Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of patients with x-linked retinitis pigmentosa (xlrp)

Conditions: X-Linked Retinitis Pigmentosa

Summary: the purpose of this study is to evaluate subjects with x-linked retinitis pigmentosa caused by rpgr-orf15 mutations in a clinical setting to fully characterize their condition, measure testing variability, and estimate rates of progression of clinical parameters.

males with a clinical diagnosis of x-linked retinitis pigmentosa (xlrp) caused by rpgr-orf15 mutations will be asked to provide informed consent and will have a single blood or saliva sample obtained for dna sequence analysis of genes known to cause xlrp, including the rpgr-orf15 gene. all participants will be informed of the results of testing for these mutations. those with qualifying mutations in the rpgr-orf15 gene will be evaluated every 6 months for 3 years using a variety of non-invasive visual function tests to more fully characterize their clinical condition. testing will include routine ophthalmic examinations and tests of visual acuity, perimetry, oct, fundus imaging, and completion of quality of life questionnaires.

Eligibility criteria:
inclusion criteria: * male subjects with a clinical diagnosis of xlrp and a documented molecular diagnosis from a clia-certified laboratory of mutation within the orf15 exon of the rpgr gene; * at least 6 years of age; * willing and able to perform study procedures; * signed informed consent(s) obtained (and child assent where applicable). exclusion criteria: * pre-existing eye conditions that would interfere with interpretation of study endpoints (e.g. glaucoma, corneal or lenticular opacities, diabetic retinopathy, history of retinal detachment); * participating in an interventional research study of drugs or devices for treatment of xlrp or other retinal diseases; * monoocular participants * any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation.

Keywords: xlrp retinal degeneration rpgr orf15
a study of galeterone compared to enzalutamide in men expressing androgen receptor splice variant-7 mrna (ar-v7) metastatic crpc

Conditions: Prostate Cancer

Summary: the purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mrna (ar-v7) in metastatic (m1) castrate resistant prostate cancer (crpc).


Eligibility criteria:
inclusion criteria: * progressive metastatic (m1) disease on androgen deprivation therapy * detectable ar-v7 from circulating tumors (ctcs) * ecog performance status 0 or 1 exclusion criteria: * prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide) * prior treatment with chemotherapy for crpc
stepped care model of lifestyle-based mental health care for depression

Conditions: Depression

Summary: this study is a two-arm parallel randomised controlled trial comprising both outcome and cost-effectiveness analyses. a total of 244 eligible participants experiencing depressive symptoms will be randomly assigned to either the stepped care model of lifestyle-based mental health care (lsc) or the care-as-usual (cau) at a 1:1 ratio. participants in the lsc will access a stepped care treatment consisting of 3 steps, including self-help multicomponent lm treatment (step 1), guided self-help based on the lm approach and low-intensity cognitive behavioural therapy for depression (step 2), and specialist mental health services (step 3). participants in the cau will be informed about their mental health condition and have unrestricted access to care. for the outcome analysis, the outcome assessments will include depressive symptoms, anxiety symptoms, insomnia symptoms, functional impairment, quality of life (qol), health-promoting behaviours (hpbs), barriers to accessing mental health services, treatment acceptability, and treatment credibility and expectancy. for the cost-effectiveness analysis, the clinical outcome will be depressive symptoms and the economic outcome will be quality-adjusted life-years. data will be collected at baseline, 3-month, 6-month (immediate post-treatment), 9-month follow-up, and 12-month follow-up assessements.


Eligibility criteria:
inclusion criteria: * hong kong residents * aged 18-64 years * able to read and understand cantonese * meeting caseness on the patient health questionnaire (phq-9) (i.e., phq-9 ≥10), with symptoms persisting for four weeks of watchful waiting * possessing an internet-enabled ios- or android-operated mobile device exclusion criteria: * meeting dsm-5 diagnosis of a severe mental illness including psychotic or bipolar disorders as determined by the mini international neuropsychiatric interview 7.0.2 (mini-7) * having a medical condition or neurocognitive disorder that may prevent lifestyle modifications based on the research team's clinical knowledge and experience (e.g., at high risk of fall or dietary change is not suitable as recommended by physicians or dietitians) * significant functional impairment as assessed by the work and social adjustment scale (wsas) (i.e., wsas ≥20) * unstable medication in the past two months * are receiving psychotherapy or other medical procedures (e.g., transcranial magnetic stimulation) for depression * current involvement in lifestyle modifications prescribed by medical (e.g., psychiatrist) or allied health professionals (e.g., clinical psychologists, dietitians) * prominent suicidal ideation or intent (i.e., non-fleeting intent or plan) as measured by the phq-9 item 9 score \>2 (24-hour emergency hotlines and referral information for public mental health services will be provided) * participating in another clinical trial * pregnancy * hospitalisation * unwilling to provide informed consent or comply with the research protocol

