Kornimate/medical-research-clean huggingface dataset:
genomic evaluation in patients with diffuse large b cell lymphoma after first relapse/progression

Conditions: Lymphoma, Large B-Cell, Diffuse

Summary: dlbcl has the highest frequency out of all lymphoid malignancies. with the recent development of antitumor agents targeting intracellular/extracellular cell signaling pathways, patients have access to various treatment options after relapse. therefore, for the purpose of developing effective treatment strategies, large-scale genomic data accumulation is necessary to understand the mechanism of relapse and refractory state of dlbcl.

* to understand the mechanism of relapse by genome sequencing with tissues/blood obtained at diagnosis and relapse in patients with diffuse b cell lymphoma who relapsed after standard chemotherapy, to evaluate their response and survival following a salvage therapy depending on the genomic sequencing results, and to understand the prognostic or predictive value of genomic mutation. * to understand the predictive value of genetic information with regard to the response to salvage chemotherapy and survival outcome in patients with newly diagnosed/relapsed or refractory large b cell lymphoma * to determine the association between gene mutation, treatment response and prognosis in relapsed/refractory diffuse large b cell lymphoma (dlbcl), and to develop a clinically applicable platform by establishing a genetic data register based on prospective studies

Eligibility criteria:
inclusion criteria: * histopathologically confirmed dlbcl * dlbcl who relapsed or were refractory to first-line treatment with rituximab-based immunotherapy * available for genomic analysis of tissues both at diagnosis (paraffin-embedded and stored) and at relapse (paraffin-embedded) * aged ≥18 years * written informed consent for participation in the prospective cohort study * written informed consent to peripheral blood collection and genetic testing of human tissues exclusion criteria: * no lymphoid malignancy, e.g. myeloid leukemia * any of the following lymphoid malignancies: 1. plasma cell dyscrasia, amyloidosis 2. hodgkin lymphoma 3. subtypes of b cell non-hodgkin lymphoma, other than dlbcl 4. t or nk(natural killer) cell non-hodgkin lymphoma 5. other diseases in the who(world health organization) classification of lymphoid malignancies * experienced a relapse before * insufficient or no tissue sample at diagnosis for genomic analysis * can not understand or provide written informed consent * who do not provide written informed consent to blood collection and genetic testing
clinical evaluation of dailies total 1® multifocal compared to 1-day acuvue® moist® multifocal in a japanese population

Conditions: Refractive Error; Presbyopia

Summary: the purpose of this clinical study is to evaluate dailies total1® multifocal (dt1mf) contact lenses compared to 1-day acuvue® moist® multifocal (ammf) contact lenses for investigator-graded lens centration in a japanese population.

subjects will be randomly assigned to one of two sequences of investigational product wear ((dt1mf→ammf, ammf→dt1mf). each product will be worn in both eyes for at least 11 days.

Eligibility criteria:
inclusion criteria: * sign informed consent * habitually wear multifocal soft/ silicone hydrogel contact lenses * require a near spectacle add of +0.50 diopters (d) to +2.50d (inclusive) * correctable to 20/30 snellen or 0.2 logarithm minimum angle of resolution (logmar) or better in each eye at distance * willing to wear contact lenses and attend all study visits exclusion criteria: * currently wearing dailies total 1® multifocal or 1-day acuvue® moist® multifocal contact lenses * any eye condition that would make contact lens wear unadvisable * any use of medication that would make contact lens wear unadvisable * prior refractive surgery

Keywords: contact lenses lens centration multifocal
gadolinium contrast-enhanced abbreviated mri (amri) vs. standard ultrasound for hepatocellular carcinoma (hcc) surveillance in patients with cirrhosis

Conditions: Liver Cancer; Liver Cirrhoses; Liver Carcinoma

Summary: this study compares gadolinium contrast-enhanced abbreviated mri (amri) to standard ultrasound for hepatocellular carcinoma (hcc) screening and surveillance in subjects with liver cirrhosis.

