Kornimate/medical-research-clean huggingface dataset:
mesenchymal stem cell transplantation for acute-on-chronic liver failure

Conditions: Acute-On-Chronic Liver Failure

Summary: mesenchymal stem cells (msc) has been reported to improved outcomes of acute-on-chronic liver failure(aclf). more randomization controlled studies are needed to confirm the effect of msc treatment for aclf. this study aimed to investigate the efficacy of mesenchymal stem cells in aclf patients. this study is an double-blind multicenter randomized and placebo-controlled study. patients with with aclf will be randomly assigned to receive msc treatment (experimental) or standard medical treatment (control). three times of msc infusion (0.1-1x10e6cells/kg body weight) via peripheral vein will be given to the experimental group (once per week). the primary outcome is 12 week mortality. secondary outcomes are clinical remission rate and changes of liver function indices and liver function scores.


Eligibility criteria:
inclusion criteria: * age between 18-70 years old * meeting the criteria of aclf defined as: 1. definitive chronic liver diseases, acute decompensation within 4 weeks; 2. significant gi symptom as such fatigue, jaundice,; 3. total bilirubin (tbil) ≥170 µmo1/l or daily increase of tbil ≥17.1 µmo1/l; 4. pta≤40% or inr≥ 1.5; 5. decompensation of liver functions such as ascites or hepatoencephalopathy; * meld score between 17-30. (meld(i) = 0.957 × ln(cr) + 0.378 × ln(bilirubin) + 1.120 × ln(inr) + 0.643) * chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases * informed consent exclusion criteria: * sever complications with 30 days ( gi bleeding, severe infection)； --liver cancer or other malignancies * patients on liver transplantation list * patients with uncontrolled infections * severe renal failure * severe chronic obstructive pulmonary disease copd (gold iii-iv) * extrahepatic cholanstasis patients due to biliary obstruction. * hiv infection * pregnant or breast-feeding females. * enrolled in other clinical trials with 3 months * other conditions considered inappropriate for the study

Keywords: acute-on-chronic liver failure, mesenchymal stem cell,
trial of endobronchial ultrasound guided fine needle aspiration techniques

Conditions: Lung Cancer

Summary: endobronchial ultrasound-guided transbronchial fine needle aspiration (ebus-tbna) techniques have not been well studied. the investigators will conduct a randomized study comparing the diagnostic yield and specimen quality of ebus-fna performed with and without suction applied.

consecutive patients with suspected malignant peribronchial masses or lymph nodes undergoing endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) will be enrolled. all participants will have 4 needle aspirations of each targeted peribronchial lesion. two needle aspirations will be performed while applying suction and 2 needle aspirations will be performed without applying suction in random order. the investigators will compare the diagnostic yield and the quality of the specimens obtained using the two techniques.

Eligibility criteria:
inclusion criteria: * adult undergoing ebus at aubmc for suspected malignancy exclusion criteria: * coagulopathy * the lesion cannot be sampled because of intervening tumor or blood vessels.
lubricating eye drops after routine cataract surgery

Conditions: Dry Eye; Cataract

Summary: patient satisfaction and dry symptoms in patients undergoing routine uncomplicated cataract surgery in nhs patients treated with prophylactic phosphate-free, preservative-free lubricant eye drops (0.3% cross linked sodium hyaluronate, aeontm protect plus and0.15% sodium hyalu-ronate with vitamins a and e, aeontm repair): a randomized, prospective, controlled study.

the aim of this study is to investigate the routine use of such lubricating drops in a randomized, prospective methodology in patients undergoing uncomplicated cataract surgery in the nhs setting. as these drops are provided with the intraocular lens, if found to be of benefit in reducing dry eye problems such a study might provide evidence for the universal implementa-tion of post-operative ocular lubricant drops

Eligibility criteria:
inclusion criteria: 1. bilateral or unilateral cataracts requiring surgical intervention 2. age over 18 years 3. able to understand informed consent and the objectives of the trial 4. not pregnant, not breast feeding 5. no previous eye surgery exclusion criteria: 1. age-related macula degeneration 2. glaucoma 3. previous retinal vascular disorders 4. previous retinal detachment or tear 5. any neuro-ophthalmological condition 6. any inherited retinal disorder or pathology 7. previous strabismus surgery or record of amblyopia 8. previous tia, cva or other vaso-occlusive disease 9. already enrolled in another study 10. already on prescribed lubricating drops
predictive octa biomarkers after endoscopic endonasal pituitary surgery

Conditions: Pituitary Adenoma

Summary: this study evaluates the structural parameters, by spectral domain optical coherence tomography (oct), retinal vessel density, using oct angiography, and visual acuity in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

the primary outcome was to detect the changes in visual acuity, retinal structural and vascular features at 48 hours and 1 year after endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve. the secondary outcome was to identify potential biomarker that could predict the functional recovery at 1 year follow up.

