Kornimate/medical-research-clean huggingface dataset:
effect of phytosterols on nonalcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: phytosterols are plant sterols . phytosterols have anti-inflammation effect. investigators have a hypothesis: phytosterols reduce oxidative stress , enhance insulin-like growth factor-1(igf-1) and endothelial progenitor cells(epcs). therefore, phytosterols has novel role in cardiovascular protection.

fatty liver is the hepatic feature of metabolic syndrome. metabolic syndrome increase the risk of atherosclerosis and cardiovascular disease. adipose tissue secrete adipocytes accumulate in the liver result in fatty liver. excess fat become low density lipoprotein-cholesterol(ldl-c) from liver. oxidized- ldl-c adherence in the vessel result in atherosclerosis via inflammation and immune response. phytosterols are present in the nuts, plant oil, broccoli and so on. the structure of phytosterols are similar with cholesterols. after the competition, the smaller absorption of cholesterols. studies showed the average consumptions of phytosterols were 200mg daily but the enough amount for cardiovascular protection of phytosterols were 2000mg daily. daily 2000mg phytosterols inhibit the absorption of intestine, reduce the ldl-c about 7-10%. besides, phytosterols have the effect of anti-inflammation and anti-immune response. the anti-inflammation effect obvious inhibit the monocyte to transform to macrophage, inhibit the formation of foam cell. clinical studies divided into two groups: 20/20 patients and 4 weeks follow up with cross-over test.first group a: phytosterols 1800mg/day for 4 weeks ,washout 2 weeks, then placebo 4 weeks. another group b: placebo 4 weeks, washout 2 weeks, then phytosterols 4 weeks.cross-over, double blind study was designed. investigators check the possible benefits of ldl-c, total -cholesterol,anti-oxidant capacity,c reactive protein,insulin-like growth factor-1, endothelial progenitor cells ; the possible side effect including liver function,muscle enzyme .

Eligibility criteria:
inclusion criteria: * (1)25-80 years * (2)fatty liver was diagnosed by abdominal echo by the same gastrologist, review by another gastrologist exclusion criteria: * (1)serological markers of hepatitis b virus(hepatitis b surface antigen and anti-hbs antibody) and hepatitis c virus infection (anti-hcv antibody) * (2)autoimmune liver disease or alcoholic liver disease(alcohol intake more than 20g per day by using a questionnaire) * (3)malignant diseases * (4)pregnancy or breast feeding * (5)clinical evidence of angina, congestive heart failure, valvular heart disease, inflammatory disease or thyroid dysfunction

Keywords: phytosterols endothelial progenitor cells
evaluation of the safety and immunogenicity of the recombinant subunit vaccine "gamtbvac" against the tuberculosis.

Conditions: Tuberculosis

Summary: the study is aimed to evaluate the safety and immunogenicity of the medicinal product "gamtbvac" - a recombinant subunit vaccine against the tuberculosis. the study is designed as a comparative placebo-controlled study with a two-fold increase of an applied dose among healthy volunteers aged 18-49 years.

the clinical trial study of the "gamtbvac" vaccine against the tuberculosis is a comparative placebo-controlled study with a two-fold increase of an applied dose among healthy volunteers aged 18-49 years. the product "gamtbvac" is a lyophilized substance consisted of the purified recombinant subunit antigens of mycobacterium tuberculosis, that is applied for the preparing of the solution for a subcutaneous administration. currently the study is at the first phase. the aims of the study are: a) to confirm the safety of the product in the healthy volunteers; b) to select the optimal administration dose; c) to evaluate of the immunogenicity of the vaccine; d) to investigate the immune cell memory as a response to the vaccination. the total number of the volunteers in the study is 60: 1. at the first stage to estimate the safety and portable of the vaccine, two groups of volunteers each includes 12 persons got the single decreased dose (0.25 of the planned dose for regular administration) of the vaccine (the first group, 12 persons), and the 0.5 ml of the placebo (the second group, 12 persons); 2. at the second stage to select the optimal dose and the scheme of the vaccine administration, additionally three groups, each consist of 12 persons of volunteers will be recruited. the first group will get double vaccination of a decreased dose (0.25 of the regular dose), the second group will get the double vaccination of a mean dose (0.5 of the regular dose), and the third one will get the double vaccination of the maximum (1.0 regular) dose. the inclusion criteria for the volunteers of the study are: healthy males either females aged 18-49 years who have previously got the bcg vaccine. the exclusion criterion is the presence of the latent tuberculosis in the patient that is confirmed during the preliminary laboratory screening.

