Kornimate/medical-research-clean huggingface dataset:
hematoma block as an adjunct to procedural sedation for forearm fracture reduction

Conditions: Forearm Fracture

Summary: the purpose of our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the emergency department. to determine this, we have designed a randomized, double-blind, placebo controlled trial of hematoma block versus saline for the manipulation of forearm fractures under conscious sedation with ketamine and midazolam. our hypotheses are two-fold: first, the use of a hematoma block together with conscious sedation will allow for improved pain control. second, the use of a hematoma block together with conscious sedation will allow us to use less sedation, therefore promoting faster recovery from sedation and more efficient patient turnover in the emergency department.


Eligibility criteria:
inclusion criteria: * english or spanish speaking * ages 3-17 * closed distal forearm fracture requiring reduction under sedation in the emergency department * fracture involves the distal third of the forearm exclusion criteria: * multiple trauma victims * associated nerve or vascular damage * associated elbow or humerus injury * sensitivity or allergy to lidocaine * contraindications to procedural sedation * previous attempts at reduction for the same injury

Keywords: hematoma block lidocaine forearm fracture radius fracture ulna fracture ketamine midazolam procedural sedation
treatment of acute periprosthetic total hip arthroplasty infections

Conditions: Periprosthetic Infection Total Hip Arthoplasty

Summary: the purpose of this study is to determine the success rate of two treatments for infection after total hip replacement: single stage arthroplasty exchange (your surgeon will take out your original implants and replace them with a complete new set) compared to irrigation and debridement with modular exchange (your surgeon will clean your implants with a surgical solution and take out the plastic liner and replace it with a new one - the rest of your hip implants will stay in place). the goal is to see if one is better than the other for the treatment of hip infection after a total hip replacement. a successful treatment means that you did not have to have another surgery on your hip for an infection-related reason.


Eligibility criteria:
inclusion criteria: 1. return to the or for a drainage procedure within six weeks of index primary uncemented arthroplasty 1a) exam findings within six weeks of index operation: * drainage for more than 7 days * wound appearance consistent with deep infection or hematoma * persistent fever or evidence of bacteremia * all patients currently deemed appropriate for irrigation and debridement 2. labs - rising inflammatory seromarkers 3. aspiration with a positive culture exclusion criteria: 1. previous history of periprosthetic infection 2. prisoners 3. patients not willing to consent for the proposed treatment 4. patients with altered mental status 5. concurrent metastatic infection 6. superficial infection
survey in a population of sickle cell disease patients to evaluate the transition between the queen fabiola children hospital and the chu brugmann hospital, and the quality of the hospital care within the chu brugmann hospital.

Conditions: Sickle Cell Disease

Summary: sickle cell disease is a genetic disease responsible for an abnormal hemoglobin.the anomaly has several consequences: a low hemoglobin rate (chronic anemia), plugs formed by red blood cells in blood vessels (extremely painful vaso-occlusive crises) and greater susceptibility to infections. patients with this disease should be monitored medically continuously from birth. at adulthood, they will pass from a pediatric medical care system to an adult medical care system.this transition can be experienced with more or less ease, depending on the organization within the pediatric and adult hospitals. this questionnaire aims to assess the quality of the transition between pediatric and adult services.the investigators want to better estimate hospital work and improve the quality of care for this type of patients, throughout their entire medical history.

sickle cell disease is a genetic disease responsible for an abnormal hemoglobin. it particularly affects populations with an african ascent (300 000 african children are born every year with this genetic anomaly). the anomaly has several consequences: a low hemoglobin rate (chronic anemia), plugs formed by red blood cells in blood vessels (extremely painful vaso-occlusive crises) and greater susceptibility to infections. the severity of sickle cell disease is variable among children. some develop frequent and serious complications, while others don't. a child with sickle cell disease is hospitalized about a week a year in average (for a painful crisis, infection or worsening of anemia). patients with this disease should be monitored medically continuously from birth. at adulthood, they will pass from a pediatric medical care system to an adult medical care system.this transition can be experienced with more or less ease, depending on the organization within the pediatric and adult hospitals. this questionnaire aims to assess the quality of the transition between pediatric and adult services.the investigators want to better estimate hospital work and improve the quality of care for this type of patients throughout their entire medical history.

