Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of multifocal intraocular lens: optivis.tm

Conditions: Cataract Senile; Lenses, Intraocular

Summary: this study evaluated visual outcome after cataract surgery with bilateral implantation of either a diffractive - refractive (hybrid) multifocal intraocular lens (mfiol) or monofocal intraocular lens (iol) as a control grup.

purpose: to present the outcomes of hybrid multifocal and monofocal intraocular lenses (iol) setting: parc de salut mar, universidad pompeu-fabra - autónoma, barcelona, spain. design: prospective clinical trial. methods: consecutive patients with bilateral cataract were included. phacoemulsification with randomized implantation of either a monofocal iol (ar40e, amo-abbot 30 laboratories inc. abbot park, illinois, usa) or multifocal iol (optivis™, aaren scientific, inc, ontario, ca, usa) was performed by the same surgeon and under the same conditions. over a 3-month follow-up, the main outcome measures were uncorrected distance visual acuity (udva), corrected distance visual acuity (cdva), uncorrected intermediate visual acuity at 60 cm (uiva), distance-corrected intermediate visual acuity (dciva), uncorrected near visual acuity at 33 cm (unva), distance-corrected near visual acuity (dcnva), spherical equivalent (se), contrast sensitivity (cs), presence of dysphotopsia, use of spectacles and patient satisfaction with the test vf-14 (visual function index) .

Eligibility criteria:
inclusion criteria: * senile cataract with snellen visual acuity ≤ 0.5, * motivation for spectacle independence for near vision (as the study was conducted in spanish public health care system, entering study was the only option to get multifocal lens, as they are not provided by public health care, and the patients were conscious of the possibility of randomization to monofocal group.) exclusion criteria: * corneal astigmatism ≥ 1.10 diopters (d) and irregular astigmatism, * axial length \< 21.5 or ≥ 25 mm, * pupillary diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm, * ocular pathology that could affect the visual function and/or intraocular lens centering and intraoperative or postoperative complications. * highly demanding patients and those whose profession could be affected by a multifocal design (professional drivers, jewelers etc.) were also excluded (as in the spanish public health care system secondary procedures needed to satisfy patients' expectation, such as lri´s, lasik, prk´s, are not available).

Keywords: optivis hybrid multifocal intraocular lens multifocal intraocular lens presbyopia
electrical patient reported outcome of prostate cancer radiotherapy

Conditions: Prostate Cancer

Summary: this is an observational study where prostate cancer related proms (epic-26) is collected using two different methods (by paper questionnaires and electronically) and patient experience and preference is asked.

prostate cancer patients that are treated with radiation therapy for local prostate cancer receive epic-26 before treatment and during follow-up. epic-26 is collected both traditionally using paper questionnaires and electronically. patients experience and preference for these are asked.

Eligibility criteria:
inclusion criteria: * ct1-4n0m0, gleason 6-10, psa \< 100, who ≤ 2 prostate cancer eligible for radiation therapy * willing to complete epic-26 questionnaires both in paper and electronically * willing to consent for the study exclusion criteria: * not able to complete epic-26 both in paper and electronically

Keywords: prom epic-26 electronic questionnaire mobile quality of life radiation therapy
effectiveness of a smoking cessation intervention in a mental health day hospital

Conditions: Tobacco Use Disorder; Smoking Cessation; Mental Disorder

Summary: background: nicotine contained in tobacco is highly addictive and tobacco use is a major risk factor for cardiovascular and respiratory diseases. every year, more than 8 million people die from tobacco use. smoking-related mortality is significantly higher in people with serious mental illness. is estimated that half of all deaths among individuals with mental illnesses are attributable to tobacco use. people with serious mental illness have greater daily tobacco consumption, nicotine dependence, and smoking relapse. while significant progress has been made in reducing tobacco use within the general population, rates of tobacco use remain high among individuals with mental illness. smoking cessation often requires numerous attempts by these people. thus, smokers with mental health illnesses may find it more difficult to quit, although highly motivated to quit. smoking cessation during hospitalization (total or partial) is cost-effective, as it reduces hospital readmissions, and mortality, and improves smokers' quality of life. available quitting aids are both safe and effective in supporting cessation in tobacco users with mental illness and stopping smoking is associated with an improvement in mental health. the investigators aimed to evaluate the feasibility and efficacy of adding an intensive smoking intervention to the usual treatment for patients with psychiatric disorders attending a day hospital of a tertiary hospital.

the investigators will perform a quasi-experimental, longitudinal, and prospective study in the mental health day hospital of the hospital clinic of barcelona. adults attending the day hospital and willing to participate, under informed consent, will be invited to participate. consecutive eligible individuals will be recruited and will be assigned to two groups, the control group, and the experimental group. initially, patients will be recruited for the control group, once the control group is completed the experimental group will begin. an assessment will be conducted at baseline (admission) and in the discharge. sociodemographic and clinical data will be obtained.

