Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of rizatriptan-naproxen (10/550 mg) in the acute treatment of migraine

Conditions: Migraine

Summary: a phase iii study, multicenter, double-blind, double-dummy, randomized, single-dose, placebo-controlled study to evaluate the efficacy and safety of rizatriptan-naproxen (10/550 mg) in the acute treatment of migraine. ⚠️study will only be conducted in research centers in brazil (please do not send e-mail if your center is outside brazil).

this is a prospective, randomized, double-blind, double-dummy and placebo-controlled study in individuals with disabling migraine. the participants will be randomized to receive rizatriptan + naproxen (10/550mg), rizatriptan (10mg), naproxen (550mg) or placebo. ⚠️study will only be conducted in research centers in brazil (please do not send e-mail if your center is outside brazil).

Eligibility criteria:
inclusion criteria: * patients of both sexes; * aged between 18 and 65 years old; * capable and willing to give free and informed informed consent in writing; * migraine patients with or without aura, according to the international headache society (ihs). exclusion criteria: * chronic migraine; * headache other than migraine (that is, tension-type headache, sinusitis, etc.).
prognosis and long term pubertal outcome of girls previously diagnosed with a prenatal ovarian cyst

Conditions: Ovarian Cyst

Summary: puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date.

the prenatal diagnosis of ovarian cysts is a common disease with an estimated incidence of 1 case per 2500 births. this pathology is the first diagnosis of abdominal cystic picture on the female fetus in the third trimester of pregnancy.various complications of ovarian cysts have been described, such as ovarian torsion, breaking the cyst, hemorrhage intra cystic and compression of adjacent viscera. a conservative attitude for uncomplicated cysts is proposed in the literature but surgical care and / or puncture can be made to prevent the occurrence of complications and thus to protect ovarian tissue.however, no data on puberty and long-term ovarian prognosis in this disease is published in the literature. without this information, no support for the recommendation of a prenatal ovarian cyst can be established formally.

Eligibility criteria:
inclusion criteria: * collection of the written consent by the patients or the parents * membership in a health insurance scheme * group 1 : girl with prenatal ovarian cyst group 2: girl without prenatal ovarian cyst exclusion criteria: * refusal of participation of the patient or one of the two parents * deprived of freedom * pregnancy and current feeding * prenatal, neonatal or infantile history of ovarian pathology (group 2) * genital congenital deformation or malformation syndrome gives a complex (group 2) * endocrine pathology except the juvenile disorders (group 2)

Keywords: ovarian cyst prenatal diagnosis puberty
establishment of genomic and phenotypic database for niemann-pick disease, type c

Conditions: Niemann-Pick Disease, Type C

Summary: background: niemann-pick type c (npc) disease is a rare, progressive neurodegenerative disease that affects mainly the brain, liver, and spleen but also other parts of the body. there is no cure for npc, and symptoms only get worse over time. symptoms can include seizures, difficulty moving or talking, or dementia. but symptoms can vary among different people with the disease. some may have seizures, while others do not, for example. some people begin showing symptoms in childhood; in others, symptoms may not appear until they are adults. researchers want to learn more about why npc affects people differently. this natural history study will gather data from people with npc in order to understand more about the disease and how it affects the body. objective: this study will create the first and largest database about npc. eligibility: people of any age who have npc. design: participants will have blood drawn from a vein. this will happen only once. the blood will be used to analyze the participants dna. the participants medical records will be reviewed. the study team will collect data on participants npc diagnosis and symptoms; they will record how long participants have had each symptom. the study team will also collect data on each participants age, sex, race, height, weight, medications, and other test results. the study team will communicate with participants. they will discuss the study and answer any questions. participants will receive up to $190.

study description: the primary objective of this protocol is to investigate the phenotypic heterogeneity of npc by using clinical and genomic data, and to establish a comprehensive database to facilitate future investigations. objectives: 1. identify correlations between npc clinical phenotypic findings and genomic markers to facilitate the understanding of the heterogeneity of this disease. 2. identify genetic contributions to npc disease progression that can be utilized as potential therapeutic targets. 3. establish the first and largest database of genomic and phenotypic information for npc to benefit the npc research and patient community.

