Kornimate/medical-research-clean huggingface dataset:
airway clearance system (k031876) phase iv device efficacy

Conditions: Cystic Fibrosis, Pulmonary

Summary: phase iv interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis (mild, moderate or severe). the study is completely voluntary and is designed to measure participants use and the effectiveness of the device within the 510k indication of: airway clearance therapy when external manipulation of the thorax. the trial period shall be 21 days and include use of a fda cleared pulse oximetry monitor (k131111), manual spirometer as well as completion of semi-weekly participant survey.

phase iv interventional study, of participants with cystic fibrosis with mild, moderate or severe conditions, for the efficacy of the electro flo percussor, model 5000 (k031876), regulation number: 21 cfr 868.5665, with current fda indication of: provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. indications for this form of therapy are described by the american association for respiratory care (aarc) in the clinical practices guidelines for postural drainage therapy ( i ) (1991). according to aarc guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. in addition, the med systems electro flo percussor model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

Eligibility criteria:
inclusion criteria: * previously diagnosed with cystic fibrosis (mild, moderate or severe) * prescribed (licensed medical provider) airway clearance device/system for at home, self-treatment for airway clearance * physically able to perform self-treatment or treatment by an at home medical provider exclusion criteria: * history of tobacco use * history of excessive alcohol consumption, more than 2 drinks per day, 10 per week * any other medical condition that would preclude use of an airway clearance device * previously diagnosed with major cardiological disease

Keywords: airway clearance system cystic fibrosis lung secretion clearance
use of lidocaine in endoscopic submucosal dissection

Conditions: Gastric Neoplasm

Summary: the primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection. the secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.


Eligibility criteria:
inclusion criteria: 1. endoscopic submucosal dissection for the treatments of early gastric neoplasm exclusion criteria: 1. allergy to lidocaine 2. chronic pain 3. chronic abuse of opioid or nsaid 4. atrioventricular conductance block 5. liver dysfunction 6. renal dysfunction
reliability of the melbourne assessment

Conditions: Cerebral Palsy; Stroke; Traumatic Brain Injury; Meningomyelocele; Central Nervous System Diseases

Summary: the aim of the study is to investigate the reliability of the melbourne assessment.

children with central motor disorders will be tested twice within one week with the melbourne assessment. the assessments will be video scored. at a later time point, different raters will rate the same video for inter-rater reliability, the same rater will score the same video for intra-rater reliability, and the same rater will score the repeated assessment videos for test-retest reliability.

Eligibility criteria:
inclusion criteria: * central motor disorders * ambulant or stationary patients of the rehabilitation center affoltern am albis * ability to understand test instructions * ability to sit upright for 25 minutes * minimal activity in the assessed upper limb exclusion criteria: * severe visual and/or auditory problems * acute lesion in the to assessed upper limb * lack of compliance

Keywords: children rehabilitation upper limb assessments outcome measures
anlotinib for esophageal cancer (afec)

Conditions: Esophageal Cancer

Summary: the purpose of this study is to observe and explore the effect of single or combined treatment of arotinib on the survival and prognosis of patients with advanced esophageal cancer in the real world, and to summarize the treatment experience of a wide range of people.


Eligibility criteria:
inclusion criteria: 1. age: ≥ 18 years old, male or female; 2. patients with esophageal cancer were diagnosed; 3. patients assessed by doctors to benefit from single or combined treatment of arotinib; 4. patients volunteered to join the project. exclusion criteria: none
dialogical family guidance postdoc study

Conditions: Family Dynamics; Family Relations; Family Support

Summary: this new family intervention, called dialogical family guidance (dfg) is developed to target family needs especially in families with a child with neurodevelopmental disorders. phd study showed, that this intervention is functioning with this target group. participants (families) experienced that they got information, guidance to ordinary life and that the dfg-therapists were listening to them and above all, helping with individual problems and questions. dfg include six meetings and professionals need to attend on a 3-day long education before using this intervention.

previous studies have highlighted the need for families with a child with neurodevelopmental disorders, to get guidance to daily life, information and also professionals who allow parents to share their own experiences, feelings and questions. dialogical family guidance is developed to offer target families (participants) the help mentioned above. this study is a postdoctoral study to achieve more knowledge and understanding about dfg intervention. this postdoctoral study is focusing on dfg effectivity offered to families with young children (5-7years). researchers also want to receive information about dfg effectivity between different units inside and outside the university hospital. comparation between different units using dfg is one goal with this postdoc study. these results may give researchers deeper understanding when deciding where (university hospital och basic level units) and for whom (childrens age?) dfg intervention is giving the most optimal help.