Eligibility criteria:
inclusion criteria: * mental health day hospital inpatient. * smoker of at least 1 cigarette per day, electronic cigarette, or heated tobacco product daily for at least 1 month. * individuals who accept to participate in the study and give informed consent. exclusion criteria: * cognitive impairment, dementia, or brain damage. * medically unstable. * explicitly demanding tobacco treatment. * trying to quit smoking using another intervention. * insufficient comprehension skills in spanish or catalan.

Keywords: motivational interviewing group counseling
effectiveness of symptom management application on parental care ability of children with tourette syndrome

Conditions: Tourette Syndrome; Tic Disorder; Neurodevelopmental Disorder

Summary: this study developed a tourette syndrome (ts) symptom management application (app) to improve the care needs, sleep quality, anxiety, quality of life, and parenting relationship of parents of children with tourette syndrome.

tourette syndrome (ts) is a common chronic neurodevelopmental disorder in children. parents play critical roles in helping to manage their child's symptoms, leading to several issues associated with care needs and the parent-child interaction. this study adopted a randomized control study design. the investigators developed a ts symptom management app based on symptom management theory and the relevant literature. the research subjects were parents of children with ts between 6 and 12 years old. the experimental group received ts symptom management app intervention for four weeks. the experimental group recorded the patterns and treatments of tics at least twice a week and completed relevant readings on ts care information during these four weeks. the control group continued to receive outpatient verbal and paper health education guidance from healthcare providers. the participants in both groups were requested to complete the following questionnaires, including the care needs scale, whoqol-bref, pittsburgh sleep quality index (chinese version), beck anxiety inventory (chinese version), parent-child relationship quality inventory, and the yale global tic severity scale. these questionnaires were completed before the intervention and directly after the four-week intervention. the participants were completed again one month and three months after the intervention. to understand the users' satisfaction with this app, only the participants in the experimental group were requested to complete the inventory of technology acceptance model when completing the questionnaires during the third posttest. the goal was to strengthen parents' symptom management ability and improve their psychosocial functions and children's disease severity.

Eligibility criteria:
inclusion criteria: 1. parents of children between 6-12 years old who are diagnosed with tourette syndrome by pediatricians. 2. parents who are the primary caregivers 3. parents with normal cognitive functioning who can communicate in mandarin. exclusion criteria: 1. children with tourette syndrome who are suffering from intellectual disability or critical diseases.

Keywords: symptom management application parent children with tourette syndrome
diaphragmatic function in ventilated patients

Conditions: Critically Ill

Summary: animal studies showed that controlled mechanical ventilation (cmv) can induce dysfunction of the diaphragm, resulting in an early-onset and progressive decrease in diaphragmatic force-generating capacity, called ventilator-induced diaphragmatic dysfunction (vidd).


Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation (tracheally intubated or tracheotomized) less than 48h.· * duration of mechanical ventilation for at least 72h.· * subject itself or its next of kin has given written informed consent exclusion criteria: * patient is less than 18 years or more than 85 years of age· * the attending physician refuses to allow enrollment· * the patient refuses informed consent * next of kin is unavailable or refuses informed consent· * pregnant or breast-feeding female. * a pregnancy test will be performed in all female patients less than 60 years of age.· * any contraindication to use cervical magnetic stimulation (mechanical cardiac assist device ...).· * presence or suspicion of prior diaphragm injury or chronic disease· * presence or suspicion of a central nervous system (cns) disorder, including (but not limited to): cns infarction, bleeding, tumor, or infection

Keywords: mechanical ventilation ventilator induced diaphragmatic dysfunction weaning neuromuscular diseases- respiratory function tests intubated patients in intensive care unit
retrobulbar block versus ketamine infusion for post-enucleation analgesia

Conditions: Enucleated; Eye; Evisceration; Operation Wound; Pain, Postoperative

Summary: this study compares the efficacy and safety of two techniques, retrobulbar block versus intra-operative ketamine infusion, for control of post-operative pain occurring in patients undergoing ocular enucleation or evisceration performed under general anesthesia.


