Kornimate/medical-research-clean huggingface dataset:
the impact of material on microbiota in association with tongue and lip piercing

Conditions: Bacteremia

Summary: biofilms on oral piercings may serve as a bacterial reservoir and lead to systemic bacteraemia or local transmission of periopathogenic microbiota. the investigators hypothesize that there are microbiological differences in bacterial samples collected from tongue /or lip piercings made of different materials. the investigators also hypothesize that the piercings carry the same characteristic bacteria as found in the piercing channels and that independently the biofilm on the tongue/adjacent teeth is similar to the other study locations. 85 subjects with tongue and 85 subjects with lip piercing will participate. periodontal clinical parameters, traumata of hard tissues, and characteristics of the stud are evaluated. sterile piercings of four different materials will be randomly allocated to the study subjects. after two weeks, microbiologic samples are collected and are processed by checkerboard dna-dna hybridization methods.


Eligibility criteria:
inclusion criteria: * lip/tongue piercing for at least six month in situ exclusion criteria: * pregnancy and lactating women * medication with known effects on gingival tissues * antibiotic medication in the last six months or need for antibiotic prophylaxis * chlorhexidine use in the last six months * non-plaque induced gingival disease * prior diagnosis of periodontitis

Keywords: adolescent body piercing/adverse effects tongue piercing tongue/microbiology
genomic determinants of outcome in cardiogenic shock

Conditions: Cardiogenic Shock

Summary: the aim of this project is to understand the heterogeneity of both the immune consequences and treatment responses in cs. we will explore this heterogeneity through identification of transcriptomic sub-phenotypes and their association with outcomes, including therapeutic responses.

this is a prospective observational cohort study in 8-10 cardiac centres across europe. we will recruit patients presenting with acute myocardial infarction (ami) and cs who are supported medically (n=100); with extracorporeal membrane oxygenation (n=50); and with the impella device (n=50). we will also enrol patients who present with either ami and no evidence of cs (n=50) or cs due to non-ischaemic pathologies (e.g. myocarditis: n=50) as comparators. the recruitment target is 300 patients.

Eligibility criteria:
inclusion criteria: * all of the following are required for inclusion following screening: * willing to provide informed consent or appropriate consent from a nominated consultee or personal consultee * presentation within 24 hours of onset of acs symptoms. * cs can only be secondary to acs (type 1 mi stemi or n-stemi) or myocarditis * planned or completed revascularisation of culprit coronary artery cs will be defined by: * systolic blood pressure \<90 mmhg for at least 30 minutes * a requirement for a continuous infusion of vasopressor or inotropic therapy to maintain systolic blood pressure \> 90 mmhg. * clinical signs of pulmonary congestion, plus signs of impaired organ perfusion with at least one of the following manifestations: * altered mental status. * cold and clammy skin and limbs. * oliguria with a urine output of less than 30 ml per hour. * elevated arterial lactate level of \>2.0 mmol per litre. exclusion criteria: * any of the inclusion criteria not met and: 1. unwilling to provide informed consent. 2. echocardiographic evidence (recorded within 90 mins of end of pci procedure) of mechanical cause for cs: eg ventricular septal defect, lv-free wall rupture, ischaemic mitral regurgitation. 3. age \<18 and ≥80 years. 4. shock from another cause (sepsis, haemorrhagic/hypovolaemic shock, anaphylaxis, etc). 5. significant systemic illness 6. known dementia of any severity 7. comorbidity with life expectancy \<12 months. 8. out-of-hospital cardiac arrest (ohca) and any of the following: 1. no return of spontaneous circulation (ongoing resuscitation effort) 2. ph \<7 3. without bystander cpr within 10 minutes of collapse 9. arterial lactate level of \<2.0 mmol per litre.

Keywords: acs, cardiogenic shock ecmo impella gene expression endotype
systemic consolidation therapy after chemoradiation therapy following operation for high risk early stage cervical cancer

Conditions: Cervical Cancer

Summary: the purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following radical hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.

systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (3 cycles per 3 weeks) for high risk early stage cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.

Eligibility criteria:
inclusion criteria: * patients who underwent radical hysterectomy for cervical cancer stage ib-iia * patients who had at least one of the following risk factors in pathologic results; lymph node metastasis, positive residual resection margin, parametrial invasion * above 20 years * gog performance status 0-2 * informed consent * platelet\>100k, hb\> 10.0 g/dl, anc\>1500/mm3, cr \<1.25\*upper normal limit, bilirubin\<1.5mg/dl, ast \& alt\<\*3 upper normal limit * expected life \> 6 months exclusion criteria: * peripheral neurotoxicity \> nci grade 2 * sever infection * previous history with chemotherapy or radiation therapy * pleural effusion, pericardial effusion, and ascites which could cause dyspnea \> nci grade 2 * paraaortic lymph node metastasis * allergy with platinum * previous history of atrial or ventricular arrhythmia or congestive heart failure * uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months * severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade
electrical stimulation and expression of vegf, vegfr-2, hif and no in the diabetic foot ulcer

Conditions: Diabetic Foot

Summary: the purpose of this study is to determine whether electrical stimulation is effective in the expression of vegf, vegfr-2, hif-1α and no and healing in diabetic foot ulcer.