Eligibility criteria:
inclusion criteria: * families with a child with clinical diagnosis within neurodevelopmental ambrella (adhd, tourette, autism disorder, ocd...). * the child must be between 4-13 years. exclusion criteria: * families who do not understand finnish language (because they can not fill the questionnaires and professionals offering dfg are all finnish speaking). at least one parent needs to talk finnish. * families who are not motivated to receive dfg. * families who do not have a child with neurodevelopmental disorders.

Keywords: neurodevelopmental disorders family health family functionality family support
a comparison of nsaids for acute, non-radicular low back pain.

Conditions: Back Pain Without Radiation; Low Back Pain

Summary: purpose: this is a randomized clinical trial comparing the effects of three different medications for acute low back pain (lbp):ketorolac, ibuprofen, diclofenac hypothesis: a daily regimen of ketorolac will provide greater relief of lbp than ibuprofen or diclofenac 5 days after an emergency department (ed) visit, as measured by the roland morris disability questionnaire (rmq)

more than 2.5 million patients present to us emergency departments (ed) annually with low back pain. up to half of ed patients with acute, new onset low back pain (lbp) report persistent moderate or severe pain one week after the ed visit. non-steroidal anti-inflammatory drugs (nsaids) are an effective treatment of acute lbp, though their impact is only modest.given the poor pain and functional outcomes that persist beyond an ed visit for acute lbp, this clinical trial proposes to determine whether there is a difference in efficacy between the nsaids ketorolac, ibuprofen, and diclofenac and for the treatment of acute, non-traumatic, non-radicular low back pain.

Eligibility criteria:
inclusion criteria: * men or women age 18-64. * present to ed primary for management of low back pain (lbp) * functionally impairing back pain: a baseline score of greater than 5 on the roland-morris disability questionnaire * musculoskeletal etiology of low back. * non-radicular pain. * pain duration \<2 weeks (336 hours). * non-traumatic lbp * participant is to be discharged home. exclusion criteria: * flank pain, that is pain originating from tissues lateral to the paraspinal muscles. * not available for follow-up * pregnant * chronic pain syndrome * allergic to or intolerant of investigational medications * contra-indications to investigational medications

Keywords: ketorolac diclofenac ibuprofen low back pain back pain
clinical study to evaluate the safety, tolerability, and preliminary efficacy of intravitreal (ivt) injection of abi-110 (aav2.n54-vegf trap) in subjects with neovascular (wet) age-related macular degeneration (wamd), including symptomatic macular polypoidal choroidal vasculopathy (pcv)

Conditions: Neovascular (Wet) AMD

Summary: this will be a clinical study to assess initial safety and tolerability of ivt abi-110 in patients diagnosed with wet macular degeneration (wamd), including symptomatic macular pcv.

this is a phase 1/2a, open-label, multiple-cohort, dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of ivt abi-110 (aav2.n54-vegf-trap) injection in subjects with wamd), including symptomatic macular pcv. this trial will include a screening period, confirmation of response to eylea (aflibercept), single administration of abi-110, and follow-up period of 104 weeks after ivt abi-110 injection.

Eligibility criteria:
key inclusion criteria: * general: 1. must be willing and able to provide written, signed informed consent. 2. age: subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent study eye: 3. diagnosis of wamd, including symptomatic macular pcv, confirmed by the central reading center 4. the macular neovascularization lesion must be confirmed as determined by the central reading center based on sd-oct imaging at screening. 5. bcva ≤ 20/32 and ≥ 20/250 (≤ 78l and ≥ 30l etdrs letters) 6. history of ≥ 2 anti-vegf injections prior to trial entry with meaningful response to anti-vegf and continued need for anti-vegf treatment 7. response to anti-vegf at trial entry 8. must be pseudophakic key exclusion criteria: * study or fellow eye: 1. prior gene therapy, either eye 2. any active ocular/intraocular infection or inflammation (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis) or history of idiopathic or autoimmune-associated uveitis, either eye 3. history of retinal disease other than wamd or pcv, study eye 4. any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, or retinal epithelial tear in the center of the fovea), study eye. 5. history of (or active) retinal detachment, study eye 6. uncontrolled glaucoma (defined as iop \> 25 mmhg despite treatment), study eye, or history of steroid-response ocular hypertension/glaucoma in either eye 7. history of intravitreal therapy, (other than anti-vegf therapy) such as intravitreal steroid injection or investigational product, in the 6 months prior to screening, study eye 8. any prior treatment with photodynamic therapy or laser photocoagulation, study eye 9. history of glaucoma filtration, vitrectomy, or other procedure that could affect drug distribution or clearance, study eye.
observational study of preoperative screen for substance abuse

Conditions: Preoperative Screen for Substance Abuse in in Patients Undergoing Emergency Operation

Summary: substance abuse is a growing problem world wide, and treatment of substance abusers in the perioperative period, especially for emergency operation is challenging. the objectives of this study are to determine the proportions of substance abusers in the trauma patients undergoing emergency operation by preoperative screen, observe the differences of consumption of anesthetics and other medications during perioperative period between substance abusers and non-abusers, as well as postoperative complications, and explore an optimal scheme for substance abusers.