Eligibility criteria:
inclusion criteria: * age older than 40 years * diagnosis of pituitary adenoma * treatment-naïve with endoscopic endonasal pituitary surgery * absence of other neurological diseases * absence of vitreoretinal and vascular retinal diseases exclusion criteria: * age younger than 40 years * no diagnosis of pituitary adenoma * previous treatments with endoscopic endonasal pituitary surgery * presence of neurological diseases * presence of vitreoretinal and vascular retinal diseases
effect of a multi-directional power toothbrush on recession

Conditions: Gingival Recession

Summary: background: clinical studies have explored the relationship between toothbrushing and the development of recession, but relevant recession data for the multi-directional power toothbrush (pt) are lacking. the aim of this study was to evaluate the effect of brushing with either a multi-directional power toothbrush (pt) or an ada (american dental association) reference manual toothbrush (mt) on pre-existing mid-buccal gingival recession (pre-gr) over 12 months methods: this was a 12-month, prospective, single-blind, parallel-group, randomized controlled clinical study. healthy participants without periodontitis but with at least 2 teeth showing pre-gr ≥2mm were randomized to a group either brushing with a mt or a pt. the primary outcome parameter was the change at sites with pre-gr ≥2mm. all recession measurements were performed by one calibrated examiner at baseline, 6 and 12 months. secondary outcomes were changes of recession at all buccal sites (with or without pre-gr), changes in the percentage of recession sites demonstrating a change of ≥1mm as well as changes in pocket probing depths.


Eligibility criteria:
inclusion criteria: * 18 scorable teeth without orthodontic appliances or crowns and bridges * at least 2 teeth showing recession of ≥ 2 mm on the mid-buccal surfaces (high risk teeth) exclusion criteria: * evidence of neglected dental health * periodontitis and/or major hard/soft tissue lesions * any physical limitations or restrictions potentially interfering with normal oral hygiene * therapy with any drug within 28 days prior to the study * pregnancy or breast feeding * any systematic condition or significant illness

Keywords: multi-directional power toothbrush manual toothbrush
forced oscillations for diagnosis help in bronchiolitis obliterans syndrome in post bone marrow transplantation

Conditions: Bronchiolitis Obliterans; Bone Marrow Transplantation

Summary: a study to evaluate the role of forced oscillations in diagnosis of bronchiolitis obliterans syndrome in patients after bone marrow transplantation. the force oscillations technique will be compared with classical spirometry.


Eligibility criteria:
inclusion criteria: * patients over 18 years * bone marrow or hematopoietic stem cells transplantation for more than 100 days * clinical stability * patients affiliated to a social security system * patients having given his (her) written consent. exclusion criteria: * bronchiolitis obliterans already diagnosed * unresolved respiratory infection * unresolved mechanical complication (pneumothorax, effusions) * medicinal pneumopathy * inability to perform pulmonary function tests
study on the safety and effectiveness of the snowytm pfo closure system

Conditions: Patent Foramen Ovale

Summary: to evaluate the safety and effectiveness of the snowytm pfo closure system in plugging patent foramen ovale

a prospective, multicenter, randomized controlled clinical trial is conducted to evaluate the safety and effectiveness of pfo closure system produced by hangzhou dinova ep technology co., ltd.., ltd. in closing patent foramen ovale (pfo). 242 patients are expected to be selected. they are randomly divided into the pfo closure system treatment group (121 cases) and the chinese medicine shengjie cardi-o-fix pfo occluder treatment group (121 cases) according to 1:1. all patients will be followed up to 7 days after operation or before discharge, 1 month, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year.

