Kornimate/medical-research-clean huggingface dataset:
lipiodol as an imaging biomarker in patients with primary and metastatic liver cancer

Conditions: Liver Cancer

Summary: the purpose of this study is to determine the whether lipiodol can be used as an imaging biomarker, predicting tumor response to therapy in patients with primary and metastatic liver cancer. lipiodol-based transarterial chemoembolization (tace) has been an accepted standard of care procedure for unresectable liver lesions for several decades. lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. in tace procedures, lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). response to therapy will be evaluated every 1, 3 and 6 months by clinic visits, mri/ct/pet scans and blood tests (to include assessment of liver function and tumor markers).


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older. 2. eastern cooperative oncology group (ecog) performance status of 0-2. 3. childs class of a or b (up to 9). 4. hepatocellular carcinoma (hcc) is unresectable with liver-predominant disease or subject has hcc and refused surgery or subject is diagnosed hepatic metastases from any solid tumor. (multifocal hcc is acceptable, no diffuse hcc). 5. subject is voluntarily participating in the study and has signed the informed consent. exclusion criteria: 1. contraindications to doxorubicin, cisplatin, or mytomycin-c administration (or specific mixture of chemotherapy drugs to be used). 2. evidence of severe or uncontrolled systemic diseases. 3. congestive cardiac failure \>nyha class 2 mi within 6 months, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, unstable angina, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial. 4. known allergy to lipiodol (ethiodol), poppy seed oil, or iodinated contrast agents (that cannot be adequately mitigated with pre-procedure medication). 5. main portal vein thrombosis is excluded; segmental or branch portal vein thrombosis is acceptable. 6. subject is breastfeeding. 7. subject is pregnant

Keywords: primary liver cancer metastatic liver cancer
study of sp059 given subcutaneously as a three-dose primary and booster vaccination in infants in japan

Conditions: Poliomyelitis; Polio

Summary: the aim of the study is to assess the immunogenicity and safety of sp059 as a three-dose primary and booster vaccination in japanese infants aged 3 through 68 months. primary objective: * to assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (ipv). secondary objective: * to describe the immunogenicity (in terms of seroprotection / seroconversion vaccine response rates and geometric mean titers) of ipv before and after the primary vaccination and before and after the booster vaccination. * to describe the safety after each dose of ipv.

study participants will receive three doses of inactivated polio vaccine (ipv) (at each visit and given 3-8 weeks apart) as a three-dose primary vaccination starting at 3-68 months of age and followed by a single dose of ipv as a booster vaccination 6-18 months after completion of the three-dose primary vaccination. subjects will be observed by the investigator or sub-investigator for 30 minutes following the vaccine injection. the duration of each participant's participation in the trial will be approximately 1 year.

Eligibility criteria:
inclusion criteria: * aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion * informed consent form signed by the parent(s) or other legal representative * able to attend all scheduled visits and to comply with all trial procedures exclusion criteria: * fever ≥ 37.5°c (axillary temperature) on the day of inclusion * any serious disease whether acute or chronic * history of poliomyelitis infection * history of a life threatening reaction to a vaccine containing the same substances of the study vaccine * history of anaphylaxis or allergy to any of the study vaccine components * previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine * congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * participation in another clinical trial preceding the trial inclusion * planned participation in another clinical trial during the present trial period * blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins). * any vaccination with live vaccines within the past 27 days preceding the first trial vaccination. * any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination. * clinical or known serological evidence of systemic illness including hepatitis b, hepatitis c and/or human immunodeficiency virus infection * subject ineligible according to the investigator's clinical judgment.

Keywords: poliomyelitis inactivated polio vaccine polio poliovirus
electromagnetic therapy for autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the investigators hypothesize that electromagnetic therapy (emt) could produce greater improvement on autism spectrum disorder (asd) compared to the waitlist control. to test this hypothesis, a pilot randomized waitlist-controlled trial is designed to achieve the 2 aims: 1. to evaluate the efficacy of emt in improving children with asd as measured by childhood autism rating scale (cars) by comparing the change in cars scores from baseline to week 12 between the two groups. 2. to assess the safety of emt by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group. a pilot randomized waitlist-controlled trial is designed. a total of 30 children aged 3-12 years with a principal diagnosis of asd will be recruited. they will be randomly assigned to care-as usual (cau) and cau+emt groups (n = 15 each group). participants on the cau+emt group will receive a total of 30 sessions of emt within 12 weeks (2 - 3 sessions/week).those who are initially assigned to cau group will receive emt for 12 weeks after they complete the trial. the post-trial treatment will serve as a compensation for their participation.


