Kornimate/medical-research-clean huggingface dataset:
low back pain and quality of life among the ambulance drivers in malaysia's hospitals

Conditions: Low Back Pain; Quality of Life

Summary: the study is a community interventional study by using an integrated back pain module (ibpm). the purpose of this study is to find out if the module training has any benefit on low back pain among ambulance drivers. the effectiveness of the module is determined by baseline quality of life results compared with after the intervention program completed.

an integrated back pain module (ibpm) will be implemented for ambulance drivers (respondent) in peninsular malaysia. pre-intervention assessment and post-intervention assessment will be conducted in 18 government hospitals involved. there is nine hospital in perak that has been selected as an intervention group and nine hospital in kelantan will be the control group. two different regions are selected; the north region will be the intervention group (perak) while east coast will be the control group (kelantan). the clinical benefits of the ibpm module low back pain and quality of life will be reported at the beginning and the end of the intervention and after a period of 6 months follow up. the protocol for the intervention group (perak) included five components of the education module (ibpm) such as the structure and function of the spine, causes of lbp, how to avoid low back pain at the workplace, exercise methods, and psychology management. the overall objectives are to help ambulance driver manage their lbp and prevent future lbp recurrences. the first step of the protocol is subjects are required to attend an introductory course for one day and then the intervention will last for 6 months. research staff will explain how to operate and use the module. subjects must comply with all the care and prevention guidelines of the research module so that it achieves the expected results. they also need to complete the checklist provided in the edmodo software via their respective smartphones. tokens in the form of top-ups will be entered automatically after the checklist is received by researchers. the exercise will be performed by participants 5 times per week for a total of 24 weeks. each individual session will take around 5 minutes to perform exercises independently and sending their report through edmodo. light soft tissue exercises techniques such as active muscle stretching, and strengthening exercises will be used as needed to facilitate the educational module therapy.

Eligibility criteria:
inclusion criteria: * adult ≥ 18 years old. * working experience ≥ 1 year exclusion criteria: * patients with uncontrolled chronic illness such as hypertension, diabetes mellitus, osteoarthritis and gout. * injury or surgery of the spine

Keywords: lbp qol
the effect of feedback regarding illness behavior on patient satisfaction in hand surgery

Conditions: Hand Surgery

Summary: the investigators of this study would like to see whether providing feedback to patients regarding their illness behavior/coping strategies, using online questionnaires, improves patient-physician communication in orthopaedic surgery. the investigators aim to enroll 128 patients.

psychological and sociological factors are important in the human illness experience, but biomedical factors are the focus of most office visits, particularly in hand surgery. both patients and surgeons can feel uncomfortable discussing emotions, stress, and coping strategies. detmar et al. randomized patients in an oncology practice to receive feedback on a hrql assessment or not during office visits. they observed that feedback on the hrql assessment contributed to physicians' awareness of healthy issues and patient-physician communication. there was a difference in perceived emotional support, but not in overall satisfaction with the visit\[1\]. a retrospective study observed in patients with local prostate cancer, that pre-therapy hrql assessment is associated with a better sexual function, sexual bother and bowel function according to post-therapy hrql scores\[2\]. the investigators propose a two arm unblended, randomized (1:1) controlled trial to assess the effect of providing feedback to patients regarding illness behavior/coping strategies (using patient reported outcomes measurement information system (promis) computer adaptive testing (cat) instruments) on patient satisfaction and patient-physician communication in orthopaedic surgery. if the results of the study suggest that feedback of results from the questionnaires increases patients' satisfaction, such an intervention may be used in the future to benefit future patients. aim: the aim of this study is to assess the effect of feedback regarding illness behavior measured with patient reported outcomes measurement instrument system - computerized adaptive testing (promis- cat) on patient satisfaction. primary null hypothesis: there is no difference in satisfaction between patients who receive feedback about their illness behavior, measured with promis-cat, compared to patients who do not. secondary null hypotheses: there is no difference in patient-physician communication about patient's illness behavior between patients who receive feedback about their illness behavior, measured with promiscat, compared to patients who do not. there are no predictors for patient satisfaction.

