Kornimate/medical-research-clean huggingface dataset:
face-q in blepharoplasty

Conditions: Dermatochalasis of Upper Eyelid

Summary: the aim of this study is to assess the effect of two different suturing techniques in patients undergoing bilateral upper eyelid blepharoplasty on the results of the face-q eye module questionnaire for measuring patient-reported outcomes as well as on the blinded objective assessment by two experienced surgeons using the same questionnaire. we aim to investigate the differences of the 2 most common techniques of skin closure with running cutaneous or subcuticular nylon (6-0 prolene) sutures in upper blepharoplasties and their effect on postoperative complications and scar formation. besides the functional outcomes (visual field) and objective postoperative results, we aim to measure the patients' satisfaction using the face-q eye module as a comprehensive, procedure- and disease-specific patient-reported outcome instrument.


Eligibility criteria:
inclusion criteria * women and men between 18-99 years * with bilateral dermatochalasis and resulting visual field restriction * willingness and ability to comply with regular visits * signed informed consent form exclusion criteria * any disease affecting wound closure/healing such as diabetes, connective tissue disease or non-medically induced bleeding disorders, known autoimmune disease, known tendency for hypertrophic scars or keloids; * untreated hypertension or metabolic syndrome, * smoker * asymmetric brow ptosis, * previous surgery on the eye lids * sequelae after facial nerve palsy * allergy or adverse reaction to any substance or material used. * active or chronic eyelid inflammation pregnant or breast-feeding women: women of childbearing potential (18-50) are not excluded form this study. breastfeeding or pregnant women are however excluded, as bilateral upper eye lid blepharoplasty can be easily postponed.
exercising with a surgical mask in both athletic and non-athletic individuals

Conditions: Healthy

Summary: this study aimed to examine the impact of surgical masks on maximal and submaximal exercise in both athlete and non-athlete individuals.

all participants will be informed about the procedure and, will sign an informed consent form. they will undergone a detailed physical examination before enrollment in the study. the study is conducted in 2-phases, in non-randomized, controlled design. cardiopulmonary exercise tests (cpet) are going to be performed with and without a surgical mask with 48 hours in between.

Eligibility criteria:
inclusion criteria: * healthy athletes * healthy non-athletes exclusion criteria: * any musculoskeletal, cardiac or respiratory problem

Keywords: surgical mask cardiopulmonary exercise test covid-19 (coronovirus-19 disease) exercise
comparison of senza to commercial spinal cord stimulation for the treatment of chronic pain

Conditions: Chronic Low Back Pain

Summary: the purpose of this investigational study is to establish the safety and effectiveness of electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain of the trunk and/or limbs and will be a comparison of the senza system with commercially available scs systems.


Eligibility criteria:
inclusion criteria: * have been diagnosed with chronic, intractable pain of the trunk and/or limbs (vas ≥ 5) which has been refractory to conservative therapy for a minimum of 3 months. * be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician * be 18 years of age or older at the time of enrollment * be willing and capable of giving informed consent * be willing and able to comply with study-related requirements, procedures, and visits exclusion criteria: * have a medical condition or pain in other area(s), not intended to be treated with scs, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator * have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist * have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus * have a diagnosis of scoliosis that precludes lead placement * have an existing drug pump and/or scs system or another active implantable device such as a pacemaker * have prior experience with scs * have a condition currently requiring or likely to require the use of mri or diathermy * have metastatic malignant disease or active local malignant disease * have a life expectancy of less than 1 year * have an active systemic or local infection * be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal) * have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) * be concomitantly participating in another clinical study * be involved in an injury claim under current litigation * have a pending or approved worker's compensation claim

Keywords: back pain spinal cord stimulation
pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the extreme regimen in recurrent or metastatic head and neck squamous cell carcinoma (keynote-669/echo-304)

Conditions: Head and Neck Cancer

Summary: the purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the extreme regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (hnscc).


