Kornimate/medical-research-clean huggingface dataset:
comparison of image based robotic total knee arthroplasty vs imageless augmented reality assisted total knee arthroplasty

Conditions: Knee Osteoarthritis; Total Knee Arthroplasty\(TKA\); Total Knee Replacement Surgery

Summary: this study compares the accuracy of two different techniques in placing a total knee replacement. in one technique, accurate instrument placement is facilitated by a robot, and in the other technique, augmented reality is used for correct instrument placement. both surgical techniques are already commonly used. during both the robotic technique and the augmented reality technique, the additional information (angles - axes) obtained during the operation is used to optimize the placement of the various prosthesis components. patients that were recently diagnosed with advanced osteoarthritis of the knee can participate in this study. this means that the cartilage of the knee is affected by wear and tear. this causes pain, stiffness and swelling resulting in reduced mobility. when non-operative treatments are insufficient in treating the osteoarthritis, surgery is proposed wherein a knee arthroplasty is performed. the goal of this study is to further optimize and personalize patient care. additionally, the aim of the study is to investigate whether both techniques are equivalent in optimally placing the prosthesis and whether both techniques lead to comparable results.


Eligibility criteria:
inclusion criteria: * subjects from 18 years up to 85 years old * patients eligible and planned for a primary total knee arthroplasty * patients willing to sign the informed consent form (icf) for participating in this study * indication of surgery is primary osteoarthritis exclusion criteria: * revision knee surgery * other medical conditions contributing to the rehabilitation process of the tka according to the surgeon, such as parkinson's disease, dementia, multiple sclerosis and cerebral vascular accident * the patient received a tka within the last three months or has a tka planned in the next three months, for the contralateral knee * patient is participating in another clinical trial * patient is not able to understand dutch, french or english * patients who did not meet all of the inclusion criteria

Keywords: total knee arthroplasty (tka) knee osteoarthritis assistive technologies robotics augmented reality
individual response to different volumes of resistance training

Conditions: Healthy

Summary: the literature is not clear as to which training volume to employ during initial phases of resistance training programs to ensure optimal muscular adaptations. the purpose of this study is therefore to compare effects of strength training with low versus moderate volume on muscular function and hypertrophy in previously untrained, healthy individuals. furthermore, the investigators will relate individual variation in responses to proxy markers of individual training state, such as baseline muscular function and muscle fiber type. the study will include 25 women and 25 men and will consist of a 12-week resistance training protocol. each study participant will act as their own control, performing both the low- (1-set) and the moderate-volume (3-sets) protocol, allocated to either the dominant or non-dominant leg, in a stratified and randomized fashion. primary outcome measures are thigh muscle cross section area and unilateral knee extension strength. additionally, muscle fiber type composition will be evaluated as well as additional parameters of muscular function. the primary hypothesis is that low-volume protocols will be beneficial for individuals with glycolytic muscle phenotypes, whereas the opposite will be true for individuals with more aerobic phenotypes.


Eligibility criteria:
inclusion criteria: * healthy * non-smoking * able to tolerate resistance exercise training exclusion criteria: * presence or history of cardiovascular, metabolic, endocrine or neuromuscular disease * diagnosed mental health disorder * intolerance to local anesthetic * no experience with exercise training * performing regular resistance training (more than 1 session per week during last 12 months) * impaired strength/ neuromuscular function due to previous injury * recurrent pain in lower back, knee or shoulders * taking prescribed medication that may affect outcome of training intervention

Keywords: muscle hypertrophy strength resistance training exercise physical fitness health physical conditioning
clinical assessment of a customized free-form progressive addition lens spectacle

Conditions: Presbyopia

Summary: the purpose of this study was to compare objective clinical measures of visual performance and subjective measures of satisfaction and preference between standard progressive addition lens (pal) spectacles and a new type of free-form surfaced, optically customized pal spectacle.

in a double-masked crossover trial, 95 experienced wearers wore customized free-form pal spectacles (test) and standard non-free-form pal spectacles (control) for one week each. all subjects wore both test and control spectacles, and the pair to be worn first was randomly assigned. at dispensing and after 1 week of wear, subjects were tested for distance and near visual acuity (va) under both high and low contrast; in addition, 30 degree off-axis va was measured using a novel apparatus, as was the horizontal extent of undistorted vision at reading distance. subjects also completed a set of questionnaires detailing their satisfaction levels, adaptation times, and preferences for test or control spectacles for different visual tasks.

