Kornimate/medical-research-clean huggingface dataset:
comparative analysis of the visual performance after ticl implantation in patients with stable keratoconus

Conditions: Keratoconus

Summary: to report on 4-year postoperative safety, efficacy, stability and predictability outcomes(to evaluate the visual, refractive, contrast sensitivity, defocus curve and aberrometric data preoperation, and compare with a similar postoperative outcomes) with the toric implantable contact lens (ticl) for stable keratoconus. investigators will study the four-year follow-up from this standardized, multi-center clinical investigation, support from clinical and optical viewpoints ticl implantation, in stable keratoconus.


Eligibility criteria:
inclusion criteria: * age (25-38). * stable refraction was distinctive by 6 subjective refractions within ± 0.50 diopters(d) of spherical equivalent during 6 months after cxl. * best spectacle-corrected visual acuity (bcva) of +0.4 logmar (20/40) or better, -clear central cornea. * normal anterior chamber depth at least 3 mm to endothelium . * intraocular pressure (iop)\<20 mm hg and preoperative endothelial cell count related to age and the anterior chamber depth with regard to food and drug administration recommendations. * width of angle greater than 30°, a pupil diameter of less than 6.25 mm. exclusion criteria: * patients with central corneal thickness of less than 450 μm. * endothelial cell count of less than 2,000 cells/mm2 . * anterior chamber depth of \<3 mm from endothelium to anterior capsule . * corneal opacification or scars, cataract, retinal detachment, glaucoma, retinopathy, macular degeneration, neuro ophthalmic diseases or ocular inflammation, history of keratitis (any form), peripheral marginal degeneration, previous corneal and/or intraocular surgeries, and autoimmune and/or connective tissue disease. the central corneal thickness limit of 450 μm would account for around 400 μm of remaining stromal thickness after removal of the epithelium, which is considered as the safety thickness for the residual stroma to avoid endothelial cell damage during the cxl procedure.

Keywords: keratoconus crosslinking toric icl
comparing efficacy and safety of combigan with timolol adjunctive to xalatan in glaucoma or ocular hypertension subjects

Conditions: Glaucoma; Ocular Hypertension

Summary: efficacy and safety evaluation of combigan with timolol when each is used as adjunctive therapy to xalatan in subjects with glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * give written informed consent * be in good general health as determined by your doctor * have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension * if you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills) * understand the study instructions, and be able to follow the study instructions; and * be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits exclusion criteria: * have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation * history of severe renal or hepatic impairment * subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist * contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure * any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and * concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the screening visit
role of self-monitoring of blood glucose and intensive education in patients with type 2 diabetes not receiving insulin

Conditions: Type 2 Diabetes

Summary: the aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with smbg, aimed at lifestyle modification and timely changes in therapy, when needed.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic; * patients on treatment with oha monotherapy (i.e. metformin alone or sulphonylureas alone or tzds alone); * no need for insulin treatment; * male and female patients, aged between 45-75 years; * hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value) * no experience of self monitoring of blood glucose in the previous 12 months (smbg performed with a frequency of \< 1 times/week) * ability and willingness to comply with all study requirements * signature of consent form exclusion criteria: * patients incapable to perform smbg * patients needing insulin or multiple oha association therapy * patients needing a regular use of smbg (e.g. frequent hypoglycemic episodes) * diabetes care not exclusively managed by diabetic clinics * patients with serious underlying medical or psychiatric condition

Keywords: diabetes self monitoring blood glucose
quality of life, lifestyle, and psychosocial factors in patients with melanoma

Conditions: Cutaneous Melanoma

Summary: this study investigates the extent to which lifestyle factors including mental health, social support, diet, and exercise are associated with quality of life and melanoma patient outcomes. knowledge gained from this study may be used to guide the design of prospective clinical trials of lifestyle interventions to improve the outcomes of melanoma patients and assist doctors in counseling their patients.

primary objectives: i. collect systematic data on mental health, quality of life (qol), social support, diet, and exercise behaviors in melanoma patients. ii. examine whether psychosocial factors and lifestyle are associated with clinical outcomes in melanoma patients. iii. examine the association between lifestyle and psychosocial factors and tissue and blood biomarkers in melanoma patients. iv. examine whether psychosocial factors and lifestyle are associated with qol adjustment in melanoma patients. outline: patients complete a maximum of 3 paper or electronic questionnaires over 30 minutes within 2 weeks of presentation to md anderson, new diagnosis of melanoma, and/or initiating a new treatment, within 2 weeks of first restaging, and within 2 weeks of the end of treatment. patients may complete an additional paper or electronic dietary questionnaire over 10 minutes for 3 days (30 minutes total) or a phone-based dietary recall. patients who start a new treatment of interest may repeat the questionnaires at the same time points. patients' medical records are also reviewed.

