Kornimate/medical-research-clean huggingface dataset:
prospective randomized controlled trial of vr cognitive training in reducing postoperative delirium in elderly patients with cerebral small vessel disease undergoing non-cardiac surgery

Conditions: Postoperative Delirium (POD); Cerebral Small Vessel Diseases

Summary: this clinical study investigates whether virtual reality (vr)-based cognitive training can help prevent postoperative delirium (pod) in elderly non-cardiac patients with pre-existing cerebral small vessel disease (csvd). with the global aging population undergoing more surgical procedures, pod has emerged as a serious complication in surgical patients that can prolong hospital stays and increase the risk of developing alzheimer's disease. the study utilizes an innovative vr system that combines eye-tracking cognitive assessment with interactive rehabilitation games to evaluate and train patients' cognitive function before non-cardiac and non-intracranial operations. conducted at peking university third hospital and first hospital, this research specifically targets patients undergoing general surgery, orthopedic surgery and other non-intracranial/non-cardiac procedures to determine if this technology-based intervention can effectively reduce pod incidence in this population while exploring its underlying mechanisms. the findings could lead to a practical solution for protecting cognitive health in elderly patients undergoing routine surgical procedures during recovery


Eligibility criteria:
inclusion criteria: age ≥ 65 years; preoperative mri diagnosis of cerebral small vessel disease (csvd); scheduled to undergo non-cardiac, non-intracranial procedures under general anesthesia; expected surgery duration \> 2 hours; asa physical status classification: i-iii; no use of cognitive-enhancing medications within 3 months prior to surgery; willing to participate and provide written informed consent. exclusion criteria: contraindications to cranial mri (e.g., cardiac pacemaker, metallic implants, etc.); patients experiencing subjective discomfort (dizziness, nausea, vomiting) during vr device adaptation; severe visual or auditory impairment; severe hepatic or renal dysfunction; pre-existing neuropsychiatric disorders (schizophrenia, epilepsy, parkinson's disease, delirium, etc.); inability to complete preoperative neuropsychological assessments (dementia, deaf-mutism, communication disorders); history of cerebrovascular events (stroke, transient ischemic attack, etc.) within 3 months prior to surgery; current use of sedatives/antidepressants or history of psychoactive substance abuse/alcoholism.

Keywords: postoperative delirium cerebral small vascular disease virtual reality cognitive function
pt005 mdi dose ranging versus foradil aerolizer study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of inhaled pt005 mdi compared to placebo and foradil aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
key inclusion criteria: * signed written informed consent * 40 - 80 years of age * clinical history of copd with airflow limitation that is not fully reversible * females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods * current/former smokers with at least a 10 pack-year history of cigarette smoking * a measured post- bronchodilator fev1/fvc ratio of \< or = 0.70 * a measured post- bronchodilator fev1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values * able to change copd treatment as required by protocol * demonstratead reversibility to short acting beta agonist (ventolin hfa) (\> 12% and \>150 ml improvement in baseline fev1 approximately 30 minutes following administration of 4 puffs of ventolin hfa or \> 200 ml improvement in baseline fev1 30 minutes following administration of 2 puffs of ventolin hfa) key exclusion criteria: * women who are pregnant or lactating * primary diagnosis of asthma * alpha-1 antitrypsin deficiency as the cause of copd * active pulmonary diseases * prior lung volume reduction surgery * abnormal chest x-ray (or ct scan) not due to the presence of copd * hospitalized due to poorly controlled copd within 3 months of screening * clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ecg, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) * cancer that has not been in complete remission for at least 5 years * treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives other inclusion/exclusion criteria as defined by the protocol

Keywords: copd
endoscopic submucosal dissection (esd) versus endoscopic mucosal resection (emr) for large non pedunculated colonic adenomas: a randomized comparative trial

Conditions: Colonic Polyp

Summary: initially developed in japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (esd) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. it allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% however, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for wf-emr) and longer. submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by wf-emr. scientific debate is agitating the western world1,2 and japanese experts do not perform wf-emr anymore, whereas no comparative prospective study has compared these two procedures. we therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon.


