Kornimate/medical-research-clean huggingface dataset:
hfsrt with concurrent tmz for large bms

Conditions: Brain Metastases; Chemotherapy; Radiotherapy

Summary: a multi-center randomized phase iii trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

a previous single arm phase ii trial and propensity- matched study of our institution have shown that hfsrt combined with concurrent tmz was safe and efficient for patients with bms of ≥ 6cc in volume. the 1-year local control, intracranial progression free survival, progression free survival and overall survival rates were better than hfsrt alone group. thus, the investigator conducted this randomized phase iii trial to broad the sample size and verify our previous results. to finish the study in time, the investigator designed a multi-center trial.

Eligibility criteria:
inclusion criteria: * histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced mri or ct; * the number of bms ≤ 3 * the tumor volume ≥6cc, or maximum diameter of bms≥ 3cm; * karnofsky performance score (kps)≥60, or kps≥40 but simply caused by bms; * age: 18-75 years old; * adequate function of major organs, and blood test reached the following level: wbc≥4.0x109/l, neu≥1.5x109/l hemoglobin≥110 g/l, platelets≥100 x109/l; liver function test results\<1.5 times the institutional upper limit of normal (uln); bun and cr: within the normal range. exclusion criteria: * patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia); * unable or unwilling to comply with the study protocol; * patient whose survival expectancy was less than 3 months; * the large bm locates in brainstem; * patient who anticipated in other clinical trials of brain metastases; * the large lesions have been treated with srt in other hospitals; * pregnant patients or female patients whose hcg is positive.
ctdna dynamic monitoring and its role of prognosis in stage ii to iiia nsclc by ngs

Conditions: NSCLC

Summary: the second generation of high-throughput gene sequencing (ngs) is an important means of detecting the tumor dna and circulating tumor dna (ctdna), which can detect trace ctdna from smaller plasma samples. this project is chiefly to study the role of ctdna dynamic monitoring of stage iia to iiia nsclc by ngs technique to verify the prognostic predictive effect of ctdna. and the investigators also wander the concordance of lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes.

in the ngs era, ctdna detection can truly reflect the real tumor tissue gene mutation map and frequency. it becomes the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after surgery and adjuvant chemotherapy. the second generation of high-throughput gene sequencing (ngs) is an important means of detecting ctdna, which can detect trace ctdna from smaller plasma samples. the dna dynamic monitoring of stage ii to iiia non-small cell lung cancer (nsclc) was performed by the ngs technique to verify prognostic predictive effect of ctdna in stage iia to iiia nsclc patients after operation. the lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes seems not exactly consistent. in this study, the investigators will compare the lung cancer related genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node by the ngs technique.

Eligibility criteria:
inclusion criteria: * postoperative histopathological diagnosis of tnm stage iia to iiia nsclc with r0 resection; * no previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer； * eastern cooperative oncology group (ecog) behavior status score 0 to 1. exclusion criteria: * patients with other cancers other than nsclc within five years prior to this study; * who can not get enough tumor histological specimens (non-cytological) for analysis; * human immunodeficiency virus (hiv) infection; * nsclc mixed with patients with small cell lung cancer; * pregnant or lactating women; * there is a clear history of neurological or mental disorders, including epilepsy or dementia; * conditions that investigators think is not suitable for inclusion.

Keywords: non-small cell lung cancer stage ii to iiia circulating tumor dna the next generation of high-throughput gene sequencing
a study to assess the safety and drug levels of bms-986256 in participants with active cutaneous lupus erythematosus

Conditions: Lupus Erythematosus, Cutaneous

Summary: the purpose of this study is to assess the safety and drug levels of bms-986256 in participants with cutaneous lupus erythematosus.


