Kornimate/medical-research-clean huggingface dataset:
mp-376 (aeroquin™, levofloxacin for inhalation) in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: patients with cystic fibrosis (cf) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in cf patients. aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. mp-376 (aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. preclinical and clinical studies conducted to date show that aerosol doses of mp-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. high concentrations of levofloxacin in the lung delivered as mp-376 are active against cf pathogens including those with high minimum inhibitory concentration (mic) levels to aminoglycosides such as tobramycin (tobi®) and other inhaled antimicrobial agents. inhaled mp-376 can be delivered rapidly and efficiently using a customized pari investigational configuration of the eflow® nebulizer system.

this trial will be a double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin administered as mp-376 given for 28 days by the aerosol route to cf patients. study with completed results acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria (selected): * \>/= 12 years of age * confirmed diagnosis of cystic fibrosis * positive sputum culture for p. aeruginosa at screening and within the past 12 months * patients are able to elicit an fev1 \>/= 25% but \</= 85% of predicted value at screening * have received at least 3 courses of inhaled antimicrobials over the preceding 12 months * clinically stable with no changes in health status within the last 28 days * able to reproducibly produce sputum and perform spirometry exclusion criteria (selected): * use of any nebulized or systemic antibiotics within 28 days prior to baseline * history of hypersensitivity to fluoroquinolones or intolerance with aerosol medication * evidence of respiratory infections within 14 days prior to dosing * crcl \< 20ml/min or \< 20ml/min/1.73 m2 at screening
efficacy and safety of tocilizumab in combination with dmards in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active ra and inadequate response to current dmard treatment


Eligibility criteria:
inclusion criteria: * adult patients, \>= 18 years of age * active ra of \> 6monts duration * received permitted dmards each at a stable dose for at least 8 weeks exclusion criteria: * rheumatic autoimmune disease other than ra * significant systemic involvement secondary to ra * alt or ast \> ulnⅹ1.5 * platelet count \< 100,000/mm3 * hemoglobin \< 8.5 g/dl * white blood cells \< 3,000/mm3 * absolute neutrophil count \< 2,000/mm3 * absolute lymphocyte count \< 500/mm3
a study to measure stomach emptying in overweight non-diabetic and diabetic participants using tirzepatide

Conditions: Overweight; Obesity; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. participants include those without diabetes and those with type 2 diabetes. the study will last about 13 weeks for each participant, including screening.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening * for nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening * for participants with a confirmed type 2 diabetes diagnosis: the condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months * willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff key exclusion criteria * have undergone gastric bypass or bariatric surgery * have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening * for participants with a confirmed type 2 diabetes diagnosis: have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months * have any lifetime history of a suicide attempt * have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study * unwilling to comply with smoking and alcohol restrictions during the study
ultrasonographic measurement of diaphragmatic thickness in adolescents with thoracal hyperkyphosis

Conditions: Hyperkyphosis; Spine Deformity; Diaphragm Issues

Summary: spinal deformity is common in childhood and adolescence. any spinal deformity, especially one that affects the thoracic spine, can affect lung function.the diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. the investigators aimed to measure the diaphragmatic thickness in adolescents with increased thoracal kyphosis (thoracal hyperkyphosis) deformities.

spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracal kyphosis deformity with various etiologies. any spinal deformity, especially one that affects the thoracic spine, can affect lung function. if left untreated, the curves may distort over time as skeletal growth accelerates. in some patients, this can lead to restrictive or obstructive lung disease and, rarely, death as a result of cor pulmonale. the alignment of the skeletal system in the chest and its harmony with the compliance of the chest wall are related to respiratory function; thoracic kyphosis and the resulting changes in the rib cage lead to a decrease in lung capacity. the diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. in recent years, ultrasonography (usg) has gained increasing utility for visualizing the diaphragm and assessing its function, with several advantages. based on this, the investigators aimed to measure the diaphragmatic thickness in adolescents with increased thoracal kyphosis (thoracal hyperkyphosis) deformities, to show whether there is any relationship between increased kyphosis deformity and diaphragmatic thickness, and to show whether there is any change in diaphragmatic thickness before or after the treatment for kyphosis.

