Kornimate/medical-research-clean huggingface dataset:
retrospective analysis of procedural aspects of transcatheter aortic valve implantation (tavi) on peri-procedural stroke

Conditions: Aortic Valve Stenosis

Summary: retrospective analysis of all patients receiving tavi in the united kingdom (uk). stroke rates following tavi are roughly 3%. there are several device and procedure related characteristics which may increase the risk of stroke. we will examine if there is a signal in the uk registry. this will be important is tavi is to be extended down to lower risk patient cohorts.

retrospective analysis of all patients receiving tavi in the uk. stroke rates following tavi are roughly 3%. there are several device and procedure related characteristics which may increase the risk of stroke. we will examine if there is a signal in the uk registry. this will be important is tavi is to be extended down to lower risk patient cohorts. factors to be examined include (but not limited to): need for pre-procedure balloon aortic valvuloplasty (bav) need for two valves need for post-dilatation need for rapid ventricular burst pacing

Eligibility criteria:
inclusion criteria: * had tavi procedure in uk exclusion criteria: * nil
enhanced recovery after bilateral reduction mammaplasty

Conditions: Pain

Summary: this single-center, clinical trial is being conducted to determine whether non-narcotic pain regiments are as effective as narcotic-based regiments in reducing post-operative pain in patients undergoing breast reduction in the outpatient setting.

this is a non-blinded, non-inferiority, randomized control trial with the primary outcome of interest being overall pain, with secondary outcomes including adverse effects from pain medications, patient satisfaction with their pain regiment and with their surgery, and the impact of pain on their daily activities. this study is designed to follow one-hundred (100) qualified and consenting patients seeing the pi/surgeon (jmk) at his office at ut southwestern for their initial operative consultation for macromastia. if patients meet eligibility criteria, they will be offered enrollment in the trial.

Eligibility criteria:
inclusion criteria: * patients undergoing bilateral breast reduction (reduction mammaplasty) with the pi in the outpatient setting * age 18 and older * bmi less than 40, non-smokers. exclusion criteria: * age less than 18, * bmi over 40, * smokers, * uncontrolled diabetes, * american society of anesthesiologists (asa) status scores 3 or higher * patients with allergies to any of the medications in the eras or current practice regiments (gabapentin, celecoxib, ketorolac, ondansetron, or hydrocodone). * history of narcotic or iv drug abuse * history of chronic pain * hypersensitivity or allergy to any of these drugs: gabapentin, celecoxib, ketorolac, hydrocodone, ibuprofen or acetaminophen * current pregnancy or planning pregnancy in the next xx weeks/ months * contraindications to nsaid drugs (ketorolac, ibuprofen, celecoxib): coagulation disorder, active bleeding, severe renal impairment, hepatic impairment. * contraindications to gabapentin: caution for crcl \<60, caution in elderly, caution if alcohol consumption * contraindications to acetaminophen: hepatic or renal impairment, chronic alcohol use
prospective comparison of the tuberculin skin test and interferon-gamma release assays in diagnosing infection with mycobacterium tuberculosis and in predicting progression to tuberculosis

Conditions: Latent Tuberculosis Infection; Tuberculosis

Summary: this is a prospective cohort study of persons tested for latent tuberculosis infection at either high risk for exposure to mycobacterium tuberculosis or high risk for progression to tuberculosis disease. the study will assess the relative performance and cost of three diagnostic tests for latent tuberculosis infection (tuberculin skin test, quantiferon-tb gold in-tube, and t-spot.tb) and will examine the rates of positive results among the cohort. this study will also determine the risk and rate of progression to active tb disease, overall and by the results of the three tests.