Eligibility criteria:
inclusion criteria: 1. age: 18 to 65 years old, regardless of gender 2. transthoracic echocardiographic contrast echocardiography (ctte) confirmed the presence of pfo and at least moderate (see above definition) rls (in valsalva active/resting state) 3. existence of at least one of the following conditions： 1) unexplained stroke or tia 2) intractable or chronic migraine 4. the subjects are informed of the nature of the study and agreed to all requirements for participation in the study, signed the informed consent form, and agree to complete the follow-up and follow-up examination exclusion criteria: 1. patients have definite causes of stroke unrelated to the pfo 2. rls caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt 3. atrial fibrillation or atrial flutter 4. mitral and aortic stenosis or severe regurgitation 5. dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy 6. active endocarditis or other untreated infectious diseases 7. left ventricular ejection fraction (lvef) \< 40%, or nyha cardiac function grade iii-iv 8. uncontrollable hypertension 9. previous intracardiac surgery 10. myocardial infarction or unstable angina pectoris within 6 months 11. contraindications to anticoagulants or antiplatelet drugs 12. high risk of bleeding 13. severe liver function impairment（alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 3 times the upper limit of normal value） 14. serum creatinine greater than 2 times the upper limit of normal or with any history of renal dialysis or renal transplantation 15. severe pulmonary disease including pulmonary hypertension (clinical diagnosis) 16. nickel or contrast allergy 17. active or planned (within 12 months) pregnancy, or lactating female patients 18. malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months 19. psychiatric conditions that may interfere with medical compliance and compliance with follow-up 20. concomitant participation in other clinical trials 21. the investigator determines that the patient is unsuitable because of reasons not listed but thought to interfere with safe trial participation
virtual therapy in rehabilitation spastic hemiparesis

Conditions: Stroke

Summary: evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic muscles of patients with sequelae of stroke.

considered the second most frequent cause of death worldwide , the stroke is also responsible for the largest number of functional disability in individuals. the socio - economic hardship that many patients face to perform a program of intensive rehabilitation sensorimotor, has led to functional limitations in many cases , promote irreversible consequences. spasticity in the upper and lower limb after stroke results in loss of function and mobility being the key therapeutic approaches in order to restore its function. currently, the virtual therapy has been used in physical therapy, demonstrating safety, feasibility and potential to facilitate the effective rehabilitation treatment, promoting motor recovery. the objective of this study is to analyze and compare the effectiveness of virtual therapy and conventional physiotherapy in paretic upper and lower limbs of patients with sensory motor deficit after stroke. virtual therapy will be based on a custom application using virtual reality projection, and conventional treatment will be based on cinesiotherapy for members upper and lower paretic. the evaluation will be performed by biomedical instrumentation using dynamometry, electromyography and analysis from functional movement. statistical differences are based on t test with significance level of p 0 , 05 . as a result expected - scientifically proven the effectiveness of this new form of treatment aimed at improving quality of life and functional independence of patients with neurological sequel.

Eligibility criteria:
inclusion criteria: * medical referral for physiotherapy; * maximum grade 2 spasticity in the upper and lower limbs according to the modified ashworth scale; * total passive range of elbow joint and knee to the movement of flexion and extension; * independent ambulation, with or without support; * cognitive preserved, being able to respond to the command of the examiner; * least 6 months of injury; exclusion criteria: * active infection, and rash at the site of application of nmes; * visual and hearing impairment; * joint stiffness and musculoskeletal injuries of the elbow and knee, * inability to interpret the therapeutic resources to be displayed; * presenting lesions in areas of wernick and drill; * uncontrolled hypertension.

Keywords: stroke spasticity physiotherapy virtual reality
a clinical study to assess the gingivitis effects of various dentifrices

Conditions: Gingivitis

Summary: the objective of this learning clinical study is to assess the gingivitis effects of four different dentifrices over a 3-month period.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * be in general good health as determined by the investigator based on a review of the health history/update for participation in the trial; * have at least 16 gradable teeth; * have mild to moderate gingivitis with a range of 10% to 70% bleeding sites; * agree to return for scheduled visits and follow the study procedures; * agree to refrain from use of any non-study oral hygiene products for the duration of the study; * agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study. exclusion criteria: * having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the baseline visit; * have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; * removable oral appliances; * fixed facial or lingual orthodontic appliances; * self-reported pregnancy or lactation; * any diseases or condition that might interfere with the safe participation in the study; and * inability to undergo study procedures.
open-label pharmacokinetic study of iron isomaltoside 1000 (monofer®) administered as single bolus injections in subjects with stage 5 chronic kidney disease on dialysis therapy (ckd-5d)

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to assess pharmakokinetic properties of iron isomaltoside 1000 (monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with stage 5 chronic kidney disease on dialysis therapy (ckd-5d).


