Kornimate/medical-research-clean huggingface dataset:
pilot study of familial nonsyndromal mondini dysplasia

Conditions: Mondini Dysplasia

Summary: objectives: i. determine the mode of inheritance of nonsyndromal mondini inner ear dysplasia, an inner ear malformation causing deafness, vestibular dysfunction, and recurrent meningitis.

protocol outline: the parents of 1 family with known mondini dysplasia are screened for the disorder using temporal bone computerized tomography without contrast. this information is used to determine the mode of inheritance.

Eligibility criteria:
protocol entry criteria: parents of a study family with nonsyndromal mondini dysplasia

Keywords: mondini dysplasia genetic diseases and dysmorphic syndromes rare disease
optical coherence tomography angiography criteria of the choroidal neovascular membrane in wet age related macular degeneration and in pathological myopia (comparative study).

Conditions: Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia

Summary: this study aims to compare choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia.

all patients will be examined by optical coherence tomography (oct) and optical coherence tomography angiography (oct-angio) . the size, the location, the criteria of the choriodal neovascular membrane will be examined and imaged. study include 50 cases of cnv in age related macular degeneration and 50 cases of cnv in pathological myopia.

Eligibility criteria:
inclusion criteria: * patients with age related macular degeneration should be at least 50 years of age with cnv with no other causes. patients with pathological myopia where axial length more than 26 mm or refractive power more than -6 diopter with cnv in oct with clear media and oct-angio can be used. exclusion criteria: * exclude other pathological causes of cnv .
anticancer vigilance of cardiac events (avocette) in metastatic colorectal cancer

Conditions: Colorectal Cancer Metastatic

Summary: this study is a retrospective observational study that evaluates the rate of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer in the french county calvados by drug exposure.

this study investigates the characteristics of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer. descriptive analysis will include incidence, type of cardiovascular adverse events. we will explore the incidence of cardiovascular adverse events with regard of the antineoplastic drug exposures. this will provide information about the individual drug safety profiles.

Eligibility criteria:
inclusion criteria: * patients with a metastatic colorectal cancer diagnosed between 2004 and 2014 in the french county calvados exclusion criteria: * minors \< 18 year old * patients without a metastatic colorectal cancer diagnosed between 2004 and 2014 in the french county calvados
investigation of vascular pathology in eye diseases using using optical coherence tomography angiography (oct-a)

Conditions: Retinal Disease

Summary: comparison of octa to conventional imaging modalities for the diagnosis of eye diseases

optical coherence tomography angiography (octa) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information. octa compares the decorrelation signal between sequential oct b-scans taken at precisely the same cross-section in order to construct a map of blood flow. at present, level 1 evidence of the technology's clinical applications doesn't exist. the investigators plan to compare octa as an imaging modality to conventional imaging modalities used in clinical routine.

Eligibility criteria:
inclusion criteria: patients from the department of ophthalmology, university hospital bern requiring conventional imaging for eye disease and willing to sign informed consent patients of 18 years or older exclusion criteria: patients not willing or able to sign informed consent patients younger than 18 years patients with epilepsy patients having had photodynamic therapy within the last 48 hours prior to imaging with octa
a trial to assess the long-term safety of octreotide subcutaneous depot in patients with acromegaly

Conditions: Acromegaly

Summary: the purpose of this trial is to assess the long-term safety and efficacy of cam2029 in patients with acromegaly. patients will be administered cam2029 subcutaneously once monthly during 12 months. patients fulfilling trial nct04076462 will be offered to continue with open-label treatment week 24-52 in this trial. patients completing the main part of the trial will be offered 52 weeks continued open-label treatment in an extension part.


Eligibility criteria:
inclusion criteria: * male or female patients, ≥18 years at screening * able to provide written informed consent to participate in the trial * diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly * treatment with a stable dose of octreotide lar or lanreotide atg for at least 3 months as monotherapy prior to screening * igf-1 levels ˃1xuln and ≤2.0xuln at screening or igf-1 levels ≤1xuln at screening with or without prior pituitary radiotherapy * adequate liver, pancreatic, renal and bone marrow functions * normal ecg exclusion criteria: for roll-over patients from nct04076462: * unresolved, drug-related serious adverse event (sae) from the preceding trial * patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation for new patients: * have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening \[whichever is longer\] * patients who usually take octreotide lar or lanreotide atg less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks) * patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated * patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening * patients who have undergone pituitary surgery within 6 months prior to screening * patients who have received prior pituitary irradiation within 3 years prior to screening * patients with poorly controlled diabetes mellitus (hemoglobin a1c \>8.0%)

