Kornimate/medical-research-clean huggingface dataset:
feasibility and accuracy of a wireless vital sign monitor for observation of adult patients in uganda

Conditions: Critical Illness

Summary: this feasibility study will demonstrate the safety and accuracy of the neopenda's wireless vital signs monitor, neoguard, on 30 adult patients in a ugandan clinical setting. the technology will be tested against a conventional patient monitor. root mean square deviation (rmsd) and bland-altman plots will be used to assess concordance between paired measurements from the two equipment collected over a 1-hour period for each patient.

continuous vital sign monitoring is a basic tenet of specialized care in the developed world that is vastly underutilized in the intensive care units of most low-and-middle income countries. despite the positive outcomes associated with vital signs monitoring (i.e. increased survival-to-discharge, lower complication rates and shorter length of hospitalization), the prohibitive costs of conventional patient monitors and the difficulty in maintaining complex medical equipment limit its accessibility in the developing world. this feasibility study will demonstrate the safety and accuracy of the neopenda's wireless vital signs monitor, neoguard, on adult patients in a ugandan clinical setting. the technology will be tested against a conventional patient monitor. root mean square deviation (rmsd) and bland-altman plots will be used to assess concordance between paired measurements from the two equipment collected over a 1-hour period for each patient. this technology innovation has large potential to impact health outcomes in low-resource settings, as it is a portable, reusable, long-lasting, cost-efficient monitoring tool designed for settings where patient loads are high and such solutions are direly needed.

Eligibility criteria:
inclusion criteria: * aged 18+ years (legal adult) * admitted for suspected or confirmed respiratory illness (excluding covid-19) * stable clinical status (as determined by key physiological parameters pulse rate = 60-100 beats per minute, respiratory rate = 12-18 breaths per minute, oxygen saturation = 90 100% and temperature 36.5°c - 37.5° c) * willing and able to provide consent to receive vital sign monitoring exclusion criteria: * aged \<18 years * unstable clinical status as determined by physiological parameters (pulse rate \ 100bpm, respiratory rate \ 18bpm, oxygen saturation \ 37.5°c)

Keywords: critical care health technology vital sign monitoring
evaluation of respiratory muscle in patient with pulmonary arterial hypertension

Conditions: Pulmonary Artery Hypertension

Summary: the aim of the study is that evaluation of basic and accessory respiratory muscles and their relationship of six minute walk test in patient with pulmonary arterial hypertension (pah)


Eligibility criteria:
inclusion criteria: * patients with diagnosis of pulmonary arterial hypertension * patients with stabil drug therapy at least three months exclusion criteria: * patients with obstructive and/ or restrictive lung disease comorbidity * severe orthopedic and/ or neurological comorbidity * patients with heart failure * patients with ischemic heart disease * uncooperative patients

Keywords: respiratory muscle strength exercise capacity dyspnea accessory respiratory muscle
preemptive analgesia in total knee arthroplasty

Conditions: Acute Pain

Summary: acute pain is the most common early complication after total knee arthroplasty that caused delayed mobilization, demands of morphine, and higher operative cost. there were many researches that had been done in analgesia method to find the most effective analgesia, lowest side effect, and easy to apply. preemptive analgesia of combined celecoxib and pregabalin were reported to give a promising outcome. in a randomized, double blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. all subjects were divided into three groups. first group was given celecoxib 400mg and pregabaline 150mg 1 hour before operation, second group was given celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation, and the last group was given placebo. the outcome was measured with vas, knee rom, and post-operative mobilization


Eligibility criteria:
inclusion criteria: * 55-80 years old patients who come to orthopaedic polyclinic * underwent tka procedure * have osteoarthritis * consumed pain killer and anti inflamatory drugs routinely exclusion criteria: * psychiatric disorder * have history of renal disease * histroy of chronic neurophatic * have genu arthritis that caused by rheumatid arthritis and infection * diabetic and obesity * coagulopathy * patients with severe pain that needed immediate analgesia regimen
drug eluting stents versus bare metal stents for treatment of symptomatic extracranial vertebral artery stenosis

Conditions: Ischemic Stroke; Vertebral Artery Stenosis

Summary: stroke is one of the important causes of disability and death in the world, in which more than half were ischemic strokes. about 1/4 of the ischemic stroke occurred in the vertebral basilar artery system, especially when in the presence of extracranial proximal vertebral artery stenosis. vertebral artery stenting is a minimally invasive method for the reconstruction of vertebral artery stenosis and the early clinical studies showed that it was feasible, safe and effective, but the high rate of restenosis has become a bottleneck restricting its development. previous systematic review had suggested that the drug eluting stent might reduce the incidence of restenosis of vertebral artery. however, prospective randomized controlled trials comparing the efficacy of bare metal stents and drug eluting stents on the prevention of restenosis remains absent.

