Kornimate/medical-research-clean huggingface dataset:
evaluate the relationship between use of albuterol multidose dry powder inhaler with an emodule (emdpi) and exacerbations in participants with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a phase 3b, 12-week, multicenter, open-label study to evaluate the relationship between as-needed usage of albuterol emdpi and clinical exacerbation-chronic obstructive pulmonary disease (ce-copd) in adult participants at least 40 years of age with exacerbation-prone copd.


Eligibility criteria:
inclusion criteria: * the participant has had at least 1 episode of moderate or severe ce-copd over the past 12 months before screening. * the participant must be able to demonstrate appropriate use of albuterol from the abs emdpi. * the participant is currently using a short-acting beta agonist (saba) reliever plus at least one of the following: long-acting beta agonist (laba), an inhaled corticosteroid (ics)/laba, a long-acting muscarinic antagonist (lama), or a laba/lama. * the participant must be willing and able to comply with study requirements as specified in the protocol, including the use of a wearable accelerometer for the subset of participants who consent to use of the device. * the participant is willing to discontinue all other rescue or maintenance saba or antimuscarinic agents and replace them with the study-provided abs emdpi for the duration of the trial. * women of childbearing potential (not surgically sterile or greater than or equal to \[≥\]2 years postmenopausal) must have exclusively same-sex partners or use a highly effective method of birth control and must agree to continue the use of this method for the duration of the study and for 30 days after discontinuation of the investigational medicinal product (imp). * additional criteria apply, please contact the investigator for more information. exclusion criteria: * the participant has any clinically significant medical condition (treated or untreated) that, in the opinion of the investigator, would interfere with participation in the study. * the participant has any other confounding underlying lung disorder other than copd. * the participant has used an investigational drug within 5 half-lives of it being discontinued or within1 month of visit 2 (baseline \[day 1\]), whichever is longer. * the participant is a pregnant or lactating woman, or plans to become pregnant during the study. note: any woman becoming pregnant during the study will be withdrawn from the study. * the participant is known to be allergic to albuterol or any of the excipients in the imp or rescue medication formulation (that is, lactose \[milk protein\]). dietary lactose intolerance does not exclude the participant from inclusion in the study or as per the investigator's medical discretion. * the participant has a history or presence of "silent" infections, including positive testing for human immunodeficiency virus types 1 and 2, hepatitis b, hepatitis c, and tuberculosis. * additional criteria apply, please contact the investigator for more information.
incidence of severe covid-19 infection in patients with cll or b-nhl who received pre-exposure prophylaxis with tixagevimab and cilgavimab in italy.

Conditions: Chronic Lymphocytic Leukemia; Indolent B-Cell Non-Hodgkin Lymphoma; COVID-19

Summary: this is an observational retrospective and prospective multicenter study aimed at describing the role of the covid -19 prophylaxis with tixagevimab and cilgavimab in cll or indolent b-nhl patients who received first covid-19 prophylaxis dose between march 2022 and october 2022.

this is an observational retrospective and prospective multicenter study aimed at describing the role of the covid -19 prophylaxis with tixagevimab and cilgavimab in cll or indolent b-nhl patients. all cll or indolent b-cell nhl patients (follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma) who received first covid-19 prophylaxis dose with tixagevimab and cilgavimab according to aifa indication between march 2022 and october 2022 will be included in the study. each patient will be followed for a maximum of 12 months from the first covid-19 prophylaxis dose.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. patient with cll or indolent b-nhl who received the first covid-19 prophylaxis dose with tixagevimab and cilgavimab as per label indication between march 2022 and october 2022. 3. signed informed consent, if applicable exclusion criteria: none
effects of radio-frequency in patients with myofascial chronic neck pain

Conditions: Neck Pain

Summary: the aim of this study was to evaluate the potential clinical benefits of monopolar capacitive resistive radio-frequency (448 khz) (mcrr)f for the treatment of myofascial chronic neck pain.

a randomized, double-blind, placebo-controlled trial. setting: university community. patients with myofascial chronic neck pain with active mtrp in one upper trapezius muscle were involved. the patients were randomly divided into two groups: a radiofrequency group (rfg), who (14 patients) received 8 sessions of a monopolar capacitive resistive radiofrequency (mcrrf) application over the upper trapezius muscle and ten patients received 8 sessions of placebo radiofrequency (pg) over the same muscle. main outcome measures: visual analog scale (vas), neck disability index (ndi) and cervical range of motion (pre-treatment, immediately post-first session treatment and post-treatment.

