimate the effects of clasp-s on reducing suicidal thoughts and behaviors relative to etau.


Eligibility criteria:
inclusion criteria: * suicidal thoughts or behaviors prior to hospital admission * diagnosis of a schizophrenia-spectrum disorder * receiving pharmacotherapy * 18 years or older * speaks/reads english exclusion criteria: * psychosis due to substance use or medical condition * lack of phone access * discharge to long-term facility

Keywords: psychiatric hospitalization suicide prevention psychosis psychosocial intervention
safety, tolerability, and pharmacokinetics of hrs-3802 monotherapy in patients with malignant solid tumors

Conditions: Advanced Solid Tumors

Summary: the study is being conducted to evaluate the safety and tolerability of hrs-3802 monotherapy in patients with advanced solid tumors


Eligibility criteria:
inclusion criteria: 1. patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits. 2. age ≥18 years, male or female 3. patients with advanced malignant tumors confirmed pathologically; 4. failure of adequate standard treatment, or no effective standard treatment; 5. patients must have at least 1 extracranial measurable target lesion per recist v1.1 ; 6. the expected survival period is more than 12 weeks; 7. the eastern cooperative oncology group (ecog) physical fitness score is 0 - 1; 8. have sufficient bone marrow and organ function (have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days): 9. female subjects of childbearing age must undergo a serum pregnancy test within 7 days before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraception during the study period and within 1 months after the last administration of the study drug measures: exclusion criteria: 1. subjects had cancerous meningitis or untreated central nervous system metastases 2. subjects had severe cardiovascular and cerebrovascular diseases 3. there is third-space effusion that cannot be controlled by drainage and other methods (such as massive ascites, pleural effusion, pericardial effusion)； 4. subjects had or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia , drug pneumonia, or ct during screening showed active pneumonia； 5. arteriovenous thrombosis occurred within 6 months prior to the first dose 6. severe infection occurred within 4 weeks prior to initial administration 7. subjects with refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications: including malabsorption syndrome 8. known history of human immunodeficiency virus (hiv) seropositive status or acquired immunodeficiency syndrome (aids) 9. subjects had active hepatitis； 10. subjects were scheduled to receive other systemic antitumor therapies during the study period； 11. known allergies and contraindications to the investigational drug or any of its components； 12. other factors as judged by the investigator that may lead to the termination of the study, such as other serious diseases, serious laboratory test abnormalities, or family or social factors that could affect the safety of the subject, or the collection of study data and samples.
high-dose prednisone in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: this study will help to determine whether a high-dose weekly course of prednisone therapy is safer than and at least as effective as daily dose therapy for people with duchenne muscular dystrophy (dmd). boys who are enrolled in this study should not have taken carnitine, other amino acids, creatine, glutamine, coenzyme q10 or any herbal medicines within the last three months. there will be a two-visit screening to take place in one week to ensure a reproducible manual muscle test. the subject will then be randomized and put into either the daily or weekly regimen. the duration of the study is twelve 28-day treatment cycles (approximately 12 months) with follow-up visits at month one, three and then every three months.

duchenne muscular dystrophy (dmd) is the most common lethal inherited disorder worldwide. despite the exponential increase in our understanding of the disorder since the discovery and characterization of the causative gene and its product dystrophin in 1987, current therapeutic management remains largely supportive. awaiting a final genetic cure to be available in the future, further investments in developing better drug therapies for dmd remain important. the effect of a high dose prednisone regimen will be evaluated in comparison to a daily dose regimen in a multi-center, randomized, double-blind placebo-controlled 4-arm study. ambulant children aged 4-10 years with an established dmd diagnosis will be studied. patients will undergo 2 screening evaluations within 1 week. patients will be randomized into treatment groups on the second screening visit, followed by a 12-month treatment period. during the treatment period, patients will be evaluated at monthly intervals. the primary endpoints are percentage change in average muscle strength score and qmt performance for specific muscle groups. secondary endpoints include timed function tests, functional grades for arms and legs, and pulmonary function tests.

Eligibility criteria:
inclusion criteria: * 4 to 10 years of age * ambulant * confirmed dmd diagnosis * steroid naive * evidence of muscle weakness by mrc score or clinical functional evaluation * ability to provide reproducible qmt bicep score exclusion criteria: * history of significant concomitant illness or significant impairment of renal or hepatic function, or other contraindication to steroid therapy * symptomatic dmd carrier * positive ppd * lack of prior exposure to chickenpox or immunization * use of carnitine, glutamine, coenzyme q10, other amino acids or any herbal medications within the last 3 months * history of symptomatic cardiomyopathy * prior attainment of quota for the age group in which the patient belongs

Keywords: muscular dystrophy, duchenne and beckers beckers muscular dystrophy
zinc supplementation and cardiovascular risk in hiv

Conditions: HIV; Inflammation

Summary: the purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in hiv-infected subjects.

zinc is a dietary supplement with compelling preclinical evidence for potential health benefit that could be expanded not only to the entire hiv population, but also to other inflammatory conditions that share many facets of hiv infection, namely the persistent intestinal barrier dysfunction, monocyte activation and heightened inflammation state.

