Kornimate/medical-research-clean huggingface dataset:
a study of the safety and efficacy of a new treatment for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.


Eligibility criteria:
key inclusion criteria: * 18 years of age or older with diabetic macular edema; * decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse); * visual acuity in other eye no worse than 20/200 key exclusion criteria: * known anticipated need for ocular surgery within first 12 months of study; * history of glaucoma or current high eye pressure requiring more than 1 medication; * uncontrolled systemic disease; * known steroid-responder; * use of systemic steroids * use of warfarin/heparin
non-interventional study to capture the patient experience on gene therapy for hemophilia within the askbio009-101 study through patient and investigator interviews

Conditions: Hemophilia B

Summary: the purpose of this study is to seek to understand the patient's perspective around deciding to participate in a clinical trial for a hemophilia therapy


Eligibility criteria:
inclusion criteria for patients: * were screened and consented for the askbio009-101study at any point in time * are able to speak and understand english * are between ages of 18 and 75 * are physically able to participate in a one-hour phone interview * consented into this study independently of the askbio009-101 study exclusion criteria for patients: - n/a inclusion criteria for investigators and coordinators: * worked at a site as an investigator or study coordinator that consented a patient into the * askbio009-101 trial at any point in time, including those that no longer work at a askbio009-101 site * are able to speak and understand english * are between ages of 18 and 75 * are physically able to participate in a one-hour phone interview exclusion criteria for investigators and coordinators: - not directly involved in the consent process at the gene therapy site
real-world effectiveness of adalimumab on health outcomes in chinese patients with immune-mediated inflammatory diseases

Conditions: Ankylosing Spondylitis (AS); Psoriasis; Rheumatoid Arthritis (RA)

Summary: the objective of this study is to evaluate the effect of adalimumab on health outcomes in participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.


Eligibility criteria:
inclusion criteria: * participants with a diagnosis of rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis * decision to initiate humira® treatment in accordance with routine medical practice and in compliance with eligibility for adalimumab based on the local label * prior to any study-specific procedures, participant has voluntarily signed the authorization (or informed consent where applicable) to disclose and use anonymized personal health information after participate in this research. exclusion criteria: * inadequate response to previous standard treatment with anti-tumor necrosis factor (tnf) biological agent according to the physician's clinical judgment. * participant has been treated with adalimumab within 70 days (five half-lives) prior to the baseline visit. * participants discontinued due to adverse drug reaction of previous adalimumab treatment. * participants who fulfill any of the contraindications as per adalimumab label in china. * participants, who in the clinician's view, may not be able to comply with the study requirements.

Keywords: rheumatoid arthritis plaque psoriasis ankylosing spondylitis immune-mediated inflammatory diseases chinese patients
evaluation of the performance of an e-health system

Conditions: Chronic Diseases

Summary: prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up.

the ehealth system developed in the present study is dedicated to multimorbid patients' follow-up. the medical device consists in telemonitoring, telenotification and telecoaching. it aims to both increase patient autonomy, with regard to management of his/her pathologies, and facilitate coordination between health professionals. by providing patients with tools enabling early detection of clinical worsening combined with an appropriate management, the medium and long-term objectives are to reduce hospitalizations and improve health status and quality of life of these patients at home. in the first instance, the only objective of the present study is to evaluate the performance and feasibility of implementation of the device. this evaluation is based on a comparison between the telenotifications generated by the software and those calculated from the raw data captured by the software.

Eligibility criteria:
inclusion criteria: patients presenting all the following characteristics are eligible for inclusion: 1. adult (\>18 yrs), male or female 2. presenting at least two chronic diseases among the following three: chronic heart failure (chf), chronic obstructive pulmonary disease (copd), diabetes 3. having been hospitalized in the change or in any other medical care center (hospital or private clinic) for acute decompensation of chf or exacerbation of copd at least once during the 12 months prior to inclusion 4. able to speak and understand french to a satisfactory standard 5. having a phone land line 6. capable of understanding and accepting the study constraints 7. having signed a written informed consent after a full explanation of the study by the investigator prior to inclusion exclusion criteria: patients presenting any one of the following characteristics are not eligible for inclusion: 1. pregnant or breast-feeding woman 2. institutionalized 3. having a life expectancy of less than 3 months 4. receiving or having received chemotherapy or radiotherapy for cancer within the past 6 months 5. undergoing dialysis for chronic renal insufficiency 6. presenting a condition likely to hamper accomplishment of the study procedures, such as chronic alcoholism, drug or solvent addiction, uncontrolled psychiatric disease or severe cognitive deficiency 7. not covered by french social security 8. participating or having participated in another interventional trial within the past 30 days

