Kornimate/medical-research-clean huggingface dataset:
uterine artery embolization with microspheres in patients with leiomyoma.

Conditions: Uterine Leiomyoma

Summary: to evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres embosoft (embosoft® - scitech medical).


Eligibility criteria:
inclusion criteria: * female patients from 18 to 50 years old; * symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural; * patient agrees with study procedures; * patient signs the informed consent form. exclusion criteria: * asymptomatic women; * isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma; * leiomyoma diameter higher than 10 cm; * leiomyoma above the umbilical scar; * endometrial neoplasia or hyperplasia or presence of any malignancy * pregnant or breast feeding women; * active vasculitis; * pelvic irradiation history; * uncontrolled coagulopathies; * renal insufficiency; * contrast allergy; * concomitant use of gnrh analogues.

Keywords: embolization uterine leiomyoma embospheres microspheres
effectiveness of a computerised prompt for primary and secondary care physicians to refer or refer back type 2 diabetes patients

Conditions: Diabetes Mellitus

Summary: patients with type 2 diabetes mellitus can receive care in the general practice or at the outpatient clinic. in the region of amersfoort in the netherlands, primary care practices and the hospital are connected through diamuraal to organize the diabetes care in that region. they work in the same electronic medical record, and patients can request access to their own record (called a patient web portal). they set up diamuraal guidelines, based on the guidelines of the dutch college of general practitioners and internists, on where the patient care needs to be allocated (primary or secondary care), depending on the amount of specific care a patient needs. despite guidelines, not all patients are treated in the correct place. our hypotheses is that when we improve triage we can cause a major shift from treatment in secondary care to primary care and from primary care to self-care by using the patient web portal. furthermore, patients who needs extra attention due to problems with their diabetes or complications can receive this extra attention due to increased e-consultation between primary care and secondary care and if necessary actually can, during a short time, be treated by an internist. we hope to achieve this by introducing a signal in the electronic medical record. this signal allocates patients according to the guidelines and warns a physician if their patients is not treated according to that guideline. the health care provider can then discuss this situation with his patient. we believe that this leads to shift in allocation of care, in which optimal care is provided and patients are made more aware of their situation which hopefully leads to better self-management and satisfaction.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus * health care provider work within diamuraal setting exclusion criteria: - none

Keywords: type 2 diabetes mellitus e-health allocation of care clinical inertia quality of care patient satisfaction
intraperitoneal analgesia in pediatric laparoscopy

Conditions: Analgesia

Summary: it is important to keep children undergoing laparoscopic surgery pain free with rapid return to normal activity.

pain following laparoscopy is less intense than after laparotomy. nevertheless, laparoscopy is not pain free and control of post-laparoscopy pain remains a major concern. the exact cause of such pain remains uncertain, and yet, diaphragmatic irritation and peritoneal stretching associated with gas insufflation may be responsible for shoulder and diffuse abdominal pain. additionally poor pain control could limit the activity of children following laparoscopic surgery.

Eligibility criteria:
inclusion criteria: 1. age (1 to 6 years) 2. asa physical status i or ii. 3. scheduled for laparoscopic hernia repair under general anesthesia. exclusion criteria: 1. allergy to study drugs, 2. receiving chronic pain treatment, antiepileptic therapy or magnesium therapy, 3. sever hepatic or renal impairment,
development of a screening strategy for community-based adverse drug related events in the emergency department

Conditions: Adverse Drug Related Events

Summary: adverse drug related events (adres) are a leading cause of emergency department (ed) visits in canada. however emergency physicians recognize only half of all adres in patients presenting to the ed, missing opportunities to intervene. the objective of this study is to develop a screening strategy that identifies patients with adres. our hypothesis is that the development of a user-friendly, reliable screening strategy for adres in patients presenting to the ed is feasible. we believe that this will lead to improved patient care.

background between 9250 and 23,750 canadians die each year because of preventable adverse events related to medical care. adres account for 50% of all preventable adverse events and cause up to 12% of ed visits. unfortunately, emergency physicians recognize only half of all adres, missing crucial opportunities to intervene. objective the objective of this study is to derive a clinical decision rule that accurately stratifies patients presenting to the ed into risk categories for drug-related morbidity. this instrument will allow early identification of clinically significant adres allowing rational referral for medication optimization, treatment of adres and prevention of future events. hypothesis the development of a rapid, user-friendly reliable clinical decision rule for adres in patients presenting to the ed is feasible. methodology this prospective observational study will evaluate predictor variables (from the history, physical examination and laboratory tests) for adres in a representative sample of ed patients using standardized assessments by emergency nurses and physicians. inter-rater agreement of predictor variables will be measured, and clinical pharmacists, blinded to the nursing and physician assessments, will use a standardized, validated algorithm to identify adres. recursive partitioning and/or logistic regression analysis will be used to determine the optimal combination of predictor variables to detect the presence of an adre. we will report diagnostic test characteristics of the derived clinical decision rule. validation of the clinical decision rule is planned in a future study.