Eligibility criteria:
inclusion criteria: * diagnosis of melanoma, precursor lesions, and associated cutaneous pathology * able to read and understand english * willing to complete an online or paper survey
efficacy of two approaches in cervical single-door laminoplasty for spinal canal enlargement

Conditions: Cervical Spondylotic Myelopathy

Summary: the goal of this clinical trial is to learn if cervical single-door laminoplasty via the intermuscular space approach can better prevent axial symptom while reaching equal neurological outcome than the conventional approach in adults patients with cervical spondylotic myelopathy. the main questions it aims to answer are: * can cervical single-door laminoplasty via the intermuscular space approach better prevent axial symptom than the conventional approach? * can cervical single-door laminoplasty via the intermuscular space approach reach the neurological outcome not second to the conventional approach? if there is a comparison group: researchers will compare the intermuscular space approach and the conventional approach of cervical single-door laminoplasty to see if the intermuscular space approach better prevent axial symptom. participants will: * received cervical single-door laminoplasty via the intermuscular space approach or the conventional approach once meet the indication. * visit the clinic 1 month, 3 months, 6 months, 1 year and 2 years after the surgery. * keep a diary of their symptoms and other unexpected conditions.


Eligibility criteria:
inclusion criteria: 1. age \>18 2. patients with cervical spondylotic myelopathy meeting surgery indications. 3. sign informed consent exclusion criteria: 1. poor general condition, can not tolerate surgery 2. patients with long course of disease, degenerative spinal cord, atrophy of limb muscles, and severe joint dysfunction 3. the cervical spine has obvious segmental instability, especially in the case of injury or lesion of the anterior structure, which has not been healed 4. history of cervical spine surgery 5. combined with obvious cervical kyphosis 6. combined with cervical fracture, dislocation, etc 7. combined with cervical spinal infection, arthritis and other pathological changes 8. combined with tumors of cervical spine or spinal cord. 9. mental retardation or other causes of limited behavioral ability
vasopressin and steroids in addition to adrenaline in cardiac arrest - a randomized clinical trial

Conditions: Cardiac Arrest;In-hospital Cardiac Arrest; Methylprednisolone; Vasopressin; Adrenaline; Randomized Clinical Trial

Summary: this is an investigator initiated randomized, placebo controlled, double blind, superiority, multi-centre clinical trial. the estimated study project period runs over 3-4 years, including pilot phase. based on preliminary assumptions, to confirm or reject an increase in survival from 9% to 14%, about1400 patients will be randomized in the study. in hospital cardiac arrest patients meeting criteria(s) for adrenaline administration according to current erc guidelines are eligible for randomization in the study. informed consent for participating in the study cannot be obtained from the subject at the scene of the cardiac arrest since the victim is unconscious. therefore, all hospitalized men \> 18 years and women \> 50 years, except those fulfilling the exclusion criterias; patients not capable to comprehend information to decide about participation in the study, women considered of childbearing potential (wocbp)) and do not resuscitate (dnr) decision will be informed and asked about consent to participate in the study and in the case of cardiac arrest during the actual hospital stay randomized to either treatment. only those patients experiencing an in hospital cardiac arrest meeting criteria(s) for adrenaline administration will be randomized. patients will be randomized to, in addition adrenaline, either treatment with vasopressin and steroids (intervention) or sodium chloride (placebo) (control). primary outcome is survival at 30 days.


