Kornimate/medical-research-clean huggingface dataset:
a study to assess the pk and pharmacodynamics of ipx203 in subjects with advanced parkinson's disease

Conditions: Advanced Parkinson's Disease

Summary: primary objective: to compare the pharmacokinetics (pk) of single and multiple doses of ipx203 with immediate release carbidopa-levodopa (ir cd-ld) in subjects with advanced parkinson's disease (pd). secondary objectives: to compare the pharmacodynamics of single and multiple doses of ipx203 with ir cd-ld. to compare the efficacy of ipx203 with ir cd-ld following multiple doses. to evaluate the safety of ipx203.

ipx203 is an investigational product containing cd-ld. ipx203-b16-01 study design: a randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study. approximately 30 qualified ir cd-ld-experienced advanced pd subjects will be randomized. the study duration will be approximately 8 weeks, including the screening period.

Eligibility criteria:
eligibility will be determined at screening and visit 1 of the study. inclusion criteria: * diagnosed with idiopathic pd at age ≥ 40 years who are being chronically treated with stable regimens of cd-ld but experiencing motor complications. * hoehn and yahr stages 2, 3, or 4 * montreal cognitive assessment (moca) score ≥ 24 at screening visit in "on" state. * for the 4 weeks prior to the screening, the subject experiences daily "wearing-off" episodes with periods of bradykinesia and rigidity and experiences an "off" state upon awakening on most mornings by history. * responsive to cd-ld therapy and currently being treated on a stable regimen with cd-ld for at least 4 weeks prior to visit 1 * typically experiences an "on" response with the first dose of ir cd-ld of the day (by subject history). * by history, efficacy of the first morning dose of ir cd-ld lasts less than 4 hours exclusion criteria: * history of medical conditions or of a prior surgical procedure that would interfere with ld absorption, such as gastrectomy or proximal small-bowel resection. * liver enzyme values ≥ 2.5 x the upper limit of normal; or history of severe hepatic impairment. * history of drug or alcohol abuse within the 12 months prior to screening. * received within 4 weeks of visit 1 or planning to take during participation in the clinical study: any doses of a controlled-release (cr) ld apart from a single daily bedtime dose or any doses of rytary, additional cd (eg, lodosyn) or benserazide (eg, serazide), or catechol-o-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (stalevo). received within 4 weeks of visit 1 or planning to take during participation in the clinical study: nonselective monoamine oxidase (mao) inhibitors, apomorphine, or dopaminergic blocking agents including antiemetics. * history of psychosis within the past 10 years. * treatment with any dopamine antagonist antipsychotics for the purposes of psychosis or bipolar disorder within the last 2 years. * based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the pd diary.

Keywords: ipx203 (carbidopa-levodopa) extended-release capsules
68ga-thp-psma pet/ct imaging in high risk primary prostate cancer or biochemical recurrence of prostate cancer

Conditions: Prostate Cancer

Summary: this will be an open-labelled, single centre study in the uk. the study group will include 60 patients with three groups of patients being studied. group a will consist of 20 patients who have been newly diagnosed with primary high risk prostate cancer and are scheduled for radical prostatectomy surgery. group b will consist of 20 patients with a diagnosis of bcr with previous radical prostatectomy, and are being considered for radical salvage therapy. group c will consist of 20 patients with a diagnosis of bcr with previous radical radiotherapy (but no surgery), and are being considered for radical salvage therapy.


