Kornimate/medical-research-clean huggingface dataset:
ertapenem study in pediatric patients who have urinary tract infections, skin infections or community-acquired pneumonia (0826-036)

Conditions: Urinary Tract Infections; Bacterial Pneumonia; Soft Tissue Infections

Summary: this study will investigate the safety and efficacy of ertapenem versus ceftriaxone in pediatric patients with urinary tract infections, skin infections, or community-acquired pneumonia.


Eligibility criteria:
inclusion criteria: * patients with uti must have white blood cells and bacteria in the urine with bladder catheterization or urologic abnormality, kidney infection or both * patients with ssti must have a recent infection * patients with cap must have a chest x-ray indicating bacterial pneumonia and a fever exclusion criteria: * patients with complete urinary tract blockage or kidney abscess * patients with infected burn wounds, bone infection, or bacterial arthritis * patients on mechanical ventilation or those with cystic fibrosis, chronic lung disease or puss in the space between the chest wall and lung
budesonide capsules vs. mesalazine granules vs. placebo in collagenous colitis

Conditions: Collagenous Colitis

Summary: the purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.

this study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis. efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials. this trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis, which is chronic or recurrent non-bloody, watery diarrhea.

Eligibility criteria:
inclusion criteria (main): * \> 4 watery/soft stools on at least 4 days in the week prior to baseline * \> 3 stools per day on average within the last 7 days prior to baseline * symptoms (chronic watery diarrhea) for at least 3 months before baseline * complete colonoscopy within the last 12 weeks before baseline * histologically confirmed diagnosis of collagenous colitis exclusion criteria: * evidence of infectious diarrhea * celiac disease * endoscopic-histologic findings, which may have caused diarrhea * history of partial colonic resection * diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract * active colorectal cancer or a history of colorectal cancer * severe co-morbidity substantially reducing life expectancy * abnormal hepatic function or liver cirrhosis (alt, ast or ap \>= 2 x uln) * abnormal renal function (cystatin c \> uln) * active peptic ulcer disease, local intestinal infection * asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured * hemorrhagic diathesis
non interventional post marketing programme in neuroendocrine tumours

Conditions: Neuroendocrine Tumors

Summary: the purpose of this study, is to assess the safety and local tolerability of the long-term use of somatuline autogel when administered by patients or their partners ("home injection group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (hcp) ("reference group").


Eligibility criteria:
inclusion criteria: * the patient must give written (personally signed and dated) informed consent for their data to be included in the database for this post marketing surveillance programme and any subsequent analysis. * the patient must have been receiving treatment with somatuline autogel at a stable dose for at least 4 months. * the patient must have a diagnosis of neuroendocrine tumours * the patient must be at least 18 years of age * for patients receiving or intending to receive somatuline autogel by home injection: * the patient must be able to store somatuline autogel safely in a refrigerator in their own home and either collect it from their gp/pharmacy on a monthly basis, or receive the medication by a home delivery service. exclusion criteria: * the patient is pregnant or breast-feeding, unless continued treatment with somatuline autogel is clearly needed (as determined by the treating clinician).
myotonic dystrophy family registry

Conditions: Myotonic Dystrophy; Congenital Myotonic Dystrophy; Myotonic Dystrophy 1; Myotonic Dystrophy 2; Dystrophia Myotonica; Dystrophia Myotonica 1; Dystrophia Myotonica 2; Myotonia Dystrophica; Myotonic Dystrophy, Congenital; Myotonic Myopathy, Proximal; PROMM (Proximal Myotonic Myopathy); Proximal Myotonic Myopathy; Steinert Disease; Steinert Myotonic Dystrophy; Steinert's Disease; Myotonia Atrophica

Summary: the myotonic dystrophy family registry (mdfr) is an online, patient-entered database that collects information on myotonic dystrophy (dm) to aid researchers in developing new, effective treatments and help identify participants for research studies and clinical trials.

the myotonic dystrophy family registry (mdfr) is an online, patient-entered database that collects information on myotonic dystrophy (dm) such as disease symptoms and demographic information to aid researchers in developing new, effective treatments and help identify participants for research studies and clinical trials. the registry supports trials and studies, making it easier for researchers to explore data and identify possible trial and study participants. it is the first dm registry that gives community members the opportunity to explore anonymous registry data, to see what the dm community looks like and what others with dm experience. it also provides information on the community of people living with dm, giving researchers and other medical professionals the opportunity to improve how they treat those affected with dm and learn more about how and why certain treatments work and don't work.

