Kornimate/medical-research-clean huggingface dataset:
topical 0.2% loteprednol etabonate vs. topical 0.1% dexamethasone in impending recurrent pterygium

Conditions: Recurrent Pterygium of Eye; Steroid-Induced Glaucoma

Summary: the objective of this study was to evaluate the efficacy of topical 0.2% loteprednol etabonate, a 'soft steroid', compared with topical 0.1% dexamethasone, which is widely used in postoperative pterygium excision to prevent the recurrence of pterygium. if 0.2% loteprednol etabonate is non-inferior in efficacy compared with 0.1% dexamethasone, it may be used postoperatively in pterygium excision patients with the benefit of a low incidence of ocular hypertension or secondary glaucoma.

a prospective randomized control trial was performed from october 2015 to april 2019 at the department of ophthalmology, thammasat hospital, thailand and panyananthaphikkhu chonprathan medical center, thailand. subjects patients who had pterygium excision with amniotic membrane transplantation (amt) and who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the cornea were included. then the participants were randomized into 2 groups. both groups received subconjunctival 5-fluorouracil (5-fu) injection 5mg/0.1 ml with 27-gauge needle in the area of fibrovascular tissue, and then the eyes were irrigated with 30 ml of normal saline. 0.2% loteprednol etabonate was prescribed in group 1, and 0.1% dexamethasone (cd-oph) was prescribed in group 2 every 4-6 hours for 4 weeks. after that, the regimen was gradually decreased until cessation at 3 months. 5-fu was repeatedly injected monthly in the presence of marked inflammation and not more than 3 times to prevent complications. all patients were followed-up at 1, 3, 6, and 9 months to assess the impending recurrent pterygium severity score, intraocular pressure, complications, detection of true recurrent pterygium, and time to recurrence.

Eligibility criteria:
inclusion criteria: * patients who had pterygium excision with amniotic membrane transplantation and who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the cornea exclusion criteria: * recurrent pterygium * received adjunctive treatment with beta radiation, mitomycin c or 5-fluorouracil * glaucoma or intraocular pressure \> 21 mmhg * history of 5-fluorouracil or chloramphenicol allergy

Keywords: impending recurrent pterygium 0.2% loteprednol etabonate 0.1% dexamethasone
application of megavoltage imaging to reduce artifact after seed implants

Conditions: Prostate Cancer

Summary: this is a non-randomized study to evaluate the utility of mvct as a quality assurance measure in patients treated with interstitial permanent seed implants for low and intermediate risk prostate cancer. all patients will received the same standard of care treatment but will receive an additinoal ct image of the prostate.


Eligibility criteria:
inclusion criteria: male 50-80 years of age eligible for interstitial brachytherapy implants exclusion criteria: -

Keywords: prostate cancer
impact of the spatial resolution of several contrast-enhanced 3d t1-wi sequences when diagnosing giant cell arteritis (gca)

