Kornimate/medical-research-clean huggingface dataset:
safety study of mk-3641 and mk-7243 co-administered in adult participants with ragweed and grass pollen induced allergic rhinitis (p08607, mk-3641-006)

Conditions: Rhinitis, Allergic, Seasonal

Summary: the purpose of this study is to assess the safety and tolerability of mk-3641 (short ragweed \[ambrosia artemisiifolia\] extract, sch 039641, ragwitek®) sublingual tablets and mk-7243 (timothy grass \[phleum pratense\] extract, sch 697243, grastek®) sublingual tablets co-administered in participants 18 through 65 years of age with both ragweed- and grass polled-induced allergic rhinitis, with or without conjunctivitis and with or without asthma. the primary endpoint is the percentage of participants who experience at least one event of local swelling after co-administration of mk-3641 and mk-7243 sublingual tablets.

events of local swelling include pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema or throat tightness.

Eligibility criteria:
inclusion criteria: * clinical history of physician-diagnosed ragweed- and grass pollen-induced rhinitis with or without conjunctivitis of \>1 year duration, with or without asthma * female participants of childbearing potential must have a negative urine pregnancy test at screening and randomization visits and must agree to remain abstinent or use (or have their partner use) any one of the acceptable methods of birth control within the projected duration of the study. acceptable methods of birth control are: intrauterine device (iud), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraception. exclusion criteria: * unstable, uncontrolled or severe asthma treated with long-acting beta agonists (labas) at the time of screening * received immunosuppressive treatment within 3 months prior to randomization (except steroids for allergic reactions other than asthma) * history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause, or inhalant allergen * diagnosis of eosinophilic esophagitis * history of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy * female and breastfeeding, pregnant or intending to become pregnant * received another form of allergen immunotherapy with the past month * previously exposed to mk-3641 (ragwitek®) or other sublingual ragweed immunotherapy * previously exposed to mk-7243 (grastek®) or other sublingual grass immunotherapy * known history of allergy, hypersensitivity, or intolerance to the excipient ingredients of the study drug (except for ambrosia artemisiifolia and/or phleum pratense), or self-injectable epinephrine * unable to or will not comply with the use of self-injectable epinephrine * used an investigational drug within 30 days prior to screening visit, or plans to participate in another interventional clinical trial during the duration of this trial * family member of the investigational or sponsor staff involved in this trial * participating in this same trial at another investigational site.
pediatric endotracheal intubation

Conditions: Cardiac Arrest; Intubation, Endotracheal

Summary: we hypothesized that the mcgrath mac ems is beneficial for intubation of pediatric manikins while performing cpr. in the current study, we compared effectiveness of the mcgrath mac ems and mil laryngoscopes in child resuscitation with and without cc.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * paramedic student exclusion criteria: * not meet the above criteria * wrist or low back diseases
safety, tolerability and antiviral activity of selgantolimod in virally-suppressed participants with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly gs-9688) in virally suppressed chronic hepatitis b (chb) adults on oral antiviral (oav) agents.


Eligibility criteria:
key inclusion criteria: * must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * adult males and non-pregnant, non-lactating females * documented evidence of chronic hbv infection with detectable hepatitis b surface antigen (hbsag) levels * on commercially available hbv oav treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening * hbv deoxyribonucleic acid (dna) ≤ 20 iu/ml for 6 or more months prior to screening * screening electrocardiogram (ecg) without clinically significant abnormalities key exclusion criteria: * extensive bridging fibrosis or cirrhosis * adults meeting any of the protocol defined exclusionary laboratory parameters at screening: * alanine aminotransferase (alt) \> 3x upper limit of normal (uln) * international normalized ratio (inr) \> uln unless the adult is stable on an anticoagulant regimen * albumin \< 3.5 g/dl * direct bilirubin \> 1.5x uln * platelet count \< 100,000/ul * estimated creatinine clearance \< 60 ml/min (using the cockcroft-gault method) * co-infection with human immunodeficiency virus, hepatitis c virus or hepatitis d virus * prior history of hepatocellular carcinoma (hcc) or screening alpha-fetoprotein ≥ 50 ng/ml without imaging * diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed. * chronic liver disease of a non-hbv etiology, except for non-alcoholic fatty liver disease * received solid organ or bone marrow transplant * received prolonged therapy with immunomodulators or biologics within 3 months of screening * use of another investigational agent within 90 days of screening, unless allowed by the sponsor note: other protocol defined inclusion/exclusion criteria may apply.
single-sided deafness and asymmetric hearing loss

Conditions: Hearing Loss, Unilateral; Hearing Loss, Sensorineural

Summary: the purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.

the study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. sixty-five subjects will be enrolled in this study. six centers across the united states and canada will recruit subjects into this study. study subjects will be followed for a minimum of 3 years post-implantation of the device.