Eligibility criteria:
* inclusion criteria; in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, any age, demographic or ethnic background will be eligible for this study 4. diagnosis of npc will be based on clinical, biochemical or molecular testing. exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: 1. unwilling to provide consent 2. unable to provide biospecimen to obtain dna 3. unable to provide medical records or clinical data

Keywords: genetic clinical dna medical history natural history
sniff multi-device study 2

Conditions: Mild Cognitive Impairment; Cognitive Impairment

Summary: the sniff device study will involve using one of three devices to administer insulin through each participant's nose or intra-nasally, accompanied by a lumbar puncture. this goal of this study is to measure how much insulin the device delivers to the cerebrospinal fluid (csf). in addition, this study will look at the effects of insulin administered intra-nasally on memory, and on blood levels of insulin.

the aim of this study is to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (csf). a growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with alzheimer's disease (ad). interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels. the study will consist of a single site, randomized, double-blind trial comparing the acute effects of ini 20 international units or 40 international units delivered with one of three nebulizer-like devices on csf insulin levels, ad biomarkers and memory. at study entry, participants will be randomized to receive either 20 or 40 iu insulin first, and the opposite dose on a second visit. participants who are cognitively normal or who have amci (n=30) will be enrolled. the primary outcome measure will be to establish which device and which dose provides the greatest increase in csf insulin which will provide important evidence to be used in the design of future trials.

Eligibility criteria:
inclusion criteria: * fluent in english * cognitively normal or diagnosis of amci * stable medical condition for 3 months prior to screening visit * stable medications for 4 weeks prior to the screening and study visits * clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician exclusion criteria: * a diagnosis of dementia * history of a clinically significant stroke * current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder * diabetes (type i or type ii) insulin dependent and non-insulin dependent diabetes mellitus * current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit. * history of seizure within past five years * pregnancy or possible pregnancy. * use of anticoagulants warfarin (coumadin) and dabigatran (pradaxa) * residence in a skilled nursing facility at screening * use of an investigational agent within two months of screening visit * regular use of alcohol, narcotics, anticonvulsants, anti-parkinsonian medications, or any other exclusionary medications

Keywords: intranasal delivery of insulin cognitive testing nasal insulin
brief online study abroad alcohol intervention

Conditions: Alcohol Abuse

Summary: this study involves a randomized controlled trial that builds upon a successful pilot intervention study to address problematic and dangerous drinking among young adult college students studying abroad in foreign environments. despite universities and colleges citing alcohol misuse as the most concerning issue for their students abroad, most institutions offer no empirically-based prevention efforts tailored to this at-risk population. the proposed intervention attempts to fill a major gap for the nearly 333,000 students completing study abroad programs each year by addressing empirically-based and theoretically-informed risk and protective factors of correcting misperceived peer drinking norms and promoting cultural engagement abroad. in addition to preventing heavy and problematic drinking, the intervention seeks to prevent risky behaviors and experience of sexual violence victimization, which are strikingly common among study abroad students and have the potential for lasting physical and psychological effects upon return home. the investigators will conduct a randomized controlled trial of a developed intervention with a sample of 1,200 college students studying abroad from 35 u.s. universities and colleges. the brief, online intervention is text and video based and contains evidence-based components of personalized normative feedback to correct students' misperceived drinking norms, content to promote engagement with the cultural experience abroad and addressed difficulties adjusting to life in the foreign environment, and tips and strategies to prevent risky sexual behaviors and sexual violence victimization abroad. participants will complete online surveys at five time points (predeparture, first month abroad, last month abroad, one-month post-return, and three-months post-return) to assess for intervention effects on drinking, risky sex, and sexual violence outcomes. the investigators will examine whether the mechanisms targeted by the intervention (changes in perceived norms, engagement in the cultural experience abroad) serve as mediators of intervention efficacy.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 25 * signed up to study abroad in one of the 12 most popular destinations (i.e., united kingdom, italy, spain, france, germany, china, ireland, australia, costa rica, japan, south africa, and mexico * plan to study abroad for between 8 and 21 weeks (approximately one quarter/semester) * have a working email address exclusion criteria: * none except not meeting eligibility criteria

Keywords: alcohol sexual violence risky sex college students
"incidence and consequences of disorders of glycosylation in patients with conotruncal and septal heart defects"