Eligibility criteria:
inclusion criteria: * adults over the age of 19 years * reported having used at least one prescription or over-the-counter medication in the 2 weeks prior to presentation * speak english and/or translator available at the time of presentation. exclusion criteria: * patients previously enrolled * patients transferred directly to an admitting service. * patients who leave prior to being seen or against medical advice. * patients returning to the ed for a scheduled revisit.

Keywords: adverse drug event harm patient safety clinical decision support adverse drug related event
evaluation of a novel method for integrating insulin delivery and glucose sensing in adipose tissue of diabetic patients

Conditions: Type 1 Diabetes

Summary: the study seeks to use microdialysis and microperfusion techniques to assess the feasibility of performing insulin delivery and glucose sensing at a single subcutaneous tissue site.

glucose management in type 1 diabetic patients comprises the measurement of glucose in capillary blood obtained by fingersticking and administration of exogenous insulin in the form of a subcutaneous bolus injection or continuous subcutaneous infusion. the present study seeks to test an alternative treatment approach that combines glucose measurement and insulin delivery at a single subcutaneous tissue site, thereby circumventing the need for fingerstick blood glucose monitoring. microperfusion and microdialysis probes are applied in type 1 diabetic subjects to perform insulin delivery and glucose sampling at the same adipose tissue site. the feasibility of estimating blood glucose concentrations from the glucose levels measured at the subcutaneous insulin delivery site is then assessed during an overnight fast and an oral glucose tolerance test.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus patients aged 18 - 65 * c-peptide negative (≤ 0.05 nmol/l) * hba1c (glycosylated haemoglobin a1c) \< 10% * body mass index: 21 - 30 kg/m2 * informed consent obtained before any trial-related activities. exclusion criteria: * severe diabetic complications (e.g., proliferative retinopathy, severe nephropathy) * female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods * any condition that would interfere with trial participation or evaluation of results, as judged by the investigator * treatment with drugs that could interfere with glucose metabolism and subcutaneous insulin absorption * subject with mental incapacity or language barriers
wound vac bandage comparison after spinal fusion

Conditions: Neuromuscular Scoliosis

Summary: the purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted closure (vac) therapy in the prevention of infection after posterior spinal fusion for pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.

a prospective randomized controlled study: patients undergoing posterior spinal fusion will be randomized to a standard postoperative dressing versus an incisional vac dressing. both groups will have hematocrit, total lymphocyte count, and albumin checked preoperatively to assess nutritional status, drawn at the same time as standard preoperative labs during history and physical visit. both groups will undergo standard wound closure and dressing application before breaking the sterile field. the incisional vac group will undergo placement of an adaptic dressing over the incision. a standard vac sponge will be placed and secured with adhesive dressing, and a suction tube will be connected to a vac machine set to 75 mmhg of continuous suction. the incisional vac will be left in place for 72 hours postoperatively. remainder of postoperative care will follow our standard posterior spinal fusion protocol and will be identical in both groups. patients will be followed for a minimum of 2 years postoperatively.

Eligibility criteria:
inclusion criteria: * any patient 17 years and younger * neuromuscular scoliosis undergoing posterior spinal fusion exclusion criteria: * idiopathic and congenital scoliosis * any type of spine surgery other than posterior spinal fusion (eg. vertical expandable prosthetic titanium rib placement, growing rod placement, anterior spinal fusion) * intraoperative dural tear * documented allergy to adhesive dressings

Keywords: wound vac neuromuscular scoliosis posterior spinal fusion
breast cancer active surveillance, alternative option, aspirin included

Conditions: Breast Cancer

Summary: experimental, clinical, and epidemiological studies have all demonstrated the strong association between chronic inflammation and cancer, and many studies have correlated the prolonged presence of the inflammatory milieu with an increased risk for developing cancer.(1) although the potential mechanism for aspirin preventing breast cancer is not known, possible pathways may involve platelets, inflammation, cyclooxygenase (cox) 2, hormones, or pi3 kinase. (2). in actual clinical practice there exist clear guidelines for the use of aspirin in colorectal cancer but no such guidelines exist for the use of aspirin in breast cancer patients. in the unit´s proper experience, in patients under active surveillance and metastatic ones some present very good responses both in the neoadjuvant and in the metastatic setting but investigators intend to provide evidence and not just the experience. this study patients are proposed to combine their standard treatment with aspirin.

breast cancer patients with diagnosis of ductal or lobular invasive carcinoma or cdis that refuse to underwent surgery or are not qualified for, and independently of age or of their actual staging, are going to be allocated, randomly and in double masked way to one of two arms: arm 1: standard unit´s protocol + placebo arm 2: standard unit´s protocol + aspirin