Eligibility criteria:
inclusion criteria: * hospitalized men \> 18 years and hospitalized women \> 50 years. exclusion criteria: * patients not capable to comprehend information to decide about participation in the study * women considered of childbearing potential (wocbp) i. e. premenopausal women * patients with do not resuscitate (dnr) descision * prior enrollment and randomization in the trial
effects of korean red ginseng extract on electrical brain activity in elderly subjects

Conditions: Brain Waves

Summary: a prospective, randomized, double blind, placebo-controlled study to determine if a hydroponically-cultivated red ginseng preparation is superior to conventionally grown ginseng and placebo for positively affecting electrical activity of the brain during performance of various cognitive tasks.


Eligibility criteria:
inclusion criteria: * subject must be capable of giving informed consent. * acceptance of written consent to participate in the study after instruction in written and oral form (informed consent). exclusion criteria: * subjects with acute or chronic diseases that are relevant to the study and asked for by the study staff are excluded: * acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination. * clinically relevant allergic symptoms. * detection of alcohol at the time of initial examination (day sc) or on any study (positive alcohol test) or by case history. * consumption of clinically relevant medication during last 14 days before and during the active study period based on the notification of the subject or his case history. * consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensive drugs). known intolerance / hypersensitivity (allergy) to plant derived extracts or any of the ingredients of the investigational product (anamnestic). * consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day). * smoking in the study center on study days a, b, c and d. * participation in another clinical trial within the last 60 days. * bad compliance. * cancellation of informed consent.
impact of training on gait and strength in stroke survivors

Conditions: Stroke

Summary: background: a discrepancy between strength gain and gait changes following various training programs aimed at improving gait function after stroke has been noted. a mismatch between the training program and gait parameters could explain this finding. objective: to evaluate the impact of an isokinetic-strengthening program, matching the requirements of the affected lower-limb muscle groups involved in the energy generation of gait, to a control intervention, on gait performance and muscle strength. hypothesis: the isokinetic training program of the affected lower-limb muscles would produce greater changes in gait performance and strength than a control intervention not aiming at training these muscle groups. design: single-blinded randomized controlled trial. participants: a convenient sample of 30 individuals with chronic hemiparesis. interventions: participants were randomly assigned into two groups (n=15), each training three times/week for six weeks. the experimental group trained the affected plantarflexors, hip flexors and extensors concentrically, while the control group trained the affected upper-limb muscles. main outcome measures: baseline values and post-training values, taken at the end of the training program, of maximal voluntary concentric strength, gait speed and peak positive power.


Eligibility criteria:
inclusion criteria: * have a chronic (six months or more) unilateral stroke * be able to walk 10 meters independently with or without a cane * present residual weakness at the affected lower limb * have an activity tolerance of at least two hours with a rest period exclusion criteria: * receptive aphasia * incontinence * unstable medical condition * history of injury * anesthesia at the lower limbs

Keywords: stroke exercise muscle strength gait rehabilitation
comparison of remifentanil-induced postoperative hyperalgesia between patients from plain area and plateau area

Conditions: Pain, Postoperative; Anesthesia

Summary: purpose: 1. to compare the incidence of postoperative hyperalgesia induced by remifentanil in patients undergoing gynecological laparoscopic surgery in plateau and plain areas 2. to compare the peri-operative analgesic requirements of patients in plain and plateau areas

our research group has been committed to the research of remifentanil-induced hyperalgesia for a long time. in the previous study, it was found that intraoperative infusion of remifentanil (0.3ug/kg•min) \>1h can lead to remifentanil-induced hyperalgesia and the incidence rate is relative high in the plain area. due to the long-term low pressure and hypoxia of people living in plateau areas, a series of changes will occur in the respiratory and circulatory systems, and their anesthesia management needs to be adjusted accordingly. however, there is no relevant research on whether or not hyperalgesia occurs in people in plateau areas (altitude level \>3000 meters). therefore, this study hopes to compare the incidence and degree of remifentanil-induced hyperalgesia after gynecological laparoscopic surgery in plain areas and plateau areas.

Eligibility criteria:
inclusion criteria: 1. subject is scheduled to undergo gynecological laparoscopic surgery under a short general anesthesia of less than 2 hours 2. subject's american society of anesthesiologists physical status is i-ii. 3. the subject's parent/legally authorized guardian has given written informed consent to participate. 4. patients in plateau areas are long staying residents in above 3000 meters above sea level for enrollment, while patients in plain areas are long staying residents below 1000 meters above sea level. exclusion criteria: 1. subject has a diagnosis of renal or liver failure. 2. subject has a diagnosis of insulin dependent diabetes. 3. subject is allergy and contraindication to any drugs used during general anesthesia. 4. subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery. 5. subject has any contraindication for the use of patient-controlled analgesia (pca). 6. subject is pregnant or breast-feeding. 7. subject is obese (body mass index \>30kg/m2).

