Kornimate/medical-research-clean huggingface dataset:
study of antiretroviral therapy to prevent hbv intrauterine infection

Conditions: Hepatitis B, Chronic

Summary: 500 pregnant patients with hbeag-positive and hbv-dna≥ 106copies /ml who will do their pregnant check in the first affiliated hospital of xi'an jiaotong university will be enrolled into the study. there will be five groups to be observed. four groups are taking tenofovir to prevent intrauterine infection during pregnancy. one group is not taking any anti-hbv virus treatments.the clinical value and effectiveness of tenofovir on blocking hbv intrauterine infection will be evaluated; the hbv-dna infection status of placenta tissue will be checked by quantitative polymerase chain reaction (pcr) to assess the changes of hbv-dna of placenta after treating with tenofovir and explore the mechanism of tenofovir blocking hbv intrauterine infection. the safety of tenofovir will be assessed as well.


Eligibility criteria:
inclusion criteria: * pregnancy patients with hbeag-positive and hbv-dna≥ 106copies /ml exclusion criteria: * pregnancy patients with hbeag-negative or hbv-dna\<106copies /ml

Keywords: vertical infection transmission tenofovir
phase iv interchangeability study of a liquid pentavalent combination vaccine

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B

Summary: the objective of this study is to compare the safety and immunogenicity of a mixed sequence of 2 different pentavalent vaccines (diphtheria-tetanus- pertussis, hepatitis b and hib combination vaccines) with single sequence of shan 5 in infants.


Eligibility criteria:
inclusion criteria: * healthy children in the age group six to eight weeks * born after a normal gestational period (36 - 42 weeks) * mother's hbsag assured negative. * father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. * parents willing to fill the diary card exclusion criteria: * administration of immunoglobulin or any blood products since birth. * use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of opv \& bcg vaccine) during the study period or within 30 days preceding the first dose of the study vaccine. * previous vaccination or evidence of infection with dtp or hib. * history of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics. * major congenital or hereditary immunodeficiency. * infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a cns disorder at the time of vaccination. * infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction. * parent/s or guardian of subject unable to maintain diary card * simultaneous participation in any other clinical study

Keywords: vaccine prevention diphtheria tetanus pertussis hepatitis b haemophilus influenzae type b vaccine interchangeability single vs mixed sequence healthy infants
cytokines polymorphisms and acetaminophen toxicity

Conditions: Drug Toxicity

Summary: genotyping assays for polymorphisms in the interleukin 10(il10)gene and the inducible nitric oxide synthase (inos) gene will be performed. genotypes will be compared to the severity of toxicity following overdose.

it was recently reported that il-10 is protective in acetaminophen (apap) toxicity and it down-regulates inos production. in an ongoing pediatric pharmacology research unit (ppru) network study, plasma il-10 levels were higher in patients that developed significant toxicity, as compared to those with minimal hepatic transaminase elevations. in these patients il-10 elevation is likely a compensatory response to hepatic injury. to further examine the relationship of il-10 and inos in the apap overdose patients, we will examine genetic variability in the promotor regions of inos and il-10 in patients with apap overdose. data from the literature indicate the polymorphisms in the promotor regions of inos and il-10 influence the severity and expression of various diseases. in addition to genotyping for inos and il10 promotor region polymorphisms, plasma levels of nitrotyrosine and il-10 will be measured in overdose patients. blood samples will be obtained from study patients for the analysis of inflammatory cytokines and nitrotyrosine. blood samples will be obtained at the time of blood sampling for the routine clinical management of the apap overdose patient. patients who are hospitalized will have study blood samples drawn at the time daily blood samples are obtained. the sampling will continue daily until the patient is discharged. in addition to blood sampling the following data will be collected: age, gender, race, circumstances of the ingestion, dose of the ingestion, treatment for the ingestion, concomitant therapy, medical history and cigarette use.

Eligibility criteria:
inclusion criteria: * males and females of any age admitted to a participating site for acetaminophen overdose (acute or chronic). exclusion criteria: * patients who are unable to tolerate study procedures.

