Kornimate/medical-research-clean huggingface dataset:
role of uc-msc and cm to inhibit vision loss in retinitis pigmentosa phase i/ii

Conditions: Retinitis Pigmentosa

Summary: the study will perform uc-mscs and cm transplantation. there are two groups with different dosages. the first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. each group consists of 30 subjects. all groups will be transplanted via the peribulbar route. all groups will be observed until six months.

the eyes we will give the transplant should be given an aseptic and antiseptic technique to prevent contamination from the inside and outside. sterile cover attached to other parts of the face except for the eyes. 1.8 ml umbilical cord-derived mesenchymal stem cell (uc-msc) preparations are suspended in conditioned medium (cm) until it reaches a 2 ml volume of cell suspension. two dosages will be prepared, 1.5 million and 5 million of uc-msc. stem cell suspension will be injected by peribulbar, and patients will be given a quinolone antibiotic if the injection is done. on day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increased eye pressure. on day 7th, day 30th, and day 90th after therapy, patients will do a visual field test, visual acuity test, electroretinography, funduscopy, and optical coherence tomography examination. the observations will be written in the table and analyzed by a statistic.

Eligibility criteria:
inclusion criteria: * visus more than 20/100 * have more than 0.68 uv on conical receptor cell amplitude checked by erg * visual field equivalent diameter more than 10o * willing to sign informed consent as research subjects * willing to do the peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue * willing to do visual field checks with humphrey's perimetry, vision tests with snellen boards, optical coherent tomography (oct) examinations, electroretinogram examinations, and fill out a quality of life questionnaire exclusion criteria: * pregnant or nursing women * positive result of hiv test * have a history of eye tumors * under immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells * have another eye disease such as diabetic retinopathy, uveitis, cataract, and glaucoma * do not come to control according to the schedule determined by the researcher (loss to follow up)

Keywords: allogeneic mesenchymal stem cell umbilical cord mesenchymal stem cell conditioned medium allogeneic umbilical cord mesenchymal stem cell
quantification with lutetium-177 on cadmium-zinc-telluride camera 3d

Conditions: Prostate Cancer

Summary: the main of this study is to demonstrate the feasibility of carrying out quantitative acquisitions regardless of the energy peak considered (113 kev (kiloelectronvolts) or 208 kev or a combination of the 2 energy peaks). a study on phantom will optimise the reconstruction parameters. these parameters will then be applied to a population of patients who have already benefited from a recording on a 3d czt camera (retrospective data).

lutetium 177 is a beta emitter - and is used in therapy. it also emits during its radioactive decay, two gamma photons of energy 113 and 208 kev allowing to produce images. the dosimetry committee of the european association for nuclear medicine (eanm) recommends using only the peak at 208 kev to obtain so-called quantitative images using a conventional camera also called an anger camera. for several years, new semiconductor cameras (czt cameras) have been available in nuclear medicine departments. they offer better performances particularly in terms of detection sensitivity and energy resolution. the nuclear medicine team has already carried out studies with lutetium-177 with these semiconductor cameras on phantoms as well as dosimetry studies after treatment using lutetium-177. this study should demonstrate the feasibility of carrying out quantitative acquisitions regardless of the energy peak considered (113 kev or 208 kev or a combination of the 2 energy peaks). a study on phantom will optimise the reconstruction parameters. these parameters will then be applied to a population of patients who have already benefited from a recording on a 3d czt camera (retrospective data).

Eligibility criteria:
it is a retrospective study and the criteria to collect the imaging are: inclusion criteria: patients treated by at least one cure of lutetium vipivotide tetraxetan with imaging exclusion criteria: patient having sent an objection to the use of their data
edge-to-edge technique used as a bailout in case of sub-optimal mitral repair: very long-term results

