Kornimate/medical-research-clean huggingface dataset:
prescription of benzodiazepines by general practitioners: characteristics of prescribing trend and implementation of an online educational program

Conditions: Anxiety; Prescription Drug Abuse and Dependency

Summary: portugal has the highest benzodiazepine utilization compared to other european countries. the high utilization of benzodiazepines has been a concern due to reported side effects of long-term use and dependence. also, these data demonstrate that doctors are possibly choosing an inadequate treatment to manage anxious and depressive syndromes. this research aims to develop and implement in primary health care units an online educational program, following a cluster randomized study design; to study the impact of this educational program for changing general practitioner's benzodiazepine prescription pattern; to analyze of barriers and facilitators to the implementation of the e-primaprescribe program.

bzd excessive prescription has long been considered a serious mental health concern in many countries. a large number of interventions using different methodologies have been implemented to change bzd prescription pattern at primary health care settings, with limited positive results. the investigators propose the implementation of an effectiveness-implementation hybrid type 1 intervention. in the study it was developed an online platform, named eprimaprescribe, which was delivered using a digital behavior change intervention(dbci). the investigators included all primary health care units from one region in portugal which were randomly allocated to receive a digital behavior change intervention (dbci) in the format of an online platform to reduce bzd prescription (eprimaprescribe) or an online platform concerning communication techniques (control). the investigators primarily aimed to evaluate the effectiveness of the digital behavior change intervention (dbci) using as outcome measure the frequency of bzd prescriptions issued per month. secondarily the investigators aimed to analyze the effect of eprimaprescribe on antidepressant prescriptions, to study the effect of eprimaprescribe on diagnosis definition associated with bzd and antidepressant prescription; to perform a cost analysis considering the monthly national health service spending with bzd co-payment. the investigators finally aim to analyze the implementation process using quantitative and qualitative methods.

Eligibility criteria:
inclusion criteria: * primary care units using the portuguese online prescription tool (created by the portuguese shared services of the ministry of health and finance - spms) exclusion criteria: * primary care units involved in another trial concerning mental health topics directly related with the subject of this thesis

Keywords: prescribing patterns benzodiazepines general practitioners
pulmonary hypertension biorepository and registry

Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension; Pulmonary Hypertension Due to Left Heart Disease; Pulmonary Hypertension, Primary; Pulmonary Hypertension Due to Lung Diseases and Hypoxia; Pulmonary Hypertension, Primary, 4; Pulmonary Hypertension, Primary, 2; Pulmonary Hypertension, Primary, 3; Chronic Thromboembolic Pulmonary Hypertension

Summary: establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.

the aim of this project will be to establish a broad and wide-ranging registry and biorepository of blood samples from patients with pulmonary hypertension, including all who groups i-v to be used for future research in these areas. this will be both a retrospective and prospective project. the registry and biorepository will be utilized to study and grow our knowledge of the cellular mechanisms and mediators of the disease and, in turn, contribute to advancements in treatment.

Eligibility criteria:
inclusion criteria: 1. the participant is a patient at tukhs or has agreed to participate in a study approved by the kumc human research protection program (hrpp) 2. the participant has a diagnosis of pulmonary hypertension confirmed by right heart catheterization 3. patient is ≥ 18 years of age or older exclusion criteria: 1. participant declines to participate (living patients only) 2. participant is unable to provide informed consent (living patients only)
effects of a mindfulness intervention on temperament, anxiety and depression: the mind the child study

Conditions: Child, Only; Temperament; Anxiety; Depression

Summary: background and study aims: mindfulness is a mental state that can be achieved through meditation. so far, studies have shown that practicing mindfulness on a consistent and regular basis can improve attentional functions and emotional well-being. mindfulness has recently begun to be used in the field of child development. the aim of this study is to assess if a mindfulness program may help primary school students in reducing anxiety and depression while also improving their temperament. who can participate? students attending the fourth or fifth year of primary school what does the study involve? participants will be randomly assigned to the experimental and control groups. participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions, while the control group will follow routine daily school activities. questionnaires will be used to assess temperament, anxiety and depression before and after the intervention. what are the possible benefits and risks of participating? benefits of participating in the study may include a lowering of anxiety and depression levels, as well as an improvement of temperament.