Eligibility criteria:
inclusion criteria: * lack of the latent tuberculosis, laboratory confirmed * bcg vaccination in the past * signed informed consent exclusion criteria: * presence of the latent tuberculosis, laboratory confirmed

Keywords: tuberculosis recombinant vaccine mycobacterium tuberculosis
fixed low-dose eltrombopag and rhtpo for immune thrombocytopenia (flower)

Conditions: Immune Thrombocytopenia

Summary: this is a prospective, single-arm study to investigate the efficacy and safety of the combination of fixed low-dose eltrombopag plus recombinant human thrombopoietin (rhtpo) as treatment for corticosteroid-resistant or relapsed immune thrombocytopenia (itp) patients during the covid-19 pandemic.

eltrombopag, a small molecule agonist of thrombopoietin receptor (tpo-ra), was recommended as the subsequent treatment for itp patients, which also already showed robust efficacy.recombinant human thrombopoietin (rhtpo) is a full-length glycosylated-tpo produced by chinese hamster ovary cells, which showed its effectiveness in itp in a variety of studies. both eltrombopag and rhtpo demonstrated good safety in itp patients. because of their non-immunosuppressive nature, both of them serve as a reasonable choice during the global covid-19 pandemic. since they increase the number of platelets through different mechanisms, and previous studies demonstrated that they might exert synergic effect. the investigators hypothesized that the combination of these two agents could be a promising option for treatment of corticosteroid-resistant or relapsed itp patients.

Eligibility criteria:
inclusion criteria: 1. clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenic purpura (itp) 2. subject has signed and provided written informed consent. 3. fertile patients must use effective contraception during treatment and observational period 4. negative pregnancy test exclusion criteria: 1. have an impaired renal function as indicated by a serum creatinine level \> 2.0 mg/dl 2. have an inadequate liver function as indicated by a total bilirubin level \> 2.0 mg/dl and/or an aspartate aminotransaminase or alanine aminotransferase level \> 3×upper limit of normal 3. have a new york heart classification iii or iv heart disease 4. have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures 5. have active hepatitis b or hepatitis c infection 6. have a hiv infection 7. have active infection requiring antibiotic therapy within 7 days prior to study entry 8. are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug 9. previous splenectomy 10. had previous or concomitant malignant disease 11. not willing to participate in the study. 12. expected survival of \< 2 years 13. intolerant to murine antibodies 14. immunosuppressive treatment within the last 2 weeks 15. connective tissue disease 16. autoimmune hemolytic anemia 17. patients currently involved in another clinical trial with evaluation of drug treatment

Keywords: corticosteroid-resistant or relapsed itp eltrombopag recombinant human thrombopoietin (rhtpo)
developments of novel virtual visual and haptic stimulation systems for the elderly

Conditions: Healthy Elderly; Alzheimer Disease

Summary: previous studies indicated that sensory input can have positive impacts on finger force control in the elderly. additionally, according to previous reports, apart from pharmacotherapy, nonpharmacologic interventions, such as psychosocial-environmental treatments, are emerging for the behavior and affective symptoms in ad . moreover, enhanced finger force control and coordination lead to better hand dexterity and is believed to eventually improve life independence in the healthy elderly and the elderly with ad. therefore, this study aims to develop novel virtual visual and haptic stimulation systems for the elderly to enhance their finger force control.


Eligibility criteria:
healthy elderly inclusion criteria: * aged ≥ 65 * healthy adult (no skeletal muscle, neurological disease that will affect training). exclusion criteria: * neurological disorders * musculoskeletal problems * history of surgery patients with alzheimer's disease inclusion criteria: * diagnosed with alzheimer's disease. * no skeletal muscle, neurological disease that will affect training.

Keywords: pressing evaluation and training system virtual reality augmented reality
intraoperative radiographic detection of retained surgical sponges

Conditions: Surgical Sponge, Retained

Summary: this prospective study will determine the efficacy of intraoperative x-ray to identify retained surgical sponges. the recommended practice for finding a retained sponge is by radiography. the purpose is to find out how useful plain x-rays are in open posterior lumbar spine surgery, information which is presently unavailable. the specific aim is to compare the sensitivity (seeing a sponge when one is actually present) and specificity (not seeing a sponge when one is not present) of radiography of the surgical field for three conditions: viewing one lateral radiograph versus viewing one anteroposterior radiograph versus viewing two radiographs together, one lateral and one anteroposterior.

this is a prospective, randomized study with two cohorts: one experimental and one control. anteroposterior (ap) and lateral (lat) radiographs are routinely obtained as standard of care during spine surgery to confirm proper implant placement. these images will be used in this study. in one-half of the study subjects, after all sponges are removed, a surgical sponge will be intentionally placed in the surgical field prior to imaging. postoperatively, each subject's images will be assessed for the presence or absence of a retained surgical sponge. images will be independently read by two investigators. when there is discordance, the images will be adjudicated by a third. interobserver agreement will be quantified using the kappa statistic. those reading images will not have participated in the surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing open posterior instrumented lumbar spine surgery. * read and understand english. exclusion criteria: * pregnancy. * patients who do not consent to research. * patients less than 18 years old at the time of consent. * do not read and understand english.

