Kornimate/medical-research-clean huggingface dataset:
social risks-focused lifestyle intervention to reduce preeclampsia (sail)

Conditions: Preeclampsia

Summary: preeclampsia is a disease of pregnancy and first few weeks after birth. it is diagnosed as new onset of high blood pressure and injury to organs such as kidneys, liver, and brain. preeclampsia is growing at a rapid rate - rate that exceeds diabetes and heart disease. over half a million lives lost each year to preeclampsia. women with a history of preeclampsia have 3-4 times the risk of high blood pressure. they also have double the risk for heart disease and stroke. racial and ethnic disparities are present in preeclampsia. black women are at higher risk of developing preeclampsia. they are also at much higher risk of dying from preeclampsia than other women. the reasons behind such disparities are unclear. what may explain these differences are social determinants of health. the contribution of social determinants to differences in preeclampsia is well recognized. however, a major gap in research remains strategies that address these factors. our study will test a lifestyle intervention incorporating social risk factors to reduce the risk of preeclampsia.

preeclampsia is a significant global health problem affecting over 10 million pregnancies each year. preeclampsia disproportionately burdens ethnic minority women, especially african american women when compared to non-hispanic white women. once diagnosed with preeclampsia, african women are 3 times more likely to die of preeclampsia compared to their white counterparts. evidence supports contribution of social risk factors towards racial and ethnic disparities seen with preeclampsia. however, currently, there are few trials that examine efficacy of social risks-focused lifestyle interventions on reduction of preeclampsia and its complications. this proposal is designed to address this crucial gap by testing feasibility (aim 1), acceptability (aim 1) and efficacy (aim 2) of a social risks-focused lifestyle intervention to reduce preeclampsia in pregnant inner-city african american women. the intervention will be delivered via a randomized control trial design (n=100), with 6 monthly group sessions conducted in the second and third trimesters. the overall hypothesis is that the intervention will be feasible and acceptable, and that women randomized to the intervention group will have lower blood pressure and lower rates of preeclampsia compared with women receiving routine prenatal care.

Eligibility criteria:
inclusion criteria: * self-report as african-american/non-hispanic black * residence in inner-city milwaukee * nulliparity * gestational age at enrollment \<=16 weeks * able and willing to give informed consent exclusion criteria: * not able to communicate in english * major fetal anomaly * psychiatric illness that precludes group participation
lumbar spine on mri and low back pain in elite cross-country skiers

Conditions: Disc Degeneration

Summary: the investigators will examine the prevalence of low-back pain and disc degeneration among finnish elite skiers between 16 and 35 years of age and compare these findings with the data collected among healthy volunteers studied between 1994-2021.

the study population will consist of finnish elite cross-country skiers between 18 and 35 years of age. invitation letters will be sent to all skiers who are selected to national teams at season 2022-2023. the study population for the current study will be approximately 100 individuals. study protocol for the current study will consist of a semi-structured interview, clinical examination, lumbar spine mri and patient reported outcome measures. all participants will sign an informed consent before commencement of the study. if a participant is younger than 18 years, also his/her caregiver will be asked for a signed consent. the interview comprised of questions about the athletes training volume and possible lbp without associated trauma. (suspension from training or competition due to lbp, possible contacts to health-care providers). body height and weight were self-reported. leg length inequality was assessed comparing the height of the left and right iliac crests in standing position with straight knees. wooden blocks of different thickness (with 0.5 cm increment) were used for correction of possible leg length inequality. symmetry of the back was measured in forward bending using a scoliometer. from mri (high field 1.5 t) the signal intensity of the nucleus pulposus will be assessed both qualitatively and quantitatively. the midline t2-weighted images will be independently evaluated visually by three evaluators using a pfirrmann classification. the quantitative nucleus signal intensities will be assessed by two evaluators using a relative measure comparing the signal intensity of the nucleus pulposus to that of the adjacent cerebrospinal fluid on t2-weighted images.

Eligibility criteria:
inclusion criteria: * finnish elite cross-country skiers (national teams from the age of 16) exclusion criteria: * none

Keywords: low back pain disc degeneration athlete matched case control
early rivaroxaban for acute ischemic stroke or tia patients with atrial fibrillation

