Kornimate/medical-research-clean huggingface dataset:
the effects of disease management training and telephone counseling service for elderly patients with osteoarthritis

Conditions: Osteoarthritis

Summary: the study will be conducted to determine the difference on functional status, self-efficacy, and quality of life between groups with and without telephone counseling and training on disease management for participants.

when the literature is examined, in patients with osteoarthritis who receive face-to-face training and intermittent telephone counseling; it is observed that the level of self-efficacy, compliance with the disease and quality of life have increased. it is stated that face-to-face training and telephone counseling services provided to participants on disease management will increase the effectiveness of education and as a result; it is thought that participants may have positive outcomes such as expressing their problems more easily, feeling safer by communicating frequently, and developing methods of coping with nurse-patient cooperation. when the studies conducted in our country are examined, while there are studies examining the effect of non-pharmacological interventions such as acupressor, hot-cold application, exercise training, mud pack treatment in patients with osteoarthritis; no study was found in the elderly patient group in which education and telephone counseling were conducted. the results of the research are thought to be beneficial in managing the disease in addition to in addition to pharmacological treatment.

Eligibility criteria:
inclusion criteria: * aged 65 and over * oa was diagnosed by the physician according to the american college of rheumatology (ard) criteria, * being able to answer research questions * individuals who gave their oral and written consent to participate in the study were included. exclusion criteria: * having a history of malignancy * those who score above 5 points from the visual analogue scale * with a neuro psychiatric illness * having vision and hearing problems * receiving intraarticular medication (steroid, chondramine, hyaluronic acid) in the last month * surgery applied to the knee joint in the last 3 months * having inflammation in the joints * have an open wound in the oa area * individuals with a diagnosed vascular disease will not be included.

Keywords: osteoarthritis nurse self-efficacy quality of life functional status
treatment of periodontal intrabony defects with a-prf+ or emd

Conditions: Periodontal Diseases

Summary: the aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (a-prf+) to enamel matrix derivatives (emd) in periodontitis patients.

thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in two treatment groups: test (n = 15) and control (n = 15). the intrabony defects were filled with a-prf+ (n=15) in the test group, respectively with emd in the control group, and fixed with sutures to ensure wound closure and stability.

Eligibility criteria:
inclusion criteria: * no systemic diseases that could influence the outcome of the therapy, a good level of oral hygiene, he presence of a 2-, 3-, or combined 2-3-wall intrabony defect with a defect angle of 20-40 (+/- 5) degrees, with a minimum ppd of 6 mm and intrabony component of a minimum 4 mm as detected on radiographs, no smoking exclusion criteria: * systemic diseases that could influence the outcome of the therapy, poor oral hygiene, smoking, horizontal bone loss

Keywords: intrabony defects new-generation platelet-rich fibrin enamel matrix derivatives periodontal regeneration emd a-prf+ advanced platelet-rich fibrin
lifetech acumark™ sizing balloon post-market clinical follow-up study

Conditions: Atrial Septal Defect (ASD)

Summary: the objective of this pmcf study is to: * confirm the safety and performance of the acumarktm sizing balloon * identify previously unknown side-effects * monitor the identified side-effects (related to the procedure or to the medical devices)


Eligibility criteria:
inclusion criteria: 1. patients who have been confirmed with single secundum atrial septal defect (asd) by echocardiography; 2. the anatomy of asd is suitable for percutaneous closure; 3. patients are scheduled to perform asd closure; 4. patients or legally authorized representative(s) who are willing and capable of providing informed consent. exclusion criteria: 1. any contraindication for asd closure; 2. patients have ostium primum asd or coronary sinus asd; 3. patients who are pregnant or breastfeeding; 4. patient is currently participating in another clinical trial that has not yet completed its primary endpoint.
the effect of sympathetic dysfunction on muscle spindle in fibromyalgia

Conditions: Fibromyalgia

Summary: this study aims to reveal whether there is an impairment in the sympathetic regulation of muscle spindle sensitivity in patients with fibromyalgia syndrome (fms).

the common muscle pain and fatigue symptoms of fms can be explained by impaired sympathetic regulation of muscle spindle sensitivity. the aim of this study is to reveal whether there is an impairment in the sympathetic regulation of muscle spindle sensitivity in fms patients. material method: in the first stage, resting sympathetic tone measurement and resting h-reflex and t-reflex recordings will be taken in all cases. sympathetic tone measurement will be performed and h-reflex and t-reflex recordings will be taken during and after sympathetic stimulation maneuvers (mental arithmetic calculation and cold application) in fms patients and healthy control subjects. in the second phase, the first dose of pregabalin will be given to patients diagnosed with fms and prescribed pregabalin. pregabalin is known to reduce sympathetic activity in fms. after oral administration of pregabalin, its peak plasma concentration is reached in 0.9-1.3 hours. therefore, 1.5 hours later, sympathetic tone measurement will be made at rest and during the sympathetic stimulation maneuver, and h-reflex and t-reflex recordings will be taken. patients in the healthy control group will not be given pregabalin.

