Kornimate/medical-research-clean huggingface dataset:
effect of multimodal postoperative rehabilitation on functional and cognitive decline

Conditions: Surgery--Complications

Summary: older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery. these patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. the consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health. exercise training can prevent functional and cognitive decline and modify even the posterior trajectory

this study is a randomized clinical trial conducted in the department of surgery of a tertiary public hospital. patients undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. a total of 218 elderly patients undergoing urgent abdominal surgery( control group=109 and intervention group 109) randomly assigned to the intervention or control group. patient recruitment will begin in the 4-day after the surgical procedure, which will be identified through the list of patients admitted to the hospital and assigned to the department. the doctor who decides the inclusion in the intervention or control group will not be the attending physician. patients or their families (if the patient has cognitive impairment) will be informed of the random inclusion in one group, but will not be informed as to which they belong. randomization will be performed by applying http://www.randomizer.org/. the information in both the intervention group and the control group will obtained in four different stages: the initial visit and at months 1, 3 and 6 after hospital discharge. the intervention will consist of a multicomponent exercise training program, which will composed of supervised progressive resistance exercise training, aerobic and anaerobic exercises. this training period consist on 2 training sessions per week during 4 weeks after one week of discharge.

Eligibility criteria:
inclusion criteria: * age 70 years and older * able to tolerate exercise * able to ambulate, with or without personal / technical assistance or move unassisted in a wheelchair * able to communicate * undergoing urgent abdominal surgery * barthel index\>60 * informed consent: must be capable and willing to provide consent exclusion criteria: * severe dementia (gds 7) * duration of hospitalization \<4 days * unwillingness to either complete the study requirements or to be randomized into control or intervention group * unstable cardiovascular disease or other unstable medical condition * terminal illness * myocardial infarction in the past 3 months * upper or lower extremity fracture in the past 3 months * evisceration

Keywords: elderly patients exercises cognitive dysfunction quality of life
pharmacokinetic modeling of methadone

Conditions: Toxicomania

Summary: the management of patients with opioid addiction is a challenge insofar as many distractors or variability factors can interfere with the control of the addiction, whether they are psychological, psychiatric, environmental, pharmacokinetic or pharmacodynamic. understanding this variability is potentially to be able to adjust a priori a dosage and to identify the factors of clinical response. few population pharmacokinetic models exist for methadone and they generally concern the management of pain in palliative care patients or the management of opioid withdrawal syndrome in neonates. the hypothesis is therefore that the creation of such a model would make it possible to reduce patients' withdrawal periods, to set a target for plasma concentrations with a view to reducing dosages, and to empower the patient in his choice to monitor blood concentrations facilitated by a minimally invasive sampling device.


Eligibility criteria:
inclusion criteria: * major patients on methadone on the same dosage for at least 7 days. * hospitalization for withdrawal in the addictology department of la colombière or consultation within the unit for the treatment of drug addiction and dependence (addictology department). * 24 hours monitoring is possible and accepted exclusion criteria: * patients that cannot be sampled because of weakened veins * unable to received information about the study * exclusion period determined by previous study * adult protected by law or patient under guardianship * not affiliated to french social security system * not able to give written inform consent * pregnant or breastfeeding woman * underaged patients (under 18 years old) * patient under court protection

Keywords: pharmacokinetics methadone microsampling modeling
effect of inhaled ciclesonide versus fluticasone propionate in patients with mild to moderate asthma (18 to 65 y) (by9010/m1-129)

Conditions: Asthma

Summary: the aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (hpa axis). treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. the study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). the study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria:
main inclusion criteria: * patients who have had a history of bronchial asthma for at least 6 months * fev1 \>60% of predicted for at least 24 h * patients who are hyperresponsive to methacholine and to amp * patients who are in good health with the exception of asthma main exclusion criteria: * concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * patients suffering from copd and/or other relevant lung diseases except asthma * current smokers and ex-smokers both with ≥10 pack years

Keywords: asthma ciclesonide fluticasone propionate
designing virtual reality-based software for people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the study aims to designing virtual reality-based testing and rehabilitation software for people with multiple sclerosis and assess the feasibility of software. also, the effects of an 8-week virtual reality-based upper extremity training in persons with multiple sclerosis will be investigated.