Conditions: Cerebral Infarction; TIA

Summary: anticoagulant treatment for non-valvular atrial fibrillation (af) associated with cerebral infarction/ tia is one of the recognized treatment of stroke prevention. the acc/aha and national guidelines for the management of anticoagulation recommend that most of af patients with cerebral infarction or tia should be administrated anticoagulant therapy within 14 days of symptom onset, while european guidelines recommend that the timing of the initiation of non-vitamin k antagonist oral anticoagulants (noacs) for af patients with cerebral infarction or tia is association with stroke severity in light of the "1-3-6-12" principle. however, there are still many problems about the use of noacs in ischemic stroke with af. for example, it is unclear what time to begin noacs as to difference in stroke severity, ages, comorbidity with hypertension, diabetes, heart failure, liver and kidney dysfunction and bleeding risks. thus, the timing of the initiation of noacs is yet to be further studied. current urgent need is to develop a guideline-based specific regimen in which the benefit-risk factors are further balanced with a combination of nhiss, cha2ds2-vasc and has-bled score. rivaroxaban, a direct coagulation factor ⅹa inhibitor, blocks the formation of the clot. rocket-af study has shown that the efficacy of rivaroxaban is not inferior to that of warfarin in af patients on stroke prevention, and rivaroxaban has a significantly decreased bleeding risk compared with warfarin. recent study indicates that early administration with rivaroxaban for af patients within 14 days of onset does not significantly increase hemorrhagic transformation. however, the relevant clinical data of the efficacy and safety of early initiation of rivaroxaban in af patients with cerebral infarction or tia are lacking in china. therefore, the investigators conduct a multicenter cohort study to investigate the safety of early rivaroxaban in the af patient with cerebral infarction or tia within 12 days of onset.


Eligibility criteria:
inclusion criteria: 1. over 18 years 2. acute cerebral infarction caused by non-valvular atrial fibrillation 3. nihss score ≤ 15 4. within 12 days of onset 5. first stroke onset or past stroke without obvious neurological deficit (mrs score≤1) 6. signed informed consent exclusion criteria: 1. hemorrhagic stroke or mixed stroke 2. patients with valvular atrial fibrillation or non-cardiogenic cerebral infarction 3. patients with severe infection or serious diseases 4. gastrointestinal bleeding or major operation within 3 months 5. planed cerebrovascular reconstruction or cardiac surgery within 3 months 6. planed major surgery within 3 months 7. participating in other clinical trials within 3 months 8. unsuitable for this trial assessed by research

Keywords: rivaroxaban
400mcg sublingual misoprostol as first line treatment

Conditions: Incomplete Abortion

Summary: women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment. based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.


Eligibility criteria:
inclusion criteria: * uterine size less than 12 weeks lmp * open cervical os * current or past vaginal bleeding * willing to provide contact information for follow-up * over 18 or with guardian consent exclusion criteria: * suspicion of ectopic pregnancy * intrauterine device in place * bad general health (infection, anemia, shoc)
clinical of plain balloon dilatation combined stent versus endovascular debulking combined drug-coated balloon to treat arteriosclerosis occlusive disease of lower extremity

Conditions: Atherosclerosis; Ischemia

Summary: this is a prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions.

prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions. patients with femoral-popliteal artery lesions in our department were randomly assigned to the endovascular debulking combined drug-coated balloon group and balloon dilatation combined with stent angioplasty group. compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. at the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.

Eligibility criteria:
inclusion criteria： 1.all patients signed an informed consent form; 2.digital subtraction angiography (dsa) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (rutherford clinical category-becker class ii-iii2-3) or critical limb ischemia (cli) (rutherford clinical category 4-5-becker class iv-v) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up. exclusion criteria: 1. acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. severe calcified lesions （grade 4 in the pacss scale）; 3. in-stent restenosis lesion or surgical arterial bypass grafting; 4. severe renal insufficiency: creatinine level greater than 2.5 mg/dl; 5. platelet count below 100,000/μl or with antiplatelet / anticoagulation contraindications; 6. immunologic diseases or malignant diseases; 7. ongoing active infection; 8. decompensated congestive heart failure or acute coronary syndrome; 9. refuse to sign the informed consent unwillingness to comply with follow-up suggestions.

Keywords: stent debulking femoral artery drug-coated balloon
verification of harmonization of plasma epstein-barr virus dna measurements

Conditions: Nasopharyngeal Carcinoma

Summary: plasma epstein-barr virus (ebv) dna will be measured in native plasma samples of nasopharyngeal carcinoma (npc) patients, respectively, by three medical centers and a qualified laboratory in southern china, the highest endemic area of npc. passing-bablok regression and difference plots will be used to compare results from each center to the all-method median and mean values. agreement among methods will be evaluated against bias derived from a biological variation.

the investigators intend to collect ebv dna positive plasma samples of npc patients, distribute the samples to four test centers and compare the measurement results to obtain the current status of the agreement of plasma ebv dna measuring at different centers with various measurement systems in the endemic regions of npc. a series of statistical analyses including cohen's kappa, intraclass correlation coefficient, and passing-bablok regression will be adopted for the consistency test. a harmonization study by using the same calibrators will be conducted.