Eligibility criteria:
inclusion criteria: * presbyope * experienced pal spectacle wearer * correctable to at least 20/25 in both eyes * able and willing to use test and control spectacles for 1 week each as primary form of presbyopia correction * able and willing to complete all laboratory measurements and questionnaire batteries exclusion criteria: * purchasing free-form pal spectacles from the uc berkeley eyewear center * having eye conditions or diseases that could potentially cause a decrease in visual acuity over the course of participation in the study * having eye conditions or diseases that could potentially interfere with ability to use test and control spectacles as primary form of presbyopia correction

Keywords: progressive addition lenses customized free-form presbyopia bifocals subjective assessment visual performance visual acuity amsler grid
stress induced by screening for retinopathy of prematurity - should speculum and indentation rather be avoided

Conditions: Retinopathy of Prematurity

Summary: the purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of prematurity eye examination (ropee) screening without the use of a lid speculum and scleral indentation (speculum-free, spf) is less painful/stressful than funduscopy with speculum (sp) and scleral indentation.

a prospective randomized cross-over study was conducted for the comparison of the two techniques of funduscopy for ropee screening, i.e. with (sp) or without (spf) the use of a speculum and indentor. a random number table was used to allocate participants into either a) receiving sp funduscopy on their first and spf on their second screening examination a week later, or b) receiving spf first and sp a week later.

Eligibility criteria:
inclusion criteria: preterm neonates undergoing screening for rop, i.e. * with ga \< 32weeks and/or bw \< 1501grams * infants of greater bw and ga with increased comorbidity, e.g. sepsis, prolonged need for oxygen supplementation etc., as judged by the attending neonatologist exclusion criteria: 1. severe clinical condition with unstable vital signs to the extent that stress is not desired and the examination need to be postponed. 2. diagnosis of traumatic apoptosis of the corneal epithelium / corneal ulcer. 3. neonates under sedative/analgesic treatment. 4. intraventricular hemorrhage (iii,iv degree), moderate/severe neurological impairment, other conditions that could alter pain response.
covalent tolerance induction to factor viii-prediction of inhibitors in hemophilia

Conditions: Hemophilia A

Summary: to correlate the human leukocyte antigen type and genetic defect with hemophilia a.

one of the most serious complications of treatment in patients with hemophilia a or hemophilia b is the development of an inhibitor, which is an antibody that neutralizes the factor viii or ix coagulant activity. up to one fourth of patients with severe hemophilia a develop an inhibitor but at present it is not possible to predict which patients will develop such antibody. the ability to predict an inhibitor development at an individual level would greatly improve therapeutic approach to this serious problem

Eligibility criteria:
inclusion criteria: * severe hemophilia a with an inhibitor level of 0.6 b.u. or higher exclusion criteria: * severe hemophilia a with a negative inhibitor

Keywords: inhibitors
different stimuli were given to patients with chronic pure tone tinnitus to verify the effective treatment of tinnitus.

Conditions: Tinnitus; Acoustic Stimulation; Somatic Stimulation; Vestibular Stimulation

Summary: in this experiment, patients with chronic pure tone tinnitus were divided into three groups to receive auditory stimulation, somatosensory stimulation, vestibular stimulation and combined stimulation, in order to find an effective way to treat tinnitus

120 patients with chronic pure tone tinnitus over 6 months were randomly divided into 6 groups, one group was given auditory stimulation, one group was given somatosensory stimulation, one group was given auditory stimulation + somatosensory stimulation, one group was given auditory stimulation + vestibular stimulation, the last group was given auditory stimulation + somatosensory stimulation + vestibular stimulation.

