Kornimate/medical-research-clean huggingface dataset:
neuroform atlas stent for intracranial aneurysm treatment

Conditions: Intracranial Aneurysm

Summary: the primary objective of this study is to demonstrate effectiveness and safety of the neuroform atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.

the study is a prospective, multicenter, open-label, single arm post market follow-up registry designed to demonstrate the potential treatment of intracranial, saccular aneurysms with the next generation neuroform stent system. the study will evaluate the permanent morbidity and mortality rate within the 12 to 16 months following the procedure. the study will evaluate as well the percent occlusion of the treated target lesion on angiography in the absence of retreatment, or parent artery stenosis at the target location at 12 to 16 months. subjects with documented saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling, provided they meet the other eligibility criteria.

Eligibility criteria:
inclusion criteria: 1. patient has an intracranial aneurysm for which an endovascular treatment requiring stent assisted intracranial aneurysm coiling has been decided by the site investigator 2. patient or legal representative is willing and able to provide written informed consent 3. patient is willing able to comply with scheduled visits and examinations per protocol requirements exclusion criteria: 1. patient that is younger than 18 years old at the time of entry into the study 2. patient with mrs \> 3 3. patient has a saccular ruptured aneurysm \< 3 months 4. patient has a fusiform aneurysm 5. treatment of several aneurysms during the same procedure, except adjacent aneurysms treated with the same stent 6. planned treatment of other aneurysm in the same vascular territory within the study time period 7. patient with severe vasospasm that does not respond to pharmacological therapy 8. aneurysm associated with an arteriovenous malformation, or any other lesion that could lead to hemorrhagic complications 9. pregnant woman or child feeding 10. any condition which will not allow the patient to comply with the necessary follow-up for this study (medical condition, patient leaving abroad) 11. patient with confirmed allergy to nickel titanium (nitinol) 12. patient in whom antiplatelet and/or anticoagulation therapy is contraindicate 13. patient for whom angiography and other examinations show that access to the target cerebral aneurysm by the stent may be impossible because of anatomical features 14. patient for whom angiography and mra/mri is contraindicated 15. patient with target aneurysm previously treated with a stent -

Keywords: next generation neuroform stent system intracranial stent system saccular aneurysm stent assisted coiling
dyspnea in copd: relationship with exacerbations frequency

Conditions: Dyspnea

Summary: the perception of breathlessness varies significantly among copd patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations. cross-sectional comparison of breathlessness perception in copd patients with frequent exacerbations or without frequent exacerbations. to assess "breathlessness perception" the investigators will increase the ventilatory demand of the patients by co2-rebreathing method.

the perception of breathlessness varies between individuals. this is a well-established concept in asthma, but mostly unexplored in copd; the relationship between airflow limitation (fev1, % ref.) and breathlessness (mmrc) is weak. the perception of breathlessness varies significantly among copd patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations. it is a cross-sectional comparison of breathlessness perception in copd patients with frequent exacerbations (≥2 or ≥1 with hospitalization in the previous year) or without frequent exacerbations (0 or 1 without hospitalization in the previous year). to assess "breathlessness perception" the investigators will increase the ventilatory demand of the patients by co2-rebreathing method. co2 rebreathing test will be conducted to evaluate the acute ventilatory response to co2 inhalation used to estimate central chemoreceptor responsiveness in patients with the obstructive pulmonary disease. simple descriptive statistics (unpaired t-test) and correlation analysis (bivariate and multivariate) will be used to analyze results.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of copd (gold 2 or 3 or 4) * \>2 months from last exacerbation and no change in therapy exclusion criteria: * patients on regular sedative drugs * patients with neuromuscular diseases * patients with respiratory failure and/or in long-term oxygen therapy

Keywords: dyspnea perception copd exacerbations co2 rebreathing test
comparison of cambra123 and aapd (cat) for caries risk in egyptian children

Conditions: Caries Experience

Summary: this study goal is to compare two indices in egyptian children aged 3-6 years in caries detection and time needed for assessment which will contribute to variable data for pediatric oral health assessment locally and globally.

this study will ensure that patients receive precise evaluations and guide early, appropriate preventive measures or treatments. over time, this will contribute to reducing caries progression and related complications. also, parents become more aware of their children's dental health status, emphasizing the importance of early detection and intervention. furthermore, comparing the indices will provide insights into which tool is most efficient and reliable for detecting caries in children 3-6 years old.