Eligibility criteria:
inclusion criteria: * increased thoracal kyphosis (thoracic hyperkyphosis) * being between the ages of 10-18 exclusion criteria: * congenital spinal, costal and diaphragmatic anomalies * neuromuscular disease * respiratory system diseases that affect lung functions * patients who cannot cooperate with spirometry. * having surgery to the chest wall or spine

Keywords: thoracal hyperkyphosis diaphragma thickness ultrasonographic measurement
contributions of 3d photography and stereophotogrammetry to the evaluation of facial symmetrization by botulinum toxin injections. study of facial symmetry before and after botulinum toxin injections on the face of patients suffering from sequellar peripheral facial paralysis

Conditions: Peripheral Facial Palsy

Summary: "this is a prospective, single-center study. the main objective of our study will be to objectively evaluate the improvement of facial symmetry after botulinum toxin injection on the face in patients suffering from sequelae of peripheral facial paralysis. a secondary objective will be to assess the utility of 3d photography and stereophotogrammetry to detect and quantify facial changes relevant to this type of treatment. the number of patients included in the study is expected to be 15 at minimum. our study will rely on 3d photographs taken with the vectra h2 imaging system camera device (canfield scientific, inc., fairfield, new jersey), which will be captured before and 3 weeks to 1 month after botulinum toxin injection into the facial muscles. various analyses of static and dynamic symmetry will be performed using the vectra software: bi-pupillary line angle / bi-commissural line angle, superposition of healthy and pathological sides followed by rms (root mean square) calculation, analysis of pre- and post-injection skin displacement vectors. the results of these analyses will allow conclusions to be drawn regarding the objective efficacy of botulinum toxin injections for facial symmetrization in patients with peripheral facial paralysis, as well as to adapt injection patterns based on the severity of facial paralysis."


Eligibility criteria:
inclusion criteria: -patients who received injections of botulinum toxin in the facial muscles, aimed at facial symmetrization at head and neck institute, nice, france at head and neck institute, nice, france. exclusion criteria: * history of corrective surgery for facial palsy, significant facial surgery, neurodegenerative diseases, the presence of skin imperfections or facial tumors that would impede a rigorous analysis of wrinkles and facial movements.
post-market product surveillance of intracranial aneurysms treated with commercial registered acandis devices in france

Conditions: Intracranial Aneurysms

Summary: the aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and performance of acandis device(s) after its placing on the french market. on top of this, these cohorts will generate data for getting the renewal of the device's reimbursement on the french market.


Eligibility criteria:
inclusion criteria: * the subject has an intracranial aneurysm that can be treated with one of the acandis device indicated for the treatment of intracranial aneurysms. * the subject is 18 years of age or older. * the subject is willing to comply with scheduled visits and examinations, per institution standard of care. exclusion criteria: * the subject has provided tacit opposition to data collection. * any ifu warning will be considered for exclusion in the cohort.
program of supervised occlusive aerobic training in people with fibromyalgia.

Conditions: Fibromyalgia

Summary: occlusive training in people with fibromyalgia

intervention study in people with fibromyalgia with the implementation of a lower body occlusive tool in aerobic exercise. the study aims to descriptively test the impact on quality of life and functional autonomy of occlusive training in a controlled and individualized way in two groups: group 1 aerobic exercise with use of occlusive tool and group 2, aerobic exercise without occlusive tool in a period of 9 weeks twice a week.

Eligibility criteria:
inclusion criteria: a patient meets diagnostic criteria for fibromyalgia if the following three conditions are present: (american rheumatology association). wolfe et al., (2010). * o 1) widespread pain index (wpi) ≥ 7 and symptom severity score (ss score) ≥ 5 or wpi 3-6 and ss ≥ 9. * symptoms have been present, at a similar level, during the last three months. * the patient has no other pathology that could explain the pain. * recent negative covid-19 test. exclusion criteria: * other associated pathologies that may hinder the development of the research. * mobility limitations. * injuries that add to those of the disease itself and hinder mobility. * no medical evaluation of the diagnosis of the disease. * negative results in the inclusion tests. * cardiac pathologies. * blood pressure higher than 130-90 mmhg. * no covid-19 test.