Eligibility criteria:
inclusion criteria: 1. children aged 9 to 11 years 2. children have reasonable comprehension of spoken language and can follow simple instructions 3. children and their parents are willing to attend all intervention sessions 4. children and parents have an adequate understanding of english exclusion criteria: 1. concurrent enrollment in other intervention trials 2. child or parent regularly practice complementary health interventions such as meditation

Keywords: child mindfulness temperament anxiety depression attention
evaluation of labeling comprehension and performance of a new blood glucose meter system

Conditions: Diabetes

Summary: the purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (hcps).

the study evaluated the acceptability of product labeling for performing blood glucose testing with the new blood glucose meter system (bgms) and for using meter features. sections of the user guide and quick reference guide that gave instruction on performing a blood glucose test and operating system features were evaluated, including instructions on connectivity of the system with a computer, meter setup, glucose trends display, and other system features. the study also evaluated the performance of the blood glucose meter system (bgms) in the hands of subjects and healthcare professionals using capillary blood. subjects and healthcare professionals provided feedback about the bgms and its features. some subjects took the system home to evaluate the robustness of the bgms.

Eligibility criteria:
inclusion criteria: * have type 1 or type 2 diabetes * be at least 18 years of age but have not reached their 76th birthday, with approximately 50% (+10%) being less than 55 years of age, at time of consent * be willing to complete all study procedures * be routinely testing their blood sugar at home (at least once per day) * be able to speak, read, and understand english and understand the informed consent document * be able to read the labeling instructions * own or operate a computer for personal or professional use beyond that for email correspondence. subjects will not have to use their personal computer for the study, but computer use will be required. exclusion criteria: * minors \ 75 years of age * pregnancy * physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the bgms * disorders in the fingertip lancing areas * acute or chronic infections, particularly skin infections * infection with a blood borne pathogen * taking prescription anti-coagulants or having clotting problems that may prolong bleeding. taking aspirin daily (81mg or 325 mg) is not reason for exclusion * hemophilia or any other bleeding disorder * having a condition which, in the opinion of the principal investigator or designee, would put the person at risk or seriously compromise the integrity of the study * working for a competitive medical device company
comparison of budesonide and formoterol absorption from budesonide/formoterol easyhaler and symbicort turbuhaler

Conditions: Asthma

Summary: the purpose of this study is to compare the test product budesonide/formoterol easyhaler with the marketed product symbicort turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility criteria:
inclusion criteria: 1. healthy males and females aged 18-60 years. 2. normal weight, at least 50 kg. exclusion criteria 1. evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gi, pulmonary, metabolic-endocrine, neurological or psychiatric disease. 2. any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study. 3. any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. 4. known hypersensitivity to the active substance(s) or the excipient of the drug. 5. pregnant or lactating females.
does a transabdominal plane block decrease patient pain after ventral hernia repair?

Conditions: Ventral Hernia; Umbilical Hernia; Incisional Hernia; Postoperative Complications; Pain, Postoperative

Summary: the purpose of this study is to determine if a transabdominal plane block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.

patients coming in for a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh are randomized to either receive a transabdominal plane block injection or a placebo saline injection. the injection will be performed by surgeons under direct visualization during laparoscopic surgery prior to mesh placement. patients will be followed up post-operatively and after hospital discharge to assess for opioid usage and pain score. patients in both arms are medically cleared by the surgeon. currently there are no studies that look at the use of transabdominal plane block in ventral hernia repairs.

Eligibility criteria:
inclusion criteria: * age 18 and older * elective laparoscopic ventral (ventral, umbilical, incisional) hernia repair at mount sinai hospital exclusion criteria: * age younger than 18 * allergic reaction to bupivacaine * allergic reaction to opioids * opioid substance abuse

Keywords: transabdominal plane block ventral hernia umbilical hernia incisional hernia hernia repair
confocal laser microlaryngoscopy (clmx)

Conditions: Laryngeal Dysplasia; Laryngeal Neoplasm

Summary: the purpose of this study is to evaluate the accuracy and efficacy of using confocal laser microlaryngoscopy (clm) as a tool to perform non-invasive, in vivo, real time pathologic assessment of laryngeal lesions. in order to achieve this purpose, this study will prospectively enroll patients with clinical evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled to undergo a formal intraoperative biopsy of their lesion. while in the operating room, prior to performing a formal biopsy, clm will be used to evaluate the area of pathology, surrounding tissue, and contralateral normal tissue. then the biopsy will be performed, as per standard protocol, and the diagnostic results from clm and the formal biopsy will be compared.


