Kornimate/medical-research-clean huggingface dataset:
a comparison of optive in patients previously using systane for the treatment of dry eye

Conditions: Dry Eye

Summary: to evaluate the effectiveness of ngt (optive) vs. systane tears for patients with moderate to severe dry eye disease.


Eligibility criteria:
inclusion criteria: * · dry eye disease diagnosis * patients must currently be using systane tears at least once a day and for at least 1 month. * normal lid position and closure * male or female of legal age of consent * informed consent has been obtained * likely to complete all required follow-up visits exclusion criteria: * · concurrent enrollment in an investigational drug or device study, or participation in such a study within 30 days of entry into this study. * subject has a condition, or is in a situation which, in the investigator's opinion, may put the subject at a significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
histocompatibility leukocyte antigen (hla)-a*2402 restricted peptide vaccine therapy in patients with esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to evaluate the safety and time to progression of hla-a\*2402 restricted epitope peptides urlc10, ttk, and koc1, emulsified with montanide isa 51.

urlc10, koc1 and ttk have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cdna microarray technique. in a prior study, it has been shown that urlc10, koc1 and ttk are upregulated in human esophageal tumors. we identified that peptides derived from these proteins significantly induce the effective tumor specific ctl response in vitro and vivo. according to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. patients will be vaccinated twice a week for 8 weeks. on each vaccination day, the urlc10 peptide (1mg), koc1 peptide (1mg), and ttk peptide (1mg) mixed with montanide isa 51 will be administered by subcutaneous injection. repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. in the phase i study, we evaluate the safety and tolerability of these peptide vaccines. in the following phase ii study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility criteria:
inclusion criteria: * advanced or recurrent esophageal cancer * resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s) * ecog performance status 0-2 * life expectancy \> 3 months * hla-a\*2402 * laboratory values as follows 2000/mm3\ 100000/mm3 bilirubin \< 3.0mg/dl asparate transaminase \< 150iu/l alanine transaminase \< 150iu/l creatinine \< 3.0mg/dl * able and willing to give valid written informed consent exclusion criteria: * pregnancy (woman of childbearing potential:refusal or inability to use effective means of contraception) * breastfeeding * active or uncontrolled infection * concurrent treatment with steroids or immunosuppressing agent * prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks * uncontrolled brain and/or intraspinal metastasis * decision of unsuitableness by principal investigator or physician-in-charge

Keywords: peptide vaccine urlc10 ttk koc1
a swiss assessment of hypothalamic-pituitary-adrenal axis suppression after glucocorticoid therapy for leukemia and lymphoblastic lymphoma in children

Conditions: Adrenal Insufficiency; Leukemia, Lymphoblastic, Acute, Pediatric; Lymphoma, Lymphoblastic

Summary: plain language summary: background glucocorticoids are stress hormones produced by the human body to control inflammation and regulate the immune system. cortisol is the most well-known example of a glucocorticoid. these stress hormones are essential for the bodys healthy functioning. to treat certain types of cancer, such as leukemia (blood cancer) in children, glucocorticoids are administered as medications in large quantities. this helps rapidly reduce the number of cancer cells in the body but also leads to the suppression of the body's natural glucocorticoid production, causing a deficiency. this deficiency can be particularly dangerous for children with leukemia, as their immune defenses are already weakened by chemotherapy, leading to an increased risk of infections. moreover, the signs of glucocorticoid deficiency in children with leukemia are often indistinguishable from the side effects of chemotherapy, making the deficiency harder to detect. objectives the aim of the study is to understand how frequently and for how long the body's natural glucocorticoid production is impaired in children treated for lymphoblastic leukemia and lymphoblastic lymphoma. additionally, the goal is to identify which children are at particularly high risk. by gaining a better understanding, this study may help to improve the detection and treatment of glucocorticoid deficiency in children with blood cancer. methods regular low-dose acth tests will be conducted to assess the bodys natural glucocorticoid production during and after treatment. to avoid placing additional burden on children who are already heavily affected by the disease, we will only perform these tests when there is already a venous access established and the children are in the hospital for treatment reasons.


Eligibility criteria:
inclusion criteria: * diagnosed with all or lbl * treated for at least 21 sequential days with glucocorticoids between the 01.07.2024 and the 30.06.2027 at the childrens university hospital of basel or at the childrens hospital of aarau * lnformed consent can be obtained from the patient\&#39;s legal representatives (and the patient if at least 14 years of age) within week 2 of treatment with glucocorticoids exclusion criteria: - contraindication to the administration of intravenous synthetical acth (synacthen®): extremely rare cases of known or suspected hypersensitivity to synacthen®.

