Kornimate/medical-research-clean huggingface dataset:
peripheral iv dressing and phlebitis in patients from amazon

Conditions: Phlebitis; Catheter Complications

Summary: pragmatic, randomized, single-blinded, controlled clinical trial of the effect of dressing and stabilization of peripheral intravenous catheters on the occurrence of phlebitis in adult patients attended at a hospital from the western brazilian amazon.

peripheral venous catheterization is the most commonly performed invasive procedure in healthcare. care practices and the use of technologies may influence the results of the use peripheral intravenous catheters (pic), contributing to the reduction of complications and adverse events. phlebitis is characterized as one of the most serious complication related to the use of pic and this study has as hypothesis to analyze if the occurrence of phlebitis associated with pic is influenced by the use of sterile dressing. objectives: to verify the effect of using sterile dressing and sterile adhesive tape compared to non-sterile adhesive tape in pic on the occurrence of phlebitis in adult patients attended at a hospital from the western brazilian amazon. methods: pragmatic, randomized, controlled and single-blinded clinical study conducted in rio branco, acre. the sample was calculated in 330 patients, aged 18 years or older and who met the inclusion criteria. data collection took place between june 2018 and september 2019, after approval of ethical merit. to identify the type of sterile transparent dressing to be studied, was carried out an implementation study with a final sample of 71 patients, focusing analysis from the perspective of the patient, professional and clinics. the patients of the clinical study were randomly allocated to one of the study groups: experimental group (sterile transparent dressing) or standard group (non-sterile adhesive tape). phlebitis was diagnosed by the bedside nurse, according to presence and severity. if present, the nurse removed the cip and an external evaluator was called to perform a diagnose of phlebitis with blindness regarding the intervention. variables related to patient characterization, intravenous therapy, peripheral venipuncture, reasons for withdrawal and length of pic stay, reasons for removal and length of coverage, and associated complications were investigated. for the statistical analysis, chi-square, fisher's exact, student t test, and mann-whitney u tests were used. the multiple analysis was performed using the logistic regression model to estimate the relative risk (rr) and the kaplan-meier model, cox regression, for survival analysis. rr calculation for 95% confidence interval (ic) was applied to estimate the degree of association between variables. in all tests, the significance level of 5% was considered.

Eligibility criteria:
inclusion criteria: * iv access for more 48 hours obtained in the studied wards. * iv access 20 and 22 g. * without confusion or agitation * aged more or equal 18 years exclusion criteria: * sepsis * skin lesions
the role of metformin and colesevelam in human glp-1 secretion

Conditions: Type 2 Diabetes

Summary: our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (glp-1).


Eligibility criteria:
inclusion criteria: * normal hemoglobin * bmi \> 23kg/m2 * hba1c \<9 % * informed concent exclusion criteria: * liver disease ( aspartate aminotransferase/alanine aminotransferase \>2 × reference value) * chronic intestinal disease * history of liver and / or gallbladder disease * nephropathy (se-creatinine \>110 µm and / or albuminuria) * insulin or glp-1-based antidiabetic treatment * history of cholecystectomy or surgical resection of bowel segment * bmi \ 35 kg/m2 * pregnancy
blood and urine hpvdna as minimally invasive biomarkers for cervical cancer detection and surveillance following treatment

Conditions: Cervical Cancer

Summary: the purpose of this study is to determine if cthpvdna (circulating tumor hpv dna) can be used as a non-invasive biomarker for identification and treatment monitoring of cervical cancer by characterizing correlation between plasma cthpvdna, urine transrenal hpvdna (trhpvdna) levels and presence of cervical cancer at diagnosis and following definitive intent management.

early stage cervical cancer is managed surgically while chemoradiation is the mainstay for treatment of bulky or advanced stage disease. the primary aim of post-treatment surveillance is to detect early recurrences and guide additional therapy. there is no definitive agreement on the best practice for cervical cancer surveillance. most recurrences are detected based on patient history and physical exam as there is limited data to support cervicovaginal cytology and routine use of imaging in follow up. novel non-invasive biomarkers are needed to monitor disease status, detect early recurrence and guide personalized treatment decisions. biospecimens including urine and blood plasma will be collected from patients presenting to the unc department of gynecology oncology and multidisciplinary clinics with newly diagnosed cervical cancer to assess for hpvdna. archived or residual tissue will also be accessed. for patients who undergo definitive management with surgery or chemoradiation, a post-treatment blood plasma and urine sample will be collected 2-6 weeks after completion and will be compared to pre-therapy cthpvdna and trhpvdna levels.

