Kornimate/medical-research-clean huggingface dataset:
lung function outcomes following removal of airway mucus plugs in patients with asthma (focus)

Conditions: Asthma

Summary: this is a single-center study that will evaluate the safety and tolerability of removal of mucus plugs by bronchoscopy in patients with asthma. this protocol will also plan for the analysis of the features of the mucus plugs removed.

the investigators' research shows that a large subgroup of asthma patients have mucus plugs, and quantification of these plugs using a bronchopulmonary segment-based scoring system reveals a strong negative correlation between the ct (computed tomography) mucus plug score and fev1 (forced expiratory volume at 1 second). the focus study is a single-center study that has the overarching goal to explore the biology of airway mucus plugs in asthma. through the focus study, the investigators will initially explore the safety and tolerability of bronchoscopic removal of airway mucus plugs in patients with asthma and mucus plugs. they will then evaluate potential improvements in lung function outcomes in a dose-dependent manner (i.e., by removing mucus plugs from one lung vs both lungs). a secondary objective of the focus study is to perform detailed cellular and molecular analyses of mucus and epithelial cells from airways impacted with mucus. with these biospecimens, the investigators intend to extend their preliminary findings that mucus plugged airways are characterized by intense type 2 inflammation, determine the mechanisms of epithelial and immune cell reprogramming, as well as how cellular reprogramming affects the promotion and persistence of type 2 airway inflammation.

Eligibility criteria:
protocol a: inclusion criteria: * males or females between the ages 18 to 70 at the time of visit 1. * clinical history of asthma per patient report or medical record. * pre-bronchodilator fev1 \< 80% predicted and ≥ 35% predicted * ct mucus plug score \> 5. * written informed consent obtained from subject and ability for subject to comply with the requirements of the study. exclusion criteria: * smoking of tobacco or other recreational inhalants in the last month and/or \>10 pack-year smoking history. * history of other pulmonary disorders including cystic fibrosis and copd (chronic obstructive pulmonary disease). * history of unstable cardiovascular disease. * bmi \> 45 * current use of anticoagulant medications. * upper respiratory infection (uri) within the previous 6 weeks * currently pregnant and/or unwillingness to practice medically acceptable birth control or complete abstinence during the study * history of covid-19 (coronavirus disease) in the past 6 months. protocol b: inclusion criteria: * males or females between the ages 18 to 80 at the time of visit 1. * undergoing clinically indicated bronchoscopy for removal of mucus plugs. * clinical history of airway disease (including asthma, copd and bronchiectasis) per patient report or medical record. * written informed consent obtained from subject. exclusion criteria: * upper respiratory infection (uri) in the past 30 days. * history of covid-19 in the past 30 days. * currently pregnant during the study.
the novel use of treadmill plus music in ms patients gate rehabilitation

Conditions: Interventional Study

Summary: multiple sclerosis (ms) is characterized by demyelination andaxonal loss of the central nervous system, which progressively results in neurologic dysfunction and is often accompanied by gaite limitations, reduced fitness, and increased risk of falls. traditional exercises such as treadmill walking orstationary cycling can often be perceived as boring, because theseexercises usually involve repetitive, continuous movements. in recents years the positive effect of the auditory stimulus in the recovery of gait difficulties has been demonstrated in parkinson's disease, however this methodology on ms patients has been poorly investigated. in addiction the neurophysiological mechanisms by which coupling steps with external auditory cues improves gait remain partially unclear. for this reason, our purpose is to investigate whether patients with ms, compared to the control group, may have improvements in motor and psychological well-being, through training with devices that integrate motor training with musical stimuli (gait trainer).

although the number of studies and the extent of available evidence is greater in case of parkinsonism, there is also evidence of the effects of music-based interventions on supporting motor function and emotional well-being in people with multiple sclerosis. interventions based on music can influence multiple functions. recently it has been shown that coupling of auditory signals with motor training may be possible to form a rhythmic gait by dragging movement patterns, supporting the generation of better gait patterns; moreover, it can have effects on the rhythmic dragging; the commitment of automatic timing systems; movement planning, execution and learning; and an increase in motivation. furthermore, this type of coupling has been shown to improve various gait parameters, including cadence, gait speed, stride length, gait time variability and pitch width. the aim of our study is to evaluate the effectiveness of the treadmill training combined with ras in terms of mobility, balance and gait parameters, patient's well-being.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsing remitting ms according to polman criteria; * presence of gait impairment; * absence of auditory deficits; * edss \<4.5; * absence of clinical and/or neuroradiological ms relapse in the 3 months before enrolment; * stable therapy in the last 3 months. exclusion criteria: * presence of bone or joint disorders; * history of severe cardiovascular, respiratory, auditory, and muscular-skeletal disease; * other neurological conditions; and neurologic music therapy in the last 3 month; * ms relapse in the 6 months before enrolment; * expanded disability status scale (edss) \> 4.5.