Eligibility criteria:
inclusion criteria: * patient suffering from non-pedunculated polyp suspected larger than 25 mm in the colon * colon localization beyond 15 cm of the anal margin. * indication for endoscopic treatment * patients aged ≥ 18 years old * patients able to fill in questionnaires written in french exclusion criteria: * prior endoscopic resection attempt * contra-indication to colonoscopy * contra-indication to general anesthesia * inability to stop antiplatelet agents and anti-coagulant according to the european society of gastro-intestinal endoscopy guidelines. * recurrent adenoma: post-endoscopic or surgical resection * pregnant or lactating women * genetic polyposis (familial adenomatous polyposis, lynch syndrome, peutz-jeghers syndrome) * inability to provide informed consent * patient under legal protection and or deprived of liberty by judicial or administrative decision * patient already participating in an interventional clinical research protocol * patient who cannot be followed for the duration of the study * non-pedunculated polyp ≤ 25 mm * more than one lesion \> 25 mm that fulfilled the inclusion criteria * suspicion of deep submucosal cancer by analysis of macroscopic appearance (paris 0-iii), vascular pattern and pit pattern (sano iiib, kudo vn) * non granular pseudodepressed laterally spreading tumors due to the high risk of nonvisible submucosal cancer * polyp involving the appendice deeply (type 2 or 3 of classification of toyonaga) * polyp inside the ileo-caecal valvula * tattoing under the lesioninflammatory bowel disease with expected fibrosis (crohn disease or ulcerative colitis) * colon localization \< 15 cm of the anal margin. * polyp invading a diverticulum * pedunculated polyp * absence of lesion

Keywords: colonic polyp large non pedunculated colonic adenoma endoscopic submucosal dissection endoscopic mucosal resection
bioavailability of bimatoprost ophthalmic solution in human aqueous.

Conditions: Cataract

Summary: the purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs. hypothesis:bimatoprost is not metabolized to a prostaglandin f-2-alpha analog in human eyes * bimatoprost levels in human aqueous peak approximately three hours post dosing

the purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs

Eligibility criteria:
inclusion criteria: * all subjects must: 1. be willing and able to provide written informed consent. 2. be able and willing to follow instructions and likely to complete the entire course of the study. 3. be male or female of any race at least 18 years of age. 4. have visually significant cataract for which they have elected to undergo cataract surgery.. exclusion criteria: * no subject may: 1. have any contraindication to use of a prostaglandin analog or prostamide derivative. 3. have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). patients with mild chronic blepharitis, age-related macular degeneration, background diabetic retinopathy may be enrolled at the discretion of the investigator. 4. have laser or any other intraocular surgery within the past three months. 5. require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears. patients may not have a history of ever having used a prostaglandin analog topically. 6. have known allergy or sensitivity to the study medications or their components 7. have corneal abnormalities that would interfere with the ability to obtain an adequate sample safely or have a shallow anterior which would make obtaining an aqueous sample difficult at the time of surgery in the opinion of the investigator. 8. be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study. 9. be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation). 10. have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.

Keywords: cataract human aqueous
investigation of embryoscopy in recurrent pregnancy loss

Conditions: Recurrent Miscarriage

Summary: the purpose is to test the value of embryoscopy in women with missed abortions after recurrent miscarriages (at least two previous miscarriages) in the past. this project will assess two functions of embryoscopy:- 1. whether embryoscopy allows the diagnosis of structural anomalies (disorganized embryos). this is a fetal cause of embryo loss which cannot be diagnosed by other means. 2. whether embryoscopy allows an accurate biopsy of embryonic tissue for karyotyping. however, it may be that embryoscopy will be found to have no advantage.

in this project, embryoscopy will be evaluated in women with missed abortions (pregnancies which have ceased developing and in which the embryo is dead), after at least two previous (recurrent) miscarriages. the procedure will have two main purposes:- to allow the diagnosis of structural anomalies (disorganized embryos), and to allow an accurate biopsy of embryonic tissue for karyotyping. hence, this procedure will lead to a more accurate diagnosis of the cause of recurrent miscarriage. after confirmation of missed abortion by ultrasound, dilatation and curettage (d\&c) is normally performed under general anesthetic to evacuate the uterus in missed abortions. in this project embryoscopy will be added to the standard d\&c. an 8mm hysteroscope with irrigation channel and 300 view will be used with continuous saline flow. the embryo will be visualized, and the findings recorded. biopsies will be taken for chromosomal analysis from the embryo and the placental villi. embryoscopy will be performed with a hysteroscope which is in normal clinical use for investigating the uterine cavity, but for a slightly different indication. the first stage will be a pilot study on 20 patients to judge the value of embryoscopy.

