Kornimate/medical-research-clean huggingface dataset:
acute bronchodilator effect of inhaled albuterol sulfate and ipratropium bromide in patients with stable copd

Conditions: COPD

Summary: the purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product as measured by increases in fev1.

a single center, open label, single dose study to demonstrate the pharmacodynamic bioequivalence of the test and reference metered dose inhalers containing albuterol sulfate or albuterol sulfate/ipratropium in adult patients with copd.

Eligibility criteria:
inclusion criteria: * provide written informed consent * diagnosis of copd as defined by the american thoracic society/european respiratory society guidelines characterized by progressive airflow limitation associated with abnormal inflammatory response of the lungs to noxious particles or gases primarily caused by cigarette smoking. * have an established copd clinical history, symptomatic with dyspnea, chronic cough, chronic sputum production or wheezing. at visit 1, fev1/fvc ratio must be less than 0.70 or at least 10% less than the fev1/fvc ratio determined by the predicted normal value. fev1 must be less than 70% of the predicted normal value and greater than 25% of the predicted normal value. * must be using one or more inhaled bronchodilators for treatment of copd at the time of visit 1. * current or former smokers, with a history of at least 10 pack-years of cigarette smoking. number of pack-years = (number of cigarettes per day/20) x (number of years smoked). * willing, and in the opinion of the investigator, able to adjust current copd therapy as required by the protocol. exclusion criteria: * current diagnosis of other respiratory disorder(s) including, but not limited to: alpha-1-antitrypsin deficiency; lung cancer; cystic fibrosis; tuberculosis; sarcoidosis; idiopathic pulmonary fibrosis; primary pulmonary hypertension; or pulmonary thromboembolic disease. patients with concomitant copd and asthma will be allowed to participate. * diagnosis of non-respiratory disorder(s) that are currently affecting lung function, as determined by he principal investigator including, but not limited to: congestive heart failure; symptomatic cardiac arrhythmia; symptomatic seizure disorder; dementia; lupus; rheumatoid arthritis; or liver cirrhosis. * unable to abstain from protocol defined prohibited medications during the screening and testing period. * unable to withhold short acting bronchodilators for 6 hours prior to spirometry testing at the study visit. * unable to perform acceptable or repeatable spirometry or comply with other study procedures. * known allergic reaction to albuterol sulfate or ipratropium bromide. * diagnosis of cancer that is not presumed to be in remission or cured. * active alcohol or drug abuse. * pregnant or lactating women. pregnancy confirmed by a positive hcg test. * treatment with another investigational study drug in another clinical study within the last 30 days or five half-lives, whichever is longer.
therapy of age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: people with the disease age-related macular degeneration (amd) are treated with the medical eye trainer (met) system to improve their vision. the training is carried out over 2 months.

age-related macular degeneration (amd) is a widespread eye disease worldwide. according to the gutenberg health study, about 7000000 people in germany suffer from it. the numbers for austria are to be assumed with 700000 due to the smaller population. there are two different forms of amd, the wet form with 15% and the dry form with 85%. both types have a high risk of rapid development of significant visual impairment. for the dry form of the disease there are currently only a few therapeutic options. the main one is the nutritional supplement therapy. this treatment can only reduce the progression of deterioration in 10% of affected individuals, but there is a significant side effect profile. thus, the question arose for completely different treatment approaches. for this reason, the medical eye trainer (met) was developed. this is a training device which can easily be used in self application. the purpose of this new therapy is not to try to cure amd. instead, the eye and brain are trained to better cope with the disease. in a first study on 17 eyes, 11 cases even showed an improvement of the visual performance, the remaining 6 cases showed a stable situation. in no case did a deterioration occur. thus, for the first time, it was possible not only to slow down this disease, but even to achieve an improvement. in a second study with a planned number of 150 persons, this positive effect will be further investigated. a calculation with g\*power, based on the results of the first study, results in an optimal number of 150 examinations. the participants will be examined in the hospital ried im innkreis and treated by met. no additional measures are required for the study besides the usual eye examinations in amd. the study is open to individuals with dry amd, regardless of age. exclusion criteria are wet amd, epilepsy and double vision. other eye diseases are not a problem. the diagnosis is additionally confirmed by an examination of the ocular fundus with an optical coherence tomography (oct). as an essential factor of the severity of the disease, the visual performance for distance (5-6m) and for near (40cm) is determined. participants need a mobile electronic device with the operating system apple ios® or android®. the met training system in the form of software will be provided for the duration of the study. the therapy is performed daily by the patient him/herself and lasts 90 seconds per eye. a success control is planned after two months. the above mentioned examinations will be repeated. the met has a ce-approval in the sense of mpg class 1. this study will be performed according to the helsinki criteria.