Keywords: stepped care model lifestyle medicine randomised controlled trial cost-effectiveness
comparison of 2 tests to diagnose cognitive dysfunctions in alcohol disease

Conditions: Alcohol Use Disorder

Summary: the objective of this study is therefore to compare the results obtained with these two screening tests, using as gold standard the results obtained by the battery of neuropsychological reference tests.

recently, a new screening test for cognitive disorders was specifically developed for patients with uas: bearni (brief evaluation of alcohol-related neuropsychological impairments). since the bearni is presented as the reference test, the investigators have systematically proposed it to hospitalized patients, in combination with the usual check-up. in practice, at admission, patients were therefore given two screening tests, the moca and the bearni. in the event of an anomaly in at least one of these tests, a battery of confirmatory neuropsychological tests was performed.

Eligibility criteria:
inclusion criteria: * patients with alcoo use desorder * patient cared for in the addictology department of the university hospital of nîmes exclusion criteria: * refusal to use the data

Keywords: moca bearni
a study of the safety and tolerance of regadenoson in subjects with renal impairment

Conditions: Kidney Diseases; Coronary Artery Disease

Summary: this study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.


Eligibility criteria:
inclusion criteria: * subject has a stage iii or stage iv renal impairment based on the national kidney foundation (nkf) kidney disease outcomes quality initiative (k/doqi) glomerular filtration rate (gfr) classification * subject has a diagnosis of coronary artery disease (cad) or risk factors for cad as determined by a current medical diagnosis of at least 2 of the following conditions: type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity (body mass index (bmi) \> 30) * subject must abstain from smoking 3 hours prior and 8 hours post study drug administration * subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the follow-up visit, as these foods may reduce the effects of regadenoson derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the follow-up visit, as these foods may reduce the effects of regadenoson exclusion criteria: * subject has a history of an additional clinically significant illness, medical condition, or laboratory abnormality within 2 weeks prior to screening * female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the follow-up visit is complete

Keywords: regadenoson chronic kidney disease stage iii chronic kidney disease stage iv renal impairment coronary artery disease
effectiveness of a walking intervention on impact loading and pain

Conditions: Osteoarthritis, Knee; Knee Pain Chronic

Summary: this study investigates the feasibility of a gait-retraining program for older adults with knee osteoarthritis. the study will enroll 40 participants, with 20 receiving a gait retraining intervention and 20 receiving a graded walking program without gait retraining.

knee osteoarthritis (oa) is a chronic condition affecting \~12% of older adults in the united states and is a leading cause of disability. knee pain is a common clinical manifestation that leads individuals with oa to seek medical care. current rehabilitation approaches (e.g., bracing, taping, foot orthoses, strengthening, etc.) aim to reduce knee joint loading, a well-accepted risk factor for knee oa and pain, but are not always effective. altering gait mechanics to reduce knee loading has also been suggested. gait retraining studies for individuals with knee oa have focused on increasing trunk lean and toe out angle to reduce the knee adduction moment (a surrogate measure of joint loading). however, these strategies create an abnormal gait pattern and may not be the best long-term solutions due to the potential injury to other joints which may limit their overall effectiveness and applicability to clinical practice. impact loading, another mechanical factor related to knee oa, has been reduced using gait retraining strategies in runners with knee pain. it is unknown if gait retraining strategies to decrease impact loading can reduce symptoms of knee oa. thus, the purpose of this study is to determine the feasibility of a gait retraining program focusing on decreasing impact loading in individuals with knee oa. at baseline, following 8 intervention sessions, and at 1-month follow-up, participants will complete questionnaires, undergo three-dimensional gait analysis, and assessment of pressure pain threshold. note: for participants enrolled during covid-19 outbreak, only questionnaires will be collected at follow-up assessments.

Eligibility criteria:
inclusion criteria: subjects with a clinical definition of knee oa using nice guidelines: * age ≥ 45 * walking related joint pain in the last week that averages ≥ 4 on 11-point numeric rating scale, where 0 = no pain and 10 = worst pain possible * history of knee pain for at least 3 months * morning stiffness in the morning lasting less than 30 minutes exclusion criteria: * walk with an assistive device * current use of oral opiates or centrally acting pain medications * history of lower extremity surgery * underwent an intra-articular knee joint injection in the past 3 months * suffer from inflammatory arthritis or other conditions that affect lower extremity functions * currently receiving treatment for their knee and unwilling to stop this treatment for the duration of the study * currently pregnant * skin allergies to adhesives
virtual reality for alleviation of peripheral iv placement-associated discomfort