Keywords: chronic heart failure chronic obstructive pulmonary disease diabetes
onabotulinumtoxina in the management of psychogenic dystonia

Conditions: Torticollis, Dystonia

Summary: the purpose of this research study is to evaluate if patients with psychogenic dystonia treated with onabotulinumtoxina (botox) injections will demonstrate lower severity and disability at one month and at three months than those having received placebo injections

specific aim 1: to investigate the effect of bont on psyd severity and disability. we will measure the changes in severity, duration, and incapacitation scores of the rating scale for psychogenic movement disorders (rspmd)10 in adult patients with clinically definite psyd one month after intramuscular injections with onabotulinumtoxina in selected muscles of the affected limb(s). h1: psyd patients treated with onabotulinumtoxina injections will demonstrate lower severity and disability at one month than those having received placebo injections. specific aim 2: to investigate the effect of cbt on psyd severity and disability with and without bont pretreatment. we will examine the extent to which any changes in severity and disability of psyd, as measured by the rspmd, after 12 weekly cbt sessions, can be influenced by pre-cbt injections with onabotulinumtoxina.

Eligibility criteria:
inclusion criteria: * subjects must meet standard criteria for clinically definite psyd;17 * psyd severity and disability score ≥ 10 as measured by the rspmd (appendix 1);10 * dystonic posturing must have been present without remission for a period longer than 1 year. * between the ages of 18 and 75, inclusive exclusion criteria: * prior treatment with any bont * presence of clinically unstable medical condition other than the condition under evaluation * concurrent participation in another investigational drug or device study within 30 days prior to study enrollment. * we will also exclude subjects with medical disorders deemed at increased risk when exposed to bont, including myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or other neuromuscular disorders.
sglt2 for heart failure in chd patients

Conditions: Heart Failure

Summary: heart failure (hf) in adult patients with congenital heart disease is a major cause of morbidity and mortality. approximately 30% of patients with significant congenital heart disease will develop signs of heart failure. heart failure leads to hospitalization and disability with a longer hospital stay and higher health care costs as compared to heart failure patients without congenital heart disease. one-third of deaths in patients with congenital heart disease are attributable to heart failure. in patients with heart failure and reduced ejection fraction (ef), 2021 esc recommendations suggest the use of sodium-glucose co-transporter 2 inhibitors (sglt2i) (dapaglifozin and empaglifozin), a new therapeutic class for heart failure (hf), in a class ia recommendation. in addition to reduced ef, these molecules have shown efficacy in preserved ef, leading to their reimbursement in both preserved and reduced ejection fraction in france. unfortunately, given the relatively low number of hf-congenital heart disease, patients, they were not included in previous studies. however, the seriousness of their condition and the absence of therapeutic explain the prescription of sglt2i in those patients and the likelihood of increased use in the future. this especially underlines the need for safety data in this real-world population. to date, no data on the safety or efficacy of sglt2i in hf-congenital heart disease have been published. the results of this study would provide reassurance about the safety of sglt2i in adult congenital patients and potentially expand the indication of sglt2i in hf related to congenital heart disease the objective of this study is to assess on real-life data, through a multicenter registry: * the efficacy of sglt2i in patients with heart failure related to congenital heart disease - the indications of sglt2i use (type of congenital heart disease) * the safety of sglt2i (collection of adverse events)


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * congenital heart disease (repaired, unrepaired, or palliated) with clinical heart failure nyha class ii, iii, or iv at the time of sglt2i initiation b59 * patient in whom sglt2i therapy has been started within the previous 12 months or is started at the time of the visit. * registered to the french social security system exclusion criteria: * opposition of the patient to the use of his/her data
dexpanthenol mouthwash to treat oral mucositis

Conditions: Oral Mucositis (Ulcerative) Due to Radiation

Summary: oral mucositis can be a significant problem for cancer patients. it is typically associated with pain and increased risk of infection and can lead to impaired nutritional status and inadequate hydration.it can be seen in the patient population receiving high-dose head and neck radiation therapy (85%-100%). topical dexpanthenol acts like a moisturizer, improving stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness and elasticity. the stimulation of epithelization, granulation and mitigation of itching were the most prominent effects of formulations containing dexpanthenol. the investigators suppose that dexpanthenol mouth wash may improve oral mucositis.

patients will be given a bottle of 5% dexpanthenol mouthwash and they are asked to rinse 10 ml of it three times a day. at the onset of mucositis and then for 4 subsequent weeks they will be examined to evaluate the condition of their oral mucosa.by the advent of mucositis stage 4 ,at any time during the 4 weeks of study,the patient would be out.if any patient shows allergic reaction to dexpanthenol,he/she would be out of study too.

