Kornimate/medical-research-clean huggingface dataset:
safety of hib-mency-tt vaccine versus licensed hib conjugate vaccine, given at 12 to 15 months of age.

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Summary: the booster phase of the study will evaluate the safety of hib-mency-tt vaccine compared to a control group receiving licensed hib conjugate vaccine at 12 to 15 months of age. this protocol posting deals with objectives \& outcome measures of the booster phase. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct number = nct00345579). no new recruitment will take place during this booster phase of the study. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

hib-mency-tt = gsk biologicals' haemophilus influenzae type b and neisseria meningitidis serogroups c and y-tetanus toxoid conjugate vaccine. the study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner. all subjects will receive prevnar, m-m-r ii and varivax as study vaccines, preferencially co-administered with the booster dose of hib-mency-tt/pedvaxhib. note: this protocol posting deals with the objectives \& outcome measures for the booster phase of the study. the objectives \& outcome measures for the primary phase are presented in a separate protocol posting (nct00345579)

Eligibility criteria:
inclusion criteria: * subjects enrolled in the primary study (nct00345579) are eligible for participating in the booster study exclusion criteria: subjects should not be administered m-m-r ii and varivax if any of these criteria apply: * history of measles, mumps, rubella or varicella. * previous vaccination against measles, mumps, rubella or varicella. * hypersensitivity to any component of the vaccines, including gelatin or neomycin. * patients receiving immunosuppressive therapy. * individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. * individuals with primary and acquired immunodeficiency states. * individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * individuals with active tuberculosis. * acute disease at time of booster vaccination

Keywords: h. influenzae type b vaccine infants neisseria meningitidis vaccines, conjugate meningococcal vaccines prophylaxis comparative study safety humans
treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells

Conditions: Postoperative Hypoparathyroidism

Summary: the idea of the project is to develop a method of treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells.

the cells will be isolated and cultured from the parathyroid gland of brain-dead organ donors. cells will be tested for the immunophenotype, viability, sterility and the production of parathyroid hormone. cells will be co-cultured with the patients t-cells and the expression of perforin and granzyme b proteins will be assayed as well as the apoptosis/viability of parathyroid cells. prepared cells will be used to treat the patients with postoperative hypoparathyroidism. the safety, tolerability and clinical efficacy will be studied.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of postoperative hypoparathyroidism * decreased pth concentrations in blood serum * the patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation * written informed consent exclusion criteria: * the presence of any malignant tumor within the last 5 years * acute or chronic diseases in the stage of decompensation * chronic infectious diseases: hiv, viral hepatitis b, c, tuberculosis * patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods * chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol * patients are unable or unwilling to give written informed consent and / or follow research procedures * any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
evaluation of neuroinflammation in children with infantile spasms

Conditions: Infantile Spasms

Summary: the purpose of this study was to investigate the presence of neuroinflammation in children with infantile spasms using 11c-pk11195 positron emission tomography (pk pet) scan, and its response to acth treatment by repeating the pk pet scan after treatment.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of 'cryptogenic is' * normal mri * no other neurological disorder exclusion criteria: * abnormal mri * no anti-inflammatory medication 48 hrs prior to pk pet scans * parent/guardian unable to give written consent

Keywords: infantile spasms neuroinflammation pk11195 pet acth
assessment of sleep disordersin people living with hiv in the era of new antiretroviral therapies in north of france

Conditions: HIV Infections; Sleep Disorder

Summary: people living with hiv (plhiv) appear to present with sleep-related complaints more frequently than the general population, with a prevalence of 50-70%. the latest french multi-center epidemiological data are dated. the prevalence of the different types of sleep disorders, however, is poorly documented, with the literature focusing mainly on insomnia and neuropsychological disorders that can lead to sleep disorder-like symptoms, and on the impact of antiretroviral drugs in particular. however, there are other sleep disorders such as sleep apnea syndrome (sahos) or restless legs syndrome. sahos has been studied in small series of patients. this multicenter, cross-sectional study will identify and update the functional complaints presented by plhiv, estimate the prevalence of people at high risk of sleep apnea syndrome, and study the associated socio-demographic factors, in relation to hiv infection and antiretrovirals. this study could open up avenues for new management approaches and earlier detection of sleep disorders.


