Kornimate/medical-research-clean huggingface dataset:
an open-label extension study to evaluate the safety of the forsight vision5 product

Conditions: Primary Open-Angle Glaucoma; Ocular Hypertension

Summary: this study evaluates the long-term (13-months) safety of the bimatoprost ocular insert in participants with glaucoma or ocular hypertension who completed study fsv5-002. all participants received bimatoprost ocular insert and wore it for approximately 7 months, then had the insert removed and a new insert placed for another 6 months.


Eligibility criteria:
inclusion criteria: 1. completed fsv5-002 study. 2. written informed consent prior to any study procedure. 3. willingness to comply with the visit schedule. exclusion criteria: 1. participation in an investigational drug or device study other than fsv5-002 within the past 6 months or anticipated participation during the study period. 2. subjects who will require contact lens use during the study period. 3. any condition or situation (such as uncontrolled systemic disease) that, in the investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.
omega 3 lipid emulsions and liver transplantation

Conditions: Ischemia Re-perfusion Injury

Summary: the study aims to investigate the possible beneficial impact of peri-operative or post-operative administration of omega 3 enriched lipid emulsions on recipients for living donor liver transplantation.

patients will be divided intro three groups, a control group will receive equivalent volume of glucose 10% solution both 3 days before and 5 days after the operation . a peri-operative groups, in which patients will receive omega 3 enriched lipid emulsion (smoflipid) for 2 days pre-transplantation and 5 days post-transplantation a post-operative group, in which patients will receive glucose 10% 3 days before the operation and omega 3 enriched lipid emulsion (smoflipid) for 5 days post-transplantation the primary outcome objective will be the incidence of ischemia re-perfusion injury, secondary outcomes includes post-operative complications, graft and patient's outcomes and graft regeneration

Eligibility criteria:
inclusion criteria: * all liver transplant recipients exclusion criteria: * budd chiari * previous upper abdominal surgery * re-transplantation * known allergy to the study emulsion

Keywords: omega 3 lipid emulsions liver transplantation ischemia reperfusion injury graft function
efficacy and safety of lenalidomide with or without rituximab and other drugs in b-cell non-hodgkin's lymphomas

Conditions: Non-hodgkin Lymphoma,B Cell

Summary: describe the treatment of b-cell non-hodgkin lymphoma patients who receive lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs), and evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.

this is a multi-center prospective, observational real-world study, targeting patients with b-cell non-hodgkin's lymphomas. this study is designed to evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting. this study will mainly focus on the following three cohorts: cohort 1: patients diagnosed with cd20-positive diffuse large b-cell lymphoma; cohort 2: patients diagnosed with cd20-positive follicle lymphoma; cohort 3: patients on maintenance treatment who have achieved complete remission or partial remission after induction therapy.

Eligibility criteria:
inclusion criteria: * diagnosed as b-cell non-hodgkin's lymphoma * voluntary participation in this study and the signing of an informed consent form * the researchers assessed that the patient will benefit from the treatment of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) exclusion criteria: * contradictions to any drug in the treatment regimen * pregnant or lactating women * patients who were not considered suitable for the study by the researchers

Keywords: lenalidomide non-hodgkin lymphoma,b cell
atorvastatin study for the treatment of high cholesterol in patients from thailand

Conditions: Dyslipidemias

Summary: the purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from thailand with high cholesterol.


Eligibility criteria:
inclusion criteria: * dyslipidemic patients who were eligible for lipid lowering therapy * willingness to follow study diet for 1 month prior to screening and for the duration of the study exclusion criteria: * use of other lipid lowering agents (6-week washout period) * uncontrolled high blood pressure * impaired liver function
intracerebral gene therapy for sanfilippo type a syndrome

Conditions: Mucopolysaccharidosis Type III A; Sanfilippo Disease Type A

Summary: the clinical trial p1-saf-301 is an open-label, single arm, monocentric, phase i/ii clinical study evaluating the tolerance and the safety of intracerebral administration of adeno-associated viral vector serotype 10 carrying the human sgsh and sumf1 cdnas for the treatment of sanfilippo type a syndrome the treatment plan consists on a direct injection of the investigational medicinal product saf-301 to both sides of the brain through 6 image-guided tracks, with 2 deposits per track, in a single neurosurgical session. the primary objective is to assess the tolerance and the safety associated to the proposed treatment through a one-year follow up. the secondary objective is to collect data to define exploratory tests that could become evaluation criteria for further clinical phase iii efficacy studies. four patients will be included in the clinical trial and will be followed during one year. the enrollment and the follow-up of the patients will take place at bicêtre hospital. the neurosurgery will be performed at necker-enfants malades hospital. safety will be evaluating on clinical, radiological and biological parameters.


