Kornimate/medical-research-clean huggingface dataset:
mechanical circulatory support korea post market surveillance study (pms)

Conditions: End-stage Heart Failure

Summary: medtronic is sponsoring this mechanical circulatory support (mcs) korea post-market surveillance (pms) to evaluate the safety and performance of the heartware ventricular assist device system (hvad® system) when used in routine clinical care practice in korea. the mcs korea pms is conducted within medtronic's product surveillance platform (psr).

the mcs korea pms is an observational study conducted at two sites. this mcs korea pms is required by the ministry of food and drug safety (mfds) as a condition of product approval according to regulation on medical device re-examination. the designated re-examination period is seven years after the approval date (06 dec 2013 \~ 05 dec 2020). all patients who require treatment of a commercially available hvad system for approved indications between the designated re-examination period at a participating psr site are eligible for enrollment. all enrolled patients will be followed until patient death, transplant, explant (where applicable), or the end of the study, on 05 dec 2020.

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient has or is intended to receive or be treated with an eligible product * patient is consented within the enrollment window or waiver of consent is approved exclusion criteria: * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)
the role of breastmilk and serum exosomes in neonatal jaundice due to abo incompatibility

Conditions: Neonatal Jaundice From Other Specified Causes; ABO Incompatibility; ABO Hemolytic Disease

Summary: neonatal jaundice is a major global health issue that can lead to serious complications and even death if not promptly treated. abo incompatibility is a common cause of pathological neonatal jaundice, but there are currently no specific tests to predict its severity or progression. this project aims to study the role of exosomes in the diagnosis and treatment of newborn jaundice, focusing on their impact on infants with abo incompatibility. the study will take place at a reference neonatal intensive care unit, involving 45 infants. serum and breast milk samples will be collected and analyzed to determine any relationships and possible correlations.


Eligibility criteria:
inclusion criteria: * newborns who are needed treatment for neonatal jaundice due to abo incompatibility * newborns who are admitted to the study center due to abo hemolytic disease * newborns with abo incompatibility * healthy newborns * healthy mothers exclusion criteria: * lack of informed consent * congenital abnormalities * maternal liver diseases * neonatal liver diseases * sepsis * neonatal jaundice due to the causes other than abo incompatibility * acute or chronic disease state in newborn * maternal acute or chronic disease * medication or substance use effecting liver functions
sequential use of low-dose sunitinib with chemotherapy in advanced nsclc after failure of conventional regimen

Conditions: Cancer; Lung Cancer

Summary: the purpose of this study is to determine whether sequential application of low-dose short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung cancer after failure of conventional therapy. safety of this regimen will also be evaluated.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of stage iiib/iv nsclc * ecog ps: 0,1 * unidimensional or bi-dimensional measurable disease * receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 egf/egfr inhibitor * evidence of disease progression * life expectancy \>12 weeks * neutrophils \> 1.5 109/l, platelets \> 100 109/l, hemoglobin \> 9g/dl, total bilirubin \< 1.5 unl, ast (sgot) and alt (sgpt) \< 2.5 unl, alkaline phosphatases \< 5 unl, creatinine \< 1 unl exclusion criteria: * pre-existing hemoptysis of a severity \> grade 3 by nci ctcae criteria within 4 weeks prior to study entry * uncontrolled hypertension * chf, angina or arrhythmias * lvef \< 1 unl * existing a second malignancy within 5 years * infected with hiv

Keywords: sunitinib chemotherapy non-small cell lung cancer nsclc
a phase 1, 3 day study of safety and tolerability of nvn1000 topical gel in healthy volunteers

Conditions: Acne Vulgaris

Summary: a phase i, single-center, open-label, randomized, parallel group, 3 day study evaluating the safety and cutaneous tolerability of nvn1000 topical gel in healthy volunteers

this is a 3 day study to assess safety and tolerability of a new topical gel product, nvn1000 with and without the application of a commercially available moisturizer in approximately 15 healthy subjects. the test product will be applied to the forehead of healthy volunteers once daily for 3 days. one group of subjects will have a moisturizer applied to the same area 15 minutes after the test gel was applied and one group of subjects will be treated with the gel vehicle which does not contain the active product. the hypothesis is that the application of moisturizer will not effect safety or local tolerability.