Keywords: lumbar spine surgery radiographic imaging
the effect of the safe and sound protocol on depression and anxiety symptoms

Conditions: Anxiety; Depression

Summary: the goal of this study is to determine if a developed protocol involving modulated auditory stimulation is better than non-modulated auditory stimulation in reducing anxiety and depression in human subjects.

a protocol has been developed that provides patients an intervention of listening to specifically designed filtered and modulated music that stimulates the part of the nervous system that induces a calm physiological (bodily) state. this enhancement may help re-establish nerve pathways between auditory processing and emotional regulation systems which promotes improved emotional regulation in regards to depression and anxiety. for this study, participants will either be assigned to the active group who receives the therapy with auditory stimulation that is modulated, or be assigned to the control group who will receive the same interventions without the modulated auditory stimuli.

Eligibility criteria:
inclusion criteria: * client of daybridge * 18 years old or older * meet the dms-v diagnostic criteria of major depressive disorder and/or generalized anxiety disorder exclusion criteria: * previous participation in the ssp * self-reported hearing loss

Keywords: auditory sound
reduced radiation in patients with diffuse large b-cell lymphoma

Conditions: Diffuse Large B-cell Lymphoma

Summary: this study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity. hypothesis- the radiation dose and treatment volume can be safely reduced from 30 gy to 20 gy while maintaining high rates of local control in patients who had a negative pet scan following rituximab-containing chemotherapy.


Eligibility criteria:
inclusion criteria: * histologic documentation of diffuse large b-cell lymphoma, or any of its variants as defined in the who classification * completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy * negative post-chemotherapy (or interim) pet scan * absolute neutrophil count greater than 1500 and platelet count greater than 40,000 * negative pregnancy test in women of child-bearing potential for patients with hiv/aids, the following must be true: * the patient is compliant on combination anti-retroviral therapy (cart) * the patient has cd4 count ≥ 200 at time of diagnosis exclusion criteria: * any contraindications to irradiation * primary cns lymphoma * hiv/aids
evaluating the feasibility of point of care birth testing in eswatini

Conditions: HIV Infections; HIV/AIDS; Pediatric HIV Infection; Transmission, Perinatal Infection; Infant Morbidity; Neonatal Infection

Summary: this study aims to assess the feasibility and utility of birth testing using point-of-care (poc) testing in maternity settings in eswatini.

this unitaid-funded study aims to assess feasibility and utility of birth testing, \[early infant diagnosis for hiv, (eid)\], using point-of-care (poc) hiv nucleic acid testing (nat) at high volume maternity settings. birth testing is defined as tests within 3 days of life. outcome measures will include age at testing, turnaround time from testing to caregiver result receipt, hiv positivity rate, and timing of anti-retroviral therapy (art) initiation for hiv-positive infants. the study will document retention in care for those who tested positive at birth, and the percent of those who tested negative at birth who returned for six week testing. the study will also assess the feasibility and acceptability of poc birth testing using interviews with policymakers, health care workers and caregivers of hiv-exposed infants (hei).

Eligibility criteria:
inclusion criteria: * hiv exposed infants * must have been newly born at the study sites or presenting in study sites within 3 days after birth * tested for hiv using poc eid platform (mother or caregiver agreed to have infant tested) * health care workers (hcws) * hcws who have used poc eid for at least three months, at project sites * hcws that work directly with poc eid services at maternity providing clinical services or operating the platform * hcws who consent to be interviewed * hcws able to speak one of the study languages * laboratory managers and program leads/focal persons: * national or regional level manager or head of department whose responsibilities include eid * member of a national technical working group or advisory board member working on eid * national level representative from the moh * laboratory managers in the 3 study sites * participants 18 years and above who consent to be interviewed * mothers/caregivers: * mother/caregiver of an hei who was offered poc eid at birth * provides consent to participate in the study * is 18 years or older, or is less than 18 years old but is legally married (and thus legally emancipated) * speaks one of the study languages exclusion criteria: * heis: * hei tested for hiv using conventional eid at projects sites * hei whose caregivers refuse birth testing * hei where the clinician deems there is a contra-indication for sample collection for birth testing (e.g. severe hemophilia) * hcws: * hcws who work within project sites that do not make use of eid (i.e. hcws who are not involved directly with eid) * hcws working in non-project sites * hcws who are unable to consent or do not speak a study language * laboratory managers and program leads/focal persons: * inability to give consent * inability to speak study language * mothers/caregivers: * not eligible for poc birth testing services * not able to consent * does not speak english or siswati