Eligibility criteria:
inclusion criteria: -patients aged between 18 and 60 years with myofascial chronic neck pain. the area of neck pain was defined as the cervical region, possibly with referred or radiating pain into the occiput, nuchal muscles, shoulders and upper limbs. symptoms had to have been present for at least six months before. at least one active mtrp in one upper trapezius muscle had to be present. for bilateral neck pain, the most painful side was designated for treatment. exclusion criteria: * severe disorders of the cervical spine, such as spinal stenosis, disk prolapse, postoperative conditions of the neck and shoulder areas, history of severe trauma, whiplash, spasmodic torticollis, instability, migraine, peripheral nerve entrapment, fibromyalgia, shoulder diseases, inflammatory rheumatic diseases, severe psychiatric illness and pregnancy.
combination of irinotecan and temozolomide in children with brain tumors.

Conditions: Glioma; Medulloblastoma

Summary: this study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.


Eligibility criteria:
inclusion criteria: * cohort 1: recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease. * cohort 2: newly-diagnosed high-grade glioma (world health organization \[who\] grade 3 or 4) * life expectancy ≥ 3 months exclusion criteria: * diagnosis of brainstem glioma * concurrent administration of any other anti-tumor therapy * pre-existing uncontrolled diarrhea
a study to evaluate cooling sensation of an allergy product in adults with a history of allergies

Conditions: Allergic Rhinitis

Summary: in this study, researchers were primarily interested in evaluating the level of agreement of cooling sensation provided by this chewable, flavored, allergy medicine. participants joining this study received one test drug tablet and were asked to chew completely before swallowing the drug. a questionnaire was used to collect the feedback from participants. the study involved only one (1) visit and participant stayed in this study for about 60-75 minutes to evaluate the cooling sensation as well as other sensory attributes perceived in the mouth, nose and throat.


Eligibility criteria:
inclusion criteria: * female or male adults aged 18 to 65 years of age inclusive * were in good general health * previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine * agreed to not use antihistamine products 24 hours before and after the treatment * willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing exclusion criteria: * individuals who had used oral/systemic medications 24 hours before the first administration of test product * individuals who used medications which might influence taste perception * individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days * women who were pregnant or thinking of becoming pregnant or were nursing * participants with congestion at the time of study visit * any self-reported symptoms or conditions that might interfere with the participants ability to complete the evaluation of the product on testing day * any current medical condition that in the opinion of the investigator or designee might interfere with normal taste and/or temperature perception (e.g., active common cold, sinus infection, bronchial infection, adenoids, paresthesia etc.) * history of alcohol or drug abuse * history of hypersensitivity or allergic reactions to any ingredients in the test product * individuals with a history of glaucoma, liver or kidney disease, respiratory conditions such as chronic bronchitis or swallowing difficulties * individuals who were currently wearing any kind of dental braces or with dental work or had cavities and associated pain that might affect their ability to chew a tablet

Keywords: allergy upper respiratory allergies
the impact of small bowel obstruction (sbo) on quality of life (qol)

Conditions: Small Bowel Obstruction; Quality of Life; Bowel Obstruction

Summary: this study has two segments the first is a chart and outcome assessment of patients treated at clear passage (cp) with a history of small bowel obstruction (sbo). these patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. the second segment is a prospective observational, online questionnaire based study of subjects with a history of sbo not treated at cp. data on the impact of quality of life (qol) over time of subjects not treated at cp will be assessed using the same questionnaire used as standard of care in the clinic twice, 90 days apart. this will be accomplished using the nih assessment center, with subjects able to complete the questionnaires with ease via the internet. as this segment is observational, there is minimal risk to these subjects. the data obtained from the untreated subjects will allow for reporting of overall impact on qol in this population, data that is not available, as well as provide a control group for assessment of improvement for interventions for sbo.

this study has two segments the first is a chart and outcome assessment of patients treated at clear passage (cp) with a history of small bowel obstruction (sbo). these patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. the second segment is a prospective observational, online questionnaire based study of subjects with a history of sbo not treated at cp. data on the impact of quality of life (qol) over time of subjects not treated at cp will be assessed using the same questionnaire used as standard of care in the clinic twice, 90 days apart. this will be accomplished using the nih assessment center, with subjects able to complete the questionnaires with ease via the assessment center. as this segment is observational, there is minimal risk to these subjects. the data obtained from the untreated subjects will allow for reporting of overall impact on qol in this population, data that is not available, as well as provide a control group for assessment of improvement for interventions for sbo.