Eligibility criteria:
inclusion criteria: * healthy male and females \> 18 years of age * high degree of fluorescence of facial skin under wood's lamp exclusion criteria: * acute or chronic skin disorders * topical or systemic antibiotics within 4 weeks of study enrollment * use of medication that increases risk of methemoglobinemia or influences p. acnes counts * subjects with medical illnesses, anemia, elevated methemoglobin * women who are pregnant, nursing or planning a pregnancy

Keywords: acne
gamesquad for adults with down syndrome

Conditions: Down Syndrome; Physical Inactivity

Summary: the investigators are assessing acceptability, appropriateness, and feasibility of the adapted gamesquad-ds intervention using validated scales alongside qualitative data among young adults with down syndrome. specifically, the investigators will assess mins/wk of ring-fit adventure played, attendance at 30 min. virtual health coaching sessions, semi-structured interviews, participant retention, and intervention safety measured as number of adverse events.

adults with ds face unique barriers to participation in mvpa. exergames, which integrate mvpa into video game play are an affordable, accessible, home-based exercise program which has shown effectiveness for increasing mvpa and improving both physical and cognitive function in typically developed populations. an exergaming intervention with individual health coaching called gamesquad has been shown to be effective in improving mvpa and cardiometabolic parameters in children with overweight/obesity and adolescents with neurodevelopmental and psychiatric diagnoses. the investigators propose a two phased project to adapt/evaluate the gamesquad intervention for use in adults with ds (gamesquad-ds). in phase 1, the investigators will utilize a formative approach to develop gamesquad-ds, pilot test the intervention for 4 weeks in 10 young adults with ds and use feedback to refine the intervention for use in phase 2. in phase 2, the investigators will conduct a 12-wk. single arm pilot trial in 20 young adults with ds to assess the acceptability, appropriateness, and feasibility of the intervention and calculate effect sizes for change mvpa, physical function, muscular strength, physical activity enjoyment, and self-efficacy. successful completion of this project represents an initial step in achieving the goal of developing effective interventions to increase mvpa and promote healthy aging in adults with ds.

Eligibility criteria:
inclusion criteria: * young adults (18-30 yrs.). * diagnosis of ds. * sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language. * living at home with a parent/guardian or in a supported living environment with a parent/caregiver who agrees to serve as a study partner. exclusion criteria: * unable to participate in mvpa. * serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by their primary care provider (pcp).
diaphragmatic ultrasound associated with rsbi predict weaning issue: the rapid shallow diaphragmatic index (rsdi)

Conditions: Mechanical Ventilation; Mechanical Ventilator Weaning; Extubation; Diaphragm Ultrasound

Summary: the rapid shallow breathing index (rsbi) is the ratio between respiratory rate (rr) and tidal volume (vt). it is routinely used to predict mechanical ventilation weaning outcome in icu patients. however rsbi doesn't reflect the muscular contribution of diaphragm or accessory muscles in generating tidal volume. actually, diaphragmatic dysfunction can even delay weaning process, because accessory muscles are more fatigable than the diaphragm. hence, the investigators hypothesized that diaphragmatic displacement (dd) could be associated with rsbi in a new index named rapid shallow diaphragmatic index (rsdi) such as: rsdi = rsbi/dd. the aim of this study is to compare the ability of the rsdi versus the traditional rsbi to predict weaning success in ready-to-wean patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * mechanically ventilated patient \> 24 hours * weaning ventilator phase (peep \< 9 cmh2o and support \< 15 cm h2o) * ventilated via tracheostomy tube patient can be included on removal day of the cannula * patient's agreement to participate exclusion criteria: * moribund patient * decision to forgo life sustaining therapy patient * patient with ventilation via tracheostomy tube before admission to icu * bmi \> 45

Keywords: diaphragm ultrasound spontaneous breathing trial mechanical ventilation weaning rapid shallow breathing index
study of the influence of the expression of the calcium-sensitive receptor (casr) by monocytes in the synovial liquid on structural alterations in patients diagnosed with rheumatoid arthritis in the previous two years

Conditions: Arthritis, Rheumatoid

Summary: rheumatoid arthritis (ra) is the most frequent form of chronic inflammatory rheumatism in adults. the erosive damage influences the functional prognosis in patients with ra. at present, there are no sufficiently sensitive and specific predictive markers of erosive damage.