ultrasound (us) is currently used for hcc surveillance. however, us has certain limitations, so physicians use contrast ct or mri. however, these are expensive and time-consuming procedures. we introduced an abbreviated mri (amri) exam, which works well in cirrhotic and obese patients (unlike us), involves no ionizing radiation (unlike ct), and is rapid (unlike multi-phasic mri) with total scanner times of less than ten minutes, and can be performed at about the same cost as us. this study in adult patients with cirrhosis will compare the performance of amri vs. us for detection of early-stage disease, and will help to define and validate a novel, rapid, accurate, and potentially cost-effective imaging protocol for hcc screening in high-risk individuals.

Eligibility criteria:
inclusion criteria: * subject has been fully informed and has personally signed and dated the written informed consent and health insurance portability and accountability act (hipaa) documents. * adult subjects of any gender and any ethnic group with liver cirrhosis of any etiology, * subject is able and willing to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, lab collection if needed, research amri exam, research us exam) and the three optional surveys (if subject opts in for that) within specified time windows, and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images. exclusion criteria: * va patient * \< 18 years of age * history of any liver cancer * mri contraindication(s) * subject knows that she is pregnant or states she trying to become pregnant * positive urine pregnancy test in woman of childbearing potential * nursing mother * subject has known allergy to any gadolinium agent * does not meet uc san diego intravenous contrast media guidelines for administration of eovist\* * clinical screening exam of the liver performed at ucsd within the prior 90 days to consent
laser versus surgery in anal diseases in inflammatory bowel patients

Conditions: Inflammatory Bowel Diseases; Anal Fissure; Hemorrhoids

Summary: this is a randomized comparative clinical trial carried out to compare between laser ablation and surgery in treating anal diseases in inflammatory bowel diseases patients and find out if one is superior to the other. inflammatory bowel diseases patients with anal problems were divided into 2 groups, one group had traditional surgery and the other had laser ablation for anal diseases and results were compared between the 2 groups.


Eligibility criteria:
inclusion criteria: * patients with history of inflammatory bowel disease ( non specific colitis, crohn's disease, ulcerative colitis). * patients who accidently discovered to have inflammatory bowel disease. * age group between 18 to 60 years old exclusion criteria: * informed consent refusal. * proved malignancy in inflammatory bowel disease patients * patients less than 18 years old or more than 60 years old * contraindications to general and spinal anesthesia * other types of colitis as ischemic colitis, pseudo-membranous colitis, infective colitis

Keywords: anal fissure hemorrhoids inflammatory bowel disease crohn's disease ulcerative colitis
anti-viral effect of pc786 on rsv infection on hsct recipients

Conditions: Respiratory Syncytial Virus Infections

Summary: this study tests the effects of an experimental drug pc786 in people infected with respiratory syncytial virus (rsv). pc786 may be useful in treating patients infected with rsv as it works by interfering with the way the virus multiplies. pc786 is an inhaled medicine. participants will be treated with soc treatment (e.g. oral ribavirin and/or iv immunoglobulin), half of the participants will receive pc786 in addition and half will receive a placebo treatment. the study will take place at multiple sites in uk and will include approximately 30 participants. the maximum study duration will be about 4 weeks.


Eligibility criteria:
inclusion criteria: * received an allogeneic or autologous hematopoietic stem cell transplant (hsct) using any conditioning regimen * experienced new onset of at least one of the following respiratory symptoms ≤5 days before study day 1: nasal congestion or stuffiness, runny nose (rhinorrhoea), cough, or sore throat or worsening of at least one of those symptoms, if symptoms are chronic or wheezing, sputum production, pleuritic chest pain, increased respiratory rate, signs on chest auscultation, hypoxia, increased supplemental oxygen requirement or new infiltrates on chest x-ray/ct * a positive rsv diagnostic test * provided written informed consent exclusion criteria: * is intubated and requires invasive ventilation * has received any investigational rsv vaccine after hsct, or has received any monoclonal anti-rsv antibodies within 4 months or 5 half-lives before participation * treatment with intravenous ribavirin * positive for test for influenza or parainfluenza * significant untreated bacteraemia or fungaemia * significant untreated bacterial, fungal, or viral pneumonia * precluded from participating as a result of treatment with another investigational drug or participation in another clinical trial * other disease or condition which would preclude the subject's participation in a clinical trial * is receiving an antiretroviral protease inhibitor * has chronic, active hepatitis infection * known alcohol or drug abuse