Keywords: gait rehabilitation rhythmic auditory stimulation gaittrainer3 multiple sclerosis
comparison of postoperative quality of recovery by anesthetic method in patients undergoing shoulder arthroscopy

Conditions: Shoulder Arthroscopy

Summary: the aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used: 1. general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia 2. regional anesthesia (brachial plexus block) with intraoperative sedation.


Eligibility criteria:
inclusion criteria: * patients of age 19 years and above, scheduled for shoulder arthroscopic surgery exclusion criteria: * emergency operation * inflammation or infection at the site of nerve block administration * inability to perform the quality of recovery questionnaire due to dementia or delirium * severe lung disease (e.g. chronic obstructive pulmonary disease or interstitial lung disease) * contraindication to brachial plexus block * history of hypersensitivity or side effect to ropivacaine
trial comparing laparoscopic vs robotic-assisted colposacropexy for pelvic organ prolapse repair

Conditions: Pelvic Organ Prolapse

Summary: the aim of the study is to perspectively compare the anatomical and functional outcomes of pelvic organ prolapse (pop) repair after laparoscopic or robotic-assisted colposacropexy.

female pelvic floor disorders rank amongst the most common disorders affecting women and include conditions such as urinary incontinence and pelvic organ prolapse (pop). pop is estimated to affect 30% of women aged 50- 89 years, and the lifetime risk of requiring surgery is 11%. open abdominal sacrocolpopexy is the established gold standard procedure and is indicated when there is prolapse of the anterior and/or apical vaginal wall compartments. laparoscopic sacrocolpopexy (lscp) has not been widely adopted as it demands skill and motivation and it is associated with a long learning curve. so the hypothesis is that robot-assisted laparoscopic approach for sacrocolpopexy (ralscp) could be an alternative to a pure laparoscopic technique. in the study design 62 patients will be randomly enrolled (31 in the laparoscopic arm and 31 in the robotic assisted one). the primary outcome will be the anatomic one, secondary outcomes will be functional in terms of storage or voiding dysfunctions, sexual dysfunctions, bowel dysfunctions, qol, post operative complications. for continuous variables will be used the mann-withney test, for categorical data will be used mcnemar test and x2 test.

Eligibility criteria:
inclusion criteria: * symptomatic pop \>2 stage according to pop q system exclusion criteria: * obesity * heart failure (nyha iii-iv) * high stage copd (chronic obstructive pulmonary disease) * patients who underwent more than 2 previous abdominal surgical procedures

Keywords: laparoscopic sacrocolpopexy robotic assisted sacrocolpopexy pelvic organ prolapse
efficacy and safety of panlongqi tablet in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study evaluates the efficacy and safety of panlongqi tablet compared with placebo in the treatment of knee osteoarthritis in adults.half of participants will receive panlongqi tablet in combination,while the other half will receive a placebo.

the test group will be given panlongqi tablet 1.2g three times per day,the control group will be given placebo 1.2g three times per day. the invention will last 4 weeks.

Eligibility criteria:
inclusion criteria: 1.40-75 years of age (including 40 years and 75 years old), men and women are not limited. 2. western medicine diagnosis of knee osteoarthritis, clinical classification for primary. 3.the severity of the imaging classification of k-l≤ⅲ; 4. treatment vas pain scores than 40mm (select the subjects most obvious limb pain symptoms). 5. informed consent form signed by the patient or legal representative. exclusion criteria: 1. within 3 months prior to the trial, the patients were treated within 1 years. 2. 4 weeks before the treatment, corticosteroids, non steroidal drugs, intra-articular injections or other drugs to improve the condition (such as cartilage protective agents) were used. 3. swelling of the knee joint. 4. knee synovial crystalline (joint) inflammation, acute inflammatory arthritis, rheumatoid arthritis, metabolic bone disease, psoriatic arthritis, septic arthritis, systemic lupus erythematosus, sjogren syndrome, vasculitis and other rheumatic diseases caused by inflammatory arthritis and endocrine diseases caused by. 5. the screening period has any disease history or evidence: the basic of serious cardiovascular and cerebrovascular diseases; an active, recurrent peptic ulcer or other hemorrhagic disease risk; sales and other serious diseases of digestive system; an associated with malignant tumors, blood, or other serious diseases or system; 6. patients who are unable to cooperate or cooperate with other mental disorders. 7. before the screening, any laboratory test indicators meet the following standards: an admission of liver and kidney function showed that alt and ast is more than 1.5 times the upper limit of the normal value, cr is more than 1.2 times the upper limit of normal (reference research center laboratory where the range of normal value); an other clinically significant laboratory abnormalities, and the researchers judged not into the group. 8. allergic constitution or allergic to test seven tablets, excipients or similar ingredients; 9. doubt or indeed history of alcohol and drug abuse; 10. pregnant or lactating women or recent planned pregnancies and those who are reluctant to use contraceptives; 11. participants who participated in other clinical trials within the first 3 months. 12. the researchers believe that patients should not participate in this clinical trial.
impact of covid19 outbreak in cardiac acute care