60 patients were randomly assigned into des and bes group to compare the safety and efficacy in the treatment of symptomatic extracranial vertebral artery stenosis with drug eluting stents (yinyi) and bare metal stents (express sd), especially the stent restenosis rate after 6 months.

Eligibility criteria:
inclusion criteria: * symptomatic posterior circulation ischemia（vertebral basilar artery system tia or non-disabling ischemic stroke）result from the stenosis in the extracranial proximal vertebral artery stenosis. * atherosclerotic extracranial proximal vertebral artery stenosis demonstrated by angiography(any of the following): 1) bilateral vertebral artery stenosis ≥70%, or vertebral artery stenosis ≥70% concomitant occlusion of contralateral vertebral artery; 2) superior lateral vertebral artery stenosis ≥70%; 3) non-superior lateral vertebral artery stenosis ≥50%, but the vertebral artery was directly extended to the posterior inferior cerebellar artery on this side and symptoms were related to insufficiency of the ipsilateral posterior inferior cerebellar artery. exclusion criteria: * 1) lesions characteristics (such as diffuse lesions) which was not suitable for interventional treatment, or unstable condition that cannot tolerate the interventional therapy; * 2) vertebral artery stenosis caused by non atherosclerosis disease: takayasu arteritis or other diseases; * 3) severe stroke within 3 months; * 4) contraindicated using contrast agents: such as chronic renal insufficiency or had serious contrast agents allergy history; * 5) malignant tumor; * 6) with alzheimer's disease or mental illness previously or currently ; * 7) patients or family members refuse the operation.

Keywords: vertebral artery stenosis ischemic stroke stent
optimization of inhaled corticosteroid treatment in adult patients with asthma guided by exhaled no measurement at home

Conditions: Asthma

Summary: to compare the clinical outcome (effectiveness) of single inhaled corticosteroid (ics) controller treatment guided by exhaled no measurement made at home with usual care asthma management with regard to asthma control (primary outcome), asthma-related quality of life, lung function, airway inflammation, medication use, and asthma events. to understand changes in patient behaviour triggered by daily feno measurement at home, for example treatment adherence and voluntary allergen exposure.

the design is a pragmatic randomized controlled, open-label, parallel group study screening visit 1 and visit 2 is separated with a 2-4 week run-in period. at screening visit, informed consent is signed and atopic asthma confirmed, spirometry is performed and questionnaires responded to. at visit 2 venous blood samples are taken and serum stored at -20 °c for later transport to uppsala biobank, exhaled no is measured at both visit using niox mino (blinded in control group). * the active group if on combination inhaler, will switch to giona easyhaler (same budesonide equivalent as before study entry) and oxis (same formoterol equivalent as before study entry). these patients will receive a niox mino and will be taught about the adjustment of ics treatment according to daily exhaled no measurement at home and a personalized treatment algorithm. * the control group will stay on previous controller treatment (only changed if indicated by symptoms at visit) according to usual care. * both groups will switch short-acting beta-2-agonist to buventol easyhaler. * both groups will report symptoms (acq) monthly and in connection to asthma events via an epro system (viedocme, pcg). active group will report no values on a weekly basis via the same system. there will be a follow-up clinic visit 3 at 6 months with exhaled no measurement (blinded in control group) and limited set of questionnaires. a second follow-up visit 4 at 12 months with exhaled no, spirometry, full set of questionnaires and blood sample will be made.

Eligibility criteria:
inclusion criteria: * age ≥18, ≤64 years * physician-diagnosis of asthma * regular inhaled budesonide (giona easyhaler, pulmicort turbuhaler, novopulmon novolizer or symbicort turbuhaler) treatment since at least 6 months * verified allergy to at least one airborne perennial allergen after objective testing (immunocap rapid asthma/rhinitis adult) * acq \>1.0 * can read and understand the swedish language * written informed consent signed exclusion criteria: * regular tobacco use within past 6 months * ≥10 pack-years smoking history * keeping a furred pet at home * treatment with singulair * \>4 prednisolone courses last 12 months * ongoing pregnancy or lactation * participation in another clinical trial
cryopreserved-thawed embryo transfer with or without gonadotropin releasing hormone agonist

Conditions: Infertility

Summary: traditionally, the use of gnrh-a suppression was considered essential for adequate endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. several studies, however, have questioned its necessity for controlled endometrial preparation. using a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing folliculogenesis and excessive secretion of lh, allowing adequate endometrial preparation without gnrh-a.