Eligibility criteria:
inclusion criteria: * measurable disease based on recist v1.1. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate organ function per protocol-defined criteria. * documentation of results from testing of human papilloma virus (hpv) status for oropharyngeal cancer. * baseline archival tumor specimen available or willing to undergo a prestudy treatment tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain the specimen. exclusion criteria: * carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors. * disease progression within 6 months of completion of curatively intended systemic treatment for locoregionally advanced hnscc. * use of protocol-defined prior/concomitant therapy. * known additional malignancy that is progressing or has required active treatment within the past 3 years. * known active central nervous system (cns) metastases and/or carcinomatous meningitis. * active autoimmune disease that has required systemic treatment in past 2 years. * known history of human immunodeficiency virus (hiv) infection. hiv testing is not required unless mandated by local health authority. * known history of or is positive for active hepatitis b (defined as hepatitis b surface antigen \[hbsag\] reactive) or hepatitis c (defined as hcv rna \[qualitative\] is detected).

Keywords: head and neck squamous cell carcinoma programmed cell death 1 (pd-1) inhibitor indoleamine 2,3-dioxygenase 1 (ido1) inhibitor
molecular signatures of relapse in tissue samples from patients with small cell lung cancer who are receiving cisplatin and etoposide

Conditions: Small Cell Lung Cancer

Summary: this pilot research trial studies molecular signatures of the return of cancer after a period of improvement (relapse) in tissue samples from patients with small cell lung cancer who are receiving or planning to receive cisplatin and etoposide. studying samples of tissue from patients with small cell lung cancer in the laboratory may help doctors learn more about the changes that occur in deoxyribonucleic acid (dna) and identify biomarkers related to cancer relapse.

primary objectives: i. to collect and analyze small cell lung cancer (sclc) tumor dna and ribonucleic acid (rna) from 3 human patients before and after relapse to identify the molecular signatures of relapse. outline: previously collected tissue samples are analyzed via rna sequencing and dna methylation at baseline. patients also undergo collection of tissue samples for analysis at relapse.

Eligibility criteria:
inclusion criteria: * any patient seen at norris or county with histologically confirmed sclc, with tissue in the norris cancer center tumor repository * patients must be undergoing or about to start first line treatment with cisplatin and etoposide * patients may not have a second malignancy
trial comparing angiography and angiography with ivus for treatment of hemodialysis access failures

Conditions: Dialysis Access Malfunction

Summary: the reason the investigators are doing this study is to compare the results of angiography versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are blocked.

patients with kidney failure have a fistula or graft for long-term dialysis in order for the dialysis machine to draw blood, filter it, and give it back to the patient. over time, the fistula or graft may not work well enough to use for dialysis, most commonly because the veins may develop "scar tissue" within and around them that narrows the vein resulting in poor flow or complete blockage. these blockages are commonly opened with wires, balloons (a procedure called angioplasty), and stents. these blockages are seen with angiography, a special type of x-ray used with a dye that shows the inside of the blood vessels. intravascular ultrasound (ivus) is a type of imaging that uses sound waves to produce an image of the inside of blood vessels and to see their condition. currently, it is not known if angiography alone or angiography with ivus has better results. the reason we are doing this study is to compare the results of angiography versus angiography with ivus.

Eligibility criteria:
inclusion criteria: * \> 18 years old * male or female (non-pregnant females) * patients with hemodialysis access failure (arteriovenous fistulae or arteriovenous grafts) * patients must undergo elective angiographies (fistulograms) based on surveillance duplex ultrasound findings (stenosis) * patients with outflow stenoses between 1 cm distal to an arterial anastamosis and clavicle in av fistulae or between venous anastamosis and clavicle in av grafts found on surveillance duplex ultrasound exclusion criteria: * patients with other etiologies (inflow lesions, intragraft lesions, hypercoagulable states, lesions not readily amenable to stenting), advanced failures (thrombosis, central venous occlusion), and non-routine access conformations (chest wall/groin grafts, balloon assisted maturation)

Keywords: dialysis fistula dialysis graft stenosis intravascular ultrasound angiography
acute sodium bicarbonate supplementation in athletes

Conditions: Supplementation; Sport

Summary: the purpose of this study is to verify the effect of acute sodium bicarbonate (sb) and placebo (pla) supplementation on buffering potential kinetics, physical capacity, discipline-specific performance as well as concentration of diagnostically significant blood biochemical indices in athletes, in a randomised, double-blind, placebo-controlled crossover trial.

effective muscle work is conditioned by maintaining the proper range of muscles ph, regulated by buffering systems, in which the main role is played by bicarbonates (hco3-). for this reason, sodium bicarbonate (sb) is often proposed as an ergogenic agent, especially during high-intensity efforts. until now the major limitation to sb supplementation has been the gastrointestinal (gi) side effects. there is also a lack of data of the individual sb-induced changes of buffering potential kinetics and its actual connection with physical capacity and discipline-specific performance. therefore, this study aims to examine the effect of acute, different-dose sb ingestion on buffering potential kinetics, physical capacity, discipline-specific performance as well as changes of diagnostically significant blood biochemical indices concentration in athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Eligibility criteria:
inclusion criteria: * written consent to participate, * a current medical clearance to practice sports, * training experience: at least 2 years, * minimum of 4 workout sessions (in the discipline covered by the study) a week. exclusion criteria: * current injury, * any health-related contraindication, * declared general feeling of being unwell, * unwilling to follow the study protocol.