Eligibility criteria:
inclusion criteria: * plhiv usually treated at referral centers in northern france. exclusion criteria: * minor patient; * patient with insufficient understanding of the french language, as judged by the investigator; * patient unable to give free and informed consent; * refusal to participate; * patient under legal protection, guardianship or curatorship; * pregnant and breast-feeding women.
titration pressures in sleep apnea patients using thermosmart® versus conventional humidification

Conditions: Sleep Apnea, Obstructive

Summary: patients who have obstructive sleep apnea (osa) may have different continuous positive airway pressure (cpap)when titrated with different levels of humidification. it is hypothesised that patients with thermosmart® technology (heated breathing tube technology) will have lower titrated pressures than those who are titrated using conventional humidification (non heated breathing tube).

debate is present concerning the optimal level of humidification for obstructive sleep apnea (osa) patients who need continuous positive airway pressure (cpap) therapy. recent evidence has shown that using a heated breathing tube to increase the amount of humidification that can be delivered has decreased patient side effects, increased subjective sleep quality and decreased subjective symptom scores. anecdotal evidence exists, in the form of clinical observation, when thermosmart® technology is utilized during cpap titration, patients laboratory titrated pressure may in fact prove to be lower. the possibility exists, on a titration night, patients potentially may experience an adverse response to the positive airway pressure which manifests as increased airway resistance and inflammation necessitating higher cpap pressures to overcome upper airway resistance and flow limitation. therefore, we hypothesize the delivery of higher levels of humidity might reduce the nasal airway resistance during the titration night, reducing the overall positive airway pressure requirements. the goal is to investigate this phenomenon to find if a reduction in pressure is necessary and if so to what degree. patients who are titrated on continuous positive airway pressure devices with thermosmart® technology will have lower titrated pressures than those who are titrated using conventional humidification.

Eligibility criteria:
inclusion criteria: * male and female patients over the age of 18 * apnea hypopnea index (ahi) ≥15 * patients must have at least 5 hours sleep time on each titration night * stable medications for 2 weeks prior to entry to the study and for study inclusion duration including sleep aids exclusion criteria: * receiving or requiring bi-level ventilation * use of a full face interface or chin strap * previous uppp surgery or palatal reconstruction * recent angina symptoms within 2 weeks of entry * chf with ef \< 40% * obesity hypoventilation syndrome * cheyne stokes respiration * \> 50% central apneas recorded on diagnostic polysomnogram * supplemental oxygen use * use of narcotic pain medication * hypoxemia as determined by room air pulse oxymetry of less than 89% on room air at rest awake * inability to tolerate positive pressure therapy * split night evaluations

Keywords: obstructive sleep apnea humidification continuous positive airway pressure
continuous subcutaneous insulin infusion versus multiple dose insulin injections in routine clinical practice

Conditions: Type 1 Diabetes Mellitus

Summary: observational study about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in type 1 diabetes mellitus (t1dm) adult patients in routine clinical practice.

cross-sectional analysis about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in t1dm adult patients in routine clinical practice. all clinical variables are gathered from four emr softwares (mambrino xxi, carelink pro®, emminens econecta® and freestyle libre®). data analysis is conducted using spss (chicago, il) statistics software. results are presented as mean ± sd values or percentages. a paired student's t-test or a wilcoxon signed-rank test were used for the analysis of differences. comparisons between proportions were analyzed using a chi-squared test. a p value \< 0.05 was considered statistically significant. the protocol was approved by the reference castilla-la mancha public health institute ethic committee. all participants provided written informed consent.

Eligibility criteria:
inclusion criteria: * ≥18 years of age. * diagnosed of type 1 diabetes mellitus. * be attended in ciudad real general university hospital. * current treated with csii (csii cohort) or mdi (mdi cohort) during ≥6 months. exclusion criteria: * less than 18 years old. * other types of diabetes mellitus.
functional power training on mobility and gait parameters in cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy is a lifelong neuromuscular disorder impacting movement, posture, and muscle control, ranging from mild hand weakness to severe paralysis. risk factors are grouped into specific stages: preconception (linked to the mother's health), prenatal (during pregnancy), perinatal (at birth), and the neonatal and infant stages. functional power training is employed to improve the functional abilities of children with cerebral palsy by involving them in various power-based exercises to strengthen muscles, increase power, and build endurance. this study aims to evaluate the impact of functional power training on gait and mobility in children with cerebral palsy.

cerebral palsy (cp) is a chronic neuromuscular disorder that affects movement, posture, and muscle control, with symptoms ranging from mild weakness to severe paralysis. the risk factors for cp are classified into preconception, prenatal, perinatal, and neonatal categories. functional power training (fpt) is a therapeutic approach aimed at improving muscle strength, power, and endurance in children with cp. this study seeks to evaluate the impact of fpt on gait parameters and mobility in children with cp. this randomized controlled trial will include 26 children, aged 6 to 12 years, with gross motor function classification system (gmfcs) i or ii. participants will be randomly assigned to either the experimental group (fpt plus routine physical therapy) or the control group (routine physical therapy alone). exclusion criteria include recent botulinum toxin a treatment, serial casting within the last 6 months, or selective dorsal rhizotomy. gait parameters (step length, stride length, cadence, gait speed, and step width) and mobility outcomes (6mwt and timed up and go test) will be assessed before and after the intervention. data will be analyzed using spss version 23.