Eligibility criteria:
inclusion criteria: group a: adenocarcinoma of the prostate gland suitable for radical tx. * adenocarcinoma of prostate * gleason score 4+3 and above, or psa \> 20 ng/ml or clinical stage \>t2c. * suitable for surgical tx * no hormone therapy in last 3 months group b: pca and a diagnosis of bcr, previously treated with radical prostatectomy, being considered for radical salvage therapy (with curative intent). * original diagnosis of pca, treated with radical curative therapy at least 3 months before enrolment, and has been diagnosed with bcr based on: 1. post rp: two consecutive rises in psa and final psa \>0.lng/ml or post rp: three consecutive rises in psa. this definition is also applicable to subjects with psa persistence post rp (where the psa fails to fall to undetectable levels). 2. post rp: psa doubling time of \~15 months or psa level 0.5 ng/ml. * no previous recurrences of pca. * consideration for radical salvage therapy. * should not have received androgen-deprivation therapy within 3 months of screening. * no hormone therapy in last 3 months group c: pca and a diagnosis of bcr, previously treated with radical radiotherapy, being considered for radical salvage therapy (with curative intent). * the subject has had an original diagnosis of pca and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with bcr on the basis of: * increase in psa level \~2.0 ng/ml above the nadir level after radiotherapy (rt) or brachytherapy, no previous recurrences of bcr. * the subject is being considered for radical salvage therapy. * should not have received androgen-deprivation therapy within 3 months of screening. * no hormone therapy within the past three months. exclusion criteria: group a: * prior tx for prostate tumours * gleason \< 4+3 * hip prostheses * egfr \<20 group b: * hormone therapy in the last 3 months * hip prostheses * egfr \<20 group c: * hormone therapy in the last 3 months * hip prostheses * egfr \<20
measuring adherence to topical 5-fluorouracil in a clinic population

Conditions: Actinic Keratosis

Summary: the purpose of this research study is to measure adherence to the study drug (carac) for the treatment of actinic keratoses.

the purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. the study drug is 5-fluorouracil (carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. this proposed study will evaluate adherence to topical carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. adherence data will be collected by the mems cap (medication event monitoring system

Eligibility criteria:
inclusion criteria: * any male or female 50 years of age or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation. exclusion criteria: * age less than 50. * known allergy or sensitivity to topical carac® in the subject. * inability to complete all study-related visits. * introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study. * subjects should not receive surgical or cryotherapy while participating in the study. * pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control
simulated clinical use testing on the dropsafe safety pen needle

Conditions: Needle Stick

Summary: a simulated clinical use testing on the dropsafe safety pen needle

this study aims to evaluate the safety of the use of dropsafe safety pen needle in the prevention of needle stick injuries (nsi) and to evaluate the user's satisfaction with regards to the handling characteristics of the product.

Eligibility criteria:
inclusion criteria: 1. minimum of age 18. 2. able to understand and provide signed consent for the study. 3. willing to comply with the study protocol, including being willing to answer questions and complete questionnaires. 4. have no concerns about the ability to perform the simulated injections. 5. have no financial interest in the sponsor (htl-strefa s.a.) or the mro (namsa). exclusion criteria: 1. if in the opinion of the sponsor or mro, including the observer/monitor, the potential evaluator is not a good candidate for the study, including for reasons such as mental health.

Keywords: needlestick needlestick injury pen needle sharps injury prevention
examining psychosocial mediators of exercise behavior

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: the purpose of this study is to examine psychosocial mediators of exercise behavior.

background: physical inactivity is related to many health problems, including increased risk of cardiovascular disease, hypertension, and cancer. despite the health consequences of a sedentary lifestyle, only 25 percent of americans meet the recommended levels of physical activity. researchers postulate that theory-based interventions effectively influence physical activity behavior by changing theoretical constructs believed to be important for behavior change (i.e., potential mediators), such as self-efficacy (i.e., confidence in one's ability to be physically active). unfortunately, previous studies have generally failed to adequately test the mediating effect of theoretical constructs using appropriate statistical mediator analyses as recommended by leading behavioral scientists and statisticians. design narrative: the study will examine the mediating effect of theoretical constructs based on the transtheoretical model (ttm) and social cognitive theory (sct). the study will address the methodological, measurement, and statistical limitations of previous studies. the investigators will randomly assign 420 healthy sedentary individuals to either a theory-based physical activity intervention or a contact control group. physical activity behavior and the potential mediators will be assessed monthly over 12 months. they hypothesize that constructs based on the ttm and sct (i.e., behavioral processes, cognitive processes, self-efficacy, and decisional balance) will mediate the relationship between group assignment (intervention vs. contact control) and physical activity behavior, such that the effect of the intervention on physical activity behavior relative to the contact control group will be attenuated when controlling for the mediators. they will also examine the importance of particular mediators for different population groups (e.g., age, gender), which will help to create more effective interventions for these groups. finally, they will conduct a cost analysis to not only inform policy makers of the cost of delivering the intervention within our study but also to estimate the cost of delivering each component of the intervention (i.e., mediator). the analysis will estimate the cost of future refined interventions that incorporate those active components that affect the mediators and physical activity in this study. in summary, the study will identify which mediators (i.e., theoretical constructs) are most effective for increasing physical activity, which will have an important public health impact given that this will likely lead to more efficacious and less costly interventions.