Conditions: Acute Coronary Syndrome; Heart Failure; COVID

Summary: this registry will evaluate the impact of the covid19 outbreak on cardiac patients admitted in the intensive care unit of the pitie-salpetriere hospital in paris, france

registry on characteristics and outcomes of cardiac patients (covid- and covid+) hospitalized in the intensive care unit of the pitie-salpetriere hospital in paris, france

Eligibility criteria:
inclusion criteria: * 18 years and older * admitted in the cardiac intensive care unit from march 20th 2020 * patient informed and having expressed his non-opposition to participate in the research exclusion criteria: * minor patient * patient who expressed opposition to participation in the study

Keywords: covid19 acute coronary syndrome myocardial infarction
live attenuated influenza vaccine as a nasal model for influenza infection

Conditions: Influenza

Summary: the purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (laiv). the investigators will administer laiv to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses. in a subset of participants, cystic fibrosis transmembrane conductance regulator (cftr) function will also be evaluated via measurement of nasal potential difference (npd)


Eligibility criteria:
inclusion criteria: * ages 18-49 years old, * not yet received influenza vaccine for 2019-2020, and * capable of giving signed informed consent. exclusion criteria: * immunocompromising condition (e.g. hiv/aids, chemotherapy, immune suppressing medications), * active smoking within past 6 months, * asthma, chronic lung/liver/kidney /neurologic/hematologic/metabolic disorders,cardiovascular disease (excluding isolated hypertension), diabetes mellitus, disease, congestive heart failure, * pregnancy, * current or recent (within the past month) upper/lower respiratory tract infection, chronic sinusitis/nasal allergies requiring frequent or daily therapy (including topical corticosteroids), * prior adverse reaction to influenza vaccine, * history of guillain-barre syndrome, * egg allergy, * close contact with an individual with severe immunodeficiency/immunosuppression.
zein nanoparticles for glycemic control

Conditions: PreDiabetes; Overweight and Obesity; Adult ALL

Summary: the use of zein nanoparticles as vehicles for drug delivery is under study, but of the effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose levels was something worth studying. thus, the present research on patients with prediabetes has been proposed. the objective is to assess the efficacy of zein nanoparticles on the glycemic control. for this purpose, a randomized, double blind crossover study has been designed. target sample size is 60.


Eligibility criteria:
inclusion criteria: * overweight or obesity (bmi between 25 and 40 kg/m2 * presence of prediabetes (fasting glycemia in blood between 100 and 126 mg/dl) * no weight variations considered relevant (+/- 5%) in the last 3 months * metformin treatment is allowed, as far as dose is stable (at least 2 months with unvaried dose). * good physical and psychological state. exclusion criteria: -

Keywords: prediabetes glycemia and glucose metabolism zein glucose monitoring
selenium supplementation of patients with cirrhosis

Conditions: Cirrhosis

Summary: this study is being conducted to determine if patients with cirrhosis (liver disease) are selenium deficient. the effect of supplementation with two chemical forms of selenium on plasma selenium biomarkers will be determined and correlated with the severity of the liver disease.

selenium is an essential nutrient that plays a role in oxidant defense, among other functions. there is much interest in the role selenium may play in several disease processes. it is possible that certain diseases result in selenium deficiency because of the form of selenium taken in the normal diet. we propose to measure the selenium biomarkers associated with supplemental intakes of 200 or 400 µg of selenium per day in the chemical form selenate, or with supplemental intake of 200 µg selenium as selenomethionine. 144 patients with cirrhosis will be randomized to one of 4 treatment groups, including a placebo. after treatement for 4 weeks, all participants will receive 400 µg of selenium per day as selenate for 4 weeks. blood will be measured initially and at 4 and 8 weeks. selenium, selenoprotein p and glutathione peroxidase will be measured in the plasma.

Eligibility criteria:
inclusion criteria: * adults with cirrhosis exclusion criteria: * pregnancy or planning a pregnancy * selenium supplements of 25 µg or more within the past year

Keywords: selenium supplements selenate selenomethionine biomarkers plasma selenium concentration plasma glutathione peroxidase selenoprotein p
study to assess acute vasodilation response of inhaled nitric oxide

Conditions: Pulmonary Arterial Hypertension

Summary: the eagle study is a phase 3, open-label, multi-center, two-part, single-arm study of genosyl(r) delivery system(s) to evaluate if inhaled nitric oxide-induced vasodilation predicts successful wean from parenteral prostacyclin (pgi) in subjects with world health organization (who) group 1 pulmonary arterial hypertension (pah) undergoing a medically necessary right heart catheterization (rhc). all subjects enrolled in the study will undergo an attempt to wean from parenteral pgi per standard of care.

this study will be divided into 2 parts: a pilot phase followed by pivotal phase. * the pilot phase will enroll up to 20 subjects. the information derived from the pilot phase will evaluate safety, and assess the vasoreactivity test response rate. * approximately 150 subjects will be enrolled in the pivotal phase of the study, to gather further data on weaned successes from parenteral pgi. the investigator and study staff involved with the wean and patient management will be blinded in this phase of the study to the vasoreactivity results.