Eligibility criteria:
inclusion criteria: * all new patients visiting the orthopaedic hand and upper extremity service * english fluency and literacy * ability to provide informed consent exclusion criteria: * age \< 18 * inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
automated sms reminders to parents on their cell phones can significantly improve the on time vaccination rates children in pakistan

Conditions: Vaccination Failure

Summary: the investigators plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (sms) in improving the on-time routine immunization for children in pakistan. sms message as a reminder tool can be very effective in health care settings at public health scale. this study will be conducted in an urban- squatter settlement area, ibrahim haidry union council in karachi. parents/guardians of children randomized in intervention arm will be sent sms reminders vaccination visit reminders at 6, 10 and 14 weeks of life.

the immunization coverage in pakistan is still well below the desired level, leading to continued polio transmission, large measles outbreaks and thousands of deaths from vaccine-preventable illnesses. a major reason for poor childhood vaccine coverage is the lack of awareness among parents regarding the need for immunization in children, and the importance of completing the entire series of vaccines. this result in significant drop-out between vaccines delivered at birth and later in the infancy period. customized short messaging system (sms) text can be designed as personally tailored messages to remind and inquire parents regarding vaccination for their children according to the epi schedule. we plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (sms) in improving the on-time routine immunization for children in pakistan. this study will be conducted in an urban- squatter settlement area, ibrahim haidry union council in karachi, pakistan. our experimental plan has three components: first, we will conduct baseline survey of parents at our study site to explore their preferences for text for immunization reminders. simultaneously, we will develop a computerized application for reminders scheduling. this application will contain the phone number, message information, language preferences and date on which the message will be sent. it will be interfaced with the gateway to send the message. lastly, we will conduct a randomized controlled trial to determine the effectiveness of automated sms reminders to parents in improving the on-time vaccination rates in children. if the result shows that the vaccines compliance can be increased through the sms reminders, this program can be incorporated with the existing systems to collect the cell phone numbers of parents at the time of child's first contact with the health system and sending auto generated reminders for vaccine compliance at national level.

Eligibility criteria:
inclusion criteria: * child should be less than 14 days of age * parent/guardian or at least one person in the household having a valid cell phone connection * parent/guardian provides consent exclusion criteria: * child more than 14 days of age * not a valid cell phone connection in the household * parent/guardian not providing consent

Keywords: polio
efficacy and safety of valsartan/hydrochlorothiazide combination compared to valsartan monotherapy or hydrochlorothiazide monotherapy in elderly (>70) with mild-moderate hypertension.

Conditions: Hypertension

Summary: the purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (hctz) versus the initial treatment therapy with monotherapies (valsartan or hctz) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension


Eligibility criteria:
inclusion criteria: * age 70 years or older. * patients with hypertension prior to being randomized into study. * patients must have an office cuff mssbp ≥ 140 and ≤ 200 mmhg systolic. * have the ability to communicate and comply with all study requirements. * provide written informed consent to participate in the study prior to any screening or study procedures. exclusion criteria: * use of other investigational drugs within 30 days of enrollment. * history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. * office blood pressure measured by office machine cuff with a mean of (3) msdbp ≥ 120 mmhg at anytime during the screening / washout period. * patients taking 3 or more antihypertensive drugs and mssbp ≥ 160 mmhg at the time of visit 1. * other protocol-defined exclusion criteria may apply

Keywords: systolic blood pressure diastolic blood pressure valsartan hydrochlorothiazide
macintosh and d-blade® in simulated difficult airway

Conditions: Difficult Intubation; Cervical Injury Spine

Summary: in the presented study, our aim was to compare intubation conditions regarding the modified cormack \& lehane score (cl) between the d-blade® in indirect laryngoscopy or macintosh blade in direct and indirect laryngoscopy with c-mac pm® in a simulated setting of a difficult airway in human subjects.

patients with unexpected difficult airway requiring endotracheal intubation (eti) remain extremely challenging for emergency physicians and intubation failure with subsequent hypoxic complications still represents the majority of cases in a recent closed claims analysis. an incidence of major complications in airway management of 1 in 5,500 was estimated in the fourth national audit project in the uk. therefore, our aim was to compare intubation conditions regarding the modified cormack \& lehane score (cl) between the d-blade® in indirect laryngoscopy or macintosh blade in direct and indirect laryngoscopy with c-mac pm® in a simulated setting of a difficult airway in human subjects.