Eligibility criteria:
inclusion criteria: * patients aged 16\~70 years； * informed consent signed exclusion criteria: * aged\ 70 years； * refuse to sign consent; * other conditions that may preclude the patients from the study, such as language barrier, psychiatric disorders, unable to attend research center for follow up. * patients who enrolled to another research study or are taking experimental medication in last 3 months prior to this study. * not suitable for the study, after assessment by the investigators.

Keywords: substance abuse emergency operation preoperative screen
kinesio tape vs neuromuscular stimulation for conserative of treatment hemiplegic shoulder

Conditions: Hemiplegia

Summary: this study aimed to compare the effects of kinesiotaping, neuromuscular electric stimulation (nmes), and neuromuscular training on pain, and motor activity and function in patients with upper extremity hemiplegia.

hemiplegia in the shoulder complex and upper limb is a common secondary impairment as a result of a cerebrovascular event. although most stroke survivors regain independent ambulation, many fail to regain functional use of their impaired upper limb. actually the pathogenesis of post-stroke shoulder pain seems to be multifactorial; differential diagnosis is often difficult. changes in the shoulder complex makes the glenohumeral joint vulnerable to subluxation, which may cause pain. traction of capsule and soft tissue related subluxation of the shoulder may take place in the early stages; limited range of motion due to spasticity may develop in the later stages of stroke. these biomechanical problems may be the possible reason for pain. rotator cuff tears and rotator cuff and deltoid tendinopathies are also possible symptoms related to hemiplegic shoulder observed in magnetic resonance imaging findings. these problems in the shoulder disturb the kinetic chain system that connects the segments and works sequentially from proximal to distal to achieve the targeted movement. when a biomechanical impairment happens in the shoulder or any other segment of the body, a loss in the energy produced in the body and transferred to the upper extremity occurs. this loss adversely affects the quality of the movement . regaining functional use of the upper limb after a stroke is a challenging task for the patient, which has a significant impact on the individual's physical, psychological, and emotional well-being. lack of functional ability in the upper extremities after stroke restricts use and causes asymmetric posture and contracture in daily life, thus exacerbating functional limitations of the upper limb. also, low upper limb motor function is related to the risk of soft tissue injury during rehabilitation. a patient experienced a stroke may not feel any pain due to subluxation. however, different muscle groups may be vulnerable to overstretching, increased contraction, and premature fatigue. this can decrease the coordination of muscular activity and inhibit the functional use of the upper extremity. the posterior fibers of the deltoid, the supraspinatus, and the infraspinatus are the most important muscles that prevent the subluxation of the glenohumeral joint.

Eligibility criteria:
inclusion criteria: * had unilateral ischemic brain injury or intracerebral hemorrhage at least 1 week to maximum 24 months after the onset of single stroke without other diagnosed neurological or systematic deficits. * had enough cognition to be able to follow the training protocol as assessed by mini mental state examination. * age 30-70 years. exclusion criteria: * had a severe injury of the rotator cuff or a shoulder surgery history.

Keywords: taping, stroke rehabilitation shoulder pain electrical stimulation
clinical evaluation of chronic consciousness disorders using resting-state eeg and erp

Conditions: Disorders of Consciousness

Summary: currently, there are significant challenges in the clinical assessment of patients with consciousness disorders, such as distinguishing between vegetative state (vs) and minimally conscious state (mcs), and predicting patient prognosis. this study aims to utilize different research techniques, such as auditory stimulation, as well as modified microstate methods, to enhance the disease classification and prognosis prediction of patients with chronic consciousness disorders.

the investigators collected resting-state electroencephalograms (eegs) and eegs under various event-related potential (erp) stimuli from patients with chronic consciousness disorders, and performed analyses on these data. the resting-state eegs were subjected to spectral analysis and microstate analysis. the erp eegs were analyzed in the time domain, as well as for phase coupling and other measures.using these computed indicators, the investigators use machine learning, deep learning, and other methods to predict disease classification and prognosis assessment in patients with chronic consciousness disorders.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with coma /vs/mcs 2. the course of disease was more than 4 weeks 3. the vital signs were stable and able to tolerate the test process 4. complete skull 5. right-handed, no history of ear disease or hearing loss before onset exclusion criteria: 1. history of epilepsy 2. sedatives 3. muscle relaxants and epileptic prophylaxis within 24 hours