Keywords: rsv infection hematopoeitic stem cell transplant
mysmartskin online skin self-exam intervention for melanoma survivors

Conditions: Melanoma

Summary: this project, mysmartskin (mss), includes an innovative type 1 hybrid effectiveness-implementation trial designed to enhance the effects of mss and simultaneously assess key implementation outcomes (e.g., cost, adoption) as well as contextual factors important for scale-up in community and health care settings where melanoma survivors receive follow-up care. a type 1 hybrid effectiveness-implementation design allows us to engage multilevel stakeholders throughout this process, evaluate the effectiveness of the enhanced mss, and identify critical factors for wide-scale implementation. aim 1 will focus on enhancing the previous version of mss by collaborating with multi-level stakeholders in qualitative interviews and usability testing. aim 2 will evaluate the effects of enhanced mss on thorough skin-self examinations (sse) in a randomized-control trial (rct) and examine its impact on the diagnosis of new/recurrent melanomas. aim 3 will focus on assessing selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation.

this is a type one hybrid effectiveness-implementation study consisting of three aims. aim one (months 1-15) focuses on mss enhancement using stakeholder collaboration. aim two (months 16-60) involves the longitudinal randomized control trial (rct) comparing behavioral outcomes and effectiveness of enhanced mss versus an educational webpage. aim three (months 16-60) will assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation.

Eligibility criteria:
inclusion criteria: * diagnosis of primary pathologic stage 0-iii cutaneous malignant melanoma * three months to five years post-surgery * no current evidence of cancer * not adherent to thorough sse (i.e., did not check entire body at least once during the past three months) * ≥ 18 years old * internet access * able to speak/read english * able to provide informed consent exclusion criteria: * children

Keywords: self-examination
comparison of the effect of preemptive and post-operative erector spina plane block on intraoperative opioid consumption and postoperative analgesia in patients who will undergo elective thoracotomy surgery, guided by the nociception level index (nol)

Conditions: Erector Spina Plan Block; Preemptive Analgesia; Thoracotomy; Nociception Level Index(NoL)

Summary: the patients who will participate in the study will be determined and informed according to the inclusion and exclusion criteria, and the patients who signed the informed consent form will be included in the study.52 patients who will undergo elective thoracotomy surgery will be divided into double-blinded 2 sided as preemptive and postoperative erector spina plane block. intraoperative pain status of the patients will be determined by the "nociception level index" device and analgesia will be provided with fentanyl. the primary aim of the study is to compare the intraoperative opioid consumption of two groups with plan block at different times. in the postoperative period, patient-controlled analgesia device will be given to both groups for rescue analgesia. the opioid consumption of the patients will be controlled in this way in the postoperative period and their pain status will be determined. the secondary aim of the study is to examine the effect of plan block application time on the postoperative period.


Eligibility criteria:
inclusion criteria: * age between 18-65 years * asa classification \<4 * no history of allergy or hypersensitivity to the drugs we use throughout the procedure * bmi ≤ 35 * no history of neuropathy * surgeries other than emergency surgery * volunteer for the study * no presence of infection at the injection site * no any pyschiatric disease that would prevent the evaluation of the pain score exclusion criteria: * under the age of 18 or over the age of 65 * asa classification ≥ 4 * history of allergy or hypersensitivity to the drugs we use throughout the procedure * bmi \> 35 * history of neuropathy * undergoing emergency surgery * not be a volunteer for the study * presence of infection at the injection site * having a pyschiatric disease that would prevent the evaluation of the pain score * pregnancy * undergo surgery again during the postoperative follow-up period for any reason