Conditions: Giant Cell Arteritis

Summary: giant cell arteritis (gca) (or horton's disease) is a segmental and focal inflammatory arteritis affecting large and medium-sized arteries. its incidence is estimated at 17.8/100,000 in subjects over 50 years old (and 46/100,000 in subjects over 70 years old). this disease remains a severe pathology due in particular to its vascular, ophthalmological, neurological, cardiac and aortic complications. in case of suspected cag, management is a real therapeutic emergency. indeed, only corticosteroid therapy started as early as possible can prevent the occurrence of these complications. the gold standard for the diagnosis of cag has long been the temporal artery biopsy, but imaging is now considered as a 1st line diagnostic examination for the diagnosis of cag according to the eular 2018 recommendations. notably, temporal artery mri has excellent sensitivity and specificity for diagnosis. however, the high diagnostic performance of mri has been achieved by performing 3d t1 black blood and fat saturation sequences in high resolution (\<0.7mm), which are not accessible in all centers in france and worldwide. the realization of identical sequences with a lower resolution could allow a greater generalization of these sequences and improve the diagnostic management of gca patients, including in non-expert centers. the objective of our study is to investigate the diagnostic performance of several 3d t1 black blood and fat saturation sequences for the diagnosis of gca.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age * referred for imaging for an injected mri for suspected gca * suspicion of gca based on the presence of three major criteria or two major and one minor criteria defined as follows: * major criteria: age \> 50 years; headache of recent onset; claudication of the jaw, tongue or swallowing disorders; visual problems (blindness, diplopia, blurred vision - including visual accidents occurring during the first week of treatment); sedimentation rate at 1st hour \> 50 and/or crp \> 8mg/l * minor criteria: hypersensitivity or induration of the scalp or presence of nodules remote from the temporal artery; temporal artery abnormalities on palpation; facial pain or feeling of facial edema; general signs (fever \>38°c, weight loss \>10%, anorexia, malaise, asthenia). * cconsent to participate in the study * affiliated or beneficiary of a social security plan exclusion criteria: * newly diagnosed malignant disease (diagnosed less than one year prior to inclusion) * active infectious disease * autoimmune disease (especially but not limited to: wegener's disease, takayasu vasculitis, anca vasculitis, rheumatoid arthritis, lupus erythematosus, periarteritis nodosa). * systemic corticosteroid therapy for more than 10 days at high dose (\>0.5mg/kg/d of prednisone) * contraindication to mri * patient benefiting from a legal protection measure * pregnant or breastfeeding woman
expanded access for ace-011

Conditions: Myelodysplastic Syndrome

Summary: this is an expanded access program (eap) for eligible participants designed to provide access to ace-011.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: expanded access compassionate use
cognitive remediation therapy in schizophrenia: effects on epigenetics

Conditions: Schizophrenia

Summary: this study is a randomised and controlled trial that aims to investigate whether cognitive remediation therapy (crt) can modulate epigenetic mechanisms by changing methylation levels of bdnf gene in patients with schizophrenia.

objectives: to investigate whether cognitive remediation therapy (crt) can modulate epigenetic mechanisms by changing methylation levels of bdnf gene. it also aims to test whether bdnf valine-66-methionine (val66met) polymorphism influences crt treatment outcome among people with schizophrenia. sample and methods: a randomized and controlled study will be carried out with two groups: patients receiving crt and patients in control condition without any cognitive intervention and receiving treatment as usual (tau). methylation levels of bdnf gene at different sites will be contrasted before and after treatment. additionally, neurocognition profile, level of symptoms and psychosocial functioning will also be tested. crt outcomes will be investigated in a mixed model for repeated measures.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia according to dsm-5 and confirmed by the semi-structured interview (scid) for the axis 1. * presence of cognitive impairment confirmed by the neuropsychological battery * stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment . exclusion criteria: * presence of organic-cerebral affectation due to neurological or traumatic conditions * antipsychotic dose change \>10% * abuse of psychotropic substances * presence of other psychiatric symptomatology

Keywords: cognitive remediation epigenetics bdnf
effects of therapeutic music combined with loaded sit-to-stand resistance exercise for children with spastic diplegia

Conditions: Cerebral Palsy; Paraparesis, Spastic

Summary: the purpose of study is to investigate the effects of pse music with a "home-based" loaded sts exercise program on the functional strength, gross motor function, daily participation, exercise involvement, motor control, and gait speed for children with spastic diplegia.


Eligibility criteria:
inclusion criteria: * children with sd, aged 5 to 13 year-old, and gmfcs level between i to iii * able to stand up from a chair independently and maintain standing for more than 2 seconds without falling * able to follow verbal instructions exclusion criteria: * have orthopedic surgery, selective dorsal rhizotomy, or use of a baclofen pump within 6 months * have orthopedic problems or other medical conditions preventing the child from joining the resistance exercise program, such as obvious le joint contractures, uncontrolled epilepsy, or cardiopulmonary problems * hearing loss or using hearing aid * have mental disorders, such as pervasive developmental disorders and attention-deficit and disruptive behavior disorders

Keywords: exercise
clinical investigation of maia microperimeter device: mesopic normative database collection

Conditions: Healthy Eyes

Summary: the purpose of this pre-market, multicentric cross-sectional study is to create a mesopic normative database for a new version of the maia device. moreover, the study aims to evaluate maia safety and adverse events. these purposes will be achieved by collecting data of healthy subjects, who will undergo microperimetric examinations with the maia device during one single visit.


