Kornimate/medical-research-clean huggingface dataset:
nt-501 cntf implant for ischemic optic neuropathy: safety, neuroprotection and neuroenhancement

Conditions: Ischemic Optic Neuropathy/Optic Nerve Stroke

Summary: ciliary neurotrophic factor (cntf) has been demonstrated in multiple preclinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like ischemic optic neuropathy/optic nerve stroke. we hypothesize that cntf delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in ischemic optic neuropathy. patients in the trial will receive an nt-501 cntf implant (made by neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.


Eligibility criteria:
inclusion criteria: * age 40 years or older * must understand and sign the informed consent * must be medically able to undergo ophthalmic surgery for the nt-501 device insertion and possible removal, as well as the testing required. * diagnosis of ischemic optic neuropathy characterized by (a) non-arteritic subtype, including a normal esr and crp; (b) syndrome of acute unilateral visual loss with documented optic nerve head edema but without significant pain; (c) a relative afferent papillary defect in the affected eye, and a decrease of best-corrected visual acuity to 20/40 or worse in the affected eye, and detectable loss on visual field testing consistent with nerve fiber visual field defect but retaining measurable residual visual field preservation. exclusion criteria: * other corneal, lens, optic nerve or retinal disease causing vision loss, * blind in one eye * requirement of acyclovir and/or related products during study * receiving systemic steroids or other immunosuppressive medications. * pregnant or lactating. * considered immunodeficient or has a known history of human immunodeficiency virus (hiv) * on chemotherapy, or a history of malignancy, unless it was treated successfully 2 years prior to inclusion in the trial.
early initiation of high-flow nasal cannula oxygen therapy in patients with acute respiratory failure in the emergency department: a before-after study

Conditions: Acute Respiratory Failure

Summary: the aim of the study is to compare the efficiency on respiratory failure regression of high-flow nasal oxygen therapy versus standard oxygen in patients admitted to the ed for de novo acute respiratory failure.

prospective observational before-after study at the ed in two french centers. selection of patients with acute hypoxemic respiratory failure at the ed. application of oxygen strategy according to the period: * before period: standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir mask, with a flow rate adjusted to maintain a pulse oxymetry of at least 92%. * after period: high-flow oxygen therapy continuously applied via large-bore nasal prongs with a gas flow rate of 50 l/min and a fio2 adjusted to maintain a pulse oxymetry at least 92%.

Eligibility criteria:
inclusion criteria: * de novo acute respiratory failure cowith the following criteria: a respiratory rate \> 25 b/min, or signs of increased work of breathing. main exclusion criteria: * cardiogenic pulmonary edema, * acute exacerbation of chronic lung disease, respiratory acidosis (ph \ 50 mm hg), * hemodynamic instability * glasgow coma scale score of 12 points or less, * an urgent need for endotracheal intubation,
diabetes risk education and communication trial

Conditions: PreDiabetes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight; Body Weight Changes

Summary: a large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. this pilot study will develop and evaluate the diabetes risk education and communication trial (direct) intervention, which communicates information about diabetes risk and treatment options for preventing diabetes among primary care patients with prediabetes. given that 38% of u.s. adults have prediabetes, this project has large potential to impact public health by developing a scalable intervention to promote the use of evidence-based treatments that lower diabetes risk in this population.

landmark clinical trials have found that intensive lifestyle interventions (ili) and metformin are safe and effective treatment options for preventing diabetes among adults with prediabetes and overweight/obesity. despite being included in expert clinical guidelines, these treatments are rarely used in practice and little existing research has focused on approaches for promoting their use. this novel intervention, delivered by medical assistants before patients' routinely scheduled office visits, consists of the following 3 components intended to promote initiation of ili and metformin: 1) a prediabetes decision aid focused on diabetes risk and treatment options for preventing diabetes; 2) a "think aloud" exercise; and 3) formulating a preliminary treatment plan. previous studies report that medical assistants can improve uptake of some preventive health services in primary care, which may also be true for ili and metformin.

Eligibility criteria:
inclusion criteria: * overweight or obesity * documentation of prediabetes in medical chart or * a1c 5.7-6.4 exclusion criteria: * age \< 18; individuals who are not yet adults (infants, children, teenagers) * patient's primary care physician did not provide permission to participate in the study * pregnancy status: current or planned pregnancy during study period * serum creatinine \>1.4mg/dl in women and \>1.5mg/dl in men * patients that are blind, deaf, or otherwise unable to review study materials * prior diagnosis of diabetes mellitus type 1 or type 2 or on antidiabetic medication * diagnosis of post-surgical hypoinsulinemia * diagnosis of dementia * uncontrolled hypertension (≥160/100 mm hg) * no office visit in past 12 months
an add-on study to evaluate the efficacy and safety of xiyanping injection in pediatric bronchitis patients.