Keywords: acetaminophen toxicity liver damage tylenol overdose
emergency department discharge for type ii supracondylar fractures - prospr phase 5

Conditions: Supracondylar Fracture

Summary: the knowledge that patients will not suffer untreated pain at home is central to managing supracondylar fracture (scf) patients on an outpatient basis at a time of limited healthcare resources. the investigators hypothesize that children with uncomplicated type ii supracondylar fractures (scf) can be sent home from the emergency department (ed) in a temporary cast, and that fracture pain can be safely managed opioid-free at home both before and after surgical repair. the investigators further hypothesize that managing such patients on an ambulatory out-patient basis will increase hospital-bed availability without compromising surgical outcomes.

since january 2020, some 1050 admission-days have been accountable to type ii scf with a mean stay of 1.2 days (sd 0.52) in this institution. however, some patients spend more than 48-hours in-house awaiting surgery, often with two periods of fasting greater than 8-hours imposed, due to competing interests with higher priority cases on the or's shared add-on board. these patients occupy a hospital bed at a time when resources are severely depleted. the covid pandemic has enforced many stressors on healthcare across ontario and one mitigation for same was the diversion of pediatric admissions from surrounding community hospitals to hsc to create 'extra beds' for acute adult admissions in the community. this diversion has imposed significant bed-demands on hsc and with covid-related admission rates in the community decreasing it has proved difficult to re-route routine pediatric admissions (such as scf) to the community. this institution's pediatric intensive care unit (picu) has been operating above capacity for some time now leading to 'controlled slowdowns' in elective operative procedures, resulting in months of cancellation of some 40-75% of elective pediatric surgery. this institution's prospr program delivered standardization of opioid prescribing at hospital discharge post pediatric scf repair. since 2021 the investigators decreased overprescribing of opioids to scf patients at hospital discharge to the tune of 360%. this work has also created pathways for safe return and disposal which decreased mme amount of opioid lost to follow-up in the community by over 500%. the investigators also demonstrated that home consumption of morphine is so low that it is feasible to completely remove opioid prescribing from pediatric scf discharge planning which opens the possibility of managing surgical scheduling on an out-patient basis whererby families will derive increased satisfaction from being able to wait at home for surgery.

Eligibility criteria:
inclusion criteria: * requiring surgery for type ii supracondylar fracture exclusion criteria: * none
trial evaluating maintenance chemotherapy for metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. participants will be randomized to 3 arms. arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.

this is a phase 3 randomized clinical trial to determine the efficacy of maintenance chemotherapy for the treatment of metastatic chemotherapy and how it should be delivered. participants will be randomized to 3 arms. arm 1 (control group), participants will receive only conventional chemotherapy; arm 2 (experimental group), participants will receive up to 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3 (experimental group), after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities. participants in all 3 arms will receive similar conventional chemotherapy. four to eight cycles of conventional chemotherapy with platinum-based regimen is preferred. maintenance chemotherapy should use one of the regimens: s1 (40mg, twice a day for 14 days, every 3 weeks), capecitabine (1000mg/m\^2, twice a day for 14 days, every 3 weeks) or tegafur-uracil (100mg/m\^2, q8h, for 14 days, every 3 weeks). the response of treatment will be evaluated according to recist criteria. adverse events will be documented according to ctcae v4.03.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 70 years * histologically confirmed nasopharyngeal carcinoma, who (world health organization) classification ii/iii * with distant metastasis * with measurable lesions that can be detected by imaging studies * achieving pr (partial response) after 4 cycles of conventional chemotherapy * life expectancy ≥ 6 months * ecog (eastern cooperative oncology group): 0-1, no significant active concurrent medical illnesses * adequate laboratory values within 30 dyas of enrollment to study defined as follows: n \> 2000/mm\^3; plt (platelet count) \> 100,000/mm\^3; total bilirubin \ 60ml/min * willing to accept adequate contraception for women with childbearing potential * ability to understand character and individual consequences of the clinical trial * willing to sign the written informed consent; informed consent must be signed before the enrollment in the trial exclusion criteria: * received previous treatment for metastatic disease * pregnant or lactating women * a diagnosis of malignancy other than cis (carcinoma in situ) of the cervix, bcc (basal cell carcinoma) and scc (squamous cell carcinoma) of the skin within the past 5 years * refusal of the patient to participate into the study

Keywords: maintenance chemotherapy
mode of drainage of bilaterally obstructed kidneys

Conditions: Obstructive Nephropathy

Summary: bilaterally obstructed kidneys could be caused by benign or malignant causes it could lead to renal failure which can be avoided by urgent drainage either by pcn or dj , the aim is to determine whether unilateral or bilateral drainage make a difference in improvement of renal function of bilaterally obstructed kidneys and whether that improvement relays on the cause of the obstruction. the investigators will do that by doing a prospective comparative study on patients presented to our department by bilaterally obstructed kidneys , by either benign or malignant causes , with high serum chemistry. intervention to this cases will be done by inserting jj or pcn either unilateral or bilateral depending upon lab workups , our staff decision and patients fittness and agreement .

