Kornimate/medical-research-clean huggingface dataset:
active pharmacovigilance of anti-cancer medicines

Conditions: Oncology; Drugs; Pharmacovigilance

Summary: pharmacovigilance (pv), defined by the world health organization (who) as the "science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problem", aims to improve patient safety and quality of life. there are several objectives of pv, starting with the collection and management of safety data, to promote the safe and effective use of medicines. pv also aims to provide information on drug safety to health professionals and patients, and it contributes to updating drug labels. finally, it is active in risk management, risk minimization and the prevention of adverse effects and other drug-related problems. as defined by who, an adverse event (ae) is "any untoward medical occurrence that may be present during treatment with a medicine, but which does not necessarily have a causal relationship with this treatment". when there is a causal relationship with the treatment, an ae is classified as an adverse drug reaction (adr). the collection and reporting of aes is a process that starts from the drug development phase and proceeds continuously throughout the life cycle of the drug, and it aims to assess the benefits-to-toxicity ratios (in other words, the safety and efficacy) of all medicines. reports of adrs must accurately describe the case and be meaningful to health professionals worldwide. the aim of this project is to evaluate the impact of an active prescription surveillance of anti-cancer drugs carried out by the clinical pharmacist in pediatrics and young adults.


Eligibility criteria:
inclusion criteria: * patients aged \<25 years; * receiving cytotoxic, targeted-therapy, immunotherapy drugs for the treatment of solid and hematologic cancers * giving consent to study participation exclusion criteria: * presence of cognitive problems

Keywords: oncology drugs active pharmacovigilance
efficacy evaluation of wasabi leaf extract on skin

Conditions: Skin Condition

Summary: to assess the efficacy of wasabi leaf extract on skin


Eligibility criteria:
inclusion criteria: * 20 to 65-year-old males or females * people with dull skin, pigmentation spots or acne-prone, acne scars * acne severity assessment- investigator's global assessment scale (iga) ≥ 2 exclusion criteria: * received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial * outdoor workers (exposed to the sun more than 5 hours a day) * people who are breastfeeding, pregnant or planning to become pregnant during the test (self-report) * people with heart, liver, kidney, endocrine and other major organic diseases (self-reported) * people who have undergone major surgery (according to medical history) * people who take drugs for a long time * people with mental illness * students who are currently taking courses taught by the principal investigator of this trial
postmarketing surveillance study of berodual® metered-dose inhaler in chronic obstructive respiratory tract disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice


Eligibility criteria:
inclusion criteria: * patients of either sex over 40 years with the symptoms of a chronic obstructive airways disease * only patients which have not been treated with berodual® within the last year should be included exclusion criteria: * contraindications listed in the instructions for use/summary of product characteristics for berodual® metered-dose inhaler
cross sectional study of constipation in advanced cancer patients

Conditions: Palliative Care; Constipation; Traditional Chinese Medicine

Summary: constipation is a common problem in palliative cancer patients. however, there were insufficient randomized controlled trial (rct) data to identify the "best" laxative or combination of laxatives in these patients. traditional chinese medicine (tcm) in holistic approach is popular among cancer patients. more than half had received at least one form of tcm therapy according to the survey carried in 2008. chinese herbal medicine (chm) in compound formulation with nourishing and purging effects simultaneously may be more preferred to relieve constipation by local palliative cancer patients. tcm syndrome differentiated by collecting all symptoms and signs through the classic four diagnostic methods is the foundation for making diagnosis and prescription in tcm practice. the present study is the first local study to evaluate the bowel habits and tcm syndrome of advanced cancer patients with constipation. we hope that the results not only can shed light on patient's own reporting or experience of constipation and the effectiveness of current practice, but also can draw up a chm formulation for advanced cancer patients with constipation.


Eligibility criteria:
inclusion criteria: * advanced cancer patients * on medication for facilitating bowel movement and/or constipation visual analogue scale \>=2 exclusion criteria: * unable to communicate * cognitive impaired * put on colostomy bag * clinically diagnosed gastrointestinal obstruction * at end-of-life

Keywords: palliative care advanced cancer constipation traditional chinese medicine syndrome distribution
therapeutic stockings to prevent foot ulcers

Conditions: Diabetes

Summary: 1. to evaluate the efficacy of a therapeutic stockings (protective foot care stockings, pfc) in reducing the incidence of diabetic foot pathology among high-risk patients. 2. to evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the pfc stockings.

we will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. we plan to enroll patients from three sites: scott and white hospital in temple texas, manchester royal infirmary, uk , and trinity college dublin at st james hospital.. the two treatment arms will involve a standard therapy group, and a stocking therapy group. the stocking therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. patient enrollment will occur over a one-year period. all patients will be followed for 30 months. the standard therapy group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. the stocking therapy group will receive standard therapy as described above but use the special stockings instead of their usual hose. the investigator at each site will be blinded regarding the treatment.