Eligibility criteria:
inclusion criteria: a) must have one of following diagnoses: i) meet european league against rheumatoid (eular)/american college of rheumatology 2019 classification criteria for systemic lupus erythematosus (sle) or ii) biopsy-proven acute cutaneous lupus erythematosus (acle), subacute cutaneous lupus erythematosus (scle), or discoid lupus erythematosus (dle): participants without a concurrent sle diagnosis are eligible b) active cutaneous lupus disease, defined as a modified cutaneous lupus erythematosus disease area and severity index- activity (mclasi-a) score ≥ 6 c) active cutaneous lupus skin lesion(s) amenable to biopsy • women of childbearing potential (wocbp) and men must agree to follow instructions for method(s) of contraception, if applicable exclusion criteria: * active severe or unstable neuropsychiatric sle * active, severe lupus nephritis (ln) * any british isles lupus assessment group (bilag) a or b, unless within the constitutional, musculoskeletal and/or mucocutaneous domains other protocol-defined inclusion/exclusion criteria apply
immune function in offsprings of females with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: 1. to evaluate the immune response to vaccines in infants of ibd patients treated with anti-tnf medications during pregnancy compared to infants of ibd mother not treated with anti-tnf medications. 2. to evaluate the immune function of b and t cells at 3 months and one year of age in infants of ibd patients treated with anti-tnf medications during pregnancy compared to infants of non anti-tnf treated mothers. the secondary aims are to follow anti tnf drug levels in infants born to ibd patients treated with anti-tnf medications during pregnancy and to evaluate the risk of infections during the first year of life in this population, compared to children of ibd patients not treated with anti-tnf medications during pregnancy. significance -the results of this study have the potential to change clinical practice of anti tnf treatment during pregnancy and the follow-up of infants born to these patients

1. we aim to evaluate the immune response to vaccines in infants of ibd patients treated with anti-tnf medications during pregnancy compared to infants of ibd mother not treated with anti-tnf medications. 2 we aim to evaluate the immune function of b and t cells at 3 months and one year of age in infants of ibd patients treated with anti-tnf medications during pregnancy compared to infants of non anti-tnf treated mothers. our secondary aims are to follow anti tnf drug levels in infants born to ibd patients treated with anti-tnf medications during pregnancy and to evaluate the risk of infections during the first year of life in this population, compared to children of ibd patients not treated with anti-tnf medications during pregnancy. the results of this study have the potential to change clinical practice of anti tnf treatment during pregnancy and the follow-up of infants born to these patients

Eligibility criteria:
inclusion criteria: 1. children born to mothers with ibd who were treated with ant-tnf medications, other medications or not medically treated for ibd during pregnancy . 2. regular vaccination for hepatitis b at birth, 1 and 6 months of age and other scheduled non-live vaccines at 2,4, and 6 months of age. 3. inform consent signed by the parents. exclusion criteria: 1. children with intrauterine or perinatal infections, congenital diseases or malformations. 2. absence of immunization records. 3. known immune deficiency of mother and/or child. 4. mothers with hepatitis b

Keywords: anti- tnf inflammatory bowel disease pregnancy infant immunity immune function
understanding how alzheimer's disease impacts the therapeutic response to transcranial direct current stimulation

Conditions: Alzheimer Disease

Summary: there is currently little symptomatic therapy for alzheimer's disease (ad) and nothing effective for individuals with frontotemporal dementia (ftd). however, neuromodulation with transcranial direct current stimulation (tdcs) has the potential to be a clinically effective therapy for both ad and ftd. the challenge now is to specify the parameters and conditions under which tdcs is most effective to transition from the laboratory to clinical medicine. tdcs studies typically report significant group effects despite the variability demonstrated among participants, with some showing clear, meaningful improvement, while others only show statistical improvement or none at all. these variable results may be related to the conventional stimulation intensity level of 2ma. the investigators predict that administering tdcs at 4.0 ma, a more significant number of participants would show a meaningful response, and those who improve at 2ma may improve even more from 4.0ma due to having a larger electric field produced. the investigators aim to test this hypothesis in people with alzheimer's disease.


Eligibility criteria:
inclusion criteria: * mild to moderate ad * score between 18 and 25 on the moca * able to do the n-back task during the initial screening exclusion criteria: * no history of stroke or tbi * no shunts or metal in the body * no history of significant heart disease, alcoholism and drug use
ngs in aml relapse

Conditions: Acute Myeloid Leukemia

Summary: acute myeloid leukemia (aml) relapse is often associated with a clonal evolution at the cytogenetic and molecular level and therefore represents a challenge in the treatment of aml. targeted sequencing is now usually done at diagnosis in aml, as only a small core group of genes is frequently mutated in aml and myelodysplastic syndromes. this approach, contrary to wgs is cheaper, together with a rapid turnaround and high sequencing coverage depths allowing the detection of variant allele fractions as low as 2%. in the investigator's center, targeted analysis of aml patients is routinely realized at diagnosis and at relapse. in thses patients, five different clonal evolution patterns including cytogenetic and molecular analysis at relapse will be evaluated: (1) stability, defined by no clonal change, (2) gain, strictly defined by acquisition of additional variations (mutations or cytogenetic alterations), (3) loss, strictly defined by loss of variants or regression, (4) gain and loss, indicating the combination of both gain and loss patterns, (5) emergence, defined by the emergence of alterations that were unrelated to those found at diagnosis. karyotype and the mutations of up to 40 aml patients benefited from targeted ngs in the clinical hematology laboratory of the hopitaux universitaires de strasbourg both at the time of the diagnosis of and the relapse will be studied, together with clinical and other biological characteristics.