Eligibility criteria:
inclusion criteria: * ocular enucleation candidate patients * ocular evisceration candidate patients exclusion criteria: * any condition contra-indicating general or local anesthesia * allergy to any of the drugs used during the procedure

Keywords: retrobulbar block ketamine ocular enucleation analgesia
evaluation of effects of exercise training and arb in dm patients

Conditions: Vascular Function; Exercise Training

Summary: the aims of this clinical trial are to assess the impacts on vascular function tests and circulating biomarkers of a short-term (12-week) low-to-median intensity exercise training or arbs treatment in patients with dm and hypertension.

inclusion criteria: type ii diabetic and hypertensive patients who are aged 30 to 70 year-old with hba1c ≤ 8.0 % and systolic blood pressure ≥ 140 mmhg. neither acei nor arb is administrated in recent 6 months. none has significant concomitant systemic diseases such as active infection, malignancy, hepatic or significant renal dysfunction at the time of enrollment (i.e. total bilirubin \> 3 mg/dl，alt \> 2.5 times the upper limit of normal range and creatinine \> 3 mg/dl in our hospital). information regarding smoking, hypertension, hyperlipidemia as well as history of cardiovascular disease is obtained from all subjects. no other medication will be modified during the study period. after enrollment, patients are assessed to (1) olmesartan (20 mg per day, with titration), (2) life modification/exercise training for 12 weeks. vascular function and exercise capacity studies, and peripheral blood testing are performed at baseline and at 12- week follow-up. data are collected as mean ± sd showing comparison between groups by use of 2-sample t test and chi-square analysis for continuous and categorical variables, respectively. adjust for the hba1c level will be adjusted using simple adjustment method (ancova or equivalent regression analysis) while doing the data analysis. changes between baseline and follow-up measurements are assessed by paired t test. the frequencies of adverse effects between groups will also be comparing by 2-sample t test. a p value \<0.05 is defined as statistically significant.

Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus and hypertension * age 30-70 years，systolic blood pressure 140-160 mmhg and hba1c ≤ 8%, * no history of acei or arb use within 6 months exclusion criteria: * active cardiovascular diseases * severe hepatic * renal dysfunction (cre ≥ 3 mg/dl，t-bil ≥ 3 mg/dl)

Keywords: angiotensin receptor ii antagonist
trial of cell based therapy for dmd

Conditions: Duchenne Muscular Dystrophy

Summary: this is a single-center, single-arm, interventional phase 1 trial to evaluate the safety and tolerability of local injection of induced pluripotent stem cell (ipsc)- derived cd54+ allogeneic muscle progenitor cells in individuals with duchenne muscular dystrophy (dmd)

the university of minnesota holds equity in, and has rights to potential royalties from, myogenica, the company that has licensed this trial's stem cell therapy from the university. these interests have been reviewed and managed by the university of minnesota in accordance with its conflict of interest policies. if you would like further information please contact jon guden, associate director, conflict of interest program, at jguden@umn.edu.

Eligibility criteria:
inclusion criteria: * duchenne muscular dystrophy, diagnosed by mutations in the dmd (dystrophin) gene and/or absence of immunohistochemical staining for dystrophin on muscle biopsy * non-ambulatory * intact extensor digitorum brevis (edb) muscles bilaterally * off investigational therapies for \> 30 days * age 18 years of age or older at the time of consent * have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to enrollment (28 days for cardiac and pulmonary function): * participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) while receiving the study product and for 3 months after stopping tacrolimus therapy. * ability to follow commands sufficiently to perform voluntary aspects of outcome measures throughout the study period * willing to consent to monitoring for 15 years, including an extension period, as required for all interventional studies involving the transplantation of cells that have been genetically modified * voluntary written consent from the subject or parent(s)/guardian(s) and assent from participant prior to the performance of any research related activity. exclusion criteria: * presence of hla antibodies directed toward hla antigens on myopaxon * active treatment with another investigational therapy * known allergy to myopaxon components
study of the impact of vegf polymorphism on the development of renal carcinoma in renal transplant patients

Conditions: Polymorphism; VEGF; Renal Carcinoma; Renal Transplantation

Summary: renal transplant patients have on average 3-5 times more risk of developing cancer than the general population. this rate can be increased up to 10 to 15 times in some type of cancer like kidney cancer. among the identified risk factors, immunosuppressants and, in particular, calcineurin inhibitors (ciclosporin and tacrolimus) play a major role in increasing cancers apart from their depressant effects on the immune system. calcineurin inhibitors (ccn) are the basis of immunosuppressive therapy in renal transplantation. several mechanisms have been implicated to explain their pro-oncogenic properties. one related to an increase in vegf expression seems particularly interesting in the study of renal cell carcinoma in the transplanted patient. indeed, the physiopathology of kidney cancer has clearly been associated with an increase in the production of vegf. furthermore, some polymorphisms of the gene encoding vegf have already been associated with the survival of patients with renal carcinoma and the circulating level of vegf in the general population. the search for an association between the polymorphisms of the vegf gene and renal carcinoma in renal transplant patients could thus identify patients whose risk of renal cell carcinoma (crcc) post-transplantation is increased. if the involvement of certain polymorphisms in the development of crcc was confirmed in this population, their research before the introduction of the immunosuppressive treatment would make it possible to direct the choice of treatment towards molecules without pro-oncogenic property in the patients such as mtor protein inhibitors (sirolimus, everolimus). this research project is therefore in line with the desire to move towards a more "personalized" medicine that could be beneficial for the patient.