Eligibility criteria:
inclusion criteria: * age: 18 (eighteen) months to end of 6 (six) years * onset of clinical manifestations related to mpsiiia during the first 5 years of life * sgsh activity in peripheral blood cell and / or cultured fibroblast extracts of less than 10% of controls. * patient affiliated to the french social security or assimilated regimens * family understanding the procedure and the informed consent * signed informed consent * vital laboratory parameters within normal range exclusion criteria: * presence of brain atrophy on inclusion mri judged on a cortico-dural distance of more than 1cm * no independent walking (ability to walk without help) * any condition that would contraindicate permanently anaesthesia * any other permanent medical condition not related to mpsiiia * any vaccination 1 month before investigational drug administration * intake of aspirin within one month * any medication aiming at modifying the natural course of mpsiiia given during the 6 months before vector injection * any condition that would contraindicate treatment with prograf®, modigraf®, cellcept® and solupred®

Keywords: neurodegenerative diseases nervous system diseases genetic diseases, inborn metabolic diseases gene therapy adenovirus associated vector
pushing spatiotemporal limits for 4d flow mri and dynamic mra in the brain at ultra-high field

Conditions: Stroke

Summary: this study aims at investigating the blood hemodynamics with high spatiotemporal resolution in patients with brain aneurysms and avms as well as in healthy controls. parameters such as peak blood velocity, wall shear stress and other derived parameters will be obtained from 4d flow mri data acquired at ultra-high field strength (7 tesla).

the hemodynamic factors responsible for hemorrhagic stroke, resulting in wide variations in the clinical management of underlying vascular lesions, especially when they are found in asymptomatic individuals or individuals with symptoms not related to the disease. therefore, there is an urgent need for the development of reliable biomarkers based on hemodynamic parameters, which can then enable improvements in risk assessment in patients presenting with these lesions. this need can be met by non-invasive magnetic resonance imaging (mri) techniques that provide information on high resolution vascular anatomy, visualization of cerebral hemodynamics and quantitative information about blood velocity. however, such techniques as presently employed at 1.5 or 3 tesla are limited by spatial resolution and prolonged data acquisition times. the primary goal of this proposal is to overcome these current limitations by exploiting ultra-high fields (uhf, i.e. ≥ 7 tesla (7t)) to attain significantly higher spatial resolution, faster acquisitions and increased lesion conspicuity utilizing * qualitative exploration of intracranial blood hemodynamics, * quantitative imaging of the spatiotemporally resolved blood velocity vector, * derivation of hemodynamic parameters.

Eligibility criteria:
inclusion criteria: * subjects / patients between 18 and 75 exclusion criteria: * any kind of ferromagnetic implants. * mr-unsafe non-ferromagnetic implants. * cardiac pacemakers. * a history of shrapnel or shot gun injury. * a body mass index \> 40. * severe claustrophobia. * tattoos in the head/neck area or permanent makeup.

Keywords: stroke avm aneurysm
practice of the short wave diathermy (swd) application

Conditions: Electromagnetic Fields

Summary: various national \& international bodies like fda, csp has laid down the guidelines for the reasonable use of swd electro therapeutic agent (epa) ensuring safety \& effectiveness. however, it remains uncertain, whether the practicing physiotherapists are aware of the very existence of this guidelines and implementing them in daily practice. any lack of knowledge about this background can endanger the patient safety leading to serious health hazards. in the present survey, 49 physiotherapy practitioners were interviewed with a self-report measure to investigate their knowledge base, mode of application of swd (6 items) \& the awareness about recommended guidelines (5 items) etc.

study design: cross sectional survey design with the use of a self-report form to record the participant's views was used. sampling frame consisted of physiotherapists working in private clinics in sub-urban area of mumbai, maharashtra, india. institutional ethic committee of terna physiotherapy college granted permission to conduct this survey. the self-report forms were coded in order to conceal the identity of the therapist. in this survey 49 physiotherapists were interviewed with a self-report form consisting of total 23 item. in the initial section of this survey form a general information was collected regarding years of experience (1 item), types of condition treated (1 item), no of patients treated (item 1) duration of onset (item 1) \& the type of modality used (item 1). specific items interrogating therapist's knowledge about the emf generating modality were designed to retrieve the information about dosage prescription (7 item), acquaintance with recommended guidelines \& indications (item 5), years of experience with that particular modality (item1), any kind of side effects observed (item 1), any action taken for the same (item 2), referring personnel for recommending this modality (item 1), overall therapist's experience with the effectiveness of this modality (item1).

Eligibility criteria:
inclusion criteria: * private physical therapists practitioners exclusion criteria: * who were volunteering to participate

Keywords: swd, epa, safe practice
impact of patient education on influenza vaccine uptake among community-dwelling chinese elderly

Conditions: Influenza, Human

Summary: the purpose of this study is to test the effectiveness of brief face-to-face patient education in increasing uptake of influenza vaccine among chinese elderly in the community.