Eligibility criteria:
* inclusion criteria: * patients with aml that relapsed studied in the clinical laboratory of hematology of the hopitaux universitaires de strasbourg, france * given consentment or non-opposition for retrospective anonymous analysis of clinical and data * exclusion criteria: * person under tutorship- * persons who asked to withdraw from the study

Keywords: acute myeloid leukemia relapse mutations
executive functions and reinforcement sensitivity in women with obsessive compulsive symptoms

Conditions: Obsessive-Compulsive Symptom; Executive Dysfunction

Summary: methods: the study population consisted of all adult women living in sabzevar city (iran). using cluster sampling, 365 women were selected as the study sample. participants completed obsessive-compulsive inventory, sensitivity to punishment and sensitivity to reward questionnaire - revised and clarified (spsrq-rc) as well as behavior rating inventory of executive function (brief). data analysis was conducted using correlation and regression tests.


Eligibility criteria:
inclusion criteria: having age between 18 to 54, be female, be literacy, exclusion criteria: be male, be illiteracy, having psychotic disorders
subcutaneous testosterone enanthate safety in adult men diagnosed with hypogonadism

Conditions: Hypogonadism

Summary: evaluation of safety of a concentration controlled testosterone enanthate quickshot testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.

safety assessments, including laboratory assessments, adverse events and injection site assessments, will be conducted for all patients at scheduled intervals during the treatment titration period.

Eligibility criteria:
inclusion criteria: * adult men ≥18 and ≤75 years of age with a documented history of hypogonadism * total testosterone levels \< 300 ng/dl at two qualification visits * patients in good general health exclusion criteria: * allergy to sesame or testosterone products * bmi ≥ 40 kg/m2 * hematocrit ≥ 52% * history or current evidence of breast or prostate cancer * elevated prostate-specific antigen (psa) for age. * abnormal digital rectal examination (dre) * unstable psychiatric illnesses * obstructive uropathy of prostatic origin * poorly controlled diabetes * congestive heart failure * within 6 months of screening, myocardial infarction (mi), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease. * history or current treatment of thromboembolic disease. * use of adrenocorticotropic hormone (acth) or oral/depot corticosteroids within 6 weeks of screening. * history of severe, untreated sleep apnea * subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study * positive serology for hiv, hepatitis b or hepatitis c * current evidence of drug or alcohol abuse. * skin conditions in injection site that could confound injection site assessments. * administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer). * use of estrogen, gonadotropin-releasing hormone (gnrh) or growth hormone within 12 months of screening. * use of other androgens (dhea), anabolic steroids, other sex hormones) or other substances/supplements know to affect the pharmacokinetics (pk) of testosterone enanthate * considered or scheduled surgical or dental procedures associated with blood loss ≥500 ml during study. * donation of plasma or blood within 56 days of screening or history of donation of \> 50 ml of blood or plasma within 3 months of screening. * donation of plasma or blood during study

Keywords: hypogonadism testosterone enanthate
bone augmentation using calvarial versus iliac crest bone blocks.

Conditions: Bone Atrophy

Summary: this study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones

although the calvarial bones represent a nearby donor site for maxillary augmentation of matching bone origin, the excessive volume of bone needed to reconstruct a severely deficient arch, the limited cancellous bone volume, and the arciform pattern of the skull cap that yield the curvatures of the harvested cortical blocks incompatible with the topography of the maxillary arch, all represent limitations for the calvarial graft. the anterior iliac crest is frequently used for free bone grafting by being subcutaneous and generous to afford ample bone blocks of favorable curvatures. however, the minute cortical overlay and its endochondral origin contribute to excessive graft resorption. pikos et al. demonstrated that a reasonable amount of graft resorption could occur with atraumatic surgical intervention and intimate graft fixation. this study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones.