Eligibility criteria:
inclusion criteria: * in good health * living a sedentary lifestyle
creation of a database of healthy subjects with 18fdg pet brain imaging as part of the mobile project (multimodal whole-brain imaging in epilepsy)

Conditions: Healthy; Tomography; Brain Development

Summary: the mobile project is part of the dynamic european collaboration of the human brain project (hbp). the overall aim of the project is to characterize brain structure and function in healthy subjects and patients with epilepsy, using a quantitative multimodal approach involving both neuroimaging (mri, pet) and electrophysiology (eeg/meg). the project is funded by the european hbp consortium, and the data acquired will ultimately be made available to the scientific community formed by this international collaboration. several aspects of the project have already been initiated on the basis of extensions to previous authorizations, or as part of care activities. as part of this overall project, the present mobile-pet application concerns exclusively the performance of 18f-fdg pet (positron emission tomography) imaging in the 30 healthy adult subjects in the protocol (aged 18 to 65, with inclusion parity for gender). this cerebral examination, performed at rest on a 45-minute 3d volume acquisition, enables quantitative measurement of the metabolic consumption of glucose underlying global synaptic activity, and to determine the associated connectivity. around 1,500 examinations of this type are carried out each year in our department as part of care for patients with brain pathology, and over 10,000 for patients with cancer. this examination requires intravenous injection of a weakly radioactive tracer corresponding to a radiopharmaceutical which has been approved for marketing for over 20 years. we also carried out and finalized a similar project in 2007 on 60 healthy subjects, using a previous-generation pet camera (nct00484523). the nuclear medicine department holds clinical research authorizations for imaging in patients and healthy subjects (including early phase and first-in-man, although the present project does not fall into this research categarogy).


Eligibility criteria:
inclusion criteria: * - female or male, over 18 and under 65 years of age. * subject free of any general illness, psychiatric disorders or infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology of the central nervous system, as determined on examination, * subject not receiving chronic treatment, particularly psychotropic, * subject with no history of alcoholism or drug addiction, * subject with no contraindications to pet scintigraphic exploration (pregnancy and breast-feeding), * subject with social security coverage, * subject having read, understood and signed an informed consent form. exclusion criteria: * - minors, * pregnant or breast-feeding women, * women of childbearing age without contraception, * subjects presenting a contraindication to pet scintigraphic exploration, * adult subject to a legal protection measure, as provided for in l.1121-6 to l.1121-8 of the french public health code.
evaluation of a lamp assay for t. pallidum. pertenue

Conditions: Yaws

Summary: this is a diagnostic evaluation comparing the performance of real-time pcr performed at a national reference laboratory and a lamp assay performed at a regional hospital for the diagnosis of yaws


Eligibility criteria:
inclusion criteria: * lesion consistent with yaws * positive treponemal and non-treponemal antibodies assessed by the dpp syphilis screen and confirm rdt exclusion criteria: * unable to give consent
open-label extension study of the phase 3 vrx-ret-e22-302 double-blind trial. 115097

Conditions: Epilepsy

Summary: this phase 3 trial is an open-label extension study of the placebo-controlled, double-blind vrx-ret-e22-302 trial. patients who have completed the vrx-ret-e22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (aeds) or vagal nerve stimulation. treatment will be continued until the subject withdraws from the study or until the program is discontinued. patients will be recruited from 55-60 sites in europe, israel, australia, and south africa. the primary objective of the study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the double-blind study vrx-ret-e22-302. secondary objectives are: to evaluate efficacy of long-term treatment with retigabine and patient quality of life and to evaluate whether retinal pigmentation, unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of nails, lips, skin or mucosa change over time after discontinuation of retigabine.

this phase 3 trial is an open-label extension study of the placebo-controlled, double-blind vrx-ret-e22-302 trial. patients who have completed the vrx-ret-e22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (aeds) or vagal nerve stimulation. treatment will be continued until retigabine is commercially available, or until the program is discontinued. patients will be recruited from 55-60 sites in europe, israel, australia, and south africa. the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. in addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.