Eligibility criteria:
inclusion criteria: * sickle cell disease patients, beeing admitted in the chu brugmann hospital (horta site) after having been followed in the queen fabiola children hospital. exclusion criteria: * none

Keywords: pediatric hospital care adult hospital care sickle cell disease
trichomonas vaginalis repeat infections among hiv negative women

Conditions: Vaginitis Trichomonal or Due to Trichomonas

Summary: the overall goal of this project is to determine the influence of patient treatment and host factors on repeat trichomonas vaginalis (tv) infections among hiv-negative women

this study is a phase iii randomized clinical trial. hiv-negative women who test positive for tv at their routine gynecological exam at participating clinics will be referred to the nurse/study coordinator to screen for eligibility, provide a description of the study, and obtain written, informed consent (n=700). subjects will undergo an audio computer assisted self- interview (acasi), and will self-collect vaginal swabs for trichomonas testing by inpouch and nucleic acid amplification test (naat), gram stain testing, and a future microbiome specimen. they will be randomized into one of two arms; metronidazole (mtz) 2 g single dose (cdc recommended treatment regimen) or mtz 500 mg twice daily x 7-day dose (cdc alternative treatment regimen). all enrolled women will be scheduled for a follow-up visit at four weeks post treatment completion (window 3-13 weeks).

Eligibility criteria:
inclusion criteria: * female * english speaking * \>= 18 years old exclusion criteria: * hiv-infected * unable to provide informed consent * pregnant * breast feeding * treated by their provider for bacterial vaginosis (bv) at visit

Keywords: trichomonas vaginalis metronidazole
temporal changes of lactate in classic patients

Conditions: Septic Shock

Summary: this study aim to examine if randomization to different treatment strategies had any effect on the time to normalization of lactate in intensive care patients treated for septic shock.

this is a retrospective analysis of a subset of patients included in the conservative versus liberal approach to fluid therapy of septic shock in intensive care (classic) trial. in the classic trial patients with septic shock were randomized to either traditional (liberal) strategy for fluid treatment or a more conservative regimen. the study was an international multicenter clinical trial (clinicaltrials.gov nct03668236), and results were published in new england journal of medicine in june 2022 (doi: 10.1056/nejmoa2202707). in this substudy the investigator extract all lactate values for the study period from all patients included from karolinska university hospital, sundsvall and södersjukhuset (sweden), participating centers on zealand (denmark), and plzen university hospital (czech republic). baseline data, treatment allocation and amount of fluids administered are collected as well as outcome from classic study. primary outcome is time to lactate normalization (\< 2mmol/l). secondary outcome is lactate concentration over the first 72 hours (as peak lactate for the time intervals 0-3, 3-6, 6-12, 12-24 and then each 12h-period between 24 and 72 hours). the subgroup with blood lactate \> 4mmol/l will be analyzed separately for the same end points. time to resolution of hyperlactatemia will be modelled with a competing risks regression. death and discharge will be competing outcomes, and administrative censoring imposed 72 hours after randomisation. factors associated with time to lactate normalization will be examined through regression analysis. factors that show a relationship on univariate analysis will be included in a multivariate analysis.

Eligibility criteria:
inclusion criteria: * participation in classic trial in any of the participating centres exclusion criteria: * lack of sufficient data for analysis
the effects of puberty and weight on sugar metabolism in children

Conditions: Overweight; Leanness; Adolescent

Summary: our goal is to investigate how hormones that control blood sugar, hunger, and stomach emptying change with puberty and being overweight. these substances change with a meal. * for this, we need to compare lean and overweight children. * we need to study them before and during puberty. * all children in the study will be tested before and after a liquid meal.


Eligibility criteria:
inclusion criteria: all groups: healthy lean and otherwise healthy overweight children and adolescents between the ages of 8 and 17. exclusion criteria: same for all groups the subjects will be excluded if they have: * a history of chronic disease * allergy to acetaminophen * evidence or history of chemical abuse * abnormal lab values * pregnancy

Keywords: obese, lean, pubertal, prepubertal, glucose, adolescents, type 2 diabetes
eniluracil hand foot syndrome

Conditions: Breast Cancer; Colon Cancer

Summary: a pilot study of eniluracil containing ointment for prevention of hand foot syndrome (hrs) following capecitabine (xeloda).

primary objectives 1. to estimate the frequency of hfs following treatment with capecitabine as modulated by the unilateral local application of eniluracil containing ointment. 2. to assess any eniluracil dose response relationship in prevention of hfs. 3. to evaluate any potential toxicity of eniluracil ointment.