Keywords: sports nutrition sodium bicarbonate physical capacity exercise performance buffering potential biochemical markers
transcutaneous vagal nerve stimulation in veterans with posttraumatic stress disorder

Conditions: Stress Disorders, Post-Traumatic

Summary: this study effects the effects of transcutaneous cervical vagal nerve stimulation (tcvns) or a sham control on brain, physiology, and ptsd symptoms in veterans with posttraumatic stress disorder (ptsd). veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcvns or sham stimulation at home.

description: this study assesses brain function measured with high resolution positron emission tomography (hr-pet) during exposure to stressful traumatic scripts paired with tcvns or sham stimulation, with secondary measures of blood inflammatory biomarkers, and sympathetic function. participants then undergo three months of twice daily home treatment with repeat measures. drug/device handling: \[o-15\] radiolabeled water has a half-life of 110 seconds and is made on site at the emory center for systems imaging (csi). dr. bremner holds the investigational new drug (ind) approval for use of radiolabeled water at emory university. the investigators have performed hundreds of studies in human subjects at emory and there have been no adverse events or untoward effects to date. tcvns with the gammacore device is approved by the emory irb for a recently completed study in ptsd and others in progress for opioid use disorder and was shown to be well tolerated and there have been no adverse events or untoward effects with the device. the fda granted breakthrough device designation for ptsd for the gammacore tcvns device based on the investigators' studies. devices are blinded by electrocore and the devices and information are kept by the data manager under double lock and key. device records are kept by the data manager and stored on redcap or secured research drives. devices are given to the study team along with a device schedule under direct supervision from the investigator.

Eligibility criteria:
inclusion criteria: * veterans between the ages of 18 and 75 will be included with a diagnosis of ptsd based on dsm-5 criteria exclusion criteria: subjects will be excluded with: * a history of mild traumatic brain injury (mtbi) based on va criteria * moderate or greater tbi * positive pregnancy test * meningitis or other neurological disorder * alcohol or substance abuse use disorder based on dsm-5 criteria within the past 12 months * current or lifetime history of schizophrenia, schizoaffective disorder, bipolar i disorder, anorexia nervosa or bulimia, based on dsm-5 * active suicidal ideation with a plan * a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness that would preclude participation based on clinical judgment of the pi * active opiate or benzodiazepine treatment * history of structural abnormality on brain mri or ct if one has been performed in the past

Keywords: stress disorders, post-traumatic ptsd vagus nerve
bilateral hypoglossal nerve stimulation for treatment of obstructive sleep apnoea (blast osa)

Conditions: Obstructive Sleep Apnea of Adult

Summary: the study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the geniotm system in patients with obstructive sleep apnoea (osa).


Eligibility criteria:
main inclusion criteria: * body mass index ≤32 kg/m2 * patients who do not tolerate or do not accept positive airway pressure (pap) treatments. * obstructive apnoea-hypopnea index (ahi) of 20-60 events/hour main exclusion criteria: * unable or incapable of providing informed written consent * unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires * significant co-morbidities making the patient unable or inappropriate to participate in the trial
metabolic and chronobiological changes in vestibular rehabilitation