multiple sclerosis (ms) is a chronic, inflammatory, and demyelinating disorder that requires long-term rehabilitation. numerous systematic reviews on ms have demonstrated the effectiveness of rehabilitation strategies such as exercise training, physical therapy, occupational therapy, and multidisciplinary therapy. however, despite the importance of upper extremity performance in daily functional activities, rehabilitation of people with ms (pwms) generally focuses more on gait and balance, and upper extremity problems remain in the background. in addition, rehabilitation treatments for pwms are described as very long and systematic, leading to loss of motivation and adjustment. as a result, technology-based rehabilitation systems such as virtual reality (vr) have been promising in recent years and can provide person-centered task-oriented rehabilitation without needing a device or controller. in pwms, physiotherapy and rehabilitation programs based on today's vr studies are usually prepared with game software for computer users without physical disabilities. however, the number of these studies based solely on classical game software has a limited place in treating patients today and is considered insufficient. moreover, this software is complicated for patients, has a fast-paced structure, and fails to provide disability-focused education or meet patient needs. for this reason, it is necessary to develop specific game software for pwms. the study aims to develop virtual reality exergame software for upper extremity rehabilitation in pwms and evaluate the usability. persons who are followed by the outpatient multiple sclerosis clinic of dokuz eylül university hospital will participate in the study. fifteen participants will be included to determine the feasibility of the software, and they will experience the system for one session. then 15 participants will be included to investigate the effects of software on upper extremity functions during 8 weeks.

Eligibility criteria:
inclusion criteria: * having a definitive diagnosis of ms according to the 2017 mcdonald criteria * being over 18 years old * to be willing to participate in the study. exclusion criteria: * having a neurological disease other than ms * cognitive disability at a level that hinders assessment and treatment. * having a relapse 30 days before or during the study

Keywords: multiple sclerosis virtual reality exergaming
open-label, long-term safety extension study of afq056 in parkinson's patients with l-dopa induced dyskinesias

Conditions: Dyskinesias; Parkinson Disease; Movement Disorders; Parkinsonian Disorders; Anti-Dyskinesia Agents

Summary: this study is to evaluate long-term safety, tolerability and efficacy for afq056 in patients who have completed an afq056a study in parkinson's disease l-dopa induced dyskinesias (pd-lid).


Eligibility criteria:
inclusion criteria: * patients who have completed a previous afq056a study or are eligible as defined in the core study protocol * outpatients * patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements exclusion criteria: * atypical or secondary form of parkinson's disease * history of surgical treatment for pd including deep brain stimulation * advanced, severe, or unstable disease (other than pd) * history of malignancy * evidence of dementia * untreated/ineffectively treated mental disorders * treatment with certain prohibited medications * abnormal lab values or heart abnormalities * pregnant or nursing women

Keywords: parkinson disease l-dopa levodopa dyskinesia
lipid kinetics of patients with pneumonia

Conditions: Gram-negative Bacteria; Lipid Metabolism; Nosocomial Infections

Summary: nonfermenting gram-negative bacilli (nfgnb) are aerobic, non-motile, non-lactose fermenting, oxidase-negative, catalase-positive coccobacilli that pose a serious threat to critically ill patients. primarily pseudomonas aeruginosa (pa) and acinetobacter baumannii (ab), are nfgnb which are potential multi-drug resistant (mdr) pathogens that are related to ventilator-associated pneumonia (vap). in nonfermenting gram-negative bacilli (nfgnb) infections, which are potential multi-drug resistant (mdr) pathogens, pathogenesis is determined not only by bacterial virulence factors but more importantly by the interaction between bacteria and the host immune system. thanks to their direct immunomodulatory properties, lipoproteins and lipids bind and neutralise toxic bacterial substances. during the acute phase response and inflammation, hdl presents significant structural and functional changes. this study was planned to evaluate the relationship between the changes of the serum lipid metabolism and other inflammation markers with the antimicrobial resistance status and the results in nfgnb vap patients. also, we aimed to investigate whether there is a difference in the clinical characteristics of the patients depending on the resistance profile of nfgnb.

this prospective study was performed in adult intensive care unit (icu) patients. they were intubated endotracheally and received mechanical ventilation (mv) treatment for at least 48 hours in konya numune hospital icu, which has 42 surgery and medicine beds. the study was conducted between may 2019 and december 2020 and approved by the ethics committee of necmettin erbakan university medical school. informed consents were obtained from the patients who participated in the study or from their relatives. the characteristics of the patients and the sequential changes of the inflammatory response including the lipid profile were recorded.

