Kornimate/medical-research-clean huggingface dataset:
activation of nod2 receptors in preterm infants by lactobacillus reuteri dsm17938

Conditions: Preterm Infants

Summary: primary objective: to evaluate the capacity of lactobacillus reuteri dsm17938 to activate nod2 receptors in preterm infants. secondary objective: to analyze the impact of lactobacillus reuteri dsm17938 on the gut microbiome of preterm infants

this study was designed as an open-label, stratified, randomized, parallel-controlled pilot study, using gestational age as the stratification factor. participants were stratified according to birth gestational age \< 32 weeks, 32 weeks ≤ birth gestational age \< 37 weeks, and simple randomization method was used in each gestational age group. all subjects were enrolled after birth/hospital admission, and the experimental group started intervention at 10-14 days after birth, and the intervention period was 14 days.

Eligibility criteria:
inclusion criteria: 1. preterm infants with a gestational age of less than 37 weeks. 2. birth weight of less than 2500 grams. 3. hospitalized within 72 hours after birth. 4. parents or legal guardians have signed an informed consent form. exclusion criteria: 1. congenital digestive tract malformations, genetic metabolic diseases, or congenital immunodeficiency diseases. 2. a history of severe asphyxia, infection, or liver and kidney dysfunction at birth/enrollment. 3. death within 72 hours after birth.

Keywords: dsm17938 nod2 preterm infant
dynamic multiomics evaluation of anti-her2 and immunotherapy in her2 positive gastric cancer

Conditions: HER2 Positive Advanced Gastric Cancer

Summary: dynamic multiomics explore the efficacy and mechanism of anti-her2 \& immunotherapy of her2 positive gc

the investigators will recruit 100 her2 positive advanced gastric cancer patients.blood and tumor tissue will be collected at treatment baseline, every time point response till disease progression. all samples will be processed by next-generation sequence , 10× genomics single-cell sequence ,whole exon sequence, proteome detection and ctc detection to explore the efficacy and mechanism of anti-her2 \& immunotherapy of her2 positive gc.

Eligibility criteria:
inclusion criteria: * having signed informed consent * age:18-80 years old * her2 overexpression confirmed by ihc or ish (ihc 3+,or ihc2+/ish+) * histologically confirmed gastric adenocarcinoma * unresectable recurrent or metastatic gastric cancer * previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months * measurable disease according to the recist criteria * karnofsky performance status ≥70 * life expectancy of ≥3 month * no prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * alt and ast\<2.5 times uln (≤5 times uln in patients with liver metastases) * serum albumin level ≥3.0g/dl * serum akp \< 2.5 times uln * serum creatinine \<uln, and ccr \< 60ml/min * bilirubin level \< 1.5 uln * wbc\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, hb\>9g/dl exclusion criteria: * previous systemic therapy for metastatic gastric cancer * surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. * allergic constitution or allergic history to protium biologic product or any investigating agents. * severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ecg findings, cardiac infarction , or retractable hypertension. * pregnancy or lactation period * other previous malignancy within 5 year, except non-melanoma skin cancer * legal incapacity
technology-enabled management versus usual care for blood pressure

Conditions: Hypertension

Summary: two arm parallel randomized clinical trial

patients will be randomized 1:1 to receive mobile technology intervention versus usual care. half of patients from a clinician team will receive the intervention and half will receive usual care. we aim to recruit at least 200 patients, 100 in each arm.

Eligibility criteria:
inclusion criteria: * age 30-90 yrs. * smartphone ownership * office sbp: ≥ 140 mm hg * ≤ 2 current anti-htn meds * able to add or dose-increase at least 2 of the following classes of medications: ace-i/arb, diuretic, calcium channel blocker, beta-blocker, mineralocorticoid receptor antagonists (i.e., at least 2 classes are available for addition or dose- increases after excluding intolerant medications and medications currently at maximum dose) * english or spanish-speakers exclusion criteria: * heart failure with reduced ejection fraction (ef \< 40%) * esrd (gfr \<15) * renal replacement therapy * pregnant * myocardial infarction or stroke within preceding 6 months * hospitalization for hypertensive emergency or malignant hypertension within preceding 6 months * prior solid organ transplantation * at the clinical discretion of the investigators * enrolled in another clinical study

Keywords: high blood pressure digital health mobile technology cardiovascular risk clinical research medications
molecular epidemiology of rotavirus diarrhea among infants and young children attending maua methodist hospital, kenya