Eligibility criteria:
inclusion criteria: * patients receiving a first, second or third kidney transplant; * patients receiving a transplant from a living or deceased donor, irrespective of the immunological risk; * patients with health insurance coverage; * live or deceased patients for which genomic dna is available. * in cases : first diagnosis of native kidney cancer (histological type: papillary or clear cell) exclusion criteria: * minor transplant patients; * patients transplanted before 1 january 2002; * patients monitored in the interregion, but transplanted to another center; * patients receiving a double graft (kidney plus other organ) or a bi-graft; * patients not accepting that their medical data be included in the register; * patients not accepting that their specimen be used for scientific research purposes.
basket study of neratinib in participants with solid tumors harboring somatic her2 or egfr exon 18 mutations

Conditions: Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

Summary: this is an open-label, multicenter, multinational, phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with her (egfr, her2) mutation-positive solid tumors.

this is an open-label, multicenter, multinational, phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with her (egfr, her2) mutation-positive solid tumors. the study has a basket design and includes several cohorts, either defined by an actionable somatic mutation or by actionable mutation and tumor histology, including her2 mutant breast, her2 mutant cervical, her2 mutant salivary gland, and egfr exon 18 mutant non-small cell lung cancers. the trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period.

Eligibility criteria:
inclusion criteria: * provide written informed consent * histologically confirmed cancers for which no curative therapy exists * documented her2 or egfr exon 18 mutation * participants must agree and commit to use appropriate methods of contraception as outlined in the protocol * at least one measurable lesion, defined by recist v1.1 exclusion criteria: * participants harboring ineligible somatic her2 mutations * prior treatment with any her2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with egfr exon 18 mutated nsclc who may have received afatinib, osimertinib, or other pan her or egfr tkis remain eligible * participants who are receiving any other anticancer agents * symptomatic or unstable brain metastases * women who are pregnant or breast-feeding there are additional inclusion and exclusion criteria. the study center will determine if criteria for participation are met.

Keywords: neratinib nerlynx breast solid tumors cancer her2 mutations egfr mutations fulvestrant trastuzumab cervical salivary erbb2 exon 18 metastatic hr positive lung non-small cell lung cancer (nsclc)
research of sord-cmt natural history and epalrestat treatment

Conditions: Charcot-Marie-Tooth Disease (CMT)

Summary: charcot-marie-tooth disease (cmt) is a group of the most common hereditary peripheral neuropathy with high clinical and genetic heterogeneity. biallelic pathogenic variants in sord gene leading to loss of function of sord protein cause axonal degeneration. current research suggests that sord-cmt2 may be the most common subtype of ar-cmt2. the primary purpose of this study is to explore the natural history of sord-cmt2 patients by detecting the onls scale score and serum sorbitol level changes at 6th, 12th, 24th, and 36th months and to evaluate the effectiveness and safety of epalrestat. patients with strong treatment willingness and voluntary purchase of drugs are included in the epalrestat treatment group, and patients without drug treatment willingness are included in the control group. patients in the drug treatment group take epalrestat (50 mg) orally three times daily. this study is expected to be carried out simultaneously in 5 hospitals in mainland china. about 30 sord-cmt2 patients will be enrolled in this study, and the study period will be 36 months.


Eligibility criteria:
inclusion criteria: * genetically confirmed sord-cmt2 patients. * male or non-pregnant, non-lactating female patients, aged \> 14 and ≤ 50 years old. * rule out secondary peripheral neuropathy (e.g., diabetic peripheral neuropathy) * voluntarily participate in clinical trials, sign informed consent, and be able to understand and abide by research procedures. p.s. patients who have a strong willingness to treat and voluntarily purchase epalrestat for treatment (50mg, three times a day) are included in the treatment group. exclusion criteria: * presence of any other cause of peripheral neuropathy. * subjects with other neurological disorders affecting the evaluation of study treatment. * history of clinically significant unstable medical disease that may cause harm to subjects participating in this study within the past 1 year. * patients with major trauma or extremity surgery before enrollment or planned for extremity surgery before completion of follow-up. * patients with previous bilateral ankle stabilization surgery. * patients who were treated with other related drugs in the 3 months before enrollment. * have any history of drug abuse; have a history of alcohol dependence in the past 3 months. * subjects who are positive for syphilis antibody and hiv antibody. * subjects whose chest x-ray and b-ultrasound show tumors. * patients with poor compliance and unable to complete the study follow-up. * patients who do not agree to participate in the study. * other factors are not suitable for inclusion.