Kornimate/medical-research-clean huggingface dataset:
analysis of rom plus to detect rupture of membranes

Conditions: Rupture of Amniotic Membranes

Summary: specific objectives include confirmation: i) that the rom plus consistently and accurately diagnoses rupture of membranes (rom), ii) that the technique can be understood and applied in clinical practice, and iii) that the rom plus is easier to use than the conventional method.

this study is designed to assess the sensitivity and specificity of rom plus- a rapid, point of care, qualitative immunochromatographic test for the detection (in vitro) of amniotic fluid in cervico-vaginal secretions of women with suspected rupture of membranes (rom) during pregnancy. the rom plus detects a specific combo protein present in amniotic fluid of pregnant women in all trimesters of pregnancy. this specific protein combo is unique and found only in amniotic fluid, therefore can be used as a specific marker for the diagnosis of rom. this biomarker is an isoform of a similar biomarkers called amni-sure and actimprom and was recently approved by the fda for clinical use. like these protein markers ( amnisure or actimprom) which have been used to diagnose prom, this particular protein isoform tested for rom plus is in low concentration in other body fluids such as maternal blood, cord blood, urine and semen.

Eligibility criteria:
exclusion criteria: * known placental previa * active vaginal bleeding

Keywords: rom plus conventional clinical tests of rupture of membranes (rom) speculum exam visualization of leakage pooling of amniotic fluid in the posterior fornix nitrazine testing ferning
prevalence and outcome of acute hypoxemic respiratory failure in wales

Conditions: Acute Respiratory Insufficiency

Summary: this study is aimed to establish the epidemiological chacacteristics and clinical outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure admitted in a network of hospitals from wales (u.k.).

the present study is aimed to establish the epidemiological characteristics and clinical outcomes of adult mechanically ventilated patients with acute hypoxemic respiratory failure \[defined as a pao2/fio2 ≤300 mmhg on positive end-expiratory pressure (peep) of 5 cmh2o or more and fio2 of 0.3 or more\] admitted in a network of hospitals from wales (u.k.). although there are few previous published observational studies examining the incidence and mortality of patients with acute respiratory failure and ards, there are no studies specifically assessing the epidemiological characteristics, patterns of ventilation and clinical outcomes in patients with acute hypoxemic respiratory failure in the current era of lung protective ventilation. this study will be done simultaneously with the pandora (nct03145974) in spain. the study is aimed to improve the knowledge on the epidemiology and outcome of ventilated patients, to identify the percentage of patients developing ards under the current definition, to validate a bedside scoring system for stratification of lung severity, and to examine the prognosis of hypoxemic respiratory failure, and risk factors associated with fatal outcome.

Eligibility criteria:
inclusion criteria: * age ≥18-year old. * endotracheal intubation and mechanical ventilation, independent of whether the need for ventilatory support is shorter or longer than 24 hours. only patients receiving invasive mechanical ventilation can be included, although patients could have been on non-invasive ventilation before intubation. * pao2/fio2 ≤300 mmhg on invasive mechanical ventilation with a peep of 5 cmh2o or more, and with a fio2 of 0.3 or more. exclusion criteria: * no patients shhould be excluded (if they meet all the inclusion criteria), regardless of the underlying disease, estimated life expectancy, or duration of invasive mechanical ventilation.

Keywords: respiratory failure mechanical ventilation prevalence
stockholm hypertriglyceridemia register (strireg) study

Conditions: Familial Hypertriglyceridemia

Summary: the strireg study is a retrospective longitudinal general population-based register study including all individuals who had had at least one plasma tg measurement between 1st january 2000 and 31st december 2021 at karolinska university laboratory or unilabs ab in region stockholm (population 2.41 million 2021). the exclusion criteria were a lack of a unique swedish personal identification number (pin). the index population consisted of 1,460,184 individuals between the age 0 and 107 years. the index population was extended to form the complete cohort (n=3,607,819) by associating the parents and the siblings (n=2,147,635) to the indexes by interlinkage of personal identification numbers via the multi-generation register (see below). the study baseline for the index population was defined as the date for participant's first tg measurement.

hypertriglyceridemia (htg) is associated with atherosclerotic cardiovascular disease, pancreatitis, and non-alcoholic fatty liver disease in large population-based studies. less is known about the impact on hereditary htg and cardiometabolic disease status for the development of htg and its associated cardiometabolic outcomes. htg remains a target for lipid lowering therapies and with new pharmacological interventions being developed, there is a need to identify patients that will benefit most from treatment with these new medicines. the population-based observational stockholm hypertriglyceridemia register (strireg) study include 1,460,184 index individuals that have measured plasma triglycerides in the clinical routine in region stockholm, sweden, between 1st january 2000 and 31st december 2021. the laboratory measurements also included basic haematology, blood lipid panel, liver function tests and hba1c. using the swedish multi-generation register, 2,147,635 parents and siblings to the indexes were identified to form the complete study cohort. laboratory data from participants were combined with data from several national registers that provided information on cause of death, medical diagnoses, dispensed medicines, and socioeconomic factors including country of birth, education level and marital status. the multigenerational longitudinal strireg cohort provides a unique opportunity to investigate different aspects of familial htg as well as heredity for other metabolic diseases. important outcome measures include mortality, cardiovascular mortality, major cardiovascular events, development of incident diabetes, and non-alcoholic fatty liver disease. the strireg study will provide a deeper understanding of the impact of heredity on htg and associated cardiometabolic complications.