Eligibility criteria:
inclusion criteria: * age-related macular degeneration exclusion criteria: * epilepsy * double vision

Keywords: age-related macular degeneration amd medical eye trainer
endoscopic overlay tympanoplasty for tm perforation

Conditions: Tympanic Membrane Perforation

Summary: minimally invasive surgery is becoming more common in many surgical fields. the wide view of endoscope allows for minimally invasive transcanal approach instead of large postauricular opening. the investigators conduct this study to compared post operative pain score (by visual analogue scales) between conventional microscope lateral placing tympanoplasty and endoscopic lateral placing tympanoplasty.

a main part of tympanoplasty is repair of perforated tympanic membrane. there are two popular way to approach tympanic membrane, transcanal or postauricular approach. there are two grafting techniques are applied in tympanoplasty which includes the lateral technique (overlay) and medial technique (underlay). the lateral technique is widely used in our institute which involves placement of a graft lateral to the tympanic annulus and the fibrous layer of the tympanic remnant. the most our preferred approach in previous experience is the postauricular approach for tympanoplasty because the transcanal approach is not enough for adequate exposure. moreover, the visualization straight through transcanal provide by the microscope is difficult by a limited view of the perforation edge due to narrowing and curved external ear canal. postauricular approach cause many layers of tissue are violated along with a significant postoperative pain. the author proposed this study with the aim of determining the alleviation of postoperative pain by new technique and the efficacy of endoscope for tympanoplasty.

Eligibility criteria:
inclusion criteria: * age between 15-70 years * the patients who had perforation of tympanic membrane * the perforations are all dry at the time of surgery and have been dry for at least 3 months. * no contraindication for local or general anesthesia. * no recent upper respiratory tract infection at least 2 weeks before surgery. * no unstable underlying condition. * have at least 2 months of follow up. * agree to participate in the study * aaccept to be randomized to receive treatment * willing to sign an informed consent exclusion criteria: * medial placing or inlay surgical technique * chronic otitis media * contraindication of vasoconstriction agent (adrenaline) * allergy to analgesic agent (xylocaine or lidocaine) * concomitant with mastoiditis. * previous intracranial or extra-cranial complication of chronic otitis media. * pregnancy

Keywords: endoscope microscope transcanal
local host modulating agents alendronate & aloe vera for treatment of furcation defects in chronic periodontitis

Conditions: Chronic Periodontitis

Summary: alendronate (aln), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. av widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. the present study aims to explore the efficacy of 1% aln and av gel as a local drug delivery as an adjunct to scaling and root planing (srp) for the treatment of degree ii furcation defects

alendronate (aln), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. av widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. the present study aims to explore the efficacy of 1% aln and av gel as a local drug delivery as an adjunct to scaling and root planing (srp) for the treatment of degree ii furcation defects. methods: ninety patients with mandibular buccal class ii furcation defects were randomly allocated into three treatment groups: srp plus placebo gel (group 1), srp plus 1% aln gel (group 2) and srp plus av gel (group3). clinical and radiographic parameters were recorded at baseline and gel were delivered at respective site. then again all clinical and radiographic parameters were recorded after 6 and 12 months from baseline.

Eligibility criteria:
inclusion criteria:systemically healthy patients with mandibular class ii furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with pd ≥ 5mm and horizontal pd ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study - exclusion criteria:subjects with any known systemic disease, allergic to alendronate or aloe vera, on systemic alendronate therapy, alcoholics, tobacco users, pregnant or lactating women -
patient centered cloud-based electronic system: ambient warning and response evaluation (proccess aware)

Conditions: Critical Illness; Sepsis; Respiratory Failure; Shock; Coma; Bleeding; Trauma