Eligibility criteria:
inclusion criteria: * 20-35 years * bmi 20-30 * regular menses. * no pcos, no endometriosis * no uterine anomalies or lesions * no severe male factor * all grade 1 cleaved stage embryos exclusion criteria: * less than 20 or more than 35 years * bmi less than 20 or more than 30 * irregular cycles * pcos or endometriosis * uterine anomalies or lesions * severe male factor * poor quality embryos for transfer * severe
predictive models of hepatic decompensation and survival outcomes in pediatric patients with cirrhosis

Conditions: Cirrhosis; Biliary Atresia; Choledochal Cyst; Primary Sclerosing Cholangitis; HBV; HCV; Autoimmune Hepatitis

Summary: the aim of this study was to developed and validated models to predict hepatic decompensation and survivals in pediatric patients with cirrhosis and compared these models with currently available models.

noninvasive liver fibrosis tests such as the nafld fibrosis score (nfs), hepascore, and transient elastography were specifically developed to predict fibrosis and can help predict patients with nafld at the highest risk of developing liver-related complications. these tests have been widely applied in adult cirrhosis. the accuracy of these models, however, may be influenced by patient factors including age, body mass index, and diabetes, potentially limiting their prognostic accuracy and clinical practicability in children. therefore, it is currently unknown how to best predict hepatic decompensation and survival outcomes among pediatric patients with cirrhosis. to fill this knowledge gap, the investigators performed a retrospective-prospective cohort study with the aim of developing and validating a clinical model to predict liver-related complications and survival outcomes in pediatric patients with biopsy-proven with cirrhosis. secondly, the investigators aimed to compare the predictive accuracy with currently available noninvasive model.

Eligibility criteria:
inclusion criteria: * age up to 18 years old * no previous episodes of clinical decompensation * with written informed consent exclusion criteria: * clinical data missing * without written informed consent
study of her2 directed dendritic cell (dc1) vaccine + weekly paclitaxel, trastuzumab & pertuzumab

Conditions: HER2-positive Breast Cancer

Summary: the purpose of the study is to find out if an investigational drug called dendritic cell (dc1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with her2 (human epidermal growth factor receptor 2) positive breast cancer.


Eligibility criteria:
inclusion criteria: * participants must have histologically confirmed clinical stage i- iii, her2+ (per asco/cap criteria) invasive carcinoma of the breast. primary tumor should measure at least 1 cm by clinical exam or radiologic tests * candidate for neoadjuvant chemotherapy with paclitaxel, trastuzumab, pertuzumab regimen followed by standard of care local therapy as determined by the treating physician * eastern cooperative oncology group (ecog) performance status 0 or 1 * participants must have normal organ and marrow function as defined per protocol. * cardiac ejection fraction within institutional normal limits by either multigated acquisition scan (muga) or echocardiogram at baseline. * women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. sexually active male participants should use a barrier method or exercise abstinence during chemotherapy administration until surgery. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * participants with inflammatory breast cancer, widespread locally advanced unresectable disease involving the chest wall/nodal basins in which a curative surgical resection cannot be performed, or those in whom de novo metastatic disease is suspected or confirmed. * patients may not be receiving any other investigational agents for the treatment of their breast cancer. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study vaccine components and any of the chemotherapy drugs (paclitaxel, trastuzumab, pertuzumab). * participants who are unwilling or unable to undergo an apheresis for production of their vaccine. * 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 study requirements. * pregnant women and women who are breastfeeding. * participants with known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant).

Keywords: breast cancer
efficacy and safety study of yh16410 versus rosuvastatin and telmisartan monotherapies in patients with hypertension and hyperlipidemia

Conditions: Hyperlipidemia; Hypertension

Summary: to evaluate efficacy and safety of yh16410 versus rosuvastatin and telmisartan monotherapies in patients with hypertension and hyperlipidemia


Eligibility criteria:
inclusion criteria: * signed informed consent * men and women ≥ 19 years of age * subject who has one of 3 conditions classified by cardiovascular risk factors, 10-year risk, blood pressure, ldl-c, tg, coronary artery disease and equivalent exclusion criteria: * females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study. * other exclusions applied
assessment of asthma control level in primary care setting in malaysia

Conditions: Asthma Control Level

Summary: a prospective observational multi center study to assess the level of asthma control at primary care setting; government health clinics (klinik kesihatan) in malaysia. the specific objective of the study is to assess, in real-life clinical practice in malaysia, the level of asthma control and the potential risk factors for uncontrolled disease in asthma patients treated at government health clinics.

despite the availability of gina global guideline on asthma management which is widely referred by health care providers in malaysia, the control of asthma is still a critical challenge. according to national health and morbidity survey 2011, the prevalence of asthma in malaysia is at 6.3%. based on self-rated health status, 5.5% of patients were reported to be in good health whereas 9.9% reported poor health status although medications such as inhaled corticosteroids (ics) and long-acting beta agonists (laba) are widely available for effective asthma management. there is limited data to assess the level of asthma control at the primary care setting in malaysia which includes current clinical manifestation and future risk of exacerbation. given the lack of data on asthma control level, the awareness on the current disease control level will assist to properly characterise the patients based on gina control level thus leading to appropriate diagnosis and treatment. the specific objective of the study is to assess, in real-life clinical practice in malaysia, the level of gina-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients.