Eligibility criteria:
inclusion criteria: all individuals who had had at least one plasma triglyceride measurement between 1st january 2000 and 31st december 2021 at karolinska university laboratory or unilabs ab in stockholm county sweden. exclusion criteria: no swedish social security number.
capsule versus conventional colonoscopy in patient following colorectal surgery

Conditions: Colorectal Cancer

Summary: the study will compare the diagnostic efficacy of the vcc (pillcam colon 2) to standard colonoscopy in patients with prior colorectal surgery. the hypothesis is to validate the vcc as a means of screening for colonic polyps after resection, which would avoid a colonoscopy with its associated general anesthesia and potential side effects.

standard care after colorectal surgery is colon surveillance by standard colonoscopy with its benefits (gold standard examination, resection of lesions) and disadvantages (acceptability, general anesthesia, availability of qualified personnel, risk of perforation and associated gastrointestinal bleeding). use of a video-capsule (vcc) is a new, non-invasive technique, that allows to visualize the colon as a whole. this technique has the advantage of not requiring general anesthesia or air insufflation. the examination is performed as an outpatient procedure and therefore does not require hospitalization. in previous studies, pillcam colon 2 showed a good sensitivity and specificity in detecting colorectal lesions. however, its use requires an excellent bowel preparation. to date, no study has been conducted using the vcc in monitoring patients with prior colorectal surgery, especially on the passage of the vcc through surgical anastomosis. no information on vcc capabilities to view and recognize surgical anastomoses and vcc transit time in surgically modified colon is available. the possibility to precisely locate a colorectal lesion prior to surgery, using the vcc, also remains to be studied. the study requires a 2-month patient participation. the planned total study duration is 2 years.

Eligibility criteria:
inclusion criteria: 1. patient between 18 and 85 years old 2. patient with greater than 3 month follow-up for colorectal resection with ileo-colic , colo-colic or colorectal anastomosis, regardless of etiology 3. patient requiring a colonoscopy for regular medical care 4. absence of contra-indication to anesthesia and to colonoscopy conduct 5. patient able to understand the study related information and to provide written informed consent 6. patient registered with the french social security regime non-inclusion criteria: 1. absence of written informed consent 2. patient having had a total colectomy 3. patient with terminal stoma 4. patient with clinical suspicion of intestinal stenosis and/or anastomotic stenosis 5. patient with known zenker diverticulum 6. patient wearing a pacemaker or any other internal electronic medical device 7. patient with deglutition disorders and/or altered state of consciousness 8. patient with serious disease preventing planned study procedures 9. pregnant or breast-feeding woman 10. patient within exclusion period from other clinical trial 11. patient having forfeited their freedom of an administrative or legal obligation 12. patient being under guardianship

Keywords: colorectal cancer follow up colonoscopy videocapsule
biomarkers, tcm body constitution, dietary pattern and psychological factors in predicting depression

Conditions: Depression

Summary: this study aims to determine the predictors of depression among university students in universiti tunku abdul rahman (utar) sungai long campus.

university students are a high at risk group for development of depression. identifying the determinants of depression could help in the diagnosis and treatment of this disorder. this study will incorporate questionnaire and blood sample data collection procedures on 397 subjects. written consent will be obtained from the subjects. eligible subjects will be given self-administered questionnaires which include patient health questionnaire (phq-9), constitution in chinese medicine questionnaire (ccmq), dysfunctional attitude scale (das), depression anxiety stress scales (dass-21) - stress and anxiety subscales, perceived stress scale-10 (pss-10), rosenberg self-esteem scale (rses), and food frequency questionnaire (ffq). once the subjects completed the questionnaires, blood samples will be collected from them by a trained phlebotomist. in addition, 10 most high at risk of depression subjects (with phq-9 scores 10 and above) and 10 healthy subjects (with phq-9 scores lower than 10) will be selected randomly for protein expression to further identify the proteins that significantly expressed among them.