Eligibility criteria:
inclusion criteria: * patient has successfully completed the maintenance and transition phases of study vrx-ret-e22-302 for the treatment of partial-onset seizures * patient is expected to benefit from participation in the study in the opinion of the investigator. exclusion criteria: * patient meets any of the withdrawal criteria in the previous vrx-ret-e22-302 study or is experiencing an ongoing serious adverse event. * patient is receiving any investigational drug or using any experimental device in addition to retigabine for treatment of epilepsy or any other medical condition. * patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.

Keywords: partial seizures epilepsy rtg115097 complex partial seizures anticonvulsant potassium channels epilepsies, partial
blood pressure and central vascular stiffness in obese children. relationship to metabolic disturbances and subclinical cardiovascular damage. effect of weight reduction

Conditions: Central Blood Pressure; Obesity; Subclinical Organ Damage; Children; Adolescent

Summary: the global epidemic of obesity in childhood continues to evolve and threaten future health and life expectancy primarily due to the increased incidence of cardiovascular disease. obesity is strongly related to high blood pressure (hypertension) and both conditions pose a risk for target organ damage, which can follow a subject from childhood into adult life. the aorta study will investigate central hemodynamics and organ damage in 100 obese children and adolescents in order to gain insight to the complex interplay of hypertension, obesity and subclinical damage in order to intensify more precise prevention, thereby reducing the future development of cardiovascular disease.


Eligibility criteria:
inclusion criteria: * age 10-18 * bmi for age and sex above 95 percentile * referred for treatment at the the children's obesity clinic, department of paediatrics, holbaek hospital, university of copenhagen * oral and written consent by their parents exclusion criteria: * children who can not cooperate to dexa scanning or other procedures * linguistic difficulties that impair communication

Keywords: childhood child adolescent central blood pressure ambulatory blood pressure monitoring abpm clinic blood pressure pulse wave velocity pwv pulse cave analysis pwa heart rate variability hrv echocardiography urine microalbuminuria blood samples
the effect of telerehabilitation in patients with chronic neck pain

Conditions: Chronic Neck Pain

Summary: telerehabilitation offers more efficient follow-up of patients during their home exercise period as a cost-effective and effective treatment model. this study was planned to examine the effectiveness of telerehabilitation in patients with chronic neck pain. the aim of the study is to compare the video-based and telerehabilitation based home-exercise program in patients with chronic neck pain. it is aimed to evaluate the patients in terms of pain, functionality, quality of life, and exercise adherence.

with telerehabilitation, patients can easily adapt to home exercise programs and be monitored remotely. in this way, it will be ensured that individuals can apply their exercises at an optimum level in non-clinical settings and to prevent exercise application errors that occur due to the learning effect frequently observed in conventional methods. exercise is considered a central element in physical therapy and rehabilitation management in patients with chronic neck pain. however, studies have found that improvements after physical therapy and rehabilitation are not preserved in the long term, and recurrence of chronic low back pain is common. with a more cost-effective treatment model, "telerehabilitation", it is aimed that patients can be followed more efficiently during their home exercise period. the aim of the study is to compare the video-based and telerehabilitation based home-exercise program in patients with chronic neck pain. it is aimed to evaluate the patients in terms of pain, functionality, quality of life, and exercise adherence.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18 - 65 * patients who have suffered from neck pain for at least 3 months * signing the consent form exclusion criteria: * situations that prevent the evaluation or communication with the individual * illiterate individuals * individuals who have undergone an operation due to neck pain problem, diagnosed with a tumor, infection, ankylosing spondylitis, rheumatoid arthritis or inflammatory diseases, fracture, cauda equina syndrome * conditions in which specific pathological condition is proven such as malignant condition, fracture, systemic rheumatoid disease * orthopedic and neurological problems that prevent evaluation and/or treatment * complaints of pain and numbness spreading to the upper extremities * individuals with a diagnosed psychiatric disease * individuals who have received physiotherapy in the last 6 months * individuals using another treatment method during the study * individuals with musculoskeletal pain in any other part of the body during work * pregnant participants

Keywords: telerehabilitation