Eligibility criteria:
inclusion criteria: for the fibromyalgia group * patients diagnosed with fms based on the american college of rheumatology - 2016 criteria * between the ages of 20-50 * being a woman * patients prescribed pregabalin for the treatment for the healthy control group * between the ages of 20-50 * being a woman * being healthy exclusion criteria: * those with medical problems in the right upper and lower extremities (skin, neuromuscular, joint, vascular pathologies) * cases that cannot perform arithmetic operations * cold allergy * heart disease (arrhythmia, ischemic heart disease, heart failure) * hypertension * epilepsy

Keywords: fibromyalgia
evaluation of satisfaction regarding patient's management of ocular surface diseases

Conditions: Eyelid Diseases

Summary: multicentric study, open label, uncontrolled phase iv in 140 patients with meibomian glands dysfunction . its objective is to collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how blephasteam ® can be optimized. this study involves 2 visits, visit of inclusion, j0, then end of study visit, d21. between the two visits patients will be treated with blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.


Eligibility criteria:
* signed and dated informed consent. * male or female up to 4 years old. * known and treated symptomatic meibomian gland diseases, and/or dry eye related to mgds stable since at least a month. * without any active pathology requiring a change in ocular treatments within the last month before inclusion. * best corrected far visual acuity (va) \> 1/10

Keywords: meibomian gland dysfunction
profermin® in active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: in this study the investigators aim was to investigate the safety and possible efficacy of profermin® in patients with ulcerative colitis. the investigators also aimed at assessing the usefulness of a new online daily symptom registration system.


Eligibility criteria:
inclusion criteria:patients were eligible if they were between 18 and 50 years of age and had an established diagnosis of uc based on clinical, endoscopic and histological features. active disease was assessed by simple clinical colitis activity index (sccai) (table 1) score above 4 and below 12. - exclusion criteria: patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or methotrexate within 8 weeks prior to inclusion or tnf-α inhibitors within 12 weeks before inclusion or had changes in uc treatment within 2 weeks before inclusion were ineligible for the study. concomitant coeliac disease or lactose intolerance were also exclusion criteria. in addition any malignant or premalignant condition or recent gastroenteritis rendered patients ineligible-
a confirmatory trial of multidisciplinary digital therapeutics for patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: this randomized controlled confirmatory study will be evaluating an mobile application, mora cure (eth-01k), owned by everex, inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.

this randomized controlled confirmatory study will enroll 216 participants, where half will be randomly assigned to the digital therapeutics (s/w medical device), mora cure (n = 108), and half will be assigned to treatment as usual (tau) (n = 108), to examine safety and effectiveness in individuals with patellofemoral pain syndrome. all subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. the application provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.

Eligibility criteria:
inclusion criteria: 1. patients with peripatellar or posterior patellar pain in one or more knee joints for 3 months or longer 2. patients with peripatellar or posterior patellar pain provoked by squatting 3. patients who have pain provoked by 2 or more following activities: prolonged sitting, cycling, running, going up or down stairs, kneeling, compression of the patella, palpation of the patellar facets 4. patients who signed a written informed consent form exclusion criteria: 1. patients with osteoarthritis which scored 3 or higher grade of the kellgren-lawrence scale 2. patients diagnosed with a fracture or dislocation around the knee within the last 3 months 3. patients who had knee surgery within the last 3 months 4. patients diagnosed with patellar tendinitis based on imaging within 3 months 5. patients taking narcotic pain medications for pain control 6. patients taking or planning to take any medication that is a contraindication within the next 16 weeks at the time of screening 7. patients who are pregnant 8. patients currently participating in another clinical trial or have participated in another clinical trial within the past 3 months at the time of screening 9. patients deemed unsuitable for this study by the investigator

Keywords: pfps dtx samd msk
the effect of smart sensor combined with app for individualized precise exercise training in long covid-19

Conditions: Coronavirus Disease; COVID-19; Long Covid-19; Telerehabilitation

Summary: the coronavirus (covid -19) has rapidly turned into a global pandemic. for patients diagnosed with covid-19, it caused severe damage in the upper respiratory system and systemic complications, including the cardiovascular, mental, nervous, and musculoskeletal system. previous research has indicated that these subsequent sequelae can reduce quality of life. (a. w. wong et al., 2020) studies have indicated that exercise training is beneficial to improve blood pressure, reduce cardiovascular factors, reduce complications, and relieve depression (j. galloza et al., 2017) however, the current international research on the benefits of exercise rehabilitation and the improvement of quality of life in patients who have been infected with covid-19 is still lacking. under the international epidemic, it is pointed out that the importance of telerehabilitation has also been advocated worldwide. previous systematic review indicated that no matter it is nervous, muscular or cardiac system disease, the efficacy of telerehabilitation is superior to face-to-face rehabilitation. the purpose of this study is to compare the effect between the intervention of kneesup smart knee assistive device, and the health education in routine outpatient after diagnosis of long covid-19.