Eligibility criteria:
inclusion criteria: * pure tone tinnitus * unilateral and bilateral * female and male * tinnitus has a history of more than 6 months exclusion criteria: * pulsatile tinnitus of blood vessel * meniere's disease * chronic headache * neurological diseases (such as brain tumors) * patients with mental / mental illness undergoing treatment * pregnant women and patients with other untreatable diseases

Keywords: tinnitus stimulation
physical fitness in autism

Conditions: Autism

Summary: although there are some studies investigating the physical activity levels of children with autism in the literature, no comprehensive study investigating the relationship between posture and physical fitness parameters, family anxiety level and quality of life of individuals with autism who have continued physical activity program has not been found. the aim of our study is to compare postural disorders and physical fitness parameters, family anxiety level and quality of life between individuals with autism and healthy individuals attending physical activity program.


Eligibility criteria:
inclusion criteria: 1. being diagnosed with mild to moderate autism, 2. to have the ability to emulate, 3. to have a cognitive level and cooperation capacity that will not hinder the implementation of assessment scales, exclusion criteria: 1. having any systemic chronic disease and neurological disorder 2. during the last 6 months, individuals wih autism in the process will affect physical fitness for fracture, surgery and so on.
a treatment combination for patients with unresectable stage iii or stage iv melanoma

Conditions: Melanoma

Summary: the objectives of this study are to compare the anti-tumor activity as measured by progression free survival (pfs) and tolerability of sorafenib in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin in combination with placebo in subjects with unresectable stage iii or stage iv melanoma who progressed after receiving only one prior therapy containing dacarbazine (dtic) or temozolomide (tmz).


Eligibility criteria:
inclusion criteria: * subjects who have a life expectancy of at least 12 weeks * subjects with histologically or cytologically confirmed unresectable (stage iii) or metastatic (stage iv) melanoma * subjects must have progressed after receiving at least one cycle of dtic or tmz containing regimen * subjects who have an ecog ps of 0 or 1 * measurable disease defined as at least one lesion that can be accurately and serially measured per the modified recist criteria exclusion criteria: * primary ocular or mucosal melanoma * previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta \[noninvasive papillary carcinoma\], tis \[carcinoma in situ: "flat tumor"\]\& t1 \[tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 5 years prior to study entry * history of cardiac disease * known history of human immunodeficiency virus (hiv) infection
effect of depletive lumbar puncture on lower urinary tract dysfunction in inph

Conditions: Normal Pressure Hydrocephalus

Summary: lower urinary tract dysfunction in normal pressure hydrocephalus has received little attention from the scientific community. urinary symptoms in normal pressure hydrocephalus are mainly represented by overactive bladder, which is a significant burden for the concerned patients. a harmonization of neuro-urological practices in the pre-therapeutic evaluation of patients suffering from normal pressure hydrocephalus is necessary. the investigators conducted a bicentric prospective study aiming to evaluate the effect of depletive lumbar puncture on urinary symptoms in inph. the secondary objective was to evaluate, in the same participants previously diagnosed, the effect of cerebrospinal fluid shunt surgery on urinary symptoms.

prospective study interventional but non invasive bicentric in two universitarian hospitals in france on a cohort of patients presenting at least two out of three symptoms of the classic triad (urinary symptoms, cognitive symptoms and gait disturbance) and enlargement of ventricles non explained by cortical atrophy. participants are offered, as routine care, a diagnostic evaluation of the effect of depletive lumbar puncture on these triad symptoms (this exam is part of routine care). before the planned lumbar puncture, the participants are requested to participate to the study, with written consent and information given. the participants are requested to fill in a usp (urinary symptoms profile, validated international questionnaire) questionnaire and a micturition calendar. the same urinary evaluation is made 5 days after lumbar puncture. gait and cognition are evaluated as in routine practice. of the participants initially evaluated, some will be proposed shunt surgery (routine care). these participants will be proposed to fill in the same questionnaire and micturition calendar around 3 months after shunt surgery (post operative evaluation).