Eligibility criteria:
inclusion criteria: * malaysian citizen * able to read and communicate in english exclusion criteria: * special education disability (deaf and blind) * physical support * history of infectious diseases
validation of the diagnostic performance of the sleep apnea syndrome by the withings hwa09 device

Conditions: Sleep Apnea

Summary: sleep apnea syndrome (sas) is a common pathology affecting between 4 and 8% of the general population. it aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. it is estimated that 80%% of sas cases are not diagnosed and therefore not treated. it is however impracticable to propose a diagnostic test of polygraphy (pg) or polysomnography (psg) to every patient because of the cost and insufficient availability of these exams. it would therefore be useful to carry out a screening test before directing the patient to a complete test. several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep. the withings hwa09 is a wrist-worn watch, which allows screening of sas from four signals: movement, heart rate, breathing rate and blood oxygen saturation (spo2). the objective of the present study is to validate the diagnostic performance of the withings hwa09 for the detection of sas compared to psg.

subjects are patients having a prescription for a one-night polysomnographic consultation in order to diagnose potential sleep disorders. the investigator will collect the consent before including any patient in this study. the study last one night per patient, during which saturation signal recordings and the sleep apnea detection will be made by the hwa09 watch, in comparison to the polysomnography.

Eligibility criteria:
inclusion criteria: * adults, men and women, between 18 and 70 y/o * patient addressed for a polysomnography because of a suspicion of sleep respiratory disorders * subject having expressed his/her consent to take part in the study exclusion criteria: * recording under continuous positive pressure * subject having refuse to give his/her consent * vulnerable subjects according to regulation in force : * pregnant, parturient or breastfeeding women * subjects having a known allergy to one of the components of the sensor (silicon, stainless steel, sapphire glass) * subjects deprived of liberty by a court, medical or administrative order * subjects legally protected or unable to express their non-opposition to take part in the study * subjects unable to express their consent due to linguistic or mental incapacities
fetus anemia diagnosis by ultrasound data collection

Conditions: Anemia in Fetus

Summary: the aim of this study is to diagnose anemia in fetuses through the use of ultrasound.


Eligibility criteria:
inclusion criteria: * pregnant women from 16th week to 41st week +6 days * singleton fetus exclusion criteria: * all others
managing vascular dementia risk factors with symtrend

Conditions: Vascular Dementia

Summary: individuals with uncontrolled vascular disease are at risk for an insidious progression of brain injury starting in early to midlife and ultimately culminating in a vascular dementia, robbing them of activities of daily living independence. successful containment of this progression requires rigorous vascular risk factor management - the control of blood pressure, blood sugars, weight, and alcohol consumption; the cessation of smoking, and an increase in aerobic activity. symtrend's mobile and web system for managing vascular risk factors will help improve adherence to health and lifestyle strategies, will stem cognitive decline, and will preserve independence in the community for older adults.

neurologists from massachusetts general hospital will refer 10 adults with vascular mild cognitive impairment for participation in this project. the patients will be given bluetooth devices appropriate for their condition and will be trained to use symtrend and apple health software. they will use the software and devices for three months; will receive messages throughout from the system and/or a research coordinator about their progress, with encouragement and strategies to fully manage their symptoms; and their neurologist will be in communication with them about the progress charts and will adjust their care on the basis of this real-time data.

Eligibility criteria:
inclusion criteria: * prior incidence of neurological event such as transient ischemic attack, stroke. exclusion criteria: * inability to use smartphone, * inability to read english
comparison of genomic and transcriptomic patterns between ctc and metastatic tumormetastatic tumor

Conditions: NSCLC Stage IV; NSCLC Stage IIIB

Summary: this study aims to understand the metastasis in advanced nsclc through comparing genomic and transcriptomic patterns between the circulating tumor cells and metastatic tumor cells by single cell sequencing analysis.


Eligibility criteria:
inclusion criteria: * all subjects need to sign the informed consent form * all subjects have non-small cell lung cancer which suspected on chest ct or confirmed pathologically preoperatively * treatment naïve advanced lung cancer (including extensive stage iiib and stage iv) * patients who were suitable to provide enough metastatic tumor tissue and blood (30ml) for the single cells sequencing exclusion criteria: * patients with previous history of lung cancer * have been undergone chemotherapy or radiotherapy due to non-small call lung cancer * have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix within 5 years before enrollment
ilaris nis in korea

Conditions: Hereditary Periodic Fever Syndromes; Cryopyrin-associated Periodic Syndromes (CAPS); Colchicine Resistance Familial Mediterranean Fever (crFMF); TNF Receptor Associated Periodic Syndrome (TRAPS); Hyper-IgD Syndrome / Mevalonate Kinase Deficiency (HIDS/MKD); Systemic Juvenile Idiopathic Arthritis (sJIA)