Eligibility criteria:
inclusion criteria: every adult (above 18) y.o.patient with histologic diagnosis of breast cancer that refuse or is not suitable for surgical treatment, or with metastatic disease, remaining this way in an "active surveillance" exclusion criteria: allergy or toxicity to aspirin

Keywords: metastatic active surveillance
high dose oxytocin nasal spray for treatment of tinnitus

Conditions: Tinnitus

Summary: the purpose of this study is to evaluate the effects of high-dose intranasal oxytocin for treating tinnitus. the hypothesis is that high dose intranasal oxytocin can significantly reduce tinnitus severity and disability.

this is a pilot, proof of concept, placebo-controlled, parallel study. participants will be recruited from nyu langone medical center's ear, nose \& throat (ent) department and will receive either high-dose intranasal oxytocin or a nasal spray containing pcca mucolox and distilled water, serving as the placebo. long term treatment with high-dose oxytocin (45 iu four times daily) may reduce the frequency and severity of tinnitus, the burden tinnitus symptoms cause patients, and improve their quality of life.

Eligibility criteria:
inclusion criteria: * subjects with continuous perception of subjective tinnitus for ≥ 6 months duration. * subjects must have had a normal otolaryngologic evaluation within the past year with no evidence of otitis media or externa, a tinnitus handicap inventory (thi) of \> 16. * subjects must have tinnitus loudness rating of \>4/10. exclusion criteria: * subjects who are being treated for tinnitus \< 6 months due to the acute nature of their condition * subjects who have a slight handicap according to the tinnitus handicap inventory severity scale. * those with tinnitus of a muscular or vascular etiology * subjects with conductive hearing loss, history of migraine, or prior use of oxytocin nasal spray. * women of childbearing age will not be approached for participation due to the risk of oxytocin-induced uterine contractions. * subjects who suffer from migraines. * subjects who have history of pulmonary edema, congestive heart failure, and severe renal disease.
the colon study: colorectal cancer cohort

Conditions: Colorectal Neoplasms Malignant

Summary: the main aim of this observational, prospective cohort study is to assess associations of diet and other lifestyle factors with colorectal cancer recurrence, survival and quality of life.

the colon study is a multi-centre prospective cohort study among incident colorectal cancer patients recruited from 12 hospitals in the netherlands. patients with colorectal cancer are invited upon diagnosis. upon recruitment, after 6 months, 2 years and 5 years, patients fill out food-frequency questionnaires; questionnaires about dietary supplement use, physical activity, weight, height, and quality of life; and donate blood samples. diagnostic ct-scans are collected to assess cross-sectional areas of skeletal muscle, subcutaneous fat, visceral fat and intermuscular fat, and to assess muscle attenuation. blood samples are biobanked to facilitate future analyse of biomarkers, nutrients, dna etc. analysis of serum 25-hydroxy vitamin d levels, b-vitamins and metabolomic profiles are scheduled. a subgroup of patients with colon cancer is asked to provide faecal samples before and at several time points after colon resection to study changes in gut microbiota during treatment. for all patients, information on vital status is retrieved by linkage with national registries. information on clinical characteristics, including treatment-related toxicity and co-morbidity data, is gathered from linkage with the netherlands cancer registry and with hospital databases or medical records. hazard ratios will be calculated for dietary and lifestyle factors at diagnosis in relation to recurrence and survival. repeated measures analyses will be performed to assess changes over time in dietary and other factors in relation to recurrence and survival. the aim is to recruit at least 2000 patients with available data and blood samples.

Eligibility criteria:
inclusion criteria: - patients newly diagnosed with colorectal cancer in one of the participating hospitals exclusion criteria: * non-dutch speaking * a history of colorectal cancer or (partial) bowel resection * chronic inflammatory bowel disease * hereditary colorectal cancer syndromes (lynch syndrome, fap, peutz-jegher) * dementia or another mental condition that makes it impossible to fill out questionnaires

Keywords: colon colorectal cancer nutrition lifestyle survival recurrence quality of life
respiferon project

Conditions: Respiratory Viral Infection

Summary: respiratory viral infections (rvis) represent a major public health problem and a great burden in terms of morbidity and mortality in children and adults worldwide. to ascertain the source of an infection, microbiology laboratories routinely perform a crucial step: the search for the pathogen through polymerase chain reaction (pcr). due to the extensive variety of pathogens, testing for the existence of all potential viruses, bacteria, or fungi accountable for the infection is an impractical and time-intensive endeavor. furthermore, the rise of novel pathogens, exemplified by those accountable for the recent sars-cov-2 pandemic, underscores the urgency of promptly developing new innovative diagnostic tests. to address these needs, researchers have dedicated several years to developing indirect methodologies notably centered around utilizing markers derived from the host's immune system. among these, one particularly promising approach focuses on measuring the expression of interferon-stimulated genes, which are uniquely triggered by viral infections, thereby facilitating viral diagnosis. this methodology's efficacy has been proven in the context of sars-cov-2 infections. this study's objective is to assess the functionality of such a tool across a spectrum of respiratory viral infections (rvis) prevalent within a french population during the winter season.