Conditions: Rotavirus

Summary: rotavirus is the most common cause of severe infantile diarrhoea disease in infants and young children below five years worldwide. it is associated with high cases of morbidity and mortality and it is estimated that up to 600,000 deaths in young children occur annually in the less developed countries and approximately 150,000-200,000 deaths occur in africa alone. in kenya, most rotavirus surveillance work has been done in nairobi (an urban setting). other parts e.g eastern kenya, limited data is available and hence the prevalence and burden of rotavirus disease is under-estimated. we therefore hypothesize that rotavirus prevalence is high in meru,maua (a rural setting)and hence we designed a study to evaluate this. this is a prospective study to determine, the rotavirus disease burden and epidemiology in infants and children with severe diarrhoea hospitalized in three sentinel hospital in the eastern part of kenya (maua methodist hospital) will be carried out during the period january 2009 to december 2010. faecal samples will be collected from infants and children admitted with acute diarrhoea and screened first for the presence of human serotype a rotavirus antigen using commercially available enzyme linked immunosorbent assay kit (elisa). the positive samples will be evaluated by sodium dodecyl polyacrylamide gel electrophoresis (sds-page) to determine the electropherotypes and genotyped using reverse transcriptase polymerase chain reaction (rt-pcr) on vp7 and vp4 gene. these data/ results generated from this project will add crucial information on the rotavirus strains circulating in the eastern part of kenya.


Eligibility criteria:
inclusion criteria: * only children under 5 years of age who present with acute diarrhea having experienced an episode of 3 looser than normal or watery stools in a 24-hour period with or without episodes of vomiting will be enrolled in this study. * and the diarrhea should last for ≤ 7 days. * clinical studies have indicated that the incubation period for rotavirus illness is less than 48hrs and usually will last for 5-7days (steele, 1998) based on this fact, and as per the who's generic protocol for hospital based surveillance of rotavirus gastroenteritis in children under 5 years of age (who generic protocol, 2002) exclusion criteria: * children more than 5 years of age and with diarrhea lasting \> 7 seven days and having bloody diarrhea will be excluded in the study. * this is as per the who's generic protocol for hospital based surveillance of rotavirus gastroenteritis in children under 5 years of age (who generic protocol, 2002)

Keywords: genotypes epidemiology diarrhea
wound imaging study to gather clinical references for a device to assist selecting level-of-amputation in pad patients

Conditions: Amputation Wound; Peripheral Arterial Disease

Summary: this is a proof-of-concept study to collect images to train a cade algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to pad.

spectralmd has developed an imaging device (deepview), which simultaneously performs multispectral imaging (msi) measurements across the visible and infrared spectrum to obtain a quantitative tissue viability assessment. these optical measurements are integrated using a cade algorithm to categorize microvascular blood flow and provide a quantitative assessment to aid in selecting the appropriate amputation site. the investigators intend to gather data to train the cade algorithm to predict ultimate healing status of tissue in the lower extremities of individuals suffering from peripheral arterial disease (pad). the investigators will demonstrate the feasibility of using such an algorithm to accurately predict the location and extent of small vessel disease prior to amputation. eventually, the invesitgators expect the deepview to reduce the rate of re-amputation in patients with peripheral arterial disease if used for routine assessment of patients prior to amputation. the aims of the study are as follows: * evaluate performance of a computer assisted detection (cade) algorithm trained to assist selecting the level-of-amputation in patients with pad. * identify multispectral signatures that are strongly predictive of viable skin tissue at proposed amputation sites. * create a representative database for training the cade algorithm.

Eligibility criteria:
inclusion criteria: * patient must require amputation on a limb secondary to pad, defined as arterial insufficiency due to atherosclerosis based on one or more of the following assessments: * ankle brachial index; * duplex ultrasonography showing clinically significant occlusion; * arteriography; or * assessment demonstrating stenosis by arterial calcification. * able to give informed consent, * be at least 18 years of age. exclusion criteria: * no history of major amputation on the affected limb, or * life expectancy less than 6 months.