kidney obstruction means obstruction of urinary flow with back pressure on the kidney, which may be unilateral or bilateral, may have many causes either benign e.g; urolithiasis, retroperitoneal fibrosis, renal papillary necrosis or malignant e.g; urinary tract tumors as bladder cancer and prostate cancer, or extrinsic tumor as cervical cancer(5) , lymphoma or other pelvic tumors when kidney obstruction occurs bilaterally this raises serum chemistry and may lead to post-renal aki which represents about (1-10%) of all causes of aki. post-renal aki is an emergency case that requires an urgent and minimally invasive procedure to drain the urine either by pcn or ureteric stents. there has been always a debate about which one is better to drain the obstructed kidneys percutaneous nephrostomy or ureteric stents and which is better in improvement of renal function and with less effect on life style . also the mode of drainage of the obstructed kidneys, bilateral or unilateral, also has been a point of debate. unless bilateral renal obstruction is due to benign or treatable malignant cause, unilateral nephrostomy is always the rule according to some authors . some authors, reported better improvement in renal function with bilateral pcn with pelvic tumors the investigators will do prospective comparative study for studying mode and laterality of drainage in benign and malignant causes in bilaterally obstructed kidneys .

Eligibility criteria:
inclusion criteria: 1. adult patients ( \>18 yrs ) with bilateral obstructed kidneys 2. bilateral obstructed kidneys due to benign causes 3. bilateral obstructed kidneys due to malignant causes 4. bilateral obstructed kidneys with high serum creatinine exclusion criteria: 1. age \< 18 yrs 2. bilateral obstructed kidneys with normal serum creatinine 3. patients with chronic kidney disease 4. vesicoureteric reflux 5. severe comorbidity preventing intervention
prevention of infections in cardiac surgery (pics): a cluster-randomized factorial cross-over trial

Conditions: Infection, Surgical Site

Summary: the goal of this pragmatic, multi-centre factorial cluster randomized cross-over trial is to assess the efficacy of a combination of cefazolin plus vancomycin compared to cefazolin monotherapy, as well as a comparison of short versus long-term prophylaxis with four study arms: 1) cefazolin short-term, 2) cefazolin long-term, 3) cefazolin plus vancomycin short-term and 4) cefazolin plus vancomycin long-term.

although antibiotic prophylaxis is considered the cornerstone of prevention for sternal surgical site infections (s-ssis), the most effective antimicrobial regimen and optimal duration remain unclear. there is a pressing need to determine how best to prevent sternal surgical site infections and at the same time reduce adverse events from unnecessary antibiotic exposure. currently, due to the lack of evidence, unproven approaches prevail and adherence to guidelines is poor. rigorous randomized controlled trials data are needed for improved patient care. a factorial cluster randomized cross-over trial, a design not used previously in this field, will address these gaps. to date, we have successfully enrolled close to 6,000 eligible patients in the vanguard study, and have shown that the trial as planned is feasible and operationally highly cost-effective.

Eligibility criteria:
inclusion criteria: adult patients (≥18 years of age) undergoing open-heart surgery (i.e. sternotomy, including minimally-invasive surgical techniques through mini-sternotomies) exclusion criteria: 1. on systemic antibiotics or with an active bacterial infection at the time of surgery 2. previously enrolled in this trial 3. known to be colonized with methicillin-resistant staphylococcus aureus (mrsa). where it is unethical to not administer glycopeptides. 4. beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively 5. participation in other studies that may interfere with this trial. 6. patients undergoing cardiac transplant
safety and efficacy study of ljp 394 (abetimus sodium) to treat lupus kidney disease

Conditions: Immunologic Diseases; Autoimmune Diseases; Systemic Lupus Erythematosus; Lupus Nephritis; Lupus Glomerulonephritis

Summary: the purpose of this study is to determine whether ljp 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.

ljp 394 (abetimus sodium) is a unique drug that is specifically designed to lower production of antibodies to double-stranded dna. these antibodies are believed to contribute to kidney damage in patients with systemic lupus erythematosus (sle). rising levels of these antibodies seem to be associated with exacerbations of kidney disease that are known as "renal flares." currently, anti-inflammatory and cytotoxic drugs are used to treat renal flares. unfortunately, these drugs are often associated with certain unpleasant side effects. the purpose of this trial is to determine whether ljp 394 can delay or reduce the number of renal flares. it is possible that if renal flares can be delayed or reduced, patients may be able to take smaller amounts of anti-inflammatory or cytotoxic drugs and therefore suffer fewer of the side effects associated with these treatments.

Eligibility criteria:
inclusion criteria * diagnosed with sle * historical evidence of sle renal disease * elevated levels of dsdna antibodies * weight of 40 kg or greater exclusion criteria * active sle renal disease * use of certain anti-inflammatory or cytotoxic therapies or therapeutic interventions during the months immediately before dosing * clinical laboratory test values outside of certain limits * malignant disease or immunodeficiency syndrome * acute or chronic infections * history of serious heart disease

Keywords: immunologic diseases autoimmune diseases systemic lupus erythematosus sle lupus nephritis lupus glomerulonephritis
smartcloth. design, implementation and study of the effectiveness and usability of a digital tablecloth for self-management of diet in diabetic patients.

