Kornimate/medical-research-clean huggingface dataset:
emla-cream as pain relief during pneumococcal vaccination

Conditions: Children; Pain

Summary: the aim of this intervention study is to compare the efficacy of emla cream as a pain relief or no pain relief in connection to the first pneumococcal vaccination at the age of three months in child health care. primary objective 1.leads emla cream as pain relief to children in connection with pneumococcal vaccination at the age of three months to lower pain scores in the use of flacc as a pain measurement instrument?

the aim of this intervention study is to compare the efficacy of emla cream as a pain relief or no pain relief in connection to the first pneumococcal vaccination at the age of three months in child health care. primary objective 1. leads emla cream as pain relief to children in connection with pneumococcal vaccination at the age of three months to lower pain scores in the use of flacc as a pain measurement instrument? secondary objectives 2. leads emla cream as pain relief in connection with pneumococcal vaccination to any difference in the child's heart rate response and saturation? 3. leads emla cream as pain relief that it takes longer before the baby starts crying and does the child cry for a shorter time in connection with vaccination? method: the study is randomised and singleblind. the study involves 72 children who are 3 months old. 36 children will receive emla-cream and 36 children will receive placebo-cream. this study will lead to new knowledge about emla cream and pneumococcal vaccination. the study will give new knowledge how painful pneumococcal vaccination is for the children. if the study shows that emla cream don´t give enough pain relief during pneumococcal vaccination more studies should be done with other pain relief.

Eligibility criteria:
inclusion criteria: * healthy children, born vaginally or by cesarean section after 37 weeks of gestation, who were not admitted to the neonatal unit. children should only have been with the pku testing performed routinely at the hospital. exclusion criteria: * baby delivered by vacuum extraction or forceps. children born before gestational week 37. children in neonatal care and subjected to other testing than pku. shoulder dystocia. children susceptible to methaemoglobinaemia in glucose 6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia. children with atopic dermatitis.

Keywords: children pain vaccination emla pneumococcal painscale
activity-based therapy and transcutaneous spinal cord stimulation after spinal cord injury (abt-tcscs)

Conditions: Spinal Cord Injuries; Spinal Cord Injury Cervical

Summary: the abt-tcscs study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand recovery after cervical spinal cord injury.

the abt-tcscs is a one-arm interventional study evaluating the feasibility and efficacy of activity-based therapy and transcutaneous spinal cord stimulation on neurorestoration of upper limbs after cervical spinal cord injury. up to 24 individuals with sci who suffer from tetraplegia will be treated with abt-tcscs. all participants will receive 12 sessions of abt (4 weeks), followed by 28 sessions of abt-tcscs (7 weeks). each session will last 1 hour and delivered 3 times per week. all study participants will be assessed at the start of the study (baseline 1) and then re-assessed after 6 weeks (baseline 2) to ensure that they are neurologically stable. the baseline assessment will consist of the international standards of neurological classification of sci (isncsci), grassp version 1, the spinal cord independence measure (scim) and the tri hand function test (tri-hft). participants will be re-assessed after receiving 12 sessions of abt i.e after 4 weeks (pre-cervical stimulation assessment) and then after receiving 28 sessions of combined abt and neuromodulation i.e after 7 weeks (post-intervention assessment).

Eligibility criteria:
inclusion criteria: * individuals with chronic traumatic and non-traumatic cervical sci (asia classification a-incomplete\*\*, b, c, d) between c1-c8 * adults more than 18 years old * at least 6 months post-spinal cord injury * a score of 2 - 15 on the upper extremity motor score of the isncsci * a score between 5 - 40 on grassp version 1 strength on at least one side * individuals who are medically stable exclusion criteria: * individuals with any other upper extremity deficit * unable to provide informed consent * unable to participate in an intensive rehabilitation outpatient program * spasticity that limits the range of motion greater than 50% for the elbow or wrist

Keywords: stroke cerebrovascular accident cva
age and insulin resistance

Conditions: Obesity; Physical Inactivity; Aging

Summary: insulin resistance is a crucial factor for the development of type 2 diabetes and a major health problem for older adults. it is the principal mechanism by which obesity is considered to increase the risk for type 2 diabetes and is a key feature of the metabolic syndrome. the elevated prevalence of obesity and type 2 diabetes in the older population has important consequences on the morbidity and mortality as well as on the economic burden on society. controversy currently exists as to whether or not aging contributes to insulin resistance. many potential factors confound the association between aging and insulin resistance, including obesity and physical inactivity. ectopic lipid depositions, defined as an excess accumulation of triglycerides in non adipose tissues such as in the liver (intrahepatic lipids) and within the muscle fibers (intramyocellular lipids), are positively associated with obesity and insulin resistance. furthermore, the accumulation of intracellular lipids is often cited as being a key determinant in the underlying mechanisms of insulin resistance. in addition of playing an important role in obesity and type 2 diabetes, these ectopic fat depositions are also observed in common conditions such as aging and physical inactivity. the intervention trial will test in skeletal muscle, liver and heart of sedentary obese volunteers, normal weight volunteers and masters athletes, the overall hypotheses that exercise improvement of fat oxidation capacity and/or decrease of damaging fat metabolites is a primary factor that predicts the improvement in insulin resistance.