Eligibility criteria:
inclusion criteria: a subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. signed written informed consent. 2. male or female, at least 18 years of age. 3. histologically or cytologically confirmed diagnosis of breast or colon cancer. 4. radiologically documented measurable disease 5. planned to receive capecitabine at 1000-1250 mg/m2 po twice daily and has experienced grade 1 or greater hfs on a previous cycle of capecitabine. 6. eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 at study entry. 7. adequate liver function with sgot and sgpt \< 2.5 times upper limits of normal. 8. adequate bone marrow function evidence by wbc \> 2500/mm3, pmn \>2000/mm3 and platelet count \> 100,000/mm3. 9. adequate renal function with serum creatinine \< 1.7 mg/dl. 10. recovery from relevant toxicity before study entry. 11. negative serum or urine pregnancy test within 7 days before study entry for women of childbearing potential. effective contraception throughout the course of the study for both male and female subjects if the risk of conception exists. exclusion criteria: a subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. known dpd deficiency 2. any other investigational drug, chronic corticosteroids or radiation therapy within 28 days before study entry. 3. history of brain metastases or spinal cord compression, unless irradiated at least 28 days before study entry and stable without steroid treatment for \>28 days. 4. stroke, major surgery, or other major tissue injury within 30 days before study entry. 5. myocardial infarction within 12 months or uncontrolled congestive heart failure, angina, arrhythmias, or ecg abnormalities. 6. no concurrent or planned use of topical pharmaceuticals to the hands or feet other than aquaphor®. 7. no concurrent or planned use of cytotoxic drugs (other than capecitabine). 8. no other dermatologic condition that may complicate evaluation of the study. 9. other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic. 10. breast feeding or lactating. 11. unable to return at the regular required intervals for reassessment or study drug administration. 12. legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian. 13. allergy to lanolin

Keywords: hfs patients with breast or colon cancer receiving capecitabine
an observational study of patients with chronic gastrointestinal disease

Conditions: Gastrointestinal Diseases

Summary: target-gastro is an observational research study to conduct a comprehensive review of outcomes for patients with the chronic gastrointestinal (gi) diseases: eosinophilic gastrointestinal disease (egid), ulcerative colitis (uc) or crohn's disease (cd).


Eligibility criteria:
disease cohort inclusion criteria: * adult\* patients at the time of enrollment with a diagnosis or major symptom of egids, uc, or cd by icd-10 code in the ehr interface exclusion criteria: * death * manual removal (sponsor or site request) * no ehr interface encounter \> 3 years. engaged cohort inclusion criteria: * adult\* patients diagnosed and managed for these conditions invited to participate * ability to provide written informed consent exclusion criteria: * patient expressed desire to withdraw consent to complete pros * failure to complete pros within 24 weeks of initial invitation * greater than 24 months lapse of survey completion after baseline surveys completed * additionally, the criteria detailed for disease cohort apply to the engaged cohort.
enhanced diagnostics for early detection of atrial fibrillation - prospective validation

Conditions: Atrium; Fibrillation; Arrhythmia Atrial

Summary: prospective, blinded, multicenter international trial to test the preventicus heartbeats app in a prospective cohort.

introduction this algorithm was validated earlier in a clinical trial with retrospective data. the results were published accordingly.the algorithm is implemented in the commercial app preventicus heartbeats. detect af is designed as prospective follow up trial. study design prospective, blinded, multicenter international trial. methods the subjects will be asked to position a smartphone on their index finger to allow their pulse curve to be recorded for five minutes. at the same time, an ecg will be recorded using an digital mobile ecg recorder as a reference. data will be collected on person-related information, comorbidities and medication (estimated overall duration/patient \<20 min). no follow-up is planned. analogous to predecessor studies, the pulse wave curve data are coded with the patient's identification number (id) and externally analyzed at preventicus; based on the results, the subjects will be assigned to sr/af groups. after evaluation of all files, the grouped results will be aggregated, unblinded and evaluated under monitoring. primary target parameters are the app's sensitivity and specificity in correctly detecting atrial fibrillation compared to an automatically interpreted ecg. secondary target parameters include the proportion of non-evaluable recordings in the overall study.