Eligibility criteria:
inclusion criteria: 1. men and women, aged more than 18 years. 2. weight above 50 kg. 3. subjects diagnosed with ckd-5d and on dialysis therapy for at least 90 days prior to inclusion. 4. serum ferritin ≤ 800 ng/ml. 5. transferrin saturation ≤ 35%. 6. life expectancy beyond 12 months by principal investigator's judgement. 7. hb concentrations ≥10.0 g/dl and ≤12.5 g/dl both at screening visit 1a and at screening visit 1b (screening visit 1a and visit 1b must be separated by at least 1 week). 8. erythropoiesis stimulating agent (esa) treatment (to be kept constant during the study period and for 4 weeks prior to inclusion with only one missed dose to be allowed during this pre-entry period). 9. subjects in maintenance iron therapy with average iron administration ≤ 100 mg/week for 4 weeks prior to inclusion and willingness to switch to investigational product. 10. willingness and ability to participate after informed consent (including hipaa, if applicable). exclusion criteria: 1. anemia caused primarily by other factors than renal related anemia. 2. iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis). 3. difference of hb ≥ 1.0 g/dl between screening visits 1a and 1b. 4. known hypersensitivity to any excipients in the investigational drug products. 5. subjects with a history of multiple allergies. 6. decompensated liver cirrhosis and history of hepatitis b or c \[alanine aminotransferase (alt) \> 3 times upper limit of normal\]. 7. acute or chronic infections (assessed by clinical investigator judgment), supported by white blood cells (wbc) and c-reactive protein (crp). 8. rheumatoid arthritis with symptoms or signs of active joint inflammation. 9. pregnant or nursing women. 10. women of child bearing potential who are not using safe contraceptive methods (e.g. intrauterine device, oral contraceptives or surgically sterilized) or who are planning to become pregnant within the study period. 11. blood transfusion within the previous 12 weeks. 12. planned elective surgery during the study where significant blood loss is expected. 13. participation in any other clinical trial within 3 months prior to screening. 14. untreated vitamin b12 or folate deficiency. 15. any other medical condition that, in the opinion of principal investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. examples include uncontrolled hypertension, unstable ischemic heart disease or uncontrolled diabetes mellitus.

Keywords: chronic kidney disease ckd stage 5 iron deficiency
deep sclerectomy vs xen in solo procedure

Conditions: Glaucoma

Summary: glaucoma is the leading cause of irreversible blindness in the world and the second leading cause of blindness after cataract after the age of 50. lowering intraocular pressure (iop) is the only treatment option to prevent visual field degradation. while medical treatment and selective laser trabeculoplasty are considered first-line options in open-angle glaucoma, the surgical option is considered in patients who have uncontrolled iop under maximal tolerated medical treatment. in this situation, trabeculectomy or deep nonperforating sclerectomy may be performed. although it is uncertain whether spnp is superior to trabeculectomy, which is considered the gold standard of surgery, spnp is a procedure that offers a better quality of life and fewer intra- and postoperative complications. spnp was first described by zimmerman. it consists in peeling off the internal wall of schlemm's canal and the juxta-canalicular trabeculum which represent the main resistances to the evacuation of the aqueous humor. the trabecular meshwork is left intact and acts as a filter membrane between the subconjunctival space and the anterior chamber. the addition of mitomycin (mmc) is necessary because it is associated with better iop control and greater surgical success. although postoperative procedures such as needling or nd:yag laser-assisted gonioponctures are often required, spnp offers good long-term results in patients who are naïve to any filtering surgery. minimally invasive surgery has been used more and more over the last 10 years. it aims to reduce surgical complications in comparison to classical filtering procedures while respecting the eye's own anatomy. several devices have been invented to increase aqueous humor elimination. they can be implanted ab-interno or ab-externo and can be implanted in the suprachoroidal space, in schlemm's canal or in the subconjunctival space. the xen gelstent (allergan, dublin, ireland) is placed ab-interno between the subconjunctival space and the anterior chamber, either in combination with cataract surgery or as a solo procedure. the aim of the study is to compare the surgical success of these 2 techniques. no study has ever compared these 2 surgeries in solo procedure. a recent retrospective trial compared them in combined procedures without showing significant differences in iop reduction. nevertheless, the short follow-up period of 9 months may have been insufficient to show a real difference.


Eligibility criteria:
inclusion criteria: * patient whose age ≥ 18 years * patient with primary or secondary open angle glaucoma * patient who has undergone a spnp or xen procedure in solo * french speaking patient exclusion criteria: * angle closure * less than 6 months follow-up * history of eye filtering surgery included * patient under guardianship or curatorship * patient deprived of liberty * patient under court protection * patient objecting to the use of his/her data for this research