Conditions: Congenital Heart Diseases; Conotruncal Defects; Congenital Disorder of Glycosylation; Antithrombin III Deficiency

Summary: the objective of the study is to investigate congenital disorders of glycosylation in congenital heart diseases without a clear molecular or genetic basis.

congenital disorders of glycosylation (cdg) are a family of inherited disorders caused by defects in the synthesis of glycans, glycoproteins or other glycoconjugates. congenital disorders of glycosylation (cdg) are a family of inherited disorders caused by defects in the synthesis of glycans, glycoproteins or other glycoconjugates. glycosylation of proteins is crucial for a proper organ morphogenesis and for an appropriate coagulation system functioning. the neurological system is commonly affected in this type of disorders but cases of cdg with normal neurological development have been recently described. the group of experimental hematology and clinic oncology of the university of murcia (spain) recently described a rare disorder of glycosylation (alg12-cdg) as the cause of antithrombin deficiency in a patient of 19 years with a history of repaired ventricular septal defect. on the other hand, population studies have shown an increased incidence of thromboembolic events in patients with congenital heart disease when compared to the general population. the identified genetic defects involved in the development of congenital heart diseases have variable or incomplete penetrance and in most cases the molecular basis is completely unknown. the investigators postulate that a cdg might be behind the development of some forms of congenital heart disease and contribute to the greater prevalence of thromboembolic events in this patient population.

Eligibility criteria:
inclusion criteria: * adult with a congenital heart disease with most probability to present a congenital disorder of glycosylation of proteins exclusion criteria: * denial of informed consent.

Keywords: antithrombin iii deficiency congenital heart diseases
a study to evaluate the safety and efficacy of raltegravir (mk0518) in hiv-infected patients failing current antiretroviral therapies (mk0518-018 ext2)

Conditions: HIV Infections

Summary: this study will investigate the safety and efficacy of raltegravir as a therapy for hiv-infected patients failing current therapy with 3-class antiviral resistance.

the primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. participants who had viral failure after week 16 may have received open-label raltegravir until week 240.

Eligibility criteria:
inclusion criteria: * patient must be hiv positive with hiv rna values that are within ranges required by the study * patient must have documented failure of certain antiretroviral therapy * patient must be on the same antiretroviral therapy for at least the past two months exclusion criteria: * patient is less than 16 years old * additional study criteria will be discussed and identified by the study doctor

Keywords: treatment experienced
national survey about trajectory and life conditions of hiv trans people in france

Conditions: HIV Seropositivity

Summary: trans\&vih is a national survey that will explore condition of vulnerability and trajectory of transgender people living with hiv. to fulfill this purpose, clinical data from medical registry and socio-behavioral information collected through questionnaire, will help to explore this questions about vulnerability and condition of transgender people living with hiv.

in france, transgender still a taboo subject, and is poorly documented. there are no precise data on the number of transgender people in france or on their socio-demographic characteristics. the absence of such data reinforces their invisibility in social life and contributes to their stigmatization. transgender people faces many social barriers in our society. these barriers accumulate in hiv seropositive transgender people (trhiv), and most likely increase the burden of hiv infection. the main objective of anrs trans\&vih - the community-based research study presented here - is to identify personal and social situations of vulnerability for trhiv in france, the obstacles for receiving medical care, and their healthcare needs. anrs trans\&vih is an ongoing national, exhaustive, cross-sectional survey of all trhiv currently followed up in hiv services in france. it is a mixed-methods study, the quantitative and qualitative components includ trhiv women and men, respectively. socio-behavioral and medical data are collected (start date january 2021) by community-based interviewers in participating hospital-based hiv structures in order to explore patient care pathways and living conditions of the trhiv population with regard to transitioning and hiv. this is the first study in france to collect such data. the statistical techniques used for the data analyses will reflect the study's objectives and will be adapted to the type of data collection used: cross-sectional (questionnaires) and longitudinal (life history). several types of analyses will be performed, including: (i) a description of the individual characteristics of transgender female trhiv; (ii) comparative analyses between different groups of stakeholders (e.g., differences between the ile de france region (which covers paris and the surrounding area) and other regions); (iii) analysis of life and hiv trajectories; (iv) structural analyses using structural data collected for participating hiv structures (v) qualitative analysis of data from interviews with participating trhiv men. anrs trans\&vih results will be used to make recommendations to health authorities to ensure that a comprehensive healthcare package will be offered to trhiv which takes into account this population's specific background and problems.