Eligibility criteria:
inclusion criteria: * icu patients of 18 years of age and above, with clinical suspicion of vap as defined in the american thoracic society (ats) guidelines and a simplified version of clinical pulmonary infection score (cpis)\> 6, with significant nfgnb growth in respiratory cultures and with no signs and symptoms of infection at the time of admission, were included in the study. exclusion criteria: * patients with chronic inflammatory disease, hepatic dysfunction, active tuberculosis, malignancy, malnutrition, severe immunosuppression (i.e., neutropenia, hiv positive, organ transplant, having received immunosuppressants or used ≥ 20 mg/day prednisone for two or more weeks in the preceding three months), those that within 72 hours since being included in the study had any extrapulmonary infection other than vap, as well as those whose respiratory cultures presented bacterial agents other than nfgnb and fungal agents were not included in the study.
the relationship between single nucleotide polymorphisms of chitinase 3-like 1 gene,ykl-40 serum levels and adult asthma

Conditions: Asthma

Summary: the objective of this study was to investigate the relationship between single nucleotide polymorphism of chitinase 3-like 1 and human asthma.

chitinase 3-like 1 (chi3l1) is a member of human chitinases family. according to previous studies in literatures, increased expression of chi3l1 has been proven to be correlated with the presence of different diseases, including cancers, autoimmune diseases, and chronic inflammatory conditions. elevated serum levels of ykl-40 are associated with increased disease severity, poorer prognosis and shorter survival for many other diseases. when monitored over time, increases in serum ykl-40 parallel with disease progression. it can serve as an measurable marker of changes in disease status. there were indicated that chitinase 3-like 1 might be associated with some clinical diseases. the c-allele of the -131 c→g (rs4950928) polymorphism of chi3l1 has been shown to associate with bronchial hyperresponsiveness and reduced lung function. it is suggesting that variations in chi3l1 may influence risk of asthma. the objective of this study was to investigate the relationship between single nucleotide polymorphism of chitinase 3-like 1 and human asthma. the association between chi3l1 snps and the continuous outcomes were examined by real time pcr and gene sequencing analysis. in korean reports there was no significant associations between chi3l1 snps and asthma were observed. on the other hand, there were association between chi3l1 and asthma observed in the majority of caucasian populations. however, similar research has not been conducted in taiwan. in contrast to preliminary studies, the investigators predict the rs4950928 g allele, and not the c allele, was found to be associated with asthma. the g.-247c/t polymorphism in the chi3l1 promoter region is associated with the risk of atopy.

Eligibility criteria:
inclusion criteria: * ages 20 to 60 years * asthma patients * atopy patients * control (non-asthma and non-atopy)

Keywords: asthma chitinase 3-like 1 (chi3l1) ykl-40 single nucleotide polymorphism(snp) real time pcr gene
the effect of pneumoperitoneum timing on intracranial pressure in laparoscopy

Conditions: Intracranial Pressure Increase; Pneumoperitoneum

Summary: reverse trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. however, there are no studies on the effect of the timing of reverse trendelenburg position on intracranial pressure. this study will monitor the effect of reverse trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation.

the literature includes studies that investigate the relationship of pneumoperitoneum and different positions with intracranial pressure during laparoscopy. reverse trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. however, there are no studies on the effect of the timing of reverse trendelenburg position on intracranial pressure. this study will monitor the effect of reverse trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation. ultrasound guided measurement of the optic nerve sheath diameter as a non-invasive method will be used for measurement. the investigators believe reverse trendelenburg position before pneumoperitoneum may prevent undesired sudden increases in intracranial pressure.

Eligibility criteria:
inclusion criteria: * undergoing laparoscopic cholecystectomy operation * age between 18-65 * asa i-ii * bmi ≤ 35 exclusion criteria: * ophthalmologic disease and optic nerve pathology * increased intracranial pressure * history of cerebrovascular disease

Keywords: optic nerve sheath diameter intracranial pressure laparoscopic cholecystectomy pneumoperitoneum
evaluation of a non-cross-linked hyaluronic acid medical device ("electri" and "xela rederm") for improving facial skin appearance

Conditions: Appearance of Facial Wrinkles; Aesthetic; Hydration; Facial Skin Wrinkles

Summary: the goal of this clinical investigation is to learn whether injectable implants based on non-cross-linked hyaluronic acid (electri and xela rederm) improve the aesthetic appearance of facial skin in adult women. it will also learn about the safety of these medical devices. the main questions it aims to answer are: does skin appearance improve after a series of redermalization procedures? how do the procedures affect skin hydration and elasticity? what side effects or medical issues, if any, do participants experience? researchers did not use a control group. instead, they evaluated skin improvements in the same participants over time. participants: received 3 injections of the hyaluronic acid-based device over 6 weeks (1 injection every 14±1 days). had their skin condition assessed by doctors and by themselves using a standardized scale. underwent tests to measure skin hydration and elasticity. reported any adverse events or adverse device effects.


