Kornimate/medical-research-clean huggingface dataset:
effect of the combination of methotrexate and adalimumab on reduction of immunization in ankylosing spondylitis (comaris)

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in ankylosing spondylitis.


Eligibility criteria:
inclusion criteria: * subject 18 years of age or older * able and willing to give written informed consent and to comply with the requirements of the study protocol * subject met the definition of ankylosing spondylitis (as) based on asas criteria * subject with active as, has had an inadequate response, an intolerance or an to one or more nonsteroidal anti-inflammatory drugs exclusion criteria: * previous adalimumab treatment or previous treatment with more than one anti tnf alpha therapy. * previous methotrexate treatment, not stopped 3 month before inclusion * surgery scheduled during study * female subject without method of contraception * contraindication to adalimumab or methotrexate

Keywords: ankylosing spondylitis
softstitch™ for all-inside meniscal repair: comparative analysis of patient reported outcome measures

Conditions: Meniscus Tear

Summary: acute and traumatic knee meniscus tears are a frequent occurrence. evidence shows meniscal repair results in more favorable patient reported outcomes and articular cartilage preservation.1 this prospective, multicenter, single cohort, longitudinal study is intended to evaluate the effectiveness and safety profile of softstitch™ when used as standard of care for all-inside meniscal repair. electronic patient reported outcome measures (eprom), functional assessments of the knee, adverse events of interest and adverse device effects will be assessed.


Eligibility criteria:
inclusion criteria: 1. confirmed meniscal tear by physical exam and mri (minimum 1.5t) 2. recommended to undergo surgical intervention using softstitch™ for all-inside meniscus repair of longitudinal tears on the posterior horn that a surgeon would traditionally repair with two or more all-inside devices, as standard of care 3. normal mechanical alignment; \< 5° varus and \< 7° valgus, of the affected knee by clinical assessment or x-rays 4. male or female, ≥ 18 years old and ≤55 5. provide written informed consent 6. able and willing to participate in follow up visits 7. have a valid email and internet access to receive and respond to epros throughout the study exclusion criteria: 1. meniscal tears which are not amendable to repair, such as degenerative, flap, radial, complex, etc. 2. acl-injured knees that are unstable (concomitant acl reconstruction ok to include) 3. sensitivity to silicone, polyester, nylon, fd\&c blue no. 2 dye and beeswax 4. blood supply limitations and previous or active6, joint or systemic, infections which may decrease healing 5. skeletally immature defined as patients with open epiphyseal plates viewed on radiographs 6. concomitant disease that would interfere with study outcomes 7. congenital ligamentous hypermobility defined by beighton score 4 or 5 8. locked knee or haemarthrosis7 9. mutiligament injuries requiring multiligament surgical stabilization 10. concomitant hybrid meniscal repair techniques or devices 11. advanced osteoarthritis; kellgren lawrence ≥ 2 12. fracture of the lower extremities within 6 months prior to screening 13. previous surgery on the affected knee within 12 months prior to screening 14. subject is included in a vulnerable population (child, prisoner, etc). 15. subject is requesting or receiving worker's compensation related to the knee injury 16. inability to reply to online questionnaires because of mental impairment 17. participation in another clinical investigation in the next two years
skincare products and environmental health

Conditions: Gynecomastia; Endocrine System Diseases

Summary: the purpose of this study is to explore the potential for an association between the development of prepubertal gynecomastia and history exposure to lavender essential oil, tea tree essential oil, and other essential oils.

after being informed about the study and privacy, parents will give informed consent and complete the apichs (aromatic plant ingredient \& child health survey), a validated measurement tool for determining exposure to plant-based ingredients in pediatric personal care products.

Eligibility criteria:
inclusion criteria: * parent of child aged 2-15 living in the united states exclusion criteria: * none

Keywords: prepubertal gynecomastia essential oils lavender tea tree endocrine disruption pediatric environmental health
measuring sweat glucose of patients with diabetes - the engage study

Conditions: Diabetes Mellitus

Summary: this pilot clinical trial will explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with dm. this study will compare needleless glucose sensor readings from sweat with glucometer measurements from patients with any type of diabetes at fasting, and after a meal.

there is an unmet need for a non-invasive glucose monitoring device. ucsd nanoengineers developed a flexible, ultra-thin sensor adherent to the skin, similar to a temporary tattoo. sweat glucose correlates with blood glucose. this proposed study would be the first to examine this needle-free glucose sensor to measure glucose in endogenous sweat in individuals with dm, and would serve as the basis for future development of a continuous, non-invasive sensor. the investigators hypothesize that compared with a glucometer, a tattoo sensor can accurately measure sweat glucose in patients with dm.

