Kornimate/medical-research-clean huggingface dataset:
a study of ixekizumab (ly2439821) in participants with moderate-to-severe genital psoriasis

Conditions: Genital Psoriasis; Psoriasis

Summary: the main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.


Eligibility criteria:
inclusion criteria: * have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline. * have moderate-to-severe psoriasis in the genital area at screening and baseline. * have plaque psoriasis in a nongenital area at screening and baseline. * have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area. * must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug. exclusion criteria: * pustular, erythrodermic, and/or guttate forms of psoriasis. * history of drug-induced psoriasis. * have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments). * have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a similar mode of action. * cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study. * are currently enrolled in any other clinical trial involving an investigational product. * serious disorder or illness other than plaque psoriasis. * active or history of malignant disease within 5 years prior to baseline. * serious infection within the last 3 months. * have received a live vaccine within 3 months of baseline or plan to do so during the study. * have received a vaccination with bacillus calmette-guérin (bcg) within the past year. * pregnant or breastfeeding (lactating) women.

Keywords: genital
evaluation of axr-270 for the treatment of posterior blepharitis associated with meibomian gland dysfunction

Conditions: Posterior Blepharitis; Meibomian Gland Dysfunction

Summary: this study will evaluate the safety, tolerability and efficacy of axr-270 cream in treating posterior blepharitis associated with meibomian gland disease (mgd)

axr201901 is a multicenter, randomized, double-masked, vehicle-controlled study of axr-270 cream and axr-270 vehicle in subjects with signs and symptoms of posterior blepharitis associated with meibomian gland dysfunction

Eligibility criteria:
inclusion criteria: male or female, 18 years or older have a clinical diagnosis of moderate to severe mgd (total mgd score between 5 and 14 on a scale with a range between 0 and 15; and clinical severity score of eyelid margin vascularity of at least 2 (moderate)) have a score of ≥35 on eye discomfort using vas have a tfcs score between 3 and 14 on the nei scale have a schirmer score of \>7 mm have a osdi score \>30 if female, then subject should be non-pregnant and non-lactating exclusion criteria: subjects with iritis, uveitis in either eye subjects with conjunctivitis, keratitis, severe anterior keratitis not related to mgd subjects with lid abnormalities subjects with ocular fungal, viral or bacterial infection subjects unable or unwilling to withhold the use of eyelid scrubs subjects with glaucoma and serious systemic disease

Keywords: meibomian gland dysfunction posterior blepharitis
effectiveness of erector spinae plane block for percutaneous arthrodesis of spinal fractures

Conditions: SPINAL Fracture; Pain, Postoperative

Summary: spinal fracture surgery is a common surgery. post-operative pain has been reduced by the advent of so-called minimally invasive techniques. the immediate post-operative pain, however, remains relatively high, mainly because of muscle pain following the trauma. the erector spinae plane block (espb) is a loco-regional anesthesia technique first described in 2016. a retrospective cohort study showed an improvement in post-operative analgesia of percutaneous osteosynthesis spinal surgery through a reduction in 24-hour morphine use. in order to prove and confirm the effectiveness of this technique, we will conduct a double-blind randomized controlled study. the objective will be to demonstrate the analgesic effectiveness of the technique by reducing morphine consumption in post-operative. the expected reduction in morphine consumption is set at 30%, based on the clinical experience developed in our practice.


Eligibility criteria:
inclusion criteria: 1. patients with percutaneous arthrodesis spine surgery for fracture 2. insured persons 3. age 18 years 4. being able to receive informed information 5. have agreed to participate in writing exclusion criteria: 1. minor patient 2. patient refusal 3. pregnancy 4. lack of social security coverage 5. under guardianship or curatorship 6. inability to express consent 7. history of spinal surgery 8. unable to use morphine pca 9. contraindication to the use of local morphines and/or anesthetics 10. contraindication to loco-regional anesthesia 11. long-term opioid patient (level ii and level iii analgesics) 12. patient with preoperative neuropathic pain (score greater than or equal to 4 on the dn4 questionnaire or taking anti-epileptic or anti-depressant treatments for neuropathic pain)

Keywords: erector spinae plane block spinal trauma percutaneous spinal osteosynthesis
the effect of the brochure on testicular self-exam

Conditions: Testicular Cancer

Summary: this study aims to examine the effect of the educational brochure given to university students on testicular cancer and its early diagnosis on their health beliefs and self-examination; in non-randomized groups, pretest-posttest was conducted in a quasi-experimental design with control group. the research was carried out with students studying in the psychological counseling and guidance department of a state university in turkey. the study group consisted of 92 students, 48 of which were experimental and 44 were control. only the experimental group was given an educational brochure about testicular cancer and testicular self-examination. data; personal information form, testicular cancer and health beliefs scale about testicular self-examination were collected with the form for self-examination. in the evaluation of the data; mann whitney u, wilcoxon and chi-square analyzes were performed.


