Kornimate/medical-research-clean huggingface dataset:
what do stroke survivors actually learn when regaining walking ability after stroke? the target phase i study

Conditions: Stroke; Paresis; Gait, Hemiplegic

Summary: phase i: exploring what stroke survivors exactly learn when recovering the ability to stand and walk.

general: pre-clinical research has pointed towards a time window of enhanced responsiveness to therapy early after stroke. for example, training has led to substantial recovery if initiated 5 or 14, but not 30 days post-stroke in a rodent model (biernaski 2004). it is suggested that this early period is characterized by heightened levels of plasticity and that training can exploit this leading to improved outcome. the typically observed non-linear recovery pattern in stroke survivors (kwakkel 2004) might suggest that similar mechanisms are induced in the human brain, however clinical research on this is disappointingly sparse. in two closely inter-related phases, we aim to examine the biomechanical changes related to walking recovery in general (phase i) and the specific effects of robot-assisted training (phase ii). by that, we aim to detect a time window in stroke survivors which resembles the same characteristics as observed in animal models. to initiate gait training at an early stage, when patients usually present severe weakness and balance deficits, a mobile exoskeleton is used which is developed to provide intensive walking practice. objectives: (i.a) is there a distinct time window of behavioral restitution (i.e., returning towards pre-stroke movement patterns) underlying early walking recovery? (i.b) are improvements in standing and walking throughout the first 6 months post-stroke explained by behavioral restitution or learning to use compensation strategies?

Eligibility criteria:
inclusion criteria: * first-ever, mri- or ct-confirmed, ischemic or hemorrhagic, anterior circulation stroke * age: 18 - 90 years * baseline assessments within the first 14 days after stroke onset * weakness of the lower limb (nihss item \>0 at 72 hours post-stroke) * pre-morbid independence in activities of daily living (mrs \ 3) * able to communicate and comprehend * sufficient motivation to participate * provided a written informed consent exclusion criteria: * no other neurological condition affecting motor functions of the lower limbs * pre-existing musculoskeletal impairment severely affecting the gait pattern

Keywords: walking recovery compensation
evaluation of biomarkers of traumatic brain injury extension study

Conditions: Traumatic Brain Injury

Summary: the primary objective of this study is to evaluate ubiquitin c-terminal hydrolase-l1 (uch-l1) and glial fibrillary acidic protein (gfap) biomarker levels in a population of ct-positive subjects (as determined by an independent neuroimaging review committee) presenting acutely with traumatic brain injury (glasgow coma scale score 9-15).


Eligibility criteria:
inclusion criteria: * the subject is at least 18 years of age at screening. * the subject has presented to a health care facility (hcf) or emergency department (ed) with a suspected traumatically induced head injury, as a result of insult to the head from an external force. * a glasgow coma scale score of 9-15 at the time of informed consent. * the subject is ct-positive for acute intracranial lesion(s) based on the local neuroradiologist's review of the subject's head ct scan. * the ct scan and ct report used to determine eligibility must be available. * the blood sample is collected as close to the time of head injury as possible, but no later than 12 hours. * the subject or their legal representative is willing to undergo the informed consent process prior to enrollment into this study exclusion criteria: * participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study would be acceptable). * time of injury cannot be determined. * primary diagnosis of ischemic or hemorrhagic stroke. * venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., iv drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)). * the subject has a neurodegenerative disease or other neurological disorder including dementia, parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors. * the subject has a history of neurosurgery within the last 30 days. * administration of blood transfusion after head injury and prior to the study blood draw. * the subject is a female who is pregnant or lactating. * the subject is otherwise determined by the investigator to be an unsuitable candidate for participation. if this criterion applies, a reason must be provided

Keywords: traumatic brain injury head injury
health education in perimenopausal women to promote self-care and quality of life

Conditions: Perimenopausal Women

Summary: objective: to evaluate the efficiency of a group intervention opposite to the usual care to improve the quality of life, measured with the sf-12 questionnaire, in women between 45-55 years to the primary health care centres.

methods: clinical controlled trial with parallel groups, random assignment of primary care units and blinded evaluation of principal label. setting: study in primary health care centres (phccs) of madrid health service and castilla león health service. subjects: women between 45-55 years to medical consultation in primary care. intervention: application of good clinical practice procedure and cognitive - behavioural grupal intervention. sample size: n=355 patients. data: principal response variables: quality of life measured with the sf-12 questionnaire. secondary response variables: visits number, medicine /month number, and transitory disability days. other prognosis and descriptive variables. data analysis: main effectiveness will be analyzed by comparing the improvement in 4 or more points in the sf-12 mental health area at 6, 12, 18 y 24 months post- intervention, between intervention and control group. logistic regression will be used to adjust for prognostic factors. confounding factors or factors that might alter the effect, recorder will be taken in account in this analysis. all statistical tests will be performed with intention to treat.