Conditions: Bronchitis

Summary: this is a multicenter, randomized, open label,add-on study.

this is an add-on study of efficacy and safety of intravenous injection of xiyanping injection in subjects with pediatric bronchitis. the purpose to determine the efficacy and safety of conventional treatment combined with or without xiyanping injection in the treatment of pediatric bronchitis and to further evaluate the clinical value of xiyanping injection in shortening the course of pediatric bronchitis the study will enroll 240 pediatric bronchitis volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive routine treatment for pediatric bronchitis and xiyanping injection; volunteers from the second group will receive routine treatment for pediatric bronchitis. xiyanping injection will be administration as intravenous injection of 0.2-0.4ml/kg/day once daily for 5 days concomitantly with routine treatment for pediatric bronchitis

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pediatric bronchitis with hospital treatment needed * males and female subjects * age between 1 and 3 years old * with fever, cough, gasp and expectoration symptoms * have wheeze and/ or mid-fine rales on one's lungs * white blood cell count \< 12 x 109 / l, categorized priority to leukocyte * c-reactive protein≤8mg/l or normal super c- reactive protein * had experienced ≤48 h course before enrollment * previous wheezing episodes≤2 * written informed consent exclusion criteria: * participants with severe clinical symptoms, meet any of the following： * sao2≤0.92;（2）shock or disturbance of consciousness;（3） significantly speed up breathing , rapid pulse accompany with severe respiratory distress; or（4）repeated occurrence of apnea or slow and irregular respiration; * acute infectious disease such as measles, pertussis and influenza * participants with bronchial asthma, bronchopneumonia and other respiratory diseases * chronic lung diseases * participants with complicated pyopneumothorax, airway obstruction, toxic encephalopathy, cardiac failure or respiratory failure * participants with complicated severe underlying myocardial, liver, kidney, digestive and hematopoietic system diseases * severe malnutrition and history of immune deficiency which may seriously affect the self-limiting process of the course * participants with epilepsy and other disturbances of central nervous system * participants with congenital diseases and psychosis * use of any other antiviral drugs within the 2 weeks before enrollment * use of systemic hormone within the 2 weeks before enrollment * participants had a history of allergic constitution and drug allergy; allergenic to xiyanping injection and andrographolide * participants participated in other clinical research in the last three months * any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason
antibiotic irrigation for pancreatoduodenectomy

Conditions: Surgery; Infection

Summary: the purpose of this study is to determine if the routine use of antibiotic irrigation during pancreas surgery (whipple procedure) will decrease superficial and organ space infections.

the primary aim of this study is to test the efficacy of routine antibiotic irrigation in reducing superficial and organ space infections among patients undergoing pancreatoduodenectomy.

Eligibility criteria:
inclusion criteria: * at least 18 years of age and older; * open pancreatoduodenectomy for any diagnosis exclusion criteria: * pregnant; * prisoners; * patients undergoing concomitant colectomy; * antibiotic allergy to study medication; * serum creatinine \> 2.0; * unable to provide informed consent

Keywords: pancreatoduodenectomy whipple
a study designed to compare 2 dose strengths of ti inhalation powder in adults with type 1 diabetes mellitus and to compare one of those formulations (30units) with an injection of insulin lispro

Conditions: Diabetes Mellitus: Type 1

Summary: 28 subjects to be enrolled for a screening period, 3 dosing visits \& a follow-up visit. visits 2 and 3 dosing of ti inhalation powder, cross over between two 15 u cartridges and one 30 u cartridge. visit 4 dosing will be a sc injection of 10 iu of raa (rapid-acting insulin analogue).

28 eligible subjects were planned to be enrolled to determine bioequivalence and safety parameters of two 15 u ti inhalation powder cartridges versus one 30 u ti inhalation powder cartridge, according to a randomized, 2-way crossover design. additionally, bioavailability of one 30 u ti inhalation powder cartridge to a single subcutaneous injection of 10 iu of raa will be compared.

