Kornimate/medical-research-clean huggingface dataset:
intensity-modulated radiotherapy (imrt) with simultaneous integrated boost (sib) for inoperable non-small-cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: lung cancer is one of the most common cancer and the leading causes of cancer death in worldwide. approximately 80% of nsclc were inoperable. the prognosis of patients with la-nsclc remains disappointing. investigators hypothesized that use of simultaneous integrated boost intensity modulated radiotherapy (sib-imrt) technology can safety increasing the radiation dose and benefit for inoperable nsclc patients.

lung cancer is one of the most common cancer and the leading causes of cancer death in patients worldwide. approximately 80% of nsclc were inoperable. concurrent chemo-radiation therapy (ccrt) is a standard treatment for locally advanced nsclc who are not candidates for surgery. nevertheless, the prognosis of patients with locally advanced nsclc (la-nsclc) is still poor. local control (lc) after ccrt is one of the most important prognostic factors. local failure is common after standard-dose chemoradiation for nsclc. studies of stereotactic body radiation therapy (sbrt) have shown a steep dose response in treating early-stage lung cancer. improving the total dose and shortening the overall treatment time may be effective for improving the lc rates. however, problems remain due to the toxicity to adjacent critical structures (e.g,lung,heart, esophagus), the target volumes usually limits the doses escalated that cannot be safely delivered by conventional radiotherapy techniques. in order to avoid the acute and late radiation toxicity of normal tissues, different dose prescriptions can be delivered to different target volumes in the same fraction, which deliver a higher dose to the gross tumor volume (gtv) and a relatively lower dose to the subclinical disease. the technique is called simultaneous integrated boost intensity modulated radiotherapy (sib-imrt). investigators hypothesized that use of sib-imrt technology can safety increasing the radiation dose and benefit for inoperable nsclc patients.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed nsclc, inoperable stages iia-iiib, according to american joint committee on cancer （ajcc）cancer stage 7th 2. performance status 0 to 2, ≤5% weight loss within the past 6 months 3. a forced expiratory volume at 1 second of ≥ 1 l 4. life expectancy \> 3 months 5. no invasion of large vessels, heart, esophagus, spinal cord. 6. based on conformal treatment planning, the volume of lung at or exceeding 20 gy (v20) must have been≤30%, the mean esophagus dose≤34 gy, and the volume of esophagus exceeding 55 gy (v55)≤30% 7. tolerable and agree for intensity-modulated radiation therapy（imrt） and concurrent chemoradiotherapy 8. without severe other diseases 9. informed consent exclusion criteria: 1. had received prior thoracic radiotherapy 2. supraclavicular lymph node metastasis, pleural or pericardial effusions, and superior vena cava syndrome 3. pregnant and lactating women 4. serious complications 5. other primary malignancies

Keywords: sib-imrt nsclc radiochemothearpy
burden, mortality and supply costs in intensive care unit patients

Conditions: Burden, Dependency; Mortality; End-of-life Care; Intensive Care Unit; Critically Ill Patient; Frailty; Multiple Organ Failure

Summary: this study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs).

this study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs). the 3 endpoints and 3 respective risk groups (high, intermediate, low) are 1. endpoint burden of care due to clinical frailty scale (frailty) high 7 - 9 intermediate 5 - 6 low 1 - 4 2. endpoint mortality due to severity of disease regarding simplified acute physiology score (saps) ii score values high saps ii \> 70, suspected mortality \> 40% intermediate saps ii \> 40 - 70, suspected mortality 10 - 40% low saps ii ≤ 40, suspected mortality \< 10% 3. endpoint supply costs due to number of organ systems to be supported or replaced high ≥ 3 organ systems replaced intermediate 1 - 2 organ systems replaced low 0 - 2 organ systems replaced

Eligibility criteria:
inclusion criteria: * all patients dying on the icu and all patients staying for at least 72 hours on the icu exclusion criteria: * no

Keywords: burden mortality end-of-life care intensive care unit critically ill patient frailty multiple organ failure
placebo-controlled trial of ifx-hu2.0 followed by pembrolizumab in checkpoint inhibitor naïve patients with advanced or metastatic merkel cell carcinoma