Eligibility criteria:
inclusion criteria: * children aged 3 to 6 years. * both genders. * no underlying medical conditions affecting oral health. exclusion criteria: * uncooperative patient. * children with cognitive impairments that prevent understanding the study procedures. * parents refused.
risk factors of outcomes associated with disease progression in patients with atrial fibrillation and heart failure (hf) who are receiving a direct oral anticoagulant (rivaroxaban)

Conditions: Heart Failure

Summary: evaluation of the risk factors associated with heart failure (hf) worsening (measured by hospitalizations and emergency visits because of hf exacerbations) in spanish patients with atrial fibrilation and hf treated with rivaroxaban.


Eligibility criteria:
inclusion criteria: * adult males and females aged 18 years or older. * patients with a diagnosis of nonvalvular atrial fibrilation (af). * patients with a diagnosis of chronic heart failure, new york heart association (nyha) class i-iv hf with preserved ejection fraction (hfpef), hf with reduced ef (hfref) or hf with mid-range ef (hfmref). * patients receiving antithrombotic treatment because of af, with rivaroxaban since at least 4 months before entering the study. * patients who have been given appropriate information about the study objectives and procedures and with the mental and physical capacity to give their informed consent to participate in the study. exclusion criteria: * patients participating in a research program which involves some intervention beyond clinical practice. * patients who started rivaroxaban after the start of the inclusion period. * patients with significate mitral stenosis or other heart valvular diseases that requires or have needed specific treatment (prosthesis or valvuloplasty). * patients with severe cognitive impairment.
axium™ microfx™ for endovascular repair of intracranial aneurysm-a multicenter study

Conditions: Aneurysm

Summary: this is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the axium microfx coil system in 100 aneurysms.

this is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the axium microfx coil system in 99 patients at 13 study centers. the primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the raymond classification. secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured. * information on data collection provided to the patient or legally authorized representative and signed informed consent. * aneurysm diameter ≤10mm . * age range of 18 - 90. exclusion criteria: * aneurysm previously treated. * aneurysm avm related or dissecting. * participation in a clinical investigation of other aneurysm treating or related devices. * any condition that would preclude the conduct of protocol follow-up. * aneurysm anatomy that is determined inappropriate for axium coil placement, prior to opening of an axium coil.

Keywords: patients presenting with an intracranial aneurysm
pediatric traumatic brain injury: methylphenidate effects on early recovery

Conditions: Brain Injuries

Summary: traumatic brain injury (tbi) is the leading cause of acquired long term disability among children and young adults. deficits in attention and memory are common and persist for years after moderate or severe tbi. the similarity between these symptoms and those of children with ad/hd, the efficacy of methylphenidate in the treatment of ad/hd, and the efficacy of methylphenidate in improving recovery of animals with brain injuries, support the need to study methylphenidate effects in children with tbi. this investigation of methylphenidate in children with moderate to severe tbi aims to: (1) assess the acute effects of 2 different dosages of methylphenidate on attention and reaction time when the medication is administered to children early in recovery; (2) assess the ability of 8 weeks of methylphenidate to improve the rate of recovery of cognitive, memory, and attentional skills in children with tbi; (3) identify the frequency of common methylphenidate side effects in children with tbi.

during the first phase of the study which is of 8-days duration subjects will receive placebo on some days and methylphenidate on others. during this phase of the study the effects of the medication on children's performance on a computerized test of attention will be assessed. individuals who do not have significant methylphenidate side effects during the first phase of the study will then participate in the second phase of the study. during the second phase subjects will receive either methylphenidate or placebo for 8 weeks. neuropsychological measures of attention, memory, behavioral inhibition, cognitive flexibility, and motor performance will be obtained at baseline and after the 8 week medication trial in order to assess methylphenidate effects on the rate of recovery. recovery will also be assessed using an interview measure of adaptive behavior and cognitive functioning. a stimulant medication side effect rating scale will be used to monitor for common methylphenidate adverse effects throughout both phases of the study

Eligibility criteria:
moderate to severe traumatic brain injury

Keywords: pediatric traumatic brain injury
effectiveness of empowerment group sessions for treating suicidal african american women in abusive relationships