Conditions: Procedural Anxiety; Procedural Pain; Perioperative Care

Summary: immersive virtual reality (ivr) has been used successfully to manage pain with distraction. it is a non-invasive treatment modality unassociated with worrisome well-known side effects typically seen when opioids and nsaids are used, and has previously been used safely in place of analgesia during dressing changes and burn care. this study investigates whether ivr can be useful as a stand-alone option to manage the pain associated with placement of peripheral intravenous (piv) catheters in adults.

this is a prospective study of the effect of immersive virtual reality on the perception of pain during peripheral iv (piv) placement. adult patients who require piv placement for elective surgery will be consented for intervention while in the peri-operative suites (ps). the vr intervention will consist of a headset and immersive vr software that allows the patient to engage in a virtual world during piv placement. subjects will be queried immediately after piv placement using the validated graphic rating scale regarding the sensory, cognitive, and affective aspects of discomfort they experienced with piv placement (appendix a). they will also be asked two validated questions concerning patient satisfaction (dexter et al 1997). a control group of patients will undergo a similar assessment with slightly different wording after receiving piv placement without ivr.

Eligibility criteria:
inclusion criteria: brooke army medical center patients age 19-89 undergoing peripheral intravenous catheter placement in preparation for elective surgery will be eligible for participation. exclusion criteria: patients will be excluded with head wounds/head bandages preventing the use of a headset, active nausea/vomiting, history of seizure, dementia, psychosis, mania, vertigo, or motion sickness, if the patient is pregnant or incarcerated on the day of surgery, and if the patient is unable to consent self.

Keywords: adult peripheral iv procedural pain procedural anxiety virtual reality peripheral intravenous catheter
efficacy and safety of nitazoxanide for post exposure prophylaxis of covid-19 in household contacts

Conditions: Covid19; SARS-CoV-2 Infection; Households Contacts

Summary: the primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 500 mg, administered three times a day, in relation to placebo in preventing the development of covid-19 in household contacts of patients diagnosed with the disease.

eligible participants (cohabitants of a recently confirmed covid19 case) residing in buenos aires city will be identified by the ministry of health and contacted with the investigators, who will visit them at home and offer to participate. for consenting individuals, a rapid serological test and a nasopharyngeal pcr sample for sars-cov-2 will be performed and participants will be then randomized to ntz or placebo to be taken during 7 days. sars-cov-2 pcr will be repeated on day 14th and the serologic rapid test repeated on day 28th. clinical status of participants will be assessed daily by phone. individuals meeting case definition will be evaluated at home and a pcr will be performed. those with confirmed covid19 case will discontinue study medication and followed until symptoms resolution.

Eligibility criteria:
inclusion criteria: * men and women over 18 and under 65. * household contact with a confirmed case of covid-19 by pcr for sars-cov-2. * initiate study medication within 4 days from the last close contact with the index case. * the patient must not present symptoms suggestive of covid19 (cough, dyspnea, fever\> 37.5 c, fatigue, sore throat, myalgia, diarrhoea) at the time of admission to the study and from previous 14 days. * informed consent from the patient or legal representative. exclusion criteria: * history of infection confirmed by sars-cov-2. * positive igg antibodies test for sars-cov-2 at the time of admission. * have received any dose of nitazoxanide within 7 days prior to screening. * known hypersensitivity to any of the study medication components. * use of any investigational or unregistered drug or vaccine within 30 days prior to screening, or use planned during the study period. * inability to comply with study procedures. * current breastfeeding. * pregnancy. * intolerance or inability to take oral medication. * history of severe liver disease (child-pugh b or c) and/or chronic kidney disease.
comparison of vitrectomy without internal limiting membrane peeling versus inverted ilm flap technique for macular hole retinal detachment in highly myopic eyes

Conditions: Macular Holes; Retina Detachment

Summary: the aim of this study was to determine whether inverted ilm peeling technique could contribute to high reattachment and closure rates after vitrectomy in patients with myopic macular hole retinal detachment (mhrd) in comparison to no ilm peeling. this retrospective study will include 40 patients presenting by myopic macular hole retinal detachment. exclusion criteria will include history of trauma, choroidal neovascularization, and the presence of a peripheral retinal break or proliferative vitreoretinopathy before the initial surgery. subjects will be divided into 2 groups; group 1 will include 20 patients that were treated by vitrectomy without ilm peeling and postoperative gas or silicone oil tamponade with or without cataract surgery. group 2 will include 20 patients that were treated by vitrectomy with ilmflap technique and postoperative gas or silicone oil tamponade with or without cataract surgery.