Eligibility criteria:
inclusion criteria: * 45-55 years women * users of the health center * able to follow the demands of the study: does not have the intention to move from home in the next 24 months * have ability to read and write the spanish language and agreeing to participate by giving their informed consent in writing. exclusion criteria: * women immobilized at home, with mental disorder or cognitive impairment and/or sensory impairments that prevent to participate in a group intervention.
the use of picato® (ingenol mebutate) to treat actinic keratosis in standard clinical practice

Conditions: Actinic Keratosis

Summary: this is a prospective, non-interventional study of adult patients prescribed topical treatment with ingenol mebutate gel (picato®) as part of provision of care for the treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (ak). patients with complete clearance at 8 weeks will be followed for one year or until retreatment of ak in the area initially treated, whatever comes first. for patients with incomplete clearance in the treated area at 8 weeks the treatment strategy for this area will be recorded but no further follow-up will take place. the effectiveness, tolerability, adherence, patient satisfaction and health-related quality of life (hrqol) associated with picato® treatment will be evaluated.

actinic keratosis (ak) is caused by exposure to uv radiation and has the potential to regress to normal skin or to progress to squamous cell carcinoma. ingenol mebutate gel is a relatively new topical treatment option for ak in greece. taking into consideration the limited real-world evidence that is attributed to the recent advent of picato in the greek market, this non-interventional observational study aims primarily at assessing the characteristics of patients selected for this treatment, the effectiveness and tolerability of the treatment, patient satisfaction and the impact of the therapy on patients' hrqol in standard clinical practice.the study will be carried out by approximately 30 physicians practicing in private or public hospitals and clinics in representative geographical regions of greece.

Eligibility criteria:
inclusion criteria: * planned to receive topical ingenol mebutate gel for treatment of actinic keratosis according to current labelling in greece. * written informed consent obtained to use the patient's data for the study. exclusion criteria: * contraindications according to prescribing information. * previous treatment with picato in the selected treatment area.

Keywords: actinic keratosis topical ingenol mebutate picato®
the prevalence of lower urinary tract symptoms (luts) in poland

Conditions: To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland

Summary: the first large population-based study to evaluate lower urinary tract symptoms (luts) in poland. the study objective is to assess the prevalence and bother of luts in the population aged ≥40 years in poland.

the first large population-based study to evaluate lower urinary tract symptoms (luts) in poland. the study objective is to assess the prevalence and bother of luts in the population aged ≥40 years in poland. this study will be conducted as a telephone survey with assessment of luts using a standardized protocol, which included the international prostate symptom score (ipss) and, for overactive bladder (oab), the oab-v8 questionnaire. participants will be asked to rate how often they experienced individual luts and the degree of associated bother. the study will be performed in a representative group of polish population (n = 6,000) covering all geographic regions of poland (defined by the central statistical office of poland).

Eligibility criteria:
inclusion criteria: age \>40 exclusion criteria: age \<40 pregnancy urinary tract infection in the past 4 weeks
lactobacillus plantarum: thumb osteoarthritis following orange peeling

Conditions: Lactobacillus Plantarum

Summary: case description osteoarthritis + amputation of the distal phalanx of the right thumb caused by lactobacillus plantarum after an orange peel. the natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.

case description osteoarthritis + amputation of the distal phalanx of the right thumb caused by lactobacillus plantarum after an orange peel. the natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of an osteoarthritis, * amputation of the distal phalanx of the right thumb exclusion criteria: * not exclusion criteria
real-life effectiveness of the kaletra adherence support assistance (kasa) program

Conditions: Human Immunodeficiency Virus Infection

Summary: the overall purpose of the study was to describe the real-life adherence, effectiveness and safety of the kaletra adherence support assistance (kasa) program in human immunodeficiency virus (hiv)-positive patients who were receiving treatment with lopinavir / ritonavir (lpv/r; kaletra®) in canada.

the kaletra adherence support assistance (kasa) program is a customized support network that has been offered to patients treated with lopinavir / ritonavir (lpv/r; kaletra®). kasa offers individual counseling with an hiv experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events. patients enrolled in kasa may also have access to various healthcare professionals (dietician, social worker, psychologist, etc.) or may be offered other types of support (transportation, exercise, etc.), which may help improve their quality of life as well as adherence or compliance while taking lpv/r. this was a 12-month, multi-center, canadian post marketing observational study utilizing a prospective single cohort design. all treatments including participation in the kasa program were according to the decision of the treating physician and the patients and were not affected in any way by their decision to participate in the study. follow-up was for 12 months at an interval of every six months.