Conditions: Mitral Regurgitation

Summary: the absence of residual mitral regurgitation (mr) after mitral valve repair is of paramount importance for the long term durability of the valve repair. thus, ideally, after weaning from cardio-pulmonary by-pass (cpb) the trans-esophageal echocardiogram (tee) should show no (or only trivial) residual mr, good coaptation length and no iatrogenic mitral valve stenosis. however, mild or more residual mr can be present in up to 4% of the patients after the initial mitral valve repair and a second cpb run may be necessary to improve the repair results. mechanism of residual mr can be dynamic, related to systolic anterior motion (sam) or to severe left ventricular dysfunction, and anatomical, related to residual prolapse, cleft, and suture or ring dehiscence. in several cases medical therapy can be effective in the management of the intra-operatively detected sam, and residual cleft or suture dehiscence can be easily corrected during a second cpb run. however, in other cases sam is not responsive to medical therapy or the residual mr jet would require complex and time-consuming techniques to be addressed, or even worse scenario, a mitral valve replacement could be necessary. in such cases the edge-to-edge (ee) technique can be used as a bail-out procedure. the anatomical characteristics of the mitral valve after an initial sub-optimal repair are certainly not ideal for the edge-to-edge technique, due to a possible significant reduction in the valve area, especially in case of posterior leaflet resection or small ring implanted. nevertheless, in the short term the edge-to-edge technique used to rescue patients with sub-optimal initial repair resulted effective. however, the very long-term results of the edge-to-edge technique used as bail-out are not known. thus, the aim of this study is to evaluate the clinical and echocardiographic results of the edge-to-edge technique used to rescue patients with initial sub-optimal mitral repair.


Eligibility criteria:
inclusion criteria: * adult patients; * patients underwent mitral valve repair, with more than mild residual mr at the intraoperative tee after leaving the cpb; * patients in whom ete alone has been added to the repair already performed, as a technique to reduce residual mr after first attempt of mitral valve repair; * patients operated both in median sternotomy or in minithoracotomy; * patients operated on at the cardiac surgery departmet of san raffaele hospital since january 1999 to december 2015. exclusion criteria: * patients in whom other techniques have been used as a bailout procedure, concurrently or instead of ete; * patients where the initial repair has been modified or undone; * patients whose mitral valve has been replaced.
mobilization with movement (mwm) on knee osteoarthritis (oa)

Conditions: Knee Osteoarthritis

Summary: movement with mobilization (mwm) is an effective manual therapy to improve pain and function of patients with knee osteoarthritis (oa). however, immediate, and prolonged effects after prolonged mwm period was under-investigated. in this double-blinded randomized control trial, 40 patients are needed. the subjects and assessors will be blinded. subjects in intervention group will receive mwm twice a week and corresponding home exercise for 6 weeks. participants in control group will only receive sham treatment with light touch. the effects on knee pain in visual analogue scale (vas); flexion and extension range of motion (rom) by goniometer; strength by hand-held dynamometer; function by timed up and go test (tug) and 30-second chair stand test; and health-related quality of life (hrqol) by knee injury and osteoarthritis outcome score (koos) and western ontario and mcmaster universities arthritis index (womac) just after, 1-month and 3-month after treatment will be compared with baseline. six-month after treatment, koos and womac will be conducted.


Eligibility criteria:
inclusion criteria: * history of knee oa for at least 1-year * pain intensity level ≥ 3 on a 10-cm visual analogue scale (vas) * both unilateral or bilateral knee pain * having morning stiffness less than 30 minutes * having crepitus on active movement * having bony tenderness * having bony enlargement exclusion criteria: * having active inflammatory or infectious knee conditions * having bone integrity conditions like osteoporosis * having knee joint instability * having skin integrity conditions like frail skin or lower limb peripheral vascular disease * history of hip or knee fracture * history of knee surgical history * use of knee corticosteroid or opioid injection
relationship between oct coronary plaque morphology and clinical outcome

Conditions: Coronary Artery Disease

Summary: the multicenter observational clima registry has been conceived to explore correlation between oct morphology of atherosclerotic plaques located in the left anterior descending artery with mid and long term clinical outcome.

acute myocardial infarction (mi) is commonly caused by plaque ulceration and subsequent local thrombosis. plaques that tend to rupture are typically characterized by a large superficial lipid pool, delimited by a thin fibrous cap and often exhibit local signs of inflammation. such atherosclerotic lesions are commonly described as vulnerable plaques (1-4). identification of these plaque features with imaging modalities is potentially a valid approach to identify patients at increased risk of m (5). optical coherence tomography is capable of visualizing superficial plaque components at a high resolution (in the range of 10-15 microns) and can depict all the features of plaque vulnerability or thrombogenicity (6,7). the aim of the study is to relate presence of multiple oct criteria of plaque vulnerability with following clinical events in a subset of coronary lesions. for this purpose all plaques in the proximal-mid portion of the left anterior descending artery will be evaluated with fd-oct assessing the following criteria: * minimum lumen area (mla) \<3.5 mm2: * fibrous cap minimum thickness \<75 µm: * lipid arc extension \>180°; * presence of macrophages;