Eligibility criteria:
inclusion criteria: * cantonese speaking * chinese exclusion criteria: * cognitively impaired * unable to communicate effectively * having known contraindication of vaccination * institutionalized
evaluation of visual acuity and patient satisfaction with at lisa tri 839mp intraocular lenses

Conditions: Cataract

Summary: the purpose of the study is to evaluate the far, intermediate and near visual acuities with a trifocal iol.

after bilateral cataract surgery, monocular and binocular uncorrected (ucva) and best distance corrected visual acuity (bcva) will be measured at far (4m), intermediate (80 cm) and near (40 cm) distance as well as the subjective refraction. a patient questionnaire will be used to assess the patient satisfaction and spectacle independence.

Eligibility criteria:
inclusion criteria: * man or woman, over 50 years of age * bilateral implantation of a trifocal intraocular lens * capsular bag implantation exclusion criteria: * existing ocular pathology * surgical complications * corneal astigmatism ≥ 1.0d
a comprehensive assessment and follow up descriptive study on bipolar disorder

Conditions: Bipolar Disorder; Unipolar Disorder

Summary: the purpose of this study was to investigate the reliability and validity of the bipolar index (bpx) to diagnosis bipolar disorder, and to verify the stability of it in identifying bipolar disorder; the secondary purpose was to understand the dynamic changes of bipolar disorder in natural status.


Eligibility criteria:
inclusion criteria: 1. age 18-65 years old； 2. be able to understand the content of assessment and cooperate； 3. currently patients are depressive episode, and / or manic / hypomanic episode, also can be mood stable； 4. currently according to diagnostic criteria of the u.s diagnostic and statistical manual fourth edition of mental disease (dsm-iv) of bipolar disorder (type i, ii, rapid cycling, mixed episodes)； 5. currently according to diagnostic criteria of the u.s diagnostic and statistical manual fourth edition of mental disease (dsm-iv) of depressive disorder； 6. no other mental illness or a history of physical disease，or patients with physical disease; 7. not received modified ect at least four weeks or more before entering the group. exclusion criteria: 1. can not understand the content of assessment and cooperate； 2. meet the diagnosis criteria of schizophrenia and other psychotic disorders; 3. meet the diagnosis criteria of diagnosis of mental retardation or pervasive developmental disorder; 4. clinically significant neurological disease or loss of consciousness more than one hour of traumatic brain injury；
pilot study of cnep for the treatment of snoring

Conditions: Snoring

Summary: this pilot study will examine the efficacy and safety of continuous negative external pressure ("cnep") for the treatment of chronic snoring in people without obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * sleep test within the previous six months that shows snoring of at least 30 db for at least 30% of total sleep time * ahi \< 10/hr exclusion criteria: * previous neck surgery or radiation * carotid artery disease * serious medical or psychiatric illness * pregnancy * silicone allergy * excessive use of alcohol or sedating drugs
clinical assessment and psychosocial impact of psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the initial years of the psoriasis disease (longitudinal part).

this is a prospective, non-interventional, observational, multicenter study to document the prevalence of alexithymia in adult men and women, 18 years of age and older, who have had the onset of the first symptoms of plaque psoriasis less than 10 years before study entry, are naïve or experienced to topical treatment, and are eligible for phototherapy or systemic treatment. only data available from routine clinical practice will be collected and all treatment decisions will be made at the discretion of the treating physician. additionally, where local regulations permit, participating physicians will be asked to obtain patient-reported outcome (pro) data from patients participating in this observational study. a target of 800 adult patients will participate in this study at approximately 80 sites. the enrollment period of this study is expected to continue for approximately 9 months. each patient will receive treatment as per standard clinical practice and will be followed up for 12 months. therefore, the total duration of this observational study is expected to be approximately 21 months. overall psoriasis disease severity as assessed by the physician will be documented at baseline (cross-sectional) and in the observational (longitudinal) phase of the study. several outcomes related to psychosocial comorbidities (eg, alexithymia, anxiety, depression), addiction, and work and activity impairment as measured by pro questionnaires and scales will also be collected. information on psoriasis treatment(s) (topical, phototherapy, systemic \[non-biologic, biologic\]), mental health drugs (including those used for sleep), and concomitant medications given for comorbid medical conditions will also be collected. the data for this study will be analyzed and reported separately for the cross-sectional data (baseline) and for the longitudinal data (from baseline to month 12).

Eligibility criteria:
inclusion criteria: have onset of first symptoms of plaque psoriasis less than 10 years before baseline; be either naïve or experienced to topical treatment; be eligible for phototherapy or systemic treatment, as determined by the participating physician at the patient's baseline visit. exclusion criteria: has a history of or current treatment with a systemic agent (including biologic agents); has non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular); has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point.