the purpose of kneesup measuring equipment used in this research is to improve the recovery rate and reduce the sequelae after treatment. kneesup connects the subjects and researchers through technologies such as iot and ai. the evaluation of the rehabilitation results can be presented as a data chart, and the treatment effects are also clearly presented. for the subject, the subject puts on kneesup knee pads in a long sitting position, bends the knees about 30 degrees, aligns the position of the knee pad circle with the bone, and uses the strap on the lower side, upper side, and the knee pads. after wearing, press and hold the sensor on the outer side of the knee pad for 3 seconds, and then open the mobile app. after the hardware setting and connection are completed, the evaluation and exercise can begin.

Eligibility criteria:
inclusion criteria: * symptoms last at least one month after recovery * without physical impairment * understood verbal or non-verbal communication * normal cognitive function * were willing to participate in the study and accept random allocation exclusion criteria: * diagnosed with transient ischemic attack or stroke * had neuromuscular injury or surgery in the lower limbs in the past six months * had heart rhythm regulator * hospitalized during training * had aggravated symptoms due to infection again * had participated in other clinical trials or received other alternative treatments
treatment of scars and dysfunctions of the pelvic floor in postpartum

Conditions: Pelvic Floor Disorders

Summary: recruitment of patients who have suffered third- and fourth-degree perineal tear during childbirth, and who have given birth at the hospital universitario marqués de valdecilla (santander, spain). they are distributed randomly in two groups an experimental group who apply techniques of physiotherapy and a control group, receiving medical treatment. at the same time is recruited the same number of patients who have not suffered tear and whose birth has been instrumental, dividing into two groups, control and experimental. and the same number of patients who have given birth but have not suffered tear or instrumental delivery, divided also into control group and experimental.


Eligibility criteria:
inclusion criteria: * patients who have dysfunctions in the pelvic floor after childbirth * patients who have given birth at the hospital universitario marqués de valdecilla * patients who do not have any medical alteration that does not indicate the treatment exclusion criteria: * patients who do not have pelvic floor dysfunctions after childbirth * patients who have not given birth at the hospital universitario marqués de valdecilla * patients who have any medical changes that counter the treatment
neoadjuvant chemo-endocrine therapy versus chemotherapy alone in er-positive, her2-negative breast cancer

Conditions: Breast Cancer Female

Summary: this was an open-label, randomized controlled trial that aims to compare the efficacy and safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant chemotherapy alone in er-positive, her2-negative breast cancer.

data showed that concurrent neoadjuvant chemotherapy with endocrine therapy was a effective option for er-positive, her2-negative breast cancer patients. however this is still a controversial issue. the present study is an open-label randomized controlled clinical trial that aims to investigate the efficacy of concurrent nct with endocrine therapy (ai with or without gnrh-a) in patients with er-positive, her2-negative breast carcinoma.

Eligibility criteria:
inclusion criteria: 1. estrogen receptor-positive and her2-negative breast cancer patients, with histological stage of iia-iiic. 2. without previous chemotherapy or endocrine therapy. 3. ecog scores of 0-2 points 4. with measurable and evaluable breast tumor pathologically confirmed as invasive ductal carcinoma 5. age: 18-70 years 6. lateral breast cancer 7. normal or acceptable kidney, liver, cardiovascular, and bone marrow functions exclusion criteria: 1. pregnant women or nursing mothers 2. with distant metastasis 3. with a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, in situ cervical cancer or other cured malignant tumor without the basis of recurrence for at least five years 4. with mental illness or other conditions affecting the patient compliance 5. with other serious diseases or medical conditions: 1. congestive heart failure or unstable angina pectoris, myocardial infarction within 6 months before the enrollment, uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator 2. obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases may affect the understanding and sign of the informed consent for 3. uncontrolled acute infection 6. concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study 7. with allergic constitution and any known or suspected drug allergy 8. not suitable for the trial considered by the investigator

Keywords: breast cancer neoadjuvant chemotherapy endocrine therapy concurrent
nudge-ehr replication trial at mass general brigham

Conditions: Aging; Benzodiazepine Sedative Adverse Reaction; Anticholinergic Adverse Reaction; Adverse Drug Event