Keywords: acromegaly octreotide cam2029 phase 3
home-based hit in obese individuals

Conditions: Obese

Summary: this study aims to investigate the efficacy of a novel home-based high-intensity interval training (home-hit) intervention in obese individuals, with elevated cardiovascular disease (cvd) risk. it was hypothesised that home-hit would 1) have high adherence to the prescribed exercise intensity (compliance), 2) improve markers of cvd risk, and 3) lead to favourable skeletal muscle adaptations.

the applicability of current high intensity interval training (hit) protocols to the sedentary obese population has been disputed by public health experts. existing hit interventions have been successful only under optimal conditions with high levels of supervision and specialised equipment, creating further barriers to exercise in those most in need. we aimed to eliminate many of these barriers by modifying existing hit protocols to create a new home-based hit (home-hit) intervention tailored to individuals with low fitness and mobility. it was hypothesised that home-hit would 1) have high adherence to the prescribed exercise intensity (compliance) and 2) improve markers of cardiovascular disease (cvd) risk. 32 obese adults with at least 3 additional cvd risk factors (age 36±2 y; bmi 34.3±0.8 kg∙m-2; vo2peak 24.6±1.0 ml∙kg∙min-1), completed one of three 12-week training programmes 3x/week: home-hit (n=9); laboratory-based supervised hit (lab-hit; n=10) or home-based moderate intensity continuous training (home-mict; n=13). adherence and compliance were monitored online in almost "real time" using a heart rate (hr) monitor and mobile app. the home-hit group completed 4 progressing to 8 1min intervals interspersed with 1min of rest in an unsupervised place of their choosing. the intervals were composed of simple bodyweight exercises that required no equipment. changes in vo2peak, insulin sensitivity, body composition, flow-mediated dilation (fmd) and aortic pulse wave velocity (pwv) were assessed. muscle biopsies were taken to assess changes in capillarisation, mitochondrial density, intramuscular triglyceride (imtg) content and enos and glut4 protein expression using quantitative immunofluorescence microscopy.

Eligibility criteria:
inclusion criteria: * obesity (bmi \>30 kg/m2) * age 18-55 exclusion criteria: * diagnosed cvd and other contraindications to participate in an exercise intervention * bmi \<30 kg/m2
clinical trial to assess the effect of food on the pharmacokinetics of yhd1119 in healthy volunteers

Conditions: Peripheral Neuropathic Pain

Summary: this is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of yhd1119 in healthy male volunteers. hypothesis: "yhd1119" is showing equal equal pharmacokinetics in fasted and fed state.

this is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of yhd1119 in healthy male volunteers. group 1: 12 subjects will be assigned and they will be administered yhd1119 in fasted state at day 1 and in fed state at day 8. group 2: 12 subjects will be assigned and they will be administered yhd1119 in fed state at day 1 and in fasted state at day 8.

Eligibility criteria:
inclusion criteria: * healthy male with body mass index(bmi) between 18.5 and 30 kg/m2 * who has not suffered from clinically significant disease * provision of signed written informed consent exclusion criteria: * history of and clinically significant disease * a history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs * administration of other investigational products within 3 months prior to the first dosing * volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ecgs, or vital signs
talking circle for native american youth

Conditions: Mental Health Wellness 1; Behavior, Health; Emotional Stress

Summary: native american youth have higher rates of depression and lifetime major depressive episodes, and, by age 11, are more likely to have initiated alcohol and substance use than any other racial/ethnic group. the covid19 pandemic only compounded this suffering--anxiety, stress, depression, substance use, and suicide related mental health disorders skyrocketed in many native american communities, especially among youth. though many are desperate for help, treatment options are scarce to non-existent. to meet this urgent need, our overarching objective is to leverage the empirically proven, highly effective, school based, talking circle intervention to promote the mental, emotional, and behavioral (meb) health of geographically diverse (rural, urban) native american youth. this study, "talking circle for native american youth living well (a yo li)" uses a community based participatory research (cbpr) approach to evaluate talking circle effectiveness, partnering with the united keetoowah band (ukb) of cherokee indians tribe in oklahoma, with members living in two geographically diverse areas, adair county (rural), and tulsa city (urban). "a yo li" in the ukb tribal language means "youth".

specific aims for phase 1 (ug3) include: ug3 aim 1. to inform adaptation of the school-based talking circle intervention, a community partnership committee (cpc) of ukb members will be developed to conduct a needs/asset mapping process to assess the needs, priorities, and resources for meb health of ukb youth, paying special attention to the nuances of cultural difference between rural and urban ukb communities in oklahoma. ug3 aim 2. to conduct a talking circle intervention facilitator training program with rural and urban ukb tribal community members to catalyze capacity building and sustainability for future intervention. ug3 aim 3. to pilot the adapted evidenced-based talking circle intervention for the promotion of meb health among (n=20) 10 to 12 year-olds ukb youth in oklahoma.