Eligibility criteria:
inclusion criteria: * age between 18-70 years * histologically confirmed npc or non-npc with positive plasma cell-free ebv dna exclusion criteria: * unsatisfactory performance status: karnofsky scale (kps) \<= 70 * any severe intercurrent disease * any contraindication of blood sampling

Keywords: nasopharyngeal carcinoma plasma ebv dna harmonization
spl7013 gel - male tolerance study

Conditions: Human Immunodeficiency Virus (HIV)

Summary: the purpose of this study is to determine if spl7013 gel (vivagel™) is safe when applied topically once a day for seven consecutive days to the shaft and glans of the penis in healthy male volunteers. the study will compare the safety of spl7013 gel on the penile epithelium and urethral mucosa to the safety of a placebo gel. the study will also assess the systemic safety of spl7013 gel, systemic absorption of the active ingredient of spl7013 gel, and the acceptability of the study products to the male volunteers.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * healthy males aged 18 years or older * hiv negative * reports vaginal intercourse in the past 12 months * agrees to abstain from vaginal, anal (receptive and insertive) and oral sexual intercourse, and agrees to refrain from masturbation during the 7 days of product use until after the end-of-treatment (day 7) study visit exclusion criteria: * known or suspected allergy to any component of the study products or similar ingredients in other products * history of significant drug reaction or allergy * recent history (within 12 months) or presence at screening of contact dermatitis or other dermatological condition * recent history (within three months of screening) of a sexually transmitted infection (sti) * current signs or symptoms of uti and/or sti at screening or baseline * positive urine leukocyte esterase test (≥ trace) * biochemical and/or haematological parameters outside the laboratory's normal reference ranges at screening * evidence of genital piercing, ulceration, genital dermatoses, tinea cruris or other dermatological condition of the genitalia or upper thighs * genital pain or discomfort at screening or baseline * any other abnormal finding on physical examination or other medical condition

Keywords: microbicide spl7013 vivagel
sodium glucose cotransporter-2 inhibitors and salt-sensitivity in type 2 diabetes

Conditions: Blood Pressure; Salt; Excess; Diabete Type 2

Summary: the goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (sglt2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes. participants will undergo a dietary intervention consisting of a week of high-sodium diet, followed by a week of low-sodium diet. at the end of each week the patients will undergo: * 24-h ambulatory blood pressure measurement; * 24-h urine collection; * bioimpedance analysis for body composition determination; * blood and urine tests. the study will compare patients treated with sglt2i and patients not treated with sglt2i to test whether the treatment reduces the effects of high sodium intake on blood pressure, body composition and biochemical variables.


Eligibility criteria:
inclusion criteria: * age 18-65 years; * both males and females; * type 2 diabetes. exclusion criteria: * type 1 diabetes; * insulin treatment; * uncontrolled hypertension (sbp \> 160 mmhg and/or dbp \>95 mmhg); * pregnancy; * other acute or chronic conditions influencing blood pressure and glucose metabolism.

Keywords: salt sensitivity sodium glucose cotransporter 2 inhibitors type 2 diabetes blood pressure
efficacy and safety of mp-424, peginterferon alfa-2a (peg-ifn alfa-2a), and ribavirin(rbv) in treatment-naïve or relapsed hepatitis c

Conditions: Chronic Hepatitis C (CHC)

Summary: this study will evaluate the efficacy and safety of mp-424 with peg-ifn alfa-2a and rbv in patients with genotype 1 hepatitis c, who are naïve to its treatment or relapsed after previous treatment.


Eligibility criteria:
inclusion criteria: * genotype 1 chc * treatment-naïve or relapsers (patient who relapsed after previous treatment) * able and willing to follow contraception requirements exclusion criteria: * cirrhosis of the liver or hepatic failure * hepatitis b surface antigen-positive or hiv (human immunodeficiency virus) antibodies-positive * history of, or concurrent hepatocellular carcinoma * history of, or concurrent depression, schizophrenia, or suicide attempt in the past * pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Keywords: pegasys
myopia assessment of two manufacturing processes

Conditions: Juvenile Myopia

Summary: randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two sightglass vision diffusion optics technology (dot) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.