Eligibility criteria:
inclusion criteria: * five years of age or older at the time of implantation * unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 hz) of 90 db or greater in the ear to be implanted * sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 db at two or more frequencies out of 500, 1000, 2000, and 4000 hz and a diagnosed pathology of the outer or middle ear * normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 hz) of 55 db or less * word recognition in the ear to be implanted of 5% or less on cnc word score in quiet * previous experience with an appropriately-fit contralateral routing of signal (cros) hearing aid, bi-contralateral routing of signal (cros) hearing aid, bone conduction, or traditional hearing aid, as deemed appropriate by investigator * fluent in english exclusion criteria: * duration of profound hearing loss of 10 years or more * absence of cochlear development or non-functionality of cochlear nerve * other retrocochlear hearing loss * evidence of severe cochlear malformation (i.e., common cavity or ossification) * external or middle ear infection * suspected developmental or cognitive concern * other medical contraindication for surgery or anesthesia
difficulties and obstacles to the integration in community of children with type 1 diabetes before primary school.

Conditions: Type 1 Diabetes Mellitus

Summary: the incidence of type 1 diabetes is increasing worldwide and in france, including among young children. type 1 diabetes has consequences for integration in community, especially on the management of hypoglycemia and hyperglycemia, mealtimes, participation in sporting activities and school trips. this works' purpose is to describe obstacles and difficulties to the integration in community before primary school (day care center, childminder, and nursery school) of a complete sample of children with type 1 diabetes followed in the diabetology department of lyon pediatric hospital, at the start of the school year 2018-2019. the investigating team will carry out a descriptive study, using different questionnaires addressed to the professionals (nursery school directors, day care nursery directors, childminders, school doctors, pediatricians and doctors of child and maternal protection centers) and to the parents of children with type 1 diabetes. these different questionnaires will help to take into account different points of view, in order to identify all the obstacles to integration of children with type 1 diabetes in community. through this work, secondary information actions through training and/or information leaflets will be carried out in order to facilitate the reception of these children in the community.


Eligibility criteria:
inclusion criteria: children: * type 1 diabetes * followed in the diabetology department of lyon pediatric hospital * who are too young to go to primary school in 2018-2019 * residing in the rhône-alpes region of france * no parental opposition to the completion of the questionnaire (reflection period of 15 days after receipt the leaflet information) for school directors, school doctors, pediatricians, child and maternal protection center doctors * questionnaire responses will be considered as evidence of no opposition. directors of nurseries and childminders who will agree to answer the telephone questionnaire after parents allow the study team to contact them exclusion criteria: children: * child requiring another facilities for school (food allergies, celiac disease...) * language barrier not permitting a response to the questionnaires for childminders and nursery directors * refusal of parents to contact them * refusal to participate declared during the telephone interview for school directors, doctors and school doctors * no prior involvement in the reception in community of a type 1 diabetes child
a pharmacokinetic (pk) and pharmacodynamic (pd) study of golimumab in patients with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: this is a phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.

a phase 1, randomized (study drug route of administration assigned by chance), open label (both physician and patient know that golimumab has been assigned), study of golimumab in patients with rheumatoid arthritis (ra). the purpose of this study is to compare the pharmacokinetic (how the body effects the drug) and pharmacodynamic (how the drug effects the body) effects of golimumab administered through a vein in the arm or by injection under the skin. safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. the study will also assess the clinical effects of golimumab on ra. the study is planned for approximately 45 patients, which are randomized at a 2:1 ratio to receive golimumab sc or iv. male or female patients who have been diagnosed with ra for at least 3 months and who are 18 years of age or older may be able to participate. subcutaneous (sc) injections of 100 mg golimumab every 4 weeks through week 20 or intravenous (iv) administrations of 2 mg/kg golimumab on days 1 and 85.