Keywords: resting-state electroencephalograms erp microstate
diabetes distress, psychological well-being and family hardiness in parents of children and adolescents with t1d

Conditions: Type 1 Diabetes

Summary: parents have an important role in child's diabetes management. many studies show that parental psychological stress and family dynamics are associated with parental diabetes-related distress and treatment outcomes among children and adolescents with type 1 diabetes. the aim of this study is to analyze diabetes distress (diabetes-related parenting burden and fear of hypoglycemia), parental psychological well-being (anxiety, satisfaction with life, positive and negative affect and adult attachment relationship pattern), family hardiness and characteristics of children with type 1 diabetes in a sample of mothers and fathers of children and adolescents with type 1 diabetes of ages up to 18 years. in this study it is hypothesized that: 1. greater parental fear of hypoglycemia and diabetes-related burden are associated with lower family hardiness and worse psychological well-being parents and higher hba1c levels in children and adolescents with type 1 diabetes; 2. mothers will report greater fear of hypoglycemia, diabetes-related burden and lower psychological well-being comparing to fathers. 3. parents of children and adolescents with type 1diabetes will report greater anxiety, lower psychological well-being and family hardiness comparing to parents of children without diabetes. standardized and validated questionnaires will be used to determine: parental fear of hypoglycemia, diabetes-related burden, parent level of anxiety, psychological well-being, adult attachment relationship pattern and family hardiness. the investigators will also measure parent daily involvement in child's diabetes management, frequency of blood glucose monitoring and parent general satisfaction with glycemic control. objective measures such as child's hba1c level and experience of severe hypoglycemia episode will also be obtained. these measures will be correlated with other research variables.


Eligibility criteria:
inclusion criteria: * parents or caregivers of children and adolescents with t1d of ages up to 18 years * minimal 1 year duration of type 1 diabetes exclusion criteria: * parents or caregivers of children and adolescents with t1d of ages over 18 years

Keywords: diabetes related distress, children, t1d, family hardiness, psychological well-being
development of child with equinus deformity idiopathic

Conditions: Equinus Deformity

Summary: identification and characterization of the link between psychomotor development and the appearance of associated signs in children with "equinus deformity " considered isolated at birth.

the main objective of this study is to define the frequency of developmental abnormalities in children with "equinus deformity idiopathic" compared to the general population the secondary objective is to identify the prenatal and / or neonatal characteristics that could be predictive of the occurrence of developmental abnormalities in prenatal and postnatal follow-up data are derived from the child's medical file. to complete these data and after inclusion, parents of children carrying "equinus deformity idiopathic" will be sent a questionnaire that assesses overall psychomotor development and lists the medical events since the birth of their child (scoliosis, epilepsy ...).

Eligibility criteria:
inclusion criteria: * children born between january 2002 and august 2015 * prenatal or postnatal diagnosis of idiopathic or syndromic equinus deformity * followed by the pediatric orthopedic service of rennes university hospital * parent having received the information on the protocol and having not expressed their opposition. exclusion criteria: * parents opposing the study

Keywords: developmental abnormalities psychomotor development
phase 1 safety study of alk-001 in healthy volunteers

Conditions: Stargardt Disease; Age-related Macular Degeneration; Other Retinal Dystrophies

Summary: this protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of alk-001 in healthy volunteers. please contact trials@alkeus.com for any questions.


Eligibility criteria:
main inclusion criteria * adult between 21 and 70 years old (inclusive) * healthy subject, as judged by investigator * subject is able and willing to comply with study requirements (study medication compliance, schedule of follow-up visits) * subject has provided informed consent to participate * if female, subject uses a medically accepted birth control method and agrees to use such a method for entire clinical trial period main exclusion criteria: * subject has taken disallowed items during the past 30 days * female with a positive urine pregnancy test at screening * lactating woman * subject has participated in any clinical study involving an investigational drug, biologic or device, during the past 30 days * history or current evidence of gastrointestinal malabsorption * subject has any other medical condition, which in the opinion of the investigator, is likely to prevent compliance with protocol and/or interfere with successful collection of study * subject has, in the opinion of investigator, clinically significant laboratory result(s), positive drug or alcohol screening, or ecg, which makes subject unsuitable for participation.
palpation versus ultrasonography for identifying the cricothyroid membrane in case of a laterally deviated larynx

Conditions: Airway Management

Summary: test persons, anaesthesiologists will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography. the larynx-model is deviated to one of the sides to simulate a patient with neck pathology

test persons, anaesthesiologists will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography. the larynx-model is deviated to one of the sides to simulate a patient with neck pathology. the test persons are randomised to use other palpation or ultrasonography. al attempts are video-taped

Eligibility criteria:
inclusion criteria: * participants in a course of airway management exclusion criteria: unwillingness to participate -