Eligibility criteria:
inclusion criteria: * recurrent miscarriage, (at least 2 consecutive miscarriages) * confirmation of missed abortion by ultrasound * at least 5 1/2 weeks of gestation * d \& c is clinically indicated exclusion criteria: * sporadic miscarriages * less than two consecutive miscarriages. * if d \& c is not clinically indicated

Keywords: embryoscopy recurrent miscarriage missed abortion structural anomalies in recurrent miscarriage embryoscopically directed biopsy for karyotyping
rapid autopsy protocol for patients with small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: this is pilot study to establish a rapid autopsy program in small cell lung cancer (sclc) at the indiana university simon comprehensive cancer center and outline the components necessary for tumor tissue collection.

the goal of this project to establish a rapid autopsy program in sclc at the iusccc and outline the key components necessary for tumor tissue acquisition. this proposal is a collaboration between scientists, lung cancer physicians, pathologists, and the iusccc translational research core. tumor tissue collected will be used for protein and gene analysis and rna, whole exome sequencing in addition to the establishment of sclc. this research is part of a discovery project in which biological and molecular markers of sclc will be identified.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old at the time of informed consent 2. written informed consent and hipaa authorization for release of personal health information. 3. active sclc diagnosis.

Keywords: lung cancer small cell lung cancer future research
number of rotavirus (rv) related hospitalizations in belgium - season 2006-2007

Conditions: Infections, Rotavirus

Summary: this study aims to collect data and assess the number of rotavirus related hospitalizations in 11 hospitals in belgium - season 2006-2007 in order to develop proper age-cohort analysis over time.

this retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of june 2006 until the 31st of may 2007. ims health sales data will be used to provide rotavirus vaccine coverage estimates (rotarix and rotateq) for the belgian population during the study period. any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.

Eligibility criteria:
inclusion criteria: * child aged ≤5 years; * a stool sample has been provided for a rotavirus detection test during the study period; * laboratory test result of rotavirus is available. exclusion criteria: not applicable.

Keywords: rotavirus hospitals belgium
endovascular gsn ablation in subjects with hfpef

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: the purpose of this study is to evaluate the safety and potential benefits of single-side block of a nerve that connects to the intestines, liver and spleen called the "greater splanchnic nerve" for the treatments of patients with symptomatic heart failure who have normal pumping of the heart. the study will be performed in patients whose heart failure is not responding well to standard treatments and remain symptomatic.


Eligibility criteria:
key inclusion criteria: * chronic heart failure * transthoracic echocardiographic evidence of diastolic dysfunction * ongoing stable gdmt hf management and management of potential comorbidities * lvef ≥50% in the past 3 months key exclusion criteria: * cardiac resynchronization therapy initiated within the past 6 months * advanced heart failure * admission for hf within the past 30 days * presence of significant valve disease * mean right atrial pressure (rap) \>20mmhg during hemodynamic screening

Keywords: heart failure preserved ejection fraction
retrospective study on cenos stem with bonemaster ha

Conditions: Osteoarthritis

Summary: retrospective data collection of the cenos implant comparing with and without bonemaster ha coatings.

not applicable as study was withdrawn

Eligibility criteria:
patients who received cenos prosthesis for intended uses
pharmacological modulations of allergen-specific immunotherapy

Conditions: Asthma

Summary: there is mounting evidence that successful allergen immunotherapy (sit) functions through the induction of different subset of treg including foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. based on previous findings we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin d3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy

there is mounting evidence that successful allergen immunotherapy (sit) functions through the induction of different subset of treg including foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. since corticosteroids directly induce the development of an il-10-synthesizing regulatory t-cell population (tr1) and this effect can be greatly increased with vitamin d3 treatment we , we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin d3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy, therefore we conducted the stud comparing the effect of glucocorticosteroid, glucocorticosteroid with vitamin d3 or montelukast sodium on early immunological and clinical effect of allergen-specific immunotherapy in asthmatic children.

