Kornimate/medical-research-clean huggingface dataset:
multicenter study of the safety and performance of fabian-prico for saturation targeting routine use in the nicu

Conditions: Respiratory Insufficiency in Children

Summary: this study is planned as a part of the post market clinical follow-up (pmcf) on a ce marked product. the purpose of the study is to demonstrate, in a routine clinical environment across a number of centers, that the fabian-prico can adequately maintain oxygen saturation, with minimal staff intervention.

this is a randomized cross-over study. subjects will be assigned to two, nominally 24-hour interventions, one with standard manual titration of fio2 and the other with automated adjustment (prico). the order of these two interventions will be random. in addition to the ventilators data, basic demographics (i.e., gestational age, birth weight, age, weight at study) of the participating infants will be recorded in the ecrf. this study has no additional follow-up visits.

Eligibility criteria:
inclusion criteria: * respiratory insufficiency of infants in the neonatal unit who require respiratory support and supplemental oxygen in one of 4 the therapeutic categories (intubated hfo, intubated cmv, non-invasive nasal mask, nasal cannula). * \<30 kg at study entry * informed consent form obtained as per ec requirement exclusion criteria: * not expected to complete 48 hours of the current respiratory support therapeutic category * congenital anomalies * uncontrolled hemodynamics * severe airflow obstruction * intracranial hypertension * start of caffeine therapy within 12 hours * attending physician does not believe participation of the patient is in their best interest.
evaluation of the washington intensive supervision program

Conditions: Behavior; Drug Users

Summary: this study entails an evaluation of the washington intensive supervision program (wisp). the purpose of the evaluation is to test whether subjects assigned to wisp perform better than those assigned to parole-as-usual (pau).

this study entails an evaluation of the washington intensive supervision program (wisp). wisp is a program targeting high-risk parolees in seattle, and is modeled after the hope program in hawaii. the purpose of the evaluation is to test whether subjects assigned to wisp perform better than those assigned to parole-as-usual (pau) on a number of outcomes, including drug use, missed appointments, recidivism, prison and jail stays, and parole revocations. wisp uses regular random drug testing and close community supervision, paired with swift and certain, but modest sanctions for every detected violation.

Eligibility criteria:
inclusion criteria: * inmates released by doc to community corrections supervision * supervised out of the seattle cjc (community justice center) to include field offices and offenders from the downtown "metro" unit, southeast seattle unit, northgate (north seattle) and west seattle. * have a parole supervision discharge date at least one year from the date of release from entry into wisp exclusion criteria: * level iii sex offenders * existing assignment to supervision that precludes wisp. these include: drug offender sentencing alternative (dosa)and special sex offender sentencing alternative (ssosa). * dangerously mentally ill (dmio)

Keywords: behavior drug users
correlation of platelets count with endoscopic findings in a cohort of egyptian patients with liver cirrhosis

Conditions: Portal Hypertension

Summary: portal hypertension is a common complication of liver cirrhosis that can lead to development of esophageal varices (ev). they are abnormally dilated veins within the wall of the esophagus that lead to haemorrhage (1). majority of patients with cirrhosis will develop ev at some point, and about third of these patients will have at least one bleeding episode because of rupture of a varix . for this reason, screening endoscopy for detection of the presence of ev should be part of the diagnostic work-up in patients with cirrhosis. this is a very important preventive step for identification of those patients with variceal bleeding risk and furthermore, identification of patients in urgent need for prophylactic treatment. all guidelines stress on screening endoscopy for early detection of ev in cirrhotic patients with portal hypertension. however this approach is limited by its invasiveness and cost effectiveness issues of screening endoscopy .

recent research has focused on the use of noninvasive methods to detect patients with the intention of avoiding endoscopy in low-risk cases . thrombocytopenia (platelet count \< 150,000/μl) is a common complication in patients of chronic liver disease (cld) . so, the investigators in this research formulated this study to determine whether platelet count can predict the presence of ev or varices which need prophylactic therapy (medium or large size ev) in a cohort of egyptian patients with liver cirrhosis and can identify patients with the intention of avoiding endoscopy in low-risk cases.