Conditions: Advanced Or Metastatic Merkel Cell Carcinoma

Summary: this phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate objective response rate (orr) of ifx-hu2.0 as an adjunctive therapy to pembrolizumab in adult patients (≥18 years) with advanced or metastatic merkel cell carcinoma. a total of 118 participants will be randomized to receive either ifx-hu2.0 or placebo intralesional injection in a single lesion, followed by pembrolizumab.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age. 2. life expectancy equal to or greater than six months. 3. eastern cooperative oncology group (ecog) performance status ≤ 2. 4. must be recurrent and/or unresectable stage iii or stage iv american joint committee on cancer (ajcc) (8th edition) and have histologically confirmed merkel cell carcinoma 1. must have at least one injectable lesion equal to or greater than 3 mm. 2. must have measurable disease as defined by recist v1.1. 5. subject should be cpi naïve i.e., no prior therapy with cpi including but not limited to pembrolizumab, avelumab, ipilimumab, nivolumab. 6. tumor tissue from an archival core biopsy or resected site of disease must be provided for biomarker analyses. if archival tissue is not available, then a new biopsy should be performed. 7. adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol. exclusion criteria: 1. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements. 2. subjects with active brain metastases with the exception of treated brain metastases that have imaging proving stability at least 4 weeks after treatment, no new metastases, and not requiring steroids. 3. subjects with recurrent resectable mcc 4. subjects with prior systemic chemotherapy 5. pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study. 6. active, known, or suspected autoimmune disease. potential subjects with type i diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. low-grade autoimmune toxicity is not an exclusion under this criterion. 7. a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. inhaled or topical steroids are permitted in the absence of active autoimmune disease.

Keywords: merkel cell carcinoma advanced metastatic mcc pembrolizumab innate immune agonist skin cancer
adrenocorticotropic hormone in membranous nephropathy

Conditions: Membranous Nephropathy

Summary: the purpose of this study is to evaluate the effect of adrenocorticotropic hormone (acth, acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous nephropathy. acthar is a hormone that stimulates steroid production from small glands above the kidneys. it has direct protective effects on the kidney and is currently approved by the fda to treat kidney disorders associated with proteins in the urine, but the mechanisms of action are not entirely understood and will be studied in the present trial.

patients with membranous nephropathy and nephrotic syndrome will be treated with acth for 6 months. proteinuria remission at 12 months will be the primary endpoint. different biomarkers including anti-pla2r autoantibodies, circulating regulatory t cells, and autoreactive memory b cells will be serially measured to identify predictors of response to therapy.

Eligibility criteria:
inclusion criteria: * age 18 to 70 years * free of immunosuppression for at least 3 months * capability of understanding the purpose of the study * written informed consent exclusion criteria: * epidermal growth factor receptor (egfr) \< 30ml/min/1.73m2 * kidney transplant * secondary mn (defined on the basis of clinical criteria) * type 1 or type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not an exclusion) * history of previous use of acthar for treatment of nephrotic syndrome * prior sensitivity to acthar or other porcine protein products * contraindication to acthar per prescribing information * planned treatment with live or live attenuated vaccines once enrolled in the study * more than three previous treatment regiments * participation to other clinical trials over the previous 12 months * history of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas * pregnancy * lactation * current substance abuse * any clinically relevant condition that might affect study participation and/or study results

Keywords: membranous nephropathy adrenocorticotropic hormone acth proteinuria glomerulonephritis
robotic rehabilitation for stroke survivors

Conditions: Chronic Stroke

Summary: pilot study on the physiological response of robotic rehabilitation therapy for improving the performance of activities of daily living of stroke patients

the purpose of this research is to study the feasibility of the robotic therapy that can train activities of daily living tasks for chronic stroke patients. the participant will be involved in a feasibility study (one-time visit) to prove the efficacy of the robotic device with different force feedback (assistive and resistive force) and other feedback such as vr (virtual reality). we will collect movement data from a motion capture system and semg sensors that measure muscle activity to monitor the effect of a robotic rehabilitation device, named spherical parallel instrument for daily living emulation (spindle). we will use a robotic therapy device to practice activities during daily living. this pilot study will be used to understand the effect of spindle to translate the device as a home-based training for chronic stroke patients.

Eligibility criteria:
inclusion criteria: * adults with chronic stroke, which affected their upper limb motor functions * adults could able to understand the verbal cues during the training exclusion criteria: * adults with chronic stroke, who did not lose their upper limb motor functions
effectiveness of ultrasound-guided scalp block for supratentorial craniotomy

Conditions: Pain, Postoperative; Anesthesia

Summary: pain management in patients undergoing neurosurgery is a very important issue. the effectiveness of usg-guided scalp blocks for pain management in craniotomy surgery is currently not known. the purpose of this clinical trial is to evaluate the effectiveness of ultrasound-guided scalp block when performed in patients who undergo supratentorial craniotomies.

the main research questions this trial will answer are: 1. in patients undergoing elective supratentorial craniotomy under general anaesthesia, does usg-guided scalp block affect postoperative pain compared to standard treatment? 2. in patients undergoing elective supratentorial craniotomy under general anaesthesia, does usg-guided scalp block affect postoperative opioid consumption compared to standard treatment? 3. in patients undergoing elective supratentorial craniotomy under general anaesthesia, does usg-guided scalp block affect intraoperative haemodynamic parameters (blood pressure and heart rate) compared to standard treatment? this clinical trial compares ultrasound-guided scalp block with ropivacaine 0.375% versus standard treatment. the findings of this clinical trial may potentially revolutionise the practice of regional anaesthesia and analgesia in intracranial surgeries. this will lead to better patient outcomes by improving the perioperative care of patients undergoing craniotomy surgery.

