Kornimate/medical-research-clean huggingface dataset:
patient reported outcomes with wavelight lasik

Conditions: Myopia

Summary: this study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral lasik surgery. subjects will be assessed 12+ months post-operatively. clinical evaluations will include administration of the osdi, modified prowl, and dry eye questionnaires.


Eligibility criteria:
inclusion criteria: * wavefront optimized or phorcidies planned contoura lasik for myopia or myopic astigmatism 12 to 15 months ago * age: 21 to 35 years of age at the time of surgery. * preoperative myopic sphere of -1.00 d to -8.00 d * preoperative regular astigmatism of 0.00 d to -3.00 d. * stable refraction preoperatively defined as \< 0.5 d of change over at least 1 year. * refractive target of bilateral emmetropia. exclusion criteria: * corneal ectatic disorders. * patients with a calculated residual stromal depth of \< 300 um. * pre-existing retinal or corneal pathology, or irregular astigmatism. * pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc. * previous corneal surgeries prior to lasik. * lasik enhancements.
systemic sclerosis clinical and biomarker study

Conditions: Healthy; Systemic Sclerosis

Summary: the primary objective of the study is to assess the change in systemic sclerosis (ssc)-associated gastrointestinal (gi) tract symptoms over a 1-year period in participants with ssc.

no study treatment will be administered. study participants will continue to be treated by their respective physicians according to standard clinical practice. data on concomitant therapy and procedures, administered as part of standard of care, will be collected at baseline and at each study visit.

Eligibility criteria:
key inclusion criteria: healthy volunteers * must be in good health as determined by the investigator, based on medical history, physical examination, and vital signs. participants with diffuse cutaneous systemic sclerosis (dcssc): * must fulfill the 2013 classification criteria for ssc of the american college of rheumatology (acr) and european league against rheumatism (eular). * absence of the anti-centromere autoantibody. participants with limited cutaneous systemic sclerosis (lcssc): * must fulfill the 2013 classification criteria for ssc of the acr and eular. * subjects with lcssc must have disease duration of less than 5 years. key exclusion criteria: * history of any clinically significant medical condition that can interfere with the conduct of the study, or that in the opinion of the investigator, would compromise data interpretation. * an active severe infection as determined by the investigator. * female subjects who are pregnant or currently breastfeeding. * a known history of malignancy. note: other protocol defined inclusion/exclusion criteria may apply
postoperative analgesia with local infiltration after hip fracture of intertrochanteric type

Conditions: Hip Fracture of Intertrochanteric Type

Summary: reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric fractures. systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. the investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.


Eligibility criteria:
inclusion criteria: * intertrochanteric hip fracture * fracture due to low energy trauma * ability to understand danish and give informed consent * ability to walk before trauma * indication for osteosynthesis •≥ 8 in omc (orientation-memory-concentration) test with a possible maximum of 28 points * informed consent exclusion criteria: * drug or medical abuse * drug intolerance * pathological fractures * inflammatory arthritis * patient included in the study with the contralateral hip

Keywords: hip fracture intertrochanteric
a study to evaluate the safety and efficacy of medi6012 in acute st elevation myocardial infarction

Conditions: ST Elevation Myocardial Infarction

Summary: this is a phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, pk/pharmacodynamic, and immunogenicity of repeat doses of medi6012 in adult participants presenting with acute stemi (st segment elevation myocardial infarction). the study will enrol participants presenting with acute stemi who are planned for primary percutaneous coronary intervention (ppci). for all participants, an end of study cmr will be performed at 10-12 weeks (70-84 days following dose 1). a subset of participants will also undergo an index and an end of study cta.


Eligibility criteria:
inclusion criteria: * acute stemi (st segment elevation myocardial infarction) diagnosed by st elevation * planned for primary pci (percutaneous coronary intervention) * men and women without child-bearing potential aged 30-80 years of age * capable and willing to provide informed consent. * capable of completing study visits exclusion criteria: * fibrinolytic administration for index event * known prior mi or prior coronary artery bypass graft (cabg) surgery * known pre-existing cardiomyopathy * history of anaphylaxis * suspected non-thrombotic etiology (ie, vasospasm, dissection, takotsubo cardiomyopathy)
lipad - lrrk2 international parkinson's disease study