Eligibility criteria:
inclusion criteria: * to study in the department of psychological counseling and guidance * studying in 3rd and 4th grade exclusion criteria: * any previous diagnosis of cancer * having received previous training in testicular self examination

Keywords: testicular cancer screening university student
effects of caffeine and intermittent hypoxia on leg function in human spinal cord injury

Conditions: Spinal Cord Injuries

Summary: accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury (sci). the goal of the study is to understand how caffeine may augment the effects of intermittent hypoxia on motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following sci.

the investigators will examine the effects of acute intermittent hypoxia (aih) as a possible therapeutic intervention to promote functionally useful motor recovery. in this sub-study, the investigators will assess changes in leg motor function in response to repetitive aih with and without caffeine. participants will receive caffeine+aih, placebo+aih, caffeine+sham in a randomized order. before each intervention round, subjects will be asked to avoid caffeine-containing substances for 48 hrs (\> 5\* half-life of \~7 hrs) prior to arrival to control for baseline plasma levels of caffeine. subjects will then ingest capsules containing either placebo (dextrose) or caffeine (up to 6mg/kg). capsules will be prepared by johnson compounding \& wellness. blood samples will be collected before and after the breathing intervention to assess caffeine concentrations within the body. during and after each intervention, both the rate and extent of magnitude changes in voluntary and involuntary muscle response behaviors important for walking will be compared between interventions within participants. repeated measurements will be collected on all subjects that participate in the multiple interventions.

Eligibility criteria:
inclusion criteria: * age 18 and 75 years (the latter to reduce likelihood of heart disease) * medical clearance to participate * lesion at or below c2 and above l5 with non-progressive etiology * classified as motor-incomplete with visible volitional leg movement * injury greater than 6 months * ability to advance one step overground without human assistance exclusion criteria: * concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications) * pregnant women because of the unknown affects of aih on pregnant women and fetus * history of seizures, brain injury, and/or epilepsy * undergoing concurrent physical therapy * diabetes * cirrhosis * caffeine and/or nsaid allergies or intolerances

Keywords: hypoxia spinal cord injury rehabilitation strength walk function low oxygen
safety and efficacy of small frequent paracentesis using an indwelling catheter compared with repeated large volume paracentesis in cirrhotic patients with refractory ascites

Conditions: Liver Cirrhosis

Summary: the aim of the study is to assess the efficacy of intermittent small quantity (upto 3l per day) paracentesis through an indwelling catheter for up to 5 days in comparison with large volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3 months. the project will be conducted at ilbs between april 2020 and march 2021. the concept of the study is to evaluate the efficacy of indwelling catheter in reducing the refilling rates of ascites by 50 % over 3 months in comparison to lvps and also in reducing the incidence and risk of ppcd. all refractory ascites patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives. the expected outcomes are primary outcome: proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis after a short duration (5day) intermittent small quantity (up to 3l/ day) paracentesis through an indwelling catheter in comparison to a single large volume paracentesis in the next 3 months. secondary outcome: 1. proportion of cirrhotic patients with refractory ascites developing p 2 . during a 30 d, 60 d and 90 d follow up, to assess between the groups * need for repeated paracentesis : number assessed * aki : improvement or worsening of renal functions * hepatic encephalopathy: grading as per west haven classification * hyponatremia * diuretic tolerability : dose and duration tolerated * bacterial peritonitis : ascitic fluid neutrophil count \> 250 cells/cumm * transplant free survival * risk of procedure related complications * changes in meld or ctp between the groups ( improvement vs worsening ) * need for hospitalization between the groups


Eligibility criteria:
inclusion criteria: * cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function (s.creatinine \< 2 mg/dl). exclusion criteria: * ctp \>12, meld\>25 * prior or current spontaneous bacterial peritonitis (sbp) * recurrent or current overt hepatic encephalopathy * serum creatinine \>2 * hvoto (hepatic venous outflow tract obstruction) * hepatic or extrahepatic malignancy * recent ugi bleed * sepsis * serum sodium \< 120
implementation of a multicomponent intervention to prevent physical restraints in nursing home residents (imprint)