Summary: in this multicenter project, we will introduce aware (electronic interface) using a cloud-based technology . the goal of this project is to improve compliance with best practice through the use of a new acute care interface with built-in tools for error prevention, practice surveillance and reporting (proccess aware - patient centered cloud-based electronic system: ambient warning and response evaluation).the goal of this project is to develop and test a novel acute care interface with built-in tools for error prevention, practice surveillance, decision support and reporting (proccess aware - patient centered cloud-based electronic system: ambient warning and response evaluation). in preliminary studies, these novel informatics supports built on an advanced understanding of cognitive and organizational ergonomics, have significantly decreased the cognitive load of bedside providers and reduced medical errors. using a cloud-based technology, aware will be uniformly available on either mobile or fixed computing devices and applied in a standardized manner in medical and surgical icus of five geographically diverse acute care hospitals predominantly serving medicare and medicaid patients. the impact of proccess aware on processes of care and outcomes in study icus; expected to enroll more than 10,000 critically ill patients during the study period.


Eligibility criteria:
inclusion criteria: for the primary objective, all critically ill adult patient admitted to an icu participating in the study will be eligible. exclusion criteria: for the primary objective, all children younger than 18years of age will be excluded.

Keywords: aware, checklist, icu, outcome, adults
probiotics for alleviating functional constipation in adults

Conditions: Constipation

Summary: to investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.


Eligibility criteria:
inclusion criteria: 1. chinese adults who meet the diagnostic criteria of rome iii, aged between 18 and 70; 2. patients with chronic constipation (disease duration exceeding 6 months, with fewer than 3 bowel movements per week and/or bristol stool form scale types 1 and 2); 3. able to complete the study according to the requirements of the experimental protocol; 4. patients who have signed the informed consent form; 5. research participants (including male participants) who do not have fertility plans from 14 days before screening to 6 months after the end of the trial and are willing to take effective contraceptive measures voluntarily. exclusion criteria: 1. individuals who have taken items with similar functions to the tested product within a short period of time, which may affect the judgment of the results; 2. patients who have changed their diet during the study period; 3. patients with severe allergies and immune deficiencies; 4. female patients who are pregnant, breastfeeding, or have plans to become pregnant; 5. patients with severe diseases in vital organs such as cardiovascular, lung, liver, and kidney, as well as severe metabolic diseases such as diabetes, thyroid disease, malignant tumors, and severe immune system diseases; 6. individuals who have used antibiotics within the past two weeks; 7. individuals with severe psychological or mental illnesses; 8. participants who have not consumed the tested samples as required or failed to follow up on time, resulting in an inability to determine the effectiveness; 9. other research participants deemed unsuitable for participation by the researchers.
an open single centre study to assess treatment of chronic constipation in children

Conditions: Chronic Constipation

Summary: the purpose of this study was to evaluate the safety and efficacy of movicol in the treatment of chronic constipation in children.

this was a phase iii, open, single centre, non-comparative study. all patients were assigned to treatment with movicol for a period of 12 weeks. all patients were screened at day 0 (visit 1) when baseline assessment of their bowel movements over the previous 14 days were made. patients were dispensed with movicol to commence treatment on the following day (day 1). during the first 5 days the dose was increased on an every second day basis until normal bowel movement was achieved. thereafter until the end of the study the dosage was titrated according to the stool consistency (diarrhoea, loose stool, hard stools or no bowel movement for 2 days, respectively). four on-treatment visits were performed on day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5). at each visit bowel movements over the previous period were assessed by the investigator using the patient's daily diary card data.

Eligibility criteria:
inclusion criteria: * children aged 24 months - 11 years old inclusive * patients with constipation defined as: * ≤ 2 spontaneous complete bowel movements per week (over the previous 14 days), and one or more of the following: * 1/4 or more of bowel movements with straining * 1/4 or more of bowel movements with hard or lumpy stools * patients in whom these symptoms have been present for ≥ 3 months * new patients or those whose management is unsatisfactory on current laxative treatment * patients of either sex * patients of any ethnic origin * hospital in-patients or outpatients. exclusion criteria: patients with: * history of bowel washout within the last 2 months * intestinal perforation or history of obstruction * recent history of urinary tract infection (within last month) * hirschsprungs disease * paralytic ileus * toxic megacolon * severe inflammatory conditions of the intestinal tract * clinically uncontrolled renal/hepatic/cardiac disease(s) * clinically uncontrolled endocrine disorder(s) * any other severe unstable co-existing disease * hypersensitivity to macrogol or other constituents of movicol * encopresis * patients who have taken any investigational drug in the last three months * patients or patients whose parents would in the opinion of the investigator be unable to comply with the requirements of the study.