Eligibility criteria:
inclusion criteria: * age: ≥18 years old; * best corrected visual acuity (bcva): ≥ 0.8 decimal (≥ 20/25 ft, ≤ +0.1 logmar) at least in the study eye; * equivalent spherical refraction between the range ≥ -6d and ≤ +6d; astigmatism within 2d (≤ 2d) at least in the study eye; * intraocular pressure (iop) ≤ 21 mmhg in both eyes (goldmann applanation tonometer); * clinically normal appearance of the optic nerve head according to clinical judgement (no evidence of excavation, rim thinning, notching, disc hemorrhages, rnfl thinning) in both eyes. this is examined with spectralis or solix oct; * clinically normal appearance of the macula according to clinical judgement, in both eyes. this is examined with spectralis or solix oct; * no ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery or peripheral laser retinopexy performed at least 6 months before enrollment) in both eyes; * absence of pathologies that can affect visual field in both eyes; * no use of drugs interfering with the correct execution of perimetry. exclusion criteria: * glaucoma or glaucoma suspect diagnosis in either eye; * presence or history of ocular hypertension (iop ≥ 22 mmhg) in either eye; * presence or history of disc hemorrhage in either eye; * presence of amblyopia in either eye; * nystagmus or poor fixation in either eye; * previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment in both eyes; * any active infection of anterior or posterior segments in the study eye; * subjects with significant ocular media opacities preventing acquisition of acceptable infrared (ir) fundus image quality in the study eye; * evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease in either eye; * use of any drug that can interfere with the correct execution of mp or that would produce visual field loss; * unable to tolerate ophthalmic imaging; * claustrophobia; * inability to provide informed consent.
rotational stability of acrysof iq vivity extended vision toric iol and refractive visual outcome.

Conditions: Cataract

Summary: the purpose of this research is to assess the rotational stability of the acrysof iq vivity extended vision toric iol and refractive visual outcome.

assessment of the rotational stability and refractive visual outcome of the acrysof iq vivity extended vision toric iol at the end of surgery, post op 1 day, post op 1 week and post op 4 weeks. participants in this research study are 45 years of age or older and have planned implantation in at least one eye.

Eligibility criteria:
inclusion criteria: * subjects undergoing cataract extraction with intraocular lens implantation. * age: 45 years and older. * willing and able to comply with scheduled visits and other study procedures. * subjects who require an iol power in the range of +15.0 d to +25.0 d. * subjects with regular corneal astigmatism that can be treated with t3-t5. * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * potential postoperative visual acuity of 0.2 logmar/etdrs (20/32 snellen) or better in both eyes. exclusion criteria: * glaucoma. * clinically significant corneal dystrophy. * previous corneal refractive surgery (i.e lasik, prk, rk) * pupil abnormalities. * concurrent infectious/non-infectious uveitis. * history of chronic intraocular inflammation. * visually significant macular disease. * history of retinal detachment.

Keywords: vivity cataract intraocular lens
arginase inhibition in ischemia-reperfusion injury

Conditions: Coronary Artery Disease; Type 2 Diabetes Mellitus

Summary: the present project is designed to test the hypothesis that arginase contributes to endothelial dysfunction induced by ischemia-reperfusion in patients with coronary artery disease.