Eligibility criteria:
inclusion criteria: * native american students * english speakers * read and write english * at risk for mental health and behavioral health issues exclusion criteria: * not native american * non-english speakers * not able to read and write english * not at risk for mental health or behavioral health issues

Keywords: mental well-being emotional well-being behavioral well-being
randomized study of hormonal regulation of infantile hemangioma

Conditions: Hemangioma

Summary: objectives: i. evaluate the clinical efficacy of leuprolide, a gonadotropin-releasing hormone agonist (gnrha), in treating infants with vision-endangering or large, disfiguring hemangiomas. ii. assess the impact of gnrha on growth and development during infancy. iii. assess the safety of gnhra in these patients.

protocol outline: this is a randomized, placebo-controlled study. patients are stratified according to gender and by position of the lesion (periorbital vs nonperiorbital). all patients receive oral prednisone daily for 3 weeks. patients are then randomized to receive either placebo or leuprolide im every 3 weeks, while continuing oral prednisone. tumors are assessed at 1, 3, and 6 weeks. if the tumor is not responding, the leuprolide will be administered every 2 weeks. tumors are reassessed at 3 and 6 months, at which point the treatment is stopped. responding patients are observed every 3 weeks for 3 months. if the tumor begins to grow again, leuprolide may be administered for another 3 months. patients whose tumors grow rapidly during treatment may crossover to the alternate therapy, repeat the leuprolide or prednisone therapy, or undergo surgical excision.

Eligibility criteria:
* presence of hemangioma meeting at least one of the following criteria: vision-threatening because of induced astigmatism or occlusion of the visual axis or proptosis severe anatomic distortion compromising function of an organ or creating an unacceptable cosmetic outcome other complications, e.g., kasabach-merritt consumptive coagulopathy, high-output heart failure, etc. * no lesions that are clearly regressing before therapy * no vascular malformations other than juvenile hemangiomas

Keywords: cardiovascular and respiratory diseases hemangioma rare disease
promoting cognitive resilience and reducing frailty in older veterans with bright light therapy

Conditions: Veteran Aged 65 and Older

Summary: frailty is a multifactorial syndrome characterized by vulnerability to stressors that is intricately linked to cognitive impairment and mortality risk. bright light therapy (blt) reduces circadian disturbances by resynchronizing the hypothalamic biological clock via specific wavelengths of light. human trials have demonstrated that blt improves sleep quality and cognitive function in older adults. however, blt has not been examined for use in older veteran populations, particularly the impact on frailty. this randomized trial will assess the feasibility of employing blt to study impacts on frailty, cognition, and sleep in older veterans. findings from this pilot will establish the power and effect size necessary for larger trials to support the use of blt as readily available home-based treatment to improve healthspan of veterans.

promoting cognition and reducing frailty in older veterans with bright light therapy frailty is a multifactorial syndrome characterized by vulnerability to stressors that increases disability and mortality risk. thirty percent of veterans 65 years or older are frail, which is three-times higher than aged matched non-veterans. frailty is intricately linked with cognitive impairment and veterans are particularly susceptible with 14 percent exhibiting cognitive decline, some with early onset as young as 45 years of age. importantly, 70% of frail and cognitively impaired older adults exhibit sleep disturbances, which makes identifying and improving sleep quality an attractive therapeutic strategy to enhance healthspan. furthermore, this is of special interest as 55% of older veterans experience sleep disturbances. the goal of this study is to examine the feasibility of utilizing bright light therapy (blt) as a strategy to improve sleep via reduction of circadian rhythm disturbances. the long-term goal is to assess the potential for improving cognition and reducing frailty in older veterans. blt works by resynchronizing the hypothalamic biological clock via brief exposure to specific wavelengths of light following awakening, which restores melatonin and circadian rhythms. however, blt has not been examined for reducing frailty in older veteran populations. this project will therefore lay the foundation for larger trials the evaluate blt in the treatment and prevention of cognitive disorders and to promote healthy aging.