Eligibility criteria:
1. study participants must be at high risk for latent tuberculosis infection or at high risk for progression to tuberculosis disease, including being a: • close contact of a person with pulmonary tuberculosis who is part of a current contact investigation and the index/source case meets the following criteria: 1. culture-positive, or 2. culture-negative and smear positive and nucleic acid amplification test-positive. participants may be enrolled before the culture results for the index/source case are available. if the criteria described above are not met once results are available, the participant will be terminated from the study and any collected data will be immediately destroyed. a close contact is defined as spending 15 or more hours over a week's period in a shared airspace with a person with active pulmonary tuberculosis while that person was presumed to be infectious. * foreign-born person from a high risk country. * foreign-born person from a medium risk country who moved to the united states within the past 5 years. * person who has spent at least 30 days in total in a high risk country within the last 5 years. * person belonging to a population with a prevalence of latent tuberculosis infection ≥ 25% as demonstrated by local surveys. these populations will vary by site; examples include mexican immigrants in san diego, california or homeless drug users in baltimore, maryland. * hiv-positive person. 2. study participants (or a parent/guardian, if applicable) must be willing and able to provide informed consent. 4.2 subject exclusion criteria subjects meeting any of the exclusion criteria will be excluded from study enrollment. 1. people with known current active tuberculosis. 2. people with a previous anaphylactic reaction to tuberculin. 3. persons currently being treated for latent tuberculosis infection. 4. persons anticipating or scheduled to permanently leave the united states (e.g., tourists, visiting scholars, exchange students) in less than 2 years from the time of proposed study enrollment. 5. foster children.

Keywords: t-spot.tb quantiferon-tb gold in-tube latent tuberculosis infection tuberculin skin test discordance predictive value tuberculosis disease development
pain and bleeding following hypertonic saline sclerotherapy compared to brand ligation for symptomatic hemorrhoids

Conditions: Hemorrhoids; Bleeding; Pain

Summary: the investigators aim at prospectively comparing procedural pain, adverse events and rebleeding rates of anoscopic rubber band ligation and endoscopic hypertonic saline injection in patients with symptomatic hemorrhoidal disease

hemorrhoidal disease is a common encounter in a gastroenterologist's practice. these are often symptomatic, either bleeding or prolapsing. there are no set guidelines in our institution (the american university of beirut medical center - aubmc) for the treatment of symptomatic hemorrhoidal disease. two types of treatment are available at our institution: anoscopic rubber band ligation (rbl) or endoscopic sclerotherapy (esc) with hypertonic (20%) saline. both methods have been shown to be effective in the literature, with above 75% complete symptomatic relief from a single application after 8-12 months. post procedural pain of rbl in two randomized studies ranged 40-47%, while different studies showed post procedural pain following esc to be 12-39%. however no study has ever compared these two therapeutic methods head-on, neither has any study compared both procedures for tolerability and rebleeding rates. research design and methods: this study is a randomized, prospective study conducted at the american university of beirut medical center which will involve 30 patients suffering from symptomatic hemorrhoidal disease requiring therapeutic intervention. patients meeting inclusion criteria will be randomized using a computer generated randomization list to either rubber band ligation (rbl) or hypertonic saline sclerotherapy as a therapeutic interventional procedure. - patients will be approached by their gastroenterologist during clinic visits and informed about the study. if participants wish to take part in the study, they will be given additional study information, screened for inclusion criteria, and consented by the research assistant or clinic nurse. recruitment and randomization will occur during the same visit after patient consent in order to properly schedule patients for their therapeutic interventional procedures. all rubber band ligations will be performed by one endoscopist and all sclerotherapies will be performed by the other endoscopist.

Eligibility criteria:
inclusion criteria: * age 18+ * consent to the study * bleeding grade 1,2 and 3 hemorrhoids exclusion criteria: * age under 18 years * refusal to sign consent * prior surgical and non surgical hemorrhoid procedure/manipulation * external hemorrhoids * thrombosed hemorrhoids * active anal fissure * active anal fistula * immunocompromised * grade 4 internal hemorrhoids * chronic pain requiring analgesics * antiplatelets and anticoagulation intake other than aspirin

Keywords: pain bleeding hemorrhoids band ligation hypertonic saline sclerotherapy
efficacy of antenatal maternal supplementation with gos/inulin prebiotics on atopic dermatitis prevalence in high-risk one-year-old children