30 type 2 diabetic patients with ischemic foot ulceration were enrolled. patients were randomly assigned to electrical stimulation (es, n=15) or sham es (placebo, n=15) groups. es group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). wound fluid sample was collected for vegf, vegfr-2, hif-1α and no measurement in the first and last treatment sessions before and after intervention. wound surface area (wsa) was measured at 1st, 6th, and 12th session.

Eligibility criteria:
inclusion criteria: * ischemic diabetic foot ulcer * wagner classification dfu 2 * 0.5\<abi\<0.9 * mild to moderate diabetic neuropathy exclusion criteria: * fracture in a lower limb * a severe infection * a malignancy * kidney failure * skin diseases * osteomyelitis * pregnancy
precision transcranial magnetic stimulation for patients with post-stress sleep disorders

Conditions: Stress, Psychological; Sleep Initiation and Maintenance Disorders; Transcranial Magnetic Stimulation

Summary: this is a randomized, double-blind controlled study that recruited patients with insomnia problems after suffering a stressful event to undergo individualized transcranial magnetic stimulation

this is a randomized, double-blind controlled study that will recruit patients who have experienced a stressful event and currently exhibit severe sleep problems for transcranial magnetic stimulation. they will be randomly assigned to the trial and control groups and will receive 5 consecutive days of continuous theta-wave stimulation, and before and after the treatment they will be assessed on clinical scales and undergo magnetic resonance examinations as well as sleep monitoring.

Eligibility criteria:
inclusion criteria: 1. be between the ages of 18 and 60 (both 18 and 60) and of any gender; 2. experienced a severe traumatic event; 3. stanford acute stress reaction questionnaire (sasrq) ≥40 points; 4. psqi \> 7 points; 5. good compliance and willingness to undergo this therapy. exclusion criteria: 1. sleep disorders that can be explained by a primary illness; 2. concurrent psychotherapy; 3. those with contraindications to magnetic resonance examination and transcranial magnetic stimulation therapy; 4. combined with serious cardiovascular, hepatic, renal, digestive, hematopoietic system and other primary diseases.
the impact of contraception on postpartum weight loss

Conditions: Weight

Summary: this is a prospective mixed methods study to assess weight changes in women randomized to receive implanon ® or depo provera® (dmpa) immediately postpartum compared to women who choose non-hormonal contraception or no contraception immediately postpartum. after enrollment, subjects return for a visit at 3, 6 and 12 months postpartum to be asked a series of questions, take a pregnancy test, and be weighed. total length of participation for each subject is 1 year or until pregnancy.


Eligibility criteria:
inclusion criteria: * english speaking * aged 18-45 at enrollment (inclusive) * immediately postpartum of a live singleton infant, 37 weeks gestation, at hup * desiring to delay another pregnancy for 6 months * willing and able to follow the study protocol exclusion criteria: * breastfeeding during study participation * plans for relocation outside of philadelphia in the next six months * plans for use of weight loss medication or diet pills in the next six months * women who wish to start implanon ® or dmpa prior to discharge but who do not want to be randomized. 5. issues or concerns in the judgment of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
intra-articular platelet rich plasm use in osteoarthritis of knee.

Conditions: Knee Osteoarthritis

Summary: osteoarthritis of the knee is a very prevalent disease. however, there are few therapeutic options for its patients. platelet-rich plasma is a treatment option for chronic pain. if proven to be effective in its intra-articular use, platelet-rich plasma may help in the treatment of these patients. goal: primary objective: to compare effectiveness in improving pain and function and the medium-term tolerance (12 weeks) of intra-articular injection of platelet-rich plasma versus intraarticular injection of triamcinolone hexacetonide in patients with symptomatic primary knee osteoarthritis. secondary objective: to compare the medium-term effectiveness of intra-articular injection of platelet-rich plasma versus intra-articular injection of triamcinolone hexacetonide to improve synovial hypertrophy and quality of life in these patients. methods: a prospective randomized controlled double-blind study with three groups (each with n = 33) of patients with symptomatic osteoarthritis of knees who will receive intra-articular infiltration in a single moment. patients will be allocated to one of three groups: 1) platelet-rich plasma group: patients who will receive plasma; 2) triamcinolone hexacetonide group: patients who will receive 40mg of triamcinolone hexacetonide; and 3) isotonic saline solution group: patients who will receive isotonic saline solution. the patients will be evaluated by "blind" evaluators in 4 assessment times up to 12 weeks of follow-up through clinical assessment instruments (rest and movement pain, joint edema, goniometry, clinical improvement scale, quality of life questionnaire as the sf36), functional (womac questionnaire, m. lequesne functional knee index, 6 min walk test, time up and go test), and ultrasound test (quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative power doppler). statistics: the following statistical tests will be used according to the need: student's t test, mann-whitney, pearson's chi-square test and anova for repeated measures. a statistical significance of 5% will be considered.