Eligibility criteria:
inclusion criteria: 1. without any systemic disease 2. estimated survival of at least 6 months 3. without any mental disorders 4. grade 1 to 3 who mucositis exclusion criteria: 1. development of grade 4 who mucositis 2. brachytherapy 3. allergy to the drug 4. dissatisfaction of the patient

Keywords: dexpanthenol radiotherapy chemotherapy mucositis
a study to evaluate safety and tolerability of miv-711 in osteoarthritis patients

Conditions: Osteoarthritis, Knee

Summary: this is a multicentre, open-label, one-arm phase ii extension study to evaluate the safety and tolerability of miv-711 in patients with knee joint osteoarthritis (oa).


Eligibility criteria:
inclusion criteria: - previously enrolled in the miv-711-201 study including completion of visit 8 either by * receiving miv-711 200 mg and had non-significant clinical worsening on the primary endpoint as defined by a numeric rating scale (nrs) increase of ≤2 or by * receiving placebo and had a clinically significant worsening on the primary endpoint as defined by a nrs increase of ≥2 exclusion criteria: * the presence of any inflammatory arthritis * any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator. * any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the investigator, would impair ability to give informed consent or take part in or complete this clinical study. * known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
study of vx-121 in healthy subjects and in subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate safety and tolerability of vx-121 in healthy subjects and in subjects with cystic fibrosis (cf).


Eligibility criteria:
key inclusion criteria: * part a, b, and c: healthy volunteers * female subjects must be of non-childbearing potential * between the ages of 18 and 55 years, inclusive * body mass index (bmi) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight \>50 kg * part d: subjects with cf * heterozygous for f508del and an mf mutation (f/mf) * fev1 value ≥40% and ≤90% of predicted mean for age, sex, and height * body weight ≥35 kg key exclusion criteria: * part a, b and c: healthy volunteers * any condition possibly affecting drug absorption * history of febrile illness or other acute illness within 5 days before the first study drug dose * part d: subjects with cf * history of clinically significant cirrhosis with or without portal hypertension * history of solid organ or hematological transplantation * lung infection with organisms associated with a more rapid decline in pulmonary status other protocol defined inclusion/exclusion criteria may apply
tnf alpha in refractory asthma

Conditions: Asthma

Summary: the purpose of this study was to investigate whether the administration of etanercept to patients with severe asthma improved their asthma related quality of life and a measure of the degree of reactivity of the airways

although steroid dependent asthma represents a small population of patients with asthma, they consume a disproportionately large amount of the health resource burden attributed to asthma. treatment options in this group are extremely limited; the development of effective treatments for this group of patients should be a priority, not only for increasing individual patient quality of life but for long term reduction of health spending. this randomised, double blind, placebo controlled, cross over trial will investigate the efficacy of a soluble tnf receptor, etanercept, in severe, steroid dependant asthma.

Eligibility criteria:
inclusion criteria: * symptomatic asthma methacholine pc20\<8mg/ml exclusion criteria: * history of poor treatment concordance history of tuberculosis radiographic evidence of previous tuberculosis recent tuberculosis contact respiratory tract infection within 3 months current smoker or ex-smoker with more than 5 pack years symptomatic co-morbid condition contra-indication to etanercept pregancy breast feeding

Keywords: asthma refractory
role of anxio-depressive history on return to work and sport after rotator cuff surgery

Conditions: Anxiety Depression Disorder

Summary: anxiety-depressive disorders are also very frequent, in the form of different pathologies that are often intertwined (prevalence of generalized anxiety disorders in 5% of the population, characterized depressive episodes in 5%, etc.). and it is even more frequent in patients with a cuff tendinopathy (26% and 23% of depression and anxiety respectively). these 2 pathologies are therefore responsible for significant economic expenses. it is in this context that the investigators' wish to carry out this study seems justified in order to better understand and therefore manage this problem, which is frequently encountered in daily practice and which would therefore allow better understanding and therefore better information for the patients concerned.