Eligibility criteria:
inclusion criteria: * diagnosis of cirrhosis based on history, physical examination, laboratory tests, ultrasound scans and liver biopsy in some occasion. exclusion criteria: * hepatocellular carcinoma. * portal vein thrombosis. * parenteral drug addiction.
relationship between core muscles endurance and saliba's postural classification system in patients with chronic mechanical low back pain

Conditions: Core Muscles; Endurance; Saliba's Postural Classification System; Low Back Pain, Mechanical

Summary: the aim of the study is to investigate the relationship between core muscles endurance and saliba postural classification system in patients with chronic mechanical low back pain.

chronic mechanical low back pain (cmlbp) is a significant health issue affecting 85-90% of the general and athletic population, causing a significant socioeconomic burden. this study aims to address functional deficits in patients with cmlbp, reducing the burden and improving care delivery and work performance. core muscle dysfunction, particularly multifidus and transversus abdominus muscles, is found in patients with cmlbp. however, the relationship between posture, function, and pain is not established due to the absence of a standardized postural classification system. the proposed tests can help infer the stability and function of core muscles in patients with cmlbp, enabling researchers to develop effective treatment programs. this study may also benefit physical therapists by providing an evidence-based approach in assessment using a valid and reliable postural classification system. future research may address the relationship between core muscle endurance and saliba postural classification system in patients with cmlbp.

Eligibility criteria:
inclusion criteria: 1. sixty male and female patients with cmlbp of more than 3 months duration 2. patients with body mass between 18-25 3. patients aged between 20-50 years old 4. moderate level of pain (4-6 on visual analogue scale) 5. minimal level of disability (0% to 20%) on oswestry disability index as defined as "the patient can cope with most living activities. usually, no treatment is indicated apart from advice on lifting, sitting, and exercise. exclusion criteria: participants will be excluded if they did not meet the inclusion criteria mentioned above.
bismuth quadruple therapy with cefuroxime for helicobacter pylori eradication treatment

Conditions: Helicobacter Pylori Infection

Summary: to observe the efficacy of cefuroxime-containing bismuth quadruple regimen in the eradication treatment of helicobacter pylori, and to evaluate whether it can be used as a remedial treatment for helicobacter pylori after initial or repeated treatment failure.

introducing cefuroxime into the remedy treatment of helicobacter pylori, on the one hand, the investigators will observe whether cefuroxime can replace tetracycline like amoxicillin, on the other hand, the investigators will observe whether it can reduce the rate of adverse effects caused by tetracycline and avoid the allergy of penicillin. if the experiment is successful, it will provide an effective and safe second-line treatment for the majority of patients with failed treatment of helicobacter pylori.

Eligibility criteria:
inclusion criteria: * employees, family members, and patients with positive c13 breath test in our hospital; * has received one or more previous helicobacter pylori eradication therapy (no use of cefuroxime or tetracycline), and the result is still positive by c13 breath test; * willing to undergo gastroscopy and hp cultivation and identification; * age 18-70, gender unlimited; * willing to participate in and cooperate with the study, and willing to sign the informed consent. exclusion criteria: * drugs that may affect the study results, such as ppi, h2 blockers, bismuth agents, antibiotics, etc. were taken in the 4 weeks before enrollment; * patients with gastrointestinal malignancy tumor; * patients with gastrinoma; * after gastric or esophageal surgery; * suffers from serious diseases of the heart, lung, kidney, liver, blood, nervous system, endocrine system or mental system; * patients with contraindications or previous allergic reactions to the drugs used in this study; * pregnant or breastfeeding women; * patients with other medical conditions that may increase the treatment side effects; * those who cannot give informed consent; * has participated in other drug trials within 3 months; * not considered suitable for participants by the investigator.
prediction of feeding problems in prostaglandin-dependent prematurely born infants with congenital heart disease

Conditions: Congenital Heart Disease; Prematurity; Necrotizing Enterocolitis

Summary: prematurely born infants with ductal-dependent congenital heart disease (chd) are at increased risk to develop necrotizing enterocolitis (nec). abnormal left to right blood flow through a patent ductus arteriosus can cause intestinal ischemia and compromise the gastrointestinal tract as a barrier to infection. in some infants, bacterial translocation leads to nec which may result in death, intestinal perforation, cholestasis and, at the very least, feeding problems. predicting which infants with chd will develop nec will potentially decrease the severity of disease if interventions were started earlier. near-infrared spectroscopy (nirs) allows determination of regional oxygen saturation levels in tissues such as brain, kidney, and as recently reported, intestine. this study will test whether or not decreasing intestinal oxygen saturations can predict the development of nec in this at risk population before the symptoms become severe. nirs probes will be placed on the forehead, flank and abdomen of eligible infants and regional oxygen saturations will be recorded prospectively and continuously with the clinical care team blinded to the data. the development of nec and significant feeding problems will then be correlated with the regional oxygen saturations to determine whether decreased intestinal oxygen saturations predicted early signs and symptoms of nec. we anticipate generating pilot data in 30 infants who meet inclusion criteria. support of this research will be provided partially by somanetics, the manufacturer of the invos regional oxygen saturation monitors. they will, however, have no control over the data generated by this study.