Eligibility criteria:
inclusion criteria: * age 60-80 * sedentary or highly trained * bmi 18-40 * non-smoker * normal glucose tolerance or impaired glucose tolerance * willingness to comply with the protocol exclusion criteria: * contraindication to moderate exercise or clinical conditions precluding from joining an exercise program, such as clinically significant cardiovascular disease, peripheral vascular disease, uncontrolled hypertension, neurological or orthopedic disease * recent weight loss or weight gain * known diabetes * known drugs to affect glucose homeostasis such as nicotinic acid, glucocorticoids * severe anemia or lipid disturbances, hepatic or renal disease * recent history of cancer * hypothyroidism * recent hormone replacement therapy * known allergy to lidocaine or other local anesthetic * positive stress test * active alcohol or substance abuse

Keywords: aging insulin resistance ectopic lipids obesity exercise physical activity oxidative capacity diabetes metabolic syndrome
a prospective evaluation of infraorbital filler injection

Conditions: Dermal Filler; Rejuvenation

Summary: the goal of this clinical trial is to measure the facial volumetric changes over time in patients injected with hyaluronic acid dermal filler (juvéderm volbella xc) in the infraorbital (under eye) region. participants will be injected with juvéderm volbella xc filler and asked to return for 3d photography at 2 weeks, 1 month, and 3 months post-injection.

undereye or infraorbital hollowing is a result of a loss of volume causing shadowing and darkness of the infraorbital region often interpreted as a tired, stressed, and aged appearance. the goal of this clinical trial is to measure the facial volumetric changes over time in patients injected with hyaluronic acid dermal filler (juvéderm volbella xc) in the infraorbital (under eye) region. participants will be injected with juvéderm volbella xc filler and asked to return for 3d photography and to complete a validated patient satisfaction questionnaire at 2 weeks, 1 month, and 3 months post-injection. 3d photogrammetry technology allows for high level feature enhancement and microscopic anatomical evaluation that was not previously possible and can be used to make volumetric measurements at injection sites to evaluating minimally invasive injection efficacy.

Eligibility criteria:
inclusion criteria: * female * age 22 to 65 * interested in filler injections to reduce undereye volume loss exclusion criteria: * male * age \ 65 * prior undereye filler * filler/neurotoxin injection within the past 12 months * prior facial cosmetic surgery * prior facial trauma * planned dental work within next 2 weeks * travel 1 week prior or 2 weeks after injection

Keywords: injectables tear trough rejuvenation aesthetic improvement
cost-effectiveness of a specialized ultrasound instrument to diagnose carotid stenosis as a way to reduce the risk of stroke

Conditions: Carotid Stenosis; Cerebrovascular Accident

Summary: carotid stenosis, a condition in which plaque builds up inside the arteries of the neck and blocks blood flow to the brain, is one common cause of stroke. this study will evaluate the cost-effectiveness of using a new, specialized ultrasound device to screen individuals who are at risk for carotid stenosis.

stroke is the third leading cause of death, and the leading cause of long-term disability in the united states. at least half of all strokes are caused by carotid stenosis, a condition in which the arteries in the neck become blocked with plaque and harden. plaque that breaks off the carotid artery wall and travels to the brain can block critical blood vessels, possibly resulting in a stroke. carotid endarterectomy, a procedure that removes plaque buildup, can greatly reduce an individual's risk for stroke. currently, the conventional duplex doppler ultrasound examination that is used to screen for carotid stenosis requires a skilled sonographer or physician, and is therefore expensive. study researchers have developed a more cost-effective option: a specialized ultrasound instrument specifically designed to perform carotid stenosis screenings and meant to be used by non-specialist nurses. previous research has shown that this instrument is inexpensive, easy to use, and effective at diagnosing carotid stenosis. the purpose of this study is to evaluate the cost-effectiveness of the alternative ultrasound instrument at screening older adults who are at risk for carotid stenosis. if the instrument is shown to be cost-effective, it may eventually lead to widespread screening and a reduced incidence of stroke. in this study, nurses in selected physician's offices will be trained to use the carotid ultrasound screening instrument. patients over 65 years of age with at least one risk factor for carotid stenosis but with no symptoms will be screened with the device. screening will take place in the doctors' offices or, when more convenient, at a central screening location; however, in all cases the nurses will use the instrument rather than specialized ultrasound technologists. individuals found to have carotid stenosis will be referred to undergo a conventional duplex doppler ultrasound examination for a definitive diagnosis.