Conditions: Dermatitis, Atopic

Summary: allergies are increasing worldwide affecting 30-40% of the population. among this, atopic dermatitis (ad) is the earliest and the most common manifestation of allergic diseases (prevalence 20%). recent studies have shown that allergies were associated with a disruption of the gut microbial 'balance' suggesting that the use of nutritional intervention very early in life may restore an optimal pattern of microflora aiming at improving the host's health. so far, most human intervention studies have mainly focused on improving postnatal infant colonization. our study will test the hypothesis that a maternal antenatal prebiotics (gos/inulin) supplementation may be superior to placebo for ad prevention in high-risk children.

study design : inclusion visit at 20 weeks of gestation : * randomization * start of supplementation (gos/inulin or placebo) phone call at 24 weeks of gestation : * checking tolerance * checking observance 32 weeks of gestation visit : * replenishment of prebiotics * collect of ae day 1 : assessment of the transepidermal waterlos evaluated by a tewameter delivery/per partum visit at m3 : the national recommendations for the dietary diversification of the child will be transmitted to the patients at m6 : evaluation of ad prevalence by parents at m12 : pediatric dermatology consultation * clinical exam of child * the scorad * the poem questionnaire * prevalence of ad * skin prick tests * fdqli score * assessment of the transepidermal waterlos evaluated by a tewameter * prevalence of food allergies

Eligibility criteria:
inclusion criteria: * pregnant women with an eutocic pregnancy before 20 weeks of gestation * women with personal history of atopy diagnosed by a healthcare professional * women accepting a complete avoidance of dietary supplements containing prebiotics or probiotics during study supplementation * women accepting dermato-pediatric follow-up during the first year of life of the new-born (phone calls at 24 weeks of gestation and 6 months of child and a consultation at 12 months of age) * non tobacco user women * women over 18 years * women without history of severe gestational diabetes exclusion criteria: * women not giving up on intake of dietary supplements containing prebiotics or probiotics during study supplementation * women refusing dermato-pediatric follow-up during the first year of the newborn * ongoing allergy and/or intolerance to cow's milk proteins * term \>21 weeks of gestation

Keywords: atopic dermatitis prevention prebiotics pregnancy
phase i study to assess the effect on healthy male volunteers of ketoconazole on the pharmacokinetics of a single dose of azd5069 administered orally.

Conditions: Asthma,; Pharmacokinetics,; Cmax,; Tmax,; λz,; AUC,; Ketoconazole,; Metabolite

Summary: the main purpose of the study is to compare the change of the azd5069 pharmacokinetic profile when administered with ketoconazole. subjects will be treated first with azd5069 only followed by a washout period before starting with the combined treatment (both ketoconazole and azd5069).

an open-label, fixed-sequence, single-centre phase i study to assess the effect of ketoconazole on the pharmacokinetics of azd5069 after oral administration of a single dose azd5069 to healthy male volunteers

Eligibility criteria:
inclusion criteria: * healthy male volunteers aged 18 to 50 years (inclusive). * veins suitable for cannulation or repeated venipuncture. * healthy volunteers with neutrophil counts within the laboratory normal reference range at screening * body mass index (bmi) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum weight 50 kg and maximum weight 100 kg. * non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening and a smoking history of less than 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for 1 year) at screening. exclusion criteria: * healthy volunteers with latent tuberculosis as suggested by their history and judged by the investigator * healthy volunteers who belong to a high-risk group for hiv infection. * known or suspected history of significant drug abuse as judged by the investigator. * history of alcohol abuse or excessive intake of alcohol as judged by the investigator. * plasma donation within 1 month of screening or any blood donation/blood loss \>500 ml during the 3 months and/or 1350 ml within the 12 months prior to screening.

Keywords: phase i, healthy volunteers, fixed-sequence, open-label, ketoconazole, combination, safety
the effect of cyclosporin before cataract surgery

Conditions: Dry Eye Syndromes

Summary: to evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of post cataract surgery dry eye syndrome.