Eligibility criteria:
inclusion criteria: * 18 years of age or older on day of signing informed consent * new diagnosis of cervical cancer * subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee exclusion criteria: * women who are pregnant
technological based rehabilitation on individuals with rheumatic disease

Conditions: Rheumatic Diseases; Hand Rheumatism; Virtual Reality Therapy

Summary: affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of international classification of function system. leap motion controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. the aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life.

in the study, 45 adult individuals diagnosed with rheumatic disease with hand involvement will be randomly divided into 3 groups. the first group will be given virtual reality exercises via leap motion controller. virtual reality exercises will be applied 30 minutes a day, 3 days a week for 8 weeks. to the second group, a conventional hand rehabilitation program will be applied under the supervision of a physiotherapist. the hand rehabilitation program will be applied 30 minutes a day, 3 days a week for 8 weeks. the third group will be the control group, which continues with its routine medications and is not included in any exercise program. after randomization, the individuals' joint range of motion, gross and fine grip strength, functionality, and disease activities will be evaluated. evaluations will be made twice, at the beginning and at the end of the 8-week program. disease activity score 28 (das 28), hand dynamometer, picnometer, jebsen hand function test, nine hole peg test, duruoz hand index and michigan hand outcome questionnairre will be used for evaluation.

Eligibility criteria:
inclusion criteria: * having been diagnosed with a rheumatic disease that meets the latest criteria by a rheumatologist * involvement in hand joints (pain, swelling, tenderness) * being 18 years or older * being on stable drug treatment for the last 6 months * having sufficient cooperation to participate in the study * volunteering to participate in the study exclusion criteria: * not volunteering to participate in the study * having difficulty in cooperating at work * having an additional orthopedic and/or neurological disease that will affect hand functions

Keywords: rheumatic diseases hand exercises leap motion functionality
weight-loss treatment program in children and adolescents

Conditions: Childhood Obesity; Health Behavior; Weight Loss; Motivation

Summary: the study will evaluate the effect of an existing hospital-based obesity treatment in children and adolescents in relation to weight loss and motivation. this is to ensure that children who have developed obesity have the possibility to obtain a healthier lifestyle, including a healthier body weight during their school years. this study will test whether an obesity treatment program designed for school children can reduce the degree of overweight in children and adolescents with overweight and obesity.


Eligibility criteria:
inclusion criteria: * 2-18 years old * bmi sds above the 90th percentile exclusion criteria: * reached a bmi sds below the 75th percentile * attained 19 years of age

Keywords: childhood obesity treatment
pharmacokinetic,safety and exploratory efficacy of rectiv® in adolescents with chronic anal fissure

Conditions: Anal Fissure

Summary: rectiv® is an ointment containing 0.4% nitroglycerin (ntg) for the treatment of moderate to severe pain associated with chronic anal fissure approved in june 2011 by the us food and drug administration (fda) for adults. the purpose of this study is to assess the safety, pharmacokinetics, and exploratory efficacy of rectiv® in adolescents

this is an open-label, multicenter study conducted in up to 10 sites in the united states. a total of 13 pediatric male or female patients age ≥12 to \<17 years will be enrolled. the patients will administer a dose of rectiv® twice daily to characterize the safety, pharmacokinetics , and exploratory efficacy of nitroglycerin ointment 0.4% (rectiv® )over 5 days

Eligibility criteria:
key inclusion criteria: * male or female ≥12 and \<17 years of age * at least 1 anal fissure for a minimum of 3 weeks in duration * anal fissure pain experienced over the last 24 hours at screening and before enrollment * patient (and parent or caregiver as appropriate) has provided written informed consent key exclusion criteria: * current diagnosis of hemorrhoids * hypersensitivity, allergy, or contraindication to nitroglycerin * history of hypertension and/or cardiovascular disease * history or current diagnosis of inflammatory bowel disease * history or current diagnosis of fistula(e)-in-ano or an anal abscess * fibrotic anal stenosis * previous anal surgery * diagnosis of cancer * history of migraine or chronic headaches requiring treatment with analgesics * pregnant or lactating female patients * weight \<36 kg

Keywords: anal fissure nitroglycerin pediatrics rectiv® pediatric research equity act
dermacyd infantile (lactic acid)- compatibility.

Conditions: Hygiene

Summary: primary objective: to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product dermacyd infantile.


Eligibility criteria:
inclusion criteria: * photo type skin i,ii, iii e iv * integral skin test in the region * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion. exclusion criteria: * lactation or gestation * use of anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection * diseases which can cause immunity decrease, such as hiv, diabetes * previous atopy * history of sensitivity or irritation for topic products * active cutaneous diseases which can interfere in the study results * use of new drugs and/ or cosmetics during the study * cutaneous reactivity * previous participation in studies, which had used the product * volunteers who have immunodeficiency congenital or acquired * relevant clinical history or present evidence of alcohol abuse or others drugs * non tolerance to some component of the study product. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
everolimus for treating pediatric patients with recurrent or refractory tumors

Conditions: Tumors; Brain Tumors; Rhabdomyosarcoma; Sarcoma, Soft Tissue

Summary: patients with recurrent or refractory solid tumors or brain tumors that are unresponsive to conventional therapy, or with no known effective therapy, will be treated. experiments in the laboratory have shown the experimental drug rad001c (rad001, everolimus) can prevent cells from multiplying. rad001 is now being tested in diseases such as cancer, in which excessive cell multiplication needs to be stopped. the drug has been tested in adult cancer patients and has been well tolerated by subjects in these studies. it is experimental and, therefore, available in clinical trials.

although a phase ii portion of this study was planned, it was never initiated.