Eligibility criteria:
inclusion criteria: * the subject or subject's legally authorized representative signs and dates an institutional review board (irb) approved informed consent form prior to the initiation of any study-related activities. * the subject has been diagnosed with pah (who group 1) and is who functional class i or ii at screening. * the subject has documented continuous pgi use for ≥ 1 year from screening, without a significant interruption (i.e., ≤ 2 day interruption) and without a failed complete wean attempt. * the subject is a candidate for weaning off parenteral pgi therapy (per investigator judgment and standard of care). exclusion criteria * the subject has a hypersensitivity or allergy to ingredients of inhaled nitric oxide or other clinically significant allergies (clinical significance per investigator judgment). * the subject has a pcwp or left ventricular end diastolic pressure (lvedp) ≥15 mmhg at baseline. * the subject has participated in an investigational product or device study within the 30 days prior to screening.
measurement of low-energy stimulation in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: multistage low-energy pulses are being evaluated for their effect on atrial fibrillation during an acute testing procedure.

this is a research feasibility study to evaluate various parameters of the multistage low-energy pulses and their effect on atrial fibrillation.

Eligibility criteria:
inclusion criteria: * patients indicated for an atrial fibrillation ablation procedure exclusion criteria: -
physical parameters in osteoarthritis stages

Conditions: Osteoarthritis; Pain; Quality of Life

Summary: to investigate the extent to which pain, functionality, and quality of life change over the progression of osteoarthritis grades.


Eligibility criteria:
inclusion criteria: * having the same oa grade in both knees * volunteering to participate in the study * not having undergone previous lower extremity surgery exclusion criteria: * neurological disorders; * those with a history of surgery related to the lower extremities; * those with orthopedic problems in the lower extremities, such as tendinopathy and bursitis; * those who had neurological, orthopedic, or cognitive disorders that would prevent walking; * those with a diagnosis of diabetes, obesity, or rheumatological disorders; * those who had received intra-articular injection therapy within the last three months; * and those with malignancy or perception problems.
methadone maintenance outcome study in taiwan: 5-year follow-up

Conditions: Heroin Dependence; Sleep Impairment; Mortality; Quality of Life; Treatment Outcome

Summary: methadone maintenance treatment (mmt) has been one of the most effective treatment choices for opioid addicts to reduce their heroin use, criminality and spread of hiv. in taiwan, mmt has been introduced since 2006. to date, more than 30,000 opioid addicts have ever participated in mmt, but only around 10,000 retains in treatment. outcomes of the ever-treated mmt patients remain unclear. it is crucial to trace the opioid addicts' treatment career, outcomes and unmet treatment needs for the service providers to modify treatment strategy to help these individual to maintain abstinence. moreover, understanding of the determinants for these subjects' long-term outcomes is important for policy makers to implement realistic policies to motivate the service providers and patients. from the results of previous research, the research team found that early dropout, defined as stayed in-treatment less than one month, of mmt participants were 14.4%. the rate of maintaining in treatment at 3rd , 6th, and 12th month were 65.7%、51.3% and 33.8%, respectively. average treatment days for 12-month is 186.9±141.2. this result showed that the effectiveness of the mmt was varied among different facilities. on the other hand, the quality of the mmt can be improved largely through different dimensions. besides, if one participant can enhance its motivation in staying in-treatment, it could reduce 15% early dropout. above all, the result also showed that though the quality of life was recorded as improved after mmt, it appeared to be significantly lower than their healthy counterparties. the assessments of health outcomes after participating mmt are rare, but in need. it is necessary to make some modification to improve the effectiveness. moreover, the evaluation of the needs shall not limit to patients, but also extend to their family members. therefore, in this study, the research team plans to probe the dimensions from physical, psychiatric, to social conditions by assessing patients and their family members after treated by mmt for five years. the research team would like to know more about the outcomes of those who attended mmt five years ago, their physical and mental health conditions, also health status of their family members.


Eligibility criteria:
inclusion criteria: * attended ec0980203, ec0980209, ec1010102 projects * nationality: taiwan * 20-year-old and above * match the diagnosis of heroin dependence from dsm-iv * able to fill out the informed consent exclusion criteria: * acute major physical or mental illness (need immediate health care)