Eligibility criteria:
inclusion criteria: * individuals with an existing diagnosis of diabetes mellitus, of any type, defined as having a fasting plasma glucose (fpg) \> 126 mg/dl, or hemoglobin a1c (hba1c) \> 6.5%. * ability to provide informed consent for participation. exclusion criteria: * individuals who do not have diabetes. * those who have an allergy to pilocarpine. * frequent episodes of low blood sugar (hypoglycemia), have no warning symptoms of hypoglycemia (hypoglycemia unawareness), or are at high risk of having hypoglycemia. * if taking any of the following medications: any beta-blockers (including atenolol, carvedilol, metoprolol, and propanolol), chlorthalidone, hydrochlorothiazide, oxybutynin, and tiotropium. * individuals who have the following conditions, for which it is not safe to take pilocarpine, including: known or suspected gallstones or gallbladder disease kidney stones conditions that affect your thinking and/or memory, including parkinson's disease and alzheimer's disease asthma chronic obstructive pulmonary disease (copd) glaucoma irritable bowel syndrome pregnancy - a pregnancy test will be obtained for each woman of child-bearing age.

Keywords: sensor glucose sweat
conservative treatment of postprostatectomy incontinence

Conditions: Urinary Incontinence

Summary: the primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. the study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.

the primary purpose of this project is to test the effectiveness, impact on quality of life, and durability of conservative therapies for persistent post-prostatectomy urinary incontinence in a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation. the second purpose of the study is to examine and compare the cost-effectiveness of the 8-week, multi-component behavioral training program to the same program with the addition of biofeedback and pelvic floor electrical stimulation. prostate cancer is the most common internal cancer in men in the united states. the most common treatment for early disease is radical prostatectomy, the removal of the prostate gland. the two most common sequelae of prostatectomy are incontinence and erectile dysfunction. the incontinence improves and often resolves in the first year after prostatectomy, but surveys of patients show that 40% of men have incontinence severe enough to require pads 1 and 2 years after their surgery. there are currently no randomized, controlled studies of non-surgical treatments for persistent post-prostatectomy incontinence.

Eligibility criteria:
inclusion criteria: 1. involuntary loss of urine that started immediately after radical prostatectomy and has persisted for at least one year. 2. one-week bladder diary with interpretable data and at least two incontinence episodes exclusion criteria: 1. any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina 2. cardiac pacemaker or implanted cardiac defibrillator 3. current use of anticholinergic agents for detrusor instability 4. folstein's mini-mental state exam score below 24 (impaired mental status) 5. one-week bladder diary with continual leakage - defined as always being damp or wet or unable to quantitate individual accidents. 6. poorly controlled diabetes, defined as (glycosylated hemoglobin \> 9 within last 3 months). 7. hematuria on microscopic examination. enrollment will be permitted after urologic evaluation. 8. urodynamic evaluation: post-void residual volume greater than 200 ml

Keywords: urinary incontinence therapy prostatectomy prostate cancer
place of flixovate® in the treatment pathway and its conditions of use in infants aged from 3 to 12 months between 2010 and 2012 by french gps and private paediatricians

Conditions: Dermatitis, Atopic

Summary: this study has been request by french health authorities to evaluate the use of flixovate in infants and its place in the treatment pathway. this study has 2 main pbjectives: 1/ evaluation of changes in the prescription share of flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st january 2010 to 31st december 2012. 2/description of the conditions of use of flixovate® in infants aged less than 12 months (infant profile, dosage form, dosage, treatment duration, prior, concomitant and subsequent treatments etc.).


Eligibility criteria:
inclusion criteria: analysis of changes in share of prescriptions: * infants who received at least one prescription of topical steroids between 1st january 2010 and 31st december 2012. * infants aged 3 to 12 months on the day of prescription of topical steroids. description of the conditions of use and patient profiles: * infants who received at least one prescription of topical steroids between 1st january 2010 and 31st december 2012. * infants aged 3 to 12 months on the day of prescription of topical steroids. exclusion criteria: * none
stepwise research program to promote ingenious online supportive solutions in the relief of cancer-related fatigue

Conditions: Cancer Diagnosis; Moderate or Severe Score of Cancer-related Fatigue (CRF)

Summary: decentralized, randomized hybrid type 2 (effectiveness/implementation) controlled trial comparing the effectiveness of three different digital aid modalities programs in reducing the perceived burden of crf in cancer patients while also gathering data on the implementation strategy.