Eligibility criteria:
inclusion criteria: * have a diagnosis of ra for at least 3 months prior to screening * have no history of latent or active tuberculosis (tb) and test negative for tb exclusion criteria: * have inflammatory diseases other than ra * have been treated with disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives other than methotrexate (mtx), sulfasalazine, or hydroxychloroquine during the 4 weeks prior to the first administration of study agent * have received intramuscular (im), iv, or intra-articular corticosteroids within 4 weeks of study agent administration * have a known hypersensitivity to human ig proteins * have received infliximab, golimumab, adalimumab or abatacept within 3 months, or etanercept or anakinra within 1 month prior to the first administration of study agent * have received alefacept, efalizumab, natalizumab, rituximab, or any b-cell-depleting agent * have been treated with any other biologics or investigational drugs, within 5 half-lives of that drug prior to the first administration of study agent * have a history of latent or active granulomatous infection, including tuberculosis (tb), histoplasmosis, or coccidioidomycosis, prior to screening * have had a bacille calmette-guerin (bcg) vaccination within 12 months of screening * have had a serious infection (eg, hepatitis, pneumonia, pyelonephritis, or sepsis)

Keywords: golimumab simponi rheumatoid arthritis pk pd
double-blind placebo controlled study of safety,tolerability, and efficacy of liris® in women with interstitial cystitis

Conditions: Interstitial Cystitis

Summary: the purpose of this study is to determine if liris®, an investigational drug-delivery system, is safe, tolerable and effective in women with interstitial cystitis. liris® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.

the study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (liris® - contains lidocaine), liris placebo (liris with inactive substance) or sham(insertion procedure only with neither liris nor liris placebo), followed by an open extension part in which all patients are assigned to receive liris® (with lidocaine). in part 1 of the study, treatment is managed in a double-blind manner for liris® and liris placebo arms; and in a single-blind manner for the sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to sham). all patients who complete part 1 of the study have the option to enter the extension.

Eligibility criteria:
inclusion criteria: * women age 18 and over * diagnosed with interstitial cystitis as defined by protocol * able and willing to complete questionnaires and diary * able to comply with visit schedule including day 14 removal visit * completion of blinded study prior to enrolling in unblinded part of study exclusion criteria: * pregnant or lactating women * bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product * history or presence of any condition that would make it difficult to evaluate symptoms * did not complete blinded study (unblinded part of study only)
retaining short-term training effects on gait adaptability in people with stroke

Conditions: Stroke

Summary: background: the majority of stroke survivors regain walking ability. however, the ability to adapt gait patterns to meet environmental demands remains impaired in a majority of people in the chronic phase after stroke. this impaired gait adaptability has a profound impact on activities of daily living and quality of life. treatment targeting gait adaptability is therefore critical for safe and independent community ambulation in people with stroke. augmented or virtual reality in rehabilitation programs can be used to train gait adaptability in a controlled situation. a few studies have evaluated gait adaptability training in people with stroke. although results were promising, these studies did not include an adaptability-related outcome measure, or were limited to uncontrolled or small-scaled pilot studies. moreover, it is unknown if beneficial training effects can be fostered for 1 year after completion of a training program. we evaluate the short-term effects of a 5-week gait adaptability training in an adequately powered, waiting-list controlled clinical trial \[ref naar clin trial nummer\]. in the current study, we focus on the retention of potentially beneficial effects of this 5 week gait adaptability training program. we will evaluate if short-term effects of gait adaptability training can be retained through single training sessions to boost performance, or by an home exercise program. we hypothesize that booster sessions and home-based exercise will both yield better retention of training effects at 1 year follow-up as compared to the control arm without an experimental intervention. objective: the primary objective of this study is to test the hypothesis that retention of training-induced gains in gait adaptability can be fostered by providing booster sessions or by prescribing home-based training. study design: explorative randomized study, comparing the effect of 3 1-hr booster training sessions against home-based exercise against no intervention on gait adaptability performance 1 year after completion of a 5-week gait adaptability training program. study population: stroke patients in the chronic phase after stroke, who completed the 5-week gait adaptability training using the c-mill and agreed to continue in this follow-up study. we expect this to be 50-75 participants.