Eligibility criteria:
inclusion criteria: * major subject (≥ 18 years) * operated between january 2008 and september 2009 arthroscopically for a symptomatic supraspinatus tendon rupture, retracted in zone 1, resistant to medical treatment with a mobile shoulder, fatty degeneration of stage 2 or less with also a preserved subacromial space * subject not objecting to the reuse of their data for scientific research purposes. exclusion criteria: - subject having expressed his opposition to the reuse of his data for scientific research purposes.

Keywords: anxiety depression disorder rotator cuff repair
educational needs of patients with systemic vasculitis

Conditions: Behcet's Disease; Churg-Strauss Syndrome; Vasculitis, Central Nervous System; Giant Cell Arteritis; Wegener Granulomatosis; Henoch-Schoenlein Purpura; Microscopic Polyangiitis; Polyarteritis Nodosa; Takayasu's Arteritis

Summary: a cross-sectional study design and online questionnaire was used to assess the informational needs of patients with several different types of systemic vasculitis. patients were recruited from within the vasculitis clinical research consortium (vcrc) online patient contact registry1. survey responses from participants in the vcrc patient contact registry were compared to responses from a similar survey recently administered to patients within a united kingdom (uk) based vasculitis support group (vasculitis uk).

all patients enrolled in the vasculitis clinical research consortium's contact registry were invited via email to participate in this study. the contract registry includes people who self-identify as having one of the following types of vasculitis: behçets disease, churg-strauss syndrome, cns vasculitis, giant cell arteritis, granulomatosis with polyangiitis (wegener's granulomatosis), henoch-schöenlein purpura, microscopic polyangiitis, polyarteritis nodosa, or takayasu's arteritis. people voluntarily enroll in this registry with the understanding that they will receive information about clinical studies for which they might be eligible. the introductory email included basic information about the study and all of the required elements for informed consent in a brief format. once participants agreed to participate in the study, they were directed to the online questionnaire. when completing the questionnaire, the patients were asked a series of questions. the questionnaire content was included as an appendix. the online questionnaire version was thoroughly tested for usability. it was expected that most participants wouldrequire approximately 10-15 minutes to complete the questionnaire. the survey data is stored by the rare diseases clinical research network data management and coordinating center (dmcc) at the university of south florida. the data is de-identified. names or other personal health information were not collected.

Eligibility criteria:
inclusion criteria: * enrolled in the vcrc contact registry * patient reported diagnosis of behçets disease, churg-strauss syndrome, cns vasculitis, giant cell arteritis, granulomatosis with polyangiitis (wegener's granulomatosis), henoch-schöenlein purpura, microscopic polyangiitis, polyarteritis nodosa, takayasu's arteritis. * 18 years of age or older * english speaking exclusion criteria: * inability to provide informed consent and complete survey
implementation of illness management and recovery in mental health services

Conditions: Bipolar Disorder; Schizophrenia; Affective Disorders, Psychotic; Mood Disorders; Mental Disorders

Summary: the purpose of this study is to examine the barriers and facilitators of implementing illness management and recovery (imr) in norwegian mental health services.

imr is an evidence-based practice developed for people with severe mental illnesses. it is based on the principles of recovery to help people set individual meaningful goals for their lives and gain illness self-management skills and thereby contribute to their individual recovery-process. imr can be given individually or in groups, once a week for 10-12 months. in this project the investigators will implement illness management and recovery (imr) in mental health services. the implementation strategy are carried out according to the imr toolkits which include informational and training materials, implementation recommendations, and fidelity scales to facilitate use of the model in routine practices. the implementation process and outcome will be of main focus. the study has an observational prospective cohort design. 30 therapists from 9 different mental health services will be trained and supervised in imr. the investigators aim to enrol 40 patients. the primary outcome is therapists' fidelity to the model and organisational implementation outcome. secondary outcomes are patients' level of functioning and hope.

Eligibility criteria:
inclusion criteria therapists: * voluntary recruited therapists in the participating mental health services * trained and consulted in imr inclusion criteria patients: * adults (18+) * associated with one of the participating mental health services * symptoms on or diagnosis of severe mental illness with or without drug abuse * giving informed consent verbally and in writing exclusion criteria patients: * patients with acute risk of suicidal behaviour * not able to communicate in norwegian

Keywords: implementation process implementation strategy implementation research evidence based practice recovery illness management and recovery