Eligibility criteria:
inclusion criteria: * patient must be adults 18 years of age or older who present to clinic with a history of hoarseness and voice changes and are noted to have changes to their vocal folds that are concerning for the possibility of dysplasia or early stage malignancy. * patient will have vocal fold leukoplakia or other abnormal epithelial changes. * patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document. exclusion criteria: * patient must not have a history of radiation to the neck. * patient must not have a documented reaction to fluorescein * patient must not have a previous history of laryngeal cancer. * patient must not have a history of allergy or bronchial asthma. * patient must not be pregnant or breastfeeding.
cholecalciferol supplementation in hemodialysis patients

Conditions: Anemia; Hemodialysis Complication; Vitamin D Deficiency

Summary: this is prospective single-blind randomized study, in ain shams university hospital) in egypt, to assess the impact of cholecalciferol on anemia status in regular hemodialysis outpatients

this srudy is to assess the impact of cholecalciferol on anemia status in regular hemodialysis outpatients in terms of increase of hgb \>11 g/dl, transferrin saturation (tsat) of ≥ 30%, and ferritin levels to achieve a range of (300 to \< 800 ng/ml), and effect on epoetin dose needed. this study is also to adress the factors affecting the correcetion of anemia by cholecalciferol supplementation, such as oxidative stress and inflammatory markers.

Eligibility criteria:
inclusion criteria: * : male or female patients who are willing to participate in the trial should have been on maintenance hemodialysis sessions for not less than 3 months, aged between 18-70 years old, clinically stable (no prior hospitalization on the past three months), with serum 25(oh)d levels of less than 30 ng/ml and their ipth levels of 150-800 pg/ml, and hemoglobin levels of less than 11 mg/dl. exclusion criteria: * patients with previous or known hypersensitivity to cholecalciferol, * patients who are already on cholecalciferol therapy, or patients on immunosuppressants. * blood transfusion in the past 4 month, and patients who had anemia for other than renal causes, * those who were participating in another clinical trial within the past 4 weeks or pregnant/breastfeeding female patients were excluded as well.
validation of hyperdetector for sars-cov-2

Conditions: SARS-COV2 Infection

Summary: to evaluate the hyperdetector as a method to rapidly screen sars-cov-2 to determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated rt-pcr covid-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples. to determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated rt-pcr covid-19 assay.


Eligibility criteria:
inclusion criteria: * subjects at covid-19 testing site for rt-pcr test. exclusion criteria: * minors under the age of 5
brain abscesses in transplant recipients: a multicentre retrospective study (bat-study)

Conditions: Brain Abscess

Summary: allotransplantation is the process of transferring organ(s), tissue(s) or cell(s) from a healthy donor to a recipient. the two main applications of allotransplantation are solid organ transplantation and allogeneic hematopoietic stem cell transplantation. for several reasons, including the need to use immunosuppressive drugs after transplantation, recipients of allografts carry a high risk of infectious complications. central nervous system infections are dreadful complications of transplantation, which can be divided into brain abscesses, meningitis, and encephalitis. in particular, brain abscesses pose major diagnostic and therapeutic challenges to transplant physicians, and are frequently fatal in transplant recipients. as compared with immunocompetent patients, transplant recipients and other immunocompromised patients have an increased risk of brain abscesses due to opportunistic pathogens, including fungi, parasites, bacteria, and mycobacteria. determining the epidemiology of brain abscesses is critical to guide transplant teams regarding the diagnosis and management of brain abscesses in transplant recipients. because the incidence of brain abscesses is low after transplantation, transplant teams often have limited clinical experience in the management of these infections. similarly, most publications focusing on post-transplant brain abscesses are either case reports, small case series, or review articles. we therefore aim to conduct a multicentre retrospective study on the epidemiology, the characteristics, and the outcome of brain abscesses in transplant recipients in the era of new diagnostic tools and progress in prophylaxis.


Eligibility criteria:
inclusion criteria: * transplant recipient (i.e., solid organ transplant recipient or allogeneic hematopoietic stem cell transplant recipient) * radiological evidence of brain abscess(es) after transplantation * brain abscess(es) classified as either proven, probable or possible (see definitions below)diagnosis of brain abscess made between january 2010 and december 2021 exclusion criteria: * opposition of the research * patients under guardianship

Keywords: brain abscess solid organ transplantation allogeneic hematopoietic stem cell transplantation immunosuppression opportunistic infections
ethyl chloride for npwt

Conditions: Pain, Acute

Summary: negative pressure wound therapy (npwt) has been shown to improve wound care outcomes for acute and chronic wounds as well as for surgical incision sites. we have found that patients report significant pain during dressing changes specifically with the removal of the clear adhesive drape. upon review of the literature, there were multiple studies related to pain and the removal of the sponge (filler) but limited studies relating to the pain associated with the removal of the drape. the patient reported pain with drape removal has led to increased psychological stress and decreased compliance with the dressing change protocol. application of a topical anesthetic to the drape during the dressing change has the potential to decrease the pain experienced by the patient. an fda approved ethyl chloride spray is a topical anesthetic that can be sprayed onto the outer perimeter of the drape during the dressing change as a means to decrease pain. we hypothesize that the use of ethyl chloride spray will result in patients experiencing less pain leading to decreased psychological stress, improved compliance with dressing changes, and overall improved customer satisfaction.