Eligibility criteria:
inclusion criteria: * hiv-1 infection * age ≥18 years * zinc level ≤0.75 mg/l * receiving a stable antiretroviral regimen with no plans to change during study * documentation of an hiv-1 rna level of ≤400 copies/ml * no diarrhea or nausea/vomiting for the last month exclusion criteria: * pregnancy/lactation * presence of inflammatory condition * regular use of agents that may affect inflammation in the last 3 months. the regular use of nsaids, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study. * presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs * known cardiovascular disease * uncontrolled diabetes * allergy or intolerance to zinc sulfate. * aspartate aminotransferase (ast) and alanine aminotransferase (alt) \> 2.5 x upper limit of normal (uln) * hemoglobin \< 9.0 g/dl * glomerular filtration rate (gfr) \< 50 ml/min

Keywords: zinc
quality of life of pancreatic cancer patients:psychometric validation of chinese version in taiwan

Conditions: Pancreatic Cancer

Summary: this study will investigate the reliability and validity of chinese version of the quality of life scale in eortc qlq-pan26 and eortc qlq-c30 on pancreatic cancer patients in taiwan

1. verify the reliability and validity of chinese version of the eortc qlq-c30 quality of life scale and the chinese version of the eortc qlq-pan26 quality of life scale. 2. verify the construct validity of the chinese version of the eortc qlq-pan26 quality of life scale, perform factor analysis, test-retest reliability, and known group validity 3. verify the criterion related validity of chinese version of the eortc qlq-c30 quality of life scale and the sf-36 quality of life scale

Eligibility criteria:
inclusion criteria: 1. paitent who aged over 20, with clear consciousness, is capable of communicating with chinese. 2. pancreatic cancer patients(stage i.ii.iii.iv) 3. the subject who agrees and is willing to participate in the research after explaining the purpose of the research. exclusion criteria: 1. patient who is younger than 20 years old, illiterate, or is unable to cooperate with intervention measures.

Keywords: quality of life psychometric validation
c2-c4 compartment block versus block of costagliola, in teac

Conditions: Somatic Pain; Neuropathic Pain

Summary: c2-c4 compartment block compared to the costaiola block, in the control of persistent postoperative pain (somatic and neuropathic) in patients undergoing carotid thromboendarterectomy

a comparative analysis will assess the somatic pain (scores ≥4 on the nrs scale) and neurapathic pain (by the lindblom roller and von frei hair tests) between group a (block group of the c2-c4 compartment ) and the control group b (block group according to costagliola), during the 3 months after surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing to carotid thromboendarterectomy exclusion criteria: * asa status: 4 * pregnancy * bmi \> 39,99 * neurological impairment * neck anatomical abnormalities * status of sepsis * coagulopathy * neck cancer * neck infections

Keywords: carotid thromboendarterectomy carotidodynia
18f-fdg tomography and labeled leukocyte scintigraphy

Conditions: Malignant Otitis Externa

Summary: the study will aim to show that there is a superiority of 18f-fdg pet/ct compared to labeled leukocyte scintigraphy in patients with a malignant otitis externa.

the management of malignant otitis externa (meo) is a major issue in patients who are often polypathological and fragile. appropriate antibiotic therapy must be started quickly after the diagnosis is made and followed for a period of at least 6 weeks. imaging plays a major role in assessing the extent of the infection and especially healing, after 6 weeks of antibiotic therapy. the persistence of an infection at the end of the treatment, observed in imaging, will allow a change of antibiotic line. this study consists in studying in a population affected by an oem, the performance of pet/ct with 18f-fdg compared to scintigraphy with labeled leukocytes. the usefulness of the latter in the follow-up of the pathology after antibiotic therapy has already been proven in the literature. the study will aim to show that there is a superiority of 18f-fdg pet/ct compared to labeled leukocyte scintigraphy.

Eligibility criteria:
inclusion criteria: * patients with malignant otitis externa who received a 18f-fdg positron emission tomography and a labelled leukocyte scintigraphy exclusion criteria: * patients who refuse to have their imaging data used