Eligibility criteria:
inclusion criteria: * patients consulting in the department of rheumatology at amiens university hospital * age ≥ 18 * ra meeting the 2010 acr/eular criteria * less than 2 years of ra progression * effusion in at least 1 joint exclusion criteria: * inability to give informed consent * ongoing pregnancy * previous treatment with an anti-osteoporosis medication * intra-articular corticoid or hyaluronic acid injection in the previous 6 months * coagulation disorders preventing arthrocentesis * incarceration or legal guardianship

Keywords: calcium-sensitive receptor
effect of structured education on menopause-specific quality of life

Conditions: Menopause; Quality of Life

Summary: this study aims to evaluate the impact of a structured education program delivered under midwife guidance on menopause-specific quality of life among women aged 45-55 undergoing natural menopause, and to assess the sustainability of its effects over time.

this randomized controlled longitudinal study was conducted with 101 women aged 45-55 experiencing natural menopause (intervention: 51, control: 50). the intervention group received a structured menopause education program developed based on literature and expert review. data were collected using a personal information form and the menopause-specific quality of life questionnaire (menqol) at three time points: baseline (t1), after education (t2), and six months later (t3). the intervention consisted of four weekly face-to-face sessions delivered by a midwife. the education content included information on menopausal changes, symptoms, and coping strategies. the control group received no intervention during the study but received educational material after final data collection. data were analyzed using spss 20.0 with p\<0.05 considered statistically significant.

Eligibility criteria:
inclusion criteria: * • women aged 45-55 * experiencing natural (non-surgical) menopause * literate and able to complete questionnaires * no neurological or cognitive impairments * willing to participate and attend sessions * has access to phone/internet exclusion criteria: * surgical menopause * hormonal disorders causing amenorrhea * current use of hormonal therapy or antidepressants * diagnosed psychiatric conditions removal criteria (if applicable): * did not attend at least 80% of sessions * lost to follow-up at 6 months * developed a new health issue affecting menopause * participated in other menopause interventions * incomplete or inconsistent questionnaire

Keywords: menopause structured education midwifery menqol women's health
chlamydia trachomatis immunology and vaccinology study

Conditions: Chlamydia

Summary: the primary objective is to prospectively follow 200 women with or at risk of cervicitis to determine the chlamydia-specific cellular responses that correlate with protection against incident infection. the hypothesis is that a positive ifn-y response by peripheral cd4+ t cells responding to stimulation with hsp60 will be significantly associated with protection from incident c. trachomatis infection.

a total of 200 women with or at high risk of having cervicitis will be prospectively followed for correlations between chlamydia-specific cellular responses and protection against incident infection. at enrollment participants will undergo a history and physical examination; blood draw; and pelvic examination including collection of vaginal and cervical samples, std testing and endometrial biopsy. participants will have follow up visits conducted at 1, 4, 8 and 12 months following enrollment. at the follow-up visits, participants will undergo a repeat history and physical, blood draw and pelvic examination including collection of vaginal and cervical samples and std testing. the study design will allow comprehensive identification of the antigen-specific cell mediated immune responses most strongly associated with protection against c. trachomatis infection. the primary objective is to prospectively follow 200 women with or at risk for cervicitis to determine the chlamydia-specific cellular responses that correlate with protection against incident infection.

Eligibility criteria:
inclusion criteria 1. women 15-35 years of age. note: minors must have written informed consent from her parent/legal guardian to participate. 2. at least one of the following: 1. current , untreated endocervical c. trachomatis infection. 2. mucopurulent cervicitis: defined by the presence of yellow or green endocervical mucopurulent discharge and/ or easily induced endocervical bleeding (bleeding when the first swab is placed in the endocervix). 3. sexual contact with a male partner (regardless of condom use) recently diagnosed (within the past 3 months) with c. trachomatis and/or non-gonococcal urethritis. exclusion criteria: 1. pregnant or nursing a baby. note: a urine pregnancy test will be done at enrollment. result must be negative to participate in the study. 2. gynecologic surgery or surgical abortion in preceding 2 months of enrollment. 3. allergy to any of the study medications and/or derivatives (cephalosporins, azithromycin, erythromycin, any macrolide or ketolide antibiotic) or type 1 hypersensitivity allergic reaction to penicillin. 4. systemic or vaginal antibiotic therapy in preceding 7 days of enrollment. 5. prior hysterectomy. 6. menopause. 7. any condition, in the opinion of the investigator that would interfere with the participant's safety or with study outcomes. 8. participation in any study involving an investigational product in the past 30 days or anticipation of participation in any study using an investigational product in the next 30 days. 9. previous participation in this study.
infection watch study

Conditions: COVID-19 Respiratory Infection; Respiratory Syncytial Virus Infections; Rhinoviral Infections; Influenza Viral Infections