Keywords: peripheral arterial disease re-amputation optical imaging computer assisted detection (cade)
effect of losartan in patients with nonobstructive hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: the purpose of this study is to determine whether taking losartan helps people with hypertrophic nonobstructive cardiomyopathy feel better by decreasing the amount of heart muscle thickening and/or the amount of heart muscle scarring.

hypertrophic cardiomyopathy (hcm) is characterized by idiopathic cardiac hypertrophy, heart failure, ischemia even in the absence of epicardial coronary artery disease, and arrhythmias. the pathological features of hcm include hypertrophy and disarray, interstitial fibrosis, and increased arteriolar wall thickness. hypertrophy and fibrosis are major determinants of morbidity and mortality in hypertrophic cardiomyopathy. some investigators have demonstrated that interstitial fibrosis and hypertrophy occur secondarily, in response to trophic and mitotic factors in the heart. therefore, blocking trophic factors may attenuate or potentially reverse hypertrophy and fibrosis in hcm. angiotensin ii has trophic and profibrotic effects on the heart, and blockade of angiotensin ii type i receptors has been shown to attenuate myocardial hypertrophy and fibrosis in acquired cardiac disease in humans and animal models. we hypothesize that treatment with the selective angiotensin ii type receptor antagonist, losartan, will decrease both hypertrophy and fibrosis, improve diastolic function, reduce symptoms, and improve functional status in patients with hcm.

Eligibility criteria:
inclusion criteria: * patients with hypertrophic cardiomyopathy * left ventricular outflow tract (lvot) gradient less than 30 mm hg at rest * age 18 years or older exclusion criteria: * contraindication to losartan * already taking losartan * contraindication to mri * hemodynamic instability

Keywords: hypertrophic nonobstructive cardiomyopathy
tension in posterior component separation for abdominal wall reconstruction

Conditions: Ventral Incisional Hernia

Summary: the purpose of this study is to measure the changes in tension after each release in a standard posterior component separation during abdominal wall reconstruction.

myofascial component separation techniques are purported to reduce tension in abdominal wall reconstruction, but few objective data exist regarding tension reduction with posterior component separation (pcs) techniques. pcs techniques include several unique steps: division of the posterior rectus sheath, division of the posterior lamella of the internal oblique aponeurosis, and transversus abdominis release. each of these releases carries a certain amount of morbidity, including neurovascular injuries, posterior sheath breakdowns, and musculofascial disruptions resulting in lateral hernias, and thus should only be undertaken if necessary to achieve physiologic tension. more importantly, during a pcs, the surgeon must achieve posterior elements apposition in the midline to allow an adequate pocket to deploy the mesh and avoid breakdown and interstitial hernias and recurrences. further, the anterior sheath should be reapproximated to complete a functional abdominal wall reconstruction. during each procedure, the surgeon must assess the tension on the posterior closure and decide whether further release is necessary to achieve a safe, durable repair of the posterior elements. demographic information, including patient age, gender, bmi, history of diabetes, chronic immunosuppression, smoking history, and history of prior ventral hernia repairs will be captured in the abdominal core health quality collaborative (achqc), per the investigators' practice standard. additional intraoperative information collected will be hernia size, extent of posterior component separation, mesh size and type, and location of mesh placement. the achqc is a hernia-specific, nationwide registry for quality improvement, featuring prospectively-collected, surgeon-entered data. the aim of this study is to determine the changes in abdominal wall tension with progressive pcs in abdominal wall reconstruction. the investigators also aim to quantify the reduction in tension on both the anterior and posterior elements of a pcs.

Eligibility criteria:
inclusion criteria: * candidates for abdominal wall reconstruction * patients able to provide informed consent exclusion criteria: * patients unable to provide informed consent

Keywords: ventral hernia repair tension
molecular evaluation of aml patients after stem cell transplant to understand relapse events

Conditions: Acute Myeloid Leukemia in Remission

Summary: prospective determination of the clinical utility of measurable residual disease (mrd) testing for relapse and survival of patients with acute myeloid leukemia (aml) undergoing allogeneic hematopoietic cell transplantation (allohct).

this is a multi-center non-randomized prospective study designed to establish a national framework for introducing measurable residual disease testing into the clinical care of aml patients undergoing allogeneic transplantation. enrollment is expected to occur over a 4-year period, with an additional 3 years of follow-up. subject participation this study will be approximately 3 years. up to 1,000 subjects will be enrolled. subjects will be asked to provide blood samples at months 1-6, 9, 12, 15, and 18 post-transplant, and archived specimens from time of aml diagnosis and any bone marrow samples collected for clinical purposes will be requested for research testing. additional blood and marrow samples will be requested at relapse (if applicable).