Keywords: adrenal insufficiency leukemia leukaemia childhood pediatric paediatric glucocorticoid
retrospective study of the safety and efficacy of patients with rvo in subjects who completed parent study cls1003-201

Conditions: Macular Edema; Retinal Vein Occlusion

Summary: the purpose of this non interventional retrospective study is to continue to collect data from patients following their completion of protocol cls 1003-201: "safety and efficacy of suprachoroidal cls-ta with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion" (ie, the parent study).

this is a non-interventional, retrospective study of up to 6 months for subjects that completed the parent study cls1003-201. this study is designed to collect data from patients following their parent study exit visit, through either the time of the next treatment for rvo or at least 6 months following the parent study exit visit, whichever occurs first. during this non-interventional retrospective study, the following data will be collected in an online questionnaire (or where required, on paper) provided by clearside: * next rvo therapy administered (if applicable), including reason for treatment * continued documentation of current or changes in medical or ocular conditions following parent study * concomitant drug or therapy changes * visual acuity, including details on the method used in the assessment * central retinal thickness, including details on the equipment used in its determination * intraocular pressure, including details on the equipment used in its determination subjects will be selected based on parent study primary investigator's access to their medical records access, following exit from cls1003-201. data will also be collected on the total number of patients included in this non interventional study as well as reasons patients were excluded. data will be summarized from the randomization treatment assignment in the parent study.

Eligibility criteria:
inclusion criteria: * completed enrollment and did not receive additional aflibercept therapy in the parent study, cls1003-201 exclusion criteria: * n/a

Keywords: rvo me central subfield thickness oct optical coherence tomography cystoid macular edema subretinal fluid eylea aflibercept anti-vegf
screening of susceptibility genes in postoperative cognitive dysfunction(pocd)

Conditions: Cardiac Surgery Patients

Summary: the aim of this study is to perform a whole-genome linkage analysis for identification of the susceptibility loci for pocd

background: postoperative cognitive dysfunction is probably the most frequent type of postoperative cognitive impairment. as it mainly affect the elderly population, pocd is receiving increasing attention. however, the pathophysiology of pocd remains incompletely understood. no study had elucidate why somebody are apt to suffer from pocd, but others not. in current study, we try to use gwas technology to find out whether there is a correlation between pocd and gene specificity. designing: 120 patients will be screened who are schedule to receive selective on-pump cardiac surgery， 5 ml blood of the patient will be collected before anesthesia induction. investigetors will measure the cognitive function of the patients one day before surgery and 7 d after surgery and identify whether the patient suffer from pocd used in mmse test. randomly select 36 patients who suffer from pocd and 36 patients without pocd(control), gwas technology will be used to screen the susceptibility gene between these two groups. expected results ：find out some susceptibility genes correlate to pocd. conclusions: the patients who are apt to suffer from pocd have some special susceptibility genes differ from normal people.

Eligibility criteria:
inclusion criteria: 1. age from 60 to 75 years old; 2. schedule for on-pump cardiac surgery; 3. undergoing full intravenous anesthesia; 4. without hepatic, renal, pulmonary disease or full intravenous anesthesia surgery history; 5. gave the informed consent. exclusion criteria: 1. emergency surgery; 2. a history of cerebrovascular disease; 3. the history of mental disease; 4. long term use of sedative and antidepressant drugs; 5. alcoholism; 6. serious vision, hearing impairment and inapprehensive language; 7. chromosomal abnormalities; 8. blood disease; 9. refused to sign the informed consent.

Keywords: cardiac surgery pocd gwas susceptibility gene
allogeneic cellular vaccine 1650-g for non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: rationale: vaccines made from allogeneic tumor cells may help the body build an effective immune response to kill tumor cells. the purpose of this study is to evaluate the effects of a lung cancer vaccine in patients with stage i or stage ii non-small cell lung cancer (nsclc) after completion of initial definitive therapies.

the study is an open label investigation of the cellular vaccine called 1650-g. patients receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. patients will be followed weekly after each vaccine injection and then monthly for 4 months. patient follow-up continues with evaluations at 6 months and 1 year after receiving the first vaccine injection. immunologic responses to the vaccine will be assessed from blood samples obtained at each visit following immunizations.

