Kornimate/medical-research-clean huggingface dataset:
a study to learn about the adherence and clinical outcomes in colombian patients with an e-device for etanercept administration in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a descriptive, ambispective, and single-site study in colombia, which is designed to evaluate the adherence, persistence, and clinical outcomes (defined as the patient's disease activity and functional status) of ra patients within 40 weeks after the patient administered the first injection of the etanercept medication through the smartclic® device. the study data seeks from medical records containing the smartclic device injection log and pharmacy claims database available from an institution specialized in rheumatological care. the study will only include records of patients treated or starting treatment with etanercept and whose indicated autoinjection device has been smartclic.

non-interventional study: the clinical records of eligible patients will be identified by the rheumatologist from the patients who attended the rheumatologist visit or institutional training sessions according to the standard of care. patients have been prescribed etanercept according to the standard of care, and smartclic has been indicated as an administration method.

Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * patients aged ≥18 years with an established diagnosis of rheumatoid arthritis according to eular-acr criteria recorded in medical record. * patients who are on etanercept treatment and are being switched to smartclic, or new etanercept patients that have been prescribed smartclic® device (either in combination with a conventional synthetic dmard or in monotherapy). * medical records and pharmacy claims database of the ips available after the index date for a period of 40 weeks. exclusion criteria: - any serious ongoing infections, pregnancy, or other social or medical conditions that are anticipated in the investigator's judgment to lead to discontinuation of etanercept administration with the device during the 40 weeks of data collection.

Keywords: observational study
effect of nmes+ on hamstring lesion (3a/3b)

Conditions: Hamstring Injury; Muscle Rupture; Hamstring Sprain

Summary: the goal of this clinical trial is to analyze the effect of the electrical stimulation superimposed onto movement in healthy semi-professional athletes who sustained a type 3a/3b hamstring strain injury. the main questions it aims to answer are: * is nmes+ useful for the treatment of type 3a/3b hamstring strain injury? * does nmes+ improve the quality of the injured muscle tissue? participants will follow a 3 week protocol, following the latest evidence available.\[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. if there is a comparison group: researchers will compare \[insert groups\] to see if \[insert effects\].


Eligibility criteria:
inclusion criteria: * recreational or semi-professional athletes * body mass index between 18,5 e 24,9 * hamstring strain lesion type 3a/3b exclusion criteria: * previous hamstring strain lesions * anterior cruciate ligament reconstruction using hamstring graft * current hamstring strains

Keywords: electrical muscle stimulation (ems) nmes+ hamstring strain injury neuromuscular electrical stimulation (nmes)
a clinical study evaluating the safety and efficacy of idp-107 in patients with acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to assess the safety and effectiveness of idp-107 in treating patients with acne vulgaris.


Eligibility criteria:
inclusion criteria: * presence of inflammatory and non-inflammatory lesions exclusion criteria: * dermatological conditions of the face that could interfere with clinical evaluations * female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
protein supplementation in dialysis patients

Conditions: Peritoneal Dialysis Patients

Summary: the dialysis population has a strikingly high incidence of mortality. the life expectancy of chronic dialysis patients is 20 years less than that of the general population. approximately 50% of individuals with end stage renal disease (esrd) die from a cardiovascular (cv) cause with mortality being 15 to 30 times higher than the age-adjusted cv mortality in the general population. there is also a steady increase of patients with diabetes and the older age groups coming into dialysis. the treatment of patients with esrd aims at prolonging life, achieving good nutritional status and promoting the best possible functioning and quality of life (qol). several factors that are beyond adequacy of dialysis predict high mortality in esrd patients. associated co-morbidities and malnutrition factors are independently associated and the combined presence of both malnutrition and co-morbidities manifest the worst survival.therefore this study investigates the efficacy of protein supplementation in improving health status and quality of life among peritoneal dialysis (pd) patients. this research will also generate basic data about significant health markers critical to the health status of pd patients.