Eligibility criteria:
inclusion criteria: males and females \> 18 and \ 6 months since cessation) pulmonary function testing (fev1 \> 70%, fev1/fvc \> 70%, tlc \> 80% dlco \[unc\] \> 70% of predicted written informed consent exclusion criteria: two or more severe hypoglycemic episodes within 6 months of screening/visit 1 severe complications of diabetes previous exposure to any inhaled insulin product other than ti inhalation powder or similar formulation inability to perform pft maneuvers meeting recommended american thoracic society (ats) standards of acceptability and repeatability criteria respiratory tract infection within 8 weeks prior to screening/visit 1 history of chronic obstructive pulmonary disease (copd), clinically proven asthma, and/or any other clinically important pulmonary disease (eg. obstructive sleep apnea), confirmed by pulmonary function testing, and/or radiologic findings major organ system diseases including seizures, heart failure, uncontrolled hypertension, cancer within the past 5 years, liver disease, anemia or autoimmune disorder clinically significant abnormalities on screening laboratory evaluation female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period or not practicing adequate birth control unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions

Keywords: diabetic adult male, diabetic adult female
limb-girdle video assessment

Conditions: Limb-Girdle Muscular Dystrophy ; Subtypes 2A, 2B, and 2I

Summary: the purpose of this study is to develop a new remote-based video assessment outcome measure for limb-girdle muscular dystrophy (lgmd) trials. the overall objectives for this study are: 1. identify domains and tasks meaningful to participants with a limb-girdle muscular dystrophy (lgmd) for development of the lgva, including considerations for subtype heterogeneity and functional subgroup branching; 2. determine the feasibility and reliability of the lgva with test-retest of the lgva video capture manual; 3. assess and refine the lgva video capture manual to ensure standardization and incorporate feedback from participants; 4. collect source material videos using the lgva video capture manual to support the development of scorecards for the lgva.

the purpose of this study is to gain insight from people living with an lgmd and gather source material videos to develop and test limb-girdle video assessment (lgva), a new outcome measure designed to assess changes in functional abilities of participants in lgmds clinical trials. the lgva is being designed as a remote video capture to assess nuanced changes in compensatory movement patterns over time. this study involves two stages. in the concept elicitation stage, the tasks for the lgva video capture manual will be finalized based on feedback from participants living with an lgmd 2a, 2b, or 2i in various stages of disease progression. after finalizing the lgva video capture manual, source material videos will be collected to evaluate the feasibility and appropriateness of the lgva tasks, standardize capture procedures, and inform the development of scorecards for the lgva.

Eligibility criteria:
* person with confirmed diagnosis of an lgmd 2a, 2b, or 2i * ≥14 years of age at the timing of consent (if age 14 - 17, consent from the parent/ legal guardian is also needed) * able to read, speak, and understand english * residing in the usa * willing and able to complete an electronic survey, which includes questions about personal characteristics and medical history as well as review of tasks * willing and able to discuss their experiences as a person living with an lgmd in a group setting * willing and able to complete 2 rounds of video capture following instructions in the lgva video capture manual in a 30-day period * willing and able to complete an exit interview to discuss their experiences capturing and recording videos with the lgva video capture manual

Keywords: limb-girdle muscular dystrophy outcome measure development video captures remote assessment concept elicitation feasibility testing
effectiveness of dental trauma educational poster to secondary students

Conditions: Injuries

Summary: to investigate the effectiveness of the educational poster regarding knowledge of dental trauma for the secondary school students

to investigate the effectiveness of the educational poster about dental trauma to increase the knowledge of secondary students. schools will be randomly divided into two groups, baseline score of knowledge in questionnaire will be collected for all subjects. poster will be sent to intervention group, the school will place it at the notice broad or area of similar function in the classroom. for the control group, nothing will be given, then after 2 weeks, the score of knowledge by the second questionnaire of both groups will be collected again. to compare the difference in knowledge before and after in both groups, statistical test will be performed. investigators conduct a cluster randomized controlled trial. a list of secondary schools was requested from the education bureau. secondary schools will be invited to join the study and then randomized to the intervention group and the control group in the unit of school using computer generated numbers. all students will fill in the first questionnaire and send it back to the investigator in 1 week. then copies of the same poster will be given to the intervention schools, these schools will be requested to place them in the classrooms of the participating students. no poster will be given to the control group. after 2 weeks, the poster will be removed. the same questionnaire will be filled out by all the students in both groups and sent back in 1 week. then the data will be processed to show whether the poster is effective to improve the knowledge of the students.