Eligibility criteria:
inclusion criteria: * primary knee osteoarthritis * degree ii and ii in kellgren \& lawrence classification * pain duration: more than three months * pain in the visual analogue scale between 4 and 8cm * agree in participate and sign the consent form exclusion criteria: * secondary knee osteoarthritis * skin lesion in knee * intraarticular joint injection in the previous three months * steroids use in the previous 30 days * degree i or iv in kellgren \& lawrence classification * inflammatory arthritis, gout and pseudo-gout * cancer * previous surgery in knee * cardiovascular and respiratory disease that change functional status * pregnancy and breastfeed * coagulation disturb * bacterial infection * handicapped * nsaids and platelet anticoagulant in the previous month
hospitalised pneumonia with extended treatment (hope) study

Conditions: Pneumonia

Summary: an intervention study to determine if a longer duration of antibiotics (compared to shorter duration) improves the short and long term clinical outcomes of children hospitalised for pneumonia

a multi-centre double-blind randomised controlled trial to determine if a longer duration of amoxicillin-clavulanic acid (compared to shorter duration) improves the short and long term clinical outcomes of children hospitalised with community-acquired pneumonia, in indigenous children and a developing country

Eligibility criteria:
inclusion criteria: 1. hospitalised children aged 3-mo to 5-yrs (in darwin, children have to be indigenous) 2. have features of severe pneumonia on admission (temperature \>37.5 celsius or a history of fever at home or observed at the referring clinic, age-adjusted tachypnoea \[respiratory rate\>50 if \ 40 if \>12-months\] with chest wall recession and/or oxygen saturation \<92% in air), and consolidation on chest x-ray as diagnosed by treating clinician 3. after 1-3 days of iv antibiotics, are afebrile, with improved respiratory symptoms and signs, oxygen saturation\>90% in air and are ready to be switched to oral amoxicillin-clavulanate, and 4. have symptoms of no longer than 7 days at point of hospitalisation. exclusion criteria: 1. current wheeze 2. underlying chronic illness other than asthma (e.g. bronchiectasis, cyanotic congenital heart disease or cardiac failure, neuromuscular disorders, immunodeficiency) that could potentially influence the current illness 3. severe malnutrition (weight-for-height z-score \<-3) 4. complicated (effusion, empyema or abscess) pneumonia, including tuberculosis 5. extra-pulmonary infection requiring antibiotic therapy (e.g. meningitis) 6. beta-lactam allergy 7. previously enrolled 8. lack a mobile phone and/or unable to return for follow-up clinic visits during the next 24 months

Keywords: children anti-bacterial agents indigenous population hospitals
pragmatic impact of proteomic risk stratification in diabetes mellitus

Conditions: Type 2 Diabetes

Summary: single-center, prospective, 2:1 randomized controlled parallel-group study, with an open label extension to evaluate somasignal informed medical management (informed) versus standard of care (uninformed).

primary aim: to determine whether risk stratification from somalogic's cardiovascular risk in type 2 diabetes (cvd-t2d) test leads to riskconcordant changes in prescriptions and/or medical management in patients with diabetes. secondary aims: secondary aim 1: to evaluate the perspectives of healthcare providers on the impact of somalogic's cardiovascular risk in type 2 diabetes (cvd-t2d) test risk calculator in clinical practice. secondary aim 2: to enable future health economic analyses of the impact of precision risk-stratified treatment. secondary aim 3: in an open-label extension, to determine the impact of additional metabolic factor test results (beyond the somasignal cardiovascular risk in type 2 diabetes (cvd-t2d)) on medical management of the previously uninformed group at the end of the study.