this study is a randomised, open labeled controlled trial where a total of 74 pd patients (37 supplemented; 37 control) were recruited from government and private settings. subjects were randomised to either the intervention or control group. the intervention group received hydrolysed whey protein supplement and diet counselling for 6 months while the control group received only diet counselling for 6 months. patients who consented were first subjected to a screening for identification of eligible subjects. the screening involved basic anthropometry measures (height, weight, bmi), routine biochemistry result obtained from medical record, assessment of nutritional status and dietary evaluation. about 4ml of pre-dialysis blood was also collected by respective nurses for additional laboratory parameters (hscrp). during the 6 months of treatment period, patients in both control and intervention groups were assessed at baseline and end of the study (at 6 months) for anthropometry assessment, laboratory results, medical condition, hospitalisations, nutritional status, dietary intake and compliance towards supplementation (intervention group only).

Eligibility criteria:
inclusion criteria: * aged \> 18 years old and ≤70 years old * undergone dialysis at least for 6 months. * categorised as malnourished based on bmi \<24 kg/m² and serum albumin ≤40 g/l criteria * no incidence of hospitalisation for past 3 months, free of infection/sepsis and have not undergone surgery for past 6 months. exclusion criteria: * patients with high inflammatory diseases, malignancy, cancer * vegetarian patients
a study of randomized sham-control auricular tens unit stimulation in pediatric functional gastrointestinal disorders

Conditions: Functional Gastrointestinal Disorders; Vagus Nerve Autonomic Disorder; Irritable Bowel Syndrome; Nausea; Dyspepsia

Summary: the purpose of this study is to see if using a micro-current through a device called a tens (transcutaneous electrical nerve stimulator) unit helps to improve functional gastrointestinal disorder (fgid) symptoms in children by stimulation of the vagus nerve. the study will compare two methods of stimulation to determine if there is a difference in the two methods.


Eligibility criteria:
inclusion criteria: * female patients 12-18 years old with chronic idiopathic nausea, function abdominal pain, dyspepsia and/or irritable bowel syndrome * english speaking exclusion criteria: * patients who are unable to stand upright during the heart rate variability recording * patients with a known bleeding disorder * gastric or cardiac pacer or defibrillator * poor circulation in lower limbs * swollen or inflamed outer ear * epilepsy * abdominal or inguinal hernia * any unstable medical condition, such as renal disease, uncontrolled diabetes, etc. * requires new medication during the 8 weeks of the study that may affect gastrointestinal symptoms, vagal modulation or immune response * inability to answer questionnaires or report pain on a 0-10 visual analog scale.
effects of physical activity counseling in patients with adolescent idiopathic scoliosis

Conditions: Scoliosis; Adolescent Scoliosis

Summary: scoliosis is a three-dimensional deformity of the spine of unknown etiology and is clinically defined as 10° or more lateral curvature of the spine. although there are different types of scoliosis, the most common type is adolescent idiopathic scoliosis (ais), which starts at the age of 10. ais can affect body alignment, spine and soft tissues and cause physical problems such as postural disorder, cosmetic trunk deformity, decreased flexibility of the spinal column, changes in spinal muscle characteristics, and back pain. the aim of our study is to examine the effects of physical activity counseling on physical activity level and posture, perception of deformity and quality of life in patients with ais.

ais is the most common spinal deformity seen by primary care physicians, pediatricians, and spinal surgeons. the primary goal in the conservative treatment of scoliosis in adolescents is to prevent the progression of the curvature and secondary problems associated with spinal deformity and ultimately to eliminate the need for surgery. for this reason, scoliosis-specific corrective exercise therapy given by a physiotherapist is recommended for patients with ais. however, while this treatment is effective to the gold standard on spine and posture, its effect on physical activity is not known exactly. the aim of this study is to examine the effect of physical activity counseling on physical activity level and posture, perception of deformity and quality of life in individuals with ais who are given physical activity counseling in addition to scoliosis-specific corrective exercises. individuals with ais in both groups, in accordance with the schroth classification, individually planned exercise program aimed at correcting and stabilizing the spine in three dimensions, in the form of 45-60 minutes sessions, 2 days a week for 8 weeks, a total of 16 sessions. group 1 will be given physical activity counseling as well as scoliosis-specific corrective exercises. physical activity counseling will be done face-to-face, and one-on-one interviews will be provided with each participant. each meeting will last approximately 20-30 minutes and individuals will be encouraged to participate in more physical activity by providing alternative solutions on their physical activity habits, what they like to do or how they can access activities.