Conditions: Battered Women; Suicide, Attempted

Summary: this study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal african-american women who are in abusive relationships.

most suicide attempts are a sign of great distress, often originating from depression; physical and sexual abuse; substance abuse; or family history of suicide, violence, or mental disorder. risk factors for suicidal behavior are diverse, differing with gender, age, and ethnicity. since the mid-1980s, the number of reported suicides and suicidal thoughts among young black individuals has increased alarmingly. the higher rates may be caused by high stress living situations attributed to poverty, abuse, discrimination, racism, and difficult family life. therefore, cultural environments, social situations, and intrapersonal influences are important considerations in developing an effective therapy to prevent suicide. this study will evaluate the effect of culturally competent psychoeducational empowerment sessions in treating suicidal african-american women who are in abusive relationships. the participants in this single-blind study will be randomly placed in one of two treatment groups. one group will receive psychoeducational intervention (pei) and the other will receive enhanced treatment as usual (etau). after screening, eligible participants will complete a 2-hour survey about life events, concerns, and feelings with a research team member. one week later, participants will complete a second 1-hour survey. participants will then be randomly placed in the treatment groups. participants in both groups will receive treatment at grady health system, but those in the pei group will also attend 10 weekly, 90-minute group sessions. the pei empowerment group sessions will incorporate cultural, social, and intrapersonal elements. the etau group will be given mental health treatment as usual plus an adherence enhancement protocol. follow-up surveys will occur at week 10 (after treatment completion) and at months 6 and 12 post-treatment.

Eligibility criteria:
inclusion criteria: * identifies as an african-american female * abusive relationship within the 12 months prior to study entry * suicide attempt within the 12 months prior to study entry * seeks services at grady health system exclusion criteria: * score of less than 22 on mini mental status exam (mmse) * score of less than 18 on rapid estimate of adult literacy in medicine (realm) * acutely psychotic

Keywords: abused female african american group empowerment psychoeducational intervention enhanced treatment as usual
oral anticoagulation and self-management

Conditions: Atrial Fibrillation; Embolism

Summary: an intervention program targeting patients and caregivers based on education about their condition and training in the use of portable coagulomenter to self monitor and training on the treatment adjustment to self manage, can be effective to enable patients in oacs to self manage as well as to identify determinant factors associated with the success and failure of the program.

background: the skills of patients on oral anticoagulants are critical for achieving good outcomes with this treatment. self-management, or the capacity of patients to control their inr (international normalized ratio)level and adjust their treatment, is an effective strategy of treatment. capacity of patients to self manage is determined by a range of factors. the identification of these factors would improve the design of self management programmes and in turn increase the number of patients able to self-manage. the objective of our study is to identify those factors that determine the ability of patients on oral anticoagulant therapy to achieve self-management of their treatment. method: this will be a three year quasi- experimental prospective study with a control group. 333 patients on anticoagulant therapy from five health centres of the basque health service are to be followed up for a period of six months each after the intervention, to assess their ability to self-test and self-manage. the intervention will consist of a patient training programme involving the provision of information and practical training concerning their condition and its treatment, as well as how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose. discussion: training programmes for self-management are effective in terms of enabling patients to acquire the necessary skills, though the level of success seems to depend on various patient-related factors. given the proven benefits of self-management, it would be useful to properly characterise these factors and use this information to successfully increase the percentage of patients on on oral anticoagulants able to self-manage their own treatment.

Eligibility criteria:
inclusion criteria: * anticuagulated * living in the study area exclusion criteria: * older than 16 years old * more than one year cuagulated
tibial shaft nailing treated with suprapatellar nailing

Conditions: Broken Leg

Summary: the goal of this project is to determine the incidence of intra-articular knee pathology following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial nail via mri.

suprapatellar tibial nailing is gaining popularity throughout the orthopedic community for tibial shaft fractures, however the secondary effects of this technique on the articular cartilage of the knee is unknown. additionally, the incidence of intra-articular knee pathology in the face of tibial shaft fractures has not been described in the orthopedic literature. an undiagnosed cruciate/collateral ligament injury can result in post-traumatic arthritis, as well as a delay in justified ligamentous reconstruction of the knee, causing further injury. long term sequelae of now commonplace suprapatellar nailing on the patellofemoral joint of the knee have been sparsely elucidated in the literature. the primary objective is to determine the consequences of suprapatellar tibial nailing on cartilage of the patellofemoral joint. as a secondary objective, this study will seek to determine the incidence of intra-articular knee pathology following tibial shaft fractures in patients presenting to orlando regional medical center.