Eligibility criteria:
inclusion criteria: * age \>18 years; * patients with clinical indication to coronary angiography undergoing oct evaluation of the left anterior descending artery regardless of the clinical syndrome; * patients with at least 30 mm of naïve oct-assessable proximal-mid left anterior descending artery; * patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent to the procedure; exclusion criteria: * female with childbearing potential or lactating; * acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl); * advanced heart failure (nyha iii-iv) * previous coronary artery by-pass surgery * previous stenting of proximal-mid left anterior descending artery with residual untreated segment \<30mm. * co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year; * participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study; * heavily calcified vessel and/or lesion which cannot be successfully imaged by oct

Keywords: optical coherence tomograhpy registry coronary artery disease
pro-active fecal calprotectin monitoring promote-uc

Conditions: Ulcerative Colitis

Summary: hypothesis: pro-active home fecal calprotectin testing in patients with ulcerative colitis will allow early detection and treatment of inflammation to prevent symptomatic flares. this will result in less steroid use, fewer hospitalizations and a reduced risk of surgery, as well as improved quality of life and adherence to medication.

previous studies have shown that fecal calprotectin (fc) may be useful to predict relapse of inflammatory bowel disease and response to treatment. current methods for measurement of fc require bringing stool samples to the laboratory or physician's office. the test is either not readily available or is expensive for patients. some patients also find it inconvenient to collect, transport and travel to return the sample. a prior study in our institution showed that only 77% of patients returned samples for processing. therefore, a home-based kit may offer greater uptake by patients as samples do not need to be returned to a lab or physician's office. regular monitoring of patients at home may allow the detection and prediction of flares before the appearance of symptoms. with earlier treatment, the risk of complications may be minimized and the quality of life for people living with this disease may be improved.

Eligibility criteria:
inclusion criteria: * patients age 19 years or older with ulcerative colitis * symptomatic remission defined as a modified partial mayo score ≤ 2 with a rectal bleeding score = 0 * able to use ibdoctm test kit which requires a smart phone with a camera and internet access to download the calapp® which interprets the measurement * able to give informed consent to the study protocol exclusion criteria: * patients experiencing a symptomatic flare * patients currently receiving therapy as part of a clinical trial * pregnancy

Keywords: ulcerative colitis fecal calprotectin
fast-track surgery in the treatment of hirschsprung's disease

Conditions: Surgery

Summary: to evaluate the safety and efficacy of hirschsprung's disease

the patients are divided into two groups：fast-track surgery combined with laparoscope group and laparoscope with traditional managements group.postoperative recovery,hospital stay,hospital cost and complcations were compared.

Eligibility criteria:
inclusion criteria: 1. surgical treatment for hirschsprung's disease 2. the first procedure for hirschsprung's disease 3. age\<14 years exclusion criteria: 1. conservative treatment for hirschsprung's disease 2. the reoperation for hirschsprung's disease 3. age\>14 years

Keywords: fast-track surgery
phase ii study of everolimus combined with octreotide lar to treat advanced gi net

Conditions: Gastrointestinal Neoplasms

Summary: the underlying hypothesis of the synergistic activity of octreotide and everolimus is based on the combination of a) a direct action of everolimus over mtor (mammalian target of rapamycin), and b) the inhibitory effect of octreotide on the igf-i (insulin like growth factor 1) system preventing the activation of the mtor system by this factor. both types of inhibition would completely cancel this signal transduction pathway, which is so important in neuroendocrine tumours. furthermore, the biological study proposed in this protocol will allow for better establishing the relationship between the activation of the igfr-pi3k-mtor signal transduction pathway (i.e., the mtor pathway stimulated by igfr) and treatment response; this information is relevant since the igfr-pi3k-mtor activation status could be a response prediction factor. this study will provide significant additional information about the efficacy of the combination treatment of everolimus with octreotide lar® in non-functioning gi net.

everolimus has been developed following two administration regimens: weekly and daily. phase i pharmacodynamic studies recommend doses of 50 mg weekly and 10 mg/daily, based on its toxicity and inhibitory effect of the mtor pathway in tumours; although the inhibition of this pathway has been demonstrated, the knowledge of response prediction factors has not been developed, in part due to the very low responses found in the population in phase i studies. these factors can be better outlined in a phase ii study, where patients who have received fewer previous treatments can respond better, and where the profile of responders and non-responders can be identified more easily.