Eligibility criteria:
inclusion criteria: * patients requiring general anesthesia for orthopedic surgery exclusion criteria: * known or expected difficult airway * undergoing urgent or emergent surgery * non-fasted * american society of anesthesiology class (asa) iv-vi * no consent for participation

Keywords: difficult airway carvical collar endotracheal intubation
post-icu follow-up study in covid-19 patients

Conditions: COVID-19 Pandemic; Intensive Care Unit Syndrome; Delirium

Summary: a follow up study of adult patients who have been treated in the icu at mölndal hospital due to covid19 in the period of 2020 to 2022.

the spread of covid19 in the population in sweden from 2019 and onwards posed new and serious strain on our icu capacity. the disease presented with initially influenza like symptoms and evolved into multiorgan failure. 5% of all patients with verified covid 19 were in need of critical care and among them the in-hospital mortality rate was 20%. patients will be followed up with after a minimum of three months after discharge from the icu with regards to organ function. examinations within the scope of the study are; * comprehensive heart investigation including ultrasound * arterial blood gas and lung function tests including computer tomography of the lungs. * cognitive function with validated questioners * standardized test of physical function * a panel of blood samples to assess organ function

Eligibility criteria:
inclusion criteria: * patients treated at the intensive care unit at mölndals hospital from 2020 to 2022 for covid19 * more than 3 months passed since icu discharge * over 18 years of age at time of inclusion * swedish resident with swedish unique personal identification number. * informed consent exclusion criteria: * under 18 years of age at time of inclusion * not a swedish resident * unwillingness to participate

Keywords: covid19 heart function lung function cognitive function
postmarketing surveillance study to assess handling and patient satisfaction on berodual® respimat® solution for inhalation in comparison to a powder inhaler in patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: new perceptions about handling and patient satisfaction of the everyday use of berodual® respimat® compared to a powder inhaler in patients with chronic obstructive lung disease (cold). moreover, further knowledge should be attained about the tolerability of berodual® respimat®


Eligibility criteria:
inclusion criteria: * male and female patients aged at least 18 years * patients who are suffering from symptoms of a chronic obstructive lung disease (cold) can be included in the pms. to reduce influences caused by the use of a variety of different powder inhaler, only patients who are already regularly using diskus® powder inhaler should be included, as the diskus® as well as the berodual® respimat® are multiple dose devices * during the pms the diskus® therapy is to be continued exclusion criteria: * patients who meet one or more of the general or specific contraindications mentioned in the summary of product characteristics (smpc) are excluded from the postmarketing surveillance (pms)
carotid revascularization for radiation induced carotid artery stenosis

Conditions: Radiation-induced Carotid Artery Stenosis

Summary: cervical radiotherapy (rt) has greatly reduced the mortality of patients with malignant head and neck tumors, which, however, causes a higher risk of carotid artery stenosis, namely, radiation-induced carotid artery stenosis (rics) and results in a significant increased risk of ischemic stroke. the systematic review and meta-analysis conducted by our team showed carotid endarterectomy (cea) can yield better results for these patients than carotid artery stenting (cas), which was contrary to most previous clinical guidelines. a large-scale prospective study is needed to verify the results. we will conduct a prospective registry of rics patients treated with cea to evaluate both short-term safety and long-term efficacy outcomes in a chinese population.


Eligibility criteria:
inclusion criteria: * patients with carotid stenosis who had a history of radiotherapy for head and neck cancer. (the median interval between the completion of radiation therapy and development of carotid artery stenosis detected on imaging (or vascular intervention) was no less than 1 years to avoid non-related situations. the target area of the radiotherapy included at least the ipsilateral neck, including part of the carotid system. the internal carotid stenosis was confirmed by angiography, duplex, 3d angio-cta or angio-mri, and stenosis was defined as \> 50% based on north american symptomatic carotid endarterectomy trial criteria), with or without symptom. patients with a transient ischaemic attack (tia) or stroke within 6 months were defined as symptomatic. tia was defined as a transient episode of neurological dysfunction (focal weakness/ language disturbance/transient monocular blindness/ requiring assistance to walk) caused by focal brain or retinal ischemia that lasts for at least 10 min but resolves within 24 h.) exclusion criteria: * the patients treated for restenosis. * intracranial arteriovenous malformation or aneurysm * severe stenosis or occlusion of the ipsilateral intracranial artery * unstable angina, myocardial infarction (mi), or congestive heart failure in the last 6 months * uncorrectable coagulation abnormalities * uncontrolled diabetes mellitus defined as glucose \> 300 mg/dl (16.67 mmol/l) * pregnant or in the perinatal period * severe concomitant disease with poor prognosis (life expectancy \< 2 years) * intolerance or allergies to any of the study medications, such as aspirin or clopidogrel

Keywords: radiation-induced carotid artery stenosis carotid endarterectomy outcomes
study of sta-1 as an add-on treatment to donepezil