Eligibility criteria:
inclusion criteria: * adequate performance status * adequate bone marrow, kidney, heart, and liver function exclusion criteria: * must not be receiving concomitant anti-cancer treatment * must not be pregnant

Keywords: brain tumors soft tissue sarcomas refractory solid tumors recurrent or refractory rhabdomyosarcomatous soft tissue and non-rhabdomyosarcoma soft tissue sarcomas
prevalence of psoriatic arthritis in adults with psoriasis: an estimate from dermatology practice

Conditions: Psoriasis; Psoriatic Arthritis

Summary: this is a phase 4, multicenter, randomized, non-therapeutic interventional trial in subjects with psoriasis looking for the prevalence of psoriatic arthritis. subjects will be seen and evaluated by a dermatologist at visit 1 and by a rheumatologist at visit 2. a subset of subjects will then go on to visit 3 for imaging procedures (x-ray, mri, and ultrasound).


Eligibility criteria:
inclusion criteria: * subject is \>18 years of age at the time of consent. * subject has a confirmed diagnosis of plaque psoriasis by clinical judgment. * subject is able to read and complete questionnaires. * subjects planning to undergo radiographic evaluation, should not have any contraindications to mri. exclusion criteria: * none.

Keywords: non-therapeutic interventional
trial of nadofaragene firadenovec vs. observation in participants with intermediate risk non-muscle invasive bladder cancer

Conditions: Intermediate Risk Non-Muscle Invasive Bladder Cancer

Summary: a phase 3b, randomized, controlled trial of nadofaragene firadenovec vs. observation in participants with intermediate risk non-muscle invasive bladder cancer (ir nmibc)


Eligibility criteria:
inclusion criteria: * diagnosed with intermediate risk non-muscle invasive bladder cancer (ir nmibc) as defined by american urological association (aua)/society of urologic oncology \[suo\] guideline (2020) * has undergone complete transurethral resection of bladder tumor (turbt; with or without peri-operative chemotherapy) within 60 days prior to randomization: * recurrence within 1 year, low-grade ta * solitary low-grade ta \>3 cm * low-grade ta, multifocal * solitary high-grade ta, ≤3 cm * low-grade t1 * restage turbt may be done at the discretion of the investigator exclusion criteria: * current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit high risk nmibc defined as: * high-grade t1 * any recurrent, high-grade ta * high-grade ta \>3 cm (or multifocal) * any carcinoma in situ (cis) * any bacillus calmette-guérin (bcg) failure in high-grade subject * any variant histology * any prostatic urethral involvement low risk nmibc defined as: * first occurrence of low-grade solitary ta ≤3 cm * recurrence of low-grade solitary ta ≤3 cm \>12 months from previous occurrence * papillary urothelial neoplasm of low malignant potential
a study of pf-05212384 plus irinotecan vs cetuximab plus irinotecan in patients with kras and nras wild type metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this study will investigate whether the combination of pf-05212384 plus irinotecan improves progression free survival in patients with kras and nras wild type metastatic colorectal cancer when compared with the combination of cetuximab plus irinotecan. a japanese lead in cohort will assess the safety of the combination of pf-05212384 + irinotecan in patients enrolled at japanese sites.


Eligibility criteria:
inclusion criteria: * kras and nras wild type metastatic colorectal cancer * progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting. * eastern cooperative oncology group \[ecog\] performance status of 0, 1, or 2 * at least one measurable lesion by response evaluation criterion in solid tumors \[recist\] exclusion criteria: * more than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer. * prior treatment with a pi3k, mtor, akt or egfr inhibitor * patients who have discontinued treatment with prior irinotecan therapy due to toxicity. * prior radiation to the pelvis or abdomen * patients with history of interstitial lung disease.