Eligibility criteria:
inclusion criteria: 1. 21+ adult men and women 2. those who are scheduled to undergo cataract surgery due to a diagnosis of cataract 3. corneal fluorescein staining score (oxford) is ii or less 4. preoperative mmp-9 positive 5. those who have not used the trial and the test (cyclosporine) for at least 1 month before surgery. 6. those who have voluntarily written consent to participate in this clinical trial exclusion criteria 1. those who have used systemic or topical cyclosporine within 4 weeks 2. use of eye drops for more than 4 weeks (disorders, allergies, eye inflammation / infection, etc.) other than the current dry eye syndromes 3. patients who have systemic or ocular disorders or conditions (eye surgery, trauma, disease) that can influence the results of this trial. 4. abnormal eyelid function 5. an eye disease that can impair the function of the corneal sensation: herpes keratopathy, conjunctival wounds due to scarring conjunctivitis, pterygium, pinguecula, diabetic keratitis, keratoconus , corneal transplant status 6. patients with active eye infections 7. patients with conflicts with this clinical trial 8. pregnant and lactating mothers 9. patients who are determined to be inappropriate by other investigators
evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of e2609 in healthy subjects and an elderly cohort

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of e2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. the study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.

the study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in healthy elderly volunteers.

Eligibility criteria:
inclusion: * healthy males and females * aged 30 to 55 years, inclusive (cohorts 1 through 5); aged 65 to 85 years, inclusive (cohort 6) * body mass index (bmi) of 18 to 32kg/m\^2 at screening * additional inclusion criteria for cohort 6 (healthy elderly subjects) exclusion * females of child-bearing potential * personal or family history of neurological abnormalities * any clinical abnormality of the electrocardiogram (ecg)at screening and check-in * a family history of cardiac abnormalities * thyroid abnormalities
patient satisfaction and tear osmolarity with the use of blink tears, blink gel tears and systane balance

Conditions: Dry Eye

Summary: this is a single center clinical study designed to determine patient satisfaction and the effect of the use of artificial tears on tear osmolarity with time after instillation of three commercially available artifical tear eye solutions ( blink tears, blink gel tears and systane balance).

patient satisfaction and tear osmolarity with the use of blink tears, blink gel tears and systane balance.

Eligibility criteria:
inclusion criteria: * male or femal subjects (aged 18 or older) * diagnosed with mild to moderate dry eye syndrome * provide written informed consent and sign/date a health information release * women of childbreaing potential must be willing to practice effective contraception for the duration of the study. exclusion criteria: * have any active ocular disease other than mild to moderate dry eye sundrome that would interfere with study interpretation * active ocular allergy in any eye * history of or active ocular infection/inflammation * concomitant use of contact lenses (unilateral or bilateral) * history of any corneal refractive laser surgery (e.g., lasik, lasek, rk,prk) in the study eye (s); * corneal disorder or abnormality that affects cornea sensitivity or normal spreading of the tear film in any eye. * history of any intaocular surgery or glaucoma laser surgery (e.g., alt, slt) in the study eye (s) * known sensitivity or allergy to any of the study medications or their components; * uncontrolled systemic disease; * contraindication to pupil dilation; * schirmer's test- standard test (with anesthesia) result of less than or equal to 3 mm * use of artifical tears prior to baseline visit (visit 2, day 0); * current use, use within 2 weeks prior to baseline visit ( visit 2,day 0) or likely use during the study period of any topical ophthalmic medications (e.g., antibotics, glaucoma medications) other than ophthalmic medications used in the study. * use of any omega 3 supplement, artificial tear product (s), vasoconstrictor and/or redness reliever ocular drops 30 days prior to or during the study perior; * use of cyclosporine ocular drops 12 months prior to or will require ocular surgery during the study period. * females who are pregnany, nursing or planning a pregnancy or who are of childbearing potenital and not using a reliable method of contraception; * any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and * concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the screening visit (visit 1)
renal and bone outcome after switching tenofovir to different antiretroviral strategies