Eligibility criteria:
inclusion criteria: * subject agreed to participate in the investigation and signed the informed consent form. * age over 18 years. * the subject is eager to undergo a course of skin redermalization procedures using the medical device(devices) based on non-cross-linked hyaluronic acid in concentrations of 0.55% ("electri") and 1.1%, 1.8% or 2.2% ("xela rederm") (diaco biofarmaceutici s. r. l., italy) in poland; in concentrations of 1.1%, 1.8% or 2.2% ("xela rederm") (diaco biofarmaceutici s. r. l., italy) in ukraine. * female subject confirm that she is not pregnant or lactating during the study. exclusion criteria: * infection or inflammation in the implant injection site. * pregnancy, lactation. * subject's intention to undergo procedures involving chemical peels, laser irradiation, botulinum toxin injection or other similar procedures in the injection site within the next 45 days after inclusion in the post-marketing investigation. * subject underwent procedures involving chemical peels, laser irradiation, botulinum toxin injection or other similar procedures in the injection site within 35 days prior to inclusion in the post-marketing investigation. * chronic or acute severe or decompensated visceral diseases. * known hypersensitivity to hyaluronic acid, its metabolites, or to the excipients of the injectable implant. * known hypersensitivity to analgesics. * subject took significant doses of vitamin e, nsaids or anticoagulants during the last 7 days. * refusal or suspected inability of the subject to comply with the requirements of the cip. * subject has difficulty in understanding the language in which the informed consent is written. * any other reason that, in the opinion of the investigator, prevents the subject from participating in the post-marketing investigation. * subject takes participation in other clinical investigation.

Keywords: facial skin appearance hydration elasticity xela rederm electri
a study to evaluate the efficacy and safety of rontalizumab in patients with moderately to severely active systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this is a phase ii, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely active systemic lupus erythematosus (sle).

the study will be conducted in 3 parts. parts 1 and 2 of the study will include a double-blind treatment period of 24 weeks and a safety follow-up period of 48 weeks for participants who do not continue onto part 3. patients meeting the eligibility criteria for enrollment in part 3, will enter part 3 after completion of the week 24 visit but prior to completion of the week 72 visit. in part 1, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 750 mg or matching placebo intravenously every 4 weeks for 24 weeks. part 2 was will be initiated upon the completion of recruitment for part 1. in part 2, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 300 mg or matching placebo subcutaneously every 2 weeks for 24 weeks. after week 24, patients will enter a 48-week safety follow-up period, or, after the open label extension became available via protocol amendment, will have the option of entering part 3 of the study, if eligible. in part 3, all participants will receive rontalizumab 750 mg intravenously every 4 weeks for 120 weeks (up to 144 weeks total).

Eligibility criteria:
inclusion criteria: * diagnosis of sle. * active disease at the time of screening. * agreement to use an effective form of contraception for the duration of the study. exclusion criteria: * acutely life- or organ-threatening manifestations of systemic lupus erythematosus (sle) (eg, proliferative nephritis, unstable neuropsychiatric disease). * pregnancy or breastfeeding. * history of severe allergic or anaphylactic reactions to monoclonal antibodies or intravenous (iv) immunoglobulin. * significant, uncontrolled medical disease in any organ system not related to sle that in the investigator's opinion would preclude patient participation. * concomitant conditions that required systemic corticosteroid use within 1 year prior to screening. use of topical, intraarticular, or inhaled corticosteroids is not exclusionary. * history of cancer within 5 years of screening. * any current or recent (within 4 weeks of screening) signs or symptoms of infection, except for minor infections, fungal infections of the nail beds, or oral or vaginal candidiasis. * history of severe systemic bacterial, fungal, viral, or parasitic infections (2 or more hospitalizations or 2 or more courses of iv antibiotics) within 6 months prior to screening

Keywords: rhumab ifnalpha sle