Eligibility criteria:
inclusion criteria: 1. aged 3-12 years; 2. have had a principal diagnosis of asd according to the diagnostic criteria for asd in the dsm-5; 3. the score of cars is 30-37 (mild to moderate asd) at entry; and 4. his/her parents or legal guardian give a written informed consent that indicates the permission to participate in the study. exclusion criteria: 1. children suffer a significant comorbid congenital disease or brain injury, such as down syndrome, mental retardation, and cerebral palsy; 2. children have been suffering uncontrolled epilepsy or seizure; 3. children have heart diseases; 4. children have participated in other investigational studies in previous 3 months; 5. children have pediatric massage or acupuncture in previous 2 months; or 6. they have severe skin lesions or scar on the areas the treatment will be performed.

Keywords: autism spectrum disorder asd emt electromagnetic therapy chinese medicine
selenium in preventing cancer recurrence in patients with bladder cancer

Conditions: Bladder Cancer

Summary: rationale: chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. the use of selenium may keep bladder cancer from growing or coming back. it is not yet known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer. purpose: this randomized phase iii trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.

objectives: primary * to determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence. secondary * to determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size. outline: patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral placebo daily in addition to standard care. * arm ii: patients receive oral selenium daily in addition to standard care.

Eligibility criteria:
disease characteristics: histopathologically confirmed non-muscle-invasive transitional cell carcinoma (tcc) of the bladder (\< pt2 ) patient characteristics: * able to swallow pills * not pregnant * fertile patients must use effective contraception * no other malignancy within the past 5 years * no known hypersensitivity or adverse reactions to selenium * no other serious medical or psychiatric illness that would preclude giving informed consent * no condition that, in the opinion of the investigator, may interfere with the safety of the patient or the evaluation of the study objectives prior concurrent therapy: * see disease characteristics * more than 30 days since prior daily dietary supplements containing selenium * no other concurrent selenium (contained in individual supplements, antioxidant mix, or multivitamin) intake * no concurrent participation in another study involving a medical, surgical, nutritional, or lifestyle intervention * concurrent participation in the follow-up phase of another study allowed

Keywords: stage 0 bladder cancer stage i bladder cancer transitional cell carcinoma of the bladder
multi-centre european photopatch test study

Conditions: Dermatitis, Photocontact

Summary: it is known that people can develop an allergic skin reaction to a substance which is placed on the skin and then subjected to sunlight. this process is called photocontact allergic dermatitis. it is known that people can develop photocontact allergic dermatitis to sunscreen chemicals (filters) and also cream forms of pain-killing drugs called nonsteroidal anti-inflammatory drugs (nsaids). the purpose of this study is to determine the frequency of photocontact allergic dermatitis to 19 sunscreen filters and 5 topical nsaids in 1,000 european patients who present to a dermatologist with a sun-exposed site dermatitis. each participant will have the 24 test agents plus one control of petrolatum applied to the skin of the back for 24 or 48 hours. after removal of the substances, the area of skin will be exposed to a precise amount of ultraviolet-a light. the area is then assessed 24, 48 and 72 hours later to see if a photocontact allergic reaction has occured. this method is known as photopatch testing. the study will run for one year, during which time it is planned to recruit 1,000 patients.

specific intervention names: * butyl-methoxy-dibenzoylmethane * homosalate * methylbenzylidene camphor * benzophenone-3 * octyl methoxycinnamate * phenylbenzimidazol sulfonic acid * benzophenone 4 * drometrizole trisiloxane * octocrylene * octyl salicylate * octyl triazone * isoamyl-p-methoxycinnamate * terephtalidene dicamphor sulphonic acid (mexoryl sx) * tinosorb s * tinosorb m * univul a+ * neoheliopan ap * uvasorb heb * parsol slx * ketoprofen 1% * etofenamate 2% * piroxicam 1% * diclofenac 5% * ibuprofen 5 %

Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older. * have sufficient cognitive capacity to give written informed consent. * have an eruption on photo-exposed sites, which is to be further classified using one (or more) of the categories below: * known photosensitivity disease * history of sunscreen reaction * sun exposed site dermatitis during summer months * any sun exposed site dermatitis problem exclusion criteria: * male or female aged 17 years or younger * have had potent topical steroid applied to the photopatch test site on the back in the previous 5 days. (this potentially suppresses reactions which would otherwise have been visible) * have skin disease on the back which is too active to allow testing. (this obscures the sites of testing by making differentiation between a positive result and other skin disease difficult) * be prescribed systemic immunosuppressant medication (e.g. prednisolone, methotrexate, azathioprine, ciclosporin) (this potentially suppresses reactions which would otherwise have been visible) * be taking any photoactive medicine (for example thiazides, sulphonamide derivatives, amiodarone, fluoroquinolones, chlorpromazine, nsaids, quinine). (this is a relative exclusion. many centres may wish to go ahead despite such medication).

Keywords: photocontact dermatitis nsaid sunscreen photopatch
hma+dli vs dli preemptive therapy based on mrd for al undergoing allo-hsct

Conditions: Minimal Residual Disease,Acute Leukemia, Hypomethylating Agents, Donor Lymphocyte Infusion, Allogeneic Hematopoietic Cell Transplantation

Summary: allogeneic hematopoietic cell transplantation (allo-hsct) is an effective therapy for acute leukemia, but relapse is the most common problem affecting long-term survivors of allo-hsct. therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (dli) or combination therapy. in this prospective randomized controlled study, the safety and efficacy of hypomethylating agents (hma) + dli and dli preemptive therapy based on minimal residual disease in acute leukemia undergoing allo-hsct are evaluated.

allogeneic hematopoietic cell transplantation (allo-hsct) is an effective therapy for acute leukemia, but relapse is the most common problem affecting long-term survivors of allo-hsct. therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (dli) or combination therapy. one method of solving relapse is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (mrd) . dli is an effective post-transplantation therapy based on mrd for relapse. whether combination of hypomethylating agents (hma) and dli could improve outcomes remains unclear. in this prospective randomized controlled study, the safety and efficacy of hma+dli and dli preemptive therapy based on minimal residual disease in acute leukemia undergoing allo-hsct are evaluated.

Eligibility criteria:
inclusion criteria: - a patient age of 14-65 years. al patients who achieved cr at pre-transplantation undergoing allo-hsct. subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. exclusion criteria: * al patients who were in nr at pre-transplantation undergoing allo-hsct. any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure). patients with any conditions not suitable for the trial (investigators' decision).
aqp-1 polymorphism on fluid status in hemodialysis patients

Conditions: End Stage Renal Disease on Dialysis

Summary: it is a cross sectional observational study. it is to investigate whether aqp-1 polymorphism has any impact on fluid status in hemodialysis patients. the long term stable hd patients in the current center will be enrolled to the study after informed consent. blood samples will be collected for gene-typing. fluid status including blood pressure, weekly uf and intra-dialysis body weight change will be collected through their clinical records.


Eligibility criteria:
inclusion criteria: * age 18-70 * esrd * maintained hd * no target weight change during the last week of entering the study and achieve target weight at the end of hd section * informed consented exclusion criteria: * expected survival time less than 3 months

Keywords: aqp1 fluid status
low-grade infections of the intervertebral discs

Conditions: Disc Degeneration

Summary: the purpose of this prospective, observational study was to evaluate frequency and characteristics of low-grade infections of the intervertebral discs in an unselected real-life patient population undergoing surgery for degenerative pathologies of the spine.

low-grade infection of the intervertebral discs, causing disc degeneration and consecutive pain and disability is reported in literature. microorganisms are also held responsible for modic changes of the vertebral bodies. patients underwent surgery for degenerative pathology of the spine independent of this study. after being informed about this study, all patients giving written informed consent who met eligibility requirements were included. treatment of the patients was independent of this study. intraoperative removed disc tissue was examined using microbiological culture, viral polymerase chain reaction (pcr), and histopathological analysis. other used data were demographic data (gender, age), modic changes on mri, preoperative oswestry disability index (odi), preoperative neck disability index (ndi), and preoperative c-reactive protein (crp). frequency of positive microbiological culture findings, viral pcr, and inflammation signs in histopathological analysis was described, and statistical analysis was performed to identify if any of the above mentioned parameters influences the frequency of positive microbiological culture and modic changes significant.