Eligibility criteria:
inclusion criteria: * all american society of anesthesia class i to iii patients undergoing elective supratentorial craniotomies under general anaesthesia. exclusion criteria: 1. refusal to participate in the study 2. contraindications to the performance of scalp block, such as local infections 3. allergy to ropivacaine hydrochloride 4. age \< 18 years old 5. undergoing emergency craniotomies, posterior fossa surgery, or burr holes surgery 6. pre-existing chronic pain (defined as persistent or recurrent pain lasting \> 3 months) 7. history of drug addiction (illicit substances and opioids use) or chronic alcohol abuse 8. presence of uncontrolled systemic arterial hypertension, severe cardiovascular disease, severe kidney or severe liver diseases 9. predicted to require postoperative ventilation in the intensive care unit 10. psychiatric disorders, serious neurological diseases, or reduced consciousness gcs \< 14

Keywords: scalp block pain supratentorial craniotomy ultrasound
text messaging and cognitive behavioral therapy for depression

Conditions: Depression

Summary: this study aims to asses whether adding automated text messaging to group cognitive behavioral therapy for depression increases engagement which may lead to improved outcomes.

background: cognitive behavioral therapy (cbt) for depression is efficacious, but effectiveness is limited when implemented in low-income settings due to engagement difficulties including nonadherence with skill-building homework and early discontinuation of treatment. automated messaging can be used in clinical settings to increase dosage of depression treatment and encourage sustained engagement with psychotherapy. objectives: the aim of this study was to test whether a text messaging adjunct (mood monitoring text messages, treatment-related text messages, and a clinician dashboard to display patient data) increases engagement and improves clinical outcomes in a group cbt treatment for depression. specifically, the investigators aim to assess whether the text messaging adjunct led to an increase in group therapy sessions attended, an increase in duration of therapy attended, and reductions in patient health questionnaire-9 item (phq-9) symptoms compared with the control condition of standard group cbt in a sample of low-income spanish speaking latino patients. methods: patients in an outpatient behavioral health clinic were assigned to standard group cbt for depression (control condition; n=40) or the same treatment with the addition of a text messaging adjunct (n=45). the adjunct consisted of a daily mood monitoring message, a daily message reiterating the theme of that week's content, and medication and appointment reminders. mood data and qualitative responses were sent to a web-based platform (healthysms) for review by the therapist and displayed in session as a tool for teaching cbt skills.

Eligibility criteria:
inclusion criteria: * participation in cbt group at san francisco general hospital exclusion criteria: * active suicidality * active and severe psychosis

Keywords: mhealth depression latinos text messaging cbt sms
efficacy side-effect score (ess): development and evaluation of a new tool for patients after surgery

Conditions: Postoperative Pain; Postoperative Vomiting and Nausea; Postoperative Complications; Mental Status Changes Postoperative

Summary: we hypothesized that better control of postoperative pain treatment and its side effects by monitoring ess might influence the degree of mobility and morbidity in surgical patients and consequently reduce los. thus, our aim was to validate the influence of recording ess and the application of a "call-out algorithm" on los in two university hospitals in which the routine policy of registration of pain had not been adopted yet.

using clinical experience and consensus-methodology the investigators picked up and digitalized information about mental, postoperative nausea, vomiting and pain status at the rest and during mobilization in so called efficacy safety score (ess). depending on expression of patient's complaints, all mentioned above clinical features are scored. we hypothesized that better control of postoperative pain treatment and its side effects by monitoring ess might influence the degree of mobility and morbidity in surgical patients and consequently reduce length of hospital stay (los). thus, our aim was to validate the influence of recording ess and the application of a "call-out algorithm" on los in two university hospitals in which the routine policy of registration of pain had not been adopted yet. the primary endpoint of the study was to assess los in groups of patients with different types of clinical data records and "call-out algorithms," while secondary endpoints were to compare the degree of mobilization, number of postoperative nonsurgical complications, and 28-day survival between the groups.and summarized in the total score.