Eligibility criteria:
inclusion criteria: * diagnosed with congenital, juvenile-onset or adult onset dm1 or dm2 (confirmed by clinical exam or genetic test) exclusion criteria: * not diagnosed with dm, unaffected family members
aspergillosis and humoral alveolar immunity by proteomics

Conditions: Aspergillus Fumigatus Infection

Summary: aspergillus fumigatus is the most common opportunistic mold found in lung fungal infections in humans. aspergillus is the cause of invasive pulmonary aspergillosis with a poor prognosis in immunocompromised patients and the chronic pulmonary aspergillosis which affects 3 million patients worldwide, with underlying pulmonary pathologies such as tuberculosis and its sequelae. the medicinal means to fight against these different forms are limited and not very effective. in addition, the emergence of resistance makes the search for new therapeutic strategies of major importance. the interaction between the fungal spore and our innate immune system is the first step leading to infection. the innate immune system is made up of cellular immunity and humoral immunity. while the first is well described, the second, consisting of soluble mediators, is essential for anti-aspergillus immunity but relatively little studied. the study of soluble mediators present in the alveolar fluid interacting directly with the aspergillus spore would make it possible to analyze the first stages of infection. the analysis of the proteome present in the bronchoalveolar lavage of uninfected patients, suffering from various forms of aspergillosis and suffering from other types of infections would make it possible to highlight the essential and specific components of anti- immunity aspergillary. the objective of this study is to analyze the protein profiles of innate immunity in the pulmonary alveoli in the absence or presence of aspergillus or non-fungal infection in order to highlight the soluble mediators of the more specific immunity of the aspergillosis.


Eligibility criteria:
inclusion criteria for the case group (ipa / cpa): : 1. patient who are more than 18 years old 2. patients for whom bronchial endoscopy with bal is performed as part of an exploration of ipa or cpa in current care. probable or proven invasive pulmonary aspergillosis according to the criteria of the eortc (2019). 3. patient who has given his consent. inclusion criteria in the control group : 1. patient who are more than 18 years old 2. patients for whom bronchial endoscopy with bal is performed as part of an exploration of diffuse interstitial lung disease or a lower respiratory infection other than aspergillus in routine care. chronic pulmonary aspergillosis according to the criteria of escmid / ers (2016) 3. patient who has given his consent. exclusion criteria for the case and the control group: 1. pregnant woman 2. patient deprived of their rights 3. patient under tutorship or guardianship or under the protection of a conservator
study on ventilation distribution with electrical impedance tomography for paediatric respiratory failure

Conditions: Acute Respiratory Failure

Summary: electrical impedance tomography (eit) is a non-invasive, bedside monitoring technique that provides continuous, real-time information about the regional distribution of the ventilation. there are very few data in children admitted to the picu (pediatric intensive care unit) and the aim of the study is to describe the distribution of the ventilation in children with acute respiratory failure and to study the impact of the interventions in the picu (change in ventilatory settings, change in position, suction, respiratory kinesiotherapy,...)

children with acute respiratory failure admitted to the picu (pediatric intensive care unit)

Eligibility criteria:
inclusion criteria: groupe a * children \< 18 years * admitted to the picu with acute respiratory failure * monitoring with eit * non opposition of parents or legal representative groupe b * children \< 18 years * with general anesthesia and mechanical ventilation * monitoring with eit * non opposition of parents or legal representative exclusion criteria: * monitor not available * contra indication to the use of thoracic belt * intraoperative period with use of electrocautery * child not affiliated to a social security system and under protective measures legal

Keywords: electrical impedance tomography children pediatric intensive care unit
effects of oral levosimendan on ambulatory electrocardiographic variables

Conditions: Transient Ischemic Attack; Stroke

Summary: the primary objective is to explore the safety of low doses of oral levosimendan in patients with recent history of an ischaemic cerebrovascular event (stroke or tia). the main focus will be on the evaluation of proarrhythmic potential of the different dose regimens.

this is a prospective, multicentre, phase ii, randomized, double-blind, placebo-controlled 2-arm parallel group study with 5 escalating dose-levels of oral levosimendan, each given for 13-18 days. the study population will be randomly allocated either to the levosimendan group or to the placebo group. the double-blind phase with either placebo or levosimendan is preceded by a 13-day long single-blind treatment with placebo (placebo run-in). the study consists of 9 visits (screening visit, 7 visits during the treatment period and an end-of-study visit). each subject will be on study treatment (including placebo run-in) for 78-108 days and the duration of the study for each subject, including the screening and the end of study visit, is approximately 17 weeks.

