Kornimate/medical-research-clean huggingface dataset:
mechanism of drug-drug interaction between salvianolate injection and aspirin

Conditions: Angina, Stable

Summary: the combination of anti-platelet medicine treatment and chinese traditional medicine (tcm) promoting blood circulation to removing blood stasis is widely used in treatment for cardiovascular disease. however, the material foundation, effective mechanism and drug-drug interaction is still not clear. in order to solve the puzzle of rational use of joint application by tcm and western medicine(wm),investigators conduct a research on mechanism of drug-drug interaction between salvianolate injection and aspirin based on metabolic enzyme and pk-pd model. this clinical trial contain three groups, aspirin group, salvianolate injection group and combination (salvianolate injection+aspirin) group. investigators collect blood samples at special time points during post-administration.investigators have already find out the salvianolate's pharmacokinetic characteristics in vivo and establish the biological sample-testing analysis method in previous research. depending on these results, this clinical trial aim to explore the pharmacodynamics-pharmacokinetics(pk-pd) characteristics of combination with salvianolate and aspirin through biomarkers, blood concentration. finally clarify the tcm and wm material basis and mutual mechanism of drug interaction and guide reasonable clinical prescription.


Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria of coronary heart disease. 2. meet the diagnostic criteria of stable angina pectoris. 3. meet the diagnostic criteria of syndrome of blood stasis. 4. angina in grade i-ii according to canadian cardiovascular society (ccs). 5. it could be enrolled if the subject taking aspirin or salvianolate injection with one month regularly。 6. the subjects were informed and voluntarily signed informed consent. exclusion criteria: 1. severe heart disease (acute myocardial infarction of acute myocardial infarction in 6 months), severe cardiopulmonary dysfunction (eg: cardiac function ii) 2. poorly controlled hypertension(systolic pressure \>160mmhg or diastolic pressure \>100mmhg). 3. diabetics. 4. severe primary diseases such as liver and renal hematopoietic system damage. such as:liver function（alt≥2×uln、ast≥2×uln）,kidney function（cr\>1.0×uln) or nervous and mental disorder. 5. pregnant, breast-feeding and menstrual women, or women planning pregnancy within 3 months. 6. subjects who participated in clinical trials in recent 3 months. 7. subjects who took surgery treatment or had hemorrhagic tendency in recent 4 weeks. 8. subjects who had drug allergy history or with allergic constitution. 9. subjects who has mental or physical disorders. 10. subjects who had bad compliance or is not suitable for this clinical trial by investigator's judgement

Keywords: drug-drug interaction asprin salvianolate injection pk-pd model metabolic enzymes
randomised controlled trial comparing tension-free vaginal tape (tvt), pelvicol & autologous slings for stress urinary incontinence(sui)

Conditions: Stress Urinary Incontinence

Summary: the purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, tvt or pelvicol slings.


Eligibility criteria:
inclusion criteria: * women requiring surgery for sui following failed conservative treatment exclusion criteria: * under 18 years of age * previous surgery for sui * evidence of neurological disease * pelvic organ prolapse (pop) greater than grade 2 * women with any evidence of detrusor overactivity or bladder hypocompliance on urodynamic assessment

Keywords: stress urinary incontinence autologous slings slings tvt grafts surgery
conventional photodynamic therapy versus daylight photodynamic therapy for the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: photodynamic therapy (pdt) is considered an effective treatment for acne vulgaris. the study aims to determine whether treatment with daylight as an illumination source is as effective as conventional, red light illumination. 15 patients with acne vulgaris received 4 treatment sessions at three-week intervals. first, 5-aminolevulinic acid (ala) was applied to the entire face. then the face was divided into two symmetrical contralateral treatment areas: the left was covered with a light-impermeable dressing, while the right face was exposed to sunlight. after 2 hours outdoors, the right side of the face was covered, and the left half was illuminated with red light.

photodynamic therapy (pdt) is considered an effective treatment for acne vulgaris .one of the most important drawbacks of pdt is the pain during illumination. it has been shown that daylight pdt is an effective treatment for actinic keratosis. in order to examine the efficacy of daylight pdt for acne vulgaris, we used a split-face design: the face was divided into two symmetrical contralateral treatment areas: the left was covered with a light-impermeable dressing, while the right face was exposed to daylight. after 2 hours outdoors, the right side of the face was covered, and the left half was illuminated with red light.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of acne vulgaris on the face * acne lesions include inflammatory papules/ pustules/ nodules and cysts , and non-inflammatory open and closed comedones. * acne refractory to conventional therapies * patients who are unable or do not want to take oral isotretinoin * patients who cannot tolerate isotretinoin exclusion criteria: * history of oral retinoid use within 12 months of study entry * systemic antibiotics within 6 month of study entry * topical acne treatment within 1 month of study entry * presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea * presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or by any medication prescribed for the treatment of the systemic diseases (retinoids, antibiotics). * pregnancy or intention to get pregnant * lactating woman * porphyria * photosensitive dermatoses * allergy to any component of the photosensitizer compound * personal history of melanoma or dysplastic nevi * a beard or other facial hair that might interfere with study assessments;