Summary: this study will reach out to patients who have undergone diagnostic testing for the following respiratory illnesses from january 1st, 2018 to july 9th, 2023: covid-19, influenza, rhinovirus, and respiratory syncytial virus. this study aims to develop a forecasting model to predict infection onset prior to symptom onset using wearable device data and known symptom onset and test dates.

duhs patients who have diagnostic testing for influenza, covid-19, respiratory syncytial virus, and rhinovirus testing within the past 5 years will be initially screened for an email address. participants will learn about this study via email with a link to complete the survey. a study id will be generated for all individuals with an email. participants will be asked to complete an e-consent via a redcap survey. if participants have questions, they are provided with study contact information via e-mail. participants will complete the survey which will have questions on prior symptoms and device ownership (anticipated time to complete: 5 minutes). if the participant owns one of the following wearable devices (fitbit, garmin, or apple watch), they will be sent to a redirect url to login into their device account (for fitbit or garmin) or be provided with instructions to export their healthkit data and dump their data into a unique strongbox link (for apple watch). if participants choose to contribute their wearable device data to the study and the data obtained pass through data quality thresholds, they will receive compensation. there is no compensation for survey completion. the investigators will ask participants if they wish to be re-contacted for future studies related to this project. the investigators will collect endpoint data values from the wearable. these data will be used to estimate daily activity amounts and intensity (i.e., exercise and walking), standing, sleep amounts, sleep quality, heart rate variability, spo2, respiratory rate, and heart rate. all of the wearable device data will be identified using a study id. the investigators will use statistical and machine learning models to develop personalized "baseline" models of health and detect anomalies that can help in identifying covid-19 infection. the investigators will validate and test the sensitivity and specificity of our mode for detecting respiratory infection vs. no infection against symptom surveys and diagnostic testing as ground truth. the model testing and validation will be done separately for each brand of device and will be further modified according to the type of respiratory infection.

Eligibility criteria:
inclusion criteria: * 18 years of age and older exclusion criteria: * less than 18 years of age

Keywords: wearable device smart watch
a phase 1a/1b study of ppi-383 in healthy adults and hepatitis c patients

Conditions: Hepatitis C, Chronic

Summary: ppi-383 is an antiviral agent (an inhibitor of the hepatitis c virus ns5b polymerase) that is being developed as a potential treatment for hepatitis c virus infection. this study is being done to assess the dose-related safety and tolerance of ppi-383 when given to healthy volunteers for up to 5 days (part i of the study) and to hepatitis c patients for up to 3 days (part ii). in addition, the study will assess how much ppi-383 is absorbed into the bloodstream. in part ii, the dose-related effect of ppi-383 on the amount of hepatitis c virus in patients' bloodstream (serum hcv rna levels) also will be assessed.


Eligibility criteria:
part i volunteers (single and multiple dose) - key inclusion criteria * healthy males * age 18 to 55 years * body mass index (bmi)18 to 32 kg/m2 part ii patients- key inclusion criteria * males, or females of non-childbearing potential * age 18 to 65 years * chronic hepatitis c, and absence of other known liver disease * seropositive for hcv antibody (hcv ab) or hcv rna at least once previously * seropositive for hcv ab at screening * serum hcv rna \> 5 log10 iu/ml at screening * hcv gt-1 * treatment-naïve for hepatitis c: * bmi 18 to 35 kg/m2 * otherwise in good health, without severe or clinically significant chronic or recurrent conditions requiring frequent medical intervention or continual pharmacologic management, except for anti-hypertensive use * no medical or psychosocial conditions that would potentially interfere with the subject's ability to comply with the study assessments or visit schedule. part ii patients - key exclusion criteria * seropositive for human immunodeficiency virus (hiv) antibody or hepatitis b virus (hbv) surface antigen (hbsag) * signs or symptoms of decompensated liver disease * evidence of cirrhosis or hepatocellular carcinoma * diabetes mellitus treated with insulin or hypoglycemic agents * asthma requiring hospital admission within the preceding 12 months * history of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements * any of the following laboratory values at screening * haemoglobin (hgb) \<11 g/dl in women or 12 g/dl in men * white blood cell count \<4,000/mm3 * absolute neutrophil count (anc) \< 1800 per mm3 * platelet count \<100,000 per mm3 * serum creatinine \> upper limit of normal (uln) at the central study laboratory * serum albumin \<3.4 g/dl * total bilirubin \>2.0 mg/dl * clinically significant abnormality in the electrocardiograms (ecgs) at screening

Keywords: ns5b polymerase inhibitor phase 1 genotype 1