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. aged at least 18 years old at time of consent 4. diagnosed with aml, in complete remission 1. complete remission (cr) definition per local institutional criteria 2. cr with incomplete hematologic recovery (cri) is not an exclusion criterion 3. mrd positivity is not an exclusion criterion 5. undergoing allohct 6. has a diagnostic aml specimen available exclusion criteria: 1. diagnosis of acute promyelocytic leukemia 2. prior allohct
early feasibility study: safety and efficacy of photon infusion set

Conditions: Type 1 Diabetes Mellitus

Summary: study 1: the purpose of this study is to evaluate safety and efficacy of photon infusion sets (pis) with new pfas-free cannula (catheter) in adult patients with type 1 diabetes for up to 10 days and 6 hours. this is a 1-center, prospective, open-label, 1-arm study with type 1 patients with diabetes on 780g insulin pump therapy with guardian™ 4 continuous glucose monitoring (cgm). all subjects will be instructed to change infusion sets every 246 hours (10 days \& 6 hours) or at set failure. each subject is required to wear the cgm device continuously. after completing 2 sets, the subjects have an optional office visit to download pump and cgm data and will continue to additional two wears. at day 40 or after using 4 completed wears of infusion sets (note: early infusion set failure with wear time of \<6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and cgm data, and end the study. photon infusion sets with 6-mm and 9-mm cannula length will be supplied for this study, with selection based on subjects' needs and doctor's recommendation. subjects will change insulin reservoirs at least every 7 days (the labelled wear duration of the extended reservoir). the infusion set(s) or reservoir(s) can be replaced independent of each other. the date and time of each infusion set insertion will be recorded in a daily log (diary) which will include the causes of early removal, if occurs. study 2: if study 1 is successful, the same study designed as illustrated in figure 1 may be performed on the current on-market extended infusion set (eis) for comparison of clinical performance with the pis, using the same cohort of pump users.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 1 diabetes for at least one year 2. using a minimed™ 780g insulin pump with guardian sensor 3. age 18 to 80 years 4. hemoglobin a1c level less than or equal to 10% 5. not currently known to be pregnant, nor planning pregnancy during the study. 6. willingness to follow the protocol and sign the informed consent exclusion criteria: 1. a known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. 2. pregnant or lactating females 3. subject has glycosylated hemoglobin (hba1c)\< 10 % at time of screening.

Keywords: infusion sets insulin pumps aid system
effects of multidomain intervention on cognitive function in community-dwelling elderly

Conditions: Cognitive Decline

Summary: the aging population has contributed to an increase in cognitive decline. to mitigate the rise in the dementia population, it is crucial to prevent cognitive decline in older adults with normal functioning, subjective cognitive decline (scd), and mild cognitive impairment (mci). maintaining cognitive abilities as early as possible is essential for improved overall health and quality of life. healthcare for the elderly should focus on strengthening health promotion related to aging factors, such as cognitive function, mobility, nutrition, chronic disease management, oral health, fall prevention, transportation safety, psychosocial factors, and sleep. additionally, as the etiology of dementia is multifactorial, numerous studies have been devoted to multidomain intervention, targeting multiple factors and domains in combination to enhance functions. the cumulative or synergistic effects of multidomain have garnered significant attention for their effectiveness in improving or maintaining the function of the elderly. therefore, this study aims to evaluate the effects of multidomain intervention, including combined physical and cognitive training, nutrition, chronic disease management, oral health, fall prevention, transportation safety, psychosocial factors, and sleep, on cognitive function in community-dwelling older adults.


Eligibility criteria:
inclusion criteria: 1. age ≥ 60 years old 2. mini-mental state examination (mmse) score \> 20 (folstein et al., 1975), able to follow instructions and participate in activities 3. with self-reported or caregiver-reported memory or cognitive-related problems 4. no diagnosis of any type of dementia exclusion criteria: 1. unstable medical condition that would prevent safe participation in exercise training (e.g., myocardial infarction, heart failure, recent cardiac surgery, severe asthma, concomitant neurological disorders, or joint deformities) 2. participation in other studies 3. inability to provide informed consent
characteristics and the future of the city chilblains

Conditions: Chilblains

Summary: chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic papules, evolving by painful relapse due to cold and sudden reheating. this pathology is currently poorly understood while it's frequent. the aim of the study is to evaluate all the characteristics of this pathology by reporting clinical and biological data of patient consulting for chilblains; and the other point is to assess the evolution of these patients.

investigators are going to collect data on patient medical report to fill up a case report form. and in a second time they call patient by phone to ask him/her about the evolution of their pathology.

Eligibility criteria:
inclusion criteria: * patient consulting for chilblains * diagnostic of chilblain during the consultation exclusion criteria: * patients consulting for other reason than chilblains * patient who can't reply by telephonic call