background: arginase competes with nitric oxide synthase for their common substrate l-arginine. up-regulation of arginase in coronary artery disease (cad) and diabetes mellitus may reduce nitric oxide bioavailability contributing to endothelial dysfunction and ischemia-reperfusion injury. arginase inhibition reduces infarct size in animal models. therefore the aim of the current study was to investigate if arginase inhibition protects from endothelial dysfunction induced by ischemia-reperfusion in patients with cad with or without type 2 diabetes. methods: male patients with cad (n=12) or cad + type 2 diabetes (n=12), were included in this cross-over study with blinded evaluation. endothelium-dependent vasodilatation was assessed by flow-mediated dilatation (fmd) of the radial artery before and after 20 min ischemia-reperfusion during intra-arterial infusion of the arginase inhibitor (n-hydroxy-nor-l-arginine, 0.1 mg/min) or saline. results: the forearm ischemia-reperfusion was well tolerated. endothelium-independent vasodilatation was assessed by sublingual nitroglycerin. ischemia-reperfusion decreased fmd in patients with cad from 12.7±5.2% to 7.9±4.0% during saline administration (p\<0.05). n-hydroxy-nor-l-arginine administration prevented the decrease in fmd in the cad group (10.3±4.3% at baseline vs. 11.5±3.6% at reperfusion). ischemia-reperfusion did not significantly reduce fmd in patients with cad + type 2 diabetes. however, fmd at reperfusion was higher following nor-noha than following saline administration in both groups (p\<0.01). endothelium-independent vasodilatation did not differ between the occasions. conclusions: inhibition of arginase protects against endothelial dysfunction caused by ischemia-reperfusion in patients with cad. arginase inhibition may thereby be a promising therapeutic strategy in the treatment of ischemia-reperfusion injury.

Eligibility criteria:
inclusion criteria: * coronary artery disease exclusion criteria: * age \>80 years, myocardial infarction/unstable angina within 6 weeks prior to the study, raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm, any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol, participant in an ongoing study, unwillingness to participate following oral and written information.
pilot research on opioid use disorder

Conditions: Opioid-use Disorder

Summary: this study evaluates the effects of peripheral nerve stimulation on opioid withdrawal, craving, and use in participants with opioid use disorder (oud) who are initiating treatment with buprenorphine/naloxone. this is a pilot investigation in which participants will randomized (1:1) to the active or sham treatment.

opioid use disorder (oud) has become a public health emergency. approximately 2.6 million americans suffered from oud in 2016. evidence-based approaches for treating oud include several medication-assisted treatments (mats). while mats are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are key contributors to treatment dropout, relapse, and overdose. peripheral nerve stimulation via acupuncture has been shown to directly decrease drug withdrawal, craving, and self-administration. the investigators have developed the empower neuromodulation system, a non-invasive, portable transcutaneous electrical nerve stimulation (tens) device intended to stimulate peripheral nerves for the treatment of oud. in this study, a randomized, controlled study will be conducted in participants with oud who are initiating treatment with buprenorphine/naloxone. participants will self-administer daily treatment with the empower device. endpoints will be evaluated for safety, effectiveness, and acceptability.