Conditions: Alzheimer Disease

Summary: the objective of this study is to evaluate the efficacy and safety of sta-1 vs placebo as an add-on treatment to donepezil in patients with mild to moderate alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: * male or female patient aged ≥ 50 years; * probable alzheimer's disease diagnosed by the national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association (nincds-adrda) criteria; * mmse score between 10-26, inclusive; * patient has been treated with donepezil 10 mg per day for at least 3 months prior to screening; * patient able to participate in all study evaluations and ingest oral medication as indicated; * patient has a responsible caregiver who will accompany the patient to all clinic visits during the study; * patient and the responsible caregiver have provided written informed consent before undergoing any study procedures. exclusion criteria: * brain image (computed tomography (ct) scan or magnetic resonance imaging (mri) done within past 12 months prior to the study) and laboratory tests to exclude secondary dementia or non-alzheimer's dementia; * patient with significant clinically central nervous system illness other than ad (e.g. parkinson's disease, human immunodeficiency virus (hiv) induced dementia, hachinski ischaemic score (his) \>4) or dementia complicated by other organic disease or delirium; * patient with a severe or uncontrolled diagnostic and statistical manual of mental disorders (dsm-iv) axis i disorder other than alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder; * patient suffering from cerebral disturbances following a stroke or a cerebral trauma (if the event occurred within the last 6 months); * patient with a history of hypersensitivity to study drugs; * patient who has a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine (e.g., addison's disease), immune, neurologic, or hematologic disease as determined by the clinical judgment of the investigator; * participation in any research study within the last 30 days; * patient with significant alcohol or drug abuse as judged by the investigator.
a study of imm01 plus tiselizumab versus physician's choice chemotherapy in pd(l)1-refractory classical hodgkin lymphoma

Conditions: Classic Hodgkin Lymphoma

Summary: the purpose of this study is to compare efficacy of imm01 plus tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with pd-(l)1-refractory classical hodgkin lymphoma. the study will also assess the safety and tolerability of imm01 plus tiselizumab. the primary study hypotheses are that imm01 plus tiselizuma is superior to physician's choice chemotherapy with respect to progression-free survival (pfs) and overall survival (os).


Eligibility criteria:
inclusion criteria: * has histologically confirmed diagnosis of classical hodgkin lymphoma (chl). * pd (l)-1 refractory chl and exhausted all available treatment options with known clinical benefit. * has adequate bone marrow reserves and organ functions. exclusion criteria: * history of central nervous system (cns) metastases or active cns involvement. * received prior systemic anticancer therapy within 4 weeks before randomization. * received prior ani-cd47 or sirpa treatment. * history of human immunodeficiency virus (hiv). * has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy. * history of severve allergic reactions to any components of trail durg, humanized antibodies or fusion proteins.
xh001 combination with immunocheckpoint inhibitor and chemotherapy for patients with resected pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a single-center, open label, single-arm, investigator-initiated study to evaluate the efficacy and safety of xh001 (neoantigen cancer vaccine) sequential combination with immunocheckpoint inhibitor and chemotherapy in pancreatic cancer patients following surgical resection.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form; * aged 18 to 75 years old; * histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; * completed an r0 or r1 surgical resection as determined by pathology； * have not received any prior neoadjuvant therapy; * ecog score is 0 or 1; * life expectancy of greater than 12 months; * ca19-9 \<100u/ml before initial chemotherapy; * patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug. * woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol. exclusion criteria: * borderline resectable pancreatic cancer; * evidence of disease recurrence or metastasis following surgical resection at any time; * evidence of malignant ascites; * pre-existing inflammatory bowel disease or the presence of complete or partial bowel obstruction, or persistent severe diarrhea after surgery; * needs to receive long-term systemic anti-allergic drug or known hypersensitivity to any component of the study treatment; * history of autoimmune disease; * new cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months before screening; * acute myocardial infarction within 6 months before screening, or uncontrolled angina, uncontrolled arrhythmia, severe heart failure (see appendix 3, new york heart association heart failure classification criteria nyha class ≥ iii) and other cardiovascular diseases; * received immunomodulatory medications within 4 weeks prior to the date of the first dose (d1) of xh001, including but not limited to: il-2, ctla-4 inhibitors, cd40 agonists, cd137 agonists, ifn-α; * received blood transfusion, erythropoietin (epo), granulocyte colony-stimulating factor (g-csf) or granulocyte-macrophage colony-stimulating factor (gm-csf) within 7 days prior to the first dose of xh001; * received therapeutic tumor vaccines; * with congenital or acquired immunodeficiency; * participating in other clinical trials and not enrolled at the screening period; * unable or unwilling to comply with the study protocol due to potential health, mental or social conditions in the opinion of the investigator; * other conditions that, in the opinion of the investigator, would make participation in this study inappropriate.

Keywords: cancer vaccine, mrna, neoantigen pancreatic cancer adjuvant therapy