Eligibility criteria:
inclusion criteria: * diagnosis of non-operable or metastatic non-functioning, well differentiated advanced gi net, confirmed by cytology or histology. in case of liver metastasis, neuroendocrine tumours of unknown origin are accepted. * confirmation of diagnosis of neuroendocrine carcinoma of low to intermediate histology grade * radiologically documented disease progression within 12 months prior to inclusion in the study. if the patient received anticancer treatment within the past 12 months, disease progression must be documented by radiology during or after taking this medication * adequate bone marrow. liver and renal function exclusion criteria: * previous treatment with mtor inhibitors (sirolimus, temsirolimus, everolimus, deforolimus). * patients with any serious disease and/or an uncontrolled clinical condition * patients on chronic treatment with corticosteroids or any other immunosuppressive agent

Keywords: advanced non functioning well differentiated
implementing and evaluating a social-emotional learning program for refugee children during the covid-19 pandemic

Conditions: Social Emotional Wellness

Summary: the overall goal of this overall goal is to pilot an adaptation of an established social-emotional learning program with novel wellness and covid-19 safety components that are trauma-informed and culturally-specific in a resettled refugee community. in this pilot, "empower" (emotions program outside the clinic and wellness education for refugees), the study team will assess implementation outcomes (adoption, acceptability, and feasibility) of empower with refugee children and families during the covid-19 pandemic through longitudinal evaluations and measurements of feasibility, acceptability, and attrition. the study team will also evaluate the impact of empower by assessing (a) children's social-emotional learning competence and (b) children's and family's covid-19 knowledge.

the major question that guides this research is: can an adaptation of an established social-emotional learning (sel) curriculum effectively improve social-emotional wellness for refugee children and their families? the hypothesis is that participation in this program will (a) improve children's sel competence and (b) lessen stress and improve quality of life for refugee families. the overall objective of this study is to establish and evaluate the preliminary efficacy and implementation of an adapted social-emotional learning (sel) and wellness program for refugees: empower (emotions program outside the clinic with wellness education for refugees). to achieve the two aims of this study, the study team will conduct a wait-list controlled pilot to establish and evaluate the preliminary efficacy of participation in empower by assessing (a) children's sel competence and (b) measures of mental health, stress, quality of life and wellness before and after participation in the program (aim 1). then, the study team will assess the implementation of empower with refugee children by using mixed methods to perform a summative evaluation of implementation outcomes-including fidelity, sustainability, and reach-in the afghan refugee community (aim 2).

Eligibility criteria:
inclusion criteria: * at least 1 year of schooling in the united states * must speak: pashto, dari or english * connected with the community organization: elena's light exclusion criteria: * inability to meet any of the requirements of the inclusion criteria

Keywords: refugee children
targeting normoxia in neonates with cyanotic congenital heart disease in the intra-operative and immediate post-operative period

Conditions: Hypoplastic Left Heart Syndrome; Total Anomalous Pulmonary Venous Return; Truncus Arteriosus; Pulmonary Atresia With Ventricular Septal Defect; Transposition of the Great Arteries; Double Outlet Right Ventricle, Subpulmonary VSD; Tetralogy of Fallot; Double Outlet Right Ventricle With Subaortic Ventricular Septal Defect and Pulmonary Stenosis; Cardiopulmonary Bypass

Summary: this clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery. in addition to having the various doses of oxygen, participants will also have blood samples, ultrasounds of the head, and brain wave patterns monitored. the hypotheses of this trial are: * that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group * there will be a significant difference in the measured partial pressure of oxygen (pao2) values between the two treatment groups. * the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (tbars) after cardiac surgery


Eligibility criteria:
inclusion criteria: * age less than 30 days of age at time of surgery with need for cardiopulmonary bypass with cardioplegic arrest (with or without deep hypothermic circulatory arrest) * diagnosis with cyanosis at baseline (pre-operative pao2 of less than 50mmhg) due to: * complete admixture lesion (example: hypoplastic left heart syndrome, total anomalous pulmonary venous return, truncus arteriosus, pulmonary atresia with vsd) * transposition physiology (example: d-transposition of the great arteries or double outlet right ventricle with subpulmonary vsd) * right-to-left shunt (example: tetralogy of fallot, double outlet right ventricle with subaortic vsd and pulmonary stenosis) exclusion criteria: * corrected gestation at time of surgery less than 37 weeks * prior cardiac arrest * current or prior history of extracorporeal membrane oxygenation (ecmo) support * current or prior history of needing renal replacement therapy with dialysis * prior cardiac surgery requiring cardiopulmonary bypass * diagnosis of ebstein's anomaly * known genetic syndrome other than trisomy 21 or digeorge syndrome

Keywords: open heart surgery