Conditions: Diabetes Mellitus Type 2; Diabetes Mellitus Type 1

Summary: the objective of this clinical trial is to know the usability and efficacy of smartcloth for better control and adherence to the dietary patterns recommended to patients with diabetes, both the portion diet system (more common for cases of diabetes mellitus type 1 -dm1-), and the plate method (more recommended in cases of diabetes mellitus type 2-dm2-). the main questions are: * does the use of smartcloth improve glycemic control in patients with diabetes mellitus? * do patients with diabetes mellitus find smartcloth useful in their daily lives? the researchers will compare changes over 3 months in variables related to glycemic control in two groups, one using smartcloth (intervention group) and the other following standard recommendations (control group). to do so, participants will have to: * use smartcloth for 3 months or follow the recommendations they receive from their referring health professionals. * come back after three months for a check-up of the chosen variables. * the experimental group should contact the investigators in case the hardware has any problems.


Eligibility criteria:
inclusion criteria: subjects with type 1 and 2 diabetes (eligible population) aged between 18 and 70 years with disease progression not exceeding 15 years and hba1c greater than 7.5. exclusion criteria: * degree of dependence (physical or psychological) that makes it impossible for them to perform autonomous self-care of the dietary-nutritional regimen. * oncological or autoimmune disease, chronic renal insufficiency, transplant patients and others that alter the values of the result variables or may constitute a confounding factor. * other diseases that entail surgical interventions or hospital admissions that make it impossible to follow up the study. * patients with complications due to the evolution of the diabetic pathology: retinopathy, nephropathy, polyneuropathy, ischemic heart disease, as well as other micro and macrovascular complications derived from the same and already recorded in the patient. * those subjects subjected to specific dietary regimes such as celiac disease, lactose intolerant, etc.
modifiers of tenofovir in the female genital tract

Conditions: HIV/AIDS; Contraception

Summary: two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on depo-provera contraception vs non-hormonal contraception.


Eligibility criteria:
inclusion criteria: * female, or transgender female with a cervix, aged 18-35 years old * hiv-positive * stable on antiretroviral regimen containing tdf for at least 2 weeks at time of enrollment. * virally suppressed (hiv-rna copies \<50 copies/ml) for at least 6 months at time of enrollment. * willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit. * willing and able to give signed informed consent. exclusion criteria: * currently pregnant or previous pregnancy within 3 months of enrollment * currently breast feeding * symptomatic vaginal infection within 2 weeks prior to enrollment * unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment * history of vulvar/vaginal/ cervical dysplasia, neoplasia or cancer, atypical squamous cells of undetermined significance, condyloma, or human papilloma virus (hpv) in the past year * use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to the enrollment visit

Keywords: tenofovir microbiome inflammation
an exploratory study investigating safety, tolerability and pharmacokinetics of ascending doses of lu ae04621 in parkinson disease patients

Conditions: Parkinson Disease

Summary: to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the lu ae04621 and metabolite after ascending oral doses of lu ae04621 in patients with parkinson's disease.

the study comprised 5 cohorts (cohorts 1 to 5), with each cohort consisting of 3 patients with parkinson's disease (men and/or women). each patient will be treated for 3 or 4 days, with increasing dose each day. dosing regimen will be decided at a dosing conferences. dose levels can be increased, maintained or reduced both between cohorts but also within same cohort. the results are presented by dose level and reflect the actual doses administered. a follow-up safety visit was scheduled approximately 7 days after the last dose of imp.

Eligibility criteria:
inclusion criteria: * the patient is diagnosed with idiopathic parkinson disease (consistent with the uk parkinson's disease society brain bank criteria for the diagnosis of pd). * the patient's hoehn and yahr staging score is ≤ 3 in the "on" state. * the patient experiences motor fluctuations with at least 2.5 hours of "off" periods in the awake time and has predictable morning "off" episodes, which have been consistent within the past 4 weeks. * the patient currently has a good response to l-dopa and has been receiving a stable dose of l-dopa (≥3 doses per day of standard l-dopa or ≥3 doses per day of carbidopa and l-dopa, extended-release capsules) during at least four weeks prior to screening. exclusion criteria: * the patient has cognitive impairment, defined as a mini mental state examination(mmse) score ≤ 26 at the screening visit. * the patient has severe disabling dyskinesia * the patient takes or has taken disallowed recent or concomitant medication (cyp2d6 inhibitors, cyp 3a4 substrate, dopamine agonists, 5 ht3 antagonists, anti-viral (amantadine)) other protocol defined inclusion and exclusion criteria may apply