Eligibility criteria:
inclusion criteria: * an orthopaedic/trauma wound and/or surgical incision * treatment with npwt as a hospital inpatient * minimum of at least one npwt dressing changes or discontinuation of npwt prior to discharge. * dressing change in enterostomal therapy department exclusion criteria: * cognitive impairment preventing informed consent * history of hypersensitivity to cold/vapocoolant * outpatient npwt
study to assess the tolerability and safety of ecallantide in children and adolescents with hereditary angioedema

Conditions: Hereditary Angioedema Types I and II

Summary: the objective of this study is to evaluate the safety and tolerability of a single subcutaneous (sc) dose of ecallantide in children and adolescents with hereditary angioedema (hae).

this pilot study is an open-label, non-randomized, single-arm study to evaluate the tolerability and safety of a single sc administration of ecallantide in up to approximately 10 pediatric subjects with hae during an initial acute attack. the study is planned to enroll subjects 2 through 15 years of age who present with an acute cutaneous, abdominal, or laryngeal hae attack. no more than 3 study sites will be included until a goal of 10 patients is achieved. after treatment for an initial attack, one additional open label treatment with ecallantide will be offered to subjects contingent upon having been treated previously and presenting with a subsequent acute cutaneous, abdominal, or laryngeal attack of hae at least 7 days after initial treatment. open-label treatment for a second hae attack will continue until 10 patients have been treated for an initial attack. safety evaluations will be performed at each subsequent ecallantide-treated attack as for the initial treated attack

Eligibility criteria:
inclusion criteria: 1. 2 through 15 years of age, inclusive (ie, from the second birthday through the day prior to the sixteenth birthday) at the time of the subject's first attack. 2. documented diagnosis of hae type i or ii. diagnosis must be confirmed by a documented immunogenic (below the lower limit of normal) and/or functional (\< 50% of normal levels) c1- inhibitor deficiency. diagnosis may be on the basis of historic data or by diagnostic testing conducted at the time of screening. 3. informed consent (and subject assent as appropriate) signed by the subject's parent(s) or legal guardian(s). exclusion criteria: 1. history of an adverse reaction (ae) to ecallantide in the past 2. diagnosis of angioedema other than hae 3. participation in another clinical study during the 30 days prior to treatment 4. any known factor/disease that might interfere with the treatment compliance, study conduct, or result interpretation 5. congenital or acquired cardiac anomalies that interfere significantly with cardiac function. 6. treatment with angiotensin converting enzyme (ace) inhibitors within 7 days prior to treatment. 7. use of hormonal contraception within the 90 days prior to treatment for females of childbearing potential 8. the subject is pregnant or breastfeeding

Keywords: hereditary angioedema children adolescents ecallantide
contrast enhanced mammography in the evaluation of cancer of unknown primary syndrome

Conditions: Breast Cancer Diagnosis; Breast Cancer Prevention

Summary: this study aims to evaluate the role of contrast-enhanced mammography (cem) in identifying the primary tumor site in patients presenting with cancer of unknown primary (cup) syndrome. by integrating functional and anatomical imaging, the study explores cem's diagnostic value compared to standard imaging modalities in a single-center setting.

the study of cup syndrome was conducted with mri, but we propose the study with cem

Eligibility criteria:
inclusion criteria: * age: patients aged 18 years or older. * diagnosis of cup: patients with a clinical diagnosis of cancer of unknown primary (cup) syndrome. * suspected breast malignancy: patients with clinical or imaging suspicion of a primary breast malignancy. * informed consent: patients who are able to provide informed consent to participate in the study. * presence of breast tissue: female or transgender patients with breast tissue eligible for contrast-enhanced mammography (cem). exclusion criteria: * confirmed primary tumor: patients with a confirmed primary tumor identified in an organ other than the breast. * contraindications to contrast agents: patients with contraindications to the use of iodinated contrast agents (e.g., severe allergic reactions to contrast). * severe renal impairment: patients with severe renal impairment (egfr \< 30 ml/min/1.73 m²) who cannot safely receive contrast agents. * pregnancy or breastfeeding: pregnant or breastfeeding women, as contrast administration may be harmful to the fetus or neonate. * severe medical conditions: patients with severe medical conditions that may compromise their participation or safety in the study.

Keywords: contrast-enhanced mammography (cem) cancer of unknown primary (cup) breast cancer mri (magnetic resonance imaging) diagnostic imaging