Eligibility criteria:
inclusion criteria: * va-eligible veterans * ages ≥ 18 * current diagnosis of opioid use disorder per dsm-5 by clinician assessment * scheduled to initiate, or has initiated within the past five days, treatment for oud with buprenorphine/naloxone exclusion criteria: * injury or nerve damage at the arm or palm and/or neuropathy in the upper extremities * pregnant or planning to become pregnant * currently implanted with an electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant) * use of an investigational drug/device therapy within the past 4 weeks * history of epilepsy or a seizure disorder * has an electrically conductive metal object (e.g. jewelry) that cannot be removed and will directly contact the gel electrodes of the empower neuromodulation system when applied to the skin at the stimulation location * unable to provide informed written consent * has taken a medication-assisted treatment (mat) for oud in the past two weeks or plans to take any prescription opioid or mat for oud other than buprenorphine/naloxone while enrolled in the study * is deemed unsuitable for enrollment in the study by the pi (e.g. current medical or psychiatric instability)
thoracic bio-reactance measurement of cardiac output in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: pulmonary hypertension (ph) is a rare disease characterized by an increase in pulmonary vascular resistance, leading to a progressive decline in cardiac output (co).since cardiac output is correlated with the prognosis of the disease, the conduct of a right heart catheterization (thermodilution measurement, reference technique) during the annual follow-up visit of patients in competences centres is recommended. in practice, it is not systematically performed because of it is invasive, with potential risk for the patient, and there is limited logistical capacity for its implementation. the estimation of cardiac output is thus often based on cardiac ultrasound but its measurement is potentially biased. starling ™ sv is a non-invasive cardiac output monitor based on thoracic bio-reactance measurement. several clinical studies have shown that cardiac output measured by bio-reactance is strongly correlated with the measurement obtained by catheterization in different indications. rich et al. (2013) assessed bio-reactance specifically in 50 patients with pulmonary hypertension compared with thermodilution. the results showed that the measurement of cardiac output by bio-reactance was feasible in these patients, had a better accuracy than by catheterization, and was reliable for detecting changes in cardiac output after a vasodilatation test. the starling ™ sv monitor could thus have a place in the follow-up of patients who are being treated for pulmonary hypertension. since it is a rapid, non-invasive examination, it could be performed on an outpatient basis, especially as a first-line test to check the stability of the co, thus avoiding the systematic use of right heart catheterization, which would then be reserved only to patients for whom the measurement by bio-reactance would show a decrease of cardiac output compared to the previous value. before being able to propose this use in current practice, it is necessary to carry out a pilot study which will make it possible to explore the interest of bio-reactance in this situation.


Eligibility criteria:
inclusion criteria: * aged over 18 * presenting pulmonary hypertension (ph) followed by the competence center of the hospices civils de lyon * follow-up for pulmonary hypertension groups 1, 4 or 5 * of which the cardiac index is ≥ 2,5 l/min/m² * expressing its non-opposition to the participation of this study * benefiting from a social security scheme or similar exclusion criteria: * adult patient protected by law * patient for whom a thermodilution measurement of cardiac output (co) is unreliable: right-left shunt; or uncorrected congenital heart disease; or variability\> 10% of the 3 measurements of co obtained by thermodilution * pulmonary hypertension groups 2 or 3 * hemodynamic aggravation since the previous visit: increased pressure or decreased cardiac index
telehealth for the self-management of dietary quality of life in patients after stomach cancer surgery

Conditions: Gastric Carcinoma; Gastroesophageal Junction Adenocarcinoma

Summary: this clinical trial test whether taking part in a diet support intervention will help with patients nutrition and quality of life after surgery for esophagus or stomach cancer. the information learned by doing this research study may help patients get more information and/or support on eating after esophagus and stomach cancer surgery.

primary objectives: i. assess the feasibility, retention, and satisfaction of the telehealth intervention for self-management of eating after gastric surgery (times) intervention as measured by the percentage of patients who a) agree to participate; b) complete a majority of the intervention (at least 2 sessions); and c) report satisfaction with the intervention (through structured exit interviews). ii. assess the preliminary efficacy of times for patient reported outcomes for quality of life (qol), dietary symptoms, and self-management. iii. assess the preliminary efficacy of times for objective measures of patient nutrition. outline: patients are randomized in to 1 of 2 arms. arm i: patients receive 4 telehealth sessions over 1 hour each over 4 months. patients also receive an intervention guidebook. arm ii: patients receive standard nutritional support. after completion of study, patients are followed up for 6 months.

Eligibility criteria:
inclusion criteria: * the ability to understand english or spanish. * undergone curative intent surgery for gastric or gastroesophageal (ge) junction cancer. * began oral intake within the past month. * aged 21 years and older. * able to participate in telehealth sessions. * this study will be conducted in patients aged 21 years or older who have undergone curative intent surgery for gastric or ge junction cancer. * age criterion for this trial is based on the national institute of health (nih')s age criteria, which defines an adult as individuals aged 21 years and over. there are no restrictions related to performance status or life expectancy. * all subjects must have the ability to understand and the willingness to sign a written informed consent. exclusion criteria: * subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.