Keywords: remifentanil opioid-induced hyperalgesia postoperative pain pain intensity
a clinical trial to assess com503 in participants with advanced solid malignancies

Conditions: Neoplasm; Cancer, Malignant Tumors

Summary: the overall goal of this first-in-human (fih) clinical trial is to learn about the safety and dosing of com503 when given alone or in combination with zimberelimab in participants with advanced solid tumors. the primary objectives of this study are: * to assess the safety and tolerability of com503 as monotherapy and com503 in combination with zimberelimab in participants with advanced solid tumors. * to identify the maximum tolerated dose (mtd) / maximum administered dose (mad) and/or the recommended phase 2 dose (rp2d) of com503 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * participants with histologically/cytologically confirmed advanced recurrent or metastatic solid tumor malignancy * part 1 (dose escalation): participants must have had disease progression on or following all available standard of care (soc) therapies known to confer clinical benefit. * part 2 (dose expansion): participants may be enrolled following disease progression that has progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized soc. * participants must have a solid tumor measurable by computed tomography (ct) or magnetic resonance imaging (mri) as per response evaluation criteria in solid tumors version 1.1 (recist 1.1) criteria by investigator assessment exclusion criteria: * history of another malignancy within 2 years prior to the first trial intervention administration (unless the malignancy was treated with curative intent with low risk of recurrence \[e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar\] which are allowed to enroll). * therapy with immunosuppressive doses of systemic medications, such as steroids (doses \>10 mg/day prednisone or equivalent daily) within 2 weeks before trial intervention administration * have known active central nervous system (cns) metastases and/or leptomeningeal disease (lmd). * active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively. * ascites or pleural effusion that is symptomatic and/or requiring drainage within 2 weeks prior to the first trial intervention administration. * have active hepatitis b virus (hbv) or hepatitis c virus (hcv), or participants with human immunodeficiency virus (hiv). * any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the participant's participation in the trial.

Keywords: first-in-human oncology monoclonal antibody immunotherapy
alpha-1 research registry

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: the alpha-1 research registry is a confidential database made up of individuals diagnosed with alpha-1 antitrypsin deficiency (alpha-1) and individuals identified as alpha-1 carriers. the registry was established to facilitate research initiatives and promote the development of improved treatments and a cure for alpha-1.

the purpose and goal of the alpha-1 research registry (registry, or group of patients) will be to obtain uniform, longitudinal (over the course of time), complete and accurate data that can be organized, and made available for the public to query. the collective number of registry members enables investigators to enroll sufficient subjects to carry out their studies. the community benefits from having more research and potential therapies performed in their disease. regular updates from patients will give objective data-points to measure the progression of disease.

Eligibility criteria:
inclusion criteria: * patients diagnosed with alpha-1 antitrypsin deficiency (pizz, piznull, pisz etc.) * alpha-1 carriers (pimz, pims etc.) exclusion criteria: * failure to provide informed consent * normal healthy individuals (mm)

Keywords: aatd alpha 1 copd aat zz mz carrier mm ms pizz
age-related conditions in the context of multimorbidity and frailty: relative weight of frailty in determining the course and outcomes of different chronic diseases and viceversa

Conditions: Frailty; Sarcopenia

Summary: observational study. participants of the frasnet study (9th march 2017, protocol no. 24/int/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. moreover, are going to evaluate with the same multidimensional visits patients with mild cognitive impairment and dementia followed up at the neurologic unit of the san raffaele hospital.


Eligibility criteria:
inclusion criteria: * having participated in the frasnet study or being a patient with mild cognitive impairment or dementia followed up at the neurologic unit of the san raffaele hospital * ability to sign written informed consent * \> 18 years old exclusion criteria: * life expectancy \< 6 months * unwillingness to participate in the study * unstable clinical disease(for ex. serious acute pathologies)