Keywords: occlusive training
epidemiologic and clinical characteristics of optic neuritis in china

Conditions: Optic Neuritis

Summary: this will be a hospital-based retrospective multi-center study on epidemiologic and clinical characteristics of optic neuritis among chinese. the investigation will cover about 29 provinces or municipalities all around china.

this national investigation will be conducted to describe the epidemiology and clinical characteristics of optic neuritis in china. all the patients will be divided into 3 groups according to the serum demyelinating antibodies (aquaporin-4 antibody seropositive group, myelin oligodendrocyte glycoprotein antibody seropositive group and double seronegative group). the investigator will analyze the differences among the three groups. primary outcomes: * to dig out the different visual acuity (va, logmar) prognosis among the three groups; * to calculate the annual relapse rate (arr) differences among the three groups (relapse times in all the follow-up time in each group/ follow-up time (years) in all in each group). secondary outcomes: * other epidemiological and clinical characteristics of optic neuritis patients will be analyzed among the three groups; * orbital or brain mri is required in this study, which could avoid the misdiagnosis. we will collect and analyze these mri data too (including the optic nerve lesions in t2 weight images and t1 enhanced mri); * results of optical coherence tomography (oct) (including peripapillary retinal nerve fiber layer, macular thickness ,and ganglion cell and inner plexiform layer complex) at different time point are also needed in this study. however, oct is not necessarily required; * visual fields at different time points are also encouraged to provide if they are available.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of optic neuritis 2. the patients' medical records were complete exclusion criteria: 1. patients with unclear diagnosis of optic neuritis 2. incomplete medical records

Keywords: optic neuritis clinical characteristics epidemiology
infantile versus adult-type fibrosarcoma and the risk of multiple primary malignancies

Conditions: Fibrosarcoma

Summary: fibrosarcoma is a malignant tumor originating from mesenchymal tissues and consists of fibroblasts with various types of collagen production. it represents 10% of musculoskeletal sarcomas and less than 5% of all primary bone tumors. it affects middle-aged patients with the most common location in the femur and 70% long tubular bones. studies reported that fibrosarcoma patients tend to develop a subsequent primary malignancy, the analysis showed a higher risk of spms even a decade following the initial diagnosis of fibrosarcoma. spms affect the long-term survival of patients with soft tissue tumors, and since there are no available studies analyzing the risk of second primary malignancies in different types of fibrosarcomas, especially the infantile and adult-type. therefore, the purpose of this study was to assess the risk of second primary malignancies following primary fibrosarcoma diagnosis for a better understanding of the nature of this rare neoplasm. the investigators used the surveillance, epidemiology and end results (seer) database to extract the data and calculate the standardized incidence ratio as observed/expected and the excess risk for second primary malignancies with 95% confidence interval. significance was achieved at 0.05.


Eligibility criteria:
inclusion criteria: * patients diagnosed with fibrosarcoma from 2000 to 2021. * sequence 0 or 1. * histological types: infantile fibrosarcoma, fibromyxosarcoma, periosteal fibrosarcoma, facial fibrosarcoma, dermatofibrosarcoma, central odontogenic fibrosarcoma, ameloblastic fibrosarcoma exclusion criteria: * patients with unknown histology type

Keywords: infantile fibrosarcoma fibrosarcoma seer
safety study of bls-m22 in healthy volunteers

Conditions: Muscular Dystrophy, Duchenne

Summary: bls-m22 is being developed as an anti-myostatin agent for the treatment of duchenne muscular dystrophy (muscular dystrophy). a total of 37 subjects participated in this study to confirm the safety of bls-m22.

this study is a dose block-randomized, double-blind, placebo-controlled and dose-escalation phase i clinical trial to evaluate safety of bls-m22. the single ascending dose group participated in 9 patients in each group(500mg, 1,000mg, 2000mg/bls-m22 or placebo(n=7:2)). the multiple ascending dose group participated in 10 patients(determined dose in sad/bls-m22 or placebo(n=8:2)).

Eligibility criteria:
inclusion criteria: 1. male and female subjects between 19-55 years of age 2. bmi: 19\~28kg/m2(male), 18\~25kg/m2(female) at screening test 3. able to provide consent to participate and having signed an informed consent form (icf) 4. the subjects can obey the demands of the scheme exclusion criteria: 1. subject has a clinically significant disease or history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, digestive system, respiratory system, neuropsychiatry, blood∙tumor system. 2. hypersensitive to the lactobacillus-containing food (such as yogurt) and the lactobacillus preparation and the investigational drug 3. subject has received a investigational drug or a bioequivalence study drug within 90 days of the randomization 4. subject has received steroids or other immunosuppressive drugs within 30 days of randomization 5. positive serum test results for hepatitis c virus, hepatitis b virus, hiv or syphilis 6. those who do not use of a medically acceptable method of contraception during the trial, or who plan to provide sperm 7. pregnant women 8. subject has genetic problems such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption 9. subject has abnormal clinical laboratory test results 10. any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
analgesic efficacy of testosterone replacement in hypogonadal opioid-treated chronic pain patients: a pilot study.