Keywords: hiv poc eid pediatrics
canadian real-world outcomes of omnipod initiation in people with t1d

Conditions: Diabetes Mellitus, Type 1

Summary: the current study aims to assess clinical outcomes in adults with type 1 diabetes (t1d) who have switched from traditional multiple daily injection (mdi) therapy to continuous subcutaneous insulin infusion (csii) therapy with the omnipod insulin system.

poor glycemic control is associated with increased risk of diabetes-related complications in persons with type 1 diabetes (t1d). despite advancements in insulin therapies and an increase in diabetes technology use, only 21% of adults with t1d are meeting their targeted glycated hemoglobin (a1c) levels. the omnipod insulin system is a patch pump that consists of a handheld controller and disposable pod that delivers insulin. a retrospective analysis of medical records in the united states found that there was a significant reduction in a1c three months after initiating omnipod in pediatric, adolescent and adult populations with t1d who switched from either mdi or traditional csii. currently, the real-world effectiveness of the omnipod compared to mdi in adults with t1d on glycemic control, weight, and insulin dose, is not established. the canadian real-world outcomes of omnipod initiation in people with t1d: evidence from the lmc diabetes registry (copper) study is a retrospective, observational study using demographic and clinical data from the lmc diabetes registry, which consists of over 42,000 active patients with diabetes across 3 canadian provinces. the overall objectives of this study are to assess clinical outcomes in adults with t1d who switch from mdi to csii therapy with omnipod, and to compare clinical outcomes in the omnipod cohort to a matched cohort of mdi users.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of t1d ≥ 12 months prior to initiating the omnipod * age ≥ 18 years * switched from mdi to omnipod (omnipod cohort) * persistent with omnipod treatment for ≥ six months * no change in basal insulin type or bolus insulin type between baseline and follow up (matched mdi cohort) * ≥ one a1c measurement during the baseline and follow-up period exclusion criteria: * switched from traditional csii to omnipod * use of non-insulin diabetes therapies

Keywords: diabetes observational study glycemic control insulin pumps
transient receptor potential vanilloid one (trpv1) receptor expression in children with retrosternal pain

Conditions: Epigastric Pain; Retrosternal Pain; Esophagitis; Gastrointestinal Symptoms

Summary: we would like to evaluate the changes in nerve innervation and trpv1 receptor expression along with microscopic changes associated with heart burn and abdominal pain

approximately 5% of children between 10-17 years of age report symptoms of heart burn, epigastric pain or regurgitation. this study will evaluate the changes in nerve innervation and trpv1 receptor expression in children having upper endoscopy for evaluation of heart burn and abdominal pain.

Eligibility criteria:
inclusion criteria: * retrosternal and/or epigastric pain and esophagitis * retrosternal and/or epigastric pain but no macroscopic or microscopic esophagitis * gastrointestinal symptoms such as diarrhea, regurgitation, rumination, vomiting, feeding aversion, non-organic failure to thrive, celiac disease with no macroscopic or microscopic esophageal inflammation

Keywords: trpv1 nerve growth factor capsaicin trka retrosternal pain epigastric pain esophagitis gastrointestinal symptoms
self-control trial to evaluate the role of aprepitant in the prophylaxis of post-lumbar-punture-headache (plph)

Conditions: Leukemia; Lymphoma

Summary: headache following a lumbar puncture （post-lumbar-puncture headache,plph）is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. now there lacks of effective approaches in the prophylaxis of plph, although some physicians consider bed rest for at least 6 hours to be a useful methods (some recent meta-analysis found no benefit of bed rest for any hours in the prevention of plph). studies have found that p substances and its receptor (neurokinin-1 receptor, nk-1r)have played an important role in the pathogenesis of plph. thus, we hypothesize that use of nk-1r inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of plph and lower the severity of plph.

headache following a lumbar puncture （post-lumbar-puncture headache,plph）is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. now there lacks of effective approaches in the prophylaxis of plph, although some physicians consider bed rest for at least 6 hours to be a useful methods (some recent meta-analysis found no benefit of bed rest for any hours in the prevention of plph). studies have found that p substances and its receptor (neurokinin-1 receptor, nk-1r)have played an important role in the pathogenesis of plph. thus, we hypothesize that use of nk-1r inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of plph and lower the severity of plph.

Eligibility criteria:
inclusion criteria: * patients diagnosed as acute leukemia, or lymphoma * patients will received repeated lumbar puncture (at least 2 times, and at least 2 weeks apart) and intrathecal treatment * without cns involvement * without headache for at least 1 week before the day of lumbar puncture * the platelet count was at least 30×10e9/l exclusion criteria: * with cns involvement of disease * with headache before lumbar puncture * needs lumbar puncture more than once a week

Keywords: leukemia lymphoma lumbar puncture intrathecal treatment post-lumbar puncture headache