Eligibility criteria:
inclusion criteria: * participants studied in this project will include 30 men and 5 women of any race who are community dwellers * the investigators seek to recruit relatively healthy individuals that may or may not exhibit early-stage co-morbidities exclusion criteria: * the investigators will exclude individuals without sleep disturbances (psqi \>5) * are morbidly obese (bmi \> 40) * exhibit severe or advanced co-morbidities, or have cognitive impairment

Keywords: sleep aging veteran cognition dementia functional capacity frailty
platelet rich plasma injection versus surgical fixation procedure in management of spondylolisthesis grade1.

Conditions: Degenerative Spondylolisthesis G1

Summary: spondylolisthesis is a serious health condition that is often treated with surgery or pain-relieving lumbar epidural steroids. patients with persistent and debilitating symptoms who have failed to respond to conservative treatment should consider surgery. objectives: the aim of this study was to compare the therapeutic efficacy of three ultrasound guided prp injections of the facet joint capsule to surgical procedures in patients with degenerative spondylolisthesis g1 and their effect on neurogenic pain relief and functional improvement over a one-year follow-up period. methods: a one-year prospective randomised comparative clinical trial was performed on 60 patients with degenerative spondylolisthesis g1 who were randomly assigned to one of two groups: group 1: thirty patients were injected in the facet joint capsule with a series of three ultrasound-guided prp injections at four-week intervals, and group 2: thirty patients underwent surgery. they were exposed to clinical neuropsychological testing.they were assessed for pain and function using clinical neurological assessments, vas (visual analogue scale), fri (functional rating index), roland morris, and odi.


Eligibility criteria:
inclusion criteria: * patients with degenerative spondylolithesis grade 1 were diagnosed based on their clinical and radiological image. * patients complained of extreme pain and received medical treatment (nsaids) without improvement. exclusion criteria: * patients with more than two-level pathological lesions and those who had previously * patients undergone lumbar surgery, * hcv, hbv infected patients, * patients with local abscesses, * diabetes mellitus, * malignancy, pregnancy, * blood disorders (coagulopathy, thrombocytopenia), * patients who had previously received local injection of steroid within past 3 weeks * patients who had undergone lumbar surgery, * patients with advanced spondylolithesis, disc prolapse, * inflammatory or musculoskeletal disorders of the spine.
clinical efficacy and mechanism of rtms based on dlpfc in the intervention of generalized anxiety disorder with insomnia

Conditions: Generalized Anxiety Disorder (GAD); Insomnia; Repetitive Transcranial Magnetic Stimulation (rTMS)

Summary: to investigate the intervention effect of repetitive transcranial magnetic stimulation (rtms) on insomnia symptoms of generalized anxiety disorder patients.

stimulation was performed using a figure 8-shaped focal coil attached to a magpro 100 magnetic stimulator (magventure, copenhagen, denmark). all patients received 1 hz (10 s trains, 1 s inter-train interval, 1,360 pulses per session) rtms treatment once daily on weekdays for 2 consecutive weeks. rtms was delivered over the right dlpfc (f4 electrode site according to the international 10-20 eeg system) at 100% of the resting motor threshold (rmt) . to determine the rmt, stimulus intensity was gradually increased until 5 out of 10 trials elicited motor evoked potentials with peak-to-peak amplitudes over 50 μv in the contralateral abductor pollicis brevis muscle. adverse events attributed to rtms were documented and reported. all participants received a pre-treatment assessment with the psqi, hama, and hamd. we used the psqi to measure sleep quality, as well as hama and hamd to assess participant's anxious and depressive states. likewise, the psqi was measured post-treatment (upon completion of the final treatment session) and at 1-month follow-up.

Eligibility criteria:
inclusion criteria: 1. age between 15 and 65 years; 2. clinically diagnosed with anxiety according to the diagnostic and statistical manual of mental disorders-v (dsm-v); 3. no previous application of any insomnia pharmacological therapy for at least one week before baseline visit. exclusion criteria: 1. current or history of serious brain and body diseases; 2. current or history of schizophrenia, behavioral problems, post-traumatic stress disorder, mania, obsessive-compulsive disorder, and social phobia; 3. substance abuse or other comorbid psychological diseases.

Keywords: generalized anxiety disorder insomnia repetitive transcranial magnetic stimulation