Keywords: acne vulgaris photodynamic therapy pdt daylight pdt
positive connections: copa2

Conditions: Human Immunodeficiency Virus

Summary: this study proposes to assess the impact of a provider-based intervention to enhance re-engagement and improve retention, adherence, persistence and viral load among challenging patients in argentina

motivational interviewing (mi) has primarily been utilized as a counseling strategy by therapists to counter addiction and improve lifestyle behaviors. this application proposes to train physicians to utilize mi to promote re-engagement in hiv care and to sustain retention and adherence. the study will increase the reach of the original pilot study and increase its generalizability, expanding the patient population to a wide variety of public and private clinic and hospital patients, including transgender women, drug users, men who have sex with men (msm), and heterosexual men and women.

Eligibility criteria:
inclusion criteria: * hiv seropositive * at least 18 years of age (there will be no upper age range) * "challenging" hiv-infected patients, defined as 1) diagnosed for \> 6 months and having detectable viral load \> 500 copies/ml at last assessment following 6 months of art prescription, and 2) not retained in care, i.e., 3 missed pharmacy pick-ups in the last 6 consecutive months, or not attending a physician visit in the last 12 months or more exclusion criteria: * participants with delirium and/or psychosis will be excluded. there are no exclusions based on literacy as all materials will be administered using an audio computer assisted self-interview system (acasi) supervised by assessors.

Keywords: hiv, motivational interviewing, retention in care
the dare warfarin cer study

Conditions: Deep Venous Thrombosis; Pulmonary Embolism

Summary: approximately half a million americans annually experience venous thromboembolic disease, including deep venous thrombosis (dvt) and pulmonary embolism (pe). since 2010, four new oral anticoagulants have been approved for marketing in addition to the vitamin k antagonist warfarin. very limited head-to-head data exists comparing these treatment options, leaving patients, clinicians, and other stakeholders with little guidance for selecting the best strategy that balances recurrence reduction with risk of bleeding. in the dare warfarin cer study, the researchers compare all five currently available oral anticoagulant agents for the extended treatment of dvt and pe, as well as no extended treatment. this study also aims to evaluate whether treatment heterogeneity exists for specific populations, such as older patients or those with renal dysfunction. in a secondary aim, the study will also leverage a database of linked electronic health record-insurance claims to validate diagnosis definitions and account for potential residual confounding by factors unmeasured in claims data. as the patient population includes all medicare novel anticoagulant users and large numbers of commercially insured and medicaid patients, the results will likely be transportable to the majority of us patients experiencing a dvt or pe. pursuant to the objectives of the patient-centered outcomes research institute, a study advisory committee consisting of key stakeholders will be actively involved in the study design and dissemination of results.


Eligibility criteria:
inclusion criteria: 1. inpatient stay with diagnosis code of dvt/pe (see appendix a), 1/1/2010 - 9/30/2015 for which the patient has at least 365 days continuous medical and pharmacy eligibility prior and no other inpatient stays with dvt/pe diagnosis. set discharge date as index diagnosis date. take only the first eligible episode for a patient, if multiple. 2. prescription fill for an anticoagulant \[generic name=dabigatran (150mg), apixaban (2.5mg, 5mg, 10mg), rivaroxaban (15mg, 20mg), edoxaban (30mg, 60mg), or warfarin\] within 30 days of and including index diagnosis date. set earliest anticoagulant prescription as index generic and date as index rx date. 3. no anticoagulant prescription fill in the 365 days prior to index diagnosis date. 4. continuous enrollment and use of an anticoagulant for the first 90 days including and following the index rx date, defined as no gaps in therapy \>7 days. for each patient, assign a variable to indicate whether the patient filled an anticoagulant with a different generic name as index during this period. exclusion criteria: 1. any safety outcome between index diagnosis date and index rx date + 90, defined as: intracranial bleed, gastrointestinal bleed, or other major bleed. 2. any dvt/pe between index diagnosis date and index rx date + 90.