Eligibility criteria:
inclusion criteria: * malaysians who have been diagnosed with asthma by a physician verified by an investigator and seen at government health clinic (klinik kesihatan) from october - december 2017 * be at least 18 years of age exclusion criteria: * clinical features suggesting emphysema or chronic bronchitis and other chronic lung diagnosis * pregnancy
500mg fulvestrant in hr+ mbc

Conditions: Breast Cancer

Summary: to study the real world use of 500mg fulvestrant in hr+ mbc.

an observational, retrospective study of 500mg fulvestrant in hormone receptor+/her2- advanced breast cancer

Eligibility criteria:
inclusion criteria: 1. diagnosed with er/pr+，her2- advanced breast cancer 2. advanced breast cancer included unresectable locally advanced breast cancer, de novo stage iv breast cancer, and recurrent metastatic breast cancer. 3.500mg fulvestrant treatment of advanced breast cancer for at least one month, between jan 2011 and dec 2015. 4.available medical history exclusion criteria: 1. incomplete medical history 2. her2 overexpression or gene amplification, ie, immunohistochemistry (ihc) 3+ or fluorescence in situ hybridisation (fish)+, where appropriate.
intradetrusor triamcinolone injection in the management of interstitial cystitis/bladder pain syndrome

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Summary: this initial pilot project aims to study the use of fda-approved 40mg triamcinolone injections in the bladder for the management of interstitial cystitis with or without hunner's lesions. intradetrusor triamcinolone injections are already the standard of care for ic patients with hunner's lesions, but its role in management of ic without hunner's lesions has yet to be determined. triamcinolone is a long-acting corticosteroid that acts by inhibiting the migration of polymorphonuclear leukocytes, which may contribute to attenuation of inflammation in interstitial cystitis. we will recruit 27 females 18 years of age or older that have been diagnosed with ic/bps. patients will undergo a one-time cystoscopy along with the triamcinolone injections for ic management as a part of the research study. validated questionnaires will be provided before the treatment to quantify symptoms at baseline and after treatment at follow-up visits. follow up visits will occur in clinic every 4 to 6 weeks, which will continue for a maximum of 1 year. scores at follow-up visits will be compared to baseline.


Eligibility criteria:
inclusion criteria: * patients must meet an appropriate diagnosis of ic from niddk (national institute of diabetes and digestive and kidney diseases) * patients must be female * 18 years or older * have an official diagnosis of interstitial cystitis/bladder pain syndrome exclusion criteria: * patients who do not meet niddk inclusion criteria for interstitial cystitis as described above will not me enrolled in the study * the presence of urinary tract or sexually transmitted infection (may be included once existing infection is treated and cleared) * pregnant women * patients who have the inability to consent on their own behalf * prisoners
which is the best dose of dysport in helping with hip pain for children with cerebral palsy?

Conditions: Cerebral Palsy

Summary: the purpose of the study is to compare the effectiveness of 3 doses of dysport (5, 10 or 15 units/kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.


Eligibility criteria:
inclusion criteria: * male or female aged between 4 and 16 years (inclusive). * diagnosis of cerebral palsy. * presence of clinical bilateral hip pain (of at least 6 months duration) due to cerebral palsy as defined by the child/young person and/or parents. * paediatric pain profile score of 25 or greater. exclusion criteria: * prior treatment with botulinum toxin (any serotype, administered anywhere in the body) within 4 months prior to screening. * planned or anticipated requirement for surgery during the study period. * history of hypersensitivity to the investigational drug or any of its excipients. * likely to require treatment during the study with drugs that are not permitted by the study protocol or that in the opinion of the investigator may interfere with the evaluation of the efficacy or safety of the study medication.
efficacy and safety of rebamipide in subjects with dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: the purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.


Eligibility criteria:
inclusion criteria: * history of dry eye-related ocular symptoms for at least 20 months. * meet protocol-defined criteria for corneal and conjunctival staining. * meet protocol-defined criteria for ocular discomfort. exclusion criteria: * active anterior segment ocular disease other than dry eye syndrome. * inability to suspend the use of topical ophthalmic medications throughout the duration of the study. * inability to suspend the use of contact lenses for the duration of the study. * judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns. * received any other investigational product within 4 months before the screening visit.