Eligibility criteria:
inclusion criteria: * histologically confirmed stage i or stage ii non-small cell lung cancer * surgically resected at least 4 weeks ago but not more than 6 months ago * bronchoalveolar carcinomas allowed * completion of any chemotherapy or radiation given in conjunction with surgery (neoadjuvant or adjuvant) * no evidence of disease following initial therapy evidenced by a cxr, ct or pet scan within 6 weeks of enrollment * ecog performance status of 0 to 2 * adequate organ and marrow function defined as follows: * hemoglobin ≥9.0 gm/dl * bilirubin \< 2.5 x upper limit of normal * ast \<2.5 x upper limit of normal * alt \<2.5 x upper limit of normal * creatinine \<3 mg/dl * women of childbearing potential must have a negative pregnancy test and be willing to use acceptable methods of contraception through week 16. exclusion criteria: * cardiovascular disease defined as: * new york heart association class iii or iv (section 19.2) congestive heart failure * hemodynamically significant valvular heart disease * myocardial infarction within the last six months * active angina pectoris * uncontrolled ventricular arrhythmias * stroke within one year * known cerebrovascular disease * history of hiv, infectious hepatitis, or chronic immunosuppressive disease * concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment * history of an allergic reactions to any colony stimulating factor (gcsf, gmcsf) * female patients must not be pregnant or breastfeeding. * history of participation in any investigational drug study within 4 weeks preceding initiation of study treatment.

Keywords: lung cancer vaccine early stage lung cancer lung cancer
a study of hiv in newly infected individuals

Conditions: HIV Infections

Summary: the purpose of this study is to see how hiv reacts in the immune systems of patients who have recently been infected with hiv. this study also examines hiv's resistance to anti-hiv drugs in newly infected patients. certain populations are good candidates for participation in hiv vaccine trials. these groups include men who have sex with men, iv drug users, and women at risk of getting hiv through heterosexual contact. learning how hiv behaves in these populations once they become infected can help with the planning of future hiv vaccine studies.

this study provides an opportunity to prospectively monitor markers of hiv infection and disease progression in cohorts suitable for hiv vaccine trials. the detection of changes in hiv phenotype and genotype, clinical progression rates, and antiretroviral resistance within study populations over time are important for planning future hiv vaccine trials. this study consists of two parts. part a includes hiv-infected patients who enrolled in hivnet d01.1 (infected-participants cohort of hivnet d01) and whose hiv disease has been closely monitored and characterized. this study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter. part b includes newly hiv-infected patients. these patients are monitored with clinical and laboratory evaluations at 0, 1, 3, 6, 9, 12, and 18 months, and then every 6 months through year 5.

Eligibility criteria:
inclusion criteria patients must have: * hiv infection, as documented by enrollment in hivnet d01.1 (part a patients) or by standard hiv serological tests or demonstrated hiv infection on virologic assay (part b patients). part a only: * previous enrollment in infected-participants cohort of hivnet d01. part b only: * initial hiv-seronegativity on an hivnet protocol (other than an hiv vaccine protocol) and testing positive for hiv at a subsequent clinic visit. * confirmation of hiv infection and documentation of hiv negative antibody test within 8 months of first positive test. exclusion criteria co-existing condition: patients with the following conditions are excluded: * an obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the study. prior medication: excluded: * participation in a hivnet hiv vaccine trial.

Keywords: sexual partners drug resistance, microbial cohort studies risk factors substance abuse, intravenous disease progression homosexuality, male genotype phenotype
in vivo quantification of dental demineralisation using oct with and without esomeprazole

Conditions: Tooth Erosion

Summary: dental erosions in 30 male and female patients with proven abnormal gastrooesophageal reflux will be assessed clinically and using a novel optical coherence tomography (oct) laser technique before and after double-blind randomization to antisecretory treatment with esomeprazole 20mg or placebo bid for 3 weeks. the primary objective is to quantify tooth substance loss as well as changes in optical reflectance and scattering of dental hard tissues with and without acid inhibition. secondary objectives are: to compare standardised visual scoring with oct quantification of reflux damage at the different time points on different teeth. to assess sex differences in oct- quantified dental tissue loss.

dental erosions in 30 male and female patients with proven abnormal gastrooesophageal reflux will be assessed clinically and using a novel optical coherence tomography (oct) laser technique before and after double-blind randomization to antisecretory treatment with esomeprazole 20mg or placebo bid for 3 weeks. the primary objective is to quantify tooth substance loss as well as changes in optical reflectance and scattering of dental hard tissues with and without acid inhibition. secondary objectives are: to compare standardised visual scoring with oct quantification of reflux damage at the different time points on different teeth. to assess sex differences in oct- quantified dental tissue loss

Eligibility criteria:
inclusion criteria: 1. dental erosions with lussi score greater than 1, diagnosed by dentist 2. provision of informed consent 3. male or female aged 18 or above years 4. gord defined by time with ph\<4 greater than 3.5% during 24 hours demonstrated by 24h-hour ph-metry in the last 6 months before the start of the study exclusion criteria: 1. significant illness within 2 weeks of study begin as judged by investigator. 2. established or suspected non-reflux causes for dental erosions. 3. inadequate exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities, vomiting, etc). 4. inability or unwillingness to give informed consent. 5. inability to attend all study. 6. new dental treatment (including dental products) may not be begun from 2 weeks before study begin until the end of the study, except usual dental hygiene with usual toothpaste. 7. allergy to or other contraindication for treatment with esomeprazole. 8. use of proton pump inhibitors in 2 weeks or other acid inhibitory drugs in 3 days before study inclusion. 9. substantial change or planned change in dietary pattern, esp. diets within 2 weeks of study start and for the duration of the entire study. 10. change or planned change in normal medication or use of herbal, mineral, vitamin preparations within 2 weeks of study start and until the end of the study. 11. congenital dental defects. 12. ongoing pregnancy or breast-feeding.