Summary: this is a study to evaluate safety and effectiveness of ilaris in adult and pediatric patients receiving the drug in a clinical setting for any of the following indications, hereditary periodic fever syndromes, cryopyrin-associated periodic syndromes (caps), colchicine resistance familial mediterranean fever (crfmf), tnf receptor associated periodic syndrome (traps), hyper-igd syndrome / mevalonate kinase deficiency (hids/mkd) or systemic juvenile idiopathic arthritis (sjia).

this is a prospective observational, multicenter, uncontrolled, open-label non-interventional study in ≥2 year and \<19 year-old pediatric and ≥19 year-old adult hereditary periodic fever syndrome patients and ≥2 year and \<19 year-old sjia patients receiving ilaris for the treatment of caps, crfmf, traps, hids/mkd and sjia, respectively, partially using retrospective observation to collect and evaluate data on the safety and effectiveness of ilaris in patients receiving this drug in a clinical setting for any of these indications. the whole study period is up to 4 years, consisting of a 2-year enrollment period and 2-year observation period. as all pediatric and adult hereditary periodic fever syndrome patients and all sjia patients receiving ilaris for approved indications will be enrolled, this study has no fixed sample size. for subjects who started ilaris before enrolling in this study, the safety and effectiveness baseline and early period data will be retrospectively collected.

Eligibility criteria:
inclusion criteria: 1. written informed consent/assent of the patient or their legal representative/parent (≥2 year and \<19 year-old pediatric patient) for voluntarily participating in this study 2. age: ≥2 year and \<19 year-old pediatric and ≥19 year-old adult hereditary periodic fever syndrome (caps, crfmf, traps and hids/mkd) patients and ≥2 year and \<19 year-old sjia patients 3. patient who have an agreement to be treated or who have already started treatment with ilaris in accordance with the approved label information exclusion criteria: 1. patients receiving ilaris treatment for autoimmune disease other than caps, crfmf, traps, hids/mkd or sjia 2. patients participating in an interventional clinical trial which would have an impact on routine clinical treatment

Keywords: hereditary periodic fever syndromes cryopyrin-associated periodic syndromes (caps) colchicine resistance familial mediterranean fever (crfmf) tnf receptor associated periodic syndrome (traps) hyper-igd syndrome / mevalonate kinase deficiency (hids/mkd) systemic juvenile idiopathic arthritis (sjia)
clinical study with axitinib in advanced kidney cancer, who have failed first line treatment

Conditions: Renal Cell Carcinoma

Summary: this is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. the study will recruit a maximum of 30 patients from 2 countries including australia and canada. patients will be followed up for efficacy, safety and health related outcomes.


Eligibility criteria:
inclusion criteria: * metastatic renal cell carcinoma with a component of clear cell subtype. * prior first line systemic therapy * at least 1 measurable lesion as per response evaluation criterion in solid tumors \[recist 1.1\]. * adequate hematology, liver and kidney functions * eastern cooperative oncology group \[ecog\] performance status of 0 or 1. * life expectancy of ≥12 weeks. * normotensive or well controlled hypertension (less than/equal to 140/90 mm hg.) * negative pregnancy test * adequate recovery time from prior systemic therapy, surgery or radiation * willing and able subjects who have signed consent exclusion criteria: * more than one prior systemic therapy regimen * major bowel-penetrating surgery \<4 weeks * active gastro intestinal bleed in past 3 months * active peptic ulcer disease in the past 6 months * current or anticipated use of potent cyp3a4/5 inhibitors * current or anticipated use of known cyp3a4/5 or cyp1a2 inducers * requirement for therapeutic warfarin or high dose steroids * symptomatic or untreated brain metastases * a serious uncontrolled medical disorder or active infection * pregnant or breastfeeding females * history of another active malignancy * dementia

Keywords: axitinib metastatic renal cell carcinoma
covid-19 risk reduction among african american parishioners

Conditions: Coronavirus

Summary: african american adults, specifically those managing chronic disease and social isolation, are one of the most vulnerable groups susceptible to covid-19. this intervention involves a multi-disciplinary and culturally sensitive approach to address two major covid-19 related challenges in this population. first, this program collaborates with predominantly african american churches to implement federal and state guidelines aimed at preventing outbreaks of covid-19 at faith-based gatherings. second, this program trains church-based health advisors to help african american older parishioners manage their chronic health conditions and reduce psychological distress during the pandemic.

to jointly implement and evaluate a telehealth-based, multidisciplinary, culturally-sensitive intervention with 265 aa older parishioners: (i) to mitigate the negative impact of covid-19 on the management of chronic health conditions, and (ii) to reduce healthcare avoidance behaviors and psychological distress.

Eligibility criteria:
inclusion criteria: * african american older adults aged 55 years with a chronic medical condition or 65years and older * have at least one risk factor for covid-19 exclusion criteria: * resident of care facility * cognitive deficit (identified by short version of mini-mental instrument) * does not self-identify as african american and/or black * under the age of 55years * unable to speak and/or read english