Eligibility criteria:
inclusion criteria: 1. skeletally mature 2. open or closed fractures of the tibial shaft exclusion criteria: 1. concomitant tibial plateau or tibial pilon injuries 2. a knee dislocation 3. skeletally immature 4. those who will undergo standard (infra-patellar) tibial nailing
influence of working length methods in the performance of pulpectomies in primary teeth

Conditions: Endodontically Treated Teeth

Summary: verify, through a randomized double-blinded clinical trial, the influence in the performance of pulpectomies in primary teeth, based on two working length methods, electronic and radiographic.

samples will be composed of children between 6 and 9 years of age, with the need for endodontic treatment in primary teeth. they will be submitted to anamnesis, clinical and radiographic exams for identification of eligibility criteria for the study. these patients will be divided randomly into 2 groups: g1 - pulpectomy with working length method performed through radiography (n=100) and g2 - pulpectomy with working length method performed with the aid of an apex locator (n=100). endodontic treatment will be done by a single trained operator. after definite restoration and final radiography, an evaluation of the obturation quality will be performed by another blinded operator, who will evaluate the appropriate obturation length. the clinical treatment success and the radiographies will also be analyzed during a period of 24 months through clinical and radiographic exams, also by a blinded operator.

Eligibility criteria:
inclusion criteria: * primary molars teeth with caries or defected restorations associated with signs or symptoms of irreversible pulpal inflammation - spontaneous pain or pulpal necrosis - presence of abscess, fistula, edema, periapical or inter-radicular radiolucency exclusion criteria: * primary molars teeth previously manipulated, with obliteration of the root canal, with bone reabsorption involving the crypt of the permanent tooth, internal or external pathological or physiological reabsorption involving more then half of the shortest root and unrestorable tooth

Keywords: pulpectomy primary teeth working length apex locator
a study of ly3305677 in participants with obesity or overweight

Conditions: Overweight; Obesity

Summary: the main purpose of this study is to learn about the safety and tolerability of ly3305677 when given to participants with obesity or overweight. blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. each enrolled participant will receive injections of ly3305677 or placebo given just under the skin. for each participant, the study will last about approximately 28 weeks.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy as determined by medical evaluation * participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²) exclusion criteria: * have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma
pulmonary tuberculosis patients with diabetes mellitus

Conditions: Diabetes Mellitus; Pulmonary Tuberculosis

Summary: the purpose of this study is to evaluate the effect of enhanced glycemic monitoring of diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis- diabetes patients.

tight glycemic control may improve tuberculosis (tb) treatment outcome and help reduce symptoms. however, active tb and tb treatment hamper glycemic control. patients starting tb treatment experience rapid changes in appetite, body composition, and inflammation (which increases insulin resistance); inflammation is a feature of untreated tb and following an increase as a result of initial bacterial killing, inflammation subsides with successful treatment. in addition, tb medication (rifampicin) increases the metabolism of oral anti-diabetic drugs including the widely used sulphonylureas and thiazolidinediones, though a possible interaction with the antidiabetic drug metformin has not been previously examined. frequent monitoring of blood glucose with adjustments in anti-diabetes medication during the course of tb treatment may therefore be needed. however, frequent monitoring is associated with additional costs, and tools and skills for glucose monitoring and diabetes treatment may be lacking in tb or pulmonary clinics, creating a need to refer patients to other health providers. as such, a less intense schedule, preferably following the established decision points in tb treatment after 2 and 6 months would offer significant advantage. none of these issues have been addressed systematically so far.

Eligibility criteria:
inclusion criteria: * adult (\> 18 years old) diabetes mellitus patients * diagnosed as having active pulmonary tb * willing to join the study exclusion criteria: * under tb treatment more than 72 hours * steroid-induced or gestational diabetes

Keywords: diabetes mellitus tuberculosis management randomized controlled trial