Eligibility criteria:
inclusion criteria: * age 18 years and older. * having a clinical diagnosis of cancer including patients on active treatment or cancer survivors. * self-reporting moderate to severe crf for at least one week (worst level of fatigue ≥ 4 on a 10-point numerical rating scale, retained in international guidelines as an optimal cutoff for identifying clinically significant crf). * being able to read and understand french. * having access to a smartphone. * patients must be affiliated to a social security system or beneficiary of the same. exclusion criteria: * suffering from current psychiatric disorder or cognitive disorder that would interfere with the ability to consent or participate. * currently engaging in cognitive-behavioral therapy. * currently engaging in another non-drug (behavioral) clinical trial. * suffering from physical related reversible and treatable causes of fatigue (anemia, electrolytes unbalance, infections, renal dysfunction, active metastases causing fatigue, hormonal unbalances (hypothyroidism, adrenal insufficiency, etc.) - according to physician's judgement at the moment of inclusion.
incidence and risk factor of hydroxychloroquine and chloroquine retinopathy

Conditions: Toxic Maculopathy

Summary: the purpose of this study is to evaluate the incidence and risk factor of toxic maculopathy who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus. total 5-year of the study periods, the investigators will screen these patients by baseline examination (fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, humphrey visual field test and multifocal electroretinography) and observe with same examination for every year.


Eligibility criteria:
inclusion criteria: * patient who treated with hcq or cq due to autoimmune diseases such as ra, sle * patient who did not previously diagnosed with hcq/cq toxic retinopathy exclusion criteria: * aged less than 19 years

Keywords: autoimmune disease rheumatoid arthritis systemic lupus erythematosus hydroxychloroquine(hcq) chloroquine(cq) toxic maculopathy
high dose vitamin d supplementation in chronic spontaneous urticaria

Conditions: Urticaria

Summary: chronic spontaneous urticaria is an inflammatory disease which is characterized with intermittent or daily urticaria. this diseases lasts for more than 6 weeks. several recent studies have suggested a role for vitamin d in modulation of immune system and pathogenesis of chronic urticaria.


Eligibility criteria:
inclusion criteria: * uriticaria or angioedema daily or more than 3 days a weeks for at least 6 weeks exclusion criteria: * physical urticaria aquired or hereditary angioedema calcium level \> 10.3 mg/dl glomerular filtration rate \<50 sarcoidosis primary hyperparathyroidism granulomatous diseases malignancies pregnancy lactation
ekstracorporal shock wave therapy as a treatment for erectile dysfunction in men after prostatectomy

Conditions: Erectile Function

Summary: extra corporal shock wave therapy has proven effective as treatment with mild to moderate erectile dysfunction in men with erectile dysfunction. investigator will examine whether the treatment also applies to men with moderate to severe erectile dysfunction after nerve injury associated with prostatectomy.

all patients have undergone prostatectomy and are without recurrence. none of the men have sufficient effect of medical treatment for erectile dysfunction (tablets or injection therapy). each participant will fill out two validated sexual function questionnaires: iief-5 (international index of erectile function), and ehs (erection hardness score). our treatment protocol consists of one treatment sessions per week for 5 wk. the shockwaves are delivered to the distal, mid, and proximal penile shaft, and the left and right crura. the duration of each li-eswt session was about 20min, and each session comprised 500 shocks per treatment point (3000 per session) at an energy density of 0.15 mj/mm2. patients are randomized to active treatment or placebo.by placebo added a blocking membrane in the machine, handling is carried out exactly the same way as the active treatment. none of the attending staff members will be familiar with who receive active and who receive placebo treatment. for evaluation, the international index of erectile function (iief-5) will be used after 1, 3- and 6-mo follow-up.

Eligibility criteria:
inclusion criteria: * erectil dysfunction after radical prostatectomy less than two years ago * iief - less than 20 * ehs - less than 4 exclusion criteria: * drop out * not sexual active * penile prostesis

Keywords: erectile function prostatectomy extracorporeal shock wave therapy iief-5
evaluating of the hospital universitario de canarias massive transfusion protocol

Conditions: Massive Transfusion; Hemorrhage

Summary: massive haemorrhage is defined as the necessity of 3 or more packed red blood cells in one hour, the transfusion of 10 packed blood cells, the loss of the half of the blood volume, the loss of 4-5 cc/kg/h or more, and haemorrhage shock. haemorrhage shock provokes changes in the bloodstream with celular and organic disfunction. in many cases massive transfusion is needed to stabilize the vital function. this massive transfusion can have serious side effects (infectious and immunologic and no immunologic reactions) and increase the morbidity and mortality. massive transfusion protocols improve the survival in severe trauma injury patients. the transfusion of fixed rate of packed red blood cells, fresh frozen plasma and platelet concentrates have decreased the severity of trauma induced coagulopathy. recently several studies have shown the benefit of massive transfusion protocols with high transfusion ratios (1:1:1 rbc:ffp:plt) in mortality after severe trauma. so early and aggressive transfusion improve the outcomes and the resources. massive transfusion protocol have been elaborated in the hospital universitario de canarias with high transfusion ratios (1:1:1 rbc:ffp:plt) . the goals of this protocol is to reduce the variability in the clinic experience, to reduce the transfusion necessities and to assure an safe treatment with blood products. so with this study the investigators will evaluate if the goals of this protocol are followed and if the use of this protocol is really safe and efficient.