Conditions: Dementia

Summary: background: physical restraints as bedrails and belts are still regularly applied in german nursing homes despite clear evidence showing their lack of effectiveness and safety. in a cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent intervention has been shown with a significant reduction in physical restraints use without adverse events. the present study aims to apply different versions of the original intervention in nursing home residents in four different regions throughout germany in order to evaluate the effectiveness of the programme. methods/design: pragmatic cluster-randomized controlled trial comparing two intervention groups ((1) updated original programme and (2) brief version of the updated programme) with a control group (3) receiving printed study materials (optimized usual care). intervention (1) consists of an information programme for all nurses, additional training and structured support for nominated key nurses, and provision of printed study material and other supportive material. for intervention (2) nurses' training is only optional carried out facultatively by key nurses who have received an additional train-the-trainer module. the control group (3) receives printed study material only. overall, 120 nursing homes including approximately 10800 residents will be recruited, randomized to one of the three groups and followed up for 12 months. the primary outcome is defined as proportion of residents with at least one physical restraint at 12 months. physical restraint use will be assessed by direct observation. secondary outcomes are residents' quality of life as well as safety parameters as i.g. falls and fall-related fractures. process and cost measures will also be assessed.


Eligibility criteria:
cluster level inclusion criteria: * randomly selected nursing homes in each region; no specific inclusion criteria will be applied exclusion criteria: * no specific exclusion criteria will be applied individual level inclusion criteria: * all residents within the cluster present on the day of data collection * all residents newly admitted to clusters during follow-up and present on the day of follow-up data collection exclusion criteria: * no specific exclusion criteria will be applied

Keywords: nursing home care physical restraints dementia implementation research cluster-randomized controlled trial
investigating acute heart failure decongestion guided by lung ultrasonography

Conditions: Acute Heart Failure

Summary: the goal of this clinical trial is to investigate whether a lung ultrasonography (lus)-guided decongestion strategy in adults hospitalized for acute heart failure (ahf) can improve patient-centered outcomes. the main questions it aims to answer are: * does this strategy shorten the length of stay and reduce early hospital readmissions? * does this strategy improve patients' symptoms and quality of life ? researchers will compare lus to physical examination (pe).

background: despite recent medical advances, ahf remains one of the leading causes of hospital admissions and one of the most frequent reasons for readmission. as the main reason for ahf hospitalization is congestion-driven symptoms, the cornerstone of treatment is decongestive therapy. in the absence of specific quantitative measures, however, undertreatment often occurs and is associated with an increased risk of readmission. lus is highly accurate for detecting extravascular lung water (evlw). it has shown clinical benefits when used to guide decongestive therapy in chronic heart failure ambulatory patients. however, data for its use in ahf inpatients are currently lacking. aim: to investigate the effect of a bedside lus-guided decongestive therapy in hospitalized ahf adults on patient-centered outcomes, as compared to usual care. methodology: this will be a swiss multicenter, blinded, randomized controlled trial (rct) aiming to recruit 222 adults hospitalized for congestive acute heart failure (ahf). study participants will be included within the first 48 hours of their hospital arrival. patients will be randomized to either a lus-guided decongestive strategy or a decongestive strategy based on a structured physical examination. the primary outcome will be the number of days spent alive outside the hospital within a 40-day timeframe from study inclusion (daoh-40). this outcome integrates length of stay, early readmission, emergency room visits, and mortality.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * planned or actual admission to intermediate care units, general internal medical or cardiology wards * diagnosis of congestive ahf on admission chart (primary or secondary diagnosis) * raised value of n terminal-pro-brain natriuretic peptide (≥1000 ng/l). key exclusion criteria: * known isolated right heart failure * systolic blood pressure \<90 mmhg, mean arterial pressure \<65 mmhg at the moment of inclusion * the following conditions mimicking lung cardiogenic oedema on lus if known at inclusion and documented: interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion * known virologically confirmed sars-cov-2 pneumonia in the preceding 3 months * unwillingness to give consent * subjects who are pregnant or breastfeeding * hospitalisation for palliative care and probable end-life within 30 days

Keywords: lung ultrasonography ultrasound point-of-care ultrasonography decongestion diuretic
effects of animal-assisted therapy on the physical function and communication of adults with autism