Eligibility criteria:
inclusion criteria: * subjects of legal age, * patients with either sinus rhythm (group sr) or atrial fibrillation (group af) * informed consent exclusion criteria: * legally incompetent persons

Keywords: atrial fibrillation rhythm monitoring cardiovascular app m-health
a long-term study to evaluate safety and efficacy of pregabalin for pain associated with diabetic peripheral neuropathy

Conditions: Diabetic Neuropathy, Painful

Summary: the purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in study a0081163


Eligibility criteria:
inclusion criteria: * patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in study a0081163. * patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study exclusion criteria: * patients who experienced serious adverse events in the preceding study (a0081163) that were determined by the investigator or the study sponsor to be causally related to the study medication. * patients exhibiting treatment non-compliance in the preceding study (a0081163)
a long-term follow-up study of patients with ard103 car-t cell therapies

Conditions: Acute Myeloid Leukemia, in Relapse; Acute Myeloid Leukemia, in Relapsed or Refractory; MDS (Myelodysplastic Syndrome)

Summary: this study will evaluate the long-term safety of ard103 cellular therapies

participants who receive administration of ard103 (i.e., a partial dose or a full dose) will roll into the ltfu study upon completion of the 24-month interventional study period (study: ard103_arce-cl-p-001), or after early discontinuation from the interventional study protocol. the ltfu study is a study intended to characterize long-term safety for 15 years post-ard103 administration. participants who complete the full 24-month interventional study period will undergo an additional 13 years of monitoring under the ltfu study. no ip will be administered during the ltfu study. the number and percentage of participants with ard103 car-t cell therapy related aes, saes, and aesis will be recorded throughout the ltfu period.

Eligibility criteria:
inclusion criteria: * the participant has r/r aml or mds and has previously received ard103 car-t cell therapies in the parent study. * the participant is able to understand and comply with protocol-required study procedures and has provided a written informed consent document. exclusion criteria: * there are no specific exclusion criteria for this study
effect of using two different construction techniques of nasoalveolar molding devices in unilateral cleft lip and palate patients

Conditions: Unilateral Cleft Lip and Palate

Summary: this study includes three dimensional evaluation of maxillary arch changes after using two different construction techniques of nasoalveolar molding devices in unilateral cleft lip and palate patients (randomized controlled trial) null hypothesis: there is no difference between using conventionally constructed nasoalveolar molding device and using digitally constructed nasoalveolar molding device


Eligibility criteria:
inclusion criteria: good general health without any systematic disease, disability or other syndromes non syndromatic unilateral cleft lip and palate both genders age less than one month parents willing to participate in the study and sign informed consent exclusion criteria: * patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent
effectiveness of group gds and individual gds for treatment of low back pain in primary care

Conditions: Subacute Nonspecific Low Back Pain; Chronic Nonspecific Low Back Pain

Summary: a cluster, randomized, controlled clinical trial, where the hypothesis is that group gds and individual gds are effective in the treatment of nonspecific low back pain. the clusters will be the participating physiotherapy departments in primary care who treat patients with low back pain. in each physiotherapy department there will be 3 groups: education group, group gds and individual gds. patients will be followed for 12 months. variables will be: demographic,intensity of pain, disability, quality of life, patient satisfaction, medication intake for current episode, non-pharmacologic treatment for current episode, co-morbidity, diagnostic tests, sick leave, and habitual physical activity. the questionnaires to be used are: roland morris disability questionnaire, pi-nrs, vas, sf-12 and eq-5d.


Eligibility criteria:
inclusion criteria: * diagnosed with nonspecific low back pain by the primary care physician * more than or equal to 18 and less than or equal to 65 years of age exclusion criteria: * not signing the informed consent form * pregnancy * diagnosis of inflammatory rheumatologic disease, cancer, or fibromyalgia * signs for suspicion of fibromyalgia * having red flags for systemic disease * presenting criteria for urgent referral to surgery * presenting criteria for non-urgent referral to surgery * inability to read, understand, or follow verbal orders (dementia,blindness, doesn´t know how to read) * bedridden * having received physiotherapy in last 12 months

Keywords: low back pain physiotherapy exercise active management