Eligibility criteria:
inclusion criteria: * patients with massive haemorrhage and surgery * informed consent exclusion criteria: * \<18 years old patients * patients didn´t want to participate in this study * patients were participated in other studies
high volumes of hypertonic saline and chest physiotherapy in cf patients

Conditions: Cystic Fibrosis

Summary: background nebulised hypertonic saline (hs) is an established basic airway clearance treatment in cystic fibrosis (cf). however, there is scarce evidence regarding the practical implementation and administration of different hs volumes, including physiotherapy and aspects of breathing pattern. the aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.

aims: to establish a safe, efficient routine for implementation of hs in daily treatment and to investigate the efficiency and tolerance of high volumes of hs integrated with chest physiotherapy. hs was given twice daily with volumes of 4,5 ml in children aged 0-5 years, 6 ml at age 6-16 years and 9 ml at age \> 16 years. the protocol included guidance of standardized breathing pattern, upright and sideways positioning and voluntary cough.

Eligibility criteria:
inclusion criteria: * cystic fibrosis exclusion criteria: * non-adherence

Keywords: hypertonic saline lung physiotherapy
tens in optimizer(r) patients

Conditions: Heart Failure

Summary: systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart failure. patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation (tens). it is applied to strengthen the musculature and improve exercise tolerance and quality of life. it is unclear if application of tens can cause electromagnetic interference (emi) in patients with optimizer® pacemaker systems for improvement of heart failure. this pilot safety study enrolled 6 patients with chronic heart failure and reduced left ventricular ejection fraction. all patients had an optimizer® pacemaker system implanted for a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to the study, and all were in clinically stable condition and willing to participate in this study. neuromuscular stimulation was administered via tens in 4 different modes (hf, lf, burst, mf) on the right and left musculus trapezius and on both musculi quadriceps femoris. all patients were tested for emi without or with cardiac contractility modulation (ccm) delivery of the optimizer®-system respectively.


Eligibility criteria:
inclusion criteria: * \>18 years, with implantation of the optimizer ® \>6 months ago, clinically stable condition and without any ventricular arrhythmic episode in the last 3 months. exclusion criteria: * local swelling or edema at the site of stimulation, intolerance to electrical stimulation, or presence of other metallic implants at the site of stimulation
single non-fasting ogtt versus fasting ogtt for screening of hyperglycaemia in pregnancy (hip)

Conditions: Diabetes in Pregnancy

Summary: with the increasing prevalence of diabetes in pregnancy it is necessary to design a simple, sensitive, cost effective method for screening of hyperglycaemia in pregnancy specially in resource constrained settings. there is no universally agreed screening and diagnostic criteria to detect hyperglycemia in pregnancy. in present study, dipsi (non-fasting ogtt) is compared with fasting oral glucose tolerance test (ogtt) to evaluate sensitivity and specificity of both methods in our population.


Eligibility criteria:
inclusion criteria: all pregnant women exclusion criteria: known diabetic
pre-analytical factors affecting ctdna analysis in early and locally advanced breast cancer

Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Early Stage Breast Carcinoma; Locally Advanced Breast Carcinoma

Summary: this study evaluates pre-analytical factors affecting circulating tumor deoxyribonucleic acid (ctdna) analysis in breast cancer that not spread beyond the breast and or lymph nodes (early and locally advanced). ctdna refers to freely circulating tumor dna fragments found in the blood plasma. pre-analytical factors such as blood collection tubes, delays in separation of plasma, centrifugation speeds, storage conditions, shipping and dna extraction methods can all affect ctdna measurements. inappropriate processing can cause breaking down of the membrane (lysis) of peripheral blood cells that release background wild-type dna and may also cause degradation of circulating tumor-specific dna fragments. both mechanisms will dilute levels of ctdna in plasma and make it more difficult to detect. evaluating the pre-analytical factors of the collection of blood and left over tissue samples for the research of cancer may help researchers to evaluate the impact of the blood collection/processing and long-term storage from patients with locally advanced breast cancer.

primary objectives: i. to evaluate the impact of blood collection/processing. ii. to evaluate the impact of long-term storage of plasma and extracted dna. outline: this is an observational study. patients undergo blood sample collection throughout the study. patients also undergo collection of leftover tissue samples from standard of care (soc) procedures and have medical records reviewed.

Eligibility criteria:
inclusion criteria: * all women \> 18 years of age * stage i-iii breast cancer * subject has consented to irb 2130-00 tissue registry exclusion criteria: * stage iv breast cancer * unwilling or unable to give consent * unable to participate for 1 year * no one with a concurrent cancer except those diagnosed with an in situ cancer or non-melanoma skin cancer