Eligibility criteria:
inclusion criteria: * all adult postoperative patients that are inpatients, and scheduled for hospitalization for more than 8 hours exclusion criteria: * children, mental illness, communication difficulties

Keywords: score postoperative pain nausea mental status tool
rehabilitation of facial emotion recognition in alzheimer's disease

Conditions: Alzheimer's Dementia (AD); Family Caregivers

Summary: eye-tar(ad+) is an observational study based on the same design as the princeps eye-tar(ma) study, but with a larger number of patients and including an additional evaluation of facial emotion recognition (based on a more ecological material), in order to reinforce conclusions of the study eye-tar(ma) https://doi.org/10.1016/j.npg.2020.08.003. the main objective is to confirm that facial emotion recognition can be improved in ad using the "training of affect recognition program" (tar). the secondary objectives are to: evaluate the impact of the "training of affect recognition program" (tar) on oculomotor behavior in a situation of social cognition, on behavioral disorders and on caregiver burden. confirm that improvement in facial emotion recognition is related to modification of observation strategies. confirm the link between improved recognition of facial emotions, reduced behavioral disorders and caregiver burden.


Eligibility criteria:
inclusion criteria: * male or female. * ad diagnosed according to l'iwg-2 (dubois \& al. 2014) criteria, * mini-mental state (mms-e) ≥15 * subject accompanied by a family caregiver and whose participation in a cognitive stimulation workshop was recommended in memory centre of the rainier centre (princesses grace hospital - monaco) * written informed consent signed by patient and family caregiver. exclusion criteria: * general anaesthesia within 3 months. * history of psychiatric and/or neurological disorder (other than the diagnosed neurodegenerative pathology); * history of alcoholism or drug addiction * ophthalmological or neurological problems preventing a video-oculography examination. * oculomotor disorders such as "fixation disorders" or "ocular tracking disorders". * cognitive disorders of the neurovisual type (visual agnosia, prosopagnosia, visuo-spatial disorder or visuo-perceptual disorder) or aphasia.

Keywords: facial emotion recognition training of affect recognition behavioral disorders caregiver's burden alzheimer's dementia gaze strategies eye-tracking oculomotor behaviors
hyperpolarized c pyruvate magnetic resonance imaging, and blood-based biomarkers for early detection of pancreatic adenocarcinoma in patients with intraductal papillary mucinous neoplasms

Conditions: Pancreatic Cyst

Summary: the purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/pdac early to avoid the invasive procedure of surgery. the study researchers think a combination of imaging and a series of blood tests may be an effective way to detect pdac early. in this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect pdac in pancreatic cysts: * the immunopet scan (immune-positron emission tomography scan) with the imaging agent 89zr-dfo-humab-5b1 * the hp mri scan (hyperpolarized pyruvate magnetic resonance imaging scan)


Eligibility criteria:
inclusion criteria: * men and women aged \>18 years * pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection * able to provide informed consent exclusion criteria: * pathologic evidence of pancreatic cancer * pregnant or breast-feeding patients * refusal or inability to tolerate scan (eg anxiety or claustrophobia) * inability to lay flat or meet the standard requirements of traditional mri * hepatic function from assays obtained within 6 weeks prior to the study enrollment. for each patient, the upper limit of normal (uln) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay 1. bilirubin \> 1.5 x uln 2. ast/alt \> 2.5 x uln 3. albumin \< 3 g/dl 4. ggt \> 2.5 x uln if alkaline phosphatase \> 2.5 x uln * renal function with creatinine \> 1.5 x uln or creatinine clearance \< 60 ml/min, from assays obtained within 6 weeks prior to study enrollment * cardiac: congestive heart failure with new york heart association (nyha) status ≥2, poorly controlled hypertension, a history of clinically significant ekg abnormalities, or myocardial infarction within 6 months of study enrollment.

Keywords: pancreatic cyst memorial sloan kettering cancer center 23-367
xience v/promus everolimus-eluting stent system post-marketing surveillance protocol for japan

Conditions: Angina; Chronic Coronary Occlusion; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Summary: the objectives of this post-marketing surveillance, conducted in japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.

the surveillance is to be conducted in accordance with the japanese ministerial ordinance concerning the standards for postmarketing surveillance and tests of medical devices.

Eligibility criteria:
inclusion criteria: * only xience v stent(s)or promus stent(s) is (are) implanted in the coronary vasculature during the index procedure. exclusion criteria: * neither xience v stent(s) nor promus stent(s) is (are) implanted in the coronary vasculature during the index procedure.

Keywords: drug eluting stents stents angioplasty