Keywords: dabigatran warfarin apixaban edoxaban extended treatment oral anticoagulant rivaroxaban comparative safety comparative effectiveness
prep demonstration study in swaziland

Conditions: HIV Negative People Identified at Substantial Risk for HIV Infection

Summary: this stepped-wedge cluster-randomized trial is embedded in an 18-month observational cohort study that has the aim to assess the operationalization of oral pre-exposure prophylaxis (prep) in swaziland as an additional hiv combination prevention method among individuals at high risk of hiv infection. the trial aims to determine the effect of a healthcare facility-based prep promotion package on the number of clients who take up prep.

the study will assess who will be reached with an introduction to and an offer of prep - and who will take up prep - when prep becomes available through different delivery points in the public-sector health system, including outpatient department (opd), antenatal care (anc), postnatal care (pnc) , family planning (fp) , and following hiv counseling and testing (vct). in addition to prep reach and prep uptake, the study aims to establish prep retention and average costs per client, by different health systems delivery points and to assess the effectiveness of a feasible and low-cost prep promotion package (ppp). the exact composition of ppp will be informed by findings from in-depth- interviews with clients, providers, and prep stakeholders. the effect of the ppp on the monthly number of clients who are initiated on prep will be studied using a stepped-wedge cluster-randomized design. specifically, the trial will have two sequences with three healthcare facilities in each sequence, and three periods. in the first period, all healthcare facilities will be in the control phase; in the second period three healthcare facilities will implement the ppp; and in the third period all six healthcare facilities will implement the ppp.

Eligibility criteria:
inclusion criteria: * confirmed hiv negative by rapid antibody test following the national hiv testing services (hts) algorithm on the day of prep initiation * \> 16 years of age * willing and able to provide written informed consent * identified at substantial risk of acquiring hiv infection * no current or recent illness (within past month) consistent with acute hiv infection in combination with a preceding high risk exposure for hiv * no contraindications to the use of tenofovir(tdf)/lamivudine (3tc) * ready to adhere to prep and willing to attend the follow up evaluations including repeat hiv testing and monitoring for side-effects exclusion criteria: * younger than 16 years of age * currently having symptoms of acute hiv infection * suspicion of window period following a potential exposure to hiv * body weight \< 40 kg * creatinine clearance \<60 ml/min * using other nephrotoxic drugs (e.g. aminoglycosides) * not willing to come for follow up visits every 3 months which will include hiv testing and counselling and monitoring for side-effects.

Keywords: prep
vaccination against sars-cov2 (covid-19) in chronic inflammatory rheumatism and factors determining its decision.

Conditions: Rheumatoid Arthritis; Spondyloarthritis

Summary: rheumatoid arthritis and spondyloarthritis (ankylosing spondylitis and psoriatic arthritis mainly) are chronic inflammatory rheumatism (ric), frequently onset in young adults. the prevalence is respectively 0.3 to 0.8% and 0.4%. or about 600,000 people. the "basic" treatments (dmards), essential to control the progression of the disease, are classified into csdmards (chemical), the first of which is methotrexate, or bdmards (biological). these treatments are immunomodulators and there is an increased risk of severe infection under these therapies. several vaccinations are therefore recommended by learned societies in patients receiving these treatments, in order to prevent certain infectious risks.in the current pandemic context, the vaccination of these patients against sars-cov2 is a major issue in their management and is recommended by the french society of rheumatology. however, many patients express doubts about this vaccination or refuse it. the factors associated with the vaccination will are not known. better identifying them would make it possible to adapt the information to be given to our patients to promote their adherence.


Eligibility criteria:
inclusion criteria: * ambulatory patients * men or women of any age * follow-ups for chronic inflammatory rheumatism such as rheumatoid arthritis or spondyloarthritis * treated with methotrexate or biotherapy. exclusion criteria: * patients not treated with biotherapy or methotrexate. * patients in whom the assessment could not be performed reliably

Keywords: sars cov 2 vaccination
endotoxin and bronchial inflammation in asthma

Conditions: Asthma; Lung Diseases; Inflammation

Summary: to evaluate airway inflammation in persons with asthma exposed to endotoxin, a common occupational air contaminant. subjects are subsequently challenged with allergen.