Eligibility criteria:
inclusion criteria: * \>/+ 30 and 0/7 weeks gestation age at birth * anticipated time to surgical repair is \> 7 days * meets criteria for management via the pcmc chd feeding protocol exclusion criteria: * any extracardiac major congenital anomalies

Keywords: prostaglandin-dependent congenital heart disease prematurity feeding intolerances necrotizing enterocolitis regional oxygen saturation near infrared spectroscopy somanetics invos oxyalert
optimized vs. standard automated peritoneal dialysis regimens study

Conditions: End Stage Kidney Disease; Chronic Kidney Disease Requiring Chronic Dialysis

Summary: this clinical study is designed to evaluate the theoretical prediction of a lower glucose absorption in optimized automated peritoneal dialysis regimes. patients will receive both a standard 6 x 2l 1.36% glucose regime or an optimized 7 x 2 l 2.27% glucose + 5 x 2 l 0.1% glucose regime in a crossover fashion.

automated peritoneal dialysis (apd) is a rapidly growing, home-based kidney replacement therapy promoting patient autonomy, and is associated with lower societal costs compared to hemodialysis. however, in light of the growing number of diabetic patients on pd, the unwanted glucose absorption during apd is problematic. recent results (öberg cm, rippe b, 2017, see references), using a theoretical model of apd, indicate that large reductions in glucose absorption are possible by using specialized so-called optimized bi-modal treatment regimes having "uf cycles" using a higher glucose concentration (e.g. 2.27% glucose) and "clearance cycles" using a low glucose concentration (e.g. 0.1% glucose).

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years; * duration of pd (automated peritoneal dialysis (apd) or continuous ambulatory peritoneal dialysis (capd)) \>4 weeks exclusion criteria: * severe heart failure (new york heart association functional classification; nyha iii or iv); * pregnancy; * catheter malfunction or * peritonitis within 3 months prior to the trial.

Keywords: dialysis peritoneal dialysis
impact of peer support on diabetes in china

Conditions: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes

Summary: the prevalence of diabetes has been growing rapidly in developing countries causing a devastating economic burden and increasing demands on healthcare systems. therefore, there is an urgent need to find cost-effective and multi-faceted approach for diabetes care. peer support models provide a potentially low-cost, flexible means that is complimentary to the current existing health care services. trained peer leaders can become qualified extenders to a formal healthcare system, thereby, assisting with the education delivery and bolstering the efforts of the professional staff. to implement a culturally- specific peer support program and determine whether it is acceptable, cost-effective in china is important. this study aims to implement and evaluate biophysical and psychosocial outcomes of a peer support program and to explore it's feasibility and sustainability in china


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. with voluntary participation and have signed the patient informed consent sheet 3. reside in stable places during the intervention period exclusion criteria: 1. patients with reduced life expectancy and unstable mood or major psychiatric conditions 2. suffering from cancer and have been receiving radiotherapy and/ or chemotherapy in the past half year 3. enrolling in other research program at present

Keywords: diabetes,peer support
has inflammation a significant implication in lung cancer evolution?

Conditions: Lung Neoplasms

Summary: systemic inflammation is a potential prognostic factor in cancer. inflammation scores as the glasgow score have been tested in cancer and specifically in lung cancer patients. the aim of the study is to look at the prognostic and predictive value of inflammation during cancer evolution, on the risk of complications leading to icu admission and the risk of death.

patients with newly diagnosed lung cancer will be eligible. all patients will have a blood sampling allowing testing inflammation and cytokine analyses at diagnosis, during work-up and in case of complication.

Eligibility criteria:
inclusion criteria: * lung neoplasms irrespective of stage, histology exclusion criteria: * previously treated lung neoplasms * a history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)

Keywords: inflammation glasgow score intensive care unit emergency
a study to assess the effect of tocilizumab plus methotrexate on safety and signs and symptoms in patients with moderate to severe active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. the anticipated time on study treatment is 3-12 months, and th e target sample size is \<500 individuals.


Eligibility criteria:
inclusion criteria: * patients \>=18 years with moderate to severe active ra for at least 6 months; * swollen joint count \>=6 (66 joint count) and tender joint count \>=8 (68 joint count) at screening; * inadequate response to stable dose of mtx; * patients of reproductive potential must be using a reliable means of contraception. exclusion criteria: * rheumatic autoimmune disease other than ra; * patients with functional class iv ra; * diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than ra; * prior treatment failure with anti-tumor necrosis factor agent; * pregnant or breastfeeding women.
headpulse large vessel occlusion validation study

Conditions: Stroke, Ischemic

Summary: acute ischemic stroke (ais) is a treatable disease if patients can be transported and treated at stroke centers. mindrhythm, inc (sponsor) has developed an investigational medical device that is designed for prehospital field use to differentiate the two major forms of acute ischemic stroke, namely large vessel occlusion (lvo) stroke and non-large vessel occlusion stroke. the intended use is for paramedics to decide which destination hospital is best for the patient based on the device result. large vessel occlusion stroke patients should be brought directly to comprehensive stroke centers which can perform thrombectomy, and non-large vessel occlusion stroke should be brought to primary stroke centers. use of the device will save time getting the patient to thrombectomy and all others to intravenous thrombolytics or blood thinners that clear clots improves outcomes for all patients. the harmony 5000 device manufactured by mindrhythm has been tested in the pre-hospital environment, but because large vessel occlusion stroke is less common than non-large vessel occlusion stroke, the sponsor wants to obtain additional recordings from patients with large vessel occlusion to better refine their algorithms. investigators will perform acute recordings on patients who arrive at the medical center who have computed tomography angiography studies showing the presence of large vessel occlusion stroke stroke, and on patients transferred to the angiography suite for thrombectomy. recordings are performed in parallel to standard workflow of large vessel occlusion stroke patients so the research will not delay treatments.

eligible participants will be 18 years of age plus with known large vessel occlusion who have been transferred to the emergency department. recordings can be made just prior to the thrombectomy or within 2 hours of computed tomography angiography and no thrombectomy performed. participants will be excluded if they have an open wound on the scalp or are prisoners. the mindrhythm harmony headset will be placed on the subject (a total of 50 subjects) along with ecg leads and a 3 minute recording of the headpulse (cranial waveform) will be performed while the subject remains as still as possible. the data will then be transferred to mindrhythm for analysis and ultimate improvement of the diagnostic stroke algorithm.

Eligibility criteria:
inclusion criteria: * adult patient known lvo (transferred or arrived at our ed) ica-t, m1, m2 or basilar artery recording can be made just prior to thrombectomy, or within 2 hours of cta and no thrombectomy performed exclusion criteria: * prisoner open scalp wound
a study of ds-1001b in patients with chemotherapy- and radiotherapy-naive idh1 mutated who grade ii glioma

Conditions: WHO Grade II Glioma

Summary: this phase 2 study is conducted to assess the efficacy and safety of ds-1001b in patients with chemotherapy- and radiotherapy-naive idh1 mutated who grade ii glioma.


Eligibility criteria:
inclusion criteria: * has a histopathologically documented idh1 mutated who grade ii glioma according to the 2016 who classification. * has confirmed idh1 mutation at the r132 locus by testing at the central laboratory conducted during the screening period. * has no prior anticancer treatment (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy. * has at least 1 measurable and non-enhancing lesion. * has an interval of at least 90 days from the latest surgery. * has no sign of malignant transformation including the appearance of enhancing lesions and/or rapid growth of non-enhancing lesions. * has an eastern cooperative oncology group (ecog) performance status (ps) of 0 to 1. exclusion criteria: * has had a histopathological diagnosis of who grade iii or iv glioma. * has had a contrast enhancing lesion on brain mri. * has received a prior treatment with any mutant idh1 inhibitor. * has received other investigational products within 28 days before the start of the study drug treatment. * has an active infection requiring systemic treatment. * has multiple primary malignancies. * has a history of clinically significant cardiac disease. * is a pregnant or lactating woman.

Keywords: ds-1001 idh1 glioma idh-mutant glioma who grade ii glioma low-grade glioma