Eligibility criteria:
inclusion criteria: * men or women 18 years old or older * diagnosis of diabetes mellitus\* * history of diabetes related foot ulceration spanish-speaking subjects will be eligible to participate. exclusion criteria: * active charcot arthropathy * gangrene, active infection * midfoot or higher level amputation * alcohol or substance abuse within 6 months * unreliable, unwilling or unable to comprehend informed consent

Keywords: diabetes foot ulcer prevention therapeutic stockings
improving self-efficacy through a telenovela: feasibility study

Conditions: Healthy

Summary: in the novela intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (hfcg) education during weekly hospice visits to prepare caregivers for proper use of hospice support and healthcare services

telenovela is a television drama or soap opera that can be used to lead viewers to contemplate and discuss critical issues through video storytelling. prior work showed informational telenovelas had a positive effect on latino family caregivers' attitudes toward end-of-life (eol) care services. the role of videos in hospice and palliative care shows significant promise, underscoring the videos as a mode of education for family caregivers that could potentially enhance caregiver's self-efficacy, decrease caregiver's anxiety, and reduce burnout. despite the value of video education, many programs have failed to provide engaging material. based on input from hfcg, the investigators have produced a bilingual (spanish and english version) four chapter telenovela video series (to care/ el privilegio de cuidar) as part of nci funded diversity supplement study. founded upon extensive preliminary work, to care portrays the journey of one hospice family as the family struggle with the hospice decision, pain management, decision-making, and finally the dying process. averaging only 4:65 minutes, each chapter addresses one of these problems, validating family experiences and identifying potential solutions. based on this work and interviews with hospice staff the investigators have built an intervention, novela, to disseminate telenovelas to family caregivers in hospice agencies. the investigators will test the feasibility of novela delivery in the hospice setting and evaluate efficacy of the intervention. the overall expectation is that novela will improve self-efficacy thus lowering anxiety in hospice family caregivers. this proposal has the following aims: * specific aim 1: to pilot test the feasibility and acceptability of integrating novela with hospice care for family caregivers of hospice patients * specific aim 2: to investigate the preliminary efficacy of integrating novela with hospice care for family caregivers of hospice patients

Eligibility criteria:
inclusion criteria: * identified family caregiver of patients enrolled in hospice * caregivers must be over the age of 18 * without cognitive impairment * with access to wireless device and internet. exclusion criteria: * hfcg of patients that are actively dying * caregivers younger than 18 years * with cognitive impairment * without internet access.

Keywords: videos hospice family caregivers education telenovelas self-efficacy anxiety feasibility
effect of subanesthetic dose of ketamine combined with propofol on cognitive function in depressive patients undergoing electroconvulsive therapy

Conditions: Depressive Symptoms; Impaired Cognition; Electroconvulsive Therapy

Summary: electroconvulsive therapy (ect) is an effective treatment for depression compared with the current antidepressant agents，but the most important side effect is cognitive dysfunction. the purpose of this study is to determine whether subanesthetic dose of ketamine combined with propofol is superior to propofol anesthesia alone in improving cognitive function in depressive patients undergoing ect.

depression is one of the most debilitating and widespread illnesses affecting up to 20% of individuals in their lifetime. however, the current antidepressant agents take weeks to work, and fail to help at least 40% of depressed patients. electroconvulsive therapy (ect) is a remarkably effective treatment for depression, but its use is limited by cognitive dysfunction. as a result, it is becoming a clinical problem which need to be settled urgently. previous clinical study showed that subanesthetic dose of ketamine could play a role in antidepressant effects with safety and minimal positive psychotic symptoms.the investigators also found that subanesthetic dose of ketamine combined with other anesthetics could improve cognitive function in depressive rats receiving electroconvulsive shock (a model for analogy with ect). few clinical researches concerned the effects of subanesthetic dose of ketamine combined with propofol anesthesia on cognitive function in patients after ect, therefore the investigators conduct this randomized controlled double-blind trial. in this study, cognitive function will be rated by mini-mental state examination score.