Keywords: dental erosion oct proton pump inhibitor
use of rituximab in opsoclonus-myoclonus in children with neuroblastoma

Conditions: Neuroblastoma; Opsoclonus-myoclonus

Summary: the purpose of this study is to evaluate the feasibility of giving four weekly doses of rituximab (anti-cd20 antibody) in the treatment of children with refractory neuroblastoma associated opsoclonus-myoclonus. patients must have continued symptoms of opsoclonus, myoclonus and or ataxia despite surgical resection and a minimum of one month of steroid therapy. evaluations include clinical symptoms of opsoclonus-myoclonus and ataxia as well as detailed evaluation of learning and development.

opsoclonus-myoclonus ataxia syndrome (oms) is a rare immune mediated paraneoplastic syndrome that occurs in approximately 2 to 3% of children with neuroblastoma. children with neuroblastoma associated opsoclonus-myoclonus tend to have a favorable prognosis from the standpoint of the cure of their cancer. unfortunately,approximately two-thirds of this subgroup of patients are left with long term sequellae of the syndrome, including residual symptoms of opsoclonus, myoclonus, ataxia, learning difficulties and disturbance of sleep and mood. multiple lines of evidence indicate an immune mechanism to this rare disorder. this includes occurence of oms in the post-infectious state, aggressive lymphocytic infiltration of the tumor in children with oms, and documented responses to therapries that act through suppression of the immune system. the current study utilizes four weekly doses of anti-cd 20 antibody (rituximab) to treat children with refractory oms. refractory disease is defined as continued symptoms of oms despite surgical resection of the tumor and a minimum of one month of steroid therapy. all patients have baseline oms evaluation and detailed neurocognitive testing with all studies being repeated at the completion of the four weekly infusions. oms testing is repeated at month 3. oms testing and detailed neurocognitive testing is conducted at 6 months intervals until 2 years from the initial infusion. the goal of the study is to utilize this novel therapy to improve long term neurologic and neurodevelopmental outcome in children with refratory neuroblastoma associated opsoclonus-myoclonus.

Eligibility criteria:
inclusion criteria: pathologic confirmation of diagnosis of neuroblastoma surgical resection of primary tumor symptoms of oms despite a minimum of one month of steroid therapy must meet all laboratory criteria to demonstrate adequate organ function - exclusion criteria: patients currently receiving systemic chemotherapy for treatment of neuroblastoma patients with documented active infection patients who are hiv, hep b or hep c positive organ toxicity from any prior therapy or surgical intervention must be resolved prior to study entry -

Keywords: neuroblastoma opsoclonus-myoclonus rituximab
tear evaluation between habitual contact lens wearers and non contact lens wearers

Conditions: Dry Eye

Summary: to evaluate tears between habitual contact lens wearers and non contact lens wearers

the objective of this study is to evaluate tears between habitual contact lens wearers and non contact lens wearers using a schirmer strip for tear collection.

Eligibility criteria:
inclusion criteria: * have no allergic conjunctivitis. * not be using any topical ocular medications. exclusion criteria: * considered by the investigator to not be a suitable candidate for participation
estimating risk of respiratory infections attributable to cftr heterozygosity

Conditions: Carrier State; Respiratory Infections

Summary: a research team member will brush the inferior surface of the subjects' middle turbinate (nasal cavity) using a cytology brush to obtain the cells needed to perform our functional respiratory assays. an individual trained in phlebotomy will draw one 3 ml lavender top tube of blood to test c-reactive protein, calprotectin, and lactoferrin. they will also draw a 5 ml gold top serum separator tube of blood to test fibroblast growth factor-19. the participant will answer questions from the baseline survey and report their current medications interview-style with the research team member.


Eligibility criteria:
cf carrier inclusion criteria: * previously tested and shown to be a cf carrier * english-speaking control group inclusion criteria: * previously tested and shown to not be a cf carrier or cf patient * english-speaking exclusion criteria: * currently sick with a respiratory infection * prisoner status * unable to provide own written, informed consent