Eligibility criteria:
inclusion criteria: * patients with the clinical and radiographic interpretation of horizontal maxillary ridge deficiency of less than 5 mm exclusion criteria: * any previous maxillary reconstructive or dental implant treatment. * any local pathologic lesion or systemic disease that would affect the typical pattern of bone healing.

Keywords: bone graft iliac crest blocks calverial bone blocks horizontal bone gain
nimotuzumab in combination with radio-chemotherapy for the treatment of brainstem tumor in children

Conditions: Childhood Brain Stem Neoplasm

Summary: the purpose of this study is to evaluate the safety and efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumor in children.

nimotuzumab (h-r3), a recombinant humanized monoclonal immunoglobulin g1 antibody that binds to the extracellular domain of egfr, which blocks the binding of egf and transforming growth factor-α to egfr. high expression of egfr protein in glioma has been associated with tumor progression and enhanced tumorigenicity. several clinical trials have demonstrated the anti-tumor effects of nimotuzumab, such as head and neck cancer and esophageal cancer15. the purpose of this study was to evaluate the efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumors in children.

Eligibility criteria:
inclusion criteria: * patients must be \>/= 3 and \</= 21 years of age. * patients must have a newly diagnosed or progressive brain stem tumor. * if biopsy has been performed, patients with both high and low grade astrocytomas are eligible. * non-histologically confirmed brain stem tumors are eligible. neuroradiographic confirmation of brain stem glioma is mandatory for study entry. * cervicomedullary junction tumors are ineligible. * patients with a diagnosis of nf-1 are ineligible. * patients must be registered within 6 weeks from diagnosis or recurrence. * patients must have life expectancy \> 6 weeks. * patients must have adequate hematologic and renal function: anc \>1,000/ul, platelets\>100,000/ul and creatinine normal for age: \</= 0.7 mg/dl (age 3-10yrs.), \</= 1.0 mg/dl (11-12yrs.). and \</= 1.2 (13-21yrs.). * written informed consent must be obtained according to institutional guidelines. exclusion criteria: * cervicomedullary junction tumors are ineligible. * patients with a diagnosis of nf-1 are ineligible. * pregnant or nursing women are ineligible. * patients must not start treatment until informed consent is given and the patient is registered.

Keywords: radiation therapy brainstem tumor in children
studying tumor tissue samples from patients with soft tissue sarcoma

Conditions: Sarcoma

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is looking at tumor tissue samples from patients with soft tissue sarcoma.

objectives: * to develop a pilot program for the collection, archiving, and experimental analyses of soft tissue sarcomas (sts). * to obtain sts tumors from cancer patients undergoing tumor removal or core needle biopsies. * to evaluate cellular and molecular factors involved in sts oncogenesis by studying samples derived from human tumor specimens. * to develop an accompanying bioinformatics database of the demographics of sts patients from which tumor specimens are derived for experimental study. outline: tumor tissue samples are analyzed for gene and protein expression by cdna microarray analysis, rt-pcr, immunohistochemistry, in vitro transformation assays, rna interference, and western blot or immunoprecipitation.

Eligibility criteria:
disease characteristics: * meets one of the following criteria: * patients with soft tissue sarcoma (sts) undergoing evaluation, treatment, and/or follow-up at the arizona cancer center or university medical center * patients undergoing surgical treatment for sts removal or core needle biopsy for medically indicated diagnostic or therapeutic purposes patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: adult soft tissue sarcoma childhood soft tissue sarcoma
short-term telehealth follow up after hospital discharge for chronic obstructive pulmonary disease exacerbation

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate whether the introduction of a short-term telemonitoring program for chronic obstructive pulmonary disease (copd) patients discharged from the hospital after disease exacerbation produces benefits in terms of a reduction in hospital readmissions and health related quality of life. in addition the trials evaluate the economical and organisational impact of the services and examine their acceptability by patients and health professionals.

the purpose of this study is to the evaluate the use of a close phone-based tele-monitoring platform will reflected by less hospital re-admissions, will change their generic and disease specific quality of life compared with usual care. following this; it is also hypothesized that this will also lead to less patients' deaths. in addition the patients' satisfaction using the telemedicine service will be studied. a cost-effective analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.

Eligibility criteria:
inclusion criteria: * exacerbation of copd according to the gold guidelines * age \> 40 years * capability to use the devices provided * willing to participate exclusion criteria: included in previous copd monitoring study

Keywords: pulmonary disease, chronic obstructive telemedicine