Eligibility criteria:
inclusion criteria: * positive nasopharyngeal samples for the detection of a virus, for which the replicative character has been established by the viral culture technique (500µl minimum required) * samples kept at the crb since 2018 * information to patients carried out and non-objection collected- exclusion criteria: * n/a

Keywords: respiratory viruses nasal ifn-1 score nasopharyngeal swab replicative virus infectiousness
remote breast cancer screening study

Conditions: Breast Cancer; Mass Screening; Cancer Screening; Ultrasound Imaging; AI (Artificial Intelligence)

Summary: a multi-center, prospective, cohort study to evaluate the efficiency of breast cancer screening based on automated breast ultrasound (ab us) with remote reading mode.

the burden of breast cancer incidence and mortality is rapidly growing during the past two decades in china. screening has been proven to be effective in detecting early-stage disease and reducing mortality of 10% to 39% due to breast cancer. us is used as a primary screening method among chinese women because asian women characteristically have higher-density breasts than other ethnic groups. however, us is dependent on operator experience, lack of standardized scanning protocols, limited ultrasound physician and heavy workloads. in order to improve the efficiency and quality of breast cancer screening among chinese women, a new remote screening pattern based on ab us was proposed and studied for breast cancer in china. this multi-center, prospective, cohort study aims to evaluate the efficiency of breast cancer screening based on ab us with remote reading mode. in addition, we will also explore the practice value of ai on ab us screening and efficient image acquiring and reading modes of ab us.

Eligibility criteria:
inclusion criteria: 1. any age at 35 and over 2. screening breast cancer with ab us 3. obtaining written informed consent exclusion criteria: 1. symptoms of breast cancer 2. surgical of breast within 12 months prior to the study 3. known diagnosis breast cancer 4. poor image quality 5. follow-up was less than 12 months

Keywords: remote breast cancer screening ab us ai scanning and reading patterns
drug safety and the occurrence of complications during hospitalization in patients with covid-19

Conditions: COVID; Hypertension; Cardiovascular Diseases; Cardiovascular Risk Factor

Summary: hospitalized patients with covid-19 will be included in the study in centers around poland. after the hospitalization, a short questionnaire will be completed, including pre-hospitalization diagnoses, pre-hospitalization medications, clinical status on admission, the course, complication and the duration of hospitalization. the questionnaire will be available in paper form and on-line.

sars-cov-2 infection is characterized by a varied clinical course, from asymptomatic to severe respiratory failure in the course of pneumonia, which can be fatal. there are reports in the literature regarding the relationship between the course of an acute respiratory disease syndrome caused by sars-cov-2 virus infection (coronavirus 2019, covid-19) and the history of cardiovascular diseases (cvd), including hypertension. it is postulated that the shared element of the pathogenesis of cvd, hypertension and covid-19 is the renin-angiotensin system and one of its elements, the angiotensin converting enzyme 2 (ace2). it has been postulated by some authors that in the course of hypertension and antihypertensive treatment with renin-angiotensin system inhibitors, there may be an upregulation of ace2, which in turn may be related to a higher risk of more severe course of covid-19. on the other hand there is also data the renin-angiotensin system inhibitors by increasing ace2 concentration may be protective in the course of severe pneumonia. the study undertaken by the national institute of cardiology aims to assess the safety of the cardiovascular drugs in relation to the occurrence of complications during hospitalization in patients with cvd and covid-19 infection. the study is being conducted by polish-german collaboration and was initiated by prof reinhold kreutz from institute of clinical pharmacology and toxicology, charite, berlin, germany and team from national institute of cardiology lead by prof. andrzej januszewicz and prof. tomasz hryniewiecki, director of the national institute of cardiology. hospitalized patients with covid-19 will be included in the study in centers around poland. after the hospitalization, a short questionnaire will be completed, including pre-hospitalization diagnoses, pre-hospitalization medications, clinical status on admission, the course, complication and the duration of hospitalization. the questionnaire will be available in paper form and on-line. it will also be planned to include control groups from the official databases: 1) patients with sars-cov-2 infection not requiring hospitalization, and 2) structure-matched and co-existing disease matched control group from the general population.

Eligibility criteria:
inclusion criteria: * hospitalized patients with covid-19 exclusion criteria: * none

Keywords: angiotensin converting enzyme inhibitors angiotensin 2 receptor blockers renin angiotensin system covid-19 hypertension