Eligibility criteria:
inclusion criteria: * 2/3 symptoms triad : gait disturbance + cognitive disturbance + urinary symptoms * ventricular enlargement non explained by cortical atrophy exclusion criteria: * analphabetism or not french speaking * cognitive disability making understanding of study impossible (as informed consent)

Keywords: lower urinary tract dysfunction urinary incontinence normal pressure hydrocephalus overactive bladder
a pharmacokinetic analysis of posaconazole in lung transplant recipients (mk-5592-105)

Conditions: Fungal Infection

Summary: this single site study will examine plasma and alveolar compartment (ac) levels of posaconazole in cystic fibrosis (cf) and non-cystic fibrosis (non-cf) lung transplant recipients receiving routine post-operative anti-fungal prophylaxis. invasive fungal infection rates will be assessed following transplantation.


Eligibility criteria:
inclusion criteria: * scheduled to undergo lung transplantation * able to take oral/nasogastric medication * females of childbearing potential, males, and the sexual partners of males must use an effective method of birth control during this study and for 6 weeks after completing the study. exclusion criteria: * severe liver disease * current use of cytochrome p-450 (cyp)-3a4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days before transplant * treatment with posaconazole within 14 days before transplant * breastfeeding
efficacy of a new sweat collection support: impact on neonatal screening and early treatment of cystic fibrosis

Conditions: Cystic Fibrosis

Summary: in nearly 25% of children under 3 months, the sweat test produces a quantity of sweat that does not meet international recommendations and is insufficient to allow reliable and reproducible biological analyzes in the sweat collected. in children between 3 and 12 months, this rate is about 10% when it should not exceed 5%. insufficient amount of sweat prevents confirmation or reversal of the early diagnosis of cystic fibrosis and early treatment before irreversible complications of the disease. in this trial, a new support of sweat collection (macroduct® advanced model 3710 sweat collection system, wescor) will be tested with the goal to increase the amount of sweat collected during the sweat test, in comparison with the clinical routine method.


Eligibility criteria:
inclusion criteria: * subject aged of 2 days to 12 months * indication of a sweat test prescribed by a clinician in a context of neonatal screening * clinically stable * well hydrated * not under treatment with mineralocorticoids exclusion criteria: * subjects weighing less than 2 kg * subjects less than 48 hours old * presence of an acute infectious condition * presence of mineralocorticoid treatment

Keywords: cystic fibrosis children
the effects of fish oil supplementation on the brain health of collegiate football athletes

Conditions: Traumatic Brain Injury (TBI); Chronic Traumatic Encephalopathy (CTE)

Summary: determine if the daily docosahexaenoic acid (dha)/eicosapentaenoic acid (epa) supplement will reduce serum levels of biomarkers of sub-concussion injuries over a course of american football season among collegiate football athletes.

american football is one of the most popular sports in the u.s. yet this sport is associated with increased risk of concussion (also known as mild traumatic brain injury, or mtbi) and sub-concussive injury from repeated head impacts (rhi) due to the aggressive and high-speed nature of the game. current protective equipment used by players are not sufficient to reduce concussion incidence and severity, nor are there any therapeutics available to prevent concussion. this study is a randomized, double-blind, placebo controlled trial to determine if an omega-3 polyunsaturated fatty acid (pufa) fish oil supplement containing 3.0 grams of docosahexaenoic acid (dha; 22:6n-3) and eicosapentaenoic acid (epa; 20:5n-3) can reduce blood biomarkers of sub-concussion injuries compared to placebo (high-oleic safflower oil) over a course of the american football season among collegiate football athletes. the dosage of dha/epa used in this study is generally safe, and procedures involved, monthly blood draws, surveys, and magnetic resonance imaging (mri), pose minimal risks to participants. while this study provides no direct benefit to participants, successful outcomes of this study can benefit the society by shedding light on development of potential preventative therapeutics for sports-induced mtbi and brain injury from rhi. the risk-benefit profile is appropriate for conducting this study. based on preclinical studies and previous clinical study results, the investigators expect that in comparison to placebo treatment, dha and epa treatment throughout the course of one american football season can maintain lower levels of sub-concussion associated biomarkers, inflammatory cytokines, and cardiovascular risk markers. the investigators also expect participants treated with dha and epa to have lower brain mri imaging markers of sub concussion injury.