Eligibility criteria:
inclusion criteria: * age between 18 and 90 years old * previous diagnosis of partial or total bowel obstruction in the last 2 years. * able to complete the questionnaire online via assessment center. exclusion criteria: * currently pregnant * cancer within the last 10 years * chemotherapy or radiation treatments within the last 10 years * prior treatment at clear passage
primary anatomical versus primary electrophysiological approach in circumferential pulmonary vein ablation

Conditions: Paroxysmal Atrial Fibrillation

Summary: randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: primary anatomical ablation with secondary closure of possible electrical gaps versus primary electrophysiological ablation at the sites of atrio-venous electrical breakthroughs with secondary circumferential ablation around the pulmonary vein orifice


Eligibility criteria:
inclusion criteria: * paroxysmal atrial fibrillation * age over 18 years exclusion criteria: * persistent atrial fibrillation * reversible cause of atrial fibrillation * inability to comply with follow-up

Keywords: atrial fibrillation paroxysmal symptomatic drug-refractory
study comparing weekly intravenous administration of octaalpha1 with a marketed preparation glassia® in subjects with alpha-1-antitrypsin deficiency

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: this randomized trial is being conducted to show non-inferiority of octaalpha1 compared to glassia® in terms of the serum trough levels at steady state. this will be conducted in individuals with alpha-1-antitrypsin deficiency and clinical evidence of emphysema.


Eligibility criteria:
inclusion criteria: * any subject who needs chronic iv augmentation and maintenance therapy with a1pi because of congenital alpha-1-proteinase inhibitor (a1pi) deficiency and clinically diagnosed emphysema * ≥18 years of age * individuals with a1pi serum concentration \<11 µm at screening * following bronchodilators: * initial fev1(pred) between 25% and 75% or * if the initial fev1 was greater than 75% of predicted, a diffusing capacity of the lung for carbon monoxide (dlc o) less than 70% of predicted * following bronchodilators: initial forced expiratory volume/forced vital capacity (fev1/fvc) ratio less than 70% * non-smoking for at least 6 months before study treatment starts * able to understand and provide written informed consent * women of reproductive age: negative result of pregnancy test (human chorionic gonadotropin \[hcg\]-based assay) and agreement to use adequate contraception for the duration of the trial exclusion criteria: * any inflammatory condition or malignant tumor in the 7 days before treatment starts that according to investigator judgment might influence the metabolism of an enzyme inhibitor such as a1pi * more than one a1pi-deficiency related exacerbation and/or hospitalization during the 3 months before study treatment starts * clinically significant liver or kidney disease in the preceding 6 months before study treatment starts * severe gas exchange abnormality (i.e., paco2 ≥46 mmhg) * known iga deficiency with documented antibodies against iga * history of hypersensitivity to blood or plasma derived products, or any component of the product * known presence of antibodies against a1pi * seropositivity for hbsag or hcv, hiv-1/2 igg antibodies * administration of a1pi products in the 4 weeks before study treatment starts * participating in another clinical study currently or during the 3 months before study treatment starts. * live viral vaccination within the last month before study treatment starts * a current life-threatening malignancy * emergency operation within 3 months before study treatment starts * history of, or suspected, alcohol or drug abuse within 1 year before study treatment starts or currently on drug abuse therapy * pregnant and nursing women
microbiota intervention to change the response of parkinson's disease

Conditions: Parkinson Disease

Summary: the clinical phenotype of parkinson's disease (pd) is quite variable, as is the response to and side effects from medications. while many patients respond to carbidopa/levodopa early on, motor fluctuations and dyskinesias can become a problem as the condition progresses, causing significant impairment in function and quality of life. the gut microbiome is of increasing interest in pd, potentially contributing to pathophysiology and clinical phenotype. furthermore, gut bacteria are capable of metabolizing levodopa, which may decrease its ability to reach the central nervous system and could explain the variable effect seen clinically. altering the population of drug-metabolizing bacteria could improve the clinical symptoms of pd and the benefit seen with medications. the investigators hypothesize that the gut microbiome in people with pd correlates with their phenotypic characteristics, which can be improved with targeting the microbiome through dietary or therapeutic interventions. the investigators propose a two-part clinical trial. first, a cross-sectional analysis will correlate the microbiome profile with (a) the clinical phenotype of pd and (b) medication response. second, a randomized, controlled trial, will evaluate the effect of microbiome manipulation on clinical phenotype and medication response. the investigators plan to reduce the level of bacteria through antibiotic use, resetting the potentially disadvantageous microbiome population. outcomes will include changes in clinical symptoms, alterations in the the microbiome, and changes in serum markers of inflammation. this thorough characterization will broaden our understanding of the gut-brain axis significantly in pd in clinically relevant ways that have yet to be explored.