Eligibility criteria:
inclusion criteria: 1. diagnosed with moderate or severe depression according to diagnostic and statistical manual of mental disorders 2. aged from 18 to 65 years old exclusion criteria: 1. cerebrovascular malformation, arterial aneurysm, hypertension, or glaucoma; 2. classification of american society of anesthesiologists physical status score iv or v; 3. complications such as respiratory disease, cardiovascular disease, intracranial hypertension, cerebral vascular disorder; 4. presence of a foreign body such as pacemaker, intracranial electrode, and clips; 5. history of seizures; 6. history of drug abuse; 7. concomitant presence of a mental disorder; 8. pregnancy; 9. history of serious adverse effects related to anesthetics; 10. refusal to consent for the study, or refusal to undergo one single ect during the first week of therapy. 11. hyperthyreosis

Keywords: ketamine electroconvulsive therapy cognitive function
follow-up of person-centered care of young adults with rheumatic disease

Conditions: Arthritis, Rheumatoid; Spondylarthritis; Arthritis, Psoriatic

Summary: the purpose of the study is to study how a person-centered structured team caretaking of young adults (16-23 years) with newly diagnosed rheumatoid arthritis (ra), spondartrit (spa) and psoriasartrit (psa) in routine clinical care affect and predict the patient's health and ability to manage their everyday lives. also included in the project is a long-term follow-up (up to 50 years) where the investigators want to investigate factors predicting good general health, low disease activity, good physical function, and comorbidity.


Eligibility criteria:
inclusion criteria: * 16-23 years * newly diagnosed ra according to the acr / eular 2010 criteria, spa according to caspar criteria, or as according to the asas criteria. * ability to understand the swedish language in speech and writing. exclusion criteria: * existing rheumatic disease * other healthcare demanding serious illness
noise reduction preferences in teenagers and pre-teens

Conditions: Hearing Loss

Summary: noise reduction preferences and blue tooth access to hearing aid streaming features will be evaluated in experienced hearing aid users age 10-17.

the purpose of this study is to evaluate the preferences for hearing aid noise reduction settings in users age 10 -17, as well as to evaluate preferences for accessing the hearing aid bluetooth streaming programs for this population. subjective preferences will be obtained by having the participants listen to a noisy scene with different levels of noise reduction, to which they are blinded, and rate their preference. blinded objective speech performance testing will be completed by a) finding the signal-to-noise ratio at which participant can correctly repeat back 50% of the target words, and b) measuring the percent of words correctly repeated during a noisy listening task. these tasks will be done using different levels of noise reduction. subjective preferences for accessing bluetooth streaming will also be obtained by asking participants which method they prefer (phone, hearing aid, or touch control). .

Eligibility criteria:
inclusion criteria: * mild, moderate, or moderate-severe bilateral sensorineural hearing loss * native english speakers with ability to communicate verbally * able to read and follow directions * access to smartphone and willing to download a hearing aid app * experienced hearing aid user (6+ months) exclusion criteria: * unable to follow verbal directions * unable to communicate verbally * unable to wear study devices for required home trials * active middle ear infection * unable to attend lab visits required for study
effectiveness and handling of spiolto® respimat ® in copd patients - italy

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of the study is to measure changes in physical functioning in chronic obstructive pulmonary disease (copd) patients being treated with spiolto® respimat® after approximately 6 weeks in routine clinical practice.

purpose:

Eligibility criteria:
inclusion criteria: 1. written informed consent prior to participation 2. female and male patients = 40 years of age 3. patients diagnosed with copd and requiring long-acting dual bronchodilation (lama + laba) treatment according to approved spiolto® respimat® smpc and therapeutic plan recommendation exclusion criteria: 1. patients with contraindications according to spiolto® respimat® summary of product characteristics (smpc) 2. patients who have been treated with a laba/lama combination (free and fixed dose) in the previous 6 months 3. patients continuing laba-inhalative corticosteroids (ics) treatment should not be additionally treated with spiolto® respimat® in order to avoid a double dosing of long-acting beta-agonists 4. patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks 5. pregnancy and lactation 6. patients currently listed for lung transplantation 7. current participation in any clinical trial or any other non-interventional study of a drug or device
local haemodynamic effects of apelin agonists and antagonists in man in vivo

Conditions: Cardiovascular Disease

Summary: apelins are substances which occur naturally in the body, and have an important role in heart disease. they have been shown to make blood vessels dilate, and improve the way the heart works. the investigators have devised 2 sets of experiments to investigate how the apelins affect blood vessels. in the first group of experiments,the investigators will give healthy volunteers up to 3 different apelin substances, and use special research techniques to see how they affect the way that blood vessels work in the forearm. in the second group of experiments, the apelins will be given along with another form of apelin which blocks the effects of apelin in laboratory experiments. the investigators want to see if it blocks the effects of apelin in healthy humans. the investigators intend to test the hypothesis that: apelin agonists are vasodilators in human resistance vessels, this effect will be blocked by an apelin receptor antagonist. this study will help us to understand more about how apelins work, and to suggest how they might be used to treat heart disease.