Keywords: plaque psoriasis alexithymia quality of life
the aromatase inhibitor and gnrh antagonist versus methotrexate for management of undisturbed ectopic pregnancy

Conditions: Ectopic Pregnancy

Summary: the aim of this study is to : 1. use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate. 2. use of the gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate.


Eligibility criteria:
inclusion criteria: * patients who have undisturbed ectopic pregnancy .who are: 1. have no significant pain 2. have an unruptured tubal ectopic pregnancy with an adnexal mass smaller than 35mm with no visible heartbeat 3. have a serum human chorionic gonadotropins level less than 1,500 iu/litre 4. do not have an intrauterine pregnancy (as confirmed on an ultrasound scan) . exclusion criteria: 1. an undisturbed ectopic pregnancy and significant pain 2. an undisturbed ectopic pregnancy with an adnexal mass of 35 mm or larger 3. an undisturbed ectopic pregnancy with a fetal heartbeat visible on an ultrasound scan 4. an undisturbed ectopic pregnancy and a serum human chorionic gonadotropins level of 5,000 iu/litre or more 5. intrauterine pregnancy
effects of romadan fasting on variability in blood pressure in healthy and hypertensive subjects

Conditions: Hypertension

Summary: included participants who have a stable ht who intend to practice rj

stable patients with or without diagnosed hypertension that intend to fast ramadan. each participant is examined during three planned visits. the first takes place during the month preceding ramadan. the second during the last week of ramadan and the third thirty days after the end of ramadan. participants that miss one appointement or more are exluded from the study. patient recrutement is conducted in primary care centers of the state of monastir, out-patients clinic (cardiology, endocrinology) at the emergency department of fattouma bourguiba university hospital after a clarified written consent.

Eligibility criteria:
inclusion criteria: * adult patient with or without diagnosed hypertension intending to fast ramadan. exclusion criteria : * age \< 30 years old * adult patient with or without diagnosed hypertension not intending to fast ramadan.

Keywords: hypertension ramadan fasting
stimulation therapy for apnea: reporting thoughts

Conditions: Obstructive Sleep Apnea

Summary: upper airway stimulation (uas) via unilateral implantation of a phasic hypoglossal nerve stimulation device is a safe and effective alternative treatment for patients with moderate to severe obstructive sleep apnea (osa) who are unwilling or unable to adhere to positive airway pressure (pap) therapy. although adherence to uas is higher than to pap, there remain patients who are not using uas consistently. the aim of this project is to explore critical factors in the use of uas by osa patients using qualitative research methods (personal interviews). the proposed study will provide crucial information about patients' concerns regarding uas use and suggestions for how to support new uas recipients.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * adhere registry patient * received uas implant from june 2017 to present exclusion criteria: * patients without up to date contact information

Keywords: obstructive sleep apnea upper airway stimulation therapy
osteopathic evaluation on patients with non-specific back pain: an inter-examiner reliability study

Conditions: Inter-examiner Reliability; Location and Nature of Restriction or Lesion; Non-specific Back Pain

Summary: the purpose of this study is to determine whether two osteopathic evaluators with less than 5 years experience will be able to determine the same location and nature of the primary lesion(s) or restriction(s)in patients with chronic non-specific back pain using a global osteopathic evaluation approach.

back pain is one of the leading causes of consultation for rehabilitation. establishing a diagnosis in the initial patient assessment is essential to choosing a specific treatment plan for that patient, regardless of the type of therapy the patient chooses to pursue. evidence based medicine is the current gold standard for most manual-therapy professions, and there has been a great deal of research performed in an attempt to give credibility to the one tool that all manual therapy professions share in common: palpation. few studies have been able to demonstrate an acceptable rate of inter-examiner reliability for palpation. this study will combine a global testing regime, consensus training for evaluators, and access to history of injury with symptomatic subjects to verify the inter-examiner reliability of an osteopathic evaluation on patients with chronic, non-specific low back pain.

Eligibility criteria:
inclusion criteria: * men and women ages 18-60 * must have a history of non-specific back pain (not due to any known pathology eg. disc herniation or disc degenerative disease) that is currently not irritated and has not been, in the past 8 weeks * must be available for 3 consecutive hour exclusion criteria: * patients with a known cause for their back pain * patients who have had a flare up of symptoms within the last 8 weeks * patients who are currently undergoing any rehabilitation or who have received manual treatment in the last 8 weeks. * patients who are taking daily medications for pain * pregnant women * major medical conditions: fractures, degenerative arthritis, inflammatory disorders, ankylosing spondylitis, multiple sclerosis, cancer, paralysis stroke or recent concussion history * any other conditions that would prevent the participant from completing the evaluation

Keywords: global osteopathic evaluation non-specific back pain inter-examiner reliability