Conditions: Renal Disease

Summary: renal outcome could be different after switching tenofovir to different antiretroviral strategies, in case of renal toxicity. therefore, it is necessary to evaluate the importance of renal evolution in these patients, in terms of grade and time to renal improvement, according to the different options after interrupting tenofovir. the aim of this study was to explore the renal outcome after tenofovir according to new antiretroviral regimen.

renal toxicity has become an important issue in a large number of hiv infected patients receiving a tenofovir-containing regimen. however, there are no data about the best antiretroviral regimen in patients switching tenofovir because of renal toxicity, in time, grade or persistence of renal improvement. thus, patients with renal toxicity on tenofovir, defined as: * a progressive decrease of at least 25% of estimated glomerular filtration rate (gfr, by chronic kidney disease-epi equation), or * confirmed value of gfr below 60 ml/min in two successive determinations, or * proximal tubular renal dysfunction, as indicated by the presence of at least 3 of the following parameters: proteinuria\> 150 mg/g; excretion fractional of phosphorus in urine \> 20%; glucosuria \> 150 mg; or/and tubular proteinuria/albuminuria ratio above 0.4. who changed to the combination of abacavir plus a third drug, or to a nucleoside analogues-free antiretroviral combination (dual therapy, monotherapy) will be followed for 1 year to establish the time and grade of improvement (defined as the lack of above criteria).

Eligibility criteria:
inclusion criteria: * hiv-infected patients * older than 18 years * receiving a tenofovir-containing regimen, and with criteria of renal toxicity (see above) * switching the antiretroviral regimen exclusion criteria: * pregnancy * patients receiving prolonged therapy with other nephrotoxic drugs * patients not receiving or interrupting antiretroviral regimen

Keywords: renal toxicity, hiv, antiretroviral, outcome
efficacy of a physical rehabilitation program using virtual reality in patients with chronic tendinopathy (virtendon-rehab)

Conditions: Tendinopathy; Patellar Tendinopathy; Tendinopathy, Elbow; Tendinopathy Rotator Cuff; Achilles Tendinopathy

Summary: chronic tendinopathies (ct) have a high prevalence (30% of musculoskeletal injuries), causing pain, decreased physical activity and functionality, as well as limitations in daily life. virtual reality (vr) fosters patient recovery through playful activities that promote competitiveness, stimulates motivation and continuous attention, allows individualizing the exercise program, objectively assessing the execution of the treatment and monitoring the patient's evolution. therefore, the virtendon-rehab project aims to conduct a low-risk randomized controlled clinical trial to analyze the efficacy of a vr-based physical rehabilitation program in a population diagnosed with ct on pain, functionality, range of motion, strength, muscle activation pattern, kinesiophobia, quality of life, adherence to treatment and patient satisfaction with the use of the system, compared to a control group. likewise, the aim is to characterize the clinical profile of this population and to know the relationships between the previous variables. measurements will be taken at the beginning of the intervention, at the end (12 weeks) and 3 months after the end of the intervention. a descriptive analysis will be performed, inter- and intra-group differences will be analyzed by means of t-student, wilcoxon, mann-whitney u and mixed anova tests. cohen's d will be used to determine the effect size. relationships between variables will be analyzed using structural equations. the results obtained will allow improving knowledge on the management of ct using vr, as well as improving clinical care and reducing healthcare costs.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of tendinopathy (shoulder rotator cuff tendinopathy, epicondylitis/epicondylitis, patellar tendinopathy, achilles tendinopathy). * duration of symptoms: greater than 6 weeks. exclusion criteria: * people who have any pathology that prevents them from performing physical exercise. * persons who have undergone surgery. * persons who have an illness that may be a contraindication to the proposed procedure. * persons who have received exercise therapy in the last 3 months. * persons who have received corticosteroid injections in the last 3 months.

Keywords: virtual reality chronic tendinopathy physical therapy