Keywords: preemptive analgesia erector spina plan block nociception level (nol) index thoracotomy opioid consumption
a study of usage of brigatinib in the treatment of adult participants for approved indications in south korea

Conditions: Carcinoma, Non-Small-Cell Lung; Anaplastic Lymphoma Kinase

Summary: the purpose of this study is to estimate the proportion of all adverse events (aes) including serious adverse events (saes) occurring with the use of brigatinib among adult participants who have been administered brigatinib as per the approved indications.

this is a prospective observational post-marketing surveillance study of participants with alk-positive nsclc who initiate treatment for the first time with brigatinib in a routine clinical practical setting. the study will characterize the safety and effectiveness of brigatinib for its approved indications under real world use. the study will enroll approximately 257 participants. the data will be prospectively collected, at the centers from routinely scheduled and emergency visits until end of follow up, and recorded into electronic case report forms (e-crfs). all participants will be assigned to a single observational cohort. this multi-center study will be conducted in the south korea. the overall duration of this study is approximately 6 years. data will be collected over and up to a 24 month-surveillance period (per participant) once enrolled.

Eligibility criteria:
inclusion criteria: 1. with alk-positive advanced or metastatic nsclc. 2. who initiate brigatinib for the first time. exclusion criteria: 1. treated with brigatinib outside of the locally approved label in korea. 2. whom brigatinib is contraindicated as per product label. 3. participating in other clinical trials of nsclc treatment.

Keywords: drug therapy
general anesthesia versus awake surgery in resection of gliomas and metastases of motor areas

Conditions: Gliomas Benign; Glioma, Malignant; Metastases to Brain

Summary: objective of the study is to determine whether resection of gliomas and metastases of motor areas using awake surgery can achieve rarer motor deterioration after operation than using general anesthesia.

awake surgery is usually used for tumor resection located in language areas. but patient's awakening during removal of mass lesions from motor areas can give additional opportunities. besides checking of muscle contractions and integrity of motor fibers a surgeon in awake patient can assess planning of movements, praxis, visual feedback and vestibular processing of motions. preserving of voluntary movements can be an additional proof that cortical motor centers and corticospinal tract were not damaged. at the moment there are no published results of randomized trials showing advantage of awake surgery in removal of mass lesions from motor brain areas. objective of the study is to determine whether resection of gliomas and metastases of motor areas using awake surgery can achieve rarer motor deterioration after operation than using general anesthesia. participants of the study will be randomly operated using awake surgery or general anesthesia. in both groups intraoperative neuromonitoring will be used. dynamics of motor functions will be assessed before and after surgery by blinded neurologists.

Eligibility criteria:
inclusion criteria: * single gliomas without contrast enhancement in preoperative magnetic resonance imaging (presumed low-grade gliomas) * single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas) * one or several brain metastases from any cancer * location near primary motor area or corticospinal tract * newly diagnosed * karnofsky performance status 60-100% * muscle strength in assessed limbs 3-5 points in medical research council scale * age 18-69 years * body mass index 29 and less * hemoglobin 110 and more * platelets 100 and more * international normalized ratio less than 2,0 * presumed blood loss no more than 8-10 percents of circulating blood volume (no more than 450-650 milliliters) exclusion criteria: * chronic obstructive pulmonary disease * persistent smoker (smoking index 11 and more) * major comorbidities * implanted pacemaker * inability to perform intraoperative tests before surgery * severe aphasia * psychiatric disorders * barely controlled seizures * contraindications to magnetic resonance imaging * previously performed brain radiotherapy * pregnancy * breast feeding

Keywords: contrast-enhancing glioma non-enhancing glioma brain metastasis awake surgery general anesthesia motor area
cmv-tcr-t cells for refractory cmv infection after hsct