Eligibility criteria:
inclusion criteria: * patients receiving care at a university hospitals location * patients 40-89 year of age * diagnosis of type 2 diabetes mellitus * eligible for but not currently prescribed a sglt2i or glp1ra per drug label. this includes a diagnosis of type 2 diabetes plus established atherosclerotic cardiovascular disease or high risk for atherosclerotic cardiovascular disease (including age ≥55 years with coronary, carotid, or lower-extremity atherosclerotic disease) or heart failure or chronic kidney disease with or without albuminuria. * patients that are able to provide consent exclusion criteria: * intolerance or contraindication for use of both glp1ra and sglt2i * use of sglt2i or glp1ra within the 3 months prior to enrollment * history of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening * patients that have systemic lupus erythematous (sle) * end-stage renal disease * pregnancy (as determined by self-report) * inability to understand english (since must be able to understand risk report which is not translated by the manufacturer)
cultural modification of an evidence based healthy lifestyle intervention for people post stroke who identify as hispanic/latino

Conditions: Stroke

Summary: the purpose of this trial is to examine weight loss for hispanic/latino people with stroke (cva) who take part in a healthy lifestyle program that has been culturally modified for hispanic/latino people

weight gain greatly increases the risk of chronic diseases such as diabetes, metabolic syndrome, pulmonary and heart disease. the group lifestyle balance (glb) intervention is a 12-month, evidence-based weight-loss program that has been used extensively with the general population and with people after cva, however, it is not adapted to be linguistically and culturally appropriate for latino persons post stroke. we will modified the program to meet the needs of latino people with a cva (glb-cva latino). aims: 1. : to create a modification of the cdc-recognized, evidence-based glb-cva to be culturally appropriate to meet the unique needs of people who identify as hispanic/latino, available in english and spanish languages, using a community-based participatory research approach and ab of key stakeholders (patients, caregivers, clinicians, researchers). 2. : conduct a single-arm trial to describe the effect of participation in the glb-cva latino on primary and secondary outcomes for 24 individuals who identify as hispanic/latino (12 english speakers and 12 spanish speakers) at 3, 6, and 12 months from baseline. 3. : evaluate the participant compliance (feasibility) and fidelity (adherence to the dpp glb content) with the glb-cva latino intervention.

Eligibility criteria:
inclusion criteria: * bmi ≥25 * identify as hispanic or latino * 18-85 years of age * all types of stroke * medically able to participate in a weight-loss program * physical activity readiness questionnaire + * ≥12 months post first stroke exclusion criteria: * contraindications for physical activity * low cognitive function * residing in hospital, acute rehab, snf * not fluent in english or spanish * pre-existing eating disorder * pregnancy

Keywords: weight-loss stroke group lifestyle balance dietary behaviors physical activity
high fiber in parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of the research is to determine the effects of a high-fiber nutritional supplement (hfs) on the bacteria, viruses, and fungi that live in different regions of the body in those with parkinson's disease (pd). we will compare the bacteria, viruses, and fungi of those with pd to those without pd (healthy controls). we will also examine the effects of transplanting stool from humans into laboratory mice with or without parkinson-like pathology to understand how the microbiome influences the brains of animals. we can use this information to get a better understanding of how changing the microbiome might help humans.


Eligibility criteria:
inclusion criteria: * parkinson's disease patients who are untreated exclusion criteria: * occupation expected to change the microbiome (e.g. sanitation worker) * treatment with medications that may induce parkinsonism (e.g. metoclopramide, typical or atypical antipsychotic agents) * treatment within 12 weeks with oral or intravenous antibiotics * known diagnosis of inflammatory bowel disease * symptomatic organic gastrointestinal (gi) disease (other than hemorrhoids and hiatal hernia) or abdominal surgeries for symptomatic gastrointestinal disease such as bowel resection, diverticular surgery, colostomy; subjects with a history of an appendectomy or gallbladder removal for non-cancerous disease more than 5 years prior to presentation are allowed. * symptomatic functional gi disease that significantly impairs intestinal motility such as scleroderma or use of gi motility drugs * acute illness requiring immediate hospitalization * pre-existent conditions as below: * liver disease (cirrhosis or persistently abnormal ast or alt that are 2x\> normal); * kidney disease (creatinine\>2.0 mg/dl); * uncontrolled psychiatric illness; * clinically important lung disease or heart failure; * hiv disease; * alcoholism, unreliable drinking history; or consumption of alcohol more than 3 times a week or binge drinking or drinking more than or equal to 3 drinks per occasion; * transplant recipients; * diabetes; * bmi \> 30 * clinically significant dehydration or clinically detectable ascites or peripheral edema or cardiac failure * presence of short bowel syndrome or severe malnutrition with ideal body weight \< or = 90% * use of immunosuppressive medications in 3 months prior to enrollment * anti-inflammatory medication use within 3 weeks of enrollment. * chronic use of diuretics