Conditions: Autism Spectrum Disorder; Autism

Summary: the aim is to evaluate the effects of a dog-assisted therapy program on physical function and communication in a sample comprised of 24 adults with autism spectrum disorder. the sample will be divided into 2 groups, a control group and an experimental group. changes after 10 weeks (20 sessions) will be compared between-groups.

the intervention program will consist of 20 sessions conducted twice a week in the facilities of the collaborator associations. each session will be conducted in groups of 3 participants and will last 30 minutes. it will include a welcome part, a main part (based on different activities and physical exercises with the dog) and a closing part to say goodbye to the dogs. physical function measures will be conducted before and after the completion of the study. the interaction and communication will be assessed during the sessions in the first, tenth and last ones.

Eligibility criteria:
inclusion criteria: * older than 40 years * with autism spectrum disorder * able to walk autonomously, without help from other people. * able to climb and descent stairs autonomously, without help from other people. exclusion criteria: * medical condition that contraindicates the proximity or contact with the animals with the animals on the part of the user. * allergy to dog epithelium. * phobias to dogs. * history of aggression to animals. * users who do not submit a signed informed consent form.

Keywords: dog-assisted gait postural communication human-animal interaction fall risk
bifurcation absorb oct trial

Conditions: Myocardial Ischemia; Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Coronary Bifurcation Lesions; Arterial Occlusive Lesions; Infarction; Myocardial Infarction; Arteriosclerosis

Summary: the bifurcation absorb oct trial is a prospective, randomized (1:1) evaluation of the efficacy and performance of single absorb everolimus eluting bioresorbable vascular scaffold provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive subjects with and without fenestration towards the side branch. patients included in this study will be divided into three different cohorts: * cohort a (patient 1-20): angiographic fu with oct at 12 months. * cohort b (patient 21-40): angiographic fu with oct at 24 months. * cohort c (patient 41-60): angiographic fu with oct at 36 months. all patients will also have telephone fu at 30 days, 12, 24 and 36 months. inclusion of patients in the bisorb oct trial stopped in november 2016 after safety concerns of the absorb bvs were reported. bisorb oct included 3 patients, which were all included in the academic medical center


Eligibility criteria:
inclusion criteria: * subject has a bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement (medina 0,0,1 lesions are excluded). * subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography. * subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure,as approved by the appropriate ethics committee. exclusion criteria: * subject is younger than 18 years of age * subject is presenting with a stemi * subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned. * subject has known hypersensitivity or contraindication to contrast, aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (l-lactide), poly (dl-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. * known renal insufficiency (eg. estimated glomerular filtration rate (egfr) \ 2.5mg/dl or subject on dialysis) * subject with a limited life expectancy less than one year. * subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or subject unable to read or write.

Keywords: tomography, optical coherence percutaneous coronary intervention cardiac catheterization coronary biovascular scaffold
acute time-restricted eating in young healthy males

Conditions: Obesity Prevention

Summary: this study compared the metabolic response to three different eating windows (morning fast,12pm-8pm; evening fast, 8am-4pm; control, 8am-8pm).

humans have evolved as a diurnal species, internally governed by the circadian system, which dictates our hormone regulation. 'chrononutrition' is a sub-discipline which combines food timing with circadian physiology. the most popular method of time-restricted feeding in the uk is to skip breakfast. however, data from several meta-analysis have shown that skipping breakfast is associated with weight gain and insulin resistance, likely due to eating later into the evening/night and therefore, out of sync with our circadian rhythm. recent research has shown that skipping dinner (evening fasting) has improved markers of cardio-metabolic health in clinical populations, although these are typically from longer-term studies. despite these promising findings, it is not yet known whether these findings are population specific. therefore, the investigators are interested in examining the metabolic response pre and post-intervention to see whether these promising findings can translate into a healthy population. furthermore, the investigators will be monitoring subjective appetite, energy intake, and expenditure to assess whether there is any short-term adaptation to a specific feeding window.

Eligibility criteria:
inclusion criteria: * recreationally active * non-smokers * non-dieting * weight stable (self-reported for \>6 months) * were not consuming any medication known to affect appetite or physical activity exclusion criteria: * smokers * \>10 hours per week physical activity * have dieted within the past 6 months * excessive alcohol consumption (\>14 units/week) * use of medication or supplements that may affect hormone concentrations.

Keywords: chrononutrition time-restricted eating energy balance glycaemic control