Conditions: Vestibular Disorder; Metabolic Disease; Sleep Disorder

Summary: the aim of the present study is to evaluate the impact of vestibular rehabilitation on metabolic aspects when evaluated by means of bioelectrical impedenzometry analysis, smart watch device and actigraphy in a group of vestibular hypofunction patients previously studied by means of video head impulse test, posturography and clinical validated scales

recent advances in the field of vestibular-related disorders demonstrated that such conditions may interfere on different pathways underpinning metabolic behaviour, daily life activities and also chronotype behaviour. however, no studies evaluated how vestibular rehabilitation procedures - well established in literature - may interfere on these vestibular-related disorders. on the other side, recent advances in portable bioelectrical impedenzometry devices, smart watches devised to evaluate energy expenditure during daily life activities and actigraphy devices demonstrated to be useful in continuously monitoring different aspects of metabolic, activity and sleep behaviour. thus, the aim of the present study is to evaluate the impact of vestibular rehabilitation on metabolic aspects when evaluated by means bioelectrical impedenzometry analysis, smart watch device and actigraphy in a group of vestibular hypofunction patients previously studied by means of video head impulse test, posturography and clinically validated scales

Eligibility criteria:
inclusion criteria: * unilateral vestibular hypofunction achieved according to accepted criteria, by bithermal caloric irrigation, showing at least 25% reduced vestibular response on one side when calculated by means of jongkees' formula, 3 months or later after symptom onset. in order to avoid confounding factors, and following previous experiences, only subjects presenting with a concurrent reduction in vestibulo-ocular reflex (vor) gain when studied by means of video head impulse test will be included in this study. exclusion criteria: * history of falls, cardiovascular, metabolic, rheumatologic, orthopedic, or other neurological conditions, liver or renal abnormalities. * pregnancy or breastfeeding. * neurological and neuro-psychiatric diseases * insulin-dependent diabetes, vitamin deficiencies, hypothyroidism, lung diseases, hepatitis, chronic kidney failure, and cushing syndrome * medication possibly impacting on cochleo-vestibular function or with a history of drug or alcohol addiction * inability to understand and agree to the examination procedures.
a clinical study of oglemilast in patients with mild to moderate persistent asthma

Conditions: Asthma

Summary: the study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable mild to moderate persistent asthma. the study involves two weeks of run in period. this is a placebo controlled study. one of the four treatment arms is placebo. the duration of treatment is 12 weeks.


Eligibility criteria:
eligibility criteria: * adult patients with a physician-documented diagnosis of chronic, stable, persistent, mild to moderate asthma (clinical symptoms and documented reversibility of airway obstruction, with an fev1 of 60% to 85% of the predicted value). the following criteria must be met at the randomisation visit: * at least 80% compliance during the single-blind placebo run-in period * fev1 between 60% and 85% of the predicted value * without asthma exacerbation during the run-in period * reversibility: patients are required to demonstrate a ≥ 12% increase in fev1 (with an absolute improvement in fev1 of at least 200ml) ≥ 10 min and up to 15 minutes after inhalation of 400 μg salbutamol via a spacer * any symptom score being ≥ 1 for at least 4 out of the last 7 days of the run-in * use of salbutamol for symptom relief on \> 2 occasions on at least 4 out of the last 7 days of the run-in

Keywords: mild to moderate persistent asthma
point-of-care tests for bacterial vaginosis and candidosis

Conditions: Infection, Bacterial; Infection, Fungal; Preterm Birth

Summary: vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. most studies presume that vaginal infections are responsible for up to 40% of preterm birth. although the causative microorganisms of vaginal infections are manifold, the three pathogens most commonly associated with vaginal infections are gardnerella vaginalis, candida albicans and trichomonas vaginalis. the aim of this prospective study is the validation of the point-of-care tests osom bvblue for bacterial vaginosis and savvycheck vaginal yeast test for candidosis in comparison to gram stain.

in the present study, it should be examined whether the osom bvblue for bacterial vaginosis and the savvycheck vaginal yeast test for vaginal candidosis are superior, equal/comparable or inferior to diagnosis on gram stained smears. the point-of-care-tests are potential tools for the adequate diagnosis of bacterial vaginosis and vaginal candidosis in early pregnancy, since the prevention of these infections, as well as the infection screening per se, have the potential to prevent preterm birth and reduce the rate of late abortion. point-of-care-tests are easy to perform, relatively cheap, and widely available. routine implementation of the tests would be an effective contribution to the reduction of preterm labor and late-onset mortality.

Eligibility criteria:
inclusion criteria: * legal age (participants must be 18 years or over) * singleton pregnancy * no recent therapy with antibiotics within the last two weeks * no application of the following in the previous 72 hours before testing: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays exclusion criteria: * age below 18 years * multiple pregnancy * recent treatment with antibiotics * application of the following in the previous 72 hours: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays

Keywords: point-of-care test validation preterm birth bacterial vaginosis candidosis