Eligibility criteria:
inclusion criteria: 1) university of arizona national collegiate athletic association (ncaa) division i american football athletes cleared to participate in university athletics as determined by the team physician. exclusion criteria: 1. chronic daily anti-inflammatory drugs (\>20 d). 2. medications for blood lipids. 3. active fish oil or omega-3 fatty acid supplementation. 4. consumption of more than two servings of fish per week. 5. injured and unable to participate in regularly schedule conditioning or competitions. 6. acute concussion experienced within 30 days of starting the study. 7. fish allergies.

Keywords: cte (chronic traumatic encephalopathy) mtbi (mild traumatic brain injury) concussion mri nf-l (neurofilament light chain) biomarker football
hyperoxia during pulmonary rehabilitation in chronic lung disease - does it matter?

Conditions: Chronic Obstructive Pulmonary Disease; Asthma; Pulmonary Hypertension; Interstitial Lung Disease; Chronic Lung Disease

Summary: chronic respiratory diseases are a global burden. treatment options have improved in recent years, pulmonary rehabilitation plays a key role. oxygen therapy is recommended in patients with a low saturation at rest, but no clear guidance is given for patients who desaturate during exercise. the effect of ambulatory oxygen during exercise is not yet completely understood, especially in those patients with exercise-induced desaturation. aim: the goal of this study is to analyse the effect of supplemental oxygen given during a constant work rate exercise test (cwret) on a cycle ergometer compared to sham air. methods: we plan to include 25 patients respiratory patients undergoing pulmonary rehabilitation (male and female; aged \>18 years; stable condition \>3 weeks (e.g. no exacerbations); resting oxygen saturation (spo2) ≥ 88%) with exercise induced hypoxemia defined by a fall in oxygen saturation by ≥ 4% during a 6-minute walking test. patients will undergo an incremental exercise test with a ramp protocol (for evaluating the maximal workload) and two cwret (75% of the maximal workload) with ambulatory oxygen or placebo (sham air) via standard nasal canula at a flow rate of 5l/min. patients and assessors will be blinded. the difference endurance time of the cwret with oxygen vs. sham air will be the primary outcome of this study. data will be summarized by means (sd) and medians (quartiles) for normal and non-normal distributions. effects of treatment will be evaluated by mean differences with 95% confidence intervals, t-tests or wilcoxon matched pair tests as appropriate. a p-value threshold of \<0.05 or a confidence interval not including zero will be considered as statistically significant. analyses will be performed according to the intention to treat principle.


Eligibility criteria:
inclusion criteria: * we will include male and female lung disease patients undergoing pulmonary rehabilitation: aged ≥ 18 years; stable condition \> 3 weeks (e.g. no exacerbations); resting oxygen saturation (spo2) ≥ 88% and exercise induced hypoxemia defined by a fall in spo2 by ≥ 4% during a 6-minute walking test (6mwt); informed consent as documented by signature. exclusion criteria: * severe daytime resting hypoxemia (spo2 \< 88% or partial pressure of oxygen (pao2) \< 8 kpa); unstable condition requiring adaptation of pharmacologic and other treatment modalities or requirement of intensive care or relevant severe concomitant disease; inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability or inability to ride a bicycle; women who are pregnant or breast feeding; enrolment in another clinical trial with active treatment.