Conditions: Pain; Hypogonadism

Summary: the purpose of this pilot study is to test the effects of testosterone replacement on pain, fatigue, mood, cognition and libido in hypogonadal men on long-term opioid therapy for chronic pain.

opioids are increasingly used for the treatment of non-malignant chronic pain with as many as five to ten million patients treated at the time of the most recent estimate in 2002. the side effects of opioids such as fatigue, loss of libido, impaired cognition and sexual dysfunction have long been recognize and strikingly, resemble symptoms of hypogonadism in men. many studies have demonstrated a high prevalence of hypogonadism in male subjects who are long-term users of opioids. the aims of this pilot study are, in hypogonadal men being treated with opioids for chronic pain, to: 1) determine the effect of trt on pain; 2) determine effects of trt on fatigue; 3) determine the effect of trt on mood; 4) determine effects of trt on cognition and 5) characterize the effects of trt on sexual dysfunction. this study is a randomized, placebo-controlled, 6-week pilot study.

Eligibility criteria:
inclusion criteria: * adult male patients (above 18 years old and below 60 years old) * receiving greater than 20 iv morphine equivalents/day with \<20% change in dosage in the last month. * am total testosterone \<300 ng/dl * report "worst pain during the past week" grater than 4 on an 11-point numeric scale. exclusion criteria: * females * poorly controlled, symptomatic, active medical or psychiatric problems (e.g., hiv, hepatitis, diabetes, cancer, benign prostatic hypertrophy, substance abuse, major depression) * neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol. * history of prostate cancer, abnormal findings on digital rectal exam, or psa greater than 4.0 ng/m * history of polycythemia * renal or hepatic dysfunction * hematocrit \>55% * known history of hypersensitivity to transdermal testosterone gel. * abnormalities during digital rectal exam.

Keywords: opioids pain hypogonadism depression fatigue cognition libido
open/aftercare treatment for participants diagnosed with obsessive compulsive disorder

Conditions: OCD

Summary: the purpose of this study is to provide participants diagnosed with obsessive compulsive disorder (ocd) and completed one of the active study protocols at the rodriguez lab, with open/aftercare treatment.

after completing one of the active clinical studies participants have the option to enroll in this protocol that offers open treatment. the goal is to compare two forms of current standard treatments, psychotherapy vs pharmacotherapy.

Eligibility criteria:
inclusion criteria: 1. ability to speak and understand english 2. capacity to consent (e.g. as determined by assessing the patient's understanding of the risks, benefits, and procedures of the study) 3. completed an active study protocol at the rodriguez lab at stanford university exclusion criteria: 1. children younger than 18 2. active suicidality

Keywords: treatment, psychotherapy, pharmacotherapy
preoperative care in ovarian cancer patients

Conditions: Adnexal Mass; Perioperative Complication; Outcome, Fatal

Summary: a randomised controlled trial study consisting of two-group pretest-post-test.

this study was designed as a randomized controlled trial with pretest and posttest model. the sample of the research consisted of patients who would undergo ovarian cancer surgery at the gynecologic oncology unit of a university hospital in turkey between june 2019-august 2020. the women were randomly assigned using "a random number generation program (research randomizer (https://www.randomizer.org/)" by an independent researcher who was not included in the study, intervention and control groups were formed. women were not informed about the group they would be a part of. however, the groups of women were known by the researchers.

Eligibility criteria:
inclusion criteria: * 18 years and over * women who know diagnosis * women who have not psychiatric illness * women who have preoperative period * hospitalization two days before surgery exclusion criteria: -

Keywords: adnexal mass preoperative education anxiety
methotrexate polyglutamate measurements in patients with inflammatory bowel disease

Conditions: IBD

Summary: there are currently no serum levels to help guide appropriate methotrexate therapy. data from this study will assess the correlation between dosing and whole blood methotrexate(mtx) polyglutamate measurements in children and adolescents with ibd.

this is a cross-sectional study design. subjects will be requested to provide one blood sample to be collected during the conduct of their routine clinical care. data related to the diagnosis and interval assessment of enrolled subjects will also be collected.

Eligibility criteria:
inclusion criteria: * ibd * methotrexate therapy exclusion criteria: * inability to provide relevant samples