Eligibility criteria:
inclusion criteria: macular hole retinal detachment in high myopic eyes. - exclusion criteria: * eyes with previous vitreoretinal surgery, trauma, diabetic retinopathy, retinal vein occlusion, uveitis, and other retinal diseases were excluded.
cerclage for prevention on preterm birth in women with placenta previa

Conditions: Premature Birth; Placenta Previa

Summary: the purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.

the purpose of this study is to perform a large multi-center randomized trial comparing the role of cervical cerclage versus expectant management in women with placenta previa presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of gestation. in addition, the role of fetal fibronectin (ffn) for the prediction of preterm birth and hemorrhage will be elucidated. the hypothesis is that placement of a cervical cerclage between 18w0d to 26w0d in patients with a short cervix and complete placenta previa will decrease preterm birth as compared to expectantly managing these patients.

Eligibility criteria:
inclusion criteria: * singleton pregnancy, ≥ 18yrs old * ga 18w0d to 26w0d inclusive @ time of enrollment * documentation of complete placenta previa (≥ 10mm over internal os) * agrees to participate in trial and signs/date an informed consent form. exclusion criteria: * contraindication to expectant management (i.e. active labor, non-reassuring fetal heart rate (nrfhr), intrauterine fetal demise (iufd), uncontrolled hemorrhage) * fetal condition likely to cause serious neonatal morbidity independent of ga (e.g. hydrops, fetal viral infections, fetal malformations likely to need surgery like hydrocephalus, neural tube defects, cardiac defects, abdominal wall defects) * known uterine anomaly at time of enrollment * history of two or more prior cesarean deliveries * suspected placenta accrete, increta or percreta on us at enrollment * cervical cerclage present at time of enrollment

Keywords: premature birth placenta previa
development of a medical device utilizing an eeg-based algorithm for the objective quantification of pain

Conditions: Chronic Pain

Summary: obtained 19 lead eeg data from 50 chronic pain patients along with their clinical history and self-reported pain scored. machine learning was used to analyze the eeg data and derive a chronic pain biomarker.


Eligibility criteria:
inclusion criteria: * male and female chronic pain patients * patients between the ages of 18-85 years * patients exhibiting the presence of symptoms in excess of 3 months duration * patients suffering from neuropathic (e.g., lower back pain), osteoarthritis, or muscular skeletal pain * patients with evidence of pathology related to the painful condition on which diagnosis was made (e.g., results of imaging or diagnostic pain code) * patients with nrs pain scores across the full range (1-10) at the time of testing exclusion criteria: * patients with medically diagnosed psychotic illness * patients with medically diagnosed drug or alcohol dependence in the past 12 months * patients with a medical history of head injury with loss of consciousness and amnesia (within the last 2 years) * patients with skull abnormalities that preclude the proper placement of the electrodes for the eeg data acquisition * patients who have a spinal cord stimulator, or other implantable devices * patients for whom the source of pain at the time of the evaluation is associated with: neurological disorders (multiple sclerosis, parkinson, dementia), diabetes, migraines, or those with reflex / sympathetic dystrophy disorder/complex regional pain syndrome, fibromyalgia, or visceral pain * patients with cancer * patients on workers compensation or disability * patient on anticonvulsant medication * patients who have a history of seizures
evaluation of newborns presenting with suspected covid 19

Conditions: Viral Infection

Summary: this study evaluates the newborns who had respiratory symptoms at the neonatal intensive care admission


Eligibility criteria:
inclusion criteria: * all newborns who had respiratory symptoms at the nicu admission exclusion criteria: * congenital abnormalities

Keywords: newborn covid infection viral infection
oxygen saturation patterns in post-op patients at risk for obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this study will include patients who have major surgery and are at risk for or have been diagnosed with sleep apnea. the patients will be monitored the night after surgery for repeating episodes of reduced breathing and oxygen levels. the study will determine if episodes of decreased breathing are reflected in the oxygen monitor.

there is no further detailed description available.

Eligibility criteria:
inclusion criteria: * patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery. * patient must require analgesia and/or sedation postoperatively by any route (intravenous, intramuscular, oral, epidural or intrathecal) for the duration of the study * postoperative patients with at least one anticipated over night stay on the general ward with a minimum length of 14 hrs. * patients in the asa category 1-4 * patients at high risk for obstructive sleep apnea (osa) as identified by the stop-bang questionnaire or patients previously diagnosed with osa and not using a cpap device. (no screening with stop needed for these patients.) * spontaneous breathing exclusion criteria: * age less than 18 years * patients receiving or anticipated to receive postoperative positive airway pressure support * previous allergic/contact reactions to adhesives * patients unable to give informed consent * pregnancy