Eligibility criteria:
inclusion criteria: * age 6 to 12 * gross motor function classification system (gmfcs) i and ii * either gender will be included exclusion criteria: * treatment with botulinum toxin a in lower limb * serial casting of lower limb less than 6 months before the start of the functional power training * selective dorsal rhizotomy treatment * children who did not (yet) choose walking as their preferred way of mobility

Keywords: cerebral palsy gait parameters mobility functional power training
brain representation of acquisition in humans of motor-sensory skills

Conditions: Epilepsy; Cerebral Tumor

Summary: interactions between the perceptual and motor systems are fundamental to the performance of complex motor tasks and are at the heart of the fine motor control required for the production of complex sounds such as speech production or playing a musical instrument. in such situations, the brain must learn to generate relevant motor commands to a sound-producing system with fixed physical characteristics, such as the vocal tract or a musical instrument. no study has yet been able to directly test the dynamic aspect of this sensorimotor learning in an acoustic production task with fine motor control. the adolphe de rothschild foundation hospital takes care of patients requiring awake surgery. during these procedures, a direct cortical recording, called electro-corticography, is performed in order to better delineate the tumor or epileptogenic resection area. reference recordings are made in healthy areas at a distance from the lesion site making it possible to record normal brain activity. in this case, we would propose to the patient to use a tool similar to the theremin (a musical instrument the size of a golf ball whose displacement in space modulates the frequency and the harmonics of a sound). the patient should therefore learn in order to create relevant motor patterns.


Eligibility criteria:
inclusion criteria: * benefiting from an intracranial brain recording during a programmed surgery in awake condition. exclusion criteria: * patient with complete deafness * patient with a disorder or impairment that does not allow him/her to perform the experimental task according to the investigator's judgment
incidence of oral candidiasis, prevalence of c. dubliniensis in hiv patients and in-vitro azole susceptibility

Conditions: Candidiasis; HIV Infections

Summary: c. dubliniensis has been identified as pathogen in oropharyngeal candidiasis(opc)particularly among hiv patients. azole therapy is a cornerstone in opc, but resistance within c. dubliniensis isolates to diflucan is common.this is a prospective collection of biological specimens from oropharyngeal cavity with the purpose of determining the prevalence of c. dubliniensis in hiv/aids patients at the duval county department of health comprehensive care center. it is hereto proposed an estimation of azole-resistance in these isolates.

this is a study to try to establish the prevalence of c. dubliniensis as a causative organism of opc in hiv and/or aids patients. we will aim to establish the resistance pattern for azoles but also for flucytosine and amphotericin of these isolates. this study will serve as a support to previously published articles that have suggested intrinsic azole-resistance within this particular species of candida and we will try to postulate its possible correlation with clinical failure.

Eligibility criteria:
inclusion criteria: * any patient 18 years old or older with a documented diagnosis of hiv infection with or without aids-defining illnesses at the time of assessment, who is presenting with clinical symptoms and physical findings compatible with oropharyngeal candidiasis (as defined by the idsa guidelines for the treatment and management of hiv and hiv- related complications. exclusion criteria: * any prior diagnosis or established treatment for oropharyngeal, mucocutaneous or esophageal candidiasis documented in the patient's chart or any proven diagnosis based on reviews of physically available medical records and or history provided by patients that can be subject to later confirmation pertaining to the use of parenteral antifungals within 6 months prior to enrollment (azoles, echinocandins, amphotericin b, flucytosine, etc).

Keywords: candida dubliniensis candidiasis hiv aids azole resistance.
phase i study of mik665, a mcl-1 inhibitor, in patients with refractory or relapsed lymphoma or multiple myeloma

Conditions: Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma

Summary: the purpose of this first in human study is to assess safety, tolerability, pk and preliminary clinical activity and to estimate the mtd(s)/rde(s) of mik665 (also referred as s64315) as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed lymphoma or multiple myeloma.

the design of this phase i, open label, dose finding study was chosen in order to characterize the safety and tolerability of mik665 and to determine the maximal tolerated dose(s) (mtd(s)) and/or recommended dose(s) for expansion (rde(s)). this study will utilize a bayesian hierarchical model to guide dose escalation and estimate the mtd(s) based on the dose-dlt relationship(s) for mik665 in the indications. the expansion part of the study will employ an open-label multiple arm design. the purpose of the expansion part is to further assess safety, tolerability, pk, pd and the anti-tumor activity of mik665 at the selected rde/s for multiple myeloma (mm) and myc positive diffuse large b-cell lymphoma (dlbcl) identified in the dose-escalation part.