Eligibility criteria:
inclusion criteria: * spine surgery including discectomy due to degenerative diseases * availability of removed disc tissue for further analysis exclusion criteria: * signs of spondylodiscitis (clinical signs, inflammation parameters, radiological) * suspected or known tumor disease * traumatic fractures

Keywords: low-grade infection intervertebral disc spine cutibacterium acnes culture herpes simplex modic changes crp histopathology microbiology oswestry disability index neck disability index
effect of vitamin d intake in pregnancy to prevent recurrence of gestational diabetes

Conditions: Vitamin D Intake in First Trimester and Incidence of Gestational Diabetes Recurrence

Summary: primary outcome is vitamin d intake in first trimester for pregnant women with history of gestational diabetes in previous pregnancies and incidence of gestational diabetes recurrence secondary outcome is effect of vitamin d intake on mode of delivery, apgar score and neonatal birth weight

it is a prospective randomized controlled study to determined the effect of vitamin d supplementation in pregnancy in reducing the incidence of gestational diabetes recurrence. it will be conducted at the department of obstetrics and gynecology kasr el ainy hospital faculty of medicine cairo university from august 2018 to april 2020. we include in our study 430 pregnant women who had history of gestational diabetes in their previous pregnancies. patients with multiple pregnancy or with any medical disorder are excluded from study. bmi will be calculated for each participant at the time of admission and glucose challenge test will be performed for all patients in the first trimester to exclude diabetic patients from the study then a blood sample is taken from all patients enrolled in the study to measure the vitamin d level by elisa (after fasting 12 hours and not have a fatty dinner) the participants will be assigned to one of three main groups according to the serum 25 oh vitamin d level. pregnant women with normal vitamin d level assigned as group a, pregnant women with lower serum level of vitamin d (\>20 nmol/l) randomly divided into two groups: group b and c. group b will be given oral vitamin d 2800 units daily till 26 week pregnancy and group c will be given omega 3 as placebo till 26 week pregnancy. incidence of gestational diabetes will be measured in 24-26 week pregnancy with ogtt and compared in the three groups. all patients will be followed up till delivery. mode of delivery, apgar score and neonatal birth weight will be recorded.

Eligibility criteria:
inclusion criteria: * pregnant women with history of gestational diabetes in previous pregnancies exclusion criteria: * multiple pregnancy * pregnant patient with medical disorders
mutations and phenotypes of unclassifiable inherited bone marrow failure syndromes

Conditions: Inherited BMF Syndrome

Summary: inherited bone marrow failure syndromes (ibmfss) are a diverse collection of genetic illnesses characterized by various degrees of peripheral cytopenias due to defective single-lineage or multi-lineage hematopoiesis, it can manifest itself at birth or later in life.

studying the genetic etiology underlying unclassifiable ibmfss with bone fragility fractures should be useful for clarifying the undiagnosed pathophysiological mechanisms and other accessory factors to improve the diagnosis, follow-up, prognosis, and management of these patients as well as prevent future complications. moreover, early diagnosis of risk factors of unusual presentations of ibmfss will be a useful tool for better treatment strategy. in addition, along with typical ibmfss, novel clinical entities must be included in an overall molecular portrait of ibmf disorders. as a result, comprehensive genetic analysis will be effective in establishing an accurate genetic diagnosis at medical evaluation.

Eligibility criteria:
inclusion criteria: * confirmed a two-generational family with ibmfss presented with signs and symptoms of bone fragility fractures and admitted or treated in hematology division at internal medicine departments of various university hospitals will be screened for enrollment in this study. * the investigators will invite the entire family for testing for ibmfss mutations, and three additional family members consented to participate in this study. exclusion criteria: * • patients will be diagnosed with paroxysmal nocturnal hemoglobinuria * patients will be diagnosed with de novo myelodysplastic syndrome * ibmfss-patients will refuse to consent to this study. * serologic evidence of recent virus infection as hepatitis a (hav), hbv, hcv, hev, cytomegalovirus (cmv), epstein-barr virus (ebv), or positive test for hiv. * ibmfss patients with severe systemic diseases (such as cardiovascular, renal, and hepatic disease) or surgical/medical conditions that might interfere with follow-up instructions. * ibmfs patients with psychiatric disorders or a history of drug abuse,