Eligibility criteria:
inclusion criteria: * parkinson's disease * stable on levodopa therapy with fluctuations exclusion criteria: * chronic gastrointestinal disease * recent antibiotic or probiotic therapy * pregnant * immunocompromised
hybrid construct versus pedicle screw-only system for the treatment scoliosis

Conditions: Scoliosis Idiopathic; Dysplastic

Summary: the placement of pedicular screws in spinal surgery has become the gold standard for scoliosis treatment. however, the use of sublaminar bands (sbs) on the apex of the curvature in idiopathic scoliosis (ais) lowers the risk of neurological complications related to incorrect implementation of transpedicular screws into dysplastic pedicles without a cancellous channel. the latest research does not define a set of anatomical guidelines for applying sbs, nor does it use a dedicated classification system related to the structure of pedicles. the aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from ais lenke type 1. methods: twenty patients were involved in a prospective, single-center, non-randomized case series study. the patients were assigned to the group "screws" or "hybrid" where sbs were used.

adolescent idiopathic scoliosis (ais) is a three-dimensional deformation of the spine. the goal of the treatment is to achieve a reduction in deformity, restoring proper alignment and the best possible function of the spine. pedicular screw placement in spinal surgery has become the gold standard for scoliosis reduction techniques in the last 30 years \[6\]. the screw-only systems are relatively safe, as various authors have proven. however, if implemented incorrectly, the screws increase the risk of damage to nervous or vascular structures and internal organs. the latest research does not define a set of anatomical guidelines for applying sbs, nor does it use a dedicated classification system related to the structure of pedicles. the aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from ais lenke type 1. methods: twenty patients were involved in a prospective, single-center, non-randomized case series study. the patients were assigned to the group "screws" or "hybrid" where sbs were used. the inclusion criteria were this being the patients' first scoliosis operation due to ais (lenke type 1) and age under 18 years. the primary measured outcome involved correction efficacy, defined as the cobb score baseline to endpoint change.

Eligibility criteria:
inclusion criteria: * idiopathic scoliosis (ais) * lenke type 1 exclusion criteria: * ais other than lenke type 1 (neurogenic, congenial, or syndromic curvatures) * abnormalities in the structure of the central nervous system in the mri image * advanced chronic respiratory or circulatory failure * emergency surgery * reoperation
a study to establish the efficacy of qbx258 in patients with moderate to severe asthma

Conditions: Asthma

Summary: this study is designed to investigate the efficacy and safety of qbx258 in subjects with moderate to severe asthma.


Eligibility criteria:
inclusion criteria: * patients with atopic asthma \>1 year duration diagnosed according to the gina guidelines. * subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (bmi) within the range of 18 - 39 kg/m2. * asthma which is not adequately controlled on current treatment, as demonstrated by an asthma control questionnaire (acq) score of \> 1.5. * fev1 40 to 90% of predicted. exclusion criteria: * diagnosed with copd as defined by the gold guidelines * subjects who have had a respiratory tract infection within 4 weeks prior to screening. * women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration

Keywords: asthma interleukin qbx258 qax576 vak694
a study to evaluate the safety of xw001 inhalation in children with rsv

Conditions: RSV Infection

Summary: this is a randomized, double-blind, placebo-controlled phase ib/iia study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of xw001 inhalation in children with rsv infection in china

in this study, eligible participants will be randomized in a 4:1 ratio to receive xw001 inhalation (one of three dosage groups) or placebo once a day for 7 days.

Eligibility criteria:
inclusion criteria: 1. male or female, 1 to 24 months (inclusive) at screening; 2. weight: 3-20 kg, inclusive; 3. positive rsv test within 36 hours before randomization; 4. symptomatic at screening and randomization, and the onset of rsv symptoms is within 5 days prior to the first dose of xw001; 5. parents/legal guardians are able to understand the purpose and procedures of the study, and are able to provide informed consent. exclusion criteria: 1. immunocompromised as determined by the investigator; 2. known to have undergone or planned for bone marrow, stem cells, or other organ transplants, or are currently on immunosuppressive treatment; 3. positive for hbv, hcv or hiv, or patient \<6 months old whose mother is positive for hiv; 4. history of seizures or epilepsy, including febrile seizure; 5. known to have received any prohibited medications defined by the protocol within 3 days prior to randomization; 6. history of any surgery within 30 days prior to randomization; 7. severe dental or facial deformity that will impact on usage of nebulizer; 8. history of receiving measles, mumps, rubella or other vaccines within 7 days prior to screening; 9. known to have received any investigational medicinal products or devices in the past 30 days; 10. any other underlying conditions that make the patient unlikely to complete the study in the opinion of the investigator.

Keywords: xw001 respiratory syncytial virus