Eligibility criteria:
inclusion criteria: * \> 6 months after first unilateral supratentorial stroke (chronic phase) * able to walk at least 10 minutes independently * initial involvement of the lower extremity after stroke. * having completed (minimal 8/10 training sessions) the 5 week gait adaptability training program using the c-mill exclusion criteria: * any other neurological or musculoskeletal disease affecting gait or balance (e.g. parkinson's disease, knee osteoarthritis) * contractures or spasticity requiring other treatment (e.g. botulinum toxin treatment) within the duration of the training period. * severe cognitive or visuo-spatial impairments limiting comprehension of instructions or correct perception of the environments
socioeconomic deprivation and peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: atherosclerosis is a systemic disease that affects coronary, cerebral, and lower-extremity arteries. peripheral artery disease (pad) is the manifestation of atherosclerosis in the legs. three different stages can be found: asymptomatic stage (stage 1), exercise ischemia stage (stage 2) and rest ischemia stage (stage 3). the risk factors for pad are similar to those for coronary artery disease (cad) and cerebrovascular disease (cbvd), like high blood pressure, diabetes, smoking, dyslipidemia and obesity. but cigarette smoking is the single most important risk factor for the development and progression of pad. pad is a serious illness and an important predictor of cardiovascular disease with major medico-economic consequences. a low socioeconomic status (ses) is associated with higher cardiovascular mortality and morbidity. in these vulnerable populations, there is an increase in the prevalence of cardiovascular risk factors, particularly for smoking. the main objective of this study was to assess the level of precariousness in patients with symptomatic pad and compare it to the level of precariousness in the general population. patients were recruited from vascular medicine and surgery department of grenoble university hospital or therapeutic education outpatient consultation. the analysis of socio-economic and environmental data resulted in: - epices score: (evaluation of the deprivation and inequalities of health in healthcare centers score). the epices score is a quick and validated questionnaire to assess precariousness at the individual level, developed by considering all the material and psychosocial dimensions of precariousness. precariousness, according to the epices score, in the general population is estimated at 40%. - insee parameters. the investigators completed the epices score with more traditional indicators derived from the national institute of statistics and economic studies (insee) collects, analyses and disseminates information on the french economy and society. the investigators collected the level of education and professional practice based on the nomenclature of socio-professional categories defined by insee. cardiovascular risk factors were also collected to measure the links between the level of precariousness and cardiovascular risk factors.


Eligibility criteria:
inclusion criteria: * male or female, * age 18 years or older, * symptomatic pad (stage 2 or 3) exclusion criteria: * pregnant woman * person under administrative or judicial supervision
oxcarbazepine versus placebo in childhood autism

Conditions: Autism

Summary: the proposed study is designed to assess the effectiveness of treatment with oxcarbazepine vs. placebo in childhood/adolescent autism. this is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism.

the proposed study is designed to assess the effectiveness of treatment with oxcarbazepine vs. placebo in childhood/adolescent autism. this is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism. subjects will receive a psychiatric and medical evaluation by the study psychiatrist to see if she/he has any psychiatric or medical illnesses that would interfere with their ability to participate in this study. these evaluations may take up to an hour to complete. in addition, subjects will be asked to participate in a psychiatric interview designed to determine the child's diagnosis and current problem areas. the subject's parent will also be asked to fill out psychiatric questionnaires. the interview and questionnaires may take up to 4 hours to complete.

Eligibility criteria:
inclusion criteria: * subject has autism. * subject is between five and seventeen years of age * subject is not hospitalized. exclusion criteria: * subject has been diagnosed with a psychopathic disorder or a mood disorder, including depression or bipolar disorder. * subject has displayed self-injurious behavior. * subject has an active seizure disorder or epilepsy. * subject has an unstable medical illness. * subject has undergone brain injury. * subject has a history of diabetes. * subject has a history of prior treatment with oxcarbazepine of 600 mg/day for 6 weeks. * subject has used other study drugs within the previous 30 days. * subject is a pregnant female or unwilling to use acceptable contraception if sexually active.

Keywords: irritability functional ability aggression mood instability
effect of a nasal bolus allergen challenge on inflammatory markers

Conditions: Seasonal Allergic Rhinitis

Summary: the current study will investigate nasal inflammatory markers obtained by filter paper collection techniques, in subjects with allergic rhinitis, determining the most appropriate time points and handling conditions, prior to running a larger study with subjects with allergic rhinitis.


Eligibility criteria:
inclusion criteria: * male or female subjects with allergic rhinitis, that have a positive skin prick response to phleum pratense. exclusion criteria: * subjects with a history of asthma. current smokers, or recent ex-smokers and subjects that have had a respiratory tract infection in the previous 4 weeks.