Eligibility criteria:
inclusion criteria: * being diagnosed with idiopathic scoliosis by an orthopedic specialist * cobb angle determined on anteroposterior radiograph is 10 - 45 degrees exclusion criteria: * having mental problem, rheumatological, neuromuscular, cardiovascular, pulmonary disease * any treatment approach for scoliosis in the last six months * having any orthopedic problems that may affect their participation in exercise and/or physical activity * having a regular exercise habit
t-cell based immunotherapy for head and neck cancer

Conditions: Squamous Cell Carcinoma; Head and Neck Cancer

Summary: the aim of this study is to investigate the toxicity and immune response of therapy with tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary operation and radiotherapy. patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. patients will be evaluated for toxicity and immune response.


Eligibility criteria:
inclusion criteria: * patients with histological proven squamous cell carcinoma t3 or more in the oral cavity planned for primary surgery. performance status 0 to 1. acceptable cbc and blood chemistry results. acceptable organ functions. exclusion criteria: * patients with a history of any other malignancies less than five years ago. brain metastases. other significant illness including severe allergy, asthma, dm, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
pilot evaluation of the filmarray® childhood systemic infection (csi) panel

Conditions: Systemic Infection

Summary: the purpose of this study is to collect data to support decisions made by biofire regarding assay development, panel composition, and intended use for the final filmarray csi reagent pouch. the study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.


Eligibility criteria:
inclusion criteria: * subject has presented to the ed and is suspected of a systemic infection as indicated by a clinician order for blood culture * parent/guardian gives written permission (and assent is obtained from children of sufficient maturity) * blood specimen can be collected at the same time as the blood culture during the ed visit (or within 12 hours of being admitted from the ed) * specimen is at least 500 µl (1.5 ml collection desired) exclusion criteria: * parent/guardian is unavailable or unable to give permission, or assent is not obtained (from children of sufficient maturity) * physician determines that participation in the study is an unacceptable health risk * minimum volume requirement is not met
evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous csl730 in healthy adult subjects

Conditions: Immune Complex-mediated Autoimmune Diseases

Summary: this phase 1, randomized, double-blind, placebo-controlled study will assess the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of single ascending doses of csl730 administered by subcutaneous (sc) injection or sc infusion in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy male or female adult subjects aged ≥ 18 to ≤ 55 years * females must be either postmenopausal or sterile * body weight between ≥ 50 and ≤ 110 kg and body mass index between ≥ 18.0 kg/m2 and ≤ 30 kg/m2 exclusion criteria: * history or current evidence of a clinically significant medical condition, disorder, or disease, including but not limited to any of the following: hepatic (hepatitis, cirrhosis, or history of liver disease, drug reaction, or aminotransaminase elevations, if known); biliary; renal; cardiac; bronchopulmonary; vascular; hematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic (including history of migraine); psychiatric; immunologic; dermatologic; oncologic (subjects with resected cervical or skin cancer \[except melanoma\] who have had no evidence of disease in the last 5 years are eligible), that precludes designation of healthy subjects as judged by the investigator * history or evidence of congenital or acquired immunosuppressive condition(s), including positive serology for human immunodeficiency virus infection or taking immunosuppressive agents. * evidence of active or latent tuberculosis * hospitalization within 3 months before ip administration or planned hospitalization at any time during the study. * history of any drug allergy, hypersensitivity (excluding hay fever) or intolerance to latex or any drug product * a positive test result for drugs of abuse. * smokers within 3 months before screening.
safety and efficacy of urinary kallidinogenase for large artery atherosclerosis acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