Eligibility criteria:
inclusion criteria - all secondary schools in hong kong that the students can read chinese or english exclusion criteria - no school consent or individual guardian consent

Keywords: educational poster, knowledge, dental trauma,
dose escalation study of ast-opc1 in spinal cord injury

Conditions: Cervical Spinal Cord Injury; Spine Injury; Spinal Cord Trauma

Summary: the purpose of this study is to evaluate the safety of cross sequential escalating doses of ast-opc1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (sci).


Eligibility criteria:
major inclusion criteria: * sensorimotor complete, traumatic sci (asia impairment scale a) for cohorts 1,2,3 * sensorimotor incomplete, traumatic sci (asia impairment scale b) for cohorts 4,5 * last fully preserved single neurological level (snl) from c-4 to c-7 * from 18 through 69 years of age at time of injury * single spinal cord lesion on a post-stabilization magnetic resonance imaging (mri) scan, with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring * informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 37 days following injury * able to participate in an elective surgical procedure to inject ast-opc1 21-42 days following sci major exclusion criteria: * sci due to penetrating trauma * traumatic anatomical transection or laceration of the spinal cord based on prior surgery or mri * any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations * inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised * significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression * history of any malignancy (except non-melanoma skin cancers) * pregnant or nursing women * body mass index (bmi) \> 35 or weight \> 300 lbs. * active participation in another experimental procedure/intervention

Keywords: cervical spinal cord injury ast-opc1 scistar opc1 neural cell trauma spinal cord stemcell transplant cervical spine injury paralysis quadriplegia tetraplegia spine injury oligodendrocyte progenitor cell subacute spinal cord injury
diagnosis of bacterial vaginosis comparing modified hay/ison with molecular diagnosis

Conditions: Infection, Bacterial

Summary: among 300 women that are scheduled a therapeutic abortion screening diagnopsis of bv are done using gram stained vaginal smear and with a molecular test using pcr for 5 different bacteria.

the molecular test will test for atophobium vaginae, leopitrichia spp, megasphaera mobiluncus and bvab2

Eligibility criteria:
inclusion criteria: women scheduled a therapeutic abortion (before 12th week) will be screened for gential infections such as chlamydia and gc together with bacterial vaginosis exclusion criteria: * women not pregnat
self-efficacy and medication adherence in patients with coronary artery disease: a descriptive study

Conditions: Coronary Artery Disease

Summary: this descriptive study aims to examine the relationship between self-efficacy and medication adherence in individuals with coronary artery disease (cad). the study will be conducted between march and october 2025 at adıyaman university training and research hospital with a planned sample size of 135 participants. data will be collected using a descriptive information form, the self-efficacy for managing chronic disease scale, and the medication adherence report scale (mars).

coronary artery disease (cad) remains one of the leading causes of death worldwide. managing cad requires long-term treatment adherence and lifestyle changes. self-efficacy, which reflects an individual's belief in their ability to perform specific health behaviors, plays a key role in disease management. in cad patients, high levels of self-efficacy have been associated with better treatment adherence, improved symptom management, and successful adoption of healthy behaviors. this descriptive study is designed to investigate the relationship between self-efficacy and medication adherence in individuals diagnosed with cad. the study will be carried out at adıyaman university training and research hospital between march and october 2025. the target population includes patients who have been diagnosed with cad (e.g., angina pectoris, myocardial infarction) for at least one year and meet the inclusion criteria. based on a power analysis using g\*power software (effect size f² = 0.15, α = 0.05, power = 0.90), the required sample size is calculated as 112. however, accounting for possible data loss or participant dropout, the final sample size is set at 135. data collection tools include: descriptive information form to assess demographic and clinical characteristics, the 6-item self-efficacy for managing chronic disease scale, validated in turkish by i̇ncirkuş and özkan nahcivan (cronbach's alpha = 0.90), medication adherence report scale (mars), adapted to turkish by temeloğlu şen et al. (cronbach's alpha = 0.78). the findings are expected to contribute to the literature and guide healthcare professionals, particularly nurses, in planning educational and counseling services to improve self-efficacy and medication adherence among cad patients.

Eligibility criteria:
inclusion criteria: * being 18 years of age or older having been diagnosed with coronary artery disease (angina pectoris, unstable angina, myocardial infarction) at least 1 year ago being followed being able to communicate in turkish voluntarily agreeing to participate in the study having no diagnosed mental disorder exclusion criteria: * having a primary diagnosis other than coronary artery disease being unable to complete the questionnaires due to mental health problems providing incomplete data or withdrawing from the study

Keywords: nurse coronary artery disease self-efficacy medication adherence