Eligibility criteria:
inclusion criteria: * subject is hiv-positive * on treatment with lpv/r or currently initiated on treatment with lpv/r. * has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel. * willing to be enrolled in the kaletra adherence support assistance (kasa) program. * prescribed lpv/r as part of his/her treatment by the treating physician. exclusion criteria: * not willing to sign an informed consent. * in the opinion of the treating physician is unlikely to be available for the 12-month follow-up duration of the study. * is currently participating in a clinical trial of an investigational product. * not willing to participate in the kasa program.

Keywords: human immunodeficiency virus infection
cardiopulmonary effects of intrathoracic pressure overshoot during carbon dioxide insufflation in thoracoscopic surgery

Conditions: Esophageal Neoplasms

Summary: video-assisted thoracoscopic surgery (vats) has become a standard technique for addressing all types of thoracic pathology. insufflation of carbon dioxide (co2) into the operated chest cavity could increase lung collapse and improve surgical field view. the actual thoracic pressure values may not be identical with the presetting on the insufflator display. this overshoot pressure during vats may compromise cardiac and pulmonary function. the purpose of this study is to evaluate the effects of intrathoracic pressure overshoot during two-lung ventilation on the hemodynamic and respiratory function and clarify the relative safety of two different techniques of insufflation.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status ⅰ,ⅱ * patients with esophageal carcinoma * elective video-assisted thoracic surgery exclusion criteria: * allergic to drugs used in the study * refusal of vast * arrhythmia or treated with antiarrhythmic drug * surgery type were converted to thoracotomy, * massive intraoperative blood loss (\> 400ml)

Keywords: circulatory and respiratory physiological phenomena thoracoscopy
evaluation of the safety and efficacy of late-onset pompe disease gene therapy drug

Conditions: Pompe Disease (Late-onset)

Summary: this study is being conducted to evaluate the safety and effectiveness of gc301 adeno-associated virus vector expressing codon-optimized human acid alpha-glucosidase (gaa) as potential gene therapy for pompe disease. patients diagnosed with late-onset pompe disease （lopd） who are ≥ 6 years old will be studied.


Eligibility criteria:
inclusion criteria: * age ≥ 6 years, males or females; * patient has a diagnosis of lopd; * patient has upright fvc ≥ 30% of predicted normal value; * a 6mwt ≥ 40 meters, assistive device allowed; * the patient's legal guardian(s) must be able to understand the purpose and risks of the study and voluntarily provide signed and dated informed consent prior to any study-related procedures being performed. exclusion criteria: * patient who has any history or concurrent clinical organic disease, including cardiovascular and liver diseases, respiratory system, nervous system disease, or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study. * patient who requires invasive mechanical ventilation, or rely on noninvasive non-non-invasive assisted ventilation when sitting upright; * patient who is positive for human immunodeficiency (hiv) antibody, hepatitis b surface antigen, hepatitis c antibody, or treponema pallidum antibody; * patient with a history of glucocorticoid allergy; * patient who has a contraindication to study drug or to corticosteroids, or has demonstrated hypersensitivity to any of the components of the study drug; * patient who has aav9 neutralizing antibody titer ≥ 1:100； * patient who has participated in a previous gene therapy research trial; * pregnant or lactating female participants; * patients who have fertility plans within 6 months from screening to the end of the study and are unwilling to take effective physical contraceptive measures (such as a condom, intrauterine device, contraceptive ring, ligation, abstinence, etc.) for contraception (including the subject's partner);
filip: fat intake, inflammation and lipids

Conditions: Cardiometabolic Risk Factors; Inflammation; Microbiota

Summary: low-grade inflammation is involved in the pathogenesis of type 2 diabetes and cardiovascular disease. increasing evidence suggests that dietary intake may be involved in the inflammatory process. how nutritional composition of the diet affects the inflammatory response is however not well understood. the aim of this project is to study if intake of three different fat sources induce different effects on inflammation markers, blood lipids, blood glucose and the microbiota.