background: endotoxin (or lipopolysaccharide \[lps\]) is a potent inflammatory stimulant which is found in ambient air in occupational settings. asthma in the workplace is an increasingly significant problem. asthma is characterized by airway inflammation and increased reactivity to both allergic and non-allergic stimuli. lps is known to induced airway inflammation in normal subjects and to enhance airway reactivity in asthmatics. additionally, both alveolar macrophages and mononuclear cells from asthmatics secrete higher amounts of cytokines (interleukins 1 and 8 \[il-1, il-8\] and granulocyte macrophage-colony stimulating factor \[gm-csf\] ) than those from normals. thus, it is likely that lps enhances allergen-induced inflammation and that allergic asthmatics are more sensitive to the effects of lps. preliminary data show that exposure to low levels (250 ng/m3) of lps at risk for four hours enhances both immediate responsiveness to inhaled allergen and allergen-induced eosinophils as observed in induced sputum. in the nasal airways of allergics, a single dose of 1,000 nanograms of lps enhances polymorphonuclear leukocyte influx associated with allergen challenge. this latter finding also correlates well with baseline il-8 and ecp levels, suggesting that constitutive airway inflammation enhances response to these stimuli. design narrative: the effect of endotoxin lps (5,000 nanograms) is compared on airway inflammation and methacholine response and lung function in normals and asthmatics; the effect of lps (500 nanograms) is compared on allergen-induced reactivity and inflammatory cell influx following lps exposure (5,000 nanograms) in asthmatics, likely as a result of decreasing baseline inflammation. to examine potential cellular mediation of the effect of lps in asthma, cytokine secretion of mononuclear cells to lps of subjects responding to lps (or those in whom lps enhance response to allergen) is compared to those who did not respond. in vitro monocyte and in vivo airway responses of asthmatics who are responsive and non-responsive is compared to baseline sputum and nasal lavage fluid il-8 and ecp to determine if either in vitro monocyte responses or il-8 and ecp in readily obtained airway fluids may serve as biomarkers of lps responsiveness and might be used as a marker for a lps-response phenotype in humans for future mechanistic and intervention studies. finally, practical data on the effect of lps in asthmatics (at levels found in typical work settings) and the ability of standard anti-inflammatory therapy to protect asthmatic workers unavoidable exposed to lps will be obtained. the study was renewed in 2001 and continues through december, 2005.

Eligibility criteria:
no eligibility criteria
turkey thrombotic thrombocytopenic purpura disease registry: national multicenter study

Conditions: TTP - Thrombotic Thrombocytopenic Purpura

Summary: 21 hematology centers in turkey will participate in this noninterventional observational study. the recruitment target is 960 cases. patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. recruitment period will be 36 months. data will be collected via electronic case report form. since the study cohort does not include only newly diagnosed patients, all attp patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. patients recruitment duration: 3 years (36 months) patients follow-up duration: 1 year (12 months)

because of the non-interventional nature of the study, there is no predefined treatment protocol. the patients will be treated according to the routine practices of the centers. in observational drug studies, the drug to be administered in treatment should be prescribed and patient's treatment should be started prior to study inclusion decision is made as a principle. the participating physician will continue to treat the patients according to their routine practices. not only newly diagnosed patients, all attp patients within participated centers will be recruited and 12 months follow-up data will be collected. 21 hematology centers in turkey will participate in this noninterventional observational study. the recruitment target is 960 cases. patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. recruitment period will be 36 months. data will be collected via electronic case report form. since the study cohort does not include only newly diagnosed patients, all attp patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. patients recruitment duration: 3 years (36 months) patients follow-up duration: 1 year (12 months)

Eligibility criteria:
inclusion criteria: * diagnosed as attp after 01.01.2015 * patients with adams13\<10% * thrombocytopenia (\<100.000) * coombs (-) * microangiopathic hemolytic amenia * 18 years and older exclusion criteria: - patient who does not sign informed consent form

Keywords: ttp thd
nirs levels of infants in neonatal intensive care

Conditions: Premature Birth

Summary: aim: this study was conducted to determine the effect of nursing care practices on the near infrared spectroscopy (nirs) levels of premature infants in the neonatal intensive care unit (nicu). materials and method: this is a cross-sectional, analytical study. it was conducted over the period march 1 - april 26, 2019 in the neonatal intensive care unit (nicu) of eskişehir osmangazi university (esogu) health practices and research hospital. we did not calculate sample size, but included in the study, after the parents had been informed about the research, the entire universe of neonates in the nicu who matched the inclusion criteria during the period march 1 - april 26, 2019. the study was completed with 40 neonates. data collection was performed with a "descriptive data form," and a "procedures performed chart." the data were evaluated with the ibm spss 24 package program.


Eligibility criteria:
inclusion criteria: * neonates younger than a gestational age of 37 weeks * those monitored in an open or closed incubator exclusion criteria: * intubated neonates connected to a mechanical ventilator * infants of a gestational age of 37 weeks or more * infants under sedation * infants with neurological illness (e.g., hypoxic ischemic encephalopathy, hydrocdphalus)