Eligibility criteria:
inclusion criteria: * at least one risk factor for carotid stenosis (e.g., cardiac disease, elevated cholesterol, smoking, hypertension) exclusion criteria: * any symptoms or indications of carotid stenosis or stroke

Keywords: stroke
investigating efficacy and safety of two degarelix three-month dosing regimens in patients with prostate cancer requiring androgen ablation therapy

Conditions: Prostate Cancer

Summary: the study will have two treatment groups, evaluating two degarelix doses. first dose is the initial dose followed by a maintenance dose given every three months. the initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.

an open-label, multi-centre, randomized parallel-group dose-finding study, investigating efficacy and safety of two degarelix three-month dosing regimens in patients with prostrate cancer requiring androgen ablation therapy.

Eligibility criteria:
inclusion / exclusion criteria: * patients, aged 18 years or older, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. * screening testosterone level above the lower limit of normal range, globally defined as \>2.2 ng/ml. * eastern cooperative oncology group (ecog) score of ≤2. * screening prostate-specific antigen (psa) level ≥ ng/ml.

Keywords: prostate cancer
resistive expiratory muscle training in copd patients

Conditions: COPD

Summary: * to determine effects of resistive expiratory muscle training on pulmonary functions in chronic obstructive pulmonary disease (copd) patients * to determine effects of resistive expiratory muscle training on maximum expiratory pressure in copd patients * to determine effects of resistive expiratory muscle training on quality of life in copd patients


Eligibility criteria:
inclusion criteria: * copd patients (gold criteria - moderate, moderately severe) * borg scale \< 4 exclusion criteria: * patients with orthopedic disease * neurological disease, * cognitive impairment (mini-mental state examination \< 22) , * heart diseases, * pulmonary fibrosis * obstructive sleep apnea syndrome. * acute and chronic infections

Keywords: resistive expiratory muscle training breathing exercise pulmonary function quality of life
apoe impact study on brain structure and function, in a population 45 to 75 years old

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to investigate the influence of the apoe genotype on brain morphology, function and metabolism, related to other factors such as cognitive reserve, cognition and episodic memory, in subjects at greater risk of developing ad.

the purpose of this study is to investigate the influence of age and the apoe genotype on brain morphology and function, in 700 cognitively healthy individuals, 45 to 75 years old, recruited from an ongoing longitudinal cognition study exploring memory and executive functions (clinicaltrials.gov id: nct01835717). all subjects have been apoe genotyped and underwent a clinical and cognitive assessment. within this study, the subjects will be submitted to an mri scanning protocol including morphological and resting state acquisitions. an identical follow-up mri session will be performed in 2 years' time. the analyses will be focused on detecting the effect of the apoe allelic variants on the change rate of the neuroimaging variables as well as its interaction with aging.

Eligibility criteria:
inclusion criteria: * participant included in the study clinicaltrials.gov id: nct01835717 * apoe genotype obtained before mri acquisition * be willing to perform an mri and agree to a 2 years longitudinal follow up * sign informed consent exclusion criteria: * contraindication to mri scanning: claustrophobia, pacemaker, history of ocular cerclage, heart valves, aneurysm clips and carrying any metal prosthesis incompatible with mri. * incidental mri findings that result in the images not being included in the study.

Keywords: alzheimer's, mri, apoe
safety and tolerability of high dose biotin in patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a randomized double blinded randomized 2:1 study. the duration of the study is 6 month. the safety and tolerability of high doses of biotin (300 mg/ day) will be compared to placebo in patients with amyotrophic lateral sclerosis. patients will be evaluated at baseline, 3, and 6 month. the primary outcome will be any adverse effects recorded. the secondary outcomes will be motor disability measured by als-frs, change in pulmonary function test parameters (fev1- fvc), change in subject weight (in kg).