Eligibility criteria:
inclusion criteria: * age 18-60 * willing to eat the study diet exclusion criteria: * malabsorption-related condition * contraindications to consume a high fat diet * intolerance to any foods used in the study (e.g. cow's milk, egg, gluten) * established cardiovascular disease, diabetes or cancer * current use of medication known to affect lipid metabolism (e.g. statins) or inflammation (e.g. nsaid, glucocorticoids). * hemoglobin \&lt;100 g/l * ongoing pregnancy or lactation

Keywords: blood lipid profile low grade inflammation
pharmacokinetics of sildenafil in premature infants

Conditions: Persistent Pulmonary Hypertension of the Newborn

Summary: the purpose of this study is to learn more about the safety and dosing of sildenafil in infants.

pharmacokinetics and safety of sildenafil will be studied in preterm infants who are receiving sildenafil per standard of care or 1 dose prescribed for the study.

Eligibility criteria:
inclusion criteria: cohort 1: * gestational age 28 weeks or less receiving sildenafil as standard of care \< 365 postnatal days cohort 2: * gestational age 28 weeks or less * 7-28 postnatal days of age * mechanical ventilation or nasal continuous positive airway pressure (ncpap) or high-flow nasal cannula * intravenous line in place exclusion criteria: cohort 1: * any condition that would make the participant, in the opinion of the investigator, unsuitable for the study cohort 2: * previous exposure to sildenafil within 7 days prior to enrollment * any condition that would make the participant, in the opinion of the investigator, unsuitable for the study * history of allergic reactions to sildenafil * ast \> uln or alt \> 3x uln * currently on a vasopressor for hypotension * known sickle cell disease

Keywords: sildenafil preterm infants persistent pulmonary hypertension of the newborn
efficacy, tolerability and safety of dexmethylphenidate hcl extended-release capsules in children with attention-deficit/hyperactivity disorder

Conditions: ADHD, ADD

Summary: the purpose of this study is to determine which dosages of dexmethylphenidate hcl extended-release capsules may represent effective treatment for adhd in children 6-12 years of age.

the purpose of this study is to determine which dosages of dexmethylphenidate hcl extended-release capsules may represent effective treatment for adhd in children 6-12 years of age.

Eligibility criteria:
inclusion criteria: * children 6 - 12 with a diagnosis of adhd of any type , same teacher who is willing to complete the assessment during the school term exclusion criteria: * previous cardiac problems of the patient or the parents or current cardiac findings of the patient; relevant medical condition other than adhd; adhd medication within a specified timeperiod prior to study start; pregnancy or nursing; positive drug screen other protocol-defined inclusion/exclusion criteria may apply

Keywords: adhd, children, cads-t, dexmethylphenidate-hcl, extended release
effect of atorvastatin on subclinical atherosclerosis

Conditions: CMV

Summary: statin administration is supposed to reduce subclinical atherosclerosis by decreasing ldl cholesterol levels, possibly via lipid-independent anti-inflammatory effect. its pleiotropic properties also adding beneficial effect against cmv infection. the investigators plan to study atorvastatin in virally- suppressed hiv-infected patients on stable art with cmv seropositive and statin-naïve to evaluate the subclinical atherosclerosis changes assessed by carotid intima media thickness (cimt).

extended description of the protocol, including more technical information

Eligibility criteria:
inclusion criteria: * ages between 20 to 45 years old * using stable art at least 1 year * positive igg cmv * viral load hiv rna \<50 copies / ml exclusion criteria: * undergoing hepatitis c daa therapy * decompensated cirrhosis or acute liver failure * history of coronary artery disease * diabetes mellitus * history of of brain infection, epilepsy, stroke * history of rhabdomyolysis or myopathy * pregnant or breastfeeding * severe depression * using statin therapy in the past 6 weeks * history of statin hypersensitivity * framingham risk score above 10% within ldl ≥130 * framingham risk score under 10% within ldl ≥160 * out of periodontitis index (upper right molars, top series, upper left molars, lower right molars, bottom series, lower left molars)

Keywords: statin atherosclerosis
medium-term follow-up of patients with obstetric antiphospholipid syndrome: mri study of white matter

Conditions: Antiphospholipid Syndrome

Summary: the investigators hypothesize that the white matter of patients with obstetric antiphospholipid syndrome deteriorates over time


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * the patient is at least 18 years old * for the target population: only women included in the publication by pereira et al (2016) will be included, with no obsteric history (fetal death \>10 weeks or 3 unexplained consecutive losses \<10 weeks) * for the test group: patients must be positive for antiphospholipid antibodies based on results from pereira et al (2016) * for the control group. patients must be negative for antiphospholipid antibodies according to results from pereira et al (2016) exclusion criteria: * the subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * the patient is pregnant, parturient or breast feeding * the patient is claustrophobic * the patient has a metallic foreign body (e.g. pacemaker) * the patient has experienced pregnancy loss linked to infectious, metabolic, anatomic or hormonal factors