Conditions: Parkinson's Disease and Parkinsonism

Summary: the study aims to identify and systematically characterize parkinson's patients with mutations in the lrrk2 gene. in about 90% of parkinson's patients the cause of the disease is unclear. based on current knowledge, it can be assumed that there are several causes and that the causes may be differ between patients; this makes research into the pathogenesis and possible therapies very difficult. in the case of monogenic parkinson's diseases, which are due to changes in one gene (e.g. lrrk2), the function of the gene and possible disease mechanisms can be investigated. lrrk2-associated parkinson's syndrome is clinically indistinguishable from idiopathic parkinson's disease. it is inherited autosomal dominant, that means if one of the two gene copies is altered, the disease occurs. however, the disease does not occur in every mutation carrier, the penetrance is reduced and the mechanisms for that are still unclear. ideally, knowledge of what influences penetrance could make it possible to exert targeted influence and prevent the disease. the comprehensive investigation of mechanisms of reduced penetrance but also of the effects of the mutation itself requires systematic investigations of as many affected persons as possible. we therefore aim to identify 4,000 people internationally, of them 1,500 with lrrk2-associated parkinson's syndrome, 500 with lrrk2-mutations but without parkinson's symptoms, 500 without mutations and without parkinson's symptoms, 500 parkinson patients with mutations in other genes than lrrk2 and 1,000 patients with idiopathic parkinson's disease from the same populations. the participants will undergo a comprehensive survey on parkinson's symptoms, concomitant diseases, environmental factors and medication and there is the possibility of more detailed genetic examinations. participants will be asked to donate samples of blood, urine and household dust.


Eligibility criteria:
inclusion criteria: * informed consent is obtained from the participant. * the participant is clinically diagnosed with parkinson's disease or the individual is a family member of a participant with lrrk2 parkinsonism or is a member of a high risk population with an early pd onset. * the participant is equal to or older than 18 years old. exclusion criteria: * inability to provide informed consent. * the participant is not suffering from parkinson's disease or the individual is not a family member of a participant with lrrk2 parkinsonism or is not a member of a high risk population. * the participant is younger than 18 years old. * previously enrolled in the study. * participant in custody.

Keywords: genetic parkinson's disease lrrk2
development of a visio-behavioral scale to evaluate visual abilities of patients with profound multiple intellectual disabilities (plh-vision)

Conditions: Profound Multiple Intellectual Disabilities

Summary: the main objective of this study is to develop and validate a visio-behavioral scale of visual abilities for subjects with profound multiple intellectual disabilities. the secondary objectives of the study are: * to validate the structure of the scale. * to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners. * to evaluate the feasibility of visio-behavioral scale. * to evaluate the sensitivity to change. * to study the uniformity of use of the scale depending on the type of patients (age, disability level, pathology). * to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.

this study includes 3 phases: * elaboration of a list of behavioral items by a group of multi-disciplinary expertise (physicians, nurses, caregivers, ophthalmologies, orthoptists) based on their clinical experiences. * development of the scale based on the sample obtained by a prospective multicenter research trial. * validation of the sample obtained by a prospective transversal multicenter study. this study will be performed in 5 centers in france. the enrollment of patients planned for 24 months targeting 310 patients. the duration of follow-up of the study for each patient will be varied according to the group of patients, il will be 1 day for group 1, 2 weeks for group 2, or 6 months for group 3.

Eligibility criteria:
inclusion criteria: * causal brain injury occurred before the age of 3 years. * severe or deep mental retardation as defined by dsm iv. * motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders. * score of gross motor function classification system \[palisano 1997\] is iii, iv or v. * score of functional independence measure \< 55. * subject aged ≥3 years (because the visio-behavioral scale is not adapted for children younger than 3 years). * beneficiary of a social protection. * written consent signed by guardian or legal representative, or parents in case of a minor subject. exclusion criteria: * acute intercurrent pathology precluding examinations. * patient with hypersensitivity to tropicamide, atropine or benzalkonium chloride. * angle closure glaucoma suspect patient. * patient with severe hypertension. * short life expectancy.

Keywords: profound multiple intellectual disabilities visual-behavioral scale
to investigate the role of gut microbiome in adt related metabolic changes in prostate cancer patients

Conditions: Prostate Cancer

Summary: prostate cancer is the second most common cancer in male cancer globally and ranked third in hong kong. while androgen deprivation therapy (adt) is the backbone treatment for advanced prostate cancer, it could lead to obesity, metabolic syndrome and increased cardiovascular mortality. previous studies showed that adt patients have different gut microbiome compared to non-adt patients and the gut microbiome might be related to the metabolic changes. however, the underlying mechanism of these metabolic complications is still not fully understood. this study aims to investigate the relationship and related mechanism between the changes in gut microbiomes and adt-related metabolic change in prostate cancer patients.

it is a prospective longitudinal observational human study. fifty prostate cancer patients planned for adt will be recruited. fecal sample will be collected before initiation of adt, and then at 3 and 6 months after initiation of adt. anthropometric, blood metabolic parameters, serum inflammation markers and panels of microbiome metabolites will be measured at these timepoints. changes in gut microbiome from baseline to 6 months after initiation of adt will be assessed. correlation of changes in gut microbiome and metabolic changes, as well as inflammation and microbiome metabolites, will be assessed and possible mechanisms will be explored.

Eligibility criteria:
inclusion criteria: 1. male subject with age 45 or above 2. histological diagnosis of prostate cancer (acinar type) 3. clinically decided for androgen deprivation therapy (adt) as treatment for prostate cancer exclusion criteria: 1. history of diabetes 2. patients that have other active treatment for prostate cancer or other cancers (except adt) 3. patients received treatment, either surgical or medical, that could lead to decrease in serum testosterone prior to commencement of adt 4. patients will be started on other treatments, including chemotherapy, new generation of androgen-receptor targeted agents, radiotherapy etc, within 6 months of the commencement of adt. 5. subject with recent antibiotics usage within 3 months.
trial of a treatment algorithm for the management of crohn's disease

Conditions: Crohn's Disease

Summary: assess if the implementation of a treatment algorithm will improve the management of crohn's disease (cd) in comparison to usual care based gastroenterology practices.

crohn's disease (cd) is a chronic inflammatory disorder of the gastrointestinal tract. during disease exacerbations, pharmacological or surgical intervention is usually needed to re-establish remission. ideally, strategies should be employed to maintain patients in long-term remission while minimizing exposure to corticosteroids and reduce therapy-related toxicity. nevertheless, in reality many patients with cd do not receive effective therapy and their disease often remains active, leading to uncontrolled inflammation and complications from either the underlying disease or corticosteroids. although treatment guidelines exist, they do not adequately define treatment goals and the duration of treatment cycles is not specified optimizing outcomes in cd requires rapid control of inflammation. intuitively, persistent inflammation leads to persistent symptoms, tissue damage, and disease-related complications. conventional therapy is frequently ineffective in moderate to severe cd, and is often continued for a prolonged time. consequently, many patients are under-treated. an alternate strategy that minimizes the use of corticosteroids and encourages the earlier use of immunosuppressive agents and tumour necrosis factor (tnf) antagonists may be optimal. however it is unknown whether this approach is superior to usual care

Eligibility criteria:
inclusion criteria: * documented diagnosis of crohn's disease * able to speak and understand english, french or flemish * access to a telephone or email/internet service * written informed consent must be obtained and documented exclusion criteria: * any conditions (e.g., history of alcohol or substance abuse) which in the opinion of the investigator , may interfere with the patients ability to comply with study procedures * participating in other investigational studies

Keywords: crohn's disease community based gastroenterology practices canada and belgium cluster randomization controlled trial remission corticosteroids documented diagnosis of crohn's disease
effects of psychiatric admissions on self-harm and suicide in people with borderline personality disorder

Conditions: Borderline Personality Disorder; Self-harm; Non-suicidal Self-injury; Suicide

Summary: the current study aims to evaluate the impact of long (\>5 days) and/or compulsory psychiatric inpatient care on subsequent healthcare utilization for self-harm and suicide in people with borderline personality disorder, a condition characterized by frequent self-harm. the basis for this study is the diversity of clinical practices across swedish regions. by categorizing clinics based on their practices with respect to long and/or compulsory psychiatric inpatient care, it is possible to explore the impact of these practices on subsequent somatic and psychiatric healthcare, including emergency care due to self-harm as well as on completed suicides. all psychiatric clinics across sweden authorized to administer compulsory care for adults, totalling 78 clinics will be included. each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., umeå2010, linköping2013, malmö2022). data collection will involve the utilization of the national registers to capture outcome measures and account for confounding factors. the participants will be ranked based on a composite variable, which includes the average number of days spent in inpatient compulsory care and other psychiatric inpatient care exceeding 5 days, among individuals diagnosed with bpd. the top quartile of participants will be compared with the bottom quartile.


Eligibility criteria:
inclusion criteria: * psychiatric clinic in sweden authorized to administer compulsory care for adults. each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., umeå2010, linköping2013, malmö2022). exclusion criteria: * no authorization to administer compulsory care for adults
treatment of lateral epicondylitis with a percussive therapy device

Conditions: Tennis Elbow

Summary: the purpose of this study is to assess the efficacy of using a percussive therapy device in addition to physical therapy to treat acute tennis elbow

the device the investigators intend to use is class i and in a class of devices that is exempt from the fda requirement for premarket notification/approval (exempt from 510k or pma), which would not be "subject to section 510(k), 515, or 520(m) of the federal food, drug, and cosmetic act" (ref: fdaaa checklist)

Eligibility criteria:
inclusion criteria: * individuals 18 years old or older are included * patients with atraumatic lateral epicondylitis symptoms * symptoms persistent and present for at least 2 weeks * presence of 2 of the following on clinical examination: +tenderness to palpation common extensor tendons and/or lateral epicondyle origin, pain over the lateral elbow with passive flexion of the wrist in an extended position, +pain with resisted supination, +pain with resisted middle finger extension. exclusion criteria: * any records flagged "break the glass" or "research opt out." * patients with elbow osteoarthritis, * patients with a history of traumatic injury to the elbow * patients with workers compensation * patients who received cortisol injection in the elbow * mri evidence of common extensor tear * a history of surgery on the affected elbow, * cognitive or behavioral problems which would preclude informed consent. * patients with coagulopathies * patients who are pregnant * patients who had a cortisone injection within 3 months
women in steady exercise research - window of opportunity for exercise and tumor biology

Conditions: Breast Cancer

Summary: the primary aim is to examine changes in tumor perfusion, oxygen saturation, and tumor physiology before and following acute physical activity in breast cancer patients. the secondary aim is to examine changes in circulating tumor dna (ctdna) levels before and following acute physical activity in breast cancer patients. the tertiary aim is to explore changes in circulating exerkines (cytokines and growth factors altered by exercise) before and following acute physical activity in breast cancer patients.

the proposed study seeks to leverage acute exercise physiology as a tool to better understand multiple clinical and mechanistic issues in exercise oncology. an acute exercise bout causes functional changes such as increases in heart rate and stroke volume leading to increased cardiac output and increased systemic blood flow. these systemic effects also increase tumor blood flow (perfusion). additionally, an increase in mean arterial pressure increases oxygen diffusion distance within the tumor. further, acute exercise mobilizes nk cells, cytokine signaling, and a myriad of other molecular and cellular transducers of exercise. our study of acute exercise physiology in breast cancer patients will address several significant knowledge gaps both clinically and mechanistically.

Eligibility criteria:
inclusion criteria: * newly diagnosed breast cancer patients * breast tumor is more than 2 cm (t2) * with or without lymph node involvement (n0-3) * with or without metastases (m0-m1) * no initiation of neoadjuvant treatment * pre-surgical breast resection exclusion criteria: * current use of anticoagulants, including vitamin k antagonists (e.g. warfarin), direct oral anticoagulants (doacs) (e.g. pradaxa, eliquis, xarelto, bevyxxa, savaysa), low molecular weight heparins (lmwh), fragmin, lovenox, heparin. * body weight \<100 lbs * tis, t0, t1 * started neoadjuvant therapy * absolute contraindications for exercise stress testing by self-report: * acute myocardial infarction (3-5 days) * unstable angina * uncontrolled arrhythmias causing symptoms or hemodynamic compromise * syncope * acute endocarditis * acute myocarditis or pericarditis * uncontrolled heart failure * acute pulmonary embolus or pulmonary infarction * thrombosis of lower extremities * suspected dissecting aneurysm * uncontrolled asthma * pulmonary edema * room air desaturation at rest ≤85% * respiratory failure * acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise * mental impairment leading to inability to cooperate * decisional impairment * non-english speaking * pregnant women * children

Keywords: acute exercise ctdna exerkines tumor perfusion oxygen saturation