Eligibility criteria:
inclusion criteria: * male and female patients 50 to 80 years of age with ischaemic stroke or tia within 1 to 9 months before the screening visit. exclusion criteria: * stroke or tia due to cardiac embolism, vasculitis or arterial dissection * severe hemiparesis or dysphasia, haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy, any acute coronary event or angioplasty or any other major surgery within 1 month, any major surgery during the planned study period * history of life-threatening ventricular arrhythmia within 3 months. * history of torsades de pointes (tdp) or family history of long qt-syndrome * heart rate (hr) \ 100 bpm. * systolic blood pressure (sbp) \ 180 mmhg, or diastolic blood pressure (dbp) \> 100 mmhg. * ventricular tachycardia. * episode of atrial fibrillation or atrial flutter lasting \> 60 seconds. * second or third degree atrioventricular (av) block. * potassium (k) \ 5.5 mmol/l. * creatinine \> 170 µmol/l or on dialysis. * blood haemoglobin \<10 g/dl; clinically significant hepatic impairment.

Keywords: an ischaemic cerebrovascular event (stroke or tia)
the effect of dexmedetomidine on prevention of postoperative acute kidney injury in patients undergoing aortic surgery

Conditions: Acute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)

Summary: acute kidney injury(aki) is a common and severe complication after the cardiac surgery. postoperative aki increases the in-hospital stay, intensive care unit(icu) stay and postoperative mortality. aortic surgery is the most risky surgery that causes the postoperative aki, and the incidence of aki after aortic surgery is about 50%. the α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory effects, respectively. agents that attenuate renal vasoconstriction may have potential as renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology of aki. clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and cause a diuresis, and it has been evaluated in an experimental aki model, confirming its potential as a renoprotective agent. furthermore, it has been already reported that dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac operation. the aim of this study is to examine the association between preoperative dexmedetomidine infusion and the incidence of postoperative acute kidney injury(aki) in patients undergoing aortic surgery.


Eligibility criteria:
inclusion criteria: 1. the patients undergoing ascending, arch and/or proximal descending aorta surgery with cardiopulmonary bypass 2. 20 - 100 yrs old exclusion criteria: 1. having preoperative severe renal dysfunction (egfr \< 15 ml/min per 1.73m2) 2. left ventricular-ejection fraction \< 30% 3. preexisting congestive heart failure 4. severe coronary artery disease 5. hemodynamically unstable arrhythmia 6. cardiogenic shock during perioperative period 7. ventricular assist device use 8. cannot communication because of a language barrier or illiteracy
a study of peginterferon alfa-2a (40kd) (pegasys®) in participants with hepatitis b envelope antigen (hbeag) - positive chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive baltic participants with hepatitis b envelope antigen (hbeag)-positive chronic hepatitis b virus (hbv). all participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. the anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.


Eligibility criteria:
inclusion criteria: * adult participants, 18-70 years of age; * hbeag positive, hepatitis b surface antigen (hbsag) positive for greater than or equal to 6 months; * anti-hbs negative; * hepatitis b virus deoxyribonucleic acid (hbv dna) greater than 5,00,000 copies/milliliters. exclusion criteria: * previous antiviral or interferon-based therapy for chronic hepatitis b; * evidence of decompensated liver disease; * chronic liver disease other than viral hepatitis; * co-infection with active hepatitis a, c or d virus; * co-infection with human immunodeficiency virus.
lfr-260 vs traditional phoropter in visual acuity testing

Conditions: Visual Acuity; Astigmatism; Anisometropia

Summary: the purpose of this study is to establish if lfr-260 (investigational device) is not inferior in effectiveness to a traditional phoropter (control device) when applied in visual acuity test in subjects undergoing a full routine eye examination. lfr-260 proposes to provide information of the visual capabilities of the patient. the test will be provided and supervised by a qualified eye care provider. the informed consent, screening, randomization (into the order of visual test device used), (visual) device testing (to include precision testing, remote and offsite testing) will all occur at a single visit.