Eligibility criteria:
inclusion criteria: * allergic asthma with regular symptoms requiring long-term treatment with inhaled corticosteroids * disease duration of at least 2 years * sensitisation only to house dust mites * resting fev1 of more or equal 70% exclusion criteria: * sensitization to allergens other than house dust mites * discontinuation of sit from any reasons * need of a daily dose below 200 or above 800 mcg of budesonide or equivalent * other chronic disease including vitamin d3 deficiency and/or resistance which could influence the results of the study or the patient's ability to participate in the study as judged by the investigator * medications that resulted in patient exclusion included: inhaled long acting β2-agonist, leukotriene modifiers, β-blockers (eye drops included) or oral corticosteroids within 6 month before the pre-study visit.

Keywords: allergen immunotherapy premedication
phenotypic characteristics of inflammatory bowel disease in southeast asian population - a multi-centered us study

Conditions: Inflammatory Bowel Diseases

Summary: this is a retrospective, case control study of inflammatory bowel disease. this study will analyze the phenotypic characteristics of inflammatory bowel disease in the southeast asian population and will help describe clinical characteristics and serologic profiles in southeast asians with inflammatory bowel disease, comparing the phenotype differences to historical caucasian controls. the data from this study will help identify the phenotype characteristics of different ethnic groups and study the epidemiological patterns of the disease.

this study is a retrospective, case control study of inflammatory bowel disease characteristics in patients with origins from the indian sub-continent. patients will be selected from the ibd registry maintained at respective institutions. subjects from the indian sub-continent will be identified using their country of birth, parents' ethnicity, number of years since leaving the country of birth, and number of years residing in the united states. using both electronic and paper databases, demographic information regarding age, gender, body mass index, smoking history, dietary habits; medical history such as type of ibd, ibd symptoms, location and behavior, medication use (past and current), history of other autoimmune disorders; surgical history (ibd and non-ibd related); laboratory indices such as ibd serology, thiopurinemethyltransferase (tpmt), and infliximab levels will be collected. demographics will be compared between groups using descriptive statistics. using univariate analysis, variables that are significantly different will be identified. conditional logistic regression will then be performed to identify those clinical variables that are statistically significant. the study duration will be one year from irb approval.

Eligibility criteria:
inclusion criteria: * patients with origins from the indian sub-continent * patients will be selected from the ibd registry maintained at respective institutions.

Keywords: ibd
platelets induced vasodilation, in vitro and in vivo study

Conditions: Peripheral Arterial Disease

Summary: the aim of the study is to show the implication of platelets in vasodilation using in vivo and in vitro analysis and to compare the effects of placebo, aspirin and clopidogrel in this interaction platelets/vessels. the effects of 7 days of each treatment will be compared in healthy subjects and patients with arteriopathy.


Eligibility criteria:
inclusion criteria: inclusion criteria healthy subjects * man or woman 18 years * agreement signed * french health insurance * able to understand the study * biological haemostatic test normal * vascular doppler of lower limbs normal * pressure index \> 1 in both lower limbs inclusion criteria healthy subjects * man or woman 18 years * agreement signed * french health insurance * able to understand the study * biological haemostatic test normal * lower limbs arteriopathy (clinical, pressure index, doppler) exclusion criteria: * unable to sign agreement * subjects protected by low * participation to other study * changes of treatment within the 15 days before inclusion * chronic treatment with clopidogrel or drugs against inflammation * severe respiratory, cardiac, kidney, hepatic insufficiency * haemostatic troubles * diabetic neuropathy * neurologic desease (parkinson.....) * hypertension * symptomatic stomach ulcer * anaemia hb\<11g/l * pregnant women or breast feeding