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; CMV Infection

Summary: this is a single centre, single arm, open-label, phase i study to evaluate the safety and effectiveness of cmv-tcr-t cell immunotherapy in treating refractory cmv infection after hsct.

cmv infection is a major and potentially life-threatening complication after allogenic hematopoietic stem cell transplantation (allo-sct). pharmacotherapy with ganciclovir and foscarnet remains the mainstay of treatment and has significantly improve clinical results, however, it is unsatisfactory owing to toxicity, limited efficacy and risk of developing resistance. in recent years, adoptive t cell therapy has been proposed as an alternative option for cmv infection after allo-sct. however, patients with transplants from cmv-negative donors are at highest risk, and an adoptive therapy is missing because cmv-specific t cells are not available. cmv tcr-transduced donor-derived t cells (cmv-tcr-t cells) is an attractive strategy to specifically redirect t-cell immunity toward cmv. in this prospective clinical phase i trial, we propose to evaluate the safety and efficacy of stem cell donor-derived cmv-tcr-t cells for patients with refractory cmv infection after allo-sct. donor derived cmv-tcr-t(hla-a\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.3-1×10e7cmv-tcr-t cells. the cmv dna copies and cmv-tcr-t cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).

Eligibility criteria:
inclusion criteria: 1. patients with acute leukemia (al) or myelodysplastic syndrome (mds) who receive haploid allogeneic hematopoietic stem cell transplantation, pre-transplantation assessment ≤cr2; 2. age 18-60, including boundary value, gender unlimited; 3. refractory cmv infection occurred in the early stage of transplantation : after 2 weeks of standard antiviral treatment, the cmv dna copy number continued to be ≥1000 copies/ml, and the cmv dna copy number at the beginning of the treatment decreased by \<log10 ； 4. the transplant donor's hla-a matching is one of 2402, 0201 or 1101, and the physical examination is qualified; 5. ecog ≤ 3, estimated life expectancy\> 3 months; 6. patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures. exclusion criteria: 1. patients with active agvhd iii-iv and / or mild and severe cgvhd; 2. have received cell therapy such as dli, ctl, car-t, nk or participated in any other clinical research on drugs and medical devices; 3. patients who have developed cmv disease; 4. patients with organ failure: * heart: nyha heart function grade iv; * liver: grade c that achieves child-turcotte liver function grading; * kidney: kidney failure and uremia; * lung: symptoms of respiratory failure; * brain: a person with a disability; 5. pregnant or lactating women; 6. the researchers found that it was unsuitable for the recipients to be enrolled.
longitudinal study for relapsing polychondritis

Conditions: Relapsing Polychondritis; Vasculitis

Summary: relapsing polychondritis (rp) is a rare systemic inflammatory disease characterized by recurrent inflammation of cartilage including ears, nose, tracheobronchial tree, chest wall and joints. less commonly, it can cause inflammation of eyes, vasculature, nervous system, skin and inner ear. the purpose of this study is to study the pathogenesis of rp.

relapsing polychondritis (rp) is a rare systemic inflammatory disease characterized by recurrent inflammation of cartilage including ears, nose, tracheobronchial tree, chest wall and joints. less commonly, it can cause inflammation of eyes, vasculature, nervous system, skin and inner ear. there is variability in organ-system involvement and the disease course is relapsing making the diagnosis challenging. delay in diagnosis can lead to end-organ damage and significant morbidity and mortality. there are no biomarkers or blood tests that can assist with assignment of a diagnosis. development of this longitudinal cohort and multicenter approach offers the potential to generate new insights and generate new questions regarding the immunology of the disease. attainment of a better understanding of the mechanisms and trajectory of inflammation may yield insights into potential new diagnostic and treatment strategies. study visits will occur every 6 months, or annually. blood and urine collection will occur at every visit. a physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.

Eligibility criteria:
inclusion criteria: * 1. any subject considered to have a diagnosis of relapsing polychondritis according to the investigator. exclusion criteria: * 1. inability to provide consent, or in the case of minors, assent.

Keywords: rp