Eligibility criteria:
inclusion criteria: * transgender woman or transgender man * living with hiv * followed in hospitals in metropolitan france and the country's overseas territories

Keywords: transgender community-based research mixt methods
dose-ranging study of vilanterol (vi) inhalation powder in children

Conditions: Asthma

Summary: this is a phase iib, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (fp) 100mcg twice daily via diskus/accuhaler and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. at visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the novel dry powder inhaler (ndpi) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) pef at the end of the 28-day treatment period in all subjects. safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ecg, and vital signs. blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.


Eligibility criteria:
inclusion criteria: * written informed consent from at least one parent/ legal guardian to take part in the study.: * diagnosis of asthma * pre-bronchodilator pef between ≥50% to ≤90% of their best post-bronchodilator value * receiving stable asthma therapy of short acting beta-agonist (saba) plus ics (total daily dose fp 200mcg or equivalent) exclusion criteria: * history of life-threatening asthma * history of asthma exacerbation for asthma within 6 months prior to screening. * culture-documented or suspected bacterial or viral infection * significant abnormality or medical condition * present use of any tobacco products
comorbidities and healthcare utilisation: indicators for improving copd diagnosis

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to characterise and understand the current uk copd population including demographics, active comorbidities and missed opportunities for copd diagnosis in the years previous to diagnosis

using real-world primary care clinical databases, ascertain whether 1) trends in respiratory resource utilisation prior to copd diagnosis (including lower respiratory tract infections \[lrtis\], consultations and hospitalisations) could be used as 'flags' to aid earlier diagnosis, and 2) characterize comorbid conditions present at the time of copd diagnosis, and evaluate the relationship to copd disease severity and age at diagnosis.

Eligibility criteria:
inclusion criteria: * aged 40 years or older * electronically coded diagnosis of copd made between 1990 and 2009 * a minimum of three years continuous practice data including two years prior to and one year post diagnosis to ensure patients recieved copd therapy post diagnosis * recieved two or more prescriptions for copd therapies in the 12 months post diagnosis year 1. exclusion criteria: * aged less than 40 years * no diagnosis of copd between 1990 and 2009 * less than three years continuous practice data including two years prior to and one year post diagnosis * less than two prescriptions for copd therapies in the 12 months post diagnosis year 1.

Keywords: diagnosis primary care comorbidities healthcare utilisation
improving self-efficacy, quality of life and glycemic control in adolescents with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: empowerment in healthcare, particularly in the context of chronic illness management such as diabetes, entails equipping patients with knowledge, expertise, and self-assurance to proactively oversee their health and make well-informed choices. this encompasses comprehensive strategies that target psychological, social, and lifestyle elements with the goal of enhancing self-confidence and health results. the objective of this research is to evaluate how the family-centered empowerment model affects the clinical and psychological outcomes of adolescents with type 1 diabetes, with an emphasis on increases in quality of life, self-efficacy, and glycosylated hemoglobin (hba1c) levels.

diabetes mellitus (dm) is a prevalent and increasingly acknowledged medical disorder that affects individuals worldwide. it is a metabolic condition marked by elevated blood glucose levels that can cause serious side effects like renal failure, heart disease, blindness, and even amputations. to provide a better understanding of the family-centered empowerment model intervention applied in this work, the components and delivery modes are described in more detail below. furthermore, a figure or a table suggested at this part could help to present this information more shortly. details about the intervention the family-centered empowerment model intervention aimed to help engage the adolescent, an individual with type 1 dm, and his/her family in the self management process. the purpose of this study was to improve coping skills with type 1 dm population by increasing teamwork between adolescents and their members of their household.

Eligibility criteria:
inclusion criteria: * individuals with type 1 diabetes, ages 12 to 18 years * patients who had not taken part in any professional diabetes education program within a month of receiving their diagnosis * patients who had been diagnosed at least six months earlier to the commencement of the study. exclusion criteria: * adolescents who had severe long-term diseases * patients newly diagnosed type 1 diabetes. * those who were enrolled in a diabetes education program one month or less prior to the commencement of the study.

Keywords: diabetes mellitus quality of life