Eligibility criteria:
inclusion criteria: * children between the ages of 6 and 14 years old (inclusive) with myopia * best corrected visual acuity by manifest refraction of +0.10 logmar (20/25 snellen equivalent) or better in each eye * difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 0.75 d exclusion criteria: * current use of any myopia control treatment such as atropine, multifocal contact lenses, or orthokeratology (note: prior bilateral usage acceptable as long as treatment stopped at least 6 months before screening visit. any subject with a history of unilateral myopia control treatment is excluded.) * any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, marfan syndrome or other connective tissue disorder, down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)

Keywords: myopia
assessment of stainless stain crowns placed using the hall technique and traditional technique

Conditions: Primary Teeth; Dental Caries; Dentin, Carious

Summary: the purpose of this study is to evaluate and compare the clinical performance of stainless stain crowns placed using the hall technique and traditional technique

stainless stain crowns (sscs) will be placed on two primary molar teeth with proximal caries, in a split mouth design. 200 patients will be included in the study. the teeth will be randomized into two groups according to the technique. group 1: sscs that will be placed using traditional technique group 2: sscs that will be placed using hall technique the cooperation of the child during the procedure will be assessed with frankl scale. the crowns will be evaluated at baseline and 1., 6., 12., 18., 24. months. radiographical evaluations will be at 6.,12. and 24. months. the data will be analysed statistically using chi square test and log-rank test and the kaplan-meier survival method will be used to estimate survival percentages.

Eligibility criteria:
inclusion criteria: * patients and parents of the patients who accept to participate and sign the informed consent * patients who have two first and/or second primary molars with caries affecting at least two surfaces * patients who are cooperative for the dental procedure exclusion criteria: * patients and parents of the patients who does not accept to participate and sign the informed consent * teeth that are previously restored * patients with a systemic disease, * patients who have orthodontic treatment * teeth which have a short period of time for succedaneous teeth to erupt * teeth which need vital or non-vital endodontic treatment * patients and/or parents who does not accept the esthetic appearance of ssc

Keywords: stainless stain crowns hall technique children
evaluation of methods for diagnosis of cytomegalovirus pneumonia in mechanically ventilated patient

Conditions: CMV Reactivation Diagnosis in ICU Patient

Summary: viral infections are only recently been investigated in patients on mechanical ventilation (mv) in icu. it is especially the progress in the direct detection of these pathogens that allowed intensivists to try to assess objectively the impact of viruses in their patients. this is of course of viral infections "community" (influenza virus, rhinovirus ...), but some viruses also occur under mechanical ventilation in immunocompetent adults. this is called viral infection "nosocomial" whose herpesviridae are the most frequent and best studied. this replication herpesviridae in icu patients is usually a reactivation as primary infection. this reactivation is explained by the fact that after a few days of mechanical ventilation appears immunoparalysis, which can make the bed of bacterial or viral infection.several studies have compared the pp65 antigenemia for quantitative pcr in immmunodéprimés patients. for example, in transplant patients (solid organs), the sensitivity of antigenemia was 91%, quantitative pcr of 95.6% while the specificity was 57% and 81.6% respectively. no work, however, has to date compared these techniques in the intensive care patient. in a subject shortly epidemiological study, the sensitivity of the quantitative pcr performed on the lba is 80%, when compared to antigenemia. moreover this same study shows that half of the positive pcr on the bal are not accompanied by a positive antigenemia, suggesting that pcr may be more sensitive than antigenemia. this exam has never been validated to date in intensive care. finally, no work has so far evaluated the diagnostic performance of quantitative pcr performed on bal


Eligibility criteria:
inclusion criteria: * patient in icu with ventilator-associated pneumonia suspicion exclusion criteria: * icu pateint undergoing invasive ventilation for less than 48 hour
drug eluting balloon (deb) vs plain old balloon angioplasty (poba) in the treatment of failing dialysis access

Conditions: Vascular Diseases; Kidney Diseases

Summary: background conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. the most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. there is conflicting evidence in the literature regarding primary or secondary treatment with drug eluting balloons (deb). these balloons deliver paclitaxel locally, which acts as an antiproliferative drug and may improve treatment outcomes. methods this study was conducted as a prospective 1:1 randomized single centre clinical trial. participants had primary or re-stenotic lesions in native upper extremity arteriovenous fistulas or at the graft-venous anastomosis. patients were randomized to direct primary dilatation, with either a standard balloon or a deb. the primary effectiveness endpoints were freedom from target lesion revascularization (tlr), access circuit revascularization or thrombosis, functional status of access circuit at 12 months. secondary endpoints were procedural complications, procedural success, follow up survival and time to target lesion revascularization.


Eligibility criteria:
inclusion criteria: * active dialysis with a mature upper extremity dysfunctional haemodialysis access * primary stenosis or nonstented restenosis in a native av fistula or at graft-venous location * adult (\>18 years) * target vessel diameter 3-8mm exclusion criteria: * thrombosed access * in stent restenosis * pregnancy * age less than 18 years

Keywords: haemodialysis fistula stenosis paclitaxel drug-eluting balloon angioplasty