Eligibility criteria:
inclusion criteria: * between 18 and 70 years * non-regular smoking (\<5 cigarettes per week) * if female, postmenopausal or on days 2-9 of menstrual cycle exclusion criteria: * hypertension (sustained bp \>160/100mmhg) * ischaemic heart disease * renal, respiratory or neurological disease * diabetes mellitus * bmi \>30, bmi \<18 * pregnant * smoker * use of vasoactive medication or nsaids/aspirin within 48 hours of study. * current involvement in other research studies
comparison of a novel 22-gauge core biopsy needle

Conditions: Solid Pancreatic Mass Lesions; Malignant Neoplasm of Pancreas

Summary: the goal of this clinical research study is to compare the performance of a newly available needle with reverse bevel design (called the echotip® procore™ needle) with standard needles to see which needle gives better diagnostic information for pancreatic lesions.

an endoscopic ultrasound-guided needle biopsy or fna is a special endoscopic procedure used to sample lesions within or next to the digestive tract, including the pancreas. the needle is used to collect material for diagnosis. a special lighted, flexible tube called an endoscope is inserted through the mouth, into the stomach and small intestine. the endoscope also has an ultrasound probe at its tip which can be used to see the pancreas, which is located behind the stomach. the doctor will then use the ultrasound to guide the needle biopsy or fna. in this procedure, an average of 4 needle passes (needle sticks) is needed to collect enough tissue for diagnosis. however, the number of passes can be higher or lower, depending on the individual lesion and success of the needle passes. if participant agrees to take part in this study, 2 different needles (the standard straight hollow-core needle and the new echotip® procore™ needle) will be used to sample the pancreas lesion. two (2) passes will be performed with each needle type and compared. if additional passes are needed for diagnosis, they will not be included in this study. after the first set of needle passes, the doctor may decide that more passes are needed. final test results will be taken from the diagnostic results from each needle pass. the results from both types of the needle will be included in the participant's medical record. this is an investigational study. all needles used in this study are fda approved and commercially available. comparing the needles is investigational. up to 60 participants will take part in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. patient age 18 years and older. 2. all patients referred for eus fna of endoscopically accessible solid pancreatic lesions. exclusion criteria: 1. unable to obtain informed consent. 2. unable to tolerate the procedure. 3. women with known pregnancy at time. 4. patient age less than 18 years of age. 5. bleeding diathesis 6. cystic pancreatic lesions 7. lesion not accessible by eus guided fna

Keywords: solid pancreatic mass lesions 22-gauge core biopsy needle reverse bevel design endoscopic ultrasound eus guided fine needle aspiration fna
comparison of effect of nitrous oxide-oxygen conscious sedation and cognitive-behavioral therapy on children's anxiety in dentistry

Conditions: Clinical Anxiety; Clinical Cooperation

Summary: visiting anxious and fearful children is an inevitable prospect of the daily work of every dentist who treats pediatric patients. dentists have been using a wide variety of non-pharmacological and some pharmacologic techniques to assist them in the management of children with anxiety. one strategy which seems promising for pain control in stressful medical situations is teaching the child to use behavioral and cognitive coping skills or a combination of both techniques. an alternative technique to non-pharmacologic approaches in children being anxious and lacking in cooperative ability is sedative technique such as nitrous oxide conscious sedation. as there is lack of studies comparing conscious sedation and combinations of cognitive-behavioral strategies in eliminating children's uncooperative behaviors and dental anxiety, the aim of this study was to compare the effectiveness of inhalation sedation with nitrous oxide-oxygen conscious sedation and cognitive-behavioral therapy to reduce dental anxiety in preschool children.


Eligibility criteria:
inclusion criteria: * age between3 to 6.5 year of old * presence of moderate to severe dental anxiety * parents' acceptance to cooperate in sampling process and 2 sessions of dental treatment * presence of at least one mandibular primary molar needed pulp treatment * positive dental history exclusion criteria: * current episodes of medications or drug therapy * systemic or congenital disorders * mental retardation

Keywords: nitrous oxide-oxygen conscious sedation cognitive behavioral therapy children, preschool dental anxiety patient cooperation