Summary: prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable older adults, such as confusion or sedation, leading to hospitalizations, falls, and fractures. fortunately, most of these consequences are preventable. physicians' lack of awareness of alternatives, ambiguous practice guidelines, and perceived pressure from patients or caregivers are among the reasons why these drugs are used more than might be optimal. reducing inappropriate use of these drugs may be achieved through decision support tools for providers that are embedded in electronic health record (ehr) systems. while ehr strategies are widely used to support the informational needs of providers, these tools have demonstrated only modest effectiveness at improving prescribing. the effectiveness of these tools could be enhanced by leveraging principles of behavioral economics and related sciences.

this is a cluster randomized control trial (rct) to evaluate whether newly designed ehr-based tools designed using behavioral principles reduce inappropriate prescribing and adverse outcomes among older adults. this study will be conducted in outpatient primary care practices at mass general brigham (mgb), specifically massachusetts general hospital. mgb has a fully functional ehr, epiccare, that supports computerized ordering of medications. mgb is comprised of 150 outpatient practices with over 1,800 physicians. in this trial, approximately 190 primary care providers at mgh will be randomized to receive usual care or an active intervention. providers randomized to one of the 2 selected treatment arms will receive an ehr tool to guide their care of eligible patients. they will be followed for 12 months. providers randomized to usual care will receive no newly-designed ehr tool. providers will receive these ehr tools for their patients who meet the following criteria: 1) older adults (aged 65 years or more), and 2) who have been prescribed at least 90 pills of benzodiazepine or sedative hypnotic or have been prescribed at least one active orders of at least 90 pills of two different anticholinergics in the last 180 days.

Eligibility criteria:
inclusion criteria: * primary care provider at mass general brigham providers will receive these ehr tools for their patients who meet the following criteria: 1. older adults (aged 65 years or more) 2. who have been prescribed at least 90 pills of benzodiazepine or sedative hypnotic in the last 180 days. outcomes will be measured on the patient level. exclusion criteria: * n/a

Keywords: benzodiazepine sedative hypnotic overprescribing anticholinergic
the effect of vitamin d supplementation in overweight and obese pregnant women

Conditions: Overweight and Obesity

Summary: to understand the role of vitamin d supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.

the effects of vitamin d supplementation on pregnancy outcomes and metabolic status of overweight and obese pregnant women remain uncertain. in particular, the dosage of vitamin d supplementation has not been defined in this high risk group of women. this study aims to examine whether oral supplement of vitamin d3 (cholecalciferol) in total dosage of 800 iu(prenatal multivitamin containing 400 iu vitamin d3 + 400 iu vitamin d3 alone) given to overweight and obese pregnant women since early pregnancy until delivery can improve maternal and neonatal outcomes, compared with those given prenatal multivitamin containing 400 iu vitamin d3 supplementation, a commonly given antenatal supplement in singapore. the investigators' hypothesis is that higher dose vitamin d supplementation would lead to better outcomes in overweight and obese pregnant women. the investigators will conduct a two-arm, parallel non-blinded randomized controlled trial. women with body mass index ≥25kg/m2 will be randomly assigned into groups with a 1:1 randomization ratio, receiving either 800 or 400 iu vitamin d3 supplementation. the study will be conducted at the antenatal clinics, kk women's and children's hospital, singapore. measurements of serum 25-hydroxyvitamin d (25ohd), lipid profile and lifestyles information will be taken for all women at baseline (≤16 weeks gestation) and after three months of intervention (26-30 weeks gestation). all women will continue with the vitamin d3 supplementation until delivery. primary outcomes include levels of maternal serum 25ohdconcentration and lipid profile at 26-30 gestation weeks as compared with the controls, adjusting for baseline measurements. secondary outcomes include preeclampsia, gestational hypertension, gestational diabetes, glycaemic levels, caesarean section, gestational weight gain, preterm birth, low birth weight and small-for-gestational-age. this study will fill up the gap of knowledge regarding the role of vitamin d supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.

Eligibility criteria:
inclusion criteria: 1. gestation ≤16weeks (16 weeks + 6 days) upon intervention 2. pre-pregnancy bmi ≥25 kg/m2 3. aged 21-45 years 4. willing and able to provide written, informed consent exclusion criteria: 1. having current or past hypo/hyperparathyroidism, hypercalciuria, hypercalcemia or osteomalacia 2. history of renal disease (including kidney stones and etc.), liver dysfunction, tuberculosis or sarcoidosis 3. pre-existing diabetes mellitus or chronic hypertension 4. taking lipid-lowering medicine 5. gestational diabetes (as confirmed by oral glucose tolerance test) or gestational hypertensive disorder 6. multiple pregnancy

Keywords: vitamin d supplementation lipid profile vitamin d status birth outcomes pregnancy complications