Eligibility criteria:
inclusion criteria: 1. the participant or legal guardian is willing and able to understand, sign and date the ethics committee approved study specific informed consent form. 2. the participant is a male or female between the ages of 12 and 65 (inclusive). 3. the participant has no more than mild to moderate far-sightedness, near-sightedness, astigmatism or anisometropia. 4. the participant is free of ocular and systemic abnormalities that might affect visual functions. exclusion criteria: 1. the participant has diabetes mellitus (type 1 or 2). 2. the participant has an autoimmune condition. 3. the participant is pregnant (self-reported). 4. the participant has an active corneal or conjunctival infection. 5. the participant has an active corneal, conjunctival, or intraocular inflammation (i.e. - uveitis). 6. the participant has diabetic retinopathy. 7. the participant has glaucoma or ocular hypertension. 8. the participant has macular degeneration. 9. the participant has had a previous ocular surgery. 10. the participant has ocular and systemic diseases or abnormalities that might affect visual functions. 11. the participant has a history of amblyopia, strabismus, or any other binocular vision abnormality. 12. the participant has a history of amd (age macular degeneration). 13. the participant is a prisoner, a transient or has been treated for alcohol and/or drug abuse in an inpatient substance abuse program within 6 months prior to proposed study enrolment. 14. the participant will not be able to complete questionnaires. 15. the participant is currently in an investigational study for a similar purpose. 16. the participant, in the judgment of the investigator, may be inappropriate for the intended study procedures.

Keywords: ocular
antibiotics during intrauterine balloon tamponade placement

Conditions: Obstetric Complication; Postpartum Hemorrhage; Postpartum Endometritis

Summary: the goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (ibt) will result in reduction of the risk of endometritis. the investigators hypothesize that antibiotics given at the time of intrauterine balloon tamponade will reduce the likelihood of postpartum endometritis.

the investigators will perform a randomized, controlled trial of women who have had a postpartum hemorrhage and received an intrauterine balloon tamponade. patients who are candidates for study enrollment will be identified on labor \& delivery or in the maternal-fetal care unit. patients who give consent will be randomized by random number generator to receive either antibiotics (group a) or no antibiotics (group b). if the patient is randomized to group a, she will receive a 24-hour course of antibiotics. the primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. if the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead. if the patient is randomized to group b, she will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.

Eligibility criteria:
inclusion criteria: * female * able to give consent * gestational age \> 24 weeks * postpartum * placement of an ibt within the last 2 hours with plans for it to remain in situ for at least 2 hours * primary obstetrician amenable to proceeding with either method of management during the study period. exclusion criteria: * age \< 18 years old * ibt removed within 2 hours of placement * chorioamnionitis * insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes

Keywords: bakri intrauterine balloon tamponade antibiotics
the investigation of the mechanism of cachexia occurrence for patients with gastrointestinal cancer

Conditions: Cachexia

Summary: the study is going to recruit patients with gastrointestinal cancer, collect clinical data and peripheral blood sample and possible fat samples. the expression of sirt-6 in peripheral blood will be tested and connect with different status of cachexia of the patients. a mathematical model of the relationship between cachexia classification and sirt-6 expression is going to constructed as anticipated.

at the start of cancer develop, not all patients with gastrointestinal cancer manifest cachexia, it may be associated with sirt-6 expression. this study will collect and test the peripheral blood sample of patients, use it as an important indicator of the degree of cachexia, and provide references for clinical drug intervention, prognosis and dietary intervention for cachexia patients. if possible, fat sample of the patients will be collected during surgery, and the adipose progenitor cells will be cultured to find the key target proteins by detecting differences in protein expression, changes in protein modification levels, and protein interactions.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 90 years old, unlimited gender; 2. patients who are diagnosed with gastrointestinal cancer for the first time and are planning to undergo further treatment; 3. volunteer to participate and sign the informed consent form. exclusion criteria: 1. women who are pregnant or lactate; 2. patients with severe metabolic diseases; combined with cardiac function, liver and kidney dysfunction, acute myocardial infarction and acute stroke in the past 3 months , copd acute onset respiratory failure and other serious medical diseases and patients who need hormone therapy