Keywords: metastatic colorectal cancer colorectal cancer kras colon cancer mcrc crc pf-05212384 kras wild type colorectal cancer irinotecan cetuximab nras
the effect of self-titration and predictors for blood pressure control in patients with hypertension

Conditions: Primary Hypertension

Summary: this study aims to investigate the relationship among self-efficacy, anxiety, depressive symptoms, quality of life, lifestyle, heart rate variability and blood pressure control; and to examine the effects of self-titration strategy on self-efficacy, anxiety, depressive symptoms,heart rate variability, sodium excretion, lifestyle modification,quality of life, and blood pressure control in patients with hypertension.

background: hypertension is the major cause of mortality for the cardiac, vascular and renal disease. the effective control of elevated blood pressure may reduce the damages of several target organs. world health organization points out "innovation and empowerment for health". the self-titration strategy may empower patients to self-control their diseases, share decision-making and increase their ability to self-management their situations and improve their home blood pressure. methods: this experimental study included 222 hypertensive patients from outpatient services of cardiology departments of a medical center in northern taiwan. we randomly divided the 72 patients into the experimental group (n=111) and control group (n=111). the experimental group received self-titration strategy training and lifestyle modification education; the control group received usual care and lifestyle modification education. data were collected for self-efficacy, anxiety symptoms, depressive symptoms, lifestyle and health-related quality of life using self-report questionnaires. heart rate variability was measured with checkmyheart device (dailycare biomedical, chungli, taiwan). patients evaluated their home blood pressure by corrected sphygmomanometer. we used the generalized estimating equation to evaluate the effects of the intervention. purpose: primary outcome to evaluate the effects of self-titration strategy on the improvement of home blood pressure in patients with hypertension. secondary outcomes to evaluate the effects of self-titration strategy on the improvement of self-efficacy, anxiety, depressive symptoms and lifestyle quality of life in patients with hypertension.

Eligibility criteria:
inclusion criteria: 1. ≥ 20 years old. 2. diagnosed with primary hypertension. 3. no addiction to drugs or alcohol. 4. not using anti-depression therapy. 5. able to read and understand chinese or taiwanese. 6. willing to participate in this study. exclusion criteria: 1. stroke. 2. arrhythmia. 3. major psychiatric disorders 4. thyroid disease. 5. had received a heart transplant, a permanent pacemaker or an implantable cardioverter defibrillator, diagnosed with (6) cancer, (7) heart failure, or (8) acute myocardial infarction.
evaluation of homecare reablement, the trondheim model

Conditions: Mobility Limitation; Asthenia

Summary: the aim is to evaluate a model of home-based rehabilitation. the intervention targets elder persons who receive homecare services, but still are relatively independent in most activities of daily living. the model focuses on early identification of decline in function and intervention in the home environment through close cooperation between the participant, homecare services and therapists.


Eligibility criteria:
inclusion criteria: * receive homecare services * live within the catchment area exclusion criteria: * in-patient length of stay (iplos) score \> 2.0 * severe dementia

Keywords: rehabilitation evaluation studies home care services
a smartphone application for neurology and telemedicine

Conditions: Parkinson Disease(PD)

Summary: this observational research study is designed to assess the feasibility of developing a new software application that can be used in the home using a commercially available camera to measure abnormal body movements associated with parkinson's disease (pd). the goal of this study is to validate the motor outcomes derived from a consumer camera observing a sub-set of standardized assessment tasks with respect to the reference motion capture system.

the long-term goal of this project is to develop a new software application (neurovision app) for a smartphone or tablet that can be used in the home to measure abnormal body movements associated with parkinson's disease (pd). the outcomes are intended to enhance pd symptom monitoring in the context of telehealth videoconferences with a clinician. typical abnormal body movements that can be assessed with the proposed solution include uncontrolled shaking of hands and limbs (tremor) or spastic movements (dyskinesia) while at rest; abnormally slow movements when reaching or walking (bradykinesia); or inability to initiate a movement (akinesia) using 5 standardized motor assessment tasks (sitting at rest, walking, finger tapping, foot tapping, and foot stomping) derived from the unified parkinsons disease rating scale (updrs). the proposed solution will make it easier for the doctor to periodically assess the motor signs of pd during remote telehealth appointments which may be more convenient and safer for the patient. current reliance on videoconferencing apps make it difficult to record and measure such symptoms accurately in a telehealth setting.

Eligibility criteria:
inclusion criteria: * male or female; * 35 years of age or older; * physician-diagnosed parkinson's disease or other movement disorder such as essential tremor or dystonia; * one or more mild to moderate motor symptoms of pd (tremor, bradykinesia, akinesia, parkinsonian gait); * hohn and yahr (stage i-iii); * independent ambulator - walker or cane allowed; * referring neurologist indicates that prospective subject is not at high fall risk and can safely participate in the study; * have participated in prior telehealth visits using videoconferencing app; * have used a smartphone in past to record videos; * able to provide his/her written informed consent to participate in the study as stated in the informed consent document; * american-english speaking; able to follow directions in english; * normal hearing. exclusion criteria: * inability to understand spoken english or follow simple instructions; * inability to provide written informed consent.

Keywords: movement disorders parkinson's disease 3d camera smartphone motor assessment telehealth