Eligibility criteria:
inclusion criteria * age ≥ 18 years. * histologically confirmed lymphoma (who classification), or confirmed mm (imwg), that is relapsed and/or refractory. * other inclusion criteria may apply. exclusion criteria * known history of chronic liver disease * history of chronic pancreatitis. * prior treatment with mcl-1 inhibitor. * other exclusion criteria may apply.

Keywords: multiple myeloma lymphoma dlbcl
experience and feasibility of methods for early sensory training

Conditions: Nerve Injury; Peripheral Nerve Injuries

Summary: the good effects of using guided plasticity for a rehabilitative purpose in case of nerve damage have been shown, but a problem that has been presented is that some individuals find it difficult to assimilate these effects due to difficulties in carrying out abstract training or due to a lack of motivation. in early sensory training, the plasticity of the brain is used. methods for early sensory training that have been described are: 1) mental imagery of touch (mental imagery), 2) observation of touch, 3) mirror training, 4) use of images for visualization of touch. the method needs to be developed and refined to be able to offer individual training plans in order to find a motivating and meaningful form of training.


Eligibility criteria:
inclusion criteria: * \>= 50% injury of n. medianus/ n. ulnaris or 100% digital nerve injury dig i and/or dig ii * ålder: ≥ 18 år exclusion criteria: * impaired cognitive ability * documented psychiatric diagnosis * inability to master the swedish language

Keywords: periferal nerve injuries sensory relearning rehabilitation imagery mirror therapy
screening for cancer in patients with unprovoked vte

Conditions: Venous Thromboembolic Disease; Respiratory Disease; Pulmonary Disease; Deep Venous Thrombosis; Pulmonary Embolism; Screening; Undefined

Summary: open and multicenter randomized clinical trial (1:1) comparing limited screening with extended screening with the performance of positron emission tomography-computed tomography (pet-ct) scan in the search for neoplasms in patients with unprovoked venous thromboembolic disease at high risk of developing cancer at follow-up. introduction: cancer screening in patients with unprovoked venous thromboembolic disease (vte) is controversial. in the last years, a score has been developed that selects patients at high risk of developing cancer during follow-up. objective: to estimate the impact of an active cancer search strategy using 18-fluordesoxiglucose (fdg) pet-ct in unprovoked vte with high-risk to develop cancer. specific objectives: 1) number of neoplasms diagnosed in the screening process: 2) number of neoplasms diagnosed at an early stage, 3) impact on survival of the strategy; and 4) impact on the quality of life. cancer will be considered from 30 days up to 12 months after the diagnosis of vte. scope: 20 spanish hospitals. design: open-label, multicentre randomized clinical trial (1: 1) comparing the performance of pet-ct versus limited screening for cancer. population: patients older than 18 years with unprovoked vte at high risk of presenting cancer at follow-up (≥3 points in the score of jara-palomares et al., chest 2017). follow-up: 12 months after vte. sample: the sample size calculated is 650 patients, to obtain a power of 80%, with a level of significance of 5%, and taking into account a 10% loss of follow-up.


Eligibility criteria:
inclusion criteria: * over 18 years. * diagnosis of venous thromboembolic disease (proximal deep vein thrombosis of lower limbs, pulmonary embolism or both) unprovoked. * high risk classification according to previously published and validated scale * signature of informed consent form exclusion criteria: * impossibility to continue an adequate follow-up. * contrast hypersensitivity used for pet / ct (fludeoxyglucose (18fdg)) or any of the excipients according to the characteristics of the product.

Keywords: venous thromboembolic disease pulmonary embolism screening occult cancer
avastin as an adjunct to diode laser in the treatment of neovascular glaucoma

Conditions: Neovascular Glaucoma

Summary: assess the efficacy of avastin as an adjunct to diode laser cyclophotocoagulation in the treatment of neovascular glaucoma.

design: prospective, comparative interventional case series. method: patients were randomly assigned into group a which were treated with diode laser cyclophotocoagulation alone, whereas group b received intravitreal avastin (one milligram = 0.04ml of 25 mg/ml) in conjunction with the diode laser. the preoperative data included etiology, mean age; follow up period, and a full ophthalmological examination with emphasis on mean iop, iris neovascularization, pain and corneal edema.

Eligibility criteria:
inclusion criteria: * neovascular absolute glaucoma * painful blind eyes exclusion criteria: * neovascular glaucoma with useful vision or potential for useful vision

Keywords: neovascular glaucoma diode laser cyclophotocoagulation avastin