currently, evidence regarding the safety and efficacy of urinary kallidinogenase treatment in patients with acute ischemic stroke lacks, and few of related studies were large-scale and high-quality. thus, this study was designed to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old; 2. acute anterior circulation large artery atherosclerotic cerebral infarction (according to toast classification) within 48h of onset; nihss score ≥6, ≤15; 3. moderate to severe stenosis or occlusion of offending vessels; 4. the mrs score ≤2 before onset; 5. subjects or their legal representatives agreed to the treatment and signed the informed consent form. exclusion criteria: 1. transient ischemic attack; 2. patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy); 3. severe disturbance of consciousness:gcs ≤8; 4. patients who previously received angiotensin-converting enzyme inhibitor (acei) drugs regularly; 5. refractory hypertension: systolic blood pressure ≥200 mmhg or diastolic blood pressure ≥110 mmhg; hypotension: systolic blood pressure \< 90 mmhg or diastolic blood pressure \< 60 mmhg; 6. liver dysfunction (alt/ast \>1.5 × upper limit of normal \[uln\]), renal dysfunction (cr \>1 × uln); 7. coagulopathy (prolonged inr (\>1.5) or prolonged aptt (\>2 folds); 8. cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.); 9. special populations such as pregnant and lactating women, patients with life expectancy less than 3 months, or patients unable to complete the study for other reasons; 10. unwilling to be followed up or poor treatment compliance; 11. participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment; 12. other conditions considered by the investigator to be inappropriate for enrollment.

Keywords: acute ischemic stroke, urinary kallidinogenase
elastic compression in chronic venous disease

Conditions: Varicosity

Summary: patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmhg) or placebo stockings

patients with chronic venous disease causing pain or ache satisfying the inclusion and exclusion criteria will be randomised into two groups, active stockings (18-21 mmhg) or placebo stockings. the primary outcome of the study (pain/ache scored using a visual analogue scale) and a number of secondary symptoms, signs and rvcss (revised venous clinical severity score) will be obtained at baseline and after one week of wearing the active or placebo stocking.

Eligibility criteria:
inclusion criteria: * primary varicose veins causing pain/ache located only at the calf level exclusion criteria: * venous ulceration * dermatitis * itching * superficial vein thrombosis * peripheral arterial disease * symptoms of non-venous origin * previous use of elastic stockings
high cardiovascular risk management and salt reduction in rural villages in china

Conditions: Cardiovascular Disease

Summary: cardiovascular disease is the leading cause of death in china. at the village level, strategies for the control of cardiovascular disease are mostly absent. national clinical guidelines for the management of hypertension and cardiovascular disease are rarely disseminated to, or implemented by, the village primary care providers. salt reduction has greater potential in rural china than almost anywhere else in the world. very high levels of salt consumption, very little use of processed food and most dietary salt deriving from home cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in almost any other setting. the two large-scale cluster-randomized controlled trials proposed here will precisely and reliably define the effect of two highly plausible intervention strategies on important clinical outcomes. the evidence provided by the project will form the basis for policy setting that has the potential to greatly reduce the occurrence of vascular disease in rural china and take an important step towards balancing the rural urban divide in health and healthcare.


Eligibility criteria:
inclusion criteria: * physician-diagnosed history of coronary heart disease, ischemic stroke, or hemorrhagic stroke, or * older age (50 years or older for men; 60 years or older for women) and having physician-diagnosed type i or type ii diabetes * older age (50 years or older for men; 60 years or older for women) and systolic blood pressure 160 mmhg (note that for simplicity, diastolic blood pressure is not included in the criteria) exclusion criteria: * none

Keywords: high blood pressure primary care cardiovascular disease prevention salt reduction