Eligibility criteria:
inclusion criteria: * amyotrophic lateral sclerosis (als) volunteers must be diagnosed within 3 years prior to participation as having possible, probable, or definite als, either sporadic or familial according to modified el escorial criteria * age 18-80, able to provide informed consent, and comply with study procedures * participants must not have started riluzole and/or nuedexta for at least 30 days, or be on a stable dose of riluzole and/or nuedexta for at least 30 days, prior to screening (riluzole and/or nuedexta -naïve participants are permitted in the study) exclusion criteria: * the presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the participant to provide informed consent, according to pi judgment. * exposure to any experimental agent within 30 days of entry or at any time during the trial or enrollment in another research study within 30 days of or during this trial. * slow vital capacity test less than 50% of the predicted value patients who had already undergone tracheostomy

Keywords: amyotrophic lateral sclerosis biotin
7% lidocaine/7% tetracaine cream versus 2,5% lidocaine / 2,5% prilocaine cream

Conditions: Tattoo; Acne Keloidalis Nuchae

Summary: the purpose of this study is to compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal.

in this study we will compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal. patients will be asked to fill in questionnaires to: * assess the severity of pain experienced (vas score) during laser treatment, * evaluate whether the pain relief is adequate and, * evaluate the amount of money patients would be willing to pay for the cream that provided the 'best' pain relief. one week after the visit the patient will have a telephone consultation. the patients will be asked if they experienced any symptoms, which will be recorded as adverse events.

Eligibility criteria:
inclusion criteria: * • subject has provided written informed consent; * subject is ≥ 18 years of age at time of screening; * group a: subjects with acne keloidalis nuchae; * group b: subjects with an uniform, black, professionally placed tattoo exclusion criteria: * • known sensitivity to any components of the test materials; * pregnant or breast-feeding women; * use of any other pain medication during past 24 hours prior to the laser treatment; * damaged skin at the designated treatment site; * blister formation and/or scar formation after test-treatment with standard laser settings; * any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.

Keywords: 7% lidocaine / 7% tetracaine cream 2,5% lidocaine / 2,5% prilocaine cream
stay on track: a study of exercise effects during radiation

Conditions: Breast Cancer

Summary: the purpose of this study is to examine the impact of a lifestyle intervention. the study will examine the stay on track program, dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy.

research design. the investigators will be conducting an randomized trial in 60 women undergoing radiation treatment for breast cancer to examine the feasibility of a 12-week lifestyle intervention that addresses diet and physical activity and to explore the impact on behavioral, biological and psychosocial outcomes. procedure summary. patients who are eligible are consented by the research coordinator, after which a baseline assessment will be scheduled. the baseline assessment requires 60 minutes and includes questionnaires, height/weight, dual energy x-ray absorptiometry (dexa), and phlebotomy. participants will also wear the fitbit for one week to establish baseline activity level. after the baseline assessment, women are then randomly assigned to: the 12-week "stay on track" lifestyle intervention or the 12-week self-guided control. both groups complete a post-intervention and a 3-month follow-up visit identical to their baseline assessment. self-guided controls can utilize their fitbit and will receive informative binders 24 weeks' post-intervention.

Eligibility criteria:
inclusion criteria: 1. \> 18 years of age; 2. confirmed primary non-metastatic breast adenocarcinoma; 3. planned lumpectomy/segmentectomy/partial mastectomy surgery for primary breast cancer; 4. planning to undergo adjuvant whole breast radiation therapy following a lumpectomy; 5. have a karnovsky performance score of 70 or above (see appendix) 6. patient's body mass index (bmi) is greater than determine by the treating physician, not currently meeting physical activity guidelines: moderate physical activity for at least 30 minutes at least five days a week and 2 weekly sessions of resistance exercise; 7. have access to a mobile phone with capacity for text messaging (either unlimited or aware and accepting of text messaging charges); 8. understand and speak english; 9. physically able to engage in the intervention; 10. accepting of randomization (note that anti-estrogen therapy is allowed.) exclusion criteria: 1. patients who have metastatic disease; 2. patients with a history of prior malignancy within the past 3 years, other than non-melanoma skin cancer. 3. patients with serious orthopedic, cardiovascular, or pulmonary conditions, have serious psychiatric or cognitive problems. 4. patients who have received chemotherapy for their breast cancer. 5. patients with prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
study of efficacy and safety of investigational treatment in patients with nail psoriasis

Conditions: Nail Psoriasis; Plaque Psoriasis

Summary: part 1 is a randomized, double-blind, placebo-controlled phase 1b study to evaluate at193 in approximately 34 patients with nail psoriasis for 16 weeks. part 2 is an open-label extension phase where all patients will receive active drug for an additional 16 weeks followed by a 2 week nontreatment period.


Eligibility criteria:
inclusion criteria: * diagnosis of nail psoriasis for at least 3 months preceding study entry * diagnosis or history of plaque psoriasis or psoriatic arthritis * a female participant of childbearing potential must use appropriate contraceptive measures during the study period * a female participant of childbearing potential must have a negative urine pregnancy test result at screening * written informed consent must be obtained before any study procedure is performed exclusion criteria: * pregnant or breastfeeding * diagnosis of other active skin or nail diseases or skin or nail infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis * history or evidence of a clinically significant disorder, condition, or disease that would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator