Kornimate/medical-research-clean huggingface dataset:
effect of information about the benefits and harms of mammography on women's decision making

Conditions: Breast Cancer Screening

Summary: the aim of this study is to assess the effect of receiving information about the benefits and harms of mammography screening on informed choice, decisional conflict, intention to participate in the early detection of breast cancer program (edbcp), and satisfaction. the primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). the sample of participants is composed by 400 women from catalonia and the canary islands (spain) who will receive their first invitation to participate in the edbcp of the public health service in a period of 2-4 months.

the selected women will receive a letter of invitation with information about the study. in the following 1-2 weeks they will receive a phone call to confirm that they have received the mailed letter and to assess the inclusion criteria. if they agree to participate in the study, they will be asked for informed consent. all the participants will receive a first questionnaire, the pre-intervention survey (10-15 minutes), via web or regular mail. trained interviewers will collect the responses by phone for women who prefer this method. once the pre-intervention survey is completed, women will receive the leaflet (intervention or control) via regular mail. two weeks later, the participants will be contacted again to collect the post-intervention survey (15-20 minutes), via web or by phone. participation in the mammographic exams of the edbcp will be collected in the three-month period following the corresponding invitation letter.

Eligibility criteria:
inclusion criteria: * women aged 49-50 who - in 2-4 months - will be invited to participate for the first time in the edbcp of the institut hospital del mar d'investigacions mèdiques (imim, barcelona), ico-hospitalet (hospitalet de llobregat), lleida health region, and the canary islands. * women with low health literacy will be included exclusion criteria: * previous history of breast cancer * difficulty speaking spanish or catalan * cognitive impairment to understand or complete the materials based on the interviewer judgment

Keywords: breast cancer screening decision aid informed choice decisional conflict
surgical consent during the covid-19 pandemic

Conditions: Consent

Summary: multiloop audit of consenting practice in surgical procedures during the covid-19 pandemic


Eligibility criteria:
exclusion criteria: * children (under 18 years old) * participants who lack capacity and therefore cannot be consented appropriately
stem cell therapy in traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with traumatic brain injury


Eligibility criteria:
inclusion criteria: * diagnosed cases of chronic traumatic brain injury * age above 6 months exclusion criteria: * presence of acute infections such as human immunodeficiency virus/hepatitis b - virus/hepatitis c virus * malignancies * bleeding tendencies * pneumonia * renal failure * severe liver dysfunction * severe anemia \[hemoglobin \< 8\] * any bone marrow disorder * space occupying lesion in brain * other acute medical conditions such as respiratory infection and pyrexia * pregnancy * lactation
biofeedback for fecal incontinence

Conditions: Fecal Incontinence

Summary: fecal incontinence affects 2% of adults in the united states. biofeedback has been recommended for the treatment of fecal incontinence because uncontrolled studies over the past 25 years suggest that these treatments are as effective as medical or surgical management and involve no risk. however, placebo-controlled trials are still lacking. the aims of this study are: (1) to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit; (2) to identify which patients are most likely to benefit; and (3) to assess the impact of treatment on quality of life.

study i is a long-term, prospective, single-blind study comparing biofeedback for fecal incontinence to a standard therapy (kegel exercises) that is associated with a similar expectation of improvement (i.e., comparable placebo effect). prior to randomization, patients will receive medical therapy (antidiarrheal medications as appropriate) and education for 4 weeks, and only patients who remain incontinent will be randomized. anal canal squeeze pressures and rectal sensory thresholds will be tested before and after treatment. patients will keep a diary throughout baseline and treatment, and they will be re-assessed at 3, 6, and 12 months. treatment will consist of 6 clinic visits at 2-week intervals. the primary outcome is the patient's response to the question, "have you had satisfactory relief of fecal incontinence (yes/no)?" this question is asked at 3 months following the end of treatment and at each follow-up visit. the investigators will develop a detailed treatment manual for fecal incontinence which would permit other investigators to replicate our study.

Eligibility criteria:
inclusion criteria: * males or females age 16 or above who have an average of one or more episodes of fecal incontinence per week exclusion criteria: * previous biofeedback treatment

Keywords: biofeedback incontinence
melanoma accuracy study; phase 2

Conditions: Melanoma

Summary: the purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse. the long-range goal of the proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in ns. if effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.

the purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse using a dermatoscope, triaging suspicious lesions vs. benign lesions. the long-range goal of the proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in ns. if effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.

Eligibility criteria:
inclusion criteria: * new referral from a general practitioner to a dermatologist * males and females, over the age of 18 are eligible to participate * written informed consent from the patient * lesion or mole is new, changing color, growing rapidly or has a change in sensation * willing to have the lesion excised if necessary per standard of care * ability to complete the imaging procedure and willing to complete a basic history * pigmented lesion considered low, moderate or high risk for melanoma by a general practitioner exclusion criteria * lesions which are not amenable * participant unable to read, understand or sign consent * participant under active care by a dermatologist * lesion \ 15mm in diameter * lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions * lesion on hair covered areas (e.g. scalp, beard, mustache) where hair cannot be removed * lesions located on genitalia not accessible to equipment * lesions located in an area that has previously biopsied or subjected to any kind of surgical or ablative procedure * lesion with foreign matter, e.g. tattoo or splinter * lesion and/or reference located on acute sunburn * skin surface not measurable, e.g. lesion on a stalk * skin surface not accessible, e.g. inside ears, ears, under nails * skin not intact (measurement area), e.g. bleeding or with clinically noticeable ulceration * lesions located within 1cm of the eye * lesions light in pigment or thick and nodular * participants not willing to have the lesion excised
anti-inflammatory effect of atorvastatin on graft donor kidney

Conditions: Renal Insufficiency

Summary: renal insufficiency is a priority disease in health system, which may require renal replacement therapy based on renal transplantation, which is considered as therapy of choice. during the procedure of renal transplantation, the graft could be damaged by ischemia-reperfusion which generates complications in its function. recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in renal transplantation.

objective: evaluate anti-inflammatory effect of atorvastatin on renal graft in living donor transplantation. material and methods: controlled, double-blind clinical trial with posterior following for 12 months. composed by 48 patients, randomized manner, realized at the transplant department of western medical center, mexican institute of social security. universe was patients accepted as kidney donors. patients were randomized in two groups (study or control) the intervention was implemented 4 weeks before kidney transplant. previous surgical procedure, in a blood sample, c-reactive protein (c-rp) and laboratory control were measured. during surgical procedure, a biopsy was obtained to measure il-6 and tumoral necrosis factor alpha by immunohistochemistry. 24 hours after surgical procedure, 3 and 12 months of following, kidney function, complications and graft survival were registered. during surgical procedure, 3 months and 12 months of following, biopsies were obtain to performed histopathological analysis of scale of banff the statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages.

Eligibility criteria:
inclusion criteria: * accepted as kidney donor * voluntary participation * informed consent accepted * 85% fulfillment of atorvastatin treatment exclusion criteria: * hypersensibility to atorvastatin * smoking

Keywords: kidney transplantation atorvastatin c-reactive protein biopsy interleukin
efficacy of silk - like bedding fabric pillow case in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this research study is to better understand how this study pillowcase works when people use it to treat acne. most people, including people with acne, sleep six to eight hours each night in direct contact with bedding fabrics that provide no benefit to the healing process associated with acne. the fabric in this study pillowcase may be able to reduce bacteria on the skin. this study would evaluate how acne is affected by this silk-like pillowcase. this type of study has not been done before.

this is a pilot study of subjects with mild to moderate/severe facial acne vulgaris with an assessment of 2-4 on the investigator global assessment (iga) scale . we will enroll 40-60 subjects in order to obtain 40 evaluable subjects. evaluable subjects will be defined as those that complete the protocol, or those that fail to complete due to an adverse event related to the study. one-half of subjects will be assigned to sleep on the study product, which is a standard size pillowcase made of a silk-like fabric. the other half will be assigned to sleep on the placebo pillowcase made of 100% cotton. each subject will be instructed to sleep on this pillowcase every night for 12 weeks. investigators will be blinded to the type of pillowcase used by the study subject. the distribution of placebo and study product pillowcases will be randomized 1:1. the study period will last for 12 weeks. subjects will be evaluated at baseline, weeks 2, 6 and 12.

Eligibility criteria:
inclusion criteria: * male or female with facial acne vulgaris, 12 years of age or older, that agree to participate and provide written consent * greater than 5 superficial inflammatory lesions with less than 3 nodules on the face * a score of 2-4 on the investigator global assessment * women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control * female subjects will have a urine pregnancy test if applicable. exclusion criteria: * use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids * application or use within 2 weeks of baseline of topical acne or rosacea medications or topical anti-inflammatory medication, which may influence study outcome * presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments * subjects who have taken isotretinoin within the past 6 months * subjects with known allergy or sensitivity to polyester or nylon fibers in fabric * pregnant women and women who are breastfeeding
randomized switch study from hydroxyurea to ruxolitinib for relief of polycythemia vera symptoms: the relief study

Conditions: Polycythemia Vera

Summary: the purpose of the relief study is to compare symptoms in polycythemia vera (pv) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (hu) as measured by the percent of subjects who achieve a clinically meaningful symptom improvement (ie, total symptom score reduction of ≥ 50% reduction) at week 16 compared to baseline. the study is also designed to demonstrate that these responses are durable with continued treatment.

this is a phase 3 multicenter, double-blind, double-dummy, randomized study. only subjects with pv who have received hu for at least 12 weeks, have been receiving a stable dose before screening, and still have symptoms related to pv will be enrolled. subjects will be randomized (1:1) to 1 of 2 treatment arms: a: ruxolitinib and hu-placebo b: hu and ruxolitinib-placebo subjects randomized to either arm may be eligible to transition to open-label ruxolitinib after week 16.

Eligibility criteria:
inclusion criteria: * subjects must currently be reporting symptoms while on a stable dose of hu monotherapy and be eligible to continue hu on study after randomization. * before screening, the subject must have been receiving hu for at least 12 weeks and be receiving a stable dose. * subjects must meet baseline symptom criteria * subjects should meet at least 1 of the following criteria: * no more than 2 phlebotomies within the 6 months before screening or * no palpable splenomegaly. * subjects must have a hematocrit that can be controlled within 35% to 48% (inclusive) before randomization. exclusion criteria: * subjects with inadequate liver or renal function at screening. * subjects with clinically significant infection that requires therapy * subjects with known active hepatitis a, b, or c at screening or with known hiv positivity. * subjects with an active malignancy over the previous 2 years * subjects with clinically significant cardiac disease (class iii or iv).

Keywords: polycythemia vera pv
potassium nitrate gel and diode laser in the treatment of dentinal hypersensitivity

Conditions: Dentistry; Desensitization

Summary: our aim will be to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel emoform actisens, containing 5% potassium nitrate, alone and in combination with a diode laser. dental hypersensitivity (dh) will be assessed pre- (t0) and post-treatment (t1) and at 1 month (t2), 3 months (t3), and 6 months (t4).

this will be a randomized clinical trial (rct) with a split-mouth design, involving 12 subjects, with two parallel groups. the dental elements will be divided into the trial group, treated with a 980 nm diode laser and desensitizing topical gel, and the control group, treated only with the same gel. dh will be assessed using the shiff air index (sai) and visual analog scale (vas).

Eligibility criteria:
the inclusion criteria will be as follows: (a) a good standard of home oral hygiene and (b) at least two teeth affected by dh. the exclusion criteria will be: (a) individuals taking pain relievers; (b) individuals undergoing orthodontic treatment; (c) non-vital teeth; (d) teeth with restorative materials; and (e) pregnant or breastfeeding women

Keywords: desensitizing treatment diode laser oral hygiene dental sensitivity
treatment of hypoparathyroidism with synthetic human parathyroid hormone 1-34

Conditions: Hypoparathyroidism

Summary: this study has been important in establishing synthetic human parathyroid hormone 1-34 (pth) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. providing synthetic human parathyroid hormone 1-34 (pth) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, pth. the primary goals of this study are to (1) provide long-term pth therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic pth replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.

vitamin d and its analogs, the conventional treatment for hypoparathyroidism, are associated with chronic hypercalciuria due to their lack of calcium-retaining effect in the kidney. this side effect usually occurs even while maintaining the serum calcium in the normal range and may lead to calcium deposition in the kidney (nephrocalcinosis) and renal insufficiency. this study examines the long-term effects of subcutaneous parathyroid hormone (pth) therapy on calcium metabolism, bone, and renal function. our previous short-term pilot study comparing subcutaneous pth with calcitriol demonstrated a significant decrease in urinary calcium excretion during pth therapy. based upon these results, we hypothesized that treatment with pth is more physiologic and provides improved long-term metabolic control. additionally, treatment with pth may avoid the adverse side effects on the kidney that are associated with conventional therapy. patients initially come to the clinical center for a two week inpatient evaluation. subsequent follow-up will occur semiannually on an outpatient basis.

Eligibility criteria:
* inclusion criteria: this study will include patients (ages 17-69) with biochemically confirmed hypoparathyroidism. exclusion criteria women who are pregnant will be excluded.

Keywords: hypoparathyroidism parathyroid hormone vitamin d calcium metabolism pth 1-34 bone
the use of the fast (focused abdominal scan for trauma) scan by paramedics in mass casualty incidents

Conditions: Mass Casualty

Summary: initially a group of paramedics will be trained to perform fast (focused abdominal scan for trauma) scans. the paramedics will then enter a simulated mass causality incident and triage patients. volunteers in the study will include peritoneal dialysis patients ("non stable") and non-peritoneal dialysis patients ("stable"). they will use the ultrasound to perform fast scans on the patients to determine which subjects are "stable" and which are "unstable" patients. they will record which patients they consider need transport first. this data will be used to evaluate accuracy and speed of the fast scan. when the paramedic identifies free fluid within the volunteer, they will be able to make the decision to upgrade these patients and ultimately transport them more quickly. the paramedics will be evaluated for time and accuracy with the fast scan.

ultrasound and the fast (focused abdominal scan for trauma) scan is currently being used in the emergency department to help evaluate trauma patients. in the field a paramedic will use the start (simple triage rapid treatment) triage procedure to evaluate many patients and to help decide which patients are more critical and therefore need to be transported first. this study aims to create a mass casualty environment through the use of 10 volunteers who are on peritoneal dialysis and 10 patients who are not.

Eligibility criteria:
inclusion criteria: paramedic - at least one year in the field, physically able to perform the test patients: * (10)peritoneal dialysis patient that are able to leave dialysate in abdominal cavity for the duration of the test * (10) subjects not on peritoneal dialysis who are available for the duration of the test exclusion criteria: * under 18 years of age
effect of preoperative music on anxiety

Conditions: Music on Postoperative Anxiety

Summary: in this study, we are planning to evaluate whether listening to the music of the patient's choice preoperatively contributes to postoperative anxiety.

preoperative anxiety can be detected via structured and standardised screening by the state - trait anxiety inventory (stai) i and ii. 117 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 will be included in our study. preoperative stai i and ii score (anxiety questionnaire) will be applied to each patient. the patients will be divided into two groups as preoperative music played and not played. the list of patients listening to the music will be played through the headphones which are the preference of the patients. the postoperative stai questionnaire will be applied again. results will be evaluated statistically

Eligibility criteria:
inclusion criteria: * inguinal hernia surgery * speak turkish language exclusion criteria: * patients with dementia and psychiatric disorders * anxiolytic and psychiatric drug users * patients without written consent * poor vision, * significant hearing loss, * active opioid use, * unwillingness to participate in the study * unwillingness to listening to music

Keywords: postoperative anxiety state - trait anxiety inventory