Keywords: constipation
brain connectivity measured with high-density electroencephalography

Conditions: Stroke

Summary: emerging scientific results show that disrupted functional connectivity in stroke can explain behavioral impairments and predict their recovery over time. however, no technique is yet available for widespread use in clinics to examine how neural synchronization in brain networks is altered in stroke patients. this is crucial to determine favorable prognostic factors and to define individualized rehabilitation protocols. importantly, the investigators have successfully used high-density electroencephalography (hdeeg) in healthy individuals to measure neural synchronization in brain networks. in this project, the investigators will develop methods and tools based on hdeeg for assessing functional connectivity in stroke patients. these methods and tools will be employed to examine how neural changes occurring after brain lesions explain behavioral impairments. the project will open the way for the use of hdeeg at the patient's bedside, as a neurodiagnostic tool for stroke as well as other brain disorders.


Eligibility criteria:
in this study 125 stroke patients and 45 healthy participants will be recruited at the institute for research and healthcare with a scientific character (irccs) san camillo hospital. inclusion criteria (patients): * right or left hemisphere damage * unilateral stroke * compliance with magnetic resonance imaging (e.g., no claustrophobia) inclusion criteria (healthy participants): • compliance with magnetic resonance imaging (e.g., no claustrophobia) exclusion criteria (both patients and healthy participants): • no comorbidities with psychiatric disorders

Keywords: high-density electroencephalography brain connectivity
level of adherence of subjects receiving saizen® via easypod™ in czech republic

Conditions: Growth Disorders

Summary: this is multicentre, observational study to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter longitudinal observational study. parents/ subjects will provide their informed consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: • to assess the level of adherence of subjects receiving saizen® via easypod™. secondary objective: * to identify adherence subject profiling * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to asses the impact of adherence on insulin-like growth factor 1 (igf1) (i.e. above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod™ electromechanical device according to the summary of product characteristics (smpc) * over the age of \>2 years * under \<18 years of age, or over 18 without fusion of growth plates * parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the smpc * use of an investigational drug or participation in an interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
a 6-year follow-up study of the effect of neurorehabilitation training in patients with parkinson's disease

Conditions: Follow up; Parkinson Disease; Rehabilitation

Summary: individualization of exercise is recommended but rarely performed in patients with parkinson's disease (pd). unusually high intensity and individual sensor motor with visuomotor mobility trainer the clinical symptoms, mobility and posture of pd patients. after 3 weeks of intensive treatment, treated patients and the control group were subjected to a two-year observation. objectives: the effect of the unusually highly intense and strictly individualized sensomotor and visuomotor agility program was determined for the clinical symptoms, mobility and stability of non-demented pd patients with a two-year follow-up. detection and comparison of results of patients undergoing biphasic maintenance with the results of intensively treated patients and the control group. patients were recalled every 3 months after the first intensive examination and one year after a one-year control. the results of the active group were continuously compared with the results of the passive and control groups, thus determining the effectiveness of our treatment and the deterioration of the other groups in life-quality. the treated groups will be divided into two. one parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 6 years. the other group does not undergo a special series of exercises after 3 weeks of intensive therapy. main outcome measures: movement disorder society unified parkinson disease rating scale, motor experiences of daily living, a measure sensitive to changes in a broad spectrum of pd symptoms. in group time, repeated measurements of variance analysis were compared to mds-updrs m-edl, beck depression score, pdq-39, eq5d vas, schwab \& england scale for parkinson's disease. the tug test and 12 static posturographic measurements are compared and compared to the healthy group as a standard. an at-limit and individualized sensorimotor and visuomotor agility exercise program vs. standard care, will improve non-demeted, stage 2-3 pd patient's clinical symptoms, mobility, and postural stability by functionally meaningful margins. as a long-term solution, a follow-up treatment can slow down the progression of clinical symtoms.


Eligibility criteria:
inclusion criteria: * parkinson's disease * hoenh yahr scale of 2-